By Jeffrey H. Brochin, J.D.
A patient’s failure-to-warn claims related to the anticoagulant drug Eliquis® were properly dismissed due to federal law preemption, a federal district court in New York ruled. The second amended complaint (SAC) relied on information which did not, upon examination, demonstrate that any newly acquired information existed to support a label change pursuant to "changes being effected" (CBE) regulations (Utts v. Bristol-Myers Squibb Company, May 8, 2017, Cote, D.).
The patient was diagnosed with atrial fibrillation sometime before July 2014 and prescribed Eliquis. He subsequently suffered severe internal bleeding after taking the drug, but unlike other anticoagulant medications, Eliquis did not have a known antidote or reversal agent. The Food and Drug Administration (FDA) approved Eliquis for sale and marketing in the United States in 2012 after Bristol-Myers Squibb Co. and Pfizer Inc. (the manufacturers) submitted a New Drug Application (NDA), which included a description of the clinical investigations of the drug with the results of the international clinical trials known as ARISTOTLE.
Clinical study. The patient alleged several deficiencies with the study, including that the manufacturers had used incompetent and untrustworthy sources to conduct the study. The patient further alleged that the manufacturers concealed several side effects experienced by study participants. While the NDA was pending before the FDA, an FDA employee appointed to review the application recommended that the proposed label discuss the quality control problems associated with the study. In response to concerns about the study, the manufacturers decided to submit additional data to the FDA for the agency’s consideration. At the time the patient was prescribed the drug, the label contained several warnings about the risk of internal bleeding, and it referenced the ARISTOTLE study.
Allegations. The initial complaint included products liability counts of design defect, manufacturing defect, and failure to warn. The manufacturers filed their motion to dismiss in October, 2016, which the court largely granted, but with leave to amend most of the dismissed claims [see Products Liability Law Daily’s December 27, 2016 analysis]. Although the SAC focused on the alleged failure of the manufacturers to warn that the use of Eliquis posed the risk of excessive bleeding and had no known antidote, the patient largely abandoned those allegations in his opposition to the motion to dismiss. Instead, he alleged that the dosage recommendations were not individually tailored, and that the manufacturers did not recommend constant monitoring of patients using the drug.
The court noted that it was not difficult to discern why the patient abandoned his initial allegations regarding failure to warn of the risk of excessive bleeding, because that fact, along with the lack of an antidote, were clearly disclosed to the FDA when it approved the drug, and the warnings were prominently disclosed to medical practitioners and patients on the FDA-approved labeling for the drug. Therefore, the court considered the patient’s other arguments regarding a lack of recommendations as to individual tailoring of dosage and as to constant monitoring of Eliquis patients.
Failure to allege specific warnings. The patient’s allegations as to dosage and monitoring did not identify any specific warnings or guidance that should have been included on the label regarding dosage and monitoring. He did not identify research nor other clinical work that recommended another dosage strategy than that described on the label; nor did he explain what specialized monitoring of a patient would accomplish. The court noted that there was no research or clinical experience, even as of the court’s opinion, to suggest that any changes to the Eliquis label’s disclosures as to the risk of excessive bleeding were warranted.
Other litigation not relevant. The patient contended that the motion to dismiss should be denied and that he should be permitted to conduct discovery so as to try to locate evidence in the manufacturers’ files in support of his failure-to-warn claims. Although he pointed to substantial ongoing litigation over the earlier drugs in the class of drugs to which Eliquis belongs in support of his argument against dismissal, the court noted that the ability of other parties in other litigation related to other drugs to survive a motion to dismiss did not relieve the patient of his pleading requirements.
CBE regulation, newly acquired information. One procedure under which the manufacturers could have effected a label change after FDA approval was by way of CBE regulations which allow a manufacturer to change its label unilaterally to add or strengthen a contraindication, warning, precaution, or adverse reaction as soon as there is reasonable evidence of a causal association with a drug. A manufacturer also may, pursuant to the CBE regulations, add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the drug product. However, labeling changes pursuant to the CBE regulations may only be made on the basis of "newly acquired information", which is defined as data, analyses, or other information not previously submitted to the FDA, which may include (but is not limited to) data derived from new clinical studies.
The manufacturers asserted that the patient’s California failure-to-warn claims were preempted by federal law because the information on which the SAC relied to plead its claims was not "newly acquired information." The SAC relied exclusively on nine reports, studies, and articles as the bases for its assertion that the Eliquis labeling was inadequate in failing to give the dosage and monitoring warnings. However, the court held that the information contained in the literature did not constitute "newly acquired information" under the FDA’s CBE regulations. Accordingly, the patient’s claims were deemed to be preempted because federal law would not have permitted the manufacturers to make any changes to the Eliquis label, and the SAC was dismissed.
The case is No. 16cv5668 (DLC).
Attorneys: Hunter Jay Shkolnik (Napoli Bern Ripka & Associates) for Charlie Utts. Loren H. Brown (DLA Piper US LLP) for Bristol-Myers Squibb Co. and Pfizer Inc.
Companies: Bristol-Myers Squibb Co.; Pfizer Inc.
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