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Charite Spinal Disc Lawsuit

Many patients who have received the Charite artificial disc replacement are experiencing Charite disc complications, including more back pain than before their Charite spinal disc implant. Still, there has not yet been a Charite disc recall.

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Charite™ Spinal Disc Lawsuit

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 Clinical Trial

charite disc transplantJohnson & 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.

Charite 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
Charite Recall

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.”

Charite Timeline

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 Case

If 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

CHARITE™ LEGAL ARTICLES AND INTERVIEWS

One Woman's Heartbreaking Charite Story
One Woman's Heartbreaking Charite Story Washington, DC: 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]


READER COMMENTS

Posted by
California
on
Had a two-level charite disc procedure in 2006. Collapsed in two different directions within six months. Just now found out about things and why it never should have been implanted. Had multiple herniations in spine, was never FDA-approved for two-level procedure. The herniations themselves exceeded safe guidelines for replacement.

Posted by
Anonymous
on
My name is John Isaacks. I started having back problems in my early 30s. I had a small surgery Discectomy. This turned into worse problems. I turned to a Dr. Richard Francis located in Houston, Tx. He also has an office in Beaumont. He introduced me to the Charite artificial disc replacement. I was among a group of experimental patients for the artificial disc. 2005 was the year I had surgery. At first it was great. I had to mostly recover from my stomach being cut open. I went back to sports training mixed martial arts. Well one thing lead to another an I was landed back into surgery. I had a fusion of my L5-S1 (art.disc) L4-L5. Since I have never been the same. Later I had another surgery back to back. I was 42 at the time. I was not a candidate for disability even though I was an still am in horrible pain. The pills an patches no longer would help. I asked for help to get off the pills. I have went back to work an still employed with TDCJ. I am to the point were I can barely feel my feet left side. I hurt more everyday. I pray something will help. I am in horrible pain. Thanks for listening .

Posted by
Anonymous
on
Had surgery 2007 for disk replacement. Well that was the beginning of a downward spiral. Lost my job over it, my social life and personal life just absolutely sucks. Iam always in pain, I had to get a 2nd surgery last year 2013 because it blew out my facets above new disk. now I have clamps, rods, screws, and still in a lot of pain a year later. My back turns black and blue and swells up if I WALK TOO MUCH!!!!!! I was told by my Dr., you cant do enough walking. im getting shooting pains into butt and hips, down my left leg and tingles. I have been out of work for 4 years now, I am 41, did a lot of heavy work in past and a lot of hrs 60-70hrs a week. I feel bad I cant work. Nobody listens to me in Drs office, NOBODY!!!!! my dr thinks im after pills, they did a urine test to see if my scripts are in my system, and yes of coarse they were, my levels were right. Im in worse pain now and he wont give me anything stronger, even after his assistant felt something sticking out of my back, and something is cracking in there where they fussed my L5-S1. Life just down out right sucks!!!!! be better off dead, all these drs are crooked. And will NEVER admit they did wrong!!!!!! If we do we could end up in jail!!!!!


Posted by
North Carolina
on
Excessive pain in lower back and legs. Inability to perform physical activities. Partial reason for early retirement from Marine Corps.

Posted by
Colorado
on
The disc itself broke and had to be removed. They did not replace the disc. The surgery was done as an emergency surgery. Every time I coughed, sneezed, or moved in a certain way my legs would tingle and I would loose control/function of my legs. A contrast CT/milogram was done and the disc almost severed my spinal cord. Ever since then I have had extreme back pain and loss of mobility.

Posted by
Ohio
on
I now have to have a spinal fusion to stabilize the artifical disc, since it's in a location where the disc cannot be removed. The surgeon cannot correct the misalignment of the disc. He can only keep it from moving further.

Posted by
Alaska
on
Chronic pain; numbness in legs and feet; increased pain in lumbar area; diagnosis that replacement disc is protruding and disintegrating.

Posted by
Oregon
on
Loss of work, suicidal thoughts, absolutely no enjoyment of life, because of the terrible pain that this Charite Spinal Disc has caused.

Posted by
Alaska
on
Received Charite implant 11 Apr 07 for torn disc at L5-S1. Since surgery constant pain in lower lumbar and lower extremities with numbness and weakness in legs, feet and ankles. Frequent musculoskeletal spasms in back, legs and burning sensation in the buttocks. Undergone 3 Facet blocks to snap the nerves off from L-2 to S-1 with little relieve in pain. Current EMG show mild nerve damage at L-5. Pain and discomfort results in 4 to 6 hours of broken sleep. Still taking narcotics for pain. Fighting to keep my job and property. Please help me if at all possible. Thank you.

Posted by
California
on
Had two level disc replacement done with Charite disc. Doctor was told he could not do surgery with the ProDisc 48 hrs. prior to surgery and must go with Charite disc knowing it was never approved for two level operations. I was never informed device was being used off label by doctor or insurance company. It was not until nearly two years went by that my doctor declared it a failed surgery because the Charite disc was defective and had slid to the right of my back necessitating a three level spinal fusion to be done very soon. Implant has caused enormous pain and complications with my leg as well as urological issues including ED and bladder problems. Please try to help me.

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