In reviewing the grant of summary judgment to a medical device manufacturer, the Third Circuit has certified two legal issues to the Pennsylvania Supreme Court for possible guidance. MELISSA EBERT, Appellant v. C.R. BARD, INC.; BARD PERIPHERAL VASCULAR INC., a subsidiary &/or division of Defendant C.R. Bard, Inc., No. 20-2139, 2021 WL 2656690, at *1 (3d Cir. June 24, 2021).
In the decision below, Ebert v. C.R. Bard, Inc., 459 F. Supp. 3d 637, 641 (E.D. Pa. 2020), the district court analyzed the claims involving a filter implanted to deal with plaintiff’s deep vein thrombosis before the clot could reach Ebert’s heart or lungs. Plaintiff argued that defendant was liable for harms allegedly caused by the filter under both a negligent design theory and a strict liability theory. Both claims, said the Third Circuit on appeal, hinge on “unresolved questions of Pennsylvania law.” First, with regard to negligent design, it was unclear to the panel what standard of care should be applied to implantable medical devices like the under the Supreme Court’s decision in Lance v. Wyeth, 85 A.3d 434 (Pa. 2014). Second, with regard to strict liability, it was unclear to the panel whether and in what circumstances an implantable medical device like the filter is subject to strict liability under Hahn v. Richter, 673 A.2d 888 (Pa. 1996), and Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014).
Lance, of course, relied on § 6(c) of the Restatement (Third) of Torts—that “pharmaceutical companies violate their duty of care if they introduce a drug into the marketplace, or continue a previous tender, with actual or constructive knowledge that the drug is too harmful to be used by anyone.” 85 A.3d at 459, 461 (citing Restatement (Third) of Torts: Prods. Liab. 6(c) (1998). Similarly, a plaintiff may prevail in a negligent design claim against a medical device manufacturer only by showing that the device was “too harmful to be used by anyone,” id. at 461. See Keen v. C.R. Bard, Inc., 480 F. Supp. 3d 624, 637–39 (E.D. Pa. 2020); see also Pa. Suggested Standard Civil Jury Instructions § 23.40 (5th ed. 2020) (“A … [medical device] [company] … that supplies a … [medical device] that it knew or reasonably should have known is too dangerous to be used by anyone, violates its duty of care.” (brackets in original) (citing Lance, 85 A.3d 434)). But see Crockett v. Luitpold Pharms., Inc., 2020 WL 433367, at *11 (E.D. Pa. Jan. 28, 2020).
On the strict liability question, in Hahn, the Supreme Court applied comment k of the Restatement (Second) of Torts § 402A to hold that prescription drugs are categorically immune from strict liability because they are “[u]navoidably unsafe” but are nonetheless justified for some patients. 673 A.2d at 889–91. Prescription medical devices are similarly categorically immune from strict liability under Pennsylvania law. See Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. Ct. 2006); Lawrence v. Synthes Inc., No. 94-07627, 2003 WL 23914540, at *5 (Pa. C.P. Aug. 15, 2003); see also Rosenberg v. C.R. Bard, Inc., 387 F. Supp. 3d 572, 576–78 (E.D. Pa. 2019). But see Gross v. Coloplast Corp., 434 F. Supp. 3d 245, 248, 250–52 (E.D. Pa. 2020).
PLAC submitted a cogent amicus brief on these issues. See 2020 WL 7260732. They note that Plaintiff’s arguments disregarded the broader policy pronouncements by the Pennsylvania Supreme Court around “product[s] whose distribution is limited precisely because its benefits and risks are to be assessed only by licensed physicians acting on behalf of particular patients whose individual physical condition and circumstances are known to them.” Coyle ex rel. Coyle v. Richardson Merrill, Inc., 584 A.2d 1383, 1386-87 (Pa. 1991). Limiting a plaintiff to recovery only if she can demonstrate “negligence or fault” is consistent with–and is the only result consistent with–the Pennsylvania Supreme Court’s repeated recognition that “medical uncertainties exist because each patient is unique, and undesirable results occur even when the diagnosis is correct and treatment is properly administered.” Toogood v. Rogal, 824 A.2d 1140, 1151 (Pa. 2003).