Wildman v. Medtronic, Inc.

• Citation: 874 F.3d 862
• Decision Date: 31 October 2017
• Docket Number: No. 17-50010.,17-50010.
• Parties: Ray WILDMAN, Clerk Plaintiff–Appellant v. MEDTRONIC, INCORPORATED; Medtronic USA, Incorporated, Defendants–Appellees.
• Court: United States Courts of Appeals. United States Court of Appeals (5th Circuit)

874 F.3d 862

Ray WILDMAN, Clerk Plaintiff–Appellant
v.
MEDTRONIC, INCORPORATED; Medtronic USA, Incorporated, Defendants–Appellees.

No. 17-50010.

United States Court of Appeals, Fifth Circuit.

October 31, 2017

Jeffrey M. Meyerson, Meyerson Law Firm, P.C., Austin, TX, for Plaintiff–Appellant.

Mark Christopher Fleming, Esq., David Lehn, WilmerHale, L.L.P., Washington, DC, Gregory John Casas, Esq., Elizabeth Ross Hadley, Greenberg Traurig, L.L.P., Austin, TX, Lori Gail Cohen, Victoria Davis Lockard, Esq., Greenberg Traurig, L.L.P., Atlanta, GA, Ginger Pigott, Esq., Greenberg Traurig, L.L.P., Los Angeles, CA, for Defendants–Appellees.

Before WIENER, HIGGINSON, and COSTA, Circuit Judges.

GREGG COSTA, Circuit Judge:

Ray Wildman contends that a Medtronic device implanted in his back to relieve pain did not last as long as the company promised. The result was an infection that required surgery and caused him to miss months of work. Wildman brought suit alleging breach of express warranty under Texas law. If this state-law claim would impose a requirement that is "different from, or in addition to" those imposed by the Food and Drug Administration when it approved the medical device, then federal law preempts the claim. 21 U.S.C. § 360k ; see Riegel v. Medtronic, Inc. , 552 U.S. 312, 315, 128 S.Ct. 999, 169 L.Ed.2d 892 (2008). On the other hand, if the claim "parallels" federal requirements—that is, if it would enforce a duty also imposed by federal law—then it is not preempted. Id . at 330, 128 S.Ct. 999. We thus must decide whether Wildman's claim alleging false representations about the "device life" of the product would undermine FDA regulation or reinforce it.

I.

Wildman suffered from chronic back and leg pain. In an attempt to manage that pain, he had a Medtronic RestoreUltra neurostimulator (the Device) surgically implanted into his back. The Device is designed, manufactured, and marketed by Medtronic, and once inserted, it "delivers mild electrical signals to the epidural space near [the] spine through one or more thin wires that provide electrical impulses to thin plastic leads." These electrical impulses block pain signals before they reach the brain.

The Device malfunctioned about a year and a half after it had been implanted. Wildman started to experience additional pain and consulted with two doctors about removing the device. He first met with a doctor who determined that the stimulator had stopped working and that the additional pain did not seem to be the result of any physiological change in Wildman's condition. The doctor's notes suggest Medtronic representatives were present at Wildman's medical appointments, and the company was notified of problems with his device. Wildman was then referred to another doctor to "look into getting his stimulator battery replaced."

This doctor concluded that the "left side quit working and Medtronic[ ] tried to get it to work and they said it need[ed] to come out." Medtronic representatives present at this appointment determined that the "entire device [was] dead." About a month later, Wildman had surgery to remove the Device. The area where the surgical staples had been became infected, with the wound site draining liquid and causing significant pain. After about a month, Wildman saw yet another doctor who discovered that an abscess had formed, which required additional surgery. Wildman maintains that he was unable to work for five months due to the multiple

874 F.3d 866

surgeries required to remove the Device and address the resulting infection.

Wildman sued Medtronic in state court alleging breach of express warranty. He contends that the Device functioned properly for roughly a year and a half when Medtronic claimed in written marketing material that the neurostimulator had a device life of nine years. His amended complaint, filed after the case was removed to federal court, says that Wildman relied on the following statement (the Statement) from Medtronic's website about the Device:

While other manufacturers may state that their batteries have a longevity greater than 9 years, it's important to understand that many other factors and components are involved in determining the overall longevity of an implanted medical device. The result of extensive design and testing involved in manufacturing rechargeable neurostimulators give Medtronic the confidence that our device is reliable for 9 years.

To achieve this distinction, Medtronic rigorously verified and validated the many components that impact device longevity, not just the battery. The result is a rechargeable neurostimulator that delivers reliable performance over the entire period of predicted service. Medtronic is the only company to offer a Neuromodulation Product Performance Report.

The complaint further alleges that this warranty language was "never reviewed by or submitted to the FDA for approval."

As a Class III device regulated by the FDA,¹ the Device underwent a rigorous premarket approval process that resulted in a finding that there was a " ‘reasonable assurance’ of the device's ‘safety and effectiveness.’ " Riegel , 552 U.S. at 318, 128 S.Ct. 999 (quoting 21 U.S.C. § 360e(d) ). This process also includes a review of a device's labeling to ensure it is "neither false nor misleading." 21 U.S.C § 360e(d)(1)(A). As part of this process, the FDA reviewed the Device's "System Eligibility, Battery Longevity, Specifications Reference Manual." After considering this report, the FDA approved a statement that the Device's "battery life" was "9 years." The agency also evaluated the criteria for determining battery longevity and verified that nine years after implant, the Device would output the message "EOS (End of service)" when electronically analyzed by a doctor or Medtronic employee. Medtronic has not identified anything in the FDA record showing that the agency endorsed or evaluated any claim about the longevity of Device components other than the battery.²

874 F.3d 867

Wildman's original complaint included assertions that the malfunction was due to the battery, but his amended complaint contends that the neurostimulator did not conform to a "nine-year device life." Medtronic moved for judgment on the pleadings under Rule 12(c) on three grounds: (1) that the claim was preempted by federal law, (2) that Wildman failed to adequately plead reliance on the warranty, and (3) that Medtronic's Limited Warranty is the exclusive remedy available to Wildman. The district court concluded the claim was preempted. We review de novo that Rule 12 dismissal. See Bass v. Stryker Corp. , 669 F.3d 501, 506 (5th Cir. 2012).

II.

A.

The FDA, which for decades had been reviewing the safety and effectiveness of drugs before they were allowed to enter the market, began doing the same for medical devices after a 1976 amendment to the Food, Drug, and Cosmetic Act. The Medical Device Amendments of 1976 imposed comprehensive and nationally uniform regulations for an increasing number of complex medical devices. See Riegel, 552 at 315-16, 128 S.Ct. 999. The Amendments include an express preemption provision stating that:

[N]o 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). In Riegel , the Supreme Court concluded that this provision preempts not just state administrative regulation but also state tort law. Riegel, 552 U.S. at 325, 128 S.Ct. 999. Tort claims are preempted because jury verdicts holding device manufacturers liable under the common law for requirements the FDA did not impose would undermine the FDA's central oversight role. See id. at 323-26, 128 S.Ct. 999.

But preemption of state common law is not absolute. Because preemption's concern is with state requirements that conflict with FDA determinations or that require more than the premarket approval process does, Riegel clarified that state claims "premised on a violation of FDA regulations" may go forward. See id. at 330, 128 S.Ct. 999 ; Bass , 669 F.3d at 509-10 (finding state common law claims not preempted when premised on violation of federal requirements); Hughes v. Bos. Sci. Corp. , 631 F.3d 762, 769-70 (5th Cir. 2011) (same); see also Daniel W. Whitney, Guide to Preemption of State-Law Claims Against Class III PMA Medical Devices , 65 FOOD & DRUGL.J. 113, 120 (2010) ("In order to avoid preemption by § 360k(a), a state-law claim against a PMA Class III device should be premised on a breach of a state-law duty that is the same as a duty imposed under the PMA or one of its implementing regulations."). These are called "parallel" claims because they enforce FDA regulations rather than add to or undermine them. Riegel , 552 U.S. at 330, 128 S.Ct. 999.

Many courts have navigated the course between preempted and parallel express warranty claims. The essence of an express warranty claim is a broken promise.

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