Learned intermediary doctrine faces challenges.

Summary

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Pharmaceutical industry duty to warn

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Learned intermediary doctrine faces challenges.

Writing in the January newsletter of the Drug, Device and Biotech Committee, Michael J. Farrell of Farrell, Farrell, Farrell & Farrell, Huntington, West Virginia, describes recent learned intermediary cases:

Challenges to the learned intermediary doctrine continued in 1997 in the United States in both federal and state courts--and with mixed results. Let's look at several of these cases and highlight the arguments advanced by plaintiffs in their efforts to abolish or weaken its application.

What is it?

The learned intermediary doctrine provides that when a drug manufacturer properly warns the prescribing physician of dangerous propensities of its product, the manufacturer is excused from its common law duty to warn directly each patient to whom the drug is prescribed. The need for this doctrine was summarized in Comment k to Section 402A of the Restatement (Second) of Torts.

Comment k acknowledged the societal need for unreasonably unsafe pharmaceutical products. A manufacturer of such products is generally constrained from direct distribution of these products to users by federal law and regulation. As a consequence, the pharmaceutical manufacturer's duty to warn extends, in most cases, to the prescribing physician. The scope of the manufacturer's duty is to provide an adequate warming of inherent dangers not within the knowledge of or obvious to the average learned intermediary. McGowan v. Mehta, 1997 WL 159519 (E.D. La. 1997), not reported in F.Supp., quoting Willet v. Baxter International Inc., 929 F.2d 1094, 1098 (5th Cir. 1991).

An alternative formulation of the doctrine provides that the warning to the learned intermediary be "reasonable, but `not the best possible warning.'" Pfizer Inc. v. Jones, 272 S.E.2d 43, 45 (Va. 1980).

As in all other warning causes of action, a plaintiff must establish that the failure to warn the physician of the risk associated with the use of the product was not known to the pre...

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