NOT PRECEDENTIAL

                      UNITED STATES COURT OF APPEALS
                           FOR THE THIRD CIRCUIT

                                      _________

                                     No. 09-3800


                 DIANE M. WILLIAMS; KEITH M. WILLIAMS;
              AUDREY KNIGHT, INDIVIDUALLY AND ON BEHALF
                  OF ALL OTHERS SIMILARLY SITUATED,

                                                          Appellants

                                           v.

                                 CYBERONICS, INC.


                    On Appeal from the United States District Court
                       for the Eastern District of Pennsylvania
                              (D. C. No. 2-06-cv-05361)
                        District Judge: Hon. Anita B. Brody


                      Submitted under Third Circuit LAR 34.1(a)
                                  on May 11, 2010

                      Before: BARRY and ROTH, Circuit Judges
                              and HAYDEN*, District Judge


                             (Opinion filed: July 30, 2010)




*Honorable Katharine S. Hayden, United States District Judge for the District of New
Jersey, sitting by designation.
                                         OPINION


ROTH, Circuit Judge:

       This products liability case involves the malfunctioning of a medical device used

to treat depression by electronically stimulating a nerve in the neck. Diane Williams,

Keith Williams, and Audrey Knight appeal the District Court’s order, granting

manufacturer Cyberonics, Inc.’s, motion for summary judgment.1 We exercise plenary

review over a grant of summary judgment and apply the same standard as the District

Court, drawing all inferences and viewing the facts in the light most favorable to the

nonmoving party. Horn v. Thoratec Corp., 

, 165-66 (3d Cir. 2004). We

assume the parties’ familiarity with the factual and procedural history, which we describe

only as necessary to explain our decision. We will affirm the District Court’s order.

       The device at issue here is the Vagus Nerve Stimulation (VNS) Therapy System

manufactured by Cyberonics. The VNS Therapy System is a Class III medical device that

was given premarket approval (PMA) after a rigorous review by the Food and Drug

Administration (FDA), as required by the Medical Device Amendments (MDA) to the

Federal Food, Drug, and Cosmetic Act. See Medtronic, Inc. v. Lohr, 

, 477

(1996) (manufacturers of Class III medical devices must submit voluminous material to



       1
         The appellants appeal only the District Court’s ruling that the Riegel decision preempted
state-based claims founded on alleged malfunction of Cyberonics’ Class III medical device.”

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the FDA, which the FDA spends over 1,000 hours reviewing in depth and grants PMA

only if the device is found to be safe and effective). The MDA contains an express

preemption provision providing that “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.” 21 U.S.C. § 360k(a). In Riegel v. Medtronic, Inc., the Supreme Court held that

state-imposed requirements are preempted by the MDA if (1) the Federal Government has

established requirements applicable to the device and (2) the plaintiff’s claims are based

on state requirements related to safety and effectiveness that are “different from, or in

addition to” the federal requirements. 

, 321-22 (2008). Only the second

prong is at issue here.

       Appellants’ allegations of strict products liability based on manufacturing defect

and breach of warranty are pre-empted by the MDA. Generalized common law theories

of liability, such as those advanced in appellants’ complaint, are precisely the type of

claims the MDA sought to preempt. See 

(“tort law, applied by juries under a

negligence or strict-liability standard,” is pre-empted by the MDA); 

(“[I]t is firmly established that a ‘requirement’ under § 360k(a) can include legal

requirements that arise out of state common-law damages actions.”). Success on

appellants’ breach of warranty claims would require them to show that the VNS Therapy



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System device was unsafe or ineffective despite the PMA process, thereby interfering

with the requirements already established by the MDA, which has preempted safety and

effectiveness determinations for a device. 21 U.S.C. § 360k(a); see 

(holding that state law that requires a manufacturer’s devices “to be safer, but hence

less effective, than the model the FDA has approved disrupts the federal scheme”).

       Appellants also advance a strict products liability claim for a manufacturing defect

based on the malfunction theory, which allows the trier-of-fact to infer a defect from the

fact that the device malfunctioned. See Bruesewitz v. Wyeth Inc., 

, 255 (3d

Cir. 2009), cert. granted, 

(2010) (stating that the malfunction theory

permits a plaintiff to base a products liability claim on “circumstantial evidence of a

manufacturing defect.”). Although it is alleged that the VNS Therapy System stopped

working for the Williamses and malfunctioned for Knight, appellants fail to explain how

the device deviated from the FDA requirements. See 

(holding

that strict liability claims under § 360k are not preempted if “premised on a violation of

FDA regulations”); 

(rejecting plaintiff’s manufacturing defect

claim because she did “not assert[] that [defendant] has in any way failed to conform with

the FDA requirements prescribed by its PMA – nor that it deviated from, or violated, any

of the FDA’s federal statutes or regulations”). Rather, appellants seek to ground

Cyberonics’ liability on requirements that go beyond those established by the MDA.

Accordingly, appellants’ claims are preempted.



                                              4
      For the foregoing reasons, we will affirm the order of the District Court granting

summary judgment in favor of Cyberonics.




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