Medtronic Bone Graft Death to be Reported to FDA Following Lawsuit

The Wall Street Journal reports that Medtronic, Inc. is notifying the FDA about the August death of Shirley Nisbet, whose family filed a wrongful death lawsuit against the medical device manufacturer earlier this month alleging that fatal complications following her cervical spine fusion were caused by the Medtronic Infuse Bone Graft.

Shirley Nisbet underwent neck surgery on August 21, 2008, during which a Medtronic Infuse Bone Graft was implanted in the cervical area of her spine.

The Medtronic Infuse Bone Graft is only approved by the FDA for use in the lumbar spine and for certain dental procedures, and use in the cervical spine has been associated with a number of life-threatening complications.

Following her surgery, Nisbet suffered respiratory arrest on August 23, 2008 and went into a coma. She was kept alive by artificial life support until her death on August 30, 2008.

Her family filed a Medtronic Infuse wrongful death lawsuit on December 2, 2008 in Los Angeles, alleging that Medtronic failed to warn about the risks associated with use of the bone stimulator in the neck and claims that the device maker actively encouraged the off-label use. The lawsuit indicates that a Medtronic representative was in the operating room before and during Nisbet’s surgery.

Medtronic notified the FDA in August 2008 that Shirley Nisbet had trouble breathing after the spinal-fusion surgery and had fallen into a come four days after she received the Medtronic bone stimulator implant. However, the company never reported that she later died.

According to the Wall Street Journal, Medtronic, Inc. has indicated that they were unaware that Nisbet passed away less than 10 days after her surgery. However, Medtronic has not indicated what, if any, follow up requests were made about Nisbet’s status after they were notified she went into respiratory arrest and a coma.

The Medtronic Infuse Bone Graft contains a synthetic material that is implanted to encourage bone growth. Given the close proximity of the cervical spine to the airway, use of the bone stimulator in the neck has been associated with reports of swelling that may compress the airway and nerves, potentially leading to difficulty breathing, inability to speak, trouble swallowing, respiratory arrest or death.

In July 2008, the month before Nisbet’s surgery, the FDA warned that such off-label use in the cervical spine or neck, has been associated with a number of adverse event reports.

In November 2008, Medtronic disclosed that they are facing an investigation by the U.S. Justice Department into their alleged off-label marketing and promotion of the Infuse Bone Graft, which would violate federal law.

The Nisbet case is believed to be the first lawsuit filed by a patient who was injured by the bone stimulator. However, investors have filed a Medtronic Infuse class action suit alleging that the company made false and misleading statements about the bone stimulator and product liability lawyers are review other potential Medtronic Infuse Bone Graft lawsuits on behalf of individuals who have experienced complications with use of the device in the cervical spine.