Court orders review of Vioxx class suit

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on Tuesday opened the door to a potential class action lawsuit against Merck & Co. on behalf of people who took its now-withdrawn painkiller Vioxx and want the company to pay for tests to detect possible heart ailments.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

(2007-01-19)
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PHILADELPHIA (Reuters) - Merck & Co. faces a woman who blames its withdrawn pain drug Vioxx for her brother's death and the retrial of a case it had previously won in a product liability trial set to begin in Atlantic City, New Jersey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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.