Bad Blood: U.K. and U.S.A. - The Jurisprudence of Product Stewardship

George W. Conk*

Introduction

The idea is deeply entrenched in the minds of many that there is something wrong withmodern products liability law. Product liability law has been celebrated by some as “good forAmerica” because it brings “discipline” to corporate America.1 But for others it is a failure thathas damaged manufacturing efforts, and offered punishment where incentive is needed.2 Theidea that there is something wrong with strict liability for products goes back a long way, and hasexcellent pedigree. Prof. Fleming James, Jr., the torts treatise author and early apostle of thestrict liability gospel,3 urged in 1956 at a Torts Roundtable at an AALS4 meeting that “strictliability is to be preferred over a system of liability based on fault wherever you have anenterprise 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.

1 CARL T. BOGUS, WHY LAWSUITS ARE GOOD FOR AMERICA 3, 5 (2001). [“Productsliability is both the common law’s greatest advancement of the twentieth century and a subject ofgreat controversy...The ballot box is not democracy’s only instrument. The people, afterlistening to evidence and reasoned arguments, work their will in the jury box as well. The tortsystem is a system of disciplined democracy...”]; Michael L. Rustad, The Jurisprudence ofHope: Preserving Humanism in Tort Law, 28 SUFFOLK U. L. REV. 1099 (1994) [celebrating thelife and work of Prof. Thomas Lambert, who wrote “The blessing of Beshada [v. Johns ManvilleProducts Co., 90 N.J. 191, 447 A.2d 539 (1982)] is surely a consecration of the aims and goals ofstrict liability to maximize consumer protection, serve as a spur to safety incentives, simplify theplaintiff's burden of proof in products litigation, and achieve a more equitable distribution oflosses from product failure.”]

2 See, e.g., JULES L. COLEMAN, RISKS AND WRONGS, 414-15 (1992) ("Together the ruleof strict liability in conjunction with the design defect tests have wreaked havoc within themanufacturing 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 andtreatment need carrots, not sticks.").

3 Harper & James, Law of Torts (1946)

4 Association of American Law Schools.

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human life and limb...”5 Dean Leon Green responded that he would go “as far as ProfessorJames” in advocating “implied warranty”, and “severe” or “strict liability” for “food-chemicalproducts (that) are supplied ready for immediate consumption”. But “injuries resulting frommechanical products can be more acceptably adjusted as between the victim and themanufacturer...through negligence law than through any other means the judicial process has yetdeveloped.”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 themanufacturer exercised all possible care in the preparation of the product. After an initial periodof celebratory efflorescence scholars and courts have sought to return the law of product liabilityto the familiar confines of negligence law.7 The effort has largely succeeded.8 The law ofproduct liability has been absorbed into the general law of negligence. Product liability law hasthus been normalized. But despite this normalization the idea persists that there is somethingwrong - that there is something severe or different about product liability law and that certainproducers should not be subject to the duty of ordinary care which is characteristic of the law of

5 Fleming James, Jr., General Products - Should Manufacturers Be Liable WithoutNegligence?, 24 Tenn. L. Rev. 923 (1957).

6 Leon Green, Should the Manufacturer of General Products Be Liable WithoutNegligence?, 24 Tenn. L. Rev. 928 (1957).

7 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 productsspread 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 ofthe 1980s, however, judicial (and legislative) enthusiasm forsection 402A's "pro-consumer" doctrine began to falter. Duringthis time, judicial and scholarly attention began to shift away fromexamining why and how the new products liability doctrine shouldbe expanded toward why and how the doctrine should be curtailed.

8 Restatement of the Law (Third), Torts: Products Liability, § 2, comments andReporters’ Notes, passim; Mark Geistfeld, Escola v. Coca Cola Bottling Co.: Strict ProductsLiability 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 ipsaloquitur) defect alone establishes negligence, a seller is always liable for defective products. Negligence becomes equivalent to strict liability...Strict liability for design and warningdefects...has turned out to be indistinguishable from negligence...Consequently, a rule of strictliability for design and warning defects is merely another name for negligence liability.]

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negligence.

The idea persists particularly that drug and medical device product manufacturers shouldnot be treated like other manufacturers. A strong expression of that is the controversialprovision of the Third Restatement of Torts: Products Liability, § 6 (c). The American LawInstitute urges exemption of prescription products from the normal rule of liability for designdefect - 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 GeorgiaCourt of Appeals, an intermediate appellate court, divided. Two panel members rejected the ALIrule. But the third judge embraced the Restatement’s exceptional rule for prescription drugs anddevices.9

Since the ALI’s promulgation of the Second Restatement of Torts drugs have been thesubject of particular attention and dispute in the law of products liability. § 402A’s comment khas been read by some as a defense and by most as a mandate for a case-by-case negligence-based review. The former reporters for the Products Liability Restatement, disdain the lawderived from comment k as “gibberish”. They decided to start over from scratch without evenattempting to “restate” the drug product law of the Restatement 2d era.

This essay contends that drugs, biologics, and medical devices should be treated likeother products. Their sometimes great social utility is irrelevant to the choice of what standardof care should be imposed by the law of torts. Using blood cases as an exemplar, this essayembraces the law of negligence as adequate to the task of judging when a product is defectiveand compensation owed for harm done by it. It explicates the majority and minority views inBryant, and examines three blood cases - one in England and two in the United States - to showthat absorption of product liability law into that of negligence is warranted, that product liabilitylaw has been normalized, and demonstrates that the legacy of the product liability revolution ofthe 1960's is a jurisprudence of product stewardship which provides a coherent standardappropriate 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 1944Justice Roger Traynor, concurring in an exploding soda bottle case, Escola v. Coca ColaBottling Co.10, called for “absolute” liability to the consumer. The first trumpet had sounded inwhat William L. Prosser, in one of the most-cited law review articles ever written, called the

9 2003 Ga. App. LEXIS 945 (decided July 16, 2003).

10 150 P. 2d 436 (Cal. 1944 (Traynor, J., concurring).

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Assault on the Citadel11 - - the defense that only those who contracted with a seller had the rightto sue it for injury suffered due to product defect.12 Nineteen years later in Greenman v. YubaPower Products13 the Supreme Court of California embraced Traynor’s approach. The NewJersey Supreme Court followed in Henningsen v. Bloomfield Motors, Inc.14, announcing that “animplied warranty of merchantability chargeable to either an automobile manufacturer or a dealerextends to the purchaser of the car, members of his family, and to other persons occupying orusing it with his consent. ”

Prosser, the Reporter for the second Restatement of Torts, heralded the indomitable trendtoward consumer protection. In section 402A of the new Restatement the American LawInstitute (ALI) in 1965 embraced strict liability for defective products “even if made with allpossible care”.15 Prosser soon announced the Fall of the Citadel. Evolution had become

11 Some might say that the first trumpet was sounded by Judge Cardozo, in MacPhersonv. Buick Motor Co., 111 N.E. 1050 (N.Y. 1916), where in a negligence case the court held that amanufacturer is liable to the ultimate suer of the product, despite the absence of a contractualrelationship. But Cardozo was no crusader and he did not elaborate (or campaign for) all theimplications 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 comprehensiveargument for an enterprise liability and strict liability approach to product liability law, thencampaigned for the change over the next 20 years until he swung a majority of the CaliforniaSupreme court to his views. See Mark Geistfeld’s lucid doctrinal analysis of Traynor’s famousconcurrence in Rabin, et al., supra, N*.

12 William L. Prosser, The Assault upon the Citadel (Strict Liability to the Consumer), 69YALE L.J. 1099 (1960).

13 377 P. 2d 897 (Cal. 1963).

14 161 A.2d 69 (N.J. 1960).

15 See, Restatement of Torts (2d), § 402A: Special Liability of Seller of Product forPhysical Harm to User or Consumer

(1) One who sells any product in a defective condition unreasonably dangerous to the user orconsumer or to his property is subject to liability for physical harm thereby caused to theultimate 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 thecondition 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

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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 inunprecedented numbers followed.

All but a few states embraced the Restatement.17 Section 402A’s commandments andcomments achieved almost scriptural status, the hermeneutics of which became a widelypracticed judicial art. But "absolute liability" was an impossible goal, unmanageable becauseultimately 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 contractualrelation with the seller.

Caveat:

The Institute expresses no opinion as to whether the rules stated in this Section may notapply

(1) to harm to persons other than users or consumers;

(2) to the seller of a product expected to be processed or otherwise substantially changedbefore 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 strictliability, making the seller subject to liability to the user or consumer even though he hasexercised all possible care in the preparation and sale of the product.

16 William L. Prosser, The Fall of the Citadel (Strict Liability to the Consumer), 50Minn. L. Rev. 791, 799 (1966) ["[B]y placing their goods upon the market, the suppliersrepresent to the public that they are suitable and safe for use; and by packaging, advertising andotherwise they do everything they can to induce that belief"].

17 Harvey S. Perlman, Delaware and the Restatement (Third) of Torts: ProductsLiability, 2 Del. L. Rev. 179 (1999). [Exploring the anomalous jurisprudence of a state whichgrounded its product liability law in contract rather than in tort.]

18 See, for example, Myrlak v. Port Authority, 723 A. 2d 45 (N.J. 1999) [chair founddefective 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, plaintiffwas forty-three years old, six feet six inches tall, and weighed approximately 325 pounds. At thetime of the accident, plaintiff had been seated in the chair performing his duties for

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approximately one hour and forty-five minutes. He suddenly heard a loud noise, and the back ofhis chair cracked and gave way.] But such results are less obvious than might appear at firstblush. 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 productdefective?':

- If (there is sufficient evidence that) the product failed to fulfill amanifestly intended function, then the plaintiff can proceed to thejury. 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 characterizewhat type of defect caused the failure.

- If (there is sufficient evidence that) the product failed to complywith an applicable product safety statute or administrativeregulation, then the plaintiff can proceed to the jury. He or shedoes not need to show a RAD.

- A jurisdiction might allow the approach that if (there is sufficientevidence that) the product had a manifestly unreasonable design, then the plaintiff can proceed to the jury. He or she does not needto 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 dependson classification of defect:

. Where a product contains a manufacturing error it is defective;

- A product "is defective in design when the foreseeable risks ofharm posed by the product could have been reduced or avoided bythe adoption of a reasonable alternative design by the seller orother distributor, . . . and the omission of the alternative designrenders the product not reasonably safe;"

. A product "is defective because of inadequate instructions orwarnings when the foreseeable risks of harm posed by the productcould have been reduced or avoided by the provision of reasonableinstructions or warnings by the seller . . . and the omission of theinstructions or warnings renders the product not reasonably safe."

In the absence of regulatory standards on how much weight a chair should hold, one

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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 `strictliability’ is a fair description of the effect on the plaintiff’s burden of proof of the combinationof legal doctrines which have been applied, principally implied (judicially imposed) warranty intort, or negligence found as a matter of law - commonly by employing robust formulations ofdoctrines such as res ipsa loquitur.19

might get to the last stage of this analysis (should the chair have been made stronger, and shouldthere have been weight-limit warnings) before being able to answer the question of productdefect in Myrlak's case. In the end there are two plain questions to be answered - how muchweight should a chair hold? And should users be warned of that limit?

19 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 aproduct which “departs from its intended design even though all possible care was exercised inthe preparation and marketing of the product”. In such cases, according to Products LiabilityRestatement § 3, plaintiffs need not prove “a specific defect”but may rely on a robust form ofcircumstantial proof derived from the classic doctrine of res ipsa loquitur, which the court inMyrlak, supra, n*, called the "indeterminate product defect test". It is necessary to show merelythat “the harm sustained by the plaintiff...(a) was of a kind that ordinarily occurs as a result ofproduct defect; and (b) was not, in the particular case, solely the result of causes other thanproduct defect existing at the time of sale or distribution.”

As a matter of legal doctrine “manufacturing defect” liability can be understood as theimposition on manufacturer or seller of either

a) an implied warranty - the obligation in law to deliver a product which meets thestandards of safety that the manufacturer/seller has 1) declared for itself, or 2) represented toothers, 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 reasonableperson in the victim’s position has a clear right to expect. This is most often established by anexpansive use of the rule of res ipsa loquitur - that the circumstances of the injury are sufficientevidence that there was negligence by someone in the chain of design, manufacture anddistribution. Barker

These standards are normatively coherent and need not be altered. Strict liability is anadequate 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 itobscures the fact that such liability is based on demonstrated departure from plainly justifiablenorms of conduct. A realistic assessment of history’s inertial force compels the recognition thatthe language of the law will not change in this area - because the practice of the law will notchange and because the term recognizably conveys the message that liability my be imposed onan actor which is itself without fault - such as an assembler or a retailer upon whom a duty toinsure is imposed via the doctrine of vicarious liability.

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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 faultlessconduct nonetheless yields liability, but rather that injurious conduct placed an unjustifiedburden 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 oflaw.22 Contemporary judicial iterations of the nuisance-derived concept of strict liability reflectthe idea that certain conduct carries a normative duty of repair, as with toxic industrial pollutionof wetlands,23 or the determination that producers have not justified their goods’ presence on the

20 159 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).

21 Arthur Ripstein, Philosophy of Tort Law, in THE OXFORD HANDBOOK OF

JURISPRUDENCE AND PHILOSOPHY OF LAW (2001) 685, Coleman & Shapiro,eds. [Liabilityshould be “tied to the violation of a defensible norm of conduct.”]

22 The literature on modern strict liability is vast, but see, for example, the caseshighlighted in an excellent recent historical essay. Jed Handelsman Shugerman, Note: TheFloodgates of Strict Liability: Bursting Reservoirs and the Adoption of Fletcher v. Rylands in theGilded Age, 110 Yale L.J. 333 (2000) [“The 1880s ushered in a new wave of industrialsuccess...In the first years of this economic expansion, state courts were apparently still cautiousand avoided the Rylands controversy. However, once the recovery had lasted several years, moreand more state courts adopted Rylands: Michigan, Illinois, Iowa, California, and Colorado. Inaddition, Nevada and Alabama adopted rules similar to Rylands, and Wisconsin recognized itsvalidity. Whereas Massachusetts and Minnesota had focused mainly on common urban anddistinctly nonindustrial hazards (like snow falling off roofs),these other courts began applyingstrict liability to big industry, mining, and railways.

In 1886, in the midst of strong growth, Pennsylvania aggressively attacked and rejectedRylands. However, after 1890, Pennsylvania applied strict liability to numerous majorindustries, including coal mining, iron production, and oil refining. Beginning in 1891, Ohioadopted Rylands's rule in cases of gas explosions, bursting water tanks, and explodingnitroglycerine. 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 wasunnatural and "destructive." Maryland, South Carolina, and indeed, even New York [home ofLosee v. Benjamin- GWC] and New Jersey employed Rylands in imposing strict liability uponindustry, mining, gas companies, and railway companies in the 1890s.”]

23 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 evolvedso that a landowner is strictly liable to others for harm caused by toxic wastes that

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market by safety, utilitarian, or other policy measures.24 Strict liability is a species ofnegligence, the general law of torts.

It is the latter approach which underlies the narrow standard of liability adopted by theProducts Liability Restatement in § 6(c).25 That rule could be restated to say that drug andmedical device manufacturers are liable for design defect only if no identifiable group is, onbalance, benefitted by the product, or if another product comes on the market which is so farsuperior that continued distribution of the existing design has become unreasonable. An instanceof such a defective product would be the continued sale of HIV or hepatitis C infected andunpasteurized, anti-hemophilic factor concentrate after pasteurization methods had been reducedto 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, weoverrule Marshall v. Welwood...and adopt the principle of liability originallydeclared in Rylands v. Fletcher. The net result is that those who use, or permitothers to use, land for the conduct of abnormally dangerous activities are strictlyliable for resultant damages.

24 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 pesticidedesign which achieved its greater safety by using a substance later banned as destructive of theozone layer:

In strict products liability cases, juries are enjoined to determine on the basis of arisk-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 twodistinct product designs. A jury ought not, in this context, be called upon toengage in a risk-risk analysis to determine which risk ultimately must becounterbalanced with the products' utility. In permitting a jury to do so, the Courtdelegates its own nondelegable responsibility for determining as a matter of lawwhether a duty may appropriately be placed on a manufacturer.”

25 Products Liability Restatement § 6) provides:

(c) A prescription drug or medical device is not reasonably safedue to defective design if the foreseeable risks of harm posed bythe drug or medical device are sufficiently great in relation to itsforeseeable therapeutic benefits that reasonable health-careproviders, knowing of such foreseeable risks and therapeuticbenefits, would not prescribe the drug or medical device for anyclass of patients.

26 See Henderson & Twerski, Drug Designs Are Different, supra, n*; and George W.Conk, The True Test...

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Such conduct is the subject of Gullone v. Bayer Corporation, an action recently filed onbehalf 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 andcompensatory damages are understandably sought. In a recognition of the doctrinal emptiness of“strict products liability” the Gullone plaintiffs stated only counts of negligence, negligence perse, fraudulent omission and concealment, and breach of implied warranty.27 Shortly before thecomplaint was filed the export issue had been addressed in an investigative report in The NewYork Times.28

27 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 onbehalf of “all persons residing outside the United States (and their estates, infected spouses andchildren) who used any non-heat treated blood factor concentrate...in the period from1978 to1990 and who contracted HIV and/or HCV...” The defendants are the four producers of anti-hemophilic factor concentrate (a pooled donor blood product). Named as plaintiffs are citizensand residents of Italy, Germany, and the United Kingdom who suffered from classic hemophiliaor from Von Willebrand’s disease, two blood-clotting disorders treated with defendants’products.

28 See also Walt Bogdanich and Eric Koli, 2 Paths of Bayer Drug in 80's: Riskier OneSteered 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 ofblood-clotting medicine for hemophiliacs -- medicine that carried a high risk oftransmitting AIDS -- to Asia and Latin America in the mid-1980's while selling anew, safer product in the West, according to documents obtained by The NewYork Times.

The Bayer unit, Cutter Biological, introduced its safer medicine in late February1984 as evidence mounted that the earlier version was infecting hemophiliacswith H.I.V. Yet for over a year, the company continued to sell the old medicineoverseas, prompting a United States regulator to accuse Cutter of breaking itspromise to stop selling the product.

By continuing to sell the old version of the life-saving medicine, the recordsshow, Cutter officials were trying to avoid being stuck with large stores of aproduct that was proving increasingly unmarketable in the United States andEurope.

Yet even after it began selling the new product, the company kept making the oldmedicine for several months more. A telex from Cutter to a distributor suggestsone reason behind that decision, too: the company had several fixed-pricecontracts and believed that the old product would be cheaper to produce.

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As we shall see, both the common law New Jersey case Elkerson v. North Jersey BloodCenter, and the U.K. EU product liability directive-based case A and others v. National BloodAuthority, show that the traditional doctrinal approach adopted in Gullone, which does not relyon the tangled language of `strict liability in tort’ for products is entirely adequate to thequestion of liability for sale of avoidably dangerous drug products. By extension, the adequacyof modern negligence doctrine to the problems of infected blood - which legislatures and courtshave 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 adequacyvindicates the negligence-based standard of care - reasonableness of conduct under all thecircumstances.

The Decline and Fall of Strict Liability in Tort for Products

Courts developed, for design defect and inadequate warning claims, measures of productdefect 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 witheredat its birthplace - the ALI. The Products Liability Restatement30 in 1998 embraced a negligencebased view of product defect. It cabined the strict liability language of the 2d Restatement tomanufacturing defects - products which depart from specification to pose dangers not present inthe standard product. But the sense that there is something different, even unreasonable aboutproduct liability law survived in the 3rd Restatement’s stringent approach to prescription drugsand other medical product defect claims,31 and in its exclusion of blood products from the scope

29 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 productsliability, fault's true position at the center of tort law is becoming clearer by the day. ”]

30 AMERICAN LAW INSTITUTE, RESTATEMENT OF THE LAW (THIRD), TORTS: PRODUCTS

LIABILITY (1998), hereafter variously referred to as the Products Liability Restatement and thenew Restatement.

31 See Products Liability Restatement § 6(c), which would allow only claims forinadequate warnings and manufacturing defects for drugs or medical devices. The Reportersassert that challenges to drug design should not be allowed because they are unmanageablepieces of litigation because proof would require replication of the FDA approval process. SeeJames 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 theFacts While Reshaping the Law, in Rabin, et al, supra, n*. [Arguing that the privity bar toconsumer and bystander claims against product manufacturers served usefully as a screen against“factually unmanageable claims”.]

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of the new Restatement.32

But if modern product liability law is fundamentally sound, as practiced, if not always asunderstood or expressed, the argument for exclusion of blood product claims, and for a special,more manufacturer-deferential liability test for prescription pharmaceuticals and medical devicesis vitiated. A bit more history is in order.

In 1988, in Brown v. Superior Court (Abbott Laboratories), the California SupremeCourt, the font of modern `strict products liability law', held that the concept is not appropriatefor drugs. Justice Mosk wrote that its application to drugs would retard the development andavailability 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 medicaldevices. For such medical products the Reporters declared that liability would only “rarely” beimposed. A product is defective under § 6(c) only if it provides no net benefit for any foreseeableclass of patients. The ALI rule was challenged after promulgation. The exclusion of medicaldevices from ordinary liability standards,34 the application of the stringent rule even to cosmeticmedical products, and to certain blood products and to vaccines was challenged.35 In an essaytitled `Is There a Design Defect in the Restatement (Third) of Torts: Products Liability?’ Iargued 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

32 Definitions, § 19 (c): “ Human blood and human tissue, even when providedcommercially, are not subject to the rules of this Restatement.”

33 751 P. 2d 470 (Cal. 1988). [The court, citing a manufacturing defect Escola v. CocaCola, "latent" design defect Greenman v. Yuba Power Products, and a machine guarding designdefect Barker v. Lull Engineering (design defect risk/utility factors) case held strict liability to beinappropriate but reserved the possibility of a "negligence" based design defect claim.

34 Michael D. Green, Prescription Drugs, Alternative Designs, and the Restatement(Third): Preliminary Reflections, 30 Seton Hall L. Rev. 207 (1999).

35 Richard L. Cupp, Jr., The Continuing Search for Proper Perspective: WhoseReasonableness Should be at Issue in a Prescription Product Design Defect Analysis?, 30 SetonHall L. Rev. 233 (1999).

36 109 Yale L.J. 1087 (2000).

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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 trialjudge’s grant of summary judgment to the manufacturer. The court allied itself with the 1984Feldman v. Lederle Laboratories line of cases which treated the unavoidability of danger indrugs as a factual defense to be proven on a case by case basis - not a categorical rule ofexclusion of drugs from ordinary liability rules. And in Bryant v. Hoffman La Roche39 a Georgiaintermediate court rejected the Products Liability Restatement’s § 6(c).

The ALI Reporters, in rebuttal, retreated and embraced a modified alternative saferdesign test for prescription drugs and medical devices. The Reporters would limit product safetychallenges to comparison with FDA-approved products actually available on the market at thetime of sale of the accused product. In any other instance, they said, courts are incompetent tojudge drug product design defect claims because plaintiffs would have to replicate the complexFDA 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 otherclasses of products. For non-prescription products of all kinds no alternative need be shown tobe on the market. Not even a prototype needs to be produced.40

Countering the former ALI reporters Professors Henderson and Twerski who see courtsas incompetent to judge drug and medical device designs, `The True Test’41 offered three casestudies of drugs for which liability could be found under the alternative safer design test ofsection 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 extractedfrom huge pools of blood donors) which in the 1970's and early 19080's had been the source ofan epidemic infecting with Hepatitis and HIV practically the entire hemophiliac populations ofthe US, Western Europe, and Japan; (2) the anti-acne drug Accutane (a vitamin A acid protectedby a method patent issued for the enteral treatment of skin cancer for which a safer design was

37 618 N.W. 2d 827 (Neb. 2000) [Analyzing the problem in conventional `consumerexpectations’, Restatement 2d terms - relying on § 402A and comment k - unavoidably unsafeproducts, and reserving on whether to adopt § 2(b) reasonable alternative design test for allproducts, including drugs.]

38 241 N.W.2d 822 (1976).

39 2003 Ga. App. LEXIS 945 (Ga. App. 2003). See also Bennett v. Eli Lilly, 821 So. 2d794 (Miss. 2002) [relying on Freeman, supra, N*, and embracing the case by case approach.

July 16, 2003

40 Products Liability Restatement, § 2, cmt f;

41 49 UCLA L. Rev. (2002).

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offered by Roche as its patent-monopoly neared expiration; and (3) the Sabin live-virus oralpolio vaccine, which was the only source of paralytic polio in the United States for 20 years untilits removal from the market in 2000 and its replacement by the enhanced Salk injected killedpolio virus vaccine which had been relied upon exclusively in Europe since the early 1980's andwhich carried no risk of causing the disease it sought to prevent.42

I had argued earlier that unpasteurized Anti-hemophilic factor concentrate wasdefectively designed. And if § 6(c) had been the law the manufacturers would have obtainedsummary 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 ofinfection with chronic, even ultimately fatal disease. The full panoply of product liability causesof 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 protectedblood fractionators from the reach of modern product liability laws. Many states characterizedtransfusion of blood solely as a medical service not involving a product sale. The approach hadoriginated 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

42 George W. Conk, The True Test: Alternative Safer Designs for Drugs and MedicalDevices in a Patent-Constrained Market, 49 UCLA L. Rev. 737 (2002).

43 109 Yale L.J. at 1133.

44 123 N.E.2d 792 (N.Y. 1954).

45 Institute of Medicine, HIV AND THE BLOOD SUPPLY: AN ANALYSIS OF CRISIS

DECISIONMAKING 223 (1995) [hereinafter IOM Report].; The Louisiana statute is typical. InDavid v. Our Lady of the Lake Hospital, 2003 La. LEXIS 1956 (Louisiana 2003) the courtobserved:

In 1968, the legislature enacted Louisiana's first blood shieldstatute. Former LSA-C.C. art. 1764 (now repealed) was amendedby Act 301 of 1968, adding section B, as follows:

Notwithstanding the provisions of Section A.2. ofthis Article, the implied warranties ofmerchantability and fitness shall not be applicableto a contract for the sale of human blood, bloodplasma or other human tissue or organs from ablood bank or reservoir of such other tissues ororgans. Such blood, blood plasma or tissue ororgans shall not for the purposes of this Article beconsidered commodities subject to sale or barter butshall be considered as medical services.

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action were generally preserved in some form. But since products liability actions wereconsidered to be strict liability actions plaintiffs infected by blood products did not have thebenefit 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 bloodclaims, although in New Jersey, a state without a blood shield statute, claims were allowed to goforward under the state’s product liability act, making possible settlements of more than tokenvalues.46

The only viable remedy has been in negligence for transfusion related injury. Bothcourts and legislatures have chosen to leave the consequences of blood-related accidental illnesswhere it falls - unless a fault basis for liability appears.

The Institute of Medicine of the National Academy of Sciences urged consideration of ano-fault compensation system for blood product injuries - such as exists for injuries caused bymandatory childhood vaccines.47 But the suggestion proved to have no traction. The childhoodvaccine program was justified by the mandatory character of childhood vaccinations and theneed to maintain a high degree of public compliance, together with the need to maintain financialviability for a relatively low cost/low margin product of private producers. Blood shield lawseffectively protected the producers of blood products from liability and the cases which werepressed were plainly grounded in fault-based allegations such as failure to develop or implementpasteurization techniques which would effectively preclude transmission of viruses.48 In the case

*****By Act 611 of 1981, a new civil code article designated asArticle 2322.1, and by Act 331 of 1981, a new sectiondesignated as LSA-R.S. 9:2797 were enacted, providingthat strict liability "shall not be applicable to physicians,hospitals ... or nonprofit community blood banks ... in the... transfusion ... of human blood ... which results intransmission of viral diseases ... undetectable byappropriate medical and scientific laboratory tests."

46 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 theoverriding purposes of product liability law - to spread the burden of damages which flow fromsuch injuries onto those responsible for the products' design and manufacture."]

47 National Childhood Vaccine Injury Compensation Act established the nationalVaccine Injury Compensation Program. 42 U.S.C. § 300aa-10, et seq.

48 IOM REPORT; BLOOD

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of blood products which could not be pasteurized,49 cleansed with a detergent, or manufacturedfrom pure recombinant material,50 infected plaintiffs alleged negligent failure to properly screendonors.51

HIV and Hepatitis C infection of hemophiliacs’ Factor VIII concentrate blood productswas a manufacturing defect, the reporters responded. The hemophiliacs’ strict liability claimsagainst unpasteurized blood concentrate makers had been properly barred. Their claims were notfor 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 manufacturingdefects for which manufacturers are generally held strictly liableunder section 2(a) of the new Restatement.

The reporters observed that although blood shield statutes had blocked strict liabilityclaims by the infected patients they retained traditional negligent manufacturing claims under theRestatement (2d) of Torts, § 395,53 which “force(d) plaintiffs into the unusual position of beingrequired to prove that the providers were negligent in allowing the harmful contaminants to passthrough their screening and production processes.” Because customary industry methods couldnot identify Hep C or HIV-infected donors until the early 1980's, and the industry argued it haddeveloped a pasteurized product as soon as it could do so, hemophiliac plaintiffs had not fared

49 Heat treatment has been effective for anti-hemophilic factor concentrate, a pooledprotein extracted from blood, but not for other blood products. IOM REPORT AT *.

50 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 substituteproduct for anti-hemophilic factor concentrate]

51 Snyder v. American Association of Blood Banks, 676 A.2d 1036 (N.J. 1996) [juryverdict affirmed against standard-setting private, tax-exempt organization with substantial powerover the operation of blood banks. The NGO was charged by hepatitis-infected plaintiff withunreasonable failure to implement donor blood testing requirements.]; cf. N.N.V. v. AmericanAssociation 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 thecircumstances, including the state of knowledge and recommendations of other relevantorganizations, as they existed at the time the AABB adopted its standards.”]

52 William L. Prosser, THE LAW OF TORTS 659 n.72 (4th ed. 1971)[“Since proper designis a matter of reasonable fitness, the strict liability adds little or nothing to negligence [on thepart of the manufacturer]..."].

53 Text of § 395

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well in the cases that went to trial.54 The subsequent token settlements seemed fair in the face ofsuch weakness on the merits, in the reporters’ eyes. And the Products Liability Restatement’sexclusion of blood and tissue from the rules of the Restatement was an accurate reflection of thestate of the law.55

The § 395 doctrine of negligent manufacturing placed the hemophiliacs in the posturethat plaintiffs had generally occupied before the Second Restatement’s § 402A. They had toprove negligence someplace in the manufacturing process - without the benefit of the doctrinesof implied warranty/strict liability standard for manufacturing defects, the expert standard ofcare, the robust applications of res ipsa loquitur, and other plaintiff-friendly doctrines of modernproduct liability law. The reporters inadvertently confirmed the critique of the Restatement. Ifcourts had shown themselves competent to judge heavily regulated blood products56 bynegligence standards, then courts could also judge the designs of prescription drugs and devices. The Products Liability Restatement’s anomalous manufacturer-protective § 6 (c) rule ofexclusion was therefore unwarranted.

The reporters’ approach contradicts the Products Liability Restatement itself. ProfessorsOwen and Stuart Madden observed:

Under the Restatement Third, Torts: Products Liability, the[Restatement 2d’s] concept of defective condition unreasonablydangerous has been replaced by the definition of a manufacturing

54 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).

55 James A. Henderson, Jr. and Aaron D. Twerski, Drug Designs Are Different, 111 YaleL.J. 151 (2001).

56 State and federal regulations apply to both proprietary and charitable sectors of theblood-banking industry. The Food and Drug Administration (FDA) inspects and licenses bloodbanks and other blood facilities. See 21 U.S.C.A. § 321(g)(1)(B) (broadly defining "drugs" toinclude "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention ofdisease," which includes blood and blood products); 21 U.S.C.A. § 360(b) (requiring processingestablishments, 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 thatparticipate in interstate commerce); 21 C.F.R. 5.10(a)(1) and (5) (1995) (delegating to FDAauthority vested in the secretary, DHHS, and PHS in the Food, Drug and Cosmetic Act (21U.S.C.A. § § 301-95) and in 42 U.S.C.A. § § 262 and 263); 21 C.F.R. 607.3(b) (1995) (definingblood 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 ofblood). 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.

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defect as one which "departs from its intended design even thoughall possible care was exercised in the preparation and marketing ofthe product."57

But such comfortable reliance on the departure-from-specifications test of manufacturingdefect (of which Professor Henderson was the original proponent)58 was disturbed by the Anglo-Australian scholar Jane Stapleton’s critique. In her view infected-product cases highlight theabsence of any fundamental rationale for the prevailing tri-fold classification of product defectsembraced by the Products Liability Restatement (defects in manufacturing, design, andwarning).59 Professor Stapleton suggests that it is unlikely for there to be any agreement onwhere and why lines should be drawn before a full debate on the issue has occurred. Toillustrate, she observed:

A recent high-profile academic debate has unwittingly confirmedthese points. In 2000, George Conk launched a scathing attack onhow the Restatement Third had, under § 6, given especiallyprotective treatment to prescription drugs and medical devices. Asan exemplar of the problems he argued would be created by §6,Conk referred to the alleged "design defect" in blood infected withHep C. In their response article, the Reporters attempted to rebutthis classification by merely asserting that "the plaintiffs in theblood cases did not claim that the blood products that harmed themwere defectively designed... . Instead, the contaminants that causedtheir harm constituted manufacturing defects... ." Conk's otherwisepowerful reply seems just as ad hoc on the classification point.60

Appreciative of the description of my work as “powerful”, and surprised by the

57 David G. Owen and Stuart Madden, Madden & Owen on Products Liability (3d ed. 2000).

58 See James A. Henderson, Jr., Judicial Review of Manufacturers' Conscious DesignChoices: The Limits of Adjudication, 73 Colum. L. Rev. 1531, 1543 (1973) [His seminalarticle’s description of manufacturing defects is more ambiguous than is the Products LiabilityRestatement standard: “imperfections that inevitably occur in a typically small percentage ofproducts of a given design as a result of the fallibility of the manufacturing process. Adefectively manufactured product does not conform in some significant aspect to the intendeddesign, nor does it conform to the great majority of products manufactured in accordance withthat design.”]; David G. Owen, Manufacturing Defects, 53 S. Carolina L. Rev. 851 (2002)

59 Products Liability Restatement, supra, n*, § 2.

60 Jane Stapleton, Bugs in Anglo-American Products Liability, 53 S. Carolina L. Rev.1225 (2002). (footnotes omitted)

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characterization of my critique as “scathing” (I thought it rhetorically restrained), the suggestionwas less welcome that I had helped to “unwittingly confirm” the inadequacy of the conventionalAmerican trifurcation of categories of product defect.

But the classification point is important. The tri-partite classifications are coherent, ifincomplete. Stapleton’s challenge suggests that the classification choices are not based onprinciple and that the consequences of the classification may therefore be incoherent. But thecategories have value. The reporters’ characterization of viruses’ presence in blood as amanufacturing defect is mistaken. The mistake perpetuates the impression that there issomething wrong with product liability law. The distinction between design and manufacturingdefects is important normatively. To misstate them as the reporters did only confirms the doubtsabout its legitimacy which haunts modern products liability law.

The reporters suggested that but for the blood shield laws hemophiliac plaintiffs wouldhave recovered for manufacturing defects. But it would have been an injustice to impose strictliability for manufacturing defects on the manufacturers of anti-hemophilic factor concentrate. Liability for manufacturing defects would not have been warranted until after the great majorityof recipients of anti-hemophilic factor and other blood products had been infected with HepatitisC and/or HIV. Not until January 1983 did an effective donor blood screening test for Hep Cbecome available,61 and shortly after that effective anti-viral pasteurization techniques began tobe implemented.62 From the point that such new methods were adopted by manufacturers,imposed by government, or by other standard setters manufacturing defect became appropriatefor “rogue” products - those which departed from design specifications or requirements. Butbefore that point plaintiffs properly bore the burden of challenging the reasonableness ofmanufacturing methods and of industry practice. The product defects were matters of proof innegligence, not the subject of strict liability for manufacturing defects.

Until such standards were set or declared beginning in 1983 the bases for manufacturingdefect `strict liability’ against the fractionators did not exist. The manufacturers of Factor VIIIconcentrate did not depart from any specification imposed by the government. Nor did they

61 INSTITUTE OF MEDICINE, HIV AND THE BLOOD SUPPLY: AN ANALYSIS OF CRISIS

DECISIONMAKING 6 (1995) (the IOM Report). [Committee concluded "that it was reasonable torequire blood banks to implement these two screening procedures (screening male donors for ahistory of sexual activity with other males and screening donated blood for the anti-HBcantibody) in January 1983."] This is the period of time which is the subject of Elkerson v. NorthJersey Blood Center

62 In June 1982 Baxter Healthcare applied for FDA licensing of heat treated anti-hemophilic factor concentrate. Approval came in March 1983. Miles (Cutter) applied in August1983 and received approval in January 1984. Alpha Therapeutics' application was filed inDecember 1982. Approval came in February 1984. Armour Pharmaceutical applied inDecember 1982, and was approved in January 1984. See IOM Report, supra note 140, at 92.

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depart from any specification that they had declared for themselves. Nor did they breach anyindustry standard. In fact the relevant industry standards later came under attack as inadequateand tort liability was imposed on the standard setters.63

Nor did the fractionators represent that their product was free of viral contamination. Infact, the presence of hepatitis C among hemophiliacs receiving blood products was so well-known that they were often paid as donors because their anti-bodies to hepatitis werecommercially valuable in immune globulin production.64 Viral contamination of factorconcentrate was not a flaw, a departure from design expectations, or even from reasonableconsumer expectations. Rather hepatitis was considered an acceptable risk, one left by themanufacturers to their customers' physicians to manage medically.65 "(H)epatitis was viewed asan acceptable risk by the government regulatory agencies responsible for the safety of blood andblood products, the plasma fractionation industry, the physicians who treated the individualswith hemophilia, and the individuals with hemophilia," wrote the IOM.66

Thus none of the bases existed for the imposition of “strict” liability for a manufacturingdefect. Even without the benefit of blood shield laws the industry defendants could justly haveargued that plaintiffs infected before 1983 could not show any breach of implied warranty - theobligation in law to deliver a product which meets the standards of safety that themanufacturer/seller has either declared for itself, represented to others, or is bound by law tomeet. Nor could negligence per se be found by any departure of the product from that which areasonable person in the victim’s position had a clear right to expect. The presence of infectious

63 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 in1984 unreasonably resisted recognizing that blood transmits HIV.That resistance led the AABB to sacrifice an uncontaminatedsupply of blood for one that was contaminated, but more readilyavailable. The jury could have found that if the AABB had notbeen so intransigent, its members, particularly the BCBC, wouldhave instituted surrogate testing. Further, the jury could havefound that if the BCBC had instituted surrogate testing, it wouldhave rejected Unit 29F0784. Rejecting that unit could haveprevented the transfusion of contaminated blood to WilliamSnyder. It could have saved his health and his life. Against thisbackground, we believe that the imposition of liability on theAABB is both fair and reasonable.

64 Blood saga? Blood? IOM report?

65 IOM report, supra, N*at 93.

66 IOM report, N*, at 82

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agents in blood was widely accepted, no effective means of preventing it were yet known,67 andthe product was certainly useful for severe hemophiliacs, despite its dreadful risks. Infection dueto 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 containmanufacturing 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 manufacturingdefects as a basis for liability for prescription products. The classification selection thus hasnormative consequences. The fairness of product liability law would rightly be in doubt if thereporters’ classification of infected blood as a manufacturing defect were in fact the law. Ifliability were to be imposed in such circumstances, the blood shield laws would have toembraced 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 theposition 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 ofblood products from products liability law. And drug and medical device manufacturers wouldjustly seek the protection which the new restatement has afforded them. But as we shall see suchprotection 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 nothave been prevented by reasonable effort, including by withholding distribution of a product thedangers of which exceed its benefits.68 To return to the beginning, even in Rylands v. Fletcherthe strict liability ruling was apparently engendered by the lack of a remedy against the negligentengineer who constructed the reservoir.69 And at the current moment no one suggests thatcigarets contain manufacturing defects. That debate has focused on addictiveness and thetension between the industry’s knowledge, its promotional efforts, and smokers’ knowledge ofthe product’s dangers,70 both problems handled adequately by contemporary apportionment

67 As a matter of historical fact, it is the tardiness of the manufacturers’ development ofheat-treatment methods which killed all viruses that underlies the product design defect and §395manufacturing negligence claims against the blood fractionators.

68 Negatives are notoriously hard to prove. So this must be recorded as a kind of dare. Ihave never read (or read of) a case which contradicts my assertion.

69 Gary T. Schwartz on Rylands in Cane & Stapleton?

70 Gary T. Schwartz, Tobacco, Liability and Viscusi, 29 Cumb. L. Rev. 555 (1999)

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doctrines.71

But we will see in Section * that such an imposition of strict liability was adopted byJudge Burton on the case in chief in A and others v. National Blood Authority. Fortunately theday was saved for the plaintiffs by his better founded approach on the “avoidability’ case whichprovided a negligence basis for liability in the NBA’s tardy adoption of an effective screeningtest for Hepatitis C anti-bodies in donors’ blood.

The overall product design in anti-hemophilic factor was what Professor Henderson hascalled the result of “conscious design choice”.72 The fractionators accepted the transmission ofviruses 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 issuecould not be resolved “by reference to the manufacturer's own design or marketing standardsbecause those standards are the very ones that plaintiffs attack as unreasonable.”74 The decisionnot to pasteurize, like decisions on whether to include safety devices on machines or toflameproof fabrics, was a defect of design, a failure of imagination or a conscious decision toimpose the risk of infection on the patients rather than bear additional manufacturing costs.

Product Stewardship and the Duty of Inventiveness - Design Liability in ModernNegligence Law

71 Restatement of Apportionment, discussion in Tentative Draft of 3rd Restatement, BasicPrinciples criticizing Dafler v. Raymark Industries.

72 Henderson supra, N* on conscious design defect

73 Dominating the commercial sector aremanufacturers or fractionators of plasmaderivatives. In the early 1980s, fractionatorscollected approximately eighty percent of plasmafrom paid donors. The voluntary sector provided theremaining twenty percent. Fractionators poolplasma from thousands of donors and process it toproduce large batches of plasma derivatives, such asclotting factors for hemophiliacs. Each batchcontains enough clotting factor to treat thousands ofpatients. Institute of Medicine, HIV and the BloodSupply: An Analysis of Crisis Decisionmaking 15(1995) (the IOM Report).

Snyder, supra, n* at 1039.

74 Restatement (Third) of Torts: Products Liability, § 2, comment a.

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Stapleton argued in her essay, Bugs in Anglo American Products Liability Law,75 thatthere is no coherent justification for the differential treatment of manufacturing defects understrict liability principles, while a reasonableness standard prevails for design defect and warningcases. Her argument commands attention if under our law the consequences are great fordifferences that are slight. If one need only prove that causal relationship between product andillness - 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 aset of circumstances leading to liability as a matter of law) and a more rigorous burden of proofof fault is preserved for other claims, the coherence of the tri-partite classification retains somevitality, if not complete adequacy.

Professor Stapleton had consulted for the defense in the 2001 High Court of England trialof A. and others v. National Blood Authority and another.76 There the Judge, Sir Michael JohnBurton, held for the plaintiffs. Relying on the strict liability rationale of the 1985 EC productsliability directive,77 he declared that the public legitimately expected blood to be safe and heexcluded as an irrelevant circumstance, on the case in chief, the substantial defense that theHepatitis 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 inEurope was the unexpected wave of birth defects attributable to the drug thalidomide when takenby 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 -

75 53 U. South Carolina L. Rev. 1225 (2002).

76 [2001] 3 All ER 289.

77 The Council of the European Communities, Council Directive of 25 July 1985 on theapproximation of the laws, regulations and administrative provisions of the Member Statesconcerning liability for defective products (85/374/EEC).

78 Stapleton, supra, n*.

79 Greenman v. Yuba Power Products [alleged design defect in lathe function ofcombination 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 [designdefect alleged in high-lift loader which lacked stabilizing outriggers used in cranes and othersuch devices].

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unguarded machines,80 and exposure to dangerous workplace materials like asbestos.81 Thesestruggles gave rise to recognition of a non-delegable duty to make reasonable efforts to learn ofthe health effects of one’s products - a duty which necessarily required producers to study theirproduct’s users (and often its producers) to learn what health effects ensued from making orusing the product.82 It was held emphatically to be insufficient for a producer to wait for thepublic health authorities or for academic or other disinterested researchers to assess the impactand determine the damage. As Judge John Minor Wisdom wrote in Borel:

The manufacturer's status as expert means that at a minimum hemust keep abreast of scientific knowledge, discoveries, and

80 Bexiga v. Havir Mfg. Corp., 290 A.2d 281 (1972) [manufacturer may be liable forfailing to include safety devices on machinery despite its expectation that the employer whopurchased the machinery would install the devices.]

81 Borel v. Fibreboard, 493 F.2d 1076 (5th Cir. 1973) [asbestos-containing productmanufacturers have the duty to study the health effects of their products]

82 Beshada v. Johns Manville, 90 N.J. 191 (1982) [Asbestosis has been known since atleast the mid 1930's as an occupational disease among textile mill workers but defendantsasserted that the danger of which they failed to warn until the 1960's was “undiscovered at thetime the product was marketed and that it was undiscoverable given the state of scientificknowledge at that time.” The Court held, reaching the historic highwater mark on theconstructive knowledge issue, that defendants, even if they were unavoidably ignorant, wereliable for all damage done by their product, even that which was unforeseeable. The court citedDean Keeton:

Strict liability focuses on the product, not the fault of themanufacturer. "If the conduct is unreasonably dangerous, thenthere should be strict liability without reference to what excusedefendant might give for being unaware of the danger." [W. Page]Keeton, Products Liability -- Inadequacy of Information, 48Tex.L.Rev. 398, 407-08 (1970). The imputation of knowledge doesnot represent any presumption that defendants knew or even thatthey could have known of the product's dangers.

Although the ruling was unsustainable as a rule of law, the sheer chutzpah of the asbestosindustry’s lawyers claiming in unison that their clients could not have known what they clearlyshould 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 amatter of fact that no one in the industry had made a showing that it had made health researchefforts commensurate with the appreciable danger, that their claims of unavoidable ignorance asa defense were equitably estopped, and that therefore the industry would be held liable for alldisease caused by their negligently sold products. That is the net effect of the New JerseySupreme Court’s limiting its Beshada ruling to asbestos while declining to extend the principleto ethical drug manufacturers in Feldman v. Lederle Lab., 479 A.2d 374 (N.J. 1984).]

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advances and is presumed to know what is imparted thereby. Buteven more importantly, a manufacturer has a duty to test andinspect his product. The extent of research and experiment must becommensurate with the dangers involved. A product must not bemade available to the public without disclosure of those dangersthat the application of reasonable foresight would reveal. Nor maya manufacturer rely unquestioningly on others to sound the hueand cry concerning a danger in its product. Rather, eachmanufacturer must bear the burden of showing that its ownconduct was proportionate to the scope of its duty.83

Such expressions of what the duty of reasonable care demands of asbestos productmakers provide a template for what should be demanded of blood product, drug, and medicaldevice 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 ofobligations and the incoherence of the idea that products liability can sensibly look at the productand 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 humanbehaviour and the platform it provides in each case for theexamination of the complex moral and economic dilemmas thatcan characterize product cases, prompts one to ask why we have aseparate regime for product injuries at all.

83 494 F. 2d at 1089-1090.

84 Brown, supra, n*, 751 P. 2d at 478-479:But there is an important distinction between prescription drugsand other products such as construction machinery, a lawnmower,or perfume, the producers of which were held strictly liable. In thelatter cases, the product is used to make work easier or to providepleasure, while in the former it may be necessary to alleviate painand suffering or to sustain life. Moreover, unlike other importantmedical products (wheelchairs, for example), harm to some usersfrom prescription drugs is unavoidable. Because of thesedistinctions, the broader public interest in the availability of drugsat an affordable price must be considered in deciding theappropriate standard of liability for injuries resulting from theiruse.

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The challenge is a serious one. It has long struck me that the idea of the “actionableproduct” was an incoherent one. Put forward by Prosser’s successor as ALI Reporter, VanderbiltDean John Wade, the formulation had quickly become boilerplate. Like Justice Mosk inBrown,85 courts routinely explained that strict products liability law was product centered andthat 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 plaintiffmust do is show that the product was in the dangerous condition when it left the defendant’scontrol”.86

But Browder v. Pettigrew,87 a routine product liability case involving a malfunction in anew car, the exemplar case cited by Wade, reveals that the negligence/strict liability distinctionwas (and is) a thin reed. Wade cites the court's assertion that “while proof of a malfunctionalone should be sufficient under the strict liability and warranty theories in a products liabilitycase, a higher standard of specificity of proof of defect is required in order to recover under thenegligence theory.”88

The Tennessee court noted that the primary focus in a negligence action is on defendant'sconduct and the duty of due care. It concluded that in a negligence case "[it] is vital to trace theinjury 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-framesupporting the front wheel of a brand new passenger car collapses without any collision, it isdifficult to see how one could rationally escape the conclusion that someone in themanufacturing process was negligent in designing or manufacturing the part. It seems to me thatif the jury finds the facts to be as plaintiff asserts, it is grasping at the ether to divine a difference

85 751 P. 2d at 473-474:

Strict liability differs from negligence in that it eliminates thenecessity for the injured party to prove that the manufacturer of theproduct which caused injury was negligent. It focuses not on theconduct of the manufacturer but on the product itself, and holds themanufacturer liable if the product was defective.

86 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 whichis “actionable” in strict liability in tort; and calling for combining “negligence, breach ofwarranty, and strict liability into a single cause of action for products liability.”]

87 541 S.W. 2d 402 (TN 1976).

88 Wade, supra, Vanderbilt, n*. (emphasis added)

89 id. at 982. (emphasis added)

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between directing a plaintiff’s verdict based on circumstantial evidence rules, and imposing strictliability on the manufacturer.90

Laboring to sustain this sort of distinction between strict liability and negligence hasnever yielded a coherent formulation of the supposed difference between the “higher standard ofspecificity” 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 effortby industry to learn of its health effects, no adequate warning even of its undisputed dangers, andthat it was not a necessary ingredient in insulation products because man-made mineral fiberscould do the job.91

Negligence law was adequate to the challenge of asbestos. The volume of claims, thescale of damage, establishment of causal relationship, linking particular product to particularillness and particular person, the question of how much fore-knowledge was required to fairlyimpose liability, and how to assess the liability of multiple manufacturers and suppliers of atoxin whose effect is often but not always cumulative,92 were challenging to the courts as mattersof management. But negligence law’s legal doctrines regarding fault required little development- especially with the rise of modern conceptions of comparative fault and allocation ofresponsibility.93 The rhetoric of strict liability used in asbestos cases was a historical anomalyand a coincidence, not a necessary response to a social problem for which existing legal doctrinaltools were inadequate.

The central concept of negligence is that "one is liable for the foreseeable consequences

90 The imposition of vicarious liability on the retailer is a form of strict liability, as is theemployer’s vicarious liability for employees’ job-related negligence - but those are not the formsof 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 retailerof liability if it identifies a solvent manufacturer, N.J.S. 2A:58C-1, et seq.; See also RobertSachs, BAYLOR LAW REVIEW, forthcoming [arguing that knowledge alone should not be enoughto impose liability on a seller).

91 See Borel v. Fibreboard, (19**) [asserting all of the above (except the alternativeproduct) as grounds for imposing strict products liability]

92 Jane Stapleton, Lords a Leapin’...TORT LAW JOURNAL (2002). [discussing causalrelationship of mesothelioma to asbestos exposure - in light of fact that the dose causallyresponsible for the injury may not be cumulative and the party whose product factually causedthe injury may therefore be unidentifiable, a problem with which the House of Lords grappled in* v. *.]

93 See ALI, RESTATEMENT OF THE LAW (THIRD): APPORTIONMENT OF LIABILITY

27

of one's unreasonable behaviour."94 A reasonably robust deployment of the circumstantialevidence gap filling concept of res ipsa loquitur95 should be sufficient to support an inference ofnegligence which, if unrebutted, should lead to a directed or jury verdict in the plaintiff's favorfor products which do not meet established or reasonably expected norms.96 That liability shouldbe imposed for departure from an intended production norm is insured by the tort-derivedimplied warranty concept’s now routine use. We should recognize that implied warranty hasbeen imported from contract law back into the general law of torts - the law of negligence, thegeneral law of compensatory civil liability for harm unreasonably, but unintentionally, imposedon 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 ofproblems presented by well recognized classes of unacceptable product-caused injury. Productsliability law should therefore be recognized as quite thoroughly normal, and seamless. It is notthe much-maligned anomalous, even arbitrary, force that undergirds the rhetoric of those who

94 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 ConductAn actor whose failure to exercise reasonable care is a factual cause of physicalharm is subject to liability for any such harm within the scope of liability, unlessthe 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’sconduct creates [poses] a risk of physical harm.***

95 The concept was first voiced in Byrne v. Boadle, 159 Eng. Rep. 299 (Ex. 1863); Seealso 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 thedoctrine 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 See PRODUCTS LIABILITY RESTATEMENT:

§ 3 Circumstantial Evidence Supporting Inference of ProductDefect It may be inferred that the harm sustained by the plaintiff was causedby a product defect existing at the time of sale or distribution, withoutproof 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 otherthan product defect existing at the time of sale or distribution.

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see product liability law as a destructive element.

In fact all the bases of liability we impose - even for blood and drug products which havea history of being problematic - have a coherence - that liability is imposed for the “foreseeableconsequences of one’s unreasonable behaviour”, as Weir describes the essence of negligencelaw. For example negligence doctrine thus understood supports the imposition of liability in thefollowing instances. None of the results changes as a result of the governmental, non-profit, orprofit-seeking character of the actor. But the results turn on departure from self-proclaimed orgovernmentally imposed norms, or they depend on the product liability norm of judging thereasonableness of the risks imposed on others by measuring the product against any reasonablyavailable 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 anassembly 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 netbenefit to any group of patients (like the drug Yutopar which was ineffective in prolongingpregnancy 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 marketingof stocks of unpasteurized blood products after methods of pasteurization were developed), asalleged in Gullone v. Bayer and in recent news accounts.99

- unreasonable delay in efforts to develop methods of viral inactivation, as occurred in the caseof anti-hemophilic factor concentrate, or implementation of available tests to exclude infectedblood donors, as occurred in both the U.S. and the U.K. where private actors were complacentand 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 long-standing rift. Ultimately the mountain came to Mohamed on warning and design defect cases,

97 Ancure - fines and penalties

98 Tobin v. Astra Pharmaceuticals, 993 F.2d 528 (6th Cir. 1993).

99

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which are now treated, functionally at least, as negligence claims.100 But the idea that there issomething 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 - departurefrom 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 fromcircumstance, with a dollop of warranty.101 And we should say so plainly, as others haveurged.102 To persist in the notion that there is something "different", something "strict" aboutproducts liability law is to derogate the robustness of modern negligence law and it givesunwarranted encouragement to the idea that unreasonable impositions of liability threatenenterprise, and encourages the unsupportable lament that a culture of blaming the other for whatone 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,

100 Products Liability Restatement, § 2 (b), (c).

101 Unfortunately, in the case of hemophiliacs who were infected with Hepatitis C andHIV 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 thatthey were effectively barred from recovery for their avoidable, generally fatal injuries. IOMreport (cited in GWC, YLJ)

102 See David G. Owen, Defectiveness Restated: Exploding The "Strict" ProductsLiability Myth , 1996 U. ILL. L. REV. 743 (1996)[“While true strict liability has been adopted formanufacturing defects, a reasonableness standard, which includes the notions of optimality andbalance, in fact prevails in the design and warning contexts...(T)he reasonableness standardproperly applied by courts in design and warnings cases is simply negligence, wrapped in a strictliability shroud...(C)ourts might profitably dispense with the myth that responsibility in thesecontexts is strict and embrace instead both the language and doctrine of the negligence standardthey truly use. ”]; William G. Powers, Jr., A Modest Proposal to Abandon Strict ProductsLiability, 1991 U. Ill. L. Rev. 639 (1991) [“(S)trict products liability is neither a generalapproach to personal injury law nor a system of strict liability at all. Instead, it selectivelyapplies to product cases special rules that, although supposedly different from negligence, fall farshort of true strict liability. Most of the general arguments favoring strict liability fail to explainwhy product cases are special.

Strict products liability is exceedingly complex because courts have drawn arbitrarydistinctions to maintain strict products liability and negligence as separate causes of action. Without well-articulated rationales for distinguishing product cases from other personal injurycases, judges have oscillated between general arguments for strict liability and generalarguments for negligence, thereby creating a baroque system of doctrinal distinctions that defiesrationalization. By drawing doctrinal distinctions in the absence of meaningful differences, thecurrent approach to strict products liability fails to treat like cases alike. ”]

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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 yieldedfinally only to a voice vote on the floor at the final session, the Reporters lamented categoricalliability 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. Homeswimming pools are still on the market despite the risks associated with them and the occasionalimposition of liability; cigarets are freely sold but cigaret smoke is no longer ubiquitous andheavy 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, Greenobserved

The negligence law is an interesting example of the flexibility ofthe judicial process in responding to the development of anenvironment...Perhaps the most significant observation that can bemade of negligence law today is that it permits the highestindividualization of the particular case that has ever been possibleunder the common law. Court and jury, aided by counsel, can doalmost 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 whichdisease was transmitted due to tardy development of pasteurized blood products.105 In morecommon manufacturing contexts problems with raw materials have been dealt with successfullyas negligence claims, most famously by Justice Cardozo in MacPherson v. Buick Motor Co., inwhich the manufacturer claimed that there were flaws in the hickory in the painted spokes of thewheel it had received from its supplier. The court imposed a duty on Buick to conduct thetesting or to set the specifications so as to make a safe automobile. Privity as a defense innegligence cases died that day, and the long siege began in `strict liability’ cases, spurred andfinally celebrated in Prosser’s Citadel articles106.

As Leon Green observed 45 years ago, as we move beyond the obvious liability cases

103 Ellen Wertheimer, The Smoke Gets in Their Eyes: Product Category Liability andAlternative 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 certaincategories of product to be inherently defective, even absent alternative design).

104 Id at *.

105 The True Test at * - *.

106 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), 50Minnesota L. Rev. 791 (1966).

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such as for contaminated food products, many cases will be resolved by “somethingapproaching express warranties to the consumer” by virtue of the “claims made for them bymanufacturers”. Other cases dealing with flaws in lumber, disintegrating grinding wheels,exploding tires or bottles, and other analogous accidents “should be considered as negligencecases”. The “principal divergencies” among them are “due to what degree of strictness ispermitted 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 tortthat became known as strict products liability traced the origin to a series of cases involvingproduction flaws and contaminants. Coca Cola Bottling Works v. Lyons, is the case that Prossersays contained the seminal idea of the strict products liability revolution. The MississippiSupreme Court held that an “implied warranty runs with” the chattel.108 In the absence of proofthat the bottling method was “perfect” or that it was “impossible” for the foreign substance to getinto the bottle while being filled”, the judge’s jury charge was correct. He had instructed thatsince Coca Cola had put the product on the market for “human consumption” it is “your duty toreturn a verdict for the plaintiff”, if you find that the “bottle of Coca Cola so purchasedcontained 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 sortof inference of negligence by circumstantial evidence now enshrined in § 3 of the ProductsLiability Restatement.109 The absence of defense evidence of impossibility or danger despiteperfection of production methods, suggests that the reasonable person standard, with a generoususe of res ipsa loquitur and the imposition of the expert standard of care offer all that isreasonably needed to infer negligence and lack of fitness for use in the manufacture of theproduct.

Although I largely concur with Professor Stapleton about the vitality of negligence

107 24 Tenn L. Rev. at *

108 111 So. 305 (Miss. 1927).

109 § 3 Circumstantial Evidence Supporting Inference of Product Defect

It may be inferred that the harm sustained by the plaintiff wascaused by a product defect existing at the time of sale ordistribution, without proof of a specific defect, when the incidentthat harmed the plaintiff: (a) was of a kind that ordinarily occurs as a result of productdefect; and (b) was not, in the particular case, solely the result of causesother than product defect existing at the time of sale ordistribution.

Restatement (Third) of Torts, Products Liability (1998).

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law, and its adequacy to the task of establishing coherent, norm-based grounds forliability,110 I do not concur with her that there is no need for a “separate regime” forproducts liability law which distinguishes commercial from non-commercial activity. Iagree that congruence of common law norms with the “routines, customs, conventions andpractices of ordinary daily life” is important for the ability of the law successfully tocommand adherence.111 And I would generally encourage, for example, a move towardgreater congruence in the law of torts - such as by moving away from the customarystandard of care in professional negligence actions.112

But congruence does not require uniformity. There are supportable reasons forimposing different standards of care on different classes of actors. Charitable immunity and ahigher 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 basisfor liability imposition is warranted.

Few if any have attempted to extract from the welter of common law decisions a coherentstatement of why product liability cases are grouped together. The American Law Institute inthe Products Liability Restatement specifically abjured any attempt at doctrinal uniformity,adopting what it described as a “functional” approach, compatible with the various theories ofnegligence, strict liability, implied warranty.113

110 See Arthur Ripstein, supra, N*.

111 Gerald J. Postema, Philosophy of the Common Law, in Coleman & Shapiro, TheOxford Handbook of Jurisprudence and Philosophy of Law (2001) 616 [(L)aw as such canfunction only if it is congruent to a substantial degree with the social life of the community ifseeks to govern.”]

112 See, E.g. Ter Neuzen V. Korn, Supreme Court of Canada, [1995] 3 S.C.R. 674.[Rejecting customary standard of care and imposing reasonable care standard in claim arisingfrom transmission of HIV via artificial insemination]; Matthies v. Mastromonaco, 733 A. 2d 456(N.J. 1999) [Rejecting customary physician standard and imposing reasonable patient standardregarding duty to inform patient of reasonable choice between surgical or other treatment offracture.]; cf. NY Pub. Health Law § 2805-d [disclosure standard set by “reasonable medical ordental practitioner under similar circumstances”.]

113 § 1 Liability of Commercial Seller or Distributor for Harm Caused by DefectiveProducts

One engaged in the business of selling or otherwise distributing products whosells or distributes a defective product is subject to liability for harm to persons orproperty caused by the defect.

...Comment: a. History. This Section states a general rule of tort liability

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In my view the law of negligence, supplemented by the contract-derived tort principle ofimplied 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 begoverned by their desire to establish a set of coherent norms of commercial and professionalconduct - 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 andused 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 tortlaw. Historically, the focus of products liability law was on manufacturingdefects. A manufacturing defect is a physical departure from a product's intendeddesign. ... Thus, "strict products liability" is a term of art that reflects the judgment thatproducts liability is a discrete area of tort law which borrows from bothnegligence and warranty. It is not fully congruent with classical tort or contractlaw. Rather than perpetuating confusion spawned by existing doctrinal categories,§§ 1 and 2 define the liability for each form of defect in terms directly addressingthe various kinds of defects. As long as these functional criteria are met, courtsmay utilize the terminology of negligence, strict liability, or the implied warrantyof merchantability, or simply define liability in the terms set forth in the blackletter...

114 (1883) 11 QBD 503, 509, dicta of Brett M.R.:The proposition which these recognized cases suggest, and whichis, therefore, to be deduced from them, is that whenever one personis by circumstances placed in such a position with regard toanother that every one of ordinary sense who did think would atonce recognize that if he did not use ordinary care and skill in hisown conduct with regard to those circumstances he would causedanger of injury to the person or property of the other, a duty arisesto use ordinary care and skill to avoid such danger. .... Let us applythis proposition to the case of one person supplying goods ormachinery, or instruments or utensils, or the like, for the purposeof their being used by another person, but with whom there is nocontract as to the supply. The proposition will stand thus:whenever one person supplies goods, or machinery or the like, forthe purpose of their being used by another

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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 Perezv. Wyeth Laboratories122 and Sprietsma v. Brunswick Marine123 expresses a normative, coherent,negligence-based jurisprudence of product stewardship. These landmark cases establish the dutyof commercial manufacturers to deliver products that meet their own specifications, serve theneeds promised or reasonably expected, establish the expert standard of care, including the dutyto study, test for, eliminate, and effectively warn of dangers, the duty to anticipate and guardagainst the self-injuring conduct of workers and consumers, and to be inventive, to employ theinjury-preventive, safety-minded design capabilities reasonably available in the currentcircumstances.124

115 [rejecting defense of privity, imposing duty on mfr to test component parts for defects.MacPherson's analog Donoghue v. Stevenson, [1932] A C 562 , played a similarly seminal rolein the development of modern English tort law.]

116 [exploding soda bottle - rogue product]

117 [strict liability regardless of negligence for unreasonably dangerous products withlatent defects, but imposing only duty to warn on useful but unavoidably hazardous ones.]

118 [declaring duty of mfrs of asbestos products to study, test, and warn of dangers.].

119 [imposing on machine manufacturers the non-delegable duty to protect workers frominjury due to foreseeable carelessness in use of product.]

120 [establishing negligence-based risk utility factors in design defect case againstmachine mfr.]

121 [imputing knowledge of harmful propensities of product to mfr, and establishingexpert standard of care for manufacturers of pharmaceuticals, and current state of technology,rather than custom as relevant factors in gaging mfrs' "conduct".]

122 [duty of mass marketer to use both direct-to-consumer and intermediary means tocommunicate risks of pharmaceuticals]

123 [despite government decision not to impose regulations, common law tort action maybe sustained against manufacturer for failure to develop new form of guarding of outboard motorpropellers] For an interesting discussion of the high court’s product liability jurisprudence, seeAnita Bernstein, Products Liability in the United States Supreme Court: A Venture in Memoryof Gary Schwartz, 53 S.C. L. Rev. 1193 (2002).

124 Case law on post-sale duties remains to be developed, though there can be little doubtthat a manufacturer of drugs is obligated to report to public authorities and to physicianssignificant developments gained by study of performance of the product in the market place andthat a common law duty to recall is likely to be recognized even absent FDA or other regulatory

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These duties - those imposed routinely by American courts products liability casesgrounded on warning and design defect claims, are not examples of strict liability - despitecourts’ frequent use of that nomenclature.125 They are negligence-based concepts - even whereat first glance they have a strict liability feel.

Imputed knowledge A prominent feature of products liability law is the legal assumption thatthe product was known by the manufacturer to have the dangers which it is proved to carry. Thisidea was a central feature of John Wade’s thinking on “strict liability in tort” for defectiveproducts.126 But it is a product-liability-specific expression of the concept of constructiveknowledge - a negligence, a fault-based standard. Commenting on the intrusion into equitythinking of the common law, Tony Weir has observed that the inquiry is “whether though (theactor) did not know, he should have known, whether he had `constructive knowledge’, that iswas at fault in not knowing. The extension from actual to constructive knowledge entails anintrusion of negligence thinking (into equity), and a diminution of the conditions of (strictfiduciary) liability.”127

Similarly, the limitations placed in products liability law on the doctrine ofcontributory negligence may be seen to represent an element of strict liability in tort. Butthe law of negligence is the source of the view that the duty of care owed to one in a position ofvulnerability cannot be nullified by citing the voluntary character of the victim’s self-injuriousconduct.128 The point is illustrated by the New Jersey Supreme Court. In Tobia v. CooperMemorial a hospital was found liable for failing to protect a woman who fell. Breach of the dutyto restrain or otherwise protect a person who could not ambulate safety was not avoided bypointing to the voluntariness of the patient’s conduct:

In a long series of cases, we have held that when a tortfeasor's dutyincludes exercise of reasonable care to prevent a party fromengaging in self-damaging conduct, contributory negligence isbarred as a defense. See Green v. Sterling Extruder Corp., 95 N.J.263, 471 A.2d 15 (1984) (denying contributory-negligence defenseto manufacturer of blowmolding machine that injured worker whowas using machine for reasonably foreseeable purpose); Suter v.

mandate.

125 David G. Owen, Exploding the “Strict” Products Liability Myth

126 Wade, NYU or Vanderbilt or both; NJ model jury charge

127 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).

128 See cases for prop that duty is owed to prevent suicide, etc. from Tobia dissent; seecases cited in Fleming treatise.

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San Angelo Foundry & Mach. Co., 81 N.J. 150, 406 A.2d 140(1979) (denying contributory-negligence defense to manufacturerof sheet-metal-rolling machine that injured worker who was usingmachine as part of assigned task). "As one writer *** has said,'[o]nce it is established that the defendant has a duty to protectpersons from the consequences of their own foreseeable faultyconduct, it makes no sense to deny recovery because of the natureof the plaintiff's conduct.'" Green, supra, 95 N.J. at 272, 471 A.2d15 (quoting Patricia Marschall, An Obvious Wrong Does Not Make a Right: Manufacturers' Liability for Patently DangerousProducts, 48 N.Y.U. L. Rev. 1065, 1088 (1973)). Hence, to allow adefense of contributory negligence when defendants' dutiesincluded protecting plaintiff from foreseeable self-inflicted injuriesmakes no sense.129

The faultiness of the patient’s conduct goes not to liability but to damages for failure tofollow medical advice, according to the New Jersey high court. In Ostrowski v. Azzara130 Thecourt held that the jury may consider a patient's lack of concern for her own health needs as anaspect of the damages. Though the “physician takes the patient as she is”, the patient is stillliable 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 aredynamically intertwined. But they also show that the fuel for much of the development of thegeneral law of tort has been the specific challenges posed by the epidemics of occupationaldisease and the problems posed by the passivity of the consumer in the face of mass producedand marketed products for personal use and consumption. That there is a larger whole intowhich the law of products liability fits is not a prescription for denying the coherence of thedoctrinal principles which have thrived in the modern era of products liability law - thejurisprudence of product stewardship.

In the balance of this paper we will compare the negligence-based decision of the NewJersey 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 ECproduct liability Directive.131

A and Another v. National Blood Authority

129 643 A.2d 1, 8-9 (N.J. 1994)

130 545 A.2d 148 (N.J. 1988).

131 N*, supra.

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The Claims

114 claimants sought damages arising from their infection with Hepatitis C from bloodand blood products transfused from March 1, 1988. The cases of six lead claimants (what wewould call bellwether plaintiffs) were tried before Judge Burton, of the Queens Bench Divisionof the High Court of England in the fall of 2000 and winter of 2001. All had been infected withHepatitis C from transfusions from blood provided by the National Blood Authority and otherpublic entities who are the sole source of blood in England, Scotland and Wales.132 The UKrelies on voluntary blood donors. About 1% of the bags of donated blood were found to havebeen 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), whichbecame effective March 1, 1988. The act conformed British law to the strict liability standardfor product defect claims established in the 1985 EC Directive. Provisions of the CPA must beconstrued so as to conform with the directive.

At the effective date of the CPA the Hepatitis C virus was unidentified. No test for thepresence in donors’ blood of the virus was possible. Surrogate tests - to identify donors at highrisk for Hepatitis C (NANB) infection - were known. The combined effectiveness of these ALTand Heb B screening tests was estimated to exclude about 40% of Hepatitis C infected blood. [Inthe 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 ECDirective, 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) thepresentation of the product; (b) the use to which it couldreasonably be expected that the product would be put; (c) thetime when the product was put into circulation.

The consumer is entitled to expect that the blood be safe, as a matter of law, andregardless of whether the contaminant could be avoided by the blood bank, asserted the

132 The claimants had been identified from a look-back program instituted after thevirus had been identified, which disclosed which donors had been infected.

133 At the time in the US we employed paid blood donors.

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claimants.

The defenses

Conceding, as the EC Directive compels, that liability for injury due to defectiveproducts 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 theentitlement of the consumer. Not until December 1989 at the earliest was there an effectivescreening test for the presence of Hep C in donors’ blood. Until then the risk of infection couldnot 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 notsatisfy claimants’ burden on the case for defect. Plaintiffs must show that the particular infectedbags could have been identified - and the risk of harm thus avoided, said the defendants. In thisrespect they read into Article 6 the language of Article 7(e)

Defendants also raised an affirmative defense, article 7(e) of the EC product liabilitydirective, which provides:

Article 7

The producer shall not be liable as a result ofthis Directive if he proves:... (e) that the state ofscientific and technical knowledge at the timewhen he put the product into circulation was notsuch as to enable the existence of the defect to bediscovered :

The critical events are that not until May 1988 was the long-sought NON A, NON BHepatitis virus “identified, cloned, and expressed” by the Chiron Corporation, which inSeptember 1989 disclosed the details of its ELISA Assay test at a Rome conference, and inNovember 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 permittedmarketing here in May 1990. England and Ireland were the last to use the test - beginning inSeptember and October 1991. England implemented the precaution 24 months after itsintroduction 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 itsinvention and six months after the product was licensed for export. The product of long-feltneed, the test was presumably universally employed very shortly after FDA approval.

The High Court addressed first the plaintiffs’ most sweeping claims (which it accepted), andthen 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, notnegligence, was the command of the 1985 EC directive, to which the British statute must be

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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 bywhich 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 industrialprocess.” “There is of course no 'blood-shield' statute in the United Kingdom”, Judge Burtonobserved.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 thelaw of strict liability and implied warranty. 136]

134 See, e.g. Recitals 2, 3, and 6:

[2] Whereas liability without fault on the part of theproducer is the sole means of adequately solving the problem,peculiar to our age of increasing technicality, of a fairapportionment of the risks inherent in modern technologicalproduction;

[3] Whereas liability without fault should apply only tomovables which have been industrially produced; whereas, as aresult, it is appropriate to exclude liability for agricultural productsand game, except where they have undergone a processing of anindustrial nature which could cause a defect in these products :

[6] Whereas, to protect the physical well-being andproperty of the consumer, the defectiveness of the product shouldbe determined by reference not to its fitness for use but to the lackof the safety which the public at large is entitled to expect; whereasthe safety is assessed by excluding any misuse of the product notreasonable under the circumstances;

Notably agricultural products are excluded, in marked contrast to U.S. product liability law,which arose from contaminated food product cases.

135 A v. NBA at *

136 § 19 Definition of "Product" For purposes of this Restatement:

(a) A product is tangible personal property distributedcommercially for use or consumption. Other items, such as realproperty and electricity, are products when the context of theirdistribution and use is sufficiently analogous to the distribution

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The Directive here was thus construed by all to establish a uniform standard forgovernmental and commercial actors.137

Article 6 and the Relevant Circumstances

Echoing American product liability law, a major influence in the formulation of thedirective, as to Article 6, the claimants asserted that, with the need for proof of negligenceeliminated, consideration of the conduct of the producer, or of a reasonable or legitimatelyexpectable producer, is inadmissible or irrelevant. Therefore questions of avoidability of the riskof infection could not arise:

What the defendants could or should have done differently; whether there wereany steps or precautions reasonably available; and whether it was impossible totake any steps by way of prevention or avoidance, or impracticable oreconomically unreasonable. Such are not 'circumstances' falling to be consideredwithin art 6.138

and use of tangible personal property that it is appropriate to applythe rules stated in this Restatement.

(b) Services, even when provided commercially, are notproducts.

(c) Human blood and human tissue, even when providedcommercially, are not subject to the rules of this Restatement.

(Emphasis added.)

137 The defense suggested that the fact that it “had noalternative but to supply (blood) to hospitals andpatients, as a service to society...(T)his is a factor tobe taken into account in the 'basket'...(U)nlikecommercial producers, they have no option towithdraw it from the market rather than incurliabilities....Judge Burton’s response was that “thereis, in any event, no necessary reason why a publicauthority or a non-profit making organisationshould be in any different position if the product isunsafe”. (citation omitted)

138 A v. NBA at *; [This is certainly a proposition that would not get a favorable hearingin the U.S., where the Second Restatement’s comment k has long held sway. Where the productis useful and the risk unavoidable, the product is not defective if accompanied by proper

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According to Judge Burton public knowledge of the risk was sparse:

In so far as the risk was known to blood producers and the medicalprofession, it was not known to the public at large (save for thosefew patients who might ask their doctor, or read the occasionalarticle about blood in a newspaper) and no risk that any percentageof transfused blood would be infected was accepted by them. 139

The defendants asserted that the risk was known to those who mattered - the medicalprofession, through whom blood was supplied. In U.S. jurisprudence the matter of knowledgewould be tested by each plaintiff individually. Here it seems to have been treated as a genericquestion - whether, in the words of the EC Directive’s recitals it was known to “the public atlarge”.

The NBA asserted that until there was available on the market a test capable ofidentifying donors exposed to the hepatitis C virus, the risk was unavoidable. Since theDirective bases the finding of defect on what the public is “entitled to expect”, and since bothsides here agreed that it was legitimate expectations, not actual expectations which governed, “itis not and cannot be legitimate to expect the unattainable....100% clean blood” The most thepublic 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 investigationinto the nature of the risk and the adequacy of the efforts to reduce it - an effort as familiar tobench and bar in England as it is to American products liability lawyers.141

warnings. Freeman v. Hoffman LaRoche, supra, n*, at *.]

139 A v. NBA, at *.

140 See Barker? criticizing Cronin? to show similar struggling with the application ofstrict liability in U.S. law

141 See, e.g. Morris v West Hartlepool Steam Navigation Co Ltd [1956] 1 All ER 385 at399:

'. . . it is the duty of an employer, in considering whether some precaution shouldbe taken against a foreseeable risk, to weigh on the one hand the magnitude of therisk, the likelihood of an accident happening and the possible seriousness of theconsequences if an accident does happen, and on the other hand the difficulty andexpense 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 WadeRisk-utility factors of U.S. Products Liability law. See generally, Stephen G. Gilles, the

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Finally, urged the defendants “(i)f, notwithstanding the known and unavoidable risk, theblood was nevertheless defective within art 6, then it is all the more necessary to construe art7(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 Art7(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 couldreasonably have been expected, what more if anything could havebeen done: what precautions or tests could be used/should havebeen used/were available to be used/can legitimately be expectedto have been used”.

Claimants asserted that

given that it is common ground that the article imposes liabilityirrespective of fault, the exercise of considering what could orshould have been done by the producer is an impermissible andirrelevant exercise, which lets questions of fault back in by theback door. They say that the consideration of what safetyprecautions should have been expected to have been adoptedsimply amounts to the introduction of a standard of legitimateexpectability, rather than a standard of reasonableness..(I)t isnecessary only to look at the product itself (including comparisonwith similar or identical products on the market), which wouldinvolve its expected or intended use, without considering whatmore could have been done (and how easy or difficult or cheap orexpensive 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).

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unwanted contaminant).142 The defendants asserted that the court must decide if there was adesign defect (the `unscreenedness’ of the blood). If it was the former, then a strict liability sortof guaranty of safety regardless of feasibility would be imposed, and if the latter, a negligence-style 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 thepre-manufactured `raw material'. The infected blood in the U.K. was from individual, volunteerdonors.143

Judge Burton found that the different categories (manufacturing error or design defect) madeno difference. Pointing to the failure of the defendants to adequately inform the public of therisks of infected blood, he devised the concept of the “non-standard” product - one which ledinevitably to liability because

(w)hether it is appropriate to define the one infected bag of bloodin 100 as a manufacturing defect, or as an inevitable result of achosen design process which cannot guarantee uniformity ofproduct, the issue is still the same, namely whether the safety wasprovided which the public was entitled to expect in respect of thatproduct.

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 breachof a de facto fault based standard that the defendants had sought to prove.144 The infected bloodwas defective as a matter of law. Fault was an irrelevant consideration under the Directive, as allconceded. Th avoidability defense was fault-based:

Having heard the evidence of Zumutbarkeit (avoidability) over

142 The only U.S. court to adopt such a position, Cunningham v McNeal MemorialHospital, 47 Ill (2d) 443 (1970), was reversed by the Legislature’s prompt passage of a bloodshield law.

143 Dominating the commercial sector are manufacturers or fractionators of plasmaderivatives. In the early 1980s, fractionators collected approximately eighty percent ofplasma 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 ofplasma derivatives, such as clotting factors for hemophiliacs. Each batch contains enoughclotting 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)

144 The High Court ruled in the alternative. It decided first what constituted a relevantcircumstance, ruled out "avoidability", then addressed the proofs of unavoidability of infectionof blood which defendants had mustered during trial.

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some 20 days, I pay tribute to the fact that both parties werecareful never to address head on the issue of negligence, theclaimants noteworthily eschewing any such suggestion, and I amwell aware that the investigation would have been wider andlonger if it had expressly been based in negligence.

It has been quite clear to me that the claimants have had, onthe trial of the facts before me, to prove.. that the defendantsought to have acted differently from the way they did: not on aday by day, or month by month basis, assessing theirindividual conduct, but simply on the basis that tests ought tohave been introduced differently and earlier. I am satisfiedthat (claimant’s counsel) Mr Forrester was right to refer toSenator Huey Long's duck: namely 'If it looks like fault, and itquacks 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. SirBurton’s judgment was not the reasonableness determination that Lord Griffiths had predictedsome dozen years earlier in the pages of the Tulane Law Review.145 Instead a rather minimalrationale was offered by the court:

I do not consider that the legitimate expectation of the publicat large is that legitimately expectable tests will have beencarried out or precautions adopted. Their legitimateexpectation is as to the safeness of the product (or not). The

145 The judge is thrown back to the question "whatlevel of safety is a person entitled to expect?" Inthe context of failures to warn, it seems likely, if not inevitable, that as in the United States, an appealwill be made to principles which to some ears aremore appropriate in a negligence action than onebased on strict liability. This conclusion assumesthat, since the Directive is not intended to createabsolute liability, a person cannot expect that theproducer will warn him of every conceivabledanger that may arise from the use of the product. Concepts of reasonableness will therefore have tobe called upon to define those dangers of which theproducer 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 ProductLiability Law: a Comparison with the American System, 62 Tul Rev. 353, * (1988)

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court will act as...the appointed representative of the public atlarge, but in my judgment it is impossible to inject into theconsumer's legitimate expectation matters which would not byany stretch of the imagination be in his actual expectation. Hewill assume perhaps that there are tests, but his expectationswill be as to the safeness of the blood. In my judgment it is asinappropriate to propose that the public should not 'expect theunattainable'-in the sense of tests or precautions which areimpossible-at least unless it is informed as to what isunattainable or impossible, as it is to reformulate theexpectation as one that the producer will not have beennegligent 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 anon-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 tortlaw 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 unavoidablerisks, awarded to those who were infected through elective surgery, it would be coherent as a tortjudgment. 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 intort law.

This form of compensation is not congruent in any coherent way with other strict liabilitysystems, e.g. workers compensation (risks arising from the nature of the employment arecompensated), or National Childhood Vaccine Compensation Act (social goal of universalcompliance with mandatory vaccine administration secured by assurance of compensation forvaccine-related injury regardless of fault). As a form of social insurance it is incoherent. Shallwe compensate people for every toxic effect of every drug? How would we define the insurableevent?

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

146 A. v. NBA at [56].

147 See Jules Coleman, Risks and Wrongs (1992) [corrective justice is essence of tortlaw]; and Benjamin C. Zipursky, Philosophy of Private Law, in Coleman & Shapiro, The OxfordHandbook of Jurisprudence and Philosophy of Law (2001) [private right of repair for harmwrongfully inflicted is central element of the private law of torts]

148 In Tony Weir???

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of Rylands v. Fletcher has been decisively held in England to require proof of foreseeability inCambridge Water Co Ltd v. Eastern Counties Leather, PLC.149 In Burnie Port Authority v. theHigh 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 akind which might attract the rule in Rylands v Fletcher isinvolved, the standard of care remains "that which isreasonable in the circumstances, that which a reasonablyprudent man would exercise in the circumstances". In the caseof such substances or activities, however, a reasonably prudentperson 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 sostringent as to amount practically to a guarantee of safety". 150

Unlike the judgment of Sir Michael Burton there is nothing abnormal or severe about ourlaw of products liability. If we look at the huge body of cases decided under U.S. tort law ona strict liability basis - even those which stretched farthest - such as the asbestos caseBeshada v. Johns Manville, the facts supported an inference of fault in every case I haveever read that went the plaintiff’s way. Our law of products liability is the law ofnegligence, 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 (suchas producer to foreseeable user) it

gives rise to a non-delegable duty of care [It recognizes] that thedangerousness of the substance or activity involved... will heighten the degreeof care which is reasonable, it becomes apparent, subject to one qualification,that the stage has been reached where it is highly unlikely that liability willnot exist under the principles of ordinary negligence in any case whereliability 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 civiljury - that a judge can decide the case on alternative theories. Here the court listened to 20 daysof testimony on the issue of avoidability of the harm And in this respect his findings are much

149 House of Lords [1994] 1 All ER 53.

150 120 A.L.R. 42, * (1994).

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more satisfying and coherent.

As a review of the time line shows, the national Blood Authority failed to implementsurrogate testing for NANB Hepatitis (now Hep C). The surrogate tests were ALT and Hep Bsurface antigen. The Hep B test identified those who had been exposed to Hepatitis B (acommon event for intravenous drug users also at risk for Hepatitis C and HIV). The ALT testindicated hepatitis - inflammation of the liver due to any cause - including alcohol use andobesity. The tests did not identify exposure to the still unidentified hepatitis C virus, but theywere 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 tointroduce the test was never justified. The defendants were clearly negligent by the reasonableperson standard. They were charged with knowledge of the technology by virtue of the previousconstruction of the CPA in the action brought by the European Commission which was thefunctional equivalent of a declaratory judgment action. In EC v. UK [1997] All ER (EC) 481,the Commission argued

the very wording of s 4(1)(e) of the (UK Consumer Protection) Actshows 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 noreference to the ability of the producer or of another producer ofsimilar products to discover the defect, the national provision callsfor a subjective assessment in that it places the emphasis on theconduct of a reasonable producer.

In that way, the national provision has the effect of transformingthe strict or no-fault liability introduced by art 1 of the directiveinto liability founded on negligence on the part of the producer.

The Court of Justice of the European Community rejected the EC claim - but not itsconstruction of the Directive. It held that the UK understood its duty to construe any ambiguityin its statute in accordance with the objective test required by the Directive. The objective test isone of constructive knowledge which imposes upon all producers the duty to know all“accessible information”. Only what the CJEC called rather rudely “non-Manchurianlyaccessible” information was to be excluded from the ambit of what a producer is deemed toknow.

The ELISA Assay Test Implementation

The accessibility of information regarding Chiron corporation’s identification of the NON ANon B (Hepatitis C) virus (which turned out to be several) was not in doubt. The test addresseda serious health public problem which had dogged all the advanced countries for many years.

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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 Courtrecounted “gave measured evidence of great authority”, admitting “In retrospect, to his concernthat in the event routine screening for Hepatitis C was not introduced in the United Kingdomuntil September 1991 (two years after the disclosure of the test by Chiron, and 22 months afterits commercial availability).152 Ultimately Dr. Gunson conceded that the test could have beenintroduced early in 1990.153

151 A v. NBA [100]

(iv) Even on the basis of what was reported, the prevalence (that isprevalence of the virus amongst the donor population) and theincidence (that is the incidence of the infection among recipients)were higher in the United States (assessed by Dr Alter in the 1970sat between 7-12%) and, particularly, Japan, which had an evenhigher incidence, than in the United Kingdom and Europe. TheUnited States' position improved during the 1980s for a number ofreasons: the abolition of paid donors; the introduction of screeningtests for HIV, which excluded a number of donors who would alsohave been at risk of NANBH; more effective monitoring and self-exclusion of drug users etc. The incidence in the United Kingdom,which Dr Gunson believed to be the case at the material time in1986 and following, and which was generally accepted and wasreported by him to the Council of Europe, was 3%. (In fact whenscreening was introduced, and more accurate assessment was thusable to be made, the incidence became or was-and still remains-between 0705 and 1%.) There are approximately 275m donationsper year (each donor donating approximately twice per year).

152 A v. NB [87].

153 A v. NBA [171] I have already referred to Dr Gunson's evidence, subject to thequestion of a confirmatory assay as to 'certainly early in 1990', inretrospect. Later in cross-examination, he said to Mr Brown: 'MrBrown, I have now said three times-I think I did say to HisLordship yesterday-that in retrospect we should have done it adifferent way.'

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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 thedefendants:

Dr Gunson preferred the concept of 'minimum risk' to 'maximumsafety'. However, this became clarified when he was shown, orreminded of, a preliminary discussion paper for the ACTTDprepared by Dr Barbara and Dr Contreras dated 23 January 1992,which read: 'The attitude towards transfusion safety has veeredaway from the concept of "maximum benefit/minimal cost"towards the notion that if a procedure is shown to preventtransfusion-transmitted infection and disease is available, it shouldbe introduced.' He responded as follows to Mr Brown's questionabout this: 'Q. Were you aware of that shift in culture or do youthink that that had always been the position? A. I think it wasprobably always the position.'154

Armed with such evidence and concessions, and insisting that he was avoiding making anegligence determination (quite like American courts which declare that they are imposing strictliability) but looking very much like one of Huey Long’s ducks,155 Judge Burton summed up onthe “avoidability” case:

The broadbrush question of course is what tests or precautions it isreasonable or appropriate or legitimate to expect that a defendantproducer should have adopted. In the light of art 6, and theobvious emphasis on a weighing exercise, taking into account allthe circumstances, I interpret the position as being that the judge(whether as the representative of the public or otherwise) simplyweighs 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 theproducer's decision was negligent. Accepting, but somewhatadapting, another of Mr Brown's formulations, I would declaremyself as prepared, while walking Mr Underhill's tightrope, toadopt a formulation as follows. If a precaution shown toprevent, or make a material reduction in, the transfer oftransmitted infection through infected blood is available, it

154 A v. NBA [104].

155 See David G. Owen, Defectiveness Restated: Exploding the `Strict’ Products LiabilityMyth, 1996 U. Ill. L. Rev. 743.

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should be taken, unless the disadvantages outweigh theadvantages.156

We thus conclude this exercise with an alternate ground of judgment that looks very muchlike a first year torts exam, but aboard the freighter in Morris v. West Hartlepool SteamNavigation Co., rather than the barge in Carroll v. U.S. Towing. It is familiar ground forjudgment, readily squared with the facts, and familiar common law principles. And it isunencumbered 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 ProductsLiability Restatement, where would it fit? First, it would be barred from consideration - becauseof Section 19 and/or the blood shield laws. But if we chose to look at it as a products liabilitycase, it would not quite fit as a manufacturing defect case - because the defendants did not decideto 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 excludedall who were at risk for Hep C, there was world wide experience to show that such donorquestioning had not eliminated the problem. Because no realistically stated consumerexpectation or entitlement to virus-free blood had been violated, strict liability for manufacturingdefect would not be warranted.

If we proposed that after the introduction of the test on the market those who did notimplement it were strictly liable for all harm, we would only be saying that we had imposedliability 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 insuranceand tort law is maintained.

In Estate of Elkerson v. North Jersey Blood Center, 157 the Appellate Division of theSuperior Court of New Jersey took precisely that route. Ignoring precedent that had foundhemophiliacs’ factor concentrate a product,158 the court demonstrated the vitality of the

156 A v. NBA [106].

157 776 A 2d 244 (NJ. App. Div. 2001).

158 D.J.L. v. Armour Pharm. Co., 704 A.2d 104, 117 (N.J. Super. Ct. Law Div. 1997).

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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 thescreening test. In Elkerson the test for hepatitis B was known, but commonly unused. Plaintiff’sdecedent died of the disease. The complaint alleged a failure to employ the test:

Plaintiffs premised their wrongful death action against the bloodbank on the theory that the blood bank was negligent in failing toemploy the hepatitis core antibody test in 1983. Plaintiffs maintainthat test was available and would have reduced the risk of failingto detect latent hepatitis B, as compared with the surface antigentest used by NJBC, which plaintiffs allege failed to detect thevirus. n1 Accordingly, it was plaintiffs' burden to prove that NJBCwas negligent in failing to use the core antibody test; that itsnegligence enhanced the risk that decedent would contracthepatitis B; and that the enhanced risk was a substantial factor incausing 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 noblood 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 underthe Product Liability Act159 - but the Elkerson court never gave the issue a glance. The issue wasnegligence and the fight was over the standard of care.

The defendants had prevailed at trial. They defended the jury charge which stated thecustomary 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 viewedthe collecting and processing of blood as a skilled medical service,determining, therefore, that NJBC should be treated as a medicalprofessional. Consequently, the court gave a modified medicalmalpractice charge to the jury essentially instructing it that ifNJBC conformed to the generally recognized and acceptedpractices in the blood bank industry, it could not find NJBCnegligent. The court told the jury that NJBC was a health careprovider and, therefore, represents that it "possesses that degree ofknowledge, skill and care which is possessed and used by theaverage Blood Bank." It then told the jury that "the requiredknowledge, skill, and care must be judged by the standard practice

159 Fabyan v. Minster machine???

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of blood banking in April of 1983." (Emphasis added.)Elkerson at *

The Appellate Division held that the charge “virtually guaranteed a finding of nonegligence” because it was the industry practice not to use the test at the time:

NJBC, like virtually all blood banks, used the surface antigen testand not the core antibody test in 1983, thus establishing thestandard of conduct or practice in the blood bank industry as thesurface antigen test, even though the Center for Disease Control(CDC) recommended core antibody testing as early as January1983.

Elkerson at *

Demonstrating that the court, employing negligence law, was ready to establish a standard ofcare based on industry capabilities not industry practice,160 Judge Eichen turned to WilliamProsser:

Even an entire industry, by adopting such careless methods to savetime, effort or money, cannot be permitted to set its ownuncontrolled standard.... And if the only test is to be what has beendone before, no industry or group will ever have any greatincentive to make progress in the direction of safety.... Much thebetter view, therefore, is that of the great majority of the cases, thatevery custom is not conclusive merely because it is a custom, andthat it must meet the challenge of "learned reason," and be givenonly the evidentiary weight which the situation deserves. It followsthat where common knowledge and ordinary judgment willrecognize unreasonable danger, `what everyone does’ may befound to be negligent; and that there will be extreme caseswhere it is so clearly negligent in itself that (evidence of thecommon 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”

160 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 knowableor 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).

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it had decided previously, at least one of which had been brought on both negligence and strictliability grounds:

we considered the blood bank's duty of care not in terms of thenational standards actually being utilized by blood banks acrossthe country, but by analyzing the reasonableness of the bloodbank's conduct given the available testing measures that couldhave rejected this donor's blood for other reasons. Even as early asBrody v. Overlook Hospital, 66 N.J. 448, 450, 332 A.2d 596(1975), the Supreme Court remarked outright that a blood bankwas under an "obligation to use due care."

In sum, these blood bank cases clearly indicate that the standardof care for judging the conduct of blood centers and related groupsis the ordinary, reasonable care standard, not the custom-basedstandard 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 toprevail 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 courtnoted:

in Snyder I, the judge granted summary judgment, concludingthat "rational minds simply could not differ" on the issue ofwhether "the blood bank industry had a duty to high riskscreen and/or surrogate test in February of 1982." ... Weagreed and affirmed the summary judgment on that point.

We see that in Elkerson v. North Jersey Blood Center a court employing traditionalnegligence principles is able to effectuate the same policies as have motivated the law ofproducts liability. The path to decision in Elkerson and on the A v. NBA avoidability case is asmoother 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 modernproducts liability law had been to move us away from the archaic obstacles of privity and to freecourts to impose duties no longer hobbled by customary care, and cramped impositions of theconstructive knowledge requirement on commercial producers. Reasonable prudence and theexpert standard of care, combined with a generous approach to proof of defect by circumstantialevidence are adequate to preserve the jurisprudence of product stewardship.

Conclusion

The law of product liability has been absorbed into modern negligence law. The law ofnegligence has cleared its decks of obstructions like the privity requirement. It has imposedvicarious liability on commercial sellers for the defects of those earlier in the chain of

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distribution. It has focused on the manufacturer where the product departs from its intendedform. And it focuses on the designer where the product’s conception presents unreasonablerisks. In such cases the norms of reasonably safe design and warnings regarding residual safetyhazards are imposed as an expression of a reasonable manufacturer/designer/commercial sellerstandard of care.

Modern negligence law has firmly embraced an objective standard for the person of ordinaryprudence. Of a piece is product liability law’s use of an objective, expert standard of care andthe expansive constructive knowledge requirement that flows from it. The Product’sRestatement’s § 3 makes robust use of circumstantial evidence to permit a conclusion ofdefectiveness even when a specific defect cannot be identified. It is an expression and outgrowthof 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 productliability? 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. Itdescribes not a fundamental division in law, but is a coherent view of the responsibilities of

161 Restatement (Third): Products Liability:

§ 3 Circumstantial Evidence Supporting Inference of ProductDefect

It may be inferred that the harm sustained by the plaintiff was caused by a productdefect existing at the time of sale or distribution, without proof of a specificdefect, 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 productdefect existing at the time of sale or distribution.

Comment:

a. History. This Section traces its historical antecedents to the law ofnegligence, which has long recognized that an inference of negligence may bedrawn in cases where the defendant's negligence is the best explanation for thecause of an accident, even if the plaintiff cannot explain the exact nature of thedefendant's conduct. See Restatement, Second, Torts § 328D. As productsliability law developed, cases arose in which an inference of product defect couldbe drawn from the incident in which a product caused plaintiff's harm, withoutproof of the specific nature of the defect. This Section sets forth the formalrequisites for drawing such an inference.

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those who market goods. The origins reach back to the Mississippi case that Prosser lionized inhis legendary 1960 article the Assault on the Citadel - the idea of a warranty that runs with thechattel. Stewardship requires that commercial producers conceive, test, construct, and monitortheir products with the safety of others as a prime consideration along with efficacy, price, andprofit. Stewardship conveys the notion that risk which can reasonably avoided must be . Thatour 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. Itthreads the needle between caveat emptor and the fear of absolute or insurer’s liability that isimplied (though usually not delivered) by “strict products liability” court decisions. Productstewardship 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 aseller was responsible for the harm that a product did even beyond the bounds of the knowablethat we all learned from the Wagon Mound and Palsgraf cases was a prerequisite for impositionof liability. But that moment - Beshada v. Johns Manville - 20? years ago, was not characteristicof asbestos product liability law. The characteristic response of the courts was anger promptedby demonstration that the principal asbestos producers had abandoned a program of scientificresearch into the health effects of asbestos when preliminary results showed that theconsequences were severe. Only in 1965, as the result of a campaign led by Irving Selikoff ofMt. Sinai hospital, were the physicians and scientists who had observed the suspected healtheffects of asbestos brought together to share the results of the work at the conference BiologicalEffects of Asbestos, sponsored by the New York Academy of Sciences.

Many courts routinely recited the “fraud” played on their customers by the asbestosproducers. Some asbestos manufacturers were compelled to pay punitive damages. Butnegligence principles were the main driving force. Most workers using the product claimedinadequate warning cases “if we had only known” we would have protected ourselves. Manufacturing defects played no part. Design defect played role where asbestos was aningredient 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 tolearn 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 theymust act on what they learn. The manufacturer has a duty to establish an adverse event reportingsystem, to conduct recalls competently. Post-sale warnings are common. Though no court hasyet declared a common law duty to recall a product which it learns is dangerous, that seems but asmall step for courts to take. The learned intermediary doctrine is destined to weaken as adefense and to be recognized only as one (very important) prong in the arsenal of manufacturer’sto help their users make safe use of the product. Today a drug manufacturer who failed to

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maintain a consumer-friendly web site would be so out of tune that it would be evidence of lackof proper product stewardship. Integrated information strategies are the norm today and areincreasingly recognized as the duty of the reasonably prudent manufacturer.

Product liability law has been absorbed into the law of negligence. It is based on theprinciple that liability depends on having had a fair chance to avoid the harm done by theproduct. But that chance is not to be left to chance, nor to the individual capabilities of anygiven 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, butreasonably careful stewardship after the product comes into use.

For these purposes, the concept of absolute, or strict liability has proven itself to beunneeded. The modern law of negligence is sufficiently robust to have created a law of productstewardship derived from the early insight of the warranty running with the chattel, and based onthe courts’ instructive experience of asbestos, industrial machinery, blood products, and drugs.

© George W. Conk August 4, 2003

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