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Robert B. Vogel, MD, JD
Retinal Ophthalmologist at Piedmont Eye Center, Lynchburg VA;
Attorney, Overbey Hawkins & Wright, PLLS, Lynchburg, VA;
Adjunct Professor, Humanities and Bioethics, Liberty University School of Medicine, Lynchburg, VA.
Medical device manufacturer AngioDynamics Inc. will pay the federal government $12.5 million to resolve allegations that it used misleading statements to promote two of its products, causing healthcare providers to submit false claims to federal healthcare programs.
One of the products was LC Bead, which was marketed as a chemotherapy drug delivery device. It was alleged that from May 2006 to December 2011, AngioDynamics touted the device’s “superior” performance, even though the Food and Drug Administration (FDA) had denied approval twice.
It also was alleged that AngioDynamics, aware that many insurers declined to provide coverage for LC Bead, instructed providers on how to inaccurately bill for LC Bead procedures and that claims were submitted with incorrect codes. AngioDynamics settled this part of the case for $11.5 million.
The other allegation was that AngioDynamics marketed another product, the Perforator Vein Ablation Kit (PVAK), in a similar manner and again caused providers to submit false claims to healthcare programs. The PVAK was not approved by the FDA to treat perforating veins. After the FDA declined approval, the company rebranded the product but continued to market it as one that treated perforating veins. AngioDynamics has agreed to pay $1 million to resolve this allegation.
The whistleblower who brought this case under the qui tam provision of the False Claims Act will receive approximately $2.3 million. At press time, there was no mention of the settlement on the AngioDynamics website. The settlement is not an admission of wrongdoing by AngioDynamics.
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