Riegel v. Medtronic, Inc.: Revisiting pre-emption for medical devices

Journal of Law, Medicine and Ethics

Volumn 37, Issue 2, 2009, Pages 305-317

  Patsner, Bruce ^a  

^a UNIVERSITY OF HOUSTON   (United States)

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[No Author keywords available]

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EID: 67650215068     PISSN: 10731105     EISSN: 1748720X     Source Type: Journal    
DOI: 10.1111/j.1748-720X.2009.00374.x     Document Type: Article

References (91)

1. H. L. Dorfman, V. M. Quinn, and E. A. Brophy Presumption of Innocence: FDA's Authority to Regulate the Specifics of Prescription Drug Labeling and the Preemption Debate Food & Drug Law Journal 61, no. 4 (2006 585 622.
2. S. Gottlieb, FDA: Ræ Labeling Trumps State Liability Laws, available at http://www.fdaweb.com/start.php?sa=v&aid=D5101706&cate= &stid=%241%245R5.oh% (last visited March 20, 2009).
3. Id.
4. Medical Device Amendments of 1976, 21 U.S.C. § 360(k)(a) [hereafter MDA].
5. Id.
6. Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 396 (1938) [hereafter FDCA].
7. Riegel v. Medtronic, Inc., 552 U.S.(2008) [hereafter Riegel].
8. Id.
9. M. D. Hinchey Torts Play a Vital Role in Protecting Public Health Wall Street Journal, August 12, 2004, at A12. "Chief Counsel Troy's immediate predecessor, Margaret Jane Porter, clearly stated in 1997 that FDA did not view its regulations as pre-emptive of state and local law: 'even the most thorough regulation of a product such as a critical medical device may fail to identify potential problems presented by the product... Pre-emption of all such claims would result in the loss of a significant layer of consumer protection."' In 2002 the Bush administration outlined plans for FDA involvement in product liability lawsuits and began to methodically pursue that strategy which to some observers seemed more interested in protecting companies than citizens, all under the guise of "good health policy and good tort reform." See also R. Pear, "Bush Tries to Block Consumer Drug Suits, White House says Injury Claims Undermine FDA," New York Times, July 25, 2004 at A1.
10. G. Harris and A. Berenson Drug Makers Near Old Goal: A Legal Shield. Court to Rule if F.D.A. Approval Bars Suits New York Times, April 6, 2008 at A1.
11. Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996) [hereafter Lohr].
12. Wyeth v. Levine, U.S. Supreme Court Case No. 06-1249 (Slip Opinion), March 4, 2009 [hereafter Wyeth v. Levine].
13. D. M. Autor United States Department of Justice Office of Consumer Litigation, 110 Medical Device Law - An Overview available at http://www.usdoj.gov/usao/eousa/foia-reading-room/usam/title4/civ00110.htm (last visited March 18, 2009) [hereafter DOJ Overview]. The author of this document is currently the Director of Compliance for the Center for Drug Evaluation and Research, U.S. Food and Drug Administration.
14. See Riegel, supra note 7.
15. See MDA, supra note 4.
16. Medical Device Amendments of 1976, 21 U.S.C. § 360(k)(b).
17. Id.
18. Id.
19. See Lohr, supra note 11.
20. Id.
21. 21 U.S.C. § 360c(a)(1)(C). Medical devices are placed into the Class III category if, after the application of MDA's available controls, they would "present a potential unreasonable risk of illness or injury" and thus are subject to the FDCA's pre-market approval process.
22. Id.
23. See MDA, supra note 4.
24. Id.
25. P. Barton Hutt, Richard A. Merrill and L. A. Grossman, Food and Drug Law: Cases and Materials, 3rd ed. (Foundation Press, New York, 2007) [hereafter Hutt]. The chapter on Medical Devices (Chapter VII) in this definitive casebook makes this point definitively on p.997: "Safety and Effectiveness Data. The 1990 Act specifically authorized FDA to require (emphasis added) clinical data in a section 510(k) notification. Many PMN's include such data. Indeed, FDA would be unlikely to clear a PMN for a product incorporating new technologies that could affect safety or effectiveness if the notification did not contain clinical investigation data. Nevertheless, FDA assiduously avoids mentioning safety or effectiveness is letters clearing PMNs, and the agency clings to its position that a 510(k) clearance reflects a determination of equivalence, not safety and effectiveness. This distinction was critical in the Supreme Court's conclusions that a PMN clearance does not preempt a state tort action based on a devices allegedly defective design. Medtronic, Inc. v. Lohr 518 U.S. 470 492-94 (1996)." The fact is, though, that requiring submission of more, and new, data is not just equivalence; if the devices were truly equivalent there would be no need to require more safety and efficacy data, particularly on the rare occasion where new clinical trial data may be required for a 510(k).
26. The New Shorter Oxford English Dictionary, 4th ed. (New York : Oxford University Press, 1993 2557.
27. The Oxford English Dictionary, 2nd ed. (New York : Oxford University Press, 1989 682.
28. The New Oxford American Dictionary, 1st ed. (New York : Oxford University Press, 2001 1447.
29. Webster's Collegiate Dictionary, 11th ed. (New York : Merriam-Webster, 2003 1058.
30. Hutt, supra note 25. The authors point out that in any given year only several dozen PMAs are processed by CDRH while many hundreds of 510(k)s are cleared.
31. Id.
32. See MDA, supra note 4. See also L. O. Gostin The Deregulatory Effects of Preempting Tort Litigation: FDA Regulation of Medical Devices JAMA 299, no. 9 (2008 2313 2316, which argues for a "legislative intent" approach to the interpretation of the pre-emption clause of the MDA rather than plain meaning.
33. Id. The fact that 1200 hours is required to complete a PMA is irrelevant, regardless of how impressive this appears to the court. CDRH's review for substantial equivalence is known as the §510k process, named after the section of the MDA which describes the process. The point is that it is still a review, there is a process for the review, and requirements which must be met by the manufacturer for the review to be completed successfully. No question, it does not contain the full reports, studies, investigations of the device's safety and efficacy nor a "full statement" of the devices components which is required for the PMA, but it does have requirements. The requirements are not so specific as those for a PMA (and in that sense are "more general").
34. Id.
35. Id. The ruse the court uses to allow Lohr to stand is to allow products entering the market via 510k approval to do as an exception to the pre-emption statute of MDA, not under the "requirement" penumbra. Yet, a 510k review is not a simple rubber stamp of identical data for the relevant pre-1976 device it is substantially equivalent to, although the court seems to suggest this is the case. As noted, there is data, there is a review with requirements for safety and efficacy data submitted, and occasionally they are not approved because the requirements were not met. The 510k is an exception to the need to submit a PMA, not an exception to the fact that safety and efficacy data is required.
36. CDRH greatly prefers the 510k route for class III device approval. It is easier, shorter, and consumes significantly less review time and scarce agency resources for an agency generally acknowledged to be woefully understaffed and under-funded.
37. See note 25.
38. Id.
39. Medical Device Amendments of 1976, 21 U.S.C § 360c(i)(1) (A).
40. See Hutt, supra note 25, Chapter IV, New Drugs 3, Section 505(b)(2) NDA's: "The former paper NDA is therefore now called a section 505(b)(2) NDA, after the statutory provision that created it. It provides for applications in those situations where a pioneer drug has lost patent protection and market exclusivity but the modified drug differs in some way from the pioneer drug. A section 505(b)(2) NDA relies on the pioneer NDA for all required information except the data needed to support the difference. Thus, a section 505(b)(2) NDA need not include any data supporting the basic safety and effectiveness of the drug, except insofar as the difference between the pioneer drug product and the applicant's modification of that drug product [that] bears upon safety or effectiveness. In these circumstances, the section 505(b)(2) paper NDA will suffice, and a full NDA will not be required. Thus, the section 505(b) (2) NDA is mid-way between a full NDA and an abbreviated NDA.".
41. See DOJ Overview, supra note 12.
42. Id.
43. See Riegel, supra note 7.
44. See supra note 25.
45. Center for Devices and Radiological Health, United States Food and Drug Administration, available at http://www.cdrh.fda.gov (last visited March 18, 2009).
46. See Gostin, supra note 32.
47. See Riegel, supra note 7. The court never states that Lohr is reversed or invalid.
48. Id. See also Hutt, supra note 25, Chapter VII on Medical Devices: "In 2005, for example, the FDA authorized the marketing of 3,148 devices under 510(k) and granted pre-market approval to just 32 devices.".
49. See Gostin, supra note 32.
50. Id. Interestingly, there is surprising little data to support the contention that federal regulation of devices (or drugs or bio-logics, for that matter) "stifles" innovation. As a rule companies never announce that they are not going to develop products simply because there are regulatory requirements they must comply with for approval. Politically though it can be a winner ever if impossible to fairly test. If a state (e.g., California) were to have additional, more stringent class III medical device FDA-approved by a PMA, this would not interfere with the FDA approval process per-se but would interfere with national marketing of the product.
51. See Riegel, supra note 7.
52. Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 396 (1938).
53. United States Food and Drug Administration, Center for Drug Evaluation and Research (CDER), CDER Handbook, available at http://www.cder.fda.gov (last visited March 28, 2009).
54. For example, the 1938 Federal Food, Drug and Cosmetic Act requires that the new drug demonstrate substantial evidence of efficacy and safety in adequate and well-controlled clinical trials for the indications in the label before it can be approved for marketing (sale) in the United States. An off-label use by definition is one for which this safety and efficacy data was not submitted to FDA. In order to be included as a indication for prescription of the drug in the drug label, submission of efficacy and safety data is required.
55. United States Food and Drug Administration, supra note 53.
56. B. M. Psaty and W. Ray FDA Guidance on Off-Label Promotion and the State of the Literature From Sponsors JAMA 299, no. 16 (2008 1949 1951.
57. See MDA, supra note 4.
58. See Riegel, supra note 7. In discussing J. Ginsburg's dissent, J. Scalia is quick to point out that it has not yet been established whether tort lawsuits in state court are pre-empted by drug approval under the FDCA.
59. E. J. Parr, Jr. Why is FDA Attacking Injured Consumers FDLI Update (November-December 2004 30 33, at 31.
60. Public Health Services Act, 58 Stat. 682 (1944), now codified at 42 U.S.C. 262.
61. See Riegel, supra note 7.
62. Id.
63. Id.
64. Id.
65. Id.
66. Id.
67. Id.
68. A. Scalia, A Matter of Interpretation: Federal Courts and the Law (Princeton, NJ : Princeton University Press, 1997). Of course, reading a statute concerning the operation of a federal agency is no guarantee that one actually understands how the agency operates. Justice Scalia is confused what FDA does when it approves a medical device or prescription drug application when he states in Riegel that "[a] state statute, or a regulation adopted by a state agency, could at least be expected to apply cost-benefit analysis similar to that applied by the experts at the FDA." The is a profoundly incorrect generic statement about how FDA approvals work, and though it may reflect a legitimate economic efficiency concern about conflict state and federal regulations for devices reveals a significant lack of understanding of the factors used in FDA decision making. Or, in Justice Scalia's parlance, cost is not a requirement. Nor is it an exception. In fact, the review by FDA is never a cost-benefit analysis but rather is a risk-benefit analysis. Device or drug cost data is not part of the 510k, PMA, or NDA (new drug application) and is never a factor in an approval decision made by FDA experts; if it did many expensive new cancer drugs and devices would not be approved given their marginal benefit. Justice Scalia is confusing the FDA approval standard with that which can be used at CMS, another part of HHS.
69. Editor FDA Approval Preempts Medical-Device Injury Claims, Third Circuit Says Trial 19 (2004 78 79 : "The district court granted Thoratec's motion for summary judgment on the grounds that the MDA expressly preempted state law claims. The court used a two-prong test: State claims about the safety of medical devices are preempted if the FDA has established specific federal requirements that are applicable to that particular device and if the state claim is different from, or in addition to, the specific federal requirements... Other courts of appeal have held that PMA approval by the FDA constitutes approval of the products design, testing, intended use, manufacturing methods, performance standards, and labeling that is specific to the product.".
70. The main groups of products CBER evaluates includes blood, vaccines, allergenics, tissues, and cellular and gene therapies. See CBER Web site, available at http://www.fda.gov/cber/about/htm (last visited March 19, 2009).
71. National Childhood Vaccine Injury Act (NCVIA) of 1986, 42 U.S.C. §§ 300aa-1 to 300aa-34.
72. Id.
73. Id.
74. Id.
75. National Vaccine Injury Compensation Program (NVICP), National Childhood Vaccine Injury Act (NCVIA) of 1986, 42 U.S.C. §§ 300aa-1 to 300aa-34, available at http://www.uscfc.uscourts.gov (last visited March 19, 2009).
76. Id.
77. 21 C.F.R. § 314.50.
78. P. A. Offit Vaccines and Autism Revisited - The Hannah Poling Case New England Journal of Medicine 358, no. 20 (2008 2089 2091.
79. B. Patsner, Childhood Vaccines Autism, Special Courts and Torts, Health Law Perspectives, February 2008, available at http://www.law.uh.edu/healthlaw/ perspectives/homepage.asp (last visited March 19, 2009).
80. D. G. McNeil Court Says Vaccine Not to Blame for Autism The New York Times, February 13, 2009, at A1.
81. Warner Lamber Co. v. Kent, 552 U.S.(2008).
82. Wyeth v. Levine, supra note 12.
83. Id.
84. Id.
85. B. Patsner, Promotion of Off-Label Uses of Prescription Drugs and Devices: FDA Proposes a New Rule, Health Law Perspectives (June 2008), available at http://www.law.uh.edu/healthlaw/perspectives/homepage.asp (last visited March 19, 2009).
86. J. J. Leghorn, E. Brophy, and P. V. Rother The First Amendment and FDA Restrictions on Off-Label Uses: The Call for a New Approach Food and Drug Law Journal 63, no. 2 (2008 391 406.
87. See Riegel, supra, note 7.
88. It isn't clear why the Riegels didn't sue the interventional cardiologist who performed the balloon angioplasty on Mr. Riegel with the Evergreen Balloon cardiac catheterization catheter marketed by Medtronic, Inc. (and now withdrawn from the market). Mr. Riegel's physician used the device in a patient with heavily calcified, occluded vessels and greatly exceeded recommended insufflation pressures (both contraindicated, according to the label). There is real evidence of negligent medical practice, and little evidence there was anything wrong with the device per se.
89. Y. D. Fushman Case Comment: Perez v. Wyeth Labs., Inc.: Toward Creating a Direct-to-Consumer Advertising Exception to the Learned Intermediary Doctrine Boston University Law Review 80, no. 4 (2000 1161 1183.
90. See Riegel, supra note 7.
91. Committee on Oversight and Government Reform, Committee Holds Hearing on Whether FDA Regulation Should Bar Liability Claims, May 13, 2008, available at http://over-sight.house.gov/story.aspID=1943 (last visited March 19, 2009).92. The Associated Press, Bill Would Restore Right to Sue Over Medical Devices, March 6, 2009, available at http://www.nytimes.com/2009/03/06/business/06device. html?-r=1&ref=health&pagewantd (last visited March 19, 2009).