A senior quality control analyst at Alere filed a qui tam lawsuit alleging the company’s testing and diagnostic devices for heart patients and others were unreliable.
Whistleblower Amanda Wu was awarded $5.6 million when Alere settled the allegations.
She filed her qui tam lawsuit under the False Claims Act in federal court in San Diego in 2011.
Last week, Massachusetts-based Alere and its subsidiary Alere San Diego agreed to pay the United States $33.2 million to resolve the case.
Alere caused hospitals to submit false claims to Medicare, Medicaid, and other federal healthcare programs by “knowingly selling materially unreliable point-of-care diagnostic testing devices,” according to the DOJ.
The DOJ’s Chad Readler said, “The United States is fortunate that innovative healthcare companies regularly develop medical devices that improve patients’ lives, often in remarkable ways.”
But the DOJ will hold medical device manufacturers accountable “if they knowingly sell defective products that waste taxpayer dollars and adversely impact patient care,” Readler said.
Between January 2006 and March 2012, Alere “knowingly sold materially unreliable rapid point-of-care testing devices marketed under the trade name Triage®,” the DOJ said.
The Triage® devices aided in the diagnosis of acute coronary syndromes, heart failure, drug overdose, and other serious conditions.
The devices were frequently used in emergency departments.
The DOJ said Alere customers complained that some of its devices “produced erroneous results that had the potential to create false positives and false negatives that adversely affected clinical decision-making.”
Despite the complaints, Alere didn’t take “appropriate corrective actions” until FDA inspections prompted a nationwide product recall in 2012.
Of the $33.2 million settlement, Alere will return $28.4 million to the federal government and $4.6 million to individual states that funded claims for Triage devices with state Medicaid programs.
The whistleblower or qui tam provision of the False Claims Act permit private parties to sue on behalf of the United States for false claims and share in a portion of the government’s recovery.
The DOJ can take over qui tam actions, as it did in this case.
Abbott Laboratories bought Alere in October 2017.
Amanda Wu’s lawyer was Kenneth Nolan of Nolan Auerbach & White.
He said, “Our client was the lone relator behind this important qui tam recovery. As a member of the Quality Control Department, she vowed to protect the health and safety of patients. She honorably fulfilled that pledge with the help of the federal and state governments.”
The lawsuit was United States ex rel. Amanda Wu v. Alere San Diego, et al., No. GLR-11-CV-1808.
Richard L. Cassin is the publisher and editor of the FCPA Blog.