Injuries from drug side effects. Yesterday’s Supreme Court ruling in Wyeth vs. Levine, which preserved the right to sue drug companies for injuries from drug side effects, was a victory for consumers. But in the long run, it could have an impact well beyond drug personal injury lawsuits.
According to The New York Times, yesterday’s decision on drug lawsuits could compel lawmakers in Congress to move to restore the rights consumer’s lost as a result of the High Court’s ruling in Riegel vs. Medtronic last year. By an 8 to 1 decision, the Supreme Court ruled that the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act that require Food & Drug Administration (FDA) approval of medical devices preempted product liability lawsuits in state courts.
lower courts have dismissed hundreds of lawsuits
Since that ruling, lower courts have dismissed hundreds of lawsuits filed by people who claim they were injured by a defective medical device.
In Wyeth vs. Levine, the same Justices voted 6 to 3 that FDA approval of a drug did not preempt consumers from bringing lawsuits in state courts for drug injuries. In his majority opinion, Justice John Paul Stevens wrote that “Wyeth has not persuaded us that failure-to-warn claims like Levine’s obstruct the federal regulation of drug labeling.
Congress has repeatedly declined to pre-empt state law, and the FDA’s recently adopted position that state tort suits interfere with its statutory mandate is entitled to no weight.”
According to The New York Times, the Wyeth ruling could have far reaching consequences. For one thing, it may prompt drug companies to settle many personal injury lawsuits now in litigation. One attorney interviewed by the Times said that he believed some companies were waiting for the outcome of Wyeth before entering settlement discussions. Had Wyeth been decided differently, many of those cases would have been dismissed.
Drug makers might also start taking steps to revise labels on drugs
Drug makers might also start taking steps to revise labels on drugs to reflect new information about possible side effects. This could be complicated though, because all label revisions require FDA approval.
Finally, the Wyeth decision might embolden members of Congress to enact legislation that would, in effect, overturn Riegel. Such legislation was introduced in both the House and Senate last year, and Congressional aides told the Times that the bill – Medical Device Safety Act – would be reintroduced soon.
Many consumer advocates decried the Riegel ruling because of the FDA’s poor track record of policing medical device, something that has been well-documented in recent months. In fact, earlier this year, the Government Accountability Office issued a report that criticized the agency for failing to conduct appropriate medical device reviews.