Medtronic Is Sued Over Bone Product

-WSJ

12/03/2008- The family of a California woman who went into respiratory arrest and died after neck surgery filed a lawsuit blaming her death on the use of a fast-selling bone-growth protein made by Medtronic Inc.

The case of Shirley Nisbet comes amid a Justice Department investigation and a separate U.S. Senate inquiry into use of the bone-growth product -- called Infuse Bone Graft -- for purposes not approved by the Food and Drug Administration.

Medtronic Inc.'s Fridley, Minn., corporate headquarters. Government investigators are probing the off-label use of Infuse, Medtronic's bone-growth product.

Use of Infuse in the neck is one of these so-called off-label uses. The only type of spine surgery for which Infuse has been approved is a frontal approach to the lower backbone, known as the lumbar spine.

Though doctors are allowed to use FDA-approved products any way they see fit, companies aren't allowed to promote off-label uses.

The suit filed Tuesday in federal court in Los Angeles is the first to allege that Infuse was responsible for a death.

It echoes certain allegations made in lawsuits filed in 2002 and 2003 by former employees of Medtronic's spinal division.

In its suit, the Nisbet family alleges that a Medtronic salesman urged that Ms. Nisbet's surgeon use Infuse in her neck surgery even though such use wasn't FDA-approved.

The product is placed in the patient during surgery.

Marybeth Thorsgaard, a spokeswoman for Medtronic, said the Minneapolis company couldn't comment on the lawsuit because it hadn't had time to review the suit or contact the relevant employees.

The FDA declined to comment. The Justice Department didn't return a phone call seeking comment.

The lawsuit alleges Ms. Nisbet, of Vista, Calif., underwent the surgery Aug. 21, about seven weeks after the FDA had warned that Infuse in neck surgery had caused "life-threatening complications."

That July 1 advisory also linked Infuse to "compression of the airway," difficulty swallowing or breathing and the need for breathing tubes.

The suit alleges that Ms. Nisbet went in for surgery to treat neck pain, but that afterward she had swelling in the neck, then difficulty swallowing and breathing.

Early in the morning of Aug. 23, the lawsuit alleges, she went into respiratory arrest, degenerating into a vegetative state, and then was "kept alive by artificial means" until she died Aug. 30.

The lawsuit alleges that a Medtronic sales representative was in the operating room and that "prior to and during the surgery, the Medtronic sales representative encouraged and recommended" the use of Infuse to the doctor, who is identified in the lawsuit but isn't a defendant.

Government investigators haven't commented on their investigation of off-label use of Infuse, and Medtronic has declined to disclose the contents of a subpoena it received from the Justice Department last month.

Medtronic may have made an "adverse event" report on the Nisbet case to the FDA.

A report, filed by the company more than three weeks after Ms. Nisbet's death, doesn't identify the patient or location of the incident but, according to a review by The Wall Street Journal, contains details that appear to match the allegations in her case, such as the patient developing swelling and complaining of increasing difficulty swallowing.

The company's report quotes the surgeon as saying he "does not believe that Infuse played a direct role" in the patient's outcome. The report also said the patient was in a coma.

Medtronic, noting that the lawsuit was filed late in the day, said it couldn't provide an immediate comment on the report.

The lawsuit, filed by the firm Lieff, Cabraser, Heimann & Bernstein, identifies Ms. Nisbet's surgeon as Johannes Bernbeck, at Baldwin Park Medical Center in Baldwin Park, Calif.

A spokesman for the hospital said the facility and the doctor didn't have time to prepare a comment Tuesday night.

Apart from the Justice Department and Senate inquiries, Medtronic has been accused by former employees of paying kickbacks to doctors -- in the form of phony consulting arrangements, free travel to resorts and sham royalty deals -- to get them to use the company's spine products.

Medtronic, which has denied the allegations, has agreed to pay $40 million to settle claims made in two lawsuits filed by former employees in 2002 and 2003.

Medtronic Infuse Bone Graft Lawsuit
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.