(Greensboro, NC) – February 23, 2012 – In a New York Times article yesterday, Barry Meier revealed that, "In 2009 an executive at Johnson & Johnson reported in an internal e-mail that the Food and Drug Administration had refused to approve a version of the DePuy hip device, after reviewing company studies that showed that the Depuy ASR Hip Implant had failed prematurely in “significant” numbers, requiring repeat surgeries for patients."
This email came a year before the company began the process of recalls of the DePuy artificial hip. In the e-mail, the executive, Pamela Plouhar, explained the reasons for the agency’s decision to three other top executives, including DePuy’s president at the time, David Floyd. Ms. Plouhar reported that the device had not met F.D.A. approval standards and that a major concern was its high rate of early failure, or “revision,” during clinical trials. She also cautioned that providing the F.D.A. with more data might not change its stance and that it might take years to conduct new studies of the hip, known as the ASR, or articular surface replacement. “The team’s concern is that given the revision rate in the ASR group that we will still not be able to demonstrate non-inferiority, with additional downside risk,” Ms. Plouhar wrote.
Brian Kinsley, Crumley Roberts' Practice Group Leader for Defective Products adds, "In light of these concerns it is imperative that individuals implanted with these devices follow up with their healthcare providers to ensure they are getting the medical monitoring and treatment they need. Furthermore, it is important to take steps to protect their legal rights against the manufacturer of this product."
Read more from the New York Times here.Free Initial Consultation