Multiple Families Sue For Injuries Caused By Infused Bone Graft
Medtronic is facing more trouble over its Infuse Bone Graft.
A Texas woman is reportedly preparing a lawsuit blaming off-label use of Infuse for injuries she suffered after cervical spine surgery. Mary Selke claims that bone formed in her neck and it made it difficult for her to breathe and swallow resulting in more surgery, this time of an emergency nature. Her physician will also reportedly provide testimony that Medtronic promoted use of the product off-label directly to physicians.
Each year, an estimated half million people undergo spinal surgery to repair and stabilize the spine after experiencing damaged discs or to remedy the condition of scoliosis. But Infuse Bone Graft has been linked to complications that have occurred during off- label use, specifically in surgery in the neck.
The family of Shirley Nisbet has sued Medtronic over the Infuse Bone Graft after the California woman died in August 2008, says a report. Nisbet had spinal-fusion surgery using Infuse in her neck. After her surgery, the suit says, Ms. Nisbet went into respiratory arrest and a coma and was kept alive by artificial means until she died.
Infuse is not approved to be used in the neck, but doctors are free to use a medical device off-label at their own discretion. That off-label use is being investigated by the U.S. Department of Justice.
Medtronic is supposed to report adverse events to the agency, but a spokesman for the Kaiser Hospital in California, where Ms. Nisbet had her surgery, said it did not report the death to Medtronic because it didn’t consider the product to be the cause of death.
In September, the Wall Street Journal reported that at least three-quarters of the roughly 200 “adverse events” reported to the FDA involve off-label uses of Infuse Bone Graft. Adverse events including swelling, difficulty breathing, and swallowing.
And three whistleblower lawsuits were settled for $40 million, which Medtronic paid out without admitting wrongdoing. The lawsuits alleged the company paid inducements to doctors to use Infuse off-label in spinal surgeries.
With several lawsuits naming Medtronic’s Infuse, it will be interesting to see whether federal preemption of medical devices lawsuits allows them to continue. Litigation may be the only way we get a true picture of the damaged done by aggressive marketing to physicians of the off-label use of Infuse. It is important to seek quality legal representation from a skilled medical malpractice attorney in Florida.
Meanwhile patients should be made aware that serious complications are following Medtronic’s Infuse use in the neck. If you have any questions concerning this topic or other personal injury claims, please contact Farah & Farah at 1-800-533-3555 to speak to one of our experienced hospital malpractice lawyers.
