This is an action in products liability. Plaintiff Robert Oliver asserts claims against defendants for strict liability under the Restatement (Second) Torts § 402A, Pennsylvania common law negligence, misrepresentation, and breach of implied and expressed warranties. Plaintiff Linda Oliver has filed a derivative claim for loss of consortium. Plaintiffs claim Mr. Oliver was injured because of an allegedly defectively designed prosthetic knee device manufactured and sold by defendants. Defendants move the court for summary judgment arguing that plaintiffs' claims are preempted by the Medical Device Amendments of 1976 to the Food, Drug and Cosmetics Act of 1938, 21 U.S.C. § 301 et seq. ("MDA"). For the following reasons, the court finds that plaintiffs' state law causes of action are not preempted by the MDA and denies defendants' motion for summary judgment.
The facts material to the motion are neither complicated nor in dispute. On July 27, 1987, Mr. Oliver underwent a left total knee arthroplasty at the Greenville Hospital in Mercer County, Pennsylvania. Doctors implanted in Mr. Oliver a prosthetic knee device called a "Press Fit Condylar Total Knee System," that was designed and manufactured by defendant Johnson & Johnson. In August of 1990, Mr. Oliver underwent an arthrotomy of his left knee joint because he was experiencing physical problems allegedly due to the prosthetic knee system. The surgery included the removal of multiple prosthetic parts and a complete synovectomy.
Mr. Oliver claims that the prosthetic knee system was defectively designed and manufactured and that this defect caused it to fail resulting in severe injuries to the bones, joints, muscles, ligaments, tendons, nerves and tissue in his left knee. Mr. Oliver also claims that he is suffering and will continue to suffer from various complications and residual effects as a result of the defective condition of the prosthetic knee device. Hence, this suit.
II. STANDARD OF REVIEW
The court will grant summary judgment "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(c). A fact is "material" only if it might affect the outcome of the case under the governing substantive law. Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 255, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986). Factual disputes concerning issues that are irrelevant to the outcome of the case are, therefore, not considered. Id. at 248. Factual disputes must also be "genuine" in that the evidence presented must be such "that a reasonable jury could return a verdict in favor of the non-moving party," Id.
A non-moving party may not successfully oppose a summary judgment motion by resting upon mere allegations or denials contained in the pleadings, or by simply reiterating those allegations or denials in an affidavit. Lujan v. Nat'l Wildlife Federation, 497 U.S. 871, 888, 111 L. Ed. 2d 695, 110 S. Ct. 3177 (1990). Rather, the non-moving party must offer specific evidence found in the record that contradicts the evidence presented by the movant and indicates that there remain relevant factual disputes that must be resolved at trial. Id. If the non-moving party does not respond in this manner, the court, when appropriate, shall grant summary judgment.
With these concepts in mind, the court turns to the merits of defendants' motion.
Defendants contend that the prosthetic knee system is a medical device that is regulated for safety and effectiveness by the Food and Drug Administration ("FDA") and that, therefore, plaintiffs' state law causes of action are preempted by the MDA. The court disagrees.
The court is guided by the principle that there exists a presumption against the federal preemption of state laws. Cipollone v. Liggett Group Inc., U.S. , 112 S. Ct. 2608, 2618 (1992). Indeed, the court's preemption analysis "starts with the basic assumption that Congress did not intend to displace state law." Maryland v. Louisiana, 451 U.S. 725, 746, 68 L. Ed. 2d 576, 101 S. Ct. 2114 (1981). The United States Supreme Court has explained that "'the historic police powers of the state [are] not to be superseded. . . by Federal Act unless that [is] the clear and manifest purpose of Congress.'" Id. at 2617 (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 91 L. Ed. 1447, 67 S. Ct. 1146 (1947)). Additionally, even when Congress has expressly preempted state law and has explicitly defined the preemptive reach of a statute, "matters beyond that reach are not preempted." Cippollone, 112 S. Ct. at 2618.
Congress included an express preemption provision in the MDA that states, in pertinent part:
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. . . which is different from, or in addition to, any requirement applicable under this chapter to the device, and. . . 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.