Lawsuit accusing Abbott MitraClip of kickbacks will proceed

A federal judge rejected much of Abbott Laboratories’ bid to end a lawsuit accusing the medical device maker of using kickbacks to encourage doctors to perform MitraClip heart procedures.SAN DIEGO (CN) — A federal judge will allow a lawsuit accusing the medical device manufacturer Abbott Laboratories of giving kickbacks to doctors to encourage them to perform a medical procedure device to move forward.The lawsuit, initially filed in 2020, hinges on claims Abbott Laboratories provided cash, meals, marketing, and patient referrals to doctors who performed a heart procedure implanting its patented MitraClip device.The case is brought by the Department of Justice and more than two dozen state governments who say Abbott Laboratories’ scheme has caused thousands of false claims to government healthcare programs in violation of the Anti-Kickback Statute and False Claims Act.U.S. District Judge Todd Robinson, a Donald Trump appointee, ruled a jury could decide whether Abbott Laboratories was liable under those laws.The case was first brought by a whistleblower and former employee of Abbott Laboratories who says the kickbacks often took the form of expensive meals at fancy events. In the ruling, Robinson drew a line between ordinary meals at legitimate training events and events prosecutors say may have been used to improperly influence doctors.“In short, while MitraClip training events that served modest meals and beverages likely did not violate the Anti-Kickback Statute, relator’s evidence indicates that a reasonable jury could find that the training events held at expensive hotels with dinners at ‘fancy’ restaurants were of questionable educational value,” Robinson wrote. “Thus, the court denies Abbott’s motion to the extent it seeks summary judgment of claims related to the modest meals and beverages provided at educational training events.”Abbott Laboratories also sought to exclude testimony from the plaintiffs’ experts. The company argued Genevieve Kanter, a public policy expert who prepared MitraClip damages causation analyses, was unreliable and her research was irrelevant. If her testimony was excluded, the plaintiffs would have failed to show causation and summary judgment must be granted in its favor, the healthcare manufacturer argued.“Because Abbott challenges Dr. Kanter’s assumptions — that is, her assumption that the challenged activities violate the Anti-Kickback Statute — and not her methods or procedures, it goes to the weight of her testimony, not reliability,” Robinson found.The judge found her research was reliable, including her analysis into how payments can influence doctors without them even knowing. He denied Abbott’s motion to exclude her testimony.The healthcare manufacturer also sought to exclude testimony from Dr. John Karamichalis, a doctor with a specialty in cardiac surgery, as unqualified, because he was a pediatric surgeon with no experience with the MitraClip.But the judge also disagreed with this, finding that, despite never using the MitraClip, he had extensive qualifications and his testimony would ultimately be helpful.However, the judge granted summary judgment in favor of Abbott on its Florida and California claims, finding the plaintiffs did not provide credible evidence of a false claim.“Instead, relator must identify specific evidence of California or Florida Medicaid claims for MitraClip procedures from healthcare providers who allegedly attended a challenged activity,” Robinson wrote. “Because relator has not cited any such evidence, the court grants Abbott’s motion as to the California and Florida claims.”The ruling means the broader case can still proceed to trial.The MitraClip is a medical device used on patients who suffer from mitral regurgitation, which occurs when the heart’s mitral valve does not close all the way and blood flows back into the heart’s upper chamber. The result can cause the heart to work harder and, in some cases, fail.The MitraClip implantation procedure is described as minimally invasive and potentially life changing for people with mitral regurgitation.Although the device has been in use for about two decades, it was approved for use in the U.S. in 2013. The MitraClip procedure was approved for reimbursement under Medicare and Medicaid in 2014.Representatives for the parties did not immediately respond to requests for comment on the ruling.Subscribe to our free newslettersOur weekly newsletter Closing Arguments offers the latest about ongoing trials, major litigation and rulings in courthouses around the U.S. and the world, while the monthly Under the Lights dishes the legal dirt from Hollywood, sports, Big Tech and the arts.Additional Reads