Wyeth v. Levine

By November 4, 2008General

Catching up …(earlier posts here):

In this key pre-emption case, Wyeth v. Levine, arguing for Wyeth was the former solicitor general, Seth P. Waxman of Wilmer Hale, and representing the Justice Department as amicus was Deputy Solicitor General Edwin S. Kneedler. (DOJ’s amicus brief is here.) Representing Diana Levine was David C. Frederick of David C. Frederick, Kellogg, Huber, Hansen, Todd, Evans & Figel. News coverage:

  • U.S. Supreme Court, transcript of the oral arguments.
  • Legal Times, “High Court Appears Torn Over Drug Labeling Case
  • FoxNews, “Supreme Court Hears Arguments on Drug Labeling in Case of Woman
  • ABA Journal, “Court Ruling in Drug Labeling Pre-Emption Case Expected to be Narrow
  • The American Lawyer, “Wyeth v. Levine: An Actual Toss-up?
  • Washington Post, “High Court Case Looms Large for Drugmakers
  • New York Times, “Justices Weigh Effect of F.D.A. Approval of Drug Labels on Suits in State Courts
  • Adam Liptak of the New York Times did a nice job providing legal context and framing the issues:

    Several justices appeared open to the idea that pre-emption could follow from the F.D.A.’s approval of a drug label – but only if drug companies remained subject to lawsuits if they failed to disclose new information about potential risks. There was much discussion of what information should be considered new.


    Other justices seemed prepared to allow pre-emption – but only if the drug agency had considered the particular risk before approving the label.


    Given the justices’ interest in those refinements, the court seemed unlikely to rule broadly on the larger issues in the case: whether the agency and other federal regulators set minimum safety standards that states are free to augment or whether they make judgments about the optimal balance between risks and benefits that states must follow.

    Ted Frank of the American Enterprise Institute also summarized the issues well in August in the D.C. Examiner, “As even Clinton appointee Justice Stephen Breyer pointed out in a February 8-1 Supreme Court decision about medical devices, if we are to have meaningful safety regulation, those standards should be determined by federal regulators, not by untrained juries who hear only the sad stories of side effects in hindsight without considering the larger policy issues.”

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