Judging by the pattern of courtroom decisions, you'd think Vioxx was a safe drug.
A three-judge panel in Texas today overturned a jury decision awarding $26 million to the widow of a man who had died from a blood clot eight months after he began taking the drug in 2001. It was Merck's second big victory of the day. Earlier a New Jersey appeals court reversed most of a $13.9 million settlement won in a non-fatal case.
If you're into keeping score, that's 11-3 in favor of Merck in individual cases that have made their way through the court system to final jury or appeals court decisions. Does that mean that juries and judges, once they hear all the evidence, generally conclude that Vioxx is a safe drug?
Hardly. Here's one confounding variable. In Texas, the appeals court judges who ruled in the drug company's favor were elected, and in recent campaigns had received contributions from the law firms representing Merck. "Outrageous," plaintiff lawyer W. Mark Lanier told the Associated Press.
The New Jersey decision, on the other hand, gives some hope to those fighting efforts by the drug industry to use federal regulation (or the lack thereof) to preempt state product liability laws (and a tip of the hat to Ed Silverman's Pharmalot blog for pointing the errors of news accounts; he reprints the court decision here). Though the decision overturned the punitive award, the compensatory damages (about a third of the total) were left in because of a traditional product liability claim that the company had failed to adequately warn its users about potential risks.
It's unlikely this decision will affect the business-friendly Supreme Court, which recently ruled in favor of preemption in a medical device case and will hear a similar drug case next fall. The prospects for injured patients keeping their right to sue are slim.
Merck lawyers have already effectively admitted some responsibility for the Vioxx disaster. Last November the company set up a $4.85 billion pool to settle personal injury cases that involved heart attacks, strokes or death. Some 45,000 people enrolled for payments as of March 31. FDA safety expert David Graham has estimated anywhere from 40,000 to 120,000 people died from Vioxx between 1999 and 2004 before Merck voluntarily withdrew the pain reliever from the market.
Posted by gooznews at May 29, 2008 05:05 PMThanks, Gooz, for getting this right. As you point out (and we at Pharmalot did), many news accounts did not.
One addition. Besides upholding the traditional product liability suit against Merck in New Jersey, that appeals court very strongly rejected FDA preemption in general. It is some of the strongest language and argumentation i've seen on this (and I've seen a fair amount). But I agree with you - it is unlikely to have any impact on the Surpreme Court.
The part of preemption that was upheld was a relatively new New Jersey statute with allows punitive damages in the event of a certain kind of fraud. This is the same quetion that figured in the Warner Lambert v. Kent case - can juries find that the FDA was defrauded, or only the FDA itself?
Based on a case called Buckman, the latter view prevailed. I would have been very surprised if it hadn't.
In any event, we now know that this is, indeed, fully separaable from FDA preemption more generally.
Posted by: Justice in Michigan at May 31, 2008 10:06 AM