Recent reports indicate that metal-on-metal hip implant failures are rising at an alarming rate. The Federal Drug Administration has received more Complaints related to metal-on-metal hips during the first six months of this year than during the past four years combined. The National Joint Registry for England and Wales reports that the DePuy ASR has the highest failure rate of all metal-on-metal hips, with a 29% failure rate for patients who were implanted with the ASR six years ago.
The DePuy ASR is not the only all-metal hip implant with a growing failure rate. An analysis of the FDA’s computerized reporting database, the Adverse Events Reporting System (AERS), reveals that reported failures of the DePuy Pinnacle is also on the rise. AERS allows health care professionals and consumers to report adverse events caused by drugs or medical devices. Between July and September of this year, the FDA received 709 Pinnacle AERS reports, compared to 556 reports in the previous six months (January – June) and 556 in all of 2010.
The problems with the metal-on-metal Pinnacle device have led to lawsuits around the country, much like the ASR device. In fact, according to recent court documents, over 500 DePuy Pinnacle Complaints have been consolidated in the Multi-District Litigation (MDL) in the North District of Texas in front of Judge Ed Kinkeade. This is a sharp increase when compared to June of this year, when about 50 Complaints had been consolidated. Many expect the number of claims to increase steadily as lawyers continue to investigate and file new Pinnacle claims in federal court.
All of the Pinnacle suits involve similar allegations, such as design and manufacturing defects, and a failure to warn physicians and patients of the implants’ serious risks of adverse events. In many cases, the complications from the Pinnacle implants required additional surgery to revise or replace the hip replacement.
Unlike the Depuy ASR, DePuy has not recalled the all-metal version of the Pinnacle Device. But, on May 6, 2011, the FDA issued a post-market surveillance study of all-metal hip replacement devices. The study requires manufacturers of metal-on-metal hip implants to monitor adverse events of metal-on-metal devices already on the market. As a result, if you have a metal-on-metal hip replacement device, your surgeon may be contacting you to find out how your device is functioning.
Any person who has had a hip replacement should contact their orthopaedic surgeon to determine whether they received a DePuy ASR or Pinnacle metal-on-metal hip implant. For more information on this subject, contact Navan Ward, a lawyer in our Mass Torts Section, at 800-898-2034 or by email at Navan.Ward@beasleyallen.com. As we have reported, Navan is on the PSC for the MDL.
Sources: The New York Times; www.fda.gov.
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