Plaintiffs to Receive Registry Data on DePuy ASR Failures, Subject to Limits

In the federal litigation over recalled DePuy ASR hip replacements, Plaintiffs will have access to certain data from a British joint registry, which may provide additional information on DePuy ASR failure rates and when the manufacturer should have realized there were problems with the implant design.

According to an order (PDF) issued July 23, U.S. District Judge David A. Katz granted a request filed by plaintiffs to obtain access to certain data from the United Kingdom’s National Joint Registry (NJR), which is in the possession of DePuy. However, certain protective measures have been put in place to prevent the re-disclosure of the information.

The National Joint Registry was established by the United Kingdom Department of Health and Welsh Assembly Government of the United Kingdom in 2002, for public health purposes. The data is designed to track individuals in the United Kingdom who receive a hip replacement, knee replacement or ankle joint replacement, in an effort to better define, improve and maintain the care of individuals in that country.

Although the data collected in connection to those surgeries is protected under United Kingdom laws and the NJR’s arrangements with the individuals and entities who provide the data, the NJR has permitted DePuy to produce such data subject to certain protective measures.

Judge Katz has ordered that any disclosure of NJR data made as part of the federal DePuy ASR litigation will be subject to a previously agreed Protective Order of Confidentiality, which prevents the disclosure of the data. In addition, upon any settlement or other resolution of the litigation, the data is to be returned and all copies of the materials will be destroyed.

Registry Data May Provide Important Information on Failure Rates

Information gathered as part of registry systems has proven important in identifying potentially defective artificial joint replacement devices in recent years. Unfortunately, such a registry was not formed in the United States until October 2010.

In August 2010, a DePuy ASR recall was issued as a result of the data gathered through the U.K. National Joint Registry, which detected a higher-then-expected failure rate among individuals who received the implant.

Data from the registry suggested that approximately 12% of individuals who received the DePuy ASR Hip Resurfacing System and 13% of individuals who received the DePuy ASR XL Acetabular System required revision surgery within five years. However, subsequent estimates from the data have suggested that 29% of patients who received the DePuy metal-on-metal hip reported failure within six years.

By the time DePuy recalled ASR hips, more than 90,000 of the components had been sold worldwide, including about 40,000 in the United States. The manufacturer now faces claims that they knew or should have known about the problems with the DePuy ASR hip and issued the recall earlier.

DePuy ASR Lawsuits Filed Throughout United States

More than 6,000 people in the United States have filed a product liability lawsuit after experiencing problems with a DePuy ASR implant. All federal complaints have been consolidated for pretrial proceedings before Judge Katz in the U.S. District Court for the Northern District of Ohio, as part of an MDL, or multidistrict litigation.

According to allegations raised in the lawsuits, the DePuy ASR was defectively designed, featuring a a metal-on-metal configuration that causes microscopic shavings of metal to be released into the body as the metal parts rub against each other. This can cause a condition known as metallosis, which may lead to loosening or failure of the hip replacement.

Similar problems have been reported with other metal-on-metal hip replacement systems that have not been recalled, including the DePuy Pinnacle hip, Biomet M2A-Magnum hip and Wright Conserve hip.

Last month, an FDA advisory committee recommended that recpients get an  annual blood test to check for metal blood poisoning if the implant was bothering them, and to get an X-ray of the device annually even if it is not currently causing them a problem.