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RICHMAN v. W.L. GORE & ASSOCS.

December 30, 1997

JANICE RICHMAN, Plaintiff, against W.L. GORE & ASSOCIATES, INC., Defendant.

Peter K. Leisure, U.S.D.J.


The opinion of the court was delivered by: LEISURE

LEISURE, District Judge :

 Plaintiff Janice Richman moves the Court for an order, pursuant to Rule 54(b) of the Federal Rules of Civil Procedure and the Court's inherent authority, modifying and revising the Court's Opinion and Order of March 24, 1995 (the "March 1995 Opinion"). *fn1" For the reasons stated below, the motion is denied in part and granted in part.

 BACKGROUND

 This is a product liability action against W.L. Gore & Associates, Inc. ("Gore"). Plaintiff seeks recovery for injuries allegedly resulting from an artificial ligament (the "Ligament") purportedly manufactured by Gore. Richman claims that prior to April, 1992, the Ligament was surgically implanted in her body and that she suffered internal and external injuries due to the failure of the Ligament. Specifically, Richman asserts that the Ligament shredded and disintegrated, causing foreign body reactions, severe allergic reactions, and extreme pain and suffering, as well as accelerating the deterioration of the joint held together by the Ligament. The Ligament that is at issue in the instant action is the Gore-Tex Cruciate Ligament. The Ligament was a medical device regulated by the United States Food and Drug Administration (the "FDA"), as a Class III device. As a Class III device, the FDA had to approve the Ligament for marketing.

 On October 10, 1986, the FDA announced its approval of Gore's premarket approval application for the Ligament. Gore asserts that it has complied with all FDA regulations and all conditions of the approval, and that the FDA has never acted to obtain either a voluntary or involuntary withdrawal of the premarket approval for the Ligament. On May 21, 1993, Gore sent a letter to the FDA withdrawing the premarket approval for the Ligament, effective July 15, 1994.

 The history of this case from March 24, 1995, to the present is tortured and confusing. Following the March 1995 Opinion, plaintiff sought to appeal to the United States Court of Appeals for the Second Circuit. However, as the March 1995 Opinion was not a final judgment in the case, the Second Circuit Staff Counsel advised plaintiff that her appeal was premature. Plaintiff waited until August 4, 1996, to withdraw her appeal, but plaintiff soon thereafter filed a substantially identical appeal. Then, on October 10, 1996, plaintiff moved this Court to vacate the March 1995 Opinion, pursuant to Fed. R. Civ. P. 60(b), on the basis of the decision of the United States Supreme Court in Medtronic, Inc. v. Lohr, 518 U.S. 470, 135 L. Ed. 2d 700, 116 S. Ct. 2240 (1996). Plaintiff contends that the holding in Medtronic is a change in the controlling case law and mandates vacatur of the March 1995 Opinion. On January 15, 1997, this Court "so ordered" a stipulation signed by the parties dismissing with prejudice plaintiff's claim of breach of express warranty. Plaintiff then asked the Court to consider its motion as one made pursuant to Fed. R. Civ. P. 54(b), as well. Finally, on April 15, 1997, plaintiff officially withdrew her second appeal in the Second Circuit, allowing this Court to decide the motion presented in October, 1996.

 DISCUSSION

 I. Standard for Granting a Motion Under Rule 54(b)

 The Court has authority under Fed. R. Civ. P. 54(b), *fn2" as well as the inherent power of the court, to reconsider a prior decision at any time before the entry of final judgment. See Dictograph Products Co. v. Sonotone Corp., 230 F.2d 131, 134-35 (2d Cir. 1956) (Hand, L., J.). In this District, Local Rule 6.3 (formerly Local Rule 3(j)) requires a party to submit a motion to reconsider a decision within ten days of the docketing of the Court's original determination, unless the movant presents a compelling reason to ignore the time limit. See Baden v. Koch, 799 F.2d 825, 828 (2d Cir. 1986). Richman obviously did not submit this motion to the Court within ten days of the March 1995 Opinion, so plaintiff must offer a compelling reason in order for the Court to reconsider its ruling.

 The major grounds that justify a reconsideration involve an intervening change in controlling law, the availability of new evidence, or the need to correct a clear error or to prevent manifest injustice. See Wright, Miller & Cooper, Federal Practice and Procedure : Jurisdiction § 4478; see also Berish v. Richards Medical Co., 937 F. Supp. 181, 182-83 (N.D.N.Y. 1996). Plaintiff argues that the Supreme Court's decision in Medtronic constitutes an intervening change in controlling law and mandates a revision of the March 1995 Opinion. This Court examines Medtronic to determine what effect, if any, that decision has on the law to be applied in this case.

 II. Medtronic, Inc. v. Lohr

 Medtronic presented the Supreme Court with the question of whether the MDA preempts state common law actions against the manufacturer of an allegedly defective medical device. The MDA classifies medical devices into one of three categories based on the potential risk that each poses to the public. Class I devices present the least risk of harm and are the most loosely regulated, Class II devices are more heavily regulated, and Class III devices are the most heavily regulated. 21 U.S.C. §§ ...


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