Abbott INRatio

2021: Abbott will pay tens of millions for the sale of deliberately defective jellyfish

In July 2021, Abbott agreed to pay $66 million to settle legal disputes initiated by the US Department of Justice against its own subsidiaries under the Unlawful Claims Act (False Claims Act).

In particular, the medical equipment manufacturer will pay $38.75 million at the request of the federal court of Newark (New Jersey) to settle the lawsuit related to the subsidiary Alere, and $27 million to settle the lawsuit in the case of the subsidiary St. Jude Medical in federal court in Maryland.

Abbott agreed to pay $66 million to settle court disputes

According to a U.S. District Court lawsuit in Newark from 2008 to 2016, Alere deliberately sold faulty INRatio coagulometers used by people taking anticoagulant drugs such as warfarin. Control of blood coagulation parameters is necessary to determine safe doses of anticoagulants.

Alere, according to the investigation, knew that the algorithm implemented in the software, used in each version of INRatio coagulometers, had a significant defect. The US government claims that the company did not take appropriate action to resolve the problems until the recall of equipment at the level of 1st class in 2016.

As for the lawsuit in Maryland court, it says St. Jude Medical deliberately sold implantable  cardioverter defibrillators with problem batteries between November 2014 and October 2016. Abbott bought St. Jude Medical in 2017.

Medical equipment manufacturers are required to be honest with the Food and Drug Administration (FDA). The US government will not pay for devices that are unsafe and can lead to injury or death, "said Jonathan Lenzner, acting US attorney for one of Maryland's counties.[1]

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