Is There a Design Defect in the Restatement (Third) of Torts: Products Liability?

Yale Law Journal

Volumn 109, Issue 5, 2000, Pages 1087-1133

  Conk, George W ^a  

^a NONE

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EID: 0005203046     PISSN: 00440094     EISSN: None     Source Type: Journal    
DOI: 10.2307/797484     Document Type: Review

References (240)

1. See RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY § 2 cmt. d (1998) [hereinafter RESTATEMENT (THIRD)] ("Assessment of a product design in most instances requires a comparison between an alternative design and the product design that caused the injury, undertaken from the viewpoint of a reasonable person. That approach is also used in administering the traditional reasonableness standard in negligence."). The policy reasons that support use of a reasonable-person perspective in connection with the general negligence standard also support its application to products liability.
2. Wade offered a list of factors he deemed significant in applying the "unreasonably dangerous" standard: (1) The usefulness and desirability of the product - its utility to the user and to the public as a whole. (2) The safety aspects of the product - the likelihood that it will cause injury, and the probable seriousness of the injury. (3) The availability of a substitute product which would meet the same need and not be as unsafe. (4) The manufacturer's ability to eliminate the unsafe character of the product without impairing its usefulness or making it too expensive to maintain its utility. (5) The user's ability to avoid danger by the exercise of care in the use of the product. (6) The user's anticipated awareness of the dangers inherent in the product and their avoidability, because of general public knowledge of the obvious condition of the product, or of the existence of suitable warnings or instructions. (7) The feasibility, on the part of the manufacturer, of spreading the loss by setting the price of the product or carrying liability insurance. John W. Wade, On the Nature of Strict Tort Liability for Products, 44 MISS. L.J. 825, 837-38 (1973). Many courts, including those in New Jersey and California, have derived their risk-utility tests from Wade. See, e.g., Barker v. Lull Eng'g Co., 573 P.2d 443, 455 (Cal. 1978) (adopting the following five factors in its design-defect analysis: the gravity of the danger posed by the challenged design, the likelihood that such danger would occur, the mechanical feasibility of a safer alternative design, the financial cost of an improved design, and the adverse consequences to the product and to the consumer that would result from an alternative design); Cepeda v. Cumberland Eng'g Co., 386 A.2d 816, 826-27 (N.J. 1978) (citing Wade's factors in its design- defect analysis). But see James A. Henderson, Jr. & Aaron D. Twerski, Closing the American Products Liability Frontier: The Rejection of Liability Without Defect, 66 N.Y.U. L. REV. 1263, 1267 n.9 (1991) (criticizing Wade as the intellectual precursor of the "liability without defect" trend).
3. Wade offered a list of factors he deemed significant in applying the "unreasonably dangerous" standard: (1) The usefulness and desirability of the product - its utility to the user and to the public as a whole. (2) The safety aspects of the product - the likelihood that it will cause injury, and the probable seriousness of the injury. (3) The availability of a substitute product which would meet the same need and not be as unsafe. (4) The manufacturer's ability to eliminate the unsafe character of the product without impairing its usefulness or making it too expensive to maintain its utility. (5) The user's ability to avoid danger by the exercise of care in the use of the product. (6) The user's anticipated awareness of the dangers inherent in the product and their avoidability, because of general public knowledge of the obvious condition of the product, or of the existence of suitable warnings or instructions. (7) The feasibility, on the part of the manufacturer, of spreading the loss by setting the price of the product or carrying liability insurance. John W. Wade, On the Nature of Strict Tort Liability for Products, 44 MISS. L.J. 825, 837-38 (1973). Many courts, including those in New Jersey and California, have derived their risk-utility tests from Wade. See, e.g., Barker v. Lull Eng'g Co., 573 P.2d 443, 455 (Cal. 1978) (adopting the following five factors in its design-defect analysis: the gravity of the danger posed by the challenged design, the likelihood that such danger would occur, the mechanical feasibility of a safer alternative design, the financial cost of an improved design, and the adverse consequences to the product and to the consumer that would result from an alternative design); Cepeda v. Cumberland Eng'g Co., 386 A.2d 816, 826-27 (N.J. 1978) (citing Wade's factors in its design-defect analysis). But see James A. Henderson, Jr. & Aaron D. Twerski, Closing the American Products Liability Frontier: The Rejection of Liability Without Defect, 66 N.Y.U. L. REV. 1263, 1267 n.9 (1991) (criticizing Wade as the intellectual precursor of the "liability without defect" trend).
4. See RESTATEMENT (THIRD), supra note 1, § 2 cmt. n (explaining that its rules are stated functionally rather than in terms of traditional doctrinal categories such as warranty, negligence, or strict liability).
5. RESTATEMENT (SECOND) OF TORTS § 402A (1965) [hereinafter RESTATEMENT (SECOND)].
6. The Food, Drug & Cosmetics Act, 21 U.S.C. § 321(g)(1) (1994), defines "drug" broadly to include a biologic product used to diagnose, cure, mitigate, treat, or prevent any disease or to affect the function or structure of the body. Blood and blood products are included in the category of drugs under 21 C.F.R. § 607.3(b) (1998). Vaccines are drugs subject to FDA regulation under 42 U.S.C. § 262 (1994). Some vitamin products are categorized as drugs under 21 U.S.C. § 321(g)(1). See United States v. Ten Cartons, More or Less, 72 F.3d 285, 287 (2d Cir. 1995) (per curiam) (nasally administered vitamin B-12 preparation); United States v. Dianovin Pharm. 475 F. 2d 100, 102 (1st Cir. 1973) (injectable vitamin K).
7. The term "device" is defined to include any "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory . . . which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes." 21 U.S.C. § 321(h). Some devices may be sold only upon prescription. See 21 C.F.R. § 801.109.
8. See RESTATEMENT (THIRD), supra note 1, § 6(c).
9. Hemophilia A, classic hemophilia, is an X-linked hereditary blood-clotting disorder caused by defective or deficient factor VIII protein molecules. It appears worldwide in one in 10,000 male births. Hemophilia B is caused by a factor IX deficiency. See Harold R. Roberts & Maureane Huffman, Hemophilia and Related Conditions - Inherited Deficiencies of Prothrombin (Factor II), Factor V, and Factors VII to XII, in WILLIAMS HEMATOLOGY 1413, 1413 (Ernest Beutler et al. eds., 5th ed. 1995). automobile manufacturer a duty of inspection to discover product defects. Cardozo, an ALI founder who played a leading role in the ALI even after he joined the United States Supreme Court, was a strong supporter of the Restatements as a tool to improve the law. See ANDREW J. KAUFMAN, CARDOZO 174 (1998).
10. Hemophilia A, classic hemophilia, is an X-linked hereditary blood-clotting disorder caused by defective or deficient factor VIII protein molecules. It appears worldwide in one in 10,000 male births. Hemophilia B is caused by a factor IX deficiency. See Harold R. Roberts & Maureane Huffman, Hemophilia and Related Conditions - Inherited Deficiencies of Prothrombin (Factor II), Factor V, and Factors VII to XII, in WILLIAMS HEMATOLOGY 1413, 1413 (Ernest Beutler et al. eds., 5th ed. 1995). automobile manufacturer a duty of inspection to discover product defects. Cardozo, an ALI founder who played a leading role in the ALI even after he joined the United States Supreme Court, was a strong supporter of the Restatements as a tool to improve the law. See ANDREW J. KAUFMAN, CARDOZO 174 (1998).
11. One of Brandeis's innovations was the idea that privacy is a legally protectable right. See Louis D. Brandeis & Samuel D. Warren, The Right of Privacy, 4 HARV. L. REV. 193 (1890); see also Olmstead v. United States, 277 U.S. 438, 478 (1928) (Brandeis, J., dissenting) (asserting that individuals have the "right to be let alone").
12. The courts have hallowed the ALI's edict. James Henderson, Jr. and Aaron Twerski have noted: Only rarely do provisions of the American Law Institute's Restatements of the Law rise to the dignity of holy writ. Even more rarely do individual comments to Restatement sections come to symbolize important, decisive developments that dominate judicial thinking. Nevertheless, section 402A of the Restatement (Second) of Torts is such a provision. James A. Henderson, Jr. & Aaron D. Twerski, A Proposed Revision of Section 402A of the Restatement (Second) of Torts, 77 CORNELL L. REV. 1512, 1512 (1992).
13. Putman v. Erie City Mfg. Co., 338 F.2d 911, 918 (5th Cir. 1964) (quoting RESTATEMENT (SECOND) OF TORTS § 402A (Tentative Draft No. 6, 1961)).
14. Id. at 923 (quoting RESTATEMENT (SECOND) OF TORTS § 402A (Tentative Draft No. 7, 1962)).
15. See RESTATEMENT (SECOND), supra note 4, § 402A.
16. Id. (emphasis added).
17. Dean Prosser, who served as a Reporter for the Restatement (Second), noted the tension between strict liability and negligence in section 402A: "Since proper design is a matter of reasonable fitness, the strict liability adds little or nothing to negligence [on the part of the manufacturer]; but it becomes more important in the case of a dealer who does not design the product." WILLIAM L. PROSSER, THE LAW OF TORTS 659 n.72 (4th ed. 1971).
18. In its entirety, comment k reads: k. Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk. RESTATEMENT (SECOND), supra note 4, § 402A cmt. k.
19. See W. Page Keeton, Products Liability - Inadequacy of Information, 48 TEX. L. REV. 398, 408-10 (1970).
20. See generally Richard A. Merrill, The Architecture of Government Regulation of Medical Products, 82 VA. L. REV. 1753, 1788-89, 1797-99 (1996) (discussing the protracted nature of the FDA approval process).
21. See, e.g., Joseph Sanders, From Science to Evidence: The Testimony on Causation in the Bendectin Cases, 46 STAN. L. REV. 1, 4-12 (1993) (discussing the high success rate of plaintiffs in Bendectin cases despite the paucity of evidence linking the drug to birth defects).
22. See, e.g., Kearl v. Lederle Lab., 218 Cal. Rptr. 453, 463 (Ct. App. 1985) ("Because comment k itself refers to prescription drugs and vaccines as examples of products that are 'unavoidably unsafe' and hence not 'unreasonably dangerous' as long as they are properly manufactured and a proper warning is given, defendant suggests we need inquire no further before we brand the design defect evidence and instruction here as error. We prefer, however, to proceed with more caution before we confer such special protection on a product."); see also Marc Z. Edell, Risk Utility Analysis of Unavoidably Unsafe Products, 17 SETON HALL L. REV. 623, 644-46 (1987) (discussing the adequacy of warnings as insulation against strict liability).
23. See INSTITUTE OF MED., HIV AND THE BLOOD SUPPLY: AN ANALYSIS OF CRISIS DECISIONMAKING 223 (1995) [hereinafter IOM REPORT].
24. See Jay E. Menitove et al., Preparation and Clinical Use of Plasma and Plasma Fractions, in WILLIAMS HEMATOLOGY, supra note 8, at 1649, 1650.
25. See Joanne Rhoton Galbreath, Annotation, Products Liability: What Is an "Unavoidably Unsafe" Product?, 70 A.L.R.4th 16 (1989) (collecting cases).
26. Feldman v. Lederle Lab., 479 A.2d 374, 383 (N.J. 1984).
27. 218 Cal. Rptr. at 463-64.
28. Toner v. Lederle Lab., 732 P.2d 297, 306-08 (Idaho 1987).
29. Feldman, 479 A.2d at 383.
30. Kearl, 218 Cal. Rptr. at 463 (citation omitted).
31. Id. at 463-64 (citation omitted).
32. Toner, 732 P.2d at 306-08 (citations omitted).
33. See Davila v. Bodelson, 704 P.2d 1119, 1127-28 (N.M. Ct. App. 1985) (holding that for the drug Pitocin, since no alternative safer design was available, the only relevant issue was the drug's utility to users); Castrignano v. E.R. Squibb & Sons, 546 A.2d 775, 781 (R.I. 1988) (holding that for DES, courts should follow a case-by-case approach in deciding whether to extend comment k protection).
34. Oral contraceptives are one example of a combination drug. See Brochu v. Ortho Pharm. Corp., 642 F.2d 652 (1st Cir. 1981) (applying the alternative-safer-design test to an oral contraceptive); West v. Searle & Co., 806 S.W.2d 608 (Ark. 1991) (same); Ortho Pharm. Corp. v. Heath, 722 P.2d 410 (Colo. 1986) (en banc) (finding sufficient evidence to conclude that the oral contraceptive at issue was beneficial for at least one class of users and holding that the alternative-safer-design question should be submitted to the jury).
35. See Rohrbough v. Wyeth Lab., 719 F. Supp. 470, 476-77 (N.D. W. Va. 1989), aff'd, 916 F.2d 970 (4th Cir. 1990) (holding that in order to raise a comment k defense, the manufacturer must show that its DTP vaccine was "unavoidably unsafe"); White v. Wyeth Lab., 533 N.E.2d 748, 752 (Ohio 1988) (observing, in a case concerning the DTP vaccine, that comment k "[o]bviously . . . does not apply to all drugs" and noting that "[i]t is equally obvious that not all drugs are so perfectly designed that they cannot be made more pure or more safe, or that there are not safer, suitable alternatives; nor do the benefits of all drugs necessarily outweigh their risks").
36. The medical devices reviewed in these cases include intrauterine devices, implants, and surgical contrast fluids. See Coursen v. A.H. Robins Co., 764 F.2d 1329, 1337-39 (9th Cir. 1985) (upholding a jury's conclusion that the Dalkon Shield intrauterine device was defective under the alternative-safer-design test); Kociemba v. G.D. Searle & Co., 680 F. Supp. 1293, 1301 (D. Minn. 1988) (Cu-7 intrauterine device); Savina v. Sterling Drug, 795 P.2d 915, 925-27 (Kan. 1990) (concluding that the myelogram dye metrizamide is unavoidably unsafe); Tansy v. Dacomed Corp., 890 P.2d 881, 887 (Okla. 1994) (penile implant).
37. See RESTATEMENT (SECOND), supra note 4, § 402A cmt. k (noting that the rabies vaccine "not uncommonly leads to very serious and damaging consequences when it is injected," but nonetheless was not unreasonably dangerous given the grave consequences of the disease it prevented).
38. 751 P.2d 470 (Cal. 1988).
39. See id. at 481-83.
40. A California appellate court extended the reasoning of Brown to silicone breast implants, which are considered a medical device. See Artiglio v. Superior Court, 22 Cal. App. 4th 1388, 1397 (Ct. App. 1994) ("We . . . conclude that the entire category of medical implants available only by resort to the services of a physician are immune from design defect strict liability.").
41. 573 P.2d 443, 452-57 (Cal. 1978) (establishing dual approaches to defining product defects: the consumer-expectations test and negligence-based risk-utility analysis).
42. Brown, 751 P.2d at 479.
43. See Wade, supra note 2, at 837-38.
44. See Page Keeton, Product Liability and the Meaning of Defect, 5 ST. MARY'S L.J. 30, 37-38 (1973) (stating that the determination that a product is unreasonably dangerous turns on the question of whether, on balance, the danger presented by the product outweighs its utility, so that a reasonable man would not sell the product if he knew the risk involved).
45. See Feldman v. Lederle Lab., 479 A.2d 374, 385 (N.J. 1984) (determining that "[t]he question in strict liability design-defect and warning cases is whether, assuming that the manufacturer knew of the defect in the product, he acted in a reasonably prudent manner in marketing the product or in providing the warnings given" and observing that "[t]hus, once the defendant's knowledge of the defect is imputed, strict liability analysis becomes almost identical to negligence analysis in its focus on the reasonableness of the defendant's conduct."); see also David G. Owen, Defectiveness Restated: Exploding the "Strict" Products Liability Myth, 1996 U. ILL. L. REV. 743 (arguing that "strict liability" is often a negligence standard in practice).
46. See Brown, 751 P.2d at 474.
47. Marc A. Franklin, Tort Liability for Hepatitis: An Analysis and a Proposal, 24 STAN. L. REV. 439, 479 (1972).
48. Id.
49. Id.
50. See id. at 474-75. Ultimately, 47 states passed blood shield laws. See IOM REPORT, supra note 25, at 48. The jurisdictions that left the issue to the common law were New Jersey, the District of Columbia, Rhode Island, and Vermont. See id.
51. The dominant nonprofit force in the blood industry was the American Red Cross, which in the first half of the 1970s accounted for about half of the blood used in America, over five million units a year. See DOUGLAS STARR, BLOOD: AN EPIC HISTORY OF MEDICINE AND COMMERCE 252 (1998). Community blood banks, united in the rival American Association of Blood Banks, collected over 35% of the nation's blood supply. See id. Proprietary companies expanded during the 1970s and by the end of the decade had bought out almost a third of the nearly 400 blood collection centers in the United States. See id. at 258. Four major companies controlled most of the world's plasma, which was "becoming an integrated resource, mixed and distributed all over the world." Id. at 258-59.
52. PROSSER, supra note 19, at 661-62 (emphasis added).
53. ARK. CODE ANN. § 20-9-801 (b) (Michie 1987).
54. Id. § 801(c). The legislature extended this protection to all individuals and entities providing any "tissue, organ, blood, or component thereof." Id. § 802. California followed a somewhat different approach, excluding blood from the law of warranty. It removed the subject from the law of sales and placed it within the ambit of professional negligence, which is governed by the customary standard of care. See CAL. HEALTH & SAFETY CODE § 1606 (West 1990).
55. IOM REPORT, supra note 25, at 48.
56. See STARR, supra note 53, at 231-49.
57. See N.J. STAT. ANN. § 2A:14-26.1 (West Supp. 1999); N.Y. C.P.L.R. § 214-e (Consol. Supp. 1999). The New Jersey legislature explained that it was acting to assure that HIV-infected hemophiliacs would get "their day in court." A New Jersey court, upholding the statute, found that holding proprietary blood products manufacturers accountable was "consistent with one of the overriding purposes of product liability law - to spread the burden of damages which flow from such injuries onto those responsible for the products' design and manufacture." D.J.L. v. Armour Pharm. Co., 704 A.2d 104, 117 (N.J. Super. Ct. Law Div. 1997) (footnote omitted).
58. See RESTATEMENT (THIRD), supra note 1, § 2. The general rule is that [a] product is defective when, at the time of sale or distribution, it contains a manufacturing defect, is defective in design, or is defective because of inadequate instructions or warnings. A product: . . . . (b) is defective in design when the foreseeable risks of harm posed by the product could have been reduced or avoided by the adoption of a reasonable alternative design by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the alternative design renders the product not reasonably safe; (c) is defective because of inadequate instructions or warnings when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable instructions or warnings by the seller or other distributor, or a predecessor in the commercial chain of distribution, and the omission of the instructions or warnings renders the product not reasonably safe. Id.
59. David G. Owen has observed that while courts generally define the balance in terms of a weighing of the product's global costs and benefits, what juries actually decide is typically "the much more narrow 'micro-balance' of the costs and benefits of the particular design feature that te plaintiff claims the manufacturer ought to have adopted." David G. Owen, Risk-Utility Balancing in Design Defect Cases, 30 U. MICH. J.L. REFORM 239, 239 (1997) [hereinafter Owen, Risk-Utility Balancing]; see also David G. Owen, Toward a Proper Test for Design Defectiveness: "Micro-Balancing" Costs and Benefits, 75 TEX. L. REV. 1661, 1687 (1997). The Restatement (Third) embraced the "micro-balancing" approach. See RESTATEMENT (THIRD), supra note 1, § 2 cmt. f Reporter's note.
60. David G. Owen has observed that while courts generally define the balance in terms of a weighing of the product's global costs and benefits, what juries actually decide is typically "the much more narrow 'micro-balance' of the costs and benefits of the particular design feature that te plaintiff claims the manufacturer ought to have adopted." David G. Owen, Risk-Utility Balancing in Design Defect Cases, 30 U. MICH. J.L. REFORM 239, 239 (1997) [hereinafter Owen, Risk-Utility Balancing]; see also David G. Owen, Toward a Proper Test for Design Defectiveness: "Micro-Balancing" Costs and Benefits, 75 TEX. L. REV. 1661, 1687 (1997). The Restatement (Third) embraced the "micro-balancing" approach. See RESTATEMENT (THIRD), supra note 1, § 2 cmt. f Reporter's note.
61. David G. Owen has observed that while courts generally define the balance in terms of a weighing of the product's global costs and benefits, what juries actually decide is typically "the much more narrow 'micro-balance' of the costs and benefits of the particular design feature that te plaintiff claims the manufacturer ought to have adopted." David G. Owen, Risk-Utility Balancing in Design Defect Cases, 30 U. MICH. J.L. REFORM 239, 239 (1997) [hereinafter Owen, Risk-Utility Balancing]; see also David G. Owen, Toward a Proper Test for Design Defectiveness: "Micro-Balancing" Costs and Benefits, 75 TEX. L. REV. 1661, 1687 (1997). The Restatement (Third) embraced the "micro-balancing" approach. See RESTATEMENT (THIRD), supra note 1, § 2 cmt. f Reporter's note.
62. Id. § 6(c). For an example of a judicial interpretation of the net benefit test, see Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974), a suit by a child who contracted polio from the Sabin oral live polio vaccine in which the court held that an unavoidably unsafe product is unreasonably dangerous only if it is "so dangerous that a reasonable man would not sell the product if he knew the risk involved." Id. at 1273-74.
63. See RESTATEMENT (THIRD), supra note 1, § 2 cmt. e. The section 6(c) standard also bears some resemblance to a negligence-based marketing liability standard proposed by Joseph Page for generic product-defect cases. See Joseph A. Page, Liability for Unreasonably and Unavoidably Unsafe Products: Does Negligence Doctrine Have a Role To Play?, 72 CHI.-KENT. L. REV. 87, 127-28 (1996) (arguing that a product's dangers may be so great as to make its sale unreasonable even in the absence of a feasible safer alternative design).
64. See RESTATEMENT (THIRD), supra note 1, § 2 cmt. d (clarifying that the reasonable altemative-safer-design standard "applies in most instances even though the plaintiff alleges that the category of product sold by the defendant is so dangerous that it should not have been marketed at all").
65. See id. § 6 cmt. f.
66. See 74 A.L.I. PROC. 892-902 (1997); 73 A.L.I. PROC. 136-64 (1996); 72 A.L.I. PROC. 104-40 (1995); 71 A.L.I. PROC. 272-87 (1994).
67. See 74 A.L.I. PROC. 892-902 (1997); 73 A.L.I. PROC. 136-64 (1996); 72 A.L.I. PROC. 104-40 (1995); 71 A.L.I. PROC. 272-87 (1994).
68. See 74 A.L.I. PROC. 892-902 (1997); 73 A.L.I. PROC. 136-64 (1996); 72 A.L.I. PROC. 104-40 (1995); 71 A.L.I. PROC. 272-87 (1994).
69. See 74 A.L.I. PROC. 892-902 (1997); 73 A.L.I. PROC. 136-64 (1996); 72 A.L.I. PROC. 104-40 (1995); 71 A.L.I. PROC. 272-87 (1994).
70. See William A. Dreier, Design Defects Under the Proposed Section 2(b) of the Restatement (Third) of Torts: Products Liability: A Judge's View, 30 U. MICH. J.L. REFORM 221 (1997); Oscar S. Gray, The Draft ALI Product Liability Proposals: Progress or Anachronism?, 61 TENN. L. REV. 1105 (1994); Michael D. Green, The Schizophrenia of Risk-Benefit Analysis in Design Defect Litigation, 48 VAND. L. REV. 609, 622-23 (1995); Mark McLaughlin Hager, Don't Say I Didn 't Warn You (Even Though I Didn't): Why the Pro-Defendant Consensus on Warning Law Is Wrong, 61 TENN. L. REV. 1125 (1994); Owen, supra note 47, at 743; David G. Owen, The Graying of Products Liability Law, 61 TENN. L. REV. 1241 (1994); Page, supra note 63, at 87; Jerry J. Phillips, Achilles' Heel, 61 TENN. L. REV. 1265 (1994); Marshall S. Shapo, A New Legislation: Remarks on the Draft Restatement of Products Liability, 30 U. MICH. J.L. REFORM 215 (1997); John F. Vargo, The Emperor's New Clothes: The American Law Institute Adorns a "New Cloth" for Section 402A Products Liability Design Defects, 26 U. MEM. L. REV. 493 (1996); Ellen Wertheimer, The Smoke Gets in Their Eyes: Product Category Liability and Alternative Feasible Designs in the Third Restatement, 61 TENN. L. REV. 1429 (1994).
71. See William A. Dreier, Design Defects Under the Proposed Section 2(b) of the Restatement (Third) of Torts: Products Liability: A Judge's View, 30 U. MICH. J.L. REFORM 221 (1997); Oscar S. Gray, The Draft ALI Product Liability Proposals: Progress or Anachronism?, 61 TENN. L. REV. 1105 (1994); Michael D. Green, The Schizophrenia of Risk-Benefit Analysis in Design Defect Litigation, 48 VAND. L. REV. 609, 622-23 (1995); Mark McLaughlin Hager, Don't Say I Didn 't Warn You (Even Though I Didn't): Why the Pro-Defendant Consensus on Warning Law Is Wrong, 61 TENN. L. REV. 1125 (1994); Owen, supra note 47, at 743; David G. Owen, The Graying of Products Liability Law, 61 TENN. L. REV. 1241 (1994); Page, supra note 63, at 87; Jerry J. Phillips, Achilles' Heel, 61 TENN. L. REV. 1265 (1994); Marshall S. Shapo, A New Legislation: Remarks on the Draft Restatement of Products Liability, 30 U. MICH. J.L. REFORM 215 (1997); John F. Vargo, The Emperor's New Clothes: The American Law Institute Adorns a "New Cloth" for Section 402A Products Liability Design Defects, 26 U. MEM. L. REV. 493 (1996); Ellen Wertheimer, The Smoke Gets in Their Eyes: Product Category Liability and Alternative Feasible Designs in the Third Restatement, 61 TENN. L. REV. 1429 (1994).
72. See William A. Dreier, Design Defects Under the Proposed Section 2(b) of the Restatement (Third) of Torts: Products Liability: A Judge's View, 30 U. MICH. J.L. REFORM 221 (1997); Oscar S. Gray, The Draft ALI Product Liability Proposals: Progress or Anachronism?, 61 TENN. L. REV. 1105 (1994); Michael D. Green, The Schizophrenia of Risk-Benefit Analysis in Design Defect Litigation, 48 VAND. L. REV. 609, 622-23 (1995); Mark McLaughlin Hager, Don't Say I Didn 't Warn You (Even Though I Didn't): Why the Pro-Defendant Consensus on Warning Law Is Wrong, 61 TENN. L. REV. 1125 (1994); Owen, supra note 47, at 743; David G. Owen, The Graying of Products Liability Law, 61 TENN. L. REV. 1241 (1994); Page, supra note 63, at 87; Jerry J. Phillips, Achilles' Heel, 61 TENN. L. REV. 1265 (1994); Marshall S. Shapo, A New Legislation: Remarks on the Draft Restatement of Products Liability, 30 U. MICH. J.L. REFORM 215 (1997); John F. Vargo, The Emperor's New Clothes: The American Law Institute Adorns a "New Cloth" for Section 402A Products Liability Design Defects, 26 U. MEM. L. REV. 493 (1996); Ellen Wertheimer, The Smoke Gets in Their Eyes: Product Category Liability and Alternative Feasible Designs in the Third Restatement, 61 TENN. L. REV. 1429 (1994).
73. See William A. Dreier, Design Defects Under the Proposed Section 2(b) of the Restatement (Third) of Torts: Products Liability: A Judge's View, 30 U. MICH. J.L. REFORM 221 (1997); Oscar S. Gray, The Draft ALI Product Liability Proposals: Progress or Anachronism?, 61 TENN. L. REV. 1105 (1994); Michael D. Green, The Schizophrenia of Risk-Benefit Analysis in Design Defect Litigation, 48 VAND. L. REV. 609, 622-23 (1995); Mark McLaughlin Hager, Don't Say I Didn 't Warn You (Even Though I Didn't): Why the Pro-Defendant Consensus on Warning Law Is Wrong, 61 TENN. L. REV. 1125 (1994); Owen, supra note 47, at 743; David G. Owen, The Graying of Products Liability Law, 61 TENN. L. REV. 1241 (1994); Page, supra note 63, at 87; Jerry J. Phillips, Achilles' Heel, 61 TENN. L. REV. 1265 (1994); Marshall S. Shapo, A New Legislation: Remarks on the Draft Restatement of Products Liability, 30 U. MICH. J.L. REFORM 215 (1997); John F. Vargo, The Emperor's New Clothes: The American Law Institute Adorns a "New Cloth" for Section 402A Products Liability Design Defects, 26 U. MEM. L. REV. 493 (1996); Ellen Wertheimer, The Smoke Gets in Their Eyes: Product Category Liability and Alternative Feasible Designs in the Third Restatement, 61 TENN. L. REV. 1429 (1994).
74. See William A. Dreier, Design Defects Under the Proposed Section 2(b) of the Restatement (Third) of Torts: Products Liability: A Judge's View, 30 U. MICH. J.L. REFORM 221 (1997); Oscar S. Gray, The Draft ALI Product Liability Proposals: Progress or Anachronism?, 61 TENN. L. REV. 1105 (1994); Michael D. Green, The Schizophrenia of Risk-Benefit Analysis in Design Defect Litigation, 48 VAND. L. REV. 609, 622-23 (1995); Mark McLaughlin Hager, Don't Say I Didn 't Warn You (Even Though I Didn't): Why the Pro-Defendant Consensus on Warning Law Is Wrong, 61 TENN. L. REV. 1125 (1994); Owen, supra note 47, at 743; David G. Owen, The Graying of Products Liability Law, 61 TENN. L. REV. 1241 (1994); Page, supra note 63, at 87; Jerry J. Phillips, Achilles' Heel, 61 TENN. L. REV. 1265 (1994); Marshall S. Shapo, A New Legislation: Remarks on the Draft Restatement of Products Liability, 30 U. MICH. J.L. REFORM 215 (1997); John F. Vargo, The Emperor's New Clothes: The American Law Institute Adorns a "New Cloth" for Section 402A Products Liability Design Defects, 26 U. MEM. L. REV. 493 (1996); Ellen Wertheimer, The Smoke Gets in Their Eyes: Product Category Liability and Alternative Feasible Designs in the Third Restatement, 61 TENN. L. REV. 1429 (1994).
75. See William A. Dreier, Design Defects Under the Proposed Section 2(b) of the Restatement (Third) of Torts: Products Liability: A Judge's View, 30 U. MICH. J.L. REFORM 221 (1997); Oscar S. Gray, The Draft ALI Product Liability Proposals: Progress or Anachronism?, 61 TENN. L. REV. 1105 (1994); Michael D. Green, The Schizophrenia of Risk-Benefit Analysis in Design Defect Litigation, 48 VAND. L. REV. 609, 622-23 (1995); Mark McLaughlin Hager, Don't Say I Didn 't Warn You (Even Though I Didn't): Why the Pro-Defendant Consensus on Warning Law Is Wrong, 61 TENN. L. REV. 1125 (1994); Owen, supra note 47, at 743; David G. Owen, The Graying of Products Liability Law, 61 TENN. L. REV. 1241 (1994); Page, supra note 63, at 87; Jerry J. Phillips, Achilles' Heel, 61 TENN. L. REV. 1265 (1994); Marshall S. Shapo, A New Legislation: Remarks on the Draft Restatement of Products Liability, 30 U. MICH. J.L. REFORM 215 (1997); John F. Vargo, The Emperor's New Clothes: The American Law Institute Adorns a "New Cloth" for Section 402A Products Liability Design Defects, 26 U. MEM. L. REV. 493 (1996); Ellen Wertheimer, The Smoke Gets in Their Eyes: Product Category Liability and Alternative Feasible Designs in the Third Restatement, 61 TENN. L. REV. 1429 (1994).
76. See William A. Dreier, Design Defects Under the Proposed Section 2(b) of the Restatement (Third) of Torts: Products Liability: A Judge's View, 30 U. MICH. J.L. REFORM 221 (1997); Oscar S. Gray, The Draft ALI Product Liability Proposals: Progress or Anachronism?, 61 TENN. L. REV. 1105 (1994); Michael D. Green, The Schizophrenia of Risk-Benefit Analysis in Design Defect Litigation, 48 VAND. L. REV. 609, 622-23 (1995); Mark McLaughlin Hager, Don't Say I Didn 't Warn You (Even Though I Didn't): Why the Pro-Defendant Consensus on Warning Law Is Wrong, 61 TENN. L. REV. 1125 (1994); Owen, supra note 47, at 743; David G. Owen, The Graying of Products Liability Law, 61 TENN. L. REV. 1241 (1994); Page, supra note 63, at 87; Jerry J. Phillips, Achilles' Heel, 61 TENN. L. REV. 1265 (1994); Marshall S. Shapo, A New Legislation: Remarks on the Draft Restatement of Products Liability, 30 U. MICH. J.L. REFORM 215 (1997); John F. Vargo, The Emperor's New Clothes: The American Law Institute Adorns a "New Cloth" for Section 402A Products Liability Design Defects, 26 U. MEM. L. REV. 493 (1996); Ellen Wertheimer, The Smoke Gets in Their Eyes: Product Category Liability and Alternative Feasible Designs in the Third Restatement, 61 TENN. L. REV. 1429 (1994).
77. See William A. Dreier, Design Defects Under the Proposed Section 2(b) of the Restatement (Third) of Torts: Products Liability: A Judge's View, 30 U. MICH. J.L. REFORM 221 (1997); Oscar S. Gray, The Draft ALI Product Liability Proposals: Progress or Anachronism?, 61 TENN. L. REV. 1105 (1994); Michael D. Green, The Schizophrenia of Risk-Benefit Analysis in Design Defect Litigation, 48 VAND. L. REV. 609, 622-23 (1995); Mark McLaughlin Hager, Don't Say I Didn 't Warn You (Even Though I Didn't): Why the Pro-Defendant Consensus on Warning Law Is Wrong, 61 TENN. L. REV. 1125 (1994); Owen, supra note 47, at 743; David G. Owen, The Graying of Products Liability Law, 61 TENN. L. REV. 1241 (1994); Page, supra note 63, at 87; Jerry J. Phillips, Achilles' Heel, 61 TENN. L. REV. 1265 (1994); Marshall S. Shapo, A New Legislation: Remarks on the Draft Restatement of Products Liability, 30 U. MICH. J.L. REFORM 215 (1997); John F. Vargo, The Emperor's New Clothes: The American Law Institute Adorns a "New Cloth" for Section 402A Products Liability Design Defects, 26 U. MEM. L. REV. 493 (1996); Ellen Wertheimer, The Smoke Gets in Their Eyes: Product Category Liability and Alternative Feasible Designs in the Third Restatement, 61 TENN. L. REV. 1429 (1994).
78. See William A. Dreier, Design Defects Under the Proposed Section 2(b) of the Restatement (Third) of Torts: Products Liability: A Judge's View, 30 U. MICH. J.L. REFORM 221 (1997); Oscar S. Gray, The Draft ALI Product Liability Proposals: Progress or Anachronism?, 61 TENN. L. REV. 1105 (1994); Michael D. Green, The Schizophrenia of Risk-Benefit Analysis in Design Defect Litigation, 48 VAND. L. REV. 609, 622-23 (1995); Mark McLaughlin Hager, Don't Say I Didn 't Warn You (Even Though I Didn't): Why the Pro-Defendant Consensus on Warning Law Is Wrong, 61 TENN. L. REV. 1125 (1994); Owen, supra note 47, at 743; David G. Owen, The Graying of Products Liability Law, 61 TENN. L. REV. 1241 (1994); Page, supra note 63, at 87; Jerry J. Phillips, Achilles' Heel, 61 TENN. L. REV. 1265 (1994); Marshall S. Shapo, A New Legislation: Remarks on the Draft Restatement of Products Liability, 30 U. MICH. J.L. REFORM 215 (1997); John F. Vargo, The Emperor's New Clothes: The American Law Institute Adorns a "New Cloth" for Section 402A Products Liability Design Defects, 26 U. MEM. L. REV. 493 (1996); Ellen Wertheimer, The Smoke Gets in Their Eyes: Product Category Liability and Alternative Feasible Designs in the Third Restatement, 61 TENN. L. REV. 1429 (1994).
79. See James A. Henderson, Jr. & Aaron D. Twerski, Achieving Consensus on Defective Product Design, 83 CORNELL L. REV. 867 (1998); James A. Henderson, Jr. & Aaron D. Twerski, Arriving at Reasonable Alternative Design: The Reporters' Travelogue, 30 U. MICH. J.L. REFORM 563 (1997); James A. Henderson, Jr. & Aaron D. Twerski, The Politics of the Products Liability Restatement, 26 HOFSTRA L. REV. 667 (1998); James A. Henderson, Jr. & Aaron D. Twerski, Will a New Restatement Help Settle Troubled Waters: Reflections, 42 AM. U. L. REV. 1257 (1993); Aaron Twerski, From a Reporter's Perspective: A Proposed Agenda, 10 TOURO L. REV.5 (1993).
80. See James A. Henderson, Jr. & Aaron D. Twerski, Achieving Consensus on Defective Product Design, 83 CORNELL L. REV. 867 (1998); James A. Henderson, Jr. & Aaron D. Twerski, Arriving at Reasonable Alternative Design: The Reporters' Travelogue, 30 U. MICH. J.L. REFORM 563 (1997); James A. Henderson, Jr. & Aaron D. Twerski, The Politics of the Products Liability Restatement, 26 HOFSTRA L. REV. 667 (1998); James A. Henderson, Jr. & Aaron D. Twerski, Will a New Restatement Help Settle Troubled Waters: Reflections, 42 AM. U. L. REV. 1257 (1993); Aaron Twerski, From a Reporter's Perspective: A Proposed Agenda, 10 TOURO L. REV.5 (1993).
81. See James A. Henderson, Jr. & Aaron D. Twerski, Achieving Consensus on Defective Product Design, 83 CORNELL L. REV. 867 (1998); James A. Henderson, Jr. & Aaron D. Twerski, Arriving at Reasonable Alternative Design: The Reporters' Travelogue, 30 U. MICH. J.L. REFORM 563 (1997); James A. Henderson, Jr. & Aaron D. Twerski, The Politics of the Products Liability Restatement, 26 HOFSTRA L. REV. 667 (1998); James A. Henderson, Jr. & Aaron D. Twerski, Will a New Restatement Help Settle Troubled Waters: Reflections, 42 AM. U. L. REV. 1257 (1993); Aaron Twerski, From a Reporter's Perspective: A Proposed Agenda, 10 TOURO L. REV.5 (1993).
82. See James A. Henderson, Jr. & Aaron D. Twerski, Achieving Consensus on Defective Product Design, 83 CORNELL L. REV. 867 (1998); James A. Henderson, Jr. & Aaron D. Twerski, Arriving at Reasonable Alternative Design: The Reporters' Travelogue, 30 U. MICH. J.L. REFORM 563 (1997); James A. Henderson, Jr. & Aaron D. Twerski, The Politics of the Products Liability Restatement, 26 HOFSTRA L. REV. 667 (1998); James A. Henderson, Jr. & Aaron D. Twerski, Will a New Restatement Help Settle Troubled Waters: Reflections, 42 AM. U. L. REV. 1257 (1993); Aaron Twerski, From a Reporter's Perspective: A Proposed Agenda, 10 TOURO L. REV.5 (1993).
83. See James A. Henderson, Jr. & Aaron D. Twerski, Achieving Consensus on Defective Product Design, 83 CORNELL L. REV. 867 (1998); James A. Henderson, Jr. & Aaron D. Twerski, Arriving at Reasonable Alternative Design: The Reporters' Travelogue, 30 U. MICH. J.L. REFORM 563 (1997); James A. Henderson, Jr. & Aaron D. Twerski, The Politics of the Products Liability Restatement, 26 HOFSTRA L. REV. 667 (1998); James A. Henderson, Jr. & Aaron D. Twerski, Will a New Restatement Help Settle Troubled Waters: Reflections, 42 AM. U. L. REV. 1257 (1993); Aaron Twerski, From a Reporter's Perspective: A Proposed Agenda, 10 TOURO L. REV.5 (1993).
84. See Henderson & Twerski, supra note 2, at 1286-92.
85. Henderson & Twerski, supra note 14, at 1545; see also id. at 1537 ("The problem can in large part be attributed to the existing comment k, which is poorly drafted and internally inconsistent. . . . To draw on comment k as authority to resolve problems that no one even contemplated at the time of its adoption is sheer foolishness.").
86. See id. at 1522-23 (presenting proposed revisions of comment k).
87. Tentative Draft Number 1 proposed that plaintiffs should be required to prove that "[t]he foreseeable risks of harm posed by the drug or medical device were sufficiently great in relation to its therapeutic benefits as to deter a reasonable medical provider, possessing knowledge of such foreseeable risks and therapeutic benefits, from prescribing the drug or medical device for any class of patients." Teresa Moran Schwartz, Prescription Products and the Proposed Restatement (Third), 61 TENN. L. REV. 1357, 1365 n.40 (1994) (quoting RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY § 4(b)(4), at 89 (Tentative Draft No. 1, 1994)) (emphasis added).
88. The only negative word spoken on the floor concerning the proposed standard was Professor Howard Latin's comment at the 1995 meeting that section 8(c) (later section 6(c)) was "very, very friendly to drug manufacturers. 72 A.L.I. PROC. 281 (1995). There was some floor debate concerning Latin's suggestion that section 6(c)'s language be changed from "no reasonable health care provider" to "reasonable health care providers." See id. at 276. This amendment was accepted by the Reporters as a way of emphasizing the objective rather than the subjective nature of the standard. There was also debate over another motion by Latin concerning potential liability in situations in which the manufacturer knows that its drug or device is "being prescribed to a class of patients for whom the ratio of foreseeable risks to therapeutic benefits exceeds the risk-to-benefit ratio afforded by a reasonable alternative design or reasonable alternative product." Id. at 869-70. This motion was defeated.
89. RESTATEMENT (THIRD), supra note 1, § 19(c).
90. See, e.g., Schwartz, supra note 72, at 1364 ("[T]he proposal [would] establish[] a 'super' negligence standard of liability. . . . [T]he proposed standard . . . will create such a narrow band of liability that it would effectively eliminate a cause of action for defective design.").
91. See Richard L. Cupp, Jr., Rethinking Conscious Design Liability for Prescription Drugs: The Restatement (Third) Standard Versus a Negligence Approach, 63 GEO. WASH. L. REV. 76, 110 (1994) (advocating a "pure negligence" standard as "an appropriate middle step" between strict liability and the Restatement's near-immunity); Angela C. Rushton, Comment, Design Defects Under the Restatement (Third) of Torts: A Reassessment of Strict Liability and the Goals of a Functional Approach, 45 EMORY L.J. 389, 420, 435 (1996) (criticizing the Restatement (Third) approach as insufficiently protective of consumers but conceding that "a drug should receive the protection of a heightened liability standard . . . when its benefits outweigh its risks").
92. See Richard L. Cupp, Jr., Rethinking Conscious Design Liability for Prescription Drugs: The Restatement (Third) Standard Versus a Negligence Approach, 63 GEO. WASH. L. REV. 76, 110 (1994) (advocating a "pure negligence" standard as "an appropriate middle step" between strict liability and the Restatement's near-immunity); Angela C. Rushton, Comment, Design Defects Under the Restatement (Third) of Torts: A Reassessment of Strict Liability and the Goals of a Functional Approach, 45 EMORY L.J. 389, 420, 435 (1996) (criticizing the Restatement (Third) approach as insufficiently protective of consumers but conceding that "a drug should receive the protection of a heightened liability standard . . . when its benefits outweigh its risks").
93. See Frank J. Vandall, Constructing a Roof Before the Foundation Is Prepared: The Restatement (Third) of Torts: Products Liability Section 2(b) Design Defect, 30 U. MICH. J.L. REFORM 261, 270-71, 279 (1997) (advocating strict liability for drug-design defects and criticizing section 6(c) for "clearly favoring manufacturers by eliminating strict liability, skirting negligence, and adopting a radical new theory with little attempt to balance the interests of the consumers").
94. James A. Henderson, Jr., Prescription Drug Design Liability Under the Proposed Restatement (Third) of Torts: A Reporter's Perspective, 48 RUTGERS L. REV. 471, 481 (1996).
95. See Michael D. Green, Statutory Compliance and Tort Liability: Examining the Strongest Case, 30 U. MICH. J.L. REFORM 461 (1997) [hereinafter Green, Statutory Compliance]. Green commented: The analysis for design defects in drugs is quite different and driven by the unique character of most drugs. Unlike durable goods, drugs cannot be designed in an alternative fashion, at least not in light of current technological capabilities. With the Restatement (Third)'s adoption of a risk-benefit test for design defects and its insistence on proof of an alternative design, one might think that there would therefore be no place for a design defect theory involving pharmaceuticals. . . . But the Restatement (Third) does have a very limited provision for a design defect claim in the case of pharmaceuticals . . . . Id. at 471 (footnotes omitted). Green clarified in a footnote that "[t]his observation is inapplicable to medical devices. Pharmaceuticals differ from most products because it is difficult to change the design of a given drug; medical devices, such as the Dalkon Shield with a multifilament tailstring, although subject to FDA regulation, do not share that characteristic with drugs." Id. at 471 n.36; see also Michael D. Green, Prescription Drugs, Alternative Designs, and the Restatement (Third): Preliminary Reflections, 30 SETON HALL L. REV. 207, 208 n.4 (1999) (suggesting that while section 6(c) may be an appropriate regime for prescription drugs, medical devices and vaccines may be sufficiently different from drugs as to require a different liability rule); Green, supra note 67, at 619-20 (suggesting that vaccines are appropriate subjects of alternative-safer-design analysis).
96. See Michael D. Green, Statutory Compliance and Tort Liability: Examining the Strongest Case, 30 U. MICH. J.L. REFORM 461 (1997) [hereinafter Green, Statutory Compliance]. Green commented: The analysis for design defects in drugs is quite different and driven by the unique character of most drugs. Unlike durable goods, drugs cannot be designed in an alternative fashion, at least not in light of current technological capabilities. With the Restatement (Third)'s adoption of a risk-benefit test for design defects and its insistence on proof of an alternative design, one might think that there would therefore be no place for a design defect theory involving pharmaceuticals. . . . But the Restatement (Third) does have a very limited provision for a design defect claim in the case of pharmaceuticals . . . . Id. at 471 (footnotes omitted). Green clarified in a footnote that "[t]his observation is inapplicable to medical devices. Pharmaceuticals differ from most products because it is difficult to change the design of a given drug; medical devices, such as the Dalkon Shield with a multifilament tailstring, although subject to FDA regulation, do not share that characteristic with drugs." Id. at 471 n.36; see also Michael D. Green, Prescription Drugs, Alternative Designs, and the Restatement (Third): Preliminary Reflections, 30 SETON HALL L. REV. 207, 208 n.4 (1999) (suggesting that while section 6(c) may be an appropriate regime for prescription drugs, medical devices and vaccines may be sufficiently different from drugs as to require a different liability rule); Green, supra note 67, at 619-20 (suggesting that vaccines are appropriate subjects of alternative-safer-design analysis).
97. Compare the Restatement (Third) Reporters' notes' thorough state-by-state review of cases in support of section 2's alternative design standard with the Reporters' sparse defense of the section 6(c) rule. See RESTATEMENT (THIRD), supra note 1, §§ 2, 6 Reporters' notes. In their section 6(c) note, the Reporters assert that courts "traditionally have refused to review the reasonableness of the designs of prescription drugs and medical devices." Id. § 6 cmt. f Reporter's note. Fifteen jurisdictions are cited that do not follow the traditional "no review" rule and only six states are identified that "have adopted essentially the approach taken in § 6(c)." Id. Moreover, one of those six state cases. Tansy v. Dacomed Corp., 890 P.2d 881 (Okla. 1994), in fact notes the appropriateness of the alternative-safer-design test for review of medical devices. See id. at 886.
98. The Reporters' departure from the dominant common-law rules was evident. In their first alternative revision of comment k, the Reporters stated that courts had traditionally limited drug-defect claims to failure-to-warn theories, see Henderson & Twerski, supra note 14, at 1512, an approach the Reporters had long disparaged, see, e.g., James A. Henderson & Aaron D. Twerski, Doctrinal Collapse in Products Liability: The Empty Shell of Failure To Warn, 65 N.Y.U. L. REV. 265 (1990). That statement may be an accurate summary of how the bulk of drug products-liability cases have been litigated in the past, but it does not accurately capture the current majority rule.
99. See, e.g., JULES L. COLEMAN, RISKS AND WRONGS, 414-15 (1992) ("Together the rule of strict liability in conjunction with the design defect tests have wreaked havoc within the manufacturing sector of the economy. . . . [T]he modem solution has failed to provide what we seek, a principled, rational, and predictable body of law regulating product safety."); RICHARD A. EPSTEIN, SIMPLE RULES FOR A COMPLEX WORLD 103 (1995) ("Breakthroughs in technology and treatment need carrots, not sticks.").
100. See, e.g., JULES L. COLEMAN, RISKS AND WRONGS, 414-15 (1992) ("Together the rule of strict liability in conjunction with the design defect tests have wreaked havoc within the manufacturing sector of the economy. . . . [T]he modem solution has failed to provide what we seek, a principled, rational, and predictable body of law regulating product safety."); RICHARD A. EPSTEIN, SIMPLE RULES FOR A COMPLEX WORLD 103 (1995) ("Breakthroughs in technology and treatment need carrots, not sticks.").
101. See Gary T. Schwartz, Foreword: Understanding Products Liability, 67 CAL. L. REV. 435, 468 (1979) (noting that "one simply cannot talk meaningfully about a risk-benefit defect in a product design until and unless one has identified some design alternative" to serve as a referent); see also Cass R. Sunstein, On Analogical Reasoning, 106 HARV. L. REV. 741, 790-91 (1993) (expounding the virtues of analogical reasoning in judicial decisionmaking).
102. See Gary T. Schwartz, Foreword: Understanding Products Liability, 67 CAL. L. REV. 435, 468 (1979) (noting that "one simply cannot talk meaningfully about a risk-benefit defect in a product design until and unless one has identified some design alternative" to serve as a referent); see also Cass R. Sunstein, On Analogical Reasoning, 106 HARV. L. REV. 741, 790-91 (1993) (expounding the virtues of analogical reasoning in judicial decisionmaking).
103. See Owen, Risk-Utility Balancing, supra note 61, at 239 (describing the courts' struggle to frame the defect question in terms of global product risks and benefits as "balancing bedlam").
104. See RESTATEMENT (THIRD), supra note 1, § 2 cmt. e.
105. Many drugs commonly are understood to be unalterable in design, but this is not necessarily the case. The possibility of alternative designs is acknowledged by the FDA. The section of the Food, Drug & Cosmetic Act dealing with orphan drugs, for example, implicitly recognizes the possibility that two different manufacturers could produce two different versions of the same drug. See 21 U.S.C. § 360cc (1994); see also 21 C.F.R. § 316.3 (1999) (defining "same drug"). Orphan drugs are vaccines and other drugs intended for the treatment of rare diseases.
106. The Reporters did recognize in two law journal articles that competing designs for vaccines presented serious challenges to their position that drugs should be insulated from alternative design review, but this concern was nowhere manifested in the Restatement (Third). See Henderson, supra note 78, at 490-91; Henderson & Twerski, supra note 14, at 1539-40.
107. See IOM REPORT, supra note 25, at 1. Recombinant factor VIII is now available, but the Product had not yet been invented at the time of the hepatitis and HIV epidemics. See Menitove et al., supra note 26, at 1654.
108. See E. Tabor & R.J. Gerety, Non-A, Non-B Hepatitis: New Findings and Prospects for Prevention, 19 TRANSFUSION 669, 669 (1979) (stating that nearly 89% of cases of transfusion-associated hepatitis in the United States in 1979 were "non-A, non-B" hepatitis and that the risk of contracting that form of hepatitis from a blood transfusion in the United States was between 5.4% and 18.5%). Hepatitis A is transmissible through a variety of means and has a short incubation period. Its symptoms are flu-like and may have a protracted course, but it only rarely causes liver failure. Hepatitis B is a chronic viral disease that causes a variety of acute and chronic problems in the liver and other organ systems. About 90% to 95% of otherwise healthy adults recover completely from hepatitis B, but 5% to 10% remain chronically infected. Hepatitis C is a chronic disease in 50% to 80% of cases. Ten percent to 20% of hepatitis C patients suffer from cirrhosis or progressive liver failure. See Robert K. Ockner, Acute Viral Hepatitis, in CECIL TEXTBOOK OF MEDICINE 762 (J. Claude Bennett & Fred Plum eds., 1996); Robert K. Ockner, Chronic Hepatitis, in CECIL TEXTBOOK OF MEDICINE, supra, at 776.
109. See E. Tabor & R.J. Gerety, Non-A, Non-B Hepatitis: New Findings and
110. See E. Tabor & R.J. Gerety, Non-A, Non-B Hepatitis: New Findings and Prospects for Prevention, 19 TRANSFUSION 669, 669 (1979) (stating that nearly 89% of cases of transfusion- associated hepatitis in the United States in 1979 were "non-A, non-B" hepatitis and that the risk of contracting that form of hepatitis from a blood transfusion in the United States was between 5.4% and 18.5%). Hepatitis A is transmissible through a variety of means and has a short incubation period. Its symptoms are flu-like and may have a protracted course, but it only rarely causes liver failure. Hepatitis B is a chronic viral disease that causes a variety of acute and chronic problems in the liver and other organ systems. About 90% to 95% of otherwise healthy adults recover completely from hepatitis B, but 5% to 10% remain chronically infected. Hepatitis C is a chronic disease in 50% to 80% of cases. Ten percent to 20% of hepatitis C patients suffer from cirrhosis or progressive liver failure. See Robert K. Ockner, Acute Viral Hepatitis, in CECIL TEXTBOOK OF MEDICINE 762 (J. Claude Bennett & Fred Plum eds., 1996); Robert K. Ockner, Chronic Hepatitis, in CECIL TEXTBOOK OF MEDICINE, supra, at 776.
111. See George F. Grady et al., Risk of Posttransfusion Hepatitis in the United States: A Prospective Cooperative Study, 220 JAMA 692, 692-701 (1972).
112. See M. W. Hilgartner & P. Giardina, Liver Dysfunction in Patients With Hemophilia A, B, and von Willebrand's Disease, 17 TRANSFUSION 495, 497 (1977). The high rate of infection may have been attributable in part to commercial blood banks' increased use of blood donors from prisons, indigent neighborhoods, and Third World countries, where rates of hepatitis infection were high. See STARR, supra note 53, at 231-49.
113. See Grady, supra note 90, at 700.
114. See U.W. Hasiba et al., Chronic Liver Dysfunction in Multitransfused Hemophiliacs, 17 TRANSFUSION 490, 493 (1977) (concluding that "single donor products should be the preferred mode of treatment for mild hemophiliacs who require only infrequent therapy"); see also E.D. Gomperts et al., Hepatocellular Enzyme Patterns and Hepatitis B Virus Exposure in Multitransfused Young and Very Young Hemophilia Patients, 11 AM. J. HEMATOLOGY 55, 59 (1981) (concluding that "because the long-term clinical consequences of this hepatocellular dysfunction are currently unknown, and as the danger and problems associated with hemorrhagic episodes are well-characterized, under current knowledge it would seem inadvisable to withhold factor concentrates in the face of a hemorrhage or to alter present replacement therapy regimens").
115. See U.W. Hasiba et al., Chronic Liver Dysfunction in Multitransfused Hemophiliacs, 17 TRANSFUSION 490, 493 (1977) (concluding that "single donor products should be the preferred mode of treatment for mild hemophiliacs who require only infrequent therapy"); see also E.D. Gomperts et al., Hepatocellular Enzyme Patterns and Hepatitis B Virus Exposure in Multitransfused Young and Very Young Hemophilia Patients, 11 AM. J. HEMATOLOGY 55, 59 (1981) (concluding that "because the long-term clinical consequences of this hepatocellular dysfunction are currently unknown, and as the danger and problems associated with hemorrhagic episodes are well-characterized, under current knowledge it would seem inadvisable to withhold factor concentrates in the face of a hemorrhage or to alter present replacement therapy regimens").
116. The National Cancer Institute reported in a survey of 16 hemophilia care centers that 50% of hemophiliac patients were infected with HIV from 1978 to 1990. The rate of infection increased rapidly after 1978 and peaked at a rate of 22 infections per 100 person-years at risk in October 1982. See Barbara L. Kroner et al., HIV-1 Infection Incidence Among Persons with Hemophilia in the United States and Western Europe, 1978-1990, 7 J. ACQUIRED IMMUNE DEFICIENCY SYNDROMES 279, 281 (1994).
117. IOM REPORT, supra note 25, at 82.
118. Id. Physical heat or chemical detergents can be used to inactivate viruses and other infectious agents in plasma products. There are, however, no effective methods of inactivating viruses in whole blood or non-plasma products (such as red blood cells and platelets) used in transfusions. Although some derivative blood products had been heat-treated since the late 1940s, Factor VIII and IX concentrates were not pasteurized until 1983 and 1984, respectively. See id. at 5, 81.
119. See id. at 94. All four major blood products manufacturers applied for FDA approval within a six-month period between June and December 1982. See id. at 92. The first application, by Baxter Healthcare, came 12 months after the first report of a cluster of pneumocystis carinii pneumonia (a common infection in HIV patients) in Los Angeles in June 1981, and five months after the Center for Disease Control learned of the first suspected case of AIDS (then called "Gay Related Immune Deficiency") in a heterosexual hemophiliac. See id.
120. A hemophiliac's risk of contracting HIV from concentrated blood products plummeted from 22 in 100 to less than 4 in 100 by July 1984, when heat-pasteurized blood products came on the market. No cases of HIV transmission have been reported among recipients of the virus-inactivated concentrates now in use. See Kroner, supra note 94, at 284; see also Roberts & Hoffman, supra note 8, at 1423 (noting that "[s]creening of donor populations and new techniques for preparing factor VIII concentrates since 1985 have essentially eliminated the risk of HIV transmission").
121. See IOM REPORT, supra note 25, at 82 ("[B]ecause the product treatment methods used to inactivate hepatitis viruses also inactivate HIV, their availability prior to 1981 would have minimized, if not prevented, the widespread HIV infection of persons with hemophilia."). Over 16,000 hemophiliacs in the United States were infected with HIV from blood products in the early 1980s. See id. at 1. According to one study, AIDS was the primary cause of 65% of the deaths in hemophilic patients between 1986 and 1991, while bleeding was responsible for only 5%. See Roberts & Hoffman, supra note 8, at 1423. Epidemic patterns of infection similar to those of the United States were observed in other advanced countries where concentrated blood products, imported principally from the American producers, were relied on for treatment of hemophiliacs. For a discussion of the epidemiology of AIDS in several industrialized countries, see the works collected in AIDS IN THE INDUSTRIALIZED DEMOCRACIES (David L. Kirp & Ronald Bayer eds., 1992).
122. See Menitove et al., supra note 26, at 1650-51. Hepatitis B may survive pasteurization. See id. at 1650 (noting that "two patients were reported to be infected with hepatitis B after receiving pasteurized . . . factor VIII concentrates").
123. The Institute of Medicine concluded that the "fact that the plasma fractionation industry was able to produce an inactivated product for license consideration concurrent with, and shortly after, the first reports of AIDS in individuals with hemophilia suggests that hepatitis infection (rather than AIDS) provided the major motivation for the ultimate development of viral inactivation methods." IOM REPORT, supra note 25, at 95.
124. See id. at 92-95.
125. Id. at 93.
126. Id.
127. See id. at 94.
128. Id.
129. Id.
130. See id. at 92.
131. See Robert P. Merges, Commercial Success and Patent Standards: Economic Perspectives on Innovation, 76 CAL. L. REV. 803, 842-50 (1988) (discussing the limitations of the Profit-maximizing race model of commercial innovation).
132. See RESTATEMENT (THIRD), supra note 1, § 19 cmt. c.
133. Id.
134. Hemophiliac victims of HIV may be able to obtain a limited amount of compensation from the federal government. The 1998 Ricky Ray Hemophilia Relief Fund Act provides for "compassionate payments" to HIV-infected hemophiliacs (and their survivors) who received concentrated blood products from proprietary manufacturers in the period from July 1, 1982 (when the first three cases of immune suppressive disorder were identified in hemophiliacs) to December 31, 1987 (by which time all unpasteurized blood product stocks had been exhausted or destroyed). See 42 U.S.C.A. § 300c-22 (West Supp. 1999). However, Congress still has not funded the program. See Ricky Ray Hemophilia Relief Fund Act of 1998, Procedures for Filing Petitions for Payment, 69 Fed. Reg. 14,251 (1999). Prior to the Act's passage, American hemophiliacs were alone among hemophiliacs in the advanced countries in having been offered no government compensation. For a discussion of governmental compensation schemes in several industrialized nations, see generally the works collected in AIDS IN THE INDUSTRIALIZED DEMOCRACIES, supra note 99.
135. See, e.g., Doe v. Miles Lab., 927 F.2d 187, 192-94 (4th Cir. 1991) (holding that a clotting agent's benefits to patients suffering from uncontrolled bleeding precluded plaintiffs strict-liability action as well as plaintiff's negligence claim for failure to screen blood donors); McKee v. Cutter Lab., 866 F.2d 219, 221-22 (6th Cir. 1989) (finding that plaintiff's strict-liability claims against a factor-concentrate manufacturer were barred by Kentucky's blood shield statute); Coffee v. Cutter Biological, 809 F.2d 191, 193-95 (2d Cir. 1987) (holding that the HIV-infected hemophiliac plaintiff's claim was barred by Connecticut's blood shield law); Hyland Therapeutics v. Superior Court, 175 Cal. App. 3d 509, 516 (Ct. App. 1985) ("[Legislatures have determined that the production and use of human blood and its derivatives for therapeutic purposes should be encouraged; and for this purpose those who provide these products, and who are themselves free from fault, should not be required to bear the economic loss which might otherwise be imposed under the rules of strict liability which are applicable to sellers of commercial products generally."); Rogers v. Miles Lab., 802 P.2d 1346, 1350-52 (Wash. 1991) (holding that common-law strict liability was not available for claims against blood-products manufacturers because the doctrine's effect "would be that a product, essential to sustain the life of some individuals, would not be available").
136. 157 F.R.D. 410 (N.D. Ill. 1994). The other major manufacturers of fractionated blood products, Armour Pharmaceutical Co., Miles, Inc., Baxter Healthcare Corp., and Alpha Therapeutic Corp., were codefendants in the case, as was the National Hemophilia Foundation. See id. The plaintiffs alleged that the National Hemophilia Foundation, influenced by financial contributions from the fractionators, had given unfounded assurances of the safety of the fractionators' products, knowing that hemophiliacs and their physicians would rely on those assurances. See id. at 414. Wadleigh was consolidated in the Northern District of Illinois in multidistrict litigation managed by Judge John Grady. See In re Factor VIII or IX Concentrate Blood Prods. Litig., 169 F.R.D. 632 (N.D. Ill. 1996).
137. See Wadleigh, 157 F.R.D. at 414.
138. See id.
139. In re Factor VIII, 169 F.R.D. at 633-34.
140. See In re Rhone-Poulenc Rorer, Inc., 51 F.3d 1293, 1304 (7th Cir. 1995).
141. Id. at 1296.
142. Id.
143. See id. at 1298.
144. Id. at 1299.
145. See In re Factor VIII or IX Concentrate Blood Prods. Litig., 169 F.R.D. 632, 634 (N.D. III. 1996). The settlement approximated market share: Bayer paid 45%, Alpha 15%, and Armour and Baxter 20% each. See Blood Product Firms To Pay Government $12 Million To Settle Health Care Claims, 6 Health L. Rep. (BNA) 712, 712 (May 5, 1997).
146. See In re Factor VIII or IX Concentrate Blood Prods. Litig., 169 F.R.D. 632, 634 (N.D. III. 1996). The settlement approximated market share: Bayer paid 45%, Alpha 15%, and Armour and Baxter 20% each. See Blood Product Firms To Pay Government $12 Million To Settle Health Care Claims, 6 Health L. Rep. (BNA) 712, 712 (May 5, 1997).
147. In the early 1950s, approximately 50,000 cases of polio per year were identified in the United States. By 1969, only about a dozen cases were recorded. See Joseph L. Melnick, Live Attenuated Polio Virus Vaccines, in VACCINES 155, 187 tbl.7-17 (Stanley A. Plotkin & Edward A. Mortimer eds., 2d ed. 1994).
148. See Centers for Disease Control & Prevention, Poliomyelitis Prevention in the United States, MORBIDITY & MORTALITY WKLY. REP., Jan. 24, 1997, at 5 (recommendations of the Advisory Committee on Immunization Practices); Frederick C. Robbins, Polio-Historical, in VACCINES, supra note 124, at 137, 141-42.
149. See Centers for Disease Control & Prevention, Poliomyelitis Prevention in the United States, MORBIDITY & MORTALITY WKLY. REP., Jan. 24, 1997, at 5 (recommendations of the Advisory Committee on Immunization Practices); Frederick C. Robbins, Polio-Historical, in VACCINES, supra note 124, at 137, 141-42.
150. See Centers for Disease Control & Prevention, supra note 125, at 6.
151. See id. at 2.
152. See Centers for Disease Control & Prevention, supra note 125, at 7-8; Jonas Salk et al., Noninfectious Poliovirus Vaccine, in VACCINES, supra note 124, at 216-17, 219, 222.
153. See Centers for Disease Control & Prevention, supra note 125, at 1-2, 8.
154. See Marlene Cimons, End Oral Polio Vaccine, Panel Says, L.A. TIMES, June 18, 1999, at A26.
155. See Centers for Disease Control & Prevention, General Recommendations on Immunization, MORBIDITY & MORTALITY WKLY. REP., Jan. 28, 1994, at 1-38.
156. OPV satisfies the net benefit test, notwithstanding the fact that IPV is equally effective and safer because it cannot cause VAPP. The American Academy of Pediatrics, which still advocates OPV as the vaccine of choice, has since 1991 maintained that both IPV and OPV are "effective in preventing poliomyelitis," and that IPV should be offered to "individuals who have refused OPV or in whom OPV is contraindicated" - for example, persons with compromised immunity and children who have close contact with adults who have not been immunized against polio. Salk, supra note 128, at 222. The World Health Organization "prefers the use of OPV because of its low cost, ease of administration in mass campaigns, superiority in conferring intestinal immunity, and ability to infect household and community contacts" with the vaccine virus. Id. at 221. It should be noted that OPV's superiority in conferring intestinal immunity is disputed. See id. at 220. Additionally, while infection of household and community contacts with the vaccine virus can serve an immunizing function, it can also cause vaccine-associated paralytic disease in those persons. Id. at 220-21.
157. William A. Donaher et al., The Technological Expert in Products Liability Litigation, 52 TEX. L. REV. 1303, 1307 (1974). Professor Twerski was a coauthor of this article.
158. See RESTATEMENT (THIRD), supra note 1, § 2 cmt. d Reporter's note.
159. See, e.g., Henderson, supra note 78, at 495 ("[P]rescription drugs present quite different product design issues, unique unto themselves and clearly beyond the institutional competence of courts to manage.").
160. The "manifestly unreasonably design" test currently is embodied in a comment to section 2 of the Restatement (Third). See RESTATEMENT (THIRD), supra note 1, § 2 cmt. e.
161. See RESTATEMENT (THIRD), supra note 1, § 2 cmt. f.
162. See Green, supra note 67, at 619. Green asks: What of the utility of the product? Irrelevant to the analysis. What we are interested in is the marginal utility of the existing design, not the overall societal benefits of the product. To put the point another way, imagine that we have identified a one hundred percent effective vaccine for AIDS. Suppose the vaccine causes a mild auto-immune reaction - a rash that lasts for a week-in one out of a million persons who take the vaccine. The side effect can be eliminated by changing one of the inert ingredients with which the vaccine is coated to another inert ingredient, no more expensive and equally adept at serving its purpose. The vaccine is defectively designed despite its enormous social utility. Risk-benefit analysis operates at the margin-the utility of the existing design compared to the alternative-not at the level of the entire product. Id.; see also John W. Wade, On Product "Design Defects" and Their Actionability, 33 VAND. L. REV. 551, 572 (1980) (commenting that the Barker court's language should "make clear to the jury that it is to look primarily to the utility or benefit of that aspect of the design which is claimed to be improper or 'defective' rather than to the utility or benefit of the product in general").
163. See, e.g., Victor E. Schwartz, Unavoidably Unsafe Products: Clarifying the Meaning and Policy Behind Comment k, 42 WASH. & LEE L. REV. 1139, 1141 (1985).
164. Henderson & Twerski, supra note 14, at 1536.
165. See Henderson, supra note 78, at 483, 494.
166. Calcium antagonists used to treat hypertension, such as nifedipine, are one example. See Curt D. Furberg et al., Nifedipine: Dose-Related Increase in Mortality in Patients with Coronary Heart Disease, 92 CIRCULATION 1326, 1326 (1995) (finding that the use of nifedipine in moderate to high doses increases the mortality rate of patients with coronary disease and postulating that "[o]ther calcium antagonists may have similar adverse effects"); Ten A. Manolio et al., Trends in Pharmacologic Management of Hypertension in the United States, 155 ARCHIVES INTERNAL MED. 829, 829 (1995) (noting that the "[u]se of calcium antagonists and angiotensin- converting enzyme inhibitors in hypertension has increased dramatically in the past 10 years" despite a lack of evidence of the effectiveness of these drugs). Such data prompted federal health officials to issue alerts in an attempt to change the pattern of prescriptions by physicians. See Lawrence K. Altman, Risk of Death Found in Use of Heart Drug, N.Y. TIMES, Nov. 1, 1995, at A16. The overprescribing of nifedipine is of concern not only because of its health implications, but also because of the high cost of the drug. See Manolio et al., supra, at 829 (calculating that the increase in the number of nifedipine prescriptions over the 1982-1992 period resulted in an additional $3.1 billion in expenditures nationwide).
167. Calcium antagonists used to treat hypertension, such as nifedipine, are one example. See Curt D. Furberg et al., Nifedipine: Dose-Related Increase in Mortality in Patients with Coronary Heart Disease, 92 CIRCULATION 1326, 1326 (1995) (finding that the use of nifedipine in moderate to high doses increases the mortality rate of patients with coronary disease and postulating that "[o]ther calcium antagonists may have similar adverse effects"); Ten A. Manolio et al., Trends in Pharmacologic Management of Hypertension in the United States, 155 ARCHIVES INTERNAL MED. 829, 829 (1995) (noting that the "[u]se of calcium antagonists and angiotensin-converting enzyme inhibitors in hypertension has increased dramatically in the past 10 years" despite a lack of evidence of the effectiveness of these drugs). Such data prompted federal health officials to issue alerts in an attempt to change the pattern of prescriptions by physicians. See Lawrence K. Altman, Risk of Death Found in Use of Heart Drug, N.Y. TIMES, Nov. 1, 1995, at A16. The overprescribing of nifedipine is of concern not only because of its health implications, but also because of the high cost of the drug. See Manolio et al., supra, at 829 (calculating that the increase in the number of nifedipine prescriptions over the 1982-1992 period resulted in an additional $3.1 billion in expenditures nationwide).
168. Calcium antagonists used to treat hypertension, such as nifedipine, are one example. See Curt D. Furberg et al., Nifedipine: Dose-Related Increase in Mortality in Patients with Coronary Heart Disease, 92 CIRCULATION 1326, 1326 (1995) (finding that the use of nifedipine in moderate to high doses increases the mortality rate of patients with coronary disease and postulating that "[o]ther calcium antagonists may have similar adverse effects"); Ten A. Manolio et al., Trends in Pharmacologic Management of Hypertension in the United States, 155 ARCHIVES INTERNAL MED. 829, 829 (1995) (noting that the "[u]se of calcium antagonists and angiotensin- converting enzyme inhibitors in hypertension has increased dramatically in the past 10 years" despite a lack of evidence of the effectiveness of these drugs). Such data prompted federal health officials to issue alerts in an attempt to change the pattern of prescriptions by physicians. See Lawrence K. Altman, Risk of Death Found in Use of Heart Drug, N.Y. TIMES, Nov. 1, 1995, at A16. The overprescribing of nifedipine is of concern not only because of its health implications, but also because of the high cost of the drug. See Manolio et al., supra, at 829 (calculating that the increase in the number of nifedipine prescriptions over the 1982-1992 period resulted in an additional $3.1 billion in expenditures nationwide).
169. Patients, however, generally have limited choice in the physician-dominated health care environment.
170. This idea was famously expressed in OLIVER WENDELL HOLMES, THE COMMON LAW (Mark De Wolfe Howe ed., 1963) (1881): The true explanation of the reference of liability to a moral standard, in the sense which has been explained, is not that it is for the purpose of improving men's hearts, but that it is to give a man a fair chance to avoid doing the harm before he is held responsible for it. It is intended to reconcile the policy of letting accidents lie where they fall, and the reasonable freedom of others with the protection of the individual from injury. Id. at 115. This concept of preventable harm is also present in the Restatement (Third)'s section 2(b) alternative design rule. See RESTATEMENT (THIRD), supra note 1, § 2 cmt. f (referring to "the commonsense notion that liability for harm caused by product designs should attach only when harm is reasonably preventable").
171. Justice Mosk wrote: We agree with defendants that Barker contemplates a safer alternative design is possible, but we seriously doubt their claim that a drug like DES cannot be "redesigned" to make it safer. For example, plaintiff might be able to demonstrate at trial that a particular component of DES rendered it unsafe as a miscarriage preventative and that removal of that component would not have affected the efficacy of the drug. Even if the resulting product, without the damaging component, would bear a name other than DES, it would do no violence to semantics to view it as a "redesign" of DES. Brown v. Superior Court, 751 P.2d 470,478 (Cal. 1988).
172. 573 P.2d 443 (Cal. 1978).
173. Brown, 751 P.2d at 478-79 (citation omitted).
174. How much power remains in that argument is debatable. See, e.g., DeHanes v. Rothman, 727 A.2d 8, 12-13 (N.J. 1999) (citing survey evidence indicating that jurors believe liability suits increase their own costs as consumers and deeply mistrust civil litigants and paid expert witnesses).
175. See W. Kip Viscusi et al., Deterring Inefficient Pharmaceutical Litigation: An Economic Rationale for the FDA Regulatory Compliance Defense, 24 SETON HALL L. REV. 1437 (1994). Viscusi and his coauthors argue that laissez faire pharmaceutical litigation often creates perverse incentives. These incentive effects can lessen the value or even countermand the judgments of the FDA, thereby overturning the agency's well-considered risk-benefit assessments. Because a fully informed FDA almost certainly makes erroneous risk-benefit judgments less often than our tort system, the role of tort law in this context needs to be refocused. Id. at 1475.
176. 447 A.2d 539 (N.J. 1982); see also Henderson & Twerski, supra note 2, at 1271 ("Decisions published during the late 1970s and early 1980s represent what many observers consider to be the high water marks of this expansionary, remarkably proplaintiff period."). The Beshada decision was widely criticized by academic commentators. The Feldman v. Lederle Laboratories opinion, 479 A.2d 374, 388 (N.J. 1984), cites a number of these criticisms, including Joseph A. Page, Generic Product Risks: The Case Against Comment k and for Strict Tort Liability, 58 N.Y.U. L. REV. 853, 877-82 (1983); Victor Schwartz, The Post-Sale Duty To Warn: Two Unfortunate Forks in the Road to a Reasonable Doctrine, 58 N.Y.U. L. REV. 892, 901-05 (1983); John W. Wade, On the Effect in Product Liability of Knowledge Unavailable Prior to Marketing, 58 N.Y.U. L. REV. 734, 754-56 (1983); Robert D. Casale, Comment, Beshada v. Johns-Manville Products Corp.: Adding Uncertainty to Injury, 35 RUTGERS L. REV. 982, 1008-15 (1983); William R. Murray, Jr., Comment, Requiring Omniscience: The Duty To Warn of Scientifically Undiscoverable Product Defects, 71 GEO. L.J. 1635 (1983); and Robert D. Towry, Note, 13 SETON HALL L. REV. 625 (1983).
177. 447 A.2d 539 (N.J. 1982); see also Henderson & Twerski, supra note 2, at 1271 ("Decisions published during the late 1970s and early 1980s represent what many observers consider to be the high water marks of this expansionary, remarkably proplaintiff period."). The Beshada decision was widely criticized by academic commentators. The Feldman v. Lederle Laboratories opinion, 479 A.2d 374, 388 (N.J. 1984), cites a number of these criticisms, including Joseph A. Page, Generic Product Risks: The Case Against Comment k and for Strict Tort Liability, 58 N.Y.U. L. REV. 853, 877-82 (1983); Victor Schwartz, The Post-Sale Duty To Warn: Two Unfortunate Forks in the Road to a Reasonable Doctrine, 58 N.Y.U. L. REV. 892, 901-05 (1983); John W. Wade, On the Effect in Product Liability of Knowledge Unavailable Prior to Marketing, 58 N.Y.U. L. REV. 734, 754-56 (1983); Robert D. Casale, Comment, Beshada v. Johns-Manville Products Corp.: Adding Uncertainty to Injury, 35 RUTGERS L. REV. 982, 1008-15 (1983); William R. Murray, Jr., Comment, Requiring Omniscience: The Duty To Warn of Scientifically Undiscoverable Product Defects, 71 GEO. L.J. 1635 (1983); and Robert D. Towry, Note, 13 SETON HALL L. REV. 625 (1983).
178. 447 A.2d 539 (N.J. 1982); see also Henderson & Twerski, supra note 2, at 1271 ("Decisions published during the late 1970s and early 1980s represent what many observers consider to be the high water marks of this expansionary, remarkably proplaintiff period."). The Beshada decision was widely criticized by academic commentators. The Feldman v. Lederle Laboratories opinion, 479 A.2d 374, 388 (N.J. 1984), cites a number of these criticisms, including Joseph A. Page, Generic Product Risks: The Case Against Comment k and for Strict Tort Liability, 58 N.Y.U. L. REV. 853, 877-82 (1983); Victor Schwartz, The Post-Sale Duty To Warn: Two Unfortunate Forks in the Road to a Reasonable Doctrine, 58 N.Y.U. L. REV. 892, 901-05 (1983); John W. Wade, On the Effect in Product Liability of Knowledge Unavailable Prior to Marketing, 58 N.Y.U. L. REV. 734, 754-56 (1983); Robert D. Casale, Comment, Beshada v. Johns-Manville Products Corp.: Adding Uncertainty to Injury, 35 RUTGERS L. REV. 982, 1008-15 (1983); William R. Murray, Jr., Comment, Requiring Omniscience: The Duty To Warn of Scientifically Undiscoverable Product Defects, 71 GEO. L.J. 1635 (1983); and Robert D. Towry, Note, 13 SETON HALL L. REV. 625 (1983).
179. 447 A.2d 539 (N.J. 1982); see also Henderson & Twerski, supra note 2, at 1271 ("Decisions published during the late 1970s and early 1980s represent what many observers consider to be the high water marks of this expansionary, remarkably proplaintiff period."). The Beshada decision was widely criticized by academic commentators. The Feldman v. Lederle Laboratories opinion, 479 A.2d 374, 388 (N.J. 1984), cites a number of these criticisms, including Joseph A. Page, Generic Product Risks: The Case Against Comment k and for Strict Tort Liability, 58 N.Y.U. L. REV. 853, 877-82 (1983); Victor Schwartz, The Post-Sale Duty To Warn: Two Unfortunate Forks in the Road to a Reasonable Doctrine, 58 N.Y.U. L. REV. 892, 901-05 (1983); John W. Wade, On the Effect in Product Liability of Knowledge Unavailable Prior to Marketing, 58 N.Y.U. L. REV. 734, 754-56 (1983); Robert D. Casale, Comment, Beshada v. Johns-Manville Products Corp.: Adding Uncertainty to Injury, 35 RUTGERS L. REV. 982, 1008-15 (1983); William R. Murray, Jr., Comment, Requiring Omniscience: The Duty To Warn of Scientifically Undiscoverable Product Defects, 71 GEO. L.J. 1635 (1983); and Robert D. Towry, Note, 13 SETON HALL L. REV. 625 (1983).
180. 447 A.2d 539 (N.J. 1982); see also Henderson & Twerski, supra note 2, at 1271 ("Decisions published during the late 1970s and early 1980s represent what many observers consider to be the high water marks of this expansionary, remarkably proplaintiff period."). The Beshada decision was widely criticized by academic commentators. The Feldman v. Lederle Laboratories opinion, 479 A.2d 374, 388 (N.J. 1984), cites a number of these criticisms, including Joseph A. Page, Generic Product Risks: The Case Against Comment k and for Strict Tort Liability, 58 N.Y.U. L. REV. 853, 877-82 (1983); Victor Schwartz, The Post-Sale Duty To Warn: Two Unfortunate Forks in the Road to a Reasonable Doctrine, 58 N.Y.U. L. REV. 892, 901-05 (1983); John W. Wade, On the Effect in Product Liability of Knowledge Unavailable Prior to Marketing, 58 N.Y.U. L. REV. 734, 754-56 (1983); Robert D. Casale, Comment, Beshada v. Johns-Manville Products Corp.: Adding Uncertainty to Injury, 35 RUTGERS L. REV. 982, 1008-15 (1983); William R. Murray, Jr., Comment, Requiring Omniscience: The Duty To Warn of Scientifically Undiscoverable Product Defects, 71 GEO. L.J. 1635 (1983); and Robert D. Towry, Note, 13 SETON HALL L. REV. 625 (1983).
181. 447 A.2d 539 (N.J. 1982); see also Henderson & Twerski, supra note 2, at 1271 ("Decisions published during the late 1970s and early 1980s represent what many observers consider to be the high water marks of this expansionary, remarkably proplaintiff period."). The Beshada decision was widely criticized by academic commentators. The Feldman v. Lederle Laboratories opinion, 479 A.2d 374, 388 (N.J. 1984), cites a number of these criticisms, including Joseph A. Page, Generic Product Risks: The Case Against Comment k and for Strict Tort Liability, 58 N.Y.U. L. REV. 853, 877-82 (1983); Victor Schwartz, The Post-Sale Duty To Warn: Two Unfortunate Forks in the Road to a Reasonable Doctrine, 58 N.Y.U. L. REV. 892, 901-05 (1983); John W. Wade, On the Effect in Product Liability of Knowledge Unavailable Prior to Marketing, 58 N.Y.U. L. REV. 734, 754-56 (1983); Robert D. Casale, Comment, Beshada v. Johns-Manville Products Corp.: Adding Uncertainty to Injury, 35 RUTGERS L. REV. 982, 1008-15 (1983); William R. Murray, Jr., Comment, Requiring Omniscience: The Duty To Warn of Scientifically Undiscoverable Product Defects, 71 GEO. L.J. 1635 (1983); and Robert D. Towry, Note, 13 SETON HALL L. REV. 625 (1983).
182. Beshada, 447 A.2d at 545.
183. Id.
184. Id.
185. Id. at 542.
186. Id. at 544 n.3 (citation omitted).
187. See Feldman v. Lederte Lab., 479 A.2d 374, 388 (N.J. 1984).
188. See id. at 380 ("We do not agree that the protective shield of comment k immunizes all prescription drugs. Moreover, we are of the opinion that generally the principle of strict liability is applicable to manufacturers of prescription drugs.").
189. See Wade, supra note 2, at 837-38.
190. See George W. Conk, Compared to What? Instructing the Jury on Product Defect Under the Products Liability Act and the Third Restatement of Torts: Products Liability, 30 SETON HALL L. REV. 273, 275 (1999).
191. See John E. Keefe & Richard C. Henke, Presumed Knowledge of Danger: Legal Fiction Gone Awry?, 19 SETON HALL L. REV. 174, 185-86 (1989). Unlike Keeton, who argued that it was the state of knowledge of danger at the time of trial that determined liability, Wade had long argued that liability was limited to dangers that were scientifically knowable that the time of marketing. See id. at 180 & n.39.
192. See Cepeda v. Cumberland Eng'g Co., 386 A.2d 816, 826-27 (N.J. 1978).
193. See Schwartz, supra note 139, at 1145. Schwartz's article was cited approvingly both by the Idaho Supreme Court in Toner v. Lederle Laboratories, 732 P.2d 297, 305 (Idaho 1987), and by the California Supreme Court in Brown v. Superior Court, 751 P.2d 470, 475-76 (Cal. 1988).
194. See Schwartz, supra note 139, at 1139.
195. Id. at 1141.
196. See id.
197. Id. at 1141 (citing Lindsay v. Ortho Pharm. Corp., 637 F.2d 87 (2d Cir. 1980)).
198. Id. at 1145.
199. See Brown v. Superior Court, 751 P.2d 470,475-76 (Cal. 1988).
200. Id. at 483 n.12.
201. 150 P.2d 436 (Cal. 1944) (Traynor, J., concurring) (advocating the adoption of strict liability for product defects).
202. 377 P.2d 897 (Cal. 1962) (applying strict liability where the plaintiff injured himself with a power tool).
203. 501 P.2d 1153 (Cal. 1972) (applying strict liability where the plaintiff was injured when an aluminum safety hasp broke).
204. 573 P.2d 443 (Cal. 1978); see also Brown, 751 P.2d at 477 (explaining Barker). 174. Brown, 751 P.2d at 482-83 ("[W]e hold that a manufacturer is not strictly liable for injuries caused by a prescription drug so long as the drug was properly prepared and accompanied by warnings of its dangerous propensities that were either known or reasonably scientifically knowable at the time of distribution.").
205. 159 F.2d 169, 173 (2d Cir. 1947); see also Barker, 573 P.2d at 455 (adopting a five-tor design-defect test). Hand's formula for negligence states that if the probability of injury (P) multiplied by the magnitude of injury (L) was greater than the burden on the manufacturer (B) of taking additional measures to avoid the injury (in other words, if PL > B), then the manufacturer is negligent. See Carroll Towing, 159 F.2d at 173. Though a negligence case, Carroll Towing also formed the basis for Wade's enormously influential 1973 article describing his risk-utility analysis for products-liability litigation. See Wade, supra note 2.
206. See Brown, 751 P.2d at 483 n.12.
207. Id. at 478.
208. See J. Clark Kelso, Brown v. Abbott Laboratories and Strict Products Liability, 20 PAC. L.J. 1, 26-28 (1988).
209. Id. at 26.
210. Id. at 26, 28.
211. See RESTATEMENT (THIRD), supra note 1, § 6 cmt. d.
212. See id. cmt. c.
213. See id. cmt. b.
214. See id.
215. See id.
216. See id.
217. Possible regulations include the requirement that some drugs be prescribed only by physicians with special training and the approval of drugs only for certain uses. See Margaret Gilhooley, When Drugs Are Safe for Some but Not Others: The FDA Experience and Alternatives for Products Liability, 36 HOUS. L. REV. 927, 945 (1999).
218. See Perez v. Wyeth Lab., 734 A.2d 1245, 1247 (1999) (imposing a duty on the defendant drug manufacturer adequately to inform users of prescription drugs regarding risks where there is direct-to-consumer advertising). The court noted that manufacturers may be held responsible even where others have played intervening roles; for example, a manufacturer may be liable for failing to include safety devices on machinery despite its expectation that the employer who purchased the machinery would install the devices. See id. at 1261 (citing Bexiga v. Havir Mfg. Corp., 290 A.2d 281 (1972)).
219. CENTER FOR DRUG EVALUATION & RESEARCH, U.S. DEP'T OF HEALTH & HUMAN SERVS., 1998 REPORT TO THE NATION: IMPROVING HUMAN HEALTH THROUGH HUMAN DRUGS 1 (1999).
220. See RESTATEMENT (SECOND), supra note 4, § 288C (citing decisions holding that compliance with a legislative enactment or administrative regulation does not preclude a finding of negligence where a reasonable person would have taken additional precautions); cf. N.J. STAT. ANN. § 2A:58C-4 (West 1999) (providing that in failure-to-warn suits, an FDA-approved warning carries a rebuttable presumption of adequacy).
221. RESTATEMENT (THIRD), supra note 1, § 4.
222. See Teresa Moran Schwartz, Regulatory Standards and Products Liability: Striking the Right Balance Between the Two, 30 U. MICH. J.L. REFORM 431, 443-47 (1997).
223. See id. at 444-45.
224. See Merrill, supra note 22, at 1819-20. A legislative change in 1962 converted what had been a notification system (permitting marketing unless the FDA acted within 180 days) to a gatekeeping system in which the maker was obliged to wait for the agency to affirm safety and effectiveness. "The agency was empowered to require premarket approval for certain devices; however, Congress limited this form of control to products that were life-sustaining or presented significant risks to patients." Id. at 1800. The PDA's review of new products remains limited by manpower constraints, budget constraints, and design. In 1993, the FDA Committee for Clinical Review reported "certain patterns of deficiencies in the design, conduct, and analysis of clinical studies in sufficient numbers to suggest that these deficiencies represent a common problem" in reviewing pre-market approval applications. Id. at 1825.
225. A further problem with the regulatory-compliance defense is that rather than preventing litigation, the FDA-compliance defense may just shift the issues in drug injury litigation. See Green, Statutory Compliance, supra note 79, at 490-93, 508. Litigants will conduct inquiries into whether the manufacturer complied with FDA requirements for the investigation and marketing of the drug. See id. "The extensiveness of FDA regulations and the complexity of the pre-marketing testing process could transform that inquiry into a Serbian bog that would consume substantial resources." Id. at 508.
226. See Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco Products to Protect Children and Adolescents, 60 Fed. Reg. 41,314 (1995) (to have been codified at 21 C.F.R. pts. 801, 803, 804, 897) (proposed Aug. 11, 1995). The measure has been stayed. See Brown & Williamson Tobacco Co. v. FDA, 153 F.3d 155 (4th Cir. 1998), cert. granted, 119 S. Ct. 1495 (1999).
227. See, e.g., Minnesota v. Philip Morris, Inc., No. C1-94-8565, 1998 Extra LEXIS 76 (D. Minn. Mar. 7, 1998).
228. The settlement agreement between Minnesota and Philip Morris mandates the removal of all tobacco billboards in the state and provides for more than $100 million for smoking-cessation programs. See Tobacco Companies To Pay Minnesota, Blue Cross $6.6 Billion Plus Fees, MEALEY'S LITIG. REP.: TOBACCO, May 21, 1998, at 5.
229. See Mary L. Lyndon, Tort Law and Technology, 12 YALE J. ON REG. 137 (1995).
230. See Schwartz, supra note 193, at 431; see also Alloway v. Bradlees, Inc., 723 A.2d 960, 966-69 (N.J. 1999) (discussing the relevance of federal safety standards in determining the duty of care of a general contractor in preventing worksite injuries).
231. See Green, Statutory Compliance, supra note 79, at 466-67.
232. See generally Coursen v. A.H. Robins Co., 764 F.2d 1329 (9th Cir. 1985) (involving a design-defect claim against the makers of the Dalkon Shield intrauterine device).
233. See MARCIA ANGELL, SCIENCE ON TRIAL 42-44 (1996) (describing safety-enhancing inovations in breast-implant design following the introduction of the first implants by Dow Corning).
234. See Michael J. Saks, Do We Really Know Anything About the Behavior of the Tort Litigation System-And Why Not?, 140 U. PA. L. REV. 1147, 1288 (1992) ("In short, our society has been unable to produce research that is even minimally adequate to answer our most basic questions about the behavior of the civil justice system.").
235. MICHAEL D. GREEN, BENDECTIN AND BIRTH DEFECTS 340 (1996) (citing STEVEN GARBER, PRODUCT LIABILITY AND THE ECONOMICS OF PHARMACEUTICAL AND MEDICAL DEVICES 166, 174 (1993)).
236. MICHAEL D. GREEN, BENDECTIN AND BIRTH DEFECTS 340 (1996) (citing STEVEN GARBER, PRODUCT LIABILITY AND THE ECONOMICS OF PHARMACEUTICAL AND MEDICAL DEVICES 166, 174 (1993)).
237. See RESTATEMENT (THIRD), supra note 1, § 6 cmt. b Reporter's note.
238. See James A. Henderson, Jr. & Theodore Eisenberg, The Quiet Revolution in Products Liability: An Empirical Study of Legal Change, 37 UCLA L. RFV. 479 (1990) (describing the broad trends of judicial retrenchment, declining plaintiff success, and reduced awards in products-liability cases).
239. See, e.g., STEVEN EPSTEIN, IMPURE SCIENCE 339 (1996) (detailing the impact that AIDS activists have had on the FDA drug-approval process, including expanded access to experimental therapies and accelerated approval).
240. Cf. Owen, supra note 47, at 754 ("[T]he goal of both design engineers and the law should be to promote in products an ideal balance of product usefulness, cost, and safety.").