In a first-of-its-kind case, the U.S. Attorney’s Office in Boston announced today that kaléo, Inc., the manufacturer of Evzio, an expensive naloxone drug, has agreed to pay $12.7 million to resolve allegations that, among other things, kaléo encouraged doctors to send Evzio prescriptions to particular pharmacies that then submitted fraudulent prior authorization requests to payers . . .
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Medical Device Company Arthrex Pays $16 Million to Resolve Whistleblower Allegations that the Company Paid Kickbacks to a Physician via “Royalty” Payments
On November 8, 2021, the United States Attorney’s Office in Boston announced that Arthrex Inc., a large, privately-held medical device company, agreed to pay $16 million to resolve a False Claims Act qui tam case alleging that Arthrex used the guise of royalties to pay millions of dollars in kickbacks to a prominent Colorado orthopedic surgeon, Peter . . .
Court Rejects Pfizer’s Attempt to Gut HHS-OIG Guidance on Co-Pay Assistance
In a 32-page decision issued late yesterday, Southern District of New York Judge Mary Kay Vyskocil granted summary judgment for the government in a case where pharmaceutical giant Pfizer challenged an HHS-OIG Advisory Opinion finding that Pfizer could violate the anti-kickback statute (AKS) if it went ahead with a proposal to provide co-pay assistance for . . .
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United States Indicts Spinal Device Company and Two of Its Executives for Paying Kickbacks to Spine Surgeons
On September 7, 2021, the U.S. Attorney’s Office in Boston announced a grand jury indictment of medical device company SpineFrontier, Inc., and two of its executives, Kingsley Chin and Aditya Humad, for violating the anti-kickback statute by allegedly paying surgeons bogus “consulting” fees to induce the surgeons to use SpineFrontier products in their surgeries. According to the . . .
D.C. Circuit Upholds Application of Overpayment Rule to UnitedHealthcare Medicare Advantage Plan
In a precedential opinion that likely have a significant impact on several large pending cases, the United States Court of Appeals for the D.C. Circuit today upheld application of the so-called Overpayment Rule, 42 C.F.R. § 422.326, to Medicare Advantage organizations. See UnitedHealthcare Insurance Co. v. Becerra, No. 18-5326 (D.C. Cir. Aug. 13, 2021) (“UHC”). Medicare Advantage . . .
Harvard Scientist Agrees to Pay $215,000 to Resolve Allegations that He Made False Statements to Get NIH Grants; Scientist Also Agrees Not to Deny Government’s Allegations
Dr. Sam W. Lee, formerly a Principal Investigator at Harvard Medical School and Massachusetts General Hospital (MGH), has agreed to pay $215,000 to resolve allegations that he submitted false information to get a grant from the National Institutes of Health (NIH) to do research involving “DNA damage response and carcinogenesis.” According to a settlement agreement finalized on . . .
California Hospital, Its CEO, and A Physician Pay $37.5 Million to Resolve False Claims Act Kickback Claims
On July 19, 2021, the United States Department of Justice and the California Department of Justice announced that they reached a $37.5 million settlement with a California hospital company, Prime Healthcare Services, its CEO, and a physician to resolve a variety of allegations, including that the hospital company paid kickbacks to the physician to get . . .
False Claims Act Case Brought by Patient Leads to $27 Million Settlement against Pacemaker Manufacturer St. Jude Medical
On July 8, 2021, the Department of Justice announced that pacemaker manufacturer St. Jude Medical (now owned by Abbott Laboratories) agreed to pay $27 million to resolve a False Claims Act qui tam action alleging that the company sold defective heart devices. Between 2014 and 2016, according to the government, St. Jude knowingly sold four . . .
Pharmaceutical Manufacturer Incyte Becomes Latest To Settle Co-Pay Foundation Kickback Allegations
On May 4, 2021, the Department of Justice announced that Incyte Corporation, a Delaware-based pharmaceutical company, agreed to pay $12.6 million to resolve allegations that it used a foundation, Chronic Disease Fund dba Good Days (“CDF”), to funnel kickbacks to Medicare patients taking its own drug. Incyte sells Jakafi, a drug that, through 2014, was approved only . . .
Court Sentences Pharmacy Owner And Others On Charges That They Paid Kickbacks To Pharmaceutical Sales Rep In Exchange For Prescription Referrals
On April 16, 2021, the Department of Justice announced that a court sentenced six individuals, including a Virginia pharmacy owner and a former sales representative for Kaléo Pharmaceuticals, after they pled guilty to a variety of criminal charges. Mohamed Abdallah, the owner of Medex Health Pharmacy and Royal Care Pharmacy, was sentenced to four years in prison . . .