Five plaintiffs have filed a product liability lawsuit against Infuse bone graft maker Medtronic, over complications resulting from the off-label use of the medical device. The complaint was filed in Superior Court in Los Angeles on December 6, by plaintiffs Dana Schuler, James Wadsworth, Lisa Smith, Deanna Perkins and Kim Hill, all of whom received the Infuse bone graft in spinal surgeries conducted between 2006 and 2012. According to the lawsuit, the plaintiffs have since suffered serious side effects of the Medtronic Infuse device, including neuropathy, muscle atrophy, bone overgrowth and more. If you believe you have been adversely affected by Medtronic Infuse complications, or side effects of another potentially dangerous medical device, contact a knowledgeable product liability lawyer in your area to discuss your legal options.
According to the Medtronic Infuse lawsuit, the bone graft device was used off-label in the five separate surgeries, with surgeons implanting the device into the cervical spine of the patients. While the Infuse product has been approved by the U.S. Food and Drug Administration (FDA) for use in specific surgeries involving the lower spine, the controversial medical device has not been approved for use in the cervical spine area, which is where it was implanted in all five cases. Despite this lack of approval, Medtronic has marketed its Infuse bone graft device for off-label purposes, including use in cervical spine procedures.
In their complaint, the five plaintiffs allege that, prior to their surgeries, they were not properly warned by Medtronic about the risks associated with the medical device, nor were their surgeons. Previous reports have indicated a risk of major Infuse bone graft complications tied to off-label use of the product, including male sterility, bone overgrowth, increased cancer risk and urinary complications. In this Medtronic Infuse lawsuit, all five plaintiffs reportedly suffered severe complications associated with the bone graft device that have caused them emotional distress, persistent pain and the need for ongoing medical treatment.
The Infuse bone graft was first approved by the FDA in 2002 for use in specific spinal surgeries, and approval has since been extended to treatment for certain dental procedures and tibia injuries. The medical device functions by filling in spaces where bone is missing and is supposed to help the bone heal following surgical procedures. Unfortunately, mounting research has identified a host of potential risks associated with the Medtronic Infuse device, and anecdotal evidence from Infuse patients suggests that the product may not be as safe as originally thought. Early findings of clinical trials suggest that potential side effects of the Infuse bone graft may include ectopic bone growth, leading to persistent pain, spasms and even paralysis.
As a result of their injuries, the five plaintiffs involved in the Medtronic Infuse lawsuit are seeking general, punitive, consequential and exemplary damages from the medical device maker, for charges including failure to warn, fraudulent misrepresentation, negligence and defective design. In addition to this latest complaint, there are approximately 450 other Infuse lawsuits pending against Medtronic throughout the country. If you received an Infuse bone graft and you have since suffered from side effects like nerve damage, bone overgrowth or persistent pain, our consumer advocates at the Consumer Justice Foundation can help you get in touch with a Medtronic Infuse lawyer in your area. With an experienced product liability attorney on your side, you can protect your legal rights and pursue financial compensation for your injuries, medical bills, and pain and suffering.