Earlier this year, a Texas jury slammed Johnson & Johnson and its subsidiary DePuy 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.
Johnson & Johnson DePuy Pinnacle $502 Million Verdict
DePuy won the first bellwether trial two years ago, in October 2014. The second bellwether trial was won by the plaintiffs. The third bellwether trial is set to begin in September, and DePuy has filed an appeal of the $500 million Pinnacle verdict.
The verdict awarded $130 million in compensatory damages and $360 million in punitive damages to five plaintiffs who received the Ultamet implant, a metal-on-metal version of the Pinnacle hip system.
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 hip metal on metal implants. Poor patients, they 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 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.
The full extent of metallosis complications are not fully known, it has been linked to side effects, including:
- Severe joint pain
- Implant failure
- Implant loosening
- Local tissue necrosis
- Deterioration of the bone around the implant
- Cysts and pseudotumors
J&J DePuy Hip Implant Failures
Johnson & 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
Thousands of similar lawsuits allege that the DePuy Pinnacle hip has an unreasonably dangerous and defective design, which was not thoroughly studied and that inadequate warnings were provided about the risk that the device may loosen and fail.
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.