US Supreme Court Case: A Victory for patients over IndustryPublic Citizen's Allison Zieve examines the implications for patients of the US Supreme Court's decision in the Warner-I ambert v Kent case.

摘要

At issue in the case was a product liability statute unique to Michigan. Traditional state tort law allows a manufacturer, alleged to have sold a defective product, to use compliance with federal standards or regulations as evidence that the product was not defective or that the manufacturer acted non-negligently. In most states, a jury can consider that evidence, but it is not controlling.However, a Michigan statute enacted in 1995 provides that a drug manufacturer generally cannot be held liable to patients for injuries caused by its products if the drug is marketed with Food and Drug Administration approval and complied with FDA approval requirements. The statute also provides that, if a drug manufacturer did not comply with FDA disclosure requirements and the non-compliance affected the FDA's approval decision, the statutory defence does not apply and the patient can sue, as in any other state.