The third bellwether DePuy Pinnacle Hip Failure trial has started this week. Johnson & Johnson and its DePuy Orthopaedics division are exposed to seven alleged defective metal on metal hip cases consolidated in Dallas, Northern District of Texas.
Metal on metal hip implants have a high failure rate including those manufactured by Biomet, DePuy, Encore, Smith & Nephew, Stryker, Wright and Zimmer.
DePuy Pinnacle Hip Failure $502 Million Verdict
Earlier this year, a Texas jury slammed DePuy Orthopedics over its failed Pinnacle metal hip implants, awarding $500 million. The DePuy Pinnacle hip implant is a metal-on-metal implant system that was found to fail prematurely, releasing particles of metal into surrounding tissue leading to inflammation and infection.
Why do Metal on Metal Hips Fail?
According to orthopedic experts, we have only seen the tip of the iceberg when it comes to painful revisions for failing metal on metal hip implants.
Metal on metal hip replacement and hip resurfacing, leads to particle debris from the cup and ball surfaces causing implant failure. As the implant patient moves, the surfaces of these two components grind against each other. The friction and abrasive wear and tear leads to debris production.
Metal-on-metal hip implants, where both the femoral component and the cup are made of metal
, will create ionized metal debris, leading to metal poisoning called metallosis. Device makers make implants out of several metals, including cobalt, chromium, titanium, nickel and molybdenum.
Metal-on-plastic implants, made of a metal femoral component and a plastic cup, lead to polyethylene particles that causes osteolysis or hip bone loss. Metal on metal hip implants have a high failure rate including those manufactured by Biomet, DePuy, Encore, Smith & Nephew, Stryker, Wright and Zimmer.
DePuy Hip Implant Failures
DePuy Orthopaedics faces thousands of lawsuits over their defective metal-on-metal Pinnacle hip replacement. According to the latest court data from July 15, 2016, there are more than 8,000 federal product liability lawsuits that have been filed by folks who experienced severe and serious side effects with the artificial hip implant.
DePuy has an abysmal track record of early hip implant failures stretching back more than 10 years. DePuy’s 2010 recall involved the company’s Articular Surface Replacement (ASR) Acetabular Hip System and ASR Hip Resurfacing System. Like other hip devices with metal components, they were marketed as cutting-edge designs that offered better durability and more mobility than older devices.
DePuy recalled its hip systems after data from the U.K. joint registry revealed that metal devices are no more durable than older devices and had more side effects including a much higher failure rate at 5 years. In 2013, the jury in the first ASR trial found that at the time of the recall, DePuy knew that within five years, more than 40 percent of its ASR implants would fail.
Federal DePuy Pinnacle Hip Failure Multidistrict Litigation
Since 2011 all federal DePuy Pinnacle hip failure cases has been consolidated and centralized in the U.S. District Court for the Northern District of Texas, as part of an MDL, or Multidistrict Litigation.
DePuy Pinnacle Hip Failure Problems
The jury found that DePuy took a number of short cuts getting the Pinnacle hip implants on the market, in part due to the 510(k) approval process, which only requires a device be substantially equivalent to devices already in use.
The company did not seek premarket approval, and so avoided the FDA requirement to determine if a device is safe or effective. There were no Pinnacle hip clinical trials to see if it even worked, or if it was safe to use.
The FDA released new guidance for metal-on-metal hip replacements in January 2013, indicating that doctors should only use the design if other artificial hip implants are not appropriate. The agency also determined that future metal-on-metal hip designs will be required to undergo extensive human clinical trials before they will be approved.