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BRAVMAN v. BAXTER HEALTHCARE CORP.

May 18, 1992

AARON BRAVMAN and MURIEL BRAVMAN, Plaintiffs,
v.
BAXTER HEALTHCARE CORPORATION, Defendant.



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 Amended Complaint of Plaintiffs Aaron Bravman ("Bravman") and his wife Muriel. For the reasons set forth below, Baxter's motion is granted, and judgment dismissing the Amended Complaint will be entered.

 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 an Edwards-Duromedics Bileaflet Heart Valve ("Edwards-Duromedics Heart Valve") surgically implanted in Bravman's heart.

 Prior Procedures

 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 asserts four causes of action: breach of express warranty, breach of implied warranty, negligence, and strict products liability. Mrs. Bravman seeks damages for loss of consortium.

 Baxter filed the present motion on October 9, 1991. Oral argument was heard on January 9, 1992, and the motion considered submitted as of that date.

 Facts

 On April 5, 1988, Bravman underwent surgery at New York University Hospital to replace his natural mitral heart valve with an artificial Edwards-Duromedics Heart Valve. Bravman's natural valve had begun to deteriorate rapidly in the 1980's from mitral stenosis. The mitral stenosis resulted from a bout of rheumatic fever Bravman endured as a child. Without the surgery, it was estimated that Bravman would have lived no more than another five years.

 Bravman began to complain to his doctors about the noise soon after his surgery. The valve's vibrations and clicks have caused him great distress. He cannot sleep, is frequently despondent, and is unable to concentrate for very long, for he is constantly aware of the valve's presence. This resulted in his taking an early retirement several months after surgery. Bravman has also explored the possibility of replacing the valve.

 Before undergoing surgery, Bravman met once with his surgeon. During the meeting, the surgeon explained that there are two types of heart valves, porcine and mechanical. Porcine valves are fashioned from natural pig tissue. Under the circumstances, the surgeon recommended that a mechanical valve be inserted since it was likely to last longer than a porcine valve. At no time during the meeting did the surgeon explain that mechanical heart valves click. Bravman's surgeon has submitted an affidavit stating that, had he known of the reports concerning the valve's noise in 1988, he still would have implanted the Edwards-Duromedics Heart Valve in Bravman.

 Baxter ceased to manufacture the Edwards-Duromedics Heart Valve and withdrew it from the market shortly after Bravman's surgery. The company had received reports of "leaflet escape" and withdrew the valve at the suggestion of the Food and Drug Administration. The Edwards-Duromedics Heart Valve uses two movable disks, or leaflets, that open and close with each beat of the heart, thus controlling the flow of blood. Leaflet escape occurs when a leaflet structure fails, causing the leaflet to break away from the valve and enter the blood stream. Of the roughly 18,364 Edwards-Duromedics Heart Valves successfully implanted since 1982, leaflet escape had occurred in twenty mitral valves and five other valves by October 1991. Seventeen of these twenty-five patients survived.

 The leaflets in Bravman's heart valve appear to function as intended. The clicking of the valve as his heart beats indicates the leaflets are opening and closing normally. Indeed, one of Bravman's doctors believes that the characteristic clicking of all mechanical heart valves serves as a beneficial diagnostic. Absence of a click generally indicates that something is seriously amiss. See Abramowitz Depo. 92. Nevertheless, Bravman contends he "lives unnecessarily with the fear that his Duromedics valve may fail mechanically. He is reminded of this fact during every waking moment because his heart valve is so loud." Memorandum in Opposition 2.

 Bravman has submitted evidence showing that Baxter and the company from which it bought the rights to the Edwards-Duromedics Heart Valve knew that the valve tended to be noisier than other artificial heart valves before 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 also conducted a study comparing the noise generated by its valve with the St. Jude Medical Valve. An independent physician made a presentation to the American Heart Association in November 1986, during which the physician stated that one problem with the Edwards-Duromedics Heart Valve was its excessive noise. At a symposium Baxter sponsored in February 1987, other doctors noted concerns over the valve's noise. Two doctors argued that the potential for noise be discussed with patients before surgery.

 According to Baxter's director of research and development, whether a particular Edwards-Duromedics Heart Valve is noisy depends on factors unique to the individual into whom it is implanted. See Ely Depo. 139. Bravman suggests that the Edwards-Duromedics Heart Valve is noisier than the St. Jude Medical valve because the St. Jude valve uses a leaflet that is about one-half as thick as the Edwards-Duromedics Heart Valve. See Letter from D. Wieting (Dec. 13, 1986). However, a study conducted by Baxter in 1987 shows that the Edwards-Duromedics Heart Valve was less noisy than two other artificial heart valves available at that time.

 Discussion

 Baxter argues that it is fully entitled to summary judgment because Bravman's Edwards-Duromedics Heart Valve has operated as intended continuously since it was implanted in his heart. Bravman opposes the motion by contending that his heart valve is defectively noisy and that Baxter breached its duty to warn of this potential.

 "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. Fed. R. Civ. P. 56(c). '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.' However, where 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) (citations omitted). As is often stated, "viewing the evidence produced in the light most favorable to the nonmovant, if a rational trier could not ...


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