Devices

Entellus Medical, Doctor, Resolve False Claims Suit

Entellus Medical and Jeffrey Gallups, founder, owner, medical director, and past-CEO of Milton Hall Surgical Associates (MHSA), that employed multiple physicians throughout north Georgia, have agreed to pay about $1.2 million and $3 million respectively to resolve allegations they violated the False Claims Act through an unlawful kickback arrangement. A Department of Justice statement says the claims were first raised by a whistleblower who was a former MHSA physician-employee. He will receive about $614,000 from the settlement.

The government alleges that Entellus, which manufactures products used in sinus surgery, paid kickbacks to Gallups to induce him to direct MHSA physicians to use Entellus sinusplasty medical devices and to increase the volume of sinus surgeries performed at MHSA.

The department says Entellus was acquired by Stryker in 2017 and its compliance personnel flagged the arrangement and elected not to renew it. Stryker agreed to pay $1.2 million to resolve claims arising from the alleged Gallups/Entellus kickback arrangement.

The government also says that in or around 1/2016, Gallups entered into a kickback arrangement with NextHealth, a now-defunct medical laboratory, under which he directed MHSA doctors to order toxicology and genetic tests from NextHealth despite physician objections that the tests were not necessary. NextHealth reportedly paid Gallups a “commission” of 50% of the revenue generated from the tests.

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