Devices

Acclarent Agrees to pay $18 Million in Off-label Device Settlement

Johnson & Johnson subsidiary Acclarent has agreed to pay $18 million to settle a federal whistleblower false claims lawsuit alleging that the company marketed a sinus device for a drug delivery use not approved by FDA, and causing healthcare providers to submit false claims to Medicare and other healthcare programs. The settlement comes two days after a federal jury in Boston acquitted two former Acclarent executives on felony charges, but they were found guilty of misdemeanor charges of introducing adulterated or misbranded medical devices into interstate commerce (see earlier story).

Former Acclarent executives William Facteau and Patrick Fabian were indicted on 10 counts of introducing adulterated or misbranded medical devices into interstate commerce, one count of conspiracy, three counts of securities fraud, and four counts of wire fraud. The government alleged that the two engaged in a scheme to fraudulently drive up Acclarent revenues and stock valuation by illegally marketing a medical device known as the Relieva Stratus Microflow Spacer for uses not cleared or approved by FDA.

“Despite the fact that the company had told the FDA that the Stratus was a medical device intended to maintain an opening to a patient’s sinus, Facteau and Fabian launched the product intending it to be used as a steroid delivery device,” the government contended. The indictment alleged, however, that FDA had specifically refused Acclarent’s request to clear the Stratus for marketing as a drug delivery device without further submissions to support the use.

Facteau and Fabian are alleged to have concealed Acclarent’s illegal promotion and distribution from potential purchasers of the company. In 2010, Ethicon purchased Acclarent for $785 million, and Facteau and Fabian received $30 million and $4 million, respectively from the transaction.

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