The makers of Alere InRation blood test strips have agreed to pay $38.75 million to resolve False Claims Act charges brought by the Assistant U.S. Attorney for the District of New Jersey, alleging the Medicare program was billed for for defective blood coagulation monitoring products.
According to a press release issued last week by the U.S. Department of Justice (DOJ), Alere, Inc. and Alere San Diego, Inc. have resolved claims that diagnostic devices were sold with a known materially defective algorithm, which allegedly resulted in more than a dozen deaths and hundreds of injuries among users of the INRatio test strips.
The DOJ indicates that from 2008 to 2016, Alere knowingly sold defective INRatio-blood coagulation monitors used by Medicare patients taking anticoagulant drugs. For patients, blood coagulation monitors are essential because they assist patients in taking the proper amount of anticoagulant drugs.
The dosage of anticoagulant drugs is crucial, and receiving too many anticoagulant drugs can cause major bleeding, while too little can cause blood clots and strokes.
U.S. prosecutors say Alere knew the software algorithms for the monitors had a material defect. Alere allegedly was aware that INRatio devices had a “system limitation,” which produced inaccurate and unreliable results for some patients.
The problem is specifically with Prothrombin Time values, a measure of how long it takes blood to clot, which the INRatio meter software cannot reliably determine, according to the government’s complaint. Alere received repeated warnings, even from their own personnel, that the monitor was flawed, the DOJ alleges.
A developer from Alere stated that the flaw could be “identified & mitigated” by changing the INRatio algorithm, which would eliminate serious errors. The developer attempted to fix the algorithm, but did not identify an acceptable solution that meaningfully reduced discrepant results.
Alere did not pursue further work to fix the problem and acknowledged internally it made “a business decision” to close their Corrective and Preventive Action (CAPA) investigation without fixing the INRatio algorithm defect, according to the allegations.
The Justice Department claims Alere falsely reported information that it had “investigated” the INRatio meters to the Food and Drug Administration (FDA). Alere stated in their results that the investigation “did not uncover any deficiencies” in the meters.
Over eight years, the known INRatio problems became linked to more than a dozen deaths and hundreds of injuries, including gastrointestinal bleeding, bleeding requiring surgery such as endoscopic cautery or repair, bleeding requiring a blood transfusion, intra-cerebral hemorrhaging, and cardiovascular events following a bleeding episode.
The United States government alleged Alere concealed the defect for years and billed Medicare for the use of defective INRatio devices.
An Alere INRatio recall was announced in July 2016. Alere will pay $38.75 Million to settle False Claims Act violations but did not admit guilt, according to the settlement agreement filed on July 2 by the United States Attorney’s Office for the District of New Jersey.
“Patients and health care providers rely on diagnostic devices to provide reliable health information,” Acting Assistant Attorney General Brian M. Boynton, of the Justice Department’s Civil Division, said in the press release. “The Department of Justice will hold accountable medical device companies that knowingly sell defective products that can harm patients and waste taxpayer dollars.”