Devices

Device Co. Kickback Scheme Costs Physician $1.75 Million

The Massachusetts U.S. Attorney’s Office has announced that physician Jeffrey R. Carlson (Newport News, VA) has agreed to pay $1.75 million to resolve allegations that he accepted kickbacks from SpineFrontier, a Massachusetts-based medical device manufacturer. In March, the government filed a False Claims Act complaint against SpineFrontier and its executives, alleging that the company paid kickbacks to spine surgeons through a sham third-party entity, Impartial Medical Experts, which was owned and controlled by SpineFrontier’s founder and CEO, Kingsley R. Chin.

As part of the settlement with Carlson, the government contends that he received kickbacks in the form of sham consulting fees. Carlson has admitted that he estimated his purported consulting hours based on the number of times he used a SpineFrontier product in a given month, as opposed to tracking actual time he spent consulting, according to the government. “In addition, Dr. Carlson sought and received consulting payments from SpineFrontier for time he spent during his surgical procedures, for which Medicare and other federal health care programs were already paying him,” it says. Carlson also admitted to accepting free meals from SpineFrontier, for himself and his surgical staff, on almost every day that he performed a surgical procedure with a SpineFrontier product.

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