Reyes v. Wyeth Laboratories, No. 72-2251.

CourtUnited States Courts of Appeals. United States Court of Appeals (5th Circuit)
Writing for the CourtBROWN, , and WISDOM and AINSWORTH, Circuit
Citation498 F.2d 1264
PartiesEpifanio REYES, Individually and as next Friend of Anita Reyes, a minor, Plaintiff-Appellee, v. WYETH LABORATORIES, a Division of American Home Products Corporation, a Delaware corporation, Defendant-Appellant.
Docket NumberNo. 72-2251.
Decision Date31 July 1974





Loyd E. Bingham, Jr., San Antonio, Tex., Eberle, Berlin, Kading, Turnbow & Gillespie, R. B. Kading, Jr., William J. McKlveen, Boise, Idaho, for defendant-appellant.

Daniel R. Murray, Chicago, Ill., for American Academy of Pediatrics, amicus curiae.

William J. Curran, Boston, Mass., for Conference of State and Territorial Epidemiologists, amicus curiae.

Rafael H. Flores, J. Perry Jones, McAllen, Tex., for plaintiff-appellee.

Before BROWN, Chief Judge, and WISDOM and AINSWORTH, Circuit Judges.

WISDOM, Circuit Judge:

This products liability case raises significant questions concerning the scope of a drug manufacturer's duty to warn ultimate consumers of dangers inherent in his product.

In May 1970, slightly more than two weeks after she had received a dose of Wyeth Laboratories' oral polio vaccine, eight-month-old Anita Reyes was diagnosed as having paralytic poliomyelitis. Epifanio Reyes, Anita's father, filed suit against Wyeth Laboratories, alleging that the live polio virus in the vaccine had caused Anita's polio and that Wyeth was liable for her injuries because it had failed to warn her parents of this danger. Wyeth contends that it is not liable for Anita Reyes's injuries under the products liability law of Texas. In addition, Wyeth raises numerous procedural and evidentiary questions. The case was tried to a jury. The jury answered special interrogatories (see Appendix A) and returned a verdict in favor of Reyes against Wyeth for the sum of $200,000.


Twenty or thirty years ago poliomyelitis was a dread disease that especially attacked the very young. In 1952 alone, there were 57,879 reported cases of polio in the United States; 21,269 of these resulted in crippling paralysis to the victims. By 1970, when Anita Reyes contracted polio, the number of those stricken by polio had diminished dramatically; she was one of just 33 individuals to be afflicted during that year.1 Credit for this precipitous decline must go primarily to the medical researchers who discovered the viral nature of the disease, and were able to isolate and reproduce the virus in an inactivated or an attenuated form. See Appendix B. But credit for this remarkable achievement must also be given to such laboratories as Wyeth, which processed the polio vaccine, and to massive federal-state public health programs for the administration of the vaccine.

On May 8, 1970, Anita Reyes was fed two drops of Sabin oral polio vaccine by eye-dropper at the Hidalgo County Department of Health clinic in Mission, Texas. The vaccine was administered to Anita by a registered nurse; there were no doctors present. Mrs. Reyes testified that she was not warned of any possible danger involved in Anita's taking the vaccine. Mrs. Reyes has a seventh grade education, but her primary language is Spanish. She signed a form releasing the State of Texas from "all liability in connection with immunization". The form contained no warning of any sort, and it is apparent from her testimony that she either did not read the form or lacked the linguistic ability to understand its significance. About fourteen days after the vaccine was administered, Anita Reyes became ill. On May 23, 1970, she was admitted to the McAllen (Texas) General Hospital, where her disease was diagnosed as Type I paralytic poliomyelitis. See Appendix B, footnote 59. As a result of the polio, at the time of trial Anita was completely paralyzed from the waist down, her left arm had become atrophied, and she was unable to control her bladder or bowel movements.

The vaccine given Anita Reyes in the Mission clinic on May 8, 1970 was part of a "lot", No. 15509, prepared by Wyeth.2 Lot No. 15509 was trivalent oral polio vaccine that Wyeth had titered (mixed) from Types I, II, and III monovalent vaccine provided by Pfizer, Ltd. In response to an order placed by the Texas State Department of Health on December 23, 1969, Wyeth shipped 3500 vials of Lot No. 15509 vaccine to the State Health Department which in turn transferred 400 vials to the Hidalgo County Health Department. The jury found that vaccine from one of these vials was given to Anita Reyes. Included with every vial, each of which contained ten doses of vaccine, was a "package circular" provided by Wyeth which was intended to warn doctors, hospitals, or other purchasers of potential dangers in ingesting the vaccine. Mrs. Lenore Wiley, the public health nurse who administered the vaccine to Anita Reyes, testified that she had read the directions on this package insert, but that it was not the practice of the nurses at the Mission Health Clinic to pass on the warnings to the vaccinees or to their guardians. She testified that she gave Mrs. Reyes no warning before she administered the vaccine to Anita.

On October 7, 1970, Epifanio Reyes, individually and as next friend of his minor daughter, brought this action on theories of strict products liability, breach of warranty, and negligence. In his complaint he alleged that his daughter had contracted polio from the live virus in Wyeth's vaccine, and that Wyeth's failure to warn him or his wife that this might occur rendered it liable for Anita's injuries. Wyeth's main line of defense was that Anita's polio was not vaccine-induced at all. Wyeth produced experts who characterized virus isolated from a specimen of stool taken from Anita on the day after she was admitted to the hospital as "probably wild". This probability was increased, according to epidemological testimony adduced on Wyeth's behalf,3 by the fact that there was a polio "epidemic" in Hidalgo County at the time Anita fell ill. In effect, the jury rejected these theories in rendering a verdict for Reyes.

Wyeth asserts more than a score of separate grounds for reversal, each accompanied by extensive argument and citation. We have considered all of these contentions, but in this opinion we shall address only those challenges which we regard as raising substantial questions.


We turn first to the substantive issues raised by this appeal. Our inquiry is bounded by the jury's finding that Wyeth's vaccine was the producing cause of Anita Reyes's polio, and by those principles of products liability law we conclude would be applied by the courts of Texas. Erie R. R. Co. v. Thompkins, 1938, 304 U.S. 64, 58 S.Ct. 817, 82 L.Ed. 1188.

The jury's finding that the Wyeth vaccine was responsible for Anita Reyes's polio is less a conclusion than a starting point. Texas courts may hold manufacturers of products which harm consumers liable for the injuries, but, of course, manufacturers are not insurers.4 Texas courts recognize both tort and warranty theories of products liability.5 This case was tried, briefed, and argued on appeal entirely on the tort theory of strict liability. Thus the differences between the two approaches,6 and whatever contractual trappings of warranty have not been destroyed with the crumbling of the citadel of privity,7 need not detain us. Rather, we turn to the theory of strict products liability as embodied in Section 402A of the Restatement (Second) of Torts (1965),8 and approved by the Supreme Court of Texas in McKisson v. Sales Affiliates, Tex.Sup.Ct. 1967, 416 S.W.2d 787.9

Basically, Section 402A subjects to liability the seller or manufacturer of a product sold "in a defective condition unreasonably dangerous" to an ultimate user or consumer whose person or property is physically harmed by the product.10 Moreover, one who places defective goods in the stream of commerce will be liable "to the user or consumer even though he has exercised all possible care in the preparation and sale of the product". Restatement (Second) of Torts, Section 402A, comment a. Yet imposition of liability is by no means automatic; the elements tacit or explicit in Section 402A's mandate must be demonstrated to the trial court's satisfaction before the burden of the consumer's loss will be imposed on the seller of the product:

The plaintiff is faced with an arduous burden of proof. He must prove that: 1) the product in question was defective; 2) the defect existed at the time the products left the hands of the defendant; 3) that because of the defect the product was unreasonably dangerous to the user or consumer (plaintiff); 4) that the consumer was injured or suffered damages; 5) and that the defect (if proved) was the proximate cause of the injuries suffered.

Gravis v. Parke-Davis & Co., Tex.Civ. App.1973, 502 S.W.2d 863, 868. Although we do not embrace Gravis as the all-inclusive embodiment of Texas products liability law, the framework it provides suggest a useful analysis for the issue of Wyeth's liability here.

All five elements, however, which constitute the Gravis requirements need not be discussed here. There can be no question that Anita Reyes was injured, so the fourth element is not in issue. Nor is the second, since the defect alleged, failure to warn by the manufacturer, is by definition the manufacturer's dereliction. Moreover, to find that the plaintiff proved the first element is to conclude that he proved the third, for properly understood, "defective condition" has no meaning independent of "unreasonably dangerous"; the two terms are essentially synonymous.11 Thus if a product is unreasonably dangerous as marketed, the manufacturer may be held liable for injuries proximately caused by what he has produced, whether or not it was manufactured exactly as intended, that is without a production "defect".12 We do not understand this approach to dispense with the principle that to prompt liability a...

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