In 2010, news outlets began reporting that recipients of DePuy Orthopaedics’ ASR XL Acetabular System and ASR Hip Resurfacing System were submitting injury reports to federal regulators and filing lawsuits. By August, Johnson & Johnson (J&J), DePuy’s parent company, recalled the devices, which had been implanted in about 93,000 people worldwide and 37,000 in the United States.
Why Did the ASR Hip Recall Occur?
DePuy recognized that its ASR hip replacements were failing at much higher-than-normal rates compared to other metal-on-metal hip replacements and artificial hips made with other materials. Recipients could suffer from hip joint failure or even metal poisoning. At the time it was believed that the ASR devices failed in around one in eight recipients shortly after implantation. The devices are meant to last for 15 years.
One reason the recall occurred was that DePuy didn’t subject the ASR XL Acetabular System to clinical trials. The U.S. Food and Drug administration (FDA) does not require some manufacturers from subjecting their devices to clinical trials and instead allows them to claim that their hips are “substantially equivalent” to preexisting devices. Some of these “predicate” devices themselves were never tested or were problematic themselves. In other instances, the devices used different materials, like plastic or ceramic components, rather than metal ones but could still be cleared nonetheless.
The ASR Hip Resurfacing System did undergo clinical trials in the United States, but the FDA chose not to approve it due to concerns over its failure rates. That didn’t stop J&J from marketing it in other countries, which never knew that the device wasn’t cleared in the United States.
DePuy ASR Hip Recall Spawns Thousands of Lawsuits
After the DePuy ASR hip recall began, thousands of patients sued DePuy and J&J in federal, state, and foreign courts. A multidistrict litigation was formed in the U.S. District Court for the Northern District of Ohio, and cases were also centralized in New Jersey, California, Illinois, and other states. Two trials were conducted in 2013 with one resulting in an $8.3 million jury verdict for the plaintiff and the other a victory for DePuy. In late 2013, the parties agreed to a mass settlement of all remaining claims with base awards beginning at $250,000. Settlement payouts began as early as May 2014.
How Can a Lawsuit Help Me?
If you or a loved one received a device subject to the DePuy ASR hip recall, then a lawsuit can help you hold the manufacturer accountable. The amount of compensation from a DePuy ASR hip recall lawsuit can include damages for full medical expenses, lost earnings, pain and suffering, and other damages. For a free, confidential legal consultation with a lawyer from the Rottenstein Law Group, call 1-800-624-9568 or click on this link.