DePuy Orthopaedics has been battling lawsuits concerning its recalled ASR hip replacement device for years. The first trials took place this year, but the number of pending cases continue to increase. Most recently, a Canadian judge certified a class action lawsuit brought on behalf of Canadian citizens allegedly affected by the recalled device.
Court Certifies Class Action
Court documents in Crosante v DePuy Orthopaedics Inc., 2013 ONSC 5186 indicate that plaintiffs seek damages, including medical monitoring and emotional distress, for all Canadians implanted with the all-metal ASR hip device. It is estimated that as many as 4,000 people could become part of the class action lawsuit.
In his August 27, 2013 opinion, Justice Edward Belobaba approved three issues for certification. These included whether the ASR implants are defective, whether the manufacturers breached a duty of care, and whether recipients are entitled to special damages for medical costs. He denied, however, the plaintiffs’ request for medical monitoring.
Two of the four representative plaintiffs in this case were implanted with the ASR in 2008. Two years later, both had to undergo revision surgeries. Justice Belobaba noted that 30 to 40 plaintiffs involved in the pending litigation went through revision surgery to remove or replace the device after it failed.
The defendants opposed class action status for the cases, arguing that the class definition was overly broad, and that the proposed common issues were inappropriate. Justice Belobaba disagreed, and ultimately dismissed all opposition.
Metal-on-Metal Implants Create Unique Risks
In the U.S., DePuy faces over 11,000 lawsuits related to the ASR device. The first lawsuit set for trial was settled in August 2012 before trial, and a California jury awarded another plaintiff $8.3 million. A third case was resolved in favor of the defendants in Illinois.
Plaintiffs who were implanted with the device claim that it caused pain, immobility, and premature loosening, often leading to the need for revision surgery. When DePuy recalled the device in August 2010, they admitted that 12-13 percent of the implanted devices were failing, which is much higher than normal. Later studies, however, would estimate the rate to be much higher.
In January 2013, for instance, the New York Times reported that Johnson & Johnson, parent company of DePuy, knew the ASR device would fail within five years in nearly 40 percent of the patients who received it. Court records disclosed in the California trial revealed the company had performed an internal analysis in 2011 that revealed these figures, yet continued to downplay similar findings from a British implant registry.
Hip implants made of metal and plastic typically last for 15 years before they wear out and need to be replaced.
In January 2013, the FDA released new guidelines for patients with metal-on-metal hip implants like the DePuy ASR, stating that they create unique risks not seen with other types of hip replacements.
