In a stunning decision with broad implications for pharmaceutical companies in Pennsylvania and elsewhere, the Supreme Court of Pennsylvania has held that plaintiffs may assert negligence claims against pharmaceutical companies relating to the design, testing, marketing and distribution of drugs regulated by the Food and Drug Administration.

The decision upends years of accepted law in Pennsylvania. While the state Supreme Court had not previously addressed the precise issue of a pharmaceutical company’s alleged lack of care in the design and testing of a marketed drug, pharmaceutical companies generally have succeeded in securing the dismissal of such claims by relying on the learned-intermediary doctrine and the FDA’s rigid approval process for prescription drugs. ...   

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