A newly-filed lawsuit alleges that a Medtronic bone graft device is defective when used in an off-label manner and that the company knew about it, but continued to promote the off-label use. Patricia Caplinger alleges in her lawsuit that she underwent spinal surgery in 2010 in which the Infuse Bone Graft made by Medtronic was implanted through her back. She now suffers continuous back and leg pain and muscle paralysis causing foot drop, which led to a torn ligament in her knee, and is at a significantly higher risk of cancer, according to allegations in the suit.
According to her complaint, filed on June 4 in U.S. District Court for the Western District of Oklahoma, the device was approved by the Food and Drug Administration for implants through the abdomen only. It’s alleged that Medtronic downplayed the risks of known complications of implanting through the back, including ectopic bone growth, back and leg pain, and risks of sterility and cancer. The lawsuit also claims that Medtronic paid influential physicians to promote the off-label use by other physicians, and that the company omitted adverse event reports in its sponsored studies. It’s alleged further that:
A number of patients say they have been harmed in off-label uses of Infuse, which is approved by the FDA only for anterior-approach surgery in a small section of the spine in the lower, or lumbar, region. 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.
The suit alleges product defect, failure to warn, negligence and fraud, and seeks compensatory and punitive damages. James W. Dobbs of Rhodes, Dobbs & Steward in Edmond, Okla., represent the Plaintiffs.
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