Next test of Merck’s Vioxx Strategy is in Federal Court

posted on:
November 23, 2005

author:
Staff

The first federal trial over Merck & Co.’s Vioxx painkiller is scheduled to begin next week, but it could take several more trials before the drug maker decides whether to begin settling cases or stand by its vow to fight thousands of lawsuits over many years.

A trial set to begin Tuesday in federal court in Houston will center on whether Merck is liable in the May 2001 death of 53-year-old Richard Irvin. The St. Augustine, Fla., man had a heart attack about a month after he began taking Vioxx to alleviate back pain.

Irvin’s widow has alleged Vioxx caused the heart attack, and that Merck concealed from the public the health risks of taking Vioxx. Merck says Vioxx didn’t cause Irvin’s heart attack, and that it behaved in the best interest of patients when it studied and marketed Vioxx. Merck already has won one Vioxx liability case and lost another in state courts.

Merck withdrew Vioxx, a treatment for arthritis and acute pain, from the market in September 2004 after a study showed that it increased the risk of cardiovascular events – such as heart attack and stroke – in people who took the drug for at least 18 months. The Whitehouse Station, N.J., pharmaceutical company has since been hit with about 6,400 lawsuits blaming Vioxx for personal injuries and deaths.

Some 2,900 of those lawsuits were filed in federal court and are being coordinated by a single judge, Eldon Fallon. So the trial beginning next week could provide a clue to the direction of a big chunk of Merck’s litigation.

But the case involves yet another relatively short-term user of Vioxx who had a cardiac event. Legal experts say a clearer picture of how the litigation will play out may emerge when other types of scenarios are tried, including long-term users of Vioxx and those who suffered strokes.

“We still haven’t had a long-term taker” of Vioxx go to trial, said Carl Tobias, law professor at the University of Richmond School of Law. He noted the judge in New Jersey, where one case was already decided and where another big chunk of Vioxx cases will be heard, and Fallon are scheduling upcoming cases with a variety of scenarios, which could establish patterns that could influence whether Merck will continue fighting each case, as it has pledged.

The Vioxx withdrawal and subsequent litigation have raised serious questions about Merck’s future. Some analysts have estimated its potential liability could exceed $20 billion. The company hasn’t established a reserve for potential damages, but has set aside $675 million for legal defense of Vioxx cases. Vioxx, launched in the U.S. in 1999, generated about $2.5 billion in sales in 2003, the last full year it was on the market.

Merck shares have plunged more than 30% since the withdrawal, closing Tuesday at $30.51. In May, the company’s longtime Chairman and Chief Executive, Raymond Gilmartin, stepped down 10 months before his scheduled retirement.

So far, two other Vioxx cases have been tried in state courts in Texas and New Jersey, with mixed results. Merck lost the first trial in August, when a Texas jury found the company liable in the heart-related death in May 2001 of a 59-year-old man who had taken Vioxx for about eight months, and awarded his widow $253 million in damages. Under Texas law, those damages would be capped at about $26 million; Merck plans to appeal the verdict.

But Merck won the second trial in New Jersey earlier this month when a jury found Merck wasn’t liable in the September 2001 heart attack of an Idaho man who had taken Vioxx for less than two months. The man survived the heart attack.

The Texas verdict suggested Merck might have a tough time getting juries to focus on what the company believes are the scientific facts surrounding cardiovascular events. Instead, the jury seemed to focus more on the plaintiff’s argument that Merck knew it had a faulty product and tried to conceal it. The New Jersey verdict brightened Merck’s prospects somewhat because it suggested a jury would buy Merck’s defense that it hadn’t been deceitful.

Irvin’s widow, Evelyn Irvin Plunkett, alleges in her federal lawsuit that Merck knew of the potential cardiovascular risks of Vioxx as early as the 1990s. The suit says Merck marketed Vioxx in a misleading manner because some advertisements didn’t mention these risks, including ads featuring figure skater Dorothy Hamill. The suit also claims Merck falsely asserted that Vioxx was safe, and seeks unspecified damages from Merck.

Although Irvin only took the drug for about a month, his widow’s attorneys say Merck’s insistence that the health risk from Vioxx increases only after 18 months of use is “a myth.” Attorney Andy Birchfield said in a news conference last week that an autopsy of Irvin shows a blood clot caused his death, and that he was healthy before taking Vioxx.

Merck tells a different story. “There is no medical or scientific evidence that Vioxx contributed in any way to Mr. Irvin’s heart attack after one month of use,” Merck General Counsel Kenneth Frazier told reporters earlier this month. “Mr. Irvin would have suffered a heart attack when he did whether he was taking Vioxx or not.”

Frazier said Irvin’s autopsy shows he suffered from advanced heart disease “that had taken years to develop.” The autopsy showed moderate to severe narrowing of Irvin’s coronary arteries due to chronic buildup of plaque, he added.

Merck appears to view federal court as a more friendly environment than state courts. Frazier said in September the rules of evidence in federal court “are consistent with having jurors focus on what the issues are.” He said earlier this month Fallon has a reputation for being strict about admitting evidence into court.

“I think that that is a helpful thing for Merck going forward, because we believe that if cases are decided on the basis of rigorous science, that is very much in our favor,” Frazier said.

But the plaintiff’s lawyers say pretrial rulings have cleared all of their experts to testify. Moreover, Fallon recently ruled plaintiffs’ lawyers may argue that Vioxx can be lethal even if taken for a short duration, an argument Merck tried to keep out of court. For its part, Merck was permitted to argue that the threshold for increased risk is 18 months of use, which the plaintiffs had tried to keep out of court.

Tobias, the law professor, said federal judges often have cited a precedent-setting Supreme Court ruling on evidence to exclude certain plaintiffs’ expert witnesses, but that doesn’t appear to be the case in next week’s trial.

Other factors, however, might work in Merck’s favor. Institutional defendants such as large companies often feel they get a more favorable hearing in federal court than in state courts, Tobias said. Jury pools in federal court tend to be better educated than in state courts, which might help Merck as it presents complex, scientific data in court.

Fallon is a judge in the U.S. District Court for the Eastern District of Louisiana in New Orleans, but the trial was moved to Houston due to Hurricane Katrina. Merck’s trial team will be led by Philip Beck of the Chicago-based law firm of Bartlit Beck Herman Palenchar & Scott. Birchfield and Jere Beasley of Beasley Allen Crow Methvin Portis & Miles in Montgomery, Ala., are plaintiffs’ attorneys.

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