Bar Raised for Off-Label Marketing False Claims Actions

By Jason M. Brocks, Bloomberg Law

A recent opinion issued by the United States Court of Appeals for the Fourth Circuit raises the pleading standard in cases alleging False Claims Act (FCA) violations by drug companies for off-label use of their drugs resulting from their own marketing practices.

According to the court, a claim alleging violations of the FCA must “plausibly allege” that actual, identifiable claims for government reimbursement had been “presented,” or filed. Complaints that merely infer that a false claim was presented to the government are inadequate.

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