Off-Label Infuse Lawsuit
Written by Faith Anderson on March 5, 2014
Medtronic Infuse Lawsuit Filed Over Off-Label Use of Bone Graft Product
Medtronic faces a growing number of product liability lawsuits involving potential side effects of its Infuse bone growth device.
Yet another Infuse bone graft lawsuit has been filed against Medtronic, this time by a Virginia woman who claims that she suffered severe injuries due to Medtronic’s negligence, misrepresentation and failure to warn about the health risks tied to Infuse bone grafts. This latest complaint, filed by Sandra F. Danna in the U.S. District Court for the Eastern District of North Carolina on January 27, alleges that Medtronic’s Infuse bone graft product contains defects in its design that are exacerbated when the device is used “off-label” in procedures not approved by the FDA. If you believe you have been adversely affected by side effects of Medtronic Infuse, contact a reputable attorney today for legal help. You may have grounds to file a product liability lawsuit against the medical device maker, in order to pursue financial compensation for your injuries and medical bills.
Potential Side Effects of Infuse Bone Growth
According to Danna’s complaint, she underwent surgery in October 2010, during which Medtronic Infuse was used off-label, and subsequently suffered debilitating injuries, including severe back and leg pain and uncontrolled ectopic bone growth near the implantation site. Three months later, Danna required revision surgery to remove the bone overgrowth and repair the associated damage, but her injuries still cause her constant pain severe enough to prevent her from performing even simple household tasks. Because of her injuries, Danna had to move so that her adult children could help take care of her, and it is highly unlikely that she will ever be able to return to work.
Risks of Off-Label Infuse Surgery
The FDA approved Medtronic’s Infuse bone graft in 2002, and the device was designed to stimulate bone growth and relieve severe back pain when used in a specific type of spinal fusion surgery in the lower spine,. The bone graft product was not, however, approved for use in surgical procedures affecting the cervical spine, which runs from the shoulder to the head. Even so, a number of patients have undergone cervical spine surgery in which Medtronic Infuse was used off-label, putting them at risk for life-altering complications like swelling of the neck and throat tissue, and difficulty breathing, swallowing and speaking. Even more alarming, many of these patients were never informed by their doctors that the Infuse product has not been approved for use in cervical spine procedures.
Contact a Medtronic Infuse Lawyer Today
In her product liability lawsuit, Danna alleged that Medtronic’s medical literature regarding the safety of its Infuse device was ghostwritten by physicians who received compensation in return, in an effort to downplay the risk of alleged Medtronic Infuse side effects. In addition to her injuries, Danna claims that she suffered considerable financial hardship due to Medtronic’s “fraudulent misrepresentation, breach of warranties, defective product design, negligence and failure to warn about the dangers posed by Infuse bone grafts.” If you underwent surgery with Medtronic Infuse, and you have since suffered injuries like difficulty breathing or swallowing, our consumer advocates at the Consumer Justice Foundation can help put you in touch with a product liability lawyer who has experience handling Infuse bone graft cases.