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New DePuy President – New DePuy Hip Challenges

J. Cooper Carlisle | July 2nd, 2011 | Posted in Depuy Hip Recall News

DePuy Orthopaedics is moving into battle with a new leader at its helm following a major DePuy hip recall and a wave of litigation against one of the largest orthopedic device manufacturers in the world.

New president Andrew Ekdahl was appointed earlier this year to replace David Floyd, who resigned in February amid a swirl of litigation and regulatory scrutiny over the DePuy ASR and Pinnacle hip systems.

DePuy Hip recall in August 2010

Last August, the FDA issued a DePuy hip recall for more than 93,000 ASR systems implanted across the globe, after the device was found to fail prematurely in 12 percent of ASR recipients. More recent studies suggest failure rates could be as high as 49 percent over 6 years.

Today, thousands of ASR recipients have filed a DePuy ASR hip lawsuit against the company, with claims ranging from negligence to fraud.

DePuy Pinnacle Hip lawsuit as new president takes over

Ekdahl enters the fray as a separate hip system comes under scrutiny. In May 2011, a high-ranking judicial panel approved of consolidating lawsuits over the Pinnacle, an older metal-on-metal hip replacement system implicated in complications similar to those found with the ASR. The Pinnacle is a predicate device of the ASR – it’s observed safety was instrumental in the ASR’s clearance by the FDA. People who have received the Pinnacle system may file a Pinnacle hip lawsuit through the US District Court for the Northern District of Texas.

New president may be just the man to handle DePuy Hip lawsuits

People close with Ekdahl believe he is cut out for the job. He has been with DePuy and parent company Johnson & Johnson for more than twenty years, most recently serving as franchise vice president of DePuy Europe, Middle East and Africa.

“There’s no doubt (Ekdahl) is coming into a crappy situation,” Robin Young, founder of orthopedic-data firm PearDiver Technologies tells the Ft. Wayne, Indiana Journal Gazette. “But I’m sure he was selected based on experience.

The full extent of the “crappy situation” may come to light as DePuy Orthopedics complies with an FDA request to deliver post-market performance data on the metal-on-metal hip replacement systems it has put into commerce. The results could be delivered later this year.

It remains to be seen if any models other than the ASR become implicated in a DePuy hip recall or if new systems become named in lawsuits. It is tough to see the situation becoming more difficult for the company than it already is.

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