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Improperly Attempting to Circumvent the Learned Intermediary Doctrine: Challenging the Adequacy of Warnings to Physicians

By Lori Cohen and Jenifer Keenan

The learned intermediary doctrine is one of the most important doctrines for medical device and pharmaceutical drug defendants in product liability cases because under the doctrine, they are often able to obtain summary judgment on failure to warn claims. (The learned intermediary doctrine has been adopted and recognized in at least 45 states. See Larkin v. Pfizer, Inc., 153 S.W.3d 758, 767 (Ky. 2005).) The learned intermediary doctrine provides that a manufacturer, designer or distributor of a medical device or pharmaceutical drug does not have a duty to directly warn patients of possible dangers associated with the use of the device or drug. See Presto v. Sandoz Pharm. Corp., 487 S.E.2d 70 (Ga. Ct. App. 1997). Rather, “'a warning as to possible danger in its use to the prescribing physician is sufficient.'” Id. at 73. As noted in Restatement (Third) of Torts:

The rationale supporting this 'learned intermediary' rule is that only health-care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of prescription-based therapy. The duty then devolves on the health-care provider to supply to the patient such information as is deemed appropriate under the circumstances so that the patient can make an informed choice as to therapy. Restatement (Third) of Torts: Prods. Liab. '6 cmt. b.

In addition, courts throughout the country have noted that the learned intermediary doctrine is a sound and rational doctrine because: 1) “manufacturers lack effective means to communicate directly with each patient” and 2) “imposing a duty to warn upon the manufacturer would unduly interfere with the physician-patient relationship.” Larkin v. Pfizer, Inc., 153 S.W.3d 758, 764 (Ky. 2005). Consistent with these policies, courts have found that the learned intermediary doctrine applies not only to pharmaceutical drugs, but to medical devices as well, because medical devices are available only upon “prescription, application (insertion) and supervision of a physician.” Lance v. Am. Edwards Labs., 452 S.E.2d 185, 186 (Ga. Ct. App. 1994). See also Cather v. Catheter Tech. Corp., 753 F. Supp. 634, 640 (S.D. Miss. 1991).

Plaintiffs often attempt to circumvent the learned intermediary doctrine and defeat summary judgment on failure to warn claims by arguing that there is an issue of fact as to whether the warning the pharmaceutical or medical device defendant provided physicians was “adequate.” Courts, however, have consistently rejected such attempts and have held that defendants' warnings to physicians may be declared adequate as a matter of law.

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