The United States Court of Appeals for the Fourth Circuit (“Federal Appellate Court”) held in its published opinion dated January 6, 2020: “Boehringer [Boehringer Ingelheim Pharmaceuticals, Inc.] 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 is preempted.”
Federal Preemption Of Drug Claims
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 Food and Drug Administration’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. 21 C.F.R. § 314.70(c)(6)(iii).”
The Case On Appeal
Boehringer Ingelheim Pharmaceuticals, Inc. (“Boehringer”) developed a drug called Pradaxa to help reduce the risk of stroke. The FDA approved the drug and its label. After taking this drug for over a year, Betty Knight suffered a gastrointestinal bleed. She then developed other complications and eventually died. Her children, Claude Knight and Claudia Stevens, sued Boehringer asserting a variety of state-law claims alleging Boehringer failed to adequately warn about the risks associated with taking Pradaxa.
Boehringer argued that federal law preempted the claims. The Knights disagreed, claiming the risks were “newly acquired information” discovered after Pradaxa’s FDA approval. If true, then Boehringer could have added warnings to its physician label without FDA approval, and federal law would not preempt the state-law claims.
In November 2011, Boehringer revised the physician label pursuant to the CBE regulation permitting unilateral modification of physician labels to “add or strengthen a . . . warning” based upon “newly acquired information.” 21 C.F.R. § 314.70(c)(6)(iii). The revised label disclosed that “[p]atients with severe renal impairment were not studied in RE-LY. Dosing recommendations in subjects with severe renal impairment are based on pharmacokinetic modeling.” It also warned that “impaired renal function” is a “major” cause of heightened Pradaxa blood concentration levels, and recommended “assess[ing] renal function prior to initiation and, in patients” with kidney impairment or old age, at least once a year.
In June 2013, Boehringer submitted a finalized paper for publication that mirrored the draft version with one major exception: it did not conclude there was an optimal therapeutic blood concentration range for all patients. Instead, it concluded that kidney function was probably the most predictive factor of Pradaxa blood concentration levels, and that the risk of stroke falls and the risk of bleeding rises in correlation with such concentration levels.
The plaintiffs in the present case alleged that Boehringer failed to properly warn that Pradaxa created a heightened risk in certain patients for serious bleeding and that this led to Knight’s death. During a three-week trial, the Knights focused on the Medication Guide’s alleged failure to warn Knight that Pradaxa could cause bleeding and that the 75 mg dose was never tested in patients, even though these risks were disclosed in the physician label as of November 2011. At the end of the Knights’ case, Boehringer moved for judgment as a matter of law on all claims, arguing that federal law preempts any claim based on alleged misstatements or omissions in the Medication Guide.
The district court ultimately ruled “that any claim by the plaintiffs that the Medication Guide should be modified to include the warnings or statements that plaintiff has proffered is pre-empted.” The district court further held, however, that the plaintiffs’ fraud claim was not preempted because, even though claims based on the Medication Guide were preempted, the Knights had introduced evidence Boehringer had “newly acquired information” which would have permitted it to unilaterally change the physician label pursuant to the CBE regulation. Additionally, the district court ruled that, although there was no evidence Knight read the physician label, there was evidence that her doctor reviewed it and that Knight indirectly relied on that label through her doctor. Boehringer thereafter appealed.
Federal Appellate Court Opinion
The Federal Appellate Court stated, “Newly acquired information “reveal[s] risks of a different type or greater severity or frequency than previously included in submissions to [the] FDA.” 21 C.F.R. § 314.3(b). Importantly, “newly acquired information is not limited to new data, but also encompasses new analyses of previously submitted data” … Still, the new analysis must reveal “risks of a different type or of greater severity or frequency” to constitute “newly acquired information.””
The Federal Appellate Court held: “The final version of the paper was published, peer-reviewed and submitted to the FDA. And, after reviewing the Reilly Paper, the FDA has continued to approve labels with no monitoring requirement. This undermines the Knights’ claim that Boehringer’s preliminary analysis made it immediately apparent, before the paper was published, that an optimal blood concentration range existed. Because the new analysis did not “reveal” the conclusion that an optimal blood concentration range existed, Dr. Reilly’s preliminary thoughts and draft conclusions were not “newly acquired information.” 21 C.F.R. § 314.3(b).”
The Federal Appellate Court warned, however, “Our decision today, however, should not be construed to require final, peer reviewed publication of an analysis to constitute newly acquired information. Some findings may be revealed instantly … Likewise, peer review and publication of an article do not themselves prevent any contrary findings from qualifying as newly acquired information. If, for example, the record revealed that the company reached a conclusion about risks of a different type or risks of greater severity or frequency, but either elected not to publish or published something different in bad faith, the unpublished conclusion might indeed qualify as newly acquired information.” However, “preliminary thoughts and discussions are not “reasonable evidence of a causal association with a drug” and cannot, without more, reveal “newly acquired information.” 21 C.F.R. § 201.57(c)(6)(i).”
The Federal Appellate Court concluded: “there is no bright-line, one-size-fits-all line marking the moment when an analysis reveals new information. A careful review of the record is needed to determine whether a conclusion has been reached. Such a review here reveals that Boehringer 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 is preempted.”
Source Knight v. Boehringer Ingelheim Pharmaceuticals, Inc., No. 19-1636.
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