A Massachusetts federal judge rejected a whistleblower’s lawsuit Tuesday against Ireland-based Covidien’s subsidiary ev3 inc., accusing the company of promoting a blood-blocking surgical device for off-label purposes and other misconduct.
Former ev3 salesman Jeffrey D’Agostino filed the lawsuit under the qui tam, or whistleblower, provisions of the False Claims Act against ev3, executive salesman Brett Wall, and Vice President of Sales and Global Marketing John Hardin. Mr. D’Agostino sued on behalf of the U.S. government and 26 states.
U.S. District Judge Richard Stearns rejected Mr. D’Agostino’s lawsuit citing weak allegations and insufficient evidence.
The lawsuit accuses ev3 of submitting false claims to Medicare for reimbursement of costs associated with its Onyx device, which is designed to block a patient’s blood flow during surgery, and Axium, an embolization coil used to treat brain aneurisms and other neurovascular problems.
Mr. D’Agostino alleged that ev3 trained physicians to use the medical devices for purposes unapproved by the Food and Drug Administration (FDA), which, he asserted, resulted in the submission of false claims.
According to Law360, he also alleged that ev3 licensed Onyx technology to a Boston Scientific Corp. company, which used it to design a treatment that had “potentially fatal complications.”
However, Judge Stearns found that the potential hazards of that treatment were not hidden from the public and that Mr. D’Agostino’s complaint quotes heavily from FDA documents. He ruled the public disclosure bar invalidated those claims.
Mr. D’Agostino also claimed that Axium was pushed through the FDA’s approval process before it was proven safe, but the judge said the complaint failed to show how that amounted to false claims.
“In short, an FCA (False Claims Act) action is not the appropriate venue for this court to exercise its judgment in second-guessing decisions taken by the FDA in approving the use of medical devices simply because the government happens to pay for some of them,” Judge Stearns said.