Litigation

  • Report Calls for Sweeping Changes At the FDA

    In September, the Institute of Medicine of the National Academy of Sciences, a congressionally created entity dedicated to the study of policy matters pertaining to the public health, issued the results of the study of federal drug safety policy commissioned by the Food and Drug Administration (FDA). The resulting report, titled 'The Future of Drug Safety, Promoting and Protecting the Health of the Public' and published in the Archives of Internal Medicine, has been widely anticipated in light of recent publicity surrounding Vioxx' and other drugs that, subsequent to FDA-approval, proved more dangerous than thought.

    October 30, 2006Janice G. Inman

  • Kumho for Clinicians in the Courtroom

    Two Supreme Court rulings, Daubert v. Merrill Dow Pharmaceuticals Inc. and Kumho Tire v. Carmichael, have had a profound effect on the treatment of expert testimony in the courts. In 1993, the Supreme Court, in Daubert, articulated guidelines for admissibility of scientific expertise as testimony. Later, in 1999, in Kumho, the Court focused on the admissibility of clinical expertise as testimony. More recently there has been increasing recognition of the inconsistency of trial courts in their construction and articulation of evidentiary standards to medical testimony. One proposed remedy is that 'Physicians should respond by correcting courts' misinterpretations of medical practice and assisting in the development of legal standards that encourage thoughtful and informed consideration of medical testimony by judges and juries.'

    October 30, 2006Harold J. Bursztajn, Milo Fox Pulde, Darlyn Pirakitikulr And Michael Perlin
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