BOSTON (Legal Newsline) — The Department of Justice announced that Acclarent Inc., a subsidiary of Johnson & Johnson, will pay $18 million after allegations of false claim violations related to circumventing the U.S. Food and Drug Administration (FDA) approval process.

“The FDA approval process serves an important role in ensuring that federal health care participants receive devices that are safe, effective and medically appropriate,” Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division, said. “We will not permit companies to circumvent that process and put profits over patient safety.”    

The company allegedly caused health care providers to submit false claims to Medicare by marketing a sinus spacer product as a drug delivery service without FDA approval of that particular use.

“The FDA plays a fundamental role in ensuring the safety and efficacy of medical devices and drugs in this country,” U.S. Attorney Carmen M. Ortiz said. “Every time that patients receive a medical device or fill a prescription they should be able to take for granted that the FDA’s requirements have been met. We will vigorously pursue those who ignore or seek to circumvent these important patient protections.”

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