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We begin with an update on the “visiting dogs’ health crisis.”  All medications are finished, special diets are a thing of the past, and (dare we say it out loud) all canine digestive tracts seem peaceful.   The chubby Pomeranian was relieved of about four inches of hair today at the hands of a saintly groomer who is undeterred by the teeth of irascible little dogs. We report, with great hope, that the Drug and Device Law Rock Climber plans to retrieve her dogs this weekend if she is COVID-negative after her plane trip to Wyoming.  (Cue “What I Did for Love,” the all-purpose anthem from “A Chorus Line.”)

Speaking of things we love, we report today on a wonderful addition to our “comment k” series.  In Keen v. C.R. Bard, Inc., ___ F. Supp. ___, 2020 WL 4873634 (E.D. Pa. Aug. 19, 2020), the plaintiff was implanted with the defendant’s inferior vena cava (“IVC”) filter.  The filter fractured, and the plaintiff underwent revision surgeries to remove fractured portions of the filter.  He asserted the usual product liability claims, including negligence, negligent misrepresentation, implied warranty, and two strict liability claims (design defect and manufacturing defect).  And it is the strict liability claims on which we focus today.

Regular blog readers (and those of you who aren’t will have no idea from whence came the dog update) are aware that we have been following, with great interest, a chess match in Pennsylvania’s federal district courts.  Over the past year or so, as we reported here and here and here and here, decisions have proliferated on both sides of the “issue” of whether comment k to Section 402(A)  of the Restatement (Second) of Torts bars strict liability claims against manufacturers of prescription medical devices.

As we have made clear, we believe this is not an “issue” at all.  It is undisputed, under Pennsylvania law, that comment k’s “unavoidably unsafe products” exception bars strict liability claims against manufacturers of prescription drugs.  And while the Pennsylvania Supreme Court has never explicitly held that the bar also protects manufacturers of prescription medical devices, the Superior Court did (in Creazzo), dozens of federal decisions followed suit, and everyone with common sense understood that there was no principled distinction to be made.

But this didn’t stop the plaintiff bar from mis-citing new decisions – Lance and Tincher – to pique the interest of federal judges entertaining strict liability claims.  The result was a handful of good, sensible decisions and at least an equal number of very bad holdings disregarding decades of federal and state jurisprudence and overstepping anything Erie ever contemplated.

Against that backdrop, the defendant in Keen moved to dismiss the plaintiff’s strict liability claims, arguing that comment k barred the claims.  The plaintiff countered with the now-familiar argument that comment k does not apply across the board in medical device cases – that it applies only on a case-by-case basis after a determination that the device is “unavoidably unsafe.”  In a decision resoundingly in the “good and sensible” camp, Judge Gene Pratter of the Eastern District of Pennsylvania rejected the plaintiff’s argument.

Judge Pratter began with the usual retrospective – Hahn, Incollingo, Creazzo.   She moved on to cite the decision of another Eastern District judge in Rosenberg v. C.R. Bard, Inc., 387 F. Supp. 3d 572 (E.D. Pa. 2019), for the proposition that comment k “focuses on products [that] cannot be legally sold except to physicians or with a physician’s prescription” and that there is “no meaningful distinction” that can be “drawn between prescription drugs and medical devices.”  Keen, 2020 WL 4873634 at *6 (citation omitted).   She continued,

Therefore, is not surprising that a subcommittee note to the Pennsylvania Bar Institute’s Suggested Standard Civil Jury Instructions notes in regard to the duty to warn in the prescription drug and medical device context that ‘Pennsylvania courts have declined to apply strict liability in cases involving prescription drugs and medical devices.’  It is not surprising that many district courts applying Pennsylvania law have similarly predicted that the Pennsylvania Supreme Court would likely extend its bar of strict liability of prescription drug claims to prescription medical device claims.

Id. (emphasis in original, citation omitted).  For more on those suggested jury instructions, see here.  Judge Pratter went on to reject the plaintiff’s reliance on Beard v. Johnson & Johnson, Inc. 41 A.3d 823 (Pa. 2012), acknowledging that Beard permitted strict liability claims against the manufacturer of a surgical stapling tool but emphasizing that “a surgeon’s tool is distinguishable from a medical device implanted in the body only upon obtaining a physician’s prescription.”  Id. at *7 (citation omitted).   Finally, she rejected the plaintiff’s argument that, even if comment k barred the design defect claim, it did not bar the manufacturing defect claim, holding, “[T]he Court disagrees with Mr. Keen that the Pennsylvania Supreme Court would deviate from its otherwise uniform application of comment k in order to permit strict liability claims based on manufacturing defect theory.”  Id.   Judge Pratter concluded:

In sum the Court predicts that the Pennsylvania Supreme Court would apply comment k to all of Mr. Keen’s strict liability claims.  Therefore, the Court grants [the defendant] summary judgment in its favor regarding Mr. Keen’s strict liability claims alleging defects in design, manufacturing, and failure-to-warn.

Id. at *8.

This is textbook stuff, a primer on the proper “predictive” role of a federal district court sitting in diversity and on the use of case precedent and authoritative commentary in making the required prediction.  We love this part of the decision.  And we think you get the idea by now, so we likely will not report on every similar decision, though we will keep you apprised of anything noteworthy and will check in occasionally with a report on the “state of the split.”  This is a very big deal for our medical device clients, and we wish for judges who follow Judge Pratter’s template and arrive at equally correct decisions.

We are heading out for a twilight walk with too many dogs.  Our neighbors are sure that we’ve lost our mind (assuming they needed convincing), but we appreciate the distraction in these still-crazy times.  Stay safe out there.