A defense of the learned intermediary doctrine

Food and Drug Law Journal

Volumn 63, Issue 2, 2008, Pages 421-438

  Goetz, Richard B ^a   Growdon, Karen R ^a  

^a O'Melveny and Myers   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CISAPRIDE; LEVONORGESTREL; ROFECOXIB;

ADVERTIZING; CLINICAL EFFECTIVENESS; CONSUMER; COURT; DOCTOR PATIENT RELATION; DRUG CONTRAINDICATION; DRUG EFFICACY; DRUG INFORMATION; DRUG LABELING; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG PACKAGING; DRUG SAFETY; FOOD AND DRUG ADMINISTRATION; GOVERNMENT REGULATION; HEALTH CARE; HEALTH CARE POLICY; INTERNET; LEARNED INTERMEDIARY DOCTRINE; MEDICAL LIABILITY; MEDICOLEGAL ASPECT; PRESCRIPTION; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; TELECOMMUNICATION;

ADVERTISING AS TOPIC; CONSUMER PRODUCT SAFETY; DRUG INDUSTRY; DRUG INFORMATION SERVICES; DRUG LABELING; DUTY TO WARN; HUMANS; INTERNET; LEGISLATION, PHARMACY; MASS MEDIA; NEW JERSEY; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; WEST VIRGINIA;

EID: 44849087548     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (94)

1. Perez v. Wyeth Labs. Inc., 734 A.2d 1245 (N.J. 1999).
2. State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va.,2007).
3. The learned intermediary doctrine also applies to claims for injuries from medical devices obtainable only by prescription. E.g., Lacy v. G.D. Searle & Co., Inc., 567 A.2d 398, 400 (Del. 1989) (intrauterine device).
4. RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY § 2(c) & cmt. (i) ( 1998) ("Commercial product sellers must provide reasonable instructions and warnings about risks of injury posed by their products.")
5. E.g., Carlin v. Super. Ct. (The Upjohn Co.), 920 P.2d 1347, 1354 (Cal. 1996) ("[I]n the case of prescription drugs, the duty to warn runs to the physician, not to the patient."); Martin v. Hacker, 628 N.E.2d 1308, 1311 (N.Y. 1993) ("Warnings for prescription drugs are intended for the physician, whose duty it is to balance the risks against the benefits of various drugs and treatments and to prescribe them and supervise their effects.") Schaerrer v. Stewart Plaza Pharmacy, Inc., 79 P.3d 922, 928 (Utah 2003) ("[M]anufacturers of prescription drugs have a duty to warn only the physician prescribing the drug, not the end user or patient."); see also RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY § 6(d) & cmt. (d) (citing cases that stand for the proposition that "manufacturers of prescription drugs discharge their duty of care to patients by warning the health-care providers who prescribe and use the drugs to treat them").
6. E.g., In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 803 (E.D. Tex. 2002); Brown v. Super. Ct. (Abbott Labs.), 751 P.2d 470, 478 n.9 (Cal. 1988) ("[A] manufacturer fulfills its duty to warn if it provides adequate warning to the physician."); Martin, 628 N.E. 2d at 1311.
7. E.g., Larkin v. Pfizer, Inc., 153 S.W.3d 758, 770 (Ky. 2004) ("[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."); Vitanza v. Upjohn Co., 778 A.2d 829, 837 (Conn. 2001); ("The learned intermediary doctrine...is based on the principle that prescribing physicians act as 'learned intermediaries' between a manufacturer and consumer and, therefore, stand in the best position to evaluate a patient's needs and assess the risks and benefits of a particular course of treatment.") (internal citations omitted).
8. Reyes v. Wyeth Labs, Inc. 498 F.2d 1264, 1276 (5th Cir. 1974) (emphasis added).
9. See, e.g., Norplant, 215 F. Supp. 2d at 815 ("[S]tates [that] recognize the learned intermediary doctrine] are concerned that patients cannot comprehend complex medical information...."); Carmichael v. Reitz, 95 Cal. Rptr. 381, 400 (1971) ("The doctor is intended to be an intervening party in the full sense of the word.... Were the patient to be given the complete and highly technical information on the adverse possibility associated with the use of the drug, he would have no way to evaluate it....").
10. See, e.g., Vitanza, 778 A.2d at 846; Edwards v. Basel Pharms., 933 P.2d 298, 300 (Okla. 1997); Schaerrer, 79 P.3d at 929 (noting also that manufacturers are "limited in their ability to distribute FDA-regulated drugs" because they lack "direct access" to the patient).
11. Final Rule: Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3922, 3961 (cmt. 112) (Jan. 24, 2006).
12. See also Final Rule: Labeling and Prescription Drug Advertising; Content and Format for Labeling for Human Prescription Drugs, 44 Fed. Reg. 37434, 37438-37439 (June 26, 1979) ("[T]he prescription drug labeling to which [the FDA labeling] regulations apply is directed to health care professionals and not to the ultimate consumer of the drugs." (item 21) "[S]tandardization of prescription drug labeling in lay language is not warranted because the labeling for prescription drugs is directed to the health care professional and not the layperson; therefore, the labeling should be that most capable of informing the professional practitioner." (item 26)).
13. See Marcus v. Specific Pharms., 77 N.YS.2d 508, 509-10 (N.Y. Sup. Ct. 1948) ("[I]t is difficult to see on what basis this defendant can be liable to plaintiff. It made no representation to plaintiff, nor did it hold out its product to plaintiff as having any properties whatsoever. To physicians it did make representations. And should any of these be false it might be claimed with propriety that they were made for the benefit of the ultimate consumers. But there is no such claim...."). The phrase itself appears to have been first used in Sterling Drug Co. v. Cornish, 370 F.2d 82, 85 (1966). ("[I]n this case we are dealing with a prescription drug rather than a normal consumer item. In such a case the purchaser's doctor is a learned intermediary between the purchaser and the manufacturer.")
14. See Stone v. Smith, Kline & French Labs., 447 So. 2d 1301, 1304-05 (Ala. 1984); Shanks v. Upjohn Co., 835 P.2d 1189, 1200 (Alaska 1992); West v. Searle & Co., 806 S.W.2d 608, 614 (Ark. 1991); Carlin, 920 P.2d at 1350-55 (California); Vitanza, 778 A.2d at 836-39 (Connecticut); Lacy v. G.D. Searle & Co., 567 A.2d 398, 399-401 (Del. 1989); Mampe v. Ayerst Labs., 548 A.2d 798, 802 n.6 (D.C. 1988); Felix v. Hoffmann-LaRoche, Inc., 540 So. 2d 102, 104 (Fla. 1989); McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 595 (Ga. 2003); Craft v. Peebles, 893 P.2d 138, 154-56 (Haw. 1995); Kirk v. Michael Reese Hosp. & Med. Ctr., 513 N.E. 2d 387, 392-93 (Ill. 1987); Savina v. Sterling Drug, Inc., 795 P.2d 915. 929 (Kan. 1990); Larkin, 153 S.W.3d at 770 (Kentucky); Cottam v. CVS Pharmacy, 764 N.E. 2d 814, 820-21 (Mass. 2002); Gray v. Badger Min. Corp., 676 N.W.2d 268, 275-76 (Minn. 2004); Janssen Pharm., Inc. v. Bailey, 878 So. 2d 31, 56-58 (Miss. 2004); Krug v. Sterling Drug, Inc., 416 S.W.2d 143, 146-47 (Mo. 1967); Hill v. Squibb & Sons, 592 P.2d 1383, 1387-88 (Mont. 1979); Freeman v. Hoffman-LaRoche, Inc., 618 N.W.2d 827, 841-42 (Neb. 2000); Perez v. Wyeth Labs, Inc., 734 A.2d at 1259-62 (New Jersey); Martin, 628 N.E.2d at 1311 (New York); N.C. GEN. STAT. § 99B-5(a) (1995); OHIO REV. CODE ANN. § 2307.76(C) (2006); Tracy v. Merrell Dow Pharms., Inc., 569 N.E.2d 875, 878 (Ohio 1991); Edwards v. Basel Pharms., 933 P.2d at 298,300-01 (Okla. 1997); McEwen v. Ortho Pharm., 528 P.2d 522, 529 (Or. 1974) (learned intermediary doctrine applies in negligence actions); Coyle v. Richardson-Merrill, Inc., 584 A.2d 1383, 1385-86 (Pa. 1991); Pittman v. Upjohn Co., 890 S.W.2d 425, 429 (Tenn. 1994); Schaerrer v. Stewart's Plaza Pharmacy, 79 P.3d 922, 928 (Utah 2003); Pfizer, Inc. v. Jones, 272 S.E.2d 43, 44 (Va. 1980); Washington State Physicians Ins. Exch. & Ass'n v. Fisons Corp., 858 P.2d 1054, 1061 (Wash. 1993); Rohde v. Smiths Medical, 165 P.3d 433, 435 n.5 (Wyo. 2007). In three states, the highest appellate court, while not adopting the doctrine explicitly, has referred to the learned intermediary doctrine in terms that suggest that it is part of the law of that state. See Hodges v. Brannon, 707 A.2d 1225, 1227-28 (R.I. 1998) (upholding jury instructions that reflected application of the learned intermediary doctrine); Allison v. Merck & Co., Inc., 878 P.2d 948, 958 n.16, 969 (Nev. 1994) (plurality opinion announcing ruling of the court stated that narrow "mass immunization" exception to learned intermediary doctrine, which operates when a vaccine is administered at a clinic without the involvement of a physician, applied; dissenting opinion stated that learned intermediary doctrine applied without exception); Silman v. Aluminum Co. of Am., 731 P.2d 1267, 1270-71 (Idaho 1986) (referring to the learned intermediary doctrine with approval);
15. See Dyer v. Best Pharmacal, 577 P.2d 1084, 1087 (Ariz. App. 1978); Hamilton v. Hardy, 549 P.2d 1099, 1110 (Colo. App. 1976), overruled on other grounds by State Bd. of Med. Examiners v. McCroskey, 880 P.2d 1188 (Colo. 1994); Ortho Pharm. Corp. v. Chapman, 388 N.E.2d 541, 548-49 (Ind. Ct. App. 1979); Kinney v. Hutchinson, 468 So. 2d 714, 718-19 (La. App. 1985); Brown v. Drake-Willock Intern., Ltd., 530 N.W.2d 510, 516 (Mich. App., 1995); Serna v. Roche Labs., 684 P.2d 1187, 1189 (N.M. Ct. App. 1984); Wyeth-Ayerst Labs. v. Medrano, 28 S.W.3d 87, 92 (Tex. Ct. App. 2000).
16. Brazzell v. United States, 788 F.2d 1352, 1358 (8th Cir. 1986) (applying Iowa law); Violette v. Smith & Nephew Dyonics, Inc., 62 F.3d 8, 13 (1st Cir. 1995) (applying Maine law); Miller v. Bristol-Myers Squibb Co., 121 F. Supp. 2d 831, 838 (D. Md. 2000) (applying Maryland law); Brochu v. Ortho Pharm. Corp., 642 F.2d 652, 656 (1st Cir. 1981) (applying New Hampshire law); Ehlis v. Richwood, 367 F.3d 1013, 1017 (8th Cir. 2004) (applying North Dakota law); Guevara v. Dorsey Labs., 845 F.2d 364 (1st Cir. 1981) (applying law of Puerto Rico); Brooks v. Medtronic, Inc., 750 F.2d 1227, 1231 (4th Cir. 1984) (applying South Carolina law); McElhaney v. Eli Lilly, 575 F. Supp. 278 (D.S.D. 1983) (applying South Dakota law); Menges v. Depuy Motech, Inc., 61 F. Supp. 2d 817, 830 (N.D. Ind. 1999) (applying Wisconsin law).
17. Federal Food, Drug, and Cosmetic Act § 1, 21 U.S.C. § 301. Prescription drug advertising is commercial speech protected by the First Amendment. Va. State Bd. of Pharmacy v. Va. Citizens Consumer Council, 425 U.S. 748, 770 (1976). For an analysis of decisions that have delineated the proper scope of the regulation of commercial speech, see Mark I. Schwartz, To Ban or Not to Ban - That Is The Question: The Constitutionality of a Moratorium on Consumer Drug Advertising, 63 FOOD DRUG L. J. 1 (2008).
18. 21 U.S.C. §§ 321(n) (prescription drugs), 352 (q)(1) (restricted medical devices).
19. 21 U.S.C. § 352(n).
20. 21 C.F.R. § 202.1(e)(1). "Reminder advertisements," i.e., advertisements that mention the name of a prescription drug but do not give indications for use or dosage recommendations, are exempted from the requirements for the disclosure of risk information. 21 C.F.R. §§ 200.200, 202.1(e)(2)(i). As such, they cannot form the basis of any action claiming that a manufacturer failed to provide an adequate warning of a drug's risks to consumers, nor even constitute admissible evidence in actions raising that claim.
21. Id. § 202.1(e)(5).
22. Draft Guidance for Industry on Improving Information About Medical Products and Health Conditions; Withdrawal Availability, 69 Fed. Reg. 6308 (Feb. 10, 2004) ("Currently, it is commonplace for manufacturers to comply with the brief summary requirements by presenting verbatim and in small type the entire risk-related sections of the FDA-approved professional labeling.").
23. Draft Guidance for Industry on Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements; Availability, 66 Fed. Reg. 20468-01, at 2 (Apr. 23, 2001).
24. FDA, Draft Guidance For Industry: Brief Summary: Disclosing Risk Information In Consumer-Directed Print Advertisements (Jan. 2004) ("2004 Guidance") at 2, available at http://www.fda.gov/cder/guidance/ 5669dft.htm.
25. Id. at 5.
26. Id. at 6. For the Physician's Labeling Rule, see 21 C.F.R. §§ 201.56, 201.80; Final Rule: Requirements on the Content and Format of Labeling for Human Prescription Drug and Biological Products, 71 Fed. Reg. 3922 (Jan. 24, 2006). The changes in the format that are mandated by the Physician's Labeling Rule were still under consideration when the January 2004 Guidance was issued. One of the significant purposes behind the new labeling rule was to make it easier for health care providers to locate and absorb pertinent prescribing information. This was accomplished by mandating inclusion of a new section called "Highlights" that prominently displays and summarizes, among other things, the most significant risk information about the drug. The new rule mandates the enumerated labeling changes for all newly approved prescription drugs, for all drugs approved within five years of the effective date of June 30, 2006, and for all drugs whose label is changed after the effective date of the rule because of a newly approved use. 21 C.F.R. § 201.56(b)(1).
27. 2004 Guidance at 4.
28. Id.
29. Id. at 2.
30. 21 C.F.R. § 202(e)(1) (emphasis added).
31. 21 U.S.C. § 352(n). This requirement was added by a provision of the Food and Drug Administration Amendments Act of 2007 (FDAAA) that took effect March 25, 2008. See Pub. L. No. 110-85, § 901(d)(3)(A). The FDAAA includes other provisions that apply to the FDA's regulation of drug advertising. FDA now has certain limited authority to prereview television advertisements. FDA may recommend changes to such advertisements that it deems necessary to protect consumers or that are consistent with the prescribing information for the drug. 21 U.S.C. § 353b (a)-(c). The FDAAA also authorizes FDA to require specific disclosures in television advertisements, such as a disclosure about a serious risk listed in the drug's labeling, to ensure that the advertisements are not misleading. Id. § 353b (e)(1). A manufacturer that disseminates a direct-to-consumer advertisement that is false and misleading can be subject to civil penalties, but will not be required to pay a penalty if it submitted the advertisement to FDA and disseminated the advertisement only after incorporating all comments received from FDA. Id. § 333 (g)(1), (4). The FDAAA also added a provision requiring that all print advertisements for drugs include the following statement: "You are encouraged to report negative side effects of prescription drugs to FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088." 21 U.S.C. § 352(n). FDA was directed to undertake a study to determine whether the same statement should also be required in television advertisements. Pub. L. No. 110-85, § 906(b), 121 Stat. 823 (Sept. 27, 2007).
32. 21 U.S.C. § 352(n).
33. FDA, Guidance For Industry; Consumer-Directed Broadcast Advertisements (Aug. 1999), available at http://www.fda.gov/cder/Guidance/1804fnl.htm.
34. Id. at 2-3.
35. Francis B. Palumbo & Daniel Mullins, The Development of Direct-to-Consumer Drug Advertising Regulation, 57 FOOD & DRUG L.J. 423, 424 (2002) (identifying a 1981 advertisement for the prescription drug Rufen as the first direct-to consumer print advertisement in the United States).
36. See, e.g., J.S. Weissman, et al., Physicians Report On Patient Encounters Involving Direct-To-Consumer Advertising, HEALTH AFFAIRS W4-219 (Apr. 28, 2004), at http://content.healthaffairs. org/cgi/reprint/hlthaff.w4.219vl.;
37. Bernard J. Garbutt III & Melinda E. Hofmann, Recent Developments in Pharmaceutical Products Liability Law: Failure to Warn, the Learned Intermediary Doctrine, and Other Issues in the New Millennium, 58 FOOD & DRUG L. J. 269, 274 (2003).
38. See supra text accompanying note 33.
39. 68 FED. REG. 47920, 47922 (Aug. 12, 2003);
40. 60 FED. REG. 42581, 42584 (Aug. 16, 1995).
41. See FDA, Policy Development and Guidance to Industry, available at http://www.fda.gov/cder/handbook/pol_guid.htm.
42. Perez v. Wyeth Labs., 734 A.2d 1245 (N.J. 1999).
43. See In re Meridia Prods. Liab. Litig., 328 F. Supp. 2d 791, 812 (N.D. Ohio, 2004).
44. State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va., 2007).
45. Perez, 734 A.2d at 1247-48.
46. Id. at 1249.
47. Id. at 1254-56.
48. Id. at 1255.
49. Id. at 1255-56.
50. Id. at 1259.
51. Id.
52. Id. at 1260-63.
53. Johnson & Johnson, 647 S.E.2d at 900.
54. Id. at 901.
55. Id. at 914.
56. Id. at 902-10.
57. Id. at 913.
58. See In re Norplant Contraceptive Prods. Liab. Litig., 215 F. Supp. 2d 795, 803 (E.D. Tex. 2002); Vitanza v. Upjohn Co., 778 A.2d 829, 847 (Ct. 2001) ("[W]e see no reason to create an entirely new exception on the facts of the present case, where the traditional doctor-patient relationship existed, there were no communication problems, and adequate warnings were provided to the prescribing physician."). Cf. Allen v. G.D. Searle & Co., 708 F. Supp. 1142, 1147-48 (D. Ore. 1989) (applying Oregon law) (learned intermediary doctrine applied where a doctor exercised his or her "individualized medical judgment" before prescribing the product to plaintiff, even where the manufacturer promoted its product directly to consumers.) See also Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514, 547 n.30 (E.D. Pa. 2006), aff'd, _F.3d_, 2008 WL 927848 (3d Cir. Apr. 8, 2008) (noting that Pennsylvania cases had refused to follow Perez); In re Meridia, 328 F. Supp. 2d at 812 n.19, 814.
59. See, e.g., Garside v. Osco Drug, Inc., 764 F. Supp. 208, 2111 n.4 (D. Mass., 1991) ("In an appropriate case, the advertising of a prescription drug to the consuming public may constitute a third exception to the learned intermediary rule. By advertising directly to the consuming public, the manufacturer bypasses the traditional patient-physician relationship, thus lessening the role of the 'learned intermediary.'"), rev'd on other grounds, Garside v. Osco Drug, Inc., 976 F.2d 77 (1st Cir. (Mass.), 1992); Shanks, 835 P.2d at 1200; Wyeth-Ayerst Labs. Co., 28 S.W.3d at 93 n.5. The California legislature is currently considering a bill that would add a provision to the California Civil Code declaring that "[m]anufacturers of prescription pharmaceutical products shall not be relieved of a duty to warn consumers of the risks and side effects solely because the product was prescribed to a patient by a physician." See A.B. 2690, 2007-08 Reg. Sess. (Cal. 2008).
60. See Plaintiffs' Motion In Limine No. 7 To Exclude Any Evidence Or Argument Regarding The Learned Intermediary Doctrine, Grossberg v. Merck and Co., Inc.; Arrigale v. Merck & Co., Inc. (Los Angeles County Superior Court Case No. JCCP 4247, Docket Nos. BC327729 and 05CC03136) (filed May 19, 2006); Plaintiffs' Motion In Limine No. 7 To Exclude Any Evidence Or Argument Regarding The Learned Intermediary Doctrine, Arrigale v. Merck & Co., Inc.; Appell v. Merck & Co., Inc. (Los Angeles Superior Court Case No. JCCP 4247, Docket Nos. 05CC03136 and BC328858) (filed Oct. 13, 2006); Plaintiffs' Motion For Directed Verdict On Defendant's Affirmative Defense Of The Learned Intermediary Doctrine, Arrigale v. Merck & Co., Inc.; Appell v. Merck & Co., Inc. (Los Angeles Superior Court Case No JCCP 4247, Docket Nos. 05CC03136 and BC328858) (filed Dec. 18, 2006); Plaintiff's Motion in Limine No. 7 To Exclude Any Evidence Or Argument Regarding The Learned Intermediary Doctrine, Berwick v. Merck & Co., Inc. (Los Angeles County Superior Court Case No. JCCP 4247, Docket No. BC328855) (filed March 5, 2007).
61. Perez, 734 A.2d at 1256 (emphasis added).
62. See Johnson & Johnson, 647 S.E. 2d at 917 (Albright, J., dissenting) ("[T]o 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.").
63. See supra note 55 and accompanying text. The trial court in Perez reached the same conclusion in ruling that the learned intermediary rule applied. It reasoned that even if a prescription drug advertising campaign has influenced a consumer to request a particular drug, "a physician is not simply relegated to the role of prescribing the drug according to the woman's wishes." Perez, 734 A.2d at 1249 (quoting Perez v. Wyeth Labs., Inc., 713 A. 2d 588, 588 (N.J. Law Div. 1997).
64. FDA, Final Report: Patients and Physicians Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs (Nov. 19, 2004), available at http://www.fda.gov/cder/ddmac/researchka.htm.
65. Id. at 2, 5, 86, 88.
66. Id. at 63, 90.
67. Id. at 72, 74
68. Id. at 71.
69. Weissman, supra note 35, at W4-226.
70. Id. at W4-229.
71. Id. at W4-227 (Exh. 5), W4-230. In most of the visits falling into this small category, the prescribing physician was a surgeon. For this reason, the survey's authors suggested that the prescriptions for an advertised drug might have been attributable to the patients' preference for noninvasive treatment. Id. at W4-230.
72. DTC advertising of prescription medicines generates a great deal of controversy. Both proponents and opponents of such advertising can find support for their positions in various surveys and studies undertaken in the last two decades. It is not the intent of this article to present a defense of such advertising per se or to attempt to draw conclusions from small samples about patient and physician attitudes and behavior in the population as a whole. Rather, the significance of study results such as those summarized is that they strongly suggest that there is not enough evidence that direct-to-consumer advertising has changed the attitudes and behavior of patients and physicians in ways that mean that the traditional reasons for the learned intermediary doctrine are no longer valid.
73. 21 U.S.C. § 353 (b)(1).
74. See supra notes 11, 25 and accompanying text. See generally 21 C.F.R. § 201.56.
75. See supra notes 22-28 and accompanying text.
76. See supra notes 32-33 and accompanying text.
77. See supra notes 25, 28 and accompanying text.
78. See infra notes 79-80 and accompanying text.
79. Dowhal v. SmithKline Beecham Consumer Healthcare, 88 P.3d 1, 14 (2004). See also supra note 9.
80. Carlin, 920 P.2d at 1347 (citations and internal quotation marks omitted).
81. See supra text accompanying notes 26-28.
82. 71 FED. REG, supra note 12, 3935.
83. Id.
84. Perez, 734 A. 2d at 1263.
85. Johnson & Johnson, 647 S.E.2d at 914.
86. To provide just a few examples, the majority opinion in Johnson & Johnson made no real attempt to address how pharmaceutical manufacturers are to warn consumers of the risks of the many prescription drugs that do not have FDA-approved patient labeling and are not advertised, nor did it consider how manufacturers are to warn patients directly about the risks of prescription drugs administered in hospitals. One concurring opinion pointed to the latter situation as an area where a duty to warn end-users directly would not be feasible, and suggested in passing that to fulfill the duty the court was imposing "[l]abels can be placed on bottles, pamphlets tucked into boxes, and brochures packed in with the boxes of drugs and devices...." See Johnson & Johnson, 647 S.E.2d at 920 (Maynard, J., concurring) The majority reasoned that what it characterized as a "plethora" of exceptions to the learned intermediary doctrine meant that there was "no benefit in adopting a doctrine that would require the simultaneous adoption of numerous exceptions in order to be justly utilized." 647 S.E.2d at 913. There is considerable irony in this comment since it is evident that many extremely broad "exceptions" to its own ruling would have to be recognized to make the ruling "justly utilized" or workable at all in the real world.
87. Perez, 734 A.2d at 1255.
88. Martin, 628 N.E. 2d at 1312 (emphasis added). See also supra note 11 and accompanying text.
89. RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY § 2(c) ("A product...is defective because of inadequate instructions or warnings when the foreseeable risks of harm posed by the product could have been reduced or avoided by the provision of reasonable instructions or warnings by the seller or other distributor...and the omission of the instructions or warnings renders the product not reasonably safe.")
90. Some courts have recognized exceptions to the learned intermediary doctrine that require the fact-finder to evaluate the reasonableness of a standardized warning directed to end-users in the case of mass vaccinations, where a physician may not even be present (see, e.g., Reyes, 498 F.2dat 1277),and in the case of oral contraceptives, which are typically prescribed to healthy patients who take them for long periods of time without being seen by a physician, and which are dispensed with direct warnings to patients required by FDA. See MacDonald v. Ortho Pharm. Corp., 475 N.E.2d 65, 68-70 (Mass. 1985). These exceptions are narrowly drawn and were developed in view of the very specific characteristics of the medical products involved that make them different from most prescription medicines. See, e.g., MacDonald, 475 N.E. 2d at 70 ("The oral contraceptive...stands alone from other prescription drugs [.]") They are not universally recognized. In Norplant Contraceptive Prods. Liab. Litig., 955 F. Supp. 700, 704, 707 (E.D. Tex., 1997), the court noted that "[o]nly a single jurisdiction, Massachusetts, recognizes an exception to the doctrine for prescription contraceptives" and rejected the contraceptive exception because "[e]ven if it were true that women play a greater role in selecting among prescription contraceptives, these products are nevertheless available only by prescription from a physician. The fact that the patient plays a role in deciding to use a particular prescription drug does not diminish the physician's role in determining her suitability for different drugs and in counseling with her as to the benefits and potential risks of each." Id. at 707. See also Mazur v. Merck & Co., Inc., 742 F. Supp. 239, 253 (E.D. Pa., 1990) (stating that "[a]ll of the vaccine cases recognize the theoretical validity of the 'mass immunization exception' to the learned intermediary rule, but very few have found situations where its application is warranted.").
91. See McKee v. American Home Products Corp., 782 P.2d 1045, 1050-51 (Wash., 1989) ("The foreseeability of injury to an individual consumer in the absence of any particular warning...varies greatly depending on the medical history and condition of the individual."); Leesley v. West, 518 N.E.2d 758, 762 (Ill. App. 2 Dist., 1988 (same; also noting that "[t]he fact that manufacturers of a prescription drug cannot adequately evaluate the effect of the drug on any particular patient is one of the predominant reasons that courts have adopted the learned intermediary doctrine exempting those manufacturers from the duty to directly warn consumers").
92. Perez, 734 A.2d at 1259.
93. Perez held that the presumption that a warning that complied with FDA requirements was adequate could be rebutted by showing that the manufacturer deliberately withheld safety information from FDA that, if disclosed, would have changed what FDA required to be included in labeling or advertising. Perez, 734 A.2d at 1259. In the authors' view, claims of "fraud on FDA" in this context are foreclosed by the Supreme Court's ruling in Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001). In Buckman, the Court held that state tort claims directly asserting that a pharmaceutical manufacturer deliberately concealed information from FDA are preempted because allowing such claims would interfere with FDA's ability to police compliance with its own regulatory requirements. Buckman, 531 U.S. at 350. Courts have split on whether similar misrepresentations or concealment claims made in order to rebut the presumption of an adequate warning are also pre-empted under the rationale of Buckman. This issue was before the Court earlier this year in Warner-Lambert v. Kent, but the Court's disposition of the case did not resolve the issue because the decision was a 4-4 split after Chief Justice Roberts recused himself from the case. See Warner-Lambert Co., LLC v. Kent, 128 S.Ct. 1168 (Mem) (Mar. 3, 2008). The broader issue whether FDA's approval of a drug and its determination of what should be included in the drug labeling information impliedly preempt state law failure-to-warn claims is presented in Wyeth v. Levine, 128 S. Ct. 1118 (Mem) (2008) (No. 06-1249). which the Supreme Court will hear in the fall of 2008.
94. Only a minority of jurisdictions recognize a rebuttable presumption of adequacy based on compliance with FDA requirements or on compliance with applicable governmental regulatory requirements in general. See COLO. REV. STAT. ANN. § 13-21-403(1)(b) (2007); FLA. STAT. ANN. § 768.1256(1) (2007); IND. CODE ANN. § 34-20-5-1(2)(2007); KAN. STAT. ANN. § 60-3304(a)(2007); MICH. COMP. LAWS 600.2946(4)(2007); N.J. STAT. ANN. § 2A: 58C-4 (2007); N.D. CENT. CODE § 28-01.3-09 (2007); TEX. CIV. PRAC. & REM. CODE § 82.007(a) (2007); UTAH CODE ANN. § 78-15-6(3)(2007).