Opinion ID: 1375802
Heading Depth: 1
Heading Rank: 1

Heading: the learned intermediary doctrine

Text: Basel contends that the learned intermediary doctrine bars liability, because the prescribing physicians were given complete warnings regarding the use of the patches. Basel concedes that consumer warnings were required by the FDA, but argues that by complying with those FDA warning requirements the case again is controlled by the learned intermediary doctrine, with its attendant shield affording protection to the manufacturer. Mrs. Edwards disagrees, stating that the warnings given to her late husband were inadequate, regardless of whether FDA requirements were met. Our products liability law generally requires a manufacturer to warn consumers of danger associated with the use of its product to the extent the manufacturer knew or should have known of the danger. Kirkland v. General Motors, 521 P.2d 1353 (Okla.1974). Certain products, prescription drugs among them, are incapable of being made safe, but are of benefit to the public despite the risk. Their beneficial dissemination depends on adequate warnings, and the law regarding such products appears at Comment k of the Restatement (Second) of Torts, § 402A. [1] Tansy v. Dacomed Corp., 890 P.2d 881, 885 (Okla.1994). The user must be adequately warned. Id. at 886. There is, however, an exception known as the learned intermediary doctrine, which Oklahoma has recognized as applicable in prescription drug cases, McKee v. Moore, 648 P.2d 21, 24 (Okla.1982) [2] , and prosthetic implant cases, Tansy v. Dacomed Corp., supra . The doctrine operates as an exception to the manufacturer's duty to warn the ultimate consumer, and shields manufacturers of prescription drugs from liability if the manufacturer adequately warns the prescribing physicians of the dangers of the drug. McKee, at 24. The reasoning behind this rule is that the doctor acts as a learned intermediary between the patient and the prescription drug manufacturer by assessing the medical risks in light of the patient's needs. Cunningham v. Pfizer & Co., Inc., 532 P.2d 1377, 1381 (Okla.1975). Where a product is available only on prescription or through the services of a physician, the physician acts as a `learned intermediary' between the manufacturer or seller and the patient. It is his duty to inform himself of the qualities and characteristics of those products which he prescribes for or administers to or uses on his patients, and to exercise independent judgment, taking into account his knowledge of the patient as well as the product. The patient is expected to and, it can be presumed, does place primary reliance upon that judgment. The physician decides what facts should be told to the patient. Thus, if the product is properly labeled and carries the necessary instructions and warnings to fully apprize the physician of the proper procedures for use and the dangers involved, the manufacturer may reasonably assume that the physician will exercise the informed judgment thereby gained in conjunction with his own independent learning, in the best interest of the patient. Wooderson v. Ortho Pharmaceutical Corp., 235 Kan. 387, 681 P.2d 1038, 1052 (1984), cert. denied, 469 U.S. 965, 105 S.Ct. 365, 83 L.Ed.2d 301 (1984). The doctrine extends to prescription drugs because, unlike over the counter medications, the patient may obtain the drug only through a physician's prescription, and the use of prescription drugs is generally monitored by a physician. Lukaszewicz v. Ortho Pharmaceutical Corp., 510 F.Supp. 961, 962 (E.D.Wis.1981). The learned intermediary doctrine has been held applicable to prescription nicotine gum, because there was a sufficient relationship established between doctor and patient. Tracy v. Merrell Dow Pharmaceuticals, 58 Ohio St.3d 147, 569 N.E.2d 875 (1991).