It has been a while since we now have mentioned False Claims Act (“FCA”) litigation over alleged promotion of a prescription drug for off-label makes use of. And once we learn United States ex rel. Hearrell v. Allergan, Inc., 2024 U.S. Dist. LEXIS 70888 (E.D. Tex. Apr. 18, 2024) we had been reminded why. Off-label promotion just isn’t ipso facto false.
Plaintiff alleged that defendant promoted Botox for the off-label use of pediatric migraine remedy. However an FCA declare has to start with a “false assertion or fraudulent course of conduct.” Id. at *7. As soon as upon a time, FDA took the place, and relators ran with it, that each one off-label promotion was false or deceptive. However courts will not be shopping for that anymore. Afterall, physicians are allowed to prescribe medicine off-label, so an off-label prescription is neither factually false nor deceptive. Furthermore, neither Medicare nor Medicaid categorically prohibits reimbursement for off-label makes use of. Id. at *8. The usual for reimbursement is whether or not the therapy is “affordable and mandatory.” Right here, plaintiff conceded the reasonableness and necessity of the therapy. Id. at *9-10. Plaintiff additionally tried to ascertain falseness by claiming that defendant violated different federal legal guidelines such because the Federal Meals, Drug & Beauty Act, the Public Well being Service Act, and the Anti-Kickback Statute. However that was not sufficient absent allegations that defendant licensed compliance with these statutes. Id. at *10.
The absence of a false assertion or false certification was deadly to plaintiff’s off-label promotion declare, however the courtroom didn’t cease there. The second aspect of an FCA declare is materiality—had the federal government recognized of the claimant’s violation, it will not have paid the declare. The relator on this case didn’t supply any information to help an inference that the off-label nature of the drug prescriptions was materials to both Medicare or Medicaid’s cost selections. Id. at *11. Nor may he for the reason that cost choice activates medical reasonableness and necessity, not the drug’s labeling.
The ultimate aspect of an FCA declare thought of by the courtroom was scienter—that the alleged fraud “quantities to greater than harmless mistake or negligence.” Id. at *8. Plaintiff alleged that 48 claims for pediatric remedy had been submitted to the federal government for cost. However the mere submission of off-label claims by third events, even with the defendant’s claimed data, just isn’t enough scienter to help an inference of fraud.
FCA off-label promotion claims have two main hurdles to beat. First, off-label promotion just isn’t in and of itself false. Second, Medicare and Medicaid reimbursement just isn’t ruled by whether or not the prescription was on or off label. Which is why we don’t see as many of those claims as we used to. Nevertheless it’s good to be reminded why we shouldn’t see any in any respect.
