"Dot.Com Medicine" - Labeling in an internet age

Food and Drug Law Journal

Volumn 56, Issue 2, 2001, Pages 143-165

  Wood, James M ^a   Dorfman, Howard L ^b  

^a Crosby Heafey Roach and May   (United States)

^b NONE

Author keywords

[No Author keywords available]

Indexed keywords

DRUG;

CONFERENCE PAPER; DRUG LABELING; DRUG MANUFACTURE; DRUG MARKETING; INTERNET; MEDICAL TECHNOLOGY; TELECOMMUNICATION;

ADVERTISING; DRUG LABELING; HUMANS; INFORMATION SERVICES; INTERNET; UNITED STATES;

EID: 0034883842     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Conference Paper

References (130)

1. U.S. Department of Commerce, The Emerging Digital Economy, Chapter 1 (1998) (last visited May 16, 2001) www.ecommerce.gov/danc1.htm.
2. Pam R. Rajendran, The Internet: Ushering in a New Era of Medicine, 285 MED. STUDENT JAMA 804 (Feb. 14, 2001).
3. Milt Freudenheim, A Plan to Send Prescriptions Electronically, N.Y. TIMES, Feb. 23, 2001, at Business Financial Desk Section (describing a venture between three companies that plan to send prescriptions from physicians to pharmacies over the Internet).
4. Market Letter, Of Internet Pharmacy Sales, At Least $1.4 Billion by 2001, Jan. 3, 2000. While the regulation of pharmacies dispensing prescription medicines over the Internet is beyond the scope of this paper, there are many excellent articles discussing this issue. See Amy J. Oliver, Internet Pharmacies: Regulation of a Growing Industry, 28 J.L. MED. ETHICS 98 (Spring 2000); Peter S, Reichertz, Legal Issues Concerning the Promotion of Pharmaceutical Products on the Internet to Consumers, 51 FOOD & DRUG L.J. 355 (1996); Sean P. Haney, Pharmaceutical Dispensing in the Wild West: Advancing Health Care and Protecting Consumers Through the Regulation of Online Pharmacies, 42 WM. & MARY L. REV. 575 (Dec. 2000); David Mills, Cybemedicine: The Benefits and Risks of Purchasing Drugs Over the Internet, 5 J. TECH L. & POL'Y (Summer 2000).
5. Market Letter, Of Internet Pharmacy Sales, At Least $1.4 Billion by 2001, Jan. 3, 2000. While the regulation of pharmacies dispensing prescription medicines over the Internet is beyond the scope of this paper, there are many excellent articles discussing this issue. See Amy J. Oliver, Internet Pharmacies: Regulation of a Growing Industry, 28 J.L. MED. ETHICS 98 (Spring 2000); Peter S, Reichertz, Legal Issues Concerning the Promotion of Pharmaceutical Products on the Internet to Consumers, 51 FOOD & DRUG L.J. 355 (1996); Sean P. Haney, Pharmaceutical Dispensing in the Wild West: Advancing Health Care and Protecting Consumers Through the Regulation of Online Pharmacies, 42 WM. & MARY L. REV. 575 (Dec. 2000); David Mills, Cybemedicine: The Benefits and Risks of Purchasing Drugs Over the Internet, 5 J. TECH L. & POL'Y (Summer 2000).
6. Market Letter, Of Internet Pharmacy Sales, At Least $1.4 Billion by 2001, Jan. 3, 2000. While the regulation of pharmacies dispensing prescription medicines over the Internet is beyond the scope of this paper, there are many excellent articles discussing this issue. See Amy J. Oliver, Internet Pharmacies: Regulation of a Growing Industry, 28 J.L. MED. ETHICS 98 (Spring 2000); Peter S, Reichertz, Legal Issues Concerning the Promotion of Pharmaceutical Products on the Internet to Consumers, 51 FOOD & DRUG L.J. 355 (1996); Sean P. Haney, Pharmaceutical Dispensing in the Wild West: Advancing Health Care and Protecting Consumers Through the Regulation of Online Pharmacies, 42 WM. & MARY L. REV. 575 (Dec. 2000); David Mills, Cybemedicine: The Benefits and Risks of Purchasing Drugs Over the Internet, 5 J. TECH L. & POL'Y (Summer 2000).
7. Market Letter, Of Internet Pharmacy Sales, At Least $1.4 Billion by 2001, Jan. 3, 2000. While the regulation of pharmacies dispensing prescription medicines over the Internet is beyond the scope of this paper, there are many excellent articles discussing this issue. See Amy J. Oliver, Internet Pharmacies: Regulation of a Growing Industry, 28 J.L. MED. ETHICS 98 (Spring 2000); Peter S, Reichertz, Legal Issues Concerning the Promotion of Pharmaceutical Products on the Internet to Consumers, 51 FOOD & DRUG L.J. 355 (1996); Sean P. Haney, Pharmaceutical Dispensing in the Wild West: Advancing Health Care and Protecting Consumers Through the Regulation of Online Pharmacies, 42 WM. & MARY L. REV. 575 (Dec. 2000); David Mills, Cybemedicine: The Benefits and Risks of Purchasing Drugs Over the Internet, 5 J. TECH L. & POL'Y (Summer 2000).
8. Market Letter, Of Internet Pharmacy Sales, At Least $1.4 Billion by 2001, Jan. 3, 2000. While the regulation of pharmacies dispensing prescription medicines over the Internet is beyond the scope of this paper, there are many excellent articles discussing this issue. See Amy J. Oliver, Internet Pharmacies: Regulation of a Growing Industry, 28 J.L. MED. ETHICS 98 (Spring 2000); Peter S, Reichertz, Legal Issues Concerning the Promotion of Pharmaceutical Products on the Internet to Consumers, 51 FOOD & DRUG L.J. 355 (1996); Sean P. Haney, Pharmaceutical Dispensing in the Wild West: Advancing Health Care and Protecting Consumers Through the Regulation of Online Pharmacies, 42 WM. & MARY L. REV. 575 (Dec. 2000); David Mills, Cybemedicine: The Benefits and Risks of Purchasing Drugs Over the Internet, 5 J. TECH L. & POL'Y (Summer 2000).
9. Cal Chang Yocum, TrialPages Recruiting Patients for Clinical Trials Via Web (last visited May 16, 2001) www.localbusiness,com/Story/0,1118,NOCITY_509675,00.html. A site for matching companies, investigators, and patients is (last visited May 16, 2001) www.acurian.com.
10. One of the latest websites, (last visited May 16, 2001) health-track.org/, provides information about cancer death data and environmental toxins. The Wall Street Journal recently reported that information as well as credit card purchases for "morning-after" pills are available through a variety of sites. Web Sites Offer Post Coital Pills for Birth Control, WALL ST. J., Mar. 5, 2001, at B1. Other popular sites include: Health Web at www.healthweb.org; Cancer Net at www.cancernet.nci.nih.gov; BioSites at www.library.ucsf.edu/biosites (all sites last visited May 16, 2001). The National Library of Medicine now has a website for physicians and patients with an average 2.3 million page hits per month. Donald Lindberg, The National Library of Medicine's Web Site for Physicians and Patients, 285 MED. STUDENT JAMA 806 (Feb. 14, 2001).
11. One of the latest websites, (last visited May 16, 2001) health-track.org/, provides information about cancer death data and environmental toxins. The Wall Street Journal recently reported that information as well as credit card purchases for "morning-after" pills are available through a variety of sites. Web Sites Offer Post Coital Pills for Birth Control, WALL ST. J., Mar. 5, 2001, at B1. Other popular sites include: Health Web at www.healthweb.org; Cancer Net at www.cancernet.nci.nih.gov; BioSites at www.library.ucsf.edu/biosites (all sites last visited May 16, 2001). The National Library of Medicine now has a website for physicians and patients with an average 2.3 million page hits per month. Donald Lindberg, The National Library of Medicine's Web Site for Physicians and Patients, 285 MED. STUDENT JAMA 806 (Feb. 14, 2001).
12. Alan F. Holmer, Direct-to-Consumer Prescription Drug Advertising Builds Bridges Between Patients and Physicians, 31 JAMA 380 (Jan. 27, 1999).
13. Leah Brannon, Regulating Drug Promotion on the Internet, 54 FOOD & DRUG L.J. 599 (1999) (footnote omitted).
14. Mason Essif, Prescription Drugs Are Crossing Borders to Buyers, available at (last visited Mar. 12, 2001) www.CNN.com.
15. Center for Devices and Radiological Health (CDRH) Ends 2000 With Record Number of Promotion-Related Warning Letters, FDA Advertising and Promotion Manual (Feb. 2001).
16. See Reichertz, supra note 4 at 355.
17. Kleinfeld et al., Human Drug Regulation Comprehensiveness Breeds Complexity, in FOOD AND DRUG LAW 243 (FDLI 1991).
18. Id.
19. Memorandum of Understanding, 36 Fed. Reg. 18,538 (Sept. 9, 1971).
20. Pub. L. No. 75-717, 52 Stat 1040 (1938) (codified as amended at 21 U.S.C. §§ 301 et seq. (1994)).
21. For purposes of advertising of medical devices, the Medical Device Amendments of 1976 (MDA) defined FDA's authority. See Pub. L. No. 94-295, 90 Stat. 539 (codified at 15 U.S.C. § 55 (1994); 21 U.S.C. §§ 31, 331, 334, 351, 352, 358, 360, 360c-360k, 374, 379, 379a, 381 (1994)). Before 1976, some devices were regulated by FDA as drugs with respect to premarket approval requirements and derivatively, advertising. FDA ADVERTISING AND PROMOTION MANUAL, (Sept. 1996), at 6. The MDA gave FDA authority to regulate medical device advertising but limited the authority to restricted devices. 21 U.S.C. § 352(g), (r).
22. 21 C.F.R. § 201 (labeling); id. § 202 (prescription drug advertisement).
23. Id. § 202(c) (prescription drug advertisement).
24. 21 U.S.C. § 321 (k) (FDCA § 201 (k)).
25. 21 U.S.C § 321(m) (FDCA § 201(m)).
26. 21 C.F.R. § 202.1(1)(2).
27. See Guidance to Industry on Dissemination of Reprints of Certain Published Original Data, 61 Fed. Reg. 52,800, 52,801 (Oct. 8, 1996); Guidance for Industry Funded Dissemination of Reference Texts, 61 Fed. Reg. 52,800, 52,801 (Oct. 8, 1996); Draft Policy Statement on Industry Supported Scientific and Educational Activities, 57 Fed. Reg. 56,412 (Nov. 27, 1992).
28. 21 C.F.R. § 201.56(d).
29. 21 U.S.C. § 352. 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. Certain parts of § 352 have been repealed pursuant to the Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, 111 Stat. 2296 (1997) (amending 21 U.S.C. §§ 201 et seq.).
30. 21 C.F.R. § 202.1(1)(1).
31. Id. §§ 202 et seq.
32. See, e.g., FDA Guidance for Industry: Consumer-Directed Broadcast Advertisements, 62 Fed. Reg. 43,171 (1997). The final Guidance can be found at (last visited May 16, 2001) www.fda.gov/cder/ guidance/1804fnl.htm, which has the adequate provision requirement, prohibits publishing "false or misleading information," and requires a description of the product's major risks.
33. 21 C.F.R. § 202.1(e)(1).
34. Id. § 202.1(e)(3). See also Patricia A. Kenney, Prescription Drug Promotion & Advertising, presented at Introduction to Drug Law and Regulation: Understanding How FDA Regulates the Drug Industry, sponsored by the Food Drug Law Institute (Sept. 16, 1997).
35. 21 C.F.R. § 202.1(e)(1).
36. Id. § 202.1 (e)(1), which defines the brief summary to be "a true statement of information . . . relating to side effects, contraindications, and effectiveness." All must be listed unless the advertisement provides a specific indication.
37. In a draft guidance for industry, the Intra Agency Working Group on Advertising and Promotion at FDA presented four elements a company could perform 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) an Internet page address in the broadcast advertisement or via the associated toll-free number that provides access to the package labeling. Consumer-Directed Broadcast Advertisements Evidence Questions and Answers, (last visited May 16, 2001) www.fda.gov/cder/guidance/1804q&a.htm.
38. 21 C.F.R. § 202.1(e)(5)(iii).
39. 21 U.S.C. § 352(r).
40. 21 C.F.R. § 814.20(b)(10).
41. See Kristen Green, Marketing Health Care Products on the Internet: A Proposal for Updated Federal Regulations, 4 AM. J.L. & MED. 365 (1998).
42. FDA, FDA and the Internet: Advertising and Promotion of Medical Products (Oct. 1996) (last visited May 16, 2001) www.fda.gov/opacom/morechoices/transcript 1096/fdainet.html.
43. Promotion of FDA-Regulated Medical Products on the Internet; Notice of Public Meeting, 61 Fed. Reg. 48,707 (Sept. 16, 1996).
44. Brannon, supra note 8, at 601.
45. FDA's Electronic Freedom of Information Reading Room, Warning Letters, (last visited June 7, 2001) www.fda.gov/cder/warn/warn2000.htm; CDRH Ends 2000 With Record Number of Promotion-Related Warning Letters, 8(12) FDA ADVERTISING AND PROMOTION MANUAL 1 (Feb. 2001).
46. FDA's Electronic Freedom of Information Reading Room, Warning Letters, (last visited June 7, 2001) www.fda.gov/cder/warn/warn2000.htm; CDRH Ends 2000 With Record Number of Promotion-Related Warning Letters, 8(12) FDA ADVERTISING AND PROMOTION MANUAL 1 (Feb. 2001).
47. Center for Drug Evaluation and Research (CDER), "Cyber" Letters 2000, (last visited June 7, 2001) www.fda.gov/cder/warn/cyber/cyber2000.htm.
48. FDA has announced that it will investigate the effect of direct to consumer advertising. The Wall Street Journal, FDA Plans to Review Policy Allowing Direct-to-Consumer Drug Ads for TV, (last visited Mar. 28, 2001) interactive.wsj.com/archive/retrievecgi?id=SB985735245119950678.djm (must be subscriber to view page). In the meantime: FDA has no formal policy as to whether the information appearing on the Internet is labeling or advertising. There is a general feeling, at least in the industry, that FDA looks at it more as labeling. Certainly, if you feel comfortable putting information out as labeling on hard copy, then you should feel comfortable putting it out on the Internet. . . . The Division of Enforcement in the Office of Compliance is reviewing if there are alternative ways to provide labeling and instructions for use over the Internet. Advertising and Promotion of Medical Devices, Transcription of Dec. 8, 2000 Audio Conference sponsored by AdvaMed.
49. In 1998, FDA stated that it was preparing a guidance, but as of publication, not one has been issued. Peer-Reviewed Studies Presumed 'Sound' for Off-Label Dissemination, F-D-C REP. ("The Gray Sheet"), Nov. 23, 1998, at 60 (47). The Medical Device Manufacturers Association has as an objective for 2001 to help "FDA develop clear, balanced, and reasonable guidelines for promotional and advertising for both print and the Internet, including suggested formats for different classes of products, disclosure statements, and claim substantiation. Medical Devices. Diagnostics and Instrumentation Reports, F-D-C REP. ("The Gray Sheet"), Jan. 29, 2001, at 6.
50. In 1998, FDA stated that it was preparing a guidance, but as of publication, not one has been issued. Peer-Reviewed Studies Presumed 'Sound' for Off-Label Dissemination, F-D-C REP. ("The Gray Sheet"), Nov. 23, 1998, at 60 (47). The Medical Device Manufacturers Association has as an objective for 2001 to help "FDA develop clear, balanced, and reasonable guidelines for promotional and advertising for both print and the Internet, including suggested formats for different classes of products, disclosure statements, and claim substantiation. Medical Devices. Diagnostics and Instrumentation Reports, F-D-C REP. ("The Gray Sheet"), Jan. 29, 2001, at 6.
51. (last visited May 16, 2001) www.fda.gov/cder/warn/cyber/cyber2001.htm.
52. See, e.g., Andrew A. Skolnick, WHO Considers Regulating Ads, Sale of Medical Products on Internet, 21 JAMA 278 (Dec. 3, 1997).
53. Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51 (D.D.C. 1998) (No. Civ. A. 94-1306 (RCL)), order amended by Washington Legal Foundation v. Friedman, 36 F. Supp. 2d 16 (D.D.C. Feb. 16, 1999) ( No. Civ. A. 94-1306 (RCL)), appeal dismissed; judgment vacated in part by Washington Legal Foundation v. Henney, 202 F.3d 331, 340, U.S. App. D.C. 108 (D.C. Cir. Feb 11, 2000) (No. 99-5304), on remand to Washington Legal Foundation v. Henney, 128 F. Supp 2d 11 (D.D.C. Nov. 30, 2000); Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51 (D.D.C. July 30, 1998) (No. Civ. A. 94-1306 (RCL)), amended by, Washington Legal Foundation v. Friedman, 36 F. Supp. 2d 418 (D.D.C. Feb. 16, 1999) (No. Civ. A. 94-1306 (RCL)); Washington Legal Foundation v. Friedman, 13 F. Supp. 2d 51 (D.D.C. July 30, 1998) (No. Civ. A. 94-1306 (RCL)), appeal dismissed; judgment vacated in part by Washington Legal Foundation v. Henney, 202 F.3d 331, 340 (U.S. App. D.C. 108) (D.C. Cir Feb. 11, 2000) (No. 99-5304), on remand to, Washington Legal Foundation v. Henney 128 F. Supp. 2d 11, 2000 WL 33121733 (D.D.C Nov. 30, 2000) (No. Civ. A. 94-1306 (RCL)); Washington Legal Foundation v. Henney, 56 F. Supp. 2d 81 (D.D.C. July 28, 1999) (No. Civ. A. 94-1306 (RCL)), appeal dismissed; judgment vacated in part by Washington Legal Foundation v. Henney, 202 F.3d 331, 340 (U.S. App. D.C. 108) (D.C. Cir. Feb, 11, 2000) (No. 99-5304), on remand to Washington Legal Foundation v. Henney, F. Supp. 2d , 2000 WL 33121733 (D.D.C. Nov. 30, 2000) (Civ. A. No. 94-1306 (RCL)).
54. Indeed, FDAMA permits certain off-label promotions. The section provides: (a) In general Notwithstanding sections 331(d), 352(f), and 355 of this title, and section 262 of Title 42, a manufacturer may disseminate to: (1) a healthcare practitioner; (2) a pharmacy benefit manager; (3) a health insurance issuer; (4) a group health plan; or (5) a Federal or State governmental agency; written information concerning the safety, effectiveness, or benefit of a use not described in the approved labeling of a drug or device if the manufacturer meets the requirements of subsection (b) of this section. (b) Specific requirements A manufacturer may disseminate information under subsection (a) of this section on a new use only if-(1)(A) in the case of a drug, there is in effect for the drag an application filed under subsection (b) or (j) of section 355 of this title or a biologies license issued under section 262 of Title 42; or (B) in the case of a device, the device is being commercially distributed in accordance with a regulation under subsection (d) or (e) of section 360c of this title, an order under subsection (f) of such section, or the approval of an application under section 360e of this title; (2) the information meets the requirements of section 360aal of this title; (3) the information to be disseminated is not derived from clinical research conducted by another manufacturer or if it was derived from research conducted by another manufacturer, the manufacturer disseminating the information has the permission of such other manufacturer to make the dissemination; (4) the manufacturer has, 60 days before such dissemination, submitted to the Secretary -(A) a copy of the information to be disseminated; and (B) any clinical trial information the manufacturer has relating to the safety or effectiveness of the new use, any reports of clinical experience pertinent to the safety of the new use, and a summary of such information; (5) the manufacturer has complied with the requirements of section 360aa3 of this title (relating to a supplemental application for such use); 6) the manufacturer includes along with the information to be disseminated under this subsection - (A) a prominently displayed statement that discloses -(i) that the information concerns a use of a drug or device that has not been approved or cleared by the Food and Drug Administration; (ii) if applicable, that the information is being disseminated at the expense of the manufacturer; (iii) if applicable, the name of any authors of the information who are employees of, consultants to, or have received compensation from, the manufacturer, or who have a significant financial interest in the manufacturer; (iv) the official labeling for the drug or device and all updates with respect to the labeling; (v) if applicable, a statement that there are products or treatments that have been approved or cleared for the use that is the subject of the information being disseminated pursuant to subsection (a)(1) of this section; and (vi) the identification of any person that has provided funding for the conduct of a study relating to the new use of a drug or device for which such information is being disseminated; and (B) a bibliography of other articles from a scientific reference publication or scientific or medical journal that have been previously published about the use of the drug or device covered by the information disseminated (unless the information already includes such bibliography). (c) Additional information If the Secretary determines, after providing notice of such determination and an opportunity for a meeting with respect to such determination, that the information submitted by a manufacturer under subsection (b)(3)(B) of this section, with respect to the use of a drug or device for which the manufacturer intends to disseminate information, fails to provide data, analyses, or other written matter that is objective and balanced, the Secretary may require the manufacturer to disseminate - (1) additional objective and scientifically sound information that pertains to the safety or effectiveness of the use and is necessary to provide objectivity and balance, including any information that the manufacturer has submitted to the Secretary or, where appropriate, a summary of such information or any other information that the Secretary has authority to make available to the public; and (2) an objective statement of the Secretary, based on data or other scientifically sound information available to the Secretary, that bears on the safety or effectiveness of the new use of the drug or device.
55. Washington Legal Foundation, 202 F.3d at 335.
56. FDA ADVERTISING AND PROMOTION MANUAL, § 637 (Jan. 1997).
57. Id.
58. See, e.g., CompuServe, Inc. v. Patterson, 89 F.3d 1257 (6th Cir. 1996) (Ohio).
59. Bruce Tells, Avoiding the Long Ann of the Law in Cyberspace, 110(227) L.A. DAILY J. 5 (Dec. 13, 1997); Charles H. Fleischer, Will the Internet Abrogate Territorial Limits on Personal Jurisdiction, 33(1) TORT & INSURANCE L.J. 107 (Fall 1997).
60. Bruce Tells, Avoiding the Long Ann of the Law in Cyberspace, 110(227) L.A. DAILY J. 5 (Dec. 13, 1997); Charles H. Fleischer, Will the Internet Abrogate Territorial Limits on Personal Jurisdiction, 33(1) TORT & INSURANCE L.J. 107 (Fall 1997).
61. See, e.g., Playboy Enter., Inc. v. Webbworld, Inc., 968 F. Supp. 1171 (N.D. Tex. 1997); Cardservice Int'l., Inc. v, McGee, 950 F. Supp. 737 (E.D Va, 1997).
62. For an excellent overview of the effect of direct-to-consumer advertising on the learned intermediary rule, see David E. Dukes et al., What You Should Know About Direct-to-Consumer Advertising of Prescription Drugs, 68(1) DEF. COUNS. J. 36 (Jan. 2001).
63. Marcus v. Specific, 77 N.Y.S.2d 508 (N.Y. Sup. 1948).
64. 370 F.2d 82, 85 (8th Cir. 1966) ("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. If the doctor is properly warned of the possibility of a side effect in some patients, and is advised of the symptoms normally accompanying the side effect, there is an excellent chance that injury to the patient can be avoided.").
65. Reyes v. Wyeth Laboratories, (5th Cir. 1974), 498 F.2d 1264, 1276, cert. denied, 419 U.S. 1096. See also Incollingo v. Ewing, 282 A.2d 206 (Pa. 1971); Leibowitz v. Ortho Pharm. Corp., 307 A.2d 449, 457 (Pa. 1973) (". . . it is for the prescribing physician to use his own independent medical judgment, taking into account the data supplied to him from the drug manufacturer, other medical literature, and any other source available to him, and weighing that knowledge against the personal medical history of his patient, whether to prescribe a given drug."); Fellows v. USV Pharm. Corp., 502 F. Supp. 297, 299 (D. Md. 1980); Love v. Wolf, 226 Cal. App. 2d 378, 38 Cal. Rptr. 183 (Cal. App. 1964). See also Carmichael v. Reitz, 17 Cal. App, 3d 958, 95 Cal. Rptr. 381 (Cal. App. 2d 1971) (citing Paul Rheingoid, Products Liability - The Ethical Manufacturer's Liability, 18 RUTGERS L. REV. 947, 987 (1964)).
66. The vast majority of courts have adopted the learned intermediary rule. For a compilation, see ABA Products Liability Committee Section of Litigation, Pharmaceutical and Medical Device Subcommittee, State-by-State Summary of the Learned Intermediary Doctrine as a Springboard for Summary Judgment (July 1993); for federal decisions, see Brochu v. Ortho Pharm. Corp., 642 F.2d 652, 656 (1st Cir. 1981) (applying New Hampshire law) (oral contraceptives); Basko v. Sterling Drug, Inc., 416 F.2d 417, 426 (2d Cir. 1969) (applying Connecticut law) (chloroquine); Hoffman v. Sterling Drug, Inc., 485 F.2d 132, 142 (3d Cir. 1973) (applying Pennsylvania law) (chloroquine phosphate); Stanback v. Parke, Davis & Co., 657 F.2d 642, 644 (4th Cir. 1981) (applying Virginia law) (influenza vaccine); Timm v. Upjohn Co., 624 F.2d 536, 538 (5th Cir. 1980) (applying Louisiana law) (antibiotic eleocin), cert. denied, 449 U.S. 1112 (1981); Givens v. Lederle, 556 F.2d 1341, 1345 (5th Cir. 1977) (applying Florida law) (oral polio vaccine); Anderson v. McNeilab, Inc., 831 F.2d 92, 93 (5th Cir. 1987) (applying Louisiana law) (Zomax); Beyette v. Ortho Pharm. Corp., 823 F.2d 990, 992 (6th Cir. 1987) (applying Michigan Law) (IUD); Kirsch v. Picker Intern. Inc., 753 F.2d 670, 671 (8th Cir. 1985), reh'g denied en banc, 760 F.2d 183 (1985) (applying Missouri law) (radiation therapy); Fellows v. USV Pharm. Corp., 502 F. Supp. 297, 299 (D. Md. 1980) (doriden); Goodson v. Searle Lab., 471 F. Supp. 546, 548 (D. Conn. 1978) (oral contraceptives); Dunkin v. Syntex Lab., Inc., 443 F. Supp. 121, 123 (W.D. Tenn. 1977) (oral contraceptives); Chambers v. G.D. Searle & Co., 441 F. Supp. 377, 381 (D. Md. 1975), aff'd, 567 F.2d 269 (4th Cir. 1977) (oral contraceptives); Robak v. Abbott Lab., 797 F. Supp. 475 (D. Md. 1992) (Omniflox); Gaston v. Hunter, 588 P.2d 326 (Ariz. Ct. App. 1978); Hatfield v. Sands-Wonder, 464 N.E.2d 1105 (Ill. App. Ct. 1984) (Mellaril); Ortho Pharm. Corp. v. Chapman, 388 N.E. 2d 541 (Ind. App. 1979); Savina v. Sterling Drug, Inc., 795 P. 2d 915 (Kan. 1990) (Metrizamide, a dye used in myelograms); Kenney v. Hutchinson, 468 So. 2d 714 (La. Ct. App. 1985); Cunningham v. Charles Pfizer & Co., Inc., 532 P. 2d 1377 (Okla. 1974) (polio vaccine but holding that there was also a duty to warn the patient); McKee v. Moore, 648 P.2d 21 (Okla. 1982); Tracy v. Merrell Dow Pharm., Inc. 569 N.E. 2d 875 (Ohio 1991) (nicotine chewing gum); Hahn v. Richter, 628 A. 2d 860 (Pa. 1993) (Depo-Medrol); Rolen v. Burroughs Wellcome, 856 S.W. 2d 607 (Tex. App. 1993); Alm v. Aluminum Co. of America, 717 S.W. 2d 588 (Tex. 1986). See Kathy King-Cameron, Caregiving Another Exception to the Learned Intermediary Doctrine: Application of the Learned Intermediary Doctrine in Silicone Breast Implant Litigation, 68 TUL. L. REV. 937 (1994).
67. The vast majority of courts have adopted the learned intermediary rule. For a compilation, see ABA Products Liability Committee Section of Litigation, Pharmaceutical and Medical Device Subcommittee, State-by-State Summary of the Learned Intermediary Doctrine as a Springboard for Summary Judgment (July 1993); for federal decisions, see Brochu v. Ortho Pharm. Corp., 642 F.2d 652, 656 (1st Cir. 1981) (applying New Hampshire law) (oral contraceptives); Basko v. Sterling Drug, Inc., 416 F.2d 417, 426 (2d Cir. 1969) (applying Connecticut law) (chloroquine); Hoffman v. Sterling Drug, Inc., 485 F.2d 132, 142 (3d Cir. 1973) (applying Pennsylvania law) (chloroquine phosphate); Stanback v. Parke, Davis & Co., 657 F.2d 642, 644 (4th Cir. 1981) (applying Virginia law) (influenza vaccine); Timm v. Upjohn Co., 624 F.2d 536, 538 (5th Cir. 1980) (applying Louisiana law) (antibiotic eleocin), cert. denied, 449 U.S. 1112 (1981); Givens v. Lederle, 556 F.2d 1341, 1345 (5th Cir. 1977) (applying Florida law) (oral polio vaccine); Anderson v. McNeilab, Inc., 831 F.2d 92, 93 (5th Cir. 1987) (applying Louisiana law) (Zomax); Beyette v. Ortho Pharm. Corp., 823 F.2d 990, 992 (6th Cir. 1987) (applying Michigan Law) (IUD); Kirsch v. Picker Intern. Inc., 753 F.2d 670, 671 (8th Cir. 1985), reh'g denied en banc, 760 F.2d 183 (1985) (applying Missouri law) (radiation therapy); Fellows v. USV Pharm. Corp., 502 F. Supp. 297, 299 (D. Md. 1980) (doriden); Goodson v. Searle Lab., 471 F. Supp. 546, 548 (D. Conn. 1978) (oral contraceptives); Dunkin v. Syntex Lab., Inc., 443 F. Supp. 121, 123 (W.D. Tenn. 1977) (oral contraceptives); Chambers v. G.D. Searle & Co., 441 F. Supp. 377, 381 (D. Md. 1975), aff'd, 567 F.2d 269 (4th Cir. 1977) (oral contraceptives); Robak v. Abbott Lab., 797 F. Supp. 475 (D. Md. 1992) (Omniflox); Gaston v. Hunter, 588 P.2d 326 (Ariz. Ct. App. 1978); Hatfield v. Sands-Wonder, 464 N.E.2d 1105 (Ill. App. Ct. 1984) (Mellaril); Ortho Pharm. Corp. v. Chapman, 388 N.E. 2d 541 (Ind. App. 1979); Savina v. Sterling Drug, Inc., 795 P. 2d 915 (Kan. 1990) (Metrizamide, a dye used in myelograms); Kenney v. Hutchinson, 468 So. 2d 714 (La. Ct. App. 1985); Cunningham v. Charles Pfizer & Co., Inc., 532 P. 2d 1377 (Okla. 1974) (polio vaccine but holding that there was also a duty to warn the patient); McKee v. Moore, 648 P.2d 21 (Okla. 1982); Tracy v. Merrell Dow Pharm., Inc. 569 N.E. 2d 875 (Ohio 1991) (nicotine chewing gum); Hahn v. Richter, 628 A. 2d 860 (Pa. 1993) (Depo-Medrol); Rolen v. Burroughs Wellcome, 856 S.W. 2d 607 (Tex. App. 1993); Alm v. Aluminum Co. of America, 717 S.W. 2d 588 (Tex. 1986). See Kathy King-Cameron, Caregiving Another Exception to the Learned Intermediary Doctrine: Application of the Learned Intermediary Doctrine in Silicone Breast Implant Litigation, 68 TUL. L. REV. 937 (1994).
68. RESTATEMENT (SECOND) OF TORTS § 402A.
69. Id. § 402A, cmt. k.
70. See, e.g., Brown v. Superior Court, 751 P. 2d 470, 475 (Cal. 1988).
71. See, e.g., DeLuryea v. Winthrop Lab., 697 F.2d 222, 228-29 (8th Cir. 1983); Werner v. Upjohn Co., Inc., 628 F.2d 848, 858 (4th Cir. 1980), cert. denied, 449 U.S. 1080 (1981); Lindsay v. Ortho Pharm. Corp., 637 F.2d 87, 91 (2d Cir. 1980) (applying New York law), accord, Martin v. Hacker, 628 N.E.2d 1308 (N.Y. 1993); Salmon v. Parke-Davis & Co., 520 F.2d 1359, 1362 (4th Cir. 1975) ("A manufacturer of an ethical drug must exercise reasonable care . . . to warn physicians effectively of the drug's inherent dangers."); Basko v. Sterling Drug, Inc., 416 F.2d 417, 426 (2d Cir. 1969) (applying Connecticut law) (The manufacturer of a dangerous commodity does have a duty to warn, but when the commodity is a prescription drug, that duty to warn is fulfilled by an adequate warning given to those members of the medical community lawfully authorized to prescribe, dispense, and administer drugs.); Snawder v. Cohen, 749 F. Supp. 1473, 1476 n.3 (W.D. Ky. 1990); Schenebeck v. Sterling Drug, Inc., 291 F. Supp. 368 (E.D. Ark. 1968), aff'd, 423 F.2d 919 (8th Cir. 1970); Gatson v. Hunter, 588 P.2d 326, 340-41 (Ariz. Ct. App. 1978); see also Walker v. Merck & Co. Inc., 648 F. Supp. 931 (M.D. Ga. 1986); (learned intermediary doctrine applied), aff'd, 831 F.2d 1069 (11th Cir. 1987); Wells v. Ortho Pharm. Corp., 615 F. Supp. 262, 295 (N.D. Ga. 1985), aff'd and modified in part, 788 F.2d 741 (11th Cir.), cert. denied, 479 U.S. 950 (1986); Stone v. Smith, Kline & French Lab., 447 So. 2d 1301, 1303 n.2 (Ala. 1984); Brown v. Superior Court, 751 P.2d 470, 477 (Cal. 1988) ("patient's expectations . . . are those related to him by his physician, to whom the manufacturer directs the warnings regarding the drug's properties"). Cited in comment d to RESTATEMENT (THIRD) OF TORTS § 10-6.
72. Unlike comment k, the Restatement (Third) applies the learned intermediary doctrine to physicians and "other healthcare providers who are in a position to reduce the risks of harm in accordance with the instructions or warnings." It also identifies the numerous justifications that are the bedrock for the policy: Comment b. Rationale. Courts have advanced a number of reasons for exclusive reliance on the learned intermediary rule. See, e.g., West v. Searle & Co., 806 S.W. 2d 608, 613-14 (Ark. 1991) (provider is best assessor of relevant risks and benefits); Brown v. Superior Court, 751 P.2d 470, 478-79 (Cal. 1988) (concern that increased liability would drive prices of drugs too high and make them less available.); Lacy v. G.D. Searle & Co., 567 A.2d 398 (Del. 1989); In re Certified Questions, 358 N.W.2d 873, 883 (Mich. 1984) (Boyle, J., dissenting) (in some cases, directly warning patient "could potentially cause undue interference with the doctor patient relationship [and] cause patient confusion"); Niemiera v. Schneider, 555 A.2d 1112, 1118 n.3 (N.J. 1989) ("The Federal Food and Drug Administration (FDA) regulates vaccine manufacturers. . . . The regulations are quite detailed in their setting of standards for safety, effectiveness and adequate labeling."); Gravis v. Paike-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 . . . upon professional people."). For a useful discussion of the rule and its underlying rationale, see Teresa Moran Schwartz, ConsumerDirected Prescription Drug Advertising and the Learned Intermediary Rule, 46 FOOD DRUG COSM. L.J. 829, 830-31 (1991).
73. RESTATEMENT (THIRD) OF TORTS § 6(d)(2).
74. Comment e states in part: "Direct warnings to patients, Warnings and instructions with regard to drugs or medical devices that can be sold legally only pursuant to a prescription are, under the ' learned intermediary rule,' directed to healthcare providers. Subsection (d)(2) recognizes that direct warnings and instructions to patients are warranted for drugs that are dispensed or administered to patients without the personal intervention or evaluation of a healthcare provider. An example is the administration of a vaccine in clinics where mass inoculations are performed. In many such programs, healthcare providers are not in a position to evaluate the risks attendant upon use of the drug or device or to relate them to patients. When a manufacturer supplies prescription drugs for a distribution to patients in this type of unsupervised environment, if a direct warning to patients is feasible and can be effective, the law requires measures to that effect."
75. Id.
76. Although the learned intermediary rule generally is accepted and a drug manufacturer fulfills its legal obligation to warn by providing adequate warnings to the health care provider, arguments have been advanced that in two other areas courts should consider imposing tort liability on drug manufacturers who fail to provide direct warnings to consumers. In the first, governmental regulatory agencies have mandated that patients be informed of risks attendant to the use of a drug. A noted example is FDA requirement that birth control pills be sold to patients accompanied by a patient package insert. In the second, manufacturers have advertised a prescription drug and its indicated use in the mass media. Governmental regulations require that, when drugs are so advertised, they must be accompanied by appropriate information concerning risk so as to provide balanced advertising. The question in both instances is whether adequate warnings to the appropriate health care provider should insulate the manufacturer from tort liability. Those who assert the need for adequate warnings directly to consumers contend that manufacturers who communicate directly with consumers should not escape liability simply because the decision to prescribe the drug was made by the health care provider. Proponents of the learned intermediary rule argue that, notwithstanding direct communications to the consumer, drugs cannot be dispensed unless a health care provider makes an individualized decision that a drug is appropriate for a particular patient and that it is for the health care provider to decide which risks are relevant to the particular patient. The Institute leaves to developing case law whether exceptions to the learned intermediary rule in these or other situations should be recognized. RESTATEMENT (THIRD) LAW OF TORTS § 6, cmt. e.
77. For a thorough discussion of academic resistance to the learned intermediary rule, see Nancy K. Plant, The Learned Intermediary Doctrine: Some Medicine for an Old Ailment, 81 IOWA L. REV. 1007 (1996); Susan A. Casey, Comment, Laying an Old Doctrine to Rest: Challenging the Wisdom of the Learned Intermediary Doctrine, 19 WM. MITCHELL L. REV. 931 (1993).
78. For a thorough discussion of academic resistance to the learned intermediary rule, see Nancy K. Plant, The Learned Intermediary Doctrine: Some Medicine for an Old Ailment, 81 IOWA L. REV. 1007 (1996); Susan A. Casey, Comment, Laying an Old Doctrine to Rest: Challenging the Wisdom of the Learned Intermediary Doctrine, 19 WM. MITCHELL L. REV. 931 (1993).
79. "Informed consent is the standard that governs the adequacy of physicians' warnings to the patient. Doctors have a duty to disclose certain information to patients and obtain patients' consent before any kind of treatment is given. Depending on the jurisdiction, doctors may have to give all or any combination of the following information: diagnosis, nature and purpose of treatment, some of the risks, probability of success, alternatives to procedure or treatment, and risks of those alternatives. Generally, the standard governing this disclosure is that a reasonable medical practitioner would disclose under similar circumstances." See Plant, supra note 68, at 1055.
80. Plant, supra note 68, at 1008. FDA, however, has published a draft guidance governing the promotional practices of Pharmacy Benefit Management Firms that, it is claimed, may have engaged in such practices. 63 Fed. Reg. 236 (Jan. 5, 1998); Bruce Ingersoll, FDA to Watch Drug Switching, Sales Practices, WALL ST. J., Jan. 6, 1998, at B1.
81. Plant, supra note 68, at 1008.
82. Peter H. Schuck, Rethinking Informed Consent, 103 YALE L.J. 899, 903 (1994); Gerald F. Tietz, Informed Consent in the Prescription Drug Context: The Special Case, 61 WASH. L. REV. 367, 395-405 (1986). Some recent cases, however, have attempted to remedy the effects of managed care on patient treatment by holding HMOs liable in medical malpractice cases. See, e.g., Robbins v. HIP of New Jersey, 625 A.2d 45 (N.J. 1993); Dunn v. Praiss, 656 A.2d 413 (N.J. 1995); Moshe v. Anchor Org. for Health Maintenance, 557 N.E.2d 451(Ill. App. Ct. 1990).
83. Peter H. Schuck, Rethinking Informed Consent, 103 YALE L.J. 899, 903 (1994); Gerald F. Tietz, Informed Consent in the Prescription Drug Context: The Special Case, 61 WASH. L. REV. 367, 395-405 (1986). Some recent cases, however, have attempted to remedy the effects of managed care on patient treatment by holding HMOs liable in medical malpractice cases. See, e.g., Robbins v. HIP of New Jersey, 625 A.2d 45 (N.J. 1993); Dunn v. Praiss, 656 A.2d 413 (N.J. 1995); Moshe v. Anchor Org. for Health Maintenance, 557 N.E.2d 451(Ill. App. Ct. 1990).
84. See supra note 72.
85. RESTATEMENT (THIRD) OF TORTS: PRODUCT LIABILITY § 6, cmt. e (1997).
86. Id. Because FDA requires that drug manufacturers include in such advertisements information about side effects, contraindications, and effectiveness, the duty to include a warning in the advertisement is government mandated. Several decisions indicate that consumer directed advertising is a factor to be taken into account in deciding whether to apply the learned intermediary rule. See, e.g., Stephens v. G.D. Searle & Co., 602 F. Supp. 379 (E.D. Mich. 1985); Hill v. Searle Lab., 884 F.2d 1064 (8th Cir. 1989); Garside v. Osco Drug, Inc., 764 F. Supp. 208, 211 n.4 (D. Mass. 1991), rev'd on other grounds, 976 F.2d 77 (1st Cir. 1992) (defendant failed to make required showing that physician would not have heeded warning even if adequately made; summary judgment reversed). Several commentators have urged the adoption of an exception to the learned intermediary rule in cases of direct consumer advertising of prescription drugs. See generally Victor Schwartz, Consumer-Directed Prescription Drug Advertising and the Learned Intermediary Rule, 46 FOOD DRUG COSM, L.J. 829 (1991) ("There are solid grounds for abandoning the learned intermediary rule where prescription drug manufacturers direct their advertisements to consumers."); Tim S. Hall, Note, Bypassing the Learned Intermediary: Potential Liability for Failure to Warn in Direct-to-Consumer Prescription Drug Advertising, 2 CORNELL J.L. & PUB. POL'Y 449, 473 (1993) (concluding that "imposition of tort liability on manufacturers who advertise directly to consumers" without adequately warning consumers of risks is appropriate).
87. Id. Because FDA requires that drug manufacturers include in such advertisements information about side effects, contraindications, and effectiveness, the duty to include a warning in the advertisement is government mandated. Several decisions indicate that consumer directed advertising is a factor to be taken into account in deciding whether to apply the learned intermediary rule. See, e.g., Stephens v. G.D. Searle & Co., 602 F. Supp. 379 (E.D. Mich. 1985); Hill v. Searle Lab., 884 F.2d 1064 (8th Cir. 1989); Garside v. Osco Drug, Inc., 764 F. Supp. 208, 211 n.4 (D. Mass. 1991), rev'd on other grounds, 976 F.2d 77 (1st Cir. 1992) (defendant failed to make required showing that physician would not have heeded warning even if adequately made; summary judgment reversed). Several commentators have urged the adoption of an exception to the learned intermediary rule in cases of direct consumer advertising of prescription drugs. See generally Victor Schwartz, Consumer-Directed Prescription Drug Advertising and the Learned Intermediary Rule, 46 FOOD DRUG COSM, L.J. 829 (1991) ("There are solid grounds for abandoning the learned intermediary rule where prescription drug manufacturers direct their advertisements to consumers."); Tim S. Hall, Note, Bypassing the Learned Intermediary: Potential Liability for Failure to Warn in Direct-to-Consumer Prescription Drug Advertising, 2 CORNELL J.L. & PUB. POL'Y 449, 473 (1993) (concluding that "imposition of tort liability on manufacturers who advertise directly to consumers" without adequately warning consumers of risks is appropriate).
88. See Amy D. White, The Mass Marketing of Prescription Drugs and Its Effect on the Learned Intermediary Doctrine, 75 OKLA. CITY U. L. REV. 745 (2000).
89. Reichertz, supra note 4, at 363 (citing Schwartz supra note 63, at 829.)
90. 734 A.2d 1245 (N.J. 1999).
91. See White, supra note 76, at 765. A discussion of the impact of Perez on direct-to-consumer advertising is Mitchell S. Berger, A Tale of Six Implants: The Perez v. Wyeth Laboratories Norplant Case and the Applicability of the Learned Intermediary Doctrine to Direct-to-Consume r Drug Promotion, 55 FOOD & DRUG L.J. 525 (2000).
92. Berger, supra note 79, at 528.
93. Perez, 734 A.2d at 1247. Other decisions have suggested that a direct-to-consumer promotion can be considered in deciding whether to apply the learned intermediary rule. See, e.g., Stephens v. G.D. Searle & Co., 602 F. Supp. 379 (E.D. Mich. 1985); Hill v. Searle Lab., 884 F.2d 1064, 1071 (8th Cir. 1989) (applying Arkansas law) (but see discussion of Arkansas law, infra, for authority arguably overruling this decision); Garside v. Osco Drug, Inc., 764 F. Supp. 208, 211 n.4 (D. Mass 1991), rev'd on other grounds, 976 F.2d 77 (1st Cir. 1992). Accord Hawkinson v. A.H. Robbins Co. Inc., 595 F. Supp. 1290, 1308 (D. Colo. 1984). Comment e to Section 6 recognizes that "[s]everal commentators have urged the adoption of an exception to the learned intermediary rule in cases of direct consumer advertising of prescription drugs"; see generally Victor Schwartz, Consumer-Directed Prescription Drug Advertising and the Learned Intermediary Rule, 46 FOOD DRUG COSM. L.J. 829 (1991) ("[T]here are solid grounds for abandoning the learned intermediary rule where prescription drug manufacturers direct their advertisements to consumers."); Tim S. Hall, Note, Bypassing the Learned Intermediary: Potential Liability for Failure to Warn in Direct-to-Consumer Prescription Drug Advertising, 2 CORNELL J.L. & PUB. POL'Y 449 (1993) (concluding that "imposition of tort liability on manufacturers who advertise directly to consumers, without adequately warning consumers of risk is appropriate"). RESTATEMENT (THIRD) OF TORTS § 6 cmt. e (Proposed Final Draft, Apr. 1, 1997).
94. Perez, 734 A.2d at 1247. Other decisions have suggested that a direct-to-consumer promotion can be considered in deciding whether to apply the learned intermediary rule. See, e.g., Stephens v. G.D. Searle & Co., 602 F. Supp. 379 (E.D. Mich. 1985); Hill v. Searle Lab., 884 F.2d 1064, 1071 (8th Cir. 1989) (applying Arkansas law) (but see discussion of Arkansas law, infra, for authority arguably overruling this decision); Garside v. Osco Drug, Inc., 764 F. Supp. 208, 211 n.4 (D. Mass 1991), rev'd on other grounds, 976 F.2d 77 (1st Cir. 1992). Accord Hawkinson v. A.H. Robbins Co. Inc., 595 F. Supp. 1290, 1308 (D. Colo. 1984). Comment e to Section 6 recognizes that "[s]everal commentators have urged the adoption of an exception to the learned intermediary rule in cases of direct consumer advertising of prescription drugs"; see generally Victor Schwartz, Consumer-Directed Prescription Drug Advertising and the Learned Intermediary Rule, 46 FOOD DRUG COSM. L.J. 829 (1991) ("[T]here are solid grounds for abandoning the learned intermediary rule where prescription drug manufacturers direct their advertisements to consumers."); Tim S. Hall, Note, Bypassing the Learned Intermediary: Potential Liability for Failure to Warn in Direct-to-Consumer Prescription Drug Advertising, 2 CORNELL J.L. & PUB. POL'Y 449 (1993) (concluding that "imposition of tort liability on manufacturers who advertise directly to consumers, without adequately warning consumers of risk is appropriate"). RESTATEMENT (THIRD) OF TORTS § 6 cmt. e (Proposed Final Draft, Apr. 1, 1997).
95. 884 F. 2d 1064, 1070 (8th Cir. 1989) (applying Arkansas law) Berger, supra note 79, at 529.
96. 165 F.3d 374 (5th Cir. 1999).
97. Citing Hurley v. Lederle Lab., 863 F.2d 1173, 1178 (5th Cir. 1988); Swayze v. McNeil Lab., 807 F.2d 464 (5th Cir. 1987).
98. Berger, supra note 79, at 573 (citing Lars Noah, Advertising Prescription Drugs to Consumers: Assessing the Regulatory and Liability Issues, 32 GA. L. REV. 141, 176 (1997)).
99. David Dukes et al., supra note 54, at 48.
100. 9 Cal. 3d 51 (1973).
101. Id. at 57-58.
102. Id. at 58.
103. Id.
104. Id. at 65.
105. 38 Cal. Rptr. 183 (1964).
106. An excellent summary is provided in Lars Noah, Advertising Prescription Drugs to Consumers: Assessing the Regulatory and Liability Issues, 32 GA. L. REV. 141 (1997).
107. 21 C.F.R. § 202.1(e) (2000).
108. Anderson v. Sandoz Pharm. Corp., 77 E Supp. 2d (S.D. Tex. 1999) (The Court explained: "By not sharing all available research with [the physician] regarding the risks connected to Parlodel (this, despite the fact that Defendant may have known about [the doctor's] use of Parlodel for off-label use), Defendant may have, in effect, prevented [the physician] from making an informed choice, thereby piercing Defendant's shield from liability under the learned intermediary doctrine.").
109. Now known as Advanced Medical Technology Association (AdvaMed) (last visited May 16, 2001) www.himanetxom.
110. Internet Links to Web Sites Containing Off-Label Data Should Be Permitted, Glaxo Attorney Says; Firms Should Monitor Upstream Lines, FDA Says, M-D-D-I REPORTS, ("The Gray Sheet") Oct 21, 1996.
111. Transcript from Department of Health and Human Services/PDA, PDA and the Internet, Advertising and Promotion of Medical Products, Public Hearing, Oct. 16-17, Vol. 1, at 1.
112. Washington Legal Foundation v. Friedman suggested at one time that PDA's ability to limit these sites is prohibited by the First Amendment's guarantee of free speech; that issue has since been mooted.
113. See Brannon, supra note 8, at 608.
114. Letter from Marlene K. Tandy, Director and Counsel, Technology and Regulatory Affairs, to FDA Dockets Management Branch (Dec. 13, 1996).
115. Id.
116. Off-Label Claims in Online Promotions Trigger CDRH Enforcement Actions, FDA Advertising and Promotion Manual, Dec. 1997 Monthly Bulletin, at 7. Examples include promoting a stimulator machine as treatment for specific conditions; urging that a therapeutic massager can reduce the appearance of cellulite which condition was unapproved.
117. Advertising and Promotion of Medical Devices - Transcription of Dec. 8, 2000 Audio Conference Sponsored by AdvaMed, at 18.
118. 21 C.F.R. § 312.7(a) (2000); see also News Report, Internet Data Prompt Warning Letter, 24 DEVICES & DIAGNOSTICS LETTER, Mar. 21, 1997, at 1; Warning Letter from CDRH to Mr. Kevin DeVito, President, Harrier, Inc. (Apr. 1, 1997) (unapproved use of Bioptron Infared Lamp) available at (last visited May 16, 2001) www.fda.gov/foi/warning_letters/m784n.pdf.
119. Washington Legal Found., 202 F.3d at 335 (citing transcript at 10 of 34).
120. See. e.g., Cybersell, Inc. v. Cybersell, Inc., 97 D.A.R 14,545 (9th Cir. 1997); Gynecare Uterine Balloon Therapy Internet Promotion Cited by FDA, M-D-D-I REP., ("The Gray Sheet"), Mar. 17, 1997, at 14-15.
121. See Prozac website (last visited May 16, 2001) www.prozac.com/home.htm.
122. See Eli Lilly (last visited May 16, 2001) www.lilly.com/healt/products/axid/index.html.
123. See Bristol-Myers Squibb (last visited May 16, 2001) www.bms.com/medicines/data.
124. See Wyeth's Featured Products, (last visited May 16, 2001) www.wyeth.com/products/.
125. Advertising and Promotion of Medical Devices - Transcription of December 8, 2000 Audio Conference Sponsored by AdvaMed, at 13.
126. Marylyn Larkin, Health Information On-Line, FDA CONSUMER (June 1998) (last visited May 16, 2001) www.fda.gov/fdac/features/596J_info.html.
127. Id.
128. CDRH Official Answers Common Internet Advertising, Promotion Questions, 8(5) FDA ADVERTISING AND PROMOTION MANUAL, (July 2000 Monthly Bulletin).
129. Dissemination of Information on Unapproved/New Uses for Marketing Drugs, Biologics, and Devices, 61 Fed. Reg. at 62,741.
130. One proposal is to define manufacturers' home pages as "labeling" and information posted by third parties as "advertising" to utilize the respective expertise of FDA and FTC, Brannon, supra note 8, at 618.