The next round of bellwether trials in the Pinnacle multidistrict litigation will move forward despite a petition by the defendants Johnson & Johnson and DePuy Orthopedics to prevent them. The 5th Circuit federal court denied their request and the trials are scheduled to begin late next month. Earlier this year, another round of trials related to the case resulted in a record $502-million dollar verdict against Johnson & Johnson.
Another Metal-on-Metal product, the DePuy ASR hip replacement first became available in 2005, but even its origin is suspect,” described Ben Gordon, a personal injury attorney with the Levin, Papantonio law firm. “The FDA gave these products special clearance, under the 510(k) system, allowing them to be marketed without DePuy first performing clinical trials.”
After numerous reports of problems, DePuy issued a voluntary recall of two ASR devices in August, 2010. However the recall was issued after 93,000 patients worldwide were given the faulty DePuy hip replacement, requiring thousands of injured victims to undergo dangerous and costly revision surgery to remove the defective devices.
Johnson & Johnson manufactured hip implants through its subsidiary company, DePuy Orthopaedics. The company continues to face thousands of lawsuits over the defective metal-on-metal Pinnacle hip replacement. It is known to fail prematurely and release metal particles into surrounding tissue causing inflammation and infection. As the implant patient moves, the surfaces of these two components grind against each other and the friction wear and tear leads to the metallic debris.
“When ‘ionic’ species of the cobalt and chromium wear metal particles get into the tissue and bloodstream, it can have a severe, adverse effect on the body, resulting in serious muscle and bone damage,” said Gordon. “A patient with a DePuy hip replacement can have as high as 100 times the normal levels of chromium and cobalt in the bloodstream. In published case reports, high levels of cobalt and chromium in the blood have been linked with heart, kidney, nervous system, and other organ damage.”
Since 2011, all federal DePuy Pinnacle cases have been consolidated and centralized in the U.S. District Court for the Northern District of Texas, as part of an MDL, or Multidistrict Litigation. The jury found that DePuy cut corners getting the implants on the market, including the fact the company did not seek premarket approval, avoiding the FDA’s requirement to determine if a device is safe or effective. Thus, there was no requirement for Pinnacle hip clinical trials to see if it worked or was safe to use.
“These could have been avoided if DePuy had been responsible and honest in the beginning,” said Gordon. “Instead, however, DePuy put its own interests ahead of its patients and perpetuated the growing problem of greed we know about all too well in present day corporate and healthcare settings.”
In 2013, after intense scrutiny and hearings on the safety of these devices, the FDA released new guidelines for metal-on-metal hip replacements, suggesting doctors should only use the design if other artificial hip implants are not appropriate. The agency also wants future metal-on-metal designs to undergo extensive human clinical trials before they can be approved.
Although the Texas jury awarded more than $500-million against Johnson & Johnson and its DePuy unit, U.S. District Judge Ed Kinkeade chopped the verdict to about $151-million. Judge Kinkeade said the move was necessary under Texas state law, which limits punitive damages. DePuy won the first bellwether trail in 2014. The next round of trials related to the DePuy Pinnacle hip injury claims are set for September.