BOSTON – Natick-based intravenous (IV) infusion pump manufacturer Zyno Medical, LLC (Zyno), has agreed to pay $493,140 to resolve allegations that it violated the False Claims Act.
The settlement resolves allegations that Zyno knowingly distributed defective IV administration sets that were used to deliver controlled dosages of chemotherapy and other medications to Medicare beneficiaries. As part of the settlement, Zyno has admitted that it knew as early as November 2015, that certain of its administration sets were defective, that the defect had caused leaks during the infusion of medication, and that the defect had the potential to cause such leaks during future infusion treatments. Zyno did not issue a recall for the affected medical administration sets, however, and even continued to sell affected medical administration sets for a certain period. In July 2016, Zyno finally issued a recall notice to its customers.
The civil settlement includes the resolution of claims that whistleblowers brought under the qui tam provisions of the False Claims Act. Under those provisions, a private party can file an action on behalf of the United States and receive a portion of any recovery. In connection with today’s settlement, the whistleblowers will receive twenty percent of the recovery. The qui tam case is captioned United States ex rel. Bertucci, et al. v. Zyno Medical LLC, et al., No. 20-cv-10388-WGY (D. Mass.).
United States Attorney Rachael S. Rollins; Principal Assistant Attorney General Brian M. Boynton, Head of the Justice Department’s Civil Division; Phillip M. Coyne, Special Agent in Charge of the Department of Health and Human Services’ Office of Inspector General; Fernando McMillan, Special Agent in Charge of the Food and Drug Administration, Office of Criminal Investigations; and Joseph R. Bonavolonta, Special Agent in Charge of the Federal Bureau of Investigation made the announcement today. Assistant U.S. Attorney Charles B. Weinograd of Rollins’ Affirmative Civil Enforcement Unit and Trial Attorney Joanna G. Persio of the Justice Department’s Civil Division, Commercial Litigation Branch, handled the matter.