Nevertheless, the adoption of strict liability in tort is not he same thing as the imposition of absolute liability upon the manufacturer or seller. As one court has stated, the doctrine of strict liability in tort is "hardly more than what exists under implied warranty when stripped of the contract doctrines of privity, disclaimer, requirements of notice of defect, and limitation through inconsistencies with express warranties." [1311

Liability is not necessarily imposed upon the manufacturer for every injury caused by a product. Although the injured party has been relieved of the burden of showing either breach of warranty or negligence on the part of the manufacturer, he still must establish that the product was "defective, that the defect caused the injury complained of and that the defect can be traced to the defendant." [132] In order that the product be considered "defective," it must be in a condition not comtemplated by the ultimate consumer, which will be unreasonably dangerous to him" at the time when the product leaves the hands of the seller. [133] In addition, the injured party must show that the 'defective condition of the product makes it unreasonably dangerous to the user or consumer." [134]

In order for an article to be "unreasonably dangerous," it must be "dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics." [135] A product, such as "good whiskey," is not unreasonably dangerous merely because it may become harmful through over-consumption or contamination. [136]

Strict liability in tort is also distinguishable from absolute liability because the manufacturer or seller has the possible defense of "assumption of risk" on the part of the injured party. Contributory negligence by the plaintiff is a major defense in actions based on negligence, but the Restatement specifies that, with respect to strict liability in tort, "contributory negligence of the plaintiff is not a defense when such negligence consists merely in a failure to discover the defect in the product, or to guard against the possibility of its existence." [137] But that form of contributory negligence which is known as "assumption of risk" and consists of "voluntarily and unreasonably proceeding to encounter a known risk" is a defense to an action based on strict liability in tort. [138] It is clear that the defense of assumption of risk is available to the drug manufacturer when the patient and physician are aware of the dangers involved in the use of a prescription drug and continue to make use of the drug despite such knowledge. [139]

With respect to drugs and vaccines, comment k to section 402A contains an important exception to the rule of strict liability in tort. "Unavoidably unsafe products," such as drugs and vaccines, which, "in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use" are specifically exempted from the rule of strict liability. The Pasteur treatment for rabies is cited as an example. "Such a product properly prepared and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous." Also exempted are certain prescription drugs and vaccines, and many new or experimental drugs which are not completely safe but whose marketing and use is justified despite 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. [140]

On the basis of this exception to the rule of strict liability, several commentators suggested that the courts would not impose strict liability in tort at all upon the manufacturers of drugs and vaccines. [141] Some of the decisions which were handed down shortly after the introduction of section 402A indicated that there was no breach of warranty when an unadulterated drug, properly prepared, tested and labelled with appropriate warning and approved by the Food and Drug Administration caused an adverse reaction. [142] These decisions stated that such a product was not "unreasonably dangerous" within the meaning of section 402A and strict liability in tort would therefore not be imposed. [143] In an action brought by a plaintiff who was nearly totally blind as a result of taking the defendant's "Aralen," the court refused to apply the theory of strict liability in tort, fearing

the far reaching consequences that may ensue if we were to take so bold a step as to impose the absolute [sic] liability suggested by the plaintiff.... We can agree with the plaintiff that the price of the drugs should include an

amount sufficient to create a fund to compensate those who suffer unanticipated harm from the use of a beneficial drug. But this kind of a system of compensation is beyond the power of the court to impose. [144]

Similarly, in one of the early cases against the manufacturer of "Chloromycetin," the court refused to apply the theories of implied warranty or strict liability in tort and held that liability must be established for a negligent failure to warn.

We have already held here there is a duty to exercise reasonable care to warn against known dangers of a product. . . . [There is] no sound basis to restate these rules in terms of the law of contract or to extend them to impose a greater degree of care. [145]

Some courts have taken another approach to the relationship of duty to warn under negligence and under strick liability in tort. In one of the "Aralen" cases the court stated that liability for failure to warn could be imposed under either the theory of negligent failure to warn in Restatement (Second) of Torts section 388 (1965) or the theory of strict liability in tort in Restatement (Second) of Torts section 402A (1965). [146] Dean Prosser has stated that, in cases involving the failure to warn of a known risk, the "liability has been placed on the basis of implied warranty, or strict liability in tort, on the ground that the product sold without warning is unsafe or 'defective.' But since the question is one of reasonable warning, the liability is not distinguishable from negligence." [147]

The first imposition of strict liability in tort upon a drug manufacturer for failure to warn of the known risk of a product occurred in a California action against the manufacturer of "MER/29." [148] The manufacturer claimed that strict liability could not be imposed for breach of implied warranty because the drug was "unadulterated and uncontaminated" and therefore fell within the exception to the rule of strict liability expressed by comment k to Restatement (Second) of Torts section 402A (1965). The court held that, because the manufacturer had falsified its test results to the Food and Drug Administration, MER/29 had not been "properly prepared and marketed." Moreover, the court held that evidence was sufficient to uphold a finding that the manufacturer had knowledge of the dangers of the drug before it was marketed and that the imposition of strict liability in tort therefore was justified.

Whether or not the vendor of a prescription drug is to be exempt from strict liability depends upon the facts surrounding the manufacture and sale of the product. If the vendor has properly prepared the product and has accompanied its sale with proper direction and warnings he will not be held to strict liability for unforeseen results. But where the facts disclose that the drug has not been properly prepared or has been placed upon the market and sold without adequate and proper warning, strict liability for resulting injury may be found. [149]

In the landmark case Davis v. Wyeth Laboratories, Inc., [150] discussed in Part II infra, the manufacturer of Type III Sabin oral polio vaccine was also held strictly liable in tort under the authority of comment K. "Strict liability is avoided in these situations only where sale is accompanied by proper directions and proper warnings." [151] The manufacturer's failure to make a "full disclosure of the existence and extent of the risk involved" had rendered the drug "unreasonably dangerous" and justified the imposition of strict liability. The manufacturer was held to knowledge of the risk on the basis of committee reports to the Surgeon General of September 1962 which indicated that the risk of vaccine induced poliomyelitis for adults was approximately one case per million doses and that the vaccine should be given to adults only in high risk groups. [152] Moreover, because the vaccine was administered in a mass immunization program and because there was no physician to whom the warning could be given, the court held that the manufacturer must give the warning to "the consumer either by giving warning itself or by obligating the purchaser to give warning." [153] In a similar vaccine-induced poliomyelitis case, the court affirmed the liability of the manufacturer on the basis of breaches of express and implied warranties, but noted that the concept of implied warranty had been virtually superseded by the theory of strict liability in tort in personal injury cases involving defective products. [154] "We observe that it is clearly the law in California that the theory of strict liability in tort is available in cases where the vaccinated individual contracts the disease the vaccine was designed to protect against.[155] The court also demonstrated a favorable attitude toward the plaintiffs in finding that they had satisfied the requirement of showing a defect in the vaccine and causation in fact. [156]

When a prescription drug is involved rather than a vaccine distributed through a mass immunization program, it is clear that the manufacturer may fulfill its

duty to warn of known side effects by an adequate warning to the prescribing physician; even when the action is based upon strict liability in tort there is still no duty to warn the patient directly. [157] But, when the manufacturer has not given adequate warning to the medical profession of dangerous side effects of a drug, the mere fact that a physician carelessly gives an open-ended prescription to the patient will not relieve the manufacturer of liability as long as its failure to warn contributed to the injury. [158]

"In the field of drug marketing, defining the outer limits of strict liability presents us with most difficult questions of policy." [159] Those outer limits have not yet been finally determined by the courts, but at this time it may generally be said that strict liability will not be imposed through warranty or in tort if the possibility of an injury resulting from a "product in its intended condition and used in its intended manner was both not known to the manufacturer and not knowable through any means of scientific discovery." [160] The factors of "lack of time and opportunity for sufficient medical experience" in comment k to Restatement (Second) of Torts section 402A (1965) indicate that the drug manufacturer must have knowledge of the danger before strict liability is imposed. [161]

Although few cases have specifically addressed the issue, it appears that the drug manufacturer is not liable for injuries resulting from a supposedly safe product until after the manufacturer knew or should have known of the risk of harm and failed to give adequate warning. [162] In Davis v. Wyeth Laboratories, Inc., [163] the court stated, "[W]hen Type III Sabin vaccine was first manufactured and sold by Wyeth, there was no known or foreseeable risk involved in taking it. Thus, Wyeth could not initially be expected to warn of unknown dangers." [164] Even in California, the duty to warn has been restricted to those situations in which the manufacturer "has knowledge, or by the application of reasonable, developed human skill and foresight should have knowledge, of . . . the danger." [165]

Certainly it may be argued that drug manufacturers should be held liable for all injuries which their products cause, even those which no “developed human skill or foresight" could have anticipated. [166] Because the drug manufacturer is at least theoretically able to spread the loss through insurance, absolute liability could be imposed making the manufacturer an insurer of the safety of its products, even for "unknowable" defects. [167] But under the theory of strict liability in tort the product must be unreasonably dangerous before liability arises, even if this requirement occasionally means that the "hapless victim of an 'unavoidably unsafe' but useful product cannot recover." [168] Experience with the rabies and smallpox vaccines "should make us aware that there are inevitably unsafe products whose benefits far outweigh their dangers. Consumers for a long time have lived with and accepted the risks inherent in their use." [169] The courts have also been unwilling to impose liability for defects which were unknown and were not reasonably foreseeable. The position of section 402A that such "unavoidably unsafe products" do not subject the manufacturer to strict liability in tort, provided that such drugs and vaccines are "properly prepared and marketed, and proper warning is given," would seem preferable to the imposition of absolute liability

PART II

A. DAVIS V. WYETH LABORATORIES, INC.[170]

1. THE DECISION

The role of public health authorities in providing medical care in the United States today is clearly increasing. Today the typical medical "consumer" is just as likely to be a client at a public health clinic as he is the patient of a private physician or the customer of a pharamacist.[171] Although they have the advantages of low cost protection and extensive coverage, mass immunization public health clinics do involve the possibility of causing injury to the consumer through drug or vaccine induced disease.[172] In order to provide greater protection for the public health service recipient from this danger, in 1968 the Court of Appeals for the Ninth Circuit in the case of Davis v. Wyeth Laboratories, Inc. [173] placed new responsibilities upon drug manufacturers who supply the clinics. [174] In so doing, the court may inadvertantly have created problems as significant as the ones it intended to resolve. Before discussing these problems and proposed solutions, the background and rationale of the Davis decision should be considered. Wyeth Laboratories was licensed by the government [175] in May 1962 to sell Type III Sabin oral polio vaccine. [176] Four months later, in September 1962,

the reports of the Advisory Committee to the Surgeon General were released, and the Surgeon General issued special reports recognizing a danger for adults of vaccin-induced poliomyelitis from the Type III vaccine of approximately one case per million doses and recommending that use of the vaccine be "restricted to preschool and school age children and to those adults in high risk groups, such as those travelling to hyperendemic areas or in areas where a Type III epidemic is present or impending." [177] Another report, in December 1962, stated that "because the need for immunization diminishes with advancing age and because potential risks of vaccine are believed by some to exist in adults, expecially above the age of 30, vaccination should be used for adults only with the full recognition of its very small risk." [178]

Wyeth Laboratories assigned one of its salesmen to assist in setting up mass immunization clinics and handling the sale of its Type III vaccine to the Idaho Falls Medical Society. The salesman informed the Society of the Surgeon General's first report, and the officials postponed their clinic scheduled for the fall of 1962. The Society later decided to proceed in the spring of 1963 and included adults in the program. Wyeth Laboratories, through its employee, played an active part in establishing the clinics and promoting the use of the vaccine by the public in Idaho. [179]

The company did include a printed insert with each bottle containing 100 doses of the vaccine which contained excerpts from the Surgeon General's report, but the insert was not read by the pharmacist who dispensed the vaccine in West Yellowstone, Montana, or by the adults who received it. Nether the medical society nor the drug manufacturer made any effort to warn the pharmacist or the adults who took the drug of the existence of a risk of vaccine-induced poliomyelitis. On the contrary, the attendant advertising and news stories represented the vaccine as being completely safe for persons of all ages. [180]

In March 1963, Glynn Richard Davis was thirty-nine years old, in good health, and engaged in the lumber business. He received a dose of the Type III oral polio vaccine manufactured by Wyeth Laboratories at the mass immunization clinic in West Yellowstone, Montana. Within thirty days he manifested paralysis and other symptoms of poliomyelitis and became paralyzed from the waist down. [181] Plaintiff Davis and his wife brought an action for damages against Wyeth Laboratories in the District Court for the District of Idaho asserting jurisdiction based on diversity of citizenship, and stated claims based upon (1) negligent manufacture, (2) failure to warn of known dangers, (3) strict liability in tort, and (4) breach of an implied warranty of fitness. The District Court judge dismissed all theories of liability except breach of warranty, and instructed the jury that

the implied warranty involved in this case is that the vaccine was reasonably fit for the particular purpose for which it was manufactured.... This warranty does not mean, however, that this vaccine could be used with absolute safety, but means only that the vaccine must have been reasonably fit and reasonably safe for use by the public as a whole. [182]

The jury returned a verdict for the defendant, Wyeth Laboratories. On appeal to the United States Court of Appeals for the Ninth Circuit, Davis challenged this instruction and contended that the warranty of the drug was that it was fit and safe as to him rather than as to the public as a whole. [183] The court of appeals rejected this claim but reversed the district court on different grounds. Purporting to apply the law of Montana, [184] the court determined that, under the circumstances, the manufacturer had a duty to warn the recipient of the risks involved in taking the vaccine, and that, since he was not so warned, strict liability attached to the sale of the vaccine under either the theory of breach of implied warranty or strict liability in tort. [185] The case was remanded for a new trial. [186]

2. THE WARNING REQUIREMENT AND ITS IMPLICATIONS

(a) Necessity of a Warning-Theory

The court of appeals based its decision in Davis v. Wyeth Laboratories, Inc. upon the "general proposition" of Restatement (Second) of Torts section 402A that strict liability shall attach to one who sells a product "in a defective condition, unreasonably dangerous" to the consumer. [187] Recognizing that the Sabin polio vaccine should be regarded as an "unavoidably unsafe product" under comment k of section 402A, the court emphasized that "strict liability is avoided in these situations only where sale is accompanied by proper directions and proper warnings." [188] The basic issues for the court's determination, then, were whether a duty to warn existed and whether the defendant Wyeth Laboratories had breached this duty. [189]

The purpose of the warning is, of course, to inform the consumer of the risks involved in taking the vaccine, and to permit him to make the decision that the personal risk is worth taking. [190] While recognizing that human experimentation with new drugs is essential to the development of medical and scientific knowledge, [191] the court stated that no person should ever be obliged to submit himself to such experimentation unless it is done "by his voluntary and informed choice or a choice made on his behalf by his physician." [192]

The manufacturer's duty to warn is clear when the "drug's danger is directed to a foreseeable and ascertainable class of persons, such as those prone to certain allergies." In such cases the warning constitutes a caution that certain persons should not take the drug; that as to them it is not "fit" although faultlessly made. [193]

The court pointed out, however, that in many instances, particularly when new drugs are involved, the risk is known to exist but cannot be limited to a certain class of persons because "knowledge does not yet explain the reason for the risk or specify those to whom it applies." The risk thus exists in some degree for all, or at least a significant portion, of those who take the drug. This, the court stated, was the case before it: "there seems to be no certain method of isolating those adults who may be affected adversely by taking Type III Sabin vaccine." [194]

In these situations, the court stated, "the drug is fit and its danger is reasonable only if the balance is struck in favor of its use." [195] When the consumer otherwise has knowledge of the risk there is no problem because he may make the necessary choice. But where the risk is unknown to the consumer, "the drug can properly be marketed only in such fashion as to permit the striking of the balance; that is, by full disclosure of the existence and extent of the risk involved." [196]

Having determined, then, that Wyeth Laboratories did have a duty to warn of the risk inherent in its vaccine, the court dealt with two further questions in order to determine whether the drug manufacturer had in fact breached its duty to warn: (1) whether the duty to warn existed at the time the plaintiff received the vaccine, and (2) whether the duty to warn extended to the individual consumers at the clinics or just to the sponsoring medical societies. The court found that the manufacturer's duty to warn did exist when Davis was immunized and that it did extend to the recipients.

Despite the requirements which the decision in Davis v. Wyeth Laboratories, Inc. [197] places upon drug manufacturers, the court clearly did not impose a duty to warn of unknown or unforeseeable risks in a product. Wyeth Laboratories, for example, had no duty to warn when the Type III Sabin vaccine was first licensed in early 1962; since there was no known or foreseeable risk, the manufacturer "could not initially be expected to warn of unknown dangers." [198] Nevertheless, the responsibility of the drug manufacturer did not end there, for "when, after further experience, the danger became apparent, the duty to warn attached." Without fixing a precise date, the court stated that certainly by March 1963 when Davis took the vaccine, six months after the Surgeon General's report, it was the responsibility of Wyeth Laboratories to see that the warning was given. [199]

Wyeth Laboratories argued that, since its only direct sale of the vaccine was to the sponsoring medical society and the decision to proceed with the clinics was made by the society, it had fulfilled the duty to warn by the disclosures of its salesman to the medical society. The court recognized that, in the case of prescription drugs, ordinarily a warning to the prescribing physician is sufficient. "In such cases the choice involved is essentially a medical one involving an assessment of medical risks in light of the physician's knowledge of his patient's needs and susceptibilities." [200]. Moreover, because it is difficult for the manufacturer to insure that the warning reaches the consumer, either by label or direct communication, a warning to the medical profession is the only effective means by which the warning can help the patient. [201]

The court pointed out, however, that, although the Type III Sabin vaccine had been denominated a prescription drug, it was not distributed as such. "It was dispensed to all comers at mass clinics without an individualized balancing by a physician of the risks involved. In such cases (as in the case of over-thecounter sales of nonprescription drugs) warning by the manufacturer to the immediate purchaser will not suffice. [202] Although the decision (that on balance and in the public interest the personal risk to the individual was worth taking) may have been that of the medical society and not the drug manufacturer, the manufacturer can neither assume for itself not allow the immediate purchaser