Parker Waichman LLP Learns that DePuy Orthopaedics Execs Discussed ASR Hip Implant Failures One Year Before Issuing Worldwide Recall

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New York Times Investigation Reveals DePuy Orthopaedics Execs Discussed via Email an FDA Non-Approval Letter That Cited Early Failures of the ASR Hip Resurfacing System in August 2009, One Year Before Worldwide Recall

Parker Waichman LLP, a national law firm representing plaintiffs in lawsuits involving defective medical devices, has recently become aware that high-ranking executives at DePuy Orthopaedics, a division of Johnson & Johnson, discussed the high rate of early failures associated with the ASR Hip Resurfacing System one year before issuing a worldwide recall of DePuy's ASR Hip Implant devices. In an internal email dated August 21, 2009 recently obtained and published by The New York Times, Pamela Plouhar, vice president for worldwide clinical affairs at DePuy, told several other high-ranking executives that the U.S. Food & Drug Administration (FDA) had issued the company a non-approval letter for its ASR Hip Resurfacing System which stated that the device had not met the agency's approval standards and that a major concern was its high rate of early failure, or need for “revision” surgery, seen during the company's clinical trials. Plouhar’s email also acknowledges that ASR Hip Implants had been the subject of overseas complaints: “This comes at a time when ASR data from national registries (Australia and UK) is being closely scrutinized because of higher revision rates,” she wrote.

According to The New York Times, the DePuy ASR Hip Resurfacing System was never marketed in the U.S., though it was sold abroad. However, in 2005, the FDA did approve a related model, the ASR Acetabular Hip Implant System, for sale in the U.S. In August 2010, both devices were subject to a worldwide recall after the National Joint Registry of England and Wales reported 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. DePuy Orthopaedics and Johnson & Johnson have since been named in at least 5,000 U.S. lawsuits filed on behalf of people allegedly injured by the recalled ASR Hip Implants.

As the Times points out, Plouhar's 2009 email contradicts many public statements DePuy Orthopaedics and Johnson & Johnson made regarding the safety of the ASR Hip Implant devices in the years leading up to the recall. In fact, in the months just before the recall, DePuy maintained its internal studies refuted complaints coming from doctors and overseas regulators that the device was defective, according to the Times. DePuy blamed surgeons for the hip implant failures, insisting they were not positioning the devices correctly. In November 2009, DePuy announced it would be phasing out the ASR Hip Implant devices, but maintained the decision had been made because of declining sales, the Times said.

According to Parker Waichman LLP, the August 2009 email published by The New York Times corroborates allegations made in DePuy ASR Hip Implant lawsuits that both Johnson & Johnson and DePuy Orthopaedics knew of problems with the devices long before the August 2010 recall. The email also backs up Plaintiffs' claims that DePuy and Johnson & Johnson tried to conceal the safety issues related to the ASR Hip Implants by publically citing lagging sales for the 2009 phase out.

Safety Issues Surrounding Metal-on-Metal Hip Implants

DePuy's ASR Hip Implants are metal-on-metal hip replacements, which as a class have been the subject of growing safety concerns in recent years. Last May, the FDA directed 21 makers of all-metal hip implants, including DePuy Orthopaedics, to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients. It is believed that metal-on-metal hip implants can shed microscopic particles of cobalt and chromium through wear, leading to cobalt poisoning and metallosis. These conditions may result in tissue damage, the development of cysts and pseudotumors, premature device failure, the need for revision surgery, and other long-term health problems.

Recently, The Sunday Telegraph reported that health regulators in the United Kingdom were preparing to issue new guidance regarding metal-on-metal hip implants amid concerns that the shedding of metal debris into patients' blood streams could lead to "systemic toxicity," and could put the nervous system, heart and lungs at risk of being slowly poisoned. In a separate report, The Sunday Telegraph also revealed that preliminary findings from a study conducted by researchers at the University of Bristol indicated that patients fitted with all-metal hip implants may be at risk of experiencing genetic changes to the cells of the bladder, a possible precursor to cancer, and possibly bladder cancer itself.

Parker Waichman LLP continues to offer free legal consultations to victims of DePuy Orthopaedics' recalled ASR hip replacement devices. If you or a loved experienced premature failure of your device or other health problems associated with a DePuy ASR Hip Implant, please contact their office by visiting the firm's DePuy ASR Hip Implant recall page at Free case evaluations are also available by calling 1 800 LAW INFO (1-800-529-4636).

For more information regarding defective hip implant lawsuits and Parker Waichman LLP, please visit: or call 1-800-LAW-INFO (1-800-529-4636).

Contact:     Parker Waichman LLP
                 Herbert Waichman, Partner
                 (800) LAW-INFO
                     (800) 529-4636


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