Because of their high failure rates and their subsequent recall, thousands of recipients of the DePuy ASR XL Acetabular System and ASR Hip Resurfacing System are filing lawsuits against DePuy Orthopaedics and its parent company, Johnson & Johnson (J&J). In December 2010, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal-level ASR hip lawsuits in the U.S. District Court for the District of Northern Ohio before Judge David A. Katz. As of June 2014, there were more than 8,600 lawsuits in that multidistrict litigation (MDL). A similar proceeding is pending in New Jersey state court before Judge Brian R. Martinotti. As of July 2013, there were more than 650 cases pending. Plaintiffs have also filed thousands of state court lawsuits against DePuy and J&J; the total nationwide at the end of 2013 was 12,340. In California, the first ASR trial resulted in an $8.3 million award for the plaintiff. The second trial, in Cook County, Ill., ended with a verdict in favor of the defendant.
What Are ASR Hips?
The ASR hip replacement series consists of two devices: The ASR XL Acetabular System is a total hip replacement that first appeared in the United States in 2005. It consists of a metal femoral stem that connects to a metal cup placed in the hip socket. DePuy used the U.S. Food and Drug Administration’s (FDA’s) 510(k) premarket notification process to clear the device. The 510(k) process allows manufacturers to forgo subjecting their products to clinical trials and instead allows them to merely show that their devices are “substantially equivalent” to preexisting ones. DePuy claimed that the ASR XL Acetabular System was substantially equivalent to other metal-on-metal hip replacements, including its own Pinnacle Acetabular Cup System—itself the subject of more than 6,000 lawsuits by June 2014—and other devices going back to the 1970s. The ASR Hip Resurfacing System was not approved in the United States, but it was approved in other countries. Hip resurfacing is a different type of hip replacement procedure from traditional total hip replacement that is meant to conserve bone mass. In hip resurfacing, rather than replacing large portions of the femur, the femoral ball is capped with an artificial ball with a short stem that is inserted into the thigh bone. This cap is then coupled with a cup that replaces the hip socket.
ASR Hip Replacements Have Been Recalled
In August 2010, J&J recalled both ASR devices. The worldwide recall affected 93,000 people, 37,000 of whom were in the United States. The recall is believed to be the largest in the history of orthopedics, and many ASR recipients are suing DePuy.
ASR Hip Replacement Risks
Over time, many recipients of the ASR hip series found that the devices caused unusual side effects that were uncommon to other hip replacements. In March 2010, several months before the recall, the New York Times reported that recipients and orthopedists filed more than 500 adverse event reports related to the ASR to the FDA, by far the majority of reports for all-metal hips. According to the FDA, symptoms of a failing ASR hip replacement can include:
- Hip replacement dislocation
- Bone fracture
- Joint infection
- Local nerve damage, numbness, and weakness
- Device loosening or breakage
- Difference in leg lengths
- Bone loss (osteolysis)
- Pain in the groin, hip or leg
- Swelling at or near the hip joint
- A limp or change in walking ability
- Noise (popping, grinding, clicking or squeaking) from the hip joint
- Metal toxicity from cobalt and chromium ions released into the blood stream
If you are experiencing any of these symptoms, contact a medical professional immediately.
ASR Hip Replacement Settlements
In November 2013, the parties to the ASR MDL litigation announced that they had reached an agreement to settle all claims related to ASR hips in the United States for $4 billion with base awards beginning at $250,000 per recipient. Additional costs would be added depending on claimants’ circumstances. By May 2014, DePuy announced that it was waiving its walk-away rights, which accelerated the disbursement process. Click here for more information on DePuy ASR hip replacement settlements.
One Study Found the ASR Fails at Higher-Than-Normal Rates
In its 2011 annual report, the National Joint Registry for England and Wales calculated that the ASR XL Acetabular System had a 29 percent failure rate after six years, and the ASR Hip Resurfacing System failed in 9.6 percent of recipients after five years. Both these failure rates are far higher than what is considered normal for artificial hip devices, which are supposed to last 15 years before being replaced.
How Can a Lawsuit Help Me?
If you or a loved one received an ASR hip replacement and you believe it caused an injury, then a lawsuit might help you hold the manufacturer responsible. However, inaction will not result in compensation. An ASR lawsuit can result in damages for full medical expenses, lost earnings, pain and suffering, and other damages. To find out if you are eligible, click on this link or call 1-888-707-4470 and a lawyer from the Rottenstein Law Group will reach out to you as soon as possible to give you a complementary, confidential legal consultation.