Green v. Dolsky , 546 Pa. 400 ( 1996 )

CAPPY, Justice,

concurring.

I am in accord with the result reached by the majority. I write separately, however, to express my disagreement with the majority’s statement that “[a]ll of the [medical] malpractice claims, of course, are circumscribed by the MDA.” Majority op. at 416.

The MDA preempts a state requirement which “(1) is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device.... ” 21 U.S.C. § 360k(a). The United States Supreme Court has held that a statute which preempts “state requirements” could also preempt some common-law tort actions. See Cipollone v. Liggett Group, Inc., 505 U.S. 504, 112 S.Ct. 2608, 120 L.Ed.2d 407 (1992); Medtronic v. Lohr, — U.S. —, 116 S.Ct. 2240, 135 L.Ed.2d 700 (1996).

Yet, for a common-law tort action to be preempted by the MDA, it must impose requirements on the device. See 21 U.S.C. § 360(k)(a). Medical malpractice law simply does not place requirements on a device. Such law establishes requirements for the professional standard of care required of our medical community. Even where the allegation is that a physician committed malpractice while employing a medical device in his treatment, the issue to be resolved — and the law created by that resolution — concerns whether the physician’s conduct was reasonable. Resolution of that issue does not create standards concerning the safety and efficaciousness of the product in question.

For the foregoing reasons, I am unable to join that portion of the majority’s opinion which concludes that the preemption provision of the MDA applies to medical malpractice claims.

CASTILLE, J., joins this concurring opinion.