Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory

Liability for Off-Label Use of Medical Devices
Since 2009, over $2.4 billion has been awarded for federal health care fraud in False Claims Act actions, including actions for the illegal marketing of medical devices not approved by the FDA.

Medical device manufacturers and physicians face significant liability for the off-label use of medical devices, potentially facing claims of malpractice, overpromotion, products liability, fraud, and more. This is dangerous territory that must be navigated with precise care.

BONUS: Because the liability of a device manufacturer is important in litigation involving injury from the off-label use of a medical device, this perspective has been discussed in addition to the perspectives of the attorney, physician, insurer, and employer.