Surfing the net in shallow waters: Product liability concerns and advertising on the internet

Food and Drug Law Journal

Volumn 53, Issue 2, 1998, Pages 213-224

  Moberg, Marilyn A ^a   Wood, James W ^b   Dorfman, Howard L ^c  

^a Crosby Heafey Roach and May   (United States)

^b Crosby Heafey Roach and May   (United States)

^c BRISTOL MYERS SQUIBB   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

COSMETIC; DRUG;

DEVICE; DRUG LABELING; DRUG MARKETING; FOOD AND DRUG ADMINISTRATION; INTERNET; LAW; PRACTICE GUIDELINE; REVIEW;

ADVERTISING; CONSUMER PRODUCT SAFETY; HUMANS; INFORMATION SERVICES; INTERNET; LIABILITY, LEGAL; MARKETING OF HEALTH SERVICES; PRODUCT LABELING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0031867405     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (73)

1. According to Internet User Statistics, this number reflects "users world-wide" as of September 1997 and includes China, the Pacific Rim, Europe, India, and Russia. Estimates are that approximately 40% of current users are located outside of the United States. Internet User Statistics, (visited Nov. 13, 1997) 〈http:// www.lsilink.com/usage_stats.html〉.
2. American Civil Liberties Union v. Reno, 929 F. Supp. 824 (1996), aff'd 117 S. Ct. 2329, 138 L.Ed.2d 874 (1997).
3. "In 1996, $2.6 billion dollars worth of transactions were conducted via the World-Wide Web from more than 32 million devices (PC's, Net-TV, etc.)." Internet User Statistics, supra note 1.
4. The power of the Internet has not been lost on FDA, which has created its own homepage (〈http:// www.fda.gov〉) and uses it for such purposes as announcing approvals and denials of PMAs and posting regulatory letters. See 63 Fed. Reg. 4571 (Jan. 30, 1998). FDA will permit device companies to fulfill the agency's site registration requirement by completing an electronic form on the FDA homepage. See M-D-D-I REP. ("The Gray Sheet"), Feb. 6, 1998, at I&W8. Summaries of labeling changes can be found at 〈www.fda.gov/medwatch〉.
5. The power of the Internet has not been lost on FDA, which has created its own homepage (〈http:// www.fda.gov〉) and uses it for such purposes as announcing approvals and denials of PMAs and posting regulatory letters. See 63 Fed. Reg. 4571 (Jan. 30, 1998). FDA will permit device companies to fulfill the agency's site registration requirement by completing an electronic form on the FDA homepage. See M-D-D-I REP. ("The Gray Sheet"), Feb. 6, 1998, at I&W8. Summaries of labeling changes can be found at 〈www.fda.gov/medwatch〉.
6. The power of the Internet has not been lost on FDA, which has created its own homepage (〈http:// www.fda.gov〉) and uses it for such purposes as announcing approvals and denials of PMAs and posting regulatory letters. See 63 Fed. Reg. 4571 (Jan. 30, 1998). FDA will permit device companies to fulfill the agency's site registration requirement by completing an electronic form on the FDA homepage. See M-D-D-I REP. ("The Gray Sheet"), Feb. 6, 1998, at I&W8. Summaries of labeling changes can be found at 〈www.fda.gov/medwatch〉.
7. The power of the Internet has not been lost on FDA, which has created its own homepage (〈http:// www.fda.gov〉) and uses it for such purposes as announcing approvals and denials of PMAs and posting regulatory letters. See 63 Fed. Reg. 4571 (Jan. 30, 1998). FDA will permit device companies to fulfill the agency's site registration requirement by completing an electronic form on the FDA homepage. See M-D-D-I REP. ("The Gray Sheet"), Feb. 6, 1998, at I&W8. Summaries of labeling changes can be found at 〈www.fda.gov/medwatch〉. A good summary of the site is Marilyn Larkin, Health Information On-Line, FDA CONSUMER, June 1, 1996, at 21; see 〈www.fda.gov/search97cgi/vtopic?action〉. A good summary of the site is Marilyn Larkin, Health Information On-Line, FDA CONSUMER, June 1, 1996, at 21; see 〈www.fda.gov/search97cgi/vtopic?action〉.
8. Pub. L. No. 75-717, 52 Stat. 1040 (1938) (as amended 21 U.S.C §§ 301 et seq. (1994)).
9. The content of pharmaceutical product promotions is regulated by two federal agencies: FDA and the Federal Trade Commission (FTC). For a detailed discussion of this topic, see Peter S. Reichertz, Legal Issues Concerning the Promotion of Pharmaceutical Products on the Internet to Consumers, 51 FOOD & DRUG L.J. 356 (1996).
10. The content of pharmaceutical product promotions is regulated by two federal agencies: FDA and the Federal Trade Commission (FTC). For a detailed discussion of this topic, see Peter S. Reichertz, Legal Issues Concerning the Promotion of Pharmaceutical Products on the Internet to Consumers, 51 FOOD & DRUG L.J. 356 (1996). Generally, FDA has jurisdiction over advertising and promotion of prescription pharmaceutical products, both drugs and biologies; FTC has jurisdiction over the promotion of over-the-counter (OTC) drug products. Id. at 356. The agencies have entered into a memorandum of understanding (MOU), which gives FDA primary jurisdiction to regulate the advertising and promotion of prescription drugs. Id. (citing MOU, 36 Fed. Reg. 18,538 (Sept 9, 1971)). The regulation of nonrestricted medical devices also is under the jurisdiction of the FTC. Id. Generally, FDA has jurisdiction over advertising and promotion of prescription pharmaceutical products, both drugs and biologies; FTC has jurisdiction over the promotion of over-the-counter (OTC) drug products. Id. at 356. The agencies have entered into a memorandum of understanding (MOU), which gives FDA primary jurisdiction to regulate the advertising and promotion of prescription drugs. Id. (citing MOU, 36 Fed. Reg. 18,538 (Sept 9, 1971)). The regulation of nonrestricted medical devices also is under the jurisdiction of the FTC. Id.
11. See 21 U.S.C §§ 321(g), (h), (m), (n), 352, 355 (FDCA §§ 201(g), (h), (m), (n), 502, 505). A device is deemed to be "restricted" if it is sold, distributed, or used only with a licensed practitioner's oral authorization or when specific conditions establishedby the agency are met FDA ADVERTISING AND PROMOTION MANUAL § 600 (Thompson Pub. 1995). Devices are decreed restricted on a case-by-case basis by either regulation (e.g., hearing aids) or as a condition of premarket approval. Id.
12. For purposes of advertising of medical devices, the Medical Device Amendments of 1976 define this authority. Prior to 1976 some devices were regulated by FDA as drugs with respect to premarket approval requirements and, derivatively, advertising. FDA ADVERTISING AND PROMOTION MANUAL § 600 (Thompson Pub. 1996).
13. In short, some of the key differences between prescription drug and restricted device advertising and drug and device promotion include the following: 1) there are no regulations governing restricted device advertising and promotion; 2) continuing medical education affects the marketing of devices and drugs differently; 3) the rules that apply to pre-approval promotion of devices are different than those for drugs; 4) there is less public and congressional focus on the issues of promotion and misleading advertising of devices than for drugs; and 5) the Prescription Drug Marketing Act of 1987 applies only to the provision of samples of pharmaceuticals as there is no comparable regulation reaching the provision of medical device samples by manufacturers' representatives. See FDA ADVERTISING AND PROMOTION MANUAL, supra note 7, § 601.
14. 21 C.F.R. §§ 201, 202 (1997).
15. 21 U.S.C. § 352 (FDCA § 502).
16. Id. § 321(k) (FDCA § 201(k)).
17. Id. § 321(m) (FDCA § 201(m)).
18. 21 C.F.R. § 202.1(1)(2).
19. See, e.g., Guidance to Industry on Dissemination of Reprints of Certain Published, Original Data, 61 Fed. Reg. 52,800 (Oct. 8, 1996); Draft Policy Statement on Industry-Supported Scientific and Educational Activities, 57 Fed. Reg. 56,412 (Nov. 27, 1992).
20. See, e.g., Guidance to Industry on Dissemination of Reprints of Certain Published, Original Data, 61 Fed. Reg. 52,800 (Oct. 8, 1996); Guidance for Industry Funded Dissemination of Reference Texts, 61 Fed. Reg. 52,800 (Oct. 8, 1996); Guidance for Industry Funded Dissemination of Reference Texts, 61 Fed. Reg. 52,800 (Oct. 8, 1996);
21. See, e.g., Guidance to Industry on Dissemination of Reprints of Certain Published, Original Data, 61 Fed. Reg. 52,800 (Oct. 8, 1996); Guidance for Industry Funded Dissemination of Reference Texts, 61 Fed. Reg. 52,800 (Oct. 8, 1996); Draft Policy Statement on Industry-Supported Scientific and Educational Activities, 57 Fed. Reg. 56,412 (Nov. 27, 1992). Draft Policy Statement on Industry-Supported Scientific and Educational Activities, 57 Fed. Reg. 56,412 (Nov. 27, 1992).
22. 21 C.F.R. § 201.56(d).
23. See 21 U.S.C. § 352 (FDCA § 502). A drug or medical device is "misbranded" if its advertising is false or misleading in any particular; fails to contain required information, fails to prominently display required information; does not contain the generic or established name in the required type size, does not contain adequate directions for use. Id. § 352(a) et seq. See also Food and Drug Administration Modernization Act of 1997 (FDAMA), Pub. L. No. 105-115, § 126, 111 Stat. 2295.
24. 21 C.F.R. § 202.1(1)(1).
25. 21 U.S.C. § 352(r) (FDCA § 502(r)).
26. Id. § 352(n) (FDCA § 502(n)).
27. 21 C.F.R. §§ 202 et seq.
28. FDAMA permits off-label promotion in certain limited circumstances in peer-reviewed journal articles. Pub. L. No. 105-115, § 551, 111 Stat. at 2356 (FDCA § 360aaa).
29. 21 C.F.R. § 202.1(e)(1).
30. Id. § 202.1(e)(3). See also Patricia J. Kenney, Prescription Drug Promotion & Advertising, Presentation at FDLI'S Workshop, "Introduction to Drug Law and Regulation: Understanding How FDA Regulates the Drug Industry," Washington, D.C. (Sept. 16, 1997).
31. 21 C.F.R. § 202.1(e)(1).
32. Id.
33. In a recently-issued draft guidance for the industry, FDA's Intra-Agency Working Group on Advertising and Promotion attempted to present its "current thinking" on procedures to fulfill the requirements for disclosure of product information in connection with consumer-directed broadcast advertisements for prescription human and animal drugs and human biological products. Draft Guidance for Industry Consumer-Directed Broadcast Advertisements, 62 Fed. Reg. 43,171 (Aug. 12, 1997); 〈http://www.fda.gov./cder/guidance.html〉. In the guidance FDA proposed an alternative, setting forth four things a company could do to satisfy the adequate provision requirements: 1) operating a toll-free number for consumers to obtain the approved package labeling by mail, fax, or by having it read over the telephone; 2) providing a mechanism to obtain package labeling for consumers with restricted access to technology, such as the Internet, and for those who are not active information seekers; 3) providing a statement in the broadcast that pharmacists or physicians may provide additional product information ; and 4) including an Internet Web page address in the broadcast advertisement or via the associated toll-free number that provides access to the package labeling. Draft Guidance, 62 Fed. Reg. at 43,171.
34. See Device Information on the Internet Likely Constitutes Labeling, M-D-D-I REP. ("The Gray Sheet"), July 15, 1996, at I&W5-6 (discussing Device Submissions Workshop, Washington, D.C. (July 11-12, 1996)).
35. Id.
36. Promotion of FDA-Regulated Medical Products on the Internet; Notice of Public Meeting, 61 Fed. Reg. 48,707 (Sept. 16, 1996).
37. See e.g., Andrew A. Skolnick, WHO Considers Regulating Ads, Sale of Medical Products on Internet, 278 JAMA 1723 (Dec. 3, 1997).
38. FDA ADVERTISING AND PROMOTION MANUAL § 637 (Thompson Pub. 1997).
39. Id.
40. 77 N.Y.S. 2d 508 (N.Y. Sup. 1948).
41. 370 F.2d 82, 85 (8th Cir. 1966).
42. Id. at 85.
43. The American Law Institute has breathed new vitality into the learned intermediary rule in its RESTATEMENT (THIRD) OF TORTS: PRODUCT LIABILITY § 6 (Proposed Final Draft 1997).
44. The American Law Institute has breathed new vitality into the learned intermediary rule in its RESTATEMENT (THIRD) OF TORTS: PRODUCT LIABILITY § 6 (Proposed Final Draft 1997). Cf. RESTATEMENT (THIRD) OF TORTS, Reporter's Note to Comment e (regarding the learned intermediary doctrine and direct-to-consumer advertising). Cf. RESTATEMENT (THIRD) OF TORTS, Reporter's Note to Comment e (regarding the learned intermediary doctrine and direct-to-consumer advertising).
45. 475 N.E.2d 65 (Mass. 1985),
46. In re Norplant Contraceptive Products Liability Litigation, 955 F. Supp. 700 (E.D. Texas 1997),
47. Id. at 706.
48. 487 S.E. 2d 70, 226 Ga. App. 547 (Ga, Ct. App. 1997), cert. denied, GA DN S97C1553 (Jan. 5, 1998).
49. Id. at 73-74, 226 Ga. App. at 549.
50. 9 Cal. 3d 51 (1973).
51. Id. at 57.
52. Id. at 58, n.4.
53. Id.
54. Id. at 65.
55. Id.
56. For example, FDA recently issued a notice to consumers advising that a home abortion kit and female self-sterilization kit promoted by a Bogota, Columbia company involved un approved drugs for these uses. See T. Nordenberg, Ads for Illegal Kits Kicked Off-Line, FDA CONSUMER, Nov. 21, 1997, at 39. The advertisements were later removed. Likewise, Fen-Phen has emerged as another "mass tort" pursued by the plaintiffs' bar. FDA has expressed concern about the information on the Internet about "herbal fen-phen."
57. For example, FDA recently issued a notice to consumers advising that a home abortion kit and female self-sterilization kit promoted by a Bogota, Columbia company involved un approved drugs for these uses. See T. Nordenberg, Ads for Illegal Kits Kicked Off-Line, FDA CONSUMER, Nov. 21, 1997, at 39. The advertisements were later removed. Likewise, Fen-Phen has emerged as another "mass tort" pursued by the plaintiffs' bar. FDA has expressed concern about the information on the Internet about "herbal fen-phen." Herbal Fen-Phen Warning, FDA CONSUMER, Jan. 11, 1998, at 2. Herbal Fen-Phen Warning, FDA CONSUMER, Jan. 11, 1998, at 2.
58. Of the 13 letters, 11 have been for devices and one for a prescription drug. Of these, one warning letter was for pre-approval promotion, nine were for off-label uses, and three were for unapproved products.
59. Food and Drug Admin., Dep't of Health and Human Servs., FDA and the Internet, Advertising and Promotion of Medical Products, Transcript of Public Hearing (Oct. 16-17, 1996) [hereinafter Hearing Transcript] (Vol. I, at 17, Discussion Group 4).
60. Food and Drug Admin., Dep't of Health and Human Servs., FDA and the Internet, Advertising and Promotion of Medical Products, Transcript of Public Hearing (Oct. 16-17, 1996) [hereinafter Hearing Transcript] (Vol. I, at 17, Discussion Group 4). See also Internet Links to Web Sites Containing Off-Label Data Should Be Permitted, Glaxo Attorney Says; Firms Should Monitor Upstream Links, FDA Says, M-D-D-I REP. ("The Gray Sheef"), Oct. 21, 1996, at 5. See also Internet Links to Web Sites Containing Off-Label Data Should Be Permitted, Glaxo Attorney Says; Firms Should Monitor Upstream Links, FDA Says, M-D-D-I REP. ("The Gray Sheef"), Oct. 21, 1996, at 5.
61. Hearing Transcript supra note 51, at 15.
62. Id. at 16.
63. 21 C.F.R. §§ 312.7(a), 812.7. See also Hearing Transcript, supra note 51, at 10 (Discussion Group 1); Warning letter from Center for Devices and Radiological Health, FDA, to Harrier, Inc. (Apr. 1, 1997) (unapproved use of skin lamp).
64. 21 C.F.R. §§ 312.7(a), 812.7. See also Hearing Transcript, supra note 51, at 10 (Discussion Group 1); Internet Data Prompt Warning Letter, 24 DEVICES & DIAGNOSTICS LETTER, Mar. 21, 1997, at 1; Internet Data Prompt Warning Letter, 24 DEVICES & DIAGNOSTICS LETTER, Mar. 21, 1997, at 1;
65. 21 C.F.R. §§ 312.7(a), 812.7. See also Hearing Transcript, supra note 51, at 10 (Discussion Group 1); Internet Data Prompt Warning Letter, 24 DEVICES & DIAGNOSTICS LETTER, Mar. 21, 1997, at 1; Warning letter from Center for Devices and Radiological Health, FDA, to Harrier, Inc. (Apr. 1, 1997) (unapproved use of skin lamp). Warning letter from Center for Devices and Radiological Health, FDA, to Harrier, Inc. (Apr. 1, 1997) (unapproved use of skin lamp).
66. Hearing Transcript, supra note 51, at 10 (Discussion Group 1).
67. See, e.g., CompuServe, Inc. v. Patterson, 89 F.3d 1257 (6th Cir. 1996).
68. Compare Bensusan Restaurant Corp. v. King, 126 F.3d 25 (2d Cir. 1997) with Inset Systems v. Instruction Set, Inc., 937 F. Supp. 161 (D. Conn. 1996).
69. Bruce Telles, Avoiding the Long Arm of the Law in Cyberspace, L.A. DAILY J., Dec. 13, 1997,; at 5.
70. Larkin, supra note 4.
71. Id.
72. Id.
73. Id.