judgment, concludes that defect was "inherent to [the patellar component] design." Notice of Mot. for Summ. J., Exh. E, at 3.
Mastrangelo's first cause of action seeks damages based on common law negligence; the second cause of action seeks strict liability damages. The third cause of action alleges that, because the patellar component "was not fit for its intended use, and was not merchantable," Howmedica breached "implied and express warranties of fitness and safety." Complaint, P 21.
As a medical device, the PCA knee falls within the scope of the MDA and must therefore be approved and regulated by the Food and Drug Administration ("FDA"). The PCA knee is categorized under the MDA as a Class III medical device, and, as such, is subject to the most extensive FDA scrutiny before and after approval. Aff't of Robert Smith ("Smith Aff't"), PP 3, 7.
The pre-market approval process is designed to provide a "reasonable assurance of . . . safety and effectiveness" for medical devices that are potentially dangerous. 21 U.S.C. § 360(a)(1)(C). Post-approval regulation is designed to keep the FDA appraised of all safety information about the device as it becomes available. Id. §§ 360e(e) & 360i(a).
Howmedica filed a pre-market approval application for the PCA knee with the FDA in October 1984. Smith Aff't, at P 5. After many revisions, the application was approved by the FDA in September 1988. Id. P 7.
A party seeking summary judgment must demonstrate 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). The moving party bears the initial burden of "informing the . . . court of the basis for its motion, and identifying those portions of 'the pleadings, depositions, answers to interrogatories, and admissions on file, together with affidavits, if any,' which it believes demonstrate the absence of a genuine issue of material fact." Celotex Corp. v. Catrett, 477 U.S. 317, 323, 91 L. Ed. 2d 265, 106 S. Ct. 2548 (1986) (quoting Fed. R. Civ. P. 56(c)). The initial burden is to demonstrate "that there is an absence of evidence to support the nonmoving party's case." Id. at 325.
The nonmoving party may defeat the summary judgment motion by producing sufficient evidence to establish a genuine issue of material fact for trial. See id. at 322. The test for existence of a genuine dispute is whether a reasonable juror could find for the nonmoving party; that is, whether the nonmovant's case, if proved at trial, would be sufficient to survive a motion for judgment as a matter of law. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250-51, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986).
In ruling on a motion for summary judgment, a court is required to resolve all ambiguities and draw all reasonable inferences in favor of the nonmoving party. See Donahue v. Windsor Locks Bd. of Fire Comm'rs., 834 F.2d 54, 57 (2d Cir. 1987). The nonmoving party, however, "must do more than simply show that there is some metaphysical doubt as to material facts." Matsushita Elec. Industrial Co. v. Zenith Radio Corp., 475 U.S. 574, 586, 89 L. Ed. 2d 538, 106 S. Ct. 1348 (1986). Indeed, the nonmoving party's opposition may not rest on mere allegations or denials of the moving party's pleading, but "must set forth specific facts showing that there is a genuine issue for trial." Fed. R. Civ. P. 56(e). "The non-movant cannot escape summary judgment merely by vaguely asserting the existence of some unspecified disputed material facts, or defeat the motion through mere speculation or conjecture." Western World Ins. Co. v. Stack Oil, Inc., 922 F.2d 118, 121 (2d Cir. 1990) (citations and quotations omitted).
Howmedica argues that no genuine issue of material fact exists in the instant case because each of Mastrangelo's state-law claims are preempted by the MDA. Even if the Court determines that no preemption exists as to one or all of the claims, Howmedica insists that summary judgment is still appropriate because the record does not establish a genuine issue of material fact.
Article VI of the United States Constitution dictates that federal law "shall be the supreme Law of the Land; and that the judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State notwithstanding." U.S. Const. art VI, cl. 2. Any state law which conflicts with federal law may be preempted. Malone v. White Motor Corp., 435 U.S. 497, 504-05, 55 L. Ed. 2d 443, 98 S. Ct. 1185 (1978). State law will not be preempted, however, unless it "was the clear and manifest purpose of Congress" to do so. Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 91 L. Ed. 1447, 67 S. Ct. 1146 (1947). Congress may express its intent to preempt state law implicitly by passing an extensive statutory scheme that fully occupies the relevant field of regulation, Fidelity Fed. Sav. & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153, 73 L. Ed. 2d 664, 102 S. Ct. 3014 (1982), or it may express its intent to preempt in the language of a statute, Jones v. Rath Packing Co., 430 U.S. 519, 525, 51 L. Ed. 2d 604, 97 S. Ct. 1305 (1977).
Congress addressed preemption in the language of the MDA. The statute reads:
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 --