As concern grows over the safety of popular painkillers, a provision in medical malpractice legislation now before Congress apparently would protect drug manufacturers from punitive damage awards as long as federal Food and Drug Administration standards are met.
The provision could dramatically affect lawsuits against Merck & Co. Inc., whose drug, Vioxx, has been tied to increased risk of heart attack and stroke.
Although the proposed legislation does not eliminate liability for harm caused by the drug, analysts are concerned that, if it became law, companies would not be held fully accountable for negligence. Moreover, there would be no threat of large punitive awards to deter a company from ignoring warning signs about a drug.
"This would be an extremely difficult requirement to meet" to sue for punitive damages, said Lucinda Finley of the Law School of the State University of New York at Buffalo, who has been researching medical malpractice and proposed reforms. "You could sort of call this the 'Merck protection provision.' "
"Lawsuits and punitive damage awards have been the catalyst to getting dangerous drugs and medical devices off the market," said Joanne Doroshow, executive director of the Center for Justice and Democracy, a plaintiffs' rights advocacy organization. As an example, she cited the 1984 removal from the market of the Dalkon Shield intrauterine device by manufacturer A.H. Robins after 11 punitive damage awards totaling about $25 million.
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