In re Medtronic, Inc. Sprint Fidelis Leads Prods., No. 08-1905 (RHK/JSM).

• Citation: 592 F.Supp.2d 1147
• Decision Date: 05 January 2009
• Docket Number: No. 08-1905 (RHK/JSM).
• Parties: In re MEDTRONIC, INC. SPRINT FIDELIS LEADS PRODUCTS LIABILITY LITIGATION, This document relates to: All Cases.
• Court: U.S. District Court — District of Minnesota

592 F.Supp.2d 1147

In re MEDTRONIC, INC. SPRINT FIDELIS LEADS PRODUCTS LIABILITY LITIGATION This document relates to: All Cases.

Multidistrict Litigation No. 08-1905 (RHK/JSM).

United States District Court, D. Minnesota.

January 5, 2009.

Daniel E. Gustafson, Gustafson Gluek, PLLC, Plaintiffs' lead counsel, Robert K Shelquist, Lockridge Grindal Nauen P.L.L.P., Plaintiffs' liaison counsel, Charles S. Zimmerman, Zimmerman Reed PLLP, Minneapolis, MN, chair of Plaintiffs' Steering Committee, on behalf of the individual Plaintiffs.

Paul R. Dahlberg, Meshbesher & Spence, Ltd., Rochester, MN, James T. Capretz, Capretz & Associates, Newport Beach, CA, for the Third-Party Payor Plaintiffs.

Kenneth S. Geller, Mayer Brown, LLP, Washington, DC, Rick Robinson, Fulbright & Jaworski, LLP, Washington, DC, George W. Soule, Bowman and Brooke, Minneapolis, MN, Daniel L. Ring, Mayer Brown, LLP, Chicago, IL, for Defendants.

MEMORANDUM OPINION AND ORDER

RICHARD H. KYLE, District Judge.

INTRODUCTION

The federal courts are frequently confronted with sympathetic plaintiffs who are, nevertheless, without remedy by operation of law. Doctrines such as qualified immunity often shield defendants from liability even when plaintiffs have been injured by the defendants' conduct. As one court has stated, "[l]itigants must believe that judges spend an inordinate amount of time wringing their hands while informing persons who have been [injured] that the court will do nothing. This is not because judges like to make litigants feel bad—or themselves feel good by expressing sympathy—but because it is important to point out that the absence of a particular remedy . . . does not imply . . . the lack of a legal wrong." Pacelli v. deVito, 972 F.2d 871, 879 (7th Cir.1992).

Like qualified immunity, the doctrine of federal preemption also leaves some plaintiffs without judicial recourse to pursue claims for damages. In one recent example, hundreds of people injured by the release of noxious gas following a 2002 train derailment in Minot, North Dakota were left without any remedy because their claims were preempted by the Federal Railroad Safety Act. See Lundeen v. Canadian Pac. Ry. Co., 532 F.3d 682, 687 (8th Cir.2008).¹ Medtronic, the Defendant in this multidistrict litigation,² asserts the same doctrine here, arguing that Plaintiffs' claims—sounding in negligence and strict products liability—are preempted by the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq. Having carefully considered the parties' voluminous submissions, the Court agrees.

BACKGROUND

I. The statutory and regulatory framework and the pre-market approval process

Every medical device intended for human use is placed into one of three categories by the Food and Drug Administration ("FDA"), based on the risks of injury or illness the device presents; each category is subjected to a different level of FDA scrutiny. See 21 U.S.C. § 360c(a)(1); Riegel v. Medtronic, Inc., ___ U.S. ___, 128 S.Ct. 999, 1003, 169 L.Ed.2d 892 (2008). Devices that either "support[] or sustain[] human life" or "present[] a potential unreasonable risk of illness or injury" are categorized as "Class III" devices. 21 U.S.C. § 360c(a)(1)(c)(ii). Class III devices are subject to the greatest level of FDA scrutiny and "must complete a thorough review process with the FDA before they may be marketed." Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 344, 121 S.Ct. 1012, 148 L.Ed.2d 854 (2001). Through this process, known as pre-market approval ("PMA"), a device maker must provide the FDA with "reasonable assurance" that its device is both safe and effective. 21 U.S.C. § 360e(d)(2).

The PMA process is "a rigorous one." Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996). "Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews, spending an average of 1,200 hours on each submission." Id. When analyzing that information, the FDA must weigh the "probable benefit to health from the use of the device against any probable risk of injury or illness from such use." 21 U.S.C. § 360c(a)(2)(C). Accordingly, the FDA sometimes grants PMA to potentially life-threatening devices, if they "offer great benefits in light of available alternatives." Riegel, 128 S.Ct. at 1004; accord Heisner ex rel. Heisner v. Genzyme Corp., No. 08-C-593, 2008 WL 2940811, at *5 (N.D.Ill. July 25, 2008) ("Out of practical necessity and the cold calculus of nationwide regulation, the FDA may be aware of a certain failure rate associated with a medical product and yet approve it."). The PMA process also requires the FDA to review a device's proposed labeling to ensure that it is neither false nor misleading. See 21 U.S.C. § 360c(a)(2)(B).

If a device receives PMA, the manufacturer may not change its design specifications, manufacturing processes, labeling, or any other attribute that would affect the device's safety or efficacy without FDA approval. 21 U.S.C. § 360e(d)(6)(A)(i). Should a manufacturer wish to make such changes, it must submit to the FDA an application for supplemental PMA, which is evaluated "under largely the same criteria as an initial application." Riegel, 128 S.Ct. at 1005; accord 21 C.F.R. § 814.39(c) ("All procedures and actions that apply to an application [for PMA] also apply to PMA supplements."). In addition, once a device receives PMA, a manufacturer must inform the FDA when it becomes aware of adverse events in patients using the device. See 21 C.F.R. §§ 803.50, 803.53.

II. The FDCA's express preemption clause

In response to a bevy of state laws regulating medical devices largely enacted due to the failure of the Dalkon Shield contraceptive in the 1970s, Congress passed the Medical Device Amendments to the FDCA in 1976. See Riegel, 128 S.Ct. at 1003. The Medical Device Amendments include an express preemption clause that "swept back some state obligations and imposed a regime of detailed federal oversight." Id. The preemption clause states:

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).³

The scope of Section 360k(a) has been the subject of repeated litigation and the results are, charitably speaking, utterly conflicted. The Supreme Court got into the act in 1996 in Lohr, but did little to clear up the confusion. That "wondrously complex" decision, In re Medtronic, Inc. Implantable Defibrillators Litig., 465 F.Supp.2d 886, 892 (D.Minn.2006) (Rosenbaum, J.)—which has been described by one court of appeals as "fractured in an all but irreconcilable manner," Goodlin v. Medtronic, Inc., 167 F.3d 1367, 1371 (11th Cir.1999)—concluded that the plaintiff's claims for negligence and strict products liability arising out of the use of a Medtronic pacemaker were not preempted by Section 360k(a).⁴ While Justice Breyer agreed with the Lohr plurality that the plaintiff's claims were not preempted, he also agreed with the four dissenters that the Medical Device Amendments "ordinarily ... pre-empt ... state-law tort action[s]." 518 U.S. at 504-05, 116 S.Ct. 2240 (Breyer, J., concurring in part and concurring in the judgment).

Given the uncertainty left in Lohr's wake, in the years that followed courts were divided over how broadly Section 360k(a) reached in medical-device cases. Compare Goodlin, 167 F.3d at 1382 (concluding that state tort-law claims regarding alleged defects in Medtronic pacemaker lead were not preempted) with Kemp v. Medtronic, Inc., 231 F.3d 216, 237 (6th Cir.2000) (concluding that state tort-law claims regarding the same types of defects in the same Medtronic pacemaker lead were preempted). Nevertheless, over time the scales began to tip decidedly in favor of preemption, with more and more courts ruling that state-law claims concerning FDA-approved medical devices were indeed preempted. See In re Sulzer Hip Prosthesis & Knee Prosthesis Liab. Litig., 455 F.Supp.2d 709, 716 (N.D.Ohio 2006) (canvassing case law and concluding that majority view is that "virtually all state law claims seeking to hold a defendant liable for injuries caused by an FDA-approved medical device are preempted").

Early last year, the Supreme Court confirmed that the prevailing view is the correct one. In Riegel, the Court held that the plaintiffs' state-law claims for strict products liability, breach of implied warranty, and negligence in the design, testing, inspection, distribution, labeling, marketing, and sale of an FDA-approved medical device were preempted under the FDCA. 128 S.Ct. at 1007-10. In reaching that conclusion, the Court undertook a two-step analysis. First, tracking the language of Section 360k(a), the Court opined that pre-market approval of a medical device by the FDA imposes "requirements" under the FDCA, because the device must be "made with almost no deviations from the specifications in [the PMA] application." Id. at 1007. Second, the Court opined that permitting the plaintiffs' claims to proceed would impose requirements "different from, or in addition to" the requirements imposed via the PMA process. Id. In so holding, the Court noted that

[s]tate tort law that requires a manufacturer's [device] 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.

Id. at 1008. Because...