Firms and lawyers from Texas and Massachusetts joined forces to represent a whistleblower in a major False Claims Act suit against AngioDynamics, a New York-based medical device company. Due to the terms of the settlement, which was announced last week, AngioDynamics will pay $11.5 Million to the federal government and various states. The allegations were that the company, the exclusive distributor for the medical device called Gelspheres, sold it as a drug eluting device when the FDA had cleared it only for embolization (blood blockage) of hypervascular tumors. Whistleblower Ryan Bliss, of Massachusetts, was a senior product manager responsible for marketing for BTG plc and its subsidiary, Biocompatibles Inc., manufacturer of the Gelspheres. Mr. Bliss was represented by Jeffrey A. Newman Esq. and Rea Kasemi of the Jeffrey Newman Law of Boston and Paul Lawrence of the firm Waters & Kraus of Dallas, Texas. “Through the courage and persistence of Mr. Bliss, AngioDynamics and BTG’s marketing of the device involved 100% for use as a drug delivery device which was never approved by the FDA. AngioDynamics never shared with medical providers that the FDA had refused to approve LC Bead for drug delivery and distributed the device for that purpose anyway,” Newman said.
BTG and Biocompatibles, the bead makers, settled their portion of the case for $36 million in November 2016. The allegations of the case included accusations that BTG’s subsidiary lied to the FDA and caused violations of the False Claims Act. For the United States, the case was overseen by Colin M. Huntley, Assistant Director of the Civil Division of the Department of Justice in Washington D.C.
More details about the settlement can be found here.
In February, Leaders In The Law reported on another whistleblower settlement that both firms secured regarding mental health coaching. Read that article here.
