Medtronic faces FCA suit over spinal device

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Amid a slew of personal injury lawsuits, Medtronic is facing whistleblower allegations that it violated the False Claims Act by improperly marketing a spinal device, according to STAT.

The suit, filed by Dan Abrams Co. LLC, says although the device—known as the INFUSE system—was approved by the FDA exclusively for the thoracic and lumbar spine, emails from the Medtronics marketing team reveal the company routinely sold the devices for cervical spine procedures. This resulted in devastating side effects for some patients.

According to the company’s annual SEC filing released in June, Medtronic has set aside $140 million to resolve approximately 6,000 claims surrounding the spine implants. The device manufacturer is also facing allegations from Humana that it conspired with physicians to promote unapproved uses of the spine devices. The manufacturer has received subpoenas from five different states.

 But attorneys told STAT the new FCA allegations could come at a significant cost.

“As a practical matter, this type of case could result in astronomical penalties,” Ross Brooks, an attorney with Sanford Heisler LLP told STAT.

Medtronic is no stranger to FCA lawsuits. In 2008, the device manufacturer paid $75 million to resolve allegations against a subsidiary accused of inducing unnecessary spine procedures, which led to a $34 million federal settlement with 56 hospitals that performed the procedures.

- here’s the STAT article

- see Medtronic’s SEC filing