title: The FDA, contraceptive marketing approval and products liability litigation: Depo-Provera and the risk of osteoporosis.
abstract: The FDA approved Depo-Provera, an injectable contraceptive, in 1992 on the condition that its manufacturer conduct a post-approval study on the risk ofosteoporosis. Then in 2004, the agency revised the drug's labeling to include a boxed (i.e. Black Box) Warning on the risk ofosteoporosis. This article will analyze the FDA's Depo-Provera approval and label revision process: the agency's acceptance of Upjohn's New Drug Application, its Fertility and Maternal Health Advisory Committee's review of the human clinical studies and approval recommendation, its marketing approval of Depo-Provera, and its 2004 drug labeling revision. Then the article will analyze the post-2004 products liability litigation by women who claimed to have been injured by their use of the drug. None of the cases have survived the manufacturer's summary judgment motions, because the women have been unable to establish by expert and physician evidence that the FDA-approved labeling was inadequate to inform their physicians of the risk of osteoporosis, that the inadequate warnings caused their osteoporosis or osteopenia, and that these are compensable injuries. As a result, the manufacturer has been able to use the FDA labeling, state products liability law, and the learned intermediary doctrine to avoid liability. The conclusion will consider the lessons of these products liability cases for other women who have received Depo-Provera and suffered bone mineral density loss.
authors.forename: William
authors.initials: W
authors.lastname: Green
mesh_terms: D000329:Advertising / Q000331:legislation & jurisprudence*; D003271:Contraceptive Agents, Female / Q000009:adverse effects*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D005260:Female; D006801:Humans; D016365:Liability, Legal; D017258:Medroxyprogesterone Acetate / Q000009:adverse effects*; D010024:Osteoporosis / Q000139:chemically induced*; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D003271:Contraceptive Agents, Female; D017258:Medroxyprogesterone Acetate