McMullen v. Medtronic, Inc.

Decision Date26 August 2005
Docket NumberNo. 04-3678.,04-3678.
Citation421 F.3d 482
PartiesJack McMULLEN and Barbara McMullen, Plaintiffs-Appellants, v. MEDTRONIC, INC., Defendant-Appellee.
CourtU.S. Court of Appeals — Seventh Circuit

Steven A. Kurowski, Schererville, IN, John P. Healy (argued), Chicago, IL, for Plaintiffs-Appellants.

Michael K. Brown (argued), Reed, Smith, Crosby & Heafey, Los Angeles, CA, for Defendant-Appellee.

Before FLAUM, Chief Judge, and POSNER and KANNE, Circuit Judges.

FLAUM, Chief Judge.

Plaintiffs-appellants Jack and Barbara McMullen filed suit against defendant-appellee Medtronic, Inc., alleging state-law claims arising out of the implantation of two of Medtronic's Activa Tremor Control Systems ("Activas") in Jack McMullen's brain. The district court granted summary judgment in favor of Medtronic on the ground that the McMullens' claims are preempted by federal requirements imposed by the Food and Drug Administration ("FDA") pursuant to the Medical Device Amendments ("MDA"), 90 Stat. 539, to the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 301 et seq. The McMullens appeal, and for the reasons stated herein, we affirm.

I. Background

The Medtronic Activa is classified under the MDA as a Class III medical device, which means that it "is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or ... presents a potential unreasonable risk of illness or injury." 21 U.S.C. § 360c(a)(1)(C)(ii). Before a Class III device may be introduced into the market, the manufacturer must provide the FDA with a "`reasonable assurance' that the device is both safe and effective." Medtronic, Inc. v. Lohr, 518 U.S. 470, 477, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996) (quoting § 360e(d)(2)). The process by which the FDA decides whether a manufacturer has provided a "reasonable assurance," known as the "premarket approval" or "PMA" process, is a rigorous one. Id. Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA thoroughly reviews. Id. Approval by the FDA may constitute acceptance of such things as the product's design, testing, intended use, manufacturing methods, performance standards, and labeling. Mitchell v. Collagen Corp., 126 F.3d 902, 913 (7th Cir.1997).

In 1997, following a full PMA review, the FDA approved Medtronic's Activa for use in the suppression of tremors in patients diagnosed with Parkinson's Disease. The Activa is composed of three parts: the implantable pulse generator ("IPG"), which is the power source; the lead, which is a thin insulated wire with a series of tiny electrodes at one end; and the extension, which connects the IPG to the lead. Electrical impulses are conveyed through the device, electrically stimulating areas of the brain that control movement and muscle function.

Pursuant to its approval, the FDA required Medtronic to track the name and contact information of patients implanted with the Activa. The FDA also required Medtronic to list specific warnings regarding "electrocautery" and "diathermy"1 in its manuals for physicians and patients. The patient manual was required to state:

Tell your dentist where your IPG is implanted, so he or she can take precautions with dental drills and ultrasonic probes used to clean your teeth. These devices should not be used directly over the implant site.

Therapeutic ultrasound, electrolysis, radiation therapy, and electrocautery also should not be used directly over the implant site.

* * *

Diathermy treatments that are sometimes used for muscle relaxation may affect the neurostimulator output and/or damage its electronics.

In May 2000, Jack McMullen, who has been experiencing the symptoms of Parkinson's Disease since 1985, was implanted with two Activas, one on each side of his brain.2 As a result of the bilateral stimulation, McMullen experienced an excellent remediation of his Parkinson's symptoms.

In January 2001, Medtronic learned of an anecdotal report involving a 70-year-old Parkinson's patient who had been implanted with an Activa. According to the report, a dentist treated the patient with diathermy following oral surgery. During the procedure, the patient was found unresponsive and it was determined that he was in a coma. The suspected cause was damage to brain tissue surrounding his Activa leads, induced by the diathermy.

About two months later, in March 2001, Jack McMullen underwent a dental procedure, which possibly involved diathermy or electrocautery. Thereafter, McMullen experienced a decline in the control of his Parkinson's symptoms. Despite further surgeries to replace components of the implanted Activas, the reduced symptom control continues to this day. McMullen suspects the cause to be damage to brain tissue surrounding the leads of his Activas.

Following further investigation of the January 2001 anecdotal report, Medtronic sent letters by mail to both physicians and patients in May 2001. Medtronic's patient letter stated:

CONTRAINDICATION: Inform anyone treating you that you CANNOT have any shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy) anywhere on your body because you have an implanted neurostimulation system. Energy from diathermy can be transferred through your implanted system, can cause tissue damage and can result in severe injury or death.

Diathermy can also damage parts of your neurostimulation system. This can result in loss of therapy from your neurostimulation system, and may require additional surgery to remove or replace parts of your implanted device. Injury or damage can occur during diathermy treatment whether your neurostimulation system is turned "on" or "off."

To make changes affecting the safety or effectiveness of a device that has gone through the PMA process, a manufacturer must submit a PMA Supplement for review and approval by the FDA. See 21 C.F.R. § 814.39(a). Medtronic submitted a PMA Supplement, seeking FDA approval to market the Activa with a new, stronger warning, like that which was provided in the May 2001 patient letter. In June 2001, three months after McMullen's injury, the FDA approved the use of the new warning.

Thereafter, Jack McMullen and his wife, Barbara McMullen, filed a complaint in the Vermillion County Indiana Circuit Court alleging that Medtronic breached its post-sale duty to warn of dangers arising from the use of diathermy or electrocautery on a patient implanted with a Medtronic Activa. Specifically, plaintiffs assert that the January 2001 report about the 70-year-old Parkinson's patient triggered Medtronic's duty to immediately issue a new warning directly to patients about the increased risks of diathermy and electrocautery. The McMullens' complaint alleges that, as a result of the use of the electrical surgical instrument during his dental procedure, Jack McMullen suffered severe brain damage. In addition, Barbara McMullen alleges a derivative claim for loss of consortium.

Medtronic removed the case to the United States District Court for the Southern District of Indiana based on diversity jurisdiction, after which the parties filed cross-motions for summary judgment. Medtronic argued that plaintiffs' claims were preempted under the express preemption clause of the MDA and, in the alternative, that it was entitled to judgment as a matter of law on the merits of the McMullens' claims. The McMullens disputed Medtronic's claim of preemption and argued that the uncontroverted facts demonstrated that they were entitled to judgment as a matter of law on both of their claims.

The district court granted Medtronic's motion, holding that the post-sale failure to warn claim is preempted and that the derivative loss of consortium claim falls with it. The McMullens appeal, asking us to reverse the district court and direct it to enter summary judgment in their favor.

II. Discussion

We review the district court's grant of summary judgment de novo, viewing all facts and drawing all reasonable inferences in the non-moving party's favor. Eisencorp, Inc. v. Rocky Mountain Radar, Inc., 398 F.3d 962, 965 (7th Cir.2005). Summary judgment is appropriate if the evidence presented by the parties "show[s] that there is no genuine issue as to any material fact and that the moving party is entitled to a judgment as a matter of law." Fed.R.Civ.P. 56(c).

At issue in this case is whether Jack McMullen's common-law claim against Medtronic for post-sale failure to warn is preempted by federal law. The principle of preemption arises from the Supremacy Clause of the Constitution which states that "the Laws of the United States ... shall be the supreme Law of the Land ... any Thing in the Constitution or Laws of any State to the Contrary notwithstanding." U.S. Const. art. VI. "Pursuant to this authority, Congress may preempt state law." Chambers v. Osteonics Corp., 109 F.3d 1243, 1246 (7th Cir.1997). "A federal law may preempt a state law expressly, impliedly through the doctrine of conflict preemption, or through the doctrine of field (also known as complete) preemption." Boomer v. AT & T Corp., 309 F.3d 404, 417 (7th Cir.2002); see also Hoagland v. Town of Clear Lake, Ind., 415 F.3d 693 (7th Cir.2005). The MDA contains an express preemption provision, under which, as we explain below, the state law that is the basis for McMullen's claim is expressly preempted. Accordingly, we do not address the doctrines of conflict and field preemption.

The MDA's preemption clause provides in relevant 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...

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