Charite Artificial Disc Generating Controversy

J&J division DePuy Spine‘s Charité total disc arthroplasty is both in demand and under scrutiny. Currently many insurace companies as well as medicare (for patients over 60) do not cover the device, which has many potential patients frustrated at their lack of options. Meanwhile, there’s at least one surgeon who takes issue with the device’s design and a malpractice lawyer with 200 clients trying to wring some cash out of J&J…

Darla Russell and Leah Coppersmith had chronic lower back problems when their doctors suggested an artificial spinal disc implant to reduce their pain and restore their mobility.
Now, Russell, 41, of Wichita Falls, Texas, rides horses and gives her daughter piggyback rides. But Coppersmith, 35, of Leonardtown, Md., remains bedridden for days at a time under a variety of medications, unable to work or take care of her children.
According to data collected during FDA clinical trials, 64% of Charité patients achieved “overall clinical success” after two years, compared with 57% of the patients who received spinal fusion surgery, an operation in which the damaged disc is removed and the vertebrae are joined.
To achieve “overall clinical success,” patients had to experience a 25% reduction in pain and have no device failures, neurological deterioration or major complications.
Since the FDA approved the artificial disc in October 2004, more than 5,000 people have received the implant, says DePuy Spine’s Bill Christianson, vice president of regulatory affairs. But opponents criticize its design as well as the methods used to approve it.
The Charité does not absorb shock like a healthy disc or mimic natural motion, says orthopedic surgeon Charles Rosen, director of the University of California-Irvine Spine Center, who believes the disc is unsafe and should be recalled. Rosen says dislocation or fractures of the disc also can cause problems.
But Christianson says that the implant gives patients more mobility than they would have without the disc and that other surgical alternatives do not allow for shock absorption, either.
“In the meantime, this is as good as we can do, and honestly, as good as it gets,” Christianson says.
Bluecross Blueshield Association’s Technology Evaluation Center determined that more research was needed over a longer period of time, though health insurance plans in each state determine coverage decisions individually. Medicare will not cover a Charité implant for anyone over 60, leaving the rest of the decisions to local carriers.
Two national and about 60 regional payers will cover the procedure, Christianson says. The operation costs $25,000 to $35,000, he says, including all fees.
In the meantime, Chicago-based attorney Pete Flowers says he has more than 200 clients who say they have complications from the Charité implant and who are seeking reparations from DePuy Spine. Twenty-eight individual lawsuits have been filed, he says, and he expects an additional 40 to 50 by August. His clients say that the Charité is defective and that DePuy improperly marketed and did not adequately warn of the disc’s dangers.
DePuy Spine has filed motions to dismiss the cases.

Hopefully sooner rather than later the orthopedics, insurance and regulatory communities will realize how much benefit this device offers to patients for whom it is well suited…and also recognizes who those patients actually are (a key indicator: non-litigious).
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