A patient who received Medtronic Inc.'s Infuse bone graft died after going into respiratory arrest, falling into a vegetative state and was temporarily kept alive by artificial means. Her family is suing Medtronic alleging that her spine surgery involved an unapproved use of the product. However, the U.S. Food and Drug Administration (FDA) wants to know why the company never informed it of the death - something Medtronic was required to do.

Product liability lawsuit

The wrongful death product liability lawsuit against Medtronic involves the family of Shirley Nisbet. According to news reports, Nisbet was admitted to a Kaiser Permanente facility in California in August of 2008 to undergo spinal surgery.

Doctors used Medtronic's Infuse bone graft product during the surgery; however, they used it in a fashion that was not approved by the FDA. Shortly after the surgery, Nesbit went into respiratory arrest, fell into a vegetative state and was kept alive by artificial means before dying.

Her family sued Medtronic and alleged that the company encouraged doctors to use the product in ways that were not approved by the FDA. They point to an FDA safety alert that was released only one month before Nesbit's surgery which linked Medtronic's Infuse bone graft product with potentially life-threatening complications when used in the neck area. Nesbit's family isn't the only one looking for answers. The product's off-label, or unapproved, use is also the subject of a Justice Department investigation, a separate U.S. Senate inquiry and now a whistleblower lawsuit.

Whistleblower lawsuit

A whistleblower lawsuit was filed against Medtronic last week in Massachusetts. According to news reports, the Qui Tam lawsuit alleges that the company entered into agreements with doctors to use its Infuse bone graft products in ways not approved by the FDA.

Why didn't Medtronic report Nesbit's death?

That's a question the FDA wants answered - especially after it sent Medtronic a warning letter last year informing the company that it had failed to report numerous adverse events in its neuromodulation business - something it is required to do. The FDA requires all medical device and drug manufacturers to report adverse events about their products and recommends that manufacturers follow up with hospitals and patients about such events at least three times. However in Nesbit's case, Kaiser Permanente said that it did not report her death to Medtronic because it did not believe that the manufacturer's product caused her death - which is something that will likely be left to a jury to decide.

If you've been injured due to a defective or dangerous product, contact an experienced medical device recall attorney to discuss your case and evaluate your options. Consultations with an attorney are free, without obligation and are strictly confidential.