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Vioxx Lawsuits: Merck Prepares For Round Two

 

By Barbara Martinez, The Wall Street Journal


September 7, 2005

 

After costly mistakes in a Texas courtroom and an astonishing defeat in the first Vioxx trial, Merck & Co. faces round two next week in New Jersey.

Defending the company in a lawsuit filed by a 60-year-old Vietnam veteran who suffered a nonfatal heart attack two months after he began taking Vioxx, Merck lawyers again will try to explain to a jury why Merck shouldn't be held liable for heart problems and strokes among consumers who took the painkiller.
A victory for the pharmaceutical giant is critical to reassuring investors that the company can make a convincing case before a jury. There are a few factors in its favor: A jury may view the plaintiff in the New Jersey case, who claims permanent injury from his heart attack, as less sympathetic than the widow who won $253 million from the Texas jury last month. And New Jersey state court in Atlantic City, were the case is being tried, may be friendlier territory for Merck, which is based in Whitehouse Station.

On the other hand, this suit may be even tougher for Merck, because it centers on a scientifically proven link between Vioxx and heart attacks and strokes. The Texas case, in contrast, involved arrhythmia, or an irregular heart beat, a symptom that lacks an established link with Vioxx.

Wall Street analysts have estimated that Merck could end up paying combined damages of anywhere from $4 billion to $50 billion, assuming unfavorable outcomes or settlements for the approximately 5,000 existing Vioxx suits as well as ones that may be on the horizon. The Texas award is expected to be reduced to about $26 million because of the state's caps on punitive damages, and Merck has said it plans to appeal the verdict.

But the animosity toward Merck that the Texas jurors expressed in interviews and in their outsized award looms over Merck's defense strategy in the New Jersey case. The company's two main challenges are to explain complicated scientific issues -- and to explain away inflammatory internal company documents. "The challenge is to present responsible and scientific information in a clear, more convincing way," said Kenneth Frazier, Merck's general counsel, in an interview a week after the Texas verdict.

In numerous courtroom filings in New Jersey in recent weeks, Merck lawyers have sought to block testimony and documents that were presented to the Texas jurors -- and that persuaded some of them that the company knew Vioxx posed heart risks.

Merck took Vioxx off the market in September last year after a company-sponsored clinical trial showed an increased risk of heart attack and stroke in people using Vioxx daily for more than 18 months. Some researchers had been saying for years that Vioxx increased patients' risks almost immediately.

Merck has pledged to fight individually in court each of the cases brought against it. But in recent weeks, the company has signaled its willingness to settle a small number of cases.

In the New Jersey case, Frederick Humeston, an Idaho postal worker, alleges that Vioxx caused his heart attack in September 2001 after he took the painkiller for two months. His lawyer says Mr. Humeston's heart is irreparably damaged, leading to quick fatigue and diminished quality of life for the former avid hiker.

In court papers, Merck denies Vioxx played any role in Mr. Humeston's heart attack and argues that he had several risk factors, including obesity, elevated blood pressure and high cholesterol. In addition, Merck says Mr. Humeston's mother died of a heart attack, signaling a family history of heart disease.
Mr. Humeston's attorney, Christopher Seeger, said doctors will tell jurors that Mr. Humeston didn't have high blood pressure or high cholesterol, that he was in great shape prior to his heart attack and that his mother, a chronic smoker, did indeed die of a heart attack -- at the age of 80.

Several early decisions have gone Mr. Humeston's way. The judge in the case, Carol Higbee, denied Merck's request to exclude testimony about Mr. Humeston's war record and an examination of its own aggressive marketing campaign for Vioxx. She granted a request from Mr. Humeston's lawyers barring Merck from telling jurors that many high-level Merck executives, scientists and their relatives took Vioxx themselves. The judge says she may revisit these rulings during the trial.

One crucial win for Merck, however, was a ruling that a letter that details one Merck executive's efforts to discredit researchers who were speaking out against Vioxx is inadmissible. The letter played a big role in the Texas case.
More legal wrangling will center on the admissibility of Merck's massive profits and its executives' pay levels, as well as on whether Merck can tell the jury about its charitable activities. The plaintiffs have requested that the court disallow as evidence a Food and Drug Administration memo suggesting that Vioxx is no more dangerous than several more commonly used painkillers.
Mr. Humeston has recovered from the heart attack and is back at work. Merck has asked the judge to bar him from showing any pictures of himself in court. The jury in the Texas case was shown a giant picture of the 59-year-old Robert Ernst running in a marathon before he died.

Mr. Humeston's lawyer, Mr. Seeger, is a formidable presence, according to attorneys who have worked with him or tried a case against him. A former construction worker and amateur boxer, he has jury appeal, these people say, because he comes across as amiable, using simple words to explain complex terms.

For Merck, New Jersey could be an easier playing field than Texas. John Brenner, a partner at the law firm McCarter & English who does defense work for pharmaceutical companies -- but not for Merck -- says that in New Jersey the compensatory-damages part of a liability trial can be heard separately from the punitive-damages part. The effect is to limit the evidence that a jury sees in determining liability. In addition, a New Jersey statute makes it difficult to find a drug company liable if the drug's label has been approved by the FDA, as Vioxx's was.


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