Edwards v. Basel Pharmaceuticals

Decision Date04 March 1997
Docket NumberCIBA-GEIGY,No. 87192,87192
Citation1997 OK 22,933 P.2d 298
Parties, Prod.Liab.Rep. (CCH) P 14,894, 57 A.L.R.5th 793, 1997 OK 22 Alpha EDWARDS, Personal Representative of the Estate of John T. Edwards, Deceased, Plaintiff-Appellant, v. BASEL PHARMACEUTICALS, a DIVISION OFCORPORATION, Defendant-Appellee.
CourtOklahoma Supreme Court

Rex K. Travis, Margaret E. Travis, Oklahoma City, for Plaintiff-Appellant.

James E. Weger, C. Michael Copeland, Jones, Givens, Gotcher & Bogan, P.C., Tulsa, for Defendant-Appellee.

SUMMERS, Vice Chief Justice:

Widow claims her husband's death was due to his use of a prescribed pharmaceutical product. Her theory of liability against the manufacturer is that the manufacturer failed to adequately warn her husband of the effects of overdose. The manufacturer responds that it fully warned the prescribing physician of the pertinent risks, and further complied with Food and Drug Administration requirements for warning the ultimate user. The case is in the United States Court of Appeals for the Tenth Circuit, which has certified to us the following as an unsettled question of state law:

Under Oklahoma law, what determines the scope or extent of the prescription drug manufacturer's duty to warn the consumer when FDA recognition of the need for direct warnings has undercut application of the learned intermediary rule? More specifically, what is the effect of the manufacturer's compliance with the very FDA requirements invoking this exception to the rule?

Boiled down, our answer is that compliance with FDA warning requirements does not necessarily satisfy the manufacturer's common law duty to warn the consumer.

The facts provided in the Order of Certification are these. Alpha Edwards brought a wrongful death action for the death of her husband. He died of a nicotine-induced heart attack as a result of smoking cigarettes while wearing two Habitrol nicotine patches. Habitrol is manufactured by Basel Pharmaceuticals. Plaintiff's theory of liability was that the warnings given in conjunction with the Habitrol patches were inadequate to warn her husband of the fatal risk associated with smoking and overuse of the product. A relatively thorough warning was given to physicians providing the Habitrol patch, but the insert provided for the user did not mention the possibility of a fatal or cardiac related reaction to a nicotine overdose, cautioning that an "overdose might cause you to faint."

The pamphlet provided to Dr. Howard and other physicians prescribing the patch said:

Prostration, hypotension and respiratory failure may ensue with large overdoses. Lethal doses produce convulsions quickly and death follows as a result of peripheral or central respiratory paralysis or, less frequently, cardiac failure.

With regard to the manufacturer's warning directed by the FDA for the ultimate user, the certifying judge said this:

Although the operative administrative regulation, directive, or stipulation was never produced, defendant expressly admitted that the patient insert it included with its She further noted the Defendant's unchallenged assertion that the user's insert had been "approved by the FDA" (her emphasis). So for the purposes of our answer to the question we take as fact "the manufacturer's compliance with the very FDA requirements" of warning to the consumer.

product had been "mandated ... by the FDA."

THE LEARNED INTERMEDIARY DOCTRINE

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 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).

learning, in the best interest of the patient.

EXCEPTIONS TO THE LEARNED INTERMEDIARY DOCTRINE

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...

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