UK regulator investigates Merck's handling of Vioxx trial data

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months' use but this difference did not become statistically significant until month 34 -- one week before the drug was withdrawn.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

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?

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

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

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

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

(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

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

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

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

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

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

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

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?

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

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

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

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

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

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

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

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

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

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.