Seley v. G. D. Searle & Co.

• Decision Date: 15 July 1981
• Docket Number: 80-360,Nos. 80-336,s. 80-336
• Citation: 21 O.O.3d 121,67 Ohio St.2d 192,423 N.E.2d 831
• Parties: , 21 O.O.3d 121 SELEY et al., Appellees and Appellants, v. G. D. SEARLE & CO. et al., Appellant and Appellees. (Two cases.)
• Court: Ohio Supreme Court

Page 192

67 Ohio St.2d 192

423 N.E.2d 831, 21 O.O.3d 121

SELEY et al., Appellees and Appellants, v. G. D. SEARLE & CO. et al., Appellant and Appellees. (Two cases.)

Nos. 80-336, 80-360.

Supreme Court of Ohio.

July 15, 1981.

Syllabus by the Court

1. A manufacturer of an unavoidably unsafe ethical (prescription) drug is not strictly liable in tort to a consumer who has suffered injury as a result of ingesting that drug where the manufacturer has provided adequate warning to the medical profession of all potential adverse reactions inherent in the use of the drug of which the manufacturer, being held to the standards of an expert in the field, knew or should have known to exist at the time of marketing.

2. The "adequacy" of such warning is a question of fact to be determined by a preponderance of the evidence. A warning is adequate where, under all the circumstances, it reasonably discloses all risks inherent in the use of the drug of which the manufacturer, being held to the standards of an expert in the field, knew or should have known to exist.

3. In a strict liability claim based on a failure to provide adequate warnings of risks associated with ingestion of an ethical drug, the plaintiff must establish (1) that the lack of adequate warnings was a proximate cause of the plaintiff's ingestion of the drug, and (2) that ingestion of the drug was a proximate cause of the plaintiff's injury.

4. In satisfying the first branch of the proximate cause burden stated above, the plaintiff is aided by a rebuttable presumption that the failure to adequately warn was a proximate cause of the plaintiff's ingestion of the drug.

5. A manufacturer of ethical drugs satisfies its duty to warn of risks associated with use of the product by providing adequate warnings to the medical profession and not to the ultimate user.

Two appeals arising from the same lawsuit have been consolidated for disposition herein. In case No. 80-360, plaintiffs-appellants, Angela G. Seley and Peter S. Seley, appeal the judgment of the Court of Appeals affirming a jury finding in favor of defendants-appellees, Francis J. Froehlich, M.D., and C. J. Condorodis, M.D. and F. J. Froehlich, M.D., Inc. In case No. 80-336, defendants-appellants, G. D. Searle & Co. and Searle & Co., appeal the judgment of the Court of Appeals reversing a jury finding in their favor and remanding the cause for a new trial.

Angela G. Seley and Peter S. Seley were married in August 1968. Shortly before her marriage, Angela consulted a gynecologist in Belvoir, Illinois (where she then lived), and underwent a premarital gynecological examination. Upon her request for an oral contraceptive, Angela received a three months' supply of the ethical birth control drug, "Ovulen." Ovulen is an oral contraceptive manufactured by G. D. Searle & Co., of which Searle & Co. is a subsidiary. (Hereinafter G. D Searle & Co., and Searle & Co. will be collectively referred to as "Searle.")

In October 1968, the couple moved to Erie, Pennsylvania where another physician gave her a prescription for Ovulen. In February 1970, Angela discontinued using the pill in an attempt to become pregnant. The Seleys moved to Tulsa, Oklahoma, in November of 1970. On February 1, 1971, a son was born to the couple. The latter stage of Angela's pregnancy was complicated by a condition known as "toxemia" or "preeclampsia." In connection with that condition Angela experienced a period of elevated blood pressure immediately before and after delivery her blood pressure reaching at one point a recorded level of 196/130. Upon administration of postpartum medication her blood pressure returned to normal. In the spring of 1971, Angela Seley resumed taking Ovulen under the prescription of her Tulsa doctor.

The Seleys moved to Cincinnati in March 1972. On May 3, 1972, Angela consulted Dr. Francis J. Froehlich, an obstetrician and gynecologist, in order to undergo an annual medical examination and to obtain a renewal of her birth control pill prescription, which was nearing expiration. Following a routine examination, Dr. Froehlich gave Angela a one-year prescription for Ovulen and a one-month sample. He instructed her to return in one year for a follow-up examination.

Approximately seven to eight months thereafter, Angela intermittently experienced transcient numbness of the left arm, sensations described as "heart flutters," and shortness of breath. She called Dr. Froehlich's office in December 1972, to schedule an appointment, but did not relate specific complaints or symptoms at that time. An appointment was made for February 1973.

On January 27, 1973, at age 26, Angela suffered a stroke rendering her left side numb and partially paralyzed. Angela testifed at trial that the entire left side of her body has remained numb, and that walking is slow and difficult because her left leg is weak and hard to control. She continues to experience some facial paralysis. The likelihood of improvement in her physical condition in the future is slight. Because of her condition, Angela has, on her physician's recommendation undergone a tubal ligation rendering her permanently unable to bear children.

The Seleys brought suit asserting numerous theories of recovery against the Cincinnati prescribing physician, Dr. Froehlich et al, and Searle, Ovulen's manufacturer and distributor. The plaintiffs asserted liability on the part of Searle based on negligence and strict liability in tort. Dr. Froehlich was accused of malpractice and failure to adequately warn Angela in connection with use of the pill.

Following almost nine weeks of trial the jury returned answers to five interrogatories and a general verdict in favor of all defendants.

The Court of Appeals, as previously indicated, reversed the judgment in favor of Searle and ordered a new trial, but affirmed the dismissal of the action against Dr. Froehlich et al.

The cause is before this court upon allowance of motions to certify the record.

Dinsmore, Shohl, Coates & Deupree, Smith H. Tyler, Jr., and Jane M. Grote, Cincinnati, for Seley et al.

Bieser, Greer & Landis, David C. Greer, Dayton, Sidley & Austin and William P. Richmond, Chicago, Ill., for G. D. Searle & Co., et al.

French, Marks, Short, Weiner & Valleau, Roy W. Short and Edward S. Lee, Cincinnati, for Francis J. Froehlich, M.D., et al.

SWEENEY, Justice.

Case No. 80-336.

We turn first to the issues dealing with the alleged liability of Searle, Ovulen's manufacturer and distributor. In Temple v. Wean United, Inc. (1977), 50 Ohio St.2d 317, 364 N.E.2d 267, this court adopted Section 402 A of the Restatement of Torts 2d dealing with the theory of strict product liability. The first two paragraphs of the syllabus to that case state, in language substantially identical to Section 402 A, that:

"1. One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if "(a) the seller is engaged in the business of selling such a product, and

"(b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.

"2. The rule stated above applies although the seller has exercised all possible care in the preparation and sale of his product, and the user or consumer has not bought the product from or entered into any contractual relation with the seller."

The Seleys sought damages from Searle based on the rule set forth in Section 402 A, with particular emphasis on Comment k to that section, which reads:

"Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. * * * Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk." 2 Restatement of Torts 2d 353-354.

The Seleys do not contend that Ovulen is "defective" due to improper design or manufacture, nor do they contend that the product ingested by Mrs. Seley was contaminated or otherwise impure. They seek recovery on the theory that Searle is strictly liable to them due to the alleged fact that proper warnings were not given by Searle of the risks associated with ingestion of Ovulen by women with a prior medical history of toxemia during pregnancy.

Under Comment k, despite the inherent and unavoidable danger associated with ingestion of many prescription drugs, the seller of such a product is not strictly liable for injury resulting from use of the product if the seller has provided adequate warning of all potential adverse reactions inherent in the use of the drug of which it, being held to the standards of an expert in the field, knew or should have known to exist at the time of marketing. Sterling Drug, Inc. v. Yarrow (C.A. 8, 1969), 408 F.2d 978; Mahr v. G. D. Searle...