LAWSUITS NEWS & LEGAL INFORMATION
Charité Spinal Disc Lawsuit
Many patients who have received the Charité artificial disc replacement are experiencing Charité disc complications, including more back pain than before their Charité spinal disc implant. Still, there has not yet been a Charité disc recall.
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Charité™ Spinal Disc Lawsuit
Charité 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' clinical trial sought only to show that its Charité 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 Charité trial.
Charité Complications
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 Charité 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 Charité 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."
Charité Timeline
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 Charité for the US market based on the results of a single two-year clinical trial, that was designed only to establish that the Charité 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 Charité, 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 Charité 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 Charité 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 Charité 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 Charité disc recipients claim the medical device is defective.
December 2006: According to Johnson & Johnson, 100 lawsuits are pending against the company involving the Charité artificial spinal disc, seeking "substantial compensatory and, where available, punitive damages". Read more
April 2007: More Charité lawsuits are filed, including suits regarding implanting the device off-label for unapproved conditions. Read more
Register your Charite™ Spinal Disc Implant Case
If you or a loved one has suffered from increased back pain after having a Charité disc implanted, please click the link below to send your complaint to a lawyer for a free case evaluation.
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CHARITé LEGAL ARTICLES AND INTERVIEWS
One Woman's Heartbreaking Charite Story
March 25, 2011
Judging from the response of patients who have received the Charite artificial disc replacement, Charite disc complications have been an issue for quite some time—and even extend to those who participated in trials analyzing the effectiveness of the device, according to a ''Maude'' adverse reaction report on the official Web site of the US Food and Drug Administration (FDA). READ MORE
READ MORE Drugs/Medical Settlements and Legal News
READER COMMENTS
Jeff Hamilton
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Stacy Shellhammer
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For me, Dr Regan was a god sent and gave me my life back. I believe that having an excellent surgeon also plays a big part. Poor surgery will make any product fail Just another opinion from someone who had one installed.
Alexander Honchar
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Shannon Griffith
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Carol Velasquez
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Karen Bartlett
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He did indicate that I was in critical danger of the wire penetrating the vena cava (sp?) vein and bleeding out within five minutes and dying.
Michael
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I hope you get some help and eventually find an answer.
I live in the UK and after visiting several Consultants am of the opinion that the problems are being ignored.
Good Luck.
Matthew/California
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Surgery Date to replace L4/L5 Disc with CHARITE’ Artificial Disc was May 2006 -
Now 11 years later, and actually quite a few years before, I have had many problems in my lower back:
Radiating pain, sharp internal pain in and around L4/L5 disc and Facet area, radiating pain in the L4/L3 area along with pinching and very sharp bursts of pain, I get pain that goes around my waist that burns and feels like a knife that cuts into my entire waist, a dull cutting like pain goes into my groin, I get a numbness on the top of my thighs (mostly left thigh), I have pain in behind my left hip continually (which makes walking and sitting very uncomfortable), In the L4/L5 (replacement disc area and facet area) I get a bone on bone touching feeling that is intense and makes it very hard to turn in bed and in regular activities (when pushed on or pressure put on the area the pain is very intense, ex. Laying on my back or wearing a back brace or sitting in a car seat etc.), I am unable to stand up straight when in moderate to severe pain
I experience leg weakness and buckling (get a dead leg all of a sudden, mostly left leg), after walking or working for a long time, when I stop my legs get a flush feeling that radiates down from my lower back into my thighs and as low as my calves. Most recently (4/1/17 – 4/5/17) my R side lower back (L4/L5 region) flared up and I had extreme pain that went all the way down into my R calve, the pain in my calve was extremely sensitive to touch as if I were burned but there were no red marks or anything.
Sleeping – Difficult to turn in bed, difficult to sleep on my back and L/R sides (hard to get relief while sleeping), when I wake up in the morning it is very difficult to stand straight due to being bent or leaning to the R side “Extremely” difficult to straighten and very very painful in the Lower back L3-L5 entire area (this happens every day and I must do my best to stretch and work the area in order to get out of bed) I had to purchase an adjustable/mattress, sleep number bed in order to help. (I do not sleep well on any given night)
Right now I continue to work and this is a Continuous Trauma Claim (Lifetime Workers Comp) - I am seeing another Surgeon who is talking about having to remove the Charite' Disc and have to do Fusion, possibly from L3-L5 due to the other discs and vertebrae deteriorating. Just have to go through the motions for now.
Reading some of these has opened my eyes and I do not want to wait for a catastrophic failure.
I will try to keep all posted of what I go through and what surgery I end up with.
Thanks,Matt
David Bucher
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Ed Flory
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Michael
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Amy Layton
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David Cordell
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https://www.change.org/p/david-cordell-johnson-and-johnson-charit%C3%A9-disc-failure?recruiter=479899054&utm_source=share_petition&utm_medium=copylink
Los Angeles Guy
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I heard about this product in November of 2004 and after consultations with 3 different doctors, those who did this type of surgery and not, decided to go ahead as I was told I'd be a perfect candidate and could look forward to a tremendously improved quality of life.
For me the results have been wonderful and after my initial 4 month recovery and some basic abdominal and low back excersizes, I have been pain free for 11 years now. I am able to play sports and live a normal life.
I write this not to cause any grief for those who have had bad experiences, but just to let it be know that this product/surgery sometimes does work and extremely well.
Lindsey Truman
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Brandon Sprague
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Laurie Mandel
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I have been unable to work since July 2014.
I have been unsuccessful in finding an Attorney to take the case
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