The Rottenstein Law Group, which represents hip replacement
recipients in DePuy lawsuits, reacts to a New England Journal of
Medicine article that traces the DePuy ASR recall to an FDA regulatory
shortcut called the “510(k) process.”
(PRWEB) January 10, 2013
The
Rottenstein Law Group acknowledges an article in the New England
Journal of Medicine that pinpoints key problems with an FDA [regulatory shortcut that was a precursor to the DePuy ASR recall and DePuy lawsuits because of the device’s severe side effects.
The
510(k) process allows devices to be fast-tracked for approval that are
similar to those that have already been approved. The devices can go to
market without having to demonstrate safety and effectiveness through
clinical studies. The DePuy ASR, a metal-on-metal hip replacement
system, was one of those fast-tracked devices when Johnson & Johnson
subsidiary DePuy began selling it in July 2008 after receiving FDA
clearance without any clinical study, according to the NEJM article.
“Recipients
of the DePuy ASR who believe they have been injured by the device’s
serious side effects need a strong advocate,” said Rochelle Rottenstein,
principal of the Rottenstein Law Group, which represents hip
replacement recipients in DePuy lawsuits. “Our regulatory bodies are
supposed to protect patients, not possibly put them into more danger.”
Read full story on PRWeb.com: DePuy Recall Lawsuit Update: Rottenstein Law Group Acknowledges the Role of an FDA Regulatory Shortcut in DePuy Lawsuits