Marketing pharmaceutical products in the twenty-first century: AN analysis of the continued viability of traditional principles of law in the age of direct-to-consumer advertising

Harvard Journal of Law and Public Policy

Volumn 32, Issue 1, 2009, Pages 333-388

  Schwartz, Victor E ^a   Silverman, Cary ^b   Hulka, Michael J ^c   Appel, Christopher E ^a  

^a Public Policy Group   (United States)

^b Shook Hardy and Bacon LLP   (United States)

^c ELI LILLY AND COMPANY   (United States)

Author keywords

[No Author keywords available]

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EID: 64249109559     PISSN: 01934872     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (413)

1. Julie M. Donohue et al., A Decade of Direct-to-Consumer Advertising of Prescription Drugs, 357 NEW ENG. J. MED. 673, 673, 676 (2007).
2. id.
3. See id. at 675-77 (finding that only 14% of total industry expenditures on pharmaceutical promotion were devoted to DTC advertising in 2005).
4. U.S. GEN. ACCOUNTING OFFICE, GAO-07-54, PRESCRIPTION DRUGS: IMPROVEMENTS NEEDED IN FDA'S OVERSIGHT OF DIRECT-TO-CONSUMER ADVERTISING 13 (2006) [hereinafter 2006 GAO REPORT]. Manufacturer spending on DTC advertising also pales in comparison to industry spending on research and development, with $31.4 billion spent in 2005.
5. Id.
6. Donohue, supra note 1, at 676 (finding that the twenty drugs with the highest DTC spending made up 54.4% of total industry spending on DTC advertising).
7. See, e.g., infra Part III.C (discussing the preemption debate for DTC-advertised drugs).
8. See Michael S. Wilkes et al., Direct-To-Consumer Prescription Drug Advertising: Trends, Impact, and Implications, 19 HEALTH AFF. 110, 112 (2000).
9. See UPTON SINCLAIR, THE JUNGLE (1906).
10. Pure Food and Drugs Act of 1906, Pub. L. No. 59-384, 34 Stat 768, repealed by the Federal Food, Drug, and Cosmetic Act of 1938, Pub. L. No. 75-717, 52 Stat. 1040 (codified as amended at 21 U.S.C. §§301-399 (2000));
11. see also U.S. Food & Drug Admin., Milestones in U.S. Food and Drug Law History, FDA BACKGROUNDER, May 3, 1999, http://www.fda.gov/opacom/backgrounders/miles.html (citing, in addition to reaction to The Jungle, public unrest over "the use of poisonous preservatives and dyes in foods, and cure-all claims for worthless and dangerous patent medicines" as the "major problems leading to the enactment of the 1906 Act and the Meat Inspection Act).
12. See Francis B. Palumbo & C. Daniel Mullins, The Development of Direct-to-Consumer Prescription Drug Advertising Regulation, 57 FOOD & DRUG L.J. 423, 424-25 & n.12 (2002) (noting the portion of the 1906 Act stating that a drug would be deemed misbranded if '"its package or label shall bear or contain any statement, design, or device regarding the curative or therapeutic effect of such article . . . which is false or fraudulent"' (quoting the Pure Food and Drugs Act §8, 34 Stat, at 770)).
13. See id. at 425 & n.12.
14. See 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.
15. See id.
16. See id.
17. See, e.g., Pankaj Hari et al., Fatal Encephalopathy and Renal Failure Caused by Diethylene Glycol Poisoning, 56 J. TROPICAL PEDIATRICS 442 (2006).
18. See Ballentine, supra note 12.
19. See id.
20. See David F. Cavers, The Food, Drug, and Cosmetic Act of 1938: Its Legislative History and Its Substantive Provisions, 6 LAW & CONTEMP. PROBS. 2, 20 (1939),
21. reprinted in PETER BARTON HUTT ET AL., FOOD AND DRUG LAW, CASES AND MATERIALS 577, 577-78 (3d ed. 2007).
22. See Ballentine, supra note 12.
23. See id.
24. Federal Food, Drug, and Cosmetic Act of 1938, Pub. L. No. 75-717, 52 Stat. 1040 (codified as amended at 21 U.S.C. §§301-399 (2000)).
25. HUTT ET AL., supra note 18, at 577.
26. See id.
27. See id. at 578.
28. See Palumbo & Mullins, supra note 10, at 426.
29. Federal Trade Commission Act, Pub. L. No. 63-203, 38 Stat. 717 (1914) (codified as amended at 15 U.S.C. §§41-58 (2000)) (establishing the FTC).
30. See Palumbo & Mullins, supra note 10, at 425 & n.14 (citing FTC v. Raladam Co., 283 U.S. 643 (1931)).
31. See id. at 425 n.18 (quoting S. 1944, 73d Cong. §9(c) (1933)).
32. Id.
33. See id. at 426.
34. 31.1962 Kefauver-Harris Drag Amendments, Pub. L. No. 87-781, 76 Stat. 780 (1962) (codified as amended at 21 U.S.C. §352(n) (2000));
35. see also 15 U.S.C. §§45, 52 (2000); 21 U.S.C. §352(n) (2000) (removing any "advertisement of a prescription drug, published after the effective date of regulations issued under this paragraph applicable to advertisements of prescription drags," from the purview of the provisions of 15 U.S.C. §§52-57); 21 U.S.C. §393(b)(1) (2000) ("The [FDA] shall... promote the public health by ... taking appropriate action on the marketing of regulated products in a timely manner.").
36. See Palumbo & Mullins, supra note 10, at 427 n.29 ("There is a marked difference in the advertising and promotion of proprietary and ethical drags. Proprietary drugs-those sold over the drugstore counter-are like most other products in that sales pressures are exerted upon the final consumer who is subjected to an intensive barrage of advertisements for brand name products in newspapers, magazines, radio, and television. In the case of ethical drugs-those sold under prescription-the brunt of promotion effort is directed to the prescribing physician. Since his prescription dictates the particular drag to be used, usually the brand name, the physician is the focal center of advertising and promotional pressures." (citing S. Rep. No. 87-448, at 115 et seq. (1961))).
37. See Memorandum of Understanding Between FTC and the FDA, 36 Fed. Reg. 18,539 (Sept. 15,1971) (providing most recent agreement).
38. The FDCA's treatment of prescription drag advertising is quite brief. It requires only that the advertisement include the drug's name and formula, and a brief summary describing the drag's effectiveness and its safety risks .
39. See Palumbo & Mullins, supra note 10, at 428 (citing 21 U.S.C. §352(n) (2002)). Shortly after the 1962 Drug Amendments' passage, the FDA implemented its original drag-advertising regulations.
40. See HUTT ET AL., supra note 18, at 535 (citing 28 Fed. Reg. 1448 (Feb. 14,1963), 28 Fed. Reg. 6375 (June 20,1963), 28 Fed. Reg. 9837 (Sept. 10, 1963), 28 Fed. Reg. 10993 (Oct. 15, 1963), 29 Fed. Reg. 257 (Jan. I0,1964)). The FDA further revised those regulations later that same decade.
41. See id.
42. 21 C.F.R. §202.1(e) (1979).
43. 21 C.F.R. §202.1(e)(5)(ii) (1979).
44. See HUTT ET AL., supra note 18, at 578.
45. See id. at 579.
46. Section 505(d) of the FDCA requires "the FDA to withhold approval unless the sponsor's NDA shows the drug to be safe 'by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions of use prescribed, recommended, or suggested' in the proposed labeling."
47. Id. at 685.
48. Section 505(d) of the FDCA requires the FDA to withhold approval unless the sponsor's NDA provides "'substantial evidence that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling.'"
49. Id. at 579. Section 505(e) requires the FDA to "withdraw approval of any drug after notice and opportunity for hearing if he finds that 'on the basis of new information before him' substantial evidence of efficacy is lacking."
50. Id.
51. See 21 U.S.C. §355(d)-(e) (2000). Specifically, an NDA must summarize the general understanding of the application, the drug type, and the rationale for approval, as well as a description of the drug's chemistry, its manufacturing practices, and its quality controls.
52. See 21 C.F.R. §314.50(c)-(d) (2000). It must contain pre-clinical data (that is, the results of animal and in vitro studies) regarding the product's pharmacology and toxicology, and that data must be accompanied by a statement of compliance with good laboratory practices.
53. See id. The NDA must describe the drug's pharmacokinetics and bioavailability (that is, how the drug is expected to react in the human system).
54. See id. It must contain a wealth of clinical data from Phase I, n, and in clinical trials on humans. That data must also be accompanied by an integrated summary of the products effectiveness and safety profile, along with full disclosure of the study results. Finally, the NDA must include both a sample of the product and the products labeling.
55. See 21 C.F.R. §314.50(e) (2000).
56. See HUTT ET AL., supra note 18, at 688. The process from the discovery of a molecule's treatment potential to its submission in an NDA is laborious, long, and expensive.
57. On average, for 10,000 drugs identified as having treatment potential and therefore submitted to laboratory and animal testing, only one might make it through Phase I, D, and HI clinical testing on humans and become the subject of an NDA.
58. See PhRMA, Innovation (2008), http://www.phrma.org/innovation. The Tufts Center for the Study of Drug Development, for example, calculated that the average cost of bringing a new drug to market in 2001 was $802,000,000.
59. See Joseph A. Di-Masi et al., The Price of Innovation: New Estimates of Drug Development Costs, 22 J. HEALTH ECON. 151, 166 (2003) (presenting study by Tufts Center for the Study of Drug Development). In a 2006 study, the Center for the Study of Drug Development pegged the average cost of developing a new biotechnology drug at $1,200,000,000.
60. See TUFTS CENTER FOR THE STUDY OF DRUG DEVELOPMENT, OUTLOOK 2008, at 2 (2008), available at http://csdd.tufts.edu/InfoServices/OutlookReports.asp.
61. 21 U.S.C. §355(b) (2000). CDER examines six components of the NDA: medical, biopharmaceutical, pharmacological, statistical, chemical, and microbiological. Medical reviewers are responsible for evaluating the clinical sections of submissions and therefore take the lead role in NDA review.
62. See CTR. FOR DRUG EVALUATION & RESEARCH, FOOD & DRUG ADMIN., CDER HANDBOOK 15-19 (1998), available at http://www.fda.gov/cder/ handbook/index.htm [hereinafter CDER HANDBOOK]. CDER may also host Advisory Committee meetings at this stage to obtain outside advice and opinions from experts.
63. See id. at 11.
64. See 21 U.S.C. §352 (2000);
65. C.F.R. §201.56 (2008) (general requirements for prescription drug labeling).
66. See 21 C.F.R. § 201.56 (2008).
67. See 21 C.F.R. § 201.57(a)(6)-(8), (c)(4) (2008).
68. See 21 C.F.R. §201.57(a)(9), (c)(5) (2008) (requiring a description of situations in which the drug should not be used because the risk of use clearly outweighs any possible benefit).
69. See 21 C.F.R. §201.57(a)(10), (c)(6) (2008) (requiring a description of any serious adverse reactions and potential safety hazards, subsequent limitation in use, and steps that should be taken if they occur).
70. See 21 C.F.R. §201.57(a)(10), (c)(6), (c)(8) (2008) (requiring a description of any special care to be exercised for the safe and effective use of the drug, including general precautions and information for patients on drug interactions).
71. See 21 C.F.R. §201.57(a)(11), (c)(7) (2008) (requiring a description of any undesirable effects reasonably associated with the proper use of the drug).
72. See Palumbo & Mullins, supra note 10, at 429.
73. 21 C.F.R. §202.1(e)(2)(i) (2008). PhRMA's Guiding Principles urge its members not to engage in this practice.
74. See PHRMA, PHRMA GUIDING PRINCIPLES: DIRECT TO CONSUMER A DVERTISEMENTS ABOUT PRESCRIPTION MEDICINES 4 (2005), http://www.phrma.org/files/DTCGuidingprinciples.pdf (Principle 10: "DTC television advertising that identifies a product by name should clearly state the health conditions for which the medicine is approved and the major risks associated with the medicine being advertised.").
75. See 21 C.F.R. §202.1(e)(2) (2008).
76. Direct-to-Consumer Promotion; Public Hearing, 60 Fed. Reg. 42,581, 42,582 (Aug. 16, 1995).
77. See 21 C.F.R. §202.1(e)(1) (2008).
78. See 21 C.F.R. §202.1(e)(5)-(6) (2008) (listing ways in which drug advertisements fail to satisfy fair balance requirements).
79. See KIM SHEEHAN, CONTROVERSIES IN CONTEMPORARY ADVERTISING 209 (2004).
80. See id. at 210;
81. Palumbo & Mullins, supra note 10, at 424.
82. See SHEEHAN, supra note 57, at 210.
83. Direct-to-Consumer Advertising of Prescription Drugs; Withdrawal of Moratorium, 50 Fed. Reg. 36,677 (Sept. 9, 1985).
84. See SHEEHAN, supra note 57, at 210-11.
85. FOOD & DRUG ADMIN., GUIDANCE FOR INDUSTRY: CONSUMER-DIRECTED BROADCAST ADVERTISEMENTS (August 1999) [hereinafter GUIDANCE], available at http://www.fda.gov/cder/guidance/index. htm.
86. Id. at 1;
87. SHEEHAN, supra note 57, at 211.
88. See 21 CF.R. §202.1(e)(1) (2008).
89. On September 27, 2007, the President signed the Food and Drug Administration Amendment Acts of 2007, imposing a requirement that the major statement be presented in a "clear, conspicuous and neutral manner." FDA Amendment Act of 2007, Pub. L. No. 110-85, §503(B), 121 Stat. 823, 940 (to be codified at 21 U.S.C. §353(b)).
90. GUIDANCE, supra note 62, at 2-3.
91. See Palumbo & Mullins, supra note 10, at 430.
92. On May 8, 2008, Ruth S. Day, Ph.D, testified before the House Committee on Energy and Commerce, Subcommittee on Oversight and Investigations, on the field of "cognitive accessibility," which is the study of what people understand and remember after viewing DTC advertising. Dr. Day recommended that the FDA adopt a formal "evidence-based approach" for analyzing the cognitive accessibility of broadcast DTC advertising.
93. See Direct-to-Consumer Drug Ads: What do People Understand and Remember: Hearing Before Subcomm. on Oversight & Investigations of the H. Comm. on Energy & Commerce, 110th Cong. (2008) (testimony of Ruth S. Day), available at http://energycommerce.house.gov/images/stories/ Documents/Hearings/PDF/Testimony/OI/110-oi-hrg.050808.Day-testimony.pdf.
94. See 21 C.F.R. §312.84(c) (2008) (FDA not approvable for marketing letter);
95. see also Palumbo & Mullins, supra note 10, at 429.
96. See Palumbo & Mullins, supra note 10, at 429.
97. See 21 C.F.R. §314.120(a) (FDA "not approvable letter").
98. See Palumbo & Mullins, supra note 10, at 429. A study by the General Accounting Office (GAO) found that, in a five-year period between August 1997 and August 2002, the FDA issued eighty-eight NOV and warning letters for violative DTC advertising.
99. See U.S. GEN. ACCOUNTING OFFICE, GAO-03-177, PRESCRIPTION DRUGS: FDA OVERSIGHT OF DIRECT-TO-CONSUMER ADVERTISING HAS LIMITATIONS 18 (2002) [hereinafter 2002 GAO REPORT].
100. See 2002 GAO REPORT, supra note 71, at 21.
101. FDA Amendments Act of 2007, Pub. L. No. 110-85, §901,121 Stat. 823, 939-42 (to be codified at 21 U.S.C. §353b).
102. The FDAAA provides the FDA with authority to mandate submission of television advertisements not later than forty-five days prior to broadcast.
103. Id. at 939-43.
104. See 21 C.F.R. §202.1(j) (2008).
105. See 21 C.F.R. §202.1(j)(4) (2008).
106. User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products; Request for Notification of Participation and Number of Advertisements for Review, 72 Fed. Reg. 60,677, 60,678 (Oct. 25, 2007) [hereinafter User Fee Notice].
107. PHRMA, PHRMA GUIDING PRINCIPLES: DIRECT TO CONSUMER ADVERTISEMENTS ABOUT PRESCRIPTION MEDICINES 5 (2005), available at http://www.phrma.org/ files/DTCGuidingprinciples.pdf (Principle 8).
108. See, e.g., Eu LILLY & Co., PROVIDING VALUE TO PATIENTS AND SOCIETY: LILLY CORPORATE CITIZENSHIP REPORT 2006-07, at 28-29, available at http://www.lilly.com/pdf/citizenship-report-0607.pdf;
109. GLAXOSMITHKLINE, ANSWERING THE QUESTIONS THAT MATTER: CORPORATE RESPONSIBILITY REPORT 2007, at 64, available at http://www.gsk.com/responsibility/cr-review- 2007/downloads/CR-Report-2007.pdf;
110. MERCK, MERCK'S ALIGNMENT WITH THE "PHRMA GUIDING PRINCIPLES-DIRECT TO CONSUMER ADVERTISEMENTS ABOUT PRESCRIPTION MEDICINE" 3, available at http://www.merck.com/about/ public-policy/docs/mercks-alignment-with-phrma-guiding-principles-final.pdf.
111. See 2002 GAO REPORT, supra note 71, at 21-23.
112. See 2006 GAO REPORT, supra note 4, at 21-27.
113. See id. at 17-19.
114. User Fee Notice, supra note 77, at 60, 678.
115. See FDA Amendments Act of 2007, Pub. L. No. 110-85, §§101-109, 121 Stat. 823, 825-42.
116. See id.
117. See id. §104,121 Stat, at 837-38.
118. User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drugs and Biological Products; Program Will Not Be Implemented, 73 Fed. Reg. 2924 (Jan. 16, 2008).
119. Id. The FDA responded in May 2008 to a GAO recommendation and developed criteria to prioritize its review of promotional material for those products that have the greatest potential to negatively affect the public health. But a GAO representative testified before a congressional subcommittee that the FDA still needed to document its application of that criteria and systematically track its review of voluntarily submitted materials in order to improve oversight U.S. GEN. ACCOUNTING OFFICE, GAO-08-758T, PRESCRIPTION DRUGS: TRENDS IN FDA'S OVERSIGHT OF DIRECT-TO-CONSUMER ADVERTISING 3 (2008).
120. See supra Part I.A.
121. See supra Part I.A.
122. Palumbo & Mullins, supra note 10, at 425 n.18 (quoting S. 1944, 73d Cong. § 9(c) (1933)).
123. See id. at 425-26.
124. See Palumbo & Mullins, supra note 10, at 429.
125. See SHEEHAN, supra note 57, at 210.
126. See id. at 216.
127. A 2007 study in the Journal of Health Communication took issue with the FDA's effectiveness in policing the "fair balance" requirement, finding that the average sixty-second commercial contained less than eight seconds of side-effect information.
128. See Wendy Macias et al., A Wonderful Life or Diarrhea and Dry Mouth? Policy Issues of Direct-to-Consumer Drug Advertising on Television, 22 HEALTH COMM. 241, 247 (2007).
129. See Public Views of Direct-to-Consumer Prescription Drug Advertising: Hearing Before the H. Subcomm. on Oversight & Investigations, Comm. on Energy & Commerce, 110th Cong. 1-7 (2008) (statement of Mollyann Brodie, Vice President and Director, Public Opinion and Media Research, Henry J. Kaiser Family Foundation), available at http://energy commerce.house.gov/cmte- mtgs/110-oi-hrg.050808.DTC.shtml.
130. See Donohue, supra note 1, at 676.
131. See, e.g., id. at 676, 679-80 (noting that violation letters sent by the FDA to manufacturers had fallen from 142 in 1997 to only 21 in 2006, and attributing the decrease to policies and understaffing at the FDA that have weakened the FDA's capacity to enforce these regulations);
132. 2006 GAO REPORT, supra note 4, at 21-27. Reconciling the debate is beyond the scope of this Article, but it deserves mention that such a theory presupposes that transgressions of advertising regulations remain constant in proportion to spending (that is, violations are occurring at the same rate, but are going undetected), which rejects the notion of applied learning from previous experience or the use of DDMACs voluntary pre-market advertising review. It should be noted that, after an initial uptick in 1999 in companies seeking FDA input through launch-campaign advisory letters pursuant to the FDA's pre-market voluntary submission process, FDA advisory letters have remained relatively stable from 2000 to 2005. This fact suggests that the industry continues to seek out the FDA's insight and approval before releasing campaigns to the public.
133. See, e.g., U.S. FOOD & DRUG ADMIN., CDER 2005 REPORT TO THE NATION: IMPROVING PUBLIC HEALTH THROUGH HUMAN DRUGS 45 (2005).
134. See SHEEHAN, supra note 57, at 210;
135. see also Louis A. Morris et al, The Attitudes of Consumers toward Direct Advertising of Prescription Drugs, 101 PUB. HEALTH REP. 82, 87 (1986), cited in Palumbo & Mullins, supra note 10, at 424.
136. See SHEEHAN, supra note 57, at 215.
137. Public Views of Direct-to-Consumer Advertising of Prescription Drugs, supra note 97, at 5,12 fig.7.
138. See SHEEHAN, supra note 57, at 210.
139. See id. Although it continues to support a case-by-case approach, the AMA remains generally skeptical of DTC advertising. In testimony before Congress in May 2008, it recommended additional research into the effect, if any, of DTCadvertising on the doctor-patient relationship. Direct-to-Consumer Advertising: Marketing, Education or Deception?: Hearing Before the H. Subcomm. on Oversight & Investigation of the H. Comm. on Energy & Commerce, 110th Cong. 12 (2008) (statement of Nancy H. Nielson, President Elect, American Medical Association), available at http:// energycornmerce.house.gov/ cmte-mtgs/110-oi-hrg.050808.Nielsen-Testimony .pdf. The AMA additionally recommended a set of guidelines for DTC advertising, including a moratorium on DTC advertising of all newly approved drags until physicians "have been appropriately educated about the drag."
140. Id. at 6-7. The AMA recommends that the length of the moratorium be determined by the FDA in consultation with the manufacturer and be dependent upon numerous factors, including the innovative nature of the drug, the severity of the disease the drug is intended to treat, the availability of alternative therapies, and the intensity and the timeliness of education about the drug for physicians who are likely to prescribe it.
141. See id.
142. SHEEHAN, supra note 57, at 216.
143. KATHRYN J. AIKIN, DIRECT-TO-CONSUMER ADVERTISING OF PRESCRIPTION DRUGS: PHYSICIAN SURVEY PRELIMINARY RESULTS (2003), http://www.fda.gov/ cder/ddmac/globalsummit2003.
144. Id. at 3.
145. See id. at 32, 38.
146. See id. at 34.
147. See id. at 12.
148. Id. at 12-13.
149. Id. at 21.
150. Id. at 22.
151. See RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY §6 (1998) [hereinafter RESTATEMENT (THIRD)].
152. See Reyes v. Wyeth Labs., 498 F.2d 1264, 1276 (5th Cir. 1974) ("Prescription drugs are likely to be complex medicines, esoteric in formula and varied in effect. As a medical expert, the prescribing physician can take into account the propensities of the drug, as well as the susceptibilities of his patient. His is the task of weighing the benefits of any medication against its potential dangers. The choice he makes is an informed one, an individualized medical judgment bottomed on a knowledge of both patient and palliative.");
153. see also In re Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d 230, 266 (E.D.N.Y. 2007) (stating that '"[w]hether the physician in fact reads [the drug manufacturer's] warning or passes its contents along to the recipient of the drug is irrelevant" for purposes of the learned intermediary doctrine (quoting E.R. Squibb & Sons, Inc. v. Farnes, 697 So. 2d 825, 827 (Fla. 1997)));
154. West v. Searle & Co., 806 S.W.2d 608, 613-14 (Ark. 1991) (stating that physicians must make independent judgments as to whether drags are beneficial for their patients).
155. See Diane Schmauder Kane, Annotation, Construction and Application of the Learned-Intermediary Doctrine, 57 A.L.R.5th 1 (1998).
156. See RESTATEMENT (THIRD), supra note 114, §6 cmt. b ("[O][nly-health care professionals are in a position to understand the significance of the risks involved and to assess the relative advantages and disadvantages of a given form of prescription-based therapy.");
157. see also Barbara Pope Flannagan, Products Liability: The Continued Viability of the Learned Intermediary Rule as it Applies to Product Warnings for Prescription Drugs, 20 U. RICH. L. REV. 405, 412 (1986).
158. See Vitanza v. Upjohn Co., 778 A.2d 829, 846 (Conn. 2001) (acknowledging that a physician "is in the best position to convey adequate warnings based upon the highly personal doctor-patient relationship");
159. see also West, 806 S.W.2d at 613 (listing common rationales supporting the doctrine);
160. Terhune v. A.H. Robins Co., 577 P.2d 975, 978 (Wash. 1978) ("The reasons for this rule should be obvious.");
161. David P. Graham & Jeremy C. Vest, Doctors, Drugs, and Duties to Warn, 72 DEF. COUNS. J. 380, 381 (2005) ("The assumptions that underlie the doctrine are that patients rely upon the advice of their physicians, and physicians, in light of their experience and expertise, are in a better position than their patients to evaluate and communicate the manufacturers' warnings directly to the patients.").
162. See Monica Renee Matter, Emerging DTC Advertising of Prescription Drugs and the Learned Intermediary Doctrine, 69 DEF. COUNS. J. 79, 81 (2002) (discussing common rationales favoring the rule).
163. See, e.g., Gravis v. Parke-Davis & Co., 502 S.W.2d 863, 870 (Tex. Civ. App. 1973) ("The entire system of drug distribution in America is set up so as to place the responsibility of distribution and use upon professional people.").
164. See In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 806-09 (E.D. Tex. 2002) (concluding that forty-eight states, the District of Columbia, and Puerto Rico have either applied or recognized the learned intermediary doctrine, and providing chart reflecting the same);
165. Vitanza, 778 A.2d at 838 n.11 (finding that fortyfour other jurisdictions have adopted the learned intermediary doctrine, including lower state courts and federal courts applying state law);
166. Larkin v. Pfizer, Inc., 153 S.W.3d 758, 767 & n.3 (Ky. 2004) (observing that thirty-four states have specifically adopted the learned intermediary doctrine). West Virginia appears to be the only state expressly declining to adopt the learned intermediary doctrine.
167. See State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899, 914 (W. Va. 2007). New Jersey does not apply the learned intermediary doctrine where the prescription drug manufacturer attempts to advertise directly to consumers and the consumer relies on that advertisement.
168. See Perez v. Wyeth Labs., 734 A.2d 1245,1257-58 (N.J. 1999);
169. see also MacDonald v. Ortho Pharm. Corp., 475 N.E.2d 65, 69 (Mass. 1985) (recognizing an exception to the general application of the learned intermediary doctrine for oral contraceptives).
170. Sterling Drug, Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966);
171. see also Hruska v. Parke, Davis & Co., 6 F.2d 536, 538 (8th Cir. 1925) (acknowledging public is "not on an equal footing" with prescription drug manufacturers in terms of knowledge);
172. Marcus v. Specific Pharms., 77 N.Y.S.2d 508, 508-10 (Sup. Ct 1948) (first holding that a manufacturer's duty to warn was fulfilled by informing the physician).
173. See Kane, supra note 116.
174. See, e.g., Beyette v. Ortho Pharm. Corp., 823 F.2d 990, 992 (6th Cir. 1987);
175. Tetuan v. A.H. Robins Co., 738 P.2d 1210, 1227-28 (Kan. 1987);
176. Terhune v. A. H. Robins Co., 577 P.2d 975, 978 (Wash. 1978).
177. See RESTATEMENT (SECOND) OF TORTS §388 cmt n (1965) ("Modern life would be intolerable unless one were permitted to rely to a certain extent on others' doing what they normally do, particularly if it is their duty to do so.").
178. See RESTATEMENT (THIRD), supra note 114, §6 (1998).
179. Id. §6 cmt. e.
180. See, e.g., MISS. CODE §11-1-63(c) (2008);
181. N.C. GEN. STAT. §99B-5(c) (2007);
182. NJ. STAT. §2A:58C4 (2008);
183. OHIO REV. CODE §2307.76 (2008) (codifying the learned intermediary doctrine).
184. See RESTATEMENT (THIRD), supra note 114, §6 cmt. e.
185. Id.
186. See, e.g., Mazur v. Merck & Co., 964 F.2d 1348,1355 (3d Cir. 1992) (applying the "mass immunization exception" to the learned intermediary doctrine in an action brought against the manufacturer of a measles, mumps, and rubella vaccine (MMR H) by the parents of a child who developed a serious neurological disorder after being inoculated);
187. Brazzell v. United States, 788 F.2d 1352,1357-58 (8th Cir. 1986) (swine flu vaccine);
188. Petty v. United States, 740 F.2d 1428,1438-39 (8th Cir. 1984) (same). The most common example of the mass immunization exception has occurred with polio vaccines. See, e.g., Plummer v. Lederle Labs., 819 F.2d 349, 356 (2d Cir. 1987);
189. Givens v. Lederle, 556 F.2d 1341,1345 (5th Cir. 1977);
190. Reyes v. Wyeth Labs., 498 F.2d 1264,1276 (5th Cir. 1974);
191. Davis v. Wyeth Labs., 399 F.2d 121, 131 (9th Cir. 1968);
192. see also Cunningham v. Charles Pfizer & Co., 532 P.2d 1377,1380 (Okla. 1974).
193. See Brooks v. Medtronic, 750 F.2d 1227, 1232 (4th Cir. 1984) ("'[T]he exception established for the [vaccine] cases is quite narrow and highly fact specific.'" (quoting Stanback v. Parke, Davis & Co., 657 F.2d 642, 647 (4th Cir. 1981))).
194. See, e.g., Mazur, 964 F.2d at 1363 (stating that it is not the size of the immunization program that matters but whether the vaccine is administered "without an individualized medical balancing of the risks and benefits of inoculation").
195. Walker v. Merck & Co., 648 F. Supp. 931, 934-35 (M.D. Ga. 1986), aff'd, 831 F.2d 1069 (11th Cir. 1987).
196. See id. at 932.
197. Percival v. Cyanamid Co., 689 F. Supp. 1060, 1061-63 (W.D. Okla. 1987).
198. See id. at 1062.
199. See, e.g., Mazur, 964 F.2d at 1363.
200. See Victor E. Schwartz & Liberty Mahshigian, National Childhood Vaccine Injury Act of 1986: An Ad Hoc Remedy or a Window for the Future?, 48 OHIO ST. L.J. 387, 394 (1987) (discussing the availability of vaccines as one of the public policy reasons underlying Congress's enactment of a no-fault system for compensation of childhood vaccine-related injuries).
201. See, e.g., Odgers v. Ortho Pharm. Corp., 609 F. Supp. 867, 873-75 (E.D. Mich. 1985);
202. Stephens v. G.D. Searle & Co., 602 F. Supp. 379, 380-81 (E.D. Mich. 1985);
203. Lukaszewicz v. Ortho Pharm. Corp., 510 F. Supp. 961, 964-65 (E.D. Wis. 1981), amended on other grounds, 532 F. Supp. 211 (E.D. Wis. 1981);
204. MacDonald v. Ortho Pharm. Corp., 475 N.E.2d 65, 69-70 (Mass. 1985).
205. But see Reaves v. Ortho Pharm. Corp., 765 F. Supp. 1287, 1291 (E.D. Mich. 1991) (holding the learned intermediary doctrine applicable in cases involving oral contraceptives because oral contraceptives do not significantly differ from other prescription drugs).
206. See, e.g., MacDonald, 475 N.E.2d at 69.
207. Id.
208. Id. at 70.
209. See Martin v. Ortho Pharm. Corp., 661 N.E.2d 352, 357 (111. 1996) (concluding that the learned intermediary doctrine relieved manufacturer of duty to warn consumers that its contraceptives could cause physical deformities in children whose mothers ingested it during pregnancy);
210. McEwen v. Ortho Pharm. Corp., 528 P.2d 522 (Or. 1974) (finding the same for contraceptive warnings related to circulatory and visual damage);
211. see also In re Norplant Contraceptive Prods. Liab. Lirig., 955 F. Supp. 700, 709 (E.D. Tex. 1997) (applying Texas law);
212. MacPherson v. Searle & Co., 775 F. Supp. 417, 425-26 (D.D.C 1991) (applying District of Columbia law);
213. Zanzuri v. G.D. Searle & Co., 748 F. Supp. 1511, 1514-15 (S.D. FIa. 1990) (applying Florida law);
214. Goodson v. Searle Labs., 471 F. Supp. 546, 549 (D. Conn. 1978) (applying Connecticut law);
215. Chambers v. G.D. Searle, 441 F. Supp. 377, 381 (D. Md. 1975), aff'd, 567 F.2d 269 (4th Cir. 1977).
216. See, e.g., Hill v. Searle Labs., Inc., 884 F.2d 1064, 1070 (8th Cir. 1989) ("[W]e believe that IUDs, like other forms of birth control, are atypical from most prescription drug products because the treating physician generally does not make an intervening, individualized medical judgment in the birth control decision.").
217. Lacy v. G.D. Searle & Co., 567 A.2d 398, 400 (Del. 1989) (applying the learned intermediary doctrine to IUD manufacturer where patient was required to undergo surgical removal of her ovaries and fallopian tubes after the IUD perforated her uterus).
218. See Doe v. Solvay Pharm., Inc., 350 F. Supp. 2d 257, 273 (D. Me. 2004) (rejecting application of learned intermediary exception for oral contraceptives to failure-to-warn claim brought by patient against manufacturer of prescription drag developed for treatment of obsessive-compulsive disorder (OCD)).
219. See Mitchell v. VLI Corp., 786 F. Supp. 966, 970 (M.D. Fla. 1992) (concluding that the learned intermediary doctrine did not apply in products liability action brought by user of a nonprescription contraceptive sponge);
220. cf. Prager v. Allergan, Inc., No. 89-C-6721, 1990 WL 70875, at *4 (N.D. Ill. May 2, 1990) (holding that doctrine did not apply to manufacturer of a nonprescription contact lens solution that allegedly caused plaintiff permanent eye damage).
221. See supra notes 140-48 and accompanying text.
222. Edwards v. Basel Pharms., 933 P.2d 298, 301 (Okla. 1997).
223. Id. at 303.
224. See id.
225. 734 A.2d 1245 (N.J. 1999). Until 2007, the closest resemblance to the Perez ruling came in an Oklahoma Supreme Court ruling more than a decade earlier which recognized a narrow exception to the learned intermediary doctrine where the FDA mandated communication of a particular warning directly to the patient as well as to the physician.
226. See McKee v. Moore, 648 P.2d 21, 25 (Okla. 1982);
227. see aiso Edwards, 933 P.2d at 303 (FDA compliance does not necessarily satisfy state requirements which may or may not conform to the learned intermediary rule);
228. Tansy v. Dacomed Corp., 890 P.2d 881, 886 (Okla. 1994) (applying the
229. See Edwards, 933 P.2d at 301.
230. Perez, 734 A.2d at 1251.
231. See id. at 1248.
232. See id. at 1247.
233. Id. at 1246.
234. See id. at 1247.
235. See In re Meridia Prods. Liab. Litig., 328 F. Supp. 2d 791, 812 n.19 (N.D. Ohio 2004) ("In the intervening period [after Perez], no other state has followed New Jersey's lead.");
236. see also Corey Schaecher, Comment, "Ask Your Doctor if This Product is Right for You": Perez v. Wyeth Laboratories, Inc., Direct-to-Consumer Advertising and the Future of the Learned Intermediary Doctrine in the Face of the Flood of Vioxx®Claims, 26 ST. LOUIS U. PUB. L. REV. 421, 443 (2007) (stating that post-Perez courts have been "reluctant, at best,... to delineate an exception").
237. See, e.g., In re Meridia, 328 F. Supp. 2d at 812 n.19 ("The Court thus could not apply Perez's logic even if it desired to do so.");
238. In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, at 827 (E.D. Tex. 2002) ("This argument ... lacks merit in all jurisdictions, except New Jersey.... [A]part from New Jersey, direct-to-consumer advertising does not negate the applicability of the learned intermediary doctrine.");
239. Vitanza v. Upjohn Co., 778 A.2d 829 (Conn. 2001);
240. McCombs v. Synthes (U.S.A.), 587 S.E.2d 594 (Ga. 2003);
241. Larkin v. Pfizer, Inc., 153 S.W.3d 758 (Ky. 2004);
242. Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827 (Neb. 2000).
243. State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007).
244. Id. at 906.
245. Id. at 910 (quoting Lars Noah, Advertising Prescription Drugs to Consumers: Assessing the Regulatory and Liability Issues, 32 GA. L. REV. 141, 160-61 n.78 (1997)).
246. Id. at 911.
247. See id. at 908-09.
248. Id. at 913.
249. See supra notes 153-58 and accompanying text.
250. Karl, 647 S.E.2d at 917 (Albright, J., dissenting).
251. See Am. Med. Ass'n, Council on Ethical & Judicial Affairs, Code of Medical Ethics, Direct-to-Consumer Advertising of Prescription Drugs, Op. 5-015, at 126 (2006-2007) ("Physicians must maintain professional standards of informed consent when prescribing. When a patient comes to a physician with a request for a drug he or she has seen advertised, the physician and the patient should engage in a dialogue that would assess and enhance the patients understanding of the treatment. Although physicians should not be biased against drags that are advertised, physicians should resist commercially induced pressure to prescribe drugs that may not be indicated. Physicians should deny requests for inappropriate prescriptions and educate patients as to why certain advertised drugs may not be suitable treatment options, providing, when available, information on the cost effectiveness of different options.").
252. See RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY §103 (Council Draft No. 1, 1993);
253. see also Noah, supra note 163, at 162-63 (detailing the Restatement Reporters' changes regarding DTC advertising).
254. See RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY §4(b)(3) (Council Draft No. IA, 1994).
255. Id., Memorandum at 2.
256. See id. ("We have removed from the black letter a special exception to the learned intermediary rule for direct advertising to patients. Instead we have amended comment e to indicate that, where government agencies mandate that advertisements carry warnings to patients, the learned intermediary rule does not apply.").
257. The learned intermediary exception relevant to advertisements was amended such that liability could exist if "[r]easonable instructions or warnings regarding foreseeable risks of harm posed by the drug or medical device were not provided directly to the patient when the manufacturer knew or had reason to know that no medical provider would be in the position" to reduce the risks of harm through appropriate warnings or instructions." RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY §4(b)(3) (Tentative Draft No. 1, 1994).
258. See Noah, supra note 163, at 166.
259. RESTATEMENT (THIRD), supra note 114, at §6 cmt. e.
260. See Vitanza v. Upjohn Co., 778 A.2d 829 (Conn. 2001);
261. McCombs v. Synthes (U.S.A.), 587 S.E.2d 594 (Ga. 2003);
262. Larkin v. Pfizer, Inc., 153 S.W.3d 758 (Ky. 2004);
263. Freeman v. Hoffman-La Roche, Inc., 618 N.W.2d 827 (Neb. 2000).
264. See Rohrbough by Rohrbough v. Wyeth Labs., 719 F. Supp. 470, 478 (N.D. W. Va. 1989) (finding that a registered nurse who administered a Diphtheria and Tetanus Toxoids and Pertussis Vaccine (DTP) in a public health clinic qualified as a learned intermediary), aff'd on other grounds 916 F.2d 970 (4th Cir. 1990);
265. Walker v. Merck & Co., 648 F. Supp. 931, 934 (M.D. Ga. 1986);
266. Singleton v. Aireo, Inc., 314 S.E.2d 680, 682 (Ga. Ct. App. 1984) (implying a nurse anesthetist qualified as a learned intermediary).
267. See Haste v. Am. Home Prods. Corp., 577 F.2d 1122, 1124 (10th Cir. 1978), cert, denied 439 U.S. 955 (1978) (suggesting a veterinarian could be a learned intermediary in product liability action brought against the manufacturer of an animal vaccine).
268. See, e.g., Smith v. Walter C. Best, Inc., 927 F.2d 736, 739 (3d Cir. 1990) (using the term "knowledgeable purchaser");
269. Higgins v. E.I. DuPont de Nemours & Co., 671 F. Supp. 1055, 1061 (D. Md. 1987) (referring to a "knowledgeable industrial purchaser");
270. Phillips v. A.P. Green Refractories Co., 630 A.2d 874, 883 (Pa. Super. Ct. 1993) (using the term "knowledgeable employer");
271. see also Keith Laughery, Warnings in the Workplace: Expanding the Learned Intermediary Rule to Include Employers in the Context of Product Manufacture/Employer/Employee Relationship, 46 S. TEX. L. REV. 627 (2005) (advocating expansion of the doctrine in certain manufacturing relationships);
272. Victor E. Schwartz & Christopher E. Appel, Effective Communication of Warnings in the Workplace: Avoiding Injuries in Working with Industrial Materials, 73 MO. L. REV. 1 (2008) (discussing the parallels and doctrinal interplay of the learned intermediary rule with the sophisticated user doctrine in the case of industrial materials);
273. Carole A. Cheney, Comment, Not Just For Doctors: Applying the Learned Intermediary Doctrine to the Relationship Between Chemical Manufacturers, Industrial Employers, and Employees, 85 NW. U. L. REV. 562, 575 (1991) (discussing the mixed results of the learned intermediary doctrine outside of the prescription drag context).
274. See supra notes 117-120 and accompanying text.
275. See State ex rel. Johnson & Johnson Co. v. Karl, 647 S.E.2d 899, 917 (W. Va. 2007) (Albright, J., dissenting) ("But to presume, as the majority appears to, that the mere presence of pharmaceutical advertising in our society relegates the role of the physician to a mere dispensary of prescriptions is simply not true.").
276. The Massachusetts Supreme Judicial Court, for example, recently held that a physician could be liable to third parties injured as a result of the failure to warn a patient.
277. See Coombes v. Florio, 877 N.E.2d 567, 571-72 (Mass. 2007) (holding that a doctor may be liable when his patient, who alleged he was not adequately warned that the medication he was on could cause drowsiness or fainting, injured the plaintiff in an automobile accident).
278. See Brown v. Superior Court, 751 P.2d 470, 478-79 (Cal. 1988) (expressing concern that increased liability would drive prices of drugs too high and make them less available).
279. See Richard C. Ausness, The Case for a "Strong" Regulatory Compliance Defense, 55 MD. L. REV. 1210, 1241 (1996).
280. See id. at 1241-47 (1996) (providing examples of cases in which courts gave little weight to federal safety regulations spanning a variety of areas, such as flammability standards for clothing, pesticide warnings, automobile design, prescription drag warnings, aircraft design, and workplace safety standards).
281. See id.
282. See 2 AM. LAW INST., REPORTER'S STUDY, ENTERPRISE RESPONSIBILITY FOR PERSONAL INJURY 95-97 (1991);
283. see also Richard B. Stewart, Regulatory Compliance Preclusion of Tort Liability: Limiting the Dual-Track System, 88 GEO. L.J. 2167, 2168-70 (2000).
284. RESTATEMENT (THIRD), supra note 114, at §4 cmt. e.
285. Id.
286. See id. §4 Reporters' Note cmt. d (citing as an example Hawkins v. Evans Cooperage Co., 766 F.2d 904, 909 (5th Cir. 1985)).
287. See, e.g., Sims v. Washex Mach. Corp., 932 S.W.2d 559, 565 (Tex. App. 1995) ("Compliance with government regulations is strong evidence, although not conclusive, that a machine was not defectively designed.").
288. See, e.g., Lorenz v. Celotex Corp., 896 F.2d 148, 152 (5th Cir. 1990) (compliance with safety regulation is strong and substantial evidence of lack of defect);
289. Dentson v. Eddins & Lee Bus Sales, Inc., 491 So. 2d 942, 944 (Ala. 1986) (ruling that a school bus that is not equipped with seatbelts is not defective when the legislature has not required seatbelts);
290. Ramirez v. Plough, Inc., 863 P.2d 167, 176 (Cal. 1993) (concluding that "the prudent course is to adopt for tort purposes the existing legislative and administrative standard of care").
291. Beatty v. Trailmaster Prods., Inc., 625 A.2d 1005, 1014 (Md. 1993).
292. See infra note 203 and accompanying text.
293. See States v. R.D. Werner Co., 799 P.2d 427, 430 (Colo. Ct. App. 1990) (ruling that the trial court did not err by admitting expert testimony on a ladder's compliance with federal regulations).
294. See Slisze v. Stanley-Bostitch, 979 P.2d 317, 321 (Utah 1999) (ruling that federal OSHA standards regulating the design of a pneumatic nailer were admissible as government standards and established a rebuttable presumption of nondefectiveness as they provided "a legitimate source for determining the standard of reasonable care").
295. See Uptain v. Huntington Lab, Inc., 685 P.2d 218, 222 (Colo. Ct. App. 1984) (finding that manufacturer of a cleaning compound was entitled to presumption of nondefectiveness where an expert testified that the product label's warnings complied with federal and local laws and was approved by the Environmental Protection Agency).
296. See Alvarado v. J.C Penney Co., 735 F. Supp. 371, 372-74 (D. Kan. 1990). In a case involving a nightgown and robe that were ignited by an open-flame gas heater, the court held that that the regulatory compliance provision of the Kansas Products Liability Act did not create a conclusive presumption and thus a constitutional challenge by plaintiffs was moot.
297. See id.
298. See Champlain Enters., Inc. v. United States, 957 F. Supp. 26, 28 (N.D.N.Y. 1997) (ruling that the regulatory compliance provision of the Kansas Products Liability Act would provide an airplane manufacturer with a defense against liability if it established that the aircraft complied with government safety standards, unless the plaintiff can show that "a reasonable prudent product seller could and would have taken additional precautions").
299. See Brand v. Mazda Motor Corp., 978 F. Supp. 1382, 1387-88, 1391-93 (D. Kan. 1997) (ruling that automobile manufacturer's compliance with federal regulatory standards was not dispositive of liability or punitive damages absent clear and convincing evidence that the manufacturer acted with reckless indifference to consumer safety).
300. COLO. REV. STAT. § 13-21403(1) (2008).
301. See KAN. STAT. § 60-3304(a) (2007);
302. KY. REV. STAT. § 411.310(2) (2008);
303. MICH. COMP. LAWS § 600.2946(4) (2000);
304. TENN. CODE §29-28-104 (2008);
305. TEX. CIV. PRAC. & REM. CODE § 82.008 (2008);
306. UTAH CODE § 78B-6-703 (2008).
307. See, e.g., Kernke v. The Menninger Clinic, Inc., 173 F. Supp. 2d 1117, 112122 (D. Kan. 2001) (finding insufficient evidence to overcome Kansas's presumption of nondefectiveness and raise a jury question with respect to an FDAapproved clinical trial of an experimental treatment for schizophrenia). At least two additional states, Arkansas and Washington, specifically provide by statute that parties may introduce evidence of regulatory compliance to show that a product is not defective or that its warnings are not inadequate.
308. See ARK. CODE § 16-116-105(a) (2007);
309. WASH. REV. CODE §7.72.050(1) (2008). These statutes do not assign any particular evidentiary weight to compliance with safety standards.
310. See Henry I. Miller, Failed FDA Reform, 21 REGULATION 24, 24 (1998) (attributing an increase in cost for new drug development and approval from $359 million to $500 million-in pretax 1990 dollars-between 1990 and 1993, and an increase in the time for approval from 8.1 years to 15.2 years since the 1960s, to the "FDA's regulatory zeal").
311. See N.J. STAT. § 2A:58C-5c (2008);
312. OHIO REV. CODE §2307.80(C) (2008);
313. OR. REV. STAT. §30.927 (2007). In 2005, the Ohio legislature expanded coverage of the statute to include medical devices and over-the-counter drugs in addition to prescription drugs. OHIO LAWS FILE 144 (Am. Sub. S.B. 80) (amending OHIO REV. CODE § 2307.80) (effective Apr. 7, 2005).
314. See ARIZ. REV. STAT. § 12-701(A) (2009);
315. UTAH CODE § 78B-8-203(1) (2008).
316. See MICH. COMP. LAWS § 600.2946(5) (2000). The Supreme Court of the United States recently found that an exception in the Michigan law which preserves liability if the drug company withheld or misrepresented information that would have altered the FDA's decision to approve the drug product (i.e., "fraud-on-the-FDA") was valid and not preempted. Warner-Lambert Co. v. Kent, 128 S. Ct. 1168 (2008).
317. See OHIO REV. CODE § 2307.80(B)-(C) (2008).
318. Compare OR. REV. STAT. § 30.927 (2007) (requiring "clear and convincing" evidence of the misconduct),
319. with OHIO REV. CODE § 2307.80(C) (2008) (providing a preponderance of the evidence standard).
320. See 21 C.F.R. § 314.80(b)-(c) (2008).
321. See generally James P. Muehlberger & Cary Silverman, Lawsuits Without Injury: The Rise of Consumer Protection Claims, LITIG. WATCH, Oct. 2006, at 4.
322. See id.
323. See N.J. Citizen Action v. Schering-Plough Corp., 842 A.2d 174, 177 (N.J. Super. Ct. App. Div. 2003) (holding plaintiffs who claimed allergy medication was not as effective as advertised failed to establish a causal nexus between representations and any loss suffered under the New Jersey Consumer Fraud Act).
324. See Williams v. Purdue Pharma Co., 297 F. Supp. 2d 171, 177-78 (dismissing District of Columbia's Consumer Protection Procedures Act claim that the manufacturer over-promoted the drug as providing "smooth and sustained" pain relief for twelve hours with little chance of addiction, which allowed the manufacturer artificially to inflate its prices).
325. See In re Prempro Prods. Liab. Litig., 230 F.R.D. 555, 566-68 (E.D. Ark. 2005) (denying certification of a consumer-protection class due to material variations in the consumer laws of the twenty-nine states at issue and the need to show individual plaintiffs relied on the allegedly deceptive advertisement and were injured as a result).
326. See In re W. Va. Rezulin Litig., 585 S.E.2d 52, 62-65 (W. Va. 2003) (ruling that the statutory requirement that a plaintiff show an "ascertainable loss" under West Virginia Consumer Credit and Protection Act did not require a showing of actual damages and finding that plaintiffs needed only to allege that they received a product that was different or inferior to that which they believed they purchased).
327. See Int'l Union of Operating Eng'rs Local No. 68 Welfare Fund v. Merck & Co., 929 A.2d 1076, 1088 (N.J. 2007).
328. See Victor E. Schwartz & Cary Silverman, Common-Sense Construction of Consumer Protection Acts, 54 KAN. L. REV. 1, 32-33 (2005).
329. See id. at 22-27.
330. See, e.g., Victor E. Schwartz, Cary Silverman & Christopher E. Appel, "That's Unfair!" Says Who-The Government or Litigant? Consumer Protection Claims Involving Regulated Conduct, 47 WASHBURN L.J. 93, 119 (2007).
331. See id. at 102. Regulatory-compliance exemptions to state consumer laws vary from state to state but generally fit within three categories: (1) rales of construction suggesting or requiring that courts interpret the state consumer law consistently with the interpretations and policy of the FTC; (2) exemptions for authorized or permitted conduct; (3) exemptions applicable to specific regulated industries or conduct.
332. See id. at 102-17.
333. Id. at 106 (quoting Taylor v. Bear Stearns & Co., 572 F. Supp. 667 (N.D. Ga. 1983)).
334. See id. at 119-22;
335. see also Muehlberger & Silverman, supra note 212, at 5-6.
336. U.S. CONST, art. VI, cl. 2.
337. See La. Pub. Serv. Comm'n v. FCC, 476 U.S. 355, 369 (1986) ("Pre-emption may result not only from action taken by Congress itself; a federal agency action within the scope of its congressionally delegated authority may pre-empt state regulation.").
338. See 21 U.S.C. §393(b) (2006) (charging the FDA with ensuring that drugs are safe and effective).
339. See 21 U.S.C. §360k(a) (2006) (providing that a state shall not "establish or continue in effect with respect to a device intended for human use any requirement-(1) which is different from, or in addition to, any requirement applicable under [federal law] to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under" relevant federal law).
340. See, e.g., Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1006-08 (2008) (discussing the scope of the MDA's express preemption provision regarding medical device compliance with FDA pre-market approval process);
341. Sprietsma v. Mercury Marine, 537 U.S. 51, 67-68 (2002) (analyzing the confines of an express preemption provision in the Federal Boat Safety Act).
342. See Crosby v. Nat! Foreign Trade Council, 530 U.S. 363, 372 (2000) ("Even without an express provision for preemption, we have found that state law must yield to a congressional Act....").
343. See Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230-31 (1947).
344. Fla. Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43 (1963);
345. see also Hillsborough County v. Automated Med. Labs., Inc., 471 U.S. 707, 713 (1985).
346. Geier v. Am. Honda Motor Co., 529 U.S. 861, 869-74 (2000);
347. see also Gade v. Nat'l Solid Wastes Mgmt Ass'n, 505 U.S. 88, 98 (1992);
348. Hines v. Davidowitz, 312 U.S. 52, 67 (1941).
349. See James O'Reilly, A State of Extinction: Does Food and Drug Administration Approval of a Prescription Drug Label Extinguish State Claims for Inadequate Warning?, 58 FOOD & DRUG L.J. 287, 291 (arguing that it is unlikely that an implied field preemption claim could prevail in the prescription drug field).
350. See, e.g., Crosby, 530 U.S. at 372;
351. see also Christine H. Kim, The Case for Preemption of Prescription Drug Failure-to-Warn Claims, 62 FOOD & DRUG L.J. 399, 402 (2007) (separating the three distinct forms of implied preemption).
352. See Kim, supra note 235, at 400-01 (discussing the FDA's increased amicus curiae filings in federal preemption cases);
353. Mark C. Levy & Gregory J. Wartman, Amicus Curiae Efforts to Reform Product Liability at the Food and Drug Administration: FDA's Influence on Federal Preemption of Class III Medical Devices and Pharmaceuticals, 60 FOOD & DRUG L.J. 495, 497-99 (2005);
354. Catherine M. Sharkey, Federalism in Action: FDA Regulatory Preemption in Pharmaceutical Cases in State Versus Federal Courts, 15 J.L. & POL'Y 1013, 1032-34 (2007).
355. See, e.g., Corrected Amicus Brief for the United States, Kallas v. Pfizer, Inc., No. 04-00998 (D. Utah Sept. 29, 2005);
356. see also Sharkey, supra note 236, at 1038 (estimating that the FDA is directly involved in one quarter of federal court drug preemption cases since 2000).
357. See Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514, 528 (E.D. Pa. 2006) (citing 21 C.F.R. §314.150).
358. Geier v. Am. Honda Motor Co., 529 U.S. 861, 863 (2000) (internal quotation marks omitted).
359. See Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3922, 3933-34 (Jan. 24, 2006) (effective date June 30, 2006) [hereinafter "FDA Preamble"].
360. Id.
361. Id. at 3935.
362. Id.
363. Id. at 3935-36.
364. Id. at 3935.
365. See, e.g., W. Wylie Blair, Implied Preemption of State Tort Law Claims Against Prescription Drug Manufacturers Based on FDA Approval, 27 J. LEGAL MED. 289, 301 (2006) (proposing amendment of the Food, Drug, and Cosmetic Act, enactment of state statutes, or the use of judicial intervention to adopt the FDA's interpretation of the scope of implied preemption);
366. Teresa Curtin & Ellen Relkin, Preamble Pre- emption and the Challenged Role of Failure to Warn and Defective Design Pharmaceutical Cases in Revealing Scientific Fraud, Marketing Mischief, and Conflicts of Interest, 35 HOFSTRA L. REV. 1773, 1778 (2007) (juxtaposing the FDA's preemption position with deficiencies in the agency's post-market regulatory scheme and suggesting a possible retreat from the FDA's strong stance on implied preemption);
367. Margaret Gilhooley, Addressing Potential Drug Risks: The Limits of Testing, Risk Signals, Preemption, and the Drug Reform Legislation, 59 S.C L. REV. 347, 388 (2008) (recommending the FDA change its policy and require that drug sponsors petition the agency for a statement of preemptive effect on the need for a warning).
368. Compare Howard L. Dorfman et al., Presumption of Innocence: FDA's Authority to Regulate the Specifics of Prescription Drug Labeling and the Preemption Debate, 61 FOOD & DRUG L.J. 585, 610-11 (2006) (advocating substantial, or Chevron level, deference to the Preamble),
369. with Leslie C. Kendrick, FDA's Regulation of Prescription Drug Labeling: A Role for Implied Preemption, 62 FOOD & DRUG L.J. 227, 247 (2007) (concluding that the Preamble warrants low level or Skidmore deference).
370. See also Catherine M. Sharkey, Preemption by Preamble: Federal Agencies and the Federalization of Tort Law, 56 DEPAUL L. REV. 227, 243-45 (2007) (examining increased use of preemption by federal agencies and corresponding judicial deference to agency determinations).
371. Compare In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., No. 05-1699, 2006 WL 2374742 (N.D. Cal Aug. 16, 2006) (same Celebrex),
372. Conte v. Wyeth, Inc., No. 04-437382, 2006 WL 2692469 (Cal. App. Dep't Super. Ct. Sept. 14, 2006) (same metroclopramide),
373. and Abramowitz v. Cephalon, Inc., No. BER-L-61704, 2006 WL 560639 (N.J. Super. Ct. Law Div. Mar. 3, 2006) (finding implied preemption for FDA's approval of risks associated with pain-management drug Actiq),
374. with Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff'd sub. nom, Warner-Lambert Co. v. Kent, 128 S. Ct. 1168 (2008),
375. Weiss v. Fujisawa Pharm. Co., 464 F. Supp. 2d 666 (E.D. Ky. 2006), Jackson v. Pfizer, Inc., 432 F. Supp. 2d 964 (D. Neb. 2006),
376. and Levine v. Wyeth, 944 A.2d 179 (Vt 2006), cert. granted, 128 S. Ct. 1118 (2008).
377. Medtronic, Inc. v. Lohr, 518 U.S. 470, 505 (1996) (Breyer, J., concurring);
378. see also Chevron v. Nat'l Res. Def. Council, 467 U.S. 837, 863-64 (1984) ("The fact that the agency has from time to time changed its interpretation ... does not... lead us to conclude that no deference should be accorded the agency's interpretation of the statute. An initial agency interpretation is not instantly carved in stone.").
379. Hillsborough County, 471 U.S. 707, 718 (1985);
380. see also Dowhal v. Smith-Kline Beecham Consumer, 88 P.3d 1, 5-6, 9-10 (Cal. 2004) (according deference to FDA position expressed in letters issued in response to a manufacturer inquiry and citizen petition stating that California law was preempted to the extent it required warnings on nicotine replacement devices that conflicted with the FDA's determination that a manufacturer could include only approved warnings).
381. Levine v. Wyeth, 944 A.2d 179 (Vt. 2006), cert, granted, 128 S. Ct. 1118 (2008) (No. 06-1249). The Court also decided two other cases this term considering preemption in the FDA context.
382. See Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008);
383. Warner-Lambert Co. v. Kent, 128 S. Ct. 1168 (2008).
384. See Levine, 944 A.2d at 182.
385. See id. at 183.
386. See id. at 189.
387. See id. at 188.
388. Id.
389. Id. at 194.
390. Id. at 192.
391. See Brief for the United States as Amicus Curiae Supporting Petitioner, Wyeth v. Levine, No. 06-1249 (U.S. filed Dec. 2007), available at http://www.usdoj.gov/osg/briefs/ 2007/3mer/lami/2006-1249. mer.ami.pdf.
392. Id. at 9-11.
393. Id. at 9.
394. See id. at 11.
395. See Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D. Pa. 2006).
396. Id. at 529;
397. see also Sykes v. Glaxo-SmithKline, 484 F. Supp. 2d 289, 308-10 (E.D. Pa. 2007) (preempting state tort actions against pediatric vaccine manufacturers under the National Childhood Vaccine Injury Compensation Act).
398. See In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., MDL No. 1699, 2006 WL 2374742, at *9 (N.D. Cal. Aug. 16, 2006).
399. 499 F.3d 239, 241 (3d Cir. 2007).
400. See DEL. CODE tit. 6 §2513(b) (2009).
401. See Pennsylvania Employees, 499 F.3d at 243.
402. Id. at 251.
403. See id. at 252.
404. See Richard Epstein, Why the FDA Must Preempt Tort Litigation: A Critique of Chevron Deference and a Response to Richard Nagareda, 1 J. TORT L. 1, 1 (2006) ("[F]ederal preemption of state tort actions for pharmaceuticals is long overdue, both under current law and as a matter of sound legal policy.").
405. See Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 350 (2001) ("As a practical matter, complying with the FDA's detailed regulatory regime in the shadow of 50 States' tort regimes will dramatically increase the burdens facing potential applicants-burdens not contemplated by Congress in enacting the FDCA....").
406. See FDA Preamble, supra note 240, at 3934 ("In order to more fully address the comments expressing concern about the product liability implications of revising the labeling for prescription drugs, we believe it would be useful to set forth in some detail the arguments made in those amicus briefs.").
407. See 21 U.S.C. § 360k301 (2006).
408. See 21 U.S.C. § 360k(a) (2006).
409. See supra Part III.A.
410. See supra Part III.B;
411. see also Dorfman et al., supra note 247, at 622 ("[T]he public policy balance weighs in favor of a uniform federal scheme to provide for the introduction of urgently needed medical therapies without compromising FDA's role of ensuring that prescription drug labels are accurate, contain appropriate and scientifically sound precautionary language with regard to adverse events, and allow for clear understanding by the recipients.").
412. See, e.g., Jennifer Girod, The Learned Intermediary Doctrine: An Efficient Protection for Patients, Past and Present, 40IND. L. REV. 397, 398, 416 (2007) (discussing the potential benefits of DTC advertising);
413. Jack B. Harrison & Mina J. Jerrerson, "Some Accurate Information is Better Than No Information at All": Arguments Against An Exception to the Learned Intermediary Doctrine Based on Direct-to-Consumer Advertising, 78 OR. L. REV. 605, 606 (1999) ("DTC advertising increases consumer awareness of illnesses and their symptoms, empowers consumers to take charge of their healthcare decisions, and enhances the quality of the dialogue between physicians and patients.").