Recovering Damages for Dangerous Drugs; the U.S. Supreme Court Hears the Preemption Case

In November, the U.S. Supreme Court has heard argument on the Diana Levine case.  The decision will shape the future course of products liability law.

  Diana Levine lost her arm due to the Wyeth  drug company’s failure to warn.  She won her case in her state court in Vermont.  Her case is before the U.S. Supreme Court.  In essence, the U.S. Supreme Court will decide whether to uphold her verdict or to dismiss.  The Supreme Court’s decision will determine the future of products liability law especially in prescription drugs.

We discussed this important case in our prior post, “U.S. Supreme Court to Decide Key Products Liability Case–the Preemption Doctrine.”

In sum, under the preemption doctrine if a drug (or other product) manufacturer adhered to the the federal guidelines on warnings, then an injured plaintiff cannot sue in state court.  In essence, the preemption doctrine ends productions liability case in the drug field.

   The November issue of the ABA Journal  has an excellent article discussing the history of preemption in the Food and Drug Administration in “The Pre-emption Prescripton.”

In sum, in 2006 the FDA ruled, without public hearings, that its approval of labelling preempts any conflicting or contrary state law.  This was a reversal from the FDA’s prior position where it respected the states’ primacy in the states’ enforcement and interruption of the states’ tort liability law.  In essence, FDA administrators and scientists respected state court rulings on drug safety as a supplement to the FDA’s findings.  Prior to its ruling, the FDA administrators did not view their warnings as infallible and final.  However, the preemption doctrine makes the FDA’s warnings final, infallible, and incontestable in a courtroom.  This doctrine is being tested in Ms. Levine’s case before the Supreme Court.

The Levine decision will be watched and will be reported here in Being Prepared.

If you have any questions on preemption, please feel free to call me at 800-581-1434.

Mark E. Seitelman, 11/30/08,


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