J&J unit DePuy loses suit dismissal bidApr 13, 2007 | UPI U.S. Johnson & Johnson unit DePuy Spine has lost a bid to quash suits claiming its spinal device has defects, plaintiffs' counsel said.
A Massachusetts state court earlier this week refused to dismiss four lawsuits filed against DePuy alleging the company's Charite Artificial Disc used to replace diseased or damaged spinal discs as an alternative to spinal fusion -- doesn't work for its intended purpose.
The plaintiffs in the four cases alleged the spinal device failed, causing serious and lasting damage.
The court refused to buy DePuy's defense that approval of the product by the Food and Drug Administration insulated the company from lawsuits based on product defect, a legal strategy known as pre-emption.
"In short, DePuy was claiming that since the FDA gave its approval for the disc's use, it was inoculated against claims of defect or negligence in its design," said one of the law firms representing the plaintiffs. "We demonstrated to the court that the pre-emption defense in this case went well beyond the pale."
In its ruling, the court said, "There is evidence to support the device does not perform in the manner which DePuy represented to the FDA that it must perform."
The plaintiff also cited promotional materials used by DePuy that they said misleadingly claimed, "The Charite Artificial Disc has a clinical history spanning 17 years. Its safety, efficiency and remarkable durability have been proven through thousands of implants worldwide," and that "Natural Motion is Back."
The plaintiffs also charged that DePuy failed to notify the FDA that it had modified the design of the Charite disc sold in Europe because of safety and effectiveness concerns, yet told the agency the changes were made for physician convenience.