RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.

Regulatory Focus™ > News Articles > 7 > AngioDynamics to Pay $12.5M to Settle Allegations Over Two Unapproved Devices

AngioDynamics to Pay $12.5M to Settle Allegations Over Two Unapproved Devices

Posted 30 July 2018 | By Ana Mulero 

AngioDynamics to Pay $12.5M to Settle Allegations Over Two Unapproved Devices

Devicemaker AngioDynamics recently agreed to pay the US government $12.5 million to settle false claims allegations involving two medical devices.
The settlement resolves a 2013 whistleblower lawsuit under the False Claims Act brought on by a former employee at AngioDynamics and the British manufacturer of the drug delivery device LC Bead, known as Biocompatibles, the US Department of Justice (DOJ) announced earlier this month.
“This relates to the resolution of a matter previously reported over a year ago by the company in public filings,” Steve Trowbridge, AngioDynamics senior VP and general counsel, told Focus.
Of the total settlement amount, $11.5 million relates to AngioDynamics’ alleged marketing of LC Bead “for use as a drug-delivery device in combination with chemotherapy drugs” while serving as Biocompatibles’ US distributor, DOJ said. The US Food and Drug Administration (FDA) has twice declined this indication for use of the LC Bead, according to DOJ.
The firm allegedly caused healthcare providers to use inaccurate billing codes to skirt insurers that had declined to provide LC Bead coverage for certain procedures.
“The basic legal rule in this area could be mastered by a third-grader: Don’t lie,” said John Bash, US attorney for the Western District of Texas. “If you do, you will be held accountable. This settlement reflects that.”
As part of the settlement, AngioDynamics will also pay $1 million to resolve false claims allegations over use of its Perforator Vein Ablation Kit (PVAK). The firm initiated a voluntary recall and rebranded the device as the 400-micron kit after it failed to obtain FDA clearance for a new use in 2011.


© 2022 Regulatory Affairs Professionals Society.