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To the Editor: In their discussion of the lack of standards for medical expert testimony in tort cases, Drs Kassirer and Cecil¹ omit a number of significant points. First, most tort litigation occurs in state courts, and a number of jurisdictions (including California, Florida, and New York) do not follow the Supreme Court's Daubert rulings. Of course, these states encounter many of the same difficulties in evaluating evidence offered by medical experts, but one should not focus entirely on the federal courts.

Second, the authors' brief discussion of the allegedly lower standards of admissibility at the Food and Drug Administration (FDA) is simply incorrect. In fact, the agency imposes quite rigorous substantiation requirements in making approval and labeling decisions, generally refusing to consider anecdotal reports.² Although the FDA's adverse event reporting system considers such reports as potential early warning signals³ and it may release preliminary information to medical professionals, the . . . [Full Text of this Article]

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