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A little over a year ago, the Southern District of New York dismissed a multi-plaintiff amiodarone suit primarily on the grounds of preemption.  We discussed the decision in our post on lessons learned from the Amiodarone Litigation.  Now we can add to those lessons the Second Circuit’s affirmance of the dismissal.  Notably, the appellate court concluded that it did not need to reach the preemption issues because all of plaintiffs’ claims were implausibly pled under either Federal Rule of Civil Procedure 8 or 9.  Frei v. Taro Pharmaceutical USA, Inc., — Fed. Appx. –, 2021 WL 1541141 (2nd Cir. Apr. 20, 2021).

Plaintiffs’ complaint contained causes of action for failure to warn, negligent marketing, negligence per se, and fraud.  Id. at *1.  Regardless of the cause of the action, the appellate court found the case boiled down to three theories:  (1) defendant failed to make Medication Guides available to patients; (2) defendant failed to ensure the accuracy of reference materials relied on by physicians such as the physician Desk Reference (“ PDR”); and (3) defendant concealed information about adverse events.  Id. at *2.    What was missing from plaintiffs’ complaint however, were any allegations of the defendant’s wrongdoing.

We’ve discussed plaintiffs’ medication guide theory in the context of other cases (see post noted above).  It just doesn’t fly.  It is based solely on an FDA regulation that only requires manufacturers to provide guides “in sufficient number” or the “means to produce” them to “distributors, packers, or authorized dispensers” – not end users.  21 C.F.R. §208.24(b)(1-2).  Plaintiffs did not allege that defendant violated the requirements of the regulation. Rather, they created a “hypothetical enhanced duty” to provide medication guides directly to end users but failed to allege how defendant violated that duty either.  Id.

As far as providing misleading information in physician reference materials, plaintiffs’ complaint contains no allegations concerning what the misleading information was and only general allegations that defendant’s intent was to deceive physicians.  Id.  Moreover, the reference materials are considered labeling and therefore, defendant, as a generic manufacturer, could not change the information from that provided by the brand manufacturer.  Plaintiffs failed to explain what defendant’s “contribution to or authority to correct the reference materials was.”  Id.  Since plaintiffs could not demonstrate what role defendant had in creating the reference materials (none), this theory of liability was also not viable.

Finally, for plaintiffs’ allegation that defendant failed to report adverse events they were relying on a general statistical analysis that given the sheer number of amiodarone prescriptions and the number of people diagnosed with pulmonary toxicity, there must be “tens of thousands” of adverse events that were not reported.  Even if plaintiffs had support for this assertion, it is aimed at the entire amiodarone market, not defendant.  But an allegation that all manufacturers collectively failed to report says nothing about whether this defendant concealed information.  Id. at *3.

The opinion is short and sweet and while not preemption focused, it gets the job done.