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New York Sues Merck over Vioxx Fraud

2008-02-15T14:05:00.000-08:00

by David Gutierrez (NaturalNews)

The city and state of New York have filed a joint lawsuit against Merck & Company for deliberately concealing the dangers of its painkiller Vioxx, thereby defrauding public health programs out of millions of dollars in prescription costs.

"Merck's irresponsible and duplicitous conduct endangered the health of New Yorkers and wasted our tax dollars," said New York Attorney General Andrew M. Cuomo. "Even as evidence was piling up showing just how dangerous this drug was, Merck put profits above all else."

The New York Supreme Court will decide whether Merck defrauded New York's Medicaid and Elderly Pharmaceutical Insurance programs. The plaintiffs say that if doctors had known the risks posed by Vioxx, they never would have prescribed the drug, and state agencies would never have paid out $100 million to Merck for the product. They are asking the court to force Merck to pay back all of that money.

New York is the seventh state to file such a lawsuit against the company, following Alaska, Louisiana, Mississippi, Montana, Utah and Texas. More than 25,000 lawsuits have been brought against the company to date for its alleged malfeasance in covering up the dangers of Vioxx.

From 1999 to 2004, Vioxx was widely prescribed as a painkiller for arthritis and migraines. When it was revealed that the drug significantly increased patients' risks of heart attacks and strokes, however, Vioxx was pulled from the market.

Lawyers for the company promised that they were "vigorously defending" the case, and denied any wrongdoing on the part of their clients. "We are confident that our behavior has been responsible," said Kent Jarrell, a spokesperson for Merck's lawyers.

The city of New York also has a lawsuit pending in federal court against 44 pharmaceutical companies including Merck. In that lawsuit, the city has alleged that the companies artificially inflated the prices of their products, thereby defrauding the city's Medicaid program."

The pharmaceutical industry routinely engages in fraudulent business practices," said consumer health advocate Mike Adams. "With Big Pharma, fraud is not the exception; it's the way business is routinely conducted. And yet, despite the outrageously illegal and unethical business practices pursued by these companies, it is worth noting that they manage to pay their way out of any criminal judgments and thereby maintain a clean legal record that allows them to continue doing business with state and federal governments," Adams said.

Merck will pay $671M to settle Medicaid overcharge cases

2008-02-14T12:23:00.000-08:00

From: Associated Press

Merck (MRK) has agreed to pay a combined total of $671 million to settle claims that it overcharged Medicaid programs for two big-selling drugs, Vioxx and Zocor, and to resolve allegations of improper marketing to doctors, U.S. prosecutors and company officials announced Thursday.

The settlement with Merck resolves allegations that the company paid improper inducements to doctors to prescribe the cholesterol drug Zocor and the painkiller Vioxx.

Drug companies are required to report to the government the lowest price for its product to ensure that Medicaid programs get the benefit of the same discount. Merck, however, was hiding the steep discounts it gave to hospitals by reporting higher prices to the government, prosecutors said.

From 1997 to 2001, Merck also gave money and perks to doctors and other health care professionals to entice them to prescribe Merck drugs, a practice the government called excessive.

In a case in Philadelphia, Merck agreed to pay $399 million plus interest for improper calculation of Medicaid rebates and its marketing practices. In a Louisiana case, it agreed to pay $250 million plus interest for its rebate practices.

Merck said the settlements do not constitute an admission of any liability or wrongdoing.
The Louisiana case involved pricing for the heartburn drug Pepcid when it was sold only with a prescription. The Philadelphia case, which involved a related Nevada action, involved pricing programs for the cholesterol drugs Zocor and Mevacor and the painkiller Vioxx, which was pulled from the market in September 2004.

"What we have here is a disagreement (over) the rules of the Medicaid rebate program," said Merck spokesman Ronald Rogers. "These civil settlements were the best and most appropriate way to resolve these lengthy investigations and bring these matters to closure." "At the time that these pricing programs were in place, Merck believes that it acted in good faith and complied with the regulations that were in place at the time," he said.

When Merck reported its fourth-quarter financial results Jan. 30, they included a $671 million charge for the anticipated resolution of federal and state civil probes into past sales and marketing practices.

"The company has been working with federal and state authorities and has been making progress toward definitive agreements" to resolve the matters, the earnings report said.

The only state not involved in the settlement is Arizona.

U.S. Attorney Patrick Meehan was joined at the news conference by officials with the Department Of Health and Human Services Office of the Inspector General and representatives of state Attorneys General in Delaware, Illinois, Massachusetts and Nevada.

Challenge filed to Merck's Vioxx Settlement

2008-02-14T12:21:00.000-08:00

From: Associated Press

Lawyers for hundreds of people who sued Merck over its withdrawn painkiller Vioxx are challenging a key provision of a proposed $4.85 billion settlement.

The lawyers are based in Illinois and Missouri and represent about 2,600 plaintiffs. They are asking a federal judge in New Orleans to rule that portions of the settlement can't be enforced in all states because it prevents lawyers from giving clients their "independent professional advice."One of the attorneys says the legal team's request is similar to ones made in St. Clair County, Illinois, where there are about 60 cases against Merck.The deal is expected to end an estimated 45,000 to 50,000 state and federal lawsuits. However, at least 85% of plaintiffs in several different categories must agree to the deal before it can be completed.

Court orders review of Vioxx class suit

2007-01-20T13:43:00.000-08:00

By Associated Press TRENTON, N.J. (AP) - A New Jersey appellate court panel on Tuesday opened the door to a potential class action lawsuit against Merck & Co. on behalf of people who took its now-withdrawn painkiller Vioxx and want the company to pay for tests to detect possible heart ailments.

The ruling by the Appellate Division of the Superior Court of New Jersey came as jury selection began in Atlantic City for the next product liability trial over Merck's one-time blockbuster arthritis pill.

That trial, before Superior Court Judge Carol Higbee, is slated to begin with opening arguments Monday. It includes two plaintiffs: the son of a man who died of a heart attack after taking Vioxx and a retrial for a man who survived a heart attack, lost his first trial against Merck and was granted a new trial because of new evidence.

The ruling by a three-judge panel overturned a lower court decision in a case that sought to include patients who have not suffered medical problems but took Vioxx for at least six consecutive weeks before Whitehouse Station-based Merck pulled the drug from the market. That move in 2004 came after Merck's own research showed Vioxx doubled the risk of heart attacks and strokes.

Tuesday's decision said the lower court dismissing the case "prematurely terminated plaintiffs' opportunity" to prove they have a legal claim.

Ted Mayer, a Merck lawyer, said in a statement that the appellate ruling only "instructs a lower court to reconsider the validity of plaintiffs' claims after more fact gathering is completed."

"There is no medical science supporting the plaintiffs' position that they need to be monitored for cardiovascular conditions two years after Vioxx was voluntarily taken off the market," Mayer stated.

He said Merck is considering asking the New Jersey Supreme Court to review the appellate ruling.

Merck faces more than 27,000 personal injury lawsuits over Vioxx, plus 265 potential class-action suits. At least 14,000 additional plaintiffs have entered agreements with Merck suspending the time limit for lawsuits.

In midday trading on the New York Stock Exchange, Merck shares were up 20 cents at $44.99.

Merck faces retrial, grieving sister in Vioxx trial

2007-01-20T13:42:00.000-08:00

(2007-01-19)
By Jon Hurdle

PHILADELPHIA (Reuters) - Merck & Co. faces a woman who blames its withdrawn pain drug Vioxx for her brother's death and the retrial of a case it had previously won in a product liability trial set to begin in Atlantic City, New Jersey on Monday.

As has been its strategy in prior Vioxx trials, Merck will argue that the plaintiffs had serious health problems that caused their heart attacks, not the medicine that it pulled from the market in 2004 after a study showed it doubled the risk of heart attack in those who took it for at least 18 months.

Company lawyers will ask the jury to focus on the plaintiffs' poor health and hope their evidence is strong enough to overcome sympathy for a grieving relative, who claims that Vioxx caused her brother's fatal heart attack at the age of 44.

Brian Hermans from Waupaca, Wisconsin died in 2002 after taking Vioxx for 19 months, according to the case brought by his sister, Kathleen Hermans Messerschmidt.

The other plaintiff in the consolidated trial is Frederick Humeston, an Idaho postal worker who blames Vioxx for his 2001 heart attack but lost to Merck in November of 2005. He was a short-term Vioxx user.

That case is being retried after New Jersey Superior Court Judge Carol Higbee threw out the jury verdict because she said Merck had excluded some heart attack data from a study that was presented as evidence during Humeston's first trial.

"Both of these men unfortunately had the medical problems that cause people to have heart attacks or sudden cardiac death, regardless of whether they have been taking Vioxx," Hope Freiwald, outside counsel for Merck, said in a statement.

"Plaintiffs will have a difficult time proving that it was Vioxx and not each man's long-standing medical problems that caused these heart events," she said.

Plaintiffs allege that Merck ignored signs that Vioxx was unsafe long before it pulled the drug and that it hid the risks to protect profits from the once $2.5 billion a year medicine.

Merck faces more than 27,000 Vioxx lawsuits. It has insisted it will fight each on a case by case basis rather than submit to a large-scale settlement deal.

In trials that have reached a jury verdict so far, Merck has won nine and lost four, including the Humeston win that was thrown out.

John Brenner, an expert in pharmaceutical mass torts with McCarter & English in Newark, New Jersey, said he expects Merck will prevail in the Humeston retrial, saying inclusion of the new heart-attack data should not alter the outcome because it is not statistically significant.

Hermans' sister is being represented by Mark Lanier, who in 2005 won a $253 million award for the widow of a Texas Vioxx user. Humeston is again being represented by Christopher Seeger.

Sask. judge strikes down claims against Vioxx

2007-01-20T13:39:00.000-08:00

Provided by: Canadian Press
Written by: JENNIFER GRAHAM
Jan. 19, 2007

REGINA (CP) - An attempt to certify a class-action lawsuit against makers of the drug Vioxx will push forward in Saskatchewan, but the Canadian government has been cleared of any wrongdoing.

Court of Queen's Bench has ruled that elements of the case against Merck Frosst Canada Ltd., and U.S.-based parent company Merck & Co. Inc., warrant further consideration.

However, the deciding judge stopped short of certifying the suit.

"The court has decided that there's validity in the action against Merck," Regina lawyer Tony Merchant said Friday.

"It's a huge success."

Merchant, who represents about 2,500 claimants, said issues concerning allegations of negligence, deceit, battery and breaches of consumer legislation will proceed.

The lawsuit alleges the pain killer Vioxx caused serious, even fatal, side effects including heart problems.

Merchant said the suit was not certified as a class action yet because the court wants a plan from the plaintiffs on how the case would be pursued.

"The judge has said that issues related to notification have to be sorted out, issues related to our plan for the trial have to be sorted out and we are to go back with more information," said Merchant.

But lawyer Maurice Laprairie, who represents Merck in Saskatchewan, said it's only a first ruling from Judge John Klebuc and "there's a long road to go."

"It was an interim decision only," said Laprairie.

"The causes of action that Merck did not seriously object to, (Klebuc) found those were causes of action that could be advanced. The ones that we objected to, and there are seven of them, were all struck."

Among them, Klebuc struck down allegations that Merck violated the Food and Drugs Act and committed mass deceit and assault.

"The mere allegation that some plaintiffs may have worried over whether they could suffer a heart attack or gastrointestinal complications . . . falls short of the requirements of the tort of assault," wrote Klebuc.

"More than mere fear of harm is required."

The judge also struck down claims of negligence against Health Canada and the Canadian government.

The suit had argued that Canadian officials should not have allowed Vioxx into the country in 1999 and did not act quickly enough when problems with the drug became apparent.

Vioxx was withdrawn from the market in 2004.

Despite the judge striking down several issues, Merchant still hailed the ruling as a success because an attempt to build a national class action in the U.S. failed.

"Everything that is important . . . the judge has said, 'yes there's a valid case and it can and may be pursued,' " said Merchant.

Merck argues that people who claim they suffered injury from taking Vioxx must pursue individual lawsuits.

In November, a Quebec Superior Court judge ruled that a class-action suit can go ahead in that province.

Merck ordered to take Vioxx release off Web

2007-01-20T13:36:00.000-08:00

BY DAVID VOREACOS
BLOOMBERG NEWS
Saturday, January 20, 2007

Merck & Co. was ordered by a New Jersey judge to remove from its Web site a press release about a trial next week over whether its Vioxx painkiller caused heart attacks in two men.

Superior Court Judge Carol Higbee told Merck to take down a release discussing both lawsuits, including one on the 2002 death of Brian Hermans, 44. The release blamed his heart attack on clogged arteries and other risks, saying he had methadone in his system when he died. Methadone, a synthetic narcotic and painkiller, is used to treat addiction to heroin and OxyContin.

"To suggest that this man used illegal drugs is an outrageous smear," Mark Lanier, a lawyer for Hermans's sister, said. "There are a group of people in this world who think that methadone isn't used for anything but overcoming heroin addiction. They don't know it's also used for pain relief."

Merck, the fourth-largest U.S. drugmaker, withdrew Vioxx in 2004 when a study showed it raised the risk of heart attacks.

The Whitehouse Station, New Jersey-based company, which faces 27,000 Vioxx suits, has won eight of 12 cases tried so far. A ninth victory, over plaintiff Frederick Humeston, was overturned. His suit will be retried with the Hermans case.

Merck attorney Ted Mayer said Higbee ordered the press release removed because she hadn't ruled yet on Lanier's motion to exclude evidence about methadone from the trial. He said the release wasn't a smear of Hermans and only sought to lay out facts of the case, as Merck has done before other trials.

Autopsy Facts

"These are facts from the autopsy in the case," said Mayer, of Hughes Hubbard & Reed. "The press release was simply a matter of making available basic facts in the case."

Lanier said there is no evidence that Hermans took illegal drugs, and a false-positive test may have indicated methadone was in his system. Higbee ruled that evidence about methadone won't be allowed "at this point," Lanier said.

The first phase of the trial will be on whether Merck failed to warn doctors about the risks of the drug and whether it violated New Jersey's Consumer Fraud Act in its marketing. If jurors rule against Merck, a second phase will examine whether Vioxx caused the heart attacks of Hermans and Humeston.

Hermans died after taking Vioxx for 19 months for knee pain. The autopsy showed that Hermans, a former Wisconsin state racquetball champ, suffered a heart attack and had an arrhythmia and a clot in his heart, Lanier said.

Enlarged Heart

Merck's release said he had an enlarged heart and diseased coronary arteries, as well as a family history of heart disease and early death. It said he died from arrhythmia and had methadone and fluoxetine in his system. Fluoxetine is another name for Prozac, an antidepressant.

Methadone is used by about 20 percent of the 810,000 heroin addicts in the U.S., according to the White House Office of National Drug Control Policy.

"The general perception in the public is that methadone is primarily used to treat heroin addicts," said Dr. Bertha Madras, deputy director for demand reduction at the office. It also is "a very effective painkiller," she said.

Shares of Merck fell 14 cents to $45.60 today in New York Stock Exchange composite trading. They have climbed 37 percent in the past year.

Vioxx Plaintiffs Failed to Prove Their Cases

2007-01-20T13:31:00.000-08:00

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Jan 19, 2007 - A state court judge in Los Angeles today declared two mistrials after a jury failed to return verdicts in cases filed by two plaintiffs who alleged VIOXX contributed to their heart attacks.

"Both plaintiffs failed to prove their case," said Thomas Yoo of Reed Smith, a member of the defense team in Appell v. Merck and Arrigale v. Merck. "The evidence showed Merck acted responsibly in providing information to the medical, scientific and regulatory communities. We are fully prepared to defend these cases if they are tried again."

"All of the VIOXX cases are individual claims involving very different circumstances so we need to consider the facts of each case on an individual basis," said Kenneth C. Frazier, executive vice president and general counsel of Merck. "Heart attacks are unfortunately common in the population and caused by many different risk factors."

In the two-plaintiff trial, Lawrence Appell of Scottsdale, Arizona, alleged he used VIOXX for 18 months before suffering a heart attack, at age 51, on December 23, 2000. He continued to use VIOXX until September 2004. The other plaintiff, Rudolph Arrigale of Westminster, California, alleged he took VIOXX for 4-1/2 months before his heart attack at age 72 on March 18, 2002.

In December 2005, a federal judge in New Orleans declared a mistrial in the first federal trial when that jury was unable to reach a verdict. The case was subsequently retried and a new jury found in favor of Merck.

Merck was represented by Steve Raber and Eva Esber of Williams & Connolly in Washington, D.C.; Ralph A. Campillo of Sedgwick, Detert, Moran & Arnold in Los Angeles, and Thomas Yoo of Reed Smith in Los Angeles.

California Superior Court Judge Victoria Chaney presided.

Status of Litigation

As of September 30, 2006, the claims related to more than 3,000 alleged VIOXX users have been dismissed before being scheduled for trial. Of those, more than 1,100 were dismissed with prejudice either by plaintiffs themselves or by judges, meaning they cannot be filed again. Another 2,000 were dismissed without prejudice.

Of the 28 plaintiffs whose claims have been scheduled for trial, including the two plaintiffs in this trial, the claims of six were dismissed, the claims of seven were withdrawn from the trial calendar by plaintiffs, juries have decided in Merck's favor nine times and in plaintiffs' favor four times, and there have been three mistrials (one of which has since been retried to a verdict). A state judge set aside one of the nine Merck verdicts.

As for the four plaintiffs' verdicts, Merck already has filed an appeal or sought judicial review in each of those cases, and in one of those four, a federal judge overturned the damage award shortly after trial.

For information regarding additional cases scheduled for trial in 2007 visit http://www.merck.com/newsroom/vioxx/.

About Merck

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck currently discovers, develops, manufactures and markets vaccines and medicines to address unmet medical needs. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service. For more information, visit www.merck.com.

Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential or financial performance. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Merck's business, particularly those mentioned in the cautionary statements in Item 1 of Merck's Form 10-K for the year ended Dec. 31, 2005, and in its periodic reports on Form 10-Q and Form 8-K, which the Company incorporates by reference.

Contact

Merck & Co.
Media:
Kent Jarrell, 202/230-1833
Investor:
Graeme Bell, 908/423-5185

Lessons from Vioxx Case: New Approach Needed to Restore Faith in Pharmaceutical Industry

2007-01-20T13:30:00.000-08:00

Source: British Medical Journal

Commentary: Lessons from Vioxx litigation, BMJ Volume 334, pp 120-3

Newswise — The pharmaceutical industry, academia and government agencies need to work together to restore faith in drug development, say doctors in this weeks’ BMJ.

They argue that the recent litigation over the drug Vioxx, produced by Merck and Co. Inc., has highlighted the failings of the current system, which can be open to abuse.

Vioxx (rofecoxib) was introduced in 1999 as an effective, safer alternative to non-steroidal anti-inflammatory drugs (NSAIDS) for the treatment of pain associated with osteoarthritis. It was subsequently found that the drug increased the risk of cardiovascular disease (CV) and withdrawn from the worldwide market. Merck now faces legal claims from nearly 30,000 people taking Vioxx who experienced a CV event while taking the drug.

In the course of the litigation and in dealings with medical journals it was revealed that Merck had obscured critical data on the drug’s toxicity, given a biased presentation of Vioxx research and had used ghost writers to author papers on Vioxx – which were published in a number of academic journals.

The authors argue that the Vioxx case is “bad news for industry, academics, journals and the public” but conclude that “its [Merck's] behaviour may not be any different from that of others in the pharmaceutical or biotechnology industry.”

They say that academic medicine, industry, medical journals and government agencies must come together to define a set of principles governing drug development. They also call for new approaches to collaboration and development of drugs, including storing research data on independent academic sites – rather than with the pharmaceutical company, stricter scrutiny for research which has potentially immense financial implications and penalties for ghost-writing.

They conclude that “collaborations between academics, practicing physicians, industry and journals are essential in advancing knowledge and improving the care of patients. Trust is a necessary element of this partnership, but the recent events have made it necessary to institute proper systems that protect the interests of patients.”

Click here to view paper: http://press.psprings.co.uk/bmj/january/feat120.pdf

LA judge again denies mistrial in Merck Vioxx cases

2007-01-20T13:28:00.000-08:00

Reuters
January 18, 2007

LOS ANGELES (Reuters) - A Los Angeles judge on Thursday denied attorney requests to declare a mistrial in a case of two men who blame Merck & Co.'s withdrawn painkiller Vioxx for their heart attacks, according to representatives for both the defense and the plaintiffs.

Lawyers for the plaintiffs and Merck submitted motions seeking a mistrial in the trial that has dragged on since late October and included a lengthy break in jury deliberations over the holidays and the recent replacement of one of the jurors after she informed the judge that a relative had taken Vioxx.

Jurors in the case are expected to resume deliberations after hearing re-arguments earlier in the day in response to questions regarding whether prescribing physicians recognized the potential risks or side effects of the drug.

Lawyers for plaintiffs Rudolph Arrigale and Lawrence Appell have argued in the consolidated dual trial that Merck failed to disclose known dangers of the medicine.

"The passage of time adversely impacts the ability of the jury to deliberate accurately and fairly," Arrigale's attorney Thomas Brandi told Reuters, referring to the fact that jurors were given the case before the Christmas holidays and had a nearly three-week break in deliberations.

Merck has sought a mistrial on grounds that arguments by the plaintiffs were "inflammatory," said Merck spokeswoman Casey Stavropoulos.

Los Angeles Superior Court Judge Victoria Chaney last Thursday denied previous requests for a mistrial from both sides after a juror was replaced by an alternate, forcing deliberations to begin anew.

At the time she told attorneys that too much time had been invested in the case to not reach a verdict.

Lehman Brothers said in a research note on Thursday that it would not be surprised if the jury is unable to make a final decision and the requisite number of votes needed for a verdict is not reached.

"This will be a case not only for appeal, but may still be a case which ends in a mistrial in our estimation," the note said.

New Jersey Court Revives a Merck Suit

2007-01-20T13:27:00.000-08:00

By BLOOMBERG NEWS
Published: January 18, 2007

A lawsuit against Merck that seeks medical monitoring for former users of the painkiller Vioxx was revived yesterday by a New Jersey appeals court.

Judge Carol E. Higbee of Superior Court in Atlantic City, who is overseeing about 15,000 personal-injury suits over Vioxx, dismissed the case in May 2005. But the Appellate Division of the Superior Court of New Jersey ruled that her decision was premature.

The court instructed Judge Higbee to reconsider the claims’ validity, without endorsing them.

In the case, Phyllis Sinclair and Joseph Murray sued Merck on behalf of consumers who took Vioxx for at least six weeks before it was withdrawn in September 2004. The suit sought to have the company pay for a medical-screening program for class members.

N.J. court revives Vioxx lawsuit

2007-01-20T13:25:00.000-08:00

Ruling reinstates lawsuit that aims to force Merck to fund medical monitoring program for past Vioxx users.

January 17 2007: 5:39 PM EST

CHICAGO (Reuters) -- A New Jersey appeals court has revived a lawsuit that sought to force drugmaker Merck & Co. Inc. to fund a medical monitoring program for patients who took the painkiller Vioxx.

The state appellate court ruled on Tuesday that N.J. Superior Court Judge Carol Higbee's decision to dismiss the lawsuit was premature and failed to give the plaintiffs the opportunity to prove legally accepted claims.

Drug companies can receive funding to develop orphan drugs. CNN's Dr. Sanjay Gupta reports. (January 15)

The appeals court said in a 26-page opinion that it was not expressing an opinion on the ultimate viability of the lawsuit.

Plaintiffs in the case sought a court-administered medical screening program, funded by Merck (Charts), that would provide medical and diagnostic tests for each member of the class to detect potential heart problems arising from exposure to Vioxx.

"There is no medical science supporting the plaintiffs' position that they need to be monitored for cardiovascular conditions two years after Vioxx was voluntarily taken off the market," Merck attorney Ted Mayer said in an e-mailed statement.

Mayer said Merck is considering its options, including asking the New Jersey Supreme Court to review the case.

"Almost every court in the country has rejected class action treatment of medical monitoring claims because each plaintiff's claim needs to be evaluated individually," he said.

Deutsche Bank analyst Barbara Ryan said the ruling just means the case has been sent back to the lower court for a ruling.

If Merck is required to fund a medical monitoring program, Ryan said she doubted many former Vioxx users would take advantage of it because of the inconvenience and the low risk of suffering a heart attack if they had taken Vioxx only briefly.

"I don't think it would be a big issue for Merck or its shareholders," Ryan said.

Merck faces more than 27,000 lawsuits from those who claim to have been harmed by the drug, which once earned $2.5 billion a year.

Vioxx was pulled off the market in September 2004 after a study showed it doubled the risk of heart attack and stroke in patients taking it for at least 18 months.

The New Jersey-based drugmaker has insisted it will fight each lawsuit case by case rather than submit to any kind of broad settlement agreement.

FDA: Pay To Be Watched

2007-01-20T13:23:00.000-08:00

Matthew Herper, 01.11.07, 1:45 PM ET

In the wake of the withdrawal of Vioxx and other drug safety scandals, the U.S. Food and Drug Administration hopes to compel drug companies to pay to monitor the safety of already approved medicines.

Currently, pharmaceutical firms pay "user fees" that help fund speedy approval of new medicines. This policy has been controversial. Under the current law, approved in 1992, the very manufacturers the FDA is supposed to scrutinize pay the salaries of drug reviewers. The law, called the Prescription Drug User Fee Act (PDUFA), has successfully sped up new drug approvals, cutting review times for new medicines, especially those that are for particularly deadly ailments like cancer and AIDS.

But so far, the PDUFA fees are used only to review the safety and efficacy of drugs before they are approved. The FDA is seeking to change that as Congress takes a fresh look at the PDUFA law this year. The statute is written so that it must be reapproved, with changes, every five years. A new version of the law must be passed by Sept. 30 or the law will no longer be in effect.

The FDA is requesting that user fees paid by drug companies like Pfizer (nyse: PFE - news - people ) and GlaxoSmithKline (nyse: GSK - news - people ) be increased 28% to $393 million. Most of that increase--some $29 million--will go to fund expanded surveillance of new drugs after they hit the marketplace.

The fees would also pay for several other proposals, and the FDA will ask for new fees to pay for the review of direct-to-consumer advertisements that run on TV. The Pharmaceutical Research and Manufacturers of America, the drug industry trade group, issued a statement saying it approved of most of the major changes. The industry already funds half the FDA's budget for pre-approval evaluation of new drugs, agency officials said on a conference call.

The FDA will ask for public comments on Feb. 16 before submitting its proposals to Congress.

Drug makers and the FDA have been under fire as serious side effects have cropped up with already marketed drugs. Merck's (nyse: MRK - news - people ) Vioxx was pulled from the market after a study showed that it caused heart attacks, something critics had been warning about for years. A similar painkiller, Pfizer's Bextra, was also yanked after post-marketing studies revealed it could cause problems in heart surgery and a deadly skin reaction.

New data have forced antidepressants, like Paxil and Zoloft, to carry warnings that they may cause suicidal thoughts in adolescents. Eli Lilly (nyse: LLY - news - people ) has long been criticized for failing to warn of links between its antipsychotic Zyprexa and weight gain and elevated blood sugar. It has settled 26,000 lawsuits related to the criticism, and still faces 1,200 more.

But until now the FDA has focused the bulk of its attention on studies that lead to a new drug's approval and to new marketing claims, not to systematic efforts to pick up new side effects.

Other efforts are afoot to reform the FDA. Two bills originating in the Senate seek to reform the agency. One that may have a good shot at getting through is backed by Sens. Michael Enzi, R-Wyo., and Edward Kennedy, D-Mass. The bill, which the pair began drafting following Merck's decision to yank Vioxx in September 2004, is meant to "ensure that drug safety is not an afterthought," according to a prepared statement from Enzi's office.

Merck Goes up 5-4 in Vioxx Litigation

2007-01-20T13:20:00.000-08:00

By: United Press International

Merck & Co. Inc. has notched another win, this time in New Orleans, against the U.S. plaintiffs' bar in the ongoing war over Vioxx liabilities.

A U.S. District Court jury Tuesday took about three hours to reject a Kentucky man's claim that his 2003 heart attack was caused by the blockbuster painkiller, which the New Jersey pharmaceutical pulled from the market two years ago.

Robert Garry Smith took Vioxx for approximately four months before his heart attack.

"The jury's decision confirms that Merck acted responsibly and that Vioxx was not the cause of Mr. Smith's heart attack," said Philip Beck, Merck's lead trial lawyer in the case.

"Mr. Smith had multiple risk factors for a heart attack including elevated blood pressure, a family history of cardiac problems, coronary artery disease and he was considered medically obese," Beck said. "Finally, Mr. Smith's strenuous physical activity on the day of his heart attack -- shoveling snow, in cold temperatures, for almost an hour -- is a well-known trigger for such events. Unfortunately, Mr. Smith would have suffered a heart attack whether he was taking Vioxx or not."

Merck has won two out of three federal Vioxx trials but thousands of similar cases remain to be heard.

Vioxx Decision Upheld, Award Reduced by Texas Court

2007-01-08T20:03:00.000-08:00

Dec 26, 2006 | Newinferno.com

The good news for Felicia Garza: A Texas judge certified the ruling of a state jury that held the pharmaceutical company Merck & Co. liable for the Vioxx-related death of her husband. The bad news: The same judge decided that the initial damages awarded--to the tune of $32 million violated state law and therefore reduced the award considerably, to $8.7 million.

Leonel Garza passed away in 2001 after suffering a heart attack that plaintiffs believe was caused by him taking the controversial painkiller Vioxx. This past April, a Texas jury ruled against Merck and awarded the deceased’s family $32 million in damages: $7 million in compensatory damages and $25 million in punitive damages. However, Judge Alex Gabert ruled that the award violated a 2003 state law that set strict limits on punitive and compensatory damages.

Still, the big news for other Vioxx plaintiffs was that the original ruling was upheld, meaning that the courts accepted the premise that even short-term use of Vioxx may have led to severe side effects including heart attacks and strokes. Well more than 27,000 lawsuits have been brought against Merck, which pulled Vioxx from the shelves in September of 2004 after a study disclosed that long-term use of the drug could double a patient’s risk of a coronary event.

However, a New Orleans federal judge rejected appeals by the plaintiffs to form a class action, saying that each individual case was too distinct to be tried as a group. Merck has emerged victorious in the majority of the cases heard to this point.

A financial relationship between Felicia Garza and one of the jurors in the Texas trial has called the legitimacy of the original verdict into question, and Merck plans to seek a new trial because of the alleged improprieties. The lengthy appeals process may delay payment to the Garzas for many years to come.

Quebec court gives go-ahead for Vioxx suit

2007-01-08T20:02:00.000-08:00

Class action against Merck & Co. will be first in North America

Nov 11, 2006 | ALLISON LAMPERT | www.canada.com

Quebec is North America's first jurisdiction to allow a consumer class-action lawsuit against Merck & Co. Inc. over its painkiller Vioxx.

On Thursday, Quebec Superiour Court Judge Andre Denis authorized a class-action lawsuit by Quebec residents who suffered "damages caused by the use of the medication" between October 1999 and September 2004.

The number of Quebecers eligible to join the class-action suit isn't clear.

Merck says the class action is open only to Vioxx users who've suffered proven physical injuries because of the drug an interpretation of the term "damages" that would severely limit the number of eligible plaintiffs.

But a lawyer for the plaintiffs argued Quebecers who have suffered monetary "damages" linked to the drug's comparatively high price should also be included an interpretation that would potentially allow thousands of former users to participate.

On Sept. 30, 2004, Merck withdrew Vioxx a nonsteroidal anti-inflammatory drug related to ibuprofen after trial data showed the long-term use of the drug increased the risk of heart attacks and strokes.

Vioxx was used to treat the symptoms of arthritis, painful menstrual cycles and other types of acute pain. Merck has set aside more than $1.2 billion U.S. for Vioxx lawsuits.

On Wednesday, Merck chief executive officer Richard Clark said it could be several years before the company considers settling thousands of Vioxx lawsuits.

A lawyer for plaintiffs in Quebec and Ontario, said there have been more than 20 requests for class-action lawsuits filed across Canada over Vioxx. This is the first Vioxx class-action lawsuit that has received legal clearance to proceed.

Citing statistics by IMS Health Inc., a plantiffs attoreny said Quebecers consumed a disproportionate amount of Vioxx; between 1999 and 2004, 6.3 million prescriptions were written for the drug in Quebec, compared with 15.6 million for all of Canada.

"Given the number of people in Quebec who took Vioxx, it's a significant development," said a palntiffs attorney of the London-Ont. based Siskinds LLP.

The petition for a class action was filed by two plaintiffs, retired teacher Gerald Sigouin and Roger Ste-Marie, a car insurance adjuster. Both men, the court decision said, allege that they suffered heart attacks after using Vioxx for more than three years.

They said Merck "failed in its obligation to adequately inform consumers of (Vioxx's) side effects," a court document shows.

"If the consumers were adequately informed of the inherent risks in taking Vioxx, they wouldn't have taken it, or would have stopped taking it long before."

In his decision, Denis wouldn't allow family members and spouses of Vioxx users to participate in the class action.

Andre Payeur, attorney for Merck Frosst Canada, said the decision was a good one for the company as it limited participants to those who could prove they had been physically harmed by the drug.

"We're talking about very few people," he said.

Payeur defined "damages" as physical harm, as "this is a personal injury claim."

But in a legal squabble that could result in future court delays, plaintiffs attorney said he defined "damages" as being both physical and monetary.

The plantiffs attorney argued that Merck justified charging more for Vioxx because the company claimed it was safer than other anti-inflammatories on the market. Plaintiffs, he said, could join the class action to seek monetary damages.

"It is surprising to us that Merck is seeking to characterize this as a victory," he said.

It's now up to the plaintiffs to initiate lawsuit proceedings.

Denis's decision isn't the first Vioxx-related class action to proceed in the courts.

In New Jersey, plaintiffs composed of insurance companies were given court authorization for a class action against Merck over the drug. Merck is appealing that decision, Payeur said.

In Quebec, Merck is not permitted to appeal the court's decision.

New Vioxx Studies Could Cause Merck More Pain

2007-01-08T20:01:00.000-08:00

Sep 12, 2006 | Newsinferno.com

Two new studies each revealed troubling Vioxx safety data, putting pressure on Merck as the latest Vioxx trial is underway. One study linked Vioxx to an increase risk of kidney damage and cardiovascular events, while the other study confirmed the risk of heart problems began within the first 30 days of use of using the drug. Merck disputed the studies claims saying, “The observations in the JAMA articles and opinions expressed in an accompanying editorial regarding potential increased risks with short-term Vioxx use “are not supported by the current weight of clinical data.” These studies combined with Merck’s recent Vioxx trial loss, may make the company reconsider its decision not to seek a global settlement to resolve the thousands of cases pending against the company.

A study from Boston’s Brigham and Women’s Hospital and Harvard Medical School, which analyzed 114 studies involving more than 116,000 patients, showed that Vioxx “was associated with increased renal and (heart) arrhythmia risks.” Despite showing an increased rate of kidney problems, the study was unable to determine why the drug caused the damage.

The second report from the University of Newcastle, New South Wales, Australia, which reviewed 23 studies, confirmed findings of an increased risk of cardiovascular events associated with Vioxx, and found that these events could occur within the first 30 days of use. Merck has said that the cardiovascular risks associated with Vioxx only occurred after 18 months of use. In an editorial, Dr. David Graham of the FDA said the studies demonstrate that Vioxx “increases the risk of acute myocardial infarction at low and high doses” and that “there is no initial 18-month period of immunity from risk.”

Merck is facing more than 11,500 lawsuits on behalf of people claiming to have been injured after using Vioxx. Merck withdrew Vioxx from the market in September 2004 after a three-year study showed it doubled the risk of heart attack and strokes in patients taking it for at least 18 months. To date eight Vioxx trials have been completed with plaintiffs and Merck winning four each.

Merck Suffers 2 Setbacks in Vioxx Cases

2007-01-08T20:00:00.000-08:00

Aug 17, 2006 | MARY FOSTER | AP

Merck & Co. was stung with two major legal setbacks over the withdrawn painkiller Vioxx on Thursday when a federal jury ordered the drugmaker to pay $51 million to a heart attack victim, and a state judge in New Jersey overturned a November verdict favoring the company.

In New Orleans, the jury found that Merck "knowingly misrepresented or failed to disclose" information about Vioxx to retired FBI agent Gerald Barnett's doctors. It said Barnett, of Myrtle Beach, S.C., should get $50 million in compensatory damages. And it added $1 million in punitive damages, saying Merck "acted in wanton, malicious, willful or reckless disregard for the plaintiff's rights."

In New Jersey, state Superior Court Judge Carol Higbee ruled evidence uncovered since the November verdict showed that Merck withheld information showing heart attacks could come with use of Vioxx for less than 18 months, said one of the plantiff attorneys.

The New Jersey attorneys represented Frederick "Mike" Humeston, of Boise, Idaho, who had a heart attack in September 2001.

"Merck consistently said throughout the trial that you had to be on Vioxx for 18 months to be at increased risk of a heart attack, Humeston attorney said. "And that was false. They had data that people were having heart attacks within weeks."

Merck said it would appeal the New Orleans verdict and was considering its options in the New Jersey case.

"Both the finding and the amount of damages were totally uncalled for in this case because Merck acted appropriately in providing information to the medical, scientific and regulatory communities in a responsible and appropriate manner," Kenneth C. Frazier, a senior vice president for Merck, said of the New Orleans verdict.

As for the New Jersey case: "We have a significant disagreement with the court's decision because the evidence presented to the jury during the course of a seven-week trial in 2005 showed that Merck behaved appropriately with respect to Vioxx and also that Vioxx was in no way related to Mr. Humeston's heart attack," Ted Mayer, of Hughes Hubbard & Reed, a member of Merck's national defense team, said in a news release.

Ruling from the bench in Atlantic City, Higbee based her decision on new depositions and an editorial published in the New England Journal of Medicine asserting that Merck withheld "very important heart attack data from the public, and also that they didn't correctly state the data in the trial," Seeger said.

Mayer said the facts behind the editorial "were known to the plaintiff long before the trial, and the jury was aware of the issue because it was presented by the plaintiff's expert."

Mayer also said that the company intended to maintain its policy of trying every Vioxx case.

The lawsuits are among more than 16,000 Vioxx-related suits against Merck in state and federal courts.

David Logan, dean of Roger Williams University School of Law in Bristol, Rhode Island, said the New Orleans verdict would put pressure on Merck to consider settling cases.

"How long can Merck carry the cost of these verdicts?" Logan asked. "None of these cases are coming back small."

He said the cost of litigation and the management time devoted to overseeing the Vioxx cases remove resources that Merck should be spending on developing new products. "This is a drag on Merck going forward," he said. "it is an enormous tax on the company moving forward."

Jon LeCroy, an analyst with Natexis Bleichroeder, said there is no reason for the company to settle and every reason for it to continue to try each case, stretching out the process as long as possible so it doesn't have to dole out a lot of money at once and wearing down plaintiffs so some may go away.

"Clearly it is costing them a lot to fight the cases but that will go up ten fold if they announce a settlement", he said, noting a settlement usually triggers more lawsuits.

Barnett's lawyer, had asked for $25 million in punitive damages, arguing that it would send a message to drugmakers that they should not rush pharmaceuticals to market. Merck's lawyer, Phil Beck, argued that no further awards were needed to punish the drugmaker.

"My guess is that you have already awarded punitive damages. You sent a message loud and clear and the people at Merck heard that message," Beck said.

Outside the courtroom, Barnett said little, only that he was "very happy" with the verdict. Robinson said he was not disappointed with the relatively small punitive award, saying he wanted punitive damages added as a symbolic gesture to deter drug companies from putting unsafe drugs on the market.

On its verdict sheet, the jury had the chance to assign percentages of fault to Merck and various physicians, but assigned blame only to Merck.

The first federal trial had to be held twice. The first jury deliberated 18 hours over three days, but deadlocked over whether Vioxx was to blame for the death of a Florida man who had taken the drug for less than a month. The second jury in that case came back in less than four hours with a verdict for Merck.

In state courts, before Thursday, Merck had won four cases in New Jersey and California. It had lost two cases in Texas and one in New Jersey.

The New Jersey ruling removes one of Merck's state wins.

In federal court, the company now has one win and one loss.

The jurors who decided the Barnett case have at least two things in common with the plaintiff: All eight are men and they're all getting older.

Beck pointed out in closing arguments Wednesday that both are risk factors for heart attacks, and neither can be controlled.
Counsel for Barnett emphasized that his 62-year-old client, who underwent a quintuple bypass after a heart attack at the age of 58, was careful to keep his risks as low as possible with daily exercise, a healthy diet and drugs to control his cholesterol.

He told the jury that the problem was Vioxx, which Barnett took for 31 months before his heart attack in July 2002. He continued to take the painkiller for another two years, stopping one week before Merck pulled it from the market in September 2004, after a study showed it increased the risk of heart attacks and strokes.

Logan said that jurors may have empathized with Barnett. "Plaintiff lawyers want jurors to think `There but for the grace of God goes me.'" he said.

Merck found liable in another Vioxx case

2007-01-08T19:59:00.000-08:00

Aug 17, 2006 | www.cbsmarketwatch.com

A jury on Thursday said Merck & Co. Inc. has to pay $50 million in compensatory damages to a former FBI agent who suffered a heart attack after taking the company's painkiller Vioxx, according to media reports.

The jury in a federal court in New Orleans reportedly ruled that Merck & Co., Inc. was negligent for failing to adequately warn doctors of about the risks associated with the drug. The jury also found that Merck "knowingly misrepresented or failed to disclose" information about Vioxx to the doctors of 62-year-old Gerald Barnett, the reports said.

Barnett suffered a heart attack in September 2002; he took Vioxx for 33 months, according to The Wall Street Journal.

Barnett's doctor said that if Merck had disclosed the drug's risks earlier, he would never have prescribed it for his patient, The Wall Street Journal reported on its Web site, citing court papers. Barnett reportedly kept taking the drug even after the heart attack, and until a few weeks before it was pulled from the market in September 2004.

The jury is scheduled to deliberate punitive damages in the trial later today.

Whitehouse Station, N.J.-based Merck is involved in more than 14,000 lawsuits over Vioxx, according to the Journal. With this latest verdict, the drugmaker has now won five trials and lost four.

There was no one at the company immediately available for comment.

Lawmaker Alleges FDA, Merck Collaborated

2007-01-08T19:57:00.000-08:00

Jul 19, 2006 | ANDREW BRIDGES | AP

A federal health official worked with drug maker Merck to discredit a government whistleblower who publicized safety risks associated with the painkiller Vioxx, a lawmaker alleged Wednesday in seeking an investigation.

Sen. Charles Grassley, R-Iowa, asked the inspector general at the Health and Human Services Department to probe whether the Food and Drug Administration and Merck acted in concert to call into question the safety findings made by Dr. David Graham, an FDA drug safety official.

In a letter Wednesday, Grassley cited handwritten notes made by the Merck employee documenting an Oct. 13, 2004, conversation with the FDA official that suggests the two collaborated.

The FDA official mentioned an "opportunity to get (the) message out'' on Graham, a longtime employee of the agency, and provide journalists with a company critique of him, according to notes quoted in the letter.

"It is no secret that Dr. Graham was and is a critic of the FDA. However, that does not mean the FDA should scheme with drug sponsors to discredit its own employees,'' Grassley said in the letter to Inspector General Daniel Levinson. The FDA, Grassley said, must maintain a "clear, bright line between the regulated and the regulator.''

FDA spokeswoman Susan Bro had no comment.

Merck & Co. Inc. said in a statement that it has the "right to express our views when we believe information others have presented is not fair and balanced. Dr. Graham's conclusions with regard to Vioxx differed from those of the FDA and to that extent, the FDA and Merck separately expressed their scientific views to the public and scientific community.''

Merck announced the voluntary withdrawal of Vioxx in September 2004, citing a study that showed the pain medication could double risk of heart attack or stroke if taken for 18 months or longer.

Two months later, Graham testified before a Senate committee that the FDA had fumbled its handling of Vioxx, and mishandled safety problems with five other widely used drugs. The FDA defended its oversight of Vioxx before the hearing; an agency official later dismissed Graham's research as "junk science.''

The following month, 22 members of Congress signed a letter asking the FDA to investigate the "smear campaign'' against him.

Merck now faces more than 16,000 Vioxx-related lawsuits.

The meeting cited by Grassley was held two weeks after the drug was withdrawn.

FDA e-mails seen by The Associated Press indicate that the agency shared in advance with Merck details about a presentation that Graham was to make in France in August 2004 about the dangers of Vioxx. The e-mails suggested that such a practice was commonplace.

Merck then issued a statement saying it stood by the safety of Vioxx. An FDA spokeswoman at the time said removing the drug was "not on the table.''

The notes excerpted by Grassley indicate the FDA later went even further in helping Merck rebut Graham's work.

The FDA's Dr. Brian Harvey suggested to Merck's Dr. Ned Braunstein "an official rebuttal on Graham,'' according to the notes, which were admitted as evidence in a federal Vioxx trial.

Graham said he was "quite shocked'' to learn about Braunstein's notes.

"This actually demonstrates more clearly just how widespread the organized campaign to discredit and smear me was,'' according to a transcript of a sworn deposition that Graham gave May 9, 2006.

Blame game: Second Vioxx suit goes to trial in New Jersey

2005-09-17T22:06:00.000-07:00

ATLANTIC CITY, N.J. (AP) - Jurors hearing a product liability case against drug maker Merck & Co. on Wednesday heard starkly different assertions about whether the company's blockbuster painkiller Vioxx was to blame for an Idaho man's heart attack in 2001.

Lawyers for Boise postal worker Frederick Humeston told them that the New Jersey company rushed the product onto the market and ignored evidence of problems with some patients.

The company knew 18 months before that that Vioxx could increase the risk of heart attacks and strokes, but didn't warn doctors or users about it, according to attorney Chris Seeger. He told a seven-woman three-man jury in opening statements that the company violated founder George Merck's mantra: "Merck is for people, not profits."

Merck lawyer Diane Sullivan denied the allegations on both counts, telling jurors Merck's witnesses would prove Vioxx had nothing to do with Humeston's heart attack and that the company researched the drug's effects and reported the problems when it found out about them.

She told them the testimony in the case would be thick with medical and scientific terms and that they would be the ones to sift through it.

"You folks are going to be like detectives, like 'CSI,' where you test the allegations they've made against the evidence," Sullivan said.

The trial, one of about 2,475 Vioxx lawsuits pending in New Jersey, is the first since a Texas jury found Merck responsible for the death of a Vioxx user and ordered a $253 million award. That amount is expected to be dramatically reduced because of a Texas law capping punitive damages in civil cases.

Seeger said his client, a 60-year-old Vietnam veteran who survived his heart attack, would not have been prescribed Vioxx if the company was more forthcoming about its problems.

"Did they issue a 'Dear Doctor' letter? No. Did they warn patients? No, they didn't do that either. Did they change the label? No, they didn't," he said.

Under pressure to introduce new drugs because its patents on others were about to expire, Merck cut its customary new-drug development time in half, threw a $1 million party for 3,500 sales associates to launch it and spending $100 million on consumer advertising, Seeger told the jury.

"The survival of the company" was on the line at the time of the drug's 1999 debut, he said.

But Sullivan said the Whitehouse Station-based company had published studies about safety risks and notified the Food and Drug Administration of their findings.

Merck's scientists were keenly interested in potential safety concerns about the drug, she said, showing jurors a copy of a 2001 e-mail message from the company's research chief, Edward Scolnick, written after a study showed an increased risk of cardiovascular complications for those taking the drug for more than 18 months.

"I was sick at the thought we were doing harm to patients," Scolnick wrote.

"For you to believe the plaintiff's case, you'd have to believe that all these people got together and did something sinister," Sullivan told the jury.

Humeston limped into the courthouse Wednesday morning, holding hands with his wife Mary and favoring the damaged knee that earned him a Purple Heart and later prompted his doctor to recommend Vioxx.

The doctor, Gregory Lewer, testified that the 6-foot-1 Humeston had almost none of the risk factors normally associated with heart attack victims in their mid-50s.

His blood pressure and cholesterol were normal, his arteries were clear and he didn't smoke, said Lewer, a close friend who went whitewater rafting and hiking with Humeston. The man's only real ailment was the knee injury, said Lewer. Humeston was overweight but never obese, he added.

Lewer was to return to the stand Thursday morning, after which Seeger planned to air videotaped testimony by Dr. Alan Nies, an expert witness.

WKRC 12 Cincinnati

Heart expert admonishes Vioxx on stand

2005-09-17T22:02:00.000-07:00

By John Curran
Associated Press Writer

ATLANTIC CITY, N.J. - Fighting back tears, a heart expert told jurors Friday that Vioxx manufacturer Merck & Co. ignored evidence the painkiller posed safety risks before it hit the market in 1999.

Dr. Benedict Lucchesi, who was testifying on behalf of a man who blames Vioxx for his heart attack, was shown a series of internal Merck e-mails. Lucchesi, an expert on the heart and the effects of medications, appeared to fight back tears after plaintiff's attorney Chris Seeger referred to a 1997 message sent by Merck researcher Briggs Morrison to fellow company scientists.

In it, Morrison - discussing the proposed design of an upcoming clinical trial of the drug - advocated letting the patients in the study take aspirin at the same time as Vioxx.

"I know this has been discussed to death but real world is everyone is on it so why exclude" aspirin, Morrison wrote. Without aspirin's blood-thinning effects, he wrote, "you will get more (dangerous blood clots) and kill drug."

Lucchesi interpreted the statement to mean Merck feared that without aspirin to offset Vioxx's cardiac risk, those participating in the trial would be in greater danger and that would spell trouble for Merck as it pushed to debut Vioxx.

"When I first read that, I personally became enraged," said Lucchesi, 72, a professor at the University of Michigan who helped develop the first pacemaker.

"In my notes," he told Seeger, "I substituted 'patients' for 'drug."'

Choked up, he paused in his testimony.

"These are my colleagues," he said, meaning fellow doctors.

"Do you think they're doing something wrong?" Seeger asked.

"They're putting profits before life," he replied.

Merck's attorneys, defending the company in a product liability suit brought by 60-year-old Boise, Idaho postal worker Frederick Humeston, didn't get the chance to cross-examine Lucchesi, who spent about six hours on the stand Friday.

Jim Fitzpatrick, a Merck spokesman who was in court for the testimony, said afterward that Lucchesi had misinterpreted the e-mail. He said Morrison would rebut it when he testifies as part of Merck's case later in the trial.

"What the e-mail referred to is that if you compare Vioxx to a traditional pain reliever, you'll see a difference in clotting events. What he meant was that a misinterpretation of that difference would kill the drug," Fitzpatrick said. "That e-mail was speculating that people would misinterpret it (the trial) as being a problem with Vioxx."

The testimony, in the third day of the product liability trial, came after Humeston's lawyer showed jurors evidence that Merck & Co. was told by its own experts about potential health risks of its painkiller Vioxx before it went on sale in 1999.

In a 1998 document, Merck's board of scientific advisers told the company that Vioxx and other Cox-2 inhibitors - painkillers meant to limit stomach bleeding and irritation - could lead to blood clots breaking loose and blocking blood vessels elsewhere in some patients, the plaintiff's lawyer told jurors.

Vioxx could create rupture-prone plaque in arteries and lead to insufficient blood flow to the heart, according to the document. It said the findings weren't conclusive but should be "taken as a basis for hypotheses that should be actively pursued."

Seeger also showed jurors a 1999 letter in which Dr. John Oates, a Vanderbilt University pharmacology professor and Merck consultant, told Merck's research chief the drugs could cause dangerous blood clots in some patients.

"The purpose of this communication is a heads-up," Oates wrote.

Lucchesi offered no opinion about Humeston's heart attack in particular. Seeger didn't ask him about it.

"There is a very big possibility that Vioxx does pose a risk to patients with underlying disorders," Lucchesi testified.

Lucchesi's testimony is to continue Monday, followed by Merck's cross-examination.

Merck, based in Whitehouse Station, withdrew Vioxx from the market last September after its own research showed the popular arthritis drug doubled risk of heart attack and stroke after 18 months' use. The drug giant faces more than 5,000 lawsuits filed in state and federal courts - about half of them in New Jersey state courts - by former Vioxx users alleging the medicine harmed them.

The first trial ended last month when the jury in the Texas case stunned Merck with a $253 million liability verdict, although that will be slashed to about $26 million because Texas caps punitive damages. Merck plans to appeal. Lucchesi testified against Merck in that trial.

In a separate development, the nation's first federal civil trial involving Vioxx has been moved from Katrina-ravaged New Orleans to Houston, but will still start as scheduled on Nov. 28. It is expected to last two weeks.

The ruling was made by U.S. District Judge Eldon Fallon, who is overseeing pretrial coordination of more than 1,800 federal Vioxx lawsuits to streamline document gathering and other steps common to the cases. Fallon and a handful of his staff moved from New Orleans to temporary quarters at the federal courthouse in Houston earlier this month.

Merck shares rose 14 cents to close at $28.90 in trading on the New York Stock Exchange Friday. They rose 20 cents in after-hours trading.

Experts said to tell Merck about potential health risks regarding Vioxx before it went on sale

2005-09-17T21:58:00.000-07:00

JOHN CURRAN
Associated Press Writer

ATLANTIC CITY, N.J. — Merck & Co. was told by its own experts about the potential health risks of its painkiller Vioxx before it went on sale in 1999, a plaintiff's lawyer told jurors Friday in a trial over whether the drug caused a Boise, Idaho man's heart attack.

In a 1998 document, Merck's board of scientific advisers told the company that Vioxx and other so-called Cox-2 inhibitors could create rupture-prone plaque in arteries and lead to insufficient blood flow to the heart. The document said the findings weren't conclusive but should be "taken as a basis for hypotheses that should be actively pursued."

Chris Seeger, lead attorney for plaintiff Frederick "Mike" Humeston, also showed jurors a 1999 letter in which Dr. John Oates, a Vanderbilt University pharmacology professor and Merck consultant, told Merck's research chief the drugs could cause dangerous blood clots in some patients.

"The purpose of this communication is a heads-up," Oates wrote.

Seeger showed the documents to his first expert witness, Dr. Benedict Lucchesi, a University of Michigan professor and an authority on the impact of drugs on the heart. Lucchesi is testifying on behalf of Humeston, a 60-year-old postal worker who suffered a heart attack in September 2001, two months after he started taking Vioxx.

Lucchesi's testimony was to continue Friday afternoon, followed by Merck's cross-examination.

On Friday morning, Superior Court Judge Carol Higbee rejected a Merck motion to keep Lucchesi off the stand because, Merck said, there was no firm scientific evidence to support Lucchesi's conclusion Vioxx contributed to Humeston's heart attack. Higbee said the company's defense team had had ample opportunity to take a deposition from him or challenge his credentials previously and had not.

Merck, based in Whitehouse Station, withdrew Vioxx from the market last September after its own research showed the popular arthritis drug doubled risk of heart attack and stroke after 18 months' use. The drug giant faces more than 5,000 lawsuits filed in state and federal courts — about half of them in New Jersey state courts — by former Vioxx users alleging the medicine harmed them.

The first trial ended last month when a Texas jury stunned Merck with a $253 million liability verdict, although that will be slashed to about $26 million because Texas caps punitive damages. Merck plans to appeal.

On Thursday, the company's lead lawyer, Diane Sullivan, challenged testimony of the first witness, Humeston's physician, suggesting he should have been aware of risks associated with Vioxx because of a 2000 medical journal report.

Dr. Gregory Lewer testified he believed Vioxx caused Humeston's 2001 heart attack and wouldn't have prescribed it if he knew of research linking it to cardiovascular problems.

"The total amount of information is overwhelming. Nobody can keep up on all of it," Lewer said.

Later, Sullivan told the jury stress and other problems were responsible for Humeston's heart attack.

In a separate development, the nation's first federal civil trial involving Vioxx has been moved from Katrina-ravaged New Orleans to Houston.

The ruling was made by U.S. District Judge Eldon Fallon, who is overseeing pretrial coordination of more than 1,800 federal Vioxx lawsuits to streamline document gathering and other steps common to the cases. Fallon ruled that the federal trial, expected to last two weeks, will start as scheduled on Nov. 28. The judge and a handful of his staff moved from New Orleans to temporary quarters at the federal courthouse in Houston earlier this month.

Merck shares were down 4 cents at $28.72 in afternoon trading on the New York Stock Exchange.

Danger from Vioxx high, witness

2005-09-17T21:56:00.000-07:00

In second case against Merck, witness says company scientists put "profits before life."
September 16, 2005: 6:47 PM EDT

ATLANTIC CITY, N.J. (Reuters) - The probability that Merck & Co. Inc.'s arthritis drug Vioxx could lead to heart problems or stroke is very high, an expert witness told a court hearing a closely watched product liability lawsuit.

Fredrick Humeston, a 60-year-old postal worker and Vietnam War veteran, is suing the drug maker, blaming Merck's painkiller for his 2001 heart attack.

The trial in Atlantic City, which got underway this week, is the second such case against Merck (Research), which withdrew its blockbuster Vioxx drug, a so-called COX-2 inhibitor, from the market last year.

The drug company is hoping for a victory after losing the first Vioxx trial in Texas last month. Merck faces a slew of suits following its voluntary withdrawal of the drug in September 2004.

"The probability is very high that Vioxx and other COX-2 inhibitors, but mostly Vioxx, can lead to the development of thrombo-embololic events," said Benedict Lucchesi, professor of pharmacology at University of Michigan Medical School.

Lucchesi, responding to questions from the plaintiff's attorney Christopher Seeger, added: "Based on my medical knowledge, there is a very good probability that Vioxx does pose a risk to patients with underlying disorders."

The plaintiffs produced a letter written in 1999 by John Oates, a professor of pharmacology at Vanderbilt University and former scientific advisor to Merck, warning the company to be careful about marketing COX-2 drugs.

"He is telling Merck that you have to be careful. You can't just give (Cox-2s) to everybody," Lucchesi said.

"They are trying to tell the leadership (about the risks) before they go out and launch this drug to millions and millions of people," Lucchesi told the court, referring to a May 1998 report issued by Merck's scientific advisors to Management.

Merck withdrew the drug after its own research showed increased risk of heart attack and stroke in some patient who took Vioxx for at least 18 months.

Lucchesi broke down in court when asked about an internal Merck email in February of 1997 in which Merck scientists expressed concerns about the marketability of Vioxx in light of clinical trials.

"I became enraged," Lucchesi said when asked about his reaction to the email. He was unable to continue for several moments in the courtroom as he was overcome with emotion.

"These are my colleagues," he said, referring to the Merck scientists. "They put profits before life."

Jim Fitzpatrick, a lawyer representing Merck, said the email had been misinterpreted and that his side would be clarifying the company's position later in the trial.

Judge threatens mistrial in Vioxx case

2005-09-17T21:55:00.000-07:00

Published in the Asbury Park Press 09/16/05
THE ASSOCIATED PRESS

ATLANTIC CITY — The judge hearing a product liability lawsuit against Merck & Co., the manufacturer of painkiller Vioxx, reprimanded the company's lead lawyer Thursday for violating pretrial instructions barring comments about lawyers in front of the jury.

Threatening to declare a mistrial, Superior Court Judge Carol E. Higbee said Merck lawyer Diane Sullivan had made repeated negative references about attorneys in her opening statement to jurors Wednesday, despite being told beforehand not to do so.

"It's simply playing to the bias of jurors . . . a certain perception that there are too many lawsuits and that it's causing society problems," Higbee said while the jury was out of the courtroom.

On Wednesday, Sullivan made reference to plaintiff Frederick "Mike" Humeston being "surrounded by lawyers" and later criticized their interpretation of evidence by saying, "That's not science, that's lawyering."

Humeston, a 60-year-old postal worker from Boise, Idaho, alleges Vioxx caused him to suffer a heart attack four years ago. Humeston had been taking the drug for about two months to relieve lingering pain from a Vietnam War shrapnel wound to his knee.

His lawyers told jurors on Wednesday, when testimony began, that Merck rushed the product onto the market, ignored evidence of problems with some patients and didn't warn doctors or users that Vioxx could increase the risk of heart attacks and strokes.

Sullivan denied those allegations, telling jurors that Merck's witnesses would prove Vioxx had nothing to do with Humeston's heart attack and the company researched the drug's effects and reported the problems when it found out about them.

Whitehouse Station-based Merck withdrew Vioxx in September 2004 after its research showed the drug doubled risk of heart attack and stroke after 18 months' use.

On Thursday, the start of testimony was delayed by Higbee's criticism and a dispute over whether Merck would be allowed to admit into evidence a Food and Drug Administration advisory committee memo. The judge ruled it cannot be admitted.

Higbee on Thursday barred the lawyers from making any further references to Merck having pulled Vioxx from the market; it was raised in opening statements. Higbee said it was not relevant because the withdrawal happened after Humeston's heart attack and after he filed suit.

When testimony resumed Thursday, Dr. Gregory Lewer, Humeston's physician, said if he had known of the potential cardiovascular risks posed by Vioxx, he would never have prescribed it for Humeston.

Merck's Vioxx, Similar Drugs Lead to Blood Clots, Expert Says

2005-09-17T21:53:00.000-07:00

Sept. 16 (Bloomberg) -- Merck & Co.'s Vioxx and similar drugs promote blood clotting that can lead to heart attacks and strokes, a medical professor testified at the second product- liability trial over the painkiller.

Benedict Lucchesi, a University of Michigan pharmacologist, was the first expert to testify for Frederick Humeston, who is suing Merck over his 2001 heart attack. Lucchesi said Vioxx and similar drugs, known as Cox-2 inhibitors, can cause blood clots, or thromboembolisms, that break loose and plug blood vessels.

``The probability is very high that Vioxx and other Cox-2 inhibitors, but mostly Vioxx, can lead to the development of thromboembolic events,'' Lucchesi testified today in Atlantic City, New Jersey. ``There is a big probability that Vioxx does pose a risk to patients with underlying disorders.''

Lucchesi's testimony supported Humeston's claim that Merck had warnings about the dangers of Vioxx years before withdrawing it last year because of health concerns. Merck, which faces about 5,000 Vioxx suits, could face billions of dollars in liability if it loses several early trials, analysts say.

Merck, based in Whitehouse Station, New Jersey, says it had no scientific proof of the dangers of Vioxx before last September, when a study showed it doubled the risk of heart attacks and strokes after 18 months of use. Humeston, a 60-year- old postal worker from Idaho who used Vioxx for two months, had a heart attack because of his weight, blood pressure and work- related stress, the company contends.

Lucchesi testified at the Texas trial at which jurors returned a verdict saying Merck should pay $253 million to the widow of a man who took Vioxx. That amount will be reduced to $26 million under state law.

Cox-2 Inhibitors

Lucchesi described his 50-year medical career, which included helping to develop pacemakers. He told jurors about the working of the heart and how drugs affect it, and he recounted the development in the 1990s of Cox-2 inhibitors -- so called because they inhibit an enzyme with that name -- to prevent the stomach bleeding caused by other painkillers.

Vioxx was launched in May 1999. It later generated $2.5 billion in annual sales for Merck, the No. 3 U.S. drugmaker.

In questioning Lucchesi, Humeston's lawyer Christopher Seeger showed jurors the minutes of a 1998 meeting by a Merck scientific advisory board warning that drugs like Vioxx could lead to a buildup of plaque and clots in the blood. It urged Merck executives to study the problem further.

Lucchesi reviewed a 1999 letter by a Vanderbilt University pharmacologist, John A. Oates, to Merck's former top scientist, Edward Scolnick. In that letter, Oates described four patients who had heart attacks or strokes while taking a Cox-2 inhibitor.

`Be Cautious'

``He's telling Merck that you have to be cautious,'' Lucchesi told jurors. ``You have to identify patients who would be at high risk.''

Lucchesi testified after Merck's lawyers challenged his qualifications and said he had no evidence that Vioxx had posed a statistically significant increased risk of causing Humeston's heart attack.

Superior Court Judge Carol Higbee said the request came too later, calling it ``way, way, way beyond untimely.'' She said Merck could challenge his testimony later.

The case is Humeston v. Merck & Co., L-02272-03, Superior Court, Atlantic City, New Jersey.

Vioxx likely leads to heart problems-expert witness

2005-09-17T21:51:00.000-07:00

By Jon Hurdle

ATLANTIC CITY, N.J., Sept 16 (Reuters) - The probability that Merck & Co. Inc.'s (MRK.N: Quote, Profile, Research) arthritis drug Vioxx could lead to heart problems or stroke is very high, an expert witness told a court hearing a closely watched product liability lawsuit.

Fredrick Humeston, a 60-year-old postal worker and Vietnam War veteran, is suing the drug maker, blaming Merck's painkiller for his 2001 heart attack.

The trial in Atlantic City, which got underway this week, is the second such case against Merck, which withdrew its blockbuster Vioxx drug, a so-called COX-2 inhibitor, from the market last year.

The drug company is hoping for a victory after losing the first Vioxx trial in Texas last month. Merck faces a slew of suits following its voluntary withdrawal of the drug in September 2004.

"The probability is very high that Vioxx and other COX-2 inhibitors, but mostly Vioxx, can lead to the development of thrombo-embololic events," said Benedict Lucchesi, professor of pharmacology at University of Michigan Medical School.

Lucchesi, responding to questions from the plaintiff's attorney Christopher Seeger, added: "Based on my medical knowledge, there is a very good probability that Vioxx does pose a risk to patients with underlying disorders."

The plaintiffs produced a letter written in 1999 by John Oates, a professor of pharmacology at Vanderbilt University and former scientific advisor to Merck, warning the company to be careful about marketing COX-2 drugs.

"He is telling Merck that you have to be careful. You can't just give (Cox-2s) to everybody," Lucchesi said.

"They are trying to tell the leadership (about the risks) before they go out and launch this drug to millions and millions of people," Lucchesi told the court, referring to a May 1998 report issued by Merck's scientific advisors to Management.

Merck withdrew the drug after its own research showed increased risk of heart attack and stroke in some patient who took Vioxx for at least 18 months.

Lucchesi broke down in court when asked about an internal Merck email in February of 1997 in which Merck scientists expressed concerns about the marketability of Vioxx in light of clinical trials.

"I became enraged," Lucchesi said when asked about his reaction to the email. He was unable to continue for several moments in the courtroom as he was overcome with emotion.

"These are my colleagues," he said, referring to the Merck scientists. "They put profits before life."

Jim Fitzpatrick, a lawyer representing Merck, said the email had been misinterpreted and that his side would be clarifying the company's position later in the trial.

Merck Gets Hand Slapped ; Vioxx Judge Reprimands Lawyer

2005-09-17T21:47:00.000-07:00

Record, The; Bergen County, N.J.

ATLANTIC CITY - The judge hearing a product liability suit against Merck & Co., the manufacturer of painkiller Vioxx, reprimanded the company's lead lawyer Thursday for violating pretrial instructions barring comments about lawyers in front of the jury.

Threatening to declare a mistrial, Superior Court Judge Carol E. Higbee said Merck lawyer Diane Sullivan had made repeated negative references about attorneys in her opening statement to jurors Wednesday, despite being told not to do so.

"It's simply playing to the bias of jurors ... a certain perception that there are too many lawsuits and that it's causing society problems," Higbee said while the jury was out of the courtroom.

In Wednesday's opening, Sullivan made reference to plaintiff Frederick "Mike" Humeston being "surrounded by lawyers" and later criticized their interpretation of evidence by saying, "That's not science, that's lawyering, lawyering, lawyering."

Humeston, a 60-year-old postal worker from Boise, Idaho, alleges Vioxx caused him to suffer a heart attack four years ago. Humeston had been taking the blockbuster drug for about two months to relieve lingering pain from a Vietnam War shrapnel wound to his knee. His lawyers told jurors on Wednesday, when testimony began, that Merck rushed the product onto the market, ignored evidence of problems with some patients and didn't warn doctors or users that Vioxx could increase the risk of heart attacks and strokes.

Sullivan denied those allegations, telling jurors that Merck's witnesses would prove Vioxx had nothing to do with Humeston's heart attack and the company researched the drug's effects and reported the problems when it found out about them.

Whitehouse Station-based Merck withdrew the popular arthritis and pain treatment from the market in September 2004 after its own research showed Vioxx doubled risk of heart attack and stroke after 18 months' use.

On Thursday, the start of testimony was delayed by Higbee's criticism and a dispute over whether Merck would be allowed to admit into evidence a key 2005 memo from a Food and Drug Administration advisory committee. The judge ruled it cannot be admitted.

Besides reiterating the warning that attorneys should not cast aspersions on other lawyers, Higbee on Thursday barred them from making any further references to Merck having pulled Vioxx from the market.

Both sides had raised that fact in opening statements. Higbee said it was not relevant because the withdrawal happened after Humeston's heart attack and after he filed suit.

When testimony resumed Thursday, Dr. Gregory Lewer, Humeston's physician, returned to the stand. Under questioning by Humeston attorney Chris Seeger, Lewer said if he had known of the Vioxx's potential cardiovascular risks, he would never have prescribed it for Humeston.

"I didn't have the information I wish I had at the time," said Lewer, who said the Vioxx package insert and label didn't tell him of the risks.

Lewer said that Humeston had once asked him about amputating his leg because the pain was so bad, but Vioxx relieved his pain after other drugs had failed.

On cross-examination, Lewer acknowledged to Merck attorney Sullivan that all medications come with risks.

The trial, one of about 2,475 Vioxx lawsuits pending in New Jersey, is the first since a Texas jury found Merck responsible for the death of a Vioxx user and ordered a $253 million award.

That amount will be slashed to about $26 million because of Texas caps on punitive damages.

Merck shares were down 2 cents at $28.68 in afternoon trading on the New York Stock Exchange.

Vioxx likely leads to heart problems-expert witness

2005-09-17T21:45:00.000-07:00

Source: Reuters

By Jon Hurdle

ATLANTIC CITY, N.J., Sept 16 (Reuters) - The probability that Merck & Co. Inc.'s arthritis drug Vioxx could lead to heart problems or stroke is very high, an expert witness told a court hearing a closely watched product liability lawsuit.

Fredrick Humeston, a 60-year-old postal worker and Vietnam War veteran, is suing the drug maker, blaming Merck's painkiller for his 2001 heart attack.

The trial in Atlantic City, which got underway this week, is the second such case against Merck, which withdrew its blockbuster Vioxx drug, a so-called COX-2 inhibitor, from the market last year.

"The probability is very high that Vioxx and other COX-2 inhibitors, but mostly Vioxx, can lead to the development of thrombo-embololic events," said Benedict Lucchesi, professor of pharmacology at University of Michigan Medical School.

Lucchesi, responding to questions from the plaintiff's attorney Christopher Seeger, added: "Based on my medical knowledge, there is a very good probability that Vioxx does pose a risk to patients with underlying disorders."

The plaintiffs produced a letter written in 1999 by John Oates, a professor of pharmacology at Vanderbilt University and former scientific advisor to Merck, warning the company to be careful about marketing COX-2 drugs.

"He is telling Merck that you have to be careful. You can't just give (Cox-2s) to everybody," Lucchesi said.

"They are trying to tell the leadership (about the risks) before they go out and launch this drug to millions and millions of people," Lucchesi told the court, referring to a May 1998 report issued by Merck's scientific advisors to Management.

The drug company is hoping for a victory after losing the first Vioxx trial in Texas last month. Merck faces a slew of suits following its voluntary withdrawal of the drug in September 2004.

Merck withdrew the drug after its own research showed increased risk of heart attack and stroke in some patient who took Vioxx for at least 18 months.

Pain relief gamble enough to cause a headache

2005-09-17T21:43:00.000-07:00

17.09.05
By Geoff Cumming
The New Zealand Herald

Ann Price was a whisker away from a painkiller-induced heart attack. Early last year, the arthritis sufferer was happily popping Celebrex, one of a new breed of anti-inflammatories called cox-2 inhibitors, when a routine visit to the doctor revealed her blood pressure to be sky high.

"My blood pressure had always been slightly high but this was panic stations," she says.

The first thing was to get her blood pressure down. Ten days later her doctor phoned to say he owed her an apology. "He said he'd accepted what the salesman said and hadn't got around to reading the small print [about Celebrex]. I had to stop taking them straight away."

This was six months before a similar cox-2, Vioxx, was withdrawn by its manufacturer, Merck, after researchers in a cancer trial linked it to a doubling in the risk of heart attacks and strokes.

Another cancer prevention trial, using Celebrex, was halted last December over concerns of an increased heart risk for participants on higher than normal doses. A third brand, Bextra, was withdrawn by its manufacturer, Pfizer, in April after reports of severe skin reactions.

Merck now faces ruin after a Texan court awarded US$253 million ($358 million) to the widow of a man who died of a heart attack in 2001 after taking Vioxx. Worldwide, more than 4000 people have lodged negligence claims against Merck, either victims or relatives of those who suffered heart attacks after taking the drug.

But Celebrex and other cox-2s Mobic, Arcoxia and Dynastat remain on the market. The Ministry of Health, after reviewing cox-2s, bowed to strong arguments from patients and doctors against banning the drugs despite "unanswered questions" about their safety. Clearer warnings were placed on boxes and doctors encouraged to make them a drug of last resort for low risk patients on low doses. The ministry also extended a ban on advertising them.

In the late-1990s, cox-2s were hailed as a breakthrough painkiller and were heavily promoted in the United States and New Zealand, where direct-to-consumer advertising of prescription drugs is allowed. Television ads for Vioxx and Celebrex targeted older people with images of pain-free bowling, golf or a brisk walk along the beach.

They were good not only for arthritis but for lower back pain, painful periods and migraine. It's a lucrative market - between 10 and 20 per cent of New Zealanders are in chronic pain at any one time while studies suggest two-thirds of the over-60s suffer musculoskeletal pain.

Within a couple of years of their launch, 60,000 New Zealanders were taking cox-2 inhibitors, unsubsidised by Pharmac.

The pills took their name from an enzyme which plays a role in pain and inflammation, the cyclo-oxygenase (cox) enzyme, which comes in two forms, cox-1 and cox-2. Whereas traditional painkillers were non-selective, the "new Aspirin" worked by suppressing cox-2.

They were touted as easier on the stomach than older painkillers, long-implicated in fatalities from stomach ulcers and intestinal bleeding. What was not revealed, or not thought to be a concern, was their clotting effect on blood.

Price learned about them through her doctor. Osteoarthritis had developed in her left ankle five years ago, while her badly broken leg was in plaster.

"By the time my ankle came out of the moon boot I couldn't move it at all. Every time I put my foot to the floor was like treading on a knifeblade."

The 68-year-old now has arthritis in her upper spine, shoulders, hips, hands and both ankles. She says it waxes and wanes - but the flare ups are excruciating. "You can go out in the morning feeling fine and come back an absolute cot case."

Like many, Price could not tolerate traditional anti-inflammatories. "Voltaren and ibuprofen upset my tummy terribly. I was getting stomach pains and bleeding."

Yet it is these pills which many - especially older people and others at risk of heart problems - have reverted to after Vioxx. Arthritis educator Avro Graham starkly sums up the options: "It's as if you have a choice between a peptic ulcer or a dicky ticker - which do you want?"

Price now takes only paracetamol, which she says works nowhere near as well as Celebrex.

"I have to cope with a lot more pain and arthritis degeneration. It's not easy ... "

But the cox-2 debacle was only the beginning for those on chronic pain medication. A parade of studies has since raised doubts about the cardiovascular safety of established anti-inflammatories - brand names lurking in most household medicine cabinets. Naproxen, ibuprofen (sold in low doses over-the-counter as Nurofen and Brufen) and diclofenac (Voltaren) have all been linked to an increased heart attack risk.

In April, the US Food and Drug Administration asked all manufacturers of these non-steroidal anti-inflammatory drugs to include a boxed warning on packaging inserts about the potential for increased heart attack and stroke risk as well as life-threatening gastrointestinal bleeding.

Last month, a Spanish study suggested a death rate from gastrointestinal complications linked to anti-inflammatories of 15 for every 100,000 users.

IN the murky world of drug company-sponsored research, these studies are taken with a large grain of salt by doctors. The researchers themselves caution that their findings merely suggest the need for more studies. But until, or unless, randomised trials of sufficient size and duration take place, all people in chronic pain must live with the nagging doubt that their painkillers could kill them.

Even paracetamol is suffering bad press, with studies suggesting that small doses can double the risk of hypertension.

The latest pain reliever to come under the microscope is Coproxamol, a combination of paracetamol and the narcotic dextropropoxyphene, which is sold here as Capadex or Paradex. Taken for osteoarthritis and back pain, Copraxamol is being withdrawn in Britain because of a link to overdoses and suicides, prompting a review of its future by New Zealand authorities.

All of which leaves patients with a headache. Price, who chairs an arthritis support group on the North Shore, says it's hard enough for chronic pain sufferers to come to terms with their restricted lifestyle - most experience depression. The Vioxx withdrawal and subsequent Ministry of Health review of cox-2s caused panic.

"Most were quite upset and anxious. If you get to rely on a drug that you know eases your pain and somebody suddenly says you can't have it, you wonder how you're going to cope.

"A lot of the people who come to our support group are elderly, most live alone - it's quite frightening for them."

Many insisted they remain on cox-2s. Others, particularly those at increased risk of heart attack, switched to non-selective anti-inflammatories, despite the emerging doubts about them.

Should consumers feel like ticking timebombs? Not in most cases, say the experts. Dr Stewart Jessamine, principal medical adviser for Medsafe, says the risks for most of us are small. "Most people who take Aspirin and anti-inflammatories don't get peptic ulcers and similarly most people will not get heart attacks.

"We are talking about an increase in the background risk of two or three times and that is still a very small increase."

But the heart attack risk increases with age, says Jessamine.

"The background risk for a 40-year-old non-smoker who doesn't have high blood pressure is extremely small. But if you're 80 and not a hypertensive and you don't smoke and your blood pressure's normal, there's still a 30 to 40 per cent chance you'll have a heart attack in the next five years. So a doubling of the risk [as with Vioxx] is quite a substantial increase."

Yet some experts still query the clampdown on cox-2s when people are in severe pain waiting for hip and knee surgery. Rheumatologist Andrew Harrison and pain specialist Ted Hughes suggest regulators over-reacted to the heart attack risk.

"What's happened is that a very useful drug has been ripped out of circulation because of a small number of patients who suffer an adverse effect from it," says Hughes.

"For some people the heart risk is negligible compared to the risk of stomach ulcers and other side effects."

Harrison says doctors and specialists can reliably assess heart risks over time. Most patients are willing to take a small risk if it means they can function.

"There are a lot of patients who would prefer to make the decision themselves rather than have their options narrowed. You'd get the odd disaster occurring but, as long as the patient was fully informed and took the risk on themselves, that's the risk you take in return for making available drugs which make a huge difference to people's lives."

He concedes it's a difficult call.

"It's really hard to know which way to go as a prescriber. People steered away from cox-2s, now there's evidence that anti-inflammatories in general have an increased risk.

"When the patient is at risk you get very nervous keeping them on an anti-inflammatory."

Hughes says new drugs are subjected to much more scrutiny than established remedies.

"If you tried to legalise Aspirin or penicillin nowadays you probably wouldn't get them through the regulatory authorities - they'd be regarded as too bloody dangerous.

"There are probably as many things that cause trouble with some of the older drugs that just aren't being recognised because nobody's looking."

Certainly, doubts are growing. In December, naproxen, taken for gout and painful periods as well as arthritis, was linked to an increased risk of heart attack during a US study into its use in preventing Alzheimer's disease.

A study suggesting an increased risk for ibuprofen and diclofenac was published in the British Medical Journal in June. There are even studies questioning whether anti-inflammatories do much for pain at all.

Norwegian researchers found they reduced pain in the short term only slightly better than a placebo and recommended prescribing more critically. Last month, Australian researchers reported that Celebrex worked no better than paracetamol in most patients.

Professor Les Toop, an early whistleblower against Vioxx, says the rash of reports has the look of a smokescreen by drug companies keen to disperse blame. Previous studies have found naproxen protective against heart attack compared to Vioxx, he says. "If it's true naproxen is bad then that makes Vioxx even worse.

"The side effects of conventional anti-inflammatories were always known about. But they weren't being sold as if they were safe and being hyper-promoted to the public."

Toop says the cox-2 experience sounds warnings not only about direct-to-consumer advertising but the way drug companies use half-truths. Much of the demand for cox-2s was patient-generated but doctors were also "suckered in".

"They were promoted as cleaner and safer but there's mounting evidence that drug companies knew they were worse than the old ones.

"Cox-2s are going to be a classic example for doctors for years to come. People were screaming from the rooftops about cardiovascular problems for four or five years [but were ignored]."

Toop says the root of the problem is that regulators approve new drugs on the basis of efficacy, which is "entirely different from showing whether something is safe or not".

"As long as we have a drug licensing system which allows a company to produce one or two trials showing it's better than a placebo, and ignore trials which don't show [a positive] effect, then we've got a problem."

Efficacy studies for new drugs were neither large enough nor long enough to reveal long term adverse effects. "What tripped up Vioxx was research for a completely different use against colonic cancer."

Where does this leave patients?

"The bottom line," says Hughes, "is the fewer tablets you are on the better off you are, but if you're forced to take something you have to look at the risks."

When Price's arthritis flares up, the risk is calculated.

"Either put up with the pain or take something which you know will push your blood pressure up for a couple of days and hope you don't have a stroke. Quite honestly, I would rather get rid of the pain."

Judge in second Vioxx case reprimands Merck lawyer

2005-09-17T21:41:00.000-07:00

ATLANTIC CITY, N.J. (AP) -- The judge hearing a product liability suit against Merck & Co., the manufacturer of painkiller Vioxx, reprimanded the company's lead lawyer Thursday for violating pretrial instructions barring comments about lawyers in front of the jury.

Threatening to declare a mistrial, Superior Court Judge Carol E. Higbee said Merck lawyer Diane Sullivan had made repeated negative references about attorneys in her opening statement to jurors Wednesday, despite being told not to do so.

"It's simply playing to the bias of jurors ... a certain perception that there are too many lawsuits and that it's causing society problems," Higbee said while the jury was out of the courtroom.

In Wednesday's opening, Sullivan made reference to plaintiff Frederick "Mike" Humeston being "surrounded by lawyers" and later criticized their interpretation of evidence by saying, "That's not science, that's lawyering, lawyering, lawyering."

Humeston, a 60-year-old postal worker from Boise, Idaho, alleges Vioxx caused him to suffer a heart attack four years ago. Humeston had been taking the blockbuster drug for about two months to relieve lingering pain from a Vietnam War shrapnel wound to his knee. His lawyers told jurors on Wednesday, when testimony began, that Merck rushed the product onto the market, ignored evidence of problems with some patients and didn't warn doctors or users that Vioxx could increase the risk of heart attacks and strokes.

Sullivan denied those allegations, telling jurors that Merck's witnesses would prove Vioxx had nothing to do with Humeston's heart attack and the company researched the drug's effects and reported the problems when it found out about them.

Whitehouse Station, N.J.-based Merck withdrew the popular arthritis and pain treatment from the market in September 2004 after its own research showed Vioxx doubled risk of heart attack and stroke after 18 months' use.

On Thursday, the start of testimony was delayed by Higbee's criticism and a dispute over whether Merck would be allowed to admit into evidence a key 2005 memo from a Food and Drug Administration advisory committee. The judge ruled it cannot be admitted.

Besides reiterating the warning that attorneys should not cast aspersions on other lawyers, Higbee on Thursday barred them from making any further references to Merck having pulled Vioxx from the market. Both sides had raised that fact in opening statements. Higbee said it was not relevant because the withdrawal happened after Humeston's heart attack and after he filed suit.

When testimony resumed Thursday, Dr. Gregory Lewer, Humeston's physician, returned to the stand. Under questioning by Humeston attorney Chris Seeger, Lewer said if he had known of the Vioxx's potential cardiovascular risks, he would never have prescribed it for Humeston.

"I didn't have the information I wish I had at the time," said Lewer, who said the Vioxx package insert and label didn't tell him of the risks.

Lewer said that Humeston had once asked him about amputating his leg because the pain was so bad, but Vioxx relieved his pain after other drugs had failed.

On cross-examination, Lewer acknowledged to Merck attorney Sullivan that all medications come with risks.

The trial, one of about 2,475 Vioxx lawsuits pending in New Jersey, is the first since a Texas jury found Merck responsible for the death of a Vioxx user and ordered a $253 million award. That amount will be slashed to about $26 million because of Texas caps on punitive damages.

Merck shares rose 6 cents to close at $28.76 Thursday on the New York Stock Exchange.

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First federal Vioxx trial moved to Houston

2005-09-17T21:39:00.000-07:00

KRISTEN HAYS
Associated Press

HOUSTON - Yet another Hurricane Katrina "evacuee" has a home in Houston - the nation's first federal trial involving Merck & Co.'s withdrawn painkiller, Vioxx.

U.S. District Judge Eldon Fallon of Katrina-ravaged New Orleans, who is overseeing hundreds of federal civil lawsuits related to Vioxx, has ruled the first one will proceed as scheduled on Nov. 28 in Houston rather than in its original venue.

According to a court filing, the judge and attorneys discussed the date and venue for the case and agreed Houston "was an appropriate and convenient forum for the trial."

"He consulted with the parties and made his decision that Houston was the place to do it to keep the schedule," Ted Mayer, one of Merck's lawyers, said Friday.

Fallon and a handful of his staff moved to temporary quarters at the federal courthouse in Houston earlier this month after the hurricane devastated New Orleans. The judge is handling pretrial coordination of more than 1,800 federal Vioxx lawsuits to streamline steps common to the cases, such as document gathering and witness depositions.

The first trial is slated to last two weeks, Mayer said.

The case centers on the May 2001 death of Richard Irvin Jr., a 53-year-old Florida man, who had a fatal heart attack after he took Vioxx for a month to alleviate back pain. His wife, Evelyn Irvin Plunkett, claims in her lawsuit that her husband was in "very good health" when he started taking the once-popular painkiller.

Mayer said Merck maintains that Vioxx didn't cause Irvin's death.

Plunkett's lawyer, Andy Birchfield of Montgomery, Ala., didn't immediately return a call for comment.

Merck, based in Whitehouse Station, N.J., pulled Vioxx from the market last September after a study showed it could double risk of heart attack or stroke if taken for 18 months or longer. The drug, prescribed to relieve acute pain and arthritis while cutting risk of stomach bleeding, went on the market in 1999 and reached peak sales of $2.5 billion a year.

Another 3,200 state and other Vioxx-related lawsuits are pending across the country. Last month, a jury in Angleton, about 40 miles south of Houston, slapped Merck with a $253.4 million verdict in the first state Vioxx case to go to trial. That amount is expected to be reduced to no more than $26.1 million under Texas caps on punitive damages, and Merck will appeal.

The nation's second state trial began this week in Atlantic City, N.J.

The lawsuits largely claim Merck knew Vioxx could be dangerous years before the withdrawal but downplayed those concerns in favor of profits. Merck counters that the company was responsible and disclosed research.

Merck has vowed to fight most of litigation, though the company has said it will consider settling lawsuits that involve long-term Vioxx usage.

First federal Vioxx trial moved to Houston from New Orleans

2005-09-17T21:36:00.000-07:00

By KRISTEN HAYS
The Associated Press

Published September 16, 2005

HOUSTON — Yet another Hurricane Katrina "evacuee" has a home in Houston _ the nation's first federal civil trial involving Merck & Co.'s withdrawn painkiller, Vioxx.

U.S. District Judge Eldon Fallon of Katrina-ravaged New Orleans, who is overseeing hundreds of federal Vioxx-related lawsuits, has ruled that the first federal trial will proceed as scheduled on Nov. 28 in Houston rather than its original venue.

According to a court filing, the judge and attorneys discussed the date and venue for the first case and all agreed Houston "was an appropriate and convenient forum for the trial."

"He consulted with the parties and made his decision that Houston was the place to do it to keep the schedule," Ted Mayer, one of Merck's lawyers, said Friday.

Fallon and a handful of his staff moved to temporary quarters at the federal courthouse in Houston earlier this month after Katrina left New Orleans a sodden mess. The judge is handling pretrial coordination of more than 1,800 federal Vioxx lawsuits to streamline steps common to the cases, such as document gathering and witness depositions.

Another 3,200 state and other Vioxx-related lawsuits are pending across the country. Last month a jury in Angleton, about 40 miles south of Houston, slapped Merck with a $253.4 million verdict in the first state Vioxx case to go to trial in the nation. That amount is expected to be reduced to no more than $26.1 million under Texas caps on punitive damages, and Merck will appeal.

The nation's second state trial began this week in Atlantic City, N.J.

The first federal trial is slated to last two weeks, Mayer said.

The November case centers on the May 2001 death of Richard Irvin Jr., a 53-year-old Florida man, who had a fatal heart attack after he took Vioxx for a month to alleviate back pain. His wife, Evelyn Irvin Plunkett, claims in her lawsuit that her husband was in "very good health" when he started taking the once-popular painkiller.

Mayer said Merck maintains that Vioxx didn't cause Irvin's death.

Plunkett's lawyer, Andy Birchfield of Montgomery, Ala., didn't immediately return a call for comment.

Merck, based in Whitehouse Station, N.J., pulled Vioxx from the market last September after a study showed it could double risk of heart attack or stroke if taken for 18 months or longer. The drug, prescribed to relieve acute pain and arthritis while cutting risk of stomach bleeds, went on the market in 1999 and reached peak sales of $2.5 billion a year.

Merck has vowed to fight the lion's share of litigation, though the company has said it will consider settling lawsuits that involve long-term Vioxx usage.

The lawsuits largely claim Merck knew Vioxx could be dangerous years before the withdrawal but downplayed those concerns in favor of profits. Merck counters that the company was responsible and disclosed research.

Merck May Not See Earnings Growth Until 2009

2005-09-07T19:43:00.000-07:00

Peter Kang, 09.07.05, 3:53 PM ET
Forbes.com

Bear Stearns initiated coverage on Merck (nyse: MRK - news - people ) with a "peer perform" rating and said the drug firm's abundant cash hoards should support plans for long-term growth as well as the attractive 5% dividend yield.

However, legal liabilities will likely hinder upside in the shares, the firm said. "Lack of earnings growth until 2009, a below-average (although improving) pipeline score, and an overhang from ongoing Vioxx litigation will keep a lid on the stock, in our opinion," said Bear Stearns.

Possible near-term catalysts for the stock, according to Bear Stearns, include the uptake of cholesterol drug Vytorin, the potential launch of Pargluva with partner Bristol-Myers Squibb (nyse: BMY - news - people ) and Merck's analyst meeting in December.

"However, we see only limited upside to the stock, since earnings growth is not expected to resume for Merck until 2009 and the litigation news flow on Vioxx in the near term will be a major overhang," said Bear Stearns, particularly since the first Vioxx trial last month resulted in a plaintiff award of more than $250 million. The firm noted it expects the award be overturned on appeal.

Bear Stearns is looking for Chief Executive Richard Clarke to outline a long-term growth plan at the company's annual analyst meeting. "We expect Merck's new CEO to focus the company's R&D resources on a narrower spectrum of therapeutic areas that offer the best risk/reward for creating long-term shareholder value," it said. "In addition, we anticipate a more focused in-licensing effort aligned with its defined therapeutic footprint."

The research firm said Merck's "appealing dividend yield looks sturdy" while an ample amount of cash should aid its growth prospects. "Merck is committed to financing its appealing 5.3% dividend yield through its attractive free cash flow," it said. "Merck's abundant free cash flow, coupled with $15 billion in repatriated earnings, provide Merck's energized and engaged CEO with ample ammunition to acquire long-term growth."

Merck faces next round of lawsuits over Vioxx

2005-09-07T19:40:00.000-07:00

By LINDA A. JOHNSON
Associated Press
9/6/2005

TRENTON, N.J. - Frederick "Mike" Humeston, long bothered by knee pain from a Vietnam War wound, had been taking the painkiller Vioxx for barely two months when he had a heart attack four years ago.
Now 60, the postal worker and ex-Marine has permanent heart muscle damage, is constantly fatigued and worries about increased risk of a second heart attack, said Chris Seeger, one of his lawyers.

In the first product liability trial since a Texas jury hit Vioxx maker Merck & Co. with a whopping $253.4 million verdict last month, Humeston's lawyers plan to argue the Boise, Idaho, man had a healthy heart and that Vioxx triggered his heart attack. The trial is set to begin Sept. 12 in Atlantic City, about 100 miles from Merck's headquarters in Whitehouse Station, N.J.

"This was a heart attack that shouldn't have happened," Seeger said. "My experts are going to have no problem establishing that Vioxx was the cause."

Jim Fitzpatrick, a Merck spokesman and lawyer, said the company has "a very strong defense" focused on Humeston's medical records and cardiac risk factors. Those include his age, obesity, sedentary lifestyle, high cholesterol and high blood pressure, according to a pending Merck motion that seeks to exclude testimony by medical experts Seeger has lined up.

"The evidence will show that Mr. Humeston's myocardial infarction didn't have anything to do with Vioxx," Fitzpatrick said.

New Jersey Superior Court Judge Carol A. Higbee will preside over the trial and is coordinating about 2,475 Vioxx cases filed in New Jersey. The state has half the nearly 5,000 personal injury cases filed against Merck so far because suing in the company's home state prevents Merck from trying to move the cases to federal court, which lawyers perceive as less friendly to plaintiffs. Merck also faces about 2,100 lawsuits in federal courts.

Merck pulled Vioxx from the market last September when research showed the arthritis drug doubled the risk of heart attack and stroke after 18 months' use.

Plaintiff attorneys and some doctors have argued Merck knew the risks of Vioxx at least a few years earlier, yet downplayed its dangers and kept aggressively promoting the drug. Attorneys for Merck say the company acted responsibly, putting patients first and pulling the drug once the risks surfaced.

Merck's profits and revenues already are down sharply without Vioxx, which generated $2.5 billion in sales in 2003. Two other top drugs face generic competition and plunging sales in the next few years, and analysts consider Merck's pipeline of experimental medicines weak.

The Humeston case will be watched closely by attorneys, stock analysts and others looking for signs to the scope of Merck's liability over Vioxx, now estimated by analysts at $5 billion up to $50 billion. "If Merck is mostly successful, many plaintiffs may drop (lawsuits) or accept cheap settlements," said Howard Erichson, a Seton Hall University School of Law professor.

Federal Vioxx cases moving to Houston due to Katrina

2005-09-07T19:37:00.000-07:00

By LINDA A. JOHNSON / Associated Press

Coordination of hundreds of federal lawsuits over Merck & Co.'s withdrawn painkiller Vioxx is being moved to Houston from New Orleans, at least temporarily, because of the devastation there from Hurricane Katrina.

The judge overseeing the massive litigation, U.S. District Court Judge Eldon E. Fallon, and a handful of his staff members have already moved into temporary quarters in the federal courthouse in Houston, a law clerk for Fallon told The Associated Press late Tuesday.

The clerk, who did not want her name used, said the judge is trying to keep as close as possible to the case schedule he had set last month, which had the first federal trial starting in New Orleans on Nov. 28. It was still unclear where the trials will be heard, the clerk said.

Fallon is handling pretrial coordination of more than 1,800 federal Vioxx lawsuits alleging the drug caused patients heart attacks and other harm. Such pretrial consolidation is done to streamline steps common to the cases, such as document gathering and witness depositions.

David Bradley, chief deputy clerk for the Southern District of Texas in Houston, said his courthouse will take over electronic management of case filings on a national court system server, entering pleadings and other filings by attorneys, as well as filings of new lawsuits.

Whitehouse Station-based Merck pulled Vioxx from the market last September when research showed the arthritis drug doubled the risk of heart attack and stroke after 18 months' use. Besides the federal cases, the company faces about 3,200 state and other lawsuits over Vioxx, a blockbuster arthritis drug that had peak sales of $2.5 billion a year.

Last month, a jury in Angleton, Texas, hit Merck with a $253.4 million verdict — an amount expected to be drastically reduced — in the first Vioxx trial in state court. The second state trial is set to begin Sept. 12 in Atlantic City.

Late Tuesday, after Merck learned that Court TV had just requested permission to broadcast live from inside the courtroom during that trial, Merck filed a motion urging the judge to refuse.

"It hurts our chances in later trials," explained Merck spokesman Kent Jarrell.

Meanwhile, Fallon's clerk said staff now in Houston are trying to locate other New Orleans staffers and find places for them to work, in Houston or elsewhere.

"We certainly understand and have a great deal of empathy for the unusual personal and logistical challenges facing the court," Jarrell said late Tuesday. "We have confidence in the judge and will help him in any way because it is very important to keep the (federal trials) moving forward."

Bradley said the Houston courthouse has some available space for Fallon and staff, but the judge legally cannot hold trials there — at least not now.

"There's no statutory authority for Judge Fallon to conduct trials here," Bradley explained.

He said Congress is considering legislation to allow federal judges in Louisiana's eastern district to conduct trials elsewhere.

Meanwhile, Bradley said, about 65 staffers from the New Orleans headquarters of the 5th U.S. Circuit Court of Appeals, which covers Louisiana, Mississippi and Texas, are to be moved to the Houston federal courthouse.

Next Vioxx Suit Could Set Tone For Future Cases

2005-09-07T19:31:00.000-07:00

NEW YORK -(Dow Jones)- The second Vioxx-related lawsuit to reach trial begins next week in Atlantic City, in a case that may have far-reaching implications for thousands of similar suits filed in New Jersey.

Merck & Co. (MRK) was dealt a resounding defeat last month when a Texas jury awarded $253.5 million to the family of Robert Ernst, who died in 2001 after taking Merck's painkiller, Vioxx, for eight months.

In the latest case, Frederick "Mike" Humeston suffered a heart attack after taking Vioxx for two months to alleviate knee pain from a injury suffered during the Vietnam War.

The Humeston case will be closely watched by plaintiffs attorneys and industry executives because half of the nearly 5,000 Vioxx lawsuits are filed in Merck's home state of New Jersey.

"The case has special significance because so many of these Vioxx cases are filed here and so many people will be watching what happens," said Howard Erichson, a professor at Seton Hall University School of Law.

Plaintiffs often file lawsuits in companies' home states because it prevents defendants from attempting to move the suits to federal courts, which are perceived to be more business-friendly than some state courts.

Jury selection is set to begin in Atlantic City on Sept. 12, and opening arguments could begin as early as Sept. 14. The trial is expected to take four to six weeks.

Humeston's lawyers contend that the Boise, Idaho, resident did not have heart problems before taking Vioxx. Merck lawyers say Humeston did not take Vioxx for long enough to cause heart problems and that he had cardiac risk factors such as age and obesity.

"Vioxx just didn't cause Mr. Humeston's heart attack," said Jim Fitzpatrick, a Merck lawyer.

Merck pulled Vioxx off the market last year after research showed the painkiller doubled the risk of heart attack and stroke after 18 months of continual use.

Lawyers for Humeston couldn't immediately be reached for comment.

Legal experts cautioned that the whopping verdict against Merck in Texas doesn't necessarily mean that juries in other states will be as generous. Even in New Jersey, which is widely perceived as a consumer-friendly state, the jury verdicts are never certain, they said.

Trent Miracle, a plaintiffs attorney who has filed Vioxx suits against Merck, said the outcome of the Humeston case may be a better indicator of Merck's future liability than the Ernst case. Ernst suffered from cardiac arrhythmia, a condition not scientifically linked to Vioxx. Most plaintiffs are more likely to have suffered heart attacks or strokes rather than arrhythmia, he said.

"If Merck loses on this trial than they've got a lot more to worry about than they did in Texas because this is the kind of case they will face in the future, " Miracle said.

Howard Latin, a professor at Rutgers School of Law - Newark, said Merck likely will face some of the same evidence in Atlantic City that hurt it in Texas - particularly internal documents that Ernst's lawyers said showed that the company knew Vioxx caused health problems long before they were disclosed to the public.

"Merck is going to have a really tough time based on evidence in the Texas case," Latin said.

Fitzpatrick said Merck will show that it carefully studied Vioxx' side effects and promptly disclosed them.

"We are prepared to address whatever internal documents have been brought up at trial," Fitzpatrick said.

-By Greg Groeller, Dow Jones Newswires

Re "Whose Vioxx is gored?" Opinion, Aug. 28

2005-09-05T12:01:00.000-07:00

September 3, 2005 latimes.com : Print Edition : California Print
LETTERS
Product liability hovers over pharmaceuticals
Re "Whose Vioxx is gored?" Opinion, Aug. 28

Michael Kinsley's article about Vioxx, while clever, misstates the laws governing negligence and product liability. If a person, as Kinsley suggests, cuts up and eats a beach ball, the resulting "dire consequences" are not, nor should they be, compensable under existing law because eating a beach ball is not the intended use for the product, and the manufacturer has no duty to warn against such an unanticipated event. Except for cigarettes, which cause injury and death when used in the manner intended by the manufacturer, most products, when so used, are required to be relatively safe.

Pharmaceutical manufacturers are required to include warnings in their labeling, informing the physician, the pharmacist and the patient about potential side effects. The physician and pharmacist have a commensurate duty to communicate the most serious side effects to the patient. The patient may then make an informed decision as to whether the benefit of using the drug outweighs the potential burden.

But when a manufacturer fails to make full disclosure about potential serious side effects, even when discovered after Food and Drug Administration approval, it has breached its duty to warn. Only time will tell whether Merck has breached its duty and whether its advertised policy of placing the patient first is just an empty slogan.

HERBERT WEINBERG

Pharmacist and attorney

Marina del Rey

•

Kinsley's article makes for provocative copy and fuels the tort reform debate. However, the piece makes no constructive contribution to a critical question: How can the United States best facilitate the marketing of prescription drugs that save lives and remedy pain economically and with minimal risk?

CARL TOBIAS

Professor of law

University of Richmond, Va.

Vioxx verdict could cause local tremors

2005-09-05T11:55:00.000-07:00

Triangle Business Journal
From the September 2, 2005 print edition
Jane Paige

Merck & Co. lost the first Vioxx lawsuit to go to trial, and the implications are huge for the embattled drugmaker.

Large and small pharmaceutical companies in the Triangle also could take a financial hit because of the Merck ruling.

Potential investors in startup biotech companies are apt to become more wary after major court defeats such as Merck's, says Jim Verdonik, a Durham-based attorney with Daniels Daniels & Verdonik.

"Rulings like this in the Merck case are just one more factor to consider in an environment where investors already look at numerous risks," says Verdonik, who specializes in corporate and securities law. "This case doesn't make for the best story when startup drug companies are looking to raise money."

On Aug. 19, a Texas jury found Merck liable in the death of Robert Ernst who died in May 2001 after taking Vioxx, an arthritis painkiller made by the company.

The jury awarded Robert Ernst's widow $253.5 million. Texas' rules on punitive damages automatically lower the verdict to $26.1 million. Merck plans to appeal.

After a six-week trial, jurors said they concluded that the nation's third-largest drug maker was long aware of Vioxx's potential heart risks but hid that knowledge from patients.

The Texas case was the first Vioxx lawsuit to reach trial, but 4,000 other have already been filed and many are approaching juries. A second state trial is scheduled to begin in New Jersey this month, and the first federal suit is looming.

Over five years, about 20 million people worldwide took Vioxx before Merck stopped selling the drug in September 2004, after a clinical trial found evidence that Vioxx had heart risks compared with a placebo.

The Texas case involved a seemingly healthy produce manager who died of a heart arrhythmia after taking Vioxx for eight months.

Since Merck withdrew Vioxx, the entire class of COX-2 inhibitor painkillers has been found to pose an elevated risk of strokes and heart attacks. The drugs, which became worldwide blockbusters in the late 1990s by promising arthritis relief without the stomach problems that often come with aspirin and other painkillers, are now either off the market or sold with strong Food and Drug Administration warnings.

In the aftermath, the FDA has become more aggressive about publicly identifying emerging risks it finds in drugs and medical devices, and has sought to beef up its drug safety office.

"Rulings like this tend to have a domino effect on the entire industry," Verdonik says.

If Merck loses a few more Vioxx cases, it is likely to come under pressure from Wall Street to settle them, which could cost the company billions. Such a settlement would not necessarily threaten Merck's survival - the company brings in about $6 billion in cash annually, and payments under any settlement would likely be stretched over years, according to reports.

But analysts have said a big settlement could force Merck to cut its dividends to stockholders, which would almost certainly erode its share price. That could make Merck a takeover target.

A weakened Merck also could negatively impact local startup drug companies with investors, Verdonik says. The majority of smaller drug companies hope eventually to be purchased by one of the nation's pharmaceutical's giants, such as Merck.

Investors usually put their money into startup companies hoping the young ventures will be sold one day to a larger company, boosting the return on the investment.

Merck is building a $300 million vaccine plant north of Durham. The New Jersey-based company expects to finish construction on the 250,000-square-foot plant in 2007. Company officials say the new facility is on schedule for completion.

Bad medicine for biotech

2005-09-05T11:53:00.000-07:00

Boston Business Journal
Editorial
From the September 2, 2005 print edition

No matter how you interpret the Vioxx verdict -- jury activism or well-deserved comeuppance -- it isn't hard to feel the chill seeping into the drug industry. In awarding some $229 million (a number soon to be reduced by Texas law) to a widow whose husband died nine months after beginning to take Vioxx, the jurors effectively widened the exposure for all drug companies. More important to this region, the repercussions of the verdict cast a shadow over the ambitiousness of upstream research.

Aggressive risk-taking drives the biotech industry. Scientists make up one part of the equation and venture capitalists the other. Tack a few extra years of regulatory scrutiny and the possibility of a litigation feeding frenzy into the return-on-investment formula, and you can bet that certain compounds, perhaps ones with great potential, will be left unexplored.

The jurors said they wanted to send a message to Merck for the way it handled the Vioxx matter. The message to the innovators and gatekeepers in the drug industry is one of conservatism. When the scientists and the investors who support them have to hedge their bets out of fear, the medical needs of the nation will suffer.

Ex-Marine ready for fight against Merck

2005-09-05T11:50:00.000-07:00

Published in the Asbury Park Press 09/5/05

THE ASSOCIATED PRESS

TRENTON — Frederick "Mike" Humeston, long bothered by knee pain from a Vietnam War wound, had been taking the painkiller Vioxx for barely two months when he had a heart attack four years ago.

Now 60, the postal worker and ex-Marine has permanent heart muscle damage, is constantly fatigued and worries about increased risk of a second heart attack, said Chris Seeger, one of his lawyers.

In the first product liability trial since a Texas jury hit Vioxx maker Merck & Co. with a whopping $253.4 million verdict last month, Humeston's lawyers plan to argue the Boise, Idaho, man had a healthy heart and that Vioxx triggered his heart attack. The trial is set to begin Sept. 12 in Atlantic City, about 100 miles from Merck's headquarters in Whitehouse Station.

"This was a heart attack that shouldn't have happened," Seeger said. "My experts are going to have no problem establishing that Vioxx was the cause."

Jim Fitzpatrick, a Merck spokesman and lawyer, said the company has "a very strong defense" focused on Humeston's medical records and cardiac risk factors. Those include his age, obesity, sedentary lifestyle, high cholesterol and high blood pressure, according to a pending Merck motion that seeks to exclude testimony by medical experts Seeger has lined up.

New Jersey Superior Court Judge Carol A. Higbee will preside over the trial and is coordinating about 2,475 Vioxx cases filed in New Jersey. The state has half of almost 5,000 personal injury cases filed against Merck so far because suing in the company's home state prevents Merck from trying to move the cases to federal court, which lawyers perceive as less friendly to plaintiffs. Merck also faces about 2,100 lawsuits in federal courts.

Merck pulled Vioxx from the market last September when research showed the arthritis drug doubled the risk of heart attack and stroke after 18 months' use.

Plaintiff attorneys and some doctors have argued Merck knew the risks of Vioxx at least a few years earlier, yet played down its dangers and kept aggressively promoting the drug. Attorneys for Merck say the company acted responsibly, putting patients first and pulling the drug once the risks surfaced.

Merck's profits and revenue already are down sharply without Vioxx, which generated $2.5 billion in sales in 2003. Two other top drugs face generic competition and plunging sales in the next few years, and analysts consider Merck's pipeline of experimental medicines weak.

The Humeston case will be watched closely by attorneys, stock analysts and others looking for signs to the scope of Merck's liability over Vioxx, now estimated by analysts at $5 billion up to $50 billion.

Until late last month, Merck lawyers insisted they would fight every lawsuit individually. Now they say they will consider settling some lawsuits, ones where patients took Vioxx for at least 18 months and had little or no risk of cardiac problems.

Jury selection in the Humeston case will begin Sept. 12, and the lawyers could give their opening arguments starting Sept. 14.

A breakdown of Vioxx-related suits filed to date

2005-09-05T11:47:00.000-07:00

Monday, September 5, 2005
The Associated Press

The number of lawsuits filed against drug giant Merck & Co. since it withdrew its blockbuster painkiller Vioxx from the market last September is mounting.

More than 5,000 product liability lawsuits, nearly all of them personal injury lawsuits, have been filed against Merck. They include:

--1,811 federal lawsuits consolidated for pretrial coordination to streamline steps common to the cases, such as document gathering and witness depositions.

--More than 290 federal lawsuits pending but not yet consolidated with the others in what's called multidistrict litigation.

--More than 250 cases pending in California state courts.

--About 2,475 cases pending and coordinated under one judge in Atlantic County, New Jersey.

--More than 200 cases pending in state courts elsewhere.

The above categories include 148 potential class-action cases, which could eventually include many plaintiffs if judges certify them as class actions. A handful of those cases involve union health plans, insurers and other third-party payers seeking reimbursement of money they paid for Vioxx for their prescription plan members. One such class action suit filed by a New Jersey union has been certified.

The New Jersey total is as of Sept. 1, while the other numbers are as of Aug. 15.

The lawsuits allege Vioxx caused heart attacks, strokes, gastrointestinal bleeding, dangerous blood clots or kidney damage, and most seek financial compensation. Some potential class-action suits seek future medical monitoring for Vioxx users who have not suffered health problems yet.

Merck also faces lawsuits in federal court from stockholders seeking reimbursement for billions of dollars of losses they suffered when Merck shares plunged after the company pulled Vioxx from the market.

Sources: Merck & Co., Atlantic County Superior Court

Merck faces war hero in next Vioxx trial

2005-09-05T11:44:00.000-07:00

By Linda A. Johnson / AP Business Writer

TRENTON, N.J. (AP) -- Frederick "Mike" Humeston, long bothered by knee pain from a Vietnam War wound, had been taking the painkiller Vioxx for barely two months when he had a heart attack four years ago.

Now 60, the postal worker and ex-Marine has permanent heart muscle damage, is constantly fatigued and worries about increased risk of a second heart attack, said Chris Seeger, one of his lawyers.

In the first product liability trial since a Texas jury hit Vioxx maker Merck & Co. with a whopping $253.4 million verdict last month, Humeston's lawyers plan to argue the Boise, Idaho, man had a healthy heart and that Vioxx triggered his heart attack. The trial is set to begin Sept. 12 in Atlantic City, about 100 miles from Merck's headquarters in Whitehouse Station, N.J.

"This was a heart attack that shouldn't have happened," Seeger said. "My experts are going to have no problem establishing that Vioxx was the cause."

Jim Fitzpatrick, a Merck spokesman and lawyer, said the company has "a very strong defense" focused on Humeston's medical records and cardiac risk factors. Those include his age, obesity, sedentary lifestyle, high cholesterol and high blood pressure, according to a pending Merck motion that seeks to exclude testimony by medical experts Seeger has lined up.

"The evidence will show that Mr. Humeston's myocardial infarction didn't have anything to do with Vioxx," Fitzpatrick said.

New Jersey Superior Court Judge Carol A. Higbee will preside over the trial and is coordinating about 2,475 Vioxx cases filed in New Jersey. The state has half the nearly 5,000 personal injury cases filed against Merck so far because suing in the company's home state prevents Merck from trying to move the cases to federal court, which lawyers perceive as less friendly to plaintiffs. Merck also faces about 2,100 lawsuits in federal courts.

Merck pulled Vioxx from the market last September when research showed the arthritis drug doubled the risk of heart attack and stroke after 18 months' use.

Plaintiff attorneys and some doctors have argued Merck knew the risks of Vioxx at least a few years earlier, yet downplayed its dangers and kept aggressively promoting the drug. Attorneys for Merck say the company acted responsibly, putting patients first and pulling the drug once the risks surfaced.

Merck's profits and revenues already are down sharply without Vioxx, which generated $2.5 billion in sales in 2003. Two other top drugs face generic competition and plunging sales in the next few years, and analysts consider Merck's pipeline of experimental medicines weak.

The Humeston case will be watched closely by attorneys, stock analysts and others looking for signs to the scope of Merck's liability over Vioxx, now estimated by analysts at $5 billion up to $50 billion.

"If Merck is mostly successful, many plaintiffs may drop (lawsuits) or accept cheap settlements," said Howard Erichson, a Seton Hall University School of Law professor. But he added that "New Jersey is often perceived as relatively plaintiff friendly," like Texas courts.

Until late last month, Merck lawyers insisted they would fight every lawsuit individually. Now they say they will consider settling some lawsuits, ones where patients took Vioxx for at least 18 months and had little or no risk of cardiac problems -- a group where it would be more difficult for Merck to win in court.

In the Humeston case, a series of hearings on pretrial motions is to wrap up next Thursday. Jury selection will begin the following Monday, and the lawyers could give their opening arguments starting on Sept. 14. The trial is expected to last about five weeks.

Barry M. Epstein, a pharmaceutical industry defense attorney, said the onus will be on Seeger's team to prove Vioxx was at least a substantial factor in causing Humeston's heart attack.

"It is a very difficult thing for an expert to say that," Epstein said, adding, "The court doesn't have to buy it."

Another key issue will be Merck's marketing and promotion of Vioxx, a turning point in the Texas case. Jurors there said afterward that their verdict was a message to the pharmaceutical industry.

"I do think sometimes large drug manufacturers have difficulty seeing how the regular person on the street sees their conduct," said Ellen Presby, a Dallas plaintiff attorney specializing in pharmaceutical cases.

Another Merck loss, she said, would signal plaintiffs and lawyers that "their cases are winnable and therefore worthy of substantial settlement amounts" before a trial.

Having the trial in Merck's home territory could help the company, a major employer in New Jersey, said Carl Tobias, a professor specializing in product liability cases at University of Richmond School of Law.

"Jurors may know people who work for one of the big pharmaceutical companies" in New Jersey, he said.

David A. Logan, a dean and professor specializing in product liability at Roger Williams University School of Law in Bristol, R.I., said jury selection will be critical for Merck because the Texas verdict may be in jurors' minds.

However, he said the ethnically diverse, mostly lower- and middle-class population of Atlantic County from which the jury will be chosen is likely to have the same feeling about Merck's conduct as the Texas jury.

"It will be tough for Merck to find a jury that is sympathetic," Logan said.

Humeston, though, is a plaintiff likely to find sympathy with the jury. He earned two Purple Hearts during the Vietnam War, one for a shrapnel wound to the knee that still causes pain -- the reason his doctor switched him to Vioxx in 2001, Seeger said.

A former union official with a wife and five grown children, Humeston had planned to eventually move from Boise to a rural area, but now is afraid to be far from his doctors and hospital. He must take multiple heart medicines and stick to a restricted diet for the rest of his life, Seeger said.

"He was really looking forward to his retirement years, and Vioxx has taken a lot of that away," Seeger said.

Consumer Advocacy Group Helping Hundreds of Puerto Ricans File Suits Against Vioxx

2005-09-02T20:11:00.000-07:00

Wednesday August 31, 6:24 pm ET
By Alexandra Olson, Associated Press Writer

SAN JUAN, Puerto Rico (AP) -- A consumer advocacy group said Wednesday it was helping hundreds of Puerto Ricans file lawsuits against the maker of withdrawn painkiller Vioxx before a September deadline.

Merck & Co. pulled the popular pain reliever from the market on Sept. 30, 2004, after a study found it doubled patients' risks of heart attacks and strokes after 18 months.

Under Puerto Rican law, consumers must file lawsuits within a year of learning a product is flawed, said Eric Quetglas, a lawyer working with Consejo de Latinos Unidos (Council of United Latinos).

About 500 Vioxx users in the U.S. Caribbean territory want to file claims against Merck, said K.B. Forbes, the group's executive director. About 150 of them said they suffered strokes or heart attacks, or had relatives who died after taking the drug, he said.

"We want to make sure that Puerto Ricans get a fair shake," Forbes said.

Quetglas said he would add the 500 new claims to a suit filed by a Puerto Rican family last year in a U.S. District Court on the island.

The drug's link to heart attacks and strokes has prompted thousands of lawsuits and a US$253 million (euro205 million) jury verdict in Texas last week.

Officials at New Jersey-based Merck did not immediately return telephone calls seeking comment.

Consejo de Latinos Unidos presented a report in March saying Merck did not inform Puerto Ricans of the dangers of Vioxx in Spanish and urged pharmaceutical companies to publish health warnings in that language.

Merck had revised the pain killer's warning label and prescribing information for physicians in April 2002 to warn of possible side effects. But the new labels were published in English in Puerto Rico, even though Spanish is the most common language spoken on the island, the council said.

The council, a national nonprofit group with offices in Los Angeles and Miami, is helping the Puerto Rican consumers fill out an extensive questionnaire that a federal court in New Orleans has required of stroke or heart attack victims, Forbes said. The court is handling federal cases against Vioxx in the preliminary stages, said Quetglas.

Merck faces ongoing claims after Texan ruling on rofecoxib

2005-09-02T20:08:00.000-07:00

Janice Hopkins Tanne
New York

The drug company Merck may face thousands of lawsuits over its cyclo-oxygenase-2 inhibitor rofecoxib (Vioxx) after losing a court case concerning the death from an arrhythmia of a fit 59 year old man from Texas who was taking the drug. The jury awarded his widow $253.4m (£140m; 206m)—$24.4m for economic loss and emotional anguish and $229m in punitive damages. However, the award will be reduced under Texan law to about $26m. Merck has said it will appeal.

Robert Ernst, who died in his sleep in May 2001, had taken rofecoxib (Vioxx) for eight months

But Merck faces at least 4200 state and federal lawsuits in the United States by people or their relatives who say they were harmed by the drug.

People elsewhere—the United Kingdom and other European countries, Australia, New Zealand, Israel, and Brazil—are also planning lawsuits. About 400 000 people in the UK are reported to have taken Vioxx (Observer, "Vioxx Britons queue up to sue", 21 Aug, http://observer.guardian.co.uk).

The next US case will go to trial in Merck's home state of New Jersey this month. The case is being brought by a Vietnam veteran who had a heart attack, but survived, after taking rofecoxib for two months.

A third case, in a federal court, where rules are stricter than in state courts, will begin in November in New Orleans. The case concerns a man who died from a blood clot after he had taken the drug for a month.

The UK law firms of MSB in Liverpool and Irwin Mitchell in London are representing British people who say they were damaged by the drug. A solicitor for Irwin Mitchell said that the firm was considering suing in the US, where awards are often higher than in the UK.

About 20 million people worldwide are thought to have taken rofecoxib, which was promoted to doctors and the public as being safer than aspirin and non-steroidal anti-inflammatory drugs because it did not cause gastrointestinal bleeding.

Kenneth Frazier, Merck's senior vice president and general counsel, has said that Merck would appeal the Texan case. He said the case was flawed: the risks of traditional non-steroidal anti-inflammatory drugs and rofecoxib were similar, and no evidence has been shown that rofecoxib caused cardiac arrhythmias.

Each case, Mr Frazier said, presented a different set of facts. He told the New York Times (Aug 26; sect A: 1) that it would consider settling suits brought by people who had taken rofecoxib for a long time and had few risk factors for heart disease but that it did not plan to enter a broad settlement. Merck has set aside $675m to fight the suits.

Financial analysts have estimated that Merck faces liabilities of $10bn to $50bn.

Rofecoxib was approved by the US Food and Drug Administration in 1999. It was withdrawn from the market in September 2004 after a study showed that it doubled the risk of heart attack or stroke if it was taken for longer than 18 months. The risk was thought to be due to blood clots. Since then Merck's share price has almost halved.

News reports suggested that the Texan case was considered weak because the autopsy report for Robert Ernst said the cause of death was a cardiac arrhythmia, not a heart attack or stroke. Mr Ernst, a produce manager at the local branch of a supermarket chain and a triathlete who ran marathons, died in his sleep in May 2001. He had been taking rofecoxib for eight months to ease pain in his hands.

Mark Lanier, the winning lawyer in the case, brought the pathologist who did the autopsy, Maria Araneta, back from the United Arab Emirates, where she currently lives, to testify. She said that she didn't report a blood clot but that it might have been dislodged by cardiopulmonary resuscitation and that she was unaware of the risk from cyclo-oxygenase-2 inhibitors at the time.

Her testimony was challenged by Craig Pratt, director of research at the Methodist-DeBakey Heart Center in Houston, Texas. He said he didn't think the patient had a clot and he didn't think the death was due to rofecoxib.

VIOXX: ITALIAN CONSUMERS START CLASS ACTION AGAINST MERCK

2005-09-02T20:02:00.000-07:00

(AGI) - Rome, Italy, Sep 1 - Italian customers having been prescribed Vioxx produced by pharmaceutical company Merck can contact Italian consumer association Codacons if they wish to partake in the class-action in US courts.

The case is being brought to bear after the drug was found to have damaging side-effects. Choosing US courts de facto sets a limit to the time available to submit for damages. "According to Food and Drug Administration reports Vioxx has been deemed responsible for the death of some 27 thousand persons due to sudden heart attack", reads a Codacons communique'.

Codacons also specifies that the interests of some 100 Italian citizens have been brought to bear. "The pharmaceutical company has been forced by Illinois judge - says Chicago based Codancons lawyer Kenneth Moll - to pay 250 million dollars to the families of the victims for having deliberately covered up the nature of the drug's negative side-effects".

In the US alone some 240 thousand citizens are claiming damages. The courts are yet to designate eligibility criteria. According to Codacons as many as 3.5 million Italians may have taken Vioxx at some stage.

Codacons has also drawn up a blacklist of dangerous drugs: 28 drugs in all, 15 active ingredients; top of the list are Bextra (valdecobix) and celebrex (celecobix) leading to requests by consumers and the Italian drug agency AIFA for them to be banned. (AGI)

Vioxx case returns to Texas

2005-09-02T19:54:00.000-07:00

Houston Business Journal

Texas Attorney General Greg Abbott applauded a ruling by U.S. District Judge Lee Yeakel in Austin that returns the state's lawsuit against pharmaceutical company Merck & Co. to state district court in Austin instead of federal court in New Orleans.

Abbott says he will promptly seek a date for a state jury trial to determine the damages Merck owes the state of Texas for allegedly failing to point out what it knew to be the dangers of the painkilling drug Vioxx, even as the company offered the drug to Medicaid patients at state expense.

"This ruling affirms what we have sought from the beginning -- for this lawsuit to be tried in a Texas court before a Texas jury," Abbott says.

On Aug. 4, the company asked Judge Yeakel to send the lawsuit to federal court, and then to New Orleans, where hundreds of Vioxx-related cases against Merck wait to be heard.

Abbott filed a motion to keep the case in state court, a request the judge granted this week.

The Attorney General filed the original lawsuit in June, alleging the company deliberately misled the state about the drug's high risk in causing heart problems.

According to the lawsuit, the company's repeated failure to disclose the adverse effects of Vioxx, while offering it to the state's Medicaid program as a safe painkiller, directly violates the Texas Medicaid Fraud Prevention Act.

Abbott's suit requests restitution to the state of Texas, plus interest, for all Medicaid payments made to the company for Vioxx prescriptions.

The lawsuit also seeks civil penalties.

The Texas Medicaid program reimbursed pharmacists $56 million for Vioxx prescriptions they filled for patients over a five-year period.

The Attorney General is invoking a provision in state law that allows for that amount to be automatically tripled to $168 million, which Merck would have to pay to the state of Texas if it loses.

UK regulator investigates Merck's handling of Vioxx trial data

2005-08-30T20:12:00.000-07:00

By Nick Smith

LONDON (Agence de Presse Medicale for Reuters Health) - Merck is under investigation by the UK's Medicines and Healthcare Products Regulatory Agency over its handling of Vioxx (rofecoxib) trial data, the company said on Tuesday.

A spokeswoman for MSD UK told APM the MHRA had not revealed what it was looking for but had requested "very wide ranging documentation'' connected with the APPROVe (adenomatous polyp prevention on Vioxx) trial of rofecoxib 25 mg in colon cancer.

It was the preliminary results of this 3-year cancer prevention trial involving 2,600 patients with a history of colorectal adenomas that triggered the worldwide withdrawal of Vioxx on September 30 last year.

According to Merck, the trial's external safety board noticed that the drug might be associated with a higher than normal incidence of heart attacks and strokes after 18 months' use but this difference did not become statistically significant until month 34 -- one week before the drug was withdrawn.

The company spokeswoman said: "We are subject to an investigation in connection with Vioxx and we are co-operating fully with that. The information requested is to do with the communication (of information) surrounding the trial."

"The MHRA has not made accusations or suggested anything specific. The investigation is ongoing and it is rather difficult to comment when we don't know what it is looking for.''

A spokeswoman for the MRHA declined to say what it was looking for or when its investigation was likely to be completed.

In a statement on Vioxx last week, the MHRA said unlimited fines and up to 2 years' imprisonment could be imposed if a company failed to provide information relevant to the evaluation of the risks and benefits of a product.

It added: "The MHRA is investigating whether medicines' legislation was breached by Merck, Sharp and Dohme PLC in connection with Vioxx."

Peering Through the Merck

2005-08-30T20:09:00.000-07:00

Deconstructing the strategy choices facing the Vioxx litigants.
By Cullen Seltzer

On August 19, Merck, the giant pharmaceutical manufacturer, got smacked. In Ernst v. Merck Co., Carol Ernst sued Merck on the grounds that its pain medication, Vioxx, killed her husband, Robert. Merck denied that Vioxx was the cause of Ernst's death. But after locking horns on the case before a jury of 12 Texans, Merck came away bloodied to the tune of $253.4 million. The verdict will almost surely be dramatically reduced, since punitive damages in Texas are capped. Still, the award will likely go up on appeal to around $26 million. For Merck, with net revenues of about $6 billion a year, that news might have been bad, but palatable. But, due to the long, long line of plaintiffs champing at the bit to sue them, the Texas verdict actually means just one down, thousands to go. So what's a Fortune 100 company to do?

Over the coming months, Merck and the lawyers representing Vioxx plaintiffs will have a series of crossing-the-Rubicon decisions to make in this litigation: Each side will have to choose between expensive piecemeal litigation, expensive class-action litigation, expensive settlement, or expensive bankruptcy. And they'll make those choices with precious little information, while their costs spiral upward. So here's a little backgrounder on the calculus behind Merck's and Vioxx plaintiffs' fight-or-flight decision-making.

Merck has so far insisted that it is not going to settle the Vioxx cases. Rather, it intends to try them one at a time, steadily vindicating its position, clearing its good name, and ultimately persuading the plaintiffs' bar that tangling with Big Pharma, this time, was economically ill-advised. As strategies go, that makes pretty good sense, if they think they can consistently win each of these lawsuits, and especially given the reality of how mass tort cases get litigated and negotiated. While there are thousands of possible Vioxx claimants out there (Merck spent lots of money advertising the drug and sold lots of it, after all), the real threat to the company is actually only posed by a relatively small number of sophisticated, well-financed plaintiffs' law firms.

If you've seen law-firm advertisements on local TV, madly seeking Vioxx clients, you should understand that the local attorneys advertising for that work will very likely do almost none of it. In a series of referral agreements, many of the smaller firms that sign up Vioxx clients will agree to aggregate those cases under the umbrella of larger firms. That estimate of "thousands" of lawsuits, while daunting and real, is therefore a bit of an illusion. If those plaintiffs' firms with large inventories of clients can be persuaded, by a pattern of Merck consistently winning Vioxx trials, to quit the field, Merck can significantly cut its exposure without having to try each of those thousands of lawsuits.

In fairness to the firms representing Vioxx claimants, these referral agreements do help plaintiffs take advantage of the big firms' experience in Vioxx cases. The larger purpose behind the aggregation, though, is the same purpose behind a co-op of any sort: creating market leverage. The firms at the head of these referral chains will, with hundreds or even thousands of cases aggregated, seek some sort of "inventory" settlement with Merck. The plaintiff and defense lawyers in this negotiation will engage in lengthy discussions over the number of claimants included in the inventory, the nature of their illnesses, and the approximate value, if tried, of the whole lot.

Given the plaintiff firms' incentive to settle en masse, the question then becomes why Merck, or any defendant, when confronted with an inventory of such claims, should not pick and choose which to settle. The answer is, they'll try to do just that. Indeed, early indications in the wake of the Ernst verdict are that Merck may have already begun this shift in strategy—litigating some cases and settling others.

The plaintiffs' firms will try to hold out for a large-scale settlement because they won't want to settle their best cases and be stuck with the expense of trying the least compelling ones. Meanwhile Merck will, for its part, have the twin, and sometimes competing, aims of avoiding paying those weak claims and bringing an end to all the litigation that is distracting the company from its mission (developing and selling medicine) and sapping its assets. Merck has created a $675 million reserve for defense costs for Vioxx claims, after all. But that reserve is for defending Vioxx suits, not paying out on them.

How settlement negotiations finally play out, given all these competing interests, will be a function of how each of these parties assesses its litigation risks. If the plaintiffs' firms go on to try a handful of cases and win millions of dollars each time out of the box, Merck will be at a serious disadvantage in the negotiation, and individual plaintiffs will be disinclined to settle at almost any price. On the other hand, if plaintiff firms—which only get paid if they win—perceive any given win to be an unlikely proposition, the value of their large inventory of cases will plummet. Merck would view that weakness as a disincentive to settlement.

As in any negotiation, all this uncertainty is ultimately the lubricant of a settlement. Any party who is certain of victory has no need to compromise. In the Vioxx context, one win by one plaintiff—in circumstances that may not be typical of the whole class of Vioxx plaintiffs—is hardly enough to give the plaintiffs' bar as a whole any certainty about the outcome of Vioxx cases generally. But a few more significant plaintiff's verdicts will tend to alter the psychology of settlement discussions as the parties try to extrapolate this equation:

(% chance of recovery) x (value per claim) x (number of claims)

+ (transactional costs of litigating a claim) x (number of claims) =

Value of Vioxx Litigation

There are, by the way, mechanisms available to Merck to resolve its Vioxx problem short of litigating each case until they have all gone away, or paying out settlements until the company has wasted away. They include removing cases, where possible, from state court to federal court, then aggregating those cases in a single federal district court for consolidated pretrial proceedings. That has already happened in In re Vioxx Product Liability Litigation, MDL No. 1657, where there are already 1,106 actions pending in the Eastern District of Louisiana. These separate lawsuits will be driven through a uniform pretrial process of discovery that will tee up the cases for trial. At that stage, the MDL judge in Louisiana will send the cases back, for trial, to the federal district courts from whence they came.

Alternatively, Merck could just declare bankruptcy and force its creditors to work through a reorganization plan that would include some level of compensation fixed by the court for Vioxx-related injuries. A.H. Robins Co. did just that in Dalkon Shield-related litigation, which allowed that company to emerge from bankruptcy as an attractive takeover target for American Home Products, now Wyeth. And even if Merck does not actually declare bankruptcy, the threat of bankruptcy, and the possibility that many claimants will be left out in the cold or have small recoveries deferred for years, may drive even the most confident plaintiffs to the negotiating table.

Merck may also seek to negotiate, in the context of a nationwide class-action lawsuit, a global settlement of all Vioxx claims. There are already 120 suits seeking class-action certification pending around the country, and the MDL Court in Louisiana would be the likely forum for such a resolution. Sulzer Orthopedics Inc., since bought by Zimmer Inc., a manufacturer of hip and knee prosthetics, negotiated just such a resolution when it was confronted with massive product-liability claims. That settlement—for about $1.1 billion—resolved the claims of more than 25,000 class members. (Full disclosure: I represent the claims administrator in that class-action settlement.) That process enjoys the virtues of buying nationwide settlement of claims while avoiding bankruptcy.

Regardless of whether Merck is responsible for the injuries it's accused of causing—and those accusations are serious—there isn't any question that the company plays an important role delivering health care to Americans and as an engine of our economy. And while uncertainty may be settlement's friend, too much uncertainty renders even settlement unlikely. Right now, there probably isn't enough empirical evidence from which to "thin-slice" a prediction about Merck's future. What we can be sure about, though, is that resolution of Merck's and Vioxx plaintiffs' litigation and economic woes won't come any time soon, and they definitely won't come cheap.

Cullen Seltzer is an attorney in Richmond, Va., and an adjunct professor at the T.C. Williams School of Law at the University of Richmond.

Whose Vioxx is being gored?

2005-08-30T19:35:00.000-07:00

Posted on Tue, Aug. 30, 2005

By MICHAEL KINSLEY
Los Angeles Times

Litigators are circling like alligators around the quivering drug company Merck. Estimates of what Merck ultimately might have to pay people who used its pain pill, Vioxx, rise every day: $50 billion is the highest bid so far. Last week, in the first case to come to trial, a Texas jury awarded Carol Ernst $253 million over the death of her husband. She might get a mere tenth of that. But there are nearly 5,000 Vioxx lawsuits. Just type “Vioxx” into your favorite Internet search engine to see why that number could rise to 20,000.

Merck has set aside $675 million just to cover its legal expenses. But the lawyers collect from both sides. If Carol Ernst gets $25 million, about $8 million of that — the traditional one-third — will go to her lawyer, Mark Lanier. Lanier says that after he pays off the law firm that turned the case over to him, plus other expenses, he’ll be “lucky to get 10 percent.” Shucks.

You might be under the impression that Merck did something terribly wrong in putting Vioxx on the market. But the Vioxx cases don’t generally claim that.

Instead, they are based on the last refuge of the tort lawyer: the “duty to warn.” Any product carries some risk. If you slice up a beach ball, saute it and eat it, the consequences could be dire. But even the world’s greatest lawyer would hesitate to argue that this is the fault of the beach ball manufacturer. That doesn’t mean the lawyer won’t take your case. He or she will take it and argue that the manufacturer should have warned purchasers that beach balls are not edible, cooked or raw.

The duty to warn is one of the law’s great celebrations of hindsight. When something actually has gone wrong, it is hard to argue (especially to a jury) that this development is too unlikely to worry about. And it is nearly impossible to argue that consumers shouldn’t be given information to decide for themselves.

Speaking for myself, I set aside one day a month exclusively for reading all the warning labels on products I have bought, such as beach balls. Then I assess whether the risk I am undertaking exceeds the benefit I hope to gain. But I wonder how many of my fellow citizens are so scrupulous.

I wonder, in particular, how likely it is that Carol Ernst’s husband would even have noticed such a warning on the side of the box or bottle or speed-mumbled during one of those eerily atmospheric TV commercials for prescription drugs.

Or, if he noticed it, would he have acted? It might have saved his life, but only in the way that deciding to take a later flight has saved your life when the earlier plane crashes. There is no actual connection. The studies Merck is accused of ignoring suggest a small increased risk of a heart attack among people using Vioxx for more than 18 months. Robert Ernst had used Vioxx for only eight months, and he didn’t die of a heart attack. He died of a different heart ailment known as arrhythmia. Lanier convinced the jury that the arrhythmia could have been caused by an earlier heart attack that left no trace.

The absurdities pile on. Everyone but a few extreme libertarians can agree that the government has a legitimate role to play in protecting us from dangerous prescription drugs. Only the government can make rules that are uniform and consistent over time, so that investors in drug research can rely on them.

But in our system, the government plays two conflicting roles. The Food and Drug Administration approves or disapproves a new pharmaceutical, weighing the trade-off between risk and benefit. And then the court system comes along and sees that trade-off differently. The fact that Vioxx was approved by the FDA carries little authority in Tort World, where thousands of juries in hundreds of courts of the 50 states will draw the line in other places.

Vioxx was a nearly unnecessary product. It came on the market in 1999 as an expensive alternative painkiller for people whose stomachs couldn’t handle cheap pills such as ibuprofen. Merck’s real offense was selling Vioxx to millions of people who didn’t need the stuff. It did so by abusing the power of advertising, the reality of insurance and our national penchant for shortcuts in the pursuit of happiness. But the entire pharmaceutical industry is guilty on those charges, which apply to safe drugs as well as dangerous ones.

Then there is justice. Foreigners look with amazement on a society that gives Carol Ernst $17 million or so in trade for her 59-year-old husband — more than he’s worth to anyone else and yet almost insultingly inadequate to her — and gives tens of millions to a few lawyers like Lanier, and is about to institute a transparently phony plan to provide prescription drugs that do work to people who need them, but with no money to pay for them.

Mr. Kinsley is the Editorial and Opinion editor of the Los Angeles Times.

Stage set in NJ for second Vioxx trial

2005-08-30T19:32:00.000-07:00

Aug 30, 2005 — NEW YORK (Reuters) - Pretrial motions continued on Tuesday for the upcoming second product-liability trial involving Merck & Co.'s withdrawn arthritis drug, Vioxx, this time in a New Jersey state court.

Jury selection for the new trial is scheduled to begin on Sept. 12 in the Atlantic City courtroom of Superior Court Judge Carol Higbee. During preliminaries on Monday, she denied a request by Merck to delay the trial by 45 days.

The drug maker had requested the delay because of what it termed a "torrent" of bad publicity from the recently concluded first Vioxx trial in Texas. In that case the widow of a man who died after taking Vioxx for eight months was awarded $253 million.

The New Jersey case, one of nearly 5,000 Vioxx-related state and federal lawsuits Merck faces, was filed by Frederick Humeston of Boise, Idaho. The 60-year-old postal carrier and Vietnam War veteran contends Vioxx was responsible for his 2001 heart attack.

Merck is appealing the Texas award and aims to offer a more persuasive defense in Atlantic City, the casino resort town located 125 miles from the drug maker's headquarters in Whitehouse Station, New Jersey.

Merck withdrew Vioxx in September 2004 after it was shown to double the risk of heart attack and stroke among patients who took it 18 months or longer. Thousands of former users, or their survivors, then filed lawsuits against Merck, alleging harm from the medicine.

In the Aug. 19 award, a Texas state court jury found in favor of the widow of a triathlete who died of heart arrhythmia after taking Vioxx.

The drug, introduced in 1999, had global sales of $2.5 billion in 2003.

Judge sets dates for trio of Vioxx trials

2005-08-29T20:09:00.000-07:00

Cases to help build foundation for others

Saturday, August 27, 2005
By John Pope
Staff writer
The Times-Picayune

A federal judge in New Orleans has set trial dates for early next year in three of the thousands of lawsuits brought against the manufacturer of the pain medication Vioxx, an attempt to give lawyers for both sides an idea of how juries will react to the complaints about the drug.

The trials will start Feb. 13, March 13 and April 10 before U.S. District Judge Eldon Fallon, though the actual cases to be tried have not been selected.

Fallon, who was assigned to conduct the nationwide pretrial phase, set the dates at the monthly status conference on the process. It was the first such meeting since a Texas jury on Aug. 19 awarded a widow $253.5 million in the first trial of a Vioxx suit.

In February, a federal panel gave Fallon the task of streamlining such processes as gathering evidence and taking depositions in the federal Vioxx cases.

Fallon told attorneys for plaintiffs and for the pharmaceutical company Merck & Co., which produced Vioxx, to divide the lawsuits into three categories based on such criteria as the length of time someone took Vioxx or a side effect the drug allegedly caused, and then to pick one representative suit from each category.

"This will give a taste of each kind of litigation," he said. "It will be most instructive."

If the lawyers cannot agree on cases, Fallon said he will make the selections.

Philip Wittmann, a spokesman for the defense lawyers, estimated each trial will last two weeks.

There will be plenty from which the attorneys can choose. As of Thursday, 1,811 federal cases had been filed in New Orleans, and about 290 are en route, Wittmann said.

Fallon said the total may approach 6,000 in the next six months.

The suits claim Vioxx, a popular drug that the federal Food and Drug Administration approved in 1999, caused heart attacks or strokes that sometimes were lethal. Merck took it off the market Sept. 30.

The first federal Vioxx trial is scheduled to begin Nov. 28 before Fallon. The plaintiff is Evelyn Irvin Plunkett of Florida, who sued Merck after her husband, Richard Irvin Jr., 53, died of a heart attack in May 2001, a month after he started taking Vioxx for back pain.

At Thursday's session, Fallon told the lawyers to start working on questionnaires that potential jurors will have to fill out, as well as the charge he will deliver before jurors start to deliberate.

Although most Vioxx suits are expected to be tried in the districts where they were filed, Fallon may conduct some trials if both sides agree.

Thursday's conference was the first since a state court jury in the first Vioxx trial ordered Merck to pay $253.5 million to the family of Robert Ernst, a 59-year-old Texas marathoner who died in 2001 after taking Vioxx for eight months. A state cap on punitive damages will reduce that award.

In discussing that loss for Merck, Wittmann said, "You always take that risk when you go before a jury."

There are nearly 2,900 Vioxx suits in state courts, Wittmann said.

Although a federal suit may carry a certain amount of weight and prestige, plaintiffs might choose the state court route because they think they have a better chance of winning at a local level, where they might be better known and jurors might be more favorable, said Andy Birchfield, a spokesman for the plaintiffs' attorneys in the federal suits.

Also, he said, preparation of some state-level cases might have been well advanced before February, when a federal panel consolidated federal Vioxx litigation in New Orleans, and the attorneys might have decided to proceed where they were.

Even though suits are advancing in what Fallon called "a dual-track situation," he said participants in federal and state cases should keep in touch to learn from each other.

"It seems to me that there's an opportunity for coordination, so the states can have the benefit of the multidistrict litigation and the multidistrict litigation can have the benefit of the states."

In preparing for federal trials, Merck has turned over 10 million documents, Wittmann said.

But Fallon said it needs to move faster. Although he acknowledged the Merck team has done "yeoman work" in producing these papers, he said it "has to move the pace up a little bit."

Vioxx award excessive, though understandable

2005-08-29T20:01:00.000-07:00

Texas' cap on punitive damages will reduce multi-million-dollar payoff; meanwhile, Merck urgently needs to clean up its act.

August 29, 2005

If pharmaceutical giant Merck had been on trial in Angleton for callousness and duplicity in the selling of the painkiller Vioxx, the jury's $253 million damage award would be a pittance of what it deserved.

Certainly the evidence showed a company more focused on profit than on its obligation to be candid with doctors and patients. They needed to know that though Vioxx alleviated pain without causing stomach bleeding, it had a potential to cause heart attacks. One patient was Robert Ernst, 59. He had been taking Vioxx for seven months when he died.

But Merck wasn't on trial for being greedy. The lawsuit filed by Ernst's widow, Carol Ernst, claimed Vioxx directly led to her husband's death, this despite testimony that his arteries were clogged. One medical expert called Ernst "a walking time bomb," so dangerous was his medical condition. Jurors, however, were more persuaded by plaintiff lawyer Mark Lanier's argument that this was a story of a cover-up.

Tactically, Merck's attorneys blew it. They bad-gered the widow for more than an hour on the witness stand, a good ploy if you want to lose any sympathy for your side from a local jury. The company's top brass testified by videotape, leaving jurors to wonder why.

But no amount of legal theatrics could have been any worse for Merck's case than its own documents. They showed it had fought re-labeling Vioxx bottles to heighten awareness of its potential for heart problems, even though its own top scientist said the heart risks were great. A lap-dog Federal Drug Administration provided little restraint.

Such a bloated award justifies Texas' lawsuit reform capping punitive damages; Merck's liability will be closer to $26 million - that is, if Texas appellate judges are also convinced Ernst's death was directly tied to the drug.

The larger question is what this means for the public and the health industry. One indication is the queasiness pharmaceutical companies now feel about research and development of new drugs. That means people fighting disease and ailments will suffer needlessly. Merck, which now faces thousands of Vioxx lawsuits, may emerge as a weakened company.

There is a basic mistaken impulse that drives such lawsuits: a belief that life should be risk-free. Medicine, like life, has no such promise. What doctors and patients should demand is the information to make an informed decision about whether the risks were worth the benefits of a valuable drug.

Corpus Christi Caller Times

Prescription For Trouble

2005-08-29T19:58:00.000-07:00

(CBS) When the pharmaceutical giant Merck pulled its blockbuster pain medication Vioxx off the market last fall, it was the largest prescription drug recall in history.

The company said it had taken immediate action after new studies had shown that Vioxx doubled the risk of heart attacks and strokes in some patients.

Just over a week ago, a jury in Texas found that Merck had concerns that Vioxx could cause cardiovascular problems long before it was pulled off the market. It held Merck liable for the death of a man who took Vioxx, and awarded the family more than $250 million in damages.

Much of the evidence the jury heard was reported last November on 60 Minutes by correspondent Ed Bradley. Today, Merck is facing thousands lawsuits that have been filed on behalf of patients alleging that Vioxx was a prescription for trouble.

When it first hit the market under a barrage of TV commercials, Vioxx was hailed by Merck as a miracle drug. It was one of a new class of drugs called COX-2 inhibitors that could reduce all kinds of pain, especially arthritis, without causing serious gastrointestinal discomfort and bleeding, a risk seen in older drugs like aspirin, Aleve and Advil.

With annual sales of about $2.5 billion, Vioxx was one of the most successful new drugs ever.

It was prescribed to people like 39-year-old Janet Huggins, who had been diagnosed with early-stage rheumatoid arthritis.

According to her medical records, Huggins was in otherwise excellent health. But that was until Sept. 25, 2004, when she died of a sudden heart attack, less than a month after she started taking Vioxx. She was buried the day Merck took Vioxx off the market. Huggins' husband, Monty, is suing Merck, holding the company responsible for her death.

"The morning of her funeral, I had just gotten dressed and my sister walked in and told me that she had just seen on the news that Vioxx had been pulled from the market. And when she told me that, I can't explain what hit me," Monty Huggins says. "I dropped straight to the floor. It was just a shock, because this is a 39-year-old female that's in good shape and is healthy and she's got a heart attack."

He says that if the drug had been taken off the market a month earlier, "I believe my wife would be here."

Merck says it believes that many of the deaths being attributed to Vioxx could be explained by any number of other causes. The company insists it has acted responsibly, saying it withdrew Vioxx as soon as it received what it says was surprising data from a clinical trial it was conducting, called the APPROVe (Adenomatous Polyp Prevention on VIOXX) study, designed to determine if Vioxx could prevent colon polyps.

Instead, Merck found something potentially worse: Patients taking Vioxx for longer than 18 months were twice as likely to suffer a heart attack or stroke than those taking a placebo.

Merck declined a request from 60 Minutes for an on-camera interview, but CEO Raymond Gilmartin explained the company's decision in a news conference Sept. 30, 2004: "We're taking this action because we believe it best serves the interest of patients. We believe it would have been possible to continue to market Vioxx with labeling that would incorporate these new data. However, given the availability of alternative therapies, and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take."

Merck maintains that the APPROVe study provided the first clear evidence that Vioxx was linked to heart attacks and strokes. But attorney Andy Birchfield is spearheading an all-out legal assault against Merck.

Birchfield met in November 2004 with hundreds of plaintiffs' lawyers from across the country to coordinate their efforts in lawsuits they planned to file against Merck on behalf of more than 10,000 people who, it's claimed, were harmed or killed by Vioxx.

"Merck knew, even before this drug went on the market, that there could be significant increase in cardiovascular risk. To say that the APPROVe study was the first indication that they had of a risk is absolutely untrue," Birchfield says. "You know, they had warning sign after warning sign, study after study, that suggested a significant, a substantial increase in risk."

Birchfield says Merck ignored the studies because it needed a blockbuster drug because it had several that were coming off patent and Merck was looking for another big revenue source.

Merck denies that profits would come before patient safety. In 1999, Merck conducted its biggest clinical trial of Vioxx, a study of 8,000 people called the VIGOR (VIOXX Gastrointestinal Outcomes Research) study. It was designed to determine if Vioxx was safer on the stomach than an older pain medication called Naproxen.

While the VIGOR study found that Vioxx caused fewer gastrointestinal side effects than Naproxen, Vioxx users also had a nearly five-fold increase in heart attacks. Merck attributed the increase to what it believed was Naproxen's ability to protect the heart, not to any problem with Vioxx.

However, an internal Merck e-mail written by the company's research president in March 2000 (the day he learned about the results of the VIGOR study, and nearly a year after the drug came on the market) said that heart problems "are clearly there." And he said: "It is a shame, but it is a low incidence and it is mechanism-based as we worried it was." "Mechanism-based" refers to the molecular structure of the drug.

Plaintiff's attorneys cite that and other Merck internal memos and e-mails as far back as 1996, which they say show some Merck scientists anticipated a higher rate of heart problems. Merck says those e-mails reflect only hypothetical concerns, and that there was not enough evidence at the time to prove that Vioxx increased the risk of heart problems.

Dr. Eric Topol, chief of cardiovascular medicine at the Cleveland Clinic, was Merck's first and most persistent critic. In 2001, he conducted a statistical analysis of all the available data about Vioxx. His study was published in the Journal of the American Medical Association.

What did his study — which came out after the VIGOR study — find?

"That study, which looked at all the data available for both the medicines of these COX-2 inhibitors and all other medicines, including aspirin, that were available, showed a very substantial worrying risk of heart attacks and strokes — across the board — from the VIGOR trial and about Vioxx," says Topol.

Topol examined data from a 1998 Merck clinical trial called Study "090", which was never published. Among 978 patients studied, serious cardiovascular events, including heart attack and stroke — were found about six times more often in patients taking Vioxx than in patients taking another arthritis drug or a placebo.

Merck says that study was too small and not statistically significant enough to be able to draw any conclusions. But Topol maintains that, combined with the VIGOR trial, it showed that by the year 2000, there was solid evidence that Vioxx was not safe. Merck says Topol's methodology was flawed and disputed his findings.

"Merck took on any study that questioned the safety of Vioxx, with respect to the heart attacks and strokes. Any study," says Topol.

"But can't they say on the other hand, 'OK, there are always dissenters. We've got these other studies that say the drug is fine,'?" asks Bradley.

"Whenever you find a problem and you're thinking maybe it's not a problem, you want to see if there's independent replication," says Topol. "So if you have Study '090', and you want to discount that somehow, then you have VIGOR. You've got two trials now. You have essentially lightning striking twice. That's independent replication. That's really serious confirmation. This is unequivocal. This is a problem."

Merck says while it was concerned about the cardiovascular risks seen in the VIGOR study, it was not conclusive evidence that Vioxx caused heart attacks. And the company points out that it conducted a number of studies before and after FDA approval, which did not show the heart risk seen in the VIGOR study.

As safety questions about Vioxx continued to be raised in medical journals, Merck continued its $500 million advertising campaign. The company had developed a training document 60 Minutes obtained called "Dodge Ball Vioxx," which instructs Merck sales representatives how to promote the drug to physicians.

The document consists of a 12-page list of obstacles. These are questions a doctor could pose, such as "I am concerned about the cardiovascular effects of Vioxx."

A former Merck sales representative told 60 Minutes how she was trained to answer that question. She asked that 60 Minutes not use her name, and that 60 Minutes alter her appearance and voice.

"We were supposed to tell the physician that Vioxx did not cause cardiovascular events; that instead, in the studies, Naproxen has aspirin-like characteristics which made Naproxen a heart-protecting type of drug where Vioxx did not have that heart-protecting side," she said.

The FDA says there is no conclusive evidence that Naproxen protects the heart. Merck told 60 Minutes the use of the word "dodge" was unfortunate and that the company instructed its sales force to be honest and straightforward about Vioxx.

The former sales representative we spoke to told us she feels the company betrayed her: "I put my reputation on the line. I gave my physicians my word that Vioxx was a safe, effective product and it's been pulled from the market because it was killing people."

Merck's marketing campaign didn't sit well with the FDA, which sent a warning letter to the company in September 2001, saying that sales representatives "have engaged in false or misleading promotional activities," and that the company's promotional campaign "minimizes the potentially serious cardiovascular findings" about Vioxx.

Janet Woodcock, acting deputy commissioner of the FDA, says her agency took appropriate action based on the Vioxx studies. "Certainly, we were concerned," says Woodcock.

"If you were concerned, you weren't concerned enough to pull it off the market," says Bradley.

"That's correct," says Woodcock. "Here we had a new benefit, and I think it's important to recognize that there are many thousands of deaths every year from the gastrointestinal toxicity of the anti-inflammatory agents.

"On the other hand, we had, as you said, a red flag for clotting, for cardiovascular events. But we didn't know what it meant. There were other studies that did not show this increase with the ordinary dose of Vioxx, and more study was needed to understand what this meant."

Looking back, was there anything the FDA should have done?

"I think we were on top of the case here," says Woodcock. "And we did what we could to get all the evidence together and keep information flowing."

The FDA says Merck made certain changes, including changing the Vioxx package label in 2002 disclosing cardiovascular risks. But that was more than a year after the FDA asked the company to do so.

The British medical journal The Lancet published a study that concluded, based on an analysis of previous studies, Vioxx should have been "withdrawn several years earlier."

While Merck disputes that finding, Topol says there is a lesson to be learned.

"In trying for now two decades in my career to try to prevent heart attacks and treat heart attacks, to have a medicine that's causing heart attacks and strokes is something that can't be tolerated," Topol says. "These are the two biggest, most important killers in our society. And then it's important that we never have something like this happen again."

Vioxx isn’t the only pain medication to raise safety concerns. In April, the FDA persuaded Pfizer to withdraw its popular drug Bextra from the market and issued a requirement that more than a dozen similar pain drugs (such as Celebrex) carry strong warnings about cardiovascular risks.

Austin attorneys reviewing hundreds of potential Vioxx cases

2005-08-29T19:45:00.000-07:00

Jonathan Selden
Austin Business Journal Staff

You almost could hear the "cha-chings" all the way from the East Texas town of Angleton.

An Angleton jury's recent $253.4 million Vioxx verdict against pharmaceutical maker Merck & Co. Inc. creates the potential for big-money settlements for Austin plaintiffs' law firms with Vioxx suits on their dockets.

Austin law firm Slack & Davis LLP is one of the area's major players in Vioxx litigation, "reviewing hundreds of cases from all over the U.S.," partner Donna Bowen says. However, the number of Vioxx cases to be handled by the firm hasn't been determined.

Another Austin attorney, Tommy Jacks of Mithoff & Jacks LLP, says his firm has filed "just under a hundred [Vioxx] cases so far, and there are perhaps twice that many that we're still investigating." He says he has filed roughly a dozen of those cases in federal court in Austin.

The cases involve Merck's knowledge of alleged cardiovascular dangers associated with taking Vioxx. After internal research showed an increased risk of heart attack, the company voluntarily recalled the painkiller last September.

The Angleton verdict "is a clear message that Merck's documents make a jury angry," Bowen says. "The jury is saying that 'We don't approve of your conduct.'"

Whitehouse Station, N.J.-based Merck (NYSE: MRK) says it will appeal the Angleton ruling, which is likely to be reduced under Texas' limits on punitive-damage awards.

"We believe that we have strong points to raise on appeal and are hopeful that the appeals process will correct the verdict," Kenneth Frazier, Merck's senior vice president and general counsel, says in a statement.

Nonetheless, Bowen says the Angleton verdict doesn't alter Slack & Davis' strategy.

"We're not going to sign up ... cases that don't have merit," she says.

Although Merck's Frazier says "there are other Vioxx cases coming to trial and we will vigorously defend them one by one over the coming years," Bowen says she isn't deterred and expects to take the firm's first Vioxx cases to trial next year. She says most of her firm's potential cases are from Texas.

Even Texas Attorney General Greg Abbott has joined the Vioxx legal rush.

He's suing Merck in Travis County District Court. The claim: Merck forced Vioxx into the state's Medicaid program.

The suit alleges Texas paid $56 million for allegedly faulty Vioxx medication and accepted Merck's pitch that Vioxx should be added to the list of approved Medicaid drugs. Abbott's suit seeks $168 million in damages.

"This unanimous verdict by a Texas jury validates why my office brought suit against this company in the first place," Abbott says in a statement.

"The verdict also shows why Texas deserves to get its money back from Merck. The company purposely peddled a drug on the open market that it knew could harm people. Merck compounded this problem by giving false information to the state's Medicaid program about the drug's safety."

But Abbott's case isn't going quite as smoothly as others are.

Earlier this month, Merck filed a motion to move the case to federal court in Austin. That procedural step would transfer the case to what is viewed as the more corporate-friendly territory of the federal court system.

In his motion to shift the case back to the state court system, Abbott says Texas' "allegations in the lawsuit arise solely from [Merck's] misrepresentations of the risks associated with the drug Vioxx, which violate ... the Texas Medicaid Fraud Prevention Act."

"The company is clearly trying to evade justice by using these delay tactics," Abbott says in a statement.

"This is a major disappointment to the taxpayers of Texas, who deserve to be reimbursed for the company's wrongful scheme to defraud Medicaid. I urge Merck to stop evading their obligations. A Texas jury deserves to hear evidence of fraud in a Texas district court."

Next, Merck moved to consolidate Abbott's Texas case with thousands of other federal Vioxx cases before the federal multidistrict litigation judge in New Orleans.

In response, Abbott says: "Merck took almost $60 million from Texas taxpayers and knowingly endangered the health of our citizens. Now the company is running from its responsibility by trying to flee to Louisiana. Texans deserve better from a company that insists on doing business here."

Vioxx maker faces deluge of lawsuits

2005-08-29T19:43:00.000-07:00

US pharmaceutical giant Merck and Co. faces a growing number of class-action lawsuits in Canada after it lost a wrongful death case related to its arthritis painkiller Vioxx, an attorney representing plaintiffs said.

A Texas jury last week awarded damages totalling more than $253-million to Carol Ernst, whose 59-year-old triathlete husband Robert died in May 2001 from heart failure after using Vioxx to treat pain in his hands.

Since then, the number of legal complaints have spiked in Canada, said Murray Miskin, a Toronto attorney who represents 300 Vioxx users suing Merck.

"People are seeing that there is something happening, there is actually a decision and it is a warning: big money to somebody who used Vioxx," he said.

According to Miskin, about 3000 people have filed about 30 lawsuits in several Canadian courts.

The attorney said Merck could face damages of $41.5-million.

Vioxx was introduced to the Canadian market in 1999 and withdrawn in 2004. About 700 000 Canadians are believed to have used Vioxx.

The Texas jury found Merck guilty of liability, negligence and malice over the sale of Vioxx.

Merck has been deluged with lawsuits around the world since it yanked the $2.5-billion-a-year seller Vioxx from the market last September after an internal study showed it increased the risk of strokes and heart attacks.

The drug was taken by more than 20 million people worldwide before its withdrawal.

NJ judge rejects Merck motion to postpone next Vioxx trial

2005-08-29T19:38:00.000-07:00

By Associated Press
Monday, August 29, 2005 - Updated: 04:54 PM EST

TRENTON, N.J. - Beleaguered drug maker Merck & Co.'s request to postpone the next trial over its withdrawn painkiller Vioxx was turned down Monday by the New Jersey judge presiding over the case.

Superior Court Judge Carol E. Higbee, who is overseeing nearly 2,500 Vioxx product liability cases that have been filed in New Jersey, also rejected two other Merck motions related to the upcoming trial.

Whitehouse Station, N.J.-based Merck, in a motion filed last week, had urged Higbee to postpone the trial's start for 45 days, citing a ``media blitz'' after the first Vioxx trial. That ended Aug. 19 with an Angleton, Texas, jury awarding $253.4 million to the widow of Bob Ernst. He died in 2001 after taking Vioxx for eight months. The award is expected to be reduced to about $26 million due to Texas caps on punitive damages.

Set to start Sept. 12 in Atlantic City, the second trial over the drug involves a 60-year-old postal worker and former Marine from Boise, Idaho. Frederick ``Mike'' Humeston suffered a heart attack, but survived, four years ago shortly after he began taking Vioxx for pain from old war wounds.

Merck pulled its blockbuster arthritis treatment, which had been bringing in $2.5 billion in annual revenues, from the market when its own study showed Vioxx doubled the risk of heart attack or stroke when taken for at least 18 months.

However, the first two cases to come to trial in state courts both involve plaintiffs, Ernst and Humeston, who had taken the drug for a much shorter time.

Higbee ruled Monday morning that the trial will start with jury selection on Sept. 12, as scheduled, according to Higbee's court clerk, Chris Morgan.

The judge also ruled against Merck on motions to exclude marketing and promotional materials about Vioxx, and other evidence about Merck's conduct, which the company said were not directly related to the Humeston case. Morgan said it's possible Merck could raise those issues again during the trial.

Higbee's daylong hearing on pretrial motions was to continue Monday afternoon.

As of Aug. 15, Merck faced nearly 5,000 lawsuits alleging patients were harmed by Vioxx - nearly 600 cases more than what the company reported five weeks earlier. The total includes about 150 potential class-action suits, which could include many plaintiffs.

Shortly after providing that update last week, Merck officials said Friday that lawyers will consider settling some Vioxx cases, specifically those where plaintiffs took the drug for at least 18 months and had low risks of cardiac problems.

Plaintiff lawyer Mark Lanier, who won the Ernst case, said Friday that Merck likely will face at least 50,000 U.S. product liability suits over Vioxx, plus thousands more from patients overseas. Analysts estimate Merck's liability over Vioxx could run from several billion dollars to as high as $50 billion, but the company has yet to set aside any reserves to cover jury awards or settlements.

Merck shares rose 46 cents, or 1.7 percent, to close at $28.12. It has traded as low as $25.60 over the past 52 weeks but is well below its peak of $47 per share, shortly before Merck pulled Vioxx from the market.

Maker of Vioxx Reports Progress of Suits

2005-08-26T08:02:00.000-07:00

By ALEX BERENSON
Published: August 26, 2005

With the number of Vioxx-related lawsuits soaring, the drug maker Merck may consider offering settlements to plaintiffs in a few cases, the company's general counsel suggested yesterday.

Merck had previously said that it planned to defend every personal-injury lawsuit filed over Vioxx, a painkiller and arthritis medicine that has been shown to raise the risk of heart attacks and strokes.

But the general counsel, Kenneth C. Frazier, said in an interview yesterday that Merck would consider settling suits brought by people who took Vioxx for long periods of time and had few other risk factors for heart disease. Nearly 5,000 Vioxx suits have already been filed, and tens of thousands more are expected.

Mr. Frazier's comments appear to represent a subtle but important shift in strategy for Merck, although he denied that the company had made any change in its position. The issue of possible settlements is extraordinarily sensitive for Merck because of the prospect that plaintiffs' lawyers might file many additional lawsuits if they believe that Merck is willing to settle any of them.

But taking every case to trial also has risks, as Merck discovered last week when a jury found it liable for the death of a Texas man and ordered it to pay millions in the first Vioxx case to reach trial.

In response to a question as to whether Merck would settle cases, Mr. Frazier said, "We would look at the facts of the case and make reasonable decisions." He added, "The point is that each one of these cases raises individual sets of facts." Cases where settlements might be possible represent only a small fraction of all the lawsuits filed against Merck, Mr. Frazier said.

Merck does not plan to offer plaintiffs' lawyers an overall settlement of all the Vioxx suits, Mr. Frazier said.

"We have no interest into entering into any kind of broad global settlement," he said.

Merck's indication that it may consider settling some cases comes less than a week after a jury in Angleton, Tex., found the company liable for the death of Robert C. Ernst, a 59-year-old man who died in his bed in 2001 after taking Vioxx for eight months. The jury award was for Merck to pay $253 million to Carol Ernst, Mr. Ernst's widow, including $229 million in punitive damages.

The award was among the highest ever given to an individual plaintiff, although Texas law will automatically reduce it to about $26 million and Merck has said it will appeal.

W. Mark Lanier, the lawyer who represented Mrs. Ernst, said yesterday that Merck's willingness to consider settling some cases was an important first step in undoing the damage that Vioxx had caused.

"It's about time," Mr. Lanier said. "I hope they'll own up to full responsibility and not partial." Settling some cases may also marginally improve Merck's chance of winning lawsuits that do go to trial, he said.

"It will at least preclude lawyers like me from saying they've resolved to never settle any," Mr. Lanier said.

Merck stopped selling Vioxx in September 2004 after a clinical trial showed that patients taking the drug for more than 18 months had a substantially higher risk of heart attacks and strokes than people taking a placebo. Other trials have shown that Vioxx raises heart risks over a shorter period of time compared with a placebo or with naproxen, an older painkiller.

Sheila Birnbaum, a defense lawyer at Skadden, Arps who is not involved in the Vioxx litigation, said that Merck's willingness to consider settlements could benefit the company by increasing its legal flexibility.

"Whenever you're in this kind of situation where you're confronting lots of cases, you have to look at each case and figure out whether it's a kind of case that you want to settle or not," Ms. Birnbaum said. "One can never say never - you can only get into trouble saying never."

Merck shares fell another 6 cents yesterday, closing at $27.77.

The next Vioxx suit already scheduled for trial is a state court case next month in New Jersey involving a man who suffered a heart attack after taking the drug for a short time. Yesterday, Merck's lawyers asked the judge in that case to postpone the trial, citing the publicity over last week's verdict in Texas.

And in New Orleans yesterday, a federal judge set trial schedules for four Vioxx cases, including one in November and three more in early 2006.

The judge, Eldon E. Fallon, is overseeing 1,800 Vioxx lawsuits already filed in federal courts around the country. The four scheduled cases are to cover several different kinds of plaintiffs, including people who took Vioxx for a long period of time and those who took the drug for only a few weeks or months, Judge Fallon said.

Merck has pressed to have the federal cases tried quickly because it believes it has a better chance of success in federal court than state court. Federal courts usually have stricter rules on what evidence can be presented than state courts, and federal judges typically have less patience for the aggressive tactics sometimes used by plaintiffs' lawyers.

Merck said at a hearing before Judge Fallon in New Orleans yesterday that as of Aug. 15, it faced 4,951 lawsuits from people who claim that they suffered heart damage after taking the drug, or from the families of people who died after taking it.

The total number of cases has risen by about 650 since July, and has probably jumped again since the Texas jury returned its verdict on Friday.

Lawyers and Wall Street analysts say that Merck could eventually face more than 50,000 lawsuits. Mr. Lanier said his firm alone represented nearly 2,000 plaintiffs.

Mr. Frazier yesterday repeated Merck's vow to appeal the verdict in the Texas case, saying that Judge Ben Hardin had allowed jurors to hear irrelevant and misleading testimony.

"The jury was provided information that was unreliable and prejudicial and irrelevant and misleading," Mr. Frazier said. He said that Mr. Lanier also improperly encouraged jurors to consider the publicity they might receive if they decided against Merck.

Merck has not decided whether to continue using the two law firms that represented it in the Texas case, Fulbright & Jaworski and Williams & Connolly, Mr. Frazier said. In interviews after the case, several jurors sharply criticized Merck's lawyers as patronizing, and some of Merck's witnesses appeared to be ill prepared for Mr. Lanier's questions.

Merck has already designated lawyers from other firms to handle the New Jersey and New Orleans cases, Mr. Frazier said.

"By design we intended to have multiple trial teams going forward," he said.

Drugs giant faces legal battles over painkiller

2005-08-25T20:09:00.000-07:00

By Maxine Frith

LONDON: The growing furore surrounding the painkiller Vioxx could prove to be the most expensive legal action ever faced by a drugs company and raises questions about the marketing tactics used by a multibillion-pound pharmaceutical giant.

At least 300 British patients who claim to have suffered heart attacks and strokes as a result of Vioxx, as well as the relatives of others who died, are to sue the makers, Merck, for millions of dollars in the US courts.

More than 4,000 sufferers from around the world have also lodged negligence claims against Merck, with experts warning that the company faces a “potentially unlimited” flood of cases that could cost it more than $50bn.

Merck is accused of deliberately withholding information about the potentially fatal side-effects of Vioxx from regulators and misleading doctors about the risks of the drug in its desire to rush its product on to the market. The case highlights the way pharmaceutical companies can distort scientific data on a product to exaggerate its benefits.

More than 20mn people, including 400,000 in the UK, took Vioxx before Merck withdrew it last September following a study suggesting that taking the drug for more than 18 months could double the risk of heart attacks in some people. Merck claims that the drug was thoroughly tested and has strenuously denied any wrongdoing.

The hopes of those suing have been buoyed by a ruling by a court in Texas last week that the drugs giant was responsible for the death of an American man who died in 2001 after taking Vioxx. Merck was ordered to pay his widow $253mn in damages after the jury heard damaging testimony that Vioxx was rushed on to the market without proper testing and that doctors had not been told of the potential risks of the drug.

British solicitors dealing with the class action said they were deluged with calls from more alleged victims after details of the Texas case emerged. Russell Spargo, of MSB solicitors in Liverpool which is dealing with 150 claimants, said: “This is a ticking bomb for Merck. The Texan case was seen as one of the weakest claims and Merck were convinced they would win it. This could run into millions of pounds for the British victims alone.”

Spargo said American research estimated that more than 60,000 people may have died as a result of taking Vioxx – a death toll greater than American fatalities in the Vietnam war. “This is a drug that should never have been marketed in the way it was.”

The scale of the Vioxx case outstrips the Thalidomide scandal that led to the 1968 Medicines Act governing the way in which drugs are regulated. The Medicines and Healthcare Products Regulatory Agency (MHRA) which approves drugs in the UK, has launched an investigation into whether Merck deliberately withheld information on Vioxx when it applied for a British licence in 1999.

Documents in the Texas case alleged that officials at Merck knew as early as 1998 that the drug was linked to an increased risk of cardiovascular problems, but that the data was suppressed.

Vioxx was one of a new class of anti-inflammatory drugs called COX-2 inhibitors that were believed to be more effective than old-style painkillers, and with a reduced risk of ulcers and gastric problems.

Merck was competing with other drugs giants, including Pfizer, to bring the first COX-2 drug on to the market for treating arthritis and other conditions. The profits would have potentially run into billions of dollars, and the rival companies were spending millions on making and marketing their drugs.

In 2002 alone, Merck spent more than the Pepsi-cola company on advertising and marketing its product.

Among allegations being investigated is the possibility that in the rush to beat Pfizer, Merck did not tell the US Food and Drugs Administration (FDA) or the MHRA about the known risks of Vioxx.

Nancy Santanello, a chief researcher for Merck, told the Texas trial that the company’s research unit had raised concerns as early as 1998 over the increased risk of heart attacks and strokes. Evidence given to congressional hearings in the US has also revealed how sales representatives employed by Merck were told to dodge questions from doctors about the side-effects.

The $229mn awarded in punitive damages in the Texan case was equivalent to a 2001 estimate by Merck of the extra profit it would make if it could delay an FDA warning on the heart risks of its drug.

Vioxx was approved by the FDA in May 1999 and by the MHRA just two months later.

Incredibly, a loophole in the Medicines Act means that it is currently not illegal for a drugs company to withhold information from the MHRA when seeking a licence. That loophole is now to be closed.

Merck says it is determined to fight every case brought against it.

Vioxx case tally nearly 5,000 and growing

2005-08-25T20:04:00.000-07:00

By ADAM NOSSITER, Associated Press Writer

NEW ORLEANS (AP) - The tally of lawsuits against Merck & Co. in state and federal court over its painkiller Vioxx is nearly 5,000 and growing, lawyers said in federal court here Thursday, less than a week after the drug maker suffered a stinging defeat in a state court in Texas.
The implications of the loss in the first of the case to be tried against Merck are still playing out. But at a routine monthly meeting here lawyers - and U.S. District Court Judge Eldon Fallon - made it clear they expect the number of cases against Merck will grow.

In federal court alone some 1,800 cases have already been filed and Fallon suggested that number could eventually double, or even triple. Federal cases have been filed all over the country, but have been consolidated here because of Fallon's expertise in dealing with complicated, large-scale court fights.

Fallon reiterated his straightforward strategy for attacking this mass of litigation. He's asking the lawyers on both sides to pick representative cases from four categories of complainants including, potentially, stroke and short-term users of Vioxx. The first of the plaintiffs has already been chosen: a heart-attack victim from Florida, Richard Irvin Jr., who died in May 2001, one month after he began taking Vioxx for back pain.

The Irvin case starts here Nov. 28, and it will be followed by trials on Feb. 13, March 13, and April 10, 2006, Fallon said. Before the first federal case, however, Merck must weather a trial in New Jersey state court next month and possibly one in Texas in October.

The New Jersey case, involving a 60-year-old Boise, Idaho, postal worker who survived a heart attack after taking Vioxx briefly, is to start in Atlantic City on Sept. 12. Merck filed a motion late Wednesday asking the judge to postpone the trial's start for 45 days, and Superior Court Judge Carol E. Higbee is expected to consider the motion next week.

Lawyers for Whitehouse Station, N.J.-based Merck are arguing the huge Texas damage award "has caused such a media blitz that the specter of unfair prejudice compels Merck" to seek the delay.

"The likelihood of it being granted is about one in a million," Chris Seeger, the attorney for postal worker Frederick "Mike" Humeston, said Thursday.

Analysts have already criticized Merck's strategy in the Texas case, where a jury awarded $253.4 million in damages to the widow of Bob Ernst, who died in 2001 of irregular heart beat, or arrhythmia, after taking Vioxx for eight months. Observers said Merck's case was potentially strong - no evidence has so far linked Vioxx to arrhythmia - but that during the trial the company relied too heavily on scientific arguments, neglecting human ones.

Merck plans to appeal that verdict, which is certain to be reduced. But it is unclear what lessons, if any, will be drawn from it for the Irvin case. "Our strategy here is to defend the case on the issue of causation," Merck lawyer Phillip Wittmann said Thursday, after the hearing.

"We believe the science will carry the day," Wittmann said. He suggested that the tone in the courtroom, as well as some of the evidence allowed, will likely differ considerably from the Texas case.

"Some of the evidence we saw in Ernst, we won't see here," Wittmann said, citing what he said was "hearsay" and "spontaneous outbursts" in the Texas case.

Fallon has been praised for keeping tight deadlines and wanting to move the cases along.

Merck shares fell 6 cents to close at $27.77 Thursday on the New York Stock Exchange.

Merck Says Vioxx Lawsuits Increased 15 Percent in Past Month

2005-08-25T20:01:00.000-07:00

Aug. 25 (Bloomberg) -- Merck & Co., the third-largest U.S. drugmaker, now faces 4,951 lawsuits over the painkiller Vioxx in state and federal courts, or 15 percent more than a month ago, lawyers said.

The number of Vioxx suits filed has increased by more than 650 since mid-July, Merck's lawyers told U.S. District Judge Eldon Fallon in New Orleans. Fallon is overseeing all federal litigation over the drug, which Merck pulled off the market after it was linked to increased risk of heart attacks and strokes.

Juries may hear some of those cases next year. Fallon today set trial dates for Feb. 13, March 13 and April 3 and urged lawyers to group their Vioxx claims. That requires attorneys to separate users who had heart attacks from those who suffered strokes. Those groups will be further divided by long-term or short-term use.

``Select the categories and then I'm interested in trying a case in each category,'' Fallon said at a hearing. Picking one in each group will give attorneys with similar cases an idea of the value of their claims and their chances of winning at trial.

The first federal Vioxx case is set to start Nov. 28 in New Orleans. A Texas jury last week ordered Merck to pay $253 million to the family of Robert Ernst, who died at 59 after taking Vioxx for eight months. Merck has set aside $675 million to defend suits over the drug.

``We are pleased with these trial settings and the prospect of things going forward on a rapid basis,'' Ted Mayer, an outside attorney for Merck at Hughes Hubbard & Reed, said. ``By the last part of the second quarter of 2006, we'll know a lot more about the parameters of this litigation.''

Shares of Whitehouse Station, New Jersey-based Merck fell 7 cents to $27.76 in New York Stock Exchange composite trading at 3:40 p.m. They have fallen 38 percent since Merck pulled Vioxx off the market in September, wiping out about $38 billion in market value.

Cases to Triple

The number of Vioxx cases in federal court will probably double or triple in the next six months from 1,811, Fallon said. The paperwork generated by the filings is forcing the court clerk's office in New Orleans to hire more staff, he said.

Merck officials said the increase in cases between mid-July and mid-August wasn't prompted by the Aug. 19 verdict handed down by a state court jury in Angleton, Texas over the company's handling of Vioxx.

That decision was based on ``flawed evidence'' and is likely to be overturned on appeal, Merck lawyers contend. A state cap on punitive damages probably will cut the award to $26.1 million, lawyers said.

``I don't think some of the evidence you saw in the Ernst case you will see'' in the federal case starting in November, said Phillip Whittmann, a lawyer at Stone Pigman Walther Whittmann in New Orleans who is representing Merck. He wouldn't be more specific about what evidence may be excluded.

Attorneys for Ernst's family argued that Merck rushed Vioxx to market and played down its risks, citing e-mails in which Merck scientists expressed concerns and training materials that encouraged salespeople to dodge questions about safety.

Fallon initially set the April trial date for the fourth federal case over Vioxx for April 10. He later moved it up a week to accommodate attorneys' vacation plans.

Early Dates

``We feel good about these early trial dates,'' said Andy Birchfield, a lawyer with Beasley, Allen, Crow, Methvin, Portis & Miles in Birmingham, Alabama, who is representing Vioxx users in the federal cases. ``We just want to make sure that right cases are tried in each of these representative categories.''

Birchfield will serve as one of the lead plaintiffs' lawyers in the first federal suit set for trial in November. The case is expected to last two weeks, he said.

The family of Richard Irvin contends Vioxx caused his fatal 2001 heart attack and that Merck sought to hide the drug's health risks. The 53-year-old manager of a seafood-distribution company in Florida had taken Vioxx for a month for back pain.

Next month, Merck faces claims in state court in Atlantic City, New Jersey, from a former Marine who alleges Vioxx caused his heart attack. Frederick Humeston says he took the drug for pain in his knees, one of which he injured in Vietnam.

His lawsuit is one of about 2,400 pending before New Jersey Superior Court Judge Carol Higbee, Merck lawyers told Fallon at today's hearing.

Will Merck Fare Better in New Jersey?

2005-08-25T19:56:00.000-07:00

Stock Watch
By Mark Glassman Published: August 25, 2005

MERCK (MRK) MESSED WITH Texas and lost. Last Friday, an Angleton, Texas jury ordered Merck to pay $253 million to the family of a man who died after taking the painkilling drug Vioxx. Although that award is likely to be reduced because Texas limits punitive damages, the verdict sent Merck's stock plunging 8% on the day.
And that was just the first Vioxx award. With more than 4,000 trials still on Merck's docket, and with Merck's legal strategy in question, investors are wondering how much more pain is in store.

Analysts and lawyers say it's premature to throw in the towel. The outcome of the next several trials might be just as important in shaping perceptions of Merck's long-term liability as the Texas case was.

The next trial is set to begin with jury selection next month in New Jersey. The plaintiffs in the case are Frederick Humeston, an Idaho resident, and his wife. Humeston, 60, had a heart attack in 2001 after taking Vioxx to manage pain in his knee.

"The stakes are huge," says Howard Erichson, a law professor who studies mass torts at Seton Hall University's School of Law in South Orange, N.J. "The national media attention undoubtedly is going to be less [in the New Jersey case] than what we saw in the Texas case. But to a mass tort defendant [like Merck], what sets up the litigation is not a single trial, but a series of early trials. Merck has to be feeling a lot of pressure now to win this second case. There's a big difference between being 1-1 and being 0-2."

And, at least at the outset, it looks like Merck's chances are much better this time around.

First, consider the venue. Ask any Basking Ridge businessman or Laredo cowboy: New Jersey and Texas are a lot farther apart than the 1,300 or so miles that separate their borders. Texas is a friend to the little guy, a foe to complex legalese and a notoriously difficult environment for defendants in corporate litigation. It was in Texas that a jury awarded the family of a woman who died $1 billion in a case against Wyeth (WYE) in April 2004, after its diet drug fen-phen was linked to heart-valve injury. "Unless you're talking about Mississippi, anyplace is more favorable than Texas," says Scott Henry, an analyst with Oppenheimer & Co. in Boston. (Henry doesn't own shares of Merck; Oppenheimer doesn't have an investment-banking relationship with the company.)

Jon LeCroy, an analyst at New York-based brokerage Natexis Bleichroeder, says Texas lawyers are familiar with how best to exploit the state's population during jury selection. "In Texas, [prosecutors] tend to pick venues with high unemployment. Typically in those type of areas, you get more sympathetic juries that are more anti-big-business. In Jersey, you have a more educated population. You also have a more pharma-familiar population." (LeCroy doesn't own shares of Merck; Natexis Bleichroeder doesn't have an investment-banking relationship with the company.)

And New Jersey is a breeding ground for pharmaceutical companies. At most dinner parties, you could play a very short game of "Six-Degrees-of-Bristol-Myers-Squibb." Merck's Whitehouse Station headquarters is about 120 miles northwest of the Atlantic City courtroom where the trial will take place. Its reception is sure to be friendlier there than in Texas.

Even if the New Jersey jurors aren't tangentially connected to Merck or other pharmaceutical companies, they might be squeamish about raiding the coffers of such a large state employer. New Jersey is slated to lose more than 5,000 civilian jobs from the military base closing at Fort Monmouth, about 50 miles from Merck's headquarters. Roughly 8,000 people work for Merck in the state.

Another difference between the Texas trial and the New Jersey trial is the plaintiff. In Texas, the widow of a man who suffered a heart arrhythmia and died after taking Vioxx took the case to court. In the New Jersey case, the plaintiff, Frederick Humeston, had a heart attack after taking the drug. Vioxx was explicitly linked to heart attacks, a fact that could increase the chances that the company will be found liable. But unlike the victim in Texas, Humeston didn't die. "In this case, this gentleman is still there to testify," says C. Anthony Butler, an analyst with Lehman Brothers. That might work in Merck's favor if damages are ultimately awarded. (Butler doesn't own shares of Merck; Lehman Brothers has a non-investment-banking relationship with the company.)

What does all of this mean for Merck's stock? LeCroy, of Natexis Bleichroeder, says investors can find some upside as the legal drama plays out in New Jersey and afterward, case by case. "Whenever you get a big verdict, you can make money by buying it soon afterward and holding it for a few months," he says. "Typically, on wins, the stock doesn't move a lot, but without a big loss, over time the stock moves upward." But he cautioned that this can be a dangerous game. "You're always at risk of the next big award."

And with more than 4,000 cases to go, it'll be a long game.

UK PRESS: Merck Lawyer: No Plans To Settle Vioxx Suits

2005-08-25T19:54:00.000-07:00

08-25-05 03:39 PM EST
DOW JONES NEWSWIRES

Kenneth Frazier, Merck's & Co. (MRK) general counsel, said in an interview published Thursday that the company intends to fight each lawsuit it faces related to the drug Vioxx. Frazier told the Financial Times in an article published on the newspaper's Web site that the outcome in Angleton, Texas - in which a jury awarded damages of $253 million - was an aberration due to " specious scientific testimony" and said it would be overturned. Merck has lodged an appeal against the verdict; the damages will be reduced to about $26 million under Texas law capping punitive awards.

"Using Angleton as a predictor of all future cases is something we're not prepared to do," he told the newspaper. "We have no intention of entering into a global settlement."

Frazier told the FT that Merck must find ways to "help juries understand complicated science and how it relates to their personal experience." A key issue was to convince jurors that Merck was trustworthy, not greedy, he said. Frazier remained steadfast that Vioxx's "small absolute increase in risk" of a heart attack or stroke only appears after 18 months of continuous use of the drug.

Vioxx's Indian make still on sale

2005-08-25T19:52:00.000-07:00

KOUNTEYA SINHA
TIMES NEWS NETWORK[ THURSDAY, AUGUST 25, 2005 12:06:38 AM ]

NEW DELHI: Arthritis drugs Rofecoxib and Valdecoxib, both of which are globally banned, are openly available at many chemist shops across the Capital.

These drugs, widely used by arthritis patients needing anti-inflammatory painkillers, are also banned in India.

This reporter visited over a dozen chemist shops in south Delhi, all of which had stocks of the two banned drugs. What's worse, not a single chemist stopped this reporter from purchasing the drugs.

Hearing this, a shocked drug controller-general of India Ashwini Kumar told TOI, "This is unfortunate. I can still understand Valdecoxib being sold.

Because the ban on the drug came just three weeks back, many retailers might still not be aware. But the ban on Rofecoxib is over a year old. It should have been shelved totally. The fault lies with the retailer and manufacturer."

He added, "We have notified all state drug authorities, chemist associations and manufacturers about the ban on these two drugs. Authorities have also been told to carry out inspections from time to time. The problem, however, lies in India's complex distribution system.

"Unlike US, where companies have a monopoly over a drug and has seven to eight wholesalers, in India, there are a few hundred manufacturers and an equal number of retailers, doing business in every street. The DCAI can't go to every chemist personally to check."

Rofecoxib is the Indian version of the American painkiller Vioxx. Once considered a miracle drug, it was withdrawn in 2004 after a study concluded it could double risk of a heart attack.

On August 19, 2005, a US jury found Merck, the makers of Vioxx, "negligent" in the death of Robert C Ernst and awarded his widow Carol Ernst $253.4 million in damages. Ernst died in 2001 after taking Vioxx for eight months.

Valdecoxib, meanwhile, was withdrawn from India, just three weeks back, almost four months after this was done in US.

The generic version of this drug, invented by Pfizer, was withdrawn because it posed potential risk of heart attack and serious skin reactions like toxic epidermal necrolysis.

Vioxx Award: Not So Texas-Sized

2005-08-25T19:47:00.000-07:00

Christian Science Monitor

After Texas jurors found that Merck had intentionally withheld the risks associated with its heart drug, Vioxx, they awarded Carol Ernst a whopping $229 million in punitive damages.

The size of the award sent shudders through the drug industry, because Merck faces more than 4,200 other Vioxx-related lawsuits in the United States alone. But under a Texas law that caps punitive damages, Ms. Ernst, the winning plaintiff, will see no more than $1.65 million — less than 1 percent of the original award.

The Vioxx case, which drew national attention for its implications for drugmakers, is also an early and visible example of what happens when states limit the amounts juries award. Ever since it enacted tort reform two years ago, Texas has initiated the latest push in a controversial movement that is gathering steam around the country.

"There has been a tremendous amount of momentum at the state level ever since the enactment of Texas' statute, which was the biggest and most comprehensive legal reform bill in recent time," says Lisa Rickard, president of the US Chamber Institute for Legal Reform in Washington.
Mississippi and Ohio passed comprehensive tort reform bills similar to Texas in 2004, as did Georgia, Missouri, and South Carolina in 2005.

Also this year, Florida tackled questionable asbestos and silica lawsuits by passing standards on what constituted injury. West Virginia passed incremental insurance reforms.

This Friday, Illinois' new caps on damages in medical malpractice lawsuits take effect. The new law also increases oversight of the insurance industry.

In Texas, the legislation dramatically changed the litigation landscape for class-action suits and product-liability and medical malpractice cases.

Lawsuits plunge

For instance, the number of medical malpractice suits filed here has plummeted, leading to a significant reduction in insurance rates for most doctors, tort reform advocates say. Doctors insured with Texas Mutual Liability Trust, the state's largest medical liability carrier, have seen a 17 percent reduction in their premiums in the past two years.

"In general, the hope is that these reforms will bring predictability and stability to the legal system," says Gretchen Schaefer, a spokeswoman for the American Tort Reform Association in Washington. "And specifically in Texas, these reforms have had a positive impact on the state's economy and job growth, the cost of medical liability and access to healthcare. We should expect to see similar results in other states that have enacted similar reforms."

But plaintiffs' lawyers say there is plenty of evidence that those most in need of help — children, stay-at-home parents, and the elderly — are being punished by these tort reforms.

Fred Hagans, for instance, used to file 10 to 15 medical malpractice lawsuits per year until the new reforms were put in place two years ago.

Since that time, he has filed only one, and that one was only because he thought it was "the right thing to do" — not because he thinks it will financially benefit his clients or his law office.

"It's a money loser for us," Mr. Hagans says.

Medical malpractice suits used to represent roughly 30 percent of his caseload; now, it's down to 1 percent, he says. Similar declines are being reported in lawyers' offices across the state.

Tort reform "has essentially eliminated medical malpractice cases in this state," he says.

With a $250,000 cap on non-economic damages, the Houston lawyer says that after paying $150,000 in fees to experts and another $50,000 to take the case to trial, these cases no longer make economic sense.

"The intent of this law was to eliminate frivolous litigation, but the caps don't affect frivolous litigation," says Hagans. "So you're capping the people who need the help the most."

Other critics add that the reforms have taken power out of jurors' hands and driven some lawyers out of business.

Texas was so serious about cutting the number of medical malpractice lawsuits that it became the first state in the nation to rewrite its constitution to limit these damages after voters approved the amendment two years ago.

The concern was that the bill would be struck down as unconstitutional by the state Supreme Court, as a similar bill was in 1998 when President Bush was governor here.

Challenges spread

In Illinois, where new medical malpractice caps take effect later this week, some activists have already said they will challenge the caps in court.

Since taking office, Mr. Bush has also pushed for federal tort reforms. He began his second term traveling to several cities to promote his ideas, and in February signed the Class Action Fairness Act.

The law aims to keep lawyers from filing class-action lawsuits in states with the most sympathetic laws.

It also attempts to force cases with plaintiffs in multiple states into federal courts, where large damage awards are less common.

The president has also backed the creation of an asbestos fund, which would be paid for by companies facing asbestos litigation and their insurers, in an effort to end the flood of asbestos-injury lawsuits.

The bill to create such a fund is still working its way through the Senate, and supporters expect it will be passed in October when Congress reconvenes.
Medical malpractice reform is another important goal for Bush. It got nowhere this session.

"But we don't see it as going away," says Ms. Rickard. "This year was a bellwether year for both state and federal reforms."

Merck Faces More Challenges In Next Round

2005-08-22T21:04:00.000-07:00

LAKE JACKSON, Texas (AP) -- Drug-maker Merck & Co.'s blistering defeat in the nation's first Vioxx trial was only round one in a series of expected court battles in the coming months, many of them involving plaintiffs who have some major advantages.

The link between the patients' health problems and Vioxx is already well established. They suffered heart attacks; Merck yanked the drug from the market last year because a study showed it doubled patients' risk of heart attacks and strokes.

In contrast, Carol Ernst's lawyer in last week's lawsuit had to link Vioxx to heart arrhythmia, or irregular heartbeat, the condition that killed Ernst's husband. Doing that required a lot of complicated medical testimony.

The jury still sided with Ernst, awarding her $253.4 million, though the amount will be reduced because of Texas laws.

Ernst's victory gives lawyers in the upcoming cases something of a playbook for arguing that Merck acted recklessly when it promoted Vioxx. The company's loss is also expected to prompt more lawsuits, on top of the 4,200 already pending. The company's potential liability has already been estimated at up to $18 billion.

Merck does have some strengths in the upcoming litigation that it didn't have in the Texas case.

One of the cases is in federal court, where experts say stricter rules of evidence and testimony may benefit the New Jersey-based drug maker.

Legal experts said some of the testimony allowed in the Texas trial probably would not have been permitted in federal court, especially the surprise testimony from a coroner that a heart attack could have led to the fatal arrhythmia. Merck said its appeals will include claims that the judge erred by allowing testimony from unqualified experts and the undisclosed witness.

The federal case may be Merck's best shot at an early win, and the company desperately needs a victory if it doesn't want to be pressured into settling cases en masse, experts said.

"Federal judges are more cautious about what experts can testify in a case like this (product liability). There are stringent guidelines," said Benjamin Zipursky, a professor at Fordham Law School in New York.

The first federal trial may also present a challenge for the plaintiff because Richard Irvin had only taking Vioxx for about a month before he died of a heart attack in 2001 at age 53.

The study that led Merck to remove Vioxx from the market last year found cardiovascular problems only manifested themselves after 18 months of use. Plaintiff lawyers say other studies point to problems much earlier.

"I expect Merck to make an issue about short-term use, but I'm not worried," said attorney Andy Birchfield, who is representing Irvin's widow. Birchfield said Irvin didn't have any major risk factors for a heart attack, although he was slightly overweight. The case will be heard in federal court in New Orleans in November.

Merck declined to comment for this story. In a statement, company general counsel Kenneth Frazier said plaintiffs face a challenge in proving Vioxx caused anyone's death or injury.

The next case is slated to begin next month in Atlantic City, N.J., and revolves around postal worker Michael Humeston, who had been taking Vioxx for two months before he suffered a heart attack four years ago.

He survived and returned to work on limited duty, but his lawyer, Chris Seeger, said Humeston has permanent heart damage. His condition prevents the former Marine from enjoying favorite pastimes such as camping and hunting because his doctors don't want him too far from a hospital, Seeger said.

"Merck told so many lies. Why should a jury believe them on the 18 months issue," Seeger said. "I think juries have their own gestalt. They go through the evidence and they parse it together."

Jurors in the Texas case didn't seem particularly concerned about how long Bob Ernst took Vioxx before he died. Far more compelling to them were the multitudes of company e-mails and documents which suggested the company knew about the drug's safety problems but ignored them to pump up profits.

While some of the materials that Ernst's lawyer Mark Lanier used might not be admitted at the federal court level, experts said enough of the damaging documents likely would be allowed.

Merck also may find itself facing Lanier again soon. He was scheduled to try a wrongful death case next month in Edinburg, Texas, but asked that it be postponed because of potential time conflicts with the trial he just finished. The trial, which centers on a 39-year-old woman who died of a blood clot in 2001 after taking Vioxx for about a month, could begin in October.

UPDATE: Merck May Shift Legal Strategy After Vioxx Loss

2005-08-22T21:03:00.000-07:00

By Greg Groeller
Of DOW JONES NEWSWIRES

NEW YORK -(Dow Jones)- Merck & Co. (MRK) may alter its strategy of taking every Vioxx-related lawsuit to trial after losing its first courtroom battle last week.

The jury's decision to award a total of $253 million to the family of a man who died after taking the painkiller means that Merck may need to re-evaluate its hardline position, analysts and legal experts said.

Merck faces roughly 4,100 lawsuits related to Vioxx, which the company withdrew from the market last year after a study linked it to increased risk of strokes and heart attacks.

The drug maker needs to get a better understanding of what type of cases it can win and which ones it's more likely to lose before it starts settlement negotiations with any plaintiffs, said David Webster, president of Webster Consulting Group, which works with pharmaceutical companies.

"Merck needs to understand what types of litigants will be successful," Webster said. "Once they understand that better, they can better quantify the cost and benefits of settling with a certain class of patients."

Guy Bizzoco, a Merck spokesperson, said the company has no plans to settle any Vioxx cases. But he declined to comment on whether there were scenarios in which Merck would ever consider settling.

"We believe we have meritorious defenses and intend to defend Vioxx cases one by one," Bizzoco said.

Kim Schmid, a defense attorney for Bowman & Brooke in Minneapolis, who specializes in product-liability cases, said Merck must present a hard public stance against settlements to avoid a flood of frivolous lawsuits.

"They don't want the plaintiffs bar to believe they will tuck their tails and start settling," Schmid said. "They can't afford to send that signal now."

At some point in the future, however, Merck might need to consider settlements, particularly when lawsuits are filed in states or cities where juries are often sympathetic to plaintiffs, she said.

Ellen Wertheimer, a professor at Villanova University School of Law, said the verdict against Merck likely will be reduced by the trial judge or by an appellate court, so Merck shouldn't make any hasty decisions on settling other cases.

"In response to a jury verdict, you don't change your strategy," Wertheimer said.

However, Jon LeCroy, an analyst at Natexis Bleichroeder, said the size of Friday's verdict against Merck casts some doubt on the company's try-every-case strategy.

"We do think that settling individual, high-risk cases may make sense," LeCroy said in a research note. LeCroy doesn't own Merck shares and Natexis Bleichroeder doesn't have an investment-banking relationship with the company.

Local Widow Files Vioxx Lawsuit

2005-08-22T21:01:00.000-07:00

By Melissa Ross
First Coast News

JACKSONVILLE -- A verdict from a Texas jury is giving hope to dozens of Jacksonville famlies suing drug maker Merck over its arthritis medication, Vioxx.

Last week, that jury awarded more than $250 million to a Texas familiy, ruling that the maker of Vioxx was liable for the death of their loved one.

Jacksonville widow Toni Raices says Vioxx killed her husband, too.

"I still cry every night. I've lost my best friend," says Raices, who says her 41-year-old husband, Hector, had slightly clogged arteries but was in otherwise good health when he began taking Vioxx last year for his arthritis.

Raices died of a heart attack last June while playing a basketball game, shortly after going on the drug, his widow says.

She's suing Merck for damages, along with about 20 other area families, says an attorney for the law firm Spohrer, Wilner, Maxwell & Matthews.

"Merck.. failed to listen to the advice of its own scientists," said attorney Woody Wilner.

"They advertised the drug as safe, and it turned out it caused heart attacks and killed people."

Wilner likened the Vioxx controversy to the tobacco litigation of the 1990s, which his firm was also involved in.

Vioxx has been pulled from the market, but Merck maintains the drug has not been proven to cause heart attacks.

Lawyers for the company point out no risks appeared in 58 clinical trials involving 10,000 patients before the drug won approval from the Food and Drug Administration.

Merck's stock took a tumble Monday in the wake of the Texas verdict, and Wilner says pressure on the pharmaceutical giant to settle the Vioxx cases will only continue to mount.

"They fought the Texas case and lost," he said. "Eventually they'll have to do right by all these families." He adds his firm is looking at taking on "hundreds" of Vioxx-related cases.

Attorney: Merck failed to warn customers of Vioxx dangers

2005-08-22T21:00:00.000-07:00

an Associated Press report 08/22/05

JACKSONVILLE - Two months after a 41-year-old Orange Park man died from a heart attack suffered while playing basketball, his widow is suing Merck & Co. saying it is responsible by failing to disclose the dangers of its painkiller Vioxx.

Monday's lawsuit in Duval County Circuit Court by the widow of Hector Raices is one of about 20 Vioxx suits now filed by Jacksonville attorney Norwood "Woody" Wilner and comes on the heels of Friday's jury verdict in Texas that awarded $253.3 million to a woman whose husband died of a heart arrhythmia after taking the drug. Merck said it will appeal the Texas verdict.

About 4,100 national Vioxx-related lawsuits have been filed as of June 30, including an unknown number in Florida. Vioxx was recalled in September by Merck in response to concerns the medication could cause heart attacks and strokes.

Toni Marie Raices said her husband was visiting his son in Paterson, N.J., when he collapsed while playing basketball. He had been taking Vioxx for arthritis pain.

"My husband and I didn't know how dangerous this drug was," she said. "I still cry every night. I lost my best friend."

Guy Bizzoco, a spokesman for the New Jersey-based company, refused to comment on Raices's suit specifically or the Vioxx suits in general. In a statement after the Texas verdict, company general counsel Kenneth Frazier said future plaintiffs would face a challenge in proving Vioxx caused anyone's death or injury.

Wilner said his office is reviewing several hundred additional cases involving deaths and injuries, which may be attributed to Vioxx.

Wilner, who won a landmark $750,000 verdict against cigarette maker Brown & Williamson in 1996 in the case of former smoker Grady Carter, said the issues are similar to the case against Merck.

"Merck, like the tobacco companies, failed to listen to its own scientists. They failed to inform the public. They advertised the drug as if it was safe and it turned out it caused heart attacks and killed people," Wilner said at a news conference.

Wilner did not say how much money Toni Raices was seeking. The lawsuit seeks more than $15,000, the minimum required to file the case in Circuit Court.

"Merck ... will be called up to defend its actions and we are confident that they will be found to have violated the public trust here in Jacksonville, the way they were in Texas."

Lawyers push for Vioxx settlement

2005-08-22T20:57:00.000-07:00

Clara Pirani
23aug05

AUSTRALIAN lawyers will pressure pharmaceutical giant Merck & Co to establish a fund to settle thousands of lawsuits surrounding top-selling arthritis drug Vioxx.

Richard Meeran, a consultant with Australian law firm Slater & Gordon, said a US court's decision to award $US253 million ($337 million) on Friday to a woman whose husband died of a heart attack was the sign of things to come.

"This is the first verdict and one would hope that Merck now recognises that it is going to have to compensate people and give urgent consideration to the establishment of a settlement scheme, rather than forcing them to take on protracted litigation," Mr Meeran said.

In Australia, 1500 Vioxx users have registered for a potential class action against Merck. The drug company also faces thousands of lawsuits worldwide after a study found people who took Vioxx had a higher risk of heart attacks and strokes.

Merck, which withdrew the drug from sale last September, said it would appeal against the decision. "The American jury system and Australian legal system are distinctly different. The case as it has been run in the US could not be conducted in Australia in the same way," it said.

However, lawyers in Australia said the US ruling could pressure the company to develop a fund to settle future cases.

About 250,000 Australians were taking Vioxx when it was withdrawn from sale.

Mr Meeran said the US result was promising but warned "no one in Australia can expect to receive even a fraction of that".

Peter Humphries, a partner at law firm Duncan Basheer Hannon, said about 1000 Vioxx users had approached them about the class action.

"Merck will resist it as much as they can, and if it does get to a point where they think there's an inevitable wave of successful claims coming at them, they might think what they can do to contain it," he said.

"But I think it's probably years away before the company decides."

Mr Humphries said a decision on how to proceed with the class action would probably be made by the end of the year. "We haven't yet decided whether we will issue in Australia or we whether we will join up with proceedings in the US."

Ian Lewington, 68, hopes the decision will be made sooner rather than later. He had used Vioxx for more than five years before suffering a heart attack last August.

"When I heard about the recall I was pretty angry," Mr Lewington said. "Suddenly a lot of things made sense.

"I had suffered deep-vein thrombosis in my right leg last year even though I hadn't been on a plane for 10 years. Then I had the heart attack even though I'd been in good health and hadn't had any heart problems."

Vioxx suit verdict big pill to take

2005-08-22T20:56:00.000-07:00

Jury trials could cost drug maker billions.

Knight Ridder Newspapers
Published Monday, August 22, 2005

PHILADELPHIA - It was just the first of more than 4,200 lawsuits against Merck & Co. Inc. over its Vioxx painkiller, but news of Friday’s $253.4 million verdict in Texas against the drug maker surged through the legal profession and Wall Street.

In New York City, where Alise Reicin, Merck’s vice president of clinical research, was being deposed by lawyers representing plaintiffs in other Vioxx cases, the verdict caused a stir.

Shortly after learning the damage amount, Philadelphia lawyer Thomas Kline said he asked Reicin for her reaction to it and got no response. She has defended the company’s handling of Vioxx, including testifying in the Texas trial over the death of Robert Ernst.

"She stormed out of the room and never returned," Kline said. "Her lawyer told us that she was too upset to continue."

Kent Jarrell, a spokesman for Merck’s defense lawyers, disputed that Reicin stormed out of the deposition but acknowledged that she was upset.

"Everybody at Merck is upset about this," Jarrell said. "They believe in the drug and believe that Merck’s decisions are based on science and in the interest of the patient."

Vioxx was voluntarily recalled by Merck Sept. 30.

Kline, one of the lead lawyers in the consolidated federal litigation in New Orleans, said while each Vioxx suit would be tried individually, much of the same evidence as in the Texas case would be presented.

"I would expect to see that finding replicated repeatedly in future jury verdicts," Kline said.

Defense lawyers cautioned against reading too much into a single verdict, particularly one from Texas, which is viewed as a "plainty" venue.

"You can’t draw conclusions about what is going to happen in litigation overall from any one individual case," said John Lavelle, head of the product liability practice of Ballard Spahr Andrews & Ingersoll in Philadelphia. He said Merck has strong grounds for an appeal and that the punitive damages would be automatically reduced under Texas law.

Merck said it was examining four aspects of the trial that its lawyers believed were grounds for an appeal.

"We believe that we have strong points to raise on appeal and are hopeful that the appeals process will correct the verdict," said Kenneth Frazier, Merck’s general counsel, in a statement. "There are other Vioxx cases coming to trial, and we will vigorously defend them one by one over the coming years."

Merck has set aside $675 million to pay for its defense costs in the Vioxx suits. Defending each case could mean years of litigation. In New Jersey alone, there are nearly 2,400 pending Vioxx suits.

"If we had 20 trials a year, it would take over 100 years to try those cases," said Michael Ferrara, a Cherry Hill, N.J., lawyer representing plaintiffs in more than 200 Vioxx lawsuits.

"It is time for Merck to accept responsibility for what they did ... and sit down with the victims to work out a resolution," he said.

William Janssen, chairman of the life sciences practice at Saul Ewing LLP in Philadelphia, said the verdict suggested the passions engendered by injured plaintiffs might overwhelm the evidence and hurt Merck’s case.

Several plaintiffs’ lawyers said the decision to impose $229 million in punitive damages was significant because it meant the jury found Merck was not only responsible for Ernst’s death but had acted recklessly.

"If Merck continues to take the position that they are going to litigate each and every case to conclusion, they would similarly be reckless toward their shareholders," said James McHugh Jr., a lawyer at the Beasley Firm in Philadelphia.

Wall Street analysts expressed concerns about Merck’s potential Vioxx liability, which could exceed the record $21 billion Wyeth expects to pay out from litigation over the diet drug combination commonly known as fen-phen.

"The company may face upwards of 100,000 cases, which implies damages in the tens of billions of dollars," David Moskowitz of the investment firm Friedman Billings Ramsey in Arlington, Va., wrote Friday in a report to clients.

Vioxx Jurors Sought to Send a Message

2005-08-19T20:23:00.000-07:00

Associated Press
08.19.2005, 08:30 PM

Jurors who found Merck & Co. liable Friday for the death of a Texas man said they expected pharmaceutical companies to get the message from their $253.4 million verdict that consumers need safe drugs.

"They needed to be held accountable for putting a drug out there that shouldn't be out there," said Stacy Smith, a 21-year-old child care provider who stood with the majority in the 10-2 vote in favor of the man's widow, Carol Ernst.

"I want them to listen," said Marsha Robbins, a 53-year-old homemaker who was the presiding juror and the oldest of the panel.

One of the two dissenters, 46-year-old chemical company technician James Fruidenberg, said he never wavered from his belief that neither Merck nor Vioxx was responsible for Ernst's death. He sided with Merck's case that clogged arteries, not the drug, killed Ernst.

"I couldn't go with the probabilities," he said, referring to Carol Ernst's contention that a Vioxx-induced heart attack caused her husband's death, but that he died too quickly for the heart to show damage.

The size of the verdict will be knocked down to a maximum of $26.1 million under Texas caps on punitive damages. But jurors didn't know that, and those who voted in the majority said they didn't accept Merck's oft-repeated argument in the drug's safety when it went on the market in 1999. The company said no risks had appeared in 58 clinical trials involving 10,000 patients conducted before it won approval from the U.S. Food and Drug Administration.

Merck pulled Vioxx from the market last year when a long-term study showed it could double risk of heart attack or stroke if taken for at least 18 months. Carol Ernst, whose 59-year-old husband, Robert, died suddenly after taking the drug for eight months, alleged Merck knew years earlier that Vioxx could be dangerous, but downplayed those concerns in favor of aggressively marketing what grew into a $2.5 billion seller.

The majority of jurors agreed.

Sherry Linnett, a 43-year-old secretary, said she favored Ernst before deliberations began, and digging through mounds of documents failed to change her mind.

David Webb, a 20-year-old electrician and one of the two youngest jurors on the panel, said he went into deliberations supporting Ernst, "but I wanted to give the defendants a chance. We just really didn't find anything that helped them."

He said the majority of jurors believed Merck failed to adequately test the safety of Vioxx because many of the numerous clinical trials were small or involved patients taking the drug anywhere from one day to a few months. But Vioxx was marketed as a one-a-day pain reliever to be taken long-term because it would treat, yet not cure.

"There were a lot of really small studies," Webb said. "That's what I looked at."

Vioxx verdict casts long shadow over Merck's future

2005-08-19T20:19:00.000-07:00

By Deena Beasley

LOS ANGELES (Reuters) - Merck & Co. Inc. could face years of litigation and billions in damages, putting its stock price under pressure after a Texas jury found the company liable in the death of a man taking its painkiller Vioxx.

John LeCroy, an analyst at Natexis Bleichroeder, called the Vioxx litigation a "ten- to 20-year problem" for the company, which has so far had more than 4,200 similar lawsuits filed against it.

"I had thought this would cost them around $4 billion, but now I don't think $10 billion is an unreasonable number," he said.

The first verdict in a personal-injury case over the drug sent the company's stock down $2.35, or 7.7 percent, to close at $28.06 on the New York Stock Exchange.

A 12-member jury in Texas state court on Friday awarded a $24 million penalty to Carol Ernst, the widow of Robert Ernst, for mental anguish and loss of companionship and $229 million in punitive damages.

A Texas law limiting punitive damages is expected to reduce that $229 million award.

"This is obviously not a positive development for Merck, but most investors expected a negative ruling," said Shaojing Tong, an analyst at Mehta Partners. He put Merck's likely total damages at around $5 billion.

"The fact that Merck lost, and that the award was sizable, will likely energize the plaintiff's bar and will increase the frequency at which the company gets sued," Prudential Equity Group analyst Tim Anderson said in a report.

Lawyers said the ruling bodes well for plaintiffs.

"This was a conservative jury which makes this verdict more significant," said Jere Beasley, with the Montgomery, Alabama, law firm of Beasley, Allen, Crow, Methvin, Portis & Miles, which is investigating some 10,000 cases of Vioxx patients who suffered heart attacks or stroke.

"Merck claimed this was a weak case ... It is clear that the jury was upset," said Mitchell Breit, an attorney at Milberg Weiss in New York.

Merck, which pulled Vioxx off the market last September after it was linked to heart attack and stroke when taken for at least 18 months, said it planned to appeal the verdict.

Merck had argued that Ernest died of an irregular heartbeat -- a condition not linked to Vioxx.

"Had they won, the upside would be significantly greater than the downside we're seeing ...," said Brett Gallagher, a senior portfolio manager at Julius Baer who bought Merck shares after the downdraft and believes the stock is undervalued.

"It probably was the most expected outcome, and now unfortunately the uncertainty drags on," he said.

David Dreman, who held at least 154,000 shares of Merck as of June 30, said Merck was a very strong company and "has the financial staying power to ride this out".

"They're going to be in court for a long time. I don't think this is going to be a crippling blow to the company," he said.

Others said Thursday's verdict raises questions about Merck's stated strategy of trying every Vioxx case. "Maybe this means that they selectively settle some cases," LeCroy said.

Susan Dwyer, head of the product liability defense group at New York law firm Herrick, Feinstein said Merck fought "tooth and nail" in the courtroom, but still did not fare well. "There were a lot of bad documents, they started off poorly with their witnesses, company witnesses did not do well on the stand. I think they'll be more polished next time," she said.

Nevertheless, Merck's strategy of trying every case will probably be revisited, she said.

LeCroy said litigation is "part and parcel of doing business now for a pharmaceutical company," noting that lawsuits over the diet drug combo fen-phen -- which was linked to heart valve damage -- have so far cost Wyeth more than $21 billion.

Juries have awarded big sums to some fen-phen claimants, including a $1 billion judgment last year to the family of a Texas woman who died from a serious lung impairment. The state court jury in Beaumont deliberated six days before delivering the biggest fen-phen award to date, which includes $113 million in compensatory damages and $900 million in punitive charges.

Although Wyeth appealed that and other awards, each court defeat gives encouragement to other fen-phen plaintiffs whose cases have not yet gone to trial.

"There will be thousands more (Vioxx) cases filed," Milberg Weiss' Breit said.

The next trial is set to start Sept. 12 in New Jersey. It involves a postal worker who claims he suffered a heart attack two months after he began taking Vioxx.

(Additional reporting by Megan Davies, Herb Lash, Paul Thomasch and Ransdell Pierson in New York)

Attorneys disagree on meaning of 1st Vioxx verdict

2005-08-19T20:17:00.000-07:00

Knight Ridder - Friday, August 19, 2005
Knight Ridder Newspapers
By Josh Goldstein and Joseph N. DiStefano

PHILADELPHIA _ It was just the first of more than 4,200 lawsuits against Merck & Co. Inc. over its Vioxx painkiller, but news of Friday's $253.4 million verdict in Texas against the drugmaker surged through the legal profession and Wall Street.

In New York City, where Alise Reicin, Merck's vice president of clinical research, was being deposed by lawyers representing plaintiffs in other Vioxx cases, the verdict caused a stir.

Shortly after learning the damage amount, Philadelphia lawyer Thomas R. Kline says he asked Reicin for her reaction to it and got no response. She has defended the company's handling of Vioxx, including testifying in the Texas trial over the death of Robert Ernst.

"She stormed out of the room and never returned," Kline said. "Her lawyer told us that she was too upset to continue."

Kent Jarrell, a spokesman for Merck's defense lawyers, disputed that Reicin stormed out of the deposition, but acknowledged that she was upset.

"Everybody at Merck is upset about this," Jarrell said. "They believe in the drug and believe that Merck's decisions are based on science and in the interest of the patient."

Merck is a big employer in the Philadelphia with more than 12,000 people in Montgomery County, most at its West Point corporate campus. Much of Vioxx's global marketing, sales and legal work was done in West Point.

Vioxx was voluntarily recalled by Merck Sept. 30.

Kline, one of the lead lawyers in the consolidated federal litigation in New Orleans, said while each Vioxx suit would be tried individually much of the same evidence as in the Texas case would be presented.

"I would expect to see that finding replicated repeatedly in future jury verdicts," Kline said.

Defense lawyers cautioned against reading too much into a single verdict, particularly one from Texas, which is viewed as a "plaintiff-friendly" venue.

"You can't draw conclusions about what is going to happen in litigation overall from any one individual case," said John Lavelle, head of the product liability practice of Ballard Spahr Andrews & Ingersoll in Philadelphia. He said Merck has strong grounds for an appeal and that the punitive damages would be automatically reduced under Texas law.

Merck said it was examining four aspects of the trial that its lawyers believed were grounds for an appeal.

"We believe that we have strong points to raise on appeal and are hopeful that the appeals process will correct the verdict," said Kenneth C. Frazier, Merck's general counsel, in a statement. "There are other Vioxx cases coming to trial, and we will vigorously defend them one by one over the coming years."

Merck has set aside $675 million to pay for its defense costs in the Vioxx suits. Defending each case could mean years of litigation. In New Jersey alone there are nearly 2,400 pending Vioxx suits.

"If we had 20 trials a year it would take over 100 years to try those cases," said Michael A. Ferrara, a Cherry Hill, N.J., lawyer representing plaintiffs in more than 200 Vioxx lawsuits. "It is time for Merck to accept responsibility for what they did ... and sit down with the victims to work out a resolution."

William M. Janssen, chairman of the life-sciences practice at Saul Ewing L.L.P. in Philadelphia, said the verdict suggested the passions engendered by injured plaintiffs might overwhelm the evidence and hurt Merck's case.

Several plaintiffs' lawyers said the decision to impose $229 million in punitive damages was significant because it meant the jury found Merck was not only responsible for Ernst's death, but had acted recklessly.

"If Merck continues to take the position that they are going to litigate each and every case to conclusion, they would similarly be reckless toward their shareholders," said James J. McHugh Jr., a lawyer at the Beasley Firm in Philadelphia.

Wall Street analysts expressed concerns about Merck's potential Vioxx liability, which could exceed the record $21 billion Wyeth expects to pay out from litigation over the diet-drug combination commonly known as fen-phen.

"The company may face upwards of 100,000 cases, which implies damages in the tens of billions of dollars," David Moskowitz of the investment firm Friedman Billings Ramsey in Arlington, Va., wrote in a report to clients Friday.

Shares of Merck, a component of the Dow Jones industrial average, plunged $2.35 a share, or 7.7 percent, to close at $28.06.

Merck loss likely to increase liability, number of lawsuits

2005-08-19T20:11:00.000-07:00

By THERESA AGOVINO
Associated Press

CASES PENDING

Other lawsuits involving Vioxx pending against Merck:
• 4,275 suits in federal and state courts.
• 119 class action cases pending, but none certified.

ANGLETON — Merck & Co. suffered a serious blow today when it lost the first wrongful death lawsuit against it over its painkiller Vioxx, opening the floodgates for additional lawsuits and raising the risk that liability will climb higher than estimates that reach $18 billion.

Merck & Co.'s stock sank $1.16, or 4 percent, to $29.25 after the jury awarded $253.4 million in damages to a widow of a man who died in 2001 of heart arrhythmia, or irregular heart beat, after taking Vioxx for around eight months. The company plans to appeal.

Merck yanked the popular pain reliever from the market last September after a study found it doubled patients' risks of heart attacks and strokes after 18 months.

The loss is especially damaging because Merck initially had been expected to win what was considered a weak case because no studies have linked Vioxx to arrhythmia. And the next two cases Merck faces appear somewhat stronger, according to experts.

"If they can't win the weak ones, what does that say about the strong ones?" asked Anthony Sebok, a professor at Brooklyn Law School.

Analyst Jason Napodano Zacks Investment Research said now anyone taking Vioxx with any type of a cardiovascular problem will feel emboldened to file a lawsuit. So far, more than 4,000 cases have been filed, some presumably stronger than the Angleton case. Merck has set aside $675 million to fight them.

"A Merck loss means that the number of cases against them increases tenfold," predicted Napodano.

If this verdict marks the beginning of a losing streak, Merck may back away from its pledge to try each case individually and not settle any, experts said. But they said a rash of verdicts would be necessary before the company changes its strategy.

"Merck says there will be no surrender. But you have to wonder if that will be true," said Sebok.

The plaintiff's lawyer, Mark Lanier, attempted to convince the Angleton jury that the plaintiff's late husband, Bob Ernst, died of a heart attack. Lanier flew Dr. Maria Araneta, who performed Ernst's autopsy, in from the United Arab Emirates, where she had moved since performing the autopsy in 2001. She testified that although her report said Ernst died of an arrhythmia, it was likely he had a heart attack.

"I'm not changing my opinion, I'm just explaining it further," Araneta testified. "That's the autopsy report, but it's not the end of the story."

She said Ernst probably had a heart attack because a clot blocked the blood flow in an artery that was already clogged with plaque. She also said CPR conducted on Ernst probably dislodged the clot.

Lanier's case provided other plaintiff lawyers with a blueprint for how to prove Merck behaved irresponsibly in promoting Vioxx, said Benjamin Zipursky, a professor at Fordham University School of Law.

"A Merck loss means the jury believes the plaintiff story about the company's wrongful conduct," said Zipursky. "That carries into the future."

Merck would be foolish to dismiss Lanier's win as a fluke resulting from a talented Texas lawyer working his abundant Southern charm in what is considered a plaintiff-friendly venue, attorneys warned.

"Mark Lanier is an extraordinarily gifted attorney. But there are a lot of other gifted plaintiff attorneys and other favorable venues," said Charles Rhodes, a law professor at South Texas College of Law in Houston. "Maybe Merck will get less damages outside of Southeast Texas, but there will still be damages."

Next month, Merck faces a trail in Atlantic City, N.J., brought by Michael Humeston, a former postal worker, who had a heart attack in 2001. Humeston's lawyer, Chris Seeger, said Humeston still has lingering effects from the heart attack. Vioxx has been directly linked to heart attacks.

In November, the first of 1,800 federal cases will be heard in New Orleans. It revolves around Richard Irvin, a Florida man who was taking Vioxx for a month before his 2001 death from a blood clot in his heart. Scientists have speculated that Vioxx causes cardiovascular problems because it blocks a substance which keeps blood from clotting.

Merck, Vioxx Loss Could Be Billions: New Orleans Class Action Lawsuit Soon

2005-08-19T20:08:00.000-07:00

Author: Steve Sabludowsky | 8/19/2005 Home : Politics

New Orleans, Louisiana--After Merck was found liable by a Texas jury in the first lawsuit involving drug Vioxx, some analysts are saying the total loss to Merck could be up to 18 billion dollars. The jury´s verdict could create serious future financial consequences for Merck, which faces 4,200 lawsuits relating to Vioxx.

The first federal case against Merck is scheduled to go to trial in November in New Orleans which is known to award large jury verdicts in class action damage cases.

Plaintiff Carol Ernst has won her lawsuit in Texas Superior Court, which blames Vioxx for the 2001 death of her husband, Robert Ernst, who was taking the arthritis painkiller at the time of his death. Ernst died of a heart attack. The verdict held Merck liable for the death.

The jury awarded more than $250 million in total damages.

In a statement released after the verdict, Merck said that it was "disappointed" by the verdict and planned to appeal.

"We believe that the plaintiff did not meet the standard set by Texas law to prove Vioxx caused Mr. Ernst´s death," said Jonathan Skidmore of Fulbright & Jaworski, a member of Merck´s defense team.

Merck abruptly recalled Vioxx last fall after evidence showed there could be an increased rate of heart attack and stroke in certain circumstances. Although the Food and Drug Administration has determined the drug is safe enough to be put back on the market, albeit with many restrictions, Merck has yet to do so.

"There are other VIOXX cases coming to trial and we will vigorously defend them one by one over the coming years," said Merck general counsel Kenneth Frasier, in a release.

Jury: Merck negligent

2005-08-19T15:32:00.000-07:00

Merck blamed for death in Vioxx suit; jury awards $253 million in damages. Drug giant to appeal.

August 19, 2005: 5:54 PM EDT

NEW YORK (CNN/Money) - Merck has been held liable by a Texas jury in the first lawsuit involving its former blockbuster drug Vioxx, in a case that could have a profound effect on thousands of other cases filed against the company.

Plaintiff Carol Ernst has won her lawsuit in Texas Superior Court in Angleton, which blames Vioxx for the 2001 death of her husband, Robert Ernst, a 59-year-old marathon runner and Wal-Mart worker who was taking the arthritis painkiller at the time of his death. Ernst died of a heart attack.

The verdict held Merck liable for the death. Jurors voted 10-2 in favor of Ernst.

The jury awarded more than $250 million in total damages -- a $24 million penalty to Carol Ernst for mental anguish and loss of companionship and $229 million in punitive damages. Ernst's Houston-based lawyer, Mark Lanier, said the punitive-damages figure was based on "the money Merck made and saved by putting off their product label changes."

Lanier had been seeking $40.4 million in damages, and after the verdict, Lanier said that he expected the punitive-damages award to be reduced according to Texas law.

"Justice is a beautiful thing, isn't it?" said Lanier to reporter following the verdict.

Merck said it would appeal the decision. "We believe that the plaintiff did not meet the standard set by Texas law to prove Vioxx caused Mr. Ernst's death," said Jonathan Skidmore, a member of Merck's legal defense team, according to a statement released by Merck.

Merck (Research) shares closed down nearly 8 percent on Friday.

Deutsche Bank analyst Barbara Ryan said that Merck's appeal "could delay a resolution for several years, and will likely reduce the financial damages signficantly." Ryan lowered her price target for the stock to $31 from $35 but said the dividend "remains secure."

But David Moskowitz, analyst for Friedman, Billings, Ramsey & Co., said that if Merck continues to lose cases it will have to settle in order to save the company.

"The squeeze is coming," said Moskowitz. "With this number of cases and these types of awards, the stability of the company is at risk."

Merck has vowed not to settle. Analyst Christ Shibutani of J.P. Morgan Chase has estimated that Merck's liabilities could range from $8 billion to $25 billion.

An emotional trial; more to come
Lanier argued that Merck had concealed information about the health risks associated with the drug in order to protect sales. Lanier has used colorful analogies in his portrayal of Merck, which he has compared to Saddam Hussein and the three monkeys who see no evil, hear no evil, speak no evil.

Carol Ernst, who had divorced her first husband in the early 1980s and raised four children as a single mother, delivered emotional testimony about the death of her second husband, Robert, and said she was taking antidepressants to cope with the loss.

Merck's defense team had insisted that Vioxx did not cause Ernst's death, asserting that arrhythmia had not been linked Vioxx in studies.

Merck's legal battle began after Sept. 30, 2004, when the company pulled Vioxx, a arthritis painkiller worth $2.5 billion in annual sales and about one-tenth of total company revenue, triggering a one-third slide in the company's stock value.

Merck pulled the drug after participants in a Vioxx study experienced "adverse cardiovascular events" compared to those taking a placebo. Nonetheless, Merck never actually conceded there were health risks.

Some 20 million people have used Vioxx. Since the recall, about 4,200 product liability lawsuits representing about 7,500 plaintiff groups have been filed against Merck.

The battle continues on Sept. 12, when jury selection begins in the next case in New Jersey Superior Court in Atlantic City under Judge Carol Higbee. Plaintiffs from all over the country have sued Merck in New Jersey because the company is based in Whitehouse Station.

While the Ernst case was a wrongful death suit, the next plaintiff is a heart attack survivor. The company will face plaintiff Frederick Humeston of Boise, Idaho, a postal carrier and twice-wounded Vietnam veteran who blames Vioxx for his 2001 heart attack. Merck's lawyers say that Vioxx did not cause Humeston's heart attack and his case presents "little more than guilt by temporal association."

The outcome of the Humeston case will impact how the rest of the New Jersey cases are organized, in groups or individually. Merck has vowed to fight them all, one at a time, if necessary.

That could take a while. Judge Eldon Fallon, who is presiding over all federal cases in New Orleans district court, told reporters in May that lawsuits could ultimately reach 100,000. The first federal case begins on Nov. 28, with a pre-trial conference on Aug. 25.

Jury Questions in Merck Vioxx Trial

2005-08-19T15:29:00.000-07:00

JURY QUESTIONS
Ten of the 12 jurors had to answer the following questions in order to reach a verdict. The jury's decision was unanimous.:

• 1. Was there a defect in the marketing of Vioxx at the time it left the possession of Merck & Co., Inc., that was a producing cause of the death of Bob Ernst?
Answer: Yes

• 2. Was there a design defect in Vioxx at the time it left the possession of Merck & Co., Inc. that was a producing cause of the death of Bob Ernst?
Answer: Yes

• 3. Did the negligence, if any, of Merck & Co. Inc., proximately cause the death of Bob Ernst?
Answer: Yes

--------------------------------------------------------------------------------

If jurors answer "yes" to questions No. 1, 2 or 3, then they must answer the following.

• 4. What sum of money, if paid now in cash, would fairly and reasonably compensate Carol Ernst for her damages, if any, resulting from the death of Bob Ernst?
Answer separately, in dollars and cents, for damages, if any.

• a. Pecuniary loss sustained in the past: $100,000

• b. Pecuniary loss that, in reasonable probability, will be sustained in the future: $350,000

• c. Loss of companionship and society sustained in the past: $2 million

• d. Loss of companionship and society that, in reasonable probability, will be sustained in the future. $10 million

• e. Mental anguish sustained in the past. $2 million

• f. Mental anguish that, in reasonable probability, will be sustained in the future: $10 million

--------------------------------------------------------------------------------

If jurors answer "yes" to questions No. 1, 2 or 3 and have inserted a sum of money in answer to question No. 4, then jurors will answer the following.

• 5. Do you find by clear and convincing evidence that the harm to Bob Ernst resulted from malice attributable to Merck & Co., Inc.?
Answer: Yes

--------------------------------------------------------------------------------

If jurors answer "yes" to question No. 5, then they will answer the following question.
• 6. What sum of money, if any, should be assessed against Merck & Co. Inc. and awarded to Carol Ernst as exemplary damages for the death of Bob Ernst?
$229 million.

Vioxx jury finds Merck liable

2005-08-19T15:27:00.000-07:00

Merck & Co. liable for the death of a man who took the painkiller.

Jurors awarded Robert Ernst's widow, Carol, $253.4 million in damages, which is a combination of his lost pay as a Wal-Mart produce manager, mental anguish, loss of companionship and punitive damages.

Carol Ernst began to cry when the verdict was read while her attorneys jumped up and shouted, "Amen!"

Later, she told reporters, "I'm relieved. This has been a long road for me. But I felt strongly that this was the road I needed to take so other families wouldn't suffer the same pain I felt at the time."

She called the verdict a "wake-up call" for pharmaceutical companies.

Immediately after the verdict, her team of attorneys huddled and hugged and repeated, "Amen, amen," while plaintiff's lawyer Ben Morelli told Ernst, "It's your jury."

"Anyone who said they are too small town or won't understand, they are crazy," said her lawyer, Mark Lanier. "They know truth and they know justice."

"Merck should come to the table and accept responsibility," Lanier said.

The jury broke down the award as $450,000 in economic damages - Robert Ernst's lost pay as a Wal-Mart produce manager; $24 million for mental anguish and loss of companionship; and $229 million in punitive damages.

But the punitive damage amount is likely to be reduced as state law caps punitive damages at twice the amount of economic damages - lost pay - and up to $750,000 on top of noneconomic damages, which are comprised of mental anguish and loss of companionship.

That would give Ernst a maximum of $1.65 million in possible punitive damages, meaning her total damage award could not exceed $26.1 million.

The case drew national attention from pharmaceutical companies, lawyers, consumers, stock analysts and arbitragers as a signal of what lies ahead for Merck, which has vowed to fight the more than 4,200 state and federal Vioxx-related lawsuits pending across the country. Merck said it plans to appeal.

A seven-man, five-woman jury from a semi-rural county south of Houston deliberated for 10 1/2 hours over two days before blaming the drug for killing Ernst in his sleep in 2001. Jurors rejected Merck's argument that Ernst died of clogged arteries rather than a Vioxx-induced heart attack that led to his fatal arrhythmia.

Merck response
Jonathan Skidmore, a member of Merck's defense team, said today, "We believe that the plantiff did not meet the standard set by Texas law to prove Vioxx caused Mr. Ernst's death."

"There is no reliable scientific evidence that shows Vioxx causes cardiac arrhythmias, which an autopsy showed was the cause of Mr. Ernst's death, along with coronary atherosclerosis."

Merck also contends the case did not call for punitive damages.

"Merck acted responsibly - from researching Vioxx prior to approval in clinical trials involving almost 10,000 patients - to monitoring the medicine while it was on the market - to voluntarily withdrawing the medicine when it did," Skidmore said.

"We believe that we have strong points to raise on appeal and are hopeful that the appeals process will correct the verdict," said Kenneth C. Frazier, senior vice president and general counsel of Merck, in a written statement. "Our appeal is about fundamental rights to a fair trial."

The company will base its appeal on:

— Allowing opening testimony to be given to the jury by unqualified experts.

— Allowing opinion testimony that was not based on a reliable, scientific basis as required by Texas law.

— Allowing evidence with no relevance to the issues of the case, which unfairly prejudiced the jury.

— Allowing undisclosed surprise witness and expert testimony contrary to Texas law.

A little more than two hours into their second day of deliberations, lawyers said jurors asked for a replay of testimony from Dr. Maria Araneta, who attributed the 2001 death of Robert Ernst to an irregular heartbeat secondary to clogged arteries. The panel had yet to specify which part it wanted to hear, and any replaying of testimony must take place in open court.

Vioxx-maker Merck & Co. used that autopsy to support the company's contention that the painkiller had nothing to do with Robert Ernst's death.

Merck pulled the $2.5 billion seller from the market last year after a study showed it could double risk of heart attack or stroke if taken for 18 months or longer, but the company says no studies link Vioxx to arrhythmia, or irregular heartbeat.

Araneta, who now works at a hospital in the United Arab Emirates, testified that a blood clot probably caused a heart attack that triggered Ernst's arrhythmia. She said vigorous CPR likely dislodged the clot so she couldn't find it during the autopsy, and his death was too sudden to leave evidence of the heart attack.

Merck lost appeals to block jurors from hearing Araneta's testimony during the trial, which was presented via videotaped deposition.

Araneta didn't blame Vioxx for causing a heart attack, noting she knew little of the drug in 2001. Other plaintiff's experts blamed the drug. Experts who testified for Merck said Araneta's written conclusions in the autopsy were valid, but her opinions expressed more than four years later were not.

The trial that began July 14 was the first of more than 4,200 lawsuits in the nation to go before a jury. The case has drawn national attention as the first test of Merck's legal fate, and analysts have speculated Merck's liability could reach $18 billion.

Merck launched Vioxx in 1999 with great fanfare to relieve arthritis and acute pain while cutting risk of stomach bleeding by inhibiting a blood-thinning enzyme. Some 20 million people took Vioxx when it was available to consumers.

Lanier asked jurors to award her at least $40 million in damages.

He suggested during closing arguments that her mental anguish and loss of companionship damages could reach $229 million or more. Lanier said Merck reaped that amount from Vioxx sales in the four months leading to the February 2002 addition of cardiovascular warnings on the drug's label. The U.S. Food and Drug Administration suggested the changes in October 2001 in light of a 2000 study that showed Vioxx users suffered five times as many heart attacks as those who took the older painkiller, naproxen.

In Texas, punitive damages are capped at twice the amount of economic damages - lost pay - and up to $750,000 on top of non-economic damages, which are comprised of mental anguish and loss of companionship. Non-economic damages have no limit in Texas except in medical malpractice cases, which doesn't apply to the Ernst case.

Another trial is set to begin in New Jersey, where Merck is based, next month, and the first federal trial in New Orleans is slated for late November.

--------------------------------------------------------------------------------
Chronicle reporters Ruth Rendon and Richard Stewart, and The Associated Press contributed to this report.

Vioxx jury resumes deliberations

2005-08-19T15:22:00.000-07:00

ANGLETON, Texas (AP) -- Jurors in the nation's first Vioxx-related civil trial asked to hear again what could be crucial testimony from a pathologist who autopsied a man who took Vioxx and later died of heart problems.

A little more than two hours into their second day of deliberations, lawyers said jurors asked for a replay of testimony from Dr. Maria Araneta, who attributed the 2001 death of Robert Ernst to an irregular heartbeat secondary to clogged arteries. The panel had yet to specify which part it wanted to hear, and any replaying of testimony must take place in open court.

Vioxx-maker Merck & Co. used that autopsy to support the company's contention that the painkiller had nothing to do with Robert Ernst's death.

Merck pulled the $2.5 billion seller from the market last year after a study showed it could double risk of heart attack or stroke if taken for 18 months or longer, but the company says no studies link Vioxx to arrhythmia, or irregular heartbeat.

Plaintiff Carol Ernst alleges Vioxx caused a heart attack that led to the fatal arrhythmia.

Araneta, who now works at a hospital in the United Arab Emirates, testified that a blood clot probably caused a heart attack that triggered Ernst's arrhythmia. She said vigorous CPR likely dislodged the clot so she couldn't find it during the autopsy, and his death was too sudden to leave evidence of the heart attack.

Merck lost appeals to block jurors from hearing Araneta's testimony during the trial, which was presented via videotaped deposition.

Araneta didn't blame Vioxx for causing a heart attack, noting she knew little of the drug in 2001. Other plaintiff's experts blamed the drug. Experts who testified for Merck said Araneta's written conclusions in the autopsy were valid, but her opinions expressed more than four years later were not.

The trial that began July 14 was the first of more than 4,200 lawsuits in the nation to go before a jury. The case has drawn national attention as the first test of Merck's legal fate, and analysts have speculated Merck's liability could reach $18 billion.

Merck launched Vioxx in 1999 with great fanfare to relieve arthritis and acute pain while cutting risk of stomach bleeding by inhibiting a blood-thinning enzyme. Some 20 million people took Vioxx when it was available to consumers.

Carol Ernst's lawyer, Mark Lanier, asked jurors to award her at least $40 million in damages.

He suggested during closing arguments that her mental anguish and loss of companionship damages could reach $229 million or more. Lanier said Merck reaped that amount from Vioxx sales in the four months leading to the February 2002 addition of cardiovascular warnings on the drug's label. The U.S. Food and Drug Administration suggested the changes in October 2001 in light of a 2000 study that showed Vioxx users suffered five times as many heart attacks as those who took the older painkiller, naproxen.

In Texas, punitive damages are capped at twice the amount of economic damages -- such as lost wages -- and up to $750,000 on top of non-economic damages, such as mental anguish and loss of companionship. But the non-economic damages have no limits in this case.

By KRISTEN HAYS
AP Business Writer

Vioxx jury asks to see pathologist testimony in deliberations

2005-08-19T15:19:00.000-07:00

ANGLETON — Jurors in the nation's first Vioxx-related civil trial asked today to hear again what could be crucial testimony from a pathologist who autopsied a man who took Vioxx and later died of heart problems.

A little more than two hours into their second day of deliberations, lawyers said jurors asked for a replay of testimony from Dr. Maria Araneta, who attributed the 2001 death of Robert Ernst to an irregular heartbeat secondary to clogged arteries. The panel had yet to specify which part it wanted to hear, and any replaying of testimony must take place in open court.

Vioxx-maker Merck & Co. used that autopsy to support the company's contention that the painkiller had nothing to do with Robert Ernst's death.

Merck pulled the $2.5 billion seller from the market last year after a study showed it could double risk of heart attack or stroke if taken for 18 months or longer, but the company says no studies link Vioxx to arrhythmia, or irregular heartbeat.

Plaintiff Carol Ernst alleges Vioxx caused a heart attack that led to the fatal arrhythmia.

Araneta, who now works at a hospital in the United Arab Emirates, testified that a blood clot probably caused a heart attack that triggered Ernst's arrhythmia. She said vigorous CPR likely dislodged the clot so she couldn't find it during the autopsy, and his death was too sudden to leave evidence of the heart attack.

Merck lost appeals to block jurors from hearing Araneta's testimony during the trial, which was presented via videotaped deposition.

Araneta didn't blame Vioxx for causing a heart attack, noting she knew little of the drug in 2001. Other plaintiff's experts blamed the drug. Experts who testified for Merck said Araneta's written conclusions in the autopsy were valid, but her opinions expressed more than four years later were not.

The trial that began July 14 was the first of more than 4,200 lawsuits in the nation to go before a jury. The case has drawn national attention as the first test of Merck's legal fate, and analysts have speculated Merck's liability could reach $18 billion.

Merck launched Vioxx in 1999 with great fanfare to relieve arthritis and acute pain while cutting risk of stomach bleeding by inhibiting a blood-thinning enzyme. Some 20 million people took Vioxx when it was available to consumers.

Carol Ernst's lawyer, Mark Lanier, asked jurors to award her at least $40 million in damages.

He suggested during closing arguments that her mental anguish and loss of companionship damages could reach $229 million or more. Lanier said Merck reaped that amount from Vioxx sales in the four months leading to the February 2002 addition of cardiovascular warnings on the drug's label. The U.S. Food and Drug Administration suggested the changes in October 2001 in light of a 2000 study that showed Vioxx users suffered five times as many heart attacks as those who took the older painkiller, naproxen.

In Texas, punitive damages are capped at twice the amount of economic damages — such as lost wages — and up to $750,000 on top of non-economic damages, such as mental anguish and loss of companionship. But the non-economic damages have no limits in this case.

Jury sent case in first Vioxx trial after hearing lawyers' final arguments

2005-08-17T20:58:00.000-07:00

By Kristen Hays
ASSOCIATED PRESS

5:00 p.m. August 17, 2005

ANGLETON, Texas – Merck & Co. should have told doctors and consumers "the good, the bad and the ugly" about Vioxx long before pulling it from the market last year, a plaintiff's attorney said Wednesday in closing arguments in the nation's first civil trial involving the once-popular painkiller.

Mark Lanier, who represents the widow of a Texas man who died in 2001, accused the New Jersey pharmaceutical company of practicing denial and deception for the last decade, minimizing safety concerns about Vioxx to reap billions in annual profits.

"We have a right to know," Lanier said of any potentially lethal side effects. "They ought to tell us the good, the bad and the ugly."

Merck lawyer Gerry Lowry urged jurors to consider what would happen to the 100-year-old company if it knowingly created deadly drugs.

"Would that be good business? Would that make sense?" she asked.

The seven-man, five-woman panel formally received the case on Wednesday and were to begin deliberating Thursday morning. The South Texas case is the first to go to trial among more than 4,200 state and federal lawsuits.

The trial, which began July 14, has drawn national attention from pharmaceutical companies, lawyers, consumers and stock analysts as the first test of what lies ahead for the drug maker. Analysts have speculated Merck's liability could reach $18 billion.

In the Texas case, Lanier hinted to jurors Wednesday that mental anguish and loss of companionship damages for the plaintiff, Carol Ernst, could reach $229 million or more.

He said Merck reaped that amount from selling Vioxx in the four months leading to the February 2002 addition of cardiovascular warnings on the drug's label. The U.S. Food and Drug Administration had suggested such changes in October 2001 in light of a 2000 study that showed Vioxx users suffered five times as many heart attacks as those who took the older painkiller naproxen, sold under the brand name Aleve.

In Texas, punitive damages are capped at twice the amount of economic damages – such as lost wages – and up to $750,000 on top of non-economic damages, such as mental anguish and loss of companionship. But the non-economic damages have no limits in this case.

Lanier asked jurors to award at least $40 million in non-economic damages and implored the panel to "be the first jury in America to say 'Time out, Merck.' "

"You decide what's OK, and the drug companies will listen," Lanier said. "Merck will listen."

Merck launched Vioxx with great fanfare in 1999 as a pain reliever that cut the risk of stomach bleeding by inhibiting a blood-thinning enzyme. Last year the company pulled what grew into a $2.5 billion seller from the market after a study showed it could double the risk of heart attack or stroke if taken for 18 months or longer.

Some 20 million people took Vioxx.

Carol Ernst alleges Vioxx triggered the death of her husband, Robert, 59, in his sleep. He took the drug for eight months to ease pain in his hands. She also alleges Merck ignored its company motto of putting patients first, instead putting profits before safety.

Robert Ernst, a Wal-Mart produce manager who ran marathons and taught aerobics classes, died in his sleep one month before their first wedding anniversary.

Merck counters that the company acted responsibly, disclosed research and believed Vioxx to be safe until the study last year prompted its withdrawal.

Merck has relied heavily on Ernst's autopsy report, which attributes his death to an arrhythmia secondary to clogged arteries. The company says no studies link Vioxx to arrhythmia, so the drug couldn't have caused his death.

Lanier pointed to Merck's own medical manual, which says arrhythmia occurs in 90 percent of heart attack patients. He also presented witnesses, including the pathologist who performed the autopsy, who said a heart attack more than likely caused the fatal arrhythmia, but he died too quickly for his heart to show damage.

Lowry, like Merck's expert witnesses, told jurors the autopsy report didn't note a heart attack because there was no evidence of one beyond theories put forth more than four years later.

"In order for the plaintiffs to win, they have to ask you in that jury room to see in your imagination something that is not in the evidence in this case," she said. "Remember, possibilities are not evidence," Lowry said later.

Lanier began his closing argument by explaining that a civil verdict can be reached if 10 or more jurors agree based on a preponderance of evidence, rather than the more strict requirement in criminal cases of unanimous agreement beyond a reasonable doubt.

"You can have 49 percent doubt and cast your vote where the 51 percent is," Lanier said.

Merck awaits verdict in first Vioxx trial

2005-08-16T20:19:00.000-07:00

By Christopher Bowe
Tue Aug 16, 1:55 PM ET

It is now up to a Texas jury to weigh the evidence in the first trial considering whether Merck's withdrawn pain drug Vioxx caused the death of a patient. In closing arguments, attorneys for the US drugmaker and plaintiff Carol Ernst, a widow blaming Vioxx for the death of her husband, will make their final efforts to convince the jury.

Mrs Ernst and her attorney Mark Lanier claim Vioxx caused a heart attack that triggered an irregular heartbeat, or arrhythmia, and Robert Ernst's death in his sleep in 2001.

But Merck maintains Vioxx could not have caused Mr Ernst's arrhythmia, which, combined with clotting arteries, caused his heart to stop.

The verdict in the Brazoria County Courthouse, in the small town of Angleton, south of Houston, could help set the tone for further cases exploring Merck's liability over Vioxx. Merck potentially faces billions of dollars in claims from 4,000 lawsuits in the wake of the drug's withdrawal in September after finding increased risk of heart attacks and strokes after 18 months' use.

The plaintiff's case has crystallised around testimony from the coroner who examined Mr Ernst's body. Dr Maria Araneta testified she thought Mr Ernst's death from arrhythmia came after a heart attack.

However, Merck points out that Dr Araneta's report in 2001 cites Mr Ernst's cause of death as arrhythmia due to long-term hardening of the arteries. Merck's lawyers fought to keep her testimony out, and later tried to rebut her new theory. Dr Araneta said she was merely explaining her report further than she could at the time.

Legal experts watching the case say the weak part of the Ernst case is the nebulous link between Vioxx and Mr Ernst's arrhythmia. Moreover, Merck has used the coroner's written report as a foundation for its argument that the science does not back up the plaintiff's claim.

Forest Horne, trial attorney at Martin & Jones in Raleigh, North Carolina, says the issue of causation has not been neatly tied up, but the coroner's testimony has helped.

"One of the most important developments was the testimony of the coroner coming in," says Mr Horne, who has some Vioxx lawsuits that could go to trial in New Jersey early next year. "With the coroner testifying, I'm feeling better and better about it. But causation is still an issue."

Merck has repeatedly said science is on its side - that Vioxx could not be credibly shown as the cause of Mr Ernst's death.

In addition, it argues that Texas law requires the judge to instruct the jury that it must find Vioxx was a "substantial factor" in causing the death.

It argues that, contrary to Mr Lanier's statements to the jury, he must prove that Vioxx was more than just "a cause".

The trial, which has lasted five weeks, has featured Merck executives testifying live and via videotaped depositions, along with tearful testimony from Ms Ernst and her family.

In live testimony, Merck executives have attempted to show the company pursued rigorous science, and only pulled the drug when research conclusively showed new risks.

Using internal documents, emails and consumer advertising, Mr Lanier has challenged Merck executives over whether profit motives overruled the results of Vioxx clinical trial data - some of which showed a heart risk in 2001.

On the stand, Ms Ernst, 60, blamed herself for suggesting Vioxx for her athletic husband's joint pain after seeing television advertisements.

Timothy Anderson, analyst at Prudential Securities, estimates Merck faces an uphill battle, and shares might move by almost 10 per cent up or down depending on the outcome. "Our guess is that Merck has a greater chance than not of losing this case."

Mass tort litigation experts, such as Arvin Maskin, attorney at Weil, Gotshal & Manges, say one case will not make or break Merck's litigation liability. They say it must continue to fight to establish its scientific argument that Vioxx could not cause injuries purported in lawsuits.

But the verdict in Angleton is certain to be a milestone.

Merck Rests Its Case in Vioxx Trial

2005-08-16T20:07:00.000-07:00

Aug 16, 2005 2:07 pm US/Eastern

ANGLETON, Texas (AP) Merck & Co. rested its case Tuesday and jurors heard the last bit of testimony in the nation's first civil trial related to the drug maker's painkiller Vioxx, bringing the panel in the five-week case a step closer to deciding its outcome.

State District Judge Ben Hardin told jurors they would hear closing arguments from attorneys on both sides Wednesday. The judge released jurors at midday Tuesday so lawyers could finalize the instructions Hardin will give the seven-man, five-woman panel before deliberations begin.

The case has drawn national attention from pharmaceutical companies, lawyers, consumers and stock analysts as the first of several tests of what lies ahead for Merck, which has vowed to fight the more than 4,200 state and federal Vioxx-related lawsuits pending across the country.

Another trial is set to begin next month in Merck's home state of New Jersey, and the first federal trial is scheduled for November in New Orleans.

In the Texas case 40 miles south of Houston, 15 witnesses testified, some by videotaped deposition, since lawyers presented opening statements July 14. Of those, two-thirds testified for plaintiff Carol Ernst, including Ernst herself.

She alleges Vioxx caused the sudden death of her husband, Robert Ernst, in 2001. Robert Ernst, a Wal-Mart produce manager and marathon runner, had taken the drug for eight months to ease pain in his hands.

Merck took Vioxx off the market in September when a study showed it could double risk of heart attack or stroke if taken for 18 months or longer. Whether it caused Ernst's death will be a key question for jurors.

On Tuesday, Dr. Benedict Lucchesi, a pharmacologist who testified for the plaintiff, returned to the witness stand to rebut testimony from expert witnesses who said on Merck's behalf that Ernst's clogged arteries caused his death from arrhythmia, and Vioxx had nothing to do with it.

Lucchesi, who has studied arrhythmias — or irregular heartbeats — for 50 years, testified this month that Vioxx "contributed significantly" to Ernst's death. He said Vioxx inhibits the body's natural ability to thin the blood, which can lead to the formation of blood clots.

On Tuesday, he reiterated his theory, noting that a Vioxx-induced clot could have dissolved or been dislodged, preventing the pathologist who performed the autopsy from finding it.

"It's going to be nearly impossible to find that," he said.

Merck has repeatedly pointed to Ernst's autopsy report, which attributes his death to an arrhythmia secondary to clogged arteries. The company says no studies link Vioxx to arrhythmia, so the drug couldn't have caused his death.

But Carol Ernst alleges a Vioxx-induced heart attack is to blame, but her husband died too fast for his heart to show damage.

Merck lawyer David Kiernan on Tuesday questioned Lucchesi on his theory that vigorous CPR could have broken up a blood clot into "microemboli," or smaller bits.

"There is no evidence of microemboli in this case, correct?" Kiernan asked.

"We don't know that because they're hard to find," Lucchesi said.

The pathologist who performed the autopsy opined that vigorous CPR could have dislodged a clot, and that could have led to a heart attack she said more than likely caused Ernst's fatal arrhythmia. She didn't say Vioxx was responsible, noting she knew little about the drug in 2001, but Lucchesi was among three plaintiff's experts who said Vioxx triggered Ernst's death.

Two other cardiology and pathology experts testified on Merck's behalf that Ernst died from clogged arteries — one of which was blocked by up to 75 percent. They said the autopsy report was valid, but that pathologist's theory of a heart attack causing the arrhythmia was not.

Vioxx trial is high stakes for Merck

2005-08-16T20:03:00.000-07:00

If drug maker loses, analysts say, it may face $20 billion in liability

09:31 PM CDT on Tuesday, August 16, 2005

By BRUCE NICHOLS / The Dallas Morning News

ANGLETON, Texas – The first Vioxx case to go to trial started modestly. Carol Ernst just wanted someone to take responsibility for the sudden death of her seemingly healthy husband, Bob, who took the painkiller for eight months.

As it heads to a jury today , the case has become more than that.

The future of Vioxx's maker, Merck & Co., one of the oldest and largest U.S. drug makers, is at stake. More than 4,000 similar lawsuits have been filed nationwide. If Merck loses this case, analysts say, claims could climb to 100,000, with Merck's potential liability reaching $20 billion.

Both the U.S. Food & Drug Administration, which licensed Vioxx in 1999, and the industry as a whole have been affected. The agency appears to be taking more care as a result of controversy surrounding Vioxx and such drugs as Fen Phen for dieting, Prozac for depression and Viagra for impotence. The industry has set more cautious advertising standards for itself.

Vioxx and other drug scares have shaken public confidence, said Ken Kaitin, director of the Center for the Study of Drug Development at Tufts University in Massachusetts.

"It gives more fuel to activists that claim that the FDA is not doing its job," he said, "and that the industry is only concerned with profits, is pushing unsafe drugs onto the market."

The trial has included eyebrow-raising evidence of aggressive marketing tactics by Merck, including keeping track of prescriptions that doctors write, coaching salesmen to avoid answering questions and confronting opinion leaders who expressed doubts about Vioxx.

But Merck has maintained throughout that it acted responsibly and on the basis of good science.

The basic facts of the Ernst case are fairly straightforward.

Robert Ernst was an active, athletic 59-year-old Wal-Mart produce manager. But he suffered hip pain and tendonitis in his hands. He'd been taking as many as 16 Advil daily when his doctor prescribed once-a-day Vioxx in late 2000.

One evening in May 2001, he returned from a run feeling ill. His wife later found him unconscious in bed. Ambulance workers in his hometown of Keene, southwest of Dallas, couldn't revive him. He was declared dead of an apparent heart attack at a hospital in Cleburne.

New Jersey-based Merck rolled out Vioxx with great fanfare in 1999, saying it was easier on the stomach than other painkillers. Ulcers and gastronintestinal bleeding are big problems for some pain patients, and a study showed that Vioxx reduced such incidents by half.

Another study, however, showed that Vioxx nearly doubled the risk of heart attack and stroke, and Merck voluntarily pulled the drug off the market last September.

Beyond the basic facts, things get fuzzier.

Mrs. Ernst blamed Vioxx for her husband's death, testifying that her loss was particularly poignant because the couple had met late in life and married 11 months before he died.

But she had a problem: The coroner's report blamed an irregular heartbeat due to hardening of the arteries – not a heart attack. No study ever linked Vioxx to arrhythmia.

Mrs. Ernst's lawyer, prominent Houston plaintiffs attorney Mark Lanier, tried to overcome the finding with experts, including the coroner who autopsied Mr. Ernst. They testified that arrhythmia could be caused by a heart attack that escapes detection in sudden death.

Merck witnesses dismissed the theory as a stretch, noting that a key artery in Mr. Ernst's heart was 75 percent blocked and asserting that he could have died anytime, with or without Vioxx.

Mrs. Ernst seemed on firmer ground with her contention that Merck failed to fully disclose problems with Vioxx before her husband died.

Merck's embarrassment: Documents and e-mails suggesting that Merck fought FDA regulators over how Vioxx's risks were worded on the label. One executive even called FDA officials "bastards."

Company witnesses said that the risk wasn't clear until late 2004.

Merck's aggressive marketing was successful. By the time Vioxx was withdrawn after five years, 80 million prescriptions had been written, and sales had reached $2.5 billion a year.

Success exposed Merck to greater potential liability. Millions used Vioxx. Heart attack and stroke are common. And because it's hard to prove what caused them, juries have a lot of latitude in casting blame. In Texas and most other states, all a plaintiff has to do to win at least a partial victory is to get a jury to say the defendant was partly responsible.

Much of the trial involved statistical testimony about seemingly small differences in risk.

For example, the study that forced Vioxx off the market showed that 3.5 percent of subjects taking it had a heart attack or stroke, compared with 1.9 percent of those taking a sugar pill. Merck said studies also showed patients had to take Vioxx for 18 months or more – 10 months longer than Mr. Ernst – to experience extra risk.

Mr. Lanier tried to lighten the load for a panel sprinkled with blue-collar workers. He drew diagrams and defined terms on a big easel pad, and he used electronic equipment to project his case on a large screen.

He picked Angleton for this fight by naming a local Vioxx researcher as a defendant, then dropping him before trial.

"It's a conservative county for jurors, but by the same token, they're tough on crime. You show them a company's done something really wrong, and they'll speak out," Mr. Lanier said.

Merck's lawyers probably chose to fight the Ernst case because of the questionable cause of death, analysts said.

"The one you pick to go to court is the one you think you have the best chance of winning," said Sidney Wolfe of the consumer group Public Citizen.

Mrs. Ernst, 60, a small, soft-spoken social worker, has sat in the front row throughout the trial, looking weary and amazed.

When she started, she said in an interview that money didn't matter. But she has struggled with deep depression. And paying the bills – especially medical bills – has become a concern.

"When I first started, I never thought that I would be in this position," she said. "I initially struggled with should I do this or not. ... My kids encouraged me to do it. 'If Bob were here, he'd tell you ... to take this on,' " she quoted them as saying.

A couple of factors probably worsened Merck's legal exposure, analysts said.

FDA rules changes in 1997 allowing more direct-to-consumer television advertising spread the harm beyond the population that really needed the drug, those with gastrointestinal issues, Dr. Kaitin said.

And Merck "triggered far more litigation" by pulling Vioxx off the market without being pushed by the FDA, said John Calfee, an American Enterprise Institute scholar who has studied the issue. Merck faces shareholder suits and potential criminal investigations.

Lawsuits are part of the problem, Dr. Calfee said, arguing that juries have trouble evaluating scientific evidence and that damage awards are often out of proportion to real harm, increasing drug costs.

Others see courts as the safety net under a flawed regulatory system. "Industry has in very dangerous ways taken over the FDA," argued Dr. Wolfe, citing 1992 legislation allowing drug companies to fund FDA drug studies to get quicker review as a key example.

Ironically, Vioxx may return to pharmacy shelves "unless the litigation takes a really bad turn," said Dr. Calfee.

The FDA has begun to suspect that more common over-the-counter medications of the same type also may increase cardiovascular risks.

First Vioxx Trial Winding Down

2005-08-15T20:31:00.000-07:00

Jurors in First Vioxx Trial Get Day Off So Lawyers Can Prepare to Wind Down Testimony

By KRISTEN HAYS
The Associated Press

ANGLETON, Texas Aug 15, 2005 — Jurors hearing evidence in the nation's first Vioxx-related civil trial got a day off Monday so lawyers could prepare to wind down testimony and present closing arguments by midweek.

Lawyers on both sides said they expected to make their final arguments Wednesday, after plaintiff's lawyer Mark Lanier presents two rebuttal witnesses Tuesday. Both legal teams worked Monday to hash out issues jurors will consider in reaching a verdict.

Jonathan Skidmore, one of the lawyers for Vioxx-maker Merck & Co., said the company expected to rest its case before Lanier presents his witnesses Tuesday, barring anything unforeseen.

Fifteen witnesses have testified, some by videotaped deposition, since testimony began July 14. Of those, two-thirds testified for the plaintiff, Carol Ernst, including Ernst herself.

She alleges Vioxx caused the sudden death of her husband, Robert Ernst, in May 2001 after the Wal-Mart produce manager and marathon runner had taken the drug for eight months to alleviate pain in his hands.

Merck took Vioxx off the market in September 2004 when a study showed it could double the risk of heart attack or stroke if taken for 18 months or longer. Whether it caused Ernst's death will be a key question for the seven-man, five-woman jury.

Merck has repeatedly pointed to Ernst's autopsy report, which attributes his death to an arrhythmia or irregular heartbeat secondary to clogged arteries. The company says no studies link Vioxx to arrhythmia, so the drug couldn't have caused his death.

Carol Ernst alleges a Vioxx-induced heart attack is to blame but her husband died too fast for his heart to show damage.

The pathologist who performed the autopsy corroborated that view, saying a heart attack more than likely caused Ernst's fatal arrhythmia. She didn't say Vioxx was responsible, noting she knew little about the drug in 2001, but three other plaintiff's experts said Vioxx triggered Ernst's death.

Two other cardiology and pathology experts testified on Merck's behalf that Ernst died from clogged arteries one of which had up to 75 percent blockage. They said the autopsy report was valid, but that the pathologist's theory of a heart attack causing the arrhythmia was not.

Merck faces big Vioxx showdown in N.J.

2005-08-15T08:10:00.000-07:00

Plaintiff took Vioxx for Vietnam War wound, now blames the painkiller for his heart attack.
August 12, 2005: 1:10 PM EDT
By Aaron Smith, CNN/Money staff writer

NEW YORK (CNN/Money) - The first Vioxx trial is expected to close next week in Texas, but this is just the beginning of Merck's legal battle against more than 4,000 lawsuits from plaintiffs blaming Vioxx for health problems and untimely deaths.

In September, the battle continues in Merck & Co.'s (down $0.58 to $30.51, Research) home state of New Jersey, where the company will face Frederick Humeston, a twice-wounded Vietnam veteran who blames Vioxx for his 2001 heart attack.

The outcome of Vioxx litigation is yet to be seen, but Merck shares have already suffered. The company's stock price plunged by about one-third the day Merck pulled Vioxx off the market on Sept. 30, 2004 and has not recovered.

On Sept. 12, jury selection begins in the first of about 2,300 Vioxx cases filed jointly through New Jersey Superior Court in Atlantic City under Judge Carol Higbee. New Jersey's 56-page list of plaintiffs represents more than half of all Vioxx cases. Like Humeston, who lives in Boise, Idaho, many of these plaintiffs live out of state and filed their suits in the New Jersey court because the company is based in Whitehouse Station.

More than 4,000 Vioxx-related lawsuits have been filed against Merck, according to the drug maker's defense team, including 1,800 federal cases, 119 pending state cases, and 2,400 cases in New Jersey, which accounts for most of the state cases.

This tally is expected to grow. Judge Eldon Fallon, who is presiding over all federal cases in New Orleans district court, told reporters in May that lawsuits could ultimately reach 100,000. The first federal case begins on Nov. 28, with a pre-trial conference on Aug. 25.

Merck has vowed to defend itself in all cases.

"We intend to try these cases one by one and that is exactly what we are doing," said Kent Jarrell, spokesman for the Merck defense team.

Vioxx, an arthritis painkiller, was approved by the Food and Drug Administration in 1999. Merck withdrew its $2.5 billion blockbuster from the market after a study raised concerns about health risks.

Humeston, a postal worker and Marine Corps veteran, took Vioxx as a painkiller after he suffered a work injury to his right knee, according to papers filed in New Jersey Superior Court by Merck lawyers. Humeston continued to take Vioxx when he noticed it also reduced pain in his left knee, which was peppered by shrapnel in Vietnam, according to the papers.

Humeston, who was 56 when he suffered his heart attack, believes that Vioxx caused the blot clot that lead to the attack.

"Vioxx is a drug that has been implicated in causing clots," said Humeston's lawyer Christopher Seeger. "[Humeston] is a guy with a healthy heart with no evidence of disease and he has a clot. Getting to Vioxx from that point is not difficult. Vioxx causes clots."

Merck's lawyers contend that Vioxx did cause not Humeston's heart attack. "There is no evidence that the clot would have been smaller or less significant without Vioxx, much less that it wouldn't have happened at all," read the papers filed by Merck lawyers.

The Merck lawyers also wrote that Humeston's case presents "little more than guilt by temporal association – that is, he had [the heart attack] while on Vioxx so Vioxx must have caused it. This is not the kind of rigorous and well-supported scientific reasoning demanded by New Jersey law."

In the bellwether case in Texas Superior Court, Carol Ernst sued Merck for the 2001 death of her husband, Vioxx patient Robert Ernst. Ernst blames Vioxx for causing her husband's fatal arrhythmia, while Merck lawyers insist that Vioxx doesn't cause arrhythmia.

Ernst's lawyer, W. Mark Lanier, also accused Merck of concealing information about the health risks of Vioxx, a charge that Merck has consistently denied.

Lanier said the Ernst case could close next week, possibly by Wednesday. Though Lanier and Seeger have not specified the damages they're seeking, analyst Chris Shibutani of J.P. Morgan Chase has estimated that Merck's liabilities from all cases could range from $8 billion to $25 billion.

The outcome of the Texas case will give a "big psychological boost" to either Merck or the thousands of plaintiffs, depending on which side emerges as the winner, said attorney and legal expert Chip Babcock, chair of the Texas Supreme Court advisory committee.

A Merck victory in the Ernst case "would demonstrate they're on the right track in how they present a case to the jury," said Babcock. "Their defense in both cases [Ernst and Humeston] is basically the same, which is the science doesn't support the plaintiff's theory. If Merck loses [the Ernst case,] they'll say every case is different."

Babcock said that Merck's vow to fight every case individually is a message to plaintiffs that there will be no settlement, and therefore no easy solution.

"Merck is trying to send a very strong signal out there: 'Don't think you're going to toss you're hat in the litigation game and wait a couple months and we're going to toss you some money,'" said Babcock. "They're saying, 'If you're going to play the litigation game, you better be serious.'"

Cardiologist says Vioxx not responsible for man's death

2005-08-12T17:31:00.000-07:00

By KRISTEN HAYS
The Associated Press

ANGLETON, Texas - A cardiologist testifying Friday ruled out Vioxx as the cause of a Texas man's death who took the once-popular painkiller for eight months, citing the lack of evidence of a heart attack or blood clot in the autopsy.

Dr. Craig Pratt, director of research at the Methodist DeBakey Heart Center in Houston, said the autopsy of 59-year-old Robert Ernst "speaks for itself," attributing his death to an irregular heartbeat caused by clogged arteries with no mention of a heart attack.

His testimony for Vioxx manufacturer Merck & Co. highlighted the crux of the dispute in the nation's first Vioxx-related lawsuit to go to trial: Whether Vioxx, which Merck pulled from the market last year after a study showed it doubled the risk of heart attack or stroke if taken for 18 months or longer, had anything to do with Ernst's death.

Jurors likely will begin deliberations next week, lawyers said Friday. Merck expects to rest its defense Monday or Tuesday, and closing arguments could begin by Wednesday.

Ernst's widow, Carol, claims Merck knew years before it pulled the drug in 2004 that Vioxx could be dangerous, but minimized those concerns in favor of profits. Her husband, a Wal-Mart produce manager who also ran marathons, died in his sleep after taking Vioxx for eight months to ease pain in his hands.

Pratt was Merck's second expert to counter claims that a Vioxx-induced heart attack triggered Ernst's fatal arrhythmia. Three plaintiff's experts have blamed Vioxx.

The coroner who performed Ernst's autopsy also testified that a heart attack brought on by a clot more than likely triggered the fatal arrhythmia. Dr. Maria Araneta said she didn't note those conditions in her report because the clot was probably dislodged by vigorous CPR and Ernst died too quickly for his heart to show damage. She didn't blame Vioxx for a clot or heart attack, noting she didn't know much about the drug in 2001.

Pratt said Friday Araneta's autopsy was valid, but her opinions about a clot and heart attack were not.

"I don't think this patient had a heart attack. I don't think this patient had a clot. I think it's clear this death was not due to Vioxx," he said.

However, Carol Ernst's lawyer, Mark Lanier, challenged Pratt's credibility.

Under questioning from Merck lawyer Gerry Lowry, Pratt told jurors his past work with Merck amounted to attending a meeting of experts a dozen years ago to offer opinions on a Merck drug for the heart. He said he had testified for both plaintiffs and pharmaceutical companies before, including a case involving cholesterol-lowering Baycol.

On cross-examination, Pratt acknowledged he serves on the board of scientific advisers for Swiss pharmaceutical company Actelion, which has an exclusive research alliance with Merck. He also said his Baycol testimony came in a case in which Lowry represented Baycol-maker Bayer Corp.

A plaintiff's expert who blamed Vioxx for Ernst's death, Dr. David Egilman, acknowledged under direct examination that he had repeatedly testified on behalf of plaintiffs represented by Lanier in asbestos cases.

Carol Ernst also claims that even though her husband had one artery blocked up to 75 percent, his blood flow sustained his heart in vigorous exercise, so Vioxx is responsible for killing him in his sleep.

Pratt testified it wasn't unusual for people with blocked arteries to die while at rest. He said some studies show up to 36 percent of people with clogged arteries can die in their sleep.

But when Lanier showed the cardiologist a 1997 study that placed the rate of such deaths at less than 15 percent - by a scientist Pratt had said he relied on - Pratt couldn't cite specific studies with the higher rates.

"There are thousands of papers," Pratt said.

First Vioxx civil trial winds down in Texas

2005-08-12T17:28:00.000-07:00

ANGLETON, Texas (Reuters) - Arguments in the first civil trial against pharmaceutical company Merck & Co.'s painkiller Vioxx are expected to end next week, lawyers for the company and the plaintiff said on Friday.

The trial, pitting the family of a Texas man against New Jersey-based Merck, has lasted about a month and is the first of thousands of civil suits claiming the company hid the risks of the drug.

Members of Merck's legal team and plaintiff's lawyer Mark Lanier said they expected closing arguments in the case to begin on Tuesday or Wednesday.

Merck pulled the drug off the market in September when it said it became aware the drug increases users' risk of heart attack and stroke.

The crux of the case in Angleton, a small town about 30 miles south of Houston, is whether 59-year-old Robert Ernst died of a heart attack, and whether he had been on the drug long enough to raise his risk of cardiac problems.

An autopsy report attributed Ernst's sudden death in 2001 to a heart arrhythmia, but the doctor who authored that report testified that she believed he had suffered a heart attack.

Merck has argued that there was no evidence Ernst suffered a heart attack, and that he took the drug for only a few months, far short of the 18 months' usage that studies have said raised risks for serious health affects.

Vioxx is the trade name for rofecoxib, part of a class of drugs called NSAIDs. It was touted as a pain and inflammation reliever that did not cause ulcers or gastrointestinal bleeding, a side effect of many such medications.

And a just few side effects on the side

2005-08-12T17:26:00.000-07:00

Home News Tribune Online 08/12/05

This letter is a follow-up to the one which appeared in the Aug. 2 edition of the Home News Tribune concerning Vioxx and its maker Merck. Vioxx was an effective anti-inflammatory and analgesic agent that provided relief to thousands of pain suffers. Indeed, for many patients it was the only medication that worked.

All drugs, whether they are by prescription or over-the-counter, have side effects, and taking any of them involves some degree of risk. Because a drug is FDA approved does not mean it is completely safe or free of adverse reactions.

When a drug is given to a patient, the health-care provider must weigh the benefits versus the risks of taking the medication. A recent FDA panel concluded that the benefits of Vioxx outweighed its risks and that the drug should be brought back with a stronger warning label. A similar panel in Canada came to the same conclusion.

It appears that many reporters writing on the subject, who have little knowledge of science or medicine, have the preconceived notion that Vioxx is harmful, obtain the opinion of an "expert" or two to support this notion, and then publish an article as the gospel truth.

Rarely do they write follow-up articles presenting the other side of the argument for which experts can also be found. Such bias is inappropriate and poor journalism.

In the meantime former Vioxx users will take alternative medications, such as aspirin, ibuprofen and naproxen, which have their own inherent side effects and risks.
Philip Washko

Merck scientist says can't eliminate all drug safety risk

2005-08-11T20:03:00.000-07:00

By KRISTEN HAYS - Associated Press

ANGLETON, Texas - Merck & Co.'s head of clinical trials testified in the nation's first Vioxx-related civil trial Thursday that consumers would have no new drugs if all safety risks had to be eliminated first.

But Dr. Alise Reicin told jurors that the company does "post-market surveillance" - continued monitoring and testing once the product is for sale. Such testing led to Merck's decision to pull Vioxx from the market last year when a study showed the drug could double risk of heart attack or stroke if taken for 18 months or longer.

Reicin, calm and composed, testified in a lawsuit over the death of Robert Ernst, a 59-year-old Texas man who died in his sleep after taking the once-popular painkiller for eight months to ease aches in his hands.

"Are safety concerns seen sometimes after things come to market? Yes, they are," Reicin said. "If society decided they didn't want to take that risk we would have no new drugs on the market."

Lanier also had noted that Reicin's 2001 performance review said her major efforts included "defending the Vioxx franchise."

"You are still the defender of Vioxx, aren't you?" he asked Thursday.

"Again, that's not how I would characterize my role," Reicin replied. "I would characterize my role as a scientist."

Ernst's widow, Carol, alleges that Merck knew years before the withdrawal that Vioxx posed heart dangers, but focused on aggressive marketing that helped turn the drug into a $2.5 billion seller. Her husband, a Wal-Mart produce manager, also ran marathons and was an occasional personal trainer.

Reicin reiterated what other current and retired Merck executives have said during the trial: Safety was paramount in 58 clinical trials involving 10,000 patients that were conducted before Vioxx won approval from the U.S. Food and Drug Administration to go on the market in 1999.

But Carol Ernst's lawyer, Mark Lanier, singled out several of those studies, challenging their results because so many were small and involved patients taking Vioxx for days or weeks rather than years.

Specifically, he noted a study in 1997 where an outside scientist noted Vioxx could possibly cause blood clots that may lead to heart attacks or strokes because it inhibited an enzyme that thins the blood. That feature helped Vioxx cut risk of stomach bleeds and ulcers that can come from taking painkillers like aspirin that don't inhibit the enzyme.

The coroner who performed an autopsy on Ernst testified that Ernst more than likely had a blood clot that led to a heart attack. She didn't note either in her report because, she said, vigorous CPR likely dislodged the clot and he died of an irregular heartbeat too fast for his heart to show damage. A pathologist testified for Merck that there was no evidence of either a clot or a heart attack.

Lanier asked Reicin why patients recruited to take Vioxx in a 1997 study were warned that the drug could cause blood clots or mild strokes, but weren't warned of possible heart attacks.

"It was a completely theoretical possibility at that point in time," she said. "The same question had been raised about Tylenol, but I don't think there's anyone in the (medical) community who thinks Tylenol causes heart attacks."

In 2000, a year after Vioxx had been on the market, a study showed Vioxx users suffered five times as many heart attacks as patients who took the older painkiller naproxen, sold under the brand name Aleve.

Reicin reiterated Merck's view that the study illustrated naproxen's heart-friendly qualities rather than a defect in Vioxx. She said previous studies comparing Vioxx to sugar pills showed little to no difference, and no patients in the Vioxx/naproxen study took sugar pills.

The same scientist who hypothesized in 1997 that Vioxx could cause blood clots was co-author of an article published after the Vioxx/naproxen study that said its results could be attributed to cardioprotective qualities or chance. But the scientist, as well as another author of the same article, didn't disclose with that article that they did consulting for Merck, Lanier noted.

"He didn't get money from us to write this article," Reicin said. "He has been a consultant to us. I can tell you it does not influence his judgment."

However, the FDA rebuked Merck for attributing the study's result to naproxen's cardioprotective effect without scientific proof. Lanier questioned why Merck didn't add cardiovascular warnings to its label until two years later.

"We wanted the label change to happen," Reicin said, but the company didn't immediately agree with all FDA suggestions on how Vioxx affected gastrointestinal and cardiovascular systems.

Merck scientist says Vioxx heart risks weren't known

2005-08-11T19:55:00.000-07:00

By Bloomberg News | August 11, 2005

WILMINGTON, Del. -- Merck & Co.'s painkiller Vioxx underwent rigorous testing that showed no evidence of heart risks before it went on the market, a company scientist said yesterday in the first trial over the drug.

Dr. Alise Reicin, vice president of clinical trials, testified Vioxx was tested on almost 10,000 people in 58 studies before it was submitted to the Food and Drug Administration for approval in 1998. Another 70 studies followed after the application, she said.

"It was one of the biggest programs that Merck, or any other pharmacy company, had conducted," Reicin testified in Angleton, Texas.

The jury must decide if Vioxx caused the 2001 death of Robert Ernst, 59, a marathoner. His family says Ernst died of a Vioxx-induced heart attack and accuses Merck of playing down the risks to boost sales. Merck counters that Ernst had an irregular heartbeat brought on by hardening of the arteries unrelated to the drug.

Reicin was involved with a Vioxx study that looked at gastrointestinal bleeding, a side effect of many painkillers. The study compared Vioxx to naproxen, the ingredient in Aleve, and showed higher cardiovascular incidents, including blood clots, than with naproxen, she said.

''There was a lower rate of thrombotic events with people taking naproxen than with people taking Vioxx," Reicin said. ''I still believe the difference was because of the heart-protectiveness" of naproxen. The FDA cast doubt on that theory in a 2001 warning letter to Merck about its Vioxx marketing tactics.

Government regulators said the argument that naproxen influenced the number of heart attack incidents was ''hypothetical" and that ''another reasonable explanation" was that the drug caused the incidents, according to the letter.

The company agreed to change its label, and reviewed the results of other tests, which compared Vioxx to other painkillers and with a sugar pill, Reicin said.

Another study showed an increased risk of heart attack and stroke, and ''Merck voluntarily withdrew Vioxx from the market."

Arthritis law suit battle setback Aug 10 2005

2005-08-11T19:46:00.000-07:00

Arthritis law suit battle setback Aug 10 2005 By Deborah James, Daily Post Staff - Liverpool Daily Post

A GROUP of Merseyside arthritis sufferers has been refused public funding to fight a landmark legal case against the makers of the "miracle" arthritis drug Vioxx.

The Legal Services Commission has rejected claims for legal aid by three British solicitors' firms preparing to lodge a class action against US drugs giant Merck, the Daily Post can reveal.

The three, including Liverpool medical negligence experts Goodmans, are jointly fighting for compensation for a potential 1,000 British people who suffered heart attacks or strokes after taking Vioxx.

Merck withdrew the drug, used to treat painful conditions like rheumatoid and osteo-arthritis, last September after a study found it could increase the risk of cardio-vascular problems.

A total of around 400,000 people were prescribed the drug in the UK, and thousands more worldwide. Hundreds of cases have already been lodged in the US, where it is estimated the company's litigation bill could reach $18bn (£10bn).

Last night, solicitor Ian Cohen, who is leading the case for Goodmans' cohort of up to 200 Merseyside clients, said he was disappointed with the LSC decision.

But he said he was confident the case could still be fought on UK soil.

He confirmed Goodmans had lodged a joint appeal for funding from the LSC, with London firms Irwin Mitchell and Leigh Day, which will be heard in the autumn.

In the meantime, all three firms are now in negotiations with private "after the event" insurers to seek alternative finance for the group action, should the legal aid avenue fail.

Mr Cohen, who successfully fought a legal aid-funded compensation case for the parents of children involved in the Alder Hey scandal, said: "We are quite comfortable with our position and we are confident that funding will be in place and we will be pursuing a class action in the UK."

He added: "We understand the LSC's decision as they only have a limited budget, and they have been hit before by cases that have failed.

"The danger is that legitimate cases like this may be refused."

A separate group of Merseysiders, represented by Allerton firm MSB, have already by-passed the legal aid route and are preparing to fight a series of privately-financed cases directly in the US courts.

However, Mr Cohen said he was not prepared to go down that route.

He said only up to 30% of his potential Vioxx claimants could be classed as normally eligible for legal aid, and Goodmans would in any case have to find private backing for the remaining 60%.

A test group of 18 claims for up to £2,000 each in legal aid, lodged by Goodmans, has so far been rejected by the LSC.

A Legal Services Commission spokesman said: "Legal aid has been refused for claimants who wished to bring an action against the pharmaceutical company, Merck, in relation to its drug, Vioxx.

"The Legal Services Commission cannot go into the detail of why legal aid was refused, as this may affect the chances of the case being taken forward with private funding.

"An appeal against our decision will be heard in the autumn.

"The LSC has a limited budget and we must ensure that we make best use of taxpayers' money by only providing funding to cases that cannot proceed without it.

"For example, the case that was brought against Alder Hey Hospital for retaining body parts of children without their parents' consent..

"As the Vioxx case concerns a drug that has been withdrawn, it is highly likely that private funding, either through insurance or a 'no win, no fee' agreement, can be obtained.

"Also, there is very similar litigation currently ongoing in America. If this case is successful, the likelihood of obtaining private funding for a case in Britain is substantially increased."

Vioxx Recall Summary

2005-08-10T20:50:00.000-07:00

Vioxx Lawsuit Information. Heart Attack And Stroke Side Effects Prompt Merck Recall: Vioxx Recall Summary

The following is a short summary of information concerning the Vioxx recall:

On September 30, 2004 Merck announced the removal of the popular anti-inflammatory drug Vioxx from the market. This Vioxx recall was due to a study they were conducting that shows patients taking the drug face twice the risk of heart attack compared to those in the test taking a placebo.

Vioxx is a prescription COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms.

The Vioxx recall is the largest withdrawal of any drug. Vioxx has been on the market around the world since about 1999 and has been prescribed millions of times. In 2003 alone, the drug accounted for $2.5 billion in sales.

According the FDA, patients who are currently taking Vioxx should contact their physician for guidance regarding discontinuation and alternative therapies.

In Merck's Vioxx Gastrointestinal Outcomes Research report published in the New England Journal of Medicine (November 23, 2000), Merck compared the effectiveness of Vioxx (rofecoxib) to naproxen. The study shows a statistically significant increase in heart attacks in the rofecoxib group (0.5 percent) compared to the naproxen group (0.1 percent). There were 20 heart attacks suffered by 4,047 Vioxx patients and 4 heart attacks in 4,029 naproxen patients. While the absolute numbers are low, this is a five-fold increase that statistically is highly significant and merited further studies. In addition the study reported increased problems with blood clotting (which results in strokes and leg clots).

A study led by a Food and Drug Administration safety official projects that the widespread use of Vioxx may have led to more than 27,000 heart attacks and sudden cardiac deaths before the drug's abrupt recall.

A joint study by the Kaiser Permanente Medical Foundation and the FDA reported a tripling of heart attack risk among patients who took double the standard 25 mg. dose.

Former Merck CEO Says Vioxx Important To Growth

2005-08-10T14:12:00.000-07:00

Former Merck CEO Says Vioxx Important To Growth

Vioxx trial: Scientist says studies were not skewed

2005-08-10T13:52:00.000-07:00

Vioxx trial: Scientist says studies were not skewed

SEC Asking Pfizer for Bextra, Celebrex Data

2005-08-09T11:49:00.000-07:00

SEC Asking Pfizer for Bextra, Celebrex Data

By MADLEN READ
The Associated Press
Tuesday, August 9, 2005; 12:55 PM

NEW YORK -- Pfizer Inc. is responding to a request from the Securities and Exchange Commission for information and documents on its Bextra and Celebrex painkillers, the drugmaker said Tuesday in a filing.

The SEC made the request in the second quarter, said Pfizer spokeswoman Mariann Caprino. She said the company has no further comment on the request, except that it is cooperating.

New York-based Pfizer, the world's biggest drugmaker, had received similar requests for information and documents from the Department of Justice and a group of state attorneys general about Bextra and Celebrex, which along with Merck & Co.'s painkiller, Vioxx, are known as Cox-2 inhibitors.

In September, Whitehouse Station, N.J.-based Merck withdrew Vioxx from the market after it said the drug was associated with higher rates of heart attacks and strokes in patients who took it for more than 18 months.

In April, Pfizer's Bextra was pulled from the market because of safety risks. The U.S. Food and Drug Administration also ordered Pfizer and 19 other popular prescription competitors to provide stronger warnings about possible cardiovascular risk in pain relievers.

The SEC request did not come as a surprise to analysts, who characterized it as yet another step in the ongoing investigation of Cox-2 inhibitors.

Caris & Co. analyst Le Anne Zhao said Pfizer will likely keep working with government officials on the Celebrex label. Bextra probably won't return to the market "until more studies have been done to show risk factors," Zhao said.

Also in Pfizer's filing Tuesday, the company said the U.S. Environmental Protection Agency in July proposed a civil penalty of $275,000 to settle alleged violations of the Federal Clean Air Act at the company's Kalamazoo, Mich., facility.

Pfizer said it is in discussions with the EPA to resolve the matter and is addressing the agency's concerns.

Pfizer's filing also noted the Internal Revenue Service has begun an audit of the company's returns for 2002 and 2003.

In midday trading, shares of Pfizer rose 26 cents to $26.47 on the New York Stock Exchange.

Baylor pathologist says no heart attack in Vioxx case

2005-08-09T11:45:00.000-07:00

Baylor pathologist says no heart attack in Vioxx case

08/09/2005

By KRISTEN HAYS / Associated Press

An emergency room doctor who blamed a heart attack for a Texas man's death made a "best guess" that an autopsy later ruled out, the head of Baylor College of Medicine's pathology department testified Tuesday in the nation's first Vioxx-related civil trial.

Dr. Thomas Wheeler conceded that the doctor on duty at the ER where Robert Ernst, 59, was taken the night he died noted common heart attack symptoms of chest discomfort and shortness of breath. But Wheeler said an autopsy accurately attributed his death to arrhythmia, or an irregular heartbeat, secondary to clogged arteries.

The ER doctor "made a best guess, and the pathologist solved the problem in the autopsy," said Wheeler, a witness for Vioxx maker Merck & Co.

Whether a heart attack or arrhythmia alone caused Ernst's death is central to the first of more than 4,200 state and federal Vioxx-related lawsuits to go before a jury.

The New Jersey pharmaceutical company pulled Vioxx from the market nearly a year ago when a study showed it could double risk of heart attack or stroke if taken for 18 months or longer. But Merck says no studies link Vioxx to arrhythmia, so the drug couldn't have caused Ernst's death.

Ernst's widow, Carol, alleges the once-popular painkiller caused a blood clot that led to a heart attack, but he died too quickly for his heart to show damage. The coroner who performed his autopsy corroborated their view last week.

Wheeler said he agreed with the coroner's original conclusion, noting she did "an excellent job examining coronary arteries" that were blocked by up to 75 percent.

But he said he disagreed that the arrhythmia was likely triggered by a heart attack. Wheeler said there was no evidence of a heart attack or a blood clot that may have caused it.

Carol Ernst's lawyer, Mark Lanier, challenged Wheeler's contention that Ernst's clogged arteries led to his death. Ernst, a produce manager at a Wal-Mart who ran marathons and taught aerobics classes, died in his sleep.

Lanier presented passages in a medical textbook that said patients would need to have at least 90 percent blockage in coronary arteries to die while at rest from lack of blood to the heart. Wheeler disagreed.

Yet Wheeler acknowledged that Ernst's blood flow sustained him during strenuous exercise, including the day he died.

Pathologist says clogged arteries killed man in Vioxx case

2005-08-08T21:06:00.000-07:00

Associated Press Aug. 8, 2005, 2:26PM

ANGLETON — The head pathologist at Baylor College of Medicine told jurors today in the nation's first Vioxx-related civil trial that clogged arteries led to a Texas man's death of an irregular heartbeat. Dr. Thomas Wheeler's testimony as part of Vioxx maker Merck & Co.'s defense countered that of the pathologist who performed the autopsy, who said a heart attack more than likely caused Robert Ernst's death from arrhythmia, secondary to clogged arteries.

"Do we know in this case what caused the fatal arrhythmia?" Merck lawyer Gerry Lowry asked.

"Yes, the severe atherosclerosis," Wheeler replied, using the medical term for blocked arteries.

The cause of Ernst's death lies at the center of the case. The plaintiff, Robert Ernst's wife, Carol, claims that his fatal arrhythmia was caused by a Vioxx-induced heart attack. Dr. Maria Araneta, who performed the autopsy, testified last week that the arrhythmia was likely triggered by a blood clot that caused a heart attack, but Ernst died too quickly for his heart to show damage.

But neither her autopsy report nor Ernst's death certificate mention a heart attack or blood clot. Merck had relied heavily on those documents to corroborate its contention that no heart attack was involved.

Merck pulled Vioxx from the market in September when a study showed the once-popular painkiller doubled risk of heart attack or stroke if taken for 18 months or longer. Carol Ernst contends Merck knew years ago that Vioxx could be dangerous but minimized those concerns for profit.

Merck contends the company acted responsibly and disclosed research. Merck also claims no studies link Vioxx to arrhythmia, so the drug couldn't have caused Ernst's death.

In opening statements nearly a month ago, Merck lawyer David Kiernan praised Araneta's unbiased view, saying, "No one can argue that she was tainted by the influence of one side or the other." However, that was before she testified, and Merck lost efforts to block her appearance.

The case is the first of more than 4,200 Vioxx-related state and federal lawsuits pending against Merck to go before a jury. Two other state cases in South Texas and New Jersey are slated for trial next month, and the first federal case will go to trial in New Orleans in late November. Merck has vowed to fight them all.