Richman v. W.L. Gore & Associates, Inc., 94 Civ. 6397(PKL).

• Decision Date: 30 December 1997
• Docket Number: No. 94 Civ. 6397(PKL).,94 Civ. 6397(PKL).
• Parties: Janice RICHMAN, Plaintiff, v. W.L. GORE & ASSOCIATES, INC., Defendant.
• Court: U.S. District Court — Southern District of New York

988 F.Supp. 753

Janice RICHMAN, Plaintiff, v. W.L. GORE & ASSOCIATES, INC., Defendant.

No. 94 Civ. 6397(PKL).

United States District Court, S.D. New York.

December 30, 1997.

Mirman, Markovits & Landau, P.C. (Ephrem Wertenteil, of counsel), New York City, for Plaintiff.

Hughes Hubbard & Reed (Daniel H. Weiner, of counsel), New York City, Neal Gerber & Eisenberg (John N. Scholnick, of counsel), Chicago, IL, for Defendant.

OPINION AND ORDER

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").¹ 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.

In June, 1994, plaintiff commenced the instant action in the Supreme Court of the State of New York. Gore then removed the action to this Court, pursuant to 28 United States Code ("U.S.C.") § 2241. On March 24 1995, this Court granted summary judgment to Gore and dismissed with prejudice plaintiff's claims of negligence, strict liability, and breaches of implied warranties, because the Medical Device Amendments ("MDA"), 21 U.S.C. §§ 360c et seq., of the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. §§ 301 et seq., preempted the plaintiff's state law claims. The Court also dismissed Richman's claim for breach of express warranty for failure to state a claim upon which relief could be granted. This claim was not preempted by federal law, but plaintiff had failed to plead the cause of action properly. Therefore, the Court dismissed this claim without prejudice.

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, 116 S.Ct. 2240, 135 L.Ed.2d 700 (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),² 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. §§ 360c(a)(1)(A), (B), and (C). The Ligament, as well as the pacemaker at issue in the Medtronic case, is a Class III device.

In order to market a Class III device, a manufacturer must provide the Food and Drug Administration ("FDA") with a "reasonable assurance" that the device is both safe and effective. 21 U.S.C. § 360e(d)(2). To provide this reasonable assurance, a manufacturer must obtain premarket approval ("PMA") by submitting detailed information about the safety and effectiveness of the device. See Medtronic, 518 U.S. at ___ _ ___, 116 S.Ct. at 2246-47. The PMA process is long and rigorous, with the FDA spending approximately 1200 hours reviewing each application. See id. at ___, 116 S.Ct. at 2246.

There do exist exceptions to the PMA requirements for Class III devices. The MDA allows devices marketed before 1976 (when Congress enacted the MDA) to remain on the market until such time as the FDA initiates and completes the PMA. See 21 U.S.C. § 360e(b)(1)(A); see also 21 C.F.R. § 814.1(c)(1). The MDA also permits devices that are "substantially equivalent" to pre-1976 devices to avoid the PMA process. See 21 U.S.C. § 360e(b)(1)(B). Finally, the MDA exempts investigational devices from the PMA process in order "to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use." 21 U.S.C. § 360j(g). This exemption is called the "Investigational Device Exemption" ("IDE").

Manufacturers of "substantially equivalent" Class III devices are subject to a limited form of review. This review is known as "premarket notification" or the " § 510(k) process", and requires each manufacturer to submit limited information about the device to the FDA. If the FDA determines that the device is "substantially equivalent" to a preexisting device, it can be marketed without further regulatory analysis. See Medtronic at ___, 116 S.Ct. at 2247. This review is not comparable to the PMA process. While the FDA spends 1200 hours reviewing a device submitted for PMA, it spends only approximately 20 hours on each § 510(k) review. See id.

Gore subjected the Ligament to the PMA process, and only placed the device on the market following rigorous screening by the FDA. The pacemaker at issue in Medtronic, conversely, entered the marketplace as a Class III device "substantially equivalent" to a preexisting device. The factual background of Medtronic is therefore vastly different than that of the instant case, although the same statute and regulation are at issue in both cases.

The MDA provides:

Except as provided in subsection (b) of this section, 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 —

(1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) 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.

21 U.S.C. § 360k(a). The pertinent FDA regulation provides:

State or local requirements are preempted only when the Food and Drug Administration has established specific counterpart regulations or there are other specific requirements applicable to a particular device under the act, thereby making any existing divergent State or local requirements applicable to the device different from, or in addition to,...