ASR metal hip implant devices are the subject of more than 10,000 product liability lawsuits
DePuy Orthopaedics, a division of giant Johnson & Johnson, manufactures the Pinnacle® hip replacement system as well as acetabular implants and hip stems. But these devices have generated significant press coverage and lawsuits for failure.
In 2010, the company voluntarily recalled its ASR™ (Articular Surface Replacement) metal hip implant devices — the ASR XL Acetabular Hip System and DePuy ASR Hip Resurfacing System, but patients claimed DePuy knew about the problems and failed to warn health care professionals. Since its introduction in 2003, more than 93,000 ASR have been implanted globally in patients. They were expected to last 15 years. ASR was introduced in the United States in 2005.
What prompted the recall, the company says, was the result of post-market monitoring. It uncovered data from a U.K. national joint registry that reported 13 percent of patients had to undergo a second hip replacement surgery, known as revision surgery, sooner than expected. DePuy discontinued its ASR products and sold off its inventory of them in 2009, just weeks after the FDA requested additional safety data.
After recalling the ASR systems, DePuy continued to sell the metal Pinnacle system. There are some 3,300 cases relating to this hip replacement device.
In May 2013, DePuy announced it was phasing out production of all-metal replacement hips due to early failure rates.
Symptoms of failure in DePuy hip replacement systems
In an all-metal system, complications can arise from friction between the metal components, which causes metal debris containing toxins to enter the patient’s blood stream. Ultimately, this can lead to poisoning. Each time a patient moves, this friction can occur.
Patients with ASR implants have reported:
• Clicking in the hips
• High metal content found in the blood
• Tissue damage or loss
• Bone damage, including fractures
• Muscle damage
• Limping or loss of mobility
DePuy reports that by the end of June 2013, there were about 11,500 plaintiffs with direct claims in pending lawsuits involving the ASR systems. Multidistrict litigation (MDL) has organized 7,000 cases filed in the U.S. District Court for Northern Ohio. Law firms in Ohio, California, New Jersey, and New York represent the plaintiffs in this MDL. Another 2,000 cases have been filed in a California state court. Cases have been filed outside the United States, too.
The following are the highlights of recent cases:
• October 2013 — Legal-Bay LLC, The Lawsuit Settlement Funding Company, reports a delay in the first federal DePuy ASR Hip recall trial. Bergen County, New Jersey case settled
• April 2013 — DePuy wins a verdict in Chicago
• March 2013 — Los Angeles jury awards $8.3 million against DePuy on the basis of defective design, but rejects the plaintiff claim that the device maker failed to adequately warn of the risks associated with the product
Court records revealed that an internal 2011 Johnson & Johnson analysis expected the devices to fail in 40 percent of patients within five years of replacement.
The FDA has new guidelines for makers of hip replacement devices
In September 2013, the FDA announced new guidelines that requires hip replacement devices to bear a unique identifying number. Hip replacement devices are grouped in a category known as Class III — high risk medical devices. Such devices will also require premarket approval and comprehensive studies on safety and effectiveness. Clinical trials may also be required.
In December 2011, the FDA issued a warning directly to DePuy about its bypassing clinical trials. Even though the company claimed its devices were custom made, the FDA stated that didn’t preclude testing.
DePuy Lawsuit Attorneys in Chicago, Illinois
If you have had a DePuy hip replacement system implanted, contact Phillips Law Offices today to speak with an experienced Illinois products liability attorney. Call 312-346-4262 or contact us online today for a free consultation with an attorney about your case.