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We are delighted to report that we are in love.  The object of our affection, named Luca, is eight weeks old and weighs 9.6 pounds.  Yes, our new standard poodle puppy, trumpeted repeatedly to patient readers of these pages, is home. The couple-hundred-mile trip to pick him up was packed with excitement and anticipation but also with nostalgia.  On almost the same date, 24 years earlier, we and our then-three-year-old daughter (not yet a rock climber) drove away from the same breeder’s house with a similarly beautiful standard poodle puppy in our car.  He would grow up with our daughter and would take a huge piece of our soul with him when he left us.  He has been gone for more than 13 years, but his imprint was all over the crazy mixed-up emotions of this week’s trip. 

As for today’s case, it is also a jumble of all kinds of stuff, some of it good but the remainder very bad.   Cohen v. Johnson & Johnson, 2022 WL 5109167 (W.D. Pa. Oct. 15, 2022) is a pelvic mesh case, remanded to the Western District of Pennsylvania from the mesh MDL.  The decision addresses the defendant’s motion for summary judgment on the plaintiffs’ claims for strict liability – failure to warn, strict liability – design defect, and negligent failure to warn, along with several fraud-based claims (fraudulent concealment, constructive fraud, and negligent misrepresentation), negligent infliction of emotional distress, and violation of consumer protection laws. 

Negligent Failure to Warn

Starting with the good, Cohen includes a lovely warnings causation discussion in the context of the negligent failure-to-warn claim.  The court explained that, under Third Circuit law, “summary judgment is properly granted on a failure to warn claim where the record is devoid of evidence to support the argument that a different waning would have altered the physician’s prescribing methods.”  .”  Cohen, 2022 WL 5109167 at *15 (internal punctuation and citation omitted.)   In this case, the plaintiffs did not depose the surgeon who implanted the plaintiff’s mesh device.  As such, there was no genuine issue of material fact as to warnings causation, because” there was, and could be “no evidence in the record demonstrating that any different warning’s would have impacted [the implanter’s] decision to use” the defendant’s mesh product.  Id.  In other words, “no reasonable inference [could] be drawn from the record that an adequate warning . . . would have prevented the plaintiff’s injury.” Id.  The court held that “no trier of fact [could] properly find proximate causation . . . ,” and it granted summary judgment on the negligent failure-to-warn claim.

Strict Liability Claims

Here is where it all falls apart.  As regular readers know, Pennsylvania’s federal district courts have spent the past several years locked in a battle over the question of whether comment k to Section 402(A) of the Restatement (Second) of Torts bars strict liability claims against manufacturers of prescription medical devices.  It is undisputed that, under the Pennsylvania Supreme Court’s 1996 Hahn decision, prescription drugs are “unavoidably unsafe products,” exempt from strict liability claims under comment k.  And, as we have reported, the Pennsylvania Superior Court, along with approximately fifty Pennsylvania federal court decisions, have predicted that the Pennsylvania Supreme Court would hold that prescription medical devices are no different from prescription drugs for purposes of comment k’s protection.  (As well it should – there is no principled basis for any distinction between the two.)  But the Pennsylvania Supreme Court has not addressed this question.  It almost did, a year or so ago, when the Third Circuit certified the question to it.  But the case settled before the appeal was decided, allowing Cohen to add another stone to the counter-logical side of the scale.   

The defendant moved to dismiss both strict liability claims – design defect and failure to warn – as barred by comment k.  The court acknowledged the long line of decisions holding that Hahn would apply equally to medical devices.  But then it veered into a ditch, citing Lance and Tincher as “indications” that the Supreme Court would not extend comment k to medical devices.   All of the cases that have ruled that way (including Schrecengost v. Coloplast Corp., one of our worst cases of 2019) have relied on Lance and Tincher.  But here’s the problem:  neither case supports this [insupportable] proposition.  Lance held only that comment k did not “readily translate into the negligence arena,” (citation to Lance omitted), and Tincher dealt with steel tubing, not pharmaceutical products.   None of that troubled the Cohen court, which was “persuaded that comment k likely would not be applied by the Pennsylvania Supreme Court to categorically bar the applicability of strict liability principles as to all medical devices.”  Id., at *7.   Instead, according to the court, comment k would bar the strict liability claims only if the record established that the plaintiff’s pelvic mesh device was an “unavoidably unsafe product.” And the court held that it was not.  Why?  Because the product was not “implanted to prevent a life-threatening condition . . . .”  Id. at *8.  Never mind that comment k imposes no such requirement on prescription drugs.   Citing Schrecengost, the court also held that comment k would not bar the strict liability claims “simply because the medical device require[d] a prescription,” id., (even though this is all that is required for prescription drugs) unless the product carried an “unavoidable high degree of risk” but was “new or experimental” and “apparently useful and desirable.”  Id. (citation to Schrecengost omitted).  None of this language is rooted in comment k, or in Lance or Tincher or anything authoritative.  But it was enough for the court to hold that comment k did not bar the strict liability claims

So the court next undertook to consider the individual strict liability claims on their merits.  Holding that there were “genuine issues of material fact” as to whether defects in the design of the mesh device caused the plaintiff’s injuries, the court denied summary judgment on the strict liability – design defect claim. 

Which brings us to the strict liability – failure-to-warn claim.  Recall that the court granted summary judgment on the negligent failure-to-warn claim holding that the plaintiff could not prove proximate causation because there was no evidence that a different warning would have changed the implanter’s prescribing decision.  So the strict liability – failure-to-warn claim failed for the same reason, right?  Nope.  Again citing the execrable Schrecengost decision, the court held that the plaintiff met her burden to prove the causation element of this claim by proffering expert testimony to the effect that “the inadequate warnings were a substantial factor in causing her injuries.”  Id. at *10.  And so, having just held that the plaintiff could not prove her negligent failure-to-warn claim, the court denied summary judgment on the strict liability – failure-to-warn claim. 

This holding confounds us.  It flies in the face of decades of Pennsylvania “warnings causation” law, which Cohen was able to ignore because strict liability – failure to warn is a novel claim in the prescription medical device context.   But the distinction makes no sense.  If the plaintiff cannot prove that inadequate warnings caused her injuries, she can’t prove it, however she styles the claim.   (We note that, in seminal Pennsylvania strict liability cases, which obviously fall outside the medical device context, the causation burden is identical for strict liability and negligence.  See, e.g., Sherk v. Daisy-Heddon, 498 Pa. 594 (1982).)

Other Claims

The court held that Pennsylvania’s learned intermediary rule barred the plaintiff’s consumer protection act claim, since a prescription medical device manufacturer has a duty to warn only the prescribing physician, not the patient/consumer. 

In contrast, according to the court, the learned intermediary rule did not bar the plaintiff’s fraud and misrepresentation claims, because she could prevail if she proved that her physician reasonably relied on the defendant’s misrepresentations.  Because the implanter was not deposed, the record was devoid of evidence that she relied on – or even read – the defendant’s warnings.  So the plaintiff could not meet her burden of proving reliance, and the court granted summary judgment on the fraud and misrepresentation claims. 

Finally, the court denied the motion as to the negligent infliction of emotional distress claims, holding that there were fact issues as to the infliction of emotional distress and rejecting the defendant’s argument that the claim was “duplicative of or subsumed by” the plaintiff’s other negligence claims, including those on which the defendant did not move for summary judgment.

On balance, we do not like Cohen.  The correct holdings, even the warnings causation holding on the negligent failure-to-warn claim, do not outweigh the destructive and unsupported holdings on comment k and on the strict liability – failure to warn causation burden.  We fear the Pandora’s Box opened (or widened) by these holdings, and we’ll keep you posted on what comes next.  In the meantime, stay safe out there.