This Wednesday evening marks the beginning of the Jewish holiday of Passover. In every other year, our large extended family has gathered for Seder, a ritual dinner that commemorates, with traditional foods, songs, and prayers, the exodus of the Israelites from slavery in ancient Egypt. In our family, Seder is a beloved (and occasionally raucous) affair. Obviously, no one will "gather" this year. All are disappointed, but the Drug and Device Law Dowager Countess, well into her ninth decade, is crestfallen. And so the weekend included endless text chains and too many conference calls, the result of which was a decision to conduct a "virtual" seder using "meeting" technology. It is not a perfect solution. But it recognizes that we can adapt to the moment without scuttling decades of family tradition.
If only Pennsylvania's federal courts could strike a similar balance in cases involving comment k to Section 402A of the Restatement (Second) of Torts. Comment k exempts the manufacturers of "unavoidably unsafe products," including prescription drugs, from strict liability for allegedly defective designs. Pennsylvania jurisprudence has long recognized that there is no principled basis for a distinction between drugs and medical devices and has extended the comment k exemption to manufacturers of all prescription medical products, including drugs, devices, and vaccines.
Recently, as we told you here and here, both the Eastern and Western Districts of Pennsylvania have issued abominable opinions holding that comment k does not apply to medical devices. Today's case, James v. Siemens Medical Solutions USA, Inc., 2020 U.S. Dist. LEXIS 57847 (E.D. Pa. Apr. 2, 2020), is the latest decision in this lamentable trend.
James is an unusual case. The medical device in question was not implanted in the body; rather, it was an imaging scanner. And the plaintiff's injuries were not related to the device's medical function. The plaintiff was placed in the device for an imaging study, but he was so tall that his feet hung over the edge of the machine. When the machine started to move, it crushed the plaintiff's feet. The plaintiff asserted strict liability claims against the machine's manufacturer. The defendant filed a 12(b)(6) motion arguing that comment k immunized it, as a manufacturer of medical devices, against the plaintiff's strict liability claims. In denying the motion, the court made at least two critical mistakes.
The court explained that Pennsylvania had adopted comment k in Hahn v. Richter, 673 A.2d 888 (Pa. 1986), "preclud[ing] all strict-liability claims against prescription drug manufacturers." James, 2020 U.S. Dist. LEXIS 57847 at *6. But then the court stated that the defendant was asking it "to extend Hahn [to] immunize medical device manufacturers" from strict liability claims. Id. This is the first place where the court got it very wrong. To hold that comment k bars strict liability claims against medical device manufacturers, the court didn't have to "extend" anything – it simply had to follow decades of Pennsylvania appellate precedent as well as more than forty Pennsylvania federal decisions. But the court bought into the plaintiff's argument that "recent guidance" from Lance and Tincher was fatal to the defendant's argument. As we have explained in these pages, neither Lance nor Tincher limited the application of comment k. Lance held only that comment k did not apply to negligence actions, and Tincher did not deal with pharmaceutical products at all.
The court also suggested that the defendant's product was not a "medical device" at all. We think this is wrong, too. As technology advances, jurisprudence must keep pace, and medical innovations far beyond traditional implanted devices deserve the protection afforded to "unavoidably unsafe products."
In any event, this is another in a series of bad comment k decisions. Much of our professional life is devoted to the defense of medical device manufacturers, and we fear this trend. We will keep you posted as decisions fall on both sides of the comment k scale. In the meantime, stay safe in this unprecedented moment in which we all find ourselves.
This article is presented for informational purposes only and is not intended to constitute legal advice.