We’ve come to expect top-flight work product from the Product Liability Advisory Council (PLAC), even when it isn’t Bexis pushing the pen or pecking at the keyboard (as he has done so many times on so many important issues). PLAC’s amicus brief in support of the petition for certiorari regarding the Third Circuit Fosamax case is no exception. See Merck Sharp & Dohme Corp. v. Albrecht, et al., 2017 WL 4310719 (Appellate Petition, Motion and Filing) (Supreme Court of the United States Sept. 25, 2017). Three weeks ago, in our post entitled The Third Circuit Fosamax Preemption Error Has Got To Go, we discussed the defendant’s excellent petition for certiorari. The petition articulated the pain we felt from the Third Circuit’s misinterpretation of the “clear evidence” preemption test. That misinterpretation is clearly wrong and clearly pernicious. The Third Circuit took the already tough “clear evidence” language from the SCOTUS Wyeth v. Levine test, tweaked and twisted it, added a few words, and transformed it to make impossibility preemption virtually impossible. The Third Circuit held that a defendant could not invoke preemption without clear and convincing evidence to prove to a jury that the FDA would have rejected the plaintiff’s proposed warning. Because the clear and convincing evidence standard is so demanding, and because the court threw a quintessentially legal question to the jury, the Third Circuit made summary judgment on preemption a vanishingly slender hope. Perhaps that was the idea.

Well, it’s a bad idea. It’s bad law and bad policy. The certiorari petition made a strong case for SCOTUS to take the Fosamax case and clean up the mess made by the Third Circuit. Now the PLAC brief makes a strong case for reversal even stronger. The PLAC brief truly is brief. We recently praised brevity, and the PLAC brief shows the power of concise clarity. PLAC begins by reminding SCOTUS that conflict preemption is grounded in the Supremacy Clause of the Constitution. PLAC also reminds SCOTUS that the Third Circuit’s erasure of conflict preemption took place in the context of an MDL involving more than a thousand cases. That means that, even aside from precedential toxicity, the Third Circuit’s decision had a huge effect on the federal docket. A key plaintiff claim in those 1000+ cases is that the manufacturer should have provided a stronger warning regarding the risk of bone fractures. After a bellwether trial, with full development of a complete regulatory record, the Fosamax district court concluded that preemption was warranted because the record was clear that the FDA would have rejected the suggested label change. How clear? The FDA did, in fact, reject a label change. That apparently was not clear enough for the Third Circuit. The Third Circuit vacated and remanded the district court’s carefully considered ruling, discounting undisputed evidence. It got to that result by changing “clear evidence” to “clear and convincing evidence” and changing a legal question into a factual question.

PLAC argues that it is important for SCOTUS to get involved because the Third Circuit’s decision adds to lower court confusion on the meaning of “clear evidence.” As we have discussed before in this space, one can find cases with similar records and diametrically opposed holdings. Compare Robinson (7th Circuit)(Posner holds that clear evidence compelled preemption)(see our post here) with Reckis (Massachusetts)(reaching opposite holding based on crazy reasoning)(see our first post on Reckis here). The Third Circuit’s reasoning is even crazier than Reckis, and what drove that reasoning was language from cases having nothing to do with preemption. But if one follows the “clear evidence” trail back to SCOTUS cases such as Geier and English, the evidence is clear that SCOTUS meant “clear evidence” to mean evidence of an actual, not merely potential, conflict. SCOTUS never hinted that “clear evidence” referred to a heightened, “exacting,” “stringent” standard of proof unique to drug labeling cases. If SCOTUS intended to impose a “clear and convincing” evidence standard (something, by the way, which would seem to be a legislative determination) it would have done so … clearly. Moreover, in Geier, SCOTUS explicitly rejected an argument that a defendant invoking preemption must shoulder a “special burden.”

PLAC also demonstrates that the Third Circuit’s Fosamax decision ignores SCOTUS preemption teachings and will cause harmful consequences. Preemption is such a powerful and important defense because it can cut off meritless litigation before parties incur enormous expenses. But the Third Circuit’s Fosamax decision permits a plaintiff to keep the litigation meat-grinder going merely by speculating that the FDA ‘might’ have rejected a warning if the language or circumstances occupied a counterfactual scenario only a millimeter away from reality. That outcome is not only wasteful, it is perverse given recent SCOTUS preemption decisions in Mensing and Bartlett rejecting speculations about what FDA might or might not have done. The outcome is also wasteful because it invites companies to shower the FDA with proposed label changes that might produce the “clear evidence” that will hit the tiny bullseye maybe-possibly left open by the Third Circuit. Finally, PLAC contends that stomping out the preemption defense means that drug companies will more and more be at the mercy of the varying tort laws and jury attitudes in 50 states. That sort of exposure and uncertainty could make a difference at the margins. If even one innovative drug goes undeveloped because an innovator is scared off by the litigation lottery, that is one drug too many.

Our original title, about how the Third Circuit Fosamax decision has “Got to Go,” came from The Sopranos. This time, the PLAC petition reminded us of a historical reference, one that came up in an odd way during the testimony of the previous director of the FBI: will no one rid us of this meddlesome case?