In addition to personal injury and wrongful death lawsuits pending over Medtronic’s Infuse bone graft device, the company is now facing heat from its shareholders, who filed a securities fraud lawsuit against the company over allegations that they artificially inflated stock prices with dangerous off-label promotional schemes.
About Medtronic’s Infuse
Medtronic’s Infuse was approved by the FDA in 2002 for the treatment of degenerative disc disease in the lower spine.
It is comprised of a special bone growth substitute (rhBMP) surrounded by a protective metallic cage.
In 2008, the FDA issued a warning concerning off-label use of the Medtronic Infuse Bone Graft in the cervical spine (near the neck).
Off-label use in the cervical spine has reportedly led to life-threatening complications including swelling of the airways, which causes difficulty breathing, speaking and swallowing.
Medtronic is now facing several lawsuits over injuries and deaths linked to the use of Infuse in cervical spine surgeries.
About the Lawsuit
The securities lawsuit alleges that Medtronic artificially inflated stock price through ‘off-label’ promotional schemes, including promoting Infuse for use in the cervical spine.
The suit further alleges that Medtronic’s highly paid doctor-consultants downplayed the safety risks of Infuse and that Medtronic’s improper off-label marketing and revenue growth were directly tied to troubling and financially dangerous safety concerns.
These safety risks led to serious injury and death among patients, and prompted investigations into the safety of Infuse, which caused stock prices to fall.
In the latest development, the federal judge hearing the case ordered Medtronic to produce documents detailing the safety record of the bone growth protein used in Infuse.
Contact an Experienced Defective Medical Device Attorney
Thomas J. Henry are leaders in the area of product liability litigation. Our Defective Drug and Products Division has extensive knowledge and resources in order to represent our clients efficiently and aggressively.
Your choice does matter. If you or a loved one has suffered serious injuries because of Medtronic’s Infuse, call the Thomas J. Henry immediately. We are available 24/7, nights and weekends.