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DePuy Decision to Phase Out ASR Hip Implant Followed FDA Letter Seeking Safety Data

Mar 23, 2012 | Parker Waichman LLP

DePuy Orthopaedics and its parent, Johnson & Johnson, are facing more questions today about the way the companies responded to safety concerns surrounding its now-recalled DePuy ASR hip implants.  In November 2009, DePuy it announced was phasing out sales of the ASR hip replacement devices due to lagging sales.  However, the New York Times is reporting that the decision on the DePuy ASR hip implant phase-out was actually made just weeks after the U.S. Food & Drug Administration (FDA) asked the company for more safety data for an ASR model used in hip resurfacing procedures.

The FDA letter, dated August 13, 2009, was a so-called nonapprovable letter in which the agency confidentially notified DePuy that it would not be permitted to sell the ASR Hip Resurfacing System in the U.S. In the letter, the FDA expressed concerns about elevated levels of metal ions seen in the blood of some DePuy ASR hip implant recipients.   The letter also points out that the reports from countries where the implant was then being used showed it was performing “somewhat more poorly” than data submitted by the company’s DePuy Orthopaedics unit indicated.  If DePuy wanted the ASR hip resurfacing system approved for U.S. sale, it would need to submit additional safety data, the FDA said.

While the FDA would not approve the ASR hip resurfacing system for sale in the U.S., it had already approved the DePuy ASR XL Acetabular Hip Implant for use in total hip replacements in 2005.  That device was eligible for the agency's 510(k) approval process because DePuy was able to show it was substantially equivalent to another product on the market.  But because the resurfacing system was meant for a new type of procedure, it had to go through a more stringent approval that required clinical trials.  Ironically, data from device registries in the U.K have since revealed that the ASR hip implant that was sold in the U.S. is failing early at a far higher rate than the one the FDA refused to approve.

DePuy never provided the FDA with new data on the ASR resurfacing implant.  But in September 2009, the decision was made to phase out the ASR hip implant line, the Times said.  That month, executives launched a strategy to phase out the devices while selling their remaining stocks for use in patients both here and abroad.  The phase out was announced in November, and blamed on lagging sales.  DePuy said that sales of the ASR hip implant model would end in late 2010.  But in Spring 2010, a DePuy executive reported in an email that ASR hip implant stocks were not yet depleted, and that the rationalization program would not end on a fixed date.

DePuy finally recalled the ASR XL Acetabular Hip Implant and the ASR Hip Resurfacing System in August 2010.  By that time, some 93,000 of the devices were implanted in patients worldwide, with a third used in the U.S.   According to the Times, it's not known how many of the ASR hip implant devices were sold during the year DePuy was pursuing its phase-out strategy.

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