Since the Charite artificial spinal replacement disc was FDA-approved in 2004 for degenerative knees, degenerative hips, and degenerative disc disease, thousands of patients have reported increased back pain after being implanted with the Charite disc. A number of patients also accuse DePuy, the manufacturer and a subsidiary of Johnson & Johnson, of failing to warn that the success rate of the disc implant operation is only 57 percent. (DePuy has also come under fire for its DePuy hip replacement.
Charite™ Spinal Disc Lawsuit
Charite Clinical Trial
Johnson & Johnson was the first company to produce an artificial spinal disc in the US to potentially alleviate persistent back pain and permit natural body movement. However, before its FDA approval DePuy’s clinical trial sought only to show that its Charite spinal disc worked as well as its AcroFlex disc and the Bagby and Kuslich (BAK) cage used in spinal fusions. Many surgeons had already stopped using those discs due to a high failure rate.
Another concern is that the clinical trial used to obtain FDA approval only covered two years, which is considered far too short a time for a device that is expected to remain in the spine indefinitely without becoming displaced or causing other problems. The clinical trial also involved only 304 patients. Johnson & Johnson and DePuy are also accused of not including pain relief as a measure of success in the Charite trial.
Complications that may occur with the disc replacement surgery include blood transfusion, death, paralysis, or the need for additional surgery. Other problems include
- Increased and/or severe back & spinal pain
- Cracked vertebrae
- Additional stress and potential damage to adjacent discs
- Nerve damage
- Spinal fractures
- Vein or artery trauma
Despite much criticism—particularly by Charles Rosen, associate clinical professor of spine surgery at the University of California at Irvine--the Charite disc has not been recalled. Surgeons predict that over the next 10 to 15 years there will be a wave of patients who will suffer complications and require a more dangerous surgical removal of the device. Rosen found that patients in Europe have found the Charite artificial spinal discs regularly failing and leaving them with life-threatening complications. He said that “these artificial disc replacements should be recalled by the FDA to protect the American public.”
2003: DePuy Spine, a division of Johnson & Johnson, acquires the Link Spine Group, and gains exclusive worldwide rights to the Charite.
April 2003: Authors in a report published in the European Spine Journal titled, "Total Disc Replacement for Chronic Low Back Pain: Background and a Systematic Review of the Literature," determine that, although these devices have been implanted for almost 15 years, on the basis of this literature survey there are currently insufficient data to assess the performance of total disc replacement adequately.
2004: The FDA approves Charite for the US market based on the results of a single two-year clinical trial, that was designed only to establish that the Charite disc worked at least as well as the Bagby and Kuslich cages (BAK) used in spinal fusions.
June 2004: The team of surgeons who conducted the trial reveal to the FDA that the study was biased in favor of Charite, and that important data about patients had been excluded. Another European surgeon reported that many of his patients suffered terrible leg and back pain after the Charite device was implanted and many were unable to undergo a surgical revision of the disc due to the dangers involved in spinal surgery.
January 2006: More than 27 lawsuits are filed against DePuy claiming the Charite device has failed; five suits involve California plaintiffs.
May 2006: According to USA Today, Medicare decides to stop paying for the device in patients over 60, noting that the $30,000 to $50,000 surgery had not been sufficiently tested for long-term affects. Blue Cross and Blue Shield also determine that more research is needed over a longer period of time, although insurance plans in each state determine coverage decisions individually. Read more
July 2006: Dr. Rosen tells USA Today that the Charite disc does not absorb shock like a healthy disc or mimic natural motion and a dislocation or fracture of the disc can also cause problems.
September 2006: More than 350 Charite disc recipients claim the medical device is defective.
December 2006: According to Johnson & Johnson, 100 lawsuits are pending against the company involving the Charite artificial spinal disc, seeking "substantial compensatory and, where available, punitive damages”. Read more
April 2007: More Charite lawsuits are filed, including suits regarding implanting the device off-label for unapproved conditions. Read more
Register your Charite™ Spinal Disc Implant CaseIf you or a loved one has suffered from increased back pain after having a Charite disc implanted, please click the link below to send your complaint to a lawyer for a free case evaluation.
Last updated on Mar-29-11