Devices

Judge Hits Precision Lens with $487 Million Fine

A Minnesota federal judge has entered a $487 million judgment against Cameron-Ehlen Group, which does business as Precision Lens, for violations of the False Claims Act and Anti-Kickback Statute. The judgment stems from a jury finding earlier this year that the defendants violated the statutes by paying kickbacks to ophthalmic surgeons to induce their use of the company’s’ products in cataract surgeries reimbursed by Medicare. The jury found that 64,575 false claims were submitted to Medicare due to the illegal conduct, which resulted in $44 million in damages to Medicare.

“Under the False Claims Act (FCA), a person or entity found to have violated the FCA is liable to the United States Government for a minimum civil penalty of $5,000 per false claim and three times the amount of damages sustained by the Government,” a Justice Department release says. The judgment included $356 million in statutory penalties and an additional $131 million in trebled damages, it says.

During the earlier trial, the government identified multiple examples of trips to destinations on private jets that were provided to physicians for using company products. “Companies may not use expensive trips and other items of value to persuade physicians to use their products, and physicians may not accept that remuneration,” the government said.

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