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Local medical device manufacturers to pay nearly $39 Million over defects

Posted at 9:15 PM, Jul 08, 2021
and last updated 2021-07-09 00:15:27-04

SAN DIEGO (CNS) - Two medical device manufacturers -- one of which was previously headquartered in San Diego -- will pay nearly $39 million to resolve allegations that they knowingly sold defective blood coagulation monitors and billed Medicare for them, the Department of Justice announced Thursday.

Prosecutors allege Alere Inc. and Alere San Diego Inc. sold INRatio devices used by Medicare beneficiaries taking anticoagulant drugs, while knowing the monitors contained a material defect that provided inaccurate and unreliable results for some patients.

The devices included a reusable meter and disposable test strips to measure a patient's blood clotting. According to the DOJ, such monitoring "is essential to determining a clinically appropriate and safe dosage for (patients') medications."

But federal prosecutors said the INRatio systems were "linked to over a dozen deaths and hundreds of injuries, including intra-cerebral hemorrhaging and cardiovascular events following bleeding episodes," but the companies concealed the defect and submitted false claims to Medicare for the devices' purchase and use.

"If Alere had properly disclosed INRatio's defect, Medicare would not have paid those claims, which were for the use of an INRatio system that was neither reasonable and necessary, nor safe and effective," according to the settlement agreement.

Alere also allegedly didn't correct the issue until 2016, when the devices were removed from the market following a recall undertaken at the FDA's request.

The company was acquired by Abbott Laboratories in 2017, but prosecutors allege the conduct outlined in its complaint occurred prior to the acquisition.

Alere denies the allegations, according to the settlement agreement filed in New Jersey federal court.

"Patients and health care providers rely on diagnostic devices to provide reliable health information," Acting Assistant Attorney General Brian M. Boynton of the Department of Justice's Civil Division said. "The Department of Justice will hold accountable medical device companies that knowingly sell defective products that can harm patients and waste taxpayer dollars."