Seley v. G. D. Searle & Co.

423 N.E.2d 831, 67 Ohio St. 2d 192, 21 Ohio Op. 3d 121, 1981 Ohio LEXIS 567
CourtOhio Supreme Court
DecidedJuly 15, 1981
DocketNos. 80-336 and 80-360
StatusPublished
Cited by207 cases

This text of 423 N.E.2d 831 (Seley v. G. D. Searle & Co.) is published on Counsel Stack Legal Research, covering Ohio Supreme Court primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Seley v. G. D. Searle & Co., 423 N.E.2d 831, 67 Ohio St. 2d 192, 21 Ohio Op. 3d 121, 1981 Ohio LEXIS 567 (Ohio 1981).

Opinions

Sweeney, J.

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, 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

[196]*196“(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 [197]*197ingestion 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 & Co. (1979), 72 Ill. App. 3d 540, 390 N.E. 2d 1214; Woodill v. Parke Davis Co. (1980), 79 Ill. 2d 26, 402 N.E. 2d 194; Ortho Pharmaceutical Corp. v. Chapman (Ind. App. 1979), 388 N.E. 2d 541. On the other hand, when the drug manufacturer fails to give adequate warning, the drug may be considered “defective” and unreasonably dangerous, thereby subjecting the manufacturer to strict liability for resulting injuries. Mahr v. G. D. Searle, supra; Hamilton v. Hardy (1976), 37 Colo. App. 375, 549 P. 2d 1099.

Where a plaintiff seeks recovery from a drug manufacturer for injuries allegedly sustained as a result of the ingestion of a drug not accompanied by adequate warnings, the jury must determine numerous potentially decisive questions of fact by a preponderance of the evidence. Initially, the fact finder must decide whether the warning provided was “adequate.” The question of the adequacy of the warning given in strict liability cases has been deemed to be perhaps the central issue in determining whether the product is unreasonably dangerous within the concept of strict liability as set forth in Section 402 A of the Restatement. Lawson v. G. D. Searle & Co. (1976), 64 Ill. 2d 543, 356 N.E. 2d 779. Where the fact finder finds that an adequate warning was provided, the action must be determined in favor of the manufacturer irrespective of whether the plaintiffs use of the drug was, in fact, causally connected to the plaintiffs injury, and despite the fact that the product is unavoidably unsafe.

However, neither Section 402 A itself nor Comment k thereto gives an indication of how a jury is to arrive at a finding of adequacy.

[198]*198To fill this void, a substantial number of courts have held that a warning is “adequate” for Comment k purposes where, under all the circumstances, it reasonably discloses to the medical profession all risks inherent in the use of the drug which the manufacturer knew or should have known to exist, e.g., Smith v. E. R. Squibb & Sons, Inc. (1979), 69 Mich. App. 375, 273 N.W. 2d 476; McEwen v. Ortho Pharmaceutical Corp. (1974), 270 Ore. 375, 528 P. 2d 522; Sterling Drug, Inc., v. Yarrow, supra; Basko v. Sterling Drug, Inc. (C.A. 2, 1969), 416 F. 2d 417; Ortho Pharmaceutical Corp. v. Chapman, supra. We join those courts.

The fact finder may find a warning to be unreasonable, hence inadequate, in its factual content, its expression of the facts, or the method or form in which it is conveyed. Id., at page 558. The adequacy of such warnings is measured not only by what is stated, but also by the manner in which it is stated. A reasonable warning not only conveys a fair indication of the nature of the dangers involved, but also warns with the degree of intensity demanded by the nature of the risk. A warning may be found to be unreasonable in that it was unduly delayed, reluctant in tone or lacking in a sense of urgency. Sterling Drug, Inc., v. Yarrow, supra, at page 994. A jury may find that a warning is inadequate and unreasonable even where the existence of a “risk,” i.e., a causal relationship between use of the product and resulting injury, has not been definitely established. McCue v. Norwich Pharmacal Co. (C.A. 1, 1972), 453 F. 2d 1033; Hamilton v. Hardy, supra. Thus, where scientific or medical evidence exists tending to show that a certain danger is associated with use of the drug, the manufacturer may not ignore or discount that information in drafting its warning solely because it finds it to be unconvincing. Mahr v. G. D. Searle & Co., supra, at page 564.

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Bluebook (online)
423 N.E.2d 831, 67 Ohio St. 2d 192, 21 Ohio Op. 3d 121, 1981 Ohio LEXIS 567, Counsel Stack Legal Research, https://law.counselstack.com/opinion/seley-v-g-d-searle-co-ohio-1981.