Ra Medical Systems and affiliated physicians will pay over $8 million across three settlements to resolve allegations that they colluded in a kickback scheme related to Ra Medical's Dabra laser.
The company allegedly marketed the Dabra laser for use in atherectomies without approval by the FDA, according to a Sept. 25 news release by the Department of Justice. The DOJ also alleges that Ra Medical marketed the Dabra laser despite performance issues that caused frequent calibration and overheating problems, posing a risk to physicians and patients. The Dabra laser was recalled in August 2019.
The DOJ also alleged that Ra Medical knowingly offered and paid kickbacks to certain physicians to encourage them to use the Dabra laser in violation of the federal anti-kickback statute. The alleged kickbacks consisted of cash payments and fees in connection with training events and consulting services, and physicians were identified and tracked as high-volume customers and potential targets of the scheme through an internal document titled "Who Deserve[] Love."
Two recipients of the alleged kickbacks were Elias Kassab, MD, of Dearborn, Mich., and David Allie, MD, of Lafayette, La. In a separate, second settlement, Dr. Kassab and two of his companies agreed to pay $450,00 to resolve allegations against them. In a third settlement, Dr. Allie and his consulting company agreed to settle allegations against them for $250,000. The settlement remains under seal as the DOJ continues to investigate Drs. Kassab and Allie, among others, who were allegedly involved in the scheme.