Medtronic Sued Over Infuse Bone Graft

Medtronic faces a product liability lawsuit claiming one of its bone graft devices performs in a defective manner when used “off-label”--or for uses unapproved by federal regulators--and the company continued to promote it for such uses even though it was aware of the issue.

Plaintiff Patricia Caplinger claims in her lawsuit that when she had spinal surgery in 2010, she received an Infuse Bone Graft implanted through her back, according to Lawyers USA Online (subscription required). The suit alleges Caplinger now suffers constant pain in her leg and back as well as muscle paralysis causing foot drop, leading to a torn ligament in her knee. She also says that she is now at a higher risk for developing cancer.

The product liability lawsuit claims that the Infuse Bone Graft was approved by the U.S. Food and Drug Administration (FDA) for abdominal implant only. Risks associated with off-label use of the device such as ectopic bone growth, back and leg pain, sterility, and cancer were not highlighted by Medtronic, according to Lawyers USA Online.

The complaint states, “At least 280 reports of adverse events involving Infuse have been made to the FDA. Approximately 75 percent of those reports involve off-label use.”

If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law for a free legal consultation and to find out if a product liability lawyer may be able to help you. For legal help, call (800) 581-6358.

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