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We would be remiss (and out of character) if we plunged into a discussion of today’s case without a shout-out to “Siba,” the gorgeous black Standard Poodle who won Best in Show at last week’s Westminster Kennel Club Dog Show. Regular readers of this blog may recall that we attend Westminster every year and that Standard Poodles are the breed of our heart.  A Standard Poodle has not won the gold and purple rosette in three decades, since a glorious Standard known as Champion Whisperwind On A Carousel — “Peter” for short — won the top prize. We were thrilled, of course, but we admit that the final seven included several other dogs who also grabbed our heart. So this was pretty close to a “no lose” scenario for us.

Unlike today’s case, Gross v. Coloplast Corp., et al., 2020 WL 264691 (E.D. Pa. Jan. 17, 2020) which most emphatically is a loss for drug and device jurisprudence and for common sense. Recall that our eighth worst case of 2019 was Schrecengost v. Coloplast Corp., 2019 WL 6465398 (W.D. Pa. Dec. 2, 2019), in which the United States District Court for the Western District of Pennsylvania “predicted” that the Pennsylvania Supreme Court would allow strict liability design defect and warnings claims in cases involving prescription medical devices. In other words, the court predicted that the Pennsylvania Supreme Court would exclude prescription medical devices from the “unavoidably unsafe products” exception established by comment k to Section 402A to the Restatement (Second) of Torts.  Here, you can read Bexis’s excoriation of the Schrecengost decision, explaining that there is nothing to “predict” – that decades of Pennsylvania appellate decisions hold, unanimously, that comment k bars strict liability claims against manufacturers of all prescription medical products, including drugs, devices, and vaccines. By holding otherwise, the court disregarded the limits on federal courts’ power to “predict” novel expansions of state-law liability in diversity cases.

And the bad news keeps coming.  In Gross, the United States District Court for the Eastern District of Pennsylvania falls in line with its western counterpart, denying a medical device manufacturer’s motion to dismiss the plaintiffs’ strict liability claims. The court starts from the correct premise: that, beginning with the Pennsylvania Supreme Court’s adoption of comment k in its 1996 decision in Hahn v. Richter, prescription drugs “indisputably” have been “exempt from strict liability under Pennsylvania law.” Gross, 2020 WL 264691 at *3.   But then the decision goes off the rails. Citing Tincher, the court asserts that the Pennsylvania Supreme Court has “strongly discouraged courts from carving out certain products for special treatment within the common law of product liability” and, specifically, has “cautioned Pennsylvania courts against thoughtlessly extending Hahn and comment k.” Id. at *4. The court goes on to state that the Pennsylvania Supreme Court commented in Lance that Hahn’s analysis “offers a poor foundation for extrapolation.” Id. The court concludes that it should not “mak[e] categorical carveouts from the presumption of strict liability” without a “rich factual record on the [relevant] policy issues,” so the “better result” is to deny the defendant’s motion at the 12(b)(6) stage. Id.

But here’s the fallacy: applying comment k to prescription medical devices does not require additional “carveouts,” or “extrapolation”, or “extension of Hahn and comment k,” because there is no principled basis for a distinction between prescription drugs and prescription medical devices. To the contrary, as Pennsylvania’s appellate courts have long acknowledged, all of the policy reasons why prescription drugs are “unavoidably unsafe products” under comment k apply with identical force to prescription medical devices.

The Cross court implies that the strict liability claims may fail at the summary judgment stage, once the factual record has been developed. But these claims should never get that far. As a matter of long-established Pennsylvania law, the claims should not have survived a motion to dismiss. Cross is an early contender to follow its Western District cousin onto our Worst Cases list. We will keep you posted, both on similar dismal decisions and on decisions reaching the correct result that eluded the Cross court.