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January 10, 1994


The opinion of the court was delivered by: E. MAC TROUTMAN

 Plaintiff Patricia Kalinowski seeks damages for personal injuries allegedly resulting from the failure of a temperomandibular joint (TMJ) prosthesis fashioned from Proplast, a patented and trademarked product manufactured and sold by a now bankrupt entity, Vitek. *fn1" Defendant DuPont manufactures and sells polytetraflourethylene (PTFE), a component of Proplast, which is sold under the tradename Teflon. *fn2" Plaintiff Thomas Kalinowski likewise seeks damages for loss of consortium as a result of his wife's alleged injuries.

 In their complaint plaintiffs assert four separate theories of liability. First, they allege that defendant is subject to strict liability in tort in that it designed, manufactured and sold a product defective for use within the human body and failed to adequately warn the ultimate users of the product, i.e., doctors who perform TMJ replacement surgery and their patients, of known risks associated with the use of artificial joints containing PTFE. (Count I). Second, plaintiffs assert that defendant breached its express and implied warranty that PTFE is safe and fit for use as a component part in an artificial joint, the purpose for which defendant knew it was purchased by Vitek, manufacturer of both Proplast and the entire TMJ repalacement implanted into Patricia Kalinowski. (Count II). Third, plaintiffs allege that defendant's conduct relating to the sale of PTFE as a component of Proplast amounted to fraud and intentional or negligent misrepresentation upon which Patricia Kalinowski relied and was thereby injured. (Count III). Finally, plaintiffs allege that defendant was negligent in selling PTFE for use in human implants and in failing to adequately warn the manufacturer of Proplast and the ultimate users thereof of the dangers of implanting PTFE in the human body despite its knowledge of the problems associated with such implants. (Count IV).

 Defendant has moved for summary judgment, contending that it owed no duty to plaintiffs under any theory of liability in that it is only a bulk supplier of a raw material used in the fabrication of Proplast, a product materially different from PTFE. Defendant asserts that bulk suppliers of raw materials used in medical products which are regulated by the Food and Drug Administration owe no duty of any kind to ultimate consumers since, pursuant to the regulatory scheme, such duties are explicitly owed by the product manufacturers and by physicians who use such products. Defendant further contends that bulk suppliers of raw materials which are not inherently defective owe no duty to end users to warn of potential problems which might arise from use of the product in unusual applications and owe no duty to such end users to assure the safety of products derived from special applications of the raw material. Defendant also asserts that it owed no duty to warn ultimate consumers of products containing PTFE of any potential problems with the medical application of the finished product since the raw material was sold to a "sophisticated user" with independent knowledge of the potential risks as well as an independent duty to warn of possible dangers associated with such use. Finally, defendant contends that after leaving its control the PTFE it manufactured and sold was substantially changed by the intermediate purchaser via the process of fashioning Proplast and, therefore, did not reach the ultimate consumer in the same condition in which it was sold.

 Defendant notes that its contentions concerning the duties imposed by FDA regulation and the extent of the duties owed to ultimate consumers where the product sold as a component of a finished product is not inherently dangerous apply to both the strict liability and negligence theories of liability. Defendant further notes that its "sophisticated purchaser" argument applies only to the negligence claims, while the "substantial change" argument applies only to the strict liability claims.

  In response, plaintiffs argue that defendant's motion refers only to the PTFE it admittedly sold to Vitek for use as a component in its Proplast product while plaintiffs' claims likewise extend to the sale of FEP, a pure form of Teflon laminated to one side of the TMJ prosthesis implanted into Patricia Kalinowski. Consequently, plaintiffs argue that defendant's request for judgment fails on this basis alone. Plaintiffs further contend that defendant's duty to warn ultimate consumers of the dangers of Teflon when implanted in the human body is not abrogated by FDA regulation of medical devices, and, therefore, presents a jury question with respect to whether such duty exists and was breached. Plaintiffs also contend that DuPont cannot rely upon the "sophisticated user" defense in that it had reason to know that Vitek and its founder/principal, Charles Homsy, were not likely to forward critical information concerning the danger of incorporating PTFE/FEP into the TMJ prosthesis to doctors and patients, the ultimate users of the products. With respect to the "substantial change" contention, plaintiffs point to the factual record, including expert deposition testimony, to demonstrate that neither the process of manufacturing Proplast nor the fabrication of the TMJ prosthesis itself resulted in a fundamental change to the Teflon incorporated therein. Finally, plaintiffs argue that their warranty and misrepresentation claims are supportable since it is clear from the record that DuPont continued to sell its Teflon product(s) to Vitek for use in TMJ implants until 1989, long after defendant was fully apprised of the specific problems inherent in the use of Teflon in such a manner and of the failure of Vitek to adequately warn physicians and their patients of the danger of Proplast/Teflon implants.

 Despite the voluminous record produced by the parties in support of their respective positions, including many court decisions from various jurisdictions, it is clear that the fundamental question presently before this Court is whether, pursuant to the law of Pennsylvania, plaintiffs' various claims are cognizable under the relevant factual circumstances, which we will now relate. *fn3"

 Charles Homsy, a former DuPont employee, first became interested in the medical community's need for biocompatible materials for surgical implants in the mid-1960's as a result of medical problems experienced by his daughter. (See Exhibits to Memorandum of Law in Support of Motion of Defendant for Summary Judgment, (Doc. #22), Exh. C-2, Excerpt from 6/7/92 Deposition of Charles A. Homsy, Sc.D., at 699--712). Although Homsy's education and work experience were in the field of chemical engineering, he was ultimately invited by Methodist Hospital in Houston, Texas, to establish a biomedical engineering research facility to explore the use of polymers for prosthetic devices. (Id., Excerpt from 2/5/92 Deposition of Charles A. Homsy, Sc.D., at 10--12; Homsy Deposition of 6/7/92 at 700-701). Subsequently, Dr. Homsy patented the material known as Proplast, which contained DuPont's PTFE as a component part and which had various uses in both orthopedic and plastic surgery applications. (See note 1, supra).

 One of the applications of Proplast, developed in consultation with John Kent, D.D.S., was the subject TMJ prosthesis, which also incorporated FEP. (Id., Excerpt from Homsy Deposition of 3/23/90 at 96--103).

 In the course of developing Proplast, Homsy sought to purchase PTFE from DuPont. Such sale was refused, however, until Homsy executed a document in which he provided assurances to DuPont that all medical applications of PTFE would be in accordance with FDA regulations. By letter dated March 13, 1967, DuPont first sought such assurances from Methodist Hospital, with which Homsy was then associated, and informed the hospital that its flourocarbon resins were manufactured and sold for industrial use only, and that there were reports in the medical literature indicating serious problems inherent in the use of plastics generally and PTFE, specifically, in surgical applications. (Id., Exh. C-10).

 Homsy wrote back to DuPont to give it the assurances sought, and therein noted that the problems with PTFE reported in the medical literature arose from the failure of the reporting physicians to properly prepare and handle the PTFE for medical/surgical use. (Id., Exh. C-11).

 Further, by letter and enclosed Policy Statement dated May 13, 1977, DuPont informed Vitek that its products were tested for safety in industrial uses only, that no medical grade of PTFE existed and that DuPont could not guarantee that the composition of its resins would remain constant such as to make them suitable for use in medical applications. (Id., Exh A-1).

 DuPont, at various times beginning as early as 1966, engaged in internal discussions and in discussions with Homsy and others concerning the desirability of developing medical grades of certain fibers and/or of undertaking research into medical applications of its products. (See Plaintiffs' Patricia and Thomas Kalinowski's Reply to Defendant DuPont's Motion for Summary Judgment, Doc. #30, Exhs. L, M, NN, OO, QQ, RR, SS, XXX, CCCC, JJJJ, KKKK, CF, CI). The available record, however, does not indicate that any such possibilities for direct involvement in medical or surgical applications were ultimately pursued by defendant.

 On November 20, 1989, DuPont notified Vitek and Homsy that it would no longer fill Vitek's orders for Teflon flourocarbon resins because of litigation resulting from problems with Proplast. (Id., Exh. TT).

 Based upon the foregoing relevant and undisputed facts, we next consider the parties' arguments concerning the legal sufficiency of plaintiffs' claims in light of Pennsylvania law governing such claims.

 I. Strict Liability Claims

 As most recently noted in Phillips v. A.P. Green Refractories Co., 428 Pa. Super. 167, 630 A.2d 874 (Pa. Super. 1993), when presented with claims arising under § 402A of the RESTATEMENT (SECOND) OF TORTS, it is necessary for courts applying Pennsylvania law to determine, initially and as a matter of law, whether the product in question is "unreasoanbly dangerous." See also Mackowick v. Westinghouse Electric, 525 Pa. 52, 575 A.2d 100 (Pa. 1990); Azzarello v. Black Bros. Co., Inc., 480 Pa. 547, 391 A.2d 1020 (Pa. 1978); Dambacher by Dambacher v. Mallis, 336 Pa. Super. 22, 485 A.2d 408 (Pa. Super. 1984). Such determination is to be made by weighing the utility of the product against the likelihood and seriousness of the injury claimed and the availability of precautions which might have prevented the injury in order to reach the ultimate conclusion whether, as a matter of social policy, the risk of loss is appropriately placed upon the supplier of the product. Phillips.

 The obligation of the trial court in a strict liability action to determine whether the risk of loss for injuries arising from an allegedly defective product should fall on the supplier, i.e., to determine whether the product is "unreasonably dangerous", was also discussed in detail by the Court of Appeals for the Third Circuit in Griggs v. Bic Corporation, 981 F.2d 1429 (1992). In Griggs, the court noted that such determination is to be made prior to permitting a jury to consider plaintiff's evidence of the specific defect alleged and whether such alleged defect was the proximate cause of injury, since a decision against the plaintiff on the threshold inquiry amounts to a judicial conclusion that the product is not defective as a matter of law.

 Moreover, referring to Azzarello, wherein the Pennsylvania Supreme Court concluded that a product is not defective if it is "safe for its intended use" and, therefore, is defective only when it leaves the hands of the supplier "lacking any element necessary to make it safe for its intended use or possessing any feature that renders it unsafe for the intended use." 391 A.2d at 1026, 1027, the Griggs court held that the determination whether a product is "unreasonably dangerous" is necessarily linked to its intended use. In other words, the trial court's initial determination whether a product is defective centers on whether the product is safe for its intended use. If the court concludes that the product does not lack any element necessary to make it safe for its intended use, then it is not "unreasonably dangerous".

 In accordance with the law of Pennsylvania, therefore, we will begin our consideration of defendant's motion by determining whether, as a matter of social policy, the product(s) supplied by DuPont are "unreasonably dangerous", and therefore, whether the risk of loss from plaintiffs' alleged injuries should be placed upon the defendant. *fn4"

 The Superior Court in Phillips and the Court of Appeals in Griggs employed somewhat different analyses in their respective considerations of this threshold question. In Phillips, the Pennsylvania Superior Court was confronted with a situation similar to that here involved and, therefore, specifically focused on issues such as the utility of the raw material and the feasibility of imposing strict liability upon bulk suppliers thereof. In Griggs, the court provided more general guidelines for the unreasonably dangerous inquiry by focusing on the intended use of the product in question. ...

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