Johnson & Johnson’s California-based medical device manufacturer Acclarent will pay the U.S. government $18 million plus interest to resolve allegations that it caused health care providers to submit false claims to Medicare and other federal health care programs by marketing and distributing its Stratus sinus spacer devices without U.S. Food and Drug Administration (FDA) approval. “The FDA approval process serves an important role in ensuring that federal health care participants receive devices that are safe, effective and medically appropriate,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “We will not permit companies ... Read More
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