Lamontagne v. EI Du Pont De Nemours and Co.

• Decision Date: 07 December 1993
• Docket Number: 3:91 CV 354 (JAC) and 3:91 CV 355 (JAC).,No. 3:91 CV 142 (JAC),3:91 CV 142 (JAC)
• Parties: Annamarie LAMONTAGNE v. E.I. DU PONT DE NEMOURS AND COMPANY, INC. Doreen A. FESTA v. E.I. DU PONT DE NEMOURS AND COMPANY, INC. Susan B. PREGLER v. E.I. DU PONT DE NEMOURS AND COMPANY, INC.
• Court: U.S. District Court — District of Connecticut

834 F. Supp. 576

Annamarie LAMONTAGNE v. E.I. DU PONT DE NEMOURS AND COMPANY, INC.

Doreen A. FESTA v. E.I. DU PONT DE NEMOURS AND COMPANY, INC.

Susan B. PREGLER v. E.I. DU PONT DE NEMOURS AND COMPANY, INC.

Nos. 3:91 CV 142 (JAC), 3:91 CV 354 (JAC) and 3:91 CV 355 (JAC).

United States District Court, D. Connecticut.

December 7, 1993.

COPYRIGHT MATERIAL OMITTED

David Rief, Elizabeth L. McMahon, Susman, Duffy & Segaloff, New Haven, CT, for plaintiffs.

Shelley Wessels, Brown & Bain, Palo Alto, CA, Harry M. Stokes, Wiggin & Dana, New Haven, CT, for defendant.

AMENDED RULING ON DEFENDANT'S MOTION FOR SUMMARY JUDGMENT

JOSÉ A. CABRANES, Chief Judge:

The plaintiffs in these three product liability cases seek damages for personal injuries against the defendant E.I. Du Pont de Nemours & Company ("Du Pont"). These cases were removed to this court from the Superior Court of the State of Connecticut pursuant to 28 U.S.C. § 1441. The court approved consolidation of the three cases, upon stipulation of the parties, on December 30, 1991. Pending before the court is Du Pont's motion for summary judgment.

BACKGROUND

The plaintiffs are each recipients of a prescription medical prosthesis known as a Proplast TMJ Interpositional Implant ("Proplast TMJ Implant"). The Proplast TMJ Implant was used by oral surgeons to correct defects in the recipient's temporomandibular joint.¹ The Proplast TMJ Implants are alleged to have failed after implantation, causing permanent physical injury.

The Proplast TMJ Implant was designed, manufactured and sold by Vitek, Inc. ("Vitek"), a now-bankrupt Texas company, which marketed the implant only after it received approval to do so from the United States Food and Drug Administration ("FDA"). The Proplast TMJ Implant was composed of various synthetic substances including Proplast — a material designed and manufactured by Vitek. Proplast is made by combining polytetrafluoroethylene (or "PTFE") resins and fibers with either carbon or aluminum oxide.² The PTFE used in the Proplast TMJ Implants received by the plaintiffs was purchased by Vitek from the defendant Du Pont, which manufactures PTFE under its trade-name "Teflon." Du Pont sells PTFE, or Teflon, in bulk in resin, powder and fiber forms.

The plaintiffs contend that Teflon was not appropriate for use in the Proplast TMJ Implant manufactured and marketed by Vitek. The plaintiff's complaints³ seek recovery from Du Pont under the Connecticut Product Liability Act, Conn.Gen.Stat. §§ 52-572m et seq., on the theories: (a) that Du Pont was negligent in marketing Teflon to Vitek in the circumstances alleged; (b) that Du Pont failed to issue adequate warnings of the risks associated with the use of Teflon in the Proplast TMJ Implant; and (c) that Du Pont breached the implied warranties of merchantability and fitness for a particular use.

DISCUSSION

Du Pont has moved for summary judgment against all of the plaintiffs' claims. First, Du Pont contends that the plaintiffs' claims are preempted by federal law in the form of the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 301 et seq. (the "MDA").⁴ Second, even if the plaintiffs' claims are not preempted, Du Pont argues, it is nonetheless entitled to summary judgment. Du Pont contends that "all of the plaintiffs' claims are based on the false premise that because Du Pont provided Vitek with raw material, Du Pont had a legal responsibility to assure that Vitek's specialized medical use of that raw material was safe."⁵ Du Pont maintains, rather, that "as a bulk material supplier to a medical product manufacturer, Du Pont had no duty to assure the safety of the Proplast TMJ Implant designed, manufactured, tested and sold by Vitek."⁶ Because it had no duty to prevent or warn of any defects or dangers in the specialized application of the Proplast TMJ Implant, Du Pont claims that it is entitled to summary judgment on all of the plaintiffs' claims.

I.

Summary judgment shall be granted "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits ... 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." Fed.R.Civ.P. 56(c). "The mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment; the requirement is that there be no genuine issue of material fact." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48, 106 S.Ct. 2505, 2509-10, 91 L.Ed.2d 202 (1986) (emphasis in original). While the court must view the inferences to be drawn from the facts in the light most favorable to the party opposing the motion, Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 1356, 89 L.Ed.2d 538 (1986), a party may not "rely on mere speculation or conjecture as to the true nature of the facts to overcome a motion for summary judgment." Knight v. U.S. Fire Ins. Co., 804 F.2d 9, 12 (2d Cir.1986) (Feinberg, C.J.), cert. denied, 480 U.S. 932, 107 S.Ct. 1570, 94 L.Ed.2d 762 (1987). The non-moving party may defeat the summary judgment motion by producing sufficient specific facts to establish that there is a genuine issue of material fact for trial. Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 2552, 91 L.Ed.2d 265 (1986). Finally, "`mere conclusory allegations or denials'" in legal memoranda or oral argument are not evidence and cannot by themselves create a genuine issue of material fact where none would otherwise exist. Quinn v. Syracuse Model Neighborhood Corp., 613 F.2d 438, 445 (2d Cir.1980) (quoting SEC v. Research Automation Corp., 585 F.2d 31, 33 (2d Cir.1978)).

II.

We address first the question of whether the plaintiffs' claims are preempted by federal law. We begin with a discussion of the general principles of federal preemption before turning specifically to the MDA and the Proplast TMJ Implant at issue here.

A.

Article VI 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 notwithstanding." State laws which "interfere with, or are contrary to the laws of Congress, made in pursuance of the constitution are invalid." Wisconsin Public Intervenor v. Mortier, ___ U.S. ___, ___, 111 S.Ct. 2476, 2481, 115 L.Ed.2d 532 (1991) (citing Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1, 211, 6 L.Ed. 23 (1824)). The ways in which federal law may preempt state law are "well established and in the first instance turn on Congressional intent," id.; the "`purpose of Congress is the ultimate touchstone' of pre-emption analysis." Cipillone v. Liggett Group, Inc., ___ U.S. ___, ___, 112 S.Ct. 2608, 2617, 120 L.Ed.2d 407 (1992) (quoting Malone v. White Motor Corp., 435 U.S. 497, 504, 98 S.Ct. 1185, 1189, 55 L.Ed.2d 443 (1978)).

Congress' intent to preempt state law in a given field may be stated expressly in a statute, see Jones v. Rath Packing Co., 430 U.S. 519, 525, 97 S.Ct. 1305, 1309, 51 L.Ed.2d 604 (1977), or may be expressed implicitly by the enactment of "a scheme of federal regulation `so pervasive as to make reasonable the inference that Congress left no room for the States to supplement it.'" Wisconsin Public Intervenor, ___ U.S. at ___, 111 S.Ct. at 2481 (quoting Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230, 67 S.Ct. 1146, 1152, 91 L.Ed. 1447 (1947)). Implied preemption also occurs when compliance with both federal and state regulations is an impossibility. See Fidelity Federal Savings & Loan Ass'n v. de la Cuesta, 458 U.S. 141, 153, 102 S.Ct. 3014, 3022, 73 L.Ed.2d 664 (1982); Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43, 83 S.Ct. 1210, 1217, 10 L.Ed.2d 248 (1963). Further, as the Supreme Court recently stated in Cipillone, "when Congress has considered the issue of preemption 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 preempt state laws from the substantive provisions of the legislation." ___ U.S. at ___, 112 S.Ct. at 2618 (citations omitted). Finally, the consideration of the defendant's preemption arguments must start "`with the assumption that the historic police powers of the States are not to be superseded by ... a Federal Act unless that is the clear and manifest purpose of Congress.'" Id. at ___, 112 S.Ct. at 2617 (quoting Rice, 331 U.S. at 230, 67 S.Ct. at 1152).

B.

(1)

Before considering Du Pont's argument that the MDA preempts the plaintiffs' state law claims, we review briefly the scope and operation of that statute. The MDA gives the FDA regulatory authority over medical devices and authorizes that agency to promulgate implementing regulations. 21 U.S.C. § 371(a). Manufacturers of medical devices are required under the MDA to register each device with the FDA prior to commencing manufacture. See 21 U.S.C. § 360(c). The MDA also sets forth in Section 331 certain "prohibited acts" on the part of medical device manufacturers, which include the introduction into interstate commerce of any device that is misbranded or adulterated, 21 U.S.C. § 331(a),⁷ the failure to register a device, 21 U.S.C. § 331(p), and the submission of any false or misleading report that is required under the MDA. Prohibited acts are punishable by fines, penalties and imprisonment. 21 U.S.C. § 333.

After registration, medical devices are classified according to the level of regulatory control the FDA determines is necessary to provide for the safety and effectiveness of the device. See 21 U.S.C. § 360c. There are three levels of classification. If the FDA determines that so-called "general controls" are "sufficient to provide reasonable safety and...