Way back in September 2012, we—in its Blog-specific veiled singular usage—did our first post. We introduced ourselves with some rare first personal singular statements before proceeding to trash a Louisiana intermediate appellate court’s affirmance of a large verdict under Louisiana’s Medical Assistance Programs Integrity Law. Among our criticisms was the lack of detail on the alleged misrepresentation of the manufacturer:
What was the safety issue? The opinion never says. What did the defendant actually say about that unknown issue and why was that representation misleading in light of the information known at the time about the issue? The opinion never says.
It turns out that our first post ended up describing the second worst case of the year. It also turns out the we were prescient, because the Louisiana Supreme Court ended up reversing the trial verdict for a number of the reasons we flagged. That included that specifying the drug’s risk and the language the manufacturer used to describe it fit in with the requirement that there be some misrepresentation that caused loss.
We harken back to our first post not just to risk straining ourselves while patting ourselves on our figurative back, but because this will be the last post we wrote at Reed Smith. By the time it goes up on the Blog’s website and gets emailed around, I—truly in the singular—will be at my new firm. We—truly in the plural sense—will continue to trash bad decisions and amplify good decisions in our little niche of the legal world.
Eleven years has also seen quite a bit of change in our space. For instance, in 2012, the impacts of the decision in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), were still playing out. Its companion decision in Mutual Pharm. Co. v. Bartlett, 570 U.S. 472 (2013), had not arrived and plaintiffs had not stopped suing over alleged injuries from generic drugs. Well, they still have not. In Jankowski v. Zydus Pharms USA, Inc., No. 22-2212, 2023 U.S. App. LEXIS 18721 (3d Cir. July 24, 2023), we see the appeal of the dismissal of dozens of plaintiff’s claims against a generic manufacturer of amiodarone, which has featured in a number of generic drug preemption decisions over the years.
In Jankowski, it is hard to imagine what all these plaintiffs thought made their claims different than all of those found to be preempted by what is now a veritable chorus of courts. The allegations that the NDA holder had marketed the drug off-label were not new and it did not appear that they claimed some new injury or risk compared to past plaintiffs were preempted claims. They brought claims under the New Jersey Product Liability Act, which did not have any quirks to help them. To the contrary, as one of the panel noted in a concurrence, FDA approval of a drug’s labeling creates a presumption of adequacy. 2023 U.S. App. LEXIS 18721, *8 n.10. The warning obliquely challenged in Jankowski had been approved, both in the context of the NDA drug and the defendant’s ANDA, and plaintiffs did not plead anything to rebut the presumption. So, that judge was correct that preemption did not even need to be addressed to affirm. (We have oft complained about judges addressing preemption without first ascertaining if there was a cognizable state claim to preempt.) Plaintiffs did not even complain about the content of the package insert. Instead, they argued below that the generic manufacturer should have sent out Dear Doctor letters to emphasize some aspect of the package insert and should have somehow corrected something about “third-party physician sources” on the drug. Only the first of these was pursued on appeal. Id. at *2 n.4.
It was clear that this claim, even if viable under the NJPLA, would be preempted based on the meaning of the term “labeling.” The package insert is what most people think of as a prescription drug’s “label,” with its familiar format. Generic drugs, however, have to have meet “labeling” requirements that derive from the NDA drug. Dear Doctor letters are labeling, according to post-Mensing cases and the regulation defining what written communications can create liability for “mislabeling.” Id. at *6-7. FDA also says so, which the Supreme Court noted in Mensing. Unlike in our first post, where not mentioning what the defendant said and allegedly should have said helped the plaintiff (for a while), the Jankowski plaintiffs’ vagueness on what was supposed to have been in Dear Doctor letters did not help them. Because the NDA holder had not sent any Dear Doctor letters, whatever plaintiffs claimed New Jersey law required the generic manufacturer to send would have “violated the duty of sameness.” Id. at *7. Allowing otherwise would create a risk of “inaccurately implying a therapeutic difference between the brand and generic drug.” Id. (quoting Mensing). Indeed, where the NDA holder had not changed the label and had not sent out its own Dear Doctor letters, FDA “regulation would not allow a generic manufacturer to take such action in these circumstances.” Id. at *8-9. That makes the plaintiff’s labeling claims about as preempted as implied preemption can.