Ensuring the safety of genotech drugs through implied warranty theory

American Journal of Law and Medicine

Volumn 23, Issue 2-3, 1997, Pages 363-386

  Serra, Wayne M ^a,b  

^a UNIVERSITY OF MASSACHUSETTS   (United States)

^b BOSTON UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; DRUG APPROVAL; DRUG INDUSTRY; FOOD AND DRUG ADMINISTRATION; GENETIC ENGINEERING; INSURANCE; LEGAL ASPECT; MALPRACTICE; ORGANIZATION AND MANAGEMENT; POSTMARKETING SURVEILLANCE; UNITED STATES;

DRUG APPROVAL; DRUG INDUSTRY; GENETIC ENGINEERING; INSURANCE, LIABILITY; MALPRACTICE; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0030629709     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (287)

1. See Michael J. Malinowski & Maureen A. O'Rourke, A False Start? The Impact of Federal Policy on the Genotechnohgy Industry, 13 YALE J. ON REG. 163, 164 (1996).
2. In 1995, the biotech industry contained 1308 companies employing 108,000 people and having sales of approximately $9.3 billion. See KENNETH B. LEE, JR. & G. STEVEN BURILL, BIOTECH 96: PURSUING SUSTAINABILITY at i (1995) [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 companies 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 G. STEVEN BURILL & KENNETH B. LEE, JR., BIOTECH 94: LONG-TERM VALUE SHORT-TERM HURDLES 1, 35 (1993) [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 7.
12. For example, in the early 1960s, European women using the drug thalidomide gave birth to children with serious birth defects. See I JAMES T. O'REILLY, FOOD AND DRUG ADMINISTRATION § 13.02, at 13-7 (2d ed. 1993). Thalidomide, a widely used sleeping pill, caused the defects.
13. See Francis J. Flaherty, Last Thalidomide Suits Settle to End Legal Era, NAT'L L.J., Jul. 30, 1984, at 30. Although never formally approved in the United States, partly because of foreign scientists' discoveries during the PDA approval process, thalidomide was available as part of the investigational process then used by the PDA.
14. See O'REILLY, supra, at 13-7. During the experimentation period, thalidomide'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)).
15. 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.
16. 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).
17. Unsafe at Slow Speed: PDA Needs Overhaul, S.F. CHRON., Apr. 28, 1996, at A8.
18. "Every decade or so, a defective medical product slaps Americans in the face and reminds this country of the necessity of thorough reviews." Joshua Wolf Shenk, Warning: Cutting the FDA Could Be Hazardous to Your Health, WASH. MONTHLY, Jan. 1996, at 17, 19.
19. 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.
20. See id.
21. 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.
22. See BIOTECH 94, supra note 7, at 51.
23. See Id.
24. Id.
25. Id. at 54.
26. 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 INVESTMENT TERMS 65 (John Downes & Jordan Elliot Goodman eds., 4th ed. 1995).
27. 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 marketable securities by the monthly net burn rate. See id.
28. 24 See id.
29. See id.
30. See id.
31. See id. at 10-13.
32. See, e.g., Greg Jaffe, States Compete to Recruit Top Scientists: Spending Surges to Develop High-Tech Industries, WALL ST. J., Apr. 23, 1997, at A2;
33. Ralph Tiking & Gautam Naik, Science: Tiny Company Could Emerge a Big Winner, WALL ST. J., Feb. 25, 1997, at B1.
34. See KENNETH B. LEE, JR. & G. STEVEN BURRILL, BIOTECH 95: REFORM, RESTRUCTURE, RENEWAL 20 (1994) [hereinafter BIOTECH 95].
35. See id.
36. See id.
37. See Daniel Green, Long Way From Maturity in Spite of the Promises, FIN. TIMES (London), Nov. 26, 1996, Survey (Biotechnology) Section, at 1. For example, Arquale, a Boston, Massachusetts-based genotech company, began with over $7 million in venture funds and venture capitalists owned half of the company.
38. See Daniel Green, Long Way from Maturity in Spite of the Promises, FIN. TIMES (London), Nov. 26, 1996, Survey (Biotechnology) Section, at 1.
39. See BlOTECH 95, supra note 29, at 31.
40. See Christine Gorman, Has Gene Therapy Stalled?, TIME, Oct. 9, 1995, at 62, 63;
41. Daniel Green, There's Blotech - And There's Biotech, FIN. TIMES (London), Nov. 26, 1996, Survey (Biotechnology) Section, at 2.
42. 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).
43. 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 Commerce, 104th Cong. (1996), available in 1996 WL 7135781 (statement of John K. Clarke).
44. See id.
45. See id.
46. 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.
47. See id.
48. See id.
49. See id.
50. See id.
51. See BIOTECH 94, supra note 7, at 55.
52. 45 Id.
53. See id.
54. See id. at 60.
55. See id. 49 See id.
56. See Tracy Corrigan, Focus is on Development, FIN. TIMES (London), Nov. 26, 1996, Survey (Biotechnology) Section, at 2.
57. See BlOTECH 95, supra note 29, at 33;
58. 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.
59. See BlOTECH 95, supra note 29, at 33-34.
60. See BlOTECH 96, supra note 2, at 27.
61. See id.
62. See BlOTECH 94, supra note 7, at 11.
63. Id. at 50.
64. See text accompanying supra note 44.
65. See James Bohn & Stephen Choi, Fraud in the New Issues Market: Empirical Evidence on Securities Class Actions, 144 U. PA. L. REV. 903, 908 (1996).
66. 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.
67. See generally Greg Miller, The Attack of the Unhappy Investors: Shareholder Lawsuits Disrupt Business and Drain Companies ' Resources. For Executives, Reform Can 'I Come Too Soon, L.A. TIMES, Apr. 18, 1995, at 10 (discussing shareholder suits).
68. See, e.g., Ronald Rosenberg, Stockholder Sues Cellcor, BOSTON GLOBE, Sept. 25, 1992, at 68.
69. See Editorial, Call It Tort Terror-Initiative Is Good for Lawyers, Bad for Economy, SAN DIEGO UNION-TRIB., July 26,1996, at B10.
70. See id. In the past, genotech shareholders initiated strike suits when there was clinical failure of a drug under development. See BlOTECH 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.
71. 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 ne Nightly Business 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).
72. See Miller, supra note 60, at 10.
73. See id.
74. See id.
75. Id. Product disappointments and successes are responsible for the volatility of genotech stock. See BlOTECH 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.
76. See Ronald Rosenberg, Panel Clears Biogen Drug to Treat MS; PDA Approval Could Add S200-300M to Cambridge Firm 's Sales: Stock Leaps, BOSTON GLOBE, Dec. 5, 1995, at 41.
77. See Miller, supra note 60, at 10. For example, the Medimmune Corporation recently settled a shareholder suit for approximately $4.2 million.
78. See Kara Swisher, Medimmune Settles Suit Over Fa ll in Stock Price; Drug at Issue in Case is Backed by PDA Panel, WASH. POST, Dec. 23, 1995, at Cl. See also, e.g., Harassing High Tech Firms, ROCKY MTN. NEWS (Denver), Nov. 12, 1995, at 117A.
79. See Harassing High Tech Firms, supra note 69, at 117A.
80. See United States v. Dotterweich, 320 U.S. 277, 280 (1943).
81. 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 PDA'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.
82. See Federal Food, Drug and Cosmetic Act, 21 U.S.C. §321(p)(l) (1994).
83. See generally 21 C.F.R. ch. I (1996) (containing the PDA's regulations).
84. 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).
85. See generally O'REILLY, supra note 12, §13.01, at 13-2 to -3.
86. 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).
87. "The PDA has always been [a] controversial [agency]." Shenk, supra note 14, at 18. The drug "[ijndustry 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 PDA. See id. at 18-19. After Congress empowered the PDA in 1962 to check for efficacy as well as safety, half of all prescription drugs were removed from the market because they were ineffective.
88. See Michèle L. Robinson, Senate Panel Searches for Compromise on Regulation of Drug Promotional Materials, BIOWORLD TODAY, Feb. 23, 1996, at 1. In 1976, the PDA-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 PDA. 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.
89. See O'REILLY, supra note 12, §13.11, at 13-61.
90. See 21 C.F.R. §§56.111, 310.501 (1996).
91. O'REILLY, supra note 12, §13.11, at 13-61 to -62.
92. See 21 C.F.R. pt. 314.
93. See id. §314.100(a).
94. 8 See O'REILLY, supra note 12, §13.11, at 13-63.
95. See 21 C.F.R. §314.126(a).
96. See id.
97. See O'REILLY, supra note 12, §13.11, at 13-66.
98. See id.
99. See id.
100. See id.
101. W See id. at 13-65.
102. See id.
103. See id.
104. See id.
105. See id. at 13-66.
106. See id.
107. 96 see id.
108. See 21 C.F.R. §314.105 (1996).
109. See generally id. pt. 201 (providing specific labeling requirements for drugs).
110. The PDA'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.
111. see id. pt. 600; Malinowski & O'Rourke, supra note 1, at 205 (describing the regulation of biologies).
112. 21 U.S.C. §§301-395 (1994).
113. 12 See Public Health and Services Act, 42 U.S.C. §262 (1994).
114. Gary E. Gamerman, Regulation of Biologies Manufacturing: Questioning the Premise, 49 FOOD & DRUG L.J. 213,213 (1994).
115. See Malinowski & O'Rourke, supra note 1, at 205-06.
116. See Elizabeth Joy Hecht, Note, Beyond Animal Legal Defense Fund v. Quigg: The Controversy over Transgenic Animal Patents Continues, 41 AM. U. L. REV. 1023, 1026 (1992).
117. See ARTHUR J. VANDER ET AL., HUMAN PHYSIOLOGY: THE MECHANISMS OF BODY FUNCTION 58 (1985).
118. See James D. Watson, The Human Genome Project: Past, Present and Future, SCIENCE, Apr. 6, 1990, at 44, 44.
119. 18 See Albert H. Teich & Mark S. Frankel, Genetic Testing and the Human Genome Project, in THE GENETIC FRONTIER: ETHICS, LAW, AND POLICY at xii (1994). The Human Genome Project's goal is to map every human gene by 2005. See id. at xiv.
120. See Michael J. Malinowski, Coming Into Being: Law, Ethics, and the Practice of Prenatal Genetic Screening, 45 HASTINGS L.J. 1435, 1442 (1994).
121. "0 See Biotechnology and Genetics, supra note 11, at 4. Drugs developed using this method include human pituitary growth hormone and clotbuster TPA.
122. See John Carey, Untangling the Legal Strands ofDNA, BUS. WK., May 8, 1995, at 78, 78.
123. See Riding the Tiger, supra note 11, at 7-8.
124. See Robert A. Bohrer, Fear and Trembling in the Twentieth Century: Technological Risk, Uncertainly and Emotional Distress, 1984 WlS. L. REV. 83, 127.
125. 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 6. Despite the fact that rDNA techniques have advanced significantly since the days of selective breeding, current methods are still far from completely successful. See Marcia Wood, Powerful Promoter Speeds Genetic Engineering Tests; A Promoter is the Portion of the Gene that Activates It, AGRIC. RES., Jan. 1994, at 21, 21 (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.
126. See O'REILLY, supra note 12, §13.11, at 13-61 to -62.
127. See Laura A. Abrams, Comment, The DES Dilemma: A Study in How Hard Cases Make Bad Law, 59 U. CIN. L. REV. 489, 493 (1990). 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 PDA 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 PDA 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.
128. See id.; see also Gary M. Samuelson, Commentaries: DES, RU-486, and DEJA-VU, 2 J. PHARMACY & L. 56, 58 (1993) (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.
129. See Naomi Scheiner, Comment, DES and a Proposed Theory of Liability, 46 FORDHAM L. REV. 963, 964 (1978). "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.
130. See, e.g., Paul J. Lim, Drug Approval Called Too Slow-Critics: PDA Reforms Not Enough, SEATTLE TIMES, Apr. 4, 1996, at Cl. "The average cost of developing a single drug is about $359 million." Id.
131. See Gorman, supra note 34, at 62.
132. See Malinowski & O'Rourke, supra note 1, at 168.
133. Speaker of the House of Representatives, Newt Gingrich, has called the PDA the nation's "leading job killer." See Shenk, supra note 14, at 17. Common criticisms surround the length of time it takes the PDA to approve a new drug for market. See id. In addition, the PDA 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 PDA kills you, it's merely being cautious." Shenk, supra note 14, at 17.
134. Many conservative policy institutes, some of which have strong ties to the industry, have also criticized the PDA. 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 PDA'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 PDA policy on first amendment grounds).
135. Possibly in response to the suit, the PDA eased off-label use restrictions for drugs.
136. See Michael F. Conlan, Not Good Enough: Food & Drug Administration Eases Off-Label Restrictions, DRUG TOPICS, Jan. 22, 1996, at 68, 68. 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.
137. See Richard U. Hausknecht, Methotrexate and Misoprostol to Terminate Early Pregnancy, 333 NEW ENG. J. MED. 537, 539 (1995). Both drugs are now available in U.S. pharmacies for less than $10.
138. See Jane E. Brody, Abortion Method Using Two Drugs Gains in a Study, N.Y. TIMES, Aug. 31, 1995, at Al. However, the PDA 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.
139. 12 See BIOTECH 95, supra note 29, at 26. "If you are in the pharmaceutical business, your first client is the PDA." Id. (quoting Robert E. Ivy, Chairman, President, and Chief Executive Officer (CEO), RIBI ImmunoChem Research, Inc.).
140. See BIOTECH 96, supra note 2, at 22.
141. See generally Unsafe at Slow Speed, supra note 13, at 8 (noting that internal reforms "are not enough .... The PDA needs a more vigorous-and enduring-prod from Congress.").
142. See O'REILLY, supra note 12, §13.01, at 13-2.
143. See Shenk, supra note 14, at 18.
144. See id. at 23.
145. '26 See David Bauman, Fox Pushes Bill to Speed Up Drug Approval Process, GANNETT NEWS SERVICE, Mar. 8, 1996, 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, PDA streamlining looks more like the elimination of PDA protection, especially in the area of supplemental applications for new uses. See Robinson, supra note 77, at 1.
146. Congressional critics include Jon Fox, see Bauman, supra note 126, Barbara Mikulski, and Nancy Kassebaum.
147. See Barbara Mikulski & Nancy Kassebaum, The PDA Can Work Better, WASH. POST, July 26, 1996, atA27.
148. See Shenk, supra note 14, at 18.
149. See Mikulski & Kassebaum, supra note 127, at A27.
150. Inaction and delay victimize just as surely as the wrong action. We hear constantly about the deformities prevented in the early 1960s by the agency's not approving thalidomide. Rarely, however is a word spoken about the cases of spina bifida that could have been averted had the agency not delayed for years in permitting health claims to be made about the benefits of folic acid .... Id.
151. See Editorial, Clinton's Support for Cancer Victims, Cm. TRIB., Apr. 13, 1996, §1, at 20. Cancer drugs will now be on the same accelerated approval path as AIDS drugs. See Nancy Mathis, Clinton Steps Up Cancer Drug Approvals, HOUS. CHRON., Mar. 30, 1996, at AI. This action will put dozens of anti-cancer drugs on the market years ahead of schedule. See id. Cancer drugs comprise the largest segment of genotech drugs currently awaiting PDA approval. See supra note 10 and accompanying text.
152. In November 1995, Vice President Al Gore announced several PDA reforms that were designed to make the approval process for genotech drugs faster and less expensive for biotech firms.
153. See Michèle L. Robinson, PDA Moves Biotech Reforms Ahead on Schedule, BloWORLD TODAY, Jan. 24, 1996, at 1.
154. 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 PDA's mission to include "promoting] and protecting] the health of the American people by ... facilitating the rapid and efficient development and availability of products subject to its regulation." S. 1477 §102. The bill would also require the PDA 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.
155. Lim, supra note 116, at CI.
156. Id.
157. 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);
158. see also Stephen J. Siegel, Klug Envisions Sleeker, Faster PDA; The Congressman Calls His Plan Modernization, But Others Say It's a Gutting, WlS. STATE J., Oct. 27, 1996, at 1B.
159. 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 PDA'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 Control 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 affirmatively 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 regarding the application shall be deemed to be the decision of the Secretary and the Secretary shall implement them immediately." Id.
160. 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.
161. The PDA'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.
162. 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, 1995, 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, 1996, available in LEXIS, News Library, Curnws File. The pharmaceutical industry in Japan "has shown a positive attitude toward the proposed reform." Id.
163. See BlOTECH 96, supra note 2, at 36.
164. See Ronald Rosenberg, Biotech Group Hits Kennedy's PDA Stance, BOSTON GLOBE, Apr. 26, 1996, at 90.
165. See Lim, supra note 116, at C1.
166. See id.
167. See PDA Automatic Approval Deadline for Drug Products Suggested at American Enterprise Institute Seminar: Rx-to-OTCSwitch "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).
168. See id. at 5.
169. Id.
170. See Laurie Garrett, PDA Chief: They Asked Me to Stay, NEWSDAY, Nov. 27, 1996, at A20. 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 PDA. See id. Dr. Kessler, who is both a doctor and an attorney, tackled some of the most controversial issues the PDA has faced, including the proposed approval of the French abortion pill RU-486 and the regulation of nicotine as a drug. See Patti Waldmeir, Kessler Quits the Smoke of Battle, FIN. TIMES (London), Nov. 27, 1996, §2, at 35. Kessler's successor has not yet been named.
171. See Robert Kuttner, Clinton's Talented and Tenacious Regulators, WASH. POST, June 2, 1997, at A19. However, industry regulators and their political allies are pushing for a nominee who will be far less active than Kessler. See id.
172. See Shenk, supra note 14, at 19. The FDA is often unfavorably compared to its counterpart ih 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.
173. See Shenk, supra note 14, at 18.
174. 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).
175. See id. at 2735; FDA Proposal Would Simplify Licensing of Well-Characterized Biotech Products, Health Care Daily (BNA) d5 (Jan. 30, 1996).
176. See Robinson, supra note 131, at 1.
177. See id.
178. See BIOTECH 94, supra note 7, at 38.
179. 152 21 U.S.C. §379g-379h (1994).
180. See id. §379h.
181. See BIOTECH 94, supra note 7, at 38.
182. See id.
183. See id.
184. See id.
185. '58 See, e.g., Sindell v. Abbott Lab., 607 P.2d 924, 926 (Cal. 1980).
186. 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).
187. See RICHARD L. BLATT ET AL., PUNITIVE DAMAGES: A STATE-BY-STATE GUIDE TO LAW AND PRACTICE §1.3, at 9 (1991).
188. See id. §1.4, at 13.
189. see generally Payton v. Abbott Lab., 437 N.E.2d 171 (Mass. 1992) (holding that prescription drug cases are evaluated under negligence principles); Young v. Key Pharm., Inc., 922 P.2d 59 (Wash. 1996) (same).
190. 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).
191. 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
192. 1 See, e.g., Grinnell v. Charles Pfizer & Co., 79 Cal. Rptr. 369, 372-74 (Cal. Ct. App. 1969).
193. Douglas R. Richmond, Renewed Look at the Duty to Warn and Affirmative Defenses, 61 DEF. COUNS. J. 205,207 (1994).
194. I7 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).
195. See Richmond, supra note 166, at 205.
196. See RESTATEMENT (SECOND) OF TORTS §388(a) (1965).
197. See id. §388(b).
198. See Richmond, supra note 166, at 212-13.
199. See Carlin v. Superior Court, 920 P.2d 1347, 1349 (Cal. 1996).
200. l" See Carlin v. Superior Court, 920 P.2d 1347, 1349 (Cal. 1996).
201. I74 See Richmond, supra note 166, at 207.
202. l?5 Section 402A states: Special Liability of Seller of Product for Physical Harm to User or Consumer (1) One who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer, or to his property, if (a) the seller is engaged in the business of selling such a product, and (b) it is expected to and does reach the user or consumer without substantial change in the condition in which it is sold. (2) The rule stated in Subsection (1) applies although (a) the seller has exercised all possible care in the preparation and sale of his product, and (b) the user or consumer has not bought the product from or entered into any contractual relation with the seller. RESTATEMENT (SECOND) OF TORTS (1965).
203. 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).
204. See Chapman, 388 N.E.2d at 545 (noting that comment k is particularly relevant in determining whether marketing oral contraceptives is justified); Castrignano, 546 A.2d at 780 (adopting comment k as applied to.defective design).
205. Comment k states: 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.
206. RESTATEMENT (SECOND) OF TORTS §402A cmt. k.
207. In Carlin v. Superior Court, the Supreme Court of California expressly affirmed its landmark 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 doctrine. ... [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 justifies an exception from strict liability by focusing on the product and its relative value to society, rather than on the manufacturer's position in the stream of commerce.... The alternative would be that a product, essential to sustain the life of some individuals, would not be available-thus resulting in a greater harm to the individual than that risked through use of the product.
208. Rogers, 802 P.2d at 1351.
209. See Chapman, 388 N.E.2d at 549. Section 388 provides: One who supplies directly or through a third person a chattel for another to use is subject to liability to those whom the supplier should expect to use the chattel with the consent of the other or to be endangered by its probable use, for physical harm caused by the use of the chattel in the manner for which and by a person for whose use it is supplied, if the supplier (a) knows or has reason to know that the chattel is or is likely to be dangerous for the use for which it is supplied, and (b) has no reason to believe that those for whose use the chattel is supplied will realize its dangerous condition, and (c) fails to exercise reasonable care to inform them of its dangerous condition or of the facts which make it likely to be dangerous. RESTATEMENT (SECOND) OF TORTS §388 (1965).
210. See Sterling Drug, Inc. v. Yarrow, 408 F.2d 978, 993 (8th Cir. 1969).
211. See Richmond, supra note 166, at 206.
212. See Carlin, 920 P.2d at 1348.
213. 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 prescription 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.
214. 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).
215. 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).
216. See Richmond, supra note 166, at 209.
217. See id.
218. 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 ofthat 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.
219. 19 See U.C.C. §2-315 which provides: Where the seller at the time of contracting has reason to know any particular purpose for which goods are required and that the buyer is relying on the seller's skill or judgment to select or furnish suitable goods, there is ... an implied warranty that the goods shall be fit for such purpose. U.C.C. §2-315.
220. 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).
221. See Griggs, 456 So. 2d at 792.
222. Id.
223. Id. at 793.
224. See Grundberg v. Upjohn Co., 813 P.2d 89, 89 (Utah 1991).
225. [A] warranty that the goods shall be merchantable is implied in a contract for their sale ...." U.C.C. §2-314(1) (emphasis added).
226. See id. cmt. 7.
227. Id.
228. Id.
229. This warranty may be exactly what is needed where an otherwise safe and effective substance is improperly manufactured. However, this Note focuses on those situations where a genotech drug is produced according to the manufacturer's specifications, yet causes harm simply because it is an unsafe substance.
230. See U.C.C. § 2-314 (2)(b).
231. Id. §2-314(2)(c).
232. 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 cmt. 8.
233. U.C.C. §2-315cmt. 2.
234. See id. §2-315.
235. Because the PDA must preapprove all prescription drugs before they may be sold, and because the PDA 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.
236. Once in the marketplace, the courts are not in a position to second-guess the PDA's approval decision. See Jacobs v. Dista Prods., 693 F. Supp. 1029, 1035 (D. Wyo. 1988).
237. See Gottsdanker v. Cutter Lab., 6 Cal. Rptr. 320, 323 (Cal. Dist. Ct. App. 1960). In some instances, the PDA 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).
238. See Gottsdanker, 6 Cal. Rptr. at 323.
239. See Richmond, supra note 166, at 218.
240. 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 negligence theory for drug injuries).
241. See Spragtte, 1995 WL 376934, at4; 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).
242. See Sprague, 1995 WL 376934, at *3.
243. See Richmond, supra note 166, at 212.
244. 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 exception to the learned intermediary doctrine for oral contraceptives).
245. 2'6 See Kirk v. Michael Reese Hosp. & Med. Ctr., 513 N.E.2d 387, 392-93 (III. 1987).
246. 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.
247. See MacDonald, 475 N.E.2d at 68-69.
248. 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).
249. Carter v. Yardley & Co., 64 N.E.2d 693, 697 (Mass. 1946).
250. See, e.g., MacDonald, 475 N.E.2d at 68 (citations omitted).
251. See id; see also Wagner v. Roche Lab., 671 N.E.2d 252, 256 (Ohio 1996).
252. See Shanks, 835 P.2d at 1195 n.6.
253. 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.
254. See 142 CONG. REC. S3203 (daily ed. Mar. 29, 1996) (statement of Sen. Kennedy). Consider the following statement Sen. Kennedy made: [T]oday when Americans get up in the morning and brush their teeth, they do not think about whether the toothpaste they are using is safe. When they eat their breakfast they do not think about the safety of the food they are eating. When they take a pill to treat an illness they do not worry about whether those drugs work. Americans have confidence in all of these products because the Food and Drug Administration is an independent agency with enormous credibility. Id.
255. Although the PDA 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. lolab Corp., 927 S.W.2d848, 851 (Mo. 1996).
256. See supra note 224 and accompanying text.
257. 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 (Tcx. App. June 20, 1996).
258. 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.
259. See FED. R. EVID. 702.
260. see Frye v. United States, 293 F. 1013, 1014 (D.C. Cir. 1923). "When the question involved 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.
261. See Id.
262. see Id.
263. See Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 585-95 (1993); see also ERIC GREEN & CHARLES NESSON, PROBLEMS, CASES, AND MATERIALS ON EVIDENCE 649 (1983) (stating the Frye test was the "original and most widely used standard for the admissibility of expert testimony 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, 293V. at 1014.
264. 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 children'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 defendant's experts showed that Bendictin was safe, while plaintiffs' experts demonstrated that Bendictin was teratogenic. See id.
265. Comment k assumes that "[fjhere are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use." RESTATEMENT (SECOND) OF TORTS §402A cmt. k (1965). However, in our world, nothing is completely 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.
266. See, e.g., Daubert, 509 U.S. at 583-84.
267. 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.
268. See FED. R. EVID. 402. "Relevance is not an inherent characteristic of any piece of evidence, 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.
269. See FED. R. EviD. 401 advisory committee's note.
270. See FED. R. EVID. 702.
271. See id.
272. 2 See Daubert, 509 U.S. at 589.
273. See id at 589-90.
274. 2 See id. at 590.
275. See id.
276. 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 PDA 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).
277. See Dauberl, 509 U.S. at 593.
278. See generally Michael D. Green, Expert Witnesses and Sufficiency of Evidence in Toxic Substances Litigation: The Legacy of Agent Orange and Bendectin Litigation, 86 Nw. U. L. REV. 643, 645, 694-95 (1992) ("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").
279. See Daubert, 509 U.S. at 593.
280. See id.
281. See id.
282. See id.
283. 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 evi-dence necessary is the same evidence that the manufacturer presented to the PDA when the manufacturer tried to gain approval for its drug. The manufacturer also must produce any follow-up studies performed on the drug.
284. This is similar to the inquiry the PDA makes, but it does not displace the PDA's determination 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, at2 (D. Mass. May 10, 1994) (stating that it is the primary function of the PDA 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 disclosure 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.
285. See supra note 115 and accompanying text.
286. -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 physician 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 relative merits of such claims are therefore outside the scope of this Note.
287. Medtronic, Inc. v. Lohr, 116 S. Ct. 2240, 2255 (1996).