DePuy ASR™ Hip Replacement Implant Recall: Complaints
The following information has been obtained from various sources.
Depuy Hip Replacement Implants — Recall Background
The DePuy ASR is a metal-on-metal hip replacement system developed in 2005. The Depuy ASR XL Acetabular Hip System and Depuy ASR Hip Resurfacing System Implants was recalled on August 26, 2010. DePuy Orthopaedics announced the recall of DePuy ASR XL Acetabular Hip System and DePuy ASR Hip Resurfacing System implants, after confirming that they have an unreasonably high failure rate. DePuy recalled 93,000 ASR metal hip implants, after data suggested that about one out of every 8 may fail within five years.
Johnson & Johnson's DePuy Orthopaedics unit was already phasing out the ASR hip implant system when it finally acknowledged in March 2010 that the device was prone to early failure. By March, the US Food & Drug Administration (FDA) had received hundreds of reports describing early failure of the DePuy ASR hip implant system and the company still waited months to issue its recall. The recall was made a year-and-a-half after the first lawsuit over DePuy ASR hip problems was filed.
Approximately 93,000 DePuy ASR hips have been sold, and new data suggests that approximately 15% fail within five years which results in the need for additional hip surgery to replace the defective metal on metal artificial hip.
Soon after the DePuy ASR was introduced in 2005 there were reports of complications and failures. According to the FDA, there were nearly 100 reports of ASR problems in 2007, over 200 in 2008 and over 300 in 2009. The vast majority of these reports (over 90% of those reported in 2009) involved the need for a surgical hip revision after a DePuy ASR hip replacement.
What are the complaints?
The lawsuits over DePuy ASR hip implants involve similar allegations of design defect which usually result in the need for additional surgery to revise or replace the hip implant.
The complaints allege that DePuy failed to adequately test the metal-on-metal hip system and did not immediately issue a recall when it became apparent that the DePuy ASR had a high failure rate.
Health care professionals have increasingly been warning about problems with metal-on-metal hip implants, which can shed metal particles into the body. The particles can damage soft tissue, cause inflammatory reactions and lead to bone loss.
The DePuy ASR hip failures appear to be linked to a defective design of the acetabular cup, which is shallower than acetabular cups made by other companies, making it prone to problems.
According to data from the National Joint Registry of England and Wales 12%-13% of the patients who had received the recalled devices had to undergo revision surgery within five years of receiving it. A hip implant should last around 15 years. The ASR Hip Resurfacing System fails in about 12% of recipients within five years and the ASR XL Acetabular System fails in about 13% of recipients, with the failure rate even higher among women and those with heads smaller than 50mm.
The ASR hips recalled by DePuy can potentially release toxic metal shavings into the tissue surrounding the defective artificial hip and be spread throughout the body through the bloodstream.
British Orthopedic Association advised the the Medicines and Healthcare products Regulatory Agency (MHRA) of the UK, that over time metal debris may affect the performance of a hip implant and cause painful complications.
What Should I do if I have a DePuy ASR Hip Resurfacing System implant?
1. Call your doctor and find out if you have a DePuy ASR™ Hip Implant that was recalled.
2. If you have the Depuy ASR™ Hip Implant, Contact Dean Goetz (858-481-8844) and set up a free personal or telephone appointment to discuss your options. You will be able to talk to Attorney Dean Goetz directly. You will not be talking to a Paralegal about your case.
3. Learn More: article by San Diego injury attorney Dean Goetz
If you received an ASR hip implant and you are having hip related problems, you should call Attorney Dean Goetz today. CALL 858-481-8844. You can speak directly with Attorney Dean Goetz and get answers without any obligation.
Do not contact DePuy Orthopaedics or Johnson & Johnson without first talking to an attorney. It's important that you know what your options are.
$8.3 Million Reasons to Choose Dean as your Attorney
Metal on Metal Hip Device Recall - Depuy
Dean A. Goetz and the Gomez Law Firm were the attorneys for Mr. Loren Kranksy, the Plaintiff in the first Depuy trial in the USA. 3/6/13 at 9:38 a.m. PST A jury found Depuy liable to Mr. Loren Bill Kransky today in a Los Angeles Superior Court. FIRST verdict in the USA against Depuy for $8,328,000. We Are The Kransky Lawyers. Kranksy vs. Depuy and Johnson and Johnson, Los Angeles County Superior Court Case #BC456086.
It took three and one half more years for this to finally end for Mr. Kransky's family, on 7/21/16 Court of Appeals Upholds Kransky v. Depuy.
November 2017: Dean Goetz with Mr. Kransky's full legal team Nominated (PDF press release) for Consumer Attorneys of California Attorney of the Year 2017 for our work in Kransky vs. Depuy, and Mr. Kransky's long road to justice.
The Walking Wounded - Dean Goetz interviewed on ABC (Australia ABC, a show similar to USA "60 Minutes") Investigative Report - watch the whole investigative story on Depuy, aired 5/26/14, "Reporter Quentin McDermott reveals how a healthcare giant deceived doctors and patients using its ASR hip replacement implant." Australian Depuy class action cases go to trial in 2015, and those injured by their hip devices are now armed with what came out in Mr. Kransky's trial..
Articles published during the first Depuy trial on emerging information:
- Maker Aware of 40% Failure in Hip Implant
New York Times January 22, 2013
- J&J Failed to Warn of Hip Implant's Risks, Jurors Told
Bloomberg News January 25, 2013
- Trial underway in hip implant lawsuit
Los Angeles Times January 25, 2013
- News from Kransky v. DePuy Richmond, VA Legal Examiner January 29, 2013
- J&J Had 'Inappropriate' Risk Controls for Hip, Jury Told Bloomberg News January 31, 2013
- J&J Failed to Weigh Hip Metal Debris Risk, Witness Says Bloomberg News February 1, 2013
- J&J Recalled Hips Over Safety Concerns, Witness Testifies Bloomberg News February 4, 2013
- J&J Jury Told Hip Has Many Design Defects Causing Failure Bloomberg News February 6, 2013
- J&J Sales Rep Told Surgeon of Hip Problems, Jury Told Bloomberg News February 7, 2013
- What a Company Knew About Its Metal Hips New York Times February 10, 2013
- J&J Feared Metal Backlash Would Hurt Hip Sales, Jury Told Bloomberg News February 13, 2013
- J&J Hip Recipient Says He Feared Surgery Would Kill Him Bloomberg News February 19, 2013
Articles about Depuy recall leading up to trial:
- FDA Examines Metal Hip Devices
- Congress Wading Into Faulty Hip Implant Issue
- Defective and dangerous medical device products. rushed to market with, "Gaps in FDA's postmarket surveillance show that unsafe and ineffective devices may continue to be used, despite being recalled."
- New York Times Remedy Is Elusive as Metallic Hips Fail at a Fast Rate
- Medical News Today Hip Replacement Recall By Depuy Orthopaedics Is Big News
- Independent UK Thousands of patients left in agony by faulty hip replacements. Nearly 8,000 people may have to undergo further surgery as an implant is recalled – three years after warnings about its defects.
- 24-7 News Lawsuits involving the recalled Johnson & Johnson DePuy ASR hip implant could be consolidated in a multidistrict litigation.