For a second time the Maryland federal district court has dismissed a whistleblower suit alleging Medicare fraud for off-label use of a medication patch.  A former sales representative for the manufacturer claimed the patch was prescribed for longer than the FDA-approved 14 days.  The first time around, the court dismissed the case under Federal Rule 9(b) for failure to identify any particular case where Medicare paid for such a patch.

The whistleblower filed an amended complaint listing nine specific patients who allegedly got prescriptions for over 14 days.  On March 21, in Palmieri v. Alpharma (ELH-10-1601), the court again dismissed under 9(b) because, while identifying the patients, the complaint failed to show that Medicare payments were actually involved.  The court noted that payment could have come from a commercial insurer, and even if a patient was on Medicare, the prescription could have fallen into the “donut hole” in Part D.

The decision demonstrates that while some other circuits have adopted a more lenient 9(b) standard for whistleblower claims, the Fourth Circuit still adheres to the stricter standard ofNathan v. Takeda, 707 F.3d 451 (2013).