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January 24, 1994



The opinion of the court was delivered by: ROBERT W. SWEET

Sweet, D. J.

 Defendant Baxter Healthcare Corporation ("Baxter") has moved for summary judgment pursuant to Rule 56 of the Federal Rules of Civil Procedure to dismiss the Complaint of Plaintiffs Aaron Bravman ("Bravman") and his wife Muriel. Defendant also moves in limine to preclude all evidence concerning a third party's suicide attempt and studies concerning the noise of the heart valve. For the reasons set forth below, Baxter's motion for summary judgment is granted. The motion in limine concerning the suicide is moot as Plaintiffs have conceded at oral argument of this motion that they will not introduce any evidence. The motion in limine concerning the studies was denied at oral argument except to the extent they refer to St. Jude and other values, and granted as to any reference to the Baxter valve.

 The Parties

 Bravman and his wife are Pennsylvania residents. Bravman, a retired stock broker, is in his mid-60s.

 Baxter is an Illinois corporation with its principal place of business in Deerfield, Illinois. Baxter's Edwards CVS Division manufactured the Edwards-Duromedics Bileaflet Heart Valve (the "Valve") which was surgically implanted in Bravman's heart.

 Prior Proceedings

 The Bravmans filed this action on May 17, 1989. On June 7, 1989, they filed an Amended Complaint as a matter of right. In the Amended Complaint, Bravman had asserted four causes of action: breach of express warranty, breach of implied warranty, negligence, and strict products liability. Mrs. Bravman sought damages for loss of consortium.

 On October 9, 1991, after close of discovery, Baxter filed a motion for summary judgment, requesting that Bravman's complaint be dismissed with prejudice. On May 18, 1992, this Court granted the Defendant's motion on the grounds that Bravman's fear that the Valve might fail was legally insufficient to support an injury claim and that the excessive noise emitted from the Valve failed to state a legally cognizable product defect claim under New York State law. Bravman v. Baxter Healthcare Corp., 794 F. Supp. 96 (S.D.N.Y. 1992) ("Bravman I"), aff'd in part and rev'd in part, remanded, 984 F.2d 71, (2d Cir. 1993).

 On appeal, the Second Circuit affirmed in part and reversed in part. Bravman v. Baxter Healthcare Corp., 984 F.2d 71 (2d Cir. 1993). The Court affirmed the finding that Bravman does not have a viable claim for relief under either a product or design defect theory of liability. Id. at 75-76. The Second Circuit reversed on the question of noise, and whether Baxter owed a duty to warn Bravman's doctor of the Valve's noise level. See Id. at 72 (holding Bravman is "entitled to a jury determination whether the noise emitted by the heart valve caused a cognizable injury and whether Baxter violated a duty to warn Bravman's doctor of the potential noise.").

 Thereafter, for the first time in this action, Baxter then raised the defense of federal preemption with respect to the duty to warn claim by the instant motion for summary judgment. The motion was argued and considered fully submitted on September 8, 1993.


 The facts in this diversity action are fully set forth in the prior opinions of this Court, familiarity with which is assumed. See Bravman I, 794 F. Supp. 96 (S.D.N.Y. 1992).

 To recapitulate briefly for the purposes of these motions, on April 5, 1988, Bravman underwent surgery at New York University Hospital to replace his natural mitral heart valve with the Valve. Without the surgery, it was estimated that Bravman would have lived no more than another five years.

 The Valve implanted in Bravman has continuously functioned but according to Bravman it is excessively noisy. Although all artificial heart valves emit noise, Bravman contends that his is so loud that it can be heard at distances up to thirty feet.

 Baxter stopped manufacturing the Valve and withdrew it from the market shortly after Bravman's surgery. The company had received reports of "leaflet escape" *fn1" and withdrew the Valve at the suggestion of the Food and Drug Administration ("FDA").

 Bravman has submitted evidence showing that Baxter knew that the Valve was noisier than other artificial heart valves before the date of Bravman's surgery. As early as 1985, Baxter's predecessor had received complaints about the noise. In August 1985, the company sent someone to investigate a Valve implanted in a patient in Arizona that could be heard from twenty feet away.

 Baxter conducted a study comparing the noise generated by the Valve with the St. Jude Medical Valve. In a presentation to the American Heart Association in November 1986, an independent physician stated that one problem with the Valve was its excessive noise. Other doctors noted concerns over the Valve's noise at a Baxter-sponsored symposium in February 1987. Two doctors argued that the potential for noise should be discussed with patients before surgery.

 In August 1986, after reviewing the Valve's design and manufacture, the FDA approved it for general sale in the United States. See 51 Fed. Reg. 34,254 (1986). As part of the premarket approval process ("PMA"), the FDA considered the Valve's product specifications, the results of animal and clinical studies of the Valve, the Valve's manufacturing methods and the Valve's proposed labeling. See generally 21 U.S.C. § 360c (description of PMA process). Baxter amended its PMA application and provided supplements on ten occasions to address FDA concerns. Baxter's PMA was approved by the Circulatory System Devices Panel, an FDA advisory committee. See 21 U.S.C. § 360c(b).

 I. The Issue Presented

For twenty-five centuries, Western knowledge has tried to look upon the world. It has failed to understand that the world is not for the beholding. It is for hearing. It is not legible, but audible. Our science has always desired to monitor, measure, abstract, and castrate meaning, forgetting that life is full of noise and that death alone is silent: work noise, noise of man, and noise of beast. Noise bought, sold or prohibited. Nothing essential happens in the absence of noise. *fn2"

 In the context of a summary judgment motion, the issue presented is whether Bravman's duty to warn claim under state law is preempted by federal regulation.

 A. The Standard For Summary Judgment

 The Rule 56 motion for summary judgment is "an integral part" of the Federal Rules of Civil Procedure and facilitates the overall purpose of the Rules as stated in Rule 1, namely, "to secure the just, speedy and inexpensive determination of every action." Celotex Corp. v. Catrett, 477 U.S. 317, 327, 91 L. Ed. 2d 265, 106 S. Ct. 2548 (1986). A motion for summary judgment may be granted only when there is no genuine issue of material fact remaining for trial and the moving party is entitled to judgment as a matter of law. See Fed. R. Civ. P. 56(c); Silver v. City Univ. of New York, 947 F.2d 1021, 1022 (2d Cir. 1991).

 The Second Circuit has unambiguously defined the role of the district court in deciding Rule 56 motions:

The district court's role . . . requires the court not to resolve disputed issues of fact itself, but rather to see if there are issues of fact to be resolved by the factfinder at trial. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986). That is to say, when examining the record before it to see if there are any genuine issues of material fact, the court's focus is on issue-finding, not on issue-resolution. In making its assessment, the trial court must view the evidence in the light most favorable to the non-moving party and draw all reasonable inferences in its favor. See United States v. Diebold, 369 U.S. 654, 655, 8 L. Ed. 2d 176, 82 S. Ct. 993 (1962) (per curiam).

 Consarc Corp. v. Marine Midland Bank, N.A., 996 F.2d 568, 572 (2d Cir. 1993).

 The Second Circuit has repeatedly noted that "as a general rule, all ambiguities and inferences to be drawn from the underlying facts should be resolved in favor of the party opposing the motion, and all doubts as to the existence of a genuine issue for trial should be resolved against the moving party." Brady v. Town of Colchester, 863 F.2d 205, 210 (2d Cir. 1988) (citing Celotex v. Catrett, 477 U.S. 317, 330 n.2, 91 L. Ed. 2d 265, 106 S. Ct. 2548 (1986) (Brennan, J., dissenting) and Adickes v. S.H. Kress & Co., 398 U.S. 144, 158-59, 26 L. Ed. 2d 142, 90 S. Ct. 1598 (1970)); see United States v. Diebold, Inc., 369 U.S. 654, 655, 8 L. Ed. 2d 176, 82 S. Ct. 993 (1962); Cartier v. Lussier, 955 F.2d 841, 845 (2d Cir. 1992); Burtnieks v. City of New York, 716 F.2d 982, 983-84 (2d Cir. 1983). If, when "viewing the evidence produced in the light most favorable to the nonmovant . . . a rational trier [of fact] could not find for the nonmovant, then there is no genuine issue of material fact and entry of summary judgment is appropriate." Binder v. Long Island Lighting Co., 933 F.2d 187, 191 (2d Cir. 1991).

 When a motion for summary judgment is made and the nonmoving party will bear the burden of proof at trial, "Rule 56 permits the moving party to point to an absence of evidence to support an essential element of the nonmoving party's claim." Bay v. Times Mirror Magazines, Inc., 936 F.2d 112, 116 (2d Cir. 1991). However, if the moving party is still entitled to judgment as a matter of law after all the facts alleged by the nonmoving party are resolved in his favor as true, then any remaining factual disputes are neither "genuine" nor "material" and will not prevent the court from granting the motion. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986) ("a material fact is 'genuine' . . . if the evidence is such that a reasonably jury could return a verdict for the nonmoving party."). Thus, the nonmovant "must do more than simply show that there is some metaphysical doubt as to the material facts." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 89 L. Ed. 2d 538, 106 S. Ct. 1348 (1986).

 Finally, the court must look to the substantive law to determine which facts are "material," to wit, disputed facts that might affect the outcome of the suit under governing law. See Anderson, 477 U.S. at 248. It follows, then, that "entry of summary judgment indicates that no reasonable jury could return a verdict for the losing party." Coach Leatherware Co. v. AnnTaylor, Inc., 933 F.2d 162, 167 (2d Cir. 1991).

 B. Principles of Federal Preemption

 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. Since M'Culloch v. Maryland, 17 U.S. (4 Wheat.) 316, 4 L. Ed. 579 (1819), the Supreme Court has held that state law which conflicts with federal law may be preempted.

  In Pennsylvania v. Nelson, 350 U.S. 497, 100 L. Ed. 640, 76 S. Ct. 477 (1956), Justice Warren enunciated a three-prong judicial inquiry as to whether federal law preempts a state law or regulation: first, a court must assess the comprehensive nature of the regulatory scheme; second, a court must determine if there is a dominant federal interest in the matter to be regulated and if there is a need for national uniformity; and third, a court must analyze the threat of conflict between state laws and the effective administration of the federal program. Id. at 502-06; see also Hillsborough County v. Automated Medical Labs., Inc., 471 U.S. 707, 713, 85 L. Ed. 2d 714, 105 S. Ct. 2371 (1985).

 In analyzing the preemptive effect of federal regulations, the Supreme Court has held that: "The purpose of Congress is the ultimate touchstone." Retail Clerks Int'l Ass'n v. Schermerhorn, 375 U.S. 96, 103, 11 L. Ed. 2d 179, 84 S. Ct. 219 (1963). Accordingly, supremacy analysis must begin "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, 91 L. Ed. 1447, 67 S. Ct. 1146 (1947). However, "congress under the Commerce Clause may displace state power ( Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 234-36, 91 L. Ed. 1447, 67 S. Ct. 1146; San Diego Council v. Garmon, supra,) or it may even by silence indicate a purpose to let state regulation be imposed on the ...

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