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December 22, 1994



Presiding Justice Hoffman delivered the opinion of the court: Johnson* , and Theis, JJ., concur.

The opinion of the court was delivered by: Hoffman

PRESIDING JUSTICE HOFFMAN delivered the opinion of the court:

The plaintiffs appeal from an order of the circuit court of Cook County granting summary judgment in favor of the defendant on their two-count complaint alleging strict product liability. For the following reasons, we reverse and remand.

The plaintiffs filed a complaint against the defendant alleging that an oral contraceptive, Ortho-Novum 1/50, which it manufactured was unreasonably dangerous because, inter alia, it "was not accompanied with a warning to the general public, users and consumers" that the drug caused physical deformities in the children of mothers who ingested it. The complaint also alleged that Mrs. Martin began taking the drug in May 1979, although at the time, unknown to herself or her prescribing doctor, she was pregnant. According to the complaint, on December 8, 1979, she gave birth to the minor plaintiff who was born with deformed arms, hands, and fingers as a direct result of her use of Ortho-Novum 1/50. The defendant moved for summary judgment arguing that under the learned intermediary doctrine, its duty to warn was limited to adequately advising the prescribing doctor of the contraceptive's known side effects and that its warnings to the doctor were adequate as a matter of law. In granting summary judgment in favor of the defendant, the trial court found both that the learned intermediary doctrine precluded the plaintiffs from recovering against the defendant and that defendant's warnings to patients and prescribing physicians were adequate.

In urging reversal of the summary judgment, the plaintiffs argue that the trial court erred: (1) in applying the learned intermediary doctrine to negate the defendant's obligation to directly warn consumers of the adverse effects of its drug as mandated by Federal regulation; and (2) in holding that the defendant's warnings to the users of its oral contraceptive were adequate as a matter of law.

Before addressing the issues as fixed by the parties, we are compelled to comment upon the standard of review in this case. The defendant argues that this court cannot reverse the entry of summary judgment absent an abuse of discretion. We disagree. Summary judgment is to be granted only when the moving party is entitled to judgment as a matter of law. (735 ILCS 5/2-1005(c) (West 1992).) Because the entry of a summary judgment is not a matter committed to the discretion of the trial court, abuse of discretion is not the standard of review. On appeal, the court must independently examine the evidence presented to the trial court both in support of and in opposition to a motion for summary judgment ( Arra v. First State Bank & Trust Co. (1993), 250 Ill. App. 3d 403, 621 N.E.2d 128, 190 Ill. Dec. 259), and its review of the entry of the summary judgment is de novo ( In re Estate of Hoover (1993), 155 Ill. 2d 402, 615 N.E.2d 736, 185 Ill. Dec. 866).

To adequately address the substantive issues presented by this appeal, we begin with a brief review of the law of strict tort liability as it applies to prescription drugs and an analysis of the learned intermediary doctrine.

In the context of strict tort liability, the law imposes a duty upon a manufacturer to place into the stream of commerce only those products which are not unreasonably dangerous when used for their intended purpose. ( Rivera v. Rockford Machine & Tool Co. (1971), 1 Ill. App. 3d 641, 274 N.E.2d 828.) Failure to warn, or to adequately warn, of a product's dangerous propensities, in and of itself, can render a product unreasonably dangerous and may form the basis of strict liability in tort. Woodill v. Parke Davis & Co. (1980), 79 Ill. 2d 26, 402 N.E.2d 194, 37 Ill. Dec. 304.

Prescription drugs are no exception. If a prescription drug is placed into the stream of commerce without adequate warnings of its possible adverse side effects, the manufacturer may be subjected to strict tort liability for injuries suffered by a patient proximately resulting from its failure to so warn. ( Kirk v. Michael Reese Hospital & Medical Center (1987), 117 Ill. 2d 507, 513 N.E.2d 387, 111 Ill. Dec. 944; Lawson v. G.D. Searle & Co. (1976), 64 Ill. 2d 543, 356 N.E.2d 779, 1 Ill. Dec. 497.) Generally, a manufacturer must warn the ultimate user of the risks of its product, but in consideration of the very nature of prescription drugs and the ethics involved in the professional practice of medicine, an exception to this general rule, the learned intermediary doctrine, has been recognized as the means by which prescription drug manufacturers discharge their obligation to warn. (See Kirk, 117 Ill. 2d at 517-19, 513 N.E.2d at 392-93; Mahr v. G.D. Searle & Co. (1979), 72 Ill. App. 3d 540, 390 N.E.2d 1214, 28 Ill. Dec. 624.) Although the manufacturer's obligation to warn is for the benefit of the users of its prescription drugs, the learned intermediary doctrine as adopted in Illinois provides that a manufacturer has an obligation to warn only prescribing doctors of known dangerous propensities of its prescription drugs. There is no obligation on the part of the manufacturer to directly warn patients. ( Kirk, 117 Ill. 2d at 519, 513 N.E.2d at 393.) The rationale supporting the doctrine is that the physician functions as the learned intermediary between the manufacturer and the patient and decides which drug to prescribe and which warnings should be conveyed to the patient. Under this theory, the extent of disclosure to a patient is a matter of medical judgment which relieves the manufacturer from any responsibility to convey warnings directly to the patient. Kirk, 117 Ill. 2d at 517-19, 513 N.E.2d at 392-93.

The plaintiffs acknowledge the existence of the learned intermediary doctrine and its adoption in Illinois, but argue that because the prescription drug involved in this litigation is an oral contraceptive, an exception to the doctrine exists as a result of a Federal regulation which mandates direct warnings to the users of oral contraceptives. The question is one of first impression in Illinois. Kirk did not consider the effect of a Federal regulation upon a prescription drug manufacturer's obligation to warn users directly, and although the issue existed in Glassman v. Wyeth Laboratories, Inc. (1992), 238 Ill. App. 3d 533, 606 N.E.2d 338, 179 Ill. Dec. 506, it was not addressed.

The Federal Food, Drug, and Cosmetic Act of 1938 (21 U.S.C. § 301 et seq.), was enacted by the United States Congress pursuant the power conferred upon it under the constitution to regulate interstate commerce. ( United States v. Walsh (1947), 331 U.S. 432, 91 L. Ed. 1585, 67 S. Ct. 1283.) The primary objective of this legislation is the protection of public health. ( United States v. An Article of Drug Bacto-Unidisk (1969), 394 U.S. 784, 22 L. Ed. 2d 726, 89 S. Ct. 1410.) Section 701(a) of the act (21 U.S.C. § 371(a)), vests broad rule making power in the Secretary of Health, Education, and Welfare who is authorized to promulgate binding, substantive regulations for its enforcement. ( Weinberger v. Hynson, Westcott & Dunning, Inc. (1973), 412 U.S. 609, 37 L. Ed. 2d 207, 93 S. Ct. 2469.) The authority granted to the Secretary has been delegated to the Commissioner of the Food and Drug Administration (FDA). 21 C.F.R. § 5.1(a).

The regulation in question in this case, as it existed at the time of the events giving rise to this action, provided in pertinent part as follows:

"Information in lay language concerning effectiveness, contraindication, warnings, precautions, and adverse reactions shall be furnished to each patient receiving oral contraceptives. This information shall be given to the patient by the dispenser ***. The brief summary shall specifically include *** [a] warning regarding the serious side effects of oral contraceptives ***. The side ...

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