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January 18, 1996


Appeal from the Appellate Court for the First District; heard in the court on appeal from the Circuit Court of Cook County, the Hon. Robert V. Boharic, Judge , presiding.

The Honorable Justice Heiple delivered the opinion of the court: Justice Harrison took no part in the consideration or decision of this case.

The opinion of the court was delivered by: Heiple

The Honorable Justice HEIPLE delivered the opinion of the court:

Plaintiffs, on behalf of their minor child, brought suit in the circuit court of Cook County against the manufacturer of the oral contraceptive which the mother ingested during her pregnancy, alleging that the manufacturer's failure to warn the mother of the dangers of the oral contraceptive was the proximate cause of their child's birth defects. This court has previously held, under the learned intermediary doctrine, that a pharmaceutical manufacturer's duty to warn runs only to the prescribing physician, and not to the user of the drugs. In this cause, we consider the application of the learned intermediary doctrine in light of a Federal regulation requiring pharmaceutical manufacturers to provide direct warnings of the dangers associated with oral contraceptives to users.

Factual Background

In April of 1979, Clyntie Martin went to a physician, Dr. Sloniewicz, because she was having cramps and had missed a menstrual period. Dr. Sloniewicz did not believe that Martin was pregnant. He was mistaken in this belief. After examining her, he instructed her to return for another appointment. At the second appointment, Dr. Sloniewicz again failed to diagnose Martin's pregnancy. He then prescribed Ortho-Novum 1/50, a prescription oral contraceptive manufactured by the defendant, Ortho Pharmaceutical Corporation, after Martin told him she was concerned about becoming pregnant. In her deposition, Martin testified that her doctor told her to begin taking the pills at the end of her next period. Contrary to her doctor's instructions, however, she began taking the pills about seven days later. Martin again missed her menstrual period and, in July of 1979, she realized that she was pregnant. On December 8, 1979, Martin gave birth to her son, Robert. Robert was born with orthopedic deformities of his arms, hands, and fingers. Otherwise, he was fully developed.

In February of 1981, plaintiffs, Robert Lee Martin, Jr., and Clyntie Martin, on behalf of their minor son, Robert Lee Martin III, filed an action against defendant, Ortho Pharmaceutical Company, alleging that Ortho-Novum 1/50 caused Robert's limb reductions and seeking damages for these birth defects. Plaintiffs also filed a malpractice action against Dr. Sloniewicz. In 1983, plaintiffs settled their malpractice claim against Dr. Sloniewicz for approximately $900,000 and dismissed him from the action. After a trial date had been set for plaintiffs' action against defendant, plaintiffs voluntarily dismissed the action pursuant to section 2--1009 of the Code of Civil Procedure (735 ILCS 5/2--1009 (West 1992)).

On January 7, 1991, four days after plaintiffs dismissed their action, they refiled their complaint against defendant. This complaint alleged that Ortho-Novum 1/50 was unreasonably dangerous because 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 defendant moved for summary judgment arguing that, under the learned intermediary doctrine, its duty to warn was limited to providing warnings to the prescribing physician, and that its warnings to Dr. Sloniewicz were adequate as a matter of law. The trial judge granted summary judgment in favor of the defendant.

The appellate court reversed. (268 Ill. App. 3d 980, 645 N.E.2d 431, 206 Ill. Dec. 426.) It concluded that an exception to the learned intermediary doctrine existed for manufacturers of oral contraceptives, and that the adequacy of defendant's direct warnings to Martin was a question of fact that precluded the entry of summary judgment in defendant's favor.

We allowed the defendant's petition for leave to appeal. (145 Ill. 2d R. 315.) Subsequently, we granted leave to the Pharmaceutical Research and Manufacturers of America and G.D. Searle & Company, Syntax Laboratories, Wyeth-Ayerst Laboratories, and Parke-Davis to file amicus curiae briefs in support of defendants; we granted leave to the Illinois Trial Lawyers Association to file a brief as amicus curiae in support of plaintiffs. (134 Ill. 2d R. 345.) We reverse.


In Kirk v. Michael Reese Hospital & Medical Center (1987), 117 Ill. 2d 507, 517, 111 Ill. Dec. 944, 513 N.E.2d 387, this court, consistent with the majority of other jurisdictions, adopted the learned intermediary doctrine. This doctrine provides that manufacturers of prescription drugs have a duty to warn prescribing physicians of a drug's known dangerous propensities and that physicians, in turn, using their medical judgment, have a duty to convey any relevant warnings to their patients. The learned intermediary doctrine, a rule of common law origin, is an exception to the general rule that a failure to warn of a product's dangerous propensities may serve as a basis for holding a manufacturer strictly liable in tort. The underlying rationale for the learned intermediary doctrine was set forth in Kirk:

" ' "Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, [an] individualized medical judgment bottomed on a knowledge of both patient and palliative. Pharmaceutical companies *** in selling prescription drugs are required to warn only the prescribing physician, who acts as a 'learned intermediary' between manufacturer and consumer." ' " ( Kirk, 117 Ill. 2d at 518, quoting Stone v. Smith, Kline & French Laboratories (1984), 731 F.2d 1575, 1579.)

Pursuant to the doctrine, there is no duty on the part of the manufacturer of prescription drugs to directly warn ...

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