Williams v. Lederle Laboratories, C-1-82-1072.

• Decision Date: 09 July 1984
• Docket Number: No. C-1-82-1072.,C-1-82-1072.
• Citation: 591 F. Supp. 381
• Parties: Nancy J. WILLIAMS, Plaintiff, v. LEDERLE LABORATORIES, DIVISION OF AMERICAN CYANAMID COMPANY, Defendant.
• Court: U.S. District Court — Southern District of Ohio

591 F. Supp. 381

Nancy J. WILLIAMS, Plaintiff, v. LEDERLE LABORATORIES, DIVISION OF AMERICAN CYANAMID COMPANY, Defendant.

No. C-1-82-1072.

United States District Court, S.D. Ohio, W.D.

July 9, 1984.

Mark A. Wall, Nicholas E. Bunch, Middletown, Ohio, for plaintiff.

Mark A. Vander Laan, Cincinnati, Ohio, for defendant.

OPINION AND ORDER DENYING DEFENDANT'S MOTION FOR SUMMARY JUDGMENT

SPIEGEL, District Judge:

This matter came on for hearing on defendant's motion for summary judgment (doc. 32), plaintiff's memorandum in opposition (doc. 35), and defendant's reply (doc. 42). Having reviewed the affidavits and other materials offered in support of and opposing the motion and considering the arguments of counsel, we conclude that there are genuine issues of material fact to be resolved at trial. The first of these issues involves the adequacy of the warning supplied by defendant; the second, the proximate cause of plaintiff's injuries. Accordingly, defendant's motion for summary judgment is denied.

I.

Plaintiff, Nancy Williams, alleges that she contracted poliomyelitis as a result of contact with her infant daughter shortly after the child received Orimune, an orally administered live trivalent polio vaccine manufactured and distributed by defendant Lederle. The vaccine was administered in November 1978 in the office of Dr. Thomas Furlong, plaintiff's family physician since 1976. Plaintiff maintains that Lederle failed to provide adequate warnings of the risk associated with the vaccine, and that that failure was the proximate cause of her injuries.

Although the parties dispute the nature of plaintiff's illness, with defendant insisting that plaintiff has Guillain-Barre Syndrome rather than polio, that issue is not material to defendant's motion. Therefore, we assume arguendo that plaintiff contracted polio as a result of contact with her recently immunized daughter.

The parties agree that although plaintiff alleges several theories of recovery, the complaint primarily focuses on the theory of strict liability. The lead case in Ohio on the strict liability of a manufacturer of an ethical, i.e., prescription, drug is Seley v. G.D. Searle & Co., 67 Ohio St.2d 192, 423 N.E.2d 831 (1981). In that case the Supreme Court of Ohio adopted Comment k to Section 402A of the Restatement of Torts 2d.

Defendant asserts that it is entitled to summary judgment as a matter of law on three grounds.¹ The narrow question which we must decide on a motion for summary judgment is whether there is "no genuine issue as to any material fact and therefore that the moving party is entitled to judgment as a matter of law." Rule 56(c), Fed.R.Civ.P. The Court cannot try issues of fact on a Rule 56(c) motion, but is empowered to determine only whether there are issues to be tried. In re Atlas Concrete Pipe, Inc., 668 F.2d 905, 908 (6th Cir.1982). The moving party "has the burden of showing conclusively that there exists no genuine issue as to a material fact and the evidence together with all inferences to be drawn therefrom must be read in the light most favorable to the party opposing the motion." Smith v. Hudson, 600 F.2d 60, 63 (6th Cir.1979) (emphasis original).

Defendant asserts first that the product information about Orimune, including the package insert and information published in Physician's Desk Reference, warned that persons who came in contact with a recent vaccinee could contact poliomyelitis and that this warning was adequate as a matter of law. Secondly, defendant contends that even if the warning was inadequate, the uncontroverted facts demonstrate that the inadequacy was not the proximate cause of plaintiff's injury. Defendant further asserts that the learned intermediary rule prohibits finding defendant negligent in not communicating the risk directly to the plaintiff herself.

For reasons that follow, we find that the adequacy of the warning is a disputed issue of fact that must be resolved at trial. Moreover, we find that there is a vigorous dispute as to the proximate cause of plaintiff's injuries.

It is unnecessary at this time to resolve the third issue raised by plaintiff's motion. However, as the third contention poses a legal issue that may be essential to the trial of this case, we shall discuss our position on exceptions to the legal intermediary rule briefly. We emphasize that we do so only so that the parties will understand our view of the issues that must be resolved at trial.

II.

The parties agree that Orimune is a beneficial but potentially dangerous drug. Ohio law, following Comment k to Section 402A, provides that such a drug is not unreasonably dangerous if the manufacturer provides adequate warnings 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. The failure to provide an adequate warning renders the drug unreasonably dangerous and subjects the manufacturer to strict liability for resulting injury. Seley, 67 Ohio St.2d at 196-97, 423 N.E.2d 831.

The adequacy of a warning is a question of fact to be determined by a preponderance of the evidence. Seley, 67 Ohio St.2d at 192, 423 N.E.2d 831. Pointing out that neither Section 402A nor Comment k provides the factfinder with directions for determining the adequacy of a warning, the Ohio Supreme Court 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." 67 Ohio St.2d at 197-98, 423 N.E.2d 831 (citations omitted). The court went on to state that a warning may be inadequate because of "its factual content, its expression of the facts, or the method or form in which it is conveyed." The court explained:

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.

67 Ohio St.2d at 198, 423 N.E.2d 831.

The following warning appeared in both the Orimune package insert and the Physician's Desk Reference (PDR) at the time in issue:

Expert opinion is in agreement that the administration of live oral poliovirus vaccines is generally an effective and safe method of protecting populations against the natural disease. Paralytic disease following the ingestion of live poliovirus vaccine has been reported in individuals receiving the vaccine and in some instances in persons who were in close contact with subjects who had been given live oral poliovirus vaccine. The rare occurrence of "vaccine related cases" were considered "compatible" with vaccine induced disease where certain epidemological criteria including certain incubation, clinical and laboratory values could be judged compatible with vaccine as a cause. It has been estimated that the risk of vaccine induced paralytic poliomyelitis is about one chance per million doses.

The estimated risk of vaccine-induced paralytic disease occurring in vaccinees or those in close contact with vaccinees is extremely low. However, the risk should be considered by the physician and such information should be conveyed to the parent(s) at the time of vaccination. Those parents of a vaccinee who have not had previous polio vaccination should probably be considered among those adults as subject to increased risk of exposure and in this special situation. In the judgment of the physician responsible, protection may be needed for these intimate contacts.

This warning appeared in the package insert and PDR in a section captioned "Adverse Reactions." Doc. 32, exh. A.

Defendant presented uncontradicted evidence that beginning in 1965 Lederle provided detailed information about the risk associated with Orimune. Defendant argues that that fact plus the language of the warning constitutes an adequate warning as a matter of law because, in defendant's view, the widely disseminated warnings reasonably disclosed to the medical profession all risks inherent in the use of the drug.

Defendant also refers us to the deposition of Dr. Furlong, who prescribed Orimune for plaintiff's infant daughter. Dr. Furlong testified that at the time he prescribed Orimune for the child he was aware of the warnings contained in the package insert and PDR, and that he considered the risk that a parent might contract polio when deciding whether to warn of that risk. Defendant maintains that this testimony conclusively establishes that Dr. Furlong was fully apprised of the risk of contact polio and, therefore, that the warning is adequate as a matter of law. Defendant refers us to Dunkin v. Syntex Laboratories, Inc., 443 F.Supp. 121 (W.D.Tenn.1977) and Goodson v. Searle Laboratories, 471 F.Supp. 546 (D.Conn.1978). In both cases, the courts granted defendants' motions for summary judgment on the issue of the adequacy of the warning.

Plaintiff's position is that the warning did not convey a fair indication of the nature of the risk involved. She has provided us with the affidavit of Dr. Cyril H. Wecht. That affidavit states that prior to November 1978 it was reported that Orimune could cause poliomyelitis in persons coming into contact with vaccinees. Dr. Wecht stated further that over half of the endemic cases of polio reported in the United States during the ten years prior to November 1978 were traceable to a live oral polio vaccine. In Dr. Wecht's opinion the Orimune package insert for 1978 did not convey a fair indication of the nature of the dangers involved, was reluctant and equivocal in tone and lacked a sense of urgency. Furthermore, he found the statistical estimate provided in the warning misleading, both quantitatively and qualitatively, insofar as it...