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.
 |
Attorneys:
Counsel must develop a list of facts and circumstances, specific to the client’s fact situation, which demonstrates proof of an act causing an injury from the off-label use of a medical device.
|
 |
Physicians:
Physicians must consider this litigation checklist when defending an alleged medical malpractice or negligence claim arising from off-label use of medical devices.
|
 |
Insurers:
The insurer may use this litigation checklist to spot “red flags” and inconsistencies when investigating a claim of injury from an off-label use of a medical device.
|
 |
Employers:
A checklist for employers to determine if an off-label device use injury is "work-related."
|
|
Bonus:
A litigation checklist for the medical device manufacturer to determine if a warning was required, if it was given, if the warning was adequate, and if the use of the manufacturer’s device was the cause of the patient’s injury.
|
