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The family of a woman, who had spinal surgery then died because of complications, is suing the hospital because the victim was implanted with a spinal medical device that was not approved for this particular type of neck surgery. The medical device, Medtronic's Infuse bone graft, was used in an off label application. After the surgery the woman went into a coma and was kept alive on life support until the life support was removed.Do You Have A Medtronic Spinal Medical Device Case? »
What's wrong with this picture?
Why is a medical device being used inappropriately?
And in a weird chain of events, why didn't Medtronic notify the FDA about the woman's death?
Medtronic claims not to have known about it but there are reports that an Infuse sales representative was in the operating room. Previously, Medtronic has been warned about failing to report a number of adverse events – so they know the drill. The FDA requires that medical device makers report adverse episodes and follow up with hospitals and patients repeatedly.
What's really tormenting about this very sad event is only a month prior, a FDA safety alert was released which linked Medtronic's Infuse bone graft product with potentially life-threatening complications when used in the neck area or what is considered off label. Is no one paying attention?
This is cause for a medical malpractice and wrongful death lawsuit.Contact Our Infuse Bone Graft Lawyers Today »
Please contact Monheit Law to find out if you or your family is eligible. The consultation is complimentary; there is no obligation to proceed; whatever you say is confidential; and you can speak to a lawyer ready to listen.