Certified Questions From U.S. Dist. Court For Eastern Dist. of Mich., Southern Div., In re, Docket Nos. 68958
| Decision Date | 10 December 1984 |
| Docket Number | 21,69340,Docket Nos. 68958,Nos. 20,s. 20 |
| Citation | 419 Mich. 686,358 N.W.2d 873 |
| Parties | . Susan ODGERS, Plaintiff, v. ORTHO PHARMACEUTICAL CORPORATION, a foreign corporation, Defendant. James GRAINGER, Administrator of the Estate of Linda Grainger, Deceased, Plaintiff, v. SANDOZ PHARMACEUTICALS, A DIVISION OF SANDOZ, INC., a Foreign Corporation, Defendant. (Calendar). Supreme Court of Michigan |
| Court | Michigan Supreme Court |
Philo, Atkinson, Steinberg, Walker & White, by Harry M. Philo, Linda Miller Atkinson, Richard L. Steinberg, Detroit, for Susan Odgers.
Lopatin, Miller, Freedman, Bluestone, Erlich, Rosen & Bartnick by Steven G. Silverman, Detroit, for plaintiff in No. 69340.
Warner, Norcross & Judd by Wallson G. Knack, Paul T. Sorensen, Grand Rapids, (Patterson, Belknap, Webb & Tyler, New York City, of counsel), for defendant in No. 68958.
Harvey, Kruse, Westen & Milan, P.C. by Dane A. Lupo, Paul S. Koczkur, Detroit, for defendant in No. 69340.
Thomas H. Bleakley, P.C. by Thomas H. Bleakley, Richard J. Dimanin, Brian J. McKeen, Detroit, for amicus curiae Mich. Trial Lawyers Ass'n in No. 68958.
Baxter & Hammond by Richard B. Baxter, Robert N. Hammond, Grand Rapids, for Mich. Defense Trial Counsel, Inc.
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 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 provide 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
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 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 (E.D.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
In Odgers v. Ortho Pharmaceutical Corporation, Docket No. 78-70543 (E.D.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 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.
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 N.W.2d 476 (1979). 8 The judge first denied, but then granted, plaintiff's motion to present the issue to this Court for review. 9
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. 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.
We write separately because while we agree with the majority that Michigan courts have announced no rule of law on the questions presented, we cannot agree that we should decline to answer them. The duty of a manufacturer to warn of dangers inherent in the use of its product is a creature of common law. Thus, rulings which relate to this duty are well within the appropriate province of this Court.
The questions presented are clear, the factual predicates for the issue are before us, and the subject matter is of such jurisprudential significance as to warrant a grant of leave to appeal had the cases originated in a state...
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