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DRI - the Voice of the Defense Bar Responds to Supreme Court Ruling in Wyeth v. Levine
Date:3/5/2009

Prominent Legal Organization Optimistic About Ongoing Role for Federal Preemption in Future Liability Cases

CHICAGO, March 5 /PRNewswire/ -- DRI - the Voice of the Defense Bar has responded to the decision of the Supreme Court of the United States in Wyeth v. Levine, an important recent case involving the critical issue of federal preemption of state tort law.

On March 4, 2009, the Supreme Court allowed a Vermont state court jury award against Wyeth Pharmaceuticals to stand, holding that federal law did not preempt plaintiff's claim that labeling for the prescription drug Phenergan failed to adequately warn about the risks of a particular method of administration.

DRI, an international organization of 22,500 lawyers, had filed an amicus brief on behalf of Wyeth. While allowing the Vermont award, the Supreme Court clearly held open the possibility that preemption would apply in cases where the Food and Drug Administration has considered a specific risk and made a determination about the way to warn about that risk.

"Although we are obviously disappointed that the Court did not accept preemption in this case, we are gratified that the Court recognizes that there remains a role for FDA preemption in appropriate future cases," said Michael W. Davis, Chair of DRI's Drug and Medical Device Committee, and head of Sidley Austin LLP's Product Liability and Mass Torts Practice.

In its response to the Supreme Court's ruling, DRI also emphasizes the continued importance of case-specific analysis of preemption in the context of prescription drug litigation. In this particular case, so-called "changes-being effected" federal regulations played an important role. These regulations permit manufacturers to enhance warnings without prior FDA approval in certain circumstances. Absent clear evidence that the FDA would not have approved a change to its label, the Court s
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SOURCE DRI - The Voice of the Defense Bar
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