Snawder v. Cohen

• Citation: 749 F. Supp. 1473
• Decision Date: 20 April 1990
• Docket Number: No. C-89-0629-L(B).,C-89-0629-L(B).
• Parties: Kimberly Marie SNAWDER, Plaintiff, v. Stuart P. COHEN, M.D., et al., Defendants.
• Court: U.S. District Court — Western District of Kentucky

749 F. Supp. 1473

Kimberly Marie SNAWDER, Plaintiff, v. Stuart P. COHEN, M.D., et al., Defendants.

No. C-89-0629-L(B).

United States District Court, W.D. Kentucky, at Louisville.

April 20, 1990.

John M. Mayer, Jr., Clarksville, Ind., for Kimberly Marie Snawder.

Landrum & Shouse, Louisville, Ky., for Wyeth-Ayerst.

Brown, Todd & Heyburn, Louisville, Ky., for Lederle Labs.

Kennedy Simpson, Louisville, Ky., for Pfizer Labs.

Gerald R. Toner, Louisville, Ky., for Cohen, M.D.

MEMORANDUM

BALLANTINE, Chief Judge.

This matter is before the Court on the motions of the two remaining Defendants¹, Dr. Stuart Cohen and Lederle Laboratories, for summary judgment. This case is a product liability suit. Plaintiff, Kimberly Marie Snawder ("Plaintiff"), allegedly contracted poliomyelitis from an oral vaccine manufactured by Lederle Laboratories ("Lederle") and administered by Dr. Stuart Cohen ("Cohen") nearly twenty years ago.

The vaccine which Plaintiff allegedly received was the Sabin oral polio vaccine. A number of courts have discussed, in considerable detail, the history of poliomyelitis in this country and the development of both the Salk and Sabin type vaccines. See, e.g., Dunn v. Lederle Laboratories, 121 Mich. App. 73, 328 N.W.2d 576 (Mich.App.1982); Johnson v. American Cyanamid Co., 239 Kan. 279, 718 P.2d 1318 (1986). It is now generally known that people who receive the oral Sabin vaccine, and others who come in close contact with them, are subject to a known, but statistically small, risk of contracting polio from the live virus contained in the vaccine.² In August 1971, Cohen allegedly administered the third in a series of three polio vaccines the infant Plaintiff received. The following month, Plaintiff began limping and experienced some paralysis in one leg which Plaintiff contends was a result of polio she contracted from the vaccine.

Plaintiff complains that Lederle and Cohen failed to warn her, or her mother, of the dangers inherent in the oral polio vaccine's use. Plaintiff also complains that Lederle breached express warranties regarding the fitness of the vaccine. For purposes of their motions for summary judgment, Lederle and Cohen both assume that Plaintiff in fact contracted polio from the vaccine, and that Dr. Cohen failed to warn Plaintiff or her mother of the possibility that Plaintiff might contract polio from the vaccine.

Both Lederle and Cohen rely on certain deposition testimony by Plaintiff's mother, Mrs. Bishop, to the effect that she would have had the Plaintiff vaccinated even if she had been told of the risk of contracting polio from the vaccine. Defendants argue that they are entitled to summary judgment since their alleged failure to warn was not the legal cause of Plaintiff's injuries. In addition, Defendant Lederle argues that Plaintiff's warranty theory is precluded by Kentucky law, while Defendant Cohen argues that he had no duty to warn Plaintiff of the risks involved in taking the polio vaccine.

BACKGROUND

In this diversity case, the Court is obligated to apply Kentucky law. Erie R. Co. v. Tompkins, 304 U.S. 64, 58 S.Ct. 817, 82 L.Ed. 1188 (1938). This Court has found no Kentucky cases, however, which address the warning issue with respect to prescription drugs or vaccines. The Sixth Circuit Court of Appeals has reviewed cases from other jurisdictions which raised questions regarding liability for poliomyelitis contracted from a polio vaccine. See Schindler v. Lederle Laboratories, 725 F.2d 1036 (6th Cir.1983) (Warnings given by manufacturer of oral polio vaccine in package inserts and by association of pediatrics in committee report on infectious diseases were adequate to put pediatrician on notice regarding danger associated with giving oral polio vaccine to child suffering from immunity deficiency); Berry v. American Cyanamid Co., 341 F.2d 14 (6th Cir.1965) (Applying Tennessee law and holding that there was no privity of contract between Plaintiff and manufacturer of oral vaccine where vaccine distributed by manufacturer to physicians in original closed package to be administered to patients was administered to plaintiff by his physician).

A number of courts in other jurisdictions have also considered the liability of a manufacturer of oral live (Sabin-type) polio vaccine for injuries resulting from administration of the vaccine. See generally Annotation, Liability of Manufacturer of Oral Live Polio (Sabin) Vaccine for Injury or Death From Its Administration, 66 ALR 4th 83 (1988).

A vaccine manufacturer is generally recognized to have a duty to exercise due care in the preparation and marketing of the product it manufactures, and the degree of this duty of care is commensurate with the harm which may result from the manufacturer's negligence. Id. at 88. Included within the manufacturer's obligations is the duty to warn adequately of the dangers involved with a product's use in such a manner that the nature and seriousness of the dangers which are known or should be known to the manufacturer are conveyed to consumers; such warnings are required even where the number of consumers who may be harmed is not large. Id. Evidence that a drug was manufactured for administration only by a physician, and that the physician knew or should have known of the dangers involved in the product's use, does not of itself preclude a finding that the manufacturer was negligent in failing to communicate adequate warnings regarding the drug. Id.

There has been considerable debate regarding whether the manufacturer of a vaccine can be held liable under a theory of strict liability pursuant to RESTATEMENT (SECOND) OF TORTS § 402A (1965). The theory of strict liability has been adopted by Kentucky courts, Dealer Transport Co. v. Battery Distributing Co., 402 S.W.2d 441 (Ky.1965). Comment k of § 402A is instructive on the issue of strict liability as applied to manufacturers of unavoidably unsafe products and has commonly been applied in the field of drugs. Comment k provides:

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 ... 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. (Emphasis in original).

RESTATEMENT (SECOND) OF TORTS § 402A comment k (1965).

Some courts have allowed plaintiffs to use a strict liability theory in making defective design claims against vaccine manufacturers, with varying degrees of success. See Grinnell v. Charles Pfizer & Co., 274 Cal.App.2d 424, 79 Cal.Rptr. 369 (Cal.App. 1969) (manufacturer of oral polio vaccine could be held strictly liable in tort for injuries suffered by recipients of its vaccine despite trial judge's failure to instruct on theory of strict liability); Johnson, 718 P.2d 1318 (Where there was no claim made that the allegedly injurious vaccine was defective and the evidence indicated that vaccine was properly prepared and marketed, there was no design defect in oral polio vaccine).

The more persuasive line of cases is that which recognizes that an oral polio vaccine may qualify under comment k to § 402A as an unavoidably unsafe product for which special strict liability rules apply. Under this analysis, a vaccine manufacturer is not subject to strict liability for design defects. Instead, the manufacturer's liability is limited to manufacturing defects, for those cases in which the vaccine given had been improperly prepared, and warning defects, where a manufacturer's failure to market a drug or vaccine without adequate warnings of its dangers renders the product defective.

A number of courts have characterized the oral polio vaccine as an unavoidably unsafe product, and then proceeded to analyze the adequacy of the manufacturer's warning under the rubric of a strict product liability defect. See Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir.1974), cert. denied, 419 U.S. 1096, 95 S.Ct. 687, 42 L.Ed.2d 688 (1974); Givens v. Lederle, 556 F.2d 1341 (5th Cir.1977); Johnson, 718 P.2d 1318; Dunn, 328 N.W.2d 576; Davis v. Wyeth Laboratories, Inc., 399 F.2d 121 (9th Cir.1968); Cunningham v. Charles Pfizer & Co., 532 P.2d 1377 (Okl.1975). Where, as here, a plaintiff complained that no warning, or an inadequate warning, was given before the administration of the vaccine, the adequacy of a manufacturer's warning has been judged by a reasonableness standard. Thus, theories of negligence and strict liability in failure to warn cases have been deemed to be "functional equivalents." Feldman v. Lederle Laboratories, 97 N.J. 429, 479 A.2d 374, 386 (1984).³ Whether analyzed under a negligence or a strict liability theory, the test used in evaluating warning issues is one of reasonableness.

Historically, plaintiffs who have brought suits to recover for vaccine-related poliomyelitis have alleged causes of action against manufacturers which are based on tort and breach of...