Medtronic has reached an agreement to pay $85 million to shareholders who filed a lawsuit alleging that the company held back vital information and made misleading statements about the Medtronic Infuse bone growth product.
Shareholders filed the complaint against Medtronic after it was discovered that the company was relying heavily on “off-label” uses for the Infuse, failing to reveal that more than 85% of sales for the device were based off uses that were not approved by the FDA as safe or effective.
Medtronic Infuse is a bioengineered bone morphogenetic protein (BMP), which is used to encourage bone growth and replace spinal disks by filling the gaps between vertebrae. It was approved by the FDA in 2002 for use in lumbar fusion surgery, but it has been widely used off-label, paricularly for cervical fusions, which have been found to carry a risk of serious and potentially life-threatening complications.
In 2008, the Minneapolis Firefighter’s Relief Association filed the investor lawsuit over the Medtronic Infuse, alleging that the manufacturer’s stock price was artificially inflated because investors were unaware that so much of the Infuse’s value was based on potentially illegal marketing and off-label use.
Under terms of the settlement, Medtronic denies any wrongdoing but agreed to pay $85 million to investors who owned Medtronic stock between November 20, 2006 and November 17, 2008.
In 2008, the FDA issued an alert advising doctors not to use the Medtronic Infuse in upper spinal fusion procedures, after receiving dozens of reports involving potentially fatal complications that included swelling of the neck and breathing difficulties.
A number of patients have had to receive respiratory support tracheotomies, insertion of feeding tubes, anti-inflammatory medications and additional surgery after experiencing problems with Medtronic Infuse when used off-label during a cervical spine surgery.
The U.S. Department of Justice initiated an investigation into the actions of Medtronic that same year, investigating whether the manufacturer illegally promoted and marketed the Infuse bone graft for use in the cervical spine. While doctors are allowed to use FDA approved medical devices for non-approved purposes, the manufacturer is not allowed to promote or encourage such uses that they have not established as safe and effective.
Last year, concerns also emerged that the Medtronic Infuse bone graft may increase the risk of cancer. There have also been concerns that med treated with Medtronic Infuse may face a risk of sterility.