Odgers v. Ortho Pharmaceutical Corp.

Levin, J. The questions certified by the United States District Court present the issue whether a manufacturer of oral contraceptives or other prescription drugs has a duty to disclose the risks and potential side effects of the drugs directly to the patient. This Court has not addressed this issue, although it has, in obiter dictum, stated that the manufacturer does not ordinarily have such a duty.1 That dictum, however, did not establish or represent a rule of law.2 The issue remains undecided, and cannot be decided merely by applying existing case law. We have concluded that by stating a rule of law, we might hamper, rather than foster, the sound development of Michigan law relating to the distribution of prescription drugs. Whether the manufacturer has a duty to warn patients directly can be determined only in the broader context of deciding whether and to what extent patients should be warned and whether other persons, such as physicians or pharmacists, should provide warnings. The allocation of the duty to warn patients is a public policy question involving the marketing system and economics of a major industry and the everyday practice of an essential profession. We believe that the Legislature is in a better position [692] to allocate those duties. If, because of legislative inaction, this Court is constrained to make the choices necessary for deciding this question, it would be better to do so in a case where the factual record is fully developed, and where the history of proceedings in the courts of this state provides more assurance than the records in these proceedings that the decision of the Court responds to all the issues implicated by the questions posed. We respond to the questions certified by the district court that Michigan courts have announced no rule of law on those questions.3 I In two separate actions filed in the United States District Court for the Eastern District of Michigan, the plaintiffs sought to hold prescription drug manufacturers liable for failing to disclose directly to the patient the risks and potential side effects associated with their products. Both United States district judges, applying what they believed was established Michigan law, held that the manufacturers had no duty to warn the plaintiffs directly. They then entered orders certifying closely related questions presenting that issue to this [693] Court for review. This Court originally declined to accept the certified questions. It then granted plaintiffs’ motions for reconsideration, and agreed to respond to the certified questions.4 In Grainger v Sandoz Pharmaceuticals, Docket No. 79-40075 (ED Mich), plaintiff alleged that Linda Grainger’s death was caused by a heart attack brought on by her use of Mellaril, a prescription drug manufactured by defendant and prescribed by her treating physician. Plaintiff claimed that Sandoz Pharmaceuticals had a duty to warn Linda Grainger directly about the dangers associated with the use of Mellaril. Sandoz Pharmaceuticals moved to strike allegations that it had a duty to warn Linda Grainger directly, contending that its duty was limited to warning the prescribing physician; the judge granted the motion.5 After striking those allegations, the judge asked this Court to decide whether under Michigan law a prescription drug manufacturer has a duty to warn the patient directly.6_ [694] In Odgers v Ortho Pharmaceutical Corp, Docket. No. 78-70543 (ED Mich), Susan Odgers alleged that her partial paralysis was caused by a blood clot resulting from her use of Ortho-Novum, an oral contraceptive that Ortho Pharmaceutical Corporation had manufactured and that her physician had prescribed. Odgers alleged that Ortho failed adequately to warn her directly about the risks and potential side effects associated with the use of the contraceptive. Ortho provided the physician with a package insert that contained warnings about the potential risks of using the contraceptive. The physician prescribed the drug only after conducting a physical examination of, and performing various tests on, Susan Odgers. Ortho also published and distributed to Odgers’ physician a booklet discussing in layperson’s language the proper use of the drug and the potential risks associated with that use, in compliance with a federal Food and Drug Administration regulation as it then was written, 21 CFR 310.501. The physician gave Odgers this brochure in accordance with that regulation, which provides that physicians may give the brochure to their patients in their discretion. In addition, the package containing the contraceptive had a warning label, written by the FDA, which stated that the most serious potential side effect of oral contraceptives was abnormal blood clotting and that the condition could be fatal. Odgers read both the pamphlet and the label. The judge initially held that Ortho had a duty to warn Odgers rather than, or as well as, her physician about the risks associated with the use of Ortho-Novum. Specifically, the judge instructed [695] the jury that Ortho owed her the duty of reasonable care in the preparation of the booklet accompanying the drug that, under federal regulations, Ortho was required to distribute to physicians.7 The jury found in favor of Susan Odgers, and awarded her $3.3 million in damages. [696] The court then granted a new trial on the grounds that the instruction was erroneous under Michigan law, citing this Court’s opinion in Smith v E R Squibb & Sons, Inc, 405 Mich 79, 88; 273 NW2d 476 (1979).8 The judge first denied, but then granted, plaintiff’s motion to present the issue to this Court for review.9 [697] II In Odgers, and possibly in Grainger, the judge based his holding that a manufacturer of oral contraceptives and other prescription drugs has no duty under Michigan law to disclose the potential risks and side effects directly to the users of the drugs upon a statement in this Court’s opinion in Smith v E R Squibb & Sons, Inc, supra. In Smith, the opinion of the Court included the statement: "[a] manufacturer of a prescription drug has a legal duty to warn the medical profession, not the patient, of any risks inherent in the use of the drug which the manufacturer knows or should know to exist.” That statement was dictum, and did not establish or represent a rule of law.10 Except for that sentence of dictum, the Court did not discuss whether a manufacturer’s duty is to provide those warnings to the prescribing physician or directly to the patient. As dictum, that statement does not establish Michigan law.11 Although there are several decisions by the Court of Appeals on this issue, they too were based on the Smith dictum.12 The certified questions pose a choice between different systems for allocating between manufacturers, physicians, and pharmacists the duty to warn patients of the risks and potential side effects associated with the use of prescription drugs. [698] Although the certified questions are stated solely in terms of the manufacturer’s duty, any decision of this Court implicates the obligations of members of professions who are involved in the distribution of prescription drugs but not represented in these proceedings. The responsibility of the learned intermediary is the basis of the learned intermediary doctrine. Yet, this Court has not had occasion to consider the obligation of learned intermediaries to warn regarding the risks of using prescription drugs. Under the circumstance that it has not defined their obligation, this Court is not prepared at this time to state a rule of law regarding the duty of prescription drug manufacturers that depends on some other person providing warnings. We conclude that the Court should not in these proceedings state a rule of law determining whether a prescription drug manufacturer has a duty to disclose prescription drug risks and potential side effects directly to the patient. Kavanagh, Ryan, and Cavanagh, JJ., concurred with Levin, J. Footnotes [1] See part II. [2] See part II. [3] This Court recognizes that the Court of Appeals may, because litigants may appeal as of right to that Court (GCR 1963, 806[1]), be called upon to determine whether a manufacturer of prescription drugs has a duty to warn directly persons for whom drugs are prescribed in a case involving only a patient and a manufacturer. This Court nevertheless has discretion in deciding whether to grant leave to appeal and determine the relevant duties in such a case. GCR 1963, 853(1). This Court is not yet prepared to state a rule of law that allocates the duties to warn in a proceeding where interests of persons not represented are implicated. We do not wish to be understood as questioning the duty of the manufacturer to warn the medical community of the risks and potential side effects associated with prescription drugs. See Abel v Eli Lilly & Co, 418 Mich 311; 343 NW2d 164 (1984). [4] See fns 6, 9. [5] The parties have not provided this Court with the judge’s statement of reasons for granting the motion to strike. The order granting the motion states that it was granted "for the reasons stated on the record”. We have not been provided a transcript of the hearing. The judge may have applied what he thought to be Michigan law in light of this Court’s opinion in Smith v E R Squibb & Sons, Inc, 405 Mich 79, 88; 273 NW2d 476 (1979). [6] The court certified the following question for review pursuant to GCR 1963, 797.2: "Under Michigan law, does a drug manufacturer have a legal duty to make reasonable efforts to directly warn the ultimate consumer of the possible existence, potential likelihood, warning signs, and potential severity of harmful side effects possibly incidental to taking a prescription drug alleged to be inherently dangerous, where the [Physicians’ Desk Reference] states: " 'While there is no evidence at present that these changes are in any way precursors of any significant disturbance of cardiac rhythm, it should be noted that several sudden and unexpected deaths apparently due to cardiac arrest have occurred in patients previously showing characteristic electrocardiographic changes while taking the drug. The use of periodic electrocardiograms has been proposed but [694] would appear to be of questionable value as a predictive device. Hypotension, rarely resulting in cardiac arrest.’” (Emphasis in the original.) [7] Pursuant to GCR 1963, 797.2(b)(2), the United States District Court attached the following factual statement to its certification of the question to this Court: "1. Plaintiff has alleged in this action that defendant Ortho Pharmaceutical Corporation (Ortho), a manufacturer of the prescription oral contraceptive Ortho-Novum, failed to adequately warn her about the potential risks inherent in the use of the drug. Ortho-Novum was prescribed for plaintiff by Dr. Joan Wake in November 1975. In accordance with its common-law duty, Ortho provided Dr. Wake with a package insert which contained warnings about the potential risks and side effects of using Ortho-Novum. (Exhibit A.) "2. Dr. Wake conducted a detailed physical examination of plaintiff and performed various tests before she prescribed the oral contraceptive. Dr. Wake also gave plaintiff a booklet published by Ortho entitled 'After Your Doctor Prescribes Ortho-Novum’. (Exhibit B.) Ortho published the booklet in compliance with a federal Food and Drug Administration regulation which requires all manufacturers of oral contraceptives to set forth certain specified information, in layman’s language, in a brochure to be distributed to physicians, who may give it to patients in their discretion. 21 CFR 310.501. (Exhibit C.) "3. Plaintiff read the booklet as well as the warning label on the package itself which stated that the most serious potential side effect of oral contraceptives was abnormal blood clotting and that that condition could be fatal. (Exhibit D.) The warning label appearing on the package was written by the federal Food and Drug Administration; the federal regulations mandated that it appear only in the language specified. "4. Plaintiff stopped using Ortho-Novum no later than mid-March 1976. On April 24, 1976 plaintiff became paralyzed below the waist. She has not recovered. "5. Plaintiff claims that her injury was caused by a blood clot. She alleges that the clot resulted from her ingestion of Ortho-Novum. It is Ortho’s position that plaintiff did not suffer from a blood clot and that her injury was unrelated to her use of Ortho-Novum. "6. Oral contraceptives such as Ortho-Novum are not generally used for therapeutic purposes. The selection of oral contraceptives from among other methods of birth control is primarily based on informed choice rather than a physician’s decision. "7. This case was initially tried in June 1980. The Court instructed the jury that Ortho owed plaintiff the duty of reasonable care in the preparation of the booklet. The jury found for plaintiff. Thereafter the Court granted a new trial on the grounds that the instruction was erroneous under Michigan law.” [8] See transcript of the October 30,1980, hearing. [9] The court certified the following question for review pursuant to GCR 1963, 797.2: "Does the manufacturer of an oral contraceptive which is a prescription drug, in addition to its duty under the common law of Michigan to warn physicians of any risks inherent in the use of the oral contraceptive which it knows or should know to exist, Smith v E R Squibb & Sons, 405 Mich 79 (1979), have a duty under the common law of Michigan to provide adequate warnings directly to persons using the oral contraceptives where (1) relevant federal regulations require that the manufacturer provide limited warnings to such persons on the label of the package and certain other warnings in a brochure made available to physicians for discretionary distribution to persons prescribed oral contraceptives and (2) issuance of the prescription is based on informed choice rather than solely physician decision?” Although this question presents the same basic issue presented by the question certified in Grainger, the facts in Odgers differ from those in Grainger in two significant respects: (1) unlike most prescription drugs, oral contraceptives such as Ortho-Novum are not generally used for therapeutic purposes; and (2) unlike the selection of most prescription drugs, the selection of oral contraceptives from among other methods of birth control is based primarily on patient choice rather than a physician’s decision. See Editorial, The Pill’s Grim (?) Progress, 206 Journal of American Medical Association 124 (September 30, 1968). Plaintiff argues that, because of these differences, a manufacturer of oral contraceptives should have a duty to warn patients directly even if manufacturers of other prescription drugs have no such duty. Other courts that have considered this issue have decided that there is no special duty to warn users of oral contraceptives directly. See, e.g., Seley v G D Searle & Co, 67 Ohio St 2d 192; 423 NE2d 831 (1981); Terhune v A H Robins Co, 90 Wash 2d 9, 14; 577 P2d 975 (1978). Because we do not promulgate a rule of law, we do not consider whether these differences distinguish the duties of manufacturers of prescription oral contraceptives in particular from those of manufacturers of prescription drugs in general. Nevertheless, we do not intend to imply that under Michigan law there may be no distinction. That issue also remains unresolved. [10] The only issue decided in Squibb was whether, "in the context of an alleged failure to provide adequate warnings, breach of implied warranty and negligence involve identical evidence and require proof of exactly the same elements”. Id., p 88. [11] See Cree Coaches v Panel Suppliers, Inc, 384 Mich 646, 650; 186 NW2d 335 (1971); McNally v Wayne County Bd of Canvassers, 316 Mich 551, 556-558; 25 NW2d 613 (1946). [12] Reeder v Hammond, 125 Mich App 223, 226-227; 336 NW2d 3 (1983); Dunn v Lederle Laboratories, 121 Mich App 73, 79; 328 NW2d 576 (1982). See also Muilenberg v Upjohn Co, 115 Mich App 316, 332; 320 NW2d 358 (1982); Formella v Ciba-Geigy Corp, 100 Mich App 649, 655-656; 300 NW2d 356 (1980).