In August, a Texas jury found the pharmaceutical company Merck responsible for the death of a man who took the Cox-2 painkiller Vioxx for eight months. The verdict awarded $253.4 million to the man’s widow. Merck will appeal the decision.
In a statement released August 22 following the decision, Kenneth C. Frazier, senior vice president and general counsel for the company, said, “Merck acted responsibly, from researching Vioxx prior to approval in studies with almost 10,000 patients to monitoring the medicine while it was on the market to voluntarily withdrawing the medicine when we did.”
Merck withdrew Vioxx from the market in September 2004, after data from a clinical trial supported claims the medication was associated with an increased risk of heart attack and stroke.
Thousands of Suits Ahead
The Texas case was the first to reach trial; 4,200 other suits have been filed against the company. The first federal trial is scheduled to begin in New Orleans in November; at presstime, it was not known if the trial would be relocated or delayed in the aftermath of Hurricane Katrina.
The company initially revealed no plans to settle any of the suits. “We intend to vigorously defend individual cases one by one,” said Frazier in the August 22 statement. But statements by a Merck spokesman on August 27 suggested the company might consider settling some suits on a limited basis, in cases involving people who took the drug for more than 18 months.
“The case presented [in Texas] to the jury by the plaintiff was fundamentally flawed,” said Frazier. “The jury was allowed to hear testimony that was not based on reliable science and that was irrelevant. We intend to appeal the verdict. Our appeal is not about legal technicalities but about basic rights to a fair trial.
“We have strong points to raise on appeal and are hopeful that a higher court will correct the verdict,” said Frazier. Merck notes that even if the verdict were upheld, the $229 million in punitive damages would be capped under Texas law at about $26 million. “This case is just one more example–as if we needed more–of how modern tort law, far from holding people and firms responsible for their wrongs, is actually undermining the law of responsibility,” said Roger Pilon, director of the Center for Constitutional Studies at the Cato Institute.
“When risk is thus ‘socialized’ through large firms and insurers, the blameworthy escape blame and the blameless are made to pay,” noted Pilon. “That’s not justice. It’s a crap shoot, with the deepest pockets invariably ‘liable.'”
More Research, Fewer Lawsuits
Some experts contend more careful and extensive research and testing of drugs like Vioxx protects consumers better than lawsuits could possibly do, and that litigation actually hampers the process.
Robert Goldberg of the Manhattan Institute’s Center for Medical Progress and Paul Howard, managing editor of Medical Progress Today, pointed out in the January 2005 issue of Health Care News, “The politics of global drug withdrawals and longer drug development times is a scientific step backward in an era when both common sense and science demonstrate that, as an article in the New England Journal of Medicine noted, ‘different patients respond in different ways to the same medication.'”
“Better science, not big damage awards, [is] the way to safer and more effective drugs,” wrote Goldberg in an August Washington Times op-ed responding to the Texas verdict.
“Litigation will discourage companies from pursuing research on drugs for incurable illnesses that, even with genetic testing, will have serious side effects,” Goldberg continued. “The only way out of this mess is for companies to personalize the development and prescribing of drugs and invest more money in developing diagnostics that will tell who will respond to the drug and how.”
Susan Konig ([email protected]) is managing editor of Health Care News.
For more information …
The article by Robert Goldberg and Paul Howard, “Vioxx Backlash Could Derail Future of Medicine,” published in the January 2005 issue of Health Care News, is available online at http://www.heartland.org/Article.cfm?artId=16134.
The New England Journal of Medicine article cited by Goldberg and Howard, “Drug Therapy: Pharmacogenomics Drug Disposition, Drug Targets, and Side Effects,” by W.E. Evans and H.L. McLeod, was published in the February 6, 2003 issue and is available online at http://content.nejm.org/cgi/content/full/348/6/538.