By Elena Eyber, J.D.
A drug manufacturer did not have "newly acquired information" that would have permitted a unilateral change of blood thinner’s physician label, and therefore, the fraud claim brought by the deceased patient’s family based on the physician label was preempted.
The Fourth Circuit reversed a district court’s order denying a drug manufacturer’s post-trial motion for judgment as a matter of law. The deceased patient’s family sued the drug manufacturer asserting state-law claims alleging the manufacturer failed to adequately warn about the risks associated with taking the blood thinner Pradaxa. The appellate court held that the drug manufacturer did not have "newly acquired information" regarding an optimal Pradaxa blood concentration level which would have warranted a unilateral change to the physician label. As a result, the state-law fraud claim was preempted (Knight v. Boehringer Ingelheim Pharmaceuticals, Inc., January 6, 2021, Quattlebaum, A.).
Procedural history. Under the preemption doctrine, a state-law challenge to federally approved pharmaceutical warning labels may only proceed when the pharmaceutical company has the unilateral ability to change that labeling. The FDA’s changes- being-effected (CBE) regulation permits pharmaceutical companies to unilaterally modify their physician labels only to "add or strengthen a…warning" based upon "newly acquired information" about "evidence of a causal association" between the drug and a risk of harm.
Pradaxa was developed to help reduce the risk of stroke. The FDA approved the drug and its label. After taking this drug, the patient suffered a gastrointestinal bleed and developed other complications and eventually died. Her family sued the drug manufacturer asserting a variety of state-law claims alleging the manufacturer failed to adequately warn about the risks associated with taking Pradaxa. The manufacturer argued that federal law preempted the claims. The family disagreed, claiming the risks were "newly acquired information" discovered after Pradaxa’s FDA approval. If true, then the manufacturer could have added warnings to its physician label without FDA approval, and federal law would not preempt the state-law claims.
District court decision. The district court agreed with the patient’s family and allowed the case to go to the jury. The jury returned a mixed verdict, finding for the manufacturer on the family’s failure to warn and breach of express and implied warranty claims, but for the family on their fraud claim. The manufacturer filed a renewed motion for judgment as a matter of law. After the district court denied its post-trial motions, the manufacturer appealed, arguing it did not discover "newly acquired information" that would have permitted a unilateral change of Pradaxa’s physician label. Thus, according to the manufacturer, the family’s fraud claim based on the physician label was preempted.
Appellate court decision. The appellate court agreed with the manufacturer and reversed the district court’s order denying the manufacturer’s post-trial motion for judgment as a matter of law. The family alleged a labeling deficiency—the absence of a recommendation that patients with impaired kidney function taking Pradaxa undergo blood testing to check Pradaxa concentration levels. The family claimed the manufacturer’s post-approval study of the RE-LY data provided "newly acquired information" about the risks Pradaxa posed to certain patients and the need for blood monitoring. The appellate court held that the manufacturer did not have "newly acquired information" as defined in the CBE regulation that could have justified a unilateral change in the Pradaxa physician label. The court found a published Reilly Paper, which was the culmination of the RE-LY post-approval analysis, did not offer "newly acquired information" for three reasons.
First, the finalized version of the Reilly Paper was not sent to the publisher until June 2013, after the patient’s bleed. Thus, by the date the paper was published, the information in it would not have made any difference to the patient. Second, although the paper consisted of a new analysis of previously submitted data, it did not reveal risks of a different type or greater severity or frequency than previously included in submissions to the FDA. The paper discussed the correlation between Pradaxa blood concentration levels and bleeding risk. But the FDA was already aware of this correlation. Third, the paper’s conclusion that there was no single plasma concentration range that provided optimal benefit-risk for all patients did not establish any new risk. That conclusion tracked the manufacturer’s warnings since the FDA’s initial approval of Pradaxa and its labeling. Therefore, the article could not constitute "newly acquired information" because it did not reveal risks of a different type or greater severity or frequency.
The case is No. 19-1636.
Attorneys: Paul Schmidt (Covington & Burling LLP) for Claude R. Knight. Neal L. Moskow (Ury & Moskow, LLC) for Boehringer Ingelheim Pharmaceuticals, Inc.
Companies: Boehringer Ingelheim Pharmaceuticals, Inc.
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