Alere Inc. and Alere San Diego Inc., Medical Device Fraud, New Jersey 2023

Medical device manufacturers Alere Inc. and Alere San Diego Inc. have agreed to pay $38.75 million to resolve allegations that the companies sold defective rapid point-of-care testing devices to Medicare beneficiaries.

The settlement announced on [Date] resolves allegations that, from 2008 to 2016, Alere knowingly sold defective INRatio blood coagulation monitors used by Medicare beneficiaries taking anticoagulant drugs, such as warfarin. For those patients, blood coagulation monitoring is essential to determining a clinically appropriate and safe dosage for their medications.

Too much of an anticoagulant drug can cause major bleeding, and too little of the drug can cause blood clots and strokes. The INRatio devices allegedly contained a material defect, which produced inaccurate and unreliable results for some patients. Alere allegedly concealed the defect for years and billed Medicare for the use of defective INRatio devices.

“Patients and health care providers rely on diagnostic devices to provide reliable health information,” said Acting Assistant Attorney General Brian M. Boynton. “The government will hold accountable medical device companies that knowingly sell defective products that can harm patients and waste taxpayer dollars.”

“Health care companies have an obligation to be candid and clear in their disclosures to the FDA,” said Acting U.S. Attorney Rachael A. Honig. “The government expects companies to be proactive in investigating issues affecting patient safety. The U.S. Attorney’s Office for the District of New Jersey will hold accountable any company that fails to meet these obligations.”

“Companies that withhold information from or provide false information to FDA put patients’ health at risk and jeopardize the integrity of the regulatory process designed to protect the public health,” said Timothy Stenzel, M.D., Ph.D., Director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.

“Medical device providers who cut corners or purposefully market defective tools put profit above patient health,” said Special Agent in Charge George M. Crouch Jr. of the FBI. “The FBI will not sit idly by when people’s lives are at risk. It’s an ill-advised business model that ignores the consequences of getting caught.”

The settlement was the result of a coordinated effort between the Civil Division’s Commercial Litigation Branch (Fraud Section) and the U.S. Attorney’s Office for the District of New Jersey, with investigative support from the FBI’s Newark Division and Healthcare Fraud Unit Major Provider Response Team and the Department of Health and Human Services, Office of Inspector General.

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