Medtronic's Infuse Product is Bad to the Bone
You may remember the 2007 Medtronic recall of its heart defibrillator leads due to reports of at least five patient deaths. Now Medtronic makes the news again with its Infuse Bone Graft. Shirley Nisbet, a California woman died after neck surgery, allegedly due to the use of Infuse, which is only FDA approved for spine surgery requiring a frontal approach to the lower backbone, called the lumbar spine.
Products used other than specified and approved by the FDA are known as "off-label." What's interesting here is that although doctors can use FDA approved products how they see fit, manufacturers are not allowed to promote off-label use of these products. In the case of Shirley Nisbet, the Medtronic sales rep was apparently present before and during the surgery, and encouraged Ms. Nisbet's surgeon to use the product. What's also interesting is that although identified in the lawsuit, the surgeon is not a defendant. The lawsuit holds Medtronic solely responsible for Ms. Nisbet's death.
It turns out that lawsuits from former employees were filed in 2002 and 2003 against Medtronic. These employees accused the company of paying kickback to doctors in order to get them to use their spine products. As a result, Medtronic shelled out $40 million to settle these claims.
Why is it that big pharmaceutical companies and medical product manufacturers keep making the same mistakes over and over again? You' think forking out huge amounts of money for lawsuit verdicts and settlements would be motivation to stop their deceptive practices. But from their perspective, perhaps the billions they make in sales outweigh the millions they pay in lawsuits. It's a shame that companies trade lives for profits. I have every hope that with Obama in office, the FDA will finally get the control it needs to prevent these types of tragedies.
See the Wall Street journal article below:
Medtronic Is Sued Over Bone Product Article By THOMAS M. BURTON and DAVID ARMSTRONG
DECEMBER 3, 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.
Associated Press 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.
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I too have had a life altering problem with InFuse. I had it for fusion surgery in my L5-S1. It was implanted along with hardware to fuse the vertebrae. However, I developed a reaction to the protein from the start. I had no leg pain prior to surgery, but had life altering pain after surgery. I have had 2 more surgeries to clean up the InFuse. The last surgery was to remove the InFuse from my nerve as it had stimulated bone growth down my nerve. I still suffer from it today.