This year has seen a lot – and most of it would not fall into the positive category. The pandemic; severe wildfires in the U.S. and Australia; record setting tropical storms in the Atlantic; social unrest over police brutality; explosion in Beirut. Unfortunately, we could go on. Even more unfortunate is the fact that all of us tend to focus on the negative. It's not hard to do with today's media coverage. But there is a flipside. Anti-racist books are topping bestseller lists. Animals are being adopted by the hundreds of thousands in America. People are finally listening to their parents and washing their hands. Drive-in movie theaters made a comeback. John Krasinski's "Some Good News." Companies from Ford and GM to Apple to your local distillery shifted production to make much needed masks, ventilators, and hand sanitizer. And Hamilton the movie lived up to the hype.
That's the world in general. Here in the DDL world, our 2020 "p" word isn't pandemic. It's Pradaxa, and preemption, oh and pummels. The defense has had a lot to be happy about in the Pradaxa litigation. We've been bringing you consistent wins since January (here's a collection). Now here is one more to add to the slate – Silverstein v. Boehringer Ingelheim Pharmaceuticals, Inc., 2020 U.S. Dist. LEXIS 188176 (S.D. Fla. Oct. 7, 2020).
It's a lengthy decision that goes into extensive detail about the studies, analyses and science that were submitted to the FDA during and after the approval of the drug. See id. at *36-*88. Since the court found none of it to be "newly acquired evidence" that would support a CBE label change, we're going to skip the details and focus on the legal conclusions.
Plaintiff suffered a significant gastrointestinal bleed while on Pradaxa, an anticoagulant, and alleged that the drug was defective because defendant did not adequately warn that blood plasma concentrations should be monitored and that certain patient characteristics, such as renal impairments and concomitant use of other drugs, could increase the risk of severe bleeding. At the summary judgement stage, the primary issue was whether plaintiff could survive preemption because the manufacturer could have submitted a revised warning under the Changes Being Effected ("CBE") regulations. To make a CBE label change, however, the manufacturer would have to have "newly acquired information" – information not previously provided to the FDA – that demonstrates "risks of a different type or greater severity or frequency than previously included in the submission to FDA." Id. at *89-90.
We've already given away the ending – the court rejected the contention that the manufacturer had the evidence to support a CBE label change. Before reaching this conclusion, the court took a slightly less defense-friendly view on the burden of proof. Acknowledging that most other courts to examine the issue have held that plaintiffs bear the burden to prove that the manufacturer obtained newly acquired information to support a label change, this court took a more middle of the road position. Id. at *31.
I find that Plaintiffs should bear the initial burden of identifying the specific information that they assert [the manufacturer] acquired after the FDA approved [the drug] and should have used to modify the [drug's] label. Once Plaintiff points to this specific information, [the manufacturer] bears the burden of proving that it does not meet the definition of “newly acquired information” under the CBE regulation. This allocation of burdens avoids making [the manufacturer] prove a negative – that it acquired no new information after [the drug] was approved that would have justified a CBE modification.
Id. at *32-33. As the lengthy recitation of evidence shows, plaintiff carried their burden of proof by pointing to all sorts of supposedly new analyses, papers, etc. But so too did the manufacturer. The court found several points persuasive. Such as that the FDA had approved Pradaxa's labeling on "19 separate occasions" without requiring the warning Plaintiff wanted and after reviewing much of the evidence plaintiff argued was newly acquired. Id. at *84. Also, when the FDA approved Pradaxa it was already aware of the inconclusive evidence regarding whether stroke risk went down at higher levels of plasma concentration. So, the evidence plaintiff relied on did not reveal a risk of a different type to fall under the CBE regulations. Id. at *95. Even viewing the evidence in "a light most favorable to plaintiff," id. at *98, despite preemption being a question of law, the evidence did not support a conclusion different from what was known at the time of approval. Id. Moreover, to support a CBE label change, the evidence also must be scientifically reliable. "A CBE change cannot be rooted in conjecture or hypothesis." Id. at *20-21. Plaintiff's uncorroborated, unpeer-reviewed, and unreplicated sources were not sufficiently scientifically reliable to be newly acquired information. Finally, the type of risk at issue – a major bleed – was known by the FDA and was included in the label which "conclusively shows that it was submitted to the FDA." Id. at *109.
Because the court concluded that none of the evidence put forth by plaintiff was "newly acquired," it dd not have to reach the issue of whether the FDA would have rejected the proposed label change to conclude the plaintiff's claims were preempted. Id. at *111. The court did, however, address defendant's alternate argument that the Pradaxa label was adequate as a matter of law. Plaintiff's first mistake was relying on Dr. Plunkett for label adequacy. Because she is not a medical doctor, "[s]he does not, and presumably cannot, opine on how a treating physician would interpret and respond to the [drug's] label. Id. at *113. Even so, what plaintiff was asking the court to do is require that the manufacturer not only warn of the risk, but also the importance of and how to monitor for the risk. Under Florida law, a manufacturer "need not warn about the specific manner in which the injury may occur." Id. at *114. Because the label contained "accurate, clear, and unambiguous warnings" regarding bleeding, therapeutic monitoring, and increased risk to patients with renal impairment – it was "sufficient to educate a reasonable treating physician that Pradaxa presented" the precise risk at issue. Id. at *115. Therefore, the warnings were adequate, and defendant was entitled to summary judgment on all counts.
So, we know Pradaxa goes in the 2020 win column. But, will the 2020 Halloween rare full moon, blue moon end up as just a picturesque backdrop for outdoor parties or Night of the Living Dead? Given how the year is going . . . .
This article is presented for informational purposes only and is not intended to constitute legal advice.