New York Times Reports that DePuy Orthopedics Made Decision to Phase Out ASR Hip Implants Only After FDA Questioned ASR Failure Rates and Sought Additional Safety Data.
The attorneys of Alonso Krangle LLP, a leading law firm focused on fighting for the rights of people injured by defective medical devices, are disturbed by the timing of DePuy Orthopaedics’ decision to phase out the ASR hip replacement line in 2009. According to an investigation published by The New York Times on March 22, 2011, executives at DePuy only decided to launch the ASR hip implant phase-out in the weeks following receipt of a non-approval letter from the U.S. Food & Drug Administration (FDA) for the ASR Hip Resurfacing System that sought additional data on failure rates for the device.
At the time, DePuy was already marketing a sister version of the device, the ASR Acetabular XL Hip Replacement, in the U.S. That metal-on-metal artificial hip, designed for use in total hip replacement, was approved in 2005 through the FDA’s 510(k) process, which doesn’t require human clinical trials if the design of a device is substantially equivalent to another already approved for sale by the agency. However, since hip resurfacing constituted a new procedure, DePuy could not apply for 510(k) clearance for the ASR Hip Resurfacing System, according to The New York Times.
The confidential letter, dated August 13, 2009, requested more safety data regarding ASR failure rates from DePuy before the FDA would consider approving the ASR Hip Resurfacing System for sale in the U.S, according to the Times. The letter, which The New York Times obtained via the Freedom of Information Act, expressed concerns with the “high concentration of metal ions” in patients who received the ASR device, and noted that registries in countries where the resurfacing system was approved for sale indicated it was performing “somewhat more poorly” than data submitted to the FDA by DePuy had indicated.
According to The New York Times, DePuy never submitted the additional safety data to the FDA. However, just weeks later in September 2009, DePuy executives decided to phase out sales of the ASR hip implants. The phase-out was announced in November 2009, with DePuy maintaining the decision had been made due to slow sales of the devices. According to the Times, the company launched a strategy to sell off existing inventories of the ASR hip implants and convince surgeons to switch to other DePuy hip replacement models.
In August 2010, DePuy issued a worldwide recall of the ASR Hip Resurfacing System and the ASR Acetabular XL Hip Replacement System after data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it. By that time, roughly 93,000 of the devices had been sold worldwide, a third in the U.S., according to the Times.
DePuy Orthopaedics is currently named in more than 5,000 lawsuits involving its metal-on-metal ASR hip implant devices, most of which are pending in a multidistrict litigation underway in U.S. District Court for the District of Ohio (MDL No. 2197). Hundreds of other lawsuits involving a metal-on-metal model of the DePuy Pinnacle hip implant are pending in U.S. District Court for the Northern District of Texas (MDL No. 2244). Alonso Krangle LLP continues to offer free lawsuit evaluations to anyone injured as a result of a recalled DePuy ASR hip implant, or the metal-on-metal DePuy Pinnacle hip replacement device. To discuss a potential claim with one of the experienced and compassionate defective hip implant lawyers at Alonso Krangle LLP, please contact us at 1-800-403-6191 or visit our website, FightForVictims.com
About Alonso Krangle LLP
Andres Alonso and David Krangle, attorneys with almost 40 years of collective legal experience, have focused their law practice on the handling of significant personal injury cases, defective drug and medical device litigation, construction site accidents, nursing home abuse, medical negligence, qui tam/whistleblower actions and consumer fraud cases. A leading law firm representing injured victims throughout the U.S., Alonso Krangle LLP is headquartered in Long Island, New York, with offices in New York City, and plans to open additional locations in New Jersey.
For more information about Alonso Krangle or to join the fight and be a part of our team, please contact us at 1-800-403-6191 or visit our website,http://www.FightForVictims.com.