He told the Street that J&J compared the Charite to BAK cages in spinal fusions, a failed procedure that had not been performed in years. According to Dr Rosen, the comparison is "the worst possible operation to compare these things to."
J&J responded by saying the BAK was the standard treatment for degenerative disc disease at the time of the study.
According to the Street, Dr Rosen said J&J ignored the first patients who underwent the surgery, and that exclusion of such a significant portion of the sample size can seriously compromise the quality of statistical data.
Forty-five year old, Dane Titsworth, from a hospital bed at UCI Medical Center, recovering from his fourth back surgery, told the Register, that the pain he experienced with the Charite he had implanted in May 2005, was like driving a big rig over your legs.
After the Charite surgery, Mr Titsworth said the pain became unbearable and cost him his job with State Farm Insurance, and nearly his marriage.
Dr Rosen fused the part of his spine where another surgeon had implanted the disc.
The Charite does not absorb shock like a healthy disc or mimic natural motion, Dr Rosen told USA Today on July 25, 2006, and a dislocation or fracture of the disc can also cause problems, he said.
In March 2006, Dr Rosen says, eight more patients like Mr Titsworth contacted him, who have more pain in their back with the Charite than without it.
In May 2006, Medicare decided 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 determined that more research was needed over a longer period of time, although insurance plans in each state determine coverage decisions individually, according to USA Today.
On October 20, 2005, the Bagolie Friedman law firm announced the formation of the "International Charite Artificial Disc Practice Group," based on a belief that numerous people in the US and abroad, "suffer Charite artificial disc failure," and that "Johnson and Johnson is responsible for manufacturing a medical device they knew or should have known was unreasonably dangerous in an attempt to capture some of the lucrative multi billion dollar back surgery market."
"We will be reviewing potential cases from the United States, Australia and Europe," said Mr Bagolie.
On June 5, 2006, the Street.com reported that Chicago-based attorney, Pete Flowers, has more than 200 clients who have complications from the Charite and who are seeking reparations from DePuy Spine.
Twenty-eight lawsuits have been filed, Mr Flowers told the Street, and he expects an additional 40 to 50 more to be filed this month. Dane Titsworth is a client of the firm.
(Note: You can view every article as one long page if you sign up as an Advocate Member, or higher).
