Approval of drugs by the Food and Drug Administration (FDA) should not preempt any liability under state tort laws for pharmaceutical manufacturers, editors of the New England Journal of Medicine argue in a brief to the United States Supreme Court. One of the most closely watched cases of the Supreme Court's upcoming term is Wyeth v. Levine. Levine, a musician, lost an arm after an injection of the nausea drug, Phenergan. She sued Wyeth, claiming that it failed to adequately warn of the drug's risks and she won a $8.6 million judgment in a Vermont trial court.
Wyeth argues that it is insulated from any liability for Levine's injuries because the FDA approved Phenergan. This is the legal doctrine of "preemption."
The NEJM editors argue that "the FDA the FDA is in no position to ensure the safety of prescription drugs. Not only is the FDA seriously hampered in its ability to determine the risks of drugs before they are approved for sale, but it has proven inadequate to the task of addressing hazards that only become apparent after a drug has been widely marketed to an unsuspecting public. Post-approval dangers posed by drugs placed into the market are unfortunately quite common. However, the FDA’s ability to either anticipate these risks or react expeditiously once they have been revealed has been limited by serious information-gathering constraints in both pre- and postapproval settings." The brief can be read by clicking here.
Two former FDA Commissioners, Donald Kennedy and David Kessler, have also submitted a brief supporting Levine. They argue that the pro-preemption position advanced by the drug companies and the Bush Administration "threatens to undermine, not advance, the underlying goal of our nation’s drug safety laws, which is 'to protect consumers from dangerous products.'” A copy of their brief may be read by clicking here.
Robert L. Abell www.RobertAbellLaw.com
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