Drugs

Mixed Decision in a Preemption Case

A Tennessee federal court held that a plaintiff’s failure-to-warn case against Boehringer Ingelheim over injuries suffered when taking the firm’s Type-2 diabetes drug Jardiance (empagliflozin) could not be based on adverse event information known before FDA approved the drug, because the company could not have changed the original FDA approved labeling. Attorney Michelle Yeary (Dechert) writes in an online Drug and Device Law blog post that the court found that data the plaintiff relied on to support her allegation was pre-launch data that was known to FDA at the time the agency approved the drug’s warnings and was not newly acquired data that could have been used in a changes being effected (CBE) labeling change.

Likewise, Yeary writes, the court held that the plaintiff cannot base a failure-to-warn claim challenging the company’s failure to amend the warning after the drug was introduced based on information that existed before agency approval. Thus, the allegations would have to be based on information not known to FDA at the time of approval.

Yeary says the plaintiff alleged that additional diabetic ketoacidosis adverse events were reported in 2015, following her 2/2015 use of the drug. The company argued those 2015 reports did not provide any “new” information that would support a CBE. “The court determined that was an issue better suited to a motion for summary judgment and that plaintiff had done enough to withstand a motion to dismiss,” Yeary writes.

In addition, the court held that based on the learned intermediary doctrine, the plaintiff could not bring a failure-to-warn claim premised on failing to warn the plaintiff directly. Rather, it said, she is limited to a claim for failure to warn her prescriber. The court also reiterated that a plaintiff must plead warning inadequacies with specificity. It found that her allegations as to diabetic ketoacidosis were sufficient, but she failed to state a claim to the extent that she was looking to recover for “other health related complications,” because the claim did not specify the alleged complications or how the drug’s warnings were inadequate as to those specific complications.

“In the end,” Yeary concludes, “plaintiff is left with a narrow failure to warn claim and the hurdle of proving proximate cause.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome