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Integra LifeSciences Must Face Fraud Suit Over Off-Label Device

April 7, 2022, 3:17 PM

Integra LifeSciences Corp. wasn’t able to stop a whistleblower’s claims that the company violated the False Claims Act by improperly promoting a brain electrical activity monitor for off-label use, a Missouri district court said.

Carol Hinton plausibly alleged that Integra LifeSciences caused physicians to improperly bill federal health-care programs by using Auragen devices in an unsafe and not medically necessary manner, Judge Stephen R. Bough of the U.S. District Court for the Western District of Missouri said in a Wednesday order.

Hinton said she knows of several patients who were harmed when the device used for purposes not approved by ...