Zyno Medical Fined $500K for Defective Infusion Sets

Zyno Medical, a Mass-based medical device manufacturer, will pay $493,140 to settle allegations that it violated the False Claims Act over submitting claims to Medicare for intravenous (IV) medication administration using devices Zyno knew were materially defective.
 
Zyno was charged with knowingly distributing defective IV administration sets to deliver controlled chemotherapy doses and other medications to Medicare beneficiaries. As part of the settlement, the company admitted it knew as early as November 5, 2015 certain of its administration sets—the Z-800 series of infusion pumps—had a defect that caused leaks during infusion.
 
Zyno further admitted it didn’t institute a recall of the defective sets until July 29, 2016 and continued to sell affected administration sets for a period of time.
 
“Medicare patients who need chemotherapy or other medication administered intravenously should not have to worry about whether the devices used for their treatment will deliver the intended dosage,” Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division, told the press. “We will pursue appropriate relief when health care providers, including medical device manufacturers, knowingly put the safety and welfare of federal healthcare program beneficiaries at risk.”
 
“Medical device manufacturers who knowingly sell materially defective products undermine the integrity of federal health care programs,” added Special Agent in Charge Phillip M. Coyne of the Department of Health and Human Services Office of Inspector General (HHS-OIG). “We will continue to work with concerned citizens, the Department of Justice, and our investigative partners to ensure the federal government only pays for honest, high quality health care products and services.” 
 
The whistleblower suit was brought by former Zyno territory manager John Bertucci and former Zyno VP of sales Lowell Warner.