Alere to Pay $33.2 Million to Settle FCA Violation Allegations

hush-naidoo-382152-copy-300x200Alere, Inc. and its wholly owned subsidiary Alere San Diego agreed to pay the U.S. $33.2 million to resolve allegations that the medical device manufacturer violated the False Claims Act. (Alere was acquired by Abbott, one of the world’s largest healthcare companies, in October 2017.) According to the Department of Justice (DOJ) press release, Alere caused hospitals to submit inaccurate claims to Medicare, Medicaid, and other federal healthcare programs by willfully selling unreliable point-of-care diagnostic testing devices.

If you are aware of a company knowingly selling inaccurate medical devices, call a San Francisco healthcare fraud attorney at Brod Law Firm today.

Fraudulent Medical Devices Lead to False Claims

Between January 2006 and March 2012, the U.S. alleged that Alere knowingly and intentionally sold materially unreliable medical devices. These devices were rapid point-of-care testing devices known under the trade name “Triage.” The purpose of the Triage devices was to help physicians diagnose acute coronary syndromes, heart failure, drug overdose, and other serious medical conditions. The Triage devices were often used in emergency departments and were relied on by physicians to make quick and critical decisions affecting patient care.

Alere received numerous customer complaints regarding the Triage devices. The company was on notice that certain devices provided incorrect results, such as false positives or negatives, which adversely impacted physician decision-making. Despite being on notice of the defect, Alere failed to take any correct actions until the U.S. Food and Drug Administration conduct inspections, which prompted a nationwide recall in 2012.

Alere is set to pay $33.2 million, of which $28,378,893 will go to the federal government and $4,860,779 will go to various states.

Alere Settlement Arose From a Qui Tam Claim

The lawsuit against Alere was filed under the qui tam provision, also known as the whistleblower provision, of the False Claims Act. This provision enables a private individual to file a lawsuit against a party on behalf of the government. The Alere suit was filed by Amanda Wu, who previously worked at Alere as a senior quality control analyst.

One of the benefits of being a whistleblower and filing a qui tam suit is receiving a portion of the government’s financial recovery. We will receive about $5.6 million from the Alere settlement.

Do You Have Information About Healthcare Fraud?

If you believe you have proof of healthcare fraud conducted by a business or individual within the medical industry, do not hesitate to speak with a San Francisco healthcare fraud lawyer. An experienced qui tam lawyer from Brod Law Firm will thoroughly review your situation and advise you of your rights. Depending on your documentation, your lawyer may recommend moving forward with a qui tam suit, in which case you will file a civil lawsuit against the business or individual. The qui tam suit is filed under seal and the federal or state government is notified, enabling it to investigate your claims. If your qui tam suit leads to the government obtaining a financial recovery, you may receive a portion of the settlement or court award.

To learn more, contact Brod Law Firm at (800) 427-7020.

(image courtesy of Hush Naidoo)