Alere Settles False Claims Act Allegations for $33.2 Million

Massachusetts-based medical device manufacturer Alere (acquired by Abbott Laboratories in 2017) and its subsidiary Alere San Diego recently entered into a settlement agreement with the federal government to pay $33.2 million. The settlement stems from allegations that Alere’s faulty diagnostic devices misinformed clinicians, and therefore, led to unnecessary medical care. According to the United States Department of Justice (DOJ), from 2006 to 2012, Alere sold its Triage-branded devices to hospitals, even though the company was on the receiving end of many customer complaints warning of erroneous results. Those devices were then used in emergency departments to diagnose acute coronary syndromes, heart failure, drug overdoses, and other serious conditions. Using a sample of a patient’s blood, clinicians could use certain Triage devices to diagnose cardiac conditions. Other devices were used for toxicology testing by collecting a urine sample. According to the government, some of Alere’s devices specifications differed materially from the product labeling, which resulted in certain devices having less precision than was indicated. One of the issues the DOJ took with Alere was that the company failed to take appropriate corrective actions to solve the problem, though Alere personnel were aware of the issue and the fact that the decreased precision put the company at a considerable regulatory and financial risk. It wasn’t until a United States Food and Drug Administrat...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs