We report, with excitement and apprehension, that we have tickets to see Hugh Jackman as Harold Hill in The Music Man next month on Broadway.  The Drug and Device Law Dowager Countess blushes and giggles at the mention of Jackman, and the outing seemed a worthy one, not without apparent urgency given time’s ravages (the Countess is well into her 88th year).  But here’s the problem:  opening night has been postponed three times for COVID, and previews recently paused to allow both leads (Marian the Librarian is played by the exquisite Sutton Foster) to recover from bouts of the omicron variant.   By all appearances, the train is back on the rails.  Previews are proceeding apace.   Opening night is a week away.  Just before setting fingers to keyboard for this post, we made pre-show dinner reservations at a lovely Italian restaurant on the same block as the theatre.  And now we wait, with bated breath, to see which way the pendulum swings.  Think good thoughts for us.

We like the way the pendulum swung in today’s case, the latest in a recent series of  “which side are you on” decisions out of Pennsylvania’s federal district courts, predicting whether the Pennsylvania Supreme Court will hold that comment k to Section 402A of the Restatement (Second) of Torts bars strict liability claims against manufacturers of prescription medical devices.   We have followed these cases with great interest (you can see some of our previous posts here and here and here and here and here and here) and with a healthy dose of eye-rolling incredulity.  As we have emphasized, there is only one correct answer, as there is no colorable basis for a straight-faced distinction between prescription drugs and prescription medical devices.

We step back, briefly, for those not similarly obsessed with this jurisprudential seesaw.  By its terms, comment k bars strict liability claims against manufacturers of “unavoidably unsafe products,” explicitly including prescription drugs.  The comment does not address prescription medical devices, and the Pennsylvania Supreme Court has not yet decided this issue.  Nor, we emphasize again, should it have to.  As decades of federal and state court decisions held before the current wobble, the Pennsylvania Superior Court’s Creazzo decision was correct in predicting that the Supreme Court would reach the only logical result. (Regular readers may recall that the Third Circuit certified this question to the Pennsylvania Supreme Court, but the case was settled before the Court had a chance to rule.)

Today’s case, McDonnell v. Flowonix Med., 2022 U.S. Dist. LEXIS 12916 (E.D. Pa. Jan 25, 2022) represents another egg in the basket of all that is sensible.  (Well, almost all – the decision includes a couple of stumbles not related to the comment k issue.  Stay tuned.)  In McDonnell, the plaintiff’s serious spinal disease caused her to suffer “chronic and intractable back pain.”  McDonnell, 2022 U.S. Dist. LEXIS 12916 at *2.  She was implanted with the defendant’s infusion pump, which was supposed to “release pain medication in a semi-autonomous way through software programs.” Id. at *1.  The plaintiff alleged that the pump malfunctioned, causing her to suffer severe injuries that included physical pain, mental pain, and morphine withdrawal.   (She was comatose and ventilator-dependent for several days, according to the complaint.)  She asserted claims for negligence, strict liability, breaches of express and implied warranties, and fraudulent and negligent misrepresentation.   In addition, although the complaint did not include a separate claim for loss of consortium, it alleged facts about injuries the plaintiff’s husband allegedly suffered.  The defendant moved to dismiss all claims except negligence.

Strict Liability and Breach of Warranty

The court wasted little time in reaching the correct holding on this claim.  As the court explained, the Pennsylvania Supreme Court adopted comment k in 1996 in Hahn v. Richter, holding that comment k “denies the application of strict liability on products such as prescription drugs, which, although dangerous in that they are not without medical risks, are not deemed defective and unreasonably dangerous when marketed with proper warnings.”  Id., at *13 (internal punctuation and citation to Hahn omitted).  Ten years later, in Creazzo, the Superior Court “found no reason why the same rational[e] applicable to prescription drugs may not be applied to medical devices.” Id. (internal punctuation and citation omitted).  The court then cited all of the recent district court decisions going the right way and ignored all of the decisions inexplicably reaching opposite conclusion.  The court concluded, “Considering the decisions of courts in this Circuit and of the lower courts of Pennsylvania, this Court predicts the Pennsylvania Supreme Court will extend comment k to prescription medical devices.  Thus, Plaintiffs’ strict liability claim must be dismissed.”  Id.  (Duh.)  The court also dismissed the breach of express warranty claim because the plaintiff failed “to plead any express language used to create an express warranty at all,” and it dismissed the implied warranty claim because, under the Superior Court’s 1987 Makripodis decision, comment k also bars implied warranty claims because “the very nature of prescription drugs themselves precludes the imposition” of an implied warranty of fitness for ordinary purposes.  Id. at *18 (citation omitted).

“Doug” and Loss of Consortium

As we mentioned, it’s not all good.  The plaintiff alleged that an agent of the defendant, identified only as “Doug” stated that the plaintiff’s pump was filled with medication and was releasing medication, when, according to the plaintiff, the pump was not functioning.  The defendant argued that these allegations were not adequate to plead fraudulent misrepresentation under Pennsylvania law.  The court explained that, to establish an agency relationship, the plaintiff was required to “identify the agent by name or appropriate description.”  Id.  at *10 (citation omitted).  The court held, “Although the Amended Complaint does not give more details as to “Doug’s” last name or title, this Court finds that it sufficiently pled enough facts to survive a Motion to Dismiss. . . . Plaintiff’s ability to provide a name for the agent and the . . . examination date of the Pump satisfies [Twiqbal’s] pleading requirements.”  Id. at *10-11.   The same reasoning saved the negligent misrepresentation claim.   We question both holdings, along with the court’s holding that the plaintiff had adequately pled a loss of consortium claim even though she didn’t plead a loss of consortium claim.

But we quibble.  At some point, presumably, the Pennsylvania Supreme Court will address the comment k issue.  We are grateful for McDonnell’s weight on the correct side of that scale.  We will continue to keep you posted.  In the meantime, stay safe out there, especially as more nasty weather threatens the eastern U.S.