Blunt v. Medtronic, Inc.
| Decision Date | 31 July 2007 |
| Docket Number | No. 2006AP1506.,2006AP1506. |
| Citation | 2007 WI App 191,738 N.W.2d 143 |
| Parties | Joseph BLUNT, Sr. and Margaret Blunt, Plaintiffs-Appellants,<SMALL><SUP>†</SUP></SMALL> State of Wisconsin Department of Health and Family Services, Subrogated-Plaintiff, v. MEDTRONIC, INC., Defendant-Respondent. |
| Court | Wisconsin Court of Appeals |
On behalf of the plaintiffs-appellants, the cause was submitted on the briefs John C. Cabaniss and Rachel N. Schepp of von Briesen & Roper, S.C., of Milwaukee.
On behalf of the defendant-respondent, the cause was submitted on the briefs of Robert H. Friebert of Friebert, Finerty & St. John, S.C. of Milwaukee; Thomas J. Arenz and Pamela M. Schmidt of Whyte Hirschboeck Dudek, S.C. of Milwaukee; Michael K. Brown, pro hac vice, and Lisa M. Baird, pro hac vice, of Reed Smith, LLP, of Los Angeles, CA; and Lori G. Cohen, pro hac vice, and Jay B. Bryan, pro hac vice, of Greenberg Traurig, LLP of Atlanta, GA.
Before WEDEMEYER, P.J., FINE and CURLEY, JJ.
Joseph Blunt, Sr. and Margaret Blunt appeal from an order dismissing their claim against Medtronic, Inc., following a summary judgment hearing. The Blunts argue that the trial court erred in granting summary judgment to Medtronic. Specifically they contend that their negligence and product liability claims are not preempted by 21 U.S.C. § 360k(a) (2000)1 because the premarket approval of the defibrillator device does not constitute a specific federal requirement warranting preemption of state tort claims, a common law jury verdict does not constitute a state requirement, and even if it did, it would not be in conflict with the federal requirement. Because we conclude that the Blunts' claim is pre-empted, we affirm.
¶ 2 On December 17, 2002, the FDA approved Medtronic's request to market the Marquis 7230, an implantable cardioverter defibrillator, which used the Chi 4420L battery design. The medical device is capable of delivering a variety of therapies to patients suffering from chronic cardiac disease. In January 2003, during laboratory bench testing on the battery used in the Marquis 7230, Medtronic observed a potential shorting problem, which would cause the battery to fail. As a result, it worked to eliminate that potentiality, resulting in an improved battery for the defibrillator.
¶ 3 On October 6, 2003, Medtronic requested approval from the FDA to implement three design changes to the Chi 4420L battery to minimize the potential for internal shorting and to improve the robustness of the battery. The FDA approved the request to market the Marquis 7230 with the battery modifications on October 23, 2003. In early 2004, there were reports for the first time from the field that individual patients, who had received the original defibrillator, were experiencing the battery shorting problem.2
¶ 4 On May 19, 2004, Joseph Blunt underwent surgery, at which time the original Marquis 7230 defibrillator was implanted. In February 2005, Medtronic advised physicians of a possible battery shorting problem in the original Marquis 7230. As a result, Blunt and his physician decided as a precautionary measure to remove the previously implanted defibrillator and replace it with the improved version.
¶ 5 Subsequent to that surgery, the Blunts elected to file this lawsuit against Medtronic, alleging negligence, strict product liability, and a loss of consortium and companionship. Medtronic moved for summary judgment arguing that because the medical device had been approved by the FDA via the extensive premarket approval process, the Blunts' claims were pre-empted. The Blunts opposed the motion, contending that pre-emption should not apply here because: (1) the FDA's approval did not result in a specific federal design requirement; (2) a jury verdict in this case would not result in a state requirement different from the federal requirement applicable to the device; and (3) the Blunts' claims are based on state laws of general applicability. The trial court concluded that pre-emption applied and granted the motion for summary judgment. The Blunts filed a motion seeking reconsideration, which was also denied. They now appeal.
¶ 6 This case arises following the grant of summary judgment, and therefore the summary judgment review process applies. In reviewing a grant of summary judgment, we employ the same methodology as the trial court. Green Spring Farms v. Kersten, 136 Wis.2d 304, 315, 401 N.W.2d 816 (1987). We first examine the pleadings and affidavits to determine whether a claim for relief has been stated. Id. If a claim for relief has been stated, we then determine whether any factual issues exist. Id. If there is no genuine issue as to any material fact, and if the moving party is entitled to a judgment as a matter of law, we will affirm the trial court's decision granting summary judgment. Id.
¶ 7 The sole issue in this case is whether the Blunts' common law tort claims are pre-empted by federal law. The doctrine of pre-emption stems from the Supremacy Clause of the United States Constitution, U.S. CONST. art. VI, cl. 2, and operates to prevent state laws from conflicting with controlling federal laws. Miezin v. Midwest Express Airlines, Inc., 2005 WI App 120, ¶ 9, 284 Wis.2d 428, 701 N.W.2d 626. Our review on this issue is de novo as it involves a question of law. Id., ¶ 7, 701 N.W.2d 626.
¶ 8 In 1976, the Medical Device Amendments to the Federal Food, Drug and Cosmetic Act, see 21 U.S.C. § 360c, et seq., were passed "to provide for the safety and effectiveness of medical devices intended for human use." Pub.L. No. 94-295, 90 Stat. 539 (1976) (preamble). Medical devices were categorized into three groups related to the degree of risk posed by the device. Class I devices, such as ice packs and tongue depressors, which posed no risk, were subject only to general control regulations. See THOMAS R. MCLEAN, Cybersurgery—An Argument for Enterprise Liability, 23 J. LEGAL MED. 167, 187 (2002). Class II devices, such as oxygen masks, were subject to specific controls and general controls. Id. Class III devices, such as the defibrillator, were subject to a much more rigorous review by the FDA before the device could be marketed for sale. 21 U.S.C. § 360e(d)(2). The manufacturer of a Class III device is required to submit an application for permission to the FDA before marketing the device. See id. The trial court, in its decision below, described the process:
The manufacturer must submit the design of the device, manufacturing specifications, quality control procedures, a sample of the device and its proposed literature, instructions, labeling and advertising, and results of laboratory and clinical studies and trials. The FDA may approve the device for the use specified in the application if [the] manufacturer gives the FDA "reasonable assurance" that the device is safe and effective. 21 U.S.C. § 360e(d)(2). The FDA spends an average of about 1,200 hours per PMA application reviewing these materials....
If the FDA is satisfied with the assurances of the manufacturer, it issues "Conditions of Approval" that incorporate the design of the product. In other words, by virtue of FDA approval, the manufacturer becomes required to comply with the design, manufacturing specifications, etc. which it submitted to the FDA. 21 C.F.R. § 814.39. If any changes to the device are to be made, the manufacturer must return to the FDA for permission.... The end result ... appears to be a highly particularized set of requirements for Class III devices.
(Internal quotations omitted.). This process is referred to as "premarket approval,"3 or the PMA. The Medical Devices Amendments of 1976 also contain an express pre-emption provision, which provides:
Except as provided in subsection (b) of this section, no 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.
21 U.S.C. § 360k(a). The FDA thereafter promulgated regulations regarding the express pre-emption provision imposing some qualifications:
State or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to, the specific Food and Drug Administration requirements....
The following are examples of State or local requirements that are not regarded as preempted...:
State or local requirements of general applicability where the purpose of the requirement relates either to other products ... in which the requirements are not limited to devices.
¶ 9 The qualifications have generated much discussion in cases, as in this one, where a person files a state lawsuit involving a medical device. There has been a great multitude of litigation across the country as to whether the state common law claim is pre-empted or not. Resolution of this issue is dependent upon whether the premarket approval process constitutes a federal requirement specifically applicable to a particular device, and whether the state common law tort suit would constitute a state requirement different from or in addition to the federal requirement. Twelve decisions across nine federal circuits have concluded that the premarket approval process for Class III devices constitutes a federal requirement specifically applicable to a particular device and that the state common law tort suit would constitute a state requirement in conflict—therefore, pre-emption...
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Blunt v. Medtronic, Inc.
...judgment to Medtronic. The court of appeals, in affirming the circuit court, essentially adopted the circuit court's reasoning.11 Blunt, 305 Wis.2d 354, ¶¶ 12, 16, 738 N.W.2d 143. ¶ 12 We granted review and now affirm. II. DISCUSSION A. Standard of Review ¶ 13 We review a summary judgment d......