Photo of Bexis

Today we have another guest post from friend-of-the-Blog, Dick Dean at Tucker Ellis.  He’s familiar with the ongoing Pradaxa litigation and is pleased with the preemption pummeling Pradaxa plaintiffs have been receiving.  Here’s his post about yet another favorable decision from the state-court Pradaxa proceedings in Connecticut.  With decisions like this, who needs snap removal?  As always, our guest posters deserve 100% of the credit (and any blame) for their work.


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.

In Estep v. Boehringer Ingelheim Pharmaceuticals, Inc., No. X03 HHD CV17-6075319S, 2020 WL 5290777 (Conn. Sup. Ct. Aug. 25, 2020), the same court that decided Roberto considered a follow-up GERD case, which had an “expanded record” on the newly acquired information issue that had allowed the Roberto plaintiff to escape preemption.  Id. at *7.  The Estep Plaintiff likewise claimed the new information on the GERD issue was a European label and a 2013-2014 medical journal article.  The court again found that these items showed reasonable evidence of different or greater risks not stated in the U.S. label.  Id. at *8.  But that left the issue of “newness.”  The definition of “newly acquired information” uses phrases like “not previously submitted to the Agency” and “previously included in submissions to the FDA.”  21 C.F.R. §314.3(b).  Defendant argued that it had submitted data to the FDA that were equivalent to what plaintiff cited in the European label and the journal article—specifically, it relied on reports of bleeding in GERD patients.  Id. at *9.

Plaintiff in Estep argued that the information submitted to the FDA had to be “tethered to a proposed label change” in order to qualify as “previously submitted” to the agency.  Id.  That novel argument was to no avail.  The Court found that a straightforward application of the rules of statutory construction supported the defendant’s position.  It then looked closely at the information submitted to the agency to determine whether it was “equivalent to the claimed newly acquired information.”  Id. at *9.  The defendant pointed to several reports submitted to the FDA prior to the original approval in October 2010 that showed gastritis-like symptoms, defined to include GERD, were associated with an increased risk of GI bleed.  Id. at *13.  The court then cited almost an entire page of tables and charts linking bleeding risks in gastritis-like symptoms, which had been submitted.  Id.  In addition, in the “expanded record” defendant showed that it had submitted the very European label relied upon by plaintiffs to the FDA in September 2012, after approval but before a December 2013 label change and before plaintiff’s bleed in February 2015.  Id.

Estep is a significant decision.  It is the first holding that hard data submitted without a specific request for a label change can defeat a claim of newly acquired information.  Not that it should make any difference, but it’s another plaintiff propaganda point put down, and recognized for what it is, a distinction without a difference.

Estep stands in stark contrast to Evans v. Gilead Sciences, Inc., No. 20-cv-00123-DKW-KJM, 2020 WL 5189995 (D. Haw. Aug. 31, 2020), which the Blog discussed here last month.  That post noted the adverse warning holding in Evans that “…even if there was little or no ‘newly acquired information’ relevant to Evans’ claim, that did not make it impossible for Gilead to change its….label.”  Id. at *11.  The opinion in Estep provides a detailed refutation explaining why Evans was erroneous.  2020 WL 5290777 at *10-*11.  Estep cited to the FDA’s comments supporting the rule change in 2008 adding the concept of “newly acquired information.”  Those comments pointed out that allowing sponsors to change labeling for a product without limitation based on previously submitted information would undermine the FDA label approval process.  Id. at *11.

If a plaintiff is going to allege an inadequate warning because a CBE could have been made, then the CBE regulation’s newly acquired information prerequisite must be confronted—not glossed over.  Estep also provides an excellent summary of the law in regard to pleading “newly acquired information.”  Id. at *5-*6.  Once a defendant makes an initial showing of a preemption defense, then a plaintiff must specifically identify the “newly acquired information” he relies upon.  Numerous posts on this blog have treated this issue.  In addition to the “Pummels” posts, seeOnline Reviews Are Not ‘Newly Acquired Evidence,” “On Newly Acquired Evidence,” “‘No Newly Acquired Evidence’ Argument On Implied Preemption Gaining Traction,” and “Plaintiffs Have Burden To Plead Newly Acquired Evidence.”  As the Blog’s post about Evans discussed, that decision stumbled badly on this increasingly key pleading issue—ignoring many cases in the last three years directly on point while citing to a 2018 Ninth Circuit decision having nothing to do with “newly acquired information.”  2020 WL 5189995 at *10.

Estep underscores what an outlier decision Evans truly is.