Thousands of recipients have been adversely affected by the ASR XL Acetabular System and ASR Hip Resurfacing System, both of which were manufactured and subsequently recalled by DePuy Orthopaedics. One in eight of the 93,000 recipients need a revision surgery. Pain, inflammation and dislocation are symptoms experienced by most affected patients. Metal poisoning pose as a threat to some of them. You should take a look at the Safe Medical Device Act and see how it affects your case against DePuy , if you have already filed, or is still planning to file a lawsuit.
The following is an outline of the act’s significant requirements:
A DUF or a Medical Device User Facility is obligated to send a report to the Secretary of Health and Human Services as well as the manufacturer of the said medical device if they reckon that the device has injured a patient.
The United States Food and Drugs Administration was given numerous reports from DUFs that pertains to the devices’ early failure rate. Two years before the recall, the complaints started coming in.
Hip replacement implants fall under the Class III medical device. Companies that manufacture medical devices that fall under this category are required to submit a summary of any information pertaining to these products especially about known side effects and unfavorable influence on safety.
Correction, repair or removal of the devices must be reported to the Secretary of Health and Human Services by the manufacturer if its purpose was to reduce a health risk.
The recall made by DePuy on the ASRs from the Australian market in 2007 was spurred by data from the Australian National Joint Registry showing its early failure rate. It took the company two more years to issue the global recall. It makes one wonder why DePuy waited so long to take action about a product that clearly poses tremendous risks to recipients. Between the recall in Australia and the global recall, it is safe to assume that the manufacturer has significant knowledge about the effects and damages their products inflict on patients.
A federal violation has been made when DePuy failed to submit appropriate reports regarding the issues the ASR devices have. Losses and suffering experienced by recipients should be compensated for by the company. Speaking with a hip replacement lawyer would provide you with options regarding the DePuy case. For more information and updates, visit the DePuy hip replacement center.
Posted under Miscellaneous Content
This post was written by admin on April 11, 2011
