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March 16, 2003


The opinion of the court was delivered by: Ellen Segal Huvelle, District Judge.


Plaintiffs Arnold and Irene Webster have brought this products liability suit to recover damages from injuries suffered by Arnold Webster after heart surgery implanting a pacemaker system produced by defendant Pacesetter, Inc. Plaintiffs allege that the atrial lead of the pacemaker system is defective and caused the perforation of the wall of the atrial chamber of Arnold Webster's heart. As a result, plaintiffs have sued alleging strict liability, negligent design, breach of warranty, and fraud and deceit. Defendant now moves for summary judgment arguing that plaintiffs have failed to make a sufficient showing to establish the elements of their claims. As discussed below, the Court concludes, based on the undisputed evidence, that plaintiffs cannot sustain their burden as to any of their claims, and thus, defendant's motion for summary judgment will be granted.*fn1


Plaintiff Arnold Webster had a history of heart trouble described as sinoatrial node dysfunction. On July 24, 1998, to stabilize his heart, Arnold Webster underwent an operation to implant a cardiac pacing system, consisting of three components: the TRILOGY DR Implantable Pulse Generator, model 2360L; a TENDRIL DX Permanent Pacemaker Electrode, Atrial Lead, model 1388TC; and a Passive PLUS DX Permanent Pacemaker Electrode, Ventricular Lead, model 1346T. (Compl. ¶ 8.) All three components — the pacemaker and the two leads — were manufactured by defendant Pacesetter, Inc., a St. Jude Medical Company. (Id. ¶ 9.) After a post-surgery diagnostic examination indicating that there were no procedural complications, plaintiff was discharged from Washington Hospital Center in Washington, D.C. (Id. ¶¶ 10-12.)

On August 5, 1998, plaintiff became weak and dizzy while riding in a car. He was rushed to an emergency room at the Lady of Lourdes Medical Center in Camden, New Jersey. (Id. ¶¶ 13-14.) After review of a CAT scan and echocardiogram, plaintiff's doctors concluded that the atrial lead had perforated the atrial chamber of his heart causing cardiac tamponade (i.e., a condition where fluid accumulates in the pericardial sack surrounding the heart). (Id. ¶¶ 15-16; Defendant's Motion for Summary Judgment ["Def.'s Mot."] Ex. B, Affidavit of Paul A. Levine [" Levine Aff."] ¶ 17.) The accumulation of the fluid compresses the heart, thereby limiting its ability to fill with blood and compromising its ability to pump blood. (Levine Aff. ¶ 17.) Plaintiff underwent a procedure known as a median sternotomy and the perforation was repaired. On August 13, 1998, plaintiff was discharged from the hospital. (Compl. ¶¶ 17-18.) The original pacemaker and leads have remained implanted and continue to function properly. (Levine Aff. ¶ 18.)

On April 2, 2001, plaintiffs filed suit. The gravamen of their complaint relates solely to the model 1388TC atrial lead. The lead is inserted through a vein and positioned on the inside of the heart.*fn2 It carries electrical impulses from the pulse generator to the heart. (Levine Aff. ¶ 6.) Plaintiffs claim that the design of this lead was defective, that defendant failed to provide proper warnings regarding the risks associated with the product, and that these failings caused the perforation and cardiac tamponade suffered by Arnold Webster.


I. Summary Judgment Standard

Federal Rule of Civil Procedure 56(c) provides that a district court shall grant summary judgment "if the pleadings, depositions, answers to interrogatories, and admissions on file, together with the affidavits, if any, show that there is (1) no genuine issue as to any material fact and that (2) the moving party is entitled to judgment as a matter of law." See Fed.R.Civ.P. 56(c); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). In considering a motion for summary judgment, the "evidence of the non-movant is to be believed, and all justifiable inferences are to be drawn in his favor." Id. at 255; see also Washington Post Co. v. United States Dep't of Health and Human Servs., 865 F.2d 320, 325 (D.C. Cir. 1989). However, "the plain language of 56(c), mandates the entry of summary judgment, after an adequate time for discovery, 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." Celotex Corp v. Cotrett, 477 U.S. 317, 322 (1986). "A sufficient showing exists when the evidence is such that a reasonable jury could return a verdict for the nonmovant." Anderson, 477 U.S. at 248.

II. Strict Liability Claim

The District of Columbia recognizes a cause of action for strict liability in tort based on the principles of the Restatement (Second) of Torts § 402A. Hull v. Eaton Corporation, 825 F.2d 448, 454 (D.C. Cir. 1987). "To prevail on a claim for strict liability in tort under § 402A, a plaintiff must prove that: `(1) the seller was engaged in the business of selling the product that caused the harm; (2) the product was sold in a defective condition unreasonably dangerous to the consumer or user; (3) the product was one which the seller expected to and did reach the plaintiff consumer or user without any substantial change from the condition in which it was sold; and (4) the defect was a direct and proximate cause of the plaintiffs injuries.'" Word v. Potomac Elec. Power Co., 742 A.2d 452, 459-60 (D.C. 1999) (quoting Warner Fruehauf Trailer Co. v. Boston, 654 A.2d 1272, 1274 (D.C. 1995)). A product may be found defective under section 402(a) "in any of three ways: (1) by defective design, (2) by defective manufacture, or (3) by failure of the producer or assembler to warn adequately of a risk related to the way the product was designed." MacPherson v. Searle and Co., 775 F. Supp. 417, 422 (D.D.C. 1991) (citing W. Page Keeton et al., Prosser and Keeton on the Law of Torts Sect. 99, at 695 (5th ed. 1984)); Restatement (Second) of Torts § 402A cmt. k (1965)). In this case, plaintiffs claim both defective design and inadequate warnings.

A. Design Defect

With respect to the requirement that the product be sold in a defective and unreasonably dangerous condition, most jurisdictions, including the District of Columbia, apply some form of a risk-utility balancing test to establish strict liability in tort. Warner Fruehauf, 654 A.2d at 1276. Under this risk-utility analysis, "plaintiff must `show the risks, costs and benefits of the product in question and alternative designs' and `that the magnitude of the danger from the product outweighed the costs of avoiding the danger.'" Id. (quoting Hull, 825 F.2d at 453).

Defendant argues that plaintiffs cannot make the requisite showing to sustain a claim for design defect because they have failed to: (1) identify a defect in the design of the atrial lead; (2) show that the product was unreasonably dangerous; and (3) establish a causal link between the model 1388TC and plaintiffs' injuries. A careful review of plaintiffs' evidence, including the testimony of their two experts — John Morris and Edward Reese — demonstrates the merit of defendant's position.

First, having read the reports and testimony of plaintiffs' experts, one is hard-pressed to even paraphrase their theory as to the specific design defect. Edward Reese, who testified regarding the adequacy of the warnings, is not a medical doctor and admitted that he relied on John Morris' opinion that residual torsion can contribute to delayed tamponade. (Plaintiffs' Opposition to Defendant's Motion for Summary Judgment ["Pls.' Opp."] Ex. 16, Deposition of Edward Reese ["Reese Dep."] at 203.)*fn3 The second expert, John W. Morris, who was proffered as an expert in metallurgical engineering, stated that he did "not know of anything that is specifically defective with the atrial lead." (Pls.' Opp. Ex. 14, Deposition of John William Morris, Jr. Sc.D. ["Morris Dep."] at 94-95.) Nonetheless, plaintiffs point to other portions of Morris' deposition and his report where he claimed that Pacesetter's failure to conduct any research into the root causes of perforation and tamponade rendered the product defective (see Morris Dep. at 53), and where he opined that perforation was "most likely" caused by "residual torsion" or residual stress left in the device as a result of the implanting physician having "over-torqued" the atrial lead during the implant surgery. (See, e.g., Morris Dep. at 187; Pls.' Opp. Ex. 3, Report of John W. Morris, Jr. Sc.D. ["Morris Report"] at 6.) Despite the claim that residual stress was "the most likely cause" of the perforation, Morris admitted that he did not know whether there was "residual torsion" left in Webster's atrial lead, and significantly, that the supposed link between "residual torsion" and perforation is based on an unproven "sound mechanical hypotheses" that may or may not be true. (Morris Dep. at 55-56, 73-74.) But even if this theory about "residual torsion" could be validated, which is dubious at best,*fn4 Morris has failed to identify the design defect that resulted in the supposed existence of "residual torsion." Obviously, one cannot presuppose the existence of a defect solely on the basis that unintended or undesirable results have occurred. See Beetler v. Sales Affiliates, 431 F.2d 651 (7th Cir. 1970) ("theory of . . . strict liability does not impose upon a manufacturer liability for all harm resulting from his product. . . . the product must be shown to be defective . . . [and] the defect must render the product unreasonably dangerous."). Moreover, Morris fails to provide any basis for concluding that the lead at issue here is any more likely to result in delayed perforation and tamponade than another pacemaker lead. In fact, just the opposite is ...

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