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Orphan Drugs: The Question of Products Liability

Published online by Cambridge University Press:  24 February 2021

Susan F. Scharf
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Abstract

Orphan drugs, essential for die treatment of persons widi rare diseases, generally are unprofitable for manufacturers to develop and market. While congressional and administrative efforts to promote die development of orphan drugs have met widi modest success, application of products liability doctrine to orphan drug sponsors could subvert those efforts. This Note describes die provisions of die Orphan Drug Act and analyzes products liability law with respect to orphan drug litigation. It argues that die goals of tort law support the imposition of liability for design defect, failure to warn and negligence in testing. Finally, die Note acknowledges diat liability costs create disincentives for orphan drug development and suggests mechanisms for reducing manufacturers’ liability concerns.

Type
Notes and Comments
Information
American Journal of Law & Medicine , Volume 10 , Issue 4 , Winter 1985 , pp. 491 - 513
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 1985

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References

1 C. Asbury, Orphan Drugs: Medical VS. Market Value (1985). Asbury recognizes several categories of orphan drugs, including: drugs for rare diseases; drugs for chronic diseases; drugs for single administration (vaccines and diagnostic aids); drugs for women of childbearing age and for children; drugs that are not patentable; drugs for treating drug abuse; and drugs needed in developing nations. Id. at 4. Although similarities exist among these categories in terms of liability risk, market factors and testing limitations, this Note addresses only drugs for rare diseases and conditions.

2 Rare diseases include Huntington’s disease, myoclonus, ALS (Lou Gehrig’s disease), Tourette syndrome and muscular dystrophy. Orphan Drug Act § 1(b), 21 U.S.C. § 360aa (1982).

3 In 1984, research and development expenditures for the ten largest U.S. pharmaceutical companies ranged from 3.8 to 11.5 percent of revenues. N.Y. Times, Feb. 24, 1985, § 3 at 10. The industry spent $3.5 billion on research and development; profits totaled $4.18 billion. Id. at 1, cols. 2 and 4.

4 H.R. Rep. No. 840, 97th Cong., 2d Sess. 6, reprinted in 1982 U.S. Code Cong. & Ad. News 3577, 3578.

5 Boston Globe, Aug. 8, 1983, at 43, col. 1.

6 Staff of Subcomm. on Health and the Environment of the H.R. Comm. on Energy and Commerce, 97th Cong., 2D Sess., Preliminary Report of the Survey on Drugs for Rare Disease 6 (Comm. Print 1982) [hereinafter cited as Preliminary Report].

7 Orphan Drug Act, Pub. L. No. 97-414, 96 Stat. 2049 (1983) (codified as amended in scattered sections of 21 U.S.C., 26 U.S.C. and 42 U.S.C. (1982)).

8 H.R. Rep. No. 840, 97th Cong., 2d Sess. 6, reprinted in 1982 U.S. Code Cong. & Ad. News 3577, 3578.

9 Thirty-eight orphan drugs and biological products had been sponsored by the end of 1984. 50 Fed. Reg. 4914 (1985).

10 See generally Orphan Drug Act, 1982: Hearings on H. 5238 Before the Subcomm. on Health and the Environment of the House Committee on Energy and Commerce, 97th Cong., 2d Sess. [hereinafter cited as Hearings]. Some industry members share this view. For example, the president of the Generic Pharmaceutical Industry Association (a trade group of small drug companies) contended that the brand name companies, with average sales exceeding $3 billion in 1982, could spend much more to market orphan drugs. Boston Globe, Aug. 8, 1983, at 43, cols. 1 and 2. The decision of Bolar Pharmaceuticals, a company with sales of $19 million in 1982, to sponsor an orphan drug supports this point. Id. The Pharmaceutical Manufacturers Association (PMA) (a trade group of the largest drug companies) responded that “if drug companies start acting like charitable institutions, they're not going to last very long, and nobody will be well served.” Id. at 43, col. 4. According to the PMA, the industry already has made “significant contributions" by developing ten orphan drugs in ten years. Hearings, supra note 10, at 284 (Statement of Peter Barton Hutt of the Pharmaceutical Manufacturers Association).

11 See infra notes 41-45 and accompanying text.

12 One commentator suggests that the various incentives provided by the Orphan Drug Act reflect different underlying views on the question of social responsibility. Some believe that the pharmaceutical industry is strong by virtue of its ability to reinvest profits in profit- maximizing research; corporations should avoid social responsibility to the extent that it diverts profits from the corporation and its stockholders. Accordingly, they favor tax incentives for orphan drug development and market exclusivity for unpatentable orphan drugs. Others view social responsibility as the quid pro quo for the wide profit margins society provides to the industry. They suggest that in order not to exact a higher price than necessary from corporations holding this viewpoint, incentives should take the form of improved FDA processes for approval of all drugs and better relations between industry and academia. C. Asbury, supra note 1, at 120.

13 The Survey on Drugs for Rare Diseases revealed that liability suits had been filed for 18 percent of marketed orphan drugs. Preliminary Report, supra note 6, at 17.

14 H.R. Rep. No. 840, supra note 4, at 3579.

15 See Preliminary Report, supra note 6.

16 H.R. Rep. No. 840, supra note 4, at 3579.

17 The original FDA guidelines for seeking orphan drug designation were published in October, 1983. Address by Marion J. Finkel, M.D., Incentives for Orphan Drug Development and Other Topics 2 (June 4, 1984) [hereinafter cited as Finkel].

18 21 U.S.C. § 360bb(a)(2) (1982).

19 Under the FDA’s Interim Guidelines, “recovery from sales" is to be construed as recovery over the remaining patent life of a patented drug or the seven year exclusive marketing period for a nonpatented drug. The estimated costs include those incurred by the sponsor in connection with the Orphan Drug Act or for determining patentability of the drug: screening; animal and clinical studies; preparation of an IND, NDA or product license application; distribution under a “treatment" protocol; development of a dosage form; distribution and promotion; maintaining required records and reports; and liability insurance, depreciation and overhead. Office of Orphan Products Development, Food and Drug Administration, Interim Guidelines for Obtaining Designation of a Drug as an Orphan Drug 3-4 (Revised November, 1984).

20 Health Promotion and Disease Prevention Amendments of 1984, Pub. L. 98-551, § 4, 98 Stat. 2815, 2817(1984).

21 Finkel, supra note 17, at 6.

22 21 U.S.C. § 360bb(a)(2)(1982).

23 Finkel, supra note 17, at 8.

24 21 U.S.C. § 360aa (1982). Ordinarily, the FDA publishes general guidelines for classes of drugs but does not provide recommendations for specific drugs until clinical studies have begun. C. Asburv, supra note 1, at 162.

25 H.R. Rep. No. 840, supra note 4, at 3582-83. “[T]he Committee expects that FDA will revise its recommendations or require additional information only if the additional data is absolutely essential to assuring the safety and efficacy of the drug or biological.” Id. (emphasis added).

26 Finkel, , Orphan Products: Definition and Activities, in 127 Orphan Drugs and Orphan Diseases: Clinical Realities and Public Policy 163 (G. Brewer ed. 1983)Google Scholar (proceedings of a Conference held in Ann Arbor, Michigan, September 27-29, 1982) [Volume hereinafter cited as Brewer].

27 H.R. Rep. No. 840, supra note 4, at 3583. The Director of the Bureau of Drugs of the FDA stated:

The FDA can and does alter its data requirements depending upon the intended use of a drug. Drugs that are dramatically effective do not need large patient populations to demonstrate the point. Similarly, benefit-risk appraisal is usually not difficult when a drug is highly beneficial to a small group of patients whose alternatives are limited. The FDA has a longstanding policy of approving [New Drug Applications] on the basis of studies with relatively few patients when the disease in question is rare and the benefit-risk considerations are clearly favorable.

Id.

28 IND stands for Investigational New Drug and refers to the period during which human clinical trials are conducted.

29 21 U.S.C. §360dd (1982).

30 H.R. Rep. No. 840, supra note 4, at 3584.

31 January, 1985, telephone conversation with Roger C. Gregorio, Consumer Safety Officer, Office of Orphan Products Development, Food and Drug Administration [hereinafter cited as Gregorio].

32 One commentator has noted that the overall regulatory scheme for orphan drugs has two results:

First, the drug is almost universally available on the basis of preclinical testing ordinarily intended only to justify limited use in human clinical investigations. Second, the drug acquires FDA ’seal of approval’ based on standards far lower than those applicable to other drugs. Under these circumstances, the usual statutory requirement for ’substantial evidence’ of efficacy established by ‘adequate and well-controlled’ trials can surely not have been satisfied.

Grossman, The Orphan Drug Act: Adoption or Foster Care?, 39 Food Drug Cosmetic L. J. 147 (1984).

33 26 U.S.C. § 444 (1982), amended by Deficit Reduction Act of 1984, Pub. L. 98-369, 98 Stat. 494, 826.

34 Id.

35 See Hearings, supra note 10, at 283-99 (statement of Peter Barton Hutt of the PMA).

36 Compare Grossman, supra note 32, at 142-43 (stating that the tax subsidy, which accounts for roughly one-third of total development costs, could have been “significantly more powerful”) with C. Asbury, supra note 1, at 185 (citing industry contentions that “the major cost disincentive is ongoing toxicology and pharmacology studies" rather than the cost of clinical trials).

37 21 U.S.C. § 360cc (1982). In addition, the Act authorizes the appropriation of $4,000,000 per year for fiscal years 1983-85 for grants and contracts for qualified clinical testing. 21 U.S.C. § 360ee (1982). Finally, the Act establishes an Orphan Products Board in the Department of Health and Human Services to “promote the development of drugs and devices for rare diseases or conditions and the coordination among Federal, other public, and private agencies [in developing orphan products].” 42 U.S.C. § 236 (1982).

38 C. Asbury, supra note 1, at 3.

39 Gregorio, supra note 31. One commentator argues, however, that the small market potential for orphan drugs discourages competitors from spending resources to obtain FDA approval for a generic copy and to initiate drug production. Grossman, supra note 32, at 144.

40 See Brewer, supra note 26, at 50-51. Brewer addressed this issue in his Closing Com ments:

The investigator, his or her University, and any adopting company would all appear to be at risk for suits resulting from ‘untoward effects’ of orphan drug administration to patients. Pharmaceutical companies face this problem with all drugs, but normally plan to cover insurance and/or losses in this area by the profits from successful, profitable, drugs. Investigators and universities are understandably hesitant to assume such risks, and companies may ask—why should we assume liability risks for orphan drugs, when there is no opportunity for profit?

Id. at 250.

41 Hearings, supra note 10, at 337-38. As Representative Dannemeyer of California stated:

[T]he prospect of getting sued if something goes wrong is a valuable tool in our culture for helping [us keep] honest, quite frankly, but there are times when we have tremendous human suffering. ... If we have a goal of making everybody whole from every wrong that one encounters in life, which I guess is where Americans are today, we are not going to have much progress in terms of the pioneers . . . trying to alleviate human suffering. Why? Because they do not want to lose their shirt, just because they have humanitarian instincts in their soul.

Id. at 338.

42 Id.

43 One source states that from 1976 to 1982, the number of drug malpractice and product liability actions being filed each year has tripled. R. Patterson, Drugs in Litigation: Damage Awards Involving Prescription and Nonprescription Drugs vii-viii (1982).

44 McClellan, , Strict Liability for Drug Induced Injuries: An Excursion Through the Maze of Products Liability, Negligence and Absolute Liability, 25 Wayne L. Rev. 1, 1-2 (1978).Google Scholar

45 See C. Asbury, supra note I, at 91-93; Brewer, supra note 26 at 50-51.

46 See generally Phelan, Product Liability Update (1980).

47 Section 402A, Special Liability of Seller of Product for Physical Harm to User or Consumer, provides:

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

(a) the seller is engaged in the business of selling such a product, and

(b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold.

(2) The rule stated in Subsection (1) applies although

(a) the seller has exercised all possible care in the preparation and sale of his product, and

(b) the user or consumer has not bought the product or entered into any contractual relation with the seller.

48 Id. A third type of defect—the manufacturing defect—is not within the scope of this article.

49 Page, Generic Product Risks: The Case Against Comment k and For Strict Tort Liability, 58 N.Y.U.L. Rev. 853, 855 (1983).Google Scholar Section 402A Comments i and k provide:

i. Unreasonably dangerous. The rule stated in this section applies only where the defective condition of the product makes it unreasonably dangerous to the user or consumer. Many products cannot possibly be made entirely safe for all consumption, and any food or drug necessarily involves some risk of harm, if only from over-consumption. . . . The article sold must be dangerous to an extent beyond that which would be contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common to the community as to its characteristics. . . .

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 warnings, 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 the 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 to 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) of Torts § 402A (1965).

50 Page, supra note 49, at 865-6.

51 See, e.g., Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652 (1st Cir. 1981); Needham v. White Laboratories, 639 F.2d 394 (7th Cir. 1981); Reyes v. Wyeth Laboratories, 498 F.2d 1264 (5th Cir. 1974), cert. denied, 419 U.S. 1096 (1974); Parke-Davis and Co. v. Stromsodt, 411 F.2d 1390 (8th Cir. 1969).

52 Preliminary Report, supra note 6, at 7. One percent did not fit the categories de scribed.

53 Id. at 20.

54 642 F.2d 652 (1st Cir. 1981).

55 Id. at 654-55.

56 Id. at 655 (quoting Thibault v. Sears, Roebuck & Co., 118 N.H. 802, 807-08, 395 A.2d 843, 846-47 (1978)).

57 121 Ariz. 33, 588 P.2d 326 (Ct. App. 1978).

58 Chymopapain was designed to provide an alternative to back surgery for patients who fail to respond to conservative, non-surgical therapy.

59 Gaston, 121 Ariz, at 47, 588 P.2d at 340.

60 Hawkinson v. A.H. Robins Co., 1984-2 Trade Cas. (CCH) ¶ 66,225 (D.C. Colo. Sept. 18, 1984).

61 Id. (Citations omitted).

62 Id.

63 Id.

64 See generally McClellan, supra note 44; Page, supra note 49; Merrill, Compensation for Prescription Drug Injuries, 59 Va. L. Rev. 1 (1973).

65 See cases cited supra note 51.

66 Reyes v. Wyeth Laboratories, 498 F.2d at 1275 (5th Cir. 1974); Borel v. Fibreboard Paper Products Co., 493 F.2d 1076, 1088 (5th Cir. 1973), cert. denied, 419 U.S. 869 (1974).

67 Mahr v. G.D. Searle & Co., 72 111. App. 3d 540, 390 N.E.2d 1214, 1235 (1979); Seley v. G.D. Searle & Co., 67 Ohio St. 2d 192, 196,423 N.E.2d 831,836 (1981). As in the area of design defects, many courts purport to apply principles of strict liability to failure to warn cases but actually decide the case on principles of negligence. Furthermore, one commentator has argued that courts erroneously analyze design defect cases on failure-to-warn grounds, noting “if a proper warning would result in nonmarketability of the product, then the true issue before the court is the acceptability of the basic design.” Twerski, Weinstein, Donaher, & Piehler, , The Use and Abuse of Warnings in Products Liability—Design Defect Litigation Comes of Age, 61 Cornell L. Rev. 495, 500-01 (1976).Google ScholarPubMed

68 Basko v. Sterling Drug, Inc., 416 F.2d 417, 426 (2d Cir. 1969); Davis v. Wyeth Laboratories, Inc., 399 F.2d 121, 130 (9th Cir. 1968); Seley, 67 Ohio St. 2d at 198, 423 N.E.2d at 839 (1981). Vaccines are an exception to this rule. Davis, 399 F.2d at 131.

69 Reyes, 498 F.2d at 1276.

70 Borel, 493 F.2d at 1089; Schenebeck v. Sterling Drug, Inc., 423 F.2d 919, 922 (8th Cir. 1970); Sterling Drug v. Yarrow, 408 F.2d 978, 989 (8th Cir. 1969).

71 Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 625, 658 (1st Cir. 1981); Chambers v. G.D. Searle and Co., 441 F. Supp. 377,384 (D. Md. 1975). Cf. Mahr, 72 111. App. 3d at 561,390 N.E.2d at 1229 ; Bristol-Myers v. Gonzales, 548 S.W.2d 416 (Tex. Civ. App. 1976), rev'd on other grounds, 561 S.W.2d 801 (1978).

72 Singer v. Sterling Drug, Inc., 461 F.2d 288, 290 (7th Cir. 1972) cert. denied, 409 U.S. 878 (1972); Gaston v. Hunter, 121 Ariz. App. 33,47, 588 P.2d 326, 340 (1978). This practice also is required by federal law. 21 U.S.C. § 355(i) (1982).

73 Toole v. Richardson-Merrell, Inc., 251 Cal. App. 2d 710,60 Cal. Rptr. 398,413 (1967).

74 Brochu, 642 F.2d at 659. Contra Woodill v. Parke-Davis & Co., 79 111. 2d 26, 44, 402 N.E.2d 194, 203 (1980) (Moran, J. concurring in part, dissenting in part) (identification of the circumstances under which a product has been found safe might enable the manufacturer to avoid liability).

75 See Restatement (Second) of Torts § 402A Comment k (1965).

76 Brochu, 642 F.2d at 657; Mahr, 72 111. App. 3d at 560, 390 N.E.2d at 1229 (citing other cases); Seley, 67 Ohio St. 2d at 197, 423 N.E.2d at 836.

77 Woodill, 79 111. 2d at 33, 402 N.E.2d at 198; Basko, 416 F.2d at 426; Borel, 493 F.2d at 1088. In Woodill, the court concluded:

[R]equiring a plaintiff to plead and prove that the defendant manufacturer knew or should have known of the danger that caused the injury, and that the defendant manufacturer failed to warn plaintiff of that danger, is a reasonable requirement, and one which focuses on the nature of the product and on the adequacy of the warning rather than on the conduct of the manufacturer. . . . Such a rule is entirely consistent with the principles of strict liability.

Woodill, 79 111. 2d at 35,402 N.E.2d at 198. Another case which noted the distinction between negligence and strict liability is Seley, 67 Ohio St. 2d at 199, 423 N.E.2d at 837. Although the court equated reasonableness with adequacy after making an initial distinction between them (as did Woodill), neither test was specifically adopted because the court found that plaintiff had not proven proximate cause.

78 The Food, Drug and Cosmetic Act requires that clinical tests be carried out by “experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs.” 21 U.S.C. § 355(i) (1982).

79 H.R. Rep. No. 840, supra note 4, at 3583.

80 Brewer, supra note 26, at 213.

81 O'Hare v. Merck & Co., 381 F.2d 286, 291 (8th Cir. 1967); Hawkinson v. A.H. Robins Co., 1984-2 Trade Cas. (CCH) ¶ 66,225 (D.C. Colo. Sept. 18, 1984).

82 485 F.2d 132 (3d Cir. 1973).

83 Id. at 141 (quoting Dalehite v. United States, 346 U.S. 15, 51-52 (1953) (Jackson J., dissenting)).

84 Preliminary Report, supra note 6, at 17.

85 Brewer, supra note 26, at 163-64.

86 As Marion Finkel, M.D., Director of Orphan Product Development at the FDA, stated, it is not clear whether the FDA would require preclinical studies as complete as those for non-orphan drugs:

Clinical experience as well as the nature of the disease for which the drug is indicated and the likelihood of obtaining extensive toxicologic information should govern the preclinical requirements for marketing approval. Carcinogenicity studies would ordinarily be waived and long term human exposure may substitute for chronic toxicity studies in animals.

Brewer, supra note 26, at 164.

With respect to clinical testing, requirements will be tailored to fit the special needs of orphan drug development as well. In the view of the FDA:

[S]cientific credibility ordinarily requires independent replication of results. Thus, at least two adequate and well-controlled studies would generally be required and are feasible no matter how uncommon the disease. . . . Flexibility in choosing efficacy criteria may at times be a greater consideration for drugs for uncommon diseases than for common conditions, but, in general effectiveness measurements for a controlled study in an uncommon disease should be as precise as the current state of the art for a specific disease permits.

Id. at 163. See also Grossman, supra note 32, at 145.

87 Brewer, supra note 26, at 162.

88 See Brochu v. Ortho Pharmaceutical Corp., 642 F.2d 652, 657 (1st Cir. 1981).

89 O'Hare, 381 F.2d at 291.

90 See supra note 88 and accompanying text.

91 Owen, , Punitive Damages in Products Liability Litigation, 74 Mich. L. Rev. 1258, 1361 (1976).CrossRefGoogle Scholar

92 K. Redden, Punitive Damages § 4.2(a)(2) (1980). MER/29 was a drug marketed in the early 1960’s for the reduction of blood cholesterol.

93 251 Cal. App. 2d 689, 60 Cal. Rptr. 398 (1967).

94 378 F.2d 832 (2d Cir. 1967).

95 Toole, 251 Cal. App. 2d at 696, 60 Cal. Rptr. at 404-05.

96 Id. at 713, 60 Cal. Rptr. at 415. Cf. Hoffman, 485 F.2d at 146-47 (“failure to take action reasonably calculated to warn physicians of a risk of great magnitude was in reckless disregard of the public’s health”); Oskenholt v. Lederle Laboratories, 294 Or. 213, 223, 656 P.2d 293, 300 (1982) (punitive damages are appropriate if “defendant’s breach of duty and misrep resentations were made in deliberate disregard of the rights and welfare of others”).

97Roginsky, 378 F.2d at 844. The court cited as policy considerations: the impossibility of administering multiple claims for punitive damages so as to avoid “overkill"; the lack of need for deterrence additional to that provided by extensive drug regulation; the undesirability of manufacturers passing on liability costs to consumers or stockholders; and the effect of punitive damage awards on the pharmaceutical industry. Id. at 838-42.

98 Id. at 850.

99 Id.

100 49 Cal. App. 3d 22, 122 Cal. Rptr. 218 (1975).

101 Id. at 28, 122 Cal. Rptr. at 222.

102 Id.

103 Taylor v. Superior Court of Los Angeles County, 24 Cal. 3d 890, 589 P.2d 854, 157 Cal. Rptr. 693 (1979).

104 Id. at 895-96, 598 P.2d at 856-57, 157 Cal. Rptr. at 696. Although the dissent objected for policy reasons, it nonetheless endorsed the test as applied to drug cases because injury would be probable when a manufacturer widely distributed a known dangerous product. Id. at 907, 598 P.2d at 864, 157 Cal. Rptr. at 704.

105 Under New York law, “[a] person acts recklessly with respect to a result . . . when he is aware of and consciously disregards a substantial and unjustifiable risk that such result will occur.” Roginsky, 378 F.2d at 843 (citing N.Y. Penal Law § 15.05(3) (McKinney 1965)).

106 Gaston, 121 Ariz, at 48-49, 588 P.2d at 342.

107 Cf. Woodill, 79 111. 2d at 34, 402 N.E.2d at 199 (“the court is aculely aware of the social desirability of encouraging the research and development of beneficial drugs”).

108 page, supra note 49, at 882.

109 McClellan, supra note 44, at 25.

110 According to some commentators:

It seems clear that food and drug legislation and strict liability each developed from a concern about the frequency and magnitude of injuries suffered by consumers who were unable to take any meaningful action to avoid the injuries. Each system of law reflects a value judgment that sellers of products are in a position, vastly superior to that of consumers, to make cost-benefit decisions and act upon them.

McClellan, Tate, & Eaton, , Strict Liability for Prescription Drug Injuries: The Improper Marketing Theory, 26 St. Louis U.L.J. 1, 11 (1981).Google Scholar

111 Merrill, supra note 64. The fact that research subjects give informed consent does not negate the obligation of society to provide compensation. As the HEW Secretary’s Task Force on the Compensation of Injured Research Subjects concluded, “[i]nformed consent in the research setting functions as a recognition of and a protection for a person’s integrity and autonomy, but does not imply a waiver of the right of the person to compensation in the event of injury.” Office of the Secretary, Dep't of Health Education and Welfare, Pub. No. 05-77-003, HEW Secretary’s Task Force on the Compensation of Injured Research Subjects VI-5 (1977).

112 P. Temin, taking your medicine: drug regulation in the united states 211-13 (1980).

113 McClellan, supra note 44, at 33. McClellan states:

If this preferential treatment for drug sellers is to continue, it is time for someone to come forward with a better explanation than is offered in Comment k. The comment’s explanation that drugs pose an unavoidably high degree of risk is no explanation at all. This on its face suggests a greater need for protecting the consumer from risks that outweigh the product’s benefits or exceed his expectations. Comment k suggests that imposing strict liability on the sellers of such products would result in depriving consumers of essential drugs. This suggestion is subject to serious doubt. It certainly should not shape the development of strict liability law in the absence of substantial supporting empirical data showing that the profit margin in the drug industry is so low that the industry could not bear the costs of the injuries its products cause.

Id.

114 See supra note 86 and accompanying text.

115 Page, supra note 49, at 884.

116 See supra notes 110-11 and accompanying text.

117 Brewer, supra note 26, at 191.

ll8 Roginsky, 378 F.2d at 839.

119 Id. at 840-41.

120 Owen, supra note 91, at 1363, n.501.

121 Owen, , Problems in Assessing Punitive Damages Against Manufacturers of Defective Products, 49 U. Chi. L. Rev. 1, 16 (1982).CrossRefGoogle Scholar

122 Id. at 27.

123 For a discussion of the Swine Flu vaccine and liability arrangement as an orphan drug issue, see C. Asbury, supra note 1, at 64-74.

124 The Orphan Drug Act authorizes the appropriation of $4,000,000 per year for fiscal years 1983-1985 for qualified clinical testing only. 21 U.S.C. § 360ee(c) (1982).

125 For a discussion of no-fault compensation for subects who are injured in the course of medical experimentation, see ANNAS, G. GLANTZ, L. KATZ, B., Informed Consent to Human Experimentation: The Subject’s Dilemma 257-77 (1977).Google Scholar