1 See Malinowski, Michael J. & O'Rourke, Maureen A., A False Start? The Impact of Federal Policy on the Genotechnology Industry, 13 Yale J. on Reg. 163, 164 (1996)Google Scholar.

2 In 1995, the biotech industry contained 1308 companies employing 108,000 people and hav ing sales of approximately $9.3 billion. See Lee, Kenneth B. Jr. & Burill, G. Steven, Biotech 96: Pursuing Sustainability at i (1995)Google Scholar [hereinafter Biotech 96].

3 See Malinowski & O'Rourke, supra note 1, at 167.

4 Although the primary objective of federal nurturing is the furtherance of national policies, the presence of genotech companies is especially strong in the San Francisco Bay Area with 207 com panies and in New England with 177 companies. See Biotech 96, supra note 2, at 43. Other strong centers include, in decreasing order of the number of companies, San Diego (98), New York (84), and Los Angeles (71). See id. The presence of regional genotech centers makes the impact of any federal policy especially acute in these localities.

5 See Malinowski & O'Rourke, supra note 1, at 167.

6 See id.

7 See Burill, G. Steven & Lee, Kenneth B. Jr., Biotech 94: Long-Term Value Short- Term Hurdles 1, 35 (1993)Google Scholar [hereinafter Biotech 94].

8 See Biotech 96, supra note 2, at 24.

9 See id.

10 See id. These products comprise the largest drug segment because of the great need for them and because they require only a small manufacturer’s sales force. See id.

11 The top 10 genotech drugs produce sales of almost $4.3 billion a year. See Riding the Tiger, Economist, Feb. 25-Mar./ 3, 1995, Survey: Biotechnology and Genetics Section, at 7Google Scholar.

12 For example, in the early 1960s, European women using the drug thalidomide gave birth to children with serious birth defects. See 1 O'Reilly, James T., Food and Drug Administration § 13.02, at 13-7 (2d ed. 1993)Google Scholar. Thalidomide, a widely used sleeping pill, caused the defects. See Flaherty, Francis J., Last Thalidomide Suits Settle to End Legal Era, Nat'l L.J., Jul. 30 , 1984, at 30Google Scholar. Although never formally approved in the United States, partly because of foreign scientists’ discov eries during the FDA approval process, thalidomide was available as part of the investigational proc ess then used by the FDA. See O'REILLY, supra, at 13-7. During the experimentation period, tha lidomide’s manufacturer, “Merrell[,] distributed over [2.5 million] doses to 1,270 physicians who dispensed [the drug] to 20,771 patients.” Id. at 13-7 n.26 (citing Comment The Food and Drug Administration: Law, Science and Politics in the Evaluation and Control of New Drug Technology, 67 Nw. U. L. Rev. 858, 868 n.41 (1973))Google Scholar.

The last thalidomide cases settled before trial in 1984. See Flaherty, supra, at 30. Overall, thalidomide was the subject of “'thousands of suits’ in Europe, ‘between 100 and 200’ cases in Canada and ‘maybe 20’ suits in the United States.” Id.

Ironically, thalidomide may yet be accepted for use in the United States as an AIDS therapy. See Trental is Current Alternative HIV Therapy, 45 Weekly Pharm. Rep. (The Green Sheet) (F-D-C Rep., Inc.), No. 12, at 3, 3-4 (Mar. 18, 1996)Google Scholar.

13 Unsafe at Slow Speed: FDA Needs Overhaul, S.F. Chron., Apr. 28 , 1996, at A8Google Scholar.

14 “Every decade or so, a defective medical product slaps Americans in the face and reminds this country of the necessity of thorough reviews.” Shenk, Joshua Wolf, Warning: Cutting the FDA Could Be Hazardous to Your Health, Wash. Monthly, Jan. 1996, at 17, 19Google Scholar.

15 See Biotech 96, supra note 2, at 45. In 1995, the 260 publicly-traded biotech companies combined had total assets in excess of $16.7 billion and employed over 60,000 people. See id.

16 See id.

17 Comment k states that many drugs fall within a category of substances which are incapable of being made safe for their intended and ordinary use. See Restatement (Second) of Torts § 402A cmt. k (1977). Although proposing a safety warranty for an inherently unsafe product appears paradoxical, this Note will show that comment k and the warranty proposed herein take into account a weighing of attendant risks and benefits, and thus are not at odds with one another.

18 See BIOTECH 94, supra note 7, at 51.

19 See id.

20 Id.

21 Id. at 54.

22 Burn rate is “the rate at which a start-up company spends capital to finance overhead before generating a positive cash flow from operations.” Barron’s Dictionary of Finance and in Vestment Terms 65 (John Downes & Jordan Elliot Goodman eds., 4th ed. 1995).

23 See Biotech 96, supra note 2, at 15. Survival index represents the number of months a company can survive given its existing cash reserves and present burn rate. See id. It is calculated by dividing the sum of existing cash, cash equivalents, short-term investments, and long-term mar ketable securities by the monthly net burn rate. See id.

24 See id.

25 See id.

26 See id.

27 See id. at 10-13.

28 See, e.g., Jaffe, Greg, States Compete to Recruit Top Scientists: Spending Surges to Develop High-Tech Industries, Wall St. J., Apr. 23 , 1997, at A2Google Scholar; Tiking, Ralph & Naik, Gautam, Science: Tiny Company Could Emerge a Big Winner, Wall St. J., Feb. 25 , 1997, at BlGoogle Scholar.

29 See Lee, Kenneth B. Jr. & Burrill, G. Steven, Biotech 95: Reform, Restructure, Renewal 20 (1994)Google Scholar [hereinafter BIOTECH 95].

31 See id.

32 See Green, Daniel, Long Way From Maturity in Spite of the Promises, Fin. Times (London), Nov. 26 , 1996, Survey (Biotechnology) Section, at 1Google Scholar. For example, Arquale, a Boston, Massachu setts-based genotech company, began with over $7 million in venture funds and venture capitalists owned half of the company. See Green, Daniel, Long Way from Maturity in Spite of the Promises, Fin. times (London), Nov. 26 , 1996, Survey (Biotechnology) Section, at 1Google Scholar.

33 See Biotech 95, supra note 29, at 31.

34 See Gorman, Christine, Has Gene Therapy Stalled?, Time, Oct. 9 , 1995, at 62, 63Google ScholarPubMed; Green, Daniel, There’s Biotech—And There’s Biotech, Fin. Times (London), Nov. 26 , 1996, Survey (Biotechnology) Section, at 2Google Scholar.

35 See Barron’s Dictionary of Finance and Investment Terms, supra note 22, at 643; see also New Shorter Oxford English Dictionary 3561 (5th ed. 1993).

36 See Statement of the National Venture Capital Association on Reforming the Food and Drug Administration Before the Subcomm. on Health and the Environment of the House Comm. on Com merce, 104th Cong. (1996), available in 1996 WL 7135781 (statement of John K. Clarke).

37 See id.

38 See id.

39 Legitimate risks “include improving product safety and efficacy, securing patent protection, ascertaining the breadth of competition, and running out of money before the product reaches the marketplace.” Id.

40 See id.

41 See id.

42 See id.

43 See id.

44 See Biotech 94, supra note 7, at 55.

45 Id.

46 See id.

47 See id. at 60.

48 See id.

49 See id.

50 See Corrigan, Tracy, Focus is on Development, Fin. Times (London), Nov. 26 , 1996, Survey (Biotechnology) Section, at 2Google Scholar.

51 See Biotech 95, supra note 29, at 33; see also Malinowski & O'Rourke, supra note 1, at 188-90 (discussing the merits of strategic alliances). Large pharmaceutical companies have more leverage, market advantages, need for new products, and ability to absorb losses. See id.

52 See Biotech 95, supra note 29, at 33-34.

53 See Biotech 96, supra note 2, at 27.

54 See id.

55 See Biotech 94, supra note 7, at 11.

56 Id. at 50.

57 See text accompanying supra note 44.

58 See Bohn, James & Choi, Stephen, Fraud in the New Issues Market: Empirical Evidence on Securities Class Actions, 144 U. Pa. L. Rev. 903, 908 (1996)CrossRefGoogle Scholar.

59 However, “[m]uch uncertainty surrounds the issuance of a private company’s equity.” Id. New growth companies, such as genotech start-ups, typically lack a disclosure record. See id. Thus, these companies are susceptible to strike suits because of the inherent danger to investors in risking capital on an unknown company. See id.

60 See generally Miller, Greg, The Attack of the Unhappy Investors: Shareholder Lav/suits Dis rupt Business and Drain Companies’ Resources. For Executives, Reform Can't Come Too Soon, L.A. Times, Apr. 18 , 1995, at 10Google Scholar (discussing shareholder suits).

61 See, e.g., Rosenberg, Ronald, Stockholder Sues Cellcor, Boston Globe, Sept. 25 , 1992, at 68Google Scholar.

62 See Editorial, , Call It Tort Terror—Initiative Is Good for Lawyers, Bad for Economy, SAN Diego Union-trib., July 26, 1996, at B10Google Scholar.

63 See id. In the past, genotech shareholders initiated strike suits when there was clinical fail ure of a drug under development. See Biotech 96, supra note 2, at 27. For example, when Biogen’s lead product, Hirulog, an anti-coagulant, failed to demonstrate greater efficacy than the existing anti-coagulant, Heparin, the company’s shareholders initiated suit claiming violations of federal securities laws. See id. Similarly, shareholders of Telios Pharmaceuticals filed suit when its lead product, Argidene gel, failed to demonstrate statistically significant advantages in clinical trials. See id. at 26.

64 Miller, supra note 60, at 10. However, some companies may seem to ignore the danger of making optimistic statements about products in early stages of development. See The Nightly Busi ness Report (Community Television Foundation of South Florida broadcast, Mar. 7, 1996), available in LEXIS, News Library, Curnws File (reporting that Paracelsian Corp.’s stock jumped 141% after it announced it had a drug which blocks the growth of prostrate cancer cells, even though Phase I tests were not scheduled for another year).

65 See Miller, supra note 60, at 10.

66 See id.

67 See id.

68 Id. Product disappointments and successes are responsible for the volatility of genotech stock. See BIOTECH 96, supra note 2, at 26 fig. 8. Product disappointments can severely depress a genotech company’s stock price. See id. Some notable examples of companies whose stock price suffered because of product disappointments include: Cortech (63% decrease), Telor Ophthalmic (60% decrease), RIBI ImmunoChem (47% decrease), Telios Pharmaceuticals (42% decrease), and Celtrix Pharmaceuticals (63% decrease). See id. Conversely, product successes cause immediate jumps in a genotech company’s stock price. See Rosenberg, Ronald, Panel Clears Biogen Drug to Treat MS; FDA Approval Could Add S200-300M to Cambridge Firm’s Sales: Stock Leaps, Boston Globe, Dec. 5 , 1995, at 41Google Scholar.

69 See Miller, supra note 60, at 10. For example, the Medimmune Corporation recently settled a shareholder suit for approximately $4.2 million. See Swisher, Kara, Medimmune Settles Suit Over Fall in Stock Price; Drug at Issue in Case is Backed by FDA Panel, Wash. Post, Dec. 23 , 1995, at C1Google Scholar. See also, e.g., Harassing High Tech Firms, Rocky Mtn. News (Denver), Nov. 12 , 1995, at 117AGoogle Scholar.

70 See Harassing High Tech Firms, supra note 69, at 117A.

71 See United States v. Dotterweich, 320 U.S. 277, 280 (1943).

72 In 1937, Massengill developed an “elixir of sulfanilamide" and sold it without prior safety testing. See O‘reilly, supra note 12, § 13.02, at 13-5. The elixir did not contain the usual ingredient, alcohol, but diethylene glycol, a deadly poison. See id. As a result of taking the elixir, over 100 people died. See id. At the time, the law did not require advance testing, although a few simple animal tests would have revealed the elixir’s toxic nature. See id. at 13-5 n.15. The FDA was only able to remove the elixir from the market by claiming the drug was misbranded because of the implied representation that an elixir contained alcohol. See id. at 13-6. Massengill resisted the FDA’s efforts to remove the drug from the market. See id. at 13-6 n.18 (quoting Massengill’s chief executive who claimed that Massengill was not responsible and had not violated the law). Texas authorities jailed one Massengill salesman until he disclosed the whereabouts of drug shipments. See id. at 13-6 n.16.

73 See Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 321(p)(1) (1994).

74 See generally 21 C.F.R. ch. I (1996) (containing the FDA’s regulations).

75 See, e.g., United States v. Generix Drug Corp., 460 U.S. 453 (1983); Premo Pharm. Lab., Inc. v. United States, 629 F.2d 795 (2d Cir. 1980).

76 See generally O'REILLY, supra note 12, § 13.01, at 13-2 to -3.

77 See, e.g., Castrignano v. E.R. Squibb & Sons, Inc., 900 F.2d 455, 457-58 (1st Cir. 1990) (upholding a jury verdict finding the manufacturer of DES liable for producing an unreasonably unsafe drug).

“The FDA has always been [a] controversial [agency].” Shenk, supra note 14, at 18. The drug “[i]ndustry lobbied hard against the original Food and Drug Act in 1906 .... [T]he agency has been granted more power only when scandals shocked Congress into action.” Id. In 1962, the thalidomide tragedy in Europe was seen as a close call in the United States, where the drug’s application was held up by the FDA. See id. at 18-19. After Congress empowered the FDA in 1962 to check for efficacy as well as safety, half of all prescription drugs were removed from the market because they were ineffective. See Robinson, Michele L., Senate Panel Searches for Compromise on Regulation of Drug Promotional Materials, Bioworld Today, Feb. 23 , 1996, at 1Google Scholar. In 1976, the FDA-approved intrauterine birth control device, the Dalkon Shield, caused 18 deaths and 66,000 miscarriages. See Shenk, supra note 14, at 19. In the late 1980s, a series of scandals involving medical devices surrounded the FDA. See id. In this decade, there has been speculation that the scandal of the decade will involve rBVH, a genetically engineered version of Bovine Growth Hormone. See New Study Warns of Cancer Risk of Milk From Hormone-Treated Cows, Daily Rep. for Executives (BNA) d41 (Jan. 24, 1996), available in WESTLAW, BNA-DER Database.

78 See O'REILLY, supra note 12, § 13.11, at 13-61.

79 See 21 C.F.R. §§ 56.111, 310.501 (1996).

80 O'REILLY, supra note 12, § 13.11, at 13-61 to -62.

81 See 21 C.F.R. pt. 314.

82 See id. § 314.100(a).

83 See O'REILLY, supra note 12, § 13.11, at 13-63.

84 See 21 C.F.R. § 314.126(a).

85 See id.

86 See O'REILLY, supra note 12, § 13.11, at 13-66.

87 See id.

88 See id.

89 See id.

90 See id. at 13-65.

91 See id.

92 See id.

93 See id.

94 See id. at 13-66.

95 See id.

96 See id.

97 See 21 C.F.R. § 314.105 (1996).

98 See generally id. pt. 201 (providing specific labeling requirements for drugs).

99 The FDA’s general “good manufacturing" regulations are found in 21 C.F.R. pt. 210. Good manufacturing practices for finished pharmaceuticals are set forth in 21 C.F.R. pt. 211.

100 See id. pt. 600; Malinowski & O'Rourke, supra note 1, at 205 (describing the regulation of biologics).

101 21 U.S.C. §§ 301-395 (1994).

102 See Public Health and Services Act, 42 U.S.C. § 262 (1994).

103 Gamerman, Gary E., Regulation of Biologies Manufacturing: Questioning the Premise, 49 Food & Drug L.J. 213, 213 (1994)Google Scholar.

104 See Malinowski & O'Rourke, supra note 1, at 205-06.

105 See Elizabeth Joy Hecht, Note, Beyond Animal Legal Defense Fund v. Quigg: The Contro versy over Transgenic Animal Patents Continues, 41 Am. U. L. Rev. 1023, 1026 (1992)Google Scholar.

106 See Vander, Arthur J. Et Al., Human Physiology: The Mechanisms of Body Function 58 (1985)Google Scholar.

107 See Watson, James D., The Human Genome Project: Past, Present and Future, Science, Apr. 6 , 1990, at 44, 44CrossRefGoogle Scholar.

108 See Teich, Albert H. & Frankel, Mark S., Genetic Testing and the Human Genome Project, in The Genetic Frontier: Ethics, Law, and Policy at xii (1994)Google Scholar. The Human Genome Project’s goal is to map every human gene by 2005. See id. at xiv.

109 See Malinowski, Michael J., Coming Into Being: Law, Ethics, and the Practice of Prenatal Genetic Screening, 45 Hastings L.J. 1435, 1442 (1994)Google ScholarPubMed.

110 See Biotechnology and Genetics, supra note 11, at 4. Drugs developed using this method include human pituitary growth hormone and clotbuster TPA. See Carey, John, Untangling the Legal Strands of DNA, Bus. Wk., May 8 , 1995, at 78, 78Google Scholar.

111 See Riding the Tiger, supra note 11, at 7-8.

112 See Bohrer, Robert A., Fear and Trembling in the Twentieth Century: Technological Risk, Uncertainty and Emotional Distress, 1984 WIs. L. Rev. 83, 127Google Scholar.

113 See id. Most genotech drugs are proteins formed by connecting sequences of amino acids together in a specific sequence, as directed by the genetic code. See Getting to Know You, Economist, Feb. 25-Mar. 3, 1995, Survey: Biotechnology and Genetics Section, at 6Google Scholar. Despite the fact that rDNA techniques have advanced significantly since the days of selective breeding, current methods are still far from completely successful. See Wood, Marcia, Powerful Promoter Speeds Genetic Engineering Tests; A Promoter is the Portion of the Gene that Activates It, Agric. Res., Jan. 1994, at 21, 21Google Scholar (stating that “[t]he success rate in some [plant] genetic engineering tests is still very low”). Even if the desired substance is produced exactly as intended, long-term post-marketing surveillance is the only means to evaluate sufficiently the drug’s safety, especially given that side effects may take years to emerge and are impossible to assess fully before the drug is marketed. See Malinowski & O'Rourke, supra note 1, at 219.

114 See O'REILLY, supra note 12, § 13.11, at 13-61 to -62.

115 See Abrams, Laura A., Comment, The DES Dilemma: A Study in How Hard Cases Make Bad Law, 59 U. CIn. L. Rev. 489, 493 (1990)Google Scholar. An example of such a breakdown is diethylstilbestrol (DES). “Between the years 1947 and 1951, several hundred companies manufactured DES . . . and several million pregnant women ingested it.” Id. The FDA originally approved the use of DES for nonpregnancy-related conditions. See id. at 492. Two independent studies later indicated that DES could reduce the risk of miscarriage in high-risk pregnancies. See id. Therefore, in 1947 the FDA allowed DES to be used for such pregnancies even though the manufacturers had both failed to perform any safety studies on their own and ignored the existence of other studies contradicting those the manufacturers relied on for approval. See id.; see also Samuelson, Gary M., Commentaries: DES, RU-486, and DEJA-VU, 2 J. Pharmacy & L. 56, 58 (1993)Google Scholar (suggesting a parallel between possible future RU-486 litigation and past DES litigation). By 1971, numerous studies linked DES to cancer in the users’ daughters. See Scheiner, Naomi, Comment, DES and a Proposed Theory of Liability, 46 Fordham L. Rev. 963, 964 (1978)Google Scholar. “During the period [in which companies] marketed DES, they knew or should have known it was a carcinogenic substance . . . and that it was ineffective to prevent miscarriage.” Sindell v. Abbott Lab., 607 P.2d 924, 925-26 (Cal. 1980). The manufacturers/defendants “failed to test DES for efficacy and safety; the tests performed by others, upon which they relied, indicated that it was not safe or effective.” Id. at 926.

116 See, e.g., Lim, Paul J., Drug Approval Called Too Slow— Critics: FDA Reforms Not Enough, Seattle Times, Apr. 4 , 1996, at C1Google Scholar. “The average cost of developing a single drug is about $359 million.” Id.

117 See Gorman, supra note 34, at 62.

118 See Malinowski & O'Rourke, supra note 1, at 168.

119 Speaker of the House of Representatives, Newt Gingrich, has called the FDA the nation’s “leading job killer.” See Shenk, supra note 14, at 17. Common criticisms surround the length of time it takes the FDA to approve a new drug for market. See id. In addition, the FDA has been blamed for everything from the rising cost of health care and the failure to make vital new drugs available to desperate patient groups to the loss of the U.S.’s international competitive advantage in the biotech field. See Biotech 96, supra note 2, at 36. Criticisms have been especially harsh regarding the issue of new drug approvals for fatal diseases. The Washington Legal Foundation ran ads in major newspapers proclaiming, “If a murderer kills you, it’s homicide .... If the FDA kills you, it’s merely being cautious.” Shenk, supra note 14, at 17.

Many conservative policy institutes, some of which have strong ties to the industry, have also criticized the FDA. The Progress and Freedom Foundation is proposing that Congress shift drug approval to private research groups or universities. See id. The Competitive Enterprise Institute would remove the FDA’s monopoly, meaning that the agency would no longer have the ability to keep drugs out of the marketplace. See id. The Washington Legal Foundation has gone so far as to file suit against the agency, contesting their policy that restricts companies’ ability to provide information about off-label uses. See Washington Legal Foundation v. Kessler, 880 F. Supp. 26, 27-28 (D.D.C. 1995) (holding that the foundation had standing to challenge an FDA policy on first amendment grounds).

Possibly in response to the suit, the FDA eased off-label use restrictions for drugs. See Conlan, Michael F., Not Good Enough: Food & Drug Administration Eases Off-Label Restrictions, Drug Topics, Jan. 22 , 1996, at 68, 68Google Scholar. The agency’s new guidelines now allow manufacturers to distribute copies of peer-reviewed journal articles that contain incidental, nonhighlighted references to off-label uses to physicians. See id. Such a marketing strategy can have a major impact. For example, the New England Journal of Medicine recently published a study in which it was found that when two currently approved drugs, methotrexate and misoprostol, are combined, they have the effect of terminating early pregnancies in much the same way as the French abortion pill RU-486. See Hausknecht, Richard U., Methotrexate and Misoprostol to Terminate Early Pregnancy, 333 New Eng. J. Med. 537, 539 (1995)CrossRefGoogle ScholarPubMed. Both drugs are now available in U.S. pharmacies for less than $10. See Brody, Jane E., Abortion Method Using Two Drugs Gains in a Study, N.Y. Times, Aug. 31 , 1995, at A1Google Scholar. However, the FDA states that some restrictions on what manufacturers may say regarding off-label uses are necessary to ensure that companies continue to perform the clinical studies required to verify that the drug is safe and effective for the off-label use. See Conlan, supra, at 68.

120 See Biotech 95, supra note 29, at 26. “If you are in the pharmaceutical business, your first client is the FDA.” Id. (quoting Robert E. Ivy, Chairman, President, and Chief Executive Officer (CEO), RIBI ImmunoChem Research, Inc.).

121 See Biotech 96, supra note 2, at 22.

122 See generally Unsafe at Slow Speed, supra note 13, at 8 (noting that internal reforms “are not enough .... The FDA needs a more vigorous—and enduring—prod from Congress.”).

123 See O‘reilly, supra note 12, § 13.01, at 13-2.

124 See Shenk, supra note 14, at 18.

125 See id. at 23.

126 See y, David, Fox Pushes Bill to Speed Up Drug Approval Process, Gannett News Service, Mar. 8 , 1996Google Scholar, available in LEXIS, News Library, Curnws File. Lobbyists, such as the Citizens for a Sound Economy, are pushing hard for legislation to be passed quickly because of a perceived “short window of opportunity.” See id. In this sense, FDA streamlining looks more like the elimination of FDA protection, especially in the area of supplemental applications for new uses. See Robinson, supra note 77, at 1.

127 Congressional critics include Jon Fox, see Bauman, supra note 126, Barbara Mikulski, and Nancy Kassebaum. See Mikulski, Barbara & Kassebaum, Nancy, The FDA Can Work Better, Wash. Post, July 26 , 1996, at A27Google Scholar.

128 See Shenk, supra note 14, at 18.

129 See Mikulski & Kassebaum, supra note 127, at A27.

Id.

130 See Editorial, , Clinton’s Support for Cancer Victims, Chi. Trib., Apr. 13 , 1996, § 1, at 20Google Scholar. Cancer drugs will now be on the same accelerated approval path as AIDS drugs. See Mathis, Nancy, Clinton Steps Up Cancer Drug Approvals, Hous. Chron., Mar. 30 , 1996, at A1Google Scholar. This action will put dozens of anti-cancer drugs on the market years ahead of schedule. See id. Cancer drugs com prise the largest segment of genotech drugs currently awaiting FDA approval. See supra note 10 and accompanying text.

131 In November 1995, Vice President Al Gore announced several FDA reforms that were de signed to make the approval process for genotech drugs faster and less expensive for biotech firms. See Robinson, Michele L., FDA Moves Biotech Reforms Ahead on Schedule, Bioworld Today, Jan. 24 , 1996, at 1Google Scholar.

132 See The Food and Drug Administration Regulatory Reform Act of 1995, S. 1477, 104th Cong. (1996); Unsafe at Slow Speed, supra note 13, at 8. Senator Kassebaum’s bill would change the FDA’s mission to include “promot[ing] and protect[ing] the health of the American people by . . . facilitating the rapid and efficient development and availability of products subject to its regula tion.” S. 1477 § 102. The bill would also require the FDA to eliminate all backlogs on applications for new drugs by Jan. 1, 2000, and would expand patient access to new therapies if a new biological product “provides therapy not available from other approved therapy . . . or . . . offers significant improvement over other approved therapy.” Id. § 103.

133 Lim, supra note 116, at Cl.

134 Id.

135 See, e.g., H.R. 3201, 104th Cong. (1996) (proposing to amend the FDCA “to facilitate the development, clearance, and use of devices to maintain and improve the public health”); H.R. 4277, 104th Cong. (1996) (proposing to extend the period of exclusive marketing for certain pediatric drugs); see also Siegel, Stephen J., Klug Envisions Sleeker, Faster FDA; The Congressman Calls His Plan Modernization, But Others Say It’s a Gutting, Wis. State J., Oct. 27 , 1996, at 1BGoogle Scholar.

136 See Bauman, supra note 126. H.R. 1995, 104th Cong. (1995), a bill sponsored by Rep. Jon Fox would make “harmonization of international standards" part of the FDA’s mission. See H.R. 1995 § 2. The bill would also allow manufacturers to submit new drug applications based on evaluations from the European Medicines Evaluation Agency, the United Kingdom Medicines Con trol Agency, or “[a]ny competent governmental or nongovernmental organization established to evaluate the safety and effectiveness of drugs which meets any general criteria that the Secretary may by regulation establish.” Id. § 7. The Secretary of the FDA would then be required to act within 180 days. See id. To disapprove the application, the Secretary would be required to affirma tively prove the drug is unsafe or ineffective. See id. Additionally, if the Secretary does not act within 180 days, then “the conclusions and recommendations of the scientific review group regard ing the application shall be deemed to be the decision of the Secretary and the Secretary shall im plement them immediately.” Id.

Rep. Fox co-sponsored a second bill, introduced by Rep. Richard Burr, that is less radical, but would still allow review and approval by nongovernmental agencies. See H.R. 3199, 104th Cong. (1996). The bill would allow the FDA to designate accredited persons who could review applications. See id. § 7. If an application is approved by such an accredited person, the Secretary could disapprove the application only by affirmatively showing that “there is a reasonable probability that the drug is not safe or effective.” See id.

The FDA’s approval process has been blamed as a factor contributing to lack of job growth in the biotech industry. See Bauman, supra note 126. Jon Fox sees the agency’s process as a threat to the “20 pharmaceutical and biotech firms in [his] district that employ nearly 20,000 people.” Id. Fox noted that Great Britain, Germany, and Japan account for 60% of the world’s pharmaceutical sales and speculated that “[i]f we don't start approving new drugs and medical devices more quickly, we're going to lose jobs overseas.” Id.

Notably, during a Nov. 15, 1995 Tokyo symposium on the proper use of drugs, the president of the Japan Pharmaceutical Manufacturers Association said “that the proper use of drugs is a key to effective and safe medical care, and . . . stressed that [it] is indispensable in improving the quality of health care.” Clinical Trial Review and Consultation System Needed, Comline Daily News Biotech. & Med. Tech., Dec. 4 , 1995Google Scholar, available in LEXIS, News Library, Curnws File. Fumimaro Takaku, president of the International Medical Center of Japan stated “that one of the problems involved in clinical studies in Japan is that no pre-trial review and consultation system, such as that in the [United States], has been established" in Japan. Id. (emphasis added). Japan’s Ministry of Health and Welfare is currently planning reforms to ensure greater safety for drugs and to clarify specific requirements that drug companies must meet. See Ministry of Health and Welfare and Industry to Ensure Greater Drug Safety, Comline Daily News Biotech. & Med. Tech., Mar. 4 , 1996Google Scholar, available in LEXIS, News Library, Curnws File. The pharmaceutical industry in Japan “has shown a positive attitude toward the proposed reform.” Id.

137 See Biotech 96, supra note 2, at 36.

138 See Rosenberg, Ronald, Biotech Group Hits Kennedy’s FDA Stance, Boston Globe, Apr. 26 , 1996, at 90Google Scholar.

139 See Lim, supra note 116, at Cl.

140 See id.

141 See FDA Automatic Approval Deadline for Drug Products Suggested at American Enter prise Institute Seminar: Rx-to-OTC Switch “Sunset Law" Proposed, 57 Prescription Pharmaceuticals and Biotechnology (The Pink Sheet) (F-D-C Rep., Inc.), No. 11, at 5, 5-6 (Mar. 13, 1995).

142 See id. at 5.

143 Id.

144 See Garrett, Laurie, FDA Chief: They Asked Me to Stay, Newsday, Nov. 27 , 1996, at A20Google Scholar. Dr. Kessler held the Commissioner’s post from 1991-1996. See id. On November 25, 1996, Dr. Kessler announced that he was resigning as head of the FDA. See id. Dr. Kessler, who is both a doctor and an attorney, tackled some of the most controversial issues the FDA has faced, including the proposed approval of the French abortion pill RU-4S6 and the regulation of nicotine as a drug. See Waldmeir, Patti, Kessler Quits the Smoke of Battle, Fin. Times (London), Nov. 27 , 1996, § 2, at 35Google Scholar. Kessler’s successor has not yet been named. See Kuttner, Robert, Clinton’s Talented and Tena cious Regulators, Wash. post, June 2 , 1997, at A19Google Scholar. However, industry regulators and their politi cal allies are pushing for a nominee who will be far less active than Kessler. See id.

145 See Shenk, supra note 14, at 19. The FDA is often unfavorably compared to its counterpart in England, the British Medicines Control Agency (BMCA), which is usually presented as a model of efficiency. See id. However, a recent report by the U.S. General Accounting Office found that not only has the FDA acted on its own to speed the approval process, but also that the FDA was actually quicker than the BMCA. See id. The FDA shortened the average approval process from 33 months in 1987 to 19 months by 1992. See id.

146 See Shenk, supra note 14, at 18.

147 See Well-Characterized Biotechnology Products; Elimination of Establishment License Application, 61 Fed. Reg. 2733, 2733 (to be codified at 21 C.F.R. §§ 600-601) (proposed Jan. 29, 1996).

148 See id. at 2735; FDA Proposal Would Simplify Licensing of Well-Characterized Biotech Products, Health Care Daily (BNA) d5 (Jan. 30, 1996)Google Scholar.

149 See Robinson, supra note 131, at 1.

150 See id.

151 See Biotech 94, supra note 7, at 38.

152 21 U.S.C. § 379g-379h (1994).

153 See id. § 379h.

154 See Biotech 94, supra note 7, at 38.

155 See id.

156 See id.

157 See id.

158 See, e.g., Sindell v. Abbott Lab., 607 P.2d 924, 926 (Cal. 1980).

159 See, e.g., Christofferson v. Kaiser Found. Hosps., 92 Cal. Rptr. 825, 826 (Cal. Ct. App. 1971) (discussing a patient who suffered “severe and irreversible limitation of vision" after using the drug Aralen).

160 See Blatt, Richard L. Et Al., Punitive Damages: A State-by-State Guide to Law and Practice § 1.3, at 9 (1991)Google Scholar.

161 See id. § 1.4, at 13.

162 see generally Payton v. Abbott Lab., 437 N.E.2d 171 (Mass. 1992) (holding that prescrip tion drug cases are evaluated under negligence principles); Young v. Key Pharm., Inc., 922 P.2d 59 (Wash. 1996) (same).

163 See generally Griggs v. Combe, Inc., 456 So. 2d 790 (Ala. 1984) (holding that where a manufacturer was not and could not have been aware that product could cause dangerous reactions, manufacturer would not be held liable); Magee v. Wyeth Lab., Inc., 29 Cal. Rptr. 322 (Cal. Dist. Ct. App. 1963) (holding that where a plaintiffs injury was the result of an unusual susceptibility to dangers from manufacturer’s drug, the manufacturer did not have a duty to warn of the danger); Lake v. Konstantinu, 189 So. 2d 171 (Fla. Dist. Ct. App. 1966).

164 See In re Eli Lilly & Co., 789 F. Supp. 1448, 1451-53 (S.D. Ind. 1992); Ortho Pharm. Corp. v. Chapman, 388 N.E.2d 541, 544-45 (Ind. Ct. App. 1979) (stating that Indiana has adopted section 402A as its strict liability law); Savina v. Sterling Drug, Inc., 795 P.2d 915, 923-26 (Kan. 1990) (stating that Kansas has adopted section 402A as its strict liability law for dangerously defective products); Castrignano v. E.R. Squibb & Sons, Inc., 546 A.2d 775, 779-81 (R.I. 1988) (answering questions certified from the U.S. District Court for the District of Rhode Island in the affirmative and holding that comment k applies to unsafe drug cases in Rhode Island).

165 See, e.g., Grinnell v. Charles Pfizer & Co., 79 Cal. Rptr. 369, 372-74 (Cal. Ct. App. 1969).

166 Richmond, Douglas R., Renewed Look at the Duty to Warn and Affirmative Defenses, 61 Def. Couns. J. 205, 207 (1994)Google Scholar.

167 See Sprague v. Upjohn Co., No. CIV.A.91-40035-NMG, 1995 WL 376934, at *3 (D. Mass. May 10, 1994); Jackson v. Muhlenberg Hosp., 232 A.2d 879, 884 (N.J. 1967).

168 See Richmond, supra note 166, at 205.

169 See Restatement (Second) of Torts § 388(a) (1965).

170 See id. § 388(b).

171 See Richmond, supra note 166, at 212-13.

172 See Carlin v. Superior Court, 920 P.2d 1347, 1349 (Cal. 1996). ¹⁷³ See Carlin v. Superior Court, 920 P.2d 1347, 1349 (Cal. 1996).

174 See Richmond, supra note 166, at 207.

175 Section 402A states:

Restatement (second) of Torts (1965).

176 See Ortho Pharm. Corp. v. Chapman, 388 N.E.2d 541, 544-45 (Ind. Ct. App. 1979); Savina v. Sterling Drug, Inc., 795 P.2d 915, 923 (Kan. 1990); Castrignano v. E.R. Squibb & Sons, Inc., 546 A.2d 775, 779 (R.I. 1988).

177 See Chapman, 388 N.E.2d at 545 (noting that comment k is particularly relevant in deter mining whether marketing oral contraceptives is justified); Castrignano, 546 A.2d at 780 (adopting comment k as applied to defective design).

178 Comment k states:

Restatement (Second) of Torts § 402A cmt. k.

179 In Carlin v. Superior Court, the Supreme Court of California expressly affirmed its land mark decision in Brown v. Superior Court, 751 P.2d 470 (Cal. 1988), where it held that failures to warn of dangers associated with prescription drugs were adjudged under comment k’s strict liability standard. Carlin, 920 P.2d 1347, 1348 (Cal. 1996). The court explained that, “in the failure-to-warn context, strict liability is to some extent a hybrid of traditional strict liability and negligence doc trine. . . . [H]owever, ‘the claim that a particular component ‘rings of or ‘sounds in’ negligence has not precluded its acceptance in the context of strict liability.’” Id. at 1350-51 (quoting Anderson v. Owens-Corning Fiberglass Corp., 810 P.2d 549, 557 (Cal. 1991)). The court explained further that although the test of whether a manufacturer “knew or should have known" of the danger associated with its product incorporated a test that “sounds in negligence,” the standard is one of strict liability. See id. at 1351 n.2. The Washington Supreme Court, however, purporting to follow Brown, held that “when a manufacturer of an unavoidably unsafe product fails to adequately warn of its inherent dangers, comment k imposes liability only for negligence, not strict liability.” Young v. Key Pharm., Inc., 922 P.2d 59, 63 (Wash. 1996) (citing Rogers v. Miles Lab., Inc. 802 P.2d 1346, 1353 (Wash. 1991)).

Both interpretations seem grounded in the states’ respective public policies. The California Supreme Court declared that “[t]he purpose of [strict] liability is to insure that the costs of injuries resulting from defective products are borne by the manufacturers that put such products on the market rather than by the injured persons who are powerless to protect themselves.” Greenman v. Yuba Power Prods., Inc., 377 P.2d 897, 901 (Cal. 1963). At the same time, the Washington Supreme Court stated that the policy concerns underlying comment k show that the comment

Rogers, 802 P.2d at 1351.

180 See Chapman, 388 N.E.2d at 549. Section 388 provides:

Restatement (Second) of Torts § 388 (1965).

181 See Sterling Drug, Inc. v. Yarrow, 408 F.2d 978, 993 (8th Cir. 1969).

182 See Richmond, supra note 166, at 206.

183 See Carlin, 920 P.2d at 1348.

184 See In re Eli Lilly & Co., 789 F. Supp. 1448, 1452 (S.D. Ind. 1992); Brown, 751 P.2d at 476; Chapman, 388 N.E.2d at 548; cf. Carlin, 920 P.2d at 1348 (holding that manufacturers of pre scription drugs have a duty to warn of “known or reasonably scientifically knowable risks”). “The rules of strict liability require a plaintiff to prove only that the defendant did not adequately warn of a particular risk that was known or knowable in light of the generally recognized and prevailing best scientific and medical knowledge available at the time of manufacture and distribution.” Id. at 1351.

185 See Anderson v. Owens-Corning Fiberglas Corp., 810 P.2d 549, 559 (Cal. 1991); Magee v. Wyeth Lab., Inc., 29 Cal. Rptr. 322, 327 (Cal. Dist. Ct. App. 1963); Young v. Key Pharm., Inc., 922 P.2d 59, 62-63 (Wash. 1996).

186 See Anderson, 810 P.2d at 559. See generally Richmond, supra note 166, at 205-06, 208 (discussing a manufacturer’s duty to warn under negligence and strict liability theories).

187 See Richmond, supra note 166, at 209.

188 See id.

189 See U.C.C. § 2-314 which provides in relevant part:

• (1)[A] warranty that the goods shall be merchantable is implied in a contract for their sale if the seller is a merchant with respect to goods of that kind ....

• (2) Goods to be merchantable must be at least such as

  • (a) pass without objection in the trade under the contract description; and

  • (b) in the case of fungible goods, are of fair average quality within the description; and

  • (c) are fit for the ordinary purposes for which such goods are used; and

  • (d) run, within the variations permitted by the agreement, of even kind, quality, and quantity within each unit and among all units involved; and

  • (e) are adequately contained, packaged, and labeled as the agreement may require; and

  • (f) conform to the promise or affirmations of fact made on the container or label if any.

U.C.C. §2-314.

190 See U.C.C. § 2-315 which provides:

U.C.C. §2-315.

191 See, e.g., Griggs v. Combe, Inc., 456 So. 2d 790, 791 (Ala. 1984); Lake v. Konstantinu, 189 So. 2d 171, 173 (Fla. Dist. Ct. App. 1996).

192 See Griggs, 456 So. 2d at 792.

193 Id.

194 Id. at 793.

195 See Grundberg v. Upjohn Co., 813 P.2d 89, 89 (Utah 1991).

196 “[A] warranty that the goods shall be merchantable is implied in a contract for their sale . . . .”

U.C.C. § 2-314(1) (emphasis added).

197 See id. cmt. 7.

198 Id.

199 Id.

200 This warranty may be exactly what is needed where an otherwise safe and effective sub stance is improperly manufactured. However, this Note focuses on those situations where a geno- tech drug is produced according to the manufacturer’s specifications, yet causes harm simply be cause it is an unsafe substance.

201 See U.C.C. §2-314(2)(b).

202 Id. §2-314(2)(c).

203 In addition to quality concerns, merchantability is part of the obligation a manufacturer or seller owes to the purchaser for his use of the product. See id. § 2-314 crat. 8.

204 U.C.C. § 2-315 cmt. 2.

205 See id. §2-315.

206 Because the FDA must preapprove all prescription drugs before they may be sold, and because the FDA approves only those drugs shown to be safe and effective for a specific ailment, drug manufacturers, especially genotech drug manufacturers, target their drugs at specific ailments. See supra Part III.A.

207 Once in the marketplace, the courts are not in a position to second-guess the FDA’s approval decision. See Jacobs v. Dista Prods., 693 F. Supp. 1029, 1035 (D. Wyo. 1988).

208 see Gottsdanker v. Cutter Lab., 6 Cal. Rptr. 320, 323 (Cal. Dist. Ct. App. 1960). In some instances, the FDA may prevent the manufacturer from providing a warning. Manufacturers may only warn of known hazards, not theoretical ones. See 21 C.F.R. §201.57(d) (1996). However, a warning is required when “reasonable evidence of an association of a serious hazard with a drug" exists. Id. § 201.57(e).

209 See Gottsdanker, 6 Cal. Rptr. at 323.

210 See Richmond, supra note 166, at 218.

211 See, e.g., Sprague v. Upjohn Co., No. CIV.A.91-40035-NMG, 1995 WL 376934, at *3 (D. Mass. May 10, 1994) (applying Payton’s rule of negligence for drug liability); Payton v. Abbott Lab., 437 N.E.2d 171, 188-90 (Mass. 1992) (stating that public policy requires applying a negli gence theory for drug injuries).

212 See Sprague, 1995 WL 376934, at *4; see also Sanderson v. Upjohn Co., 578 F. Supp. 338, 339 (D. Mass. 1984) (stating legal adequacy of warning was a factual issue for the jury); MacDonald v. Ortho Pharm. Corp., 475 N.E.2d 65, 72 (Mass.) (holding that the manufacturer’s deficient warning was the proximate cause of the plaintiffs injury), cert, denied, 474 U.S. 920 (1985); Smith v. E.R. Squibb & Sons, Inc., 273 N.W.2d 476, 480 (Mich. 1979) (holding that when a failure to warn is alleged, the theories of implied warranty and negligence require exactly the same elements of proof).

213 See Sprague, 1995 WL 376934, at *3.

214 See Richmond, supra note 166, at 212.

215 Stone v. Smith, Kline & French Lab., 731 F.2d 1575, 1579 (11th Cir. 1984); see also Seley v. G.D. Searle & Co., 423 N.E.2d 831, 834 (Ohio 1981) (stating that manufacturer satisfies duty to warn by warning the medical professional). But see MacDonald, 475 N.E.2d at 70 (finding an ex ception to the learned intermediary doctrine for oral contraceptives).

216 See Kirk v. Michael Reese Hosp. & Med. Ctr., 513 N.E.2d 387, 392-93 (III. 1987).

217 See State Farm Fire & Cas. Co. v. J.B. Plastics, Inc., 505 So. 2d 1223, 1227 (Ala. 1987) (holding the jury responsible for deciding whether a duty to warn existed); Richmond, supra note 166, at 209.

218 See MacDonald, 475 N.E.2d at 68-69.

219 See Restatement (Second) of Torts § 402A cmt. j (1965); see also Hahn v. Richter, 673 A.2d 888, 890 n.3 (Pa. 1996) (citing comment j, which requires the seller to warn consumers of risks not generally known and recognized of which the seller knows or should know, and providing that the seller may assume that warnings are read and obeyed).

220 Carter v. Yardley & Co., 64 N.E.2d 693, 697 (Mass. 1946).

221 See, e.g., MacDonald, 475 N.E.2d at 68 (citations omitted).

222 See id; see also Wagner v. Roche Lab., 671 N.E.2d 252, 256 (Ohio 1996).

223 See Shanks, 835 P.2d at 1195 n.6.

224 In these circumstances, it is natural to ask if the injured consumer should be able to bring an action against the physician directly for negligence or lack of informed consent. In some cases, this may be appropriate. However these concerns, although relevant, are outside the scope of this Note.

225 See 142 Cong. Rec. S3203 (daily ed. Mar. 29, 1996) (statement of Sen. Kennedy). Con- siderthe following statement Sen. Kennedy made:

Id.

226 Although the FDA has the primary role of ensuring the safety of genotech drugs before they reach the marketplace, this role does not preclude state common law remedies if a product later proves unsafe. See Medtronic, Inc. v. Lohr, 116 S. Ct. 2240, 2245 (1996); Walker v. Johnson & Johnson Vision Prods., Inc., 552 N.W.2d 679, 685 (Mich. App. 1996); Connelly v. Iolab Corp., 927 S.W.2d 848, 851 (Mo. 1996).

227 See supra note 224 and accompanying text.

228 See, e.g., Langer v. Dista Prods. Co., No. 90-C4598, 1996 U.S. Dist. LEXIS 13284, at *5 (N.D. 111. Sept. 5, 1996); Adams v. Rios, No. 14-95-00239-CV, 1996 Tex. App. LEXIS 2461, at *3 (Tex. App. June 20, 1996).

229 Because of the general acceptance of evidentiary rules based upon the Federal Rules of Evidence in state courts, this Note generally assumes that the federal rules are applied during the trial.

230 See Fed. R. Evid. 702.

231 See Frye v. United States, 293 F. 1013, 1014 (D.C. Cir. 1923). “When the question in volved does not lie within the range of common experience or common knowledge, but requires special experience or special knowledge, then the opinions of witnesses skilled in that particular science, art, or trade to which the question relates are admissible in evidence.” Id.

232 See id.

233 Id.

234 See Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 585-95 (1993); see also Green, Eric & Nesson, Charles, Problems, Cases, and Materials on Evidence 649 (1983)Google Scholar (stating the Frye test was the “original and most widely used standard for the admissibility of expert testi mony and scientific evidence”). In Frye, the Court itself recognized the trouble in determining whether a new scientific method should be admitted or excluded, stating, “[j]ust when a scientific principle or discovery crosses the line between the experimental and demonstrable stages is difficult to define. Somewhere in this twilight zone the evidential force of the principle must be recognized.” Frye, 293 F. at 1014.

235 See id. It is especially fitting that Daubert provide the cornerstone for a warranty of safety for genotech drugs. Daubert itself is an unsafe drug case. In it, the plaintiffs alleged that the chil dren’s birth defects were caused by the mother’s prenatal ingestion of Bendictin. See id. at 582. Both sides presented testimony from “well-credentialed" experts. See id. at 582-83. The defen dant’s experts showed that Bendictin was safe, while plaintiffs’ experts demonstrated that Bendictin was teratogenic. See id.

236 Comment k assumes that “[t]here are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use.” Re Statement (Second) of Torts § 402A cmt. k (1965). However, in our world, nothing is com pletely safe. A substance as seemingly harmless and innocuous as water may be safe when someone drinks eight ounces from a glass, but deadly when one swims out too far and cannot return to shore. Safety is context-dependent. This Note attempts to create a legal definition of safety within the context of creating and marketing genotech drugs.

237 See, e.g., Daubert, 509 U.S. at 583-84.

238 The first genotech product, Humulin, gained approval in 1982. See Biotech 96, supra note 2, at 60. Today, there are over 500 genotech products either approved or awaiting approval. See id. at 24.

239 See Fed. R. Evid. 402. “Relevance is not an inherent characteristic of any piece of evi dence, but exists only as a relation between an item of evidence and a matter properly provable in the case.” Fed. R. Evid. 401 advisory committee’s note. The probability standard required by the rule is “more ... probable than it would be without the evidence.” Id. A more stringent requirement would be “unworkable and unrealistic.” See id.

240 See Fed. R. Evid. 401 advisory committee’s note.

241 See Fed. R. Evid. 702.

242 See id.

243 See Daubert, 509 U.S. at 589.

244 See id. at 589-90.

245 See id. at 590.

246 See id.

247 Concerns similar to this underlie cases that apply comment k broadly. See Grundberg v. Upjohn Co., 813 P.2d 89, 90 (Utah 1991) (exempting all FDA approved drugs “properly prepared, compounded, packaged, and distributed” from strict liability). See generally Toner v. Lederle Lab., 732 P.2d 297 (Idaho 1987), cert, denied, 485 U.S. 942 (1988) (discussing comment k’s protection against strict liability for sellers whose products’ benefits outweigh an unavoidable risk).

248 See Daubert, 509 U.S. at 593. See generally Green, Michael D., Expert Witnesses and Suf ficiency of Evidence in Toxic Substances Litigation: The Legacy of Agent Orange and Bendectin Litigation, 86 Nw. U. L. Rev. 643, 645, 694-95 (1992)Google Scholar (“Scientific methodology today is based on generating hypotheses and testing them to see if they can be falsified; indeed this methodology is what distinguishes science from other fields of human inquiry”).

249 See Daubert, 509 U.S. at 593.

250 See id.

251 See id.

252 See id.

253 On the surface it seems that the manufacturer is under a great burden to produce expert testimony and empirical evidence relating to the safety of the drug it manufactures. However, the evidence necessary is the same evidence that the manufacturer presented to the FDA when the manufacturer tried to gain approval for its drug. The manufacturer also must produce any follow-up studies performed on the drug.

254 This is similar to the inquiry the FDA makes, but it does not displace the FDA’s determina tion that it was reasonable to market the drug in the first place. Cf. Sprague v. Upjohn Co., No. CIV.A.91-40035-NMG, 1995 WL 376934, at *2 (D. Mass. May 10, 1994) (stating that it is the pri mary function of the FDA to determine whether a drug should be approved and marketed). The FDA must necessarily base its conclusions on data provided by the manufacturer which will include dis closure of a number of side effects. In an adversarial proceeding, the parties will be focused on a particular risk, which may or may not have been addressed by the manufacturer.

255 See supra note 115 and accompanying text.

256 Where a warning has been given but ignored by the patient’s physician, and the patient later is injured in the manner the warning sought to avoid, the patient may have a claim against the phy sician for lack of informed consent or malpractice. However, the existence of a claim against a third party here does not act as a supervening cause relieving the manufacturer of liability, and the rela tive merits of such claims are therefore outside the scope of this Note.

257 Medtronic, Inc. v. Lohr, 116 S. Ct. 2240, 2255 (1996).