Blunt v. Medtronic, Inc.

Citation2009 WI 16,760 N.W.2d 396
Decision Date17 February 2009
Docket NumberNo. 2006AP1506.,2006AP1506.
PartiesJoseph BLUNT, Sr. and Margaret Blunt, Plaintiffs-Appellants-Petitioners, State of Wisconsin Department of Health and Family Services, Subrogated-Plaintiff, v. MEDTRONIC, INC., Defendant-Respondent.
CourtUnited States State Supreme Court of Wisconsin
760 N.W.2d 396
2009 WI 16
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.
Argued October 7, 2008.
Decided February 17, 2009.

[760 N.W.2d 398]

For the plaintiffs-appellants-petitioners briefs were filed by John C. Cabaniss, Thomas Armstrong, and von Briesen & Roper, S.C., Milwaukee, and oral argument by John C. Cabaniss.

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 Anne Berleman Kearney, Joseph D. Kearney, and Appellate Consulting Group, Milwaukee, on behalf of the Wisconsin Manufacturers & Commerce.

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 21 U.S.C. § 360k(a) (2000),3 preempted the negligence, strict liability and loss of consortium claims asserted by the plaintiffs, Joseph and Margaret Blunt (the Blunts).

¶ 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, 21 U.S.C. § 360e, met the federal "requirement" specific to that device, pursuant to 21 U.S.C. § 360k(a), when it received premarket approval. The second question is whether the Blunts' common law claims, which allege negligence, strict liability and loss of consortium, constitute state requirements that are "different from, or in addition to," the federal requirement. The third question is whether the preemption analysis of Riegel v. Medtronic, Inc., ___ U.S. ___, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008), applies to claims against the Marquis 7230 defibrillator, even though supplemental premarket approval4 was given to a later

760 N.W.2d 399

defibrillator. Because we conclude that the United States Supreme Court's decision in Riegel provides definitive direction on these questions,5 we answer all of them in the affirmative. We therefore conclude that § 360k(a) preempts the Blunts' claims. Accordingly, we affirm the decision of the court of appeals.

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." 21 U.S.C. § 360c(a)(1)(C). With some exceptions,7 a Class III device may not be marketed or distributed without premarket approval from the FDA. Id. The procedures for obtaining premarket approval are outlined in 21 U.S.C. § 360e. In Riegel, the United States Supreme Court detailed the premarket approval process as follows:

Premarket approval is a "rigorous" process. A manufacturer must submit what is typically a multivolume 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 C.F.R. § 814.44(a) (2007), and may request additional data from the manufacturer, § 360e(c)(1)(G).

. . . .

760 N.W.2d 400

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 C.F.R. § 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 C.F.R. § 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 serious injury 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

760 N.W.2d 401

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 21 U.S.C. § 360k(a). Section 360k(a) is a provision of the Medical Device Amendments that provides in pertinent part:

[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." 21 U.S.C. § 360k(a)(1). In addition, Medtronic argued that the Blunts' state tort claims alleging negligence and strict liability were expressly preempted by § 360k(a)(1) because they constituted state requirements that were "different from, or in addition to," the federal requirement that related "to the safety or effectiveness of the device." § 360k(a). The Blunts' contentions were directly opposite Medtronic's in regard to these two issues.

¶ 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 21 U.S.C. § 360k(a)(1). See Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir.2006), aff'd, ___ U.S. ___, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008); Gomez v. St. Jude Med. Daig Div. Inc., 442 F.3d 919 (5th Cir.2006); McMullen v. Medtronic, Inc., 421 F.3d 482 (7th Cir.2005), cert. denied, 547 U.S. 1003, 126 S.Ct. 1464, 164 L.Ed.2d 246 (2006); Cupek v. Medtronic, Inc., 405 F.3d 421 (6th Cir. 2005), cert. denied sub nom Knisley v. Medtronic, Inc., 546 U.S. 935, 126 S.Ct. 420, 163 L.Ed.2d 320 (...

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