The opinion of the court was delivered by: PETER K. LEISURE
This is a product liability action brought by Janice Richman ("Richman") against W. L. Gore & Associates, Inc. ("Gore"), seeking recovery for injuries allegedly resulting from an artificial ligament purportedly manufactured by Gore. Defendant now moves this Court for an order dismissing the action on the grounds that all of plaintiff's claims are preempted by federal law. Alternatively, defendant moves to dismiss plaintiff's claims for failure to state a claim upon which relief can be granted. For the reasons stated below, defendant's motion for dismissal on the grounds of preemption is granted as to all of plaintiff's claims, except plaintiff's claim for breach of express warranty. Defendant's motion to dismiss for failure to state a claim is granted as to plaintiff's claim for breach of express warranty.
Richman alleges that prior to April 1992, an artificial ligament, allegedly manufactured by Gore, was surgically implanted in her body and that she suffered internal and external injuries while this ligament was in her body. See Memorandum of Law in Support of Defendant's Motion to Dismiss ("Defendant Mem.") at 1. Specifically, Richman asserts that the implanted ligament shredded and disintegrated causing foreign body reactions, accelerating the deterioration of the joint,
and causing severe allergic reactions and extreme pain and suffering. See Plaintiff's Memorandum of Law in Opposition to Defendant's Motion for Dismissal ("Plaintiff Mem.") at 3. The artificial ligament that is at issue in the instant action is the Gore-Tex Cruciate Ligament Prosthesis (the "Ligament"). The Ligament was a medical device regulated by the United States Food and Drug Administration (the "FDA"), as a Class III Device. Defendant Mem. at 4. As a Class III device, the Ligament had to be approved for marketing by the FDA pursuant to the premarket approval process. Id.
On October 10, 1986, the FDA announced its approval of Gore's premarket approval application for the Ligament. Defendant Mem. at 4. Gore asserts that since that time, 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. Id. at 4-5. On May 21, 1993, Gore sent a letter to the FDA withdrawing the premarket approval for the Ligament, effective July 15, 1994. Id.
I. Standard is that for Summary Judgment
Defendant's motion to dismiss on the grounds of preemption is based on the allegations of the complaint and on facts set forth in affidavits and other materials outside of the pleadings. Defendant Mem. at 5. In considering these outside materials, on a motion to dismiss, this Court must convert the motion into a motion for summary judgment and apply the standard appropriate for a motion brought pursuant to Rule 56 of the Federal Rules of Civil Procedure. See Carter v. Stanton, 405 U.S. 669, 671, 31 L. Ed. 2d 569, 92 S. Ct. 1232 (1972); Cortec Industries, Inc. v. Sum Holding L.P., 949 F.2d 42, 47 (2d Cir. 1991).
Rule 56(c) of the Federal Rules of Civil Procedure provides that summary judgment "shall be rendered forthwith 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." Celotex Corp. v. Catrett, 477 U.S. 317, 322, 91 L. Ed. 2d 265, 106 S. Ct. 2548 (1986); see also Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986); Lang v. Retirement Living Pub. Co., 949 F.2d 576, 580 (2d Cir. 1991). Summary judgment "is appropriate only 'after adequate time for discovery and upon motion, against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial.'" Thornton v. Syracuse Sav. Bank, 961 F.2d 1042, 1046 (2d Cir. 1992) (quoting Celotex, 477 U.S. at 322); accord Irvin Indus., Inc. v. Goodyear Aerospace Corp., 974 F.2d 241, 245 (2d Cir. 1992).
"In deciding whether to grant summary judgment all inferences drawn from the materials submitted to the trial court are viewed in a light most favorable to the party opposing the motion. The nonmovant's allegations are taken as true and it receives the benefit of the doubt when its assertions conflict with those of the movant." Cruden v. Bank of New York, 957 F.2d 961, 975 (2d Cir. 1992). The substantive law governing the case will identify those facts that are material, and "only disputes over facts that might affect the outcome of the suit under the governing law will properly preclude the entry of summary judgment. Factual disputes that are irrelevant or unnecessary will not be counted." Anderson, 477 U.S. at 248.
The party seeking summary judgment "bears the initial responsibility of informing the district court of the basis for its motion," and identifying which materials "it believes demonstrate the absence of a genuine issue of material fact." Celotex, 477 U.S. at 323. Once a motion for summary judgment properly is made, however, the burden then shifts to the nonmoving party, which "'must set forth specific facts showing that there is a genuine issue for trial.'" Anderson, 477 U.S. at 250 (quoting Fed. R. Civ. P. 56(e)); accord Brass v. American Film Technologies, Inc., 987 F.2d 142 (2d Cir. 1993). "Conclusory allegations will not suffice to create a genuine issue. There must be more than a 'scintilla of evidence,' and more than 'some metaphysical doubt as to the material facts.'" Delaware & Hudson Ry. Co. v. Conrail, 902 F.2d 174, 178 (2d Cir. 1990) (quoting Anderson, 477 U.S. at 252, and Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586, 89 L. Ed. 2d 538, 106 S. Ct. 1348 (1986)), cert. denied, 500 U.S. 928, 111 S. Ct. 2041, 114 L. Ed. 2d 125 (1991). "The non-movant cannot escape summary judgment merely by vaguely asserting the existence of some unspecified disputed material facts, or defeat the motion through mere speculation or conjecture." Western World Ins. Co. v. Stack Oil, Inc., 922 F.2d 118, 121 (2d Cir. 1990) (citations and quotation omitted).
II. Preemption of Non-Specific Claims
The first question this Court must decide is whether the Medical Device Amendments ("MDA"), 21 U.S.C. §§ 360c et seq., of the Federal Food, Drug and Cosmetics Act ("FDCA"), 21 U.S.C. §§ 301 et seq., preempt plaintiff's state law tort claims
pertaining to the Ligament generally.
The Supremacy Clause of the Constitution provides that the laws of the United States "shall be the Supreme Law of the Land; and the Judges in every State shall be bound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding." U.S. Const. art. VI, cl. 2. Any state law which conflicts with federal law may be preempted.
In deciding whether federal law preempts state law, a court must (1) assess the comprehensive nature of the federal regulatory scheme; (2) determine if there is a dominant federal interest in the matter to be regulated and if there is a need for national uniformity; and (3) analyze the threat of conflict between state laws and the effective administration of the state program. See Bravman v. Baxter Healthcare Corp., 842 F. Supp. 747, 751 (S.D.N.Y. 1994) (Sweet, J.); Pennsylvania v. Nelson, 350 U.S. 497, 76 S. Ct. 477, 100 L. Ed. 640 (1956). Supremacy clause analysis begins with the "assumption that the historic police powers of the States [are] not to be superseded by [a] Federal Act unless that was the clear and manifest purpose of Congress." Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S. Ct. 1146, 1152, 91 L. Ed. 1447 (1947). A valid state law is preempted, however, when Congress either expressly preempts state law or Congress intends to completely occupy the given field. See Wisconsin Pub. Intervenor v. Mortier, 501 U.S. 597, 111 S. Ct. 2476, 2481-82, 115 L. Ed. 2d 532 (1991). However,
when Congress has considered the issue of pre-emption and has included in the enacted legislation a provision explicitly addressing that issue, and when that provision provides a reliable indicium of congressional intent with respect to state authority, there is no need to infer congressional intent to pre-empt state laws from the substantive provisions of legislation.
Cipollone v. Liggett Group, 505 U.S. 504, 112 S. Ct. 2608, 2618, 120 L. Ed. 2d 407 (1992) (citations omitted).
The MDA gives the FDA authority over medical devices and authorizes the FDA to issue implementing regulations. See Martello v. CIBA Vision Corporation, 42 F.3d 1167, 1168 (8th Cir. 1994). Under the MDA, medical device manufacturers must register each device with the FDA before beginning manufacture. See id.; 21 U.S.C. § 360c. "After registration, the FDA classifies each device according to the level of regulatory control necessary to provide for the device's safety and effectiveness." Martello, 42 F.3d at 1168. 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, such as the Ligament, are the most heavily regulated and must pass premarket approval. See id.; 21 U.S.C. § 360c(a)(1). When a device has been approved, the manufacturer must maintain certain records and continue to report to the FDA about the device. See 21 U.S.C. § 360i.
The Second Circuit has not yet addressed the preemptive effect of the MDA upon tort actions such as the instant one.
Because Gore relies upon the express preemptive scope of 21 U.S.C. § 360k, this Court's task is primarily one of statutory ...