Ortho Pharmaceutical Corp. v. Chapman

Citation180 Ind.App. 33,388 N.E.2d 541
Decision Date29 March 1979
Docket NumberNo. 1-877,1-877
PartiesORTHO PHARMACEUTICAL CORPORATION, Defendant-Appellant, v. Dorothy M. CHAPMAN, Plaintiff-Appellee. A 169.
CourtCourt of Appeals of Indiana

William P. Wooden, Douglas B. King, Wooden, Stark, McLaughlin & Sterner, Indianapolis Robert W. Sparks, Johnson & Johnson, New Brunswick, N.J., McFaddin & McFaddin, Rockville, for defendant-appellant.

Clelland J. Hanner, John E. Dowd, Rockville, for plaintiff-appellee.

YOUNG, Judge.

The appellee, Dorothy Chapman, brought suit against the appellant, Ortho Pharmaceutical Corporation, for personal injury suffered by her as a result of taking Ortho-Novum, an oral contraceptive manufactured by the appellant. Her complaint alleged liability on the theories of negligence, strict tort liability under Restatement (Second) of Torts § 402A (1965), and breach of warranty for Ortho's failure to adequately warn of the risk of thrombophlebitis attendant on use of Ortho's oral contraceptive. Judgment was entered upon a jury verdict in favor of Chapman, from which Ortho brings this appeal.

Ortho has raised numerous issues which will be dealt with as they arise in the course of our determination of the following major issues:

I. Whether the trial court erred in denying Ortho's motion for judgment on the evidence, challenging the sufficiency of evidence with respect to the inadequacy of the warnings and with respect to proximate cause.

II. Whether the trial court erred in refusing to give Ortho's tendered instructions numbered 2, 3, 6, 7, 9 and 10, in giving Chapman's tendered instructions numbered 2, 3, 4, 8, 9 and 10, and in the court's instructions numbered 1 and 3.

III. Whether the trial court committed reversible error in admitting into evidence a Federal Drug Administration-mandated "Patient Warning" which was not in use until August of 1970, in admitting an Ortho-Novum 2 mg. package insert dated January, 1970, and in admitting an advertisement of Ortho-Novum from a medical periodical published after Chapman's doctor prescribed Ortho-Novum for Chapman.


Because Ortho offered evidence on its own behalf, any error in overruling Ortho's motion for judgment on the evidence at the close of Chapman's case-in-chief is waived. Lamb v. York, (1969) 252 Ind. 252, 247 N.E.2d 197; Meadowlark Farms, Inc. v. Warken, (1978) Ind.App., 376 N.E.2d 122; Ind. Rules of Procedure, Trial Rule 50(A). Therefore we need only review the propriety of the trial court's denial of Ortho's motion for judgment on the evidence at the close of all the evidence.

The rule in Indiana with respect to motions pursuant to T.R. 50, for judgment on the evidence, is that such a motion may properly be granted only if there is no substantial evidence or reasonable inference derived therefrom supporting an essential element of the claim: a complete failure of proof. When considering a motion for judgment on the evidence, the trial court must consider only the evidence and reasonable inferences favorable to the non-moving party. Huff v. Travelers Indem. Co., (1977) Ind., 363 N.E.2d 985; American Turners of South Bend v. Rodefer, (1978) Ind.App., 372 N.E.2d 516. The motion must be denied "where there is Any evidence or legitimate inference therefrom tending to support at least one of the allegations. Where the evidence is such that the minds of reasonable men Might differ, a directed verdict is improper, and the resolution of conflictive evidence is for the jury." (Original emphasis). Vernon Fire & Casualty Ins. Co. v. Sharp, (1976) 264 Ind. 599, 349 N.E.2d 173, 179. With this standard in mind, we examined the sufficiency of the evidence in support, first, of the existence of a defective condition unreasonably dangerous, and second, of the element of proximate cause.


The theory of strict liability defined in the Restatement (Second) of Torts § 402A 1 has been expressly adopted as the law in Indiana. Ayr-Way Stores, Inc. v. Chitwood, (1973) 261 Ind. 86, 300 N.E.2d 335; Perfection Paint & Color Co. v. Konduris, (1970) 147 Ind.App. 106, 268 N.E.2d 681; Cornette v. Searjeant Metal Products, Inc., (1970) 147 Ind.App. 46, 258 N.E.2d 652. A Prima facie case is established by evidence of "(1) a purchase of (2) a defective product from (3) a seller engaged in the business of selling such a product (4) and the product reached him without substantial change in its condition and (5) that the product caused physical harm because of the defect." Ayr-Way Stores, Inc. v. Chitwood, supra, 300 N.E.2d at 340. The term "defective" requires some elaboration in this case. Chapman does not contend that there was any fault in the design and manufacture of Ortho-Novum, but rather claims that the lack of adequate warnings rendered it unreasonably dangerous. 2

Section 402A, Comment K is particularly relevant in this case. It has been interpreted as creating an exception to the general rule of § 402A in the case of unavoidably unsafe products. Basko v. Sterling Drug, Inc., (2d Cir. 1969) 416 F.2d 417, 425. Chapman argues that Comment K refers only to products for which there is "dire need and no safe alternative." We disagree. As the text of Comment K indicates, the question is whether marketing of the product is justified in light of the known risks. This involves balancing the public interest in the availability of such a product against the attendant risks. There is no dispute that oral contraceptives are potentially dangerous. For this reason they are "ethical drugs" available only by prescription. 3 Nevertheless the public benefits from such a convenient and highly effective contraceptive. Therefore we have no difficulty in finding that oral contraceptives come under the protection of Comment K. See Carmichael v. Reitz, (1971) 17 Cal.App.3d 1958, 95 Cal.Rptr. 381, 398-40; Hamilton v. Hardy, infra, at 549 P.2d 1107; Lawson v. G. D. Searle & Co., (1976) 64 Ill.2d 543, 1 Ill.Dec. 497, 356 N.E.2d 779, 782-83; Vaughn v. G. D. Searle & Co., supra, [180 Ind.App. 39] at 1248; Leibowitz v. Ortho Pharmaceutical Corp., infra, 307 A.2d at 457. See also Merrill, Compensation for Prescription Drug Injuries, 59 Va.L.R. 1, 7 (1973). Comment K emphasizes, however, that strict liability is avoided only when the product is accompanied by proper warnings:

k. 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. (Emphasis added).

The rationale of this comment was explained in Borel v. Fibreboard Paper Products Corp., (5th Cir. 1973) 493 F.2d 1076, 1088-89:

Strict liability may not always be appropriate in such cases because of the important benefits derived from the use of the product. This is especially so with respect to new drugs that are essential in treating disease but involve a high degree of risk. It may also be so with respect to other commercial products possessing both unparalleled utility and unquestioned danger. As a practical matter, the decision to market such a product requires a balancing of the product's utility against its known or foreseeable danger. But, as comment k makes clear, even when such balancing leads to the conclusion that marketing is justified, the seller has a responsibility to inform the user or consumer of the risk of harm. The failure to give adequate warnings in these circumstances renders the product unreasonably dangerous. The rationale for this rule is that the user or consumer is entitled to make his own choice as to whether the product's utility or benefits justify exposing himself to the risk of harm. Thus, a true choice situation arises, and a duty to warn attaches, whenever a reasonable man would want to be informed of the risk in order to decide whether to expose himself to it. (Citations omitted).

See also Incollingo v. Ewing, (1971) 444 Pa. 263, 282 A.2d 206. Thus, proof in this case of a defective condition unreasonably dangerous depends on the absence of proper warnings. 4

In determining what is meant by "proper warnings," Comment K must be read together with Comment J. 5 Comment J appears to impose an important limitation on liability under § 402A where warnings are in issue, by conditioning a seller's duty to warn on actual or constructive knowledge of the danger. The authorities are split in this respect. Those holding that knowledge is required include Midgley v. S. S. Kresge Co., (1976) 55 Cal.App.3d 67, 127 Cal.Rptr. 217; Christofferson v. Kaiser Foundation Hospital, (1971) 15 Cal.App.3d 75, 92 Cal.Rptr. 825; Oakes v. Geigy Agricultural Chemicals & Co., (1969) 272 Cal.App.2d 645, 77 Cal.Rptr. 709; Tomer v. American Home Products, (Conn.1976) 368 A.2d 35; Woodill v. Parke, Davis & Co., (1978) 58 Ill.App.3d 349, 15 Ill.Dec. 900, 374 N.E.2d 683; Cunningham v. Charles Pfizer & Co., (Okla.1975) 532 P.2d 1377; Bristol-Meyers Co. v. Gonzales, (Tex.1978) 561 S.W.2d 801; Crocker v. Winthrop Laboratories, (Tex.1974) 514 S.W.2d 429; and Ethicon, Inc. v. Parten, (Tex.Civ.App.1975) 520 S.W.2d 527. Those indicating that the law should assume knowledge include Hamilton v. Hardy, (1976) 37 Colo.App. 375, 549 P.2d 1099 (the parties stipulated that knowledge be limited to that at the time the product was being used; the court applied the Kimwood test of defectiveness based on assumed knowledge); Johnson v. Clark Equipment Co., (1976) 274 Or. 403, 547 P.2d 132; Phillips v. Kimwood Machine Co., (Or.1974) 269 Or. 485, 525 P.2d 1033; and Little v. PPG Industries, Inc., (Wash.App.1978) 579...

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