Devices

Justice Dept. Sues SpineFrontier Over Kickbacks

The Justice Department has filed two False Claims Act lawsuits against SpineFrontier and related entities and executives, alleging that the company paid kickbacks to spine surgeons to induce the use of SpineFrontier surgical devices, which is in violation of the Anti-Kickback Statute. According to the complaint, defendants paid spine surgeons over $8 million in sham “consulting” payments for “product evaluations,” when actually the payments were for using company devices.

The government contends that the company generally paid “consulting” spine surgeons $500 for a cervical procedure, and $1,000 for a lumbar procedure as long as they used SpineFrontier devices. It alleges that consulting surgeons often performed little or no work beyond implanting the devices, which they were paid separately by insurers.

The lawsuits were originally filed under the whistleblower provisions of the False Claims Act by Charles Birchall, Jr., a former employee of a SpineFrontier, former company sales manager John Miller, and former sales rep Walter Bennett.

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