There was a time when we posted frequently about attempts to impose liability for injuries allegedly caused by the use of a generic prescription drug. Much of the attention has been directed to trying to pin liability on the company that developed the drug originally, even when the plaintiff took another company’s generic version. When it comes to the liability of the manufacturer of the generic drug that the plaintiff actually took, it seemed like things were pretty settled. The Hatch-Waxman Act requires generics to have labels matching the label of the NDA holder’s drug and does not allow the use of the CBE to go beyond it—cutting off the Levine rationale for limited preemption on warnings claims. Add these to the inability of a generic manufacturer to change the design of its drug, generic manufacturers have generally not been liable absent a failure to timely update its label to match the NDA holder’s label—and even that situation can be preempted in some courts. This combination of dead ends and hard roads has been a main driver for the push against NDA holders and innovators in the dozen years since the Conte abomination. Similarly, although there are still occasional decisions where states’ high courts officially join the ranks of the super-majority, the learned intermediary doctrine has been so widely accepted now that it seems like a long time since this was a hot topic.

Pennsylvania has been one of the strongest states on learned intermediary, so it is bit surprising to see the issue of whether there is an exception to the learned intermediary doctrine under Pennsylvania law as dispositive in a case. This is doubly so when the case involves claims against a generic drug manufacturer. That is what we have in Polt v. Sandoz, Inc., ___ F. Supp. 3d ___, No. CV 16-2362, 2020 WL 2730931 (E.D. Pa. May 26, 2020), where an earlier ruling on a motion to dismiss for preemption left plaintiff with enough of an opening to pursue “extensive discovery” and make the court decide the remaining issues on summary judgment three years later. (Thanks to our friends at Greenberg for passing on the decision.) The basic facts are as follows. The plaintiffs’ mother took defendant’s generic cardiac drug off-label for years and ultimately died from a pulmonary event that was disclosed as a risk in the label. The drug’s label matched the label of the NDA holder’s drug and there was no allegation that it was manufactured incorrectly. The drug, however, had a federal regulatory requirement for a medication guide, which the manufacturer is supposed to provide to pharmacies to be provided, in turn, to patients when they fill a prescription. One of the prescribers, although aware of the relevant pulmonary risk like the other two prescribers, claimed not to know the drug was being prescribed off-label or that it had a medication guide. Plaintiffs’ remaining claims thus turned on whether Pennsylvania law—not federal law—imposed a duty on the generic manufacturer to provide a warning to patients through a medication guide, even though Pennsylvania law otherwise focused the duty to warn inquiry for prescription drugs solely on the learned intermediaries. This ends up being a preemption issue, at least as the court framed it.

We can largely skip over the remaining warnings claims focused on the prescribers—the package insert matched the branded one and the prescribers knew the risk—to get to the purported claim based on warning the patient. If Pennsylvania did not recognize such a claim this circumstance—which would require creating a new exception to the learned intermediary doctrine—then a claim based on failing to comply with a duty would be preempted. (Frankly, the court’s lead-in on the preemption playing field was a bit off, missing the import of Mensing and injecting inapplicable law on parallel claims, but it got there.) Citing the McDaniel case out of the Sixth Circuit (discussed here and lauded as a 2018 honorable mention winner here), the court noted that most decisions on this issue had found preemption under Buckman because the applicable state law usually does not recognize “an underlying state tort law duty” to provide a medication guide for the benefit of patients.

As alluded to above, Pennsylvania’s history of recognizing the learned intermediary doctrine went back a long time—at least to the 1971 decision of the Pennsylvania Supreme Court in the Incollingo case. The court recapped some of that history—but not the more recent decisions—before acknowledging that Pennsylvania had only ever recognized one exception to the learned intermediary doctrine even though other states (or federal courts predicting state law) had made up others. Because plaintiff did not claim any recognized exception applied, we do not have to get into whether the court was right about there being any Pennsylvania exception. Instead, plaintiff urged the creating of a new court-created exception based on certain FDA regulations.

The Court will reject this suggestion for three reasons: (1) it would break new ground and significantly expand liability under Pennsylvania law; (2) even if adopted, it would be inapplicable in this case; and (3) it would be a misuse of negligence per se, which does not operate to create a new duty.

The first reason drew on a combination of the Erie restraint doctrine we tout from time to time—particularly when courts ignore it in creating new state court duties—and Pennsylvania courts’ own “reluctance” to expand tort liability without legislative action. Thus, “the Court will decline the invitation to alter Pennsylvania’s social policy calculus as it relates to the liability of manufacturers engaged in the sale of prescription drugs.”

For the second reason, the court acknowledged that the FDA regulations would need to essentially remove the prescriber from her typical role as learned intermediary. With this drug—unlike certain cases with contraceptives—there was no evidence to suggest the patient could receive it “without a learned intermediary weighing the risks and benefits.” For plaintiffs’ mother, three different physicians had done that in deciding to prescribe her the drug. Thus, without deciding that Pennsylvania would adopt any exception, the urged exception would not apply.

The last reason took the court some time to explain, but is actually fairly straightforward. Calling a claim negligence per se and claiming that a federal duty has been violated does not change what state duties do or not exist. Pennsylvania does not impose a duty to provide medication guides. Rather, it requires warnings for prescription drugs go to the learned intermediaries. Nothing about negligence per se—again, we will refrain from commenting on the larger issue of whether negligence per se based on FDA regulations can impose liability for claims like this—changes what duties exist under state law.

So, it looks like the scattered but continuing attempts to impose liability with this generic versions of this drug have failed again. Along the way, the strict application of the learned intermediary doctrine in Pennsylvania has been re-endorsed and preemption shows its strength. It would be nice if it had not taken an extra three years to get there. It seems to us that the court might have determined the non-existence of the purported claim under Pennsylvania law that plaintiffs needed to avoid preemption without three years of extensive, and presumably costly, discovery. Perhaps future courts facing similar issues will be emboldened to take, well, bold action at the 12(b)(6) stage.