Alpha EDWARDS, Personal Representative of the Estate of John T. Edwards, Deceased, Plaintiff-Appellant, v. BASEL PHARMACEUTICALS, a DIVISION OF CIBA-GEIGY CORPORATION, Defendant-Appellee.
No. 87192.
Supreme Court of Oklahoma.
March 4, 1997.
Accordingly, our PREVIOUS GRANT OF CERTIORARI IS LIMITED TO LOST PROFIT ISSUES RAISED ON CERTIORARI; CERTIORARI IS WITHDRAWN AS IMPROVIDENTLY GRANTED ON ALL OTHER ISSUES AND DENIED ON SAID ISSUES; the COURT OF CIVIL APPEALS’ OPINION IS VACATED AS TO ITS DISPOSITION OF THE LOST PROFIT AWARD AND IS WITHDRAWN FROM PUBLICATION; and the TRIAL COURT JUDGMENT IS AFFIRMED AS TO THE AWARD OF LOST PROFITS.
KAUGER, C.J., SUMMERS, V.C.J., and WILSON and WATT, JJ., concur.
HODGES, SIMMS and HARGRAVE, JJ., dissent.
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 рrescribing physician of the pertinent risks, and further complied with Food and Drug Administration
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 answеr 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 wаs 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 fоr 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 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.
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 reаsoning 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 produсt. 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-
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 cаses adopting this exception have dealt with contraceptives and the FDA‘s extensive regulation of contraceptive drugs and devices. See
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
Some courts have held compliance with FDA requirements is sufficient to bring a case back within the learned intermediary rule. In Spychala, 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, 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, 518 U.S. 470, 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,
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 presumptiоns, the Court turned to the plaintiff‘s claims of inadequate warnings accompanying the pacemaker, and held that the adequacy of warnings is a question of state law. Plaintiff‘s 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 necеssarily complete the manufacturer‘s duty. Accord Mazur v. Merck & Co., 742 F.Supp. 239, 247 (E.D.Pa.1990) (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) (compliance 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, 609 F.Supp. 867; Graham v. Wyeth Laboratories, 666 F.Supp. 1483 (D.Kan.1987); MacDonald, 475 N.E.2d 65 (1985). Even the
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 сonclude 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 case 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 Habitrol 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., сoncur.
OPALA, J., concurs in part and dissents in part.
WATT, J., dissents.
SIMMS, Justice, concurring:
I concur in the majority opinion and respectfully observe that pre-emption is not an issue in this case.
OPALA, Justice, dissenting in part.
The court pronounces that whenever the federal Food and Drug Administration‘s [FDA] safety regulations require warnings to be given directly to a user of prescription drugs, (a) an exception is to be recognized to the “learned-intermediary doctrine”1 and (b)
I would declare today that Oklahoma‘s common law follows the proposed (but not yet adopted) text of the Restatement (Third) of Torts: Products Liability2 and its pertinent comments. Inasmuch as in cases that are not federally pre-empted the proposed Restatement leaves each jurisdiction free to shape the outer limit of liability, I would announce that because compliance with a nonpre-emptive federally required warning constitutes no more than evidence of the manufacturer‘s reasonable conduct, it may not by itself be regarded as a liability-defeating defense.
I strongly disagree with the concurrеe who regards federal pre-emption as unrelated to the certified question before us. Some FDA rules are deemed preemptive.3 When pre-emption stands declared, there will be no room left for applying state law to gauge a federally prescribed warning‘s adequacy.
I
FEDERAL PRE-EMPTION, PARTIAL OR TOTAL, MUST INDEED BE ADDRESSED IN DEALING WITH LAW THAT IS TO GOVERN IN THE SCENARIO DESCRIBED BY THE CERTIFYING COURT
Federal pre-emption is fairly comprised within the certified question before us. This is so because the claim‘s scenario calls for a dichotomous division of its legal treatment. In one subclass there would be (a) cases affected by pre-emption (and hence totally or partially excluded from state-law impact) and in another (b) thosе that are unaffected by pre-emption and hence governed exclusively by state law.
In the first category, a manufacturer‘s showing of compliance with the FDA requirement that warning be given directly to the patient may take the case completely out of the state-law reach.4
Comment e, Restatement (Third) of Torts: Products Liability § 7,5 states in pertinent part:
“... [I]n federal pre-emption the court decides as a matter of federal law that the relevant federal statute or regulation reflects, expressly or impliedly, the intent of Congress to displace state law, including state tort law, with the federal statute or regulation. The question of preemption is thus a quеstion of federal law and a determination that there is preemption nullifies otherwise operational state law.
The complex set of rules and standards for resolving questions of federal preemption are beyond the scope of this Restatement. However, when federal preemption is found, the legal effect is clear. Federal preemption replaces the tort law of all states with a uniform body of federal law regulating the relevant area of product safety. Federal preemption takes one or more of three different forms. First, a federal statute may by its terms expressly preempt state lаw. Second, a federal statute which does not expressly preempt state law may otherwise reveal the intent of Congress to occupy the regulatory field. Third, even in the absence of an express preemption clause or congressional intent to occupy the field completely, a federal law preempts all state laws with which it is in actual conflict. An actual conflict exists
when the application of state law frustrates the accomplishment of congressional objectives, as when it is impossible to comply with both the state and federal law and when the state law interferes with the accomplishment of the full purposes of Congress. Judicial deference to federal product safety statutes or regulations occurs not because the court concludes that compliance with the statute or regulation shows the product to be nondefective; the issue of defectiveness under state law is never reached. Rather, the court defers because, when a federal statute or regulation is preemptive, the Constitution mandates federal supremacy.” (Emphasis added.)
There are some FDA rules that federal jurisprudence treats as absolutely preemptive.6 When this form of pre-emption stands declared, all statе law is displaced. None may be interposed.
II
THE OUTER LIMIT OF LIABILITY IN CLAIMS THAT ARE NOT FEDERALLY PRE-EMPTED
According to § 8(b), Restatement (Third) of Torts: Products Liability, a drug or medical device is defective if at the time of sale or other distribution it (1) contains a manufacturing defect, (2) is not “reasonably safe due
Section 7(b) of the Restatement10 addresses the question of what effect, if any, should be given to a manufacturer‘s compliance with a nonpre-emptive federal product safety statute or regulation upon the contested issue of product defectiveness.11 Subsection (b) follows the traditional view that most product safety statutes or regulations generally set only minimum standards.12 The proposed Restatement takes no position upon the pa-
such compliance does not preclude as a matter of law a finding of product defect.” (Emphasis added.)
Since the proposed Restatement leaves each jurisdiction free to shape the outer limit of liability, I would declare that compliance with a prescribed nonpre-emptive direct warning serves as proof of a manufacturer‘s reasonable conduct, but cannot ordinarily be invoked as a liability-defeating defense. To overcome the proof of compliance with the prescribed direct warning the plаintiff need not show more than that the warning (a) did not by itself make the product reasonably safe for use by the intended consumer or (b) was not adequate under the circumstances. The parties in litigation would thus stand free to contest whether (a) the product itself and/or (either or both) (b) the prescribed manner of its application under the warnings that were given may be regarded as reasonably safe.
The task of analyzing today‘s answer for its application to this case must be deferred to the certifying court.14 If that court should decide that FDA regulations in suit are indeed pre-emptive, no state law is invocable. If they are not to be deemed pre-emptive, our answers will apply.
SUMMARY
I would adopt today as the common law of Oklahoma the pertinent text of the proposed Restatement (Third) with the relevant comments. Because the proposed Restatement leaves Oklahoma free to shape the outer limit of liability to be borne by a manufacturer who has given the patient the prescribed nonpre-emptive direct warning, I would treat its compliance with that regulatory or statutory requirement as no more than proof of the manufacturer‘s reasonable conduct.
In the scenario submitted by the certifying court, the effect of federal pre-emption must bе taken into account. If the pertinent regulation is to be accorded pre-emptive force—a question beyond state law‘s control—a manufacturer‘s showing of compliance with the FDA requirement that warning be given directly to the patient will take the case entirely out of the reach of Oklahoma‘s common-law norms.