Massachusetts-based medical device manufacturer Zyno Medical LLC (Zyno) has agreed to pay $493,140. The device Zyno knew had serious flaws.
The settlement announced today resolves allegations that Zyno knowingly distributed defective IV administration sets used to administer controlled doses of chemotherapy and other drugs to Medicare recipients. is. As part of the settlement, Zyno acknowledged that on November 5, 2015, certain administration sets sold for use with his Z-800 series of IV infusion pumps were defective and that defects were found during use. He admitted that he was aware of what caused the leak. drug injection. Zyno further acknowledged that it did not begin recalling the defective admin set until July 29, 2016, and in fact continued to sell additional affected admin sets for a period of time.
“Medicare patients who need intravenous chemotherapy or other drugs need not worry about whether the device used for their treatment will deliver the intended dosage,” said the head of the Department of Justice’s civil affairs division. said Deputy Commissioner Brian M. Boynton. “We will seek appropriate redress when health care providers, including medical device manufacturers, knowingly endanger the safety and well-being of beneficiaries of federal health care programs.”
“Medical device manufacturers who knowingly market seriously defective products undermine the integrity of the federal healthcare program,” said Philip M. Coyne of the Department of Health and Human Services Inspector General’s Office (HHS-OIG). special investigator said. “We will continue to work with concerned citizens, the Department of Justice, and investigative partners to ensure that the federal government pays only for honest, high-quality health care products and services.”
A civil settlement includes the settlement of claims brought under litigation. Kitam Or the False Claims Act Whistleblower Provisions by John Bertucci, Zyno’s former territory manager, and Lowell Warner, Zyno’s former VP of Sales. Under these provisions, private individuals may sue on behalf of the United States and receive a portion of any recovery.of Kitam Caption on case Foreign Relations Bertucci et al. v. Zyno Medical LLC et al., No. 20-cv-10388-WGY (D., MA). As part of today’s resolution, whistleblowers will receive approximately $100,000.
The resulting solution to the problem was the result of a coordinated effort between the Civil Division’s Commercial Litigation Division, Fraud Division, and the District of Massachusetts Attorney’s Office, with support from the Department of Health and Human Services, Office of the Inspector General. I was. and the FBI Boston Field Office.
The investigation and resolution of this issue shows the government’s focus on combating medical fraud. One of the most powerful tools in this effort is the False Claims Act. Tips and complaints from any source regarding potential fraud, waste, abuse or mismanagement may be reported to the Department of Health and Human Services at 800-HHS-TIPS (800-447-8477).
The matter was handled by Civil Division Counsel Joanna G. Persio and Assistant U.S. Attorney for the District of Massachusetts Charles B. Weinograd.
Claims resolved by the Settlement are claims only, not determinations of liability.