Opinion ID: 1375802
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Heading: exceptions to the learned intermediary doctrine

Text: Two exceptions have been recognized which operate to remove the manufacturer from behind the shield of the learned intermediary doctrine. The first involves mass immunizations. Cunningham, at 1381; Allison v. Merck & Co., Inc., 110 Nev. 762, 878 P.2d 948 (1994). Mass immunizations fall outside the contemplated realm of the learned intermediary doctrine because there may be no physician-patient relationship, and the drug is not administered as a prescription drug. See Percival v. American Cyanamid Co., 689 F.Supp. 1060, 1061 (W.D.Okla. 1987). Under these conditions individualized attention may not be given by medical personnel in assessing the needs of the patient. The only warnings the patient may receive are those from the manufacturer. Oklahoma has adopted this exception. Cunningham, at 1381. The second exception, which has been adopted by several jurisdictions including Oklahoma, arises when the Food and Drug Administration mandates that a warning be given directly to the consumer. McKee v. Moore, supra . By this exception several states have held that the learned intermediary doctrine itself does not protect the manufacturer. MacDonald v. Ortho Pharmaceutical Corp., 394 Mass. 131, 475 N.E.2d 65 (1985), cert. denied, 474 U.S. 920, 106 S.Ct. 250, 88 L.Ed.2d 258 (1985); Odgers v. Ortho Pharmaceutical Corp., 609 F.Supp. 867 (E.D.Mich.1985); Spychala v. G.D. Searle Co., 705 F.Supp. 1024 (D.N.J.1988); Lukaszewicz v. Ortho Pharmaceutical Corp., 510 F.Supp. 961 (E.D.Wis.1981). But see Lacy v. G.D. Searle & Co., 567 A.2d 398 (Del.1989)(refused to adopt the exception); Kociemba v. G.D. Searle & Co., 680 F.Supp. 1293 (D.Minn.1988); Goodson v. Searle Laboratories, 471 F.Supp. 546 (D.Conn.1978). Most of the cases adopting this exception have dealt with contraceptives and the FDA's extensive regulation of contraceptive drugs and devices. See 21 C.F.R. § 310.501 and § 310.502 (requirements for patient and physician warnings with regard to intrauterine devices and birth control pills). However, courts have not limited the exception to this arena alone. We see no reason that this second exception should not apply to nicotine patches available by prescription. When direct warnings to the user of a prescription drug have been mandated by a safety regulation promulgated for the protection of the user, an exception to the learned intermediary doctrine exists, and failure on the part of the manufacturer to warn the consumer can render the drug unreasonably dangerous. According to the material certified by the Federal Court, the FDA has found a need to require that prescriptions for nicotine patches be accompanied by warnings to the ultimate consumer as well as to the physician, as is required in the distribution of oral contraceptives and intrauterine devices.