Court Opinion

ID: 9664634
Source: CourtListenerOpinion
Date Created: 2023-08-24 00:23:50.686388+00
Date Added: 2024-06-11T18:15:07.983264
License: Public Domain

ANN WALSH BRADLEY, J.
¶ 45. {concurring in the judgment). I write separately in order to express my concern that the United States Supreme Court's interpretation of the 1976 Medical Device Amendments does not adequately protect the safety of the citizens of Wisconsin. See Riegel v. Medtronic, Inc., _ U.S. _, 128 S. Ct. 999 (2008). With one stroke of a pen, it has diminished the states' traditional authority over the development of the common law and substituted instead mandatory adherence to a regulatory standard that may be substandard. I do not believe that such adherence was mandated by the express language of the amendments, although I acknowledge that I am bound by the Supreme Court's interpretation.
¶ 46. I also write separately because I disagree with the majority's reliance on Geier v. American Honda Motor Co., Inc., 529 U.S. 861 (2000). The Geier case turns on implied preemption. Nevertheless, the majority uses Geier to conclude that the Blunt's tort claims must be dismissed based on express preemption.1 Because express preemption and implied preemption are distinct *641legal theories based on different facts and analysis, Geier does not support the majority's determination in this case.
I
¶ 47. The purpose of the federal Medical Devices Amendments of 1976, 21 U.S.C. § 360 et seq., was "to provide for the safety and effectiveness of medical devices intended for human use[.]" 90 Stat. 539 (1976) (preamble); see also Medtronic, Inc. v. Lohr, 518 U.S. 470, 474 (1996). In response to public health disasters involving unsafe medical devices such as the infamous Daikon Shield, Congress determined that these devices should be more stringently regulated than most products. Riegel, _ U.S. at _, 128 S. Ct. at 1003.
¶ 48. It is the responsibility of the state legislature and courts to develop a tort system that protects the health and safety of the citizens they serve. The United States Supreme Court has "long presumed that Congress does not cavalierly pre-empt state-law causes *642of action." Lohr, 518 U.S. at 485. "[A]s a rule," the United States Supreme Court "should be and [is] reluctant to federalize matters traditionally covered by state common law." Patterson v. McLean Credit Union, 491 U.S. 164, 183 (1989) (superseded by statute) (quotations omitted). Instead, the Court "start[s] with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress." Lohr, 518 U.S. at 485 (quotations omitted).
¶ 49. The Medical Device Amendments provide that no State may "establish or continue in effect. . . any requirement" that is "different from, or in addition to" the federal requirements and "which relates to the safety or effectiveness of the device[.]" 21 U.S.C. § 360k(a). In 1996, the Court stated that "it would take language much plainer than the text of § 360k(a) to convince us that Congress intended that result [that state tort claims are preempted]." Lohr, 518 U.S. at 487.
¶ 50. However, 12 years later, with precisely the same language in force, the Court concluded that the language was apparently plain enough. The Court determined that state tort law claims are state "requirements" and that the express language of § 360k(a) preempts them. Riegel, _ U.S. at _, 128 S. Ct. at 1008.
¶ 51. Despite basing its conclusion on a determination that the language is plain, the Court turned to the policy reasons supporting its determination. The policy reason cited by the Supreme Court in favor of preemption is that it is better for one centralized agency — the Food and Drug Administration (FDA) — to do the necessary cost-benefit analysis in determining whether a device is safe enough for the market:
*643It is not our job to speculate upon congressional motives. If we were to do so, however, the only indication available — the text of the statute — suggests that the solicitude for those injured by FDA-approved devices ... was overcome in Congress's estimation by solicitude for those who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovations.2
Riegel, _ U.S. at _, 128 S. Ct. at 1009.3
¶ 52. This is a policy rationale that may be meritorious if the premarket approval process provided at least minimum assurances of safety. It presumes that the FDA premarket approval process is indeed rigorous and that the devices approved are safe for use. Recent reporting on the FDA calls these presumptions into question.
*644¶ 53. Recently, there has been a flood of criticism directed at the FDA approval process, much of the criticism coming from whistleblowers within the FDA itself. It is not at all apparent that the FDA approval process actually guarantees a minimum level of safety for medical devices. A January 2009 letter from nine FDA scientists could not be more clear: "The purpose of this letter is to inform you that the scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk." Letter from nine FDA scientists (names redacted), to John D. Podesta, Presidential Transition Team 1 (Jan. 7, 2009).
¶ 54. The letter charges managers of the Center for Devices and Radiological Health (CDRH) with "corrupting and distorting the scientific evaluation of medical devices, and. . . interfering with our responsibility to ensure the safety and effectiveness of medical devices before they are used on the American public." Id. The scientists further explained:
Managers at CDRH have ignored the law and ordered physicians and scientists to assess medical devices employing unsound evaluation methods, and to accept non-scientific, nor clinically validated, safety and effectiveness evidence and conclusions, as the basis of device clearance and approval. Managers . .. have ignored serious safety and effectiveness concerns of FDA experts. Managers have ordered, intimidated, and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations and to accept clinical and technical data that is not scientifically valid nor obtained in accordance with legal requirements.... These same managers have knowingly tried to avoid transparency and accountability by failing to properly document the *645basis of their non-scientific decisions in administrative records.
Id. at 2. The letter concludes that the current FDA approval process is "a clear and silent danger to the American public." Id. at 3.
¶ 55. As one example of the FDA's ineffectiveness in ensuring basic device safety, the FDA scientists point to the 1998 approval of a mammography computer-aided detection device. Id. The scientists charge that the FDA approved the device even though there was no clinical evidence of improved cancer detection. Id. Further, the FDA carried out no post-marketing reassessment of approved devices and "ignor[ed] accumulating clinical evidence provided by independent research publications revealing that these devices were ineffective and potentially harmful when used in clinical practice." Id.
¶ 56. Congress is aware of some of the problems within the FDA, and the House Committee on Energy and Commerce conducted an investigation on the matter in October of 2008. As a result of its findings, the Committee sent a letter to the Commissioner of the FDA, stating that the Committee "recently received compelling evidence of serious wrongdoing in connection with FDA's review, clearance, and approval process of medical devices."4 The letter states that FDA scientists "supplied substantial evidence demonstrating that medical devices submitted for FDA review . . . have *646been received and/or cleared or approved in violation of agency regulation and guidance mandated to assure safety and effectiveness."5
¶ 57. The preemption doctrine should not be employed to allow for the normal standard of care to be substandard care. I conclude, as I must, that Riegel controls and that the Blunts' tort claims are preempted.6 However, the result may be no meaningful protection for Wisconsin patients.
II
¶ 58. I also write separately to express my disagreement with the majority's discussion of Geier v. American Honda Motor Co., Inc., 529 U.S. 861 (2000). See majority op., ¶¶ 33-37. The basis for the majority's conclusion in this case (and for the Supreme Court's conclusion in Riegel) is express preemption. Yet, Geier is a case that turns on conflict preemption, a form of *647implied preemption.7 Because the cases turn on distinct legal theories, I do not find Geier relevant to the court's determination in this case.
¶ 59. Express preemption and implied preemption are separate legal theories, based on distinct factual inquiries. Express preemption is exactly what it sounds like — the text of a congressional enactment explicitly provides that state law claims are preempted. See English v. Gen. Elec. Co., 496 U.S. 72, 79 (1990). Implied preemption, however, comes in several stripes and involves a more nuanced analysis.
¶ 60. One form of implied preemption is "conflict preemption." Under this doctrine, a particular state law is preempted because of an "actual conflict" with a federal regulation — even in the absence of a broad congressional mandate to preempt all state law in the area. See id. State law is preempted due to a conflict with federal law when it is impossible for a party to simultaneously comply with state and federal requirements, or when the state law "stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress." Id.
¶ 61. The majority appears to suggest that a case about implied preemption lends support to the majority's express preemption analysis. That is, the Blunts' claims are expressly preempted because the facts of the case are "analogous" to the facts in a case regarding a different Congressional act and in which a *648different preemption doctrine applies. Majority op., ¶ 35. This cannot be. Because the majority here takes a superficial approach to the facts and the law in Geier, it misses the essence of that case and misapplies its holding.
¶ 62. In Geier, the Supreme Court determined that the plaintiffs state tort law claim was impliedly preempted via the doctrine of conflict preemption. 529 U.S. at 874. Geier had filed a tort action against Honda, alleging negligence for failure to install an airbag in her car. Id. at 865. The Court examined the Federal Motor Vehicle Safety Standards, promulgated by the Department of Transportation, to determine whether they preempted Geier's claim. The safety standards required automobile manufacturers to equip some — but not all — of their vehicles with airbags. Id.
¶ 63. In determining that Geier's claim was impliedly preempted, the Court looked to the comments and drafting history of the safety standards to determine the Department's intent. Id. at 874-79. In creating the safety standards, the Department had "rejected a proposed . . . 'all airbag' standard because of safety concerns (perceived or real) associated with airbagsf.]" Id. at 879. Instead, the Department determined that "a mix of devices would help develop data on comparative effectiveness [and] would allow the industry time to overcome the safety problems and the high production costs associated with airbags[.]" Id. The safety standards reflected the Department's "policy judgment that safety would best be promoted if manufacturers installed alternative protection systems in their fleets rather than one particular system in every car." Id. at 881 (emphasis in original).
¶ 64. In Geier, the Court concluded the Department made an affirmative determination that it did not *649want manufacturers to install airbags in all of their automobiles. Because Geier's tort claim would require manufacturers to install airbags in all of their automobiles or risk liability, the state tort claim actually conflicted with the accomplishment of a federal objective. Therefore, it was impliedly preempted. See id.
¶ 65. In this case, the facts in the record do not support a finding of implied preemption. At the time that Blunt received the allegedly defective defibrillator, the FDA permitted Medtronic to market both the original and the improved defibrillator. Majority op., ¶ 32. There is no indication in the record, however, that the FDA made an affirmative decision that its policy objectives would be best served if Medtronic sold both types of defibrillators at once. Without such affirmative determination, state tort law claims do not frustrate the accomplishment of the FDA's objective and are not preempted under the doctrine of conflict preemption.
¶ 66. For the above reason, I determine that the reasoning of Geier is inapt in this case. Because I do not agree with the majority's blending of preemption doctrines, I respectfully concur.
¶ 67. I am authorized to state that SHIRLEY S. ABRAHAMSON, C.J. joins this concurrence.

 The majority misconstrues the Blunts' arguments. The Blunts argue that their tort claims are not state requirements "different from, or in addition to" federal requirements because *641Medtronic had the option of selling one of two approved devices. Thus, the Blunts assert that Medtronic was allowed to — but was not required to — sell the allegedly defective device that was implanted in Joseph Blunt.
The majority addresses the Blunts' argument only as an afterthought. See majority op., ¶¶ 41-43. Instead, the majority focuses on an argument never advanced by the Blunts, that is, whether supplemental approval of a subsequent device extinguished the prior device's Food and Drug Administration (FDA) approval. See majority op., ¶¶ 26-40. This is an argument that does not appear in the Blunts' brief, and that counsel for the Blunts specifically disclaimed during oral argument. See Wisconsin Court System, Supreme Court Oral Arguments, http://wicourts.gov/opinions/soralarguments.htm (search "Party name" for "Blunt"; then follow "Playback" link) at 19:15.

 Concurring in the judgment, Justice Stevens stated:
There is nothing in the preenactment history of the [Medical Device Amendments] suggesting that Congress thought state tort remedies had impeded the development of medical devices. Nor is there any evidence at all to suggest that Congress decided that the cost of injuries from Food and Drug Administration-approved medical devices was outweighed "by solicitude for those who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovations." That is a policy argument advanced by the Court, not by Congress.
Riegel v. Medtronic, Inc., _ U.S. _, 128 S. Ct. 999, 1012 (2008) (Stevens, J., concurring in part and concurring in the judgment) (citations omitted).

 A recent law review article closely tracks this rationale, declaring that "preemption is necessary to ensure that federal regulatory agencies, like the Food and Drug Administration (FDA), are the only governmental actors able to impose requirements on manufacturers — thereby ensuring a nationally standardized system of safety regulations without myriad local variations." Note, Preemption of State Common Law Claims, 122 Harv. L. Rev. 405, 405 (2008).

 Letter from Representative John D. Dingell and Representative Bart Stupak, Chairmen, U.S. House of Representatives Committee on Energy and Commerce, to the Honorable Andrew C. von Eschenbach, Commissioner, U.S. Food and Drug Administration 1 (Nov. 17, 2008).

 Id.

 Tort law claims are not preempted, however, to the extent that they seek damages for a manufacturer's violation of federal requirements:
Where a slate cause of action seeks to enforce [a federal! requirement, that claim does not impose a requirement that is "different from, or in addition to," requirements under federal law. To be sure, the threat of a damages remedy will give manufacturers an additional cause to comply, but the requirements imposed on them under state and federal law do not differ. Section 360k does not preclude States from imposing different or additional remedies, but only different or additional requirements.
Medtronic, Inc. v. Lohr, 518 U.S. 470, 513 (1996) (O'Connor, J., concurring in part and dissenting in part) (emphasis in original); see also Riegel, 128 S. Ct. at 1011 ("§ 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case 'parallel,' rather than add to, federal requirements.").

 In fact, in Geier the Court determined that a Department of Transportation safety standard did not expressly preempt state tort law claims. Geier v. Am. Honda Motor Co., Inc., 529 U.S. 861, 868 (2000). However, based on the Department's comments which accompanied the standards and the drafting history, the Court determined that the claim was nonetheless preempted under the doctrine of implied preemption. Id. at 874.