Medtronic to Tell FDA About Patient's Death

-WSJ

12/12/2008- Medtronic Inc. said it was unaware for more than three months that a patient who underwent spinal surgery with one of its products had died, and the company is now moving to report the death to the Food and Drug Administration.

In August, Medtronic reported to the FDA that the patient, Shirley Nisbet, was having trouble breathing and fell into a coma four days after a spinal-fusion surgery that used a Medtronic implant for promoting bone growth. The company said it first learned last week that Ms. Nisbet had died, from a lawsuit brought against it by her family.

The FDA requires drug and medical-device makers to report any "adverse events" they learn about in patients using their products -- whether or not they believe the product caused the event. It also directs the companies to follow up on initial reports and report to the agency any new information that changes the facts of a case.

Medtronic and the hospital where the surgery was performed, a Kaiser Permanente facility in Baldwin Park, Calif., declined to discuss whether the company sought updates on Ms. Nisbet after reporting she was in a coma. She died on Aug. 30, two days after the date of Medtronic's initial report.

The FDA recommends that a manufacturer should make at least three attempts to retrieve additional information about a reported event, with at least one attempt in writing, an agency spokeswoman said. She declined to discuss Medtronic's reporting of Ms. Nisbet's case, as did the company.

Last year, the FDA issued a warning letter to Medtronic, saying it had failed to properly report adverse events related to devices in its neuromodulation business. The company said the issues raised in the letter have been resolved.

Jim Anderson, a spokesman for the Kaiser hospital where Ms. Nisbet died, said the facility didn't report the death to Medtronic or the FDA "because we do not consider the product to be the direct cause of death."

Ms. Nisbet's family filed a lawsuit in federal court in Los Angeles earlier this month alleging that the spine surgery in her neck area involved an unapproved, or off-label, use of Medtronic's Infuse Bone Graft product.

Following the surgery, the suit alleges, Ms. Nisbet went into respiratory arrest, fell into a vegetative state, and was "kept alive by artificial means" until she died.

In July an FDA safety alert linked the use of Infuse in the neck area with potentially life-threatening complications. Although Infuse isn't approved by the FDA for that part of the body, doctors are free to use FDA-approved products as they see fit for such off-label purposes.

Infuse's off-label use is the subject of a Justice Department investigation and a separate U.S. Senate inquiry. Medtronic has said Infuse is a safe product and that any complications associated with its use represent a tiny percentage of cases.

If you or a loved one have been injured as a result of the Medtronic Infuse Bone Graft you may be entitled to compensation. Contact the Infuse Bone Graft Attorneys of Ennis & Ennis today for a free case evaluation. Our experienced Medtronic lawyers can answer any questions you may have about a potential Medtronic Infuse lawsuit.