Medtronic, one of the world’s most prominent manufacturers of medical devices, has been named in a whistleblower lawsuit alleging that it regularly promoted its spinal implants for use in the neck despite the fact that the devices were not approved for such use by the FDA and specifically were labeled as being inappropriate for the cervical spine. The specific implant was the Medtronic VERTE-STACK, which is “intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine” and is part of Medtronic’s INFUSE Bone Graft system. The whistleblower suit alleges that Medtronic defrauded government healthcare entities by charging for the implantation of the spinal implant devices when the company knew that the use was illegal or unsafe. The company is already facing thousands of potential personal injury lawsuits related to the INFUSE products.
This lawsuit is just one example of what seems to be a common practice for medical device and pharmaceutical drug manufacturers – promoting “off-label” use of its products to physicians despite federal prohibitions against such practices and despite the risk for patient safety. Such practices, while making millions for medical device manufacturers, pose significant and sometimes deadly risks to patients who are implanted with the devices.
The personal injury attorneys at SUGARMAN have litigated complex medical device and defective product cases for decades. If you believe you may have a claim involving a defective medical device, please fill out a Contact Form, call us at (617) 542-1000 or e-mail email@example.com.