New York, NY (PRWEB) November 30, 2005
Martinez, Rosenbaum & Faria, LLP, a law firm with offices in New York and Los Angeles is prepared to take on another medical giant: Johnson & Johnson.
Johnson & Johnson’s recently FDA-approved Charite Artificial Disc replacement device has come under scrutiny by leaders in the spinal surgical industry after reports of alleged failures, deaths, complications, and dangerous replacement procedures have begun filtering in from Europe and Australia where the devices have been available for more than fifteen years.
Dr. Charles Rosen, an American university spinal surgeon, purports that the devices have regularly failed in Europe, leaving patients with life-threatening complications. According to Rosen, “Any prudent person, who does not have a financial conflict or industry tie, would reasonably conclude that their safety and effectiveness has not been proven by the FDA.” His comments relate to the limited two-year study conducted by Johnson & Johnson in preparation for their FDA approval hearings.
The Charite Artificial Disc, designed to replace the current practice of disc fusion in patients with vertebral and disc damage and long-term back pain, should be designed to last for four decades, according to industry experts. However, a Danish surgeon, Andrew van Ooij who tracked hundreds of the operations in Europe noted serious problems, not the least of which was the potential for retrograde ejaculation and erectile dysfunction in men, leg complications, and joint degeneration. Said van Ooij, “All of these patients have really terrible leg and back pain, and revision is dangerous and sometimes impossible.”
Martinez, Rosenbaum & Faria, LLP, a bilingual law firm, has been following the FDA approval processes for the Charite device and has concluded their research of available information, both national and international, as it relates to the device. Said Cory Rosenbaum, a partner in the law firm, “I believe Johnson & Johnson may be setting up a lot of desperate people for a lifetime of pain and the device should not be put into patients’ spines.”
As with other product liability matters, Martinez, Rosenbaum & Faria, LLP, has established an area on their website at http://www.coryrosenbaum.com to provide up-to-date information about the device, together with forums and other resources for visitors.
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