There’s more than one way to cook an egg.  And, there’s more than one way to dismiss a case. In Bennett v. Teva, the district court decision was based on preemption.  The Third Circuit took a different route basing their dismissal on TwIqbal.  While we would have preferred an appellate win on preemption, we are okay with all roads leading to dismissal.

Bennett is an amiodarone case.  Therefore, the allegations should not be news to anyone familiar with this litigation.  Amiodarone is a generic drug.  It was prescribed off-label by physicians to treat atrial fibrillation.  Plaintiffs who suffered side effects bring failure to warn and fraud claims based on three allegations – defendant did not provide FDA-mandated Medication Guides to patients; defendants failed to report adverse events to the FDA; and defendant failed to warn of the risks associated with the drug when used to treat atrial fibrillation.  2022 WL 4093739, *1 (3d Cir. Sep. 7, 2022). 

The district court dismissed all the claims as preempted either under Buckman or Mensing.   And rightly so.

Plaintiffs’ first two theories of liability – failure to provide sufficient quantities of FDA-mandated Medication Guides and failure to report adverse events to the FDA – are both premised on an alleged violation of the FDCA.  Claims that exist solely by virtue of the FDCA, are preempted by Buckman.  That left just a more traditional failure to warn theory, which because defendant manufactures a generic drug and therefore has no control over changing the label, was preempted by Mensing.  A generic drug manufacturer cannot simultaneously comply with the federal requirements to keep the label the same as the branded label and a purported state law duty to change the label. 

The Third Circuit did not disagree with any of the findings or rulings of the district court.  It just decided it did not need to address the preemption issues because plaintiffs never got over their pleading hurdle. 

On the Medication Guide, plaintiffs alleged that defendant failed to ensure that the guides were provided to all patients.  But federal law requires manufacturers to provide “the means” for distributors or sellers to produce a sufficient number of guides.  Plaintiffs made no allegations that defendant failed to comply with that requirement and therefore, their claim was not plausibly alleged.  Id. at *4.

Similarly, plaintiffs’ only support for their allegation that defendant failed to report adverse events was an assumption that because lots of people with a-fib are treated with amiodarone, defendant must have failed to report.  Not good enough.  The hurdle plaintiffs would have to clear is to provide “examples of countless adverse events” that defendant failed to report.  Absent that, this claim failed the TwIqbal standard and therefore also the heightened standard for fraud.  Id.

Plaintiffs’ last claim – failure to warn related to off-label use – was based on allegations that defendant failed to provide adequate information in reference materials used by doctors, like PDR and Epocrates.  Plaintiffs focus their claims here because they try to allege these are not labeling materials.  They would be wrong.  The Third Circuit found the lack of any “specific misrepresentation” to be fatal to their pleadings.  As was the lack of any allegation that defendant “was responsible for or otherwise contributed to” the reference materials.  As a generic manufacturer, they don’t and they can’t.  Id. 

Because the district court found all plaintiffs’ claims preempted as a matter of law, it denied their motion for leave to file an amended complaint.  Id. at *3.  That reasoning does not hold for the Third Circuit which decided the case on the insufficiency of the pleadings.  Fortunately, on this issue too the final outcomes are aligned, if not identical.  Because plaintiffs’ request to amend was a “single sentence, lacking a statement for the grounds for amendment, and dangling at the end of her memorandum in opposition to a motion to dismiss,” – a motion for leave was never properly before the district court.  Therefore, the district court did not abuse its discretion in dismissing plaintiffs’ claims with prejudice.  Id. at *5.