Shareholders were not happy that 85.2% of Medtronic Infuse sales relied on off-label uses of the product, nor that Medtronic was allegedly paying doctors to use the Infuse on patients in ways that we not approved by the FDA.

The promotion for off-label uses—which is illegal—sparked an investigation by the U.S. Department of Justice and an inquiry by the U.S. Senate. Sales dropped, and once Medtronic revealed to shareholders that the company was being questioned, a lawsuit was brought against the medical device company for $85 million.

Many of the problems started after patients began to experience injuries from Medtronic Infuse off-label uses. The Infuse is only approved by the FDA for certain uses, including adult lumbar fusions performed through the front of the body, tibial fractures and select dental procedures. The device is a sponge-like material soaked in a man-made bone morphogenetic protein housed in a metal cage that is implanted into the body to promote bone growth. When used off-label, excessive bone growth sometimes occurs, which can lead to serious nerve damage and other potentially-permanent health problems.

The best thing to do if you suspect that your medical issues are related to your Medtronic Infuse implant is to contact a lawyer experienced in handling Infuse cases. The Medtronic Infuse attorneys at Gray and White Law are experienced in litigation involving defective drugs and medical devices, and are providing free consultations to anyone experiencing adverse effects from the Medtronic Infuse. Call 888.450.4456 or fill out our online form so that you can schedule your complimentary consultation today. 
Mark K. Gray
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Louisville attorney serving the seriously injured in Kentucky
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