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Relearning the Learned Intermediary Doctrine

By Brian Raphel
May 30, 2013

In typical product liability cases, the manufacturer owes a duty to the eventual consumer to warn of any risks associated with the product. However, in the context of prescription drug cases, courts have recognized that the prescribing doctors, and not their patients, are in the best position to weigh the risks and benefits of a given drug for a particular patient. Accordingly, courts in nearly every state have embraced some form of the “learned intermediary doctrine,” which provides that a prescription drug manufacturer satisfies its duty to warn so long as it provides an adequate warning of the drug's potential risks to the plaintiff's prescribing doctor. If the warning is adequate, or even if the doctor was somehow otherwise aware of the risk, then the manufacturer will not be liable, either because it satisfied its duty to warn or because there can be no proximate causation of the plaintiff's injury if the doctor already knew of the risk but prescribed the drug anyway.

This has made the deposition of the prescribing doctor a key event in these litigations. Many courts have granted motions for summary judgment in favor of prescription drug manufacturers when the record established that the prescribing doctor was aware of the risk associated with the drug. See, e.g., McClamrock v. Eli Lilly & Co., 2012 U.S. App. Lexis 24539, at *2 (2nd Cir. Nov. 29, 2012) (“Because [the plaintiff] would have the burden of establishing proximate cause at trial, his failure to offer any evidence that [his prescriber] was unaware that diabetes was a risk associated with [the drug] when he prescribed it warranted granting summary judgment in favor of [the defendant]“); Ebel v. Eli Lilly & Co., 2009 U.S. App. LEXIS 6710, *21 (5th Cir. March 30, 2009) (affirming ruling granting summary judgment where “[the plaintiff] presented no evidence to suggest that [the doctor] would have changed either his decision to prescribe [the drug] or his risk ' benefit analysis had he received some alternative warning.”).

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