No commentator or blog has more precisely and persistently probed preemption and its “newly acquired information” component than has the Drug and Device Law Blog. And the Blog has done it with poetry, or at least alliteration. If you went right to the story and didn’t savor the headlines you missed: “Post-Albrecht Preemption Pummels Pradaxa Plaintiffs,” followed shortly by “Post–Albrecht Preemption Persistently Pummels Pradaxa Plaintiffs.” But what started this parade was “Plaintiff’s Pyrrhic Pradaxa ‘Victory’,” reporting on Roberto v. Boehringer Ingelheim Pharmaceuticals, Inc., No. CPLHHDCV166068484S, 2019 WL 5068452 (Conn. Sup. Ct. Sept. 11, 2019). The Roberto court found a labeling claim about the bleeding risk from a blood thinner preempted because there was no newly acquired information on a general bleeding risk that would have warranted a CBE label change. But the trial court also found that there was sufficient evidence to sustain a verdict of a heightened risk of bleeding in GERD (gastroesophageal reflux disease) patients, specifically. Indeed, the court concluded in Roberto that it was unclear whether information bearing on the GERD risk had been submitted to the FDA. But the Pyrrhic Victory post recognized that the bigger picture was the general bleeding risk, and that there were only a few GERD cases in this litigation. So the GERD finding was a pyrrhic victory.

But now even that plaintiff’s Pyrrhic Pradaxa victory has been put out to pasture. No longer are there GERD outliers that escape preemption.

Read the blog post here.