If You Smell Smoke, When Do You Report the Fire

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Patients may experience “adverse events” when they take drugs. Patients and physicians have the option of filing reports of these adverse events with the U.S. Food and Drug Administration, although the manufacturer is required to file if it becomes aware of the event. However, the FDA is clear that such filings are not, of themselves, evidence that the drug caused the adverse event. Therefore, if one or more of these reports are filed for a drug marketed by a publicly-traded company, management must evaluate whether the report’s contents are sufficiently material to warrant inclusion in the company’s disclosure documents. In his article, "If You Smell Smoke, When Do You Report the Fire?," published in BNA Pharmaceutical Law & Industry Report, partner Stephen Goodman analyzes the U.S. Supreme Court’s approach to this issue in its recent decision, Matrixx Initiatives Inc. v. Siracusano.

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