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Last week with dismay, we described the Eastern District of Pennsylvania’s decision in Gross v. Coloplast Corp., et al., 2020 WL 264691 (E.D. Pa. Jan. 17, 2020).   The Gross court (we are resisting the immature cheap shot) “predicted,” in the face of decades of contrary evidence, that the Pennsylvania Supreme Court would not extend the “unavoidably unsafe product” exemption of comment k to Section 402A to the Restatement (Second) of Torts to prescription medical devices. The court acknowledged that, under long-settled Pennsylvania law, comment k exempts manufacturers of prescription drugs from strict liability claims, and it identified neither law nor logic supporting a distinction between prescription drugs and prescription medical devices. Nevertheless, it denied the device manufacturer’s motion for summary judgment on the plaintiff’s strict liability claims.

We promised to keep you apprised of better-reasoned decisions that reach the (obviously) correct result, and today we deliver. In Kohn v. Ethicon, Inc., 2012 U.S. Dist. LEXIS 24996 (E.D. Pa. Feb. 12, 2020) – another pelvic mesh case – a different judge in the Eastern District of Pennsylvania considered the same question: does comment k bar strict liability claims against manufacturers of prescription medical devices. And this judge issued a decision that makes sense (at least on this issue, but stay tuned).

The plaintiff alleged strict liability design defect and failure-to-warn claims, and the defendants moved for summary judgment. This court, like the Gross court, reviewed comment k’s history under Pennsylvania law, dating back to the Pennsylvania Supreme Court’s 1996 Hahn decision holding that prescription drugs were “unavoidably unsafe products,” exempt from strict liability claims, under comment k and including appellate decisions extending the exemption to prescription medical devices. But this court rejected the plaintiff’s tortured constructions of decisions that, read properly, stand for nothing more than the proposition that the Supreme Court has not yet squarely addressed the medical device question.   The court held that it “[could] not adopt [the plaintiff’s] position” considering that Hahn had never been overruled.  Kohn, 2012 U.S. Dist. LEXIS 24996 at *10.   Nor did the court accept the plaintiff’s argument that either Lance or Tincher limited the application of comment k, holding (correctly) that Lance held only that comment k did not “readily translate into the negligence arena,” id. at *10-11 (internal punctuation and citation to Lance omitted) and that Tincher “dealt with steel tubing, not pharmaceutical products.” Id. at * 11.   The court acknowledged contrary Eastern District decisions, including Schrecengost v. Coloplast Corp., our eighth worst case of 2019, and Gross. But it also acknowledged Pennsylvania federal decisions (we count over forty) reaching the opposite result. The court concluded, “As a result of the current state of Pennsylvania law, the court finds that strict liability claims cannot proceed against medical device manufacturers.” Id. at *12.

We are sure that our grandmother must have had a saying to the effect that nothing is “all good.”  And, sure enough, just as we were about to raise a glass (a lovely Cabernet we found at a bargain price on a closeout site) to the Kohn court, we read the rest of the decision. The defendants also moved for summary judgment on the plaintiff’s negligent failure-to-warn claims, arguing that the device’s warnings were adequate as a matter of law, and that, in any event, the plaintiff could not prove the proximate causation element of her failure-to-warn claim. The court found that there were fact issues defeating summary judgment on the adequacy of the warnings. We won’t spend any time on that.  But this court, like so many, started down the correct path on the proximate causation question then contradicted itself to reach the wrong result.

A bit of background for those (unlike us) who do not spend huge portions of their professional lives litigating this question.   In a case alleging that a drug or device manufacturer failed to supply adequate warnings, a plaintiff must prove two things. First, she must prove that the warnings were inadequate – that the manufacturer did not adequately warn of the adverse events she claims she suffered. But that is only half of the equation. Even if the plaintiff can prove that the warnings were not adequate, she still must prove so-called “warnings causation;” in other words, she must prove that the inadequacy of the manufacturer’s warnings proximately caused her alleged injuries.   To prove this, the plaintiff has the burden of proving that a different or stronger warning would have changed the treating doctor’s decision to prescribe the drug or device, thereby proving that it was the inadequate warning that caused the prescribing decision and, in turn, the plaintiff’s injury.

Read that again: “the plaintiff has the burden of proving” this element of her warnings claim, just as she has the burden of proving the elements of all of her claims. There is no heeding presumption applicable to prescription medical products in Pennsylvania. It is not the defendant’s burden to prove the negative; in other words, the defendant need not prove that nothing would have changed in the face of a different warning.  Federal summary judgment procedure allows motions that point out the non-moving party’s lack of evidence on essential elements on which that party bears the burden of proof.  So, to win summary judgment on a failure-to-warn claim, a defendant need only demonstrate that the plaintiff has adduced no evidence tending to prove that the doctor would have changed his prescribing decision if the warnings were different, right?

Of course it’s right, as a matter of law. And the Kohn court got it right at first, stating, “Plaintiffs must also prove proximate causation by showing that the learned intermediary would have altered his behavior had the defendant issued a proper warning.” Id. at *14-15. That’s the last thing the court got right. The decision goes on to confirm that the plaintiff had adduced no evidence to support warnings causation (and, in fact, that there was evidence to the contrary). But the court managed to conclude that there was “a question of fact as to whether [the doctor] would have gained a different understanding of the risks associated with the devices” if a “proper” warning had been included. Id. at *17.

Not only was this the wrong answer, it was the wrong question. We learned about burden of proof in our first year of law school, all those decades ago, and the decision in Kohn turned on misapplication of this simplest of hornbook principles. We are fighting an identical battle in dozens of pending summary judgment motions. While we are grateful for Kohn’s thumb on the correct side of the comment k scale, the “warnings causation” decision is cause for despair. As always, we will keep you posted on similar decisions, and, hopefully, on dissimilar ones.