Edwards v. Basel Pharmaceuticals

1997 OK 22, 933 P.2d 298, 68 O.B.A.J. 794, 57 A.L.R. 5th 793, 1997 Okla. LEXIS 20, 1997 WL 87944

• Court: Supreme Court of Oklahoma
• Decided: March 4, 1997
• Docket: 87192
• Status: Published

Opinions

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. Plaintiffs 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 product had been “mandated ... by the FDA.”

She farther 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.

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 (OHa.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 OHahoma 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 inde-

Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. pendent 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).

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 and intrauterine devices.

DOES FDA COMPLIANCE REINSTATE THE LEARNED INTERMEDIARY DOCTRINE?

The question then becomes whether the manufacturer has fulfilled its legal obligation once the warnings are approved by the FDA and transmitted to the user. Basel contends that because it complied with FDA requirements it had no further duty to warn Mr. Edwards. Jurisdictions split on their answer to this question. In MacDonald, 475 N.E.2d at 70, 71, the court held that compliance with FDA regulation did not reinstate the learned intermediary doctrine so as to absolve the manufacturer’s liability for inadequate warnings. See also McEwen v. Ortho Pharmaceutical Corp., 270 Or. 375, 528 P.2d 522 (1974)(warnings to physicians were not sufficient even though they met FDA standards).

Some courts have held compliance with FDA requirements is sufficient to bring a case back within the learned intermediary rule. In Spychala v. G.D. Searle & Co, 705 F.Supp. at 1033, the federal district court held that the FDA exception “undercuts if not abrogates the learned intermediary rule and should be narrowly construed.” Likewise, in Lacy v. G.D. Searle & Co., 567 A.2d at 401, 402, the Delaware court found that compliance with FDA regulations and approval of the patient brochure by the FDA satisfied the requirement of a direct patient warning.

The case of Medtronic Inc. v. Lohr, — U.S. —, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) is helpful in coming to a decision. In Medtronic, the United States Supreme Court held that the FDA’s regulation of medical devices does not preclude state tort liability. The Court was faced with the question of whether FDA procedures and regulations under the Medical Device Act, 21 U.S.C. Section 360(k), preempted state law liability. Plaintiff brought suit after her pacemaker faded, alleging among other things, that the warnings were inadequate. The manufacturer claimed that federal law preempted any state cause of action.

The Court first noted that it has long been within the realm of the individual states, under their police powers, to protect the health and safety of their citizens. Although the federal government has taken an increasingly active role in this arena since the enactment of the Food and Drug Act of 1906, common law actions are not automatically preempted.

The Supreme Court continued its preemption analysis by pointing out the two critical presumptions governing this issue: (1) that a state’s police power is not superseded by federal law unless there is a clear and manifest expression to the contrary and (2) that the intent of Congress is the ultimate touchstone. Id. Relying on these presumptions, the Court turned to the plaintiffs claims of inadequate warnings accompanying the pacemaker, and held that the adequacy of warnings is a question of state law. Plaintiffs action based on inadequate warning was not precluded by the pervasive federal regulation in the area of medical devices.³

It has long been the concern of this state to protect the health and safety of its citizens. The Supreme Court has recognized that state concern is warranted and permitted. Medtronic, supra. It is the widely held view that the FDA sets minimum standards for drug manufacturers as to design and warnings. Kociemba, at 1298. We conclude that compliance with these minimum standards does not necessarily complete the manufacturer’s duty. Accord Mazur v. Merck & Co., 742 F.Supp. 239, 247 (E.D.Pa.l990)(FDA approved warnings regarding a vaccination did not preclude state tort liability for inadequate warnings); Patten v. Lederle Laboratories, 655 F.Supp. 745 (D.Utah 1987)(compli-ance with FDA requirements does not bar state law claims for manufacturer design flaws or inadequate warnings). The common law duty to warn is controlled by state law. Kociemba, at 1298-99; Odgers v. Ortho Pharmaceutical Corp. 609 F.Supp. 867 (E.D.Mich.1985); Graham v. Wyeth Laboratories, 666 F.Supp. 1483 (D.Kan.1987); MacDonald v. Ortho Pharmaceutical Corp., 394 Mass. 131, 475 N.E.2d 65 (1985). Even the FDA agrees, as noted by the FDA Commissioner who observed that civil tort liability for failure to warn is governed by state law. MacDonald, at 70, citing 43 Fed.Reg. 4214 (1978).

Although the common law duty we today recognize is to a large degree coextensive with the regulatory duties imposed by the FDA, we are persuaded that, in instances where a trier of fact could reasonably conclude that a manufacturer’s compliance with FDA labeling requirements or guidelines did not adequately apprise [prescription drug] users of inherent risks, the manufacturer should not be shielded from liability by such compliance.

MacDonald, at 70⁴. It may be that in certain instances compliance with FDA warning procedures will satisfy all state law requirements. But although compliance with FDA standards may prove an effective starting ground, it is not necessarily conclusive. The adequacy of warnings is determined by state law. Our result could improve the safety of prescription drugs by requiring that both standards are met. Mazur, at 248.

Oklahoma requires that the manufacturer warn of dangers which are foreseeable and known to the manufacturer. Duane v. Oklahoma Gas & Electric Co., 833 P.2d 284, (Okla.1992). Those warnings must be adequate to inform the user of the dangers associated with the product’s use. See Tansy, 890 P.2d at 886; Hutchins v. Silicone Specialties, 881 P.2d 64 (Okla.1993). The manufacturer is not, however, required to warn of obvious dangers. Grover v. Superior Welding, Inc., 893 P.2d 500 (Okla.1995).

In the present ease it appears the manufacturer clearly had knowledge of the dangers associated with the Habitrol patch; it furnished detailed warnings to the prescribing physicians. However, as to the warnings the late Mr. Edwards received in his Habi-trol insert, state products liability law must be applied to determine their adequacy.

CONCLUSION

We hold that when the FDA requires warnings be given directly to the patient with a prescribed drug, an exception to the “learned intermediary doctrine” has occurred, and the manufacturer is not automatically shielded from liability by properly warning the prescribing physician. When this happens the manufacturer’s duty to warn the consumer is not necessarily satisfied by compliance with FDA minimum warning requirements. The required warnings must not be misleading, and must be adequate to explain to the user the possible dangers associated with the product. Whether that duty has been satisfied is governed by the common law of the state, not the regulations of the FDA, and necessarily implicates a fact-finding process, something beyond our assignment in response to this certified question.

Question Answered.

KAUGER, C.J., and HODGES, LAVENDER, SIMMS and HARGRAVE, JJ., concur. OPALA, J., concurs in part and dissents in part. WATT, J., dissents.

1 . Comment k in relevant part, states:

2 . McKee v. Moore was actually an intrauterine contraceptive device (IUD) case, but its language makes clear that the doctrine is applicable in prescription drug cases in Oklahoma based on failure to warn. 648 P.2d at 24.

3 . Cases which have found federal preemption of state law claims have done so on the basis of express language in federal statutes or regulations. In Cipollone v. Liggett Group, Inc., 505 U.S. 504, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992), the Supreme Court held that the federal statutes preempted state law claims because the language in the statute specifically stated that no requirement or prohibition based on state law shall be imposed. Likewise, in Lewis v. American Cyanamid Co., 294 N.J.Super. 53, 682 A.2d 724 (1996), the New Jersey Superior Court held that specific language in the Federal Insecticide, Fungicide and Rodenticide Act preempted state claims that the warning labels were inadequate. See also Bokis v. American Medical Systems, Inc. 875 F.Supp. 748 (W.D.Okla.l995)(Medical Device Act preempted state law claims.); Meyer v. International Playtex Inc., 724 F.Supp. 288 (D.N.J.1988)(Medical Device Act preempted state tort action for inadequate warning since FDA requirements were met).

4 . See also Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652 (1st Cir.1981); McEwen v. Ortho Pharmaceutical Corp., 270 Or. 375, 528 P.2d 522 (1974).