ORAL CONTRACEPTIVES AND THE LEARNED INTERMEDIARY DOCTRINE
Hayenga, Matthew A.
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CitationORAL CONTRACEPTIVES AND THE LEARNED INTERMEDIARY DOCTRINE (2002 Third Year Paper)
AbstractOrdinarily prescription drug manufacturers arenâ€™t required to give direct warnings to patients regarding the risks associated with their products. Instead, manufacturers need only inform the prescribing physician of these risks. The duty to inform the patient then falls on the physician. This common law rule is referred to as the â€œlearned intermediary doctrine.â€ By providing adequate information to the prescribing physician, who is believed to be in a better position to discuss the risks and benefits of a specific drug to a particular patient, the manufacturer is relieved of its duty to provide a direct warning. However, in the mid-1980s, in a series of decisions, several courts began recognizing an exception to this doctrine for oral contraceptives, in some instances finding civil tort liability despite the presence of FDA-approved labeling accompanying the product. Although only a minority rule today, this exception to the learned intermediary doctrine has been the subject of much debate and has influenced legal scholarship on several other issues. This exception, or more accurately the questionable wisdom of its adoption, is the focus of this paper. After discussing the policy justifications for the learned intermediary doctrine and the development and risks and benefits of oral contraceptives, this paper details the case law that created the oral contraceptive exception to the learned intermediary doctrine, as well as several related extensions of the exception that courts and commentators have suggested. After setting this stage, the paper then argues against the exception as both factually flawed and contrary to public policy, ultimately advocating the abandonment of this minority rule.
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