About 200 Irish patients who received a recalled DePuy ASR hip implant are planning to file a lawsuit against DePuy Orthopaedics and its parent, Johnson & Johnson. The group’s lawyer told thejournal.ie that the plaintiffs planning the suit all received a DePuy ASR metal-on-metal hip replacement device between 2003 and 2010.
DePuy recalled the ASR Hip Resurfacing System and the ASR Acetabular Hip Implant System worldwide in August 2010, after the National Joint Registry of England and Wales reported that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving it. Since issuing the ASR hip implant recalls, DePuy and Johnson & Johnson have been named in more than 5,000 U.S. product liability lawsuits filed on behalf of people who allegedly suffered early failures of their implants.
According to thejournal.ie, 3,500 patients in Ireland have been impacted by the DePuy ASR hip implant recall. While only the ASR Acetabular Hip Implant System was sold in the U.S., but both it and the ASR Hip Resurfacing System was sold in Ireland and elsewhere overseas. In the U.K., regulators have told patients with metal-on-metal hip implants like the DePuy ASR to have yearly blood tests for the life of their implants to ensure they are not leeching dangerous amounts of toxic metal ions.
The Irish patients planning this lawsuit range from people in their 30s to men and women in their 80s. The attorney for the Irish group told thejournal.ie that some of his clients have already undergone painful revision surgery to have their failed hip implant removed, while others face that prospect in the future.
“It is very invasive surgery, which is much more difficult than the original,” the attorney told TheJournal.ie. “Patients lose more muscle, tissue and bone and end up with a greater limp than they previously had.”
“The more time that passes, the more chance of metal shredding and the rate of revision surgery inevitably goes up,” he explained.
Currently, DePuy pays for blood tests, scans and revision surgeries.
Since the DePuy ASR Hip implant recall, it has become clear that the entire class of metal-on-metal hip implants could be endangering patients. When the metal components of an all-metal hip implant rub together, the device can shed microscopic shards of metal debris into surrounding tissue that may eventually make their way into the blood stream. This can lead to metallosis, a condition that results in swelling, muscle bone and tissue loss, and searing pain. If the metal ions leech into the blood stream, patients can develop cobaltism, which can cause a variety of long-term health problems, including possibly cancer.
Last May, the U.S. Food & Drug Administration (FDA) directed 21 companies that market all-metal hip replacement devices to conduct post-market studies of their products to determine if they were shedding dangerous amounts of metallic debris in patients. Last week, The Lancet published a study conducted by University of Bristol researchers who found that people with metal-on-metal hip implants were twice as likely to experience early failure of their device compared to those fitted with other types of implants. The authors of the study asserted the devices should no longer be used. Late last month, the British Medical Journal revealed that metal-on-metal hip implant manufacturers were aware of mounting evidence linking metal-on-metal hip replacement devices to serious, long-term health consequences, but for years failed to warn the public about these dangers.
In the U.S., lawsuits involving the DePuy ASR hip implant have been consolidated in a multidistrict litigation in federal court in Ohio. Hundreds of additional lawsuits are pending against a metal-on-metal version of DePuy’s Pinnacle hip implant, which plaintiffs allege is similar in design and causes the same complications as the ASR.
Earlier this year, lawsuits involving Wright Medical Technology’s Conserve Plus metal-on-metal hip implant were consolidated in a multidistrict litigation in the U.S. District Court for the Northern District of Georgia. A number of lawsuits have also been filed around the country alleging that Biomet’s Magnum hip replacement, another all-metal device, is defective and may result in the need for revision surgery within a few years.