Qui Tam Lawsuit Prompts Novartis to Pay for Off-Label Allegations; Whistleblowers Share in $72 Million Settlement

Robert Lalley, Courtney Davis and William Manos — three former employees of a Novartis Pharmaceuticals Corporation predecessor — bravely reported what they believed to be Medicare and Medicaid fraud.  And the government now is rewarding them for it with approximately an 18% share of the $72 million Novartis has agreed to pay to settle the false claims allegations.  The three whistleblowers filed qui tam lawsuits under federal and state false claims acts against Novartis and Chiron Corporation alleging illegal marketing of the cystic fibrosis drug TOBI for off-label uses.  According to DoJ:

The Food and Drug Administration (FDA) approved TOBI, an inhaled antibiotic, for the treatment of certain cystic fibrosis patients. The United States alleges that Chiron, and then Novartis, marketed TOBI for unapproved uses, such as diseases other than cystic fibrosis, and for cystic fibrosis patients who did not meet the parameters of the FDA-approved indication and for which TOBI was not a medically accepted use.

“Pharmaceutical companies must not promote their drugs for uses that have not been proven to be safe and effective,” said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. The announcement of the Novartis settlement follows on the heels of other similar whistleblower lawsuit settlements under the qui tam provisions of the false claims act with Johnson & Johnson and Schwartz Pharma.

To report Medicare fraud or Medicaid fraud, contact Frohsin & Barger.