As for the Judiciary, the U.S. Supreme Court did not issue any relevant decisions nor grant certiorari in any notable FCA cases in FY21. To the contrary, they denied petitions to review appellate cases of potential significance (e.g., in June 2021 the Supreme Court declined to review a case from the Seventh Circuit regarding the government’s ability to move to dismiss over a relator’s objection)....
St. Jude Medical agreed to pay $27 million to settle False Claims Act charges that it knowingly sold a defective heart device to health care facilities. St. Jude was acquired by Abbott Laboratories in early 2017. St. Jude failed to disclose serious health events caused by the early depletion of the battery in certain models of its Fortify, Fortify Assura, Quadra and Unify devices which...
The False Claims Act is a powerful enforcement tool. The Justice Department with its partner agencies are ramping up enforcement efforts. The Biden DOJ is preparing to implement an aggressive FCA program across healthcare, defense industries and other government contractors. Combined with this initiative, DOJ recently implemented an antitrust enforcement task force relating to government procurement. In this environment, companies have to address these risks...
The False Claims Act is a powerful enforcement tool. The Justice Department with its partner agencies are ramping up enforcement efforts. The Biden DOJ is preparing to implement an aggressive FCA program across healthcare, defense industries and other government contractors. The False Claims Act stands as a major risk – businesses that depend on government business, including healthcare, defense and other contractors, have to address...
The U.S. Attorney’s Office for the Southern District of California recently announced a settlement of a False Claims Act case against Tungsten Heavy Powder of San Diego (THP), which was filed and prosecuted by the Volkov Law Group on behalf of two relators, Global Tungsten & Powders Corporation (GTP), and Greg Caputo, a former employee of THP. GTP and Caputo filed the original lawsuit under...
Jessica Sanderson, Partner, The Volkov Law Group and Michael Volkov review significant developments in the civil False Claims Act (“FCA”) area from the past year. With mind-boggling federal spending in FY 2020 and the obvious potential for fraud, abuse, and misuse of the trillions of dollars of federal stimulus funds, we undoubtedly will see a considerable increase in FCA audits, investigations, enforcement actions, qui tam...
Medical device maker Merit Medical Systems (“MMS”) agreed to pay $18 million to resolve allegations that the company submitted false claims to Medicare, Medicaid and TRICARE by paying kickbacks to physicians and hospitals to induce increased use of MMS products. Dr. Charles J. Wolf, Merit’s former chief compliance officer, filed a whistleblower complaint against the firm in April 2016 following his resignation, in which he...
Dr. Charles Wolf was the Chief Compliance Officer at Merit Medical Systems, Inc. (“MMS”), who ultimately became the federal whistleblower against MMS alleging violations of the Anti-Kickback Statute. Dr. Wolf’s concerns were ultimately vindicated when the Justice Department intervened in support of his complaint. MMS settled the case with DOJ and agreed to pay $18 million. Dr. Wolf received $2.65 million from the settlement under...
Medical device maker Merit Medical Systems (“MMS”) agreed to pay $18 million to resolve allegations that the company submitted false claims to Medicare, Medicaid and TRICARE by paying kickbacks to physicians and hospitals to induce increased use of MMS products. MMS manufactures and markets disposable medical devices used in interventional and diagnostic procedures, including cardiology, radiology, oncology, critical care and endoscopy. The anti-kickback statute prohibits...
DOJ’s aggressive enforcement of the opioid industry is a striking example of the power of federal prosecutors when focused on an industry. Once prioritized for enforcement, DOJ has quickly brought together prosecutors and law enforcement to target corporate actors and companies with the full force of criminal and civil statutes. In a significant case, DOJ announced the resolution of its criminal and civil investigations against...
