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DRI - the Voice of the Defense Bar Responds to Supreme Court Ruling in Wyeth v. Levine

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 said Wyeth could have complied with both federal and state requirements.

DRI - which defends the interests of business while working toward a fairer and more effective civil justice system - continues to see significant need for clarity on the preemption issue, especially as untenable burdens may be imposed on companies to conform their products to 50 different standards in 50 different states.

In its amicus brief, DRI maintained that state tort law could raise prices to the point where many sick people will not be able to obtain them. "One likely result is that prescription drug costs will increase as manufacturers face the inevitable flood of lawsuits seeking to have juries decide whether warning labels were adequate for each individual patient," added Mr. Davis.

Justice Breyer, while concurring with the majority in its decision, noted this concern over the possibility of prohibitive cost increases, and he suggested that the FDA may want to study that issue further.

"We welcome and appreciate the opportunity for DRI to contribute to the decision-making process for this case," said Marc E. Williams, President of DRI -- the Voice of the Defense Bar. "Preemption issues will continue to be an important legal issue for courts to consider and DRI is committed to participating in those discussions."

Justice Stevens authored the opinion for the Court, which was joined by Justices Kennedy, Souter, Ginsburg and Breyer. Justice Thomas joined in the judgment only and wrote separately to explain his views on so-called obstacle preemption. Justice Alito authored the dissent, which was joined by Chief Justice Roberts and Justice Scalia.

Should you wish to interview Michael Davis for further comment, please contact Julie Graceffa at the number or email address listed below.

About DRI

DRI - The Voice of the Defense Bar is the international organization of attorneys defending the interests of business and individuals in civil litigation. DRI provides numerous educational and informational resources to members and offers many opportunities for liaison among defense trial lawyers, Corporate America, and state and local legal defense organizations. DRI also has an international presence, seeking to enhance understanding of the law among members of the defense community who have reason to be concerned with the expanding globalization of litigation defense. The organization can be reached at

    CONTACT:      Julie Graceffa

SOURCE DRI - The Voice of the Defense Bar
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