Every year, more than one million Americans are seriously injured as a result of defective medical devices, according to the Institute of Medicine. Johnson & Johnson’s Charite artificial spinal disc has added to that number, with over 130 severe adverse events linked to its use since July 2006.
The Charite spinal disc, approved by the FDA in 2004, to relieve lower back pain by substituting the damaged disc with an artificial disc, has reportedly caused more pain than it cures.
Furthermore, studies have found that more than 50 percent of Charite patients have had fair to poor results and many suffered serious adverse events including severe back pain, neurological effects such as motor deficit or nerve root injury, numbness, kicking of vein or artery, pedicle fractures, or additional, potentially fatal surgery.
In October 2005, the “International Charite Artificial Disc Practice Group,” was formed based on the belief that many Charite patients in the U.S. and Europe have suffered serious harm from the artificial spinal disc. Additionally, the attorneys claim “Johnson & 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.”
Dr. Charles Rosen, an associate professor of spine surgery at the University of California at Irvine, called for an immediate product recall of Charite alleging numerous fundamental errors in J&J’s study of the device.
Chicago-based personal injury attorney Pete Flowers is representing over 200 clients who claimed they have suffered complications associated with Charite. So far, Flowers has filed 28 lawsuits against DePuy Spine (a division of J&J) that allege Charite is defective and J&J negligently marketed the disc and failed to adequately warn of the product’s dangers.
Experts predict J&J will be hit with more and more Charite lawsuits in the next several months. Since the disc’s approval, more than 5,000 people in the U.S. have received the implant.