Life after Riegel: A fresh look at medical device preemption one year after Riegel v. Medtronic, Inc.

Food and Drug Law Journal

Volumn 64, Issue 2, 2009, Pages 291-311

  Wartman, Gregory J ^a  

^a Saul Ewing LLP   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DECISION MAKING; DEVICE; DRUG LEGISLATION; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEALTH CARE POLICY; MARKETING; REVIEW; SAFETY;

DEVICE APPROVAL; DUTY TO WARN; EQUIPMENT FAILURE; FEDERAL GOVERNMENT; FRAUD; HUMANS; LIABILITY, LEGAL; PACEMAKER, ARTIFICIAL; STATE GOVERNMENT; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 66749099040     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (142)

1. The 1997 Food and Drug Administration Modernization Act (FDAMA) may provide express preemption of state law tort claims involving over-the-counter drugs (OTC).
2. Hillsborough County v. Automated Medical Laboratories, Inc., 471 U.S. 707, 719, 105 S.Ct. 2371, 2378, 85 L.Ed.2d 714 (1985).
3. Riegel v. Medtronic, Inc., 518 U.S. 470, 475 (2008).
4. Wyeth v. Levine, No. 06-1249, 129 S.Ct. 1187, (Mar. 4, 2009), available at http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf.
5. Wyeth, No. 06-1249, 129 S.Ct. at 1199, available at http://www. supremecourtus.gov/opinions/08pdf/06-1249.pdf
6. Id.
7. 518 U.S. 470, 116 S.Ct. 2240 (1996).
8. Before a class III medical device may be marketed and sold, it must either be cleared through the 510(k) clearance process or receive premarket approval. In enacting the MDA, Congress was concerned that a device manufacturer receiving PMA approval for its device would obtain an instantaneous monopoly for that type of device. As a result, Congress included section 510(k), which allows a manufacturer to market and sell a device that is the "substantial equivalent" of a device that was already on the market at the time of the MDA's enactment. 510(k) clearance would foster competition by allowing other manufacturers to enter the market. FDA provides a good discussion of the 510(k) process. See http://www.fda.gov/cdrh/devadvice/314.html.
9. Lohrv. Medtronic, Inc., 56 F3d 1335 (11th Cir. 1995).
10. Id. at 494.
11. Id.
12. Robinson v. Endovascular Tech., Inc., Sup. Ct. of Cal., Case No.: 1-03-CV-009655 (Dec. 17, 2008) (ruling that state law claims asserted against a medical device that receives an investigational device exemption are preempted under the MDA); Tuttle v. CIBA Vision Corp., 2007 WL 677134, * 2 (D. Utah Mar. 1, 2007); Busch v. Ansell Perry, Inc., 2005 WL 877805, * 2 (W.D. Ky. Mar. 8, 2005) (ruling that "premarket approval of a device is not the only way for the FDA to impose a 'requirement.'"); Papike v. Tambrands Inc., 107 F.3d 737, 740-742 (9th Cir. 1997) (ruling that FDA-mandated warning label for tampons that was both device specific and disease specific preempts failure to warn claim).
13. Tuttle, (2007) WL 677134, at*1.
14. Id. at *2.
15. Id.
16. Id.
17. Id. at 495.
18. FDA's website explains that the premarket approval process "is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.See http://www.fda.gov/cdrh/devadvice/pma/.
19. An approved Premarket Approval Application is similar to an approved New Drug Application (NDA) in that it essentially provides a manufacturer with a private license to market a particular medical device. A Class III device that fails to meet PMA requirements is considered to be adulterated under Section 501(f) of the act and cannot be marketed. See http://www.fda.gov/cdrh/pmapage. html.
20. Riegel v. Medtronic, Inc., 451 F.3d 104, 120-22 (2d Cir. 2006); Horn v. Thoratec Corp., 376 F3d 163 (3d Cir. 2004); Gomez v. St. Jude Medical Daig Div., Inc., 442 F.3d 919, 930 (5th Cir. 2006); Brooks v. Howmedica, Inc., 273 F.3d 785, 797 (8th Cir. 2001); Kemp v. Medtronic, Inc., 231 F.3d 216, 226-28 (6th Cir. 2000). But see Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1375-1380 (11th Cir. 1999).
21. Riegel v. Medtronic, Inc., 451 F.3d 104, 120-122 (2d Cir. 2006).
22. A physician uses the catheter during an angioplasty to open a patient's clogged arteries. The physician inserts the catheter into the clogged vessel, inflates the catheter like a balloon and then deflated and removes the catheter.
23. Riegel, 451 F.3d at 107
24. Id. at 109.
25. Id. at 110.
26. Id. at 121-122.
27. Id. at 122.
28. Id.
29. Id.
30. Goodlin, 167 F.3d at 1375.
31. Id. at 1378.
32. 3i Id. at 1379. See also Kennedy v. Collagen Corp., 67 F.3d 1453 (9th Cir. 1995) (ruling "it makes little sense to hold that the FDA's premarket approval process qualifies as a 'specific requirement applicable to a particular device'").
33. Riegel v. Medtronic, Inc., 128 S.Ct. 999, 1002, 169 L.Ed.2d 892 (2008).
34. Id. at 1004.
35. Id.
36. Id. at 1005.
37. Id. at 1007.
38. Id. In dissent, Justice Ginsburg takes the view that "the process for approving new drugs is at least as rigorous as the premarket approval process for medical devices." Id. at 1018. She contends that courts have "overwhelmingly" ruled that FDA approval of a new drug application does not preempt state law tort claims and the same should be true for medical devices. She recognized that the Supreme Court is scheduled to address that issue in the fall of 2008 in Wyeth v. Levine. Id. at 1019.
39. Id. at 1007.
40. Lohr, 518 U.S. at 512, 116 S.Ct. 2240.
41. Riegel, 128 S.Ct. at 1008.
42. Id. at 1015 (Ginsburg, J., dissenting).
43. Id. at 1009.
44. Id.
45. Id. at 1011.
46. Walker v. Medtronic, Inc., 2008 WL 4186854 (S.D. W Va. Sept. 9, 2008); Purcel v. Advanced Bionics Corp., 2008 WL 3874713, *4 (N.D. Tex. Aug. 13, 2008). But see Kavalir v. Medtronic, Inc., 2008 WL 4087950 (N.D. 111. Aug.27, 2008) (ruling that there was not a sufficient basis to determine, at this stage of the proceeding, that Plaintiff's state-law claims are preempted under Riegel).
47. Purcell v. Advanced Bionics Corp., 2008 WL 3874713 (N.D. Tex. Aug. 13, 2008).
48. Purcell, 2008 WL 3874713, at *2.
49. Id. at *4.
50. Id. at *3-4.
51. Id. at *4. See also Delaney v. Stryker Orthopedics, No. 08-03210 (DMC), 2009 WL 564243 (D.N.J. Mar. 5, 2009) (ruling that express warranty claim was not preempted under Riegel).
52. Id.
53. Id.
54. In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., No. 08-1905, 2009 WL 35467 (D. Minn. Jan. 5, 2009); Link v. Zimmer Holding, Inc., No. 06 C 5438, 2008 WL 5047677 (N.D. Ill. Nov. 26, 2008); Heisner v. Genzyme Corp., 2008 WL 2940811 (N.D. Ill. July 25, 2008); Stevens v. Pacesetter, Inc., 2008 WL 2637417 (D. S.C. Apr. 1, 2008) (ruling that wife's loss of consortium claim was not a parallel claim because it relied on the same alleged wrongful conduct as the patient's claims to impose additional or different requirements on the manufacturer).
55. In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., No. 08-1905, 2009 WL 35467 (D. Minn. Jan. 5, 2009).
56. Id. at *4.
57. Id.
58. Id. at*5.
59. Id. at *6-16.
60. Id.
61. Id. at *9.
62. Id.
63. Id at *10.
64. Id.
65. 2008 WL 2940811 (N.D. Ill. July 25, 2008).
66. Heisner, 2008 WL 2940811, at *4.
67. Id.
68. Id.
69. Id.
70. Id. at *5.
71. Id.
72. Id.
73. Id.
74. 2008 WL 3895381 (Ky. Cir. Ct. July 30, 2008).
75. Id.
76. Id.
77. Horowitz v. Stryker Corp., 2009 WL 436406 (E.D. N.Y. Feb. 20, 2009); Clark v. Medtronic, Inc., 2008 WL 3851538 (D. Minn. Aug. 18, 2008); Troutman v. Curtis, 185 P.3d 930, 934 (Kan. 2008); Mullin v. Guidant Corp., 2008 WL 2785498 (Conn. Super Ct. Apr. 8, 2008) (rejecting plaintiffs' parallel claims argument where "there are no such allegations in the plaintiffs' complaint"). See also Despain v. Bradburn, 372 Ark. 272, 2008 WL 1067202 (Ark. Apr. 10, 2008) (ruling that Riegel compelled granting manufacturer's motion for summary judgment on preemption grounds where there was no assertion of parallel claims). But see Hofts v. Howmedica Osteonics Corp., 2009 WL 331470 (S.D. Ind. Jan. 12, 2009)(denying motion to dismiss on preemption grounds and giving plantiff an opportunity in discovery to develop facts in support of alleged parallel claims).
78. 572 F. Supp. 2d 1090 (D. Minn. 2008).
79. Clark, 572 F. Supp. 2d at 1094.
80. Id.
81. Id.
82. Id.
83. Id.
84. Link, 2008 WL 5047677, at*5; Robinson v. Endovascular Tech., Inc., Case No. 1-03-CV-009655 (Dec. 17, 2008); Norks v. Endovascular, Inc., Case No. 1-03-CV-010668 (Dec. 17, 2008); McCutcheon v. Zimmer Holdings, Inc., 2008 WL 3153442, *5 (N.D. Ill. Aug. 6, 2008).
85. See Buckman v. Plaintiffs' Legal Committee, 531 U.S. 341, 348, 121 S.Ct. 1012, 1017 (2001).
86. Buckman, 531 U.S. at 347, 121 S.Ct. at 1017.
87. Id. at 348, 121 S.Ct. at 1017.
88. 2008 WL 3153442 (N.D. Ill. Aug. 6, 2008).
89. McCutcheon, 2008 WL 3153442, at *5.
90. Id.
91. Id. See also Clark, 572 F. Supp. 2d at 1095 (ruling that plaintiff's efforts to avoid Riegel preemption by relying on the manufacturer's alleged withholding risk information from FDA are prohibited by Buckman as "Congress has granted the FDA exclusive power to enforce MDA premarket approvals").
92. Id. But see Heisner, 2008 WL 2940811, at *4-5 (suggesting that a claim resting on a manufacturer's failure to fully participate in the PMA process is a parallel claim that is not preempted).
93. Robinson, Case No.: 1-03-CV-09655, at p.4 (citing Buckman, 531 U.S. at 354); Norks, Case No. 1-03-CV-010668, at p. 4 (citing Buckman, 531 U.S. at 354) (Steven, J. concurring).
94. See, e.g., Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 966 (6th Cir. 2004) (ruling that fraud-on-the-FDA exception to punitive damages statute was prohibited in light of Buckman absent a specific finding by the FDA that the manufacturer withheld material information); Kobar v. Novartis Corp., 378 F. Supp. 2d 1166, 1174 (D. Ariz. 2005) (ruling that because the exception to Arizona's product liability statute would require a plaintiff to prove fraud-on-the-FDA, that portion of the statute was preempted).
95. Desiano v. Warner-Lambert & Co., 467 F3d 85, 93-94 (2d Cir. 2006);
96. 467 F.3d 85 (2d Cir. 2006).
97. See Garcia, 385 F.3d at 966.
98. Warner-Lambert Co. v. Kent, 128 S.Ct. 1168 (2008).
99. See Neil v. Biggers, 409 U.S. 188, 192 (1972).
100. Id. at *5.
101. Id.
102. Id.
103. Id. at *5-6. The plaintiff asserted two additional arguments of dubious credibility. First, she contended that the Court should ignore the U.S. Supreme Court's federal preemption ruling in Riegel and, instead, follow a state court decision from 1999. Second, the Court should disregard Riegel in favor of a proposed bill introduced in the U.S. House of Representatives. The Court rejected both of these arguments as contrary to the Supremacy Clause of the U.S. Constitution.
104. See Baker v. St. Jude Medical, S.C., Inc., 178 S.W.3d 127, 135 (Tx. Ct. App. 1st Dist. 2005); In re Medtronic Polyurethane Insulated Pacing Lead Prod. Liab. Litig., 96 F.Supp.2d 568, 570 (E.D.Tex. 1999).
105. In re Medtronic Polyurethane Insulated Pacing Lead Prod. Liab. Litig., 96 F Supp. 2d at 570.
106. In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., No. 08-1905, 2009 WL 35467, at *6-7.
107. Id. at *5.
108. Id. at *6.
109. Id.
110. Id.
111. Id. at *7.
112. Id.
113. See Dorsey v. Allergan, No. 3:08-0731, slip op. (M.D. Tenn. Mar. 11, 2009), Robinson v. Endovascular Tech., Inc., Case No.: 1-03-CV-009655 (Dec. 17, 2008); Norks v. Endovascular Tech., Inc., Case No..1-03-CV-010668 (Dec. 17, 2008).
114. Robinson, Case No.: 1-03-CV-009655, at p. 3; Norks, Case No.: 1-03-CV-010668, at p. 3.
115. Robinson, Case No.: 1-03-CV-009655, at p. 3; Norks, Case No.: 1-03-CV-010668, at p. 3.
116. 2008 WL 2680474 (WD. Va. July 3, 2008).
117. Adkins, 2008 WL 2680474, at *1.
118. Id.
119. Id.
120. Id.
121. Id.
122. Id.
123. Id. at *2.
124. Id.
125. Id.
126. Id.
127. Id.
128. Id.
129. Id. at *3. See also Incollingo v. Ewing, 444 Pa. 299, 282 A.2d 206 (1971). Incollingo similarly recognized that a manufacturer can be held liable for the actions of its representatives. In Incollingo, the Pennsylvania Supreme Court ruled that where a printed warning was "proper and adequate," a prescription drug manufacturer could still be held liable for failure to warn if the warning "was in effect nullified by the representations" of detail men or sales representatives hired by the manufacturer. See Incollingo, 444 Pa. at 288-289,282 A.2d at 219-220. The Court ruled that "whether or not the warnings on the cartons, labels and literature of [the manufacturer] in use in the relevant years were adequate, and whether or not the printed words of warning were in effect cancelled out and rendered meaningless in the light of the sales effort made by the detail men, were questions properly for the jury." Id. In Incollingo, the Court upheld the jury's finding against the manufacturer on that basis.
130. Adkins, 2008 WL 2680474, at *3.
131. Id.
132. 2008 WL 4457864 (D. Colo. Oct. 1, 2008).
133. Parker, 2008 WL 4457864, at *1.
134. Id. at *2.
135. Id.
136. 2008 WL 820192 (N.D.N.Y. Mar. 26, 2008).
137. Id. at *2.
138. HR 6381 IH (2008).
139. See http://www.advamed.org/MemberPortal/About/NewsRoom/NewsReleases/pr- 06-26-08-response-med-device-safety-act-2008.htm.
140. Id.
141. See http://energycommerce.house.gov/index.php?option=com- content&task=view&id=1518&Itemid=1
142. Id.