NEW YORK – The US Attorney's Office for the District of New Jersey announced on Thursday that Alere and Alere San Diego agreed to pay $38.8 million to settle false billing allegations.
The companies, now part of Abbott, allegedly sold defective INRatio blood coagulation monitors to Medicare beneficiaries taking anticoagulant drugs and billed Medicare for the use of the defective monitors from 2008 to 2016. Alere allegedly knew the software algorithm in its monitors contained a material defect, a system limitation that provided inaccurate and unreliable results for some patients.
The systems were linked to more than a dozen deaths and hundreds of injuries, such as intra-cerebral hemorrhaging, the US Department of Justice said in a statement. The companies allegedly refused to take appropriate corrective measures until the devices were recalled by the US Food and Drug Administration in 2016.
In 2017, Alere settled another lawsuit, which alleged the firm sold the INRatio system despite knowing they were inaccurate and posed a risk to patients.
Abbott acquired Alere for $4.6 billion in October 2017.