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Warnings Case Analysis

By deciding the case on causation grounds, the decision leaves unresolved exactly the extent of pharmaceutical companies’ duties.

The only extensive discussion of duty occurs in a footnote to the decision. The court suggested, “Information and advice to a patient contained in a patient insert, in combination with more specific information and advice to a doctor contained in a product insert, may achieve the best balance between telling patients so little as to leave them unwarned and so much as to leave them overwhelmed,” and cited a law review article for that hybrid-model. Catherine A. Paytash, “Note, The Learned Intermediary Doctrine and Patient Package Inserts: A Balanced Approach to Preventing Drug-Related Injury,” 51 Stan. L.Rev. 1343, 1368-71 (1999).

Other courts, however, have rejected the hybrid-model in favor of the “learned intermediary doctrine,” which focuses on the information provided to physicians, rather than patients.

Under the learned intermediary doctrine, “the duty of the ethical drug manufacturer is to warn the doctor, rather than the patient, although the manufacturer is directly liable to the patient for a breach of such duty.” McEwen v. Ortho Pharmaceutical Corp. 270 Or. 375, 386-387, 528 P.2d 522 (1974).

Others adopt the learned intermediary approach, but reject it for oral contraceptives — often proscribed with little patient-physician interaction. MacDonald v. Ortho Pharmaceutical Corp. 475 N.E.2d 65, 69 (1985). In MacDonald, the Massachusetts court quotes, “the medical profession regards the pill, in most cases, as a convenience rather than a traditional medication.”

The court does not offer any suggestion which approach it found preferable, however, stating, “Although the parties debate how the learned intermediary doctrine affects this appeal, we need not make that determination given the bases on which we have resolved this case.”

A case that may play a role in ultimately determining the duty of pharmaceutical companies is currently pending before the Wisconsin Supreme Court — Haase v. Badger Mining Corp., 2003 WI App 192, 669 N.W.2d 73 (review granted, Jan. 23, 2004).

Haase does not involve drugs or the learned intermediary doctrine, but asbestos and the sophisticated user defense. Some courts consider the two doctrines analogous.

The Supreme Court of Connecticut recently considered the relationship between the two doctrines extensively, in Vitanza v. The Upjohn Co., 778 A.2d 829, 844-847 (2001), rejecting the argument that the two are “analogous statements of the same premise, namely, that the presence of a sophisticated intermediary absolves the manufacturer of the duty to provide a direct warning to the ultimate user and permits it to fulfill its duty to warn by providing a warning to the sophisticated intermediary.”

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The court stated, “the chain of distribution can be more attenuated under the sophisticated user doctrine, because a product can pass though many hands before it reaches the ultimate user who is injured. The safeguards in place under the learned intermediary doctrine, namely, the highly personal doctor-patient relationship and the fact that the product can be obtained legally only from a physician, simply do not exist under the sophisticated user defense.” Id. at 845.

The court added, “The fact that the two doctrines apply to significantly differently types of products, and provide different safeguards to the ultimate users of those products, strongly indicate that the two are not analogous.” Id.

Thus, Connecticut adopted the learned intermediary doctrine, even though it rejects the sophisticated user defense.

While Connecticut courts may not consider the two doctrines analogous, the decision of the Wisconsin Supreme Court whether to adopt the sophisticated user defense in Haase may play a role in whether it also ultimately adopts the learned intermediary doctrine.

-David Ziemer

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David Ziemer can be reached by email.

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