Devices

Alere Settles FCA Allegations for $33.2 Million

The Justice Department says Alere will pay the federal government $33.2 million to resolve allegations that it caused hospitals to submit false claims to federal healthcare programs by knowingly selling materially unreliable point-of-care diagnostic testing devices. A government False Claims Act complaint said that between 1/2006 and 3/2012, Alere knowingly sold materially unreliable point-of-care Triage testing devices to aid in diagnosing acute coronary syndromes, heart failure, drug overdose, and other serious conditions. The complaint said the devices were frequently used in emergency departments where timely decisions are critical to ensure proper patient care.

A Justice Department news release says Alere had received patient complaints that put it on notice that certain of its devices produced erroneous results that had the potential to create false positives and false negatives that adversely affected clinical decision-making. Nonetheless, it says, the company failed to take appropriate corrective actions until FDA inspections prompted a nationwide product recall in 2012.

Of the $33.2 million, the Justice Department says, $28,378,893 will be returned to the federal government and $4,860,779 to individual states that jointly funded claims for Triage devices submitted to state Medicaid programs.

The settlement resolves a whistleblower suit filed under the False Claims Act by former Alere senior quality control analyst Amanda Wu. Under terms of the settlement, she received about $5.6 million.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome