Court Opinion

ID: 9739583
Source: CourtListenerOpinion
Date Created: 2023-08-26 20:17:53.059557+00
Date Added: 2024-06-11T07:24:12.998291
License: Public Domain

O ’ Connor , J.
(dissenting). The court reverses the judgment below and holds Ortho Pharmaceutical Corporation (Ortho) *143liable to Carole and Brace MacDonald even though the jury found that Ortho adequately informed Carole MacDonald’s physician of the risks associated with the use of its contraceptive pills, and regardless of whether Ortho complied with the applicable Federal Food and Drag Administration (FDA) regulations governing the provision of printed information to users of oral contraceptives. I would hold that, as a matter of law, by adequately informing physicians of the risks associated with its product and by complying with applicable FDA regulations, a contraceptive pill manufacturer fulfils the duty to warn that it owes consumers. Therefore, because the jury found that Ortho adequately warned Carole MacDonald’s physician of the risks associated with its contraceptive pills and because the MacDonalds presented no evidence that Ortho failed to comply with FDA regulations, I would affirm the judgment for Ortho.
In order to fulfil its duty to warn consumers of risks associated with its product, a manufacturer of a nonprescription (“over-the-counter”) drag must place on the drag’s package printed warnings. That duty “derives from the basic marketing predicate of the over-the-counter drag industry, namely, that nonprescription drags are purchased by consumers for the purpose of self-medication typically without any intended or actual intervention by a physician.'” Torsiello v. Whitehall Laboratories, 165 N.J. Super. 311, 322 (1979) (emphasis added). In contradistinction, a manufacturer of a prescription drag fulfils its duty to warn a consumer by adequately informing the consumer’s physician — a “learned intermediary between the purchaser and the manufacturer” — of the drag’s associated risks. Sterling Drug, Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966). That role results from the fact that, by definition, before a consumer uses a prescription drag, that consumer must have some interaction with a doctor. See 21 U.S.C. § 353(b)(1) (1982).* 1 In cases involving manufacturers of con*144traceptive pills, every court but one has adhered to the “prescription drug” rule. See Hamilton v. Hardy, 37 Colo. App. 375, 387 (1976); Mahr v. G.D. Searle & Co., 12 Ill. App. 3d 540, 561 (1979); Ortho Pharmaceutical Corp. v. Chapman, 180 Ind. App. 33, 43 (1979); Cobb v. Syntex Laboratories, Inc., 444 So.2d 203, 205 (La. App. 1983); Seley v. G.D. Searle & Co., 61 Ohio St. 2d 192, 202-203 (1981); McEwen v. Ortho Pharmaceutical Corp., 270 Or. 375, 385 (1974); Leibowitz v. Ortho Pharmaceutical Corp., 224 Pa. Super. 418, 431 (1973); Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652, 656 (1st Cir. 1981); Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 91 (2d Cir. 1980); Goodson v. Searle Laboratories, 471 F. Supp. 546, 548 (D. Conn. 918); Dunkin v. Syntex Laboratories, Inc., 443 F. Supp. 121, 123 (D. Tenn. 1977); Chambers v. G.D. Searle & Co., 441 F. Supp. 377, 381 (D. Md. 1975); Skill v. Martinez, 91 F.R.D. 498, 507 (D.N.J. 1981). See also Carmichael v. Reitz, 17 Cal. App. 3d 958, 989 (1971) (oral contraceptive pills used to treat woman for endometriosis and to aid her to become pregnant); Terhune v. A.H. Robins Co., 90 Wash. 2d 9, 13 (1978) (intrauterine contraceptive device). But see Lukaszewicz v. Ortho Pharmaceutical Corp., 510 F. Supp. 961, 963, amended by order, 532 F. Supp. 211 (D. Wis. 1981). The one court that went beyond the prescription drug rule, see Lukaszewicz v. Ortho Pharmaceutical Corp., supra, imposed on Ortho the duty to adequately inform physicians of the contraceptive pill’s risks and to comply with applicable FDA regulations. 532 F. Supp. at 213. To my knowledge, no other court has embraced the rule laid down today by the court.
*145Before prescribing any drug, whether on the doctor’s initiative or at the patient’s request, the doctor must exercise professional judgment as to the medical propriety of that patient’s taking that drug and, in exercising that judgment, the doctor must conform to the standards of good medical practice laid down in Brune v. Belinkoff, 354 Mass. 102, 109 (1968). Furthermore, this court has held that a doctor must “disclose in a reasonable manner all significant medical information that the physician possesses or reasonably should possess that is material to an intelligent decision by the patient whether to undergo a proposed procedure.” Harnish v. Children’s Hosp. Medical Center, 387 Mass. 152, 155 (1982). That rule applies when a physician prescribes a drug just as it does when a physician performs any other medical procedure. “Materiality may be said to be the significance a reasonable person, in what the physician knows or should know is his patient’s position, would attach to the disclosed risk or risks in deciding whether to [use the drug].”Id. at 156, quoting from Wilkinson v. Vesey, 110 R.I. 606, 627 (1972). “Appropriate information may include the nature . . . and probability of risks involved, the benefits to be reasonably expected, the inability of the physician to predict results,. . . , and the available alternatives, including their risks and benefits.” Harnish, supra at 156.
Unless doctors have current, accurate, and complete information about a drug’s risks, they cannot properly perform their vital role. Therefore, courts have imposed on drug manufacturers the duty to provide doctors with that information. See, e.g., Brochu v. Ortho Pharmaceutical Corp., supra at 657-659. A drug manufacturer who fails properly to fulfil that duty must respond in damages to a patient who suffers an injury as a result. See, e.g., McEwen v. Ortho Pharmaceutical Corp., supra at 386-387.
I believe that the “prescription drug” rule, combined with the Harnish rule, most fairly and efficiently allocates among drug manufacturers, physicians, and drug users, the risks and responsibilities involved with the use of prescription drugs. Furthermore, I believe that those rules best ensure that a prescription drug user will receive in the most effective manner *146the information that she needs to make an informed decision as to whether to use the drug. The rules place on drug manufacturers the duty to gather, compile, and provide to doctors data regarding the use of their drugs, tasks for which the manufacturers are best suited, and the rules place on doctors the burden of conveying those data to their patients in a useful and understandable manner, a task for which doctors are best suited. Doctors, unlike printed warnings, can tailor to the needs and abilities of an individual patient the information that that patient needs in order to make an informed decision whether to use a particular drug. Manufacturers are not in position to give adequate advice directly to those consumers whose medical histories and physical conditions, perhaps unknown to the consumers, make them peculiarly susceptible to risk. Prescription drugs — including oral contraceptives — differ from other products because their dangers vary widely depending on characteristics of individual consumers. Exposing a prescription drug manufacturer to liability based on a jury’s determination that, despite adequately informing physicians of the drug’s risks and complying with FDA regulations, the manufacturer failed reasonably to warn a particular plaintiff-consumer of individualized risks is not essential to reasonable consumer protection and places an unfair burden on prescription drug manufacturers.
Even though the court recognizes the universal application of the “prescription drug” rule, it states that “[ojral contraceptives . . . bear peculiar characteristics which warrant the imposition of a common law duty on the manufacturer to warn users directly of associated risks.” Ante at 136-137. The court attempts to distinguish contraceptive pills from other prescription drugs by comparing the relative involvement of doctor and patient in the prescribing process. “Whereas a patient’s involvement in decision making concerning use of a prescription drug necessary to treat a malady is typically minimal or nonexistent,” the court asserts, “the healthy, young consumer of oral contraceptives is usually actively involved in the decision to use ‘the pill,’ as opposed to other available birth control products, and the prescribing physician is relegated to a relatively passive *147role.” Ante at 137. In making that statement, the court not only assumes facts not established on the record but also disregards the mandate of Harnish v. Children’s Hosp. Medical Center, supra.
While I would choose the “prescription drug” rule over the rule announced today by the court, I recognize that the FDA has promulgated regulations governing the provision of printed information to users of oral contraceptives. I would not consider the imposition of tort liability for failure to comply with those regulations, designed to further consumer protection, unfair nor unduly burdensome to contraceptive pill manufacturers. However, in my view, the evidence in this case would not support a finding that Ortho failed to comply with those regulations. The FDA required Ortho to place on every oral contraceptive pill dispenser a warning stating that the “most serious known side effect [of the oral contraceptive pill] is abnormal blood clotting which can be fatal.” 21 C.F.R. § 130.45(d)(1), 35 Fed. Reg. 9002-9003 (1970). Ortho complied in every way with that requirement. The FDA also required that Ortho make available to physicians for patients who requested it “information in lay language, concerning effectiveness, contraindications, warnings, precautions, and adverse reactions.” 21 C.F.R. § 130.45(e), 35 Fed. Reg. 9003 (1970). Ortho provided Carole MacDonald’s physician with a booklet that stated: “Blood clots occasionally form in the blood vessels of the legs and pelvis of apparently healthy people and may threaten life if the clots break loose and then lodge in the lung or if they form in other vital organs, such as the brain.” MacDonald’s physician gave Ortho’s booklet to MacDonald. The court finds it unnecessary to decide whether Ortho complied with FDA’s “lay language” requirement, ante at 140-141, but I do not believe that any rational trier of fact could have concluded that Ortho failed to comply with the regulation.
Furthermore, even if there be a common law duty necessitating a direct warning to the consumer with respect to the “nature and extent of the danger” of contraceptive pills, as the court declares, the MacDonalds presented no evidence that Ortho failed to fulfil that duty. The court states only that the jury *148“could have found that the lack of reference to ‘ stroke’ breached Ortho’s common law duty to warn.” Ante at 140. Surely, the statement in Ortho’s booklet that the contraceptive pill could cause life threatening blood clots to form in the brain, even though it did not contain the word “stroke,” satisfied the court’s requirement that Ortho provide “written warnings conveying reasonable notice of the nature, gravity, and likelihood of known or knowable side effects.” Ante at 139.1 would affirm the judgment for Ortho.

 Section 353(b)(1) provides: “A drug intended for use by man which — (A) is a habit-forming drug to which section 352(d) of this title applies; or (B) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not *144safe for use except under the supervision of a practitioner licensed by law to administer such drug; or (C) is limited by an approved application under section 355 of this title to use under the professional supervision of a practitioner licensed by law to administer such drug; shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist, or (in) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale."