The family of Shirley Nisbet, a California woman who went into respiratory arrest and died after neck surgery, has filed a lawsuit blaming her death on the use of a bone-growth protein made by Medtronic Inc. As you may recall, the Justice Department has been investigating Medtronic. Also, 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 – was being conducted at the time the suit was filed. Government investigators are probing the off-label use of Infuse. 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. Even 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 in federal court in Los Angeles, is the first to allege that Infuse was responsible for a death. It contains similar allegations to those made in lawsuits filed in 2002 and 2003 by former employees of Medtronic’s spinal division.
The Nisbet family alleges in their suit that a Medtronic salesman urged Ms. Nisbet’s surgeon to use Infuse in her neck surgery even though such use wasn’t FDA-approved. The product is placed in the patient during surgery. The lawsuit alleges Ms. Nisbet underwent the surgery on August 21st, about seven weeks after the FDA had warned that Infuse in neck surgery had caused life-threatening complications. That July 1st 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 developed swelling in the neck, then had difficulty swallowing and breathing. Early in the morning of August 23rd, according to the lawsuit, the woman went into respiratory arrest, degenerating into a vegetative state, and then was “kept alive by artificial means” until she died on August 30th. 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. This doctor is identified in the lawsuit, but isn’t named as a Defendant.
It appears that Medtronic may have made an “adverse event” report on the Nisbet case to the FDA. While a report filed by the company more than three weeks after Ms. Nisbet’s death doesn’t identify the patient by name or the location of the incident, it may well be the Nisbet case. According to a review by The Wall Street Journal, the report 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. This surely sounds like the Nisbet case.
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. Those lawsuits were handled by the law firm of Lieff, Cabraser, Heimann & Bernstein, which has offices in California, New York and Tennessee. That firm did a very good job.
Source: Wall Street Journal
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