Johnson & Johnson and its DePuy Orthopaedics subsidiary have settled thousands of metal-on-metal hip lawsuits involving the Pinnacle Hip Replacement System.
The metal-on-metal version of DePuy’s Pinnacle hip system – which utilizes the Ultamet liner — is at the center of more than 10,000 product liability claims consolidated in the U.S. District Court, Northern District of Texas.
According to an Order dated December 9th, Johnson & Johnson has resolved at least 3,000 pending cases. The Order further indicated that the settlement proceeds were to be disbursed as early as December 10th.
The terms of the settlement agreements are confidential. Nevertheless, five anonymous sources told Bloomberg News that the accord would cost Johnson & Johnson about $413 million, averaging $150,000 per case.
Federally-filed DePuy Pinnacle hip lawsuits were consolidated in the Northern District of Texas in 2011.
Plaintiffs pursuing these cases claim that the metal-on-metal configuration created by the Ultamet liner is defective and can shed microscopic metal particles into the surrounding tissue. This occurrence allegedly resulted in metallosis, adverse tissue reactions, pseudotumor formation, and other complications that resulted in the premature failure of the device.
The federal multidistrict litigation has already convened four bellwether trials. The most recent concluded late last year, when six plaintiffs were awarded $247 million in damages.
The third DePuy Pinnacle trial was decided in December 2016, when six Pinnacle recipients were awarded more than $1 billion. That judgment was later reduced to $543 million.
Johnson & Johnson also lost the second trial, when $500 million was awarded to five plaintiffs. However, the trial court reduced the verdict to $151 million and it was ultimately overturned on appeal.
The litigation’s first bellwether trial concluded in October 2014, with a defense win.
Bloomberg indicated that settlement negotiations are underway to resolve the remaining metal-on-metal hip lawsuits. Among other things, sources suggested Johnson & Johnson was seeking to settle the litigation before the next federal trial gets underway.
With a metal-on-metal hip replacement, the femoral head (ball), the femoral stem in the thighbone, and the acetabular component (cup) in the hip bone are all constructed of a chromium/cobalt alloy.
In January 2013, the U.S. Food & Drug Administration (FDA) confirmed that all-metal hip implants are more likely to fail prematurely compared those made from other materials. Among other things, the agency warned that particles shed from a metal-on-metal hip replacement can accumulate in surrounding tissue, leading to tissue deterioration, device loosening, and other debilitating complications.
Furthermore, the FDA expressed concern that metal particles would ultimately enter the bloodstream, resulting in:
In November 2013, Johnson & Johnson and DePuy Orthopaedics agreed to a $2.5 billion settlement that resolved ASR metal-on-metal hip lawsuits. DePuy recalled ASR hips in 2010 due to a high failure rate.
Since then, several other medical device manufacturers have announced their own metal-on-metal hip settlements.
Most recently, for example, Stryker Corp. agreed to resolve claims involving LFIT CoCr V40 femoral heads and related components.
The company had previously entered into a $1 billion settlement agreement to settle lawsuits involving Rejuvenate and ABG II Modular-Neck hip stems. Stryker recalled those components in July 2012 because of a high rate of fretting and corrosion at the modular-neck junction.
And as of November 2017, Wright Medical had settled nearly all of the metal-on-metal hip lawsuits concerning its Conserve, Dynasty and Lineage products.