Joseph BLUNT, Sr. and Margaret Blunt, Plaintiffs-Appellants-Petitioners, STATE of Wisconsin DEPARTMENT OF HEALTH AND FAMILY SERVICES, Subrogated-Plaintiff, v. MEDTRONIC, INC., Defendant-Respondent.
No. 2006AP1506
Supreme Court of Wisconsin
February 17, 2009
2009 WI 16 | 760 N.W.2d 396
Oral argument October 7, 2008.
For the defendant-respondent there was a brief by Michael K. Brown, Lisa M. Baird, and Reed Smith LLP, Los Angeles, Cal., and Robert H. Friebert and Friebert, Finerty & St. John S.C., Milwaukee, and oral argument by Michael K. Brown.
An amicus curiae brief was filed by Stephanie A. Scharf, David W. Austin, and Schoeman, Updike, Kaufman & Scharf, Chicago, Ill., and Coleen D. Ball, Wauwatosa, on behalf of The Product Liability Advisory Council.
An amicus curiae brief was filed by William C. Gleisner, III and the Law Offices of William C. Gleisner, Milwaukee, and Rhonda L. Lanford and Habush Habush & Rottier S.C., Madison, on behalf of the Wisconsin Association for Justice, and oral argument by William C. Gleisner, III.
¶ 1. PATIENCE DRAKE ROGGENSACK, J. We review a decision of the court of appeals1 affirming the circuit court‘s decision2 granting summary judgment in favor of Medtronic, Inc. Both the circuit court and the court of appeals agreed that the express preemption provision of the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act, specifically
¶ 2. Our decision in this case turns on whether the Blunts’ state law tort claims are preempted by federal law. In order to decide this issue, we must answer three questions. The first is whether Medtronic‘s Marquis 7230 implantable cardioverter defibrillator (the Marquis 7230 defibrillator), which was approved under the Food and Drug Administration‘s (FDA) premarket approval process,
answer all of them in the affirmative. We therefore conclude that
I. BACKGROUND6
¶ 3. In 2002, Medtronic applied for FDA premarket approval to market and distribute its Marquis 7230 defibrillator. Under the Medical Device Amendments, a defibrillator such as the Marquis 7230 is a Class III device, subject to the FDA‘s strictest regulation and oversight, because it is “for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health.”
Premarket approval is a “rigorous” process. A manufacturer must submit what is typically a multi-
volume application. It includes, among other things, full reports of all studies and investigations of the device‘s safety and effectiveness that have been published or should reasonably be known to the applicant; a “full statement” of the device‘s “components, ingredients, and properties and of the principle or principles of operation“; “a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device“; samples or device components required by the FDA; and a specimen of the proposed labeling. [ 21 U.S.C.] § 360e(c)(1) . Before deciding whether to approve the application, the agency may refer it to a panel of outside experts,21 CFR § 814.44(a) (2007) , and may request additional data from the manufacturer,§ 360e(c)(1)(G) .. . . .
Once a device has received premarket approval, the [Medical Device Amendments forbids] the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling, or any other attribute, that would affect safety or effectiveness.
§ 360e(d)(6)(A)(i) . If the applicant wishes to make such a change, it must submit, and the FDA must approve, an application for supplemental premarket approval, to be evaluated under largely the same criteria as an initial application.§ 360e(d)(6) ;21 CFR § 814.39(c) .After premarket approval, the devices are subject to reporting requirements.
§ 360i . These include the obligation to inform the FDA of new clinical investigations or scientific studies concerning the device which the applicant knows of or reasonably should know of,21 CFR § 814.84(b)(2) , and to report incidents in which the device may have caused or contributed to death or serious injury, or malfunctioned in a manner that would likely cause or contribute to death or seriousinjury if it recurred, § 803.50(a) . The FDA has the power to withdraw premarket approval based on newly reported data or existing information and must withdraw approval if it determines that a device is unsafe or ineffective under the conditions in its labeling.§ 360e(e)(1) ; see also§ 360h(e) (recall authority).
Riegel, 128 S. Ct. at 1004-05 (some citations omitted).
¶ 4. On December 17, 2002, the FDA provided device-specific premarket approval to Medtronic for its Marquis 7230 defibrillator. Subsequent to this approval, as a result of laboratory testing, Medtronic became aware of a potential shorting problem with the defibrillator‘s battery. This shorting problem could cause the defibrillator‘s battery to rapidly discharge, leading to a potentially fatal loss of power in the device.8
¶ 5. Medtronic submitted to the FDA a premarket approval supplemental application containing three design changes that addressed the shorting issue. On October 23, 2003, the FDA approved these changes.9
However, at no relevant time did the FDA withdraw its approval of the original defibrillator,10 and following the supplemental premarket approval, Medtronic continued to market and distribute the original defibrillator.
¶ 6. In May of 2004, an original Marquis 7230 defibrillator was implanted in Joseph Blunt. In February of 2005, Medtronic advised physicians of the shorting problem. Less than ten days after his physician received notice of this problem, Joseph Blunt underwent surgery to remove the device at his doctor‘s suggestion. However, at no time did his defibrillator malfunction.
¶ 7. Following the second surgery, the Blunts sued Medtronic, alleging negligence, strict liability and loss of consortium based on the second surgery. Medtronic moved for summary judgment, arguing that the Blunts’ claims were expressly preempted by
[N]o State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement—
(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and
(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this chapter.
¶ 8. Before the circuit court and court of appeals, Medtronic argued that federal premarket approval constituted a “requirement applicable under this chapter” to the device, also known as a federal “requirement.”
¶ 9. At the time the circuit court ruled on Medtronic‘s motion, prior to the Supreme Court‘s decision in Riegel, there was a split among federal appellate courts with respect to both issues. Regarding the first issue, most federal circuit court decisions had concluded that device-specific premarket approval constituted a federal requirement within the meaning of
¶ 10. With respect to the second issue, a majority of federal circuit courts that had addressed the issue also concluded that state tort claims that relate to safety or effectiveness of the device constituted state requirements “different from, or in addition to,” the federal requirement, and thereby were preempted under
¶ 11. In its order granting Medtronic‘s motion for summary judgment, the circuit court analyzed these lines of cases, and concluded that the reasoning of the majority of the federal circuits was more persuasive on both issues: (1) that device-specific premarket approval constituted a federal requirement; and (2) that state tort claims based on an alleged lack of safety in a device that had received premarket approval constituted state requirements “different from, or in addition to,” the federal requirement. As a result, because Medtronic‘s original Marquis 7230 had received device-specific premarket approval, and because the Blunts’ claims sounded in negligence and strict liability based on the safety of that device, the circuit court held that their claims were preempted by
¶ 12. We granted review and now affirm.
II. DISCUSSION
A. Standard of Review
¶ 13. We review a summary judgment decision independently, employing the same methodology as the circuit court. Acuity v. Bagadia, 2008 WI 62, ¶ 12, 310 Wis. 2d 197, 750 N.W.2d 817. In addition, we interpret statutes independently of the circuit court and court of appeals, but benefitting from their analyses. Richards v. Badger Mut. Ins. Co., 2008 WI 52, ¶ 14, 309 Wis. 2d 541, 749 N.W.2d 581. Finally, whether federal preemption applies is a question of federal law that we review independently. Int‘l Ass‘n of Machinists & Aerospace Workers v. U.S. Can Co., 150 Wis. 2d 479, 487, 441 N.W.2d 710 (1989).
B. Riegel v. Medtronic
¶ 14. The United States Supreme Court has given significant direction with respect to the preemptive effect of
Premarket approval . . . imposes “requirements” under the [Medical Device Amendments] . . . . Unlike general labeling duties, premarket approval is specific to individual devices. [Premarket approval] is federal safety review. . . . [T]he FDA may grant premarket approval only after it determines that a device offers a reasonable assurance of safety and effectiveness . . . . [T]he FDA requires a device that has received premarket approval to be made with almost no deviations from the specifications in its approval application, for the reason that the FDA has determined that the approved form provides a reasonable assurance of safety and effectiveness.
Riegel, 128 S. Ct. at 1007. In resolving this issue, the Court eliminated the split among federal circuits, and adopted the position of the majority of the federal courts.
¶ 15. With respect to whether
Absent other indication, reference to a State‘s “requirements” includes its common-law duties. . . . [C]ommon-law liability is “premised on the existence of a legal duty,” and a tort judgment therefore establishes that the defendant has violated a state-law obligation. . . . And while the common-law remedy is limited to damages, a liability award “‘can be, indeed is designed to be, a potent method of governing conduct and controlling policy.‘”
[With respect to premarket approval], there is nothing to contradict this normal meaning. To the contrary, in the context of this legislation excluding common-law duties from the scope of pre-emption would make little sense. State tort law that requires a manufacturer‘s [devices] to be safer, but hence less effective, than the model the FDA has approved disrupts the federal scheme no less than state regulatory law to the same effect. Indeed, one would think that tort law, applied by juries under a negligence or strict-liability standard, is less deserving of preservation. 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: How many more lives will be saved by a device which, along with its greater effectiveness, brings a greater risk of harm? A jury, on the other hand, sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court. . . . [I]t is implausible that the [Medical Device Amendments were] meant to “grant greater power (to set state standards ‘different from, or in addition to’ federal standards) to a single state jury than to state officials acting through state administrative or legislative lawmaking processes.” That perverse distinction is not required or even suggested by the broad language Congress chose in the [Medical Device Amendments], and we will not turn somersaults to create it.
Riegel, 128 S. Ct. at 1008 (citations omitted).
¶ 16. Again, the Court resolved the federal circuit split, adopting the position of the majority of circuits that have considered the issue. In doing so, the Supreme Court noted that under the Medical Device Amendments, “the solicitude for those injured by FDA-approved devices . . . was overcome in Congress‘s estimation by solicitude for those who would suffer without
¶ 17. The device at issue in Riegel was one for which supplemental approval had been issued. We shall assume for the sake of our discussion that it was the latest supplemental approval given for that medical device because the Supreme Court did not discuss whether a supplemental approval given at a subsequent date would have had any effect on an earlier approved device sold after a subsequent supplemental approval had issued. In the case before us, the original Marquis 7230 defibrillator is the subject of the Blunts’ claims, and the Marquis 7230 that was given supplemental approval is not at issue. With these principles in mind, we now proceed to discuss the Blunts’ claims in light of Riegel.
C. Riegel and the Blunts’ Claims
¶ 18. Riegel holds that state tort claims based on injuries caused by a Class III medical device that was granted device-specific premarket approval may be preempted by
¶ 19. The Blunts contend that Medtronic is liable under theories of negligence and strict products liability due to the condition of the original Marquis 7230 defibrillator when it was implanted into Joseph Blunt. Premarket approval is specific to each individual Class III medical device, and it is the federal safety review of each such device. Id. at 1007. Accordingly, we must determine whether the Blunts’ claims of negligence and
¶ 20. With respect to negligence, the Blunts’ complaint alleged that “Medtronic was negligent in the design, testing, manufacture, marketing, warnings and sale of the [defibrillator] which was implanted in plaintiff,” and the “negligence of . . . Medtronic was a proximate cause of the injuries and damages sustained by plaintiffs.” These allegations assert that the original Marquis 7230 defibrillator could have been safer to use, despite Medtronic‘s obtaining device-specific premarket approval from the FDA, had Medtronic not been negligent. As a result, the Blunts’ negligence claim does relate to the safety of the original Marquis 7230 defibrillator, as “safety” is used in
¶ 21. With respect to strict liability, the Blunts’ complaint alleged that: (1) Medtronic‘s original Marquis 7230 defibrillator, “as manufactured, designed, tested, marketed and sold by . . . Medtronic[,] was in a defective and unreasonably dangerous condition to users when it left the possession and control of . . . Medtronic“; (2) Medtronic‘s original Marquis 7230
¶ 22. Here again, the Blunts assert that, despite receiving device-specific premarket approval for the original Marquis 7230 from the FDA, Medtronic designed and sold a Class III medical device that was “defective and unreasonably dangerous.” That theory of liability is based on allegations that draw into question the safety of a Class III device for which the FDA granted device-specific premarket approval. Therefore, it is a claim that relates “to the safety or effectiveness of” such a device within the meaning of
¶ 23. We next consider the second step in our Riegel analysis: whether the state law tort claims of negligence and strict products liability are requirements “different from, or in addition to” the federal requirement. We begin by noting that these tort claims are the same tort claims that the Supreme Court held were requirements that were “different from, or in addition to,” the federal requirement of premarket approval in Riegel. Id. at 1007.
¶ 24. As the Supreme Court explained, “[i]n [Medtronic, Inc. v.] Lohr, [518 U.S. 470, 512 (1996)] five Justices concluded that common-law causes of action for negligence and strict liability do impose ‘requirement[s]’ and would be preempted by federal require-
¶ 25. Here, the FDA granted Medtronic device-specific premarket approval for the original Marquis 7230 defibrillator. Accordingly, the state law claims of negligence and strict liability do impose requirements that are different from or in addition to the federal requirement of premarket approval.
D. The Supplemental Approval of the Marquis 7230
¶ 26. The Blunts argue that their claims are not preempted because when Medtronic obtained supplemental premarket approval of its Marquis 7230 defibrillator with the design changes addressing the shorting
¶ 27. At oral argument, both parties acknowledged, with some variation, that: (1) the “original” Marquis 7230 was either the 23rd or 29th supplemental premarket-approved device; (2) there were either five or eight supplemental premarket-approved defibrillator devices between that original Marquis 7230 and the supplemental Marquis 7230 that addressed the potential shorting problem; and (3) since the first approval, there have been approximately 75 supplemental premarket approvals of the Marquis 7230 defibrillator.
¶ 28. We begin by noting that Congress expressly preempted requirements that were different from or in addition to the federal requirement of device-specific premarket approval for Class III medical devices.
Riegel, 128 S. Ct. at 1010 (emphasis in original). Nothing in the
¶ 29. It is beyond dispute that the FDA has the power to withdraw premarket approval or to recall a device to which it has given premarket approval.
[t]he FDA has the power to withdraw premarket approval based on newly reported data or existing information and must withdraw approval if it determines that a device is unsafe or ineffective under the conditions in its labeling.
¶ 30. Under the comprehensive scheme that Congress has enacted, withdrawal of the manufacturer‘s right to market its premarket-approved devices is accomplished through affirmative acts of the FDA. There is nothing to suggest that premarket approval ceases without FDA action. For example, federal law directs that for the withdrawal or temporary suspension of premarket approval “due notice and opportunity for informal hearing” must be given.
¶ 31. In addition, Medtronic continued to be obligated to comply with the premarket approval reporting requirements with respect to the original Marquis 7230 defibrillator, subsequent to supplemental premarket approval of the changes to the defibrillator. Riegel, 128 S. Ct. at 1005 (citing
Postapproval reports. Continued approval of this [premarket approval] is contingent upon the submission of postapproval reports required under
21 CFR [§] 814.84 at intervals of 1 year from the date of approval of the original [premarket approval].
The content of these premarket approvals is consistent with the discussion in Riegel, cited immediately above. Accordingly, if the premarket approval of the original Marquis 7230 defibrillator were not ongoing, there would be no need to direct Medtronic to report at least annually on the results of further use and testing of the device.15
¶ 32. We have found nothing in the comprehensive federal regulatory scheme that suggests a change in device-specific premarket approval of a Class III medical device occurs simply because a subsequent device has received supplemental premarket approval, and the Blunts have identified no such provision in the
¶ 33. Furthermore, the United States Supreme Court has interpreted other federal statutory schemes to which preemption arguments have been made in a manner that supports this conclusion. For example, in Geier v. American Honda Motor Co., 529 U.S. 861 (2000), the United States Department of Transportation had required that new automobiles employ at least one of a variety of approved passive restraint systems, including automatic seatbelts and airbags. Geier, 529 U.S. at 875-76. Geier sued Honda, alleging liability based on a theory that Honda had a duty to install airbags, even though the federal regulations explicitly permitted other passive restraint systems such as automatic seatbelts. Id. at 881. The Supreme Court, in rejecting Geier‘s argument, stated:
In effect, petitioners’ tort action depends upon its claim that manufacturers had a duty to install an airbag.... Such a state law—i.e., a rule of state tort law imposing such a duty—by its terms would have required manufacturers of all similar cars to install airbags rather than other passive restraint systems, such as automatic belts or passive interiors..., even though [the regulation] required only that 10% of a manufacturer‘s nationwide fleet be equipped with any passive restraint device at all.
Id. Since the state tort claims in Geier would have held automobile manufacturers liable for manufacturing automobiles without airbags and the federal regulations permitted the manufacturers to use other restraints,
¶ 34. Applying the reasoning of Geier to this case, we note that Medtronic had received FDA device-specific premarket approval to sell both the original and the supplemental defibrillators. The Blunts acknowledge this, yet the Blunts’ tort claims seek to impose liability for selling the original Marquis 7230 defibrillator.
¶ 35. While the ultimate holding in Geier was based on implied preemption and our decision is based on express preemption, the facts before us are analogous to the facts in Geier because in Geier the federal government approved airbags and also other restraints, such as lap and shoulder belts. Id. at 876. Here, both the original defibrillator and the supplemental defibrillator were approved by the federal government.
¶ 36. In Geier, Honda had installed airbags in some of its autos, in conformance with federal regulation; however, Geier was injured in an auto that contained lap and shoulder belts, also in conformance with federal regulations. Id. at 865. Here, Medtronic sold both defibrillators and Blunt sought recovery based on the implantation of the original defibrillator, which defibrillator was also in conformance with the federal regulation.
¶ 37. In Geier, the Court upheld a preemption defense for the lap and shoulder belts, concluding that because both types of restraint had been federally
¶ 38. In addition, other courts seem to take for granted that a manufacturer often may have a number of different supplemental premarket-approved devices on the market at any given time. See, e.g., U.S. ex rel. Gilligan v. Medtronic, Inc., 403 F.3d 386, 388 (6th Cir. 2005) (discussing premarket approval and supplemental approval for several pacemakers applied for and obtained at the same time); Scott v. CIBA Vision Corp., 38 Cal. App. 4th 307 (Cal. Ct. App. 1995) (preempting claims for an eye injury that occurred when the wrong solution was used with a contact lens after supplemental approval had been given to use a red top on the container for that solution instead of the earlier approved white top that was used on the container of the solution that caused the injury).
¶ 39. Finally, supplemental approvals do not necessarily occur because newer versions are more safe than predecessor versions, but rather, because the law
¶ 40. The relevant federal statutes, the FDA‘s regulations and the relevant case law support preemption by the device-specific premarket approval of the original Marquis 7230 defibrillator. Therefore, that premarket approval remained the federal requirement that preempts the Blunts’ claims under
¶ 41. In an effort to get around the holdings in Riegel, the Blunts also contend that the federal statute‘s use of the word “requirement” means that the medical device manufacturer is “required” to sell only one version of the device. The Blunts explain that since Medtronic had the option of selling either the original Marquis 7230 defibrillator or the supplemental Marquis 7230, it was no longer “required” to sell only the original defibrillator. Therefore, they contend that their claims that arise from the use of the original Marquis 7230 are not preempted. Stated otherwise, they argue that since there is no longer a federal “requirement” that relates solely to the original Marquis 7230, state tort law requirements have no federal requirement from which they are “different from, or in addition to.”
¶ 42. Riegel provides a precise meaning for the term, “requirement,” as used in
¶ 43. As a result, the term, “requirement,” as it is construed in Riegel, encompasses both federally mandated criteria18 for medical devices before they can be marketed and sold (a federal requirement) and state
III. CONCLUSION
¶ 44. Our decision in this case turns on whether the Blunts’ state law tort claims are preempted by federal law. In order to decide this issue, we must answer three questions. The first is whether Medtronic‘s Marquis 7230 implantable cardioverter defibrillator (the Marquis 7230 defibrillator), which was approved under the Food and Drug Administration‘s (FDA) premarket approval process,
By the Court.—The decision of the court of appeals is affirmed.
¶ 45. ANN WALSH BRADLEY, J. (concurring in the judgment). I write separately in order to express my concern that the United States Supreme Court‘s interpretation of the 1976
¶ 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
I
¶ 47. The purpose of the federal
¶ 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
¶ 49. The
¶ 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
¶ 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:
It 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.
¶ 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
basis 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
¶ 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
¶ 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
¶ 62. In Geier, the Supreme Court determined that the plaintiff‘s 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 airbags[.]” 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
¶ 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.
Notes
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).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.“).Where a state 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.