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TATUM v. CORDIS CORP.

February 14, 1991

MILLEDGE D. TATUM, et al.
v.
CORDIS CORPORATION



The opinion of the court was delivered by: WISEMAN

 THOMAS A. WISEMAN, JR., CHIEF UNITED STATES DISTRICT JUDGE

 I.

 A. Procedural History

 This is a diversity products liability action brought by Milledge D. Tatum and his wife, Gladys Tatum ("plaintiffs") against a pacemaker manufacturer, Cordis Corporation ("Cordis"). *fn1" Cordis has moved for summary judgment.

 The plaintiffs filed a complaint on May 4, 1989. At that time, the plaintiffs alleged that both Cordis pacemakers surgically implanted in Milledge Tatum were defective and unreasonably dangerous and proximately caused injury to the Tatums, including medical expenses, lost wages, loss of enjoyment of life, mental anguish and loss of consortium. The plaintiffs seek recovery under theories of strict liability in tort, negligence, misrepresentation and breach of warranty, both express and implied.

 Cordis filed a Motion for Partial Summary Judgment dismissing all claims related to the pacemaker implanted in 1978, known as the Omnicor Lambda model 190A. On July 25, 1990, the Court granted that motion, finding that the claims were barred by the statute of limitations.

 On October 11, 1990, Cordis filed another Motion for Summary Judgment with respect to the remaining claims arising from the performance of the second pacemaker, the Omni-Stanicor Gamma model 334A. The defendant's Motion for Summary Judgment is supported by affidavits taken from James A. Fortino, a registered nurse employed by Telectronics Pacing Systems, Inc. as manager of the Warranty and Medical Records Department; Alan Nielson, a long-time employee of Cordis Pacing Systems and Telectronics Holding Ltd. who performed the analysis on Tatum's pacemaker; and Duane Schultz, an engineer employed by Telectronics, Inc. as Senior Vice President of Regulatory and Clinical Affairs. Defendant also has submitted Milledge D. Tatum's medical records from St. Thomas Hospital and Dr. George Burrus' office.

 Plaintiff has filed four lengthy responses to that motion. Plaintiff proffers two main theories. First, she argues that the model 334A pacemaker is defective since it required replacement. Second, she maintains that since other model 334A pacemakers have been found to be defective, this particular model 334A pacemaker must have suffered similar problems. *fn2" To support her response, plaintiff relies on an affidavit from Milledge Tatum, congressional and federal investigations of Cordis, whistleblower memoranda, Cordis documents, and a federal case in which Cordis pled guilty to criminal charges.

 The pending Motion for Summary Judgment raises two questions for this Court to consider. First, whether the plaintiff raises a genuine issue of material fact with respect to her claims for strict liability, negligence or breach of implied warranty pursuant to T.C.A. ยง 29-28-105(a). Second, whether the plaintiff raises a genuine issue of material fact with respect to her claims for breach of express warranty and misrepresentation. These issues will be addressed below.

 B. Facts

 Internal cardiac pacemakers are powered by batteries that eventually require replacement. Affidavit of Duane Schultz ("Schultz") at 2. Pacemakers such as the model 334A are designed so that a slight slowdown in rate will occur near the end of the battery's normal life. Id. Pacemakers also may fail for other reasons and, as a result, Cordis recommends that physicians regularly monitor their patients that have pacemakers. Id.

 The instruction booklet provided by Cordis for the Omni-Stanicor Gamma pacemaker states that the pacer eventually will have to be replaced because of battery depletion or other malfunction. Nielson Affidavit, Exhibit A at 3, 4, 30, 34. The booklet also mentions the importance of regular monitoring of the pacemaker's performance. Id. at 3, 23. It emphasizes that:

 
Implantable cardiac pacing systems are designed to perform reliably over an extended period of time; however, every implanted pacer must be replaced eventually. The physician and patient must accept the fact that, in spite of the care exercised in design, manufacture, and testing, component malfunctions and other complications cannot be ...

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