The opinion of the court was delivered by: MCAVOY
The plaintiff, PAUL BERISH, commenced this action against the defendant, SMITH & NEPHEW RICHARDS, INC., in the New York State Supreme Court, Ulster County, on or about September 30, 1994. The plaintiff alleges claims sounding in negligence, strict products liability, and breach of express and implied warranties. These claims are made in relation to an allegedly defective femoral stem, a part of the Opti-Fix Total Hip System hip replacement device, that was implanted into the plaintiff's left hip on or about May 4, 1987.
On or about October 24, 1994, the defendant removed the action to this Court. Jurisdiction is based on diversity of citizenship. The defendant filed an Answer on November 21, 1994. The defendant filed the present motion with the Court on May 20, 1996, and such motion was ordered sealed at the parties' request on May 23, 1995.
The defendant has moved for summary judgment against the plaintiff, dismissing the Complaint in its entirety, on the grounds that all of the plaintiff's claims are barred by the doctrine of federal preemption. The defendant also seeks summary judgment as to the breach of express warranty claim on the basis that the plaintiff has failed to raise a material factual issue as to that claim. The plaintiff, of course, disagrees.
A. Facts Relating To The Plaintiff's Alleged Injuries
The plaintiff alleges that he was implanted with a prosthetic hip replacement device, manufactured by the defendant on May 4, 1987, as treatment for a degenerative bone condition. Records show that the device was implanted without the use of bone cement.
The device was apparently designed for use with or without bone cement, but was at different stages of FDA approval with respect to each use.
Apparently, on or about December 19, 1993, the plaintiff experienced a fracture of the femoral stem of the hip prosthesis. Shortly thereafter, the plaintiff's prosthetic hip device was replaced. The plaintiff then filed the instant lawsuit.
B. Facts Relating To The Device At Issue
On November 7, 1986, the defendant applied to the FDA for an IDE in relation to the hip replacement prosthesis system for use without bone cement. Allegedly, the FDA gave its approval for such use of the prosthetic system on or about March 27, 1987. Subsequent to the plaintiff's operation, and on March 23, 1991, the defendant submitted a 510(k) Notification to the FDA stating its intent to market the prosthetic hip system for use without bone cement. The 510(k) Notification noted the IDE covering the system's non-cement usage.
The plaintiff argues that there is a question of fact as to whether the device at issue was subject to an IDE at the time of the surgery on May 4, 1987, and whether it is preempted by the MDA. However, the plaintiff argues that factual issues about the defendant's manufacturing process preclude the grant of defendant's summary judgment motion before even reaching the preemption issues. The Court now turns to the issues raised.
A. Standard For Summary ...