Johnson & Johnson Unit to Pay $18 Million to Settle False Claims Act Allegations
Acclarent Inc., a subsidary of Johnson & Johnson has settled with the Department of Justice amid allegations that the Company marketed a sinus delivery device known as “Stratus” as a drug delivery device without FDA approval. Acclarent only received FDA approval to use “Stratus” as a spacer used only with saline to maintain sinus openings following surgery. However, “Stratus” was intended to be used as a drug-delivery device for prescription drugs. Acclarent continued to use “Stratas” as a drug delivery device even after the FDA rejected the company’s request to expand “Stratas”‘s use in 2007.
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