After winning the first trial over its Pinnacle metal-on-metal (MoM) hip implant, Johnson & Johnson’s DePuy Orthopaedics Inc. has now lost three in a row.
Patients Win 3rd Pinnacle Hip Lawsuit in a Row
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On November 16, 2017, a federal jury in Dallas ordered the company to pay $247 million to six patients who said they were injured by the implants.
This was the fourth bellwether trial of the multidistrict litigation representing patients who claim that the company failed to warn doctors and consumers about complications possible from the device, which included pain and subsequent removal surgeries.
The company won the first trial in 2014. Then in March 2016, a jury awarded more than $500 million to five patients who had similar physical and medical complications allegedly caused by the implant. That award was cut by roughly 70% due to a Texas state law capping punitive damages in plaintiff cases.
Johnson & Johnson has lost substantial damages awards in three cases. The latest $247 million award is on top of the $500 million and $1 billion from the previous cases won by patients. The awards in the earlier cases were ultimately lowered but the company still had to hand over $150 million and $543 million.
$900 Million and Holding
These four cases will serve to inform the cases of another 8,500 plaintiffs in multidistrict litigation being handled by the same Dallas federal court.
After this latest loss, John Beisner, an attorney for Johnson & Johnson, said the trial was a “disservice to everyone involved because the verdict will do nothing to advance the ultimate resolution of this six-year old litigation.” The company maintains that clinical data showed the implants were safe to use.
After the third trial, Mark Lanier, the attorney for the patients, said whoever at Johnson & Johnson was deciding against settling the Pinnacle case “is an idiot,” because the entire Pinnacle case could have been settled for $1.5 billion.
The score is now 3-1 in favor of the patients with over $900 million in damages.
If Johnson & Johnson decides to settle, it would not be the first time the company settled a metal-on-metal hip case. In 2013, the company reached a $2.5 billion settlement with 8,000 patients who claimed they were harmed by the company’s metal-on-metal ASR Hip Resurfacing System
Metal-on-Metal and the FDA
The FDA cleared the Pinnacle hips for sale in the U.S. through the 510(k) process and the company began selling the product in 2005.
On May 6, 2011, the FDA instructed manufacturers of metal-on-metal total hip replacement systems to conduct postmarket surveillance study of the devices. Five manufacturers were marketing metal-on-metal hip implants in the U.S. and all five had approved postmarket surveillance study plans. Data from these studies provided patients and healthcare providers with additional information about the safety profiles of the implants, including the effect of metal ion concentrations in the bloodstream.
The FDA then undertook an unprecedented national and international effort to gather all available information, including the clinical information discussed during a June 2012 Orthopedic and Rehabilitation Devices Advisory Panel Meeting, about currently marketed MoM hip implants.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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