September 11, 2014 — Johnson & Johnson’s DePuy subsidiary is embroiled in a trial in Texas involving the Pinnacle hip implant, which is allegedly defective because it can cause metal poisoning and other side effects.
Attorneys allege the device-maker knew as early as February 2001 that the Pinnacle could generate metal debris and potentially cause metal poisoning, according to Bloomberg.
The plaintiff in the trial, Kathleen Herlihy-Paoli, is a woman from Montana who claims that the implant is flawed. When the metal “ball-and-socket” grinds together, particles of chromium and cobalt can accumulate around the hip joint. She alleges that this complication caused an infection and she had to have the implant surgically removed.
Her attorney alleges that DePuy officials knew in 2012 that the metal-on-metal hip implant had a 15% failure-rate after five years. Evidence also included several memos from orthopedic surgeons and doctors who warned that the potential release of metal ions was a “major issue for metal-on-metal hips.”
In general, the “acceptable” failure-rate for a hip implant is 5% or less. Other DePuy hip implants, such as the ASR, have been linked to a 40% five-year failure-rate. The ASR was recalled in 2010 and the Pinnacle was “withdrawn” from the market in August 2013, shortly after the FDA asked for new safety studies.
DePuy has agreed to pay $2.5 billion to resolve about 8,000 lawsuits involving the DePuy ASR, for an average payment of about $250,000 for each surgery, plus additional costs in some cases. The company is facing about 6,000 similar lawsuits involving the Pinnacle hip implant.
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