Pin the tail on the other donkey: Allocating and avoiding injury losses after drug or device approval

Food and Drug Law Journal

Volumn 62, Issue 3, 2007, Pages 559-572

  O'Reilly, James T ^a  

^a UNIVERSITY OF CINCINNATI   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACCOUNTING; CAUSAL ATTRIBUTION; DEATH; DRUG APPROVAL; FATALITY; FOOD AND DRUG ADMINISTRATION; HEALTH INSURANCE; HUMAN; INJURY; LEGAL LIABILITY; MALPRACTICE; MARKET; MEDICAL ERROR; MEDICAL PRACTICE; OFF LABEL DRUG USE; POSTMARKETING SURVEILLANCE; PREDICTION; REVIEW; SAFETY; STATISTICS; SURVIVAL; VICTIM; ARTICLE; COMPENSATION; DRUG INDUSTRY; DRUG LABELING; DRUG SURVEILLANCE PROGRAM; ECONOMICS; EPIDEMIOLOGY; INSURANCE; LEGAL ASPECT; STANDARD; UNITED STATES;

EQUUS ASINUS;

ADVERSE DRUG REACTION REPORTING SYSTEMS; CAUSALITY; COMPENSATION AND REDRESS; CONSUMER PRODUCT SAFETY; DEVICE APPROVAL; DRUG APPROVAL; DRUG INDUSTRY; DRUG LABELING; HUMANS; INSURANCE, LIABILITY; LIABILITY, LEGAL; MALPRACTICE; MEDICAL ERRORS; PRODUCT SURVEILLANCE, POSTMARKETING; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 35548996401     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (77)

1. www.fda.gov/medwatch/safety/3500.pdf.
2. The federal IOM report, To Err Is Human: Building A Safer Health System at 1 (NATIONAL ACADEMIES PRESS, (2000) [hereinafter IOM Report] estimated that between 44,000 and 98,000 deaths each year are a result of medical errors, and 7,000 deaths each year are attributable to medication errors. The variation is in state reports; New York's estimate cited by the IOM was 98,000 in data that is now a decade old.
3. IOM Report at 180.
4. http://www.ahrq.gov/qual/errorsix.htm.
5. Address by Carolyn Clancey, M.D., The Culture of Safety, (Sept. 25, 2006), available at http://www.ahrq.gov/news/sp092506.htm.
6. See Pub. L. 109-41 (2005) and Congressional Research Service, RL33358, Medical Malpractice: An Overview (May 5, 2006), available at www.opencrs.com/document/RL33358/.
7. Restatement of Torts, Products Liability 3d § 15, 16 (1997)
8. Restatement, id. at 16 cmt. (e).
9. Plul v. Fireman's Fund Ins. Co, 85 Cal. App. 4th 98, 104 (2000).
10. Sereboff v. Mid-Atlantic Medical Services, 126 S.Ct. 1869 (2006).
11. IOM Report, at 109-110.
12. James O'Reilly, Lawyer's Guide to Elder Injury & Accident Compensation (ABA Press, 2d Ed. 2005.
13. IOM Report, at 91.
14. Form FDA-3500, Block B-1, available at www.fda.gov/medwatch/ safety/3500.pdf.
15. These issues are explored at length in IOM Report, at 86 ff.
16. 21 U.S.C. 355.
17. Testimony of Patients' Coalition, Hearings, House Commerce Comm., Subcomm. On Health, (Apr. 11, 1997).
18. Washington Legal Foundation v. Henney, 202 F.3d 331 (D.C Cir., 2000).
19. Walsh & Pyrich, FDA Efforts to Control the Flow of Information at Pharmaceutical Industry Sponsored Medical Education Programs, 24 SETON HALL L. REV. 1325 (1994).
20. Testimony of Patients' Coalition, Hearings, House Commerce Comm., Subcomm. On Health, (Apr. 11, 1997).
21. Supplemental new drug applications supported by additional safety and efficacy studies would ordinarily be required for the promotion of a new drug for an additional indication, 21 C.F.R. 314.70(a)(1).
22. "The "Off-label" provision could be better described as the "under the table" provision, allowing companies to market a product for unsupported uses that could seriously send thousands of consumers "off the cliff." In putting profits over patient care, this bill opens the door for aggressive promotion of unproven uses of drugs, while giving companies three to five years to produce scientific evidence that these off-label uses are safe and effective." Views of Rep. Edward Markey in H. REPT. 105-310, House Commerce Committee Report on Prescription Drug Reauthorization and Drug Regulatory Modernization Act of 1997, 105th Cong. 1st Sess. (1997).
23. FDA argued that legalizing off-label promotion would harm patients and erode the efficacy standard, among other problems. Address by Dr. Janet Woodcock, FDA, to Drug Information Assn., (June 23, 1997), http://www.fda.gov/ cder/present/diamontreal/regappr/sld006.htm. The background of the off-label debate is described at length in James O'Reilly, Off-Label or Out of Bounds? Prescriber and Marketer Liability for Unapproved Uses of FDA-Approved Drugs, 12 ANNALS OF HEALTH LAW 295 (2003).
24. 21 U.S.C. 360aaa-6(b) and see Elizabeth Weeks, Is It Worth the Trouble? The New Policy on Dissemination of Information on Off-Label Drug Use Under the Food and Drug Administration Modernization Act of 1997, 54 FOOD & DRUG L.J. 645 (1999).
25. 21 C.F.R. 99.1, 63 Fed. Reg. 64,555 (Nov. 20, 1998).
26. This was FDA's consistent view, 59 Fed. Reg. 59,820, 59,821 (1994).
27. David Rheingold and Paul Rheingold, Offense or Defense? Managing the Off-Label Use Claim, 37 TRIAL 52, 53-54 (Mar. 2001).
28. 21 U.S.C. 396.
29. This prescriber privilege was discussed in dicta in Thompson v. Western States Medical Center, 535 U.S. 357 (2002) and Sigma Tau Pharmaceuticals Inc. v. Schwetz, 288 F.3d 141 (4th Cir., 2002).
30. Sen. Royal Copeland's work is discussed in 1 James O'Reilly, Food and Drug Administration §3:4 (2d Ed., 2006 Supp.).
31. "In no way will it interfere with the usual methods or the use of apparatus or devices employed in their regular practice by licensed healers of any school. No practitioner of the healing arts can reasonably complain about the provisions of S. 2800." Sen. Royal Copeland, floor statement supporting S. 2800, 73d Congress, Mar. 15, 1934, reprinted at Charles Wesley Dunn, Federal Food, Drug, and Cosmetic Act (FDLI edition, 1987) at 90.
32. David Rheingold and Paul Rheingold, Offense or Defense? Managing the Off-Label Use Claim, 37 TRIAL 52, 56 (Mar. 2001) (facts specific to each case determine defendant drug maker's ability to assert the defense).
33. Hampton, Experts Weigh in on Promotion, Prescription of Off-label Drugs, 297 JAMA 683 (2007).
34. Testimony of L. Morris, Health and Human Services (HHS) Office of Insp. Genl. (OIG), to House Oversight Committee, (Feb. 9, 2007), available at http://oig.hhs.gov/testimony/docs/2007/020907tmy.pdf.
35. 21 U.S.C. 360aaa et seq.
36. See the analogy to medical device uses by surgeons, in Dyer v. Danek Medical, Inc., 115 F. Supp. 2d 732, 740 (N.D. Tex. 2000) (courts will consider "the physician's superior understanding of the interplay between the product's dangers and the patient's conditions ...").
37. After the 1997 recall request, FDA issued a Public Health Advisory re off-label uses of Fen-Phen, http://www.fda.gov/cder/news/phen/phenfen.htm and see one view of the billion-dollar litigation, Alicia Mundy, Dispensing with the Truth (St. Martin's Press, (2001)).
38. See e.g. Warning Letter, Allergan Inc., re BOTOX, (Sept. 5, 2002), available at http://www.fda.gov/cder/biologics/adpromo/botuall090502. htm.
39. Utah Sues Zyprexa Maker Eli Lilly, ASSOCIATED PRESS (May 17, 2007);
40. and Connecticut Attorney General Press Release, "Attorney General, DCP Commissioner Announce Oxycontin Maker Agrees To Halt Illegal Marketing" (May 7, 2007), http://www.ct.gov/ag/cwp/view.asp?Q=379606&A=2788.
41. Re Warner-Lambert, see Testimony of HHS Inspector General before House Subcommiittee, http://oig.hhs.gov/testimony/docs/2004/reeb120704.pdf; and (re Serono) HHS OIG Semiannual Report to Congress (2006) available at http://oig.hhs.gov/publications/docs/semiannual/2006/SemiannualSpring2006.pdf.
42. Restatement of Torts 2d § 402A (1965).
43. Restatement Third, Torts - Products Liability § 2 (1997).
44. "Foreseeable product misuse, alteration and modification must also be considered in deciding whether an alternative design should have been adopted. The post-sale conduct of the user may be so unreasonable, unusual, and costly to avoid that a seller has no duty to design or warn against them." Restatement of Torts (Third); Product Liability § 2 cmt. p (1997).
45. Jeffrey O'Connell and John Linehan, Neo No Fault Early Offers, 41 GNZ. L.REV. 103, 104 (2006) (contrasting U.S. tort system and other nations' "organized means of personal injury compensation that measures the costs arising from accidents and attempts to distribute benefits appropriately").
46. Because of malpractice liability, a prominent defense counsel argues, "joint social goals of promoting safer medicine and compensating wrongfully-injured patients are not being achieved." James Comodeca, Killing the Golden Goose By Evaluating Medical Care Through the Retroscope: Tort Reform from the Defense Perspective, 31 U. DAYTON L. REV. 207 (2006).
47. See e.g. Pa. Stat. Ann. Tit. 40, sec. 1303.508 (medical payment subrogation and collateral source recovery). Insurance subrogation is addressed in many articles, e.g., Randal Whitlatch, Subrogation Under ERISA and the Search for "Appropriate Equitable Relief", 41 TORT TRIAL & INS. PRAC. L.J. 1048 (2006)
48. and Elaine Rinaldi, Apportioning Recovery Between Insured and Insurer in a Subrogation, TORT & INS. L.J. 803 (1993).
49. Incentives of the various parties need to be examined in fixing the system. David Hyman & Charles Silver, Medical Malpractice Litigation and Tort Reform: It's the Incentives, Stupid, 59 VAND. L. REV. 1085 (2006).
50. 42 U.S.C. 2210.
51. See e.g., 49 U.S.C. 20106, CSX Transportation v. Easterwood, 507 U.S. 658, 664 (1993) and James O'Reilly, Federal Preemption of State & Local Law 188 (ABA Press, 2006).
52. 21 U.S.C. 360k(a), Pub. L. 94-295, § 2, May 28, 1976, 90 Stat. 574.
53. See Daniel O'Keefe (ed.), An Analytical Legislative History of the Medical Device Amendments of 1976 at 254-256 (FDLI, 1976). The statutory term, "requirements," was later parsed by industry advocates to include liability suits, as discussed below, but the legislative history is silent on tort recoveries.
54. Commonwealth of Massachusetts v. Hayes, 691 F.2d 57 (1st Cir., 1982).
55. The author was a junior attorney who participated on the industry side of the dialogues in 1975-1976.
56. Medtronic v. Lohr, 518 U.S. 470 (1996) (expanding scope of "requirements" to include tort liability awards).
57. James O'Reilly, An Eye for an Eye: Foresight on Remedies for LASIK Surgery's Problems, 71 U.CIN.L.REV. 541 (2002).
58. Social policies underlying preemption are addressed at length in James O'Reilly, Federal Preemption of State & Local Laws (ABA Press, 2006)
59. and Joseph Zimmerman, Federal Preemption (Iowa St. U. Press 1991).
60. A review of the literature on Medicare/Medicaid malpractice cases is found in GAO, Medicare/Medicaid Malpractice report, GAO/HRD-93-126 (Aug. 11, 1993), available at www.gao.gov.
61. But the small amount of data is not conclusive on this issue, see GAO Report, Medical Malpractice, GAO-03-836 (2003), available at www.gao.gov.
62. Form FD-3500 is sent to FDA by the healthcare institution to report the device-related injuries.
63. See www.fda.gov/medwatch.
64. Mich. Comp. L. 600.2946(5) (1995), an "absolute defense," Taylor v Smithkline Beecham, 468 Mich. 1 (2003).
65. James O'Reilly, 2005 Ohio Tort Reform Legislation, 23-24 (LexisNexis Books (2005)).
66. James O'Reilly, Tort Reform and Term Limits: The 2004 Ohio Experience, 33 CAPITAL U. L. REV. 529, 545-546 (2005).
67. Tresa Baldas, FDA drug rule splits the courts, 29 NATL. L. J. 1 (Apr. 30, 2007).
68. Witczak v Pfizer Inc., 377 F.Supp.2d 726 (D. Minn. 2005).
69. 21 U.S.C. 379r, 379s.
70. H.R. 4167, 109th Cong. 2d Sess. (2006) (failed attempt to preempt state food safety activities).
71. FDA, Drug Labeling, preamble to final rule, 71 Fed. Reg. 3022, 3936 (Jan. 24, 2006).
72. FDA Proposed Rule, 65 Fed. Reg. 81,082; 81,103 (Dec. 22, 2000).
73. Id.
74. Ralph Lindeman, Agencies Move to Override State Law As Part of Federal Rulemaking Process, BNA DAILY REPORT FOR EXECUTIVES No. 66 at C-1 (Apr. 6, 2006).
75. FDA, Drug Labeling, preamble to final rule, 71 Fed. Reg. 3022, 3936 (Jan. 24, 2006).
76. In re Zyprexa Products Liability Litigation, 2007 Westlaw 1678078, at 40 (E.D.N.Y. June 11, 2007).
77. Elizabeth Weeks, Beyond Compensation: Using Torts to Promote Public Health, 10 JOURNAL OF HEALTH CARE LAW AND POLICY 19, 30 (2007).