Chambers v. GD Searle & Co.

• Decision Date: 11 December 1975
• Docket Number: Civ. No. 73-1027-H.
• Citation: 441 F. Supp. 377
• Parties: Doreen CHAMBERS, Plaintiff, v. G. D. SEARLE & CO., Defendant.
• Court: U.S. District Court — District of Maryland

441 F. Supp. 377

Doreen CHAMBERS, Plaintiff, v. G. D. SEARLE & CO., Defendant.

Civ. No. 73-1027-H.

United States District Court, D. Maryland.

December 11, 1975.

COPYRIGHT MATERIAL OMITTED

Alan M. Perlman and Stylianos J. Gratsias, Washington, D. C., for plaintiff.

J. Joseph Barse, Washington, D. C., and William P. Richmond, Chicago, Ill., for defendant.

MEMORANDUM DECISION

HARVEY, District Judge:

In this products liability case, the plaintiff is seeking damages from the defendant, G. D. Searle & Co., a manufacturer of oral contraceptives, for injuries sustained by the plaintiff as the result of a stroke which she alleges was caused by taking the defendant's drug, Enovid-E. After approximately six days of trial, one of plaintiff's medical witnesses became ill and could not continue. However, the direct examination of such witness had been almost completed. The Court therefore permitted plaintiff to proffer the small portion of this witness' remaining testimony.

The defendant then filed a motion for a directed verdict and submitted a brief in support of such motion. Extensive argument was heard and the Court has also had the benefit of lengthy pretrial briefs filed by the parties.

In a motion such as the present one, the Court looks at the evidence in a light most favorable to the plaintiff. The determination to be made is whether such evidence would permit the case to be submitted to the jury on any one or more of the theories of liability relied upon by the plaintiff. In this case, plaintiff claims that she is entitled to recover damages on the following four theories of liability: (1) fraud; (2) implied warranty; (3) strict liability; and (4) negligence. This Court has previously ruled that District of Columbia law is to be applied.

Little time need be spent in discussing these first three theories of liability which have been advanced. To succeed on a cause of action based on allegations of fraud, a plaintiff must prove (1) a false representation of material fact made by the defendant; (2) knowledge or belief on the part of the defendant that the representation was false; and (3) an intention to induce the plaintiff to act or refrain from acting in reliance upon the misrepresentation. On the record here, this Court concludes as a matter of law that fraud has not been proven. Proof has not been sufficient to establish any of these necessary elements.

Similarly, plaintiff would not be entitled to proceed in this case on a theory of breach of implied warranty. Plaintiff relies on 28 D.C.Code, Section 2-314 (relating to an implied warranty of merchantability) and 28 D.C.Code, Section 2-315 (relating to an implied warranty of fitness for a particular purpose). But there has been no evidence to show that the drug in question contained any foreign ingredients, substances or other impurities that rendered it inherently dangerous or unfit for human consumption. Furthermore, the evidence here indicates that the plaintiff was suffering from hypertension when her doctor prescribed this drug.

In actions for breach of warranty to recover damages for injury resulting from the use of the product, there is generally no liability upon a seller where the buyer has been unusually susceptible to injury from the product. See Whittington v. Eli Lilly & Co., 333 F.Supp. 98 (S.D.W.Va.1971). A manufacturer cannot be required, under a theory of breach of implied warranty, to insure against the susceptibility of a particular individual. Its duty is to reasonably guard against probabilities, not possibilities. Plaintiff's reliance on warranty cases involving the polio vaccine and the drug Quadrigen is misplaced. See, e. g., Tinnerholm v. Parke Davis & Co., 411 F.2d 48 (2d Cir. 1969) and other cases cited there. Those cases involved situations in which a foreign element or impurity had been included in the drug which should not have been there, and the injury was caused by the defective product.

Furthermore, strict liability is not a viable theory in this case. The strict liability doctrine is set forth in Section 402A of the Restatement of Torts, 2d. Even assuming that the District of Columbia courts would apply the theory of strict liability to a products liability case involving a drug (and no case has been cited to the Court in which this has been done), the facts here show that the plaintiff could not recover under such a theory. In the first place, Enovid-E has not been shown by the proof to be unreasonably dangerous to the user or consumer. See in this regard, Comments (l) and (j) of Section 402A. Secondly and more significantly, Comment (k) of Section 402A indicates that insofar as a new drug such as Enovid-E is concerned, a theory of strict liability is essentially the same as a theory of negligence insofar as the question of furnishing warnings is concerned, and that subject will be discussed more fully hereinafter. Indeed, Comment (k) is pertinent in this case both as to plaintiff's claim based on strict liability and to plaintiff's claim based on negligence. Comment (k) reads as follows:

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. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. 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.

Oral contraceptives are just such products. They are useful and desirable products, now taken by some 10 million persons. But there are attendant risks, and as long as proper warnings are given, the manufacturer cannot be held responsible for an illness such as resulted here.

The authorities cited by plaintiff in support of her argument that strict liability applies here are not pertinent. While there may be a distinction drawn between a negligent failure to warn and the warning requirements for strict liability insofar as other products are concerned, Comment (k) itself indicates that where new drugs, sold only under the prescription of a physician, are involved, the standard is essentially the same. Therefore, Section 402A provides no separate grounds for recovery by the plaintiff.

The principal question presented by the pending motion is whether the plaintiff has produced enough evidence in support of her claim that the defendant was negligent and provided insufficient warnings of the risk of harm from the use of its product, for this issue to be presented to the jury. The standard of negligence in a case of this sort is somewhat different from that presented in the ordinary negligence case. First of all, this case concerns a prescription drug which is regulated by federal law. See 21 U.S.C. § 353(b)(1)(C). Thus, the drug can be used only under the professional supervision of a doctor licensed by law to administer the drug. Accordingly, it is quite clear that the warning which must be examined here is that given to the physician and not that given to the user. See Sterling Drug, Inc. v. Cornish, 370 F.2d 82 (8th Cir. 1966). As the Eighth Circuit said in that case, "the purchaser's doctor is a learned intermediary between the purchaser and the manufacturer." Other cases have termed the doctor an intervening party who is required to exercise his own independent judgment on the basis of the technical information furnished. See Carmichael v. Reitz, 17 Cal.App.3d 958, 95 Cal.Rptr. 381 (1971).

A drug company is not an insurer with respect to the product with which it deals. O'Hare v. Merck & Company, 381 F.2d 286, 291 (8th Cir. 1967). As the Eighth Circuit said in the O'Hare case, at page 291:

It the drug company has the duty to exercise ordinary and reasonable care not to expose the potential consumer to an unreasonable risk of harm from the use of its products. The failure to meet this standard of due care in light of all the attendant circumstances will constitute negligence and subject the manufacturer to liability for the resulting consequences. The fact that the consumer's injuries were proximately caused by the manufacturer's product does not in and of itself constitute a sufficient basis upon which to predicate the manufacturer's liability.

This rule is recognized in the District of Columbia. See Stottlemire v. Cawood, 213 F.Supp. 897, 899 (D.D.C.1963), a case in which the Court directed a verdict in favor of the drug manufacturer because the warnings given were sufficient.

Another principle that must be borne in mind in cases of this sort is that the manufacturer's duty to warn must be measured by the information available on the date when the drug was prescribed...