Thursday, November 17, 2011

An Earlier Recall for DePuy ASR Hip Replacement should have been Done

When the complaints on metal-on-metal hip implants increased, the DePuy Articular Surface Replacement (ASR) hip systems recall should have been done immediately, according to medical experts. It had taken three years after evidence showed that the hip implants had a high failure rate, for a recall to be implemented by DePuy Orthopaedics Inc. and its mother company Johnson & Johnson, said Australian medical experts.   Johnson & Johnson had to reimburse thousands to Australians in recall claims as a result.

Before the United States and Europe recalled the two DePuy hip implants in August of 2010, Australia had done it already in December 2009.  Data from a study conducted by the National Joint Registry (NJR) of England and Wales which indicated that the five-year failure rate of this product was approximately 13 percent prompted the recall. Some medical experts claim that this data have been available since 2006.  

Aside from the data which stated that the ASR hip implants also had a higher than normal failure rate, Johnson & Johnson’s DePuy Orthopaedics also said in March of 2010 that it will phase out the devices because of declining sales.  Pointed as the reason for the hip implant’s failure just five years after it was first used is its design.  By designing a shallower cup and removing the plastic liner from the inside of the implant, DePuy had intended for patients to have a wider range of motion. The design, however, allows cobalt and chromium particles to accumulate in the soft tissue around the implant area, after they wear off from the device resulting from the friction of the ball portion of the hip implant against the socket.

More alarming is the claim that other evidence indicates that the revision rate is now at 25 percent, while some experts predict that within six years, as more of the devices fail, it could reach up to 49 percent. The defective hip implant could only be removed by a revision surgery. Although DePuy promises to compensate patients’ revision surgery, lawyers said it is not willing to fully compensate those affected. Apart from the revision surgery cost, full compensation would include the pain and suffering, emotional suffering and financial loss as a result of having the defective implant.

The DePuy hip replacement recall sparked the filing of thousands of lawsuits and complaints.  All cases filed across the country was transferred to the Northern District of Ohio and, with the consent of that court, assigned Honorable David A. Katz to handle it for coordinated or consolidated pretrial proceedings last December 2010 as based on the ruling filed by the US Judicial Panel on MultiDistrict Litigation (MDL. The DePuy lawsuit alleges that the ASR hip replacement was defectively designed and that DePuy knew that there were problems with the implant early on but didn't do anything to let patients or their surgeons know about the possible problems.

References:
m.smh.com.au/national/health/three-years-to-recall-problem-implants-20110927-1kvik.html

world.einnews.com/pr_news/59900568/asymptomatic-metal-on-metal-hip-replacement-patients-may-still-be-experiencing-tissue-damage

forthepeople.com/depuy-metallosis-depuy-hip-implant-recall--12-3189.html

nytimes.com/2010/03/10/business/10device.html

moriarty.com/depuy_hip_recall/Stay_Informed/What_is_Metallosis/
orthosupersite.com/view.aspx?rid=40090