Spotlight on False Claims Act: Alere Settlement

Whistleblower to Receive $5.6 Million From False Claims Act Case

Last week, the Department of Justice announced that Alere, Inc., a Massachusetts-based medical device manufacturer and its San Diego subsidiary have agreed to pay the United States $33.2 million to resolve allegations that Alere, Inc. violated the False Claims Act.

The settlement resolves a lawsuit filed under the whistleblower provision of the False Claims Act, which permits private parties to file a lawsuit (sometimes called a qui tam lawsuit) on behalf of the United States and share in a portion of the government’s recovery.  From that settlement, the relator (which is the legal term for a whistleblower) will receive approximately $5.6 million.

According to the government, between January 2006 and March 2012, Alere knowingly sold unreliable rapid point-of-care testing devices marketed under the trade name Triage®. The Triage® devices aided in the diagnosis of acute coronary syndromes, heart failure, drug overdose, and other serious conditions, and the devices were frequently used in emergency departments where timely decisions are critical to ensuring proper patient care.

According to the government’s allegations, Alere received customer complaints that put it on notice that certain devices it sold produced erroneous results that had the potential to create false positives and false negatives that adversely affected clinical decision-making. Nonetheless, the company failed to take appropriate corrective actions until FDA inspections prompted a nationwide product recall in 2012.

Contact Crowder Stewart LLP

The attorneys at Crowder Stewart LLP have extensive experience in False Claims Act cases. Because of their background working for the federal government, the attorneys at Crowder Stewart LLP bring a comprehensive perspective to each case.  If we can assist you or your business in a False Claims Act matter, please do not hesitate to contact us at (706) 434-8799 or