Medtronic Infuse Lawsuit
Written by Faith Anderson on May 27, 2013
Off-Label Use of Medtronic’s Bone Growth Product
Medtronic’s Infuse product is a bone morphogenetic protein (BMP) meant to be applied to an absorbable collagen sponge placed within a device called an LT-Cage, which is then implanted in the body to encourage bone growth and to fuse the gaps between vertebrae. Infuse and the LT-Cage were approved by the FDA for simultaneous use in limited spinal procedures involving a single-level anterior lumbar interbody fusion (ALIF), where the spine is approached from the front. However, Medtronic’s bone growth product has been widely used for off-label purposes, including in other types of spine fusion surgery, which have been associated with an increased risk of painful complications caused by excessive or ectopic bone growth.
Potential Side Effects Related to Infuse
According to the latest Infuse lawsuit, filed in the U.S. District Court for the Southern District of Mississippi, Gerard Ledet received an Infuse implant in April 2007, and has since suffered from back pain and other chronic injuries related to bone overgrowth. Ledet’s procedure involved the use of Infuse on multiple levels and did not use the LT-Cage, which goes against the FDA’s product approval. In their complaint, the Ledet’s claim that Medtronic misled Gerard and his doctor about the safety of Infuse and about the importance of the LT-Cage. As a result of complications related to Ledet’s surgery, he has suffered uncontrolled bone growth leading to back pain, foot numbness and leg pain. Ledet underwent revision surgery in 2009 to remove the overgrown bone, but the bone eventually grew back and has since caused chronic pain and disability.
Contact a Product Liability Attorney for Legal Help
A number of lawsuits have been filed against Medtronic in recent years, claiming that the company illegally marketed Infuse for off-label uses, and the firm has also faced government investigations involving misleading claims about the safety of Infuse. In 2008, the FDA issued a warning against the off-label use of Infuse and the LT-Cage, after the agency received numerous reports of adverse side effects and deaths. Ledet’s lawsuit accuses Medtronic of failure to warn, fraud, negligence, designing a defective product, negligent misrepresentation and breach of warranty. If you received an Infuse implant in the past, and you have since suffered a defective product side effect, our consumer advocates at the Consumer Justice Foundation can help put you in touch with a lawyer who has experience handling product liability claims in your area.