I thank attendees of the 2005 Health Law Teachers Conference of the American Association of Law, Medicine, and Ethics and members of the Quinnipiac law faculty for comments on earlier drafts. I also thank my colleague Susan Nial for asking me each morning, “So, is it done, yet?” And, I especially wish to thank symposium editor Wendy Chan for being understanding in granting me extension after extension as I sought to tell a story that was still unfolding in the newspaper headlines each morning.

1 Merck Marketing Memo, Merck in-house document (advising sales representatives to “dodge” safety questions posed by physicians) (on file with author) [hereinafter Merck in-house document].

2 Rita Rubin, How Did Vioxx Debacle Happen?, USA TODAY, Oct. 12, 2004, at 1D.

3 Merck, Merck Clarifies Number of Patients and Prescriptions for VIOXX, Oct. 1, 2004, http://www.merck.com/newsroom/press_releases/corporate/2004_1001.html.

4 Id.

5 Associated Press, Judge calls Vioxx Mistrial. Jury Unable to Reach Unanimous Decision in Fed's Case Alleging Drug Company Was Liable in Man's Death, NEWSDAY, Dec. 13, 2005, at A26.

6 See Rubin, supra note 2.

7 See generally Bombardier, C. et al., Comparison of Upper Gastrointestinal Toxicity of Refecoxib and Naproxen in Patients with Rheumatoid Arthritis, 343 NEW ENG. J. MED. 1520 (2000)CrossRefGoogle ScholarPubMed [hereinafter VIGOR study].

8 See Rubin, supra note 2.

9 See Merck in-house document, supra note 1.

10 See Rubin, supra note 2 .

11 Id.

12 Alex Berenson, Merck Says It Will Soon Disclose Plans for Restructuring, N.Y. TIMES, Nov. 28, 2005, at A16.

13 James Doran, Merck to Cut 10% of Its Workforce, TIMES (U.K.), Nov. 29, 2005, at 47.

14 Alex Berenson, Chief Executive Quits at Merck; Insider Steps Up, N.Y. TIMES, May 6, 2005, at C1 ( “For [former CEO] Mr. Gilmartin, yesterday's [retirement] announcement ends years of failure. … The biggest blow to the company came in September, when Mr. Gilmartin announced that Merck would stop selling Vioxx.”).

15 Ransdell Pierson, Medical Journal Says Merck Deleted Vioxx Dangers, REUTERS, Dec. 9, 2005, available at http://www.vascularweb.org/_CONTRIBUTION_PAGES/Patient_Information/Medical_News_Reuters/Medical_journal_says_Merck_deleted_Vioxx_dangers.html.

16 See Doran, supra note 13.

17 Alex Berenson, A Mistrial is Declared in 3rd Suit Over Vioxx, N.Y. TIMES, Dec. 13, 2005, at C1.

18 Michael Orey, Presto: A New VIOXX Liability Estimate! Why Analysts’ Reports Shift Wildly With Every Twist in Litigation Against Merck, BUS. WK., Dec. 5, 2005, at 40.

19 See Linda A. Johnson, Surge in Vioxx Suits Leaves Merck Facing More Than 6,000 Cases, and Total to Grow, NEW JERSEY RECORD, Oct. 14, 2005 (“[T]he number of Vioxx lawsuits is rising like floodwater. More than 1,000 new Vioxx cases have been filed in New Jersey alone since late August, including 800 in September. [Lawyers expect to see between 10,000 and 15,000 new cases filed in New Jersey through next September].”).

20 Associated Press, Vioxx Case Leads to Hung Jury; Retrial Planned in 2001 Death, WASH. POST, Dec. 13, 2005, at A10 [hereinafter Vioxx Case leads to Hung Jury].

21 Curfman, Gregory D., Morrissey, Stephen, & Drazen, Jeffrey M., Expression of Concern: Bombardier et al., “Comparison of Upper Gastrointestinal Toxicity of Rofecoxib and Naproxen in Patients with Rheumatoid Arthritis,” 353 NEW ENG. J. MED. 26 (2005)Google Scholar. See also Associated Press, Vioxx Editorial May Bolster Merck Suits, N.Y. Times, Dec. 12, 2005.

22 Curfman et al., supra note 21, at 26.

23 Vioxx Case Leads to Hung Jury, supra note 20.

24 Id. “This respected journal issuing a critique of Merck's behavior is especially important to a jury who now sees Merck as a company that doctors studies.” Id.

25 See Alice Park, Was Vioxx Really that Dangerous?, TIME, Feb. 2, 2005, at 52.

26 Id.

27 Id.

28 Id.

29 Id.

30 Id.

31 Id.

32 See Editorial, What We Can Learn from the Vioxx Case, GLOBE & MAIL, Oct. 11, 2004, at A12 [hereinafter What We Can Learn].

33 See Park, supra note 25.

34 Id.

35 Id.

36 Id.

37 What We Can Learn, supra note 32.

38 Anna Mathews & Barbara Martinez, Warning Signs: E-Mails Suggest Merck Knew Vioxx's Dangers at Early Stage, WALL ST. J., Nov. 1, 2004, at A1.

39 Id.

40 Id.

41 Id.

42 See VIGOR study, supra note 7.

43 See Mathews & Martinez, supra note 38.

44 Richard Stewart, FDA Warning Focus in Day 1 of Vioxx Trial, HOUSTON CHRON., July 19, 2005, at B1.

45 PowerPoint slide presented at May 2000 meeting of Merck research and marketing executives (On file with author).

46 See Stewart, supra note 44.

47 Reproduced in the text, supra note 1.

48 Mathews & Martinez,, supra note 38.

49 Id.

50 Stephanie Saul, Pfizer to Finance $100 Million Safety Study of Celebrex, N.Y. TIMES, Dec. 14, 2005, at C3.

51 Mathews & Martinez,, supra note 38.

52 Id.

53 Id. (quoting Daniel Solomon, Assistant Professor of Medicine, Harvard Medical School, lead author on the Circulation study).

54 Merck: Officials Ignored Conclusion about Death in Vioxx Trial, 10 AM. HEALTH LINE (The Advisory Board Company, Washington, D.C.) April 25, 2005Google Scholar. In a May 1, 2005 letter to New York Times editor, Kenneth C. Frazier, Merck's Senior V.P. and General Counsel, questioned the import of selected, internal email messages “Internal discussions plucked from selected e-mail messages provided by ‘a person working with plaintiffs’ involved in lawsuits against Merck should in no way detract from the fact that the F.D.A. analyzed the relevant information in its decision on the Vioxx label. Merck's actions were diligent and responsible.” Kenneth C. Frazier, Letter to the Editor, N.Y.TIMES, May 1, 2005, at D13.

55 Merck: Officials Ignored Conclusion,, supra note 54.

56 Alex Berenson, Evidence in Vioxx Suits Shows Intervention by Merck Officials, N.Y. TIMES, Apr. 25, 2005, at A1.

57 Id.

58 See id.

59 See id.; Lisse, Jeffrey R. et al., Gastrointestinal Tolerability and Effectiveness of Rofecoxib Versus Naproxen in the Treatment of Osteoarthritis - A Randomized, Controlled Trial, 139 ANN. INTERN. MED. 539 (2003)CrossRefGoogle Scholar.

60 Evidence in Vioxx Suits Shows Intervention, supra note 56. This is not a particularly unusual occurrence in the world of pharmaceutical publishing. Consider, for example, Elliott, Carl, Pharma Goes to the Laundry: Public Relations and the Business of Medical Education, 34 HASTINGS CENTER REPORT 18 (2004)CrossRefGoogle ScholarPubMed. He reports fees being paid by pharmaceutical companies to academic ghost writers ($1,000 to $1,500 for ghost written article on Ritalin (Novartis), $10,000 for single letter about second hand smoke (tobacco industry), and $300,000 to write textbook on epilepsy (Warner Lambert)). In addition, he observes that pharmaceutical industry-written papers place in more prestigious journals than do papers written without industry support. Industry-supported papers also depict the pharmaceutical more positively.

61 VIGOR Study, supra note 7 (reporting percentages); Expression of Concern, supra note 21 at Table 1 (reproducing Merck's numbers).

62 Expression of Concern, supra note 21.

63 Id.

64 See id; Diedtra Henderson, Vioxx Lawsuit Ends in Mistrial. Jurors Deadlocked, but 6 of 9 Would Have Found for Widow, BOSTON GLOBE, Dec. 13, 2005, at B1.

65 John P. Swann, History of the FDA, http://www.fda.gov/oc/history/historyoffda/default.htm (last visited Apr. 18, 2006).

66 Id.

67 Id.

68 Id.

69 Pub. L. No. 59-384, 34 Stat. 768 (1906) (repealed 1938).

70 See id.

71 See id.

72 See, e.g., Carol Ballentine, Taste of Raspberries, Taste of Death: The 1937 Elixir Sulfanilamide Incident, FDA CONSUMER (June 1981), available at http://www.fda.gov/oc/history/elixir.html.

73 See id.

74 Milestones in U.S. Food and Drug Law History, http://www.fda.gov/opacom/backgrounders/miles.html (last modified Aug. 2005) [hereinafter FDA Milestones].

75 See id.

76 21 USC. §§ 301-392 (2005)

77 See id.

78 Pub. L. No. 87-781, 76 Stat. 780 (1962) (codified as amended in scattered sections of 21 USC. (2005)).

79 See Merrill, Richard A., The Architecture of Government Regulation of Medical Products, 82 VA. L. REV. 1753, 1764-68 (1996)CrossRefGoogle Scholar (discussing the FDA's new role in assessing the effectiveness of pharmaceuticals). Utilizing its own regulatory authority, on at least two occasions, the FDA enlarged its regulatory oversight. In 1970, it required patient package insert to be included with oral contraceptives. In 1980, it expanded that requirement to all prescription drugs. FDA Milestones, supra note 74.

80 21 U.S.C. § 379(g)-(h) (2005).

81 See, e.g., Zelenay, James L. Jr., The Prescription Drug User Fee Act: Is a Faster Food and Drug Administration Always a Better Food and Drug Administration?, 60 FOOD & DRUG L.J. 261, 289-94 (2005)Google ScholarPubMed (discussing the available data).

82 See id. at 262. “[U]nder PDUFA, … industry's fees pay for over half of FDA's review staff and for over fourteen percent of FDA's total budget. This presents a profound conflict of interest concern.” Id. (footnote omitted).

83 FDA, Merck and Vioxx: Putting Patient Safety First?: Hearing Before the Senate Comm. on Finance, 108th Cong. (2004) (statement of David J. Graham, M.D., M.P.H., Associate Director for Science and Medicine, FDA Office of Drug Safety), available at http://finance.senate.gov/hearings/testimony/2004test/111804dgtest.pdf.

84 See id.

85 Quality & Cost Vioxx: FDA Dismissed Internal Safety Warnings, AM. HEALTH LINE, Oct. 8, 2004.

86 Id.

87 Id.

88 FDA, Merck and Vioxx: Putting Patient Safety First?, supra note 83.

89 See Gardiner Harris & Alex Berenson, 10 Voters on Panel Backing Pain Pills Had Industry Ties, N.Y. TIMES, Feb. 25, 2005, at A1.

90 Id.

91 Id. “If the 10 advisers had not cast their votes, the committee would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx should not return to the market. The 10 advisers with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx's return.” Id.

92 Ted Agres, Drug Safety Reshaping FDA Monolith, DRUG DISCOVERY & DEV., Apr. 1, 2005, at 16 (quoting Jeff Trewhitt, spokesman for the Pharmaceutical Research and Manufacturers of America (PhRMA)).

93 Richard Horton, Editorial, Vioxx, The implosion of Merck, and Aftershocks at the FDA, LANCET, Dec. 4, 2004.

94 See Orzack, Louis H., Kaitin, Kenneth I. & Lasagna, Louis, Pharmaceutical Regulation in the European Community: Barriers to Single Market Integration, 17 J. HEALTH POL. POL'Y & L. 847, 851 (1992)CrossRefGoogle ScholarPubMed.

95 Orzack et al., supra note 94, at 851

96 Id..

97 Id. at 854.

98 The Maastricht Treaty, which became effective on November 1, 1993, created the “European Union.” Kingham, Richard F., Bogaert, Peter W.L. & Eddy, Pamela, The New European Medicines Agency, 49 FOOD & DRUG L.J. 301, 301 (1994)Google Scholar (citing, TREATY ON EUROPEAN UNION TOGETHER WITH THE COMPLETE TEXT OF THE TREATY ESTABLISHING THE EUROPEAN COMMUNITY , 1992 O.J. (No. C 224) 1 and the FINAL ACT AND DECLARATIONS ADOPTED BY THE INTERGOVERNMENTAL CONFERENCES IN MAASTRICHT, 1992 O.J. (No. C 191) 1, 95, 109 (Feb. 7, 1992)).

99 See Kidd, Dan, The International Conference on Harmonization of Pharmaceutical Regulations, The European Medicines Evaluation Agency, and The FDA: Who's Zooming Who?, 4 IND. J. GLOBAL LEG. STUD. 183, 188 n.39 (1996)Google Scholar (citing Council Directive 65/65 EEC of Jan. 26, 1965).

100 Eakin, David V., The International Conference on Harmonization of Pharmaceutical Regulations: Progress or Stagnation?, 6 TULSA J. COMP. & INT'L L. 221, 224 (1999)Google Scholar.

101 Id.

102 Id.

103 Id.

104 Kidd, supra note 99, at 190.

105 See Eakin, supra note 100, at 225.

106 Molzon, Justina A., The International Conference on Harmonization Common Technical— Global Submission Format?, 60 FOOD & DRUG L.J. 447, 447 (2005)Google ScholarPubMed.

107 Kingham et al., supra note 99, at 301-304.

108 Id.

109 See Matthews, Duncan & Wilson, Caroline, Pharmaceutical Regulation in the Single European Market, 17 MED. & L. 401, 410 (1998)Google ScholarPubMed.

110 Id.

111 Id.

112 See id. “Medicinal products from new biotechnology processes, defined in the Annex to Directive 87/22/EEC were included as “List A” products. Medicinal products of high technology, also defined in the Annex to Directive 87/22/EEC, were eligible to be considered “List B” products and could be accepted for consideration under the concertation procedure. The concertation procedure was therefore obligatory for the authorisation of medicinal products derived from biotechnology (List A) or at the choice of the applicant for high technology products (List B). The innovative nature of medicinal products using the concertation procedure also meant that improvements to the quality of the product were a frequent source of variations and led to amendments to the originally authorised product.” Id. For a very simple presentation of the regulatory framework, see generally EUROPEAN COMMISSION, PHARMACEUTICALS IN THE EURPOEAN UNION (2000), http://pharmacos.eudra.org/F2/pharmacos/docs/brochure/pharmaeu.pdf.

113 See generally Matthews & Wilson, supra note 109.

114 See generally Kingham et al., supra note 98, at 313.

115 Id.

116 See id.

117 VFA (GERMAN ASS’N OF RESEARCH-BASED PHARMACEUTICAL COS.), STATISTICS 2005: THE PHARMACEUTICAL INDUSTRY IN GERMANY (2005), http://www.vfa.de/download/en/vfa_en/publikationen_en/e_statistics/e_statistics_2005.pdf.

118 VFA, supra note 117, at 41. Japan accounts for eleven percent of the remainder and other, smaller markets fill out the remaining thirteen percent. Id

119 Id.

120 Id.

121 MARCIA ANGELL, THE TRUTH ABOUT THE DRUG COMPANIES: HOW THEY DECEIVE US AND WHAT TO DO ABOUT IT 198 (Random House 2004)Google Scholar.

122 See id.

123 See id. at 200.

124 American Medical Association (AMA) Quotes, http://www.whale.to/vaccine/quotes2.html (last visited Apr. 18, 2006).

125 WHO/Europe – Pharmaceuitcals – Lithuania, http://www.euro.who.int/pharmaceuticals/Topics/Overview/20020416_2 (last updated Nov. 2004).

126 European Association of Hospital Pharmacists, http://www.eahponline.org/asp/about.asp?m=3&s=1 (last visited Apr. 18, 2006).

127 GOVIN PERMANAND & ELIAS MOSSIALOS, THEORISING THE DEVELOPMENT OF THE EUROPEAN UNION FRAMEWORK FOR PHARMACEUTICAL REGULATION 15 (LSE HEALTH AND SOCIAL CARE, DISCUSSION PAPER NO.13) (2004), http://www.lse.ac.uk/collections/LSEHealthAndSocialCare/pdf/DiscussionPaperSeries/DP13_2004.pdf.

128 See Harris & Berenson, supra note 89.

129 Gardiner Harris, Report Details F.D.A.. Rejection of Next-Day Pill, N.Y. TIMES, Nov. 15, 2005, § A.

130 Id.

131 Id.

132 Gardiner Harris, Official Quits on Pill Delay at the F.D.A., N.Y. TIMES, Sept. 1, 2005, at A12.

133 James Kanter, Free-for-all over generic drugs in Europe Bitter pills / Why Europeans pay what they pay, INT'L HERALD TRIB., Nov. 15, 2005, § Finance, at 3. “The companies that produce branded pharmaceuticals are rich and powerful. They have united with patients seeking access to their drugs and have helped finance groups that lobby for patients’ rights.” Id.

134 Permanand & Mossialos, supra note 127, at 35.

135 Id. at 19.

136 Id. at 38.

137 See supra text accompanying note 1.

138 Matthews & Wilson, supra note 109, at 424.

139 Id.

140 Id.

141 See, e.g., Struve, Catherine T., The FDA and the Tort System: Postmarketing Surveillance, Compensation, and the Role of Litigation, YALE J. HEALTH POL'Y L. & ETHICS 587 (2005)Google ScholarPubMed (discussing the FDA's various enforcement powers).

142 See supra text accompanying notes 108-114.

143 Permanand & Massiolos, supra note 127, at 23.

144 See id.

145 Id. at 23-24.

146 See supra text accompanying note 129.

147 U.S. Food & Drug Admin. FDA's Mission Statement, http://www.fda.gov/opacom/morechoices/mission.html (last visited February 27, 2006).

148 Permanand & Massiolos, supra note 127, at 4.

149 Orzack, Kaitin & Lasagna, supra note 94, at 863.

150 See discussion supra Part V.

151 Philip Gailey, Can't Take the Politics out of Elections, Even for Judges, ST. PETERSBURG TIMES, August 18, 2002 (quoting a “Georgia legislator”), available at http://www.sptimes.com/2002/08/18/Columns/Can_t_take_the_politi.shtml.

152 See discussion supra pp. 10-11.

153 Senators Chuck Grassley (Republican, Iowa) and Chris Dodd (Democrat, Conn.). S. 930, to Amend the Federal Food, Drug, and Cosmetic Act with Respect to Drug Safety, and for Other Purposes, 109th CONGRESS, 1st Session.

154 Id.