Alere Medical - Credit: Google Street View
Massachusetts-based medical device manufacturer Alere and its San Diego subsidiary will pay $33.2 million to resolve allegations they violated the False Claims Act.
The Department of Justice said Alere was causing hospitals to submit false claims to Medicare and other federal healthcare programs related to the use of "materially unreliable" diagnostic testing devices.
The DOJ also alleged that for roughly six years, between January 2006 and March 2012, Alere knowingly sold unreliable devices for rapid point-of-care testing under the trade name Triage. The devices, often used in emergency departments, are meant to help diagnose acute coronary syndromes, heart failure, drug overdoses and other conditions.
The government argued that Alere knew some of its devices produced unreliable results, creating the dangerous potential for false results that could negatively impact clinical decision-making, and that Alere personnel knew of customer complaints regarding false results as well as the regulatory and financial risk created by the faulty devices and results but failed to take appropriate corrective actions until the FDA investigated, triggering a nationwide product recall in 2012.
"Physicians who work to treat patients with suspected myocardial infarctions rely upon devices such as Alere's Triage Cardiac products for quick and accurate readings," said Stephen Schenning, Acting United States Attorney for the District of Maryland. "When manufacturers such as Alere make changes to the specifications that affect the product's reliability without informing physicians or the FDA, patient care is put at substantial risk."
The settlement resolves a whistleblower or qui tam lawsuit filed in Maryland under which the relator, referred to by the DOJ as Ms. Wu, will receive $5,675,778. Under the qui tam provision of the False Claims Act relators are allowed to receive a portion of the recovery.
The federal share of the civil settlement is $28,378,893, and the state Medicaid share totaled $4,860,779.
The DOJ stipulated that the settlement did not include any admission of actual liability on Alere's part.