March 6, 2009 - The U.S. Supreme Court voted 6-3, that pharmaceutical companies aren’t shielded from suit by the Food and Drug Administration’s approval of a treatment and its packaging information. Justice John Paul Stevens, writing for the majority: “Congress did not intend FDA oversight to be the exclusive means of ensuring drug safety and effectiveness.”
This seems to be a major setback for business groups, including tobacco companies, that had hoped to build a barrier against injury lawsuits. According to Adam Liptak (New York Times reporter), some companies have sought tighter federal regulation in recent years in part to shield themselves from litigation.
The decision marks the second time during its current term that the high court has said federal law doesn’t preempt consumer lawsuits. The justices in December said smokers can sue tobacco companies over the marketing of “light” cigarettes. (U.S. Supreme Court Rules Against Big Tobacco..)
Reference: Wyeth, Drugmakers Lose as Top U.S. Court Allows Suits (Update4) by Greg Stohr, Bloomberg.com/3/4/2009.
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