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Last weekend, the Drug and Device Law Rock Climber passed through to drop off her two dogs – a four-pound Chihuahua and a chubby Pomeranian, now hirsute, who was nearly bald from a skin infection when he was rescued a year ago.  These are very cute dogs who mostly get along with the Drug and Device Law Little Rescue Dogs, and they are frequent houseguests.  This visit will span three weeks, and it did not begin well.  Essentially the moment that the beeps and waves were complete, the Pomeranian made it very clear that he was not feeling well.  One vet visit, one special diet, and one prescription later, we were back home.  Then the Chihuahua got sick.  Same drill, except that tiny dogs are prone to quick and deadly bouts of dehydration, so she also got subcutaneous fluids.  We should mention that the special diet is boiled chicken breast and boiled white rice.  All of the dogs eat together, so we are going on a week of cooking chicken and rice for four, twice each day.  Given the trend, we are waiting for the next shoe to drop.

In that vein, we report today on another shoe dropping on the wrong side of the comment k scale.  In recent months — here and here and here — we have kept you posted as Pennsylvania’s federal courts have wrestled with whether comment k bars strict liability claims against manufacturers of prescription medical devices.  Most of these decisions, including today’s, manage to reach the wrong conclusion, upsetting decades of jurisprudence on what should be a non-issue, (The current flurry started back in December with  Schrecengost v. Coloplast Corp., our eighth –worst case of 2019.  Bexis bemoaned that decision here.)

In today’s case, Patchcoski v W.L. Gore and Assoc., Inc., 2020 WL 4335016 (M.D. Pa. July 28, 2020), the plaintiff underwent hernia repair with the defendant’s mesh in 1999.  He filed suit twenty years later, asserting the usual product liability claims sounding in negligence and strict liability, alleging that he had learned only months before that infected mesh remained in his body after 2001 explant surgery.  Obviously, the defendant moved to dismiss on the ground that the suit was barred by Pennsylvania’s two-year statute of limitations.  That motion was denied and is not the subject of today’s post.

The defendant also moved to dismiss the strict liability claims on the ground that comment k barred them.   As most of you know, comment k to section 402(A) of the Restatement (Second) of Torts exempts manufacturers of “unavoidably unsafe products,” explicitly including prescription drugs, from strict liability for allegedly defective design.  Like similar misguided decisions, the court began by explaining that the Pennsylvania Supreme Court’s 1996 Hahn decision adopted comment k, precluding strict liability across the board in prescription drug cases.  In 2006, in Creazzo v. Medtronic, 903 A.2d 24 (Pa. Super 2006), the Pennsylvania Superior Court held that there was “no reason why the same rationale applicable to prescription drugs” did not apply to prescription medical devices.

In our view, the Creazzo court’s statement is unassailable, for there is no principled (or other) basis on which to distinguish prescription medical devices from prescription drugs or to hold that the latter are “unavoidably unsafe” while the former are not.  For decades, dozens of Pennsylvania federal court decisions acknowledged this reality.  But the Pennsylvania Supreme Court has never addressed this question.

Back to Patchcoski.  The court commented that Hahn was “limited to its facts” and did not “expand comment k to products beyond prescription drugs.”  2020 WL 4335016 at *8.  As we have explained, this is a fallacy.  No “expansion” is necessary to conclude that comment k applies equally to prescription medical devices.  But it provided a “hook” for the court to misconstrue Lance and Tincher to suggest that Pennsylvania would not favor such an “expansion.” The court stated that “Tincher cautions courts against creating such categorical exemptions,” id. at *9-10, but Tincher dealt with steel tubing, not pharmaceutical products   And while the court stated that Lance “more specifically cautions courts against expanding the reach of Hahn and comment k,” id. at *10, Lance held only that comment k did not readily translate into the negligence arena.

But why allow the law to get in the way of a good story.  The court “predicted” that “the Pennsylvania Supreme Court would not categorically extend Hahn and comment k to all prescription medical device manufacturers,” but would “analyze comment k’s applicability on a case-by-case basis determined largely by each case’s developed factual record and the individual characteristics of the medical device at issue.  Id. at *12 (citations omitted).  Motion denied.

We hate this case and the growing body of federal cases reaching the same repugnant holding, and we fear the illusion of authority they create.  We will keep you posted on any new decisions.  In the meantime, it’s time to cook the chicken and rice.  Stay safe out there.