purchaser of the raw materials. Thereafter, defendant was justified in relying upon such sophisticated purchaser, as well as others involved in the development, testing and approval for use in the human body of the device which allegedly injured the plaintiffs to assure that it was appropriate for such use.
Moreover, as discussed in Brantner v. Black & Decker, 831 F. Supp. 460, 462 (W.D. Pa. 1993), the existence, in general, of a duty running from defendant to plaintiffs under the law of negligence depends upon a two-part test: "(1) whether the risks of injury were foreseeable; and (2) whether the foreseeable risks were unreasonable." (Citing, Griggs v. Bic, 981 F.2d at 1435; Mazzagatti v. Everingham, 512 Pa. 266, 516 A.2d 672 (Pa. 1986)). The essential question with respect to the existence of a duty to plaintiffs on the part of defendant, therefore, is whether DuPont's actions in furnishing its Teflon product(s) to the immediate purchaser for ultimate use in the prosthesis later implanted into Patricia Kalinowski were "unreasonable or exposed the plaintiff to an elevated risk of foreseeable harm." Brantner, 831 F. Supp. at 462 (quoting, Mohler v. Jeke, 407 Pa. Super. 478, 595 A.2d 1247, 1252 (Pa. Super. 1991)). (Emphasis in original.)
As noted in our consideration of the applicability of the "Sophisticated User Doctrine", defendant's conduct in supplying its product(s) to the intermediate purchaser without warnings to potential ultimate consumers of medical devices to be fashioned from such product(s) was not unreasonable as a matter of law given the ensuing process of development of the finished products incorporating such material(s), as well the testing and review thereof in both the medical community and through the regulatory process.
In addition, we further conclude that the assurances sought by defendant and furnished by the intermediate purchaser to the effect that DuPont's products would not be used for medical applications except within the guidelines established by the FDA, as well as the aforementioned development and additional testing processes of which DuPont was aware, effectively eliminated any question concerning foreseeability on the part of defendant that ultimate consumers of medical devices incorporating its product(s) might be exposed to an elevated risk of harm. Defendant disclosed to the immediate purchaser what it knew concerning the suitability of its industrial product(s) for use in implantable medical devices and thereafter reasonably relied upon the explicit assurances of such purchasers to provide for the safety of the finished products. Under such circumstances, the question of foreseeability to the defendant of an enhanced risk to ultimate consumers would inevitably be transformed into the question whether DuPont was required to anticipate a breach of duty on the part of the various intermediaries standing between itself and the ultimate consumers. We conclude that imposing upon defendant the obligation to guard against the negligent or intentional conduct of such intermediaries because of the possibility that its products could cause harm as the result of such conduct would permit the imposition of virtually limitless liability. Such a broad concept of foreseeability would mean that any entity, no matter how remotely connected to the chain of circumstances leading to injury, would be potentially liable for failing to accurately predict the vagaries of the conduct of others over which it can exert no control.
Hence, our consideration of the question of defendant's duty to guard against harm to plaintiffs from potential uses of its product(s) with respect to plaintiffs' negligence claims leads to the same conclusion reached with respect to the strict liability claims: whether approached from the standpoint of existence of a duty at all or from the standpoint whether any possible duty was adequately discharged, defendant is not subject to liability in negligence as a result of its sale of Teflon product(s) which ultimately might have been incorporated into a device which allegedly caused injury to the plaintiffs. Thus, defendant is entitled to summary judgment on Count IV of the complaint as well as on Count I.
III. Breach of Warranties/Misrepresentation Claims
The elements of a claim for breach of implied warranty were set forth recently in Brantner v. Black & Decker, 831 F. Supp. at 461:
To establish the existence of an implied warranty of fitness for a particular purpose, there must be evidence that (1) the seller had reason to know of the particular purpose for which the buyer is purchasing the product and (2) the seller knows that the buyer is relying on its skill and judgment to furnish the proper good.
It is clear that plaintiffs cannot adduce evidence in support of either element of a claim for breach of implied warranty for a particular purpose, and, indeed, have not done so. In the first instance, there is no direct buyer-seller relationship between plaintiffs and defendant. Defendant had no reason to know that any of its product(s) would be incorporated into a TMJ implant ultimately "purchased" by plaintiff Patricia Kalinowski. Moreover, assuming that defendant's general knowledge that product(s) sold to Vitek and/or other prosthesis fabricators might eventually be implanted in the human body is sufficient to satisfy the first element of a claim for breach of implied warranty, it is nevertheless certain that plaintiffs have proferred no evidence that Patricia Kalinowski knew that the prosthesis she received included DuPont product(s), much less that she relied upon DuPont's expertise to assure that the raw material it supplied was appropriate for use in such a device.
In addition, there is absolutely no evidence that DuPont ever expressly warranted that any of its industrial products marketed as Teflon were suitable for medical applications. Indeed, the evidence establishes that, to the contrary, DuPont repeatedly notified purchasers seeking Teflon for such purpose that it could make no representations as to the purity, consistency or appropriateness of the products for that use. Finally, as noted in connection with the claim for breach of implied warranty, there is likewise no evidence that plaintiffs ever knew of or relied upon any representations of DuPont concerning use of its products in medical applications.
Plaintiffs' misrepresentation claims also fail for lack of evidence of any knowledge on the part of plaintiffs concerning defendant's claims for its products in medical applications, as well as the unrefuted evidence that defendant, in fact, affirmatively disclaimed the fitness of its product(s) for medical uses. Even if we assume, as plaintiffs suggest, that DuPont was actually touting such uses for Teflon behind the scenes, there is still no evidence that either plaintiffs or other intermediaries responsible for the development and testing of the medical devices incorporating Teflon relied upon any representation of DuPont. The available evidence suggests only that Homsy, as well as other researchers in the field, developed and relied upon their own knowledge and expertise in selecting materials and fabricating the medical devices in which Teflon was used. No reasonable inference to the contrary is possible from the documents supplied by plaintiffs in an attempt to refute that conclusion. At best, permitting a jury to consider the documents upon which plaintiffs rely and their innuendoes concerning the import of such documents would impermissibly invite the jury to speculate that DuPont played a greater role in the development and sale of the device which allegedly injured plaintiffs than the available evidence supports. Finally, even such ephemeral speculation falls short of establishing a causal connection between any representation of DuPont and reliance thereon by Patricia Kalinowski and/or her doctor in selecting the particular device which allegedly caused her injuries.
Having now considered all of plaintiffs' claims and having concluded that all fail for lack of legal or evidentiary support, we will grant defendant's motion for summary judgment in its entirety and will enter judgment in favor of defendant.
And now, this 10th day of January, 1994, upon consideration of defendant's motion for summary judgment, (Doc. #22), and plaintiffs' response thereto, IT IS HEREBY ORDERED that the motion is GRANTED.
IT IS FURTHER ORDERED that judgment is entered in favor of the defendant and against the plaintiffs.
IT IS FURTHER ORDERED that any remaining motions are DISMISSED as moot and that the Clerk shall mark the above-captioned action CLOSED for statistical purposes.
E. Mac Troutman, S.J.