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Ra Medical Systems and Physicians Pay Over $8M to Resolve Kickback and FCA Allegations Relating To PAD Medical Laser

Posted  September 26, 2024

Yesterday, the DOJ announced Ra Medical Systems, Inc. and two physicians have agreed to collectively pay over $8 million to settle kickback and False Claims Act allegations related to a medical laser marketed for atherectomies to treat peripheral artery disease (PAD). The settlement includes payments from Dr. Elias Kassab of Michigan and Dr. David Allie of Louisiana for allegedly accepting kickbacks to use and promote the laser.

Here’s what happened:

  • Ra Medical manufactured and sold a device called the DABRA laser between 2017 and 2019. It was supposed to help treat peripheral artery disease, a condition where arteries get blocked by plaque, but the FDA had not approved it for this specific use.
  • Despite knowing the laser had serious issues—such as overheating and needing frequent adjustments, which led to a recall in 2019—Ra Medical continued to market it for use in atherectomies on PAD patients.
  • On top of that, Ra Medical allegedly gave doctors illegal incentives, like cash and fake consulting fees, in exchange for their use and promotion of the laser. This kind of practice is illegal under the Federal Anti-Kickback Statute, which is in place to make sure medical decisions aren’t influenced by money.
  • The two doctors, Kassab and Allie, were among the physicians who allegedly accepted these kickbacks.

U.S. Attorney Dawn Ison says that this case reflects their dedication to holding both companies and physicians accountable for these unethical practices, stating, “The United States will not allow doctors to hold out their hands expecting to be paid to use and promote a device.” She continues, “The millions of people who depend on our federal healthcare programs deserve and expect medical decisions untainted by kickbacks, and this settlement reflects our commitment to pursuing not just the companies that pay illegal kickbacks, but also the physicians who willingly extract and accept them.”

Federal investigators made it clear that kickbacks undermine public trust and harm programs like Medicare and TRICARE. “The payment of kickbacks to induce referrals can undermine trust in our nation’s providers,” said Mario Pinto of the U.S. Department of Health and Human Services. This case highlights the government’s continued efforts to prevent healthcare fraud and misuse of taxpayer dollars.

Have information about illegal kickbacks, or Healthcare & Pharmaceutical Fraud and want to report it? Don’t wait. Contact us to speak to a member of the Constantine Cannon whistleblower lawyer team for a free and confidential consultation.