Attorneys Ask FDA to Investigate Legal Issues Surrounding DePuy ASR Recall
A group of attorneys involved in DePuy ASR hip recall claims recently sent a letter to the FDA asking the agency to investigate whether the artificial hip manufacturer broke federal law by inadequately testing its implants before marketing them to the public, according to recent reports.
In their letter, lawyers reminded the U.S. Food and Drug Administration (FDA) that DePuy Orthopaedics failed to address complaints that a large number of its ASR metal-on-metal hip implants were causing complications in recipients, which led European companies to stop using them prior to the U.S. recall in August 2010.
Prior to the DePuy ASR recall, which has since been associated with high metal ions in the bloodstream that may lead to tissue death, mobility problems, pain and other symptoms of metallosis, more than 33,000 ASR XL hip implants were sold. Some estimates show early failure rates stemming from the device as high as 60 percent. According to a statistic from the British National Joint Registry, 13 percent of recipients needed at least one revision surgery to replace the hip, which was considered much higher than what is considered acceptable.
Engineers for the Johnson & Johnson subsidiary may have even advised the company to redesign the DePuy ASR metal-on-metal hip in 2007—three years before the recall was announced, according to reports. There is also evidence that a surgeon letter from 2006 that detailed failure rates in ASR clinical trials may have also been covered up.
According to their letter to the FDA, lawyers said, “We believe almost all of these injuries would have been avoided had DePuy complied with the reporting requirements and informed your agency about the adverse events and concerns about the safety of the ASR which came to the company’s attention.”
11,500+ DePuy ASR Hip Lawsuits Now Pending in Federal, State Proceedings
As of August 2013, approximately 11,500 DePuy ASR lawsuit claims have been filed in the U.S. Court records show that 7,800 are pending in a federal multidistrict litigation underway in the U.S. District Court, Northern District of Ohio, which has scheduled its first bellwether trial to begin on September 9th. A court update in August indicated that the Plaintiff in this case had identified 95 potential witnesses that could be called to testify on her behalf in the upcoming hearing.
Meanwhile, at least 650 more cases are moving forward in a consolidated litigation established in New Jersey’s Bergen County Superior Court.
Pursuing a DePuy ASR Recall Lawsuit
In the three years since the DePuy ASR hip recall, the nationwide litigation involving the metal-on-metal hip implants has continued to grow. If you were injured as a result of this device, contact the lawyers at Bernstein Liebhard LLP to start the process of filing a lawsuit at (877) 779-1414.