Walker v. Medtronic Inc, CIVIL ACTION NO. 2:07-00317
| Decision Date | 24 November 2010 |
| Docket Number | CIVIL ACTION NO. 2:07-00317 |
| Parties | SHERRY ANN WALKER, Administratrix of the estate of Arnold Leroy Walker, Jr., and SHERRY ANN WALKER, Individually, Plaintiff, v. MEDTRONIC, INC., Defendant. |
| Court | U.S. District Court — Southern District of West Virginia |
By Judgment Order entered September 29, 2010, the court granted defendant's renewed motion for summary judgment. (Doc. No. 138). The reasons for that decision follow.
On May 18, 2007, plaintiff Sherry Walker filed the instant action, invoking the court's diversity jurisdiction. Plaintiff alleges that her late husband, Arnold Leroy Walker, Jr., died when his internally-implanted Medtronic SynchroMed EL Infusion Pump (hereinafter "the Pump") malfunctioned, on June 9, 2005, by administering a lethal overdose of medication. Amended Complaint 1 5. The pump had been implanted more than two years earlier, on or about May 28, 2003. See id. at 1 4. Medtronic, Inc. is the manufacturer of the SynchroMed EL Infusion Pump. Id. at 1 3. Walker's complaint asserted three causes of action against Medtronic: negligence (Count One), strict liability (Count Two), and breach of warranty (Count Three). Original Complaint 11 1122. Walker sought compensatory and punitive damages, attorney's fees, costs, and pre-and post-judgment interest. Id. at ¶ 25.
On April 21, 2008, after the United States Supreme Court issued its opinion in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), a case addressing federal preemption under the Medical Device Amendments of 1976 ("MDA"), defendant filed a motion for summary judgment arguing that plaintiff's claims were preempted. By Memorandum Opinion and Order entered on September 9, 2008, the court denied defendant's motion without prejudice concluding that "[w]here the key issue of material fact-whether the infusion pump complied with the terms of its premarket approval-has not been fully explored through the discovery process, the court is unable to grant summary judgment." The court further found, however, that the original complaint did not adequately allege the type of claim which might survive Riegel and informed plaintiff that it would entertain a motion to amend the complaint in order to correct this deficiency.
On October 29, 2008, plaintiff filed an amended complaint which, once again, asserted claims for negligence (Count One), strict liability (Count Two), and breach of warranty (Count Three). The amended complaint also alleged that "the pump failed to comply and operate in terms of its Pre-Market Approval from the Food & Drug Administration" and that "contrary to the terms of its Pre-Market Approval," Medtronic breached its express and implied warranties. Amended Complaint ¶¶ 11, 15, and 20.
On October, 29, 2009, following discovery on whether the Pump complied with the terms of its premarket approval, defendant filed a renewed motion for summary judgment. In its motion, defendant argued that because discovery had shown that Mr. Walker's pump was designed, manufactured, and sold in accordance with the terms of its premarket approval, plaintiff's claims are expressly preempted by 21 U.S.C. § 360k and, therefore, the complaint should be dismissed.
Plaintiff argued that her claims fall within the narrow exception for parallel claims carved out by Riegel and, therefore, are not preempted. Plaintiff argues that the Pump failed to adhere to the "performance standard," upon which PMA was conditioned--that the amount of medication dispensed by the Pump would be within ± 15% of the programmed dosage. See Plaintiff's Response at 6-10. According to her, because she alleges a failure to comply with this standard, which was specifically set forth in the PMA and supplement(s), her claim parallels the federal requirement.1
With respect to summary judgment, Rule 56 of the Federal Rules of Civil Procedure provides that
[t]he judgment sought shall be rendered forthwith if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show 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. The moving party has the burden of establishing that there is no genuine issue as to any material fact. See Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). As was explained in Celotex, "the plain language of Rule 56(c) mandates the entry of summary judgment, after adequate time for discovery and upon motion, against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Id. at 322.
Once the moving party has met this burden, the burden then shifts to the nonmoving party to produce sufficient evidence for a jury to return a verdict for that party.
The mere existence of a scintilla of evidence in support of the plaintiff's position will be insufficient; there must be evidence on which the jury could reasonably find for the plaintiff. The judge's inquiry, therefore, unavoidably asks whether reasonable jurors could find, by a preponderance of the evidence, that the plaintiff is entitled to a verdict....
Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 252 (1986). "If the evidence is merely colorable, or is not significantly probative, summary judgment may be granted." Id. at 250-51. Significantly, "a party opposing a properly supported motion for summary judgment may not rest upon mere allegation or denials of his pleading, but must set forth specific facts showing that there is a genuine issue for trial." Id. at 256.
Although the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. § 301 et seq., had long required Food and Drug Administration ("FDA") approval for the introduction of new drugs, prior to 1976, "the introduction of new medical devices was left largely for the States to supervise as they saw fit." Riegel v. Medtronic, Inc., 552 U.S. 312, 315 (2008). In 1976, Congress passed the Medical Device Amendments ("MDA"), 21 U.S.C. § 360c et seq., which "imposed a regime of detailed federal oversight" for medical devices. Id. at 316.
Under the MDA, medical devices are subject to varying degrees of oversight which are dependent on the risks presented by the device at issue. Id. Class I devices, such as elastic bandages and examination gloves, are subject "to the lowest level of oversight." Id. A Class II device, like powered wheelchairs or surgical drapes, "cannot be classified as a class I device because the general controls by themselves are insufficient to provide reasonable assurance of the safety of effectiveness of the device." 21 U.S.C. § 360c(a)(1)(B); Riegel, 552 U.S. at 31617. For this reason, Class II devices are subjected to additional "special controls" such as performance standards and postmarket surveillance. 21 U.S.C. § 360c(a)(1)(B); Riegel, 552 U.S. at 316-17.
Class III devices are subjected to the most federal oversight. Riegel, 552 U.S. at 317. "In general, a device is assigned to Class III if it cannot be established that a less stringent classification would provide reasonable assurance of safety and effectiveness, and the device 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.'" Id. (quoting 21 U.S.C. § 360c(a)(1)(C)(ii)).
Class III devices are required to obtain premarket approval "to provide reasonable assurance of its safety and effectiveness." 21 U.S.C. § 360c(a)(1)(C).
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. Before deciding whether to approve the application, the agency may refer it to a panel of outside experts, and may request additional data from the manufacturer.
The FDA spends an average of 1, 200 hours reviewing each application, and grants premarket approval only if it finds there is a reasonable assurance of the device's safety and effectiveness. The agency must weig[h] any probable benefit to health from the use of the device against any probable risk of injury or illness from such use. It may thus approve devices that present great risks if they nonetheless offer great benefits in light of available alternatives.
Riegel, 552 U.S. at 318 (internal citations and quotations omitted).
The MDA also includes an express preemption provision which states as follows: 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).
In Riegel, the Court considered how the FDCA's express preemption clause impacts medical devices that have received premarket approval. The Riegel court held that "[s]tate requirements are pre-empted under the MDA only to the extent that they are 'different from, or in...
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