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  • 11/03/2005

Merck Scores Major Victory
In the Second Vioxx Trial

November 3, 2005 11:07 a.m.

ATLANTIC CITY, N.J. — Merck & Co. emerged entirely unscathed from the second high-stakes trial over its Vioxx painkiller, marking a critical comeback from a big loss in the first trial and giving the drug giant some momentum as it faces a wave of lawsuits related to its former blockbuster. A state court jury concluded that Merck fairly represented the safety risks of its Vioxx painkiller, and further found that the drug played no role in the heart attack of the 60-year-old plaintiff. In addition, it determined that Merck didn’t commit consumer fraud, meaning that it fairly marketed the drug to doctors and patients. Merck stock rose sharply after the news. Its shares jumped 7%, or $1.99, to $30.40 after the verdict was announced. The jury of three men and six women deliberated for a little more than a full day before delivering its sweeping exoneration of Merck. Frederick “Mike” Humeston had alleged that Merck had failed to warn the public about its safety concerns over Vioxx, which he claimed had caused his heart attack after he took the drug intermittently for two months. The jury, which heard seven weeks of testimony, had to consider two charges: failure to warn and consumer fraud. In deciding against Mr. Humeston on the first question, it concluded that Merck either did not know that Vioxx carried cardiovascular risks at the time that Mr. Humeston was prescribed it in 2001, or that the company adequately warned physicians about those risks. It further determined that Vioxx was not a substantial factor in causing the heart attack. In considering the claim of consumer fraud, the jury examined whether the company had misrepresented Vioxx’s risks or otherwise used “unconscionable practices” in marketing the drug to physicians. It decided Merck had not done so.”We’re very pleased with the jury’s verdict,” said Jim Fitzpatrick, a spokesman for Merck. “This confirms our strategy” to fight each case individually based on the science. “I think the science is very clear that there is no short-term risk.” Merck pulled Vioxx from the market in September 2004 after a long-term study showed the drug doubled risk of heart attack or stroke if taken for 18 months or longer. At its peak, Vioxx brought Merck about $2.5 billion in annual revenues.

Inside the Case

A cornerstone of Merck’s defense has been that low-dose, short-term use of Vioxx wasn’t found to cause heart attacks. Mr. Humeston said he took the painkiller intermittently for only two months. Unlike the central figure in the Texas trial, who died, Mr. Humeston survived and is back at work.

Mr. Humeston’s lawyers and expert witnesses said the clinical studies gave warning signs about its risk and that the company failed to adequately investigate them before introducing Vioxx in 1999. The Food and Drug Administration approved Vioxx as “safe and effective” for treating different types of pain four separate times over the years, the last time a month before Merck pulled it off the market, Merck has said. Agreeing with Mr. Humeston’s lawyers that the best evidence in the case was Mr. Humeston himself, Merck’s defense tean insisted his physical condition — he had elevated blood pressure, was overweight and was under stress from a dispute with his U.S. Postal Service bosses — triggered the Sept. 18, 2001 heart attack, not Vioxx.

Mr. Humeston had been given a 30-pill Vioxx prescription in May 2001 but didn’t use it all because he said it wasn’t working for him. But he got a second prescription two months later. Mr. Humeston and his wife, who also testified, remembered that he had taken the last pills in the bottle the night he was stricken, but she couldn’t remember when his last dose was when she was asked at the hospital later.

Next Steps

The judge overseeing thousands of federal lawsuits said that an effort by plaintiff’s lawyers to keep their cases in state courts was “counterproductive” to his desire to eventually settle all claims. “There’s a movement afoot to work outside” multidistrict litigation, U.S. District Judge Eldon Fallon told lawyers at a status conference. “I think that’s counterproductive.”

The first federal Vioxx trial opens Nov. 28 in Houston.

The judge said thousands of state trials counteract his goal of reaching a global settlement of all Vioxx cases. He wants state cases folded into the same pot that holds the consolidated federal cases under his purview so he can preside over a few trials and determine a proper resolution to all the litigation.

Plaintiffs’ lawyers Mark Lanier of Houston and Perry Weitz of New York say they have assembled a legal “dream team” of 10 law firms and 350 lawyers to push all future Vioxx lawsuits into state courts. Federal courts are generally considered more defense friendly. Plaintiffs allege the company knew Vioxx was dangerous years before withdrawing the drug but downplayed those concerns to push sales.
After the Nov. 28 Vioxx trials, the next federal Vioxx trials will be in February, March and April next year.

Jury verdicts on the specific counts in Frederick Humeston et al v. Merck & Co. Inc.

Counts regarding failure to warn of Vioxx risks:

* Did Merck fail to adequately warn physicians of the link between Vioxx and higher risks of heart attack and stroke, which it knew or should have known about before Frederick “Mike” Humeston’s heart attack?

Jury: NO by an 8-1 vote.

Counts regarding failure to warn of Vioxx risks:

* Did Merck commit consumer fraud “by using unconscionable commercial practices” when marketing Vioxx to physicians?

Jury: NO by a 9-0 vote.

* Did Merck “make misrepresentations that had the capacity to mislead concerning the cardiovascular risk of Vioxx” while marketing Vioxx to physicians?

Jury: NO by a 9-0 vote.

* Did Merck “intentionally suppress, conceal or omit material information about an association between Vioxx” and increased risk of heart attack and stroke?

Jury: NO by a 9-0 vote.


Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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