Medtronic Expected to Report Infuse Patient Death to FDA
Medtronic, Inc. (NYSE: MDT) announced that it will inform the U.S. Food and Drug Administration (FDA) about the death of a patient who underwent spinal surgery and was treated with its INFUSE Bone Graft (“INFUSE”) product. Medtronic claims that it was unaware of the death of Shirley Nesbit for three months, and was only notified when her family filed a wrongful death lawsuit. The suit alleges that the surgery to her neck used INFUSE even though the product had not been approved by the FDA for this type of procedure.
The FDA requires drug and medical-device manufacturers to report any “adverse events” they have knowledge of regarding patients using their products. Additionally, companies are required to follow up on initial reports and update the agency as new information becomes available. The FDA recommends that manufacturers should make at least three attempts to retrieve additional information about reported events.
In August 2008, Medtronic informed the FDA that Nesbit fell into a coma four days after her surgery. During that surgery, the Medtronic implant, which is intended to promote bone growth, was used. Two days after that report was filed, Nesbit died. Medtronic and the hospital where Nesbit’s surgery was performed declined to discuss whether Medtronic sought updates after the initial report that she was in a coma. Medtronic is now moving to make its report to the FDA.
Last year, the FDA issued a warning letter to Medtronic, stating that it failed to properly report adverse events related to devices in its neuromodulation business. In July 2008, the FDA issued a safety alert linking the use of INFUSE in the neck area with potentially life-threatening complications. Although INFUSE has not been approved by the FDA for use in the neck area, doctors are free to use it for off-label purposes. Currently, the off-label use of INFUSE is the subject of investigations by both the Justice Department and the Senate.
If you or a loved one suffered injuries caused by INFUSE, contact us today for a confidential and free case evaluation.