The opinion of the court was delivered by: WEXLER
Plaintiff John A. Mastrangelo ("Mastrangelo" or "plaintiff") brought the above-referenced action in New York State Supreme Court, Nassau County alleging negligence, strict liability, and breach of warranty in connection with the design, manufacture, and sale by defendant Howmedica Inc. ("Howmedica" or "defendant") of an artificial knee joint. Defendant removed the action, pursuant to 28 U.S.C. § 1441, by virtue of a diversity of citizenship between the parties. Before the Court is defendant's motion, pursuant to Fed. R. Civ. P. 56(c), for an order granting summary judgment and dismissing the complaint on the ground that Mastrangelo's claims are preempted by the Medical Device Amendments of 1976 (the "MDA"), 21 U.S.C. § 360c et seq., of the Federal Food, Drug and Cosmetics Act, 21 U.S.C. § 301 et seq.
Mastrangelo was diagnosed as having bilateral gouty arthritis of both knees. On April 24, 1989, at age seventy-one, Mastrangelo underwent bilateral knee-joint replacements. He alleges that Howmedica's devices, known as the Porous Coated Anatomic Knee ("PCA knee"), were implanted at that time. Verified Complaint (the "Complaint"), P 9.
In 1991, Mastrangelo developed progressive swelling and pain in his left knee. Id. at P 10. On November 18, 1991, he underwent a revision operation on his left knee. During the operation, it was found that the patellar component of the PCA knee had become fractured, and a new patellar component was inserted. Id.; Notice of Mot. for Summ. J., Exh. D. (November 30, 1991 hospital discharge summary for Mastrangelo).
The Complaint, filed October 12, 1993, alleges that Howmedica "was negligent in the design, manufacture, assembly, sale, and delivery" of the PCA knee, and that Howmedica's negligence caused injury to Mastrangelo. Complaint, P 12-13. Further, plaintiff alleges that the patellar component "was negligently designed and manufactured so that approximately 60% of the nonmetallic button had separated from the metal backing and broke it into numerous small pieces." The "ultimate cause of the patellar component," according to the Complaint, "was high stresses at the edge of the nonmetallic button" Id. P 12. Plaintiff's experts' report, advanced by defendant in support of its motion for summary 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 ...