U.S. District Judge Ed Kinkeade has sliced the $500 million verdict against Johnson & Johnson and its DePuy unit over its defective metal-on-metal Pinnacle hip implants to about $151 million. According to Judge Ed Kinkeade, he was forced to reduce the verdict under Texas state law limiting punitive damages.
Johnson & Johnson DePuy Pinnacle $502 Million Verdict
Earlier this year, a Texas jury slammed Johnson & Johnson over its failed Pinnacle hip implants, awarding $500 million. The DePuy Pinnacle hip implant is a metal-on-metal implant system that fails prematurely, releasing particles of metal into surrounding tissue leading to inflammation and infection.
DePuy won the first bellwether trial two years ago, in October 2014. The third bellwether trial is set to begin in September, and DePuy has filed an appeal of the DePuy Pinnacle verdict and is seeking to delay the next trial.
Hip Failures: Tip of the Iceberg
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. Unfortunately, patients were sold a bill of goods from the orthopedic device manufacturers and the orthopedic doctors who peddled their costly implants.
In total hip replacement and hip resurfacing, particle debris from the cup and ball surfaces can cause 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.
Different hip implant materials can cause different long-term complications. Metal-on-metal hip implants, where both the femoral component and the cup are made of metal, will create ionized metal debris, leading to 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.
J&J DePuy Hip Implant FailuresJohnson & Johnson’s DePuy Orthopaedics subsidiary continues to face thousands of lawsuits over their defective metal-on-metal Pinnacle hip replacement. According to the latest court data from June 15, 2016, there are more than 8,357 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 Multidistrict Litigation
Since 2011 all federal DePuy Pinnacle 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 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.