Marketing Approval and Litigation
Marketing Approval and Litigation
Osteoporosis and the Realities of Medical Risk
Judith Weisz's story returns us to the national politics of drug risk management and finds an altered risk assessment environment for Depo-Provera, because the FDA decided to eliminate animal studies and rely solely on improved World Health Organization human clinical trial data, which paved the way for the agency to approve the drug for contraception in 1992. Marketing approval came with the condition that Upjohn conduct a post-approval study of a new risk: osteoporosis. When clinical trials confirmed this risk, the FDA revised the drug’s package insert in 2004 to include a black box warning of the risk of osteoporosis and a recommendation that the drug's use be limited to two years. In Depo-Provera's post-approval world, Anne MacMurdo's story is told by women who claimed that the drug caused their osteoporosis. Their stories, like hers, raise medical malpractice and products liability issues, and they, too, faced formidable obstacles. None of their cases, unlike hers, went to trial. Pfizer, Upjohn's corporate heir, had their cases dismissed on motions for summary judgment. Her story explains how Pfizer was able to use Depo-Provera’s package labelling, state products liability law, the learned intermediary doctrine, and expert evidence to avoid liability.
Keywords: clinical trial, learned intermediary doctrine, medical malpractice, osteoporosis, post-approval study, products liability
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