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Conk* Introduction The idea is deeply entrenched in the minds of many that there is something wrong with modern products liability law. Product liability law has been celebrated by some as “good for America” because it brings “discipline” to corporate America.1 But for others it is a failure that has damaged manufacturing efforts, and offered punishment where incentive is needed.2 The idea that there is something wrong with strict liability for products goes back a long way, and has excellent pedigree. Prof. Fleming James, Jr., the torts treatise author and early apostle of the strict liability gospel,3 urged in 1956 at a Torts Roundtable at an AALS4 meeting that “strict liability is to be preferred over a system of liability based on fault wherever you have an enterprise or activity, beneficial to many, which takes a more or less inevitable accident toll of
Adjunct Professor, Fordham Law School; Elected member, American Law Institute; partner, Tulipan & Conk, P.C., South Orange, New Jersey. CARL T. BOGUS, WHY LAWSUITS ARE GOOD FOR AMERICA 3, 5 (2001). [“Products liability is both the common law’s greatest advancement of the twentieth century and a subject of great controversy...The ballot box is not democracy’s only instrument. The people, after listening to evidence and reasoned arguments, work their will in the jury box as well. The tort system is a system of disciplined democracy...”]; Michael L. Rustad, The Jurisprudence of Hope: Preserving Humanism in Tort Law, 28 SUFFOLK U. L. REV. 1099 (1994) [celebrating the life and work of Prof. Thomas Lambert, who wrote “The blessing of Beshada [v. Johns Manville Products Co., 90 N.J. 191, 447 A.2d 539 (1982)] is surely a consecration of the aims and goals of strict liability to maximize consumer protection, serve as a spur to safety incentives, simplify the plaintiff's burden of proof in products litigation, and achieve a more equitable distribution of losses from product failure.”] See, e.g., JULES L. COLEMAN, RISKS AND WRONGS, 414-15 (1992) ("Together the rule of strict liability in conjunction with the design defect tests have wreaked havoc within the manufacturing sector of the economy.... The modern solution has failed to provide what we seek, a principled, rational, and predictable body of law regulating product safety."); RICHARD A. EPSTEIN, SIMPLE RULES FOR A COMPLEX WORLD 103 (1995) ("Breakthroughs in technology and treatment need carrots, not sticks.").
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Harper & James, Law of Torts (1946) Association of American Law Schools. 1
human life and limb...”5 Dean Leon Green responded that he would go “as far as Professor James” in advocating “implied warranty”, and “severe” or “strict liability” for “food-chemical products (that) are supplied ready for immediate consumption”. But “injuries resulting from mechanical products can be more acceptably adjusted as between the victim and the manufacturer...through negligence law than through any other means the judicial process has yet developed.”6 James’s view flowered in the 1965 Second Restatement of Torts which declared in § 402A the principle that liability for defective products should be imposed even when the manufacturer exercised all possible care in the preparation of the product. After an initial period of celebratory efflorescence scholars and courts have sought to return the law of product liability to the familiar confines of negligence law.7 The effort has largely succeeded.8 The law of product liability has been absorbed into the general law of negligence. Product liability law has thus been normalized. But despite this normalization the idea persists that there is something wrong - that there is something severe or different about product liability law and that certain producers should not be subject to the duty of ordinary care which is characteristic of the law of Fleming James, Jr., General Products - Should Manufacturers Be Liable Without Negligence?, 24 Tenn. L. Rev. 923 (1957). Leon Green, Should the Manufacturer of General Products Be Liable Without Negligence?, 24 Tenn. L. Rev. 928 (1957). See, e.g. David G. Owen, Products Liability Law Restated, 49 S.C. L. Rev. 273, 277 278 (1998): From the mid-1960s to the mid-1980s, section 402A's doctrine of strict products liability in tort for the sale of defective products spread like wildfire from state to state, as one court after another, and an occasional state legislature, "adopted" the new doctrine. n30 With the increasing social and govern-mental conservatism of the 1980s, however, judicial (and legislative) enthusiasm for section 402A's "pro-consumer" doctrine began to falter. During this time, judicial and scholarly attention began to shift away from examining why and how the new products liability doctrine should be expanded toward why and how the doctrine should be curtailed. Restatement of the Law (Third), Torts: Products Liability, § 2, comments and Reporters’ Notes, passim; Mark Geistfeld, Escola v. Coca Cola Bottling Co.: Strict Products Liability Unbound, TORTS STORIES, Robert L. Rabin and Stephen D. Sugarman, eds. (2003) 239, 251 [Regarding manufacturing defects, “[i]f (through employment of the doctrine of res ipsa loquitur) defect alone establishes negligence, a seller is always liable for defective products. Negligence becomes equivalent to strict liability...Strict liability for design and warning defects...has turned out to be indistinguishable from negligence...Consequently, a rule of strict liability for design and warning defects is merely another name for negligence liability.] 2
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negligence. The idea persists particularly that drug and medical device product manufacturers should not be treated like other manufacturers. A strong expression of that is the controversial provision of the Third Restatement of Torts: Products Liability, § 6 (c). The American Law Institute urges exemption of prescription products from the normal rule of liability for design defect - that if an alternative safer design has been unreasonably omitted the product is defective. Only two courts have reached the question. The first, the Nebraska Supreme Court, rejected the Restatement view in Freeman v. Hoffman LaRoche. The second court, the Georgia Court of Appeals, an intermediate appellate court, divided. Two panel members rejected the ALI rule. But the third judge embraced the Restatement’s exceptional rule for prescription drugs and devices.9 Since the ALI’s promulgation of the Second Restatement of Torts drugs have been the subject of particular attention and dispute in the law of products liability. § 402A’s comment k has been read by some as a defense and by most as a mandate for a case-by-case negligencebased review. The former reporters for the Products Liability Restatement, disdain the law derived from comment k as “gibberish”. They decided to start over from scratch without even attempting to “restate” the drug product law of the Restatement 2d era. This essay contends that drugs, biologics, and medical devices should be treated like other products. Their sometimes great social utility is irrelevant to the choice of what standard of care should be imposed by the law of torts. Using blood cases as an exemplar, this essay embraces the law of negligence as adequate to the task of judging when a product is defective and compensation owed for harm done by it. It explicates the majority and minority views in Bryant, and examines three blood cases - one in England and two in the United States - to show that absorption of product liability law into that of negligence is warranted, that product liability law has been normalized, and demonstrates that the legacy of the product liability revolution of the 1960's is a jurisprudence of product stewardship which provides a coherent standard appropriate for all producers, whether governmental, non-governmental, or commercial. Origins of Modern Product Liability Law
The origins of the modern era of product liability tort law is a story is oft-told. In 1944 Justice Roger Traynor, concurring in an exploding soda bottle case, Escola v. Coca Cola Bottling Co.10, called for “absolute” liability to the consumer. The first trumpet had sounded in what William L. Prosser, in one of the most-cited law review articles ever written, called the
2003 Ga. App. LEXIS 945 (decided July 16, 2003). 150 P. 2d 436 (Cal. 1944 (Traynor, J., concurring). 3
Assault on the Citadel11 - - the defense that only those who contracted with a seller had the right to sue it for injury suffered due to product defect.12 Nineteen years later in Greenman v. Yuba Power Products13 the Supreme Court of California embraced Traynor’s approach. The New Jersey Supreme Court followed in Henningsen v. Bloomfield Motors, Inc.14, announcing that “an implied warranty of merchantability chargeable to either an automobile manufacturer or a dealer extends to the purchaser of the car, members of his family, and to other persons occupying or using it with his consent. ” Prosser, the Reporter for the second Restatement of Torts, heralded the indomitable trend toward consumer protection. In section 402A of the new Restatement the American Law Institute (ALI) in 1965 embraced strict liability for defective products “even if made with all possible care”.15 Prosser soon announced the Fall of the Citadel. Evolution had become Some might say that the first trumpet was sounded by Judge Cardozo, in MacPherson v. Buick Motor Co., 111 N.E. 1050 (N.Y. 1916), where in a negligence case the court held that a manufacturer is liable to the ultimate suer of the product, despite the absence of a contractual relationship. But Cardozo was no crusader and he did not elaborate (or campaign for) all the implications of his seminal decision. See ANDREW L. KAUFMAN, CARDOZO (1998) 265 - 285. But Justice Traynor, a professor before he was a judge, laid out in Escola a comprehensive argument for an enterprise liability and strict liability approach to product liability law, then campaigned for the change over the next 20 years until he swung a majority of the California Supreme court to his views. See Mark Geistfeld’s lucid doctrinal analysis of Traynor’s famous concurrence in Rabin, et al., supra, N*. William L. Prosser, The Assault upon the Citadel (Strict Liability to the Consumer), 69 YALE L.J. 1099 (1960).
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377 P. 2d 897 (Cal. 1963). 161 A.2d 69 (N.J. 1960).
See, Restatement of Torts (2d), § 402A: Special Liability of Seller of Product for Physical Harm to User or Consumer (1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if (a) the seller is engaged in the business of selling such a product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold. (2) The rule stated in Subsection (1) applies although (a) the seller has exercised all possible care in the preparation and sale of his product, and 4
Revolution, he reported.16 The era of “strict products liability” law had begun in earnest. Automobile defect, machine guarding, asbestos, and drug product liability cases in unprecedented numbers followed. All but a few states embraced the Restatement.17 Section 402A’s commandments and comments achieved almost scriptural status, the hermeneutics of which became a widely practiced judicial art. But "absolute liability" was an impossible goal, unmanageable because ultimately one has to ask the question what degree of safety is it reasonable to ask of a product. How many pounds should a chair withstand?18 Some cases involve obvious defects (bicycles
(b) the user or consumer has not bought the product from or entered into any contractual relation with the seller. Caveat: The Institute expresses no opinion as to whether the rules stated in this Section may not apply (1) to harm to persons other than users or consumers; (2) to the seller of a product expected to be processed or otherwise substantially changed before it reaches the user or consumer; or (3) to the seller of a component part of a product to be assembled. Comment: a. This Section states a special rule applicable to sellers of products. The rule is one of strict liability, making the seller subject to liability to the user or consumer even though he has exercised all possible care in the preparation and sale of the product. William L. Prosser, The Fall of the Citadel (Strict Liability to the Consumer), 50 Minn. L. Rev. 791, 799 (1966) ["[B]y placing their goods upon the market, the suppliers represent to the public that they are suitable and safe for use; and by packaging, advertising and otherwise they do everything they can to induce that belief"]. Harvey S. Perlman, Delaware and the Restatement (Third) of Torts: Products Liability, 2 Del. L. Rev. 179 (1999). [Exploring the anomalous jurisprudence of a state which grounded its product liability law in contract rather than in tort.] See, for example, Myrlak v. Port Authority, 723 A. 2d 45 (N.J. 1999) [chair found defective based on inference from circumstances as in § 3 of Products Liability Restatement. John Myrlak, was injured when his chair collapsed while he was at work. At that time, plaintiff was forty-three years old, six feet six inches tall, and weighed approximately 325 pounds. At the time of the accident, plaintiff had been seated in the chair performing his duties for 5
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approximately one hour and forty-five minutes. He suddenly heard a loud noise, and the back of his chair cracked and gave way.] But such results are less obvious than might appear at first blush. Jane Stapleton suggests in Restatement Third: Products- an Anglo-Australian Perspective, 39 Washburn L.J. 363 (2000), a sequential analysis to answer the question `is a product defective?': - If (there is sufficient evidence that) the product failed to fulfill a manifestly intended function, then the plaintiff can proceed to the jury. He or she does not need to show a R(easonable) A(lternative) D(esign); indeed, there is no need in this class even to characterize what type of defect caused the failure. - If (there is sufficient evidence that) the product failed to comply with an applicable product safety statute or administrative regulation, then the plaintiff can proceed to the jury. He or she does not need to show a RAD. - A jurisdiction might allow the approach that if (there is sufficient evidence that) the product had a manifestly unreasonable design, then the plaintiff can proceed to the jury. He or she does not need to show a RAD. Other names for this class of case include: "categorically defective design," "generically defective design," and "egregiously dangerous product type." . In the remainder of cases, the approach to defectiveness depends on classification of defect: . Where a product contains a manufacturing error it is defective; - A product "is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the seller or other distributor, . . . and the omission of the alternative design renders the product not reasonably safe;" . A product "is defective because of inadequate instructions or warnings when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable instructions or warnings by the seller . . . and the omission of the instructions or warnings renders the product not reasonably safe." In the absence of regulatory standards on how much weight a chair should hold, one 6
without brakes). Other products depart from intended specifications. What the Germans call "rogue products" came to be called "manufacturing defects". For this class of cases `strict liability’ is a fair description of the effect on the plaintiff’s burden of proof of the combination of legal doctrines which have been applied, principally implied (judicially imposed) warranty in tort, or negligence found as a matter of law - commonly by employing robust formulations of doctrines such as res ipsa loquitur.19
might get to the last stage of this analysis (should the chair have been made stronger, and should there have been weight-limit warnings) before being able to answer the question of product defect in Myrlak's case. In the end there are two plain questions to be answered - how much weight should a chair hold? And should users be warned of that limit? The Products Liability Restatement declares in §2 (a), its comments and Reporters’ notes, that courts impose a form of strict liability in tort for `manufacturing defects’, defined as a product which “departs from its intended design even though all possible care was exercised in the preparation and marketing of the product”. In such cases, according to Products Liability Restatement § 3, plaintiffs need not prove “a specific defect”but may rely on a robust form of circumstantial proof derived from the classic doctrine of res ipsa loquitur, which the court in Myrlak, supra, n*, called the "indeterminate product defect test". It is necessary to show merely that “the harm sustained by the plaintiff...(a) was of a kind that ordinarily occurs as a result of product defect; and (b) was not, in the particular case, solely the result of causes other than product defect existing at the time of sale or distribution.” As a matter of legal doctrine “manufacturing defect” liability can be understood as the imposition on manufacturer or seller of either a) an implied warranty - the obligation in law to deliver a product which meets the standards of safety that the manufacturer/seller has 1) declared for itself, or 2) represented to others, or 3) is bound by law to produce, [See David G. Owen, Manufacturing Defects, 53 S.C. Rev. 851 (2002)], or b) negligence per se evidenced by departure of the product from that which a reasonable person in the victim’s position has a clear right to expect. This is most often established by an expansive use of the rule of res ipsa loquitur - that the circumstances of the injury are sufficient evidence that there was negligence by someone in the chain of design, manufacture and distribution. Barker These standards are normatively coherent and need not be altered. Strict liability is an adequate term of art to describe the imposition of liability on such bases. But not without cost. The “without fault” connotation of strict liability creates unnecessary confusion - because it obscures the fact that such liability is based on demonstrated departure from plainly justifiable norms of conduct. A realistic assessment of history’s inertial force compels the recognition that the language of the law will not change in this area - because the practice of the law will not change and because the term recognizably conveys the message that liability my be imposed on an actor which is itself without fault - such as an assembler or a retailer upon whom a duty to insure is imposed via the doctrine of vicarious liability. 7
Since Rylands v. Fletcher20 imposed liability on the personally blameless builder, developer, and owner of an industrial reservoir which flooded valuable coal mine shafts below, in common law courts “strict liability in tort” has not been a judicial determination that faultless conduct nonetheless yields liability, but rather that injurious conduct placed an unjustified burden on the party suffering a loss.21 In that sense strict liability is not liability without fault, but rather imposes liability for conduct of a type determined to be unreasonable as a matter of law.22 Contemporary judicial iterations of the nuisance-derived concept of strict liability reflect the idea that certain conduct carries a normative duty of repair, as with toxic industrial pollution of wetlands,23 or the determination that producers have not justified their goods’ presence on the
159 Eng. Rep. 737 (Ex. 1865), rev'd, 1 L.R.-Ex. 265 (Ex. Ch. 1866), aff'd, 3 L.R.-E & I. App. 330 (H.L. 1868). Arthur Ripstein, Philosophy of Tort Law, in THE OXFORD HANDBOOK OF JURISPRUDENCE AND PHILOSOPHY OF LAW (2001) 685, Coleman & Shapiro,eds. [Liability should be “tied to the violation of a defensible norm of conduct.”] The literature on modern strict liability is vast, but see, for example, the cases highlighted in an excellent recent historical essay. Jed Handelsman Shugerman, Note: The Floodgates of Strict Liability: Bursting Reservoirs and the Adoption of Fletcher v. Rylands in the Gilded Age, 110 Yale L.J. 333 (2000) [“The 1880s ushered in a new wave of industrial success...In the first years of this economic expansion, state courts were apparently still cautious and avoided the Rylands controversy. However, once the recovery had lasted several years, more and more state courts adopted Rylands: Michigan, Illinois, Iowa, California, and Colorado. In addition, Nevada and Alabama adopted rules similar to Rylands, and Wisconsin recognized its validity. Whereas Massachusetts and Minnesota had focused mainly on common urban and distinctly nonindustrial hazards (like snow falling off roofs),these other courts began applying strict liability to big industry, mining, and railways. In 1886, in the midst of strong growth, Pennsylvania aggressively attacked and rejected Rylands. However, after 1890, Pennsylvania applied strict liability to numerous major industries, including coal mining, iron production, and oil refining. Beginning in 1891, Ohio adopted Rylands's rule in cases of gas explosions, bursting water tanks, and exploding nitroglycerine. Ohio also adopted Rylands in a case of flooding caused by a coal company. Stating its position in extremely clear language, the Ohio court declared that mining was unnatural and "destructive." Maryland, South Carolina, and indeed, even New York [home of Losee v. Benjamin- GWC] and New Jersey employed Rylands in imposing strict liability upon industry, mining, gas companies, and railway companies in the 1890s.”] State Department of Environmental Protection v. Ventron, 468 A.2d 150, 151 (N.J. 1983). In imposing clean-up costs for mercury residue in a tidal marsh the court explained: We believe it is time to recognize expressly that the law of liability has evolved so that a landowner is strictly liable to others for harm caused by toxic wastes that 8
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market by safety, utilitarian, or other policy measures.24 Strict liability is a species of negligence, the general law of torts. It is the latter approach which underlies the narrow standard of liability adopted by the Products Liability Restatement in § 6(c).25 That rule could be restated to say that drug and medical device manufacturers are liable for design defect only if no identifiable group is, on balance, benefitted by the product, or if another product comes on the market which is so far superior that continued distribution of the existing design has become unreasonable. An instance of such a defective product would be the continued sale of HIV or hepatitis C infected and unpasteurized, anti-hemophilic factor concentrate after pasteurization methods had been reduced to practice, and patent applications were pending for the anti-viral heat-treatment methods.26
are stored on his property and flow onto the property of others. Therefore, we overrule Marshall v. Welwood...and adopt the principle of liability originally declared in Rylands v. Fletcher. The net result is that those who use, or permit others to use, land for the conduct of abnormally dangerous activities are strictly liable for resultant damages. See, e.g. Lewis v. American Cyanamid, 715 A.2d 967, 986 (N.J. 1998), Handler, J., dissenting from a judgment permitting a jury to find reasonable an alternative safer pesticide design which achieved its greater safety by using a substance later banned as destructive of the ozone layer: In strict products liability cases, juries are enjoined to determine on the basis of a risk-utility analysis whether a product's lack of safety outweighs its usefulness.... Plaintiff's theory of liability in this case requires a comparison of the risks of two distinct product designs. A jury ought not, in this context, be called upon to engage in a risk-risk analysis to determine which risk ultimately must be counterbalanced with the products' utility. In permitting a jury to do so, the Court delegates its own nondelegable responsibility for determining as a matter of law whether a duty may appropriately be placed on a manufacturer.”
Products Liability Restatement § 6) provides: (c) A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.
See Henderson & Twerski, Drug Designs Are Different, supra, n*; and George W. Conk, The True Test... 9
Such conduct is the subject of Gullone v. Bayer Corporation, an action recently filed on behalf of foreign patients for whose use, it is alleged, Cutter Laboratories [now a unit of Bayer] exported unpasteurized inventory in the mid-1980's. For such conduct punitive and compensatory damages are understandably sought. In a recognition of the doctrinal emptiness of “strict products liability” the Gullone plaintiffs stated only counts of negligence, negligence per se, fraudulent omission and concealment, and breach of implied warranty.27 Shortly before the complaint was filed the export issue had been addressed in an investigative report in The New York Times.28
Gullone, et al. v. Bayer Corporation, et alii, Civ. Action No. 03-2572, filed 6/2/2003, United States District Court, Northern District of California. The class action is brought on behalf of “all persons residing outside the United States (and their estates, infected spouses and children) who used any non-heat treated blood factor concentrate...in the period from1978 to 1990 and who contracted HIV and/or HCV...” The defendants are the four producers of antihemophilic factor concentrate (a pooled donor blood product). Named as plaintiffs are citizens and residents of Italy, Germany, and the United Kingdom who suffered from classic hemophilia or from Von Willebrand’s disease, two blood-clotting disorders treated with defendants’ products. See also Walt Bogdanich and Eric Koli, 2 Paths of Bayer Drug in 80's: Riskier One Steered Overseas, THE NEW YORK TIMES, Section A; Page 1; Column 5, May 22, 2003. According to The Times report: A division of the pharmaceutical company Bayer sold millions of dollars of blood-clotting medicine for hemophiliacs -- medicine that carried a high risk of transmitting AIDS -- to Asia and Latin America in the mid-1980's while selling a new, safer product in the West, according to documents obtained by The New York Times. The Bayer unit, Cutter Biological, introduced its safer medicine in late February 1984 as evidence mounted that the earlier version was infecting hemophiliacs with H.I.V. Yet for over a year, the company continued to sell the old medicine overseas, prompting a United States regulator to accuse Cutter of breaking its promise to stop selling the product. By continuing to sell the old version of the life-saving medicine, the records show, Cutter officials were trying to avoid being stuck with large stores of a product that was proving increasingly unmarketable in the United States and Europe. Yet even after it began selling the new product, the company kept making the old medicine for several months more. A telex from Cutter to a distributor suggests one reason behind that decision, too: the company had several fixed-price contracts and believed that the old product would be cheaper to produce. 10
As we shall see, both the common law New Jersey case Elkerson v. North Jersey Blood Center, and the U.K. EU product liability directive-based case A and others v. National Blood Authority, show that the traditional doctrinal approach adopted in Gullone, which does not rely on the tangled language of `strict liability in tort’ for products is entirely adequate to the question of liability for sale of avoidably dangerous drug products. By extension, the adequacy of modern negligence doctrine to the problems of infected blood - which legislatures and courts have long sought to exclude from the law of implied warranty and strict products liability shows that a consistent liability standard for all producers is warranted. And that adequacy vindicates the negligence-based standard of care - reasonableness of conduct under all the circumstances.
The Decline and Fall of Strict Liability in Tort for Products Courts developed, for design defect and inadequate warning claims, measures of product defect that were grounded in familiar negligence principles.29 The language of strict liability, still widely embraced, has outlived its practical applications. The strict liability rule has withered at its birthplace - the ALI. The Products Liability Restatement30 in 1998 embraced a negligence based view of product defect. It cabined the strict liability language of the 2d Restatement to manufacturing defects - products which depart from specification to pose dangers not present in the standard product. But the sense that there is something different, even unreasonable about product liability law survived in the 3rd Restatement’s stringent approach to prescription drugs and other medical product defect claims,31 and in its exclusion of blood products from the scope
Wade - * Mississippi L.J. *, Barker, Cepeda, David G. Owen, The Fault Pit, 26 Ga. L. Rev. 703 (1992) [“From the vantage point of the law's maturity, gained by its awkward, fitful, and ultimately unsuccessful effort to make sense out of a broad doctrine of strict products liability, fault's true position at the center of tort law is becoming clearer by the day. ”] AMERICAN LAW INSTITUTE, RESTATEMENT OF THE LAW (THIRD), TORTS: PRODUCTS LIABILITY (1998), hereafter variously referred to as the Products Liability Restatement and the new Restatement. See Products Liability Restatement § 6(c), which would allow only claims for inadequate warnings and manufacturing defects for drugs or medical devices. The Reporters assert that challenges to drug design should not be allowed because they are unmanageable pieces of litigation because proof would require replication of the FDA approval process. See James A. Henderson, Jr. and Aaron D. Twerski, Drug Designs Are Different, 111 Yale L.J. 151 (2001). See also James A. Henderson, Jr., MacPherson v. Buick Motor Co.: Simplifying the Facts While Reshaping the Law, in Rabin, et al, supra, n*. [Arguing that the privity bar to consumer and bystander claims against product manufacturers served usefully as a screen against “factually unmanageable claims”.] 11
of the new Restatement.32 But if modern product liability law is fundamentally sound, as practiced, if not always as understood or expressed, the argument for exclusion of blood product claims, and for a special, more manufacturer-deferential liability test for prescription pharmaceuticals and medical devices is vitiated. A bit more history is in order. In 1988, in Brown v. Superior Court (Abbott Laboratories), the California Supreme Court, the font of modern `strict products liability law', held that the concept is not appropriate for drugs. Justice Mosk wrote that its application to drugs would retard the development and availability of vitally important products.33 A decade after Brown, in the Products Liability Restatement the American Law Institute (ALI) rejected the ordinary test of product design defect for prescription drugs and medical devices. For such medical products the Reporters declared that liability would only “rarely” be imposed. A product is defective under § 6(c) only if it provides no net benefit for any foreseeable class of patients. The ALI rule was challenged after promulgation. The exclusion of medical devices from ordinary liability standards,34 the application of the stringent rule even to cosmetic medical products, and to certain blood products and to vaccines was challenged.35 In an essay titled `Is There a Design Defect in the Restatement (Third) of Torts: Products Liability?’ I argued that the correct answer is `yes’ and proposed applying to prescription products the § 2(b) alternative safer design rule - an expression of negligence law’s reasonable care standard.36 The first state to confront the issue, rejected the new Restatement’s rule. In Freeman v. Hoffman LaRoche, an Accutane case, the Nebraska Supreme Court embraced the critiques
Definitions, § 19 (c): “ Human blood and human tissue, even when provided commercially, are not subject to the rules of this Restatement.” 751 P. 2d 470 (Cal. 1988). [The court, citing a manufacturing defect Escola v. Coca Cola, "latent" design defect Greenman v. Yuba Power Products, and a machine guarding design defect Barker v. Lull Engineering (design defect risk/utility factors) case held strict liability to be inappropriate but reserved the possibility of a "negligence" based design defect claim. Michael D. Green, Prescription Drugs, Alternative Designs, and the Restatement (Third): Preliminary Reflections, 30 Seton Hall L. Rev. 207 (1999). Richard L. Cupp, Jr., The Continuing Search for Proper Perspective: Whose Reasonableness Should be at Issue in a Prescription Product Design Defect Analysis?, 30 Seton Hall L. Rev. 233 (1999).
36 35 34 33
109 Yale L.J. 1087 (2000). 12
offered by me and other academic writers.37 Overturning McDaniel v. McNeil Laboratories, Inc.,38 its own 25 year old precedent, which presaged Brown, Nebraska reversed the trial judge’s grant of summary judgment to the manufacturer. The court allied itself with the 1984 Feldman v. Lederle Laboratories line of cases which treated the unavoidability of danger in drugs as a factual defense to be proven on a case by case basis - not a categorical rule of exclusion of drugs from ordinary liability rules. And in Bryant v. Hoffman La Roche39 a Georgia intermediate court rejected the Products Liability Restatement’s § 6(c). The ALI Reporters, in rebuttal, retreated and embraced a modified alternative safer design test for prescription drugs and medical devices. The Reporters would limit product safety challenges to comparison with FDA-approved products actually available on the market at the time of sale of the accused product. In any other instance, they said, courts are incompetent to judge drug product design defect claims because plaintiffs would have to replicate the complex FDA approval process in order for the jury to pass upon a plaintiff’s alternative safer design. Even the modified standard poses a much greater burden than the Restatement sets for all other classes of products. For non-prescription products of all kinds no alternative need be shown to be on the market. Not even a prototype needs to be produced.40 Countering the former ALI reporters Professors Henderson and Twerski who see courts as incompetent to judge drug and medical device designs, `The True Test’41 offered three case studies of drugs for which liability could be found under the alternative safer design test of section 2(b), but which would be excused under the manufacturer-protective test of section 6(c) (1) unpasteurized Anti-Hemophilic factor concentrate (a freeze dried blood protein extracted from huge pools of blood donors) which in the 1970's and early 19080's had been the source of an epidemic infecting with Hepatitis and HIV practically the entire hemophiliac populations of the US, Western Europe, and Japan; (2) the anti-acne drug Accutane (a vitamin A acid protected by a method patent issued for the enteral treatment of skin cancer for which a safer design was
618 N.W. 2d 827 (Neb. 2000) [Analyzing the problem in conventional `consumer expectations’, Restatement 2d terms - relying on § 402A and comment k - unavoidably unsafe products, and reserving on whether to adopt § 2(b) reasonable alternative design test for all products, including drugs.]
241 N.W.2d 822 (1976).
2003 Ga. App. LEXIS 945 (Ga. App. 2003). See also Bennett v. Eli Lilly, 821 So. 2d 794 (Miss. 2002) [relying on Freeman, supra, N*, and embracing the case by case approach. July 16, 2003
Products Liability Restatement, § 2, cmt f; 49 UCLA L. Rev. (2002). 13
offered by Roche as its patent-monopoly neared expiration; and (3) the Sabin live-virus oral polio vaccine, which was the only source of paralytic polio in the United States for 20 years until its removal from the market in 2000 and its replacement by the enhanced Salk injected killed polio virus vaccine which had been relied upon exclusively in Europe since the early 1980's and which carried no risk of causing the disease it sought to prevent.42 I had argued earlier that unpasteurized Anti-hemophilic factor concentrate was defectively designed. And if § 6(c) had been the law the manufacturers would have obtained summary judgment in every product liability case brought by a Hepatitis or HIV infected patient - because on balance the product prolonged the lives of severe hemophiliacs - even at the risk of infection with chronic, even ultimately fatal disease. The full panoply of product liability causes of action should be available to patients injured by such products, I urged.43 And there was sharp criticism for the 47 state blood-shield laws which had protected blood fractionators from the reach of modern product liability laws. Many states characterized transfusion of blood solely as a medical service not involving a product sale. The approach had originated in the New York Court of Appeals decision in Perlmutter v. Beth David Hospital.44 All states barred strict liability and warranty claims for blood products.45 Negligence causes of
George W. Conk, The True Test: Alternative Safer Designs for Drugs and Medical Devices in a Patent-Constrained Market, 49 UCLA L. Rev. 737 (2002).
109 Yale L.J. at 1133. 123 N.E.2d 792 (N.Y. 1954).
Institute of Medicine, HIV AND THE BLOOD SUPPLY: AN ANALYSIS OF CRISIS DECISIONMAKING 223 (1995) [hereinafter IOM Report].; The Louisiana statute is typical. In David v. Our Lady of the Lake Hospital, 2003 La. LEXIS 1956 (Louisiana 2003) the court observed: In 1968, the legislature enacted Louisiana's first blood shield statute. Former LSA-C.C. art. 1764 (now repealed) was amended by Act 301 of 1968, adding section B, as follows: Notwithstanding the provisions of Section A.2. of this Article, the implied warranties of merchantability and fitness shall not be applicable to a contract for the sale of human blood, blood plasma or other human tissue or organs from a blood bank or reservoir of such other tissues or organs. Such blood, blood plasma or tissue or organs shall not for the purposes of this Article be considered commodities subject to sale or barter but shall be considered as medical services. 14
action were generally preserved in some form. But since products liability actions were considered to be strict liability actions plaintiffs infected by blood products did not have the benefit of the expansive spirit of liability which accompanied state courts’ embrace of § 402A. The net effect was that it was practically impossible for plaintiffs to prevail in infected blood claims, although in New Jersey, a state without a blood shield statute, claims were allowed to go forward under the state’s product liability act, making possible settlements of more than token values.46 The only viable remedy has been in negligence for transfusion related injury. Both courts and legislatures have chosen to leave the consequences of blood-related accidental illness where it falls - unless a fault basis for liability appears. The Institute of Medicine of the National Academy of Sciences urged consideration of a no-fault compensation system for blood product injuries - such as exists for injuries caused by mandatory childhood vaccines.47 But the suggestion proved to have no traction. The childhood vaccine program was justified by the mandatory character of childhood vaccinations and the need to maintain a high degree of public compliance, together with the need to maintain financial viability for a relatively low cost/low margin product of private producers. Blood shield laws effectively protected the producers of blood products from liability and the cases which were pressed were plainly grounded in fault-based allegations such as failure to develop or implement pasteurization techniques which would effectively preclude transmission of viruses.48 In the case
***** By Act 611 of 1981, a new civil code article designated as Article 2322.1, and by Act 331 of 1981, a new section designated as LSA-R.S. 9:2797 were enacted, providing that strict liability "shall not be applicable to physicians, hospitals ... or nonprofit community blood banks ... in the ... transfusion ... of human blood ... which results in transmission of viral diseases ... undetectable by appropriate medical and scientific laboratory tests." D.J. L. v. Armour Pharm. Co., 704 A.2d 104, 117 (N.J. Super. Ct. Law Div. 1997). [holding proprietary blood products manufacturers accountable is "consistent with one of the overriding purposes of product liability law - to spread the burden of damages which flow from such injuries onto those responsible for the products' design and manufacture."] National Childhood Vaccine Injury Compensation Act established the national Vaccine Injury Compensation Program. 42 U.S.C. § 300aa-10, et seq.
48 47 46
IOM REPORT; BLOOD 15
of blood products which could not be pasteurized,49 cleansed with a detergent, or manufactured from pure recombinant material,50 infected plaintiffs alleged negligent failure to properly screen donors.51 HIV and Hepatitis C infection of hemophiliacs’ Factor VIII concentrate blood products was a manufacturing defect, the reporters responded. The hemophiliacs’ strict liability claims against unpasteurized blood concentrate makers had been properly barred. Their claims were not for design defects (for which negligence type standards prevail)52 but for manufacturing flaws (for which strict liability is said to be imposed): the contaminants that caused their harm constituted manufacturing defects for which manufacturers are generally held strictly liable under section 2(a) of the new Restatement. The reporters observed that although blood shield statutes had blocked strict liability claims by the infected patients they retained traditional negligent manufacturing claims under the Restatement (2d) of Torts, § 395,53 which “force(d) plaintiffs into the unusual position of being required to prove that the providers were negligent in allowing the harmful contaminants to pass through their screening and production processes.” Because customary industry methods could not identify Hep C or HIV-infected donors until the early 1980's, and the industry argued it had developed a pasteurized product as soon as it could do so, hemophiliac plaintiffs had not fared
Heat treatment has been effective for anti-hemophilic factor concentrate, a pooled protein extracted from blood, but not for other blood products. IOM REPORT AT *. Scripps Clinic & Research Foundation v. Genentech, Inc., 927 F.2d 1565 (Fed. Cir. 1991). [patent dispute over recombinant product which was effective and disease free substitute product for anti-hemophilic factor concentrate] Snyder v. American Association of Blood Banks, 676 A.2d 1036 (N.J. 1996) [jury verdict affirmed against standard-setting private, tax-exempt organization with substantial power over the operation of blood banks. The NGO was charged by hepatitis-infected plaintiff with unreasonable failure to implement donor blood testing requirements.]; cf. N.N.V. v. American Association of Blood Banks, 89 Cal. Rptr. 2d 885 (Ct. App. Cal. 1999) [“Snyder majority's "foreseeability" analysis is flawed because it is a hindsight analysis; it focuses on the "devastating" consequences resulting from contaminated blood rather than looking to the circumstances, including the state of knowledge and recommendations of other relevant organizations, as they existed at the time the AABB adopted its standards.”] William L. Prosser, THE LAW OF TORTS 659 n.72 (4th ed. 1971)[“Since proper design is a matter of reasonable fitness, the strict liability adds little or nothing to negligence [on the part of the manufacturer]..."].
53 52 51 50
Text of § 395 16
well in the cases that went to trial.54 The subsequent token settlements seemed fair in the face of such weakness on the merits, in the reporters’ eyes. And the Products Liability Restatement’s exclusion of blood and tissue from the rules of the Restatement was an accurate reflection of the state of the law.55 The § 395 doctrine of negligent manufacturing placed the hemophiliacs in the posture that plaintiffs had generally occupied before the Second Restatement’s § 402A. They had to prove negligence someplace in the manufacturing process - without the benefit of the doctrines of implied warranty/strict liability standard for manufacturing defects, the expert standard of care, the robust applications of res ipsa loquitur, and other plaintiff-friendly doctrines of modern product liability law. The reporters inadvertently confirmed the critique of the Restatement. If courts had shown themselves competent to judge heavily regulated blood products56 by negligence standards, then courts could also judge the designs of prescription drugs and devices. The Products Liability Restatement’s anomalous manufacturer-protective § 6 (c) rule of exclusion was therefore unwarranted. The reporters’ approach contradicts the Products Liability Restatement itself. Professors Owen and Stuart Madden observed: Under the Restatement Third, Torts: Products Liability, the [Restatement 2d’s] concept of defective condition unreasonably dangerous has been replaced by the definition of a manufacturing See In re Factor VIII or IX Concentrate Blood Prods. Litig., 169 F.R.D. 632, 633-34 (N.D. Ill. 1996), and the much cited opinion of Judge Posner in In re Rhone-Poulenc Rorer, Inc., 51 F.3d 1293, 1304 (7th Cir. 1995). James A. Henderson, Jr. and Aaron D. Twerski, Drug Designs Are Different, 111 Yale L.J. 151 (2001). State and federal regulations apply to both proprietary and charitable sectors of the blood-banking industry. The Food and Drug Administration (FDA) inspects and licenses blood banks and other blood facilities. See 21 U.S.C.A. § 321(g)(1)(B) (broadly defining "drugs" to include "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease," which includes blood and blood products); 21 U.S.C.A. § 360(b) (requiring processing establishments, including blood banks, to register with the FDA); 42 U.S.C.A. § 262(c) to (d) (requiring inspection and licensing by the FDA of blood or blood-product facilities that participate in interstate commerce); 21 C.F.R. 5.10(a)(1) and (5) (1995) (delegating to FDA authority vested in the secretary, DHHS, and PHS in the Food, Drug and Cosmetic Act (21 U.S.C.A. § § 301-95) and in 42 U.S.C.A. § § 262 and 263); 21 C.F.R. 607.3(b) (1995) (defining blood as a drug). States also discharge similar responsibilities. See, e.g. N.J.S. 26:2A-1 (authorizing state Department of Health to regulate the collection, processing and distribution of blood). A blood bank in New Jersey must have both state and federal licenses. 42 U.S.C.A § § 262(a); N.J.S. 26:2A-4. 17
56 55 54
defect as one which "departs from its intended design even though all possible care was exercised in the preparation and marketing of the product."57 But such comfortable reliance on the departure-from-specifications test of manufacturing defect (of which Professor Henderson was the original proponent)58 was disturbed by the AngloAustralian scholar Jane Stapleton’s critique. In her view infected-product cases highlight the absence of any fundamental rationale for the prevailing tri-fold classification of product defects embraced by the Products Liability Restatement (defects in manufacturing, design, and warning).59 Professor Stapleton suggests that it is unlikely for there to be any agreement on where and why lines should be drawn before a full debate on the issue has occurred. To illustrate, she observed: A recent high-profile academic debate has unwittingly confirmed these points. In 2000, George Conk launched a scathing attack on how the Restatement Third had, under § 6, given especially protective treatment to prescription drugs and medical devices. As an exemplar of the problems he argued would be created by §6, Conk referred to the alleged "design defect" in blood infected with Hep C. In their response article, the Reporters attempted to rebut this classification by merely asserting that "the plaintiffs in the blood cases did not claim that the blood products that harmed them were defectively designed... . Instead, the contaminants that caused their harm constituted manufacturing defects... ." Conk's otherwise powerful reply seems just as ad hoc on the classification point.60 Appreciative of the description of my work as “powerful”, and surprised by the
David G. Owen and Stuart Madden, Madden & Owen on Products Liability (3d ed.
2000). See James A. Henderson, Jr., Judicial Review of Manufacturers' Conscious Design Choices: The Limits of Adjudication, 73 Colum. L. Rev. 1531, 1543 (1973) [His seminal article’s description of manufacturing defects is more ambiguous than is the Products Liability Restatement standard: “imperfections that inevitably occur in a typically small percentage of products of a given design as a result of the fallibility of the manufacturing process. A defectively manufactured product does not conform in some significant aspect to the intended design, nor does it conform to the great majority of products manufactured in accordance with that design.”]; David G. Owen, Manufacturing Defects, 53 S. Carolina L. Rev. 851 (2002)
Products Liability Restatement, supra, n*, § 2.
Jane Stapleton, Bugs in Anglo-American Products Liability, 53 S. Carolina L. Rev. 1225 (2002). (footnotes omitted) 18
characterization of my critique as “scathing” (I thought it rhetorically restrained), the suggestion was less welcome that I had helped to “unwittingly confirm” the inadequacy of the conventional American trifurcation of categories of product defect. But the classification point is important. The tri-partite classifications are coherent, if incomplete. Stapleton’s challenge suggests that the classification choices are not based on principle and that the consequences of the classification may therefore be incoherent. But the categories have value. The reporters’ characterization of viruses’ presence in blood as a manufacturing defect is mistaken. The mistake perpetuates the impression that there is something wrong with product liability law. The distinction between design and manufacturing defects is important normatively. To misstate them as the reporters did only confirms the doubts about its legitimacy which haunts modern products liability law. The reporters suggested that but for the blood shield laws hemophiliac plaintiffs would have recovered for manufacturing defects. But it would have been an injustice to impose strict liability for manufacturing defects on the manufacturers of anti-hemophilic factor concentrate. Liability for manufacturing defects would not have been warranted until after the great majority of recipients of anti-hemophilic factor and other blood products had been infected with Hepatitis C and/or HIV. Not until January 1983 did an effective donor blood screening test for Hep C become available,61 and shortly after that effective anti-viral pasteurization techniques began to be implemented.62 From the point that such new methods were adopted by manufacturers, imposed by government, or by other standard setters manufacturing defect became appropriate for “rogue” products - those which departed from design specifications or requirements. But before that point plaintiffs properly bore the burden of challenging the reasonableness of manufacturing methods and of industry practice. The product defects were matters of proof in negligence, not the subject of strict liability for manufacturing defects. Until such standards were set or declared beginning in 1983 the bases for manufacturing defect `strict liability’ against the fractionators did not exist. The manufacturers of Factor VIII concentrate did not depart from any specification imposed by the government. Nor did they
INSTITUTE OF MEDICINE, HIV AND THE BLOOD SUPPLY: AN ANALYSIS OF CRISIS DECISIONMAKING 6 (1995) (the IOM Report). [Committee concluded "that it was reasonable to require blood banks to implement these two screening procedures (screening male donors for a history of sexual activity with other males and screening donated blood for the anti-HBc antibody) in January 1983."] This is the period of time which is the subject of Elkerson v. North Jersey Blood Center In June 1982 Baxter Healthcare applied for FDA licensing of heat treated antihemophilic factor concentrate. Approval came in March 1983. Miles (Cutter) applied in August 1983 and received approval in January 1984. Alpha Therapeutics' application was filed in December 1982. Approval came in February 1984. Armour Pharmaceutical applied in December 1982, and was approved in January 1984. See IOM Report, supra note 140, at 92. 19
depart from any specification that they had declared for themselves. Nor did they breach any industry standard. In fact the relevant industry standards later came under attack as inadequate and tort liability was imposed on the standard setters.63 Nor did the fractionators represent that their product was free of viral contamination. In fact, the presence of hepatitis C among hemophiliacs receiving blood products was so wellknown that they were often paid as donors because their anti-bodies to hepatitis were commercially valuable in immune globulin production.64 Viral contamination of factor concentrate was not a flaw, a departure from design expectations, or even from reasonable consumer expectations. Rather hepatitis was considered an acceptable risk, one left by the manufacturers to their customers' physicians to manage medically.65 "(H)epatitis was viewed as an acceptable risk by the government regulatory agencies responsible for the safety of blood and blood products, the plasma fractionation industry, the physicians who treated the individuals with hemophilia, and the individuals with hemophilia," wrote the IOM.66 Thus none of the bases existed for the imposition of “strict” liability for a manufacturing defect. Even without the benefit of blood shield laws the industry defendants could justly have argued that plaintiffs infected before 1983 could not show any breach of implied warranty - the obligation in law to deliver a product which meets the standards of safety that the manufacturer/seller has either declared for itself, represented to others, or is bound by law to meet. Nor could negligence per se be found by any departure of the product from that which a reasonable person in the victim’s position had a clear right to expect. The presence of infectious Snyder v. American Association of Blood Banks, 676 A.2d 1036, 1055 (N.J. 1996). [rejecting qualified immunity for quasi-governmental NGO which set standards for blood banks: On the record, the jury could have concluded that the AABB in 1984 unreasonably resisted recognizing that blood transmits HIV. That resistance led the AABB to sacrifice an uncontaminated supply of blood for one that was contaminated, but more readily available. The jury could have found that if the AABB had not been so intransigent, its members, particularly the BCBC, would have instituted surrogate testing. Further, the jury could have found that if the BCBC had instituted surrogate testing, it would have rejected Unit 29F0784. Rejecting that unit could have prevented the transfusion of contaminated blood to William Snyder. It could have saved his health and his life. Against this background, we believe that the imposition of liability on the AABB is both fair and reasonable.
Blood saga? Blood? IOM report? IOM report, supra, N*at 93. IOM report, N*, at 82 20
agents in blood was widely accepted, no effective means of preventing it were yet known,67 and the product was certainly useful for severe hemophiliacs, despite its dreadful risks. Infection due to unpasteurized AHF was neither an unintended departure from manufacturer's specifications, nor a disappointed consumer expectation defect, like botulism in improperly canned food. Summary judgment for the defense would be warranted on manufacturing defect claims. But were the reporters’ view adopted, and pre-1983 blood products found to contain manufacturing defects Professor Leon Green’s early criticism of strict product liability law as “severe” would be vindicated. In § 6 (b)(1) the Products Restatement recognizes manufacturing defects as a basis for liability for prescription products. The classification selection thus has normative consequences. The fairness of product liability law would rightly be in doubt if the reporters’ classification of infected blood as a manufacturing defect were in fact the law. If liability were to be imposed in such circumstances, the blood shield laws would have to embraced as an appropriate defense to such harsh and severe tort liability. Alarmist accounts aside, there is no basis in tort law for putting product suppliers in the position of guarantors of the safety of a useful product which reasonable effort cannot make safe, or of imposing liability in the absence of a safer competing product. If the reporters’ classification were embraced the blood shield laws would be needed to protect manufacturers of blood products from products liability law. And drug and medical device manufacturers would justly seek the protection which the new restatement has afforded them. But as we shall see such protection is not needed. Despite the reporters’ classification error regarding infected blood, and despite the language of the Second Restatement about liability despite “all possible care” having been taken, there is no evidence in a reported case of liability having been imposed where the harm could not have been prevented by reasonable effort, including by withholding distribution of a product the dangers of which exceed its benefits.68 To return to the beginning, even in Rylands v. Fletcher the strict liability ruling was apparently engendered by the lack of a remedy against the negligent engineer who constructed the reservoir.69 And at the current moment no one suggests that cigarets contain manufacturing defects. That debate has focused on addictiveness and the tension between the industry’s knowledge, its promotional efforts, and smokers’ knowledge of the product’s dangers,70 both problems handled adequately by contemporary apportionment As a matter of historical fact, it is the tardiness of the manufacturers’ development of heat-treatment methods which killed all viruses that underlies the product design defect and §395 manufacturing negligence claims against the blood fractionators. Negatives are notoriously hard to prove. So this must be recorded as a kind of dare. I have never read (or read of) a case which contradicts my assertion.
69 68 67
Gary T. Schwartz on Rylands in Cane & Stapleton? Gary T. Schwartz, Tobacco, Liability and Viscusi, 29 Cumb. L. Rev. 555 (1999) 21
doctrines.71 But we will see in Section * that such an imposition of strict liability was adopted by Judge Burton on the case in chief in A and others v. National Blood Authority. Fortunately the day was saved for the plaintiffs by his better founded approach on the “avoidability’ case which provided a negligence basis for liability in the NBA’s tardy adoption of an effective screening test for Hepatitis C anti-bodies in donors’ blood. The overall product design in anti-hemophilic factor was what Professor Henderson has called the result of “conscious design choice”.72 The fractionators accepted the transmission of viruses virtually certain to infect a product extracted from thousands of donors' pooled blood.73 Any defect therefore was one of design - because, in the 3rd Restatement's words, the issue could not be resolved “by reference to the manufacturer's own design or marketing standards because those standards are the very ones that plaintiffs attack as unreasonable.”74 The decision not to pasteurize, like decisions on whether to include safety devices on machines or to flameproof fabrics, was a defect of design, a failure of imagination or a conscious decision to impose the risk of infection on the patients rather than bear additional manufacturing costs.
Product Stewardship and the Duty of Inventiveness - Design Liability in Modern Negligence Law
Restatement of Apportionment, discussion in Tentative Draft of 3rd Restatement, Basic Principles criticizing Dafler v. Raymark Industries.
Henderson supra, N* on conscious design defect
Dominating the commercial sector are manufacturers or fractionators of plasma derivatives. In the early 1980s, fractionators collected approximately eighty percent of plasma from paid donors. The voluntary sector provided the remaining twenty percent. Fractionators pool plasma from thousands of donors and process it to produce large batches of plasma derivatives, such as clotting factors for hemophiliacs. Each batch contains enough clotting factor to treat thousands of patients. Institute of Medicine, HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 15 (1995) (the IOM Report). Snyder, supra, n* at 1039.
Restatement (Third) of Torts: Products Liability, § 2, comment a. 22
Stapleton argued in her essay, Bugs in Anglo American Products Liability Law,75 that there is no coherent justification for the differential treatment of manufacturing defects under strict liability principles, while a reasonableness standard prevails for design defect and warning cases. Her argument commands attention if under our law the consequences are great for differences that are slight. If one need only prove that causal relationship between product and illness - as the reporters’ conception of manufacturing defect implies - the differences are great. But if strict liability is confined to manufacturing defects (where negligence law has defined a set of circumstances leading to liability as a matter of law) and a more rigorous burden of proof of fault is preserved for other claims, the coherence of the tri-partite classification retains some vitality, if not complete adequacy. Professor Stapleton had consulted for the defense in the 2001 High Court of England trial of A. and others v. National Blood Authority and another.76 There the Judge, Sir Michael John Burton, held for the plaintiffs. Relying on the strict liability rationale of the 1985 EC products liability directive,77 he declared that the public legitimately expected blood to be safe and he excluded as an irrelevant circumstance, on the case in chief, the substantial defense that the Hepatitis C virus could not be identified at the time of the transfusions to many of the claimants. Stapleton observes that the seminal event spurring product liability law’s arrival in Europe was the unexpected wave of birth defects attributable to the drug thalidomide when taken by pregnant women.78 The issues that drove American product liability law were more diverse. We focused on consumer devices - power tools, cars, etc.79 and on workplace safety issues -
53 U. South Carolina L. Rev. 1225 (2002).  3 All ER 289.
The Council of the European Communities, Council Directive of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (85/374/EEC).
Stapleton, supra, n*.
Greenman v. Yuba Power Products [alleged design defect in lathe function of combination home power tool that could be used as a saw, drill, and wood lathe] ; Henningsen v. Bloomfield Motors [steering malfunction in automobile]; Barker v. Lull Engineering [design defect alleged in high-lift loader which lacked stabilizing outriggers used in cranes and other such devices]. 23
unguarded machines,80 and exposure to dangerous workplace materials like asbestos.81 These struggles gave rise to recognition of a non-delegable duty to make reasonable efforts to learn of the health effects of one’s products - a duty which necessarily required producers to study their product’s users (and often its producers) to learn what health effects ensued from making or using the product.82 It was held emphatically to be insufficient for a producer to wait for the public health authorities or for academic or other disinterested researchers to assess the impact and determine the damage. As Judge John Minor Wisdom wrote in Borel: The manufacturer's status as expert means that at a minimum he must keep abreast of scientific knowledge, discoveries, and Bexiga v. Havir Mfg. Corp., 290 A.2d 281 (1972) [manufacturer may be liable for failing to include safety devices on machinery despite its expectation that the employer who purchased the machinery would install the devices.] Borel v. Fibreboard, 493 F.2d 1076 (5th Cir. 1973) [asbestos-containing product manufacturers have the duty to study the health effects of their products] Beshada v. Johns Manville, 90 N.J. 191 (1982) [Asbestosis has been known since at least the mid 1930's as an occupational disease among textile mill workers but defendants asserted that the danger of which they failed to warn until the 1960's was “undiscovered at the time the product was marketed and that it was undiscoverable given the state of scientific knowledge at that time.” The Court held, reaching the historic highwater mark on the constructive knowledge issue, that defendants, even if they were unavoidably ignorant, were liable for all damage done by their product, even that which was unforeseeable. The court cited Dean Keeton: Strict liability focuses on the product, not the fault of the manufacturer. "If the conduct is unreasonably dangerous, then there should be strict liability without reference to what excuse defendant might give for being unaware of the danger." [W. Page] Keeton, Products Liability -- Inadequacy of Information, 48 Tex.L.Rev. 398, 407-08 (1970). The imputation of knowledge does not represent any presumption that defendants knew or even that they could have known of the product's dangers. Although the ruling was unsustainable as a rule of law, the sheer chutzpah of the asbestos industry’s lawyers claiming in unison that their clients could not have known what they clearly should have been straining to learn (but were not) may have provoked a judicial overreaction. The case could have been resolved rather in Judge Wisdom’s fashion in Borel - by finding as a matter of fact that no one in the industry had made a showing that it had made health research efforts commensurate with the appreciable danger, that their claims of unavoidable ignorance as a defense were equitably estopped, and that therefore the industry would be held liable for all disease caused by their negligently sold products. That is the net effect of the New Jersey Supreme Court’s limiting its Beshada ruling to asbestos while declining to extend the principle to ethical drug manufacturers in Feldman v. Lederle Lab., 479 A.2d 374 (N.J. 1984).] 24
82 81 80
advances and is presumed to know what is imparted thereby. But even more importantly, a manufacturer has a duty to test and inspect his product. The extent of research and experiment must be commensurate with the dangers involved. A product must not be made available to the public without disclosure of those dangers that the application of reasonable foresight would reveal. Nor may a manufacturer rely unquestioningly on others to sound the hue and cry concerning a danger in its product. Rather, each manufacturer must bear the burden of showing that its own conduct was proportionate to the scope of its duty.83 Such expressions of what the duty of reasonable care demands of asbestos product makers provide a template for what should be demanded of blood product, drug, and medical device manufacturers. No special rule is required to assess the reasonableness of their conduct despite the claims made for the special benefits such products sometimes bring.84 Stapleton denounces “the artificiality of any product/service distinction in our law of obligations and the incoherence of the idea that products liability can sensibly look at the product and not the human behaviour surrounding its production and handling.” A partisan of negligence -based jurisprudence, Stapleton argues that (The) vitality of negligence, a vitality rooted in its focus on human behaviour and the platform it provides in each case for the examination of the complex moral and economic dilemmas that can characterize product cases, prompts one to ask why we have a separate regime for product injuries at all.
494 F. 2d at 1089-1090. Brown, supra, n*, 751 P. 2d at 478-479: But there is an important distinction between prescription drugs and other products such as construction machinery, a lawnmower, or perfume, the producers of which were held strictly liable. In the latter cases, the product is used to make work easier or to provide pleasure, while in the former it may be necessary to alleviate pain and suffering or to sustain life. Moreover, unlike other important medical products (wheelchairs, for example), harm to some users from prescription drugs is unavoidable. Because of these distinctions, the broader public interest in the availability of drugs at an affordable price must be considered in deciding the appropriate standard of liability for injuries resulting from their use. 25
The challenge is a serious one. It has long struck me that the idea of the “actionable product” was an incoherent one. Put forward by Prosser’s successor as ALI Reporter, Vanderbilt Dean John Wade, the formulation had quickly become boilerplate. Like Justice Mosk in Brown,85 courts routinely explained that strict products liability law was product centered and that negligence was conduct centered. But how did a product become “unreasonably dangerous” without someone having acted unreasonably? In strict liability, wrote Wade, failure to take “reasonable action” to discover or eliminate the danger was not needed: “all that the plaintiff must do is show that the product was in the dangerous condition when it left the defendant’s control”.86 But Browder v. Pettigrew,87 a routine product liability case involving a malfunction in a new car, the exemplar case cited by Wade, reveals that the negligence/strict liability distinction was (and is) a thin reed. Wade cites the court's assertion that “while proof of a malfunction alone should be sufficient under the strict liability and warranty theories in a products liability case, a higher standard of specificity of proof of defect is required in order to recover under the negligence theory.”88 The Tennessee court noted that the primary focus in a negligence action is on defendant's conduct and the duty of due care. It concluded that in a negligence case "[it] is vital to trace the injury to some specific error in construction or design of the machinery to determine whether" the defect could have been avoided by exercise of reasonable care.”89 But when the A-frame supporting the front wheel of a brand new passenger car collapses without any collision, it is difficult to see how one could rationally escape the conclusion that someone in the manufacturing process was negligent in designing or manufacturing the part. It seems to me that if the jury finds the facts to be as plaintiff asserts, it is grasping at the ether to divine a difference
751 P. 2d at 473-474: Strict liability differs from negligence in that it eliminates the necessity for the injured party to prove that the manufacturer of the product which caused injury was negligent. It focuses not on the conduct of the manufacturer but on the product itself, and holds the manufacturer liable if the product was defective.
John Wade, On Product “Design Defects” and Their Actionability, 33 VANDERBILT L. REV. 551, 553, 567, 577 (1980). [It is the product, not the conduct of the manufacturer which is “actionable” in strict liability in tort; and calling for combining “negligence, breach of warranty, and strict liability into a single cause of action for products liability.”]
541 S.W. 2d 402 (TN 1976). Wade, supra, Vanderbilt, n*. (emphasis added) id. at 982. (emphasis added) 26
between directing a plaintiff’s verdict based on circumstantial evidence rules, and imposing strict liability on the manufacturer.90 Laboring to sustain this sort of distinction between strict liability and negligence has never yielded a coherent formulation of the supposed difference between the “higher standard of specificity” required for negligence, and the lower standard of specificity required of plaintiffs in “strict products liability cases”. What made asbestos defective is that there was inadequate effort by industry to learn of its health effects, no adequate warning even of its undisputed dangers, and that it was not a necessary ingredient in insulation products because man-made mineral fibers could do the job.91 Negligence law was adequate to the challenge of asbestos. The volume of claims, the scale of damage, establishment of causal relationship, linking particular product to particular illness and particular person, the question of how much fore-knowledge was required to fairly impose liability, and how to assess the liability of multiple manufacturers and suppliers of a toxin whose effect is often but not always cumulative,92 were challenging to the courts as matters of management. But negligence law’s legal doctrines regarding fault required little development - especially with the rise of modern conceptions of comparative fault and allocation of responsibility.93 The rhetoric of strict liability used in asbestos cases was a historical anomaly and a coincidence, not a necessary response to a social problem for which existing legal doctrinal tools were inadequate. The central concept of negligence is that "one is liable for the foreseeable consequences
The imposition of vicarious liability on the retailer is a form of strict liability, as is the employer’s vicarious liability for employees’ job-related negligence - but those are not the forms of strict liability at issue here. Retailers’ liability, recognized in the PRODUCTS LIABILITY RESTATEMENT § ,1 is not without controversy. New Jersey, by statute, relieves a passive retailer of liability if it identifies a solvent manufacturer, N.J.S. 2A:58C-1, et seq.; See also Robert Sachs, BAYLOR LAW REVIEW, forthcoming [arguing that knowledge alone should not be enough to impose liability on a seller). See Borel v. Fibreboard, (19**) [asserting all of the above (except the alternative product) as grounds for imposing strict products liability] Jane Stapleton, Lords a Leapin’...TORT LAW JOURNAL (2002). [discussing causal relationship of mesothelioma to asbestos exposure - in light of fact that the dose causally responsible for the injury may not be cumulative and the party whose product factually caused the injury may therefore be unidentifiable, a problem with which the House of Lords grappled in * v. *.]
93 92 91
See ALI, RESTATEMENT OF THE LAW (THIRD): APPORTIONMENT OF LIABILITY 27
of one's unreasonable behaviour."94 A reasonably robust deployment of the circumstantial evidence gap filling concept of res ipsa loquitur95 should be sufficient to support an inference of negligence which, if unrebutted, should lead to a directed or jury verdict in the plaintiff's favor for products which do not meet established or reasonably expected norms.96 That liability should be imposed for departure from an intended production norm is insured by the tort-derived implied warranty concept’s now routine use. We should recognize that implied warranty has been imported from contract law back into the general law of torts - the law of negligence, the general law of compensatory civil liability for harm unreasonably, but unintentionally, imposed on others. Therefore strict liability in the limited form it is actually employed - for “manufacturing defects” is but an adaptation of the general law of negligence to the sorts of problems presented by well recognized classes of unacceptable product-caused injury. Products liability law should therefore be recognized as quite thoroughly normal, and seamless. It is not the much-maligned anomalous, even arbitrary, force that undergirds the rhetoric of those who Tony Weir, The Staggering March of Negligence, in Peter Cane and Jane Stapleton, THE LAW OF OBLIGATIONS 98 (1998); See also RESTATEMENT OF THE LAW THIRD, TORTS: PHYSICAL HARM, GENERAL PRINCIPLES, Tent. Draft 2 (Council draft 9/25/2002) : § 6. Liability for Negligent Conduct An actor whose failure to exercise reasonable care is a factual cause of physical harm is subject to liability for any such harm within the scope of liability, unless the court determines under § 7 that the duty of reasonable care is inapplicable. § 7. Duty (a) An actor ordinarily has a duty to exercise reasonable care when the actor’s conduct creates [poses] a risk of physical harm.*** The concept was first voiced in Byrne v. Boadle, 159 Eng. Rep. 299 (Ex. 1863); See also Mark F. Grady, Res Ipsa Loquitur and Compliance Error,142 U. Pa. L. Rev. 887 (1994) [The more developed the precautionary norm, the more likely it is that a court will employ the doctrine of res ipsa loquitur where circumstances suggest that it was breached.]; William L. Prosser, Res Ipsa Loquitur in California, 37 Cal. L. Rev. 183 (1949).
96 95 94
See PRODUCTS LIABILITY RESTATEMENT: § 3 Circumstantial Evidence Supporting Inference of Product Defect It may be inferred that the harm sustained by the plaintiff was caused by a product defect existing at the time of sale or distribution, without proof of a specific defect, when the incident that harmed the plaintiff: (a) was of a kind that ordinarily occurs as a result of product defect; and (b) was not, in the particular case, solely the result of causes other than product defect existing at the time of sale or distribution. 28
see product liability law as a destructive element. In fact all the bases of liability we impose - even for blood and drug products which have a history of being problematic - have a coherence - that liability is imposed for the “foreseeable consequences of one’s unreasonable behaviour”, as Weir describes the essence of negligence law. For example negligence doctrine thus understood supports the imposition of liability in the following instances. None of the results changes as a result of the governmental, non-profit, or profit-seeking character of the actor. But the results turn on departure from self-proclaimed or governmentally imposed norms, or they depend on the product liability norm of judging the reasonableness of the risks imposed on others by measuring the product against any reasonably available technology, constructive knowledge of which is imposed as a matter of law. - a drug which fails to meet government specified manufacturers’ safety norms, or - which falls below the manufacturer’s own standards (new car brakes that fail because of an assembly error), - the failure to disclose known defects in a category of medical devices,97 - a drug which in practice disappoints patients’ expectations because it proves to have no net benefit to any group of patients (like the drug Yutopar which was ineffective in prolonging pregnancy and carried risks of heart damage),98(the Products Liability Restatement’s § 6 (c) standard), or - the blood product which is now outmoded and its risks no longer justifiable because a new, safer, product of equivalent effectiveness has come on the market (like the continued marketing of stocks of unpasteurized blood products after methods of pasteurization were developed), as alleged in Gullone v. Bayer and in recent news accounts.99 - unreasonable delay in efforts to develop methods of viral inactivation, as occurred in the case of anti-hemophilic factor concentrate, or implementation of available tests to exclude infected blood donors, as occurred in both the U.S. and the U.K. where private actors were complacent and dilatory in the one and public actors were laggards in the other. This approach to doctrinal normalization of product liability law seeks to resolve a longstanding rift. Ultimately the mountain came to Mohamed on warning and design defect cases,
Ancure - fines and penalties Tobin v. Astra Pharmaceuticals, 993 F.2d 528 (6th Cir. 1993).
which are now treated, functionally at least, as negligence claims.100 But the idea that there is something harsh, something "severe", something "wrong" with strict liability law has persisted. But at this point I am prepared to say that strict liability for manufacturing defects - departure from intended design, malfunction, and failure to properly select, inspect, and test raw materials - is practically nothing more than negligence supported by generous rules of inference from circumstance, with a dollop of warranty.101 And we should say so plainly, as others have urged.102 To persist in the notion that there is something "different", something "strict" about products liability law is to derogate the robustness of modern negligence law and it gives unwarranted encouragement to the idea that unreasonable impositions of liability threaten enterprise, and encourages the unsupportable lament that a culture of blaming the other for what one has himself wrought has engulfed the legal system. Such laments underlay the great debate in the ALI about so-called “categorical” liability. The Reporters, in the debate preceding the adoption of the Products Liability Restatement,
Products Liability Restatement, § 2 (b), (c).
Unfortunately, in the case of hemophiliacs who were infected with Hepatitis C and HIV due to failure to develop pasteurized, virally inactivated products, the consequence of the “blood shield laws” which in 47 states bar “strict liability” actions for blood products, was that they were effectively barred from recovery for their avoidable, generally fatal injuries. IOM report (cited in GWC, YLJ) See David G. Owen, Defectiveness Restated: Exploding The "Strict" Products Liability Myth , 1996 U. ILL. L. REV. 743 (1996)[“While true strict liability has been adopted for manufacturing defects, a reasonableness standard, which includes the notions of optimality and balance, in fact prevails in the design and warning contexts...(T)he reasonableness standard properly applied by courts in design and warnings cases is simply negligence, wrapped in a strict liability shroud...(C)ourts might profitably dispense with the myth that responsibility in these contexts is strict and embrace instead both the language and doctrine of the negligence standard they truly use. ”]; William G. Powers, Jr., A Modest Proposal to Abandon Strict Products Liability, 1991 U. Ill. L. Rev. 639 (1991) [“(S)trict products liability is neither a general approach to personal injury law nor a system of strict liability at all. Instead, it selectively applies to product cases special rules that, although supposedly different from negligence, fall far short of true strict liability. Most of the general arguments favoring strict liability fail to explain why product cases are special. Strict products liability is exceedingly complex because courts have drawn arbitrary distinctions to maintain strict products liability and negligence as separate causes of action. Without well-articulated rationales for distinguishing product cases from other personal injury cases, judges have oscillated between general arguments for strict liability and general arguments for negligence, thereby creating a baroque system of doctrinal distinctions that defies rationalization. By drawing doctrinal distinctions in the absence of meaningful differences, the current approach to strict products liability fails to treat like cases alike. ”] 30
pressed for a statement disparaging and declaring impermissible tort system review of “categories of products”. In a bizarre list that survived multiple tentative drafts and yielded finally only to a voice vote on the floor at the final session, the Reporters lamented categorical liability for “above-ground swimming pools, alcoholic beverages, hand guns, and tobacco.”103 The cases involving each of these products has in fact led to rather respectable results. Home swimming pools are still on the market despite the risks associated with them and the occasional imposition of liability; cigarets are freely sold but cigaret smoke is no longer ubiquitous and heavy levies have been imposed on sales of cigarets through tort litigation. Regarding the cases that led to the fall of the citadel that Prosser had besieged, Green observed The negligence law is an interesting example of the flexibility of the judicial process in responding to the development of an environment...Perhaps the most significant observation that can be made of negligence law today is that it permits the highest individualization of the particular case that has ever been possible under the common law. Court and jury, aided by counsel, can do almost anything that ought to be done with any negligence case.104 The problem of liability may be more troublesome in cases such as we saw in which disease was transmitted due to tardy development of pasteurized blood products.105 In more common manufacturing contexts problems with raw materials have been dealt with successfully as negligence claims, most famously by Justice Cardozo in MacPherson v. Buick Motor Co., in which the manufacturer claimed that there were flaws in the hickory in the painted spokes of the wheel it had received from its supplier. The court imposed a duty on Buick to conduct the testing or to set the specifications so as to make a safe automobile. Privity as a defense in negligence cases died that day, and the long siege began in `strict liability’ cases, spurred and finally celebrated in Prosser’s Citadel articles106. As Leon Green observed 45 years ago, as we move beyond the obvious liability cases Ellen Wertheimer, The Smoke Gets in Their Eyes: Product Category Liability and Alternative Feasible Designs in the Third Restatement, 61 Tenn. L. Rev. 1429, 1454 (1994) (rejecting alternative safer design test of § 2 (b) as unduly restricting right to find certain categories of product to be inherently defective, even absent alternative design).
Id at *. The True Test at * - *.
William L:. Prosser, The Assault Upon the Citadel (Strict Liability to the Consumer), 69 Yale L.J. 1099 (1960); The Fall of the Citadel (Strict Liability to the Consumer), 50 Minnesota L. Rev. 791 (1966). 31
such as for contaminated food products, many cases will be resolved by “something approaching express warranties to the consumer” by virtue of the “claims made for them by manufacturers”. Other cases dealing with flaws in lumber, disintegrating grinding wheels, exploding tires or bottles, and other analogous accidents “should be considered as negligence cases”. The “principal divergencies” among them are “due to what degree of strictness is permitted in the use of res ipsa loquitur and (shifting the) burden of proof”.107 Prosser in his first (1960) `Citadel’ article, speaking of the merger of warranty and tort that became known as strict products liability traced the origin to a series of cases involving production flaws and contaminants. Coca Cola Bottling Works v. Lyons, is the case that Prosser says contained the seminal idea of the strict products liability revolution. The Mississippi Supreme Court held that an “implied warranty runs with” the chattel.108 In the absence of proof that the bottling method was “perfect” or that it was “impossible” for the foreign substance to get into the bottle while being filled”, the judge’s jury charge was correct. He had instructed that since Coca Cola had put the product on the market for “human consumption” it is “your duty to return a verdict for the plaintiff”, if you find that the “bottle of Coca Cola so purchased contained a quantity of small particles or pieces of glass therein”. With lack of privity no longer in the way, it strikes me that this is little more than the sort of inference of negligence by circumstantial evidence now enshrined in § 3 of the Products Liability Restatement.109 The absence of defense evidence of impossibility or danger despite perfection of production methods, suggests that the reasonable person standard, with a generous use of res ipsa loquitur and the imposition of the expert standard of care offer all that is reasonably needed to infer negligence and lack of fitness for use in the manufacture of the product. Although I largely concur with Professor Stapleton about the vitality of negligence
24 Tenn L. Rev. at * 111 So. 305 (Miss. 1927). § 3 Circumstantial Evidence Supporting Inference of Product Defect
It may be inferred that the harm sustained by the plaintiff was caused by a product defect existing at the time of sale or distribution, without proof of a specific defect, when the incident that harmed the plaintiff: (a) was of a kind that ordinarily occurs as a result of product defect; and (b) was not, in the particular case, solely the result of causes other than product defect existing at the time of sale or distribution. Restatement (Third) of Torts, Products Liability (1998). 32
law, and its adequacy to the task of establishing coherent, norm-based grounds for liability,110 I do not concur with her that there is no need for a “separate regime” for products liability law which distinguishes commercial from non-commercial activity. I agree that congruence of common law norms with the “routines, customs, conventions and practices of ordinary daily life” is important for the ability of the law successfully to command adherence.111 And I would generally encourage, for example, a move toward greater congruence in the law of torts - such as by moving away from the customary standard of care in professional negligence actions.112 But congruence does not require uniformity. There are supportable reasons for imposing different standards of care on different classes of actors. Charitable immunity and a higher burden on claimants seeking to recovery from negligent government actors are instances (though not the subject of consensus) in which many understandably hold that a divergent basis for liability imposition is warranted. Few if any have attempted to extract from the welter of common law decisions a coherent statement of why product liability cases are grouped together. The American Law Institute in the Products Liability Restatement specifically abjured any attempt at doctrinal uniformity, adopting what it described as a “functional” approach, compatible with the various theories of negligence, strict liability, implied warranty.113
See Arthur Ripstein, supra, N*.
Gerald J. Postema, Philosophy of the Common Law, in Coleman & Shapiro, The Oxford Handbook of Jurisprudence and Philosophy of Law (2001) 616 [(L)aw as such can function only if it is congruent to a substantial degree with the social life of the community if seeks to govern.”] See, E.g. Ter Neuzen V. Korn, Supreme Court of Canada,  3 S.C.R. 674. [Rejecting customary standard of care and imposing reasonable care standard in claim arising from transmission of HIV via artificial insemination]; Matthies v. Mastromonaco, 733 A. 2d 456 (N.J. 1999) [Rejecting customary physician standard and imposing reasonable patient standard regarding duty to inform patient of reasonable choice between surgical or other treatment of fracture.]; cf. NY Pub. Health Law § 2805-d [disclosure standard set by “reasonable medical or dental practitioner under similar circumstances”.]
§ 1 Liability of Commercial Seller or Distributor for Harm Caused by Defective
Products One engaged in the business of selling or otherwise distributing products who sells or distributes a defective product is subject to liability for harm to persons or property caused by the defect. ...Comment: a. History. This Section states a general rule of tort liability 33
In my view the law of negligence, supplemented by the contract-derived tort principle of implied warranty (or strict liability), is the appropriate vehicle for the law of products liability. But the courts must recognize that the degree of “strictness” which they impose should be governed by their desire to establish a set of coherent norms of commercial and professional conduct - one to which government generally should also consent to be bound. The common law negligence tradition of Heaven v. Pender,114 MacPherson v. Buick
applicable to commercial sellers and other distributors of products generally. Rules of liability applicable to special products such as prescription drugs and used products are set forth in separate Sections in Topic 2 of this Chapter. The liability established in this Section draws on both warranty law and tort law. Historically, the focus of products liability law was on manufacturing defects. A manufacturing defect is a physical departure from a product's intended design. ... Thus, "strict products liability" is a term of art that reflects the judgment that products liability is a discrete area of tort law which borrows from both negligence and warranty. It is not fully congruent with classical tort or contract law. Rather than perpetuating confusion spawned by existing doctrinal categories, §§ 1 and 2 define the liability for each form of defect in terms directly addressing the various kinds of defects. As long as these functional criteria are met, courts may utilize the terminology of negligence, strict liability, or the implied warranty of merchantability, or simply define liability in the terms set forth in the black letter...
(1883) 11 QBD 503, 509, dicta of Brett M.R.: The proposition which these recognized cases suggest, and which is, therefore, to be deduced from them, is that whenever one person is by circumstances placed in such a position with regard to another that every one of ordinary sense who did think would at once recognize that if he did not use ordinary care and skill in his own conduct with regard to those circumstances he would cause danger of injury to the person or property of the other, a duty arises to use ordinary care and skill to avoid such danger. .... Let us apply this proposition to the case of one person supplying goods or machinery, or instruments or utensils, or the like, for the purpose of their being used by another person, but with whom there is no contract as to the supply. The proposition will stand thus: whenever one person supplies goods, or machinery or the like, for the purpose of their being used by another 34
Motor Co.,115 Escola v. Coca Cola Bottling Co.,116 § 402A,117 Borel v. Fibreboard,118 Bexiga v. Havir Manufacturing,119 Barker v. Lull Engineering,120 Feldman v. Lederle Laboratories,121 Perez v. Wyeth Laboratories122 and Sprietsma v. Brunswick Marine123 expresses a normative, coherent, negligence-based jurisprudence of product stewardship. These landmark cases establish the duty of commercial manufacturers to deliver products that meet their own specifications, serve the needs promised or reasonably expected, establish the expert standard of care, including the duty to study, test for, eliminate, and effectively warn of dangers, the duty to anticipate and guard against the self-injuring conduct of workers and consumers, and to be inventive, to employ the injury-preventive, safety-minded design capabilities reasonably available in the current circumstances.124 [rejecting defense of privity, imposing duty on mfr to test component parts for defects. MacPherson's analog Donoghue v. Stevenson,  A C 562 , played a similarly seminal role in the development of modern English tort law.]
[exploding soda bottle - rogue product]
[strict liability regardless of negligence for unreasonably dangerous products with latent defects, but imposing only duty to warn on useful but unavoidably hazardous ones.]
[declaring duty of mfrs of asbestos products to study, test, and warn of dangers.].
[imposing on machine manufacturers the non-delegable duty to protect workers from injury due to foreseeable carelessness in use of product.] [establishing negligence-based risk utility factors in design defect case against machine mfr.] [imputing knowledge of harmful propensities of product to mfr, and establishing expert standard of care for manufacturers of pharmaceuticals, and current state of technology, rather than custom as relevant factors in gaging mfrs' "conduct".] [duty of mass marketer to use both direct-to-consumer and intermediary means to communicate risks of pharmaceuticals] [despite government decision not to impose regulations, common law tort action may be sustained against manufacturer for failure to develop new form of guarding of outboard motor propellers] For an interesting discussion of the high court’s product liability jurisprudence, see Anita Bernstein, Products Liability in the United States Supreme Court: A Venture in Memory of Gary Schwartz, 53 S.C. L. Rev. 1193 (2002). Case law on post-sale duties remains to be developed, though there can be little doubt that a manufacturer of drugs is obligated to report to public authorities and to physicians significant developments gained by study of performance of the product in the market place and that a common law duty to recall is likely to be recognized even absent FDA or other regulatory 35
124 123 122 121 120
These duties - those imposed routinely by American courts products liability cases grounded on warning and design defect claims, are not examples of strict liability - despite courts’ frequent use of that nomenclature.125 They are negligence-based concepts - even where at first glance they have a strict liability feel. Imputed knowledge A prominent feature of products liability law is the legal assumption that the product was known by the manufacturer to have the dangers which it is proved to carry. This idea was a central feature of John Wade’s thinking on “strict liability in tort” for defective products.126 But it is a product-liability-specific expression of the concept of constructive knowledge - a negligence, a fault-based standard. Commenting on the intrusion into equity thinking of the common law, Tony Weir has observed that the inquiry is “whether though (the actor) did not know, he should have known, whether he had `constructive knowledge’, that is was at fault in not knowing. The extension from actual to constructive knowledge entails an intrusion of negligence thinking (into equity), and a diminution of the conditions of (strict fiduciary) liability.”127 Similarly, the limitations placed in products liability law on the doctrine of contributory negligence may be seen to represent an element of strict liability in tort. But the law of negligence is the source of the view that the duty of care owed to one in a position of vulnerability cannot be nullified by citing the voluntary character of the victim’s self-injurious conduct.128 The point is illustrated by the New Jersey Supreme Court. In Tobia v. Cooper Memorial a hospital was found liable for failing to protect a woman who fell. Breach of the duty to restrain or otherwise protect a person who could not ambulate safety was not avoided by pointing to the voluntariness of the patient’s conduct: In a long series of cases, we have held that when a tortfeasor's duty includes exercise of reasonable care to prevent a party from engaging in self-damaging conduct, contributory negligence is barred as a defense. See Green v. Sterling Extruder Corp., 95 N.J. 263, 471 A.2d 15 (1984) (denying contributory-negligence defense to manufacturer of blowmolding machine that injured worker who was using machine for reasonably foreseeable purpose); Suter v.
David G. Owen, Exploding the “Strict” Products Liability Myth Wade, NYU or Vanderbilt or both; NJ model jury charge
Tony Weir, The Staggering March of Negligence, in THE LAW OF OBLIGATIONS, ESSAYS IN HONOR OF JOHN FLEMING 130 (Peter Cane and Jane Stapleton, eds., 1998). See cases for prop that duty is owed to prevent suicide, etc. from Tobia dissent; see cases cited in Fleming treatise. 36
San Angelo Foundry & Mach. Co., 81 N.J. 150, 406 A.2d 140 (1979) (denying contributory-negligence defense to manufacturer of sheet-metal-rolling machine that injured worker who was using machine as part of assigned task). "As one writer *** has said, '[o]nce it is established that the defendant has a duty to protect persons from the consequences of their own foreseeable faulty conduct, it makes no sense to deny recovery because of the nature of the plaintiff's conduct.'" Green, supra, 95 N.J. at 272, 471 A.2d 15 (quoting Patricia Marschall, An Obvious Wrong Does Not Make a Right: Manufacturers' Liability for Patently Dangerous Products, 48 N.Y.U. L. Rev. 1065, 1088 (1973)). Hence, to allow a defense of contributory negligence when defendants' duties included protecting plaintiff from foreseeable self-inflicted injuries makes no sense.129 The faultiness of the patient’s conduct goes not to liability but to damages for failure to follow medical advice, according to the New Jersey high court. In Ostrowski v. Azzara130 The court held that the jury may consider a patient's lack of concern for her own health needs as an aspect of the damages. Though the “physician takes the patient as she is”, the patient is still liable for failure to conduct herself reasonably while under the physician’s care. These concepts - show that the general law of negligence and products liability law are dynamically intertwined. But they also show that the fuel for much of the development of the general law of tort has been the specific challenges posed by the epidemics of occupational disease and the problems posed by the passivity of the consumer in the face of mass produced and marketed products for personal use and consumption. That there is a larger whole into which the law of products liability fits is not a prescription for denying the coherence of the doctrinal principles which have thrived in the modern era of products liability law - the jurisprudence of product stewardship. In the balance of this paper we will compare the negligence-based decision of the New Jersey intermediate appellate court in Estate of Elkerson v. North Jersey Blood Center, UMDNJ, and American Association of Blood Banks, with the decision of Judge Burton in A and others v. National Blood Authority and another in the “without fault”, strict liability regime of the EC product liability Directive.131
A and Another v. National Blood Authority
643 A.2d 1, 8-9 (N.J. 1994) 545 A.2d 148 (N.J. 1988). N*, supra. 37
The Claims 114 claimants sought damages arising from their infection with Hepatitis C from blood and blood products transfused from March 1, 1988. The cases of six lead claimants (what we would call bellwether plaintiffs) were tried before Judge Burton, of the Queens Bench Division of the High Court of England in the fall of 2000 and winter of 2001. All had been infected with Hepatitis C from transfusions from blood provided by the National Blood Authority and other public entities who are the sole source of blood in England, Scotland and Wales.132 The UK relies on voluntary blood donors. About 1% of the bags of donated blood were found to have been infected after an effective screening test for Hep C antibodies had been developed.
Cause of Action The claims were grounded on the Consumer Protection Act of 1987 (CPA), which became effective March 1, 1988. The act conformed British law to the strict liability standard for product defect claims established in the 1985 EC Directive. Provisions of the CPA must be construed so as to conform with the directive. At the effective date of the CPA the Hepatitis C virus was unidentified. No test for the presence in donors’ blood of the virus was possible. Surrogate tests - to identify donors at high risk for Hepatitis C (NANB) infection - were known. The combined effectiveness of these ALT and Heb B screening tests was estimated to exclude about 40% of Hepatitis C infected blood. [In the US, before implementation of the two surrogate tests in 1986 the NIH had reported that 7% to 12% of U.S. transfusion recipients suffered from post-transfusion hepatitis.]133 In England 1% to 3% of the bags of blood were infected. Claimants asserted that the product was defective because, in the language of the EC Directive, Article 6 , a product is defective if it does: not provide the safety which a person is entitled to expect, taking all circumstances into account, including: (a) the presentation of the product; (b) the use to which it could reasonably be expected that the product would be put; (c) the time when the product was put into circulation. The consumer is entitled to expect that the blood be safe, as a matter of law, and regardless of whether the contaminant could be avoided by the blood bank, asserted the
The claimants had been identified from a look-back program instituted after the virus had been identified, which disclosed which donors had been infected.
At the time in the US we employed paid blood donors. 38
claimants. The defenses Conceding, as the EC Directive compels, that liability for injury due to defective products is imposed “without fault”, the National Blood Authority asserted that “avoidability” was a relevant Article 6 “circumstance” which must be taken into account in determining the entitlement of the consumer. Not until December 1989 at the earliest was there an effective screening test for the presence of Hep C in donors’ blood. Until then the risk of infection could not be reduced. The unattainable is not legitimately expectable, said the defense. Further, proof of defendants’ knowledge of the risk of infected blood in general does not satisfy claimants’ burden on the case for defect. Plaintiffs must show that the particular infected bags could have been identified - and the risk of harm thus avoided, said the defendants. In this respect they read into Article 6 the language of Article 7(e) Defendants also raised an affirmative defense, article 7(e) of the EC product liability directive, which provides: Article 7 The producer shall not be liable as a result of this Directive if he proves:... (e) that the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of the defect to be discovered : The critical events are that not until May 1988 was the long-sought NON A, NON B Hepatitis virus “identified, cloned, and expressed” by the Chiron Corporation, which in September 1989 disclosed the details of its ELISA Assay test at a Rome conference, and in November 1989 obtained from the U.S. FDA a license to export the test. Japan was first to implement its use - in December 1989. The U.S. FDA permitted marketing here in May 1990. England and Ireland were the last to use the test - beginning in September and October 1991. England implemented the precaution 24 months after its introduction and 22 months after the product was available for export from the United States. The FDA., by contrast, permitted use of the test 8 months after Chiron published the details of its invention and six months after the product was licensed for export. The product of long-felt need, the test was presumably universally employed very shortly after FDA approval. The High Court addressed first the plaintiffs’ most sweeping claims (which it accepted), and then addressed the claims as if it had accepted defendants’ view that “avoidability” was a “circumstance” properly taken into account. It was common ground that strict liability, not negligence, was the command of the 1985 EC directive, to which the British statute must be 39
construed to conform.134 Is Blood a Product? Is the Products Liability Directive Applicable? The NBA “conceded for the purpose of these proceedings that the blood or blood products by which the claimants were infected are products within the meaning of the CPA and the directive, and that the defendants' production of blood was, for the purpose of the directive, an industrial process.” “There is of course no 'blood-shield' statute in the United Kingdom”, Judge Burton observed.135 [Blood and human tissue were excluded from the scope of the Third Restatement. The ALI acquiesced in the exclusion by all but four states of blood and blood products from the law of strict liability and implied warranty. 136]
See, e.g. Recitals 2, 3, and 6:  Whereas liability without fault on the part of the producer is the sole means of adequately solving the problem, peculiar to our age of increasing technicality, of a fair apportionment of the risks inherent in modern technological production;  Whereas liability without fault should apply only to movables which have been industrially produced; whereas, as a result, it is appropriate to exclude liability for agricultural products and game, except where they have undergone a processing of an industrial nature which could cause a defect in these products :
 Whereas, to protect the physical well-being and property of the consumer, the defectiveness of the product should be determined by reference not to its fitness for use but to the lack of the safety which the public at large is entitled to expect; whereas the safety is assessed by excluding any misuse of the product not reasonable under the circumstances; Notably agricultural products are excluded, in marked contrast to U.S. product liability law, which arose from contaminated food product cases.
A v. NBA at * § 19 Definition of "Product" For purposes of this Restatement: (a) A product is tangible personal property distributed commercially for use or consumption. Other items, such as real property and electricity, are products when the context of their distribution and use is sufficiently analogous to the distribution 40
The Directive here was thus construed by all to establish a uniform standard for governmental and commercial actors.137
Article 6 and the Relevant Circumstances
Echoing American product liability law, a major influence in the formulation of the directive, as to Article 6, the claimants asserted that, with the need for proof of negligence eliminated, consideration of the conduct of the producer, or of a reasonable or legitimately expectable producer, is inadmissible or irrelevant. Therefore questions of avoidability of the risk of infection could not arise: What the defendants could or should have done differently; whether there were any steps or precautions reasonably available; and whether it was impossible to take any steps by way of prevention or avoidance, or impracticable or economically unreasonable. Such are not 'circumstances' falling to be considered within art 6.138 and use of tangible personal property that it is appropriate to apply the rules stated in this Restatement. (b) Services, even when provided commercially, are not products. (c) Human blood and human tissue, even when provided commercially, are not subject to the rules of this Restatement. (Emphasis added.)
The defense suggested that the fact that it “had no alternative but to supply (blood) to hospitals and patients, as a service to society...(T)his is a factor to be taken into account in the 'basket'...(U)nlike commercial producers, they have no option to withdraw it from the market rather than incur liabilities....Judge Burton’s response was that “there is, in any event, no necessary reason why a public authority or a non-profit making organisation should be in any different position if the product is unsafe”. (citation omitted)
A v. NBA at *; [This is certainly a proposition that would not get a favorable hearing in the U.S., where the Second Restatement’s comment k has long held sway. Where the product is useful and the risk unavoidable, the product is not defective if accompanied by proper 41
According to Judge Burton public knowledge of the risk was sparse: In so far as the risk was known to blood producers and the medical profession, it was not known to the public at large (save for those few patients who might ask their doctor, or read the occasional article about blood in a newspaper) and no risk that any percentage of transfused blood would be infected was accepted by them. 139
The defendants asserted that the risk was known to those who mattered - the medical profession, through whom blood was supplied. In U.S. jurisprudence the matter of knowledge would be tested by each plaintiff individually. Here it seems to have been treated as a generic question - whether, in the words of the EC Directive’s recitals it was known to “the public at large”. The NBA asserted that until there was available on the market a test capable of identifying donors exposed to the hepatitis C virus, the risk was unavoidable. Since the Directive bases the finding of defect on what the public is “entitled to expect”, and since both sides here agreed that it was legitimate expectations, not actual expectations which governed, “it is not and cannot be legitimate to expect the unattainable....100% clean blood” The most the public could legitimately expect was that “all legitimately expectable (reasonably available) precautions" (in this case screening tests) had been taken. Such language had the “ring of negligence”,140 with inevitable invocations of an investigation into the nature of the risk and the adequacy of the efforts to reduce it - an effort as familiar to bench and bar in England as it is to American products liability lawyers.141
warnings. Freeman v. Hoffman LaRoche, supra, n*, at *.]
A v. NBA, at *.
See Barker? criticizing Cronin? to show similar struggling with the application of strict liability in U.S. law
See, e.g. Morris v West Hartlepool Steam Navigation Co Ltd  1 All ER 385 at
399: '. . . it is the duty of an employer, in considering whether some precaution should be taken against a foreseeable risk, to weigh on the one hand the magnitude of the risk, the likelihood of an accident happening and the possible seriousness of the consequences if an accident does happen, and on the other hand the difficulty and expense and any other disadvantage of taking the precaution.' The language is markedly like that of Judge Hand in Carroll v. U.S. Towing, and the Wade Risk-utility factors of U.S. Products Liability law. See generally, Stephen G. Gilles, the 42
Finally, urged the defendants “(i)f, notwithstanding the known and unavoidable risk, the blood was nevertheless defective within art 6, then it is all the more necessary to construe art 7(e) so as to avail those who could not, in the then state of scientific and technical knowledge, identify the defect in a particular product so as to prevent its use. The claimants urged that Art 7(e) does not apply to generic risks which are known before the distribution of the product, whether or not the defect can be identified in the particular product. The dispute on what was meant by “all circumstances” therefore invoked a choice: Defendants asserted that it is essential to consider, in deciding what level of safety could reasonably have been expected, what more if anything could have been done: what precautions or tests could be used/should have been used/were available to be used/can legitimately be expected to have been used”. Claimants asserted that given that it is common ground that the article imposes liability irrespective of fault, the exercise of considering what could or should have been done by the producer is an impermissible and irrelevant exercise, which lets questions of fault back in by the back door. They say that the consideration of what safety precautions should have been expected to have been adopted simply amounts to the introduction of a standard of legitimate expectability, rather than a standard of reasonableness..(I)t is necessary only to look at the product itself (including comparison with similar or identical products on the market), which would involve its expected or intended use, without considering what more could have been done (and how easy or difficult or cheap or expensive it would have been to have done it).”
Categories of Defect - the Non-standard Product The claimants asserted that there was a manufacturing defect (the blood was infected with an
Emergence of Cost-Benefit Balancing in English Negligence Law, 77 Chi.-Kent L. Rev. 489 (2002). 43
unwanted contaminant).142 The defendants asserted that the court must decide if there was a design defect (the `unscreenedness’ of the blood). If it was the former, then a strict liability sort of guaranty of safety regardless of feasibility would be imposed, and if the latter, a negligencestyle risk/utility test, however muted, would govern. The hemophiliacs factor VIII concentrate was a pooled blood product which increased risk of infection beyond what was present in the pre-manufactured `raw material'. The infected blood in the U.K. was from individual, volunteer donors.143 Judge Burton found that the different categories (manufacturing error or design defect) made no difference. Pointing to the failure of the defendants to adequately inform the public of the risks of infected blood, he devised the concept of the “non-standard” product - one which led inevitably to liability because (w)hether it is appropriate to define the one infected bag of blood in 100 as a manufacturing defect, or as an inevitable result of a chosen design process which cannot guarantee uniformity of product, the issue is still the same, namely whether the safety was provided which the public was entitled to expect in respect of that product. Judge Burton imposed liability as a matter of law on Article six. He rejected "avoidability" as a relevant “circumstance”. It “is outwith the purpose of the directive”, because it was breach of a de facto fault based standard that the defendants had sought to prove.144 The infected blood was defective as a matter of law. Fault was an irrelevant consideration under the Directive, as all conceded. Th avoidability defense was fault-based: Having heard the evidence of Zumutbarkeit (avoidability) over The only U.S. court to adopt such a position, Cunningham v McNeal Memorial Hospital, 47 Ill (2d) 443 (1970), was reversed by the Legislature’s prompt passage of a blood shield law. Dominating the commercial sector are manufacturers or fractionators of plasma derivatives. In the early 1980s, fractionators collected approximately eighty percent of plasma from paid donors. The voluntary sector provided the remaining twenty percent. Fractionators pool plasma from thousands of donors and process it to produce large batches of plasma derivatives, such as clotting factors for hemophiliacs. Each batch contains enough clotting factor to treat thousands of patients. Institute of Medicine, HIV and the Blood Supply: An Analysis of Crisis Decisionmaking 15 (1995) (the IOM Report). [from snyder v. aabb at 144 N.J. 269 at 276) The High Court ruled in the alternative. It decided first what constituted a relevant circumstance, ruled out "avoidability", then addressed the proofs of unavoidability of infection of blood which defendants had mustered during trial. 44
144 143 142
some 20 days, I pay tribute to the fact that both parties were careful never to address head on the issue of negligence, the claimants noteworthily eschewing any such suggestion, and I am well aware that the investigation would have been wider and longer if it had expressly been based in negligence. It has been quite clear to me that the claimants have had, on the trial of the facts before me, to prove.. that the defendants ought to have acted differently from the way they did: not on a day by day, or month by month basis, assessing their individual conduct, but simply on the basis that tests ought to have been introduced differently and earlier. I am satisfied that (claimant’s counsel) Mr Forrester was right to refer to Senator Huey Long's duck: namely 'If it looks like fault, and it quacks like fault then [to all intents and purposes] it is fault.' That left the court to decide the question of the public’s “legitimate” entitlement. Sir Burton’s judgment was not the reasonableness determination that Lord Griffiths had predicted some dozen years earlier in the pages of the Tulane Law Review.145 Instead a rather minimal rationale was offered by the court: I do not consider that the legitimate expectation of the public at large is that legitimately expectable tests will have been carried out or precautions adopted. Their legitimate expectation is as to the safeness of the product (or not). The
The judge is thrown back to the question "what level of safety is a person entitled to expect?" In the context of failures to warn, it seems likely, if not inevitable, that as in the United States, an appeal will be made to principles which to some ears are more appropriate in a negligence action than one based on strict liability. This conclusion assumes that, since the Directive is not intended to create absolute liability, a person cannot expect that the producer will warn him of every conceivable danger that may arise from the use of the product. Concepts of reasonableness will therefore have to be called upon to define those dangers of which the producer ought to have warned or to define the adequacy of such warnings as may be given. Lord Griffiths, M.C., Peter De Val, and R.J. Dormer , Developments in English Product Liability Law: a Comparison with the American System, 62 Tul Rev. 353, * (1988) 45
court will act as...the appointed representative of the public at large, but in my judgment it is impossible to inject into the consumer's legitimate expectation matters which would not by any stretch of the imagination be in his actual expectation. He will assume perhaps that there are tests, but his expectations will be as to the safeness of the blood. In my judgment it is as inappropriate to propose that the public should not 'expect the unattainable'-in the sense of tests or precautions which are impossible-at least unless it is informed as to what is unattainable or impossible, as it is to reformulate the expectation as one that the producer will not have been negligent or will have taken all reasonable steps.146
In my view this determination of the existence of a defect by reliance on the concept of a non-standard product - one which falls short not of the attainable, but of an aspiration, abandons any realistic meaning for the concept of defect, and departs from the basics of tort law as a mechanism for repair of harm wrongfully inflicted.147 If one narrowed the court’s judgment to one based on failure to warn of unavoidable risks, awarded to those who were infected through elective surgery, it would be coherent as a tort judgment. But as stated it is a judgment in favor of those who suffered from unavoidable danger. The premise for compensation established here by Judge Burton for no wrong has no place in tort law. This form of compensation is not congruent in any coherent way with other strict liability systems, e.g. workers compensation (risks arising from the nature of the employment are compensated), or National Childhood Vaccine Compensation Act (social goal of universal compliance with mandatory vaccine administration secured by assurance of compensation for vaccine-related injury regardless of fault). As a form of social insurance it is incoherent. Shall we compensate people for every toxic effect of every drug? How would we define the insurable event? The law of negligence is vital, a common law system which spurns the unreasonable result (if it is unreasonable then it cannot be the common law of England)148 The strict liability concept
A. v. NBA at .
See Jules Coleman, Risks and Wrongs (1992) [corrective justice is essence of tort law]; and Benjamin C. Zipursky, Philosophy of Private Law, in Coleman & Shapiro, The Oxford Handbook of Jurisprudence and Philosophy of Law (2001) [private right of repair for harm wrongfully inflicted is central element of the private law of torts]
In Tony Weir??? 46
of Rylands v. Fletcher has been decisively held in England to require proof of foreseeability in Cambridge Water Co Ltd v. Eastern Counties Leather, PLC.149 In Burnie Port Authority v. the High Court of Australia found that the Rylands concept of strict liability has been "absorbed" into the general law of negligence: Even where a dangerous substance or a dangerous activity of a kind which might attract the rule in Rylands v Fletcher is involved, the standard of care remains "that which is reasonable in the circumstances, that which a reasonably prudent man would exercise in the circumstances". In the case of such substances or activities, however, a reasonably prudent person would exercise a higher degree of care. Indeed, depending upon the magnitude of the danger, the standard of "reasonable care" may involve "a degree of diligence so stringent as to amount practically to a guarantee of safety". 150 Unlike the judgment of Sir Michael Burton there is nothing abnormal or severe about our law of products liability. If we look at the huge body of cases decided under U.S. tort law on a strict liability basis - even those which stretched farthest - such as the asbestos case Beshada v. Johns Manville, the facts supported an inference of fault in every case I have ever read that went the plaintiff’s way. Our law of products liability is the law of negligence, as Weir defined it. The products liability law has absorbed both the Rylands v. Fletcher notion and the idea that once a special relationship is recognized in the law (such as producer to foreseeable user) it gives rise to a non-delegable duty of care [It recognizes] that the dangerousness of the substance or activity involved... will heighten the degree of care which is reasonable, it becomes apparent, subject to one qualification, that the stage has been reached where it is highly unlikely that liability will not exist under the principles of ordinary negligence in any case where liability would exist under the rule in Rylands v Fletcher.
Looking back - The Avoidability Case It is a strength of the British system - the result of the abolition 80 years ago of the civil jury - that a judge can decide the case on alternative theories. Here the court listened to 20 days of testimony on the issue of avoidability of the harm And in this respect his findings are much
House of Lords  1 All ER 53. 120 A.L.R. 42, * (1994). 47
more satisfying and coherent. As a review of the time line shows, the national Blood Authority failed to implement surrogate testing for NANB Hepatitis (now Hep C). The surrogate tests were ALT and Hep B surface antigen. The Hep B test identified those who had been exposed to Hepatitis B (a common event for intravenous drug users also at risk for Hepatitis C and HIV). The ALT test indicated hepatitis - inflammation of the liver due to any cause - including alcohol use and obesity. The tests did not identify exposure to the still unidentified hepatitis C virus, but they were found to be successful in reducing the risk by about 40%. The U.S. required the tests in 1986. England never employed the tests. The failure to introduce the test was never justified. The defendants were clearly negligent by the reasonable person standard. They were charged with knowledge of the technology by virtue of the previous construction of the CPA in the action brought by the European Commission which was the functional equivalent of a declaratory judgment action. In EC v. UK  All ER (EC) 481, the Commission argued the very wording of s 4(1)(e) of the (UK Consumer Protection) Act shows that it is incompatible with art 7(e) of the directive. Whereas the test in art 7(e) is objective in that it is based on the 'state of scientific and technical knowledge' and makes no reference to the ability of the producer or of another producer of similar products to discover the defect, the national provision calls for a subjective assessment in that it places the emphasis on the conduct of a reasonable producer. In that way, the national provision has the effect of transforming the strict or no-fault liability introduced by art 1 of the directive into liability founded on negligence on the part of the producer. The Court of Justice of the European Community rejected the EC claim - but not its construction of the Directive. It held that the UK understood its duty to construe any ambiguity in its statute in accordance with the objective test required by the Directive. The objective test is one of constructive knowledge which imposes upon all producers the duty to know all “accessible information”. Only what the CJEC called rather rudely “non-Manchurianly accessible” information was to be excluded from the ambit of what a producer is deemed to know. The ELISA Assay Test Implementation
The accessibility of information regarding Chiron corporation’s identification of the NON A Non B (Hepatitis C) virus (which turned out to be several) was not in doubt. The test addressed a serious health public problem which had dogged all the advanced countries for many years. 48
The Chiron breakthrough was big news.151
Judge Burton reviewed the evidence. He paid particular mind to Dr. Harold Gunson CBE “the most experienced expert in blood transfusion in the United Kingdom” who, the Court recounted “gave measured evidence of great authority”, admitting “In retrospect, to his concern that in the event routine screening for Hepatitis C was not introduced in the United Kingdom until September 1991 (two years after the disclosure of the test by Chiron, and 22 months after its commercial availability).152 Ultimately Dr. Gunson conceded that the test could have been introduced early in 1990.153
A v. NBA  (iv) Even on the basis of what was reported, the prevalence (that is prevalence of the virus amongst the donor population) and the incidence (that is the incidence of the infection among recipients) were higher in the United States (assessed by Dr Alter in the 1970s at between 7-12%) and, particularly, Japan, which had an even higher incidence, than in the United Kingdom and Europe. The United States' position improved during the 1980s for a number of reasons: the abolition of paid donors; the introduction of screening tests for HIV, which excluded a number of donors who would also have been at risk of NANBH; more effective monitoring and selfexclusion of drug users etc. The incidence in the United Kingdom, which Dr Gunson believed to be the case at the material time in 1986 and following, and which was generally accepted and was reported by him to the Council of Europe, was 3%. (In fact when screening was introduced, and more accurate assessment was thus able to be made, the incidence became or was-and still remainsbetween 0705 and 1%.) There are approximately 275m donations per year (each donor donating approximately twice per year).
A v. NB . A v. NBA  I have already referred to Dr Gunson's evidence, subject to the question of a confirmatory assay as to 'certainly early in 1990', in retrospect. Later in cross-examination, he said to Mr Brown: 'Mr Brown, I have now said three times-I think I did say to His Lordship yesterday-that in retrospect we should have done it a different way.' 49
Walking, in this alternative finding very much like Huey Long’s duck, Judge Burton declared “there is no questions of a conclusion that the public is entitled to every marginal improvement (in the safety of blood transfusions)”. In fact, he noted, this was quite close to the view of the defendants: Dr Gunson preferred the concept of 'minimum risk' to 'maximum safety'. However, this became clarified when he was shown, or reminded of, a preliminary discussion paper for the ACTTD prepared by Dr Barbara and Dr Contreras dated 23 January 1992, which read: 'The attitude towards transfusion safety has veered away from the concept of "maximum benefit/minimal cost" towards the notion that if a procedure is shown to prevent transfusion-transmitted infection and disease is available, it should be introduced.' He responded as follows to Mr Brown's question about this: 'Q. Were you aware of that shift in culture or do you think that that had always been the position? A. I think it was probably always the position.'154 Armed with such evidence and concessions, and insisting that he was avoiding making a negligence determination (quite like American courts which declare that they are imposing strict liability) but looking very much like one of Huey Long’s ducks,155 Judge Burton summed up on the “avoidability” case: The broadbrush question of course is what tests or precautions it is reasonable or appropriate or legitimate to expect that a defendant producer should have adopted. In the light of art 6, and the obvious emphasis on a weighing exercise, taking into account all the circumstances, I interpret the position as being that the judge (whether as the representative of the public or otherwise) simply weighs up the advantages and disadvantages, the pros and cons, without the benefit of hindsight, and reaches his own decision, neither reviewing the producer's decision, nor declaring that the producer's decision was negligent. Accepting, but somewhat adapting, another of Mr Brown's formulations, I would declare myself as prepared, while walking Mr Underhill's tightrope, to adopt a formulation as follows. If a precaution shown to prevent, or make a material reduction in, the transfer of transmitted infection through infected blood is available, it
A v. NBA .
See David G. Owen, Defectiveness Restated: Exploding the `Strict’ Products Liability Myth, 1996 U. Ill. L. Rev. 743. 50
should be taken, unless the disadvantages outweigh the advantages.156 We thus conclude this exercise with an alternate ground of judgment that looks very much like a first year torts exam, but aboard the freighter in Morris v. West Hartlepool Steam Navigation Co., rather than the barge in Carroll v. U.S. Towing. It is familiar ground for judgment, readily squared with the facts, and familiar common law principles. And it is unencumbered by the somewhat awkward categories of our Products Liability Restatement.
The Avoidability Case in U.S. Law
If we were to look at the A v. NBA “avoidability case” in the terms of the Products Liability Restatement, where would it fit? First, it would be barred from consideration - because of Section 19 and/or the blood shield laws. But if we chose to look at it as a products liability case, it would not quite fit as a manufacturing defect case - because the defendants did not decide to adopt the screening tests. The products therefore did not depart from their specifications. If we suggested that the manufacturer could have via donor screening questionnaire excluded all who were at risk for Hep C, there was world wide experience to show that such donor questioning had not eliminated the problem. Because no realistically stated consumer expectation or entitlement to virus-free blood had been violated, strict liability for manufacturing defect would not be warranted. If we proposed that after the introduction of the test on the market those who did not implement it were strictly liable for all harm, we would only be saying that we had imposed liability on a negligence per se basis - as a matter of law.
Estate of Elkerson and the Vitality of Negligence-based Law of Product Stewardship It is only via negligence-based principles that the distinction between social insurance and tort law is maintained. In Estate of Elkerson v. North Jersey Blood Center, 157 the Appellate Division of the Superior Court of New Jersey took precisely that route. Ignoring precedent that had found hemophiliacs’ factor concentrate a product,158 the court demonstrated the vitality of the
A v. NBA . 776 A 2d 244 (NJ. App. Div. 2001). D.J.L. v. Armour Pharm. Co., 704 A.2d 104, 117 (N.J. Super. Ct. Law Div. 1997). 51
negligence approach to such issues. The issues presented were like those claimants in A v. National Blood Authority who were infected after development but before deployment of the screening test. In Elkerson the test for hepatitis B was known, but commonly unused. Plaintiff’s decedent died of the disease. The complaint alleged a failure to employ the test: Plaintiffs premised their wrongful death action against the blood bank on the theory that the blood bank was negligent in failing to employ the hepatitis core antibody test in 1983. Plaintiffs maintain that test was available and would have reduced the risk of failing to detect latent hepatitis B, as compared with the surface antigen test used by NJBC, which plaintiffs allege failed to detect the virus. n1 Accordingly, it was plaintiffs' burden to prove that NJBC was negligent in failing to use the core antibody test; that its negligence enhanced the risk that decedent would contract hepatitis B; and that the enhanced risk was a substantial factor in causing her injury. Snyder v. Mekhjian, 244 N.J. Super. 281, 293, 582 A.2d 307 (App. Div. 1990) (Snyder I), aff'd o.b., 125 N.J. 328, 593 A.2d 318 (1991). The case did not revolve around whether the product liability law applied (New Jersey has no blood shield law and the definition of a product is a broad one in statute and at common law). There is appellate authority in New Jersey that all products liability cases must be brought under the Product Liability Act159 - but the Elkerson court never gave the issue a glance. The issue was negligence and the fight was over the standard of care. The defendants had prevailed at trial. They defended the jury charge which stated the customary standard of care - a modified version of the usual medical malpractice charge. Plaintiff proposed a “reasonable person” charge, but (t)he (trial) court rejected the proposed charge because it viewed the collecting and processing of blood as a skilled medical service, determining, therefore, that NJBC should be treated as a medical professional. Consequently, the court gave a modified medical malpractice charge to the jury essentially instructing it that if NJBC conformed to the generally recognized and accepted practices in the blood bank industry, it could not find NJBC negligent. The court told the jury that NJBC was a health care provider and, therefore, represents that it "possesses that degree of knowledge, skill and care which is possessed and used by the average Blood Bank." It then told the jury that "the required knowledge, skill, and care must be judged by the standard practice
Fabyan v. Minster machine??? 52
of blood banking in April of 1983." (Emphasis added.) Elkerson at * The Appellate Division held that the charge “virtually guaranteed a finding of no negligence” because it was the industry practice not to use the test at the time: NJBC, like virtually all blood banks, used the surface antigen test and not the core antibody test in 1983, thus establishing the standard of conduct or practice in the blood bank industry as the surface antigen test, even though the Center for Disease Control (CDC) recommended core antibody testing as early as January 1983. Elkerson at * Demonstrating that the court, employing negligence law, was ready to establish a standard of care based on industry capabilities not industry practice,160 Judge Eichen turned to William Prosser: Even an entire industry, by adopting such careless methods to save time, effort or money, cannot be permitted to set its own uncontrolled standard.... And if the only test is to be what has been done before, no industry or group will ever have any great incentive to make progress in the direction of safety.... Much the better view, therefore, is that of the great majority of the cases, that every custom is not conclusive merely because it is a custom, and that it must meet the challenge of "learned reason," and be given only the evidentiary weight which the situation deserves. It follows that where common knowledge and ordinary judgment will recognize unreasonable danger, `what everyone does’ may be found to be negligent; and that there will be extreme cases where it is so clearly negligent in itself that (evidence of the common practice) may even be excluded from evidence. Wellenheider v. Rader, 227 A 2d 329, * (1967), quoting Prosser, Torts ' 33, 170 (3d ed. 1964)). This is the lesson that the New Jersey Court drew from the “trilogy of blood bank cases”
See on negligence as providing expert standard of care - Birnbaum, 33 Vand. L Rev. 593,636 (1980); Hoenig, 8 Sw U L Rev 109 (1976) and cases cited at Wade, 58 NYU L Rev 734, 748, note 55, finding the product to be unreasonably dangerous only if the hazard was knowable or foreseeable. See, e.g., Karjala v. Johns-Manville Prods. Corp., 523 F.2d 155, 158-59 (8th Cir. 1975) (applying Minnesota law); Bristol-Myers v. Gonzales, 561 S.W.2d 801, 804 (Tex. 1978); Crocker v. Winthrop Labs., 514 S.W.2d 429, 433 (Tex. 1974). 53
it had decided previously, at least one of which had been brought on both negligence and strict liability grounds: we considered the blood bank's duty of care not in terms of the national standards actually being utilized by blood banks across the country, but by analyzing the reasonableness of the blood bank's conduct given the available testing measures that could have rejected this donor's blood for other reasons. Even as early as Brody v. Overlook Hospital, 66 N.J. 448, 450, 332 A.2d 596 (1975), the Supreme Court remarked outright that a blood bank was under an "obligation to use due care." In sum, these blood bank cases clearly indicate that the standard of care for judging the conduct of blood centers and related groups is the ordinary, reasonable care standard, not the custom-based standard of conduct the trial court used in this case. That the court does not impose “strict liability” makes little difference, it appears to me. Even on a negligence basis it seems to me that the plaintiff on remand would probably be able to prevail on a motion for summary judgment. What disadvantages, after all, could with a cold eye, justify the failure to implement the test? In a previous blood bank case, the Elkerson court noted: in Snyder I, the judge granted summary judgment, concluding that "rational minds simply could not differ" on the issue of whether "the blood bank industry had a duty to high risk screen and/or surrogate test in February of 1982." ... We agreed and affirmed the summary judgment on that point. We see that in Elkerson v. North Jersey Blood Center a court employing traditional negligence principles is able to effectuate the same policies as have motivated the law of products liability. The path to decision in Elkerson and on the A v. NBA avoidability case is a smoother road than the forced march to strict liability that we saw in the Article 6 case in chief. The vitality of negligence law is demonstrated. The essential accomplishment of modern products liability law had been to move us away from the archaic obstacles of privity and to free courts to impose duties no longer hobbled by customary care, and cramped impositions of the constructive knowledge requirement on commercial producers. Reasonable prudence and the expert standard of care, combined with a generous approach to proof of defect by circumstantial evidence are adequate to preserve the jurisprudence of product stewardship. Conclusion The law of product liability has been absorbed into modern negligence law. The law of negligence has cleared its decks of obstructions like the privity requirement. It has imposed vicarious liability on commercial sellers for the defects of those earlier in the chain of 54
distribution. It has focused on the manufacturer where the product departs from its intended form. And it focuses on the designer where the product’s conception presents unreasonable risks. In such cases the norms of reasonably safe design and warnings regarding residual safety hazards are imposed as an expression of a reasonable manufacturer/designer/commercial seller standard of care. Modern negligence law has firmly embraced an objective standard for the person of ordinary prudence. Of a piece is product liability law’s use of an objective, expert standard of care and the expansive constructive knowledge requirement that flows from it. The Product’s Restatement’s § 3 makes robust use of circumstantial evidence to permit a conclusion of defectiveness even when a specific defect cannot be identified. It is an expression and outgrowth of the law of negligence and the doctrine of res ipsa loquitur.161 And so what is the answer to Professor Stapleton? Is there any need for the law of product liability? Have Traynor and Prosser left any legacy? Yes and that is what might be called the `jurisprudence of product stewardship’. It is a pragmatic, rather than a doctrinal legacy. It describes not a fundamental division in law, but is a coherent view of the responsibilities of
Restatement (Third): Products Liability: § 3 Circumstantial Evidence Supporting Inference of Product Defect
It may be inferred that the harm sustained by the plaintiff was caused by a product defect existing at the time of sale or distribution, without proof of a specific defect, when the incident that harmed the plaintiff: (a) was of a kind that ordinarily occurs as a result of product defect; and (b) was not, in the particular case, solely the result of causes other than product defect existing at the time of sale or distribution. Comment: a. History. This Section traces its historical antecedents to the law of negligence, which has long recognized that an inference of negligence may be drawn in cases where the defendant's negligence is the best explanation for the cause of an accident, even if the plaintiff cannot explain the exact nature of the defendant's conduct. See Restatement, Second, Torts § 328D. As products liability law developed, cases arose in which an inference of product defect could be drawn from the incident in which a product caused plaintiff's harm, without proof of the specific nature of the defect. This Section sets forth the formal requisites for drawing such an inference. 55
those who market goods. The origins reach back to the Mississippi case that Prosser lionized in his legendary 1960 article the Assault on the Citadel - the idea of a warranty that runs with the chattel. Stewardship requires that commercial producers conceive, test, construct, and monitor their products with the safety of others as a prime consideration along with efficacy, price, and profit. Stewardship conveys the notion that risk which can reasonably avoided must be . That our responsibility for our work is not extinguished at the point of sale. The notion of product stewardship makes explicit what modern product liability law does. It threads the needle between caveat emptor and the fear of absolute or insurer’s liability that is implied (though usually not delivered) by “strict products liability” court decisions. Product stewardship says that the producer’s moral obligations run with the chattel. The product that transformed product liability law, that ushered in the era of the mass tort - was asbestos. Asbestos inspired product liability law’s farthest reach toward the idea that a seller was responsible for the harm that a product did even beyond the bounds of the knowable that we all learned from the Wagon Mound and Palsgraf cases was a prerequisite for imposition of liability. But that moment - Beshada v. Johns Manville - 20? years ago, was not characteristic of asbestos product liability law. The characteristic response of the courts was anger prompted by demonstration that the principal asbestos producers had abandoned a program of scientific research into the health effects of asbestos when preliminary results showed that the consequences were severe. Only in 1965, as the result of a campaign led by Irving Selikoff of Mt. Sinai hospital, were the physicians and scientists who had observed the suspected health effects of asbestos brought together to share the results of the work at the conference Biological Effects of Asbestos, sponsored by the New York Academy of Sciences. Many courts routinely recited the “fraud” played on their customers by the asbestos producers. Some asbestos manufacturers were compelled to pay punitive damages. But negligence principles were the main driving force. Most workers using the product claimed inadequate warning cases “if we had only known” we would have protected ourselves. Manufacturing defects played no part. Design defect played role where asbestos was an ingredient in a product. Asbestos’s presence rendered a product not reasonably safe. Because of the asbestos experience the landscape has changed. We are less risk tolerant. Particularly in the case of drugs we have accepted the notion that the manufacturer’s duty to learn and improve its product does not end with the premarketing approval granted by the FDA, or even at the point of sale. Manufacturers must monitor the performance of their products in the field. And they must act on what they learn. The manufacturer has a duty to establish an adverse event reporting system, to conduct recalls competently. Post-sale warnings are common. Though no court has yet declared a common law duty to recall a product which it learns is dangerous, that seems but a small step for courts to take. The learned intermediary doctrine is destined to weaken as a defense and to be recognized only as one (very important) prong in the arsenal of manufacturer’s to help their users make safe use of the product. Today a drug manufacturer who failed to 56
maintain a consumer-friendly web site would be so out of tune that it would be evidence of lack of proper product stewardship. Integrated information strategies are the norm today and are increasingly recognized as the duty of the reasonably prudent manufacturer. Product liability law has been absorbed into the law of negligence. It is based on the principle that liability depends on having had a fair chance to avoid the harm done by the product. But that chance is not to be left to chance, nor to the individual capabilities of any given producer. The norm for doing business is that one must make a reasonably safe product, and the safety consequences of that require not only careful original product conception, but reasonably careful stewardship after the product comes into use. For these purposes, the concept of absolute, or strict liability has proven itself to be unneeded. The modern law of negligence is sufficiently robust to have created a law of product stewardship derived from the early insight of the warranty running with the chattel, and based on the courts’ instructive experience of asbestos, industrial machinery, blood products, and drugs. © George W. Conk August 4, 2003
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