September 17, 2014 — Executives for Johnson & Johnson and DePuy Orthopedics took the stand in the first trial out of more than 6,400 DePuy Pinnacle hip implants, according to Reuters.
The plaintiff, Kathy Herlihy-Paoli, filed her lawsuit in 2012. The 58 year-old woman was implanted with who Pinnacle hips in 2009.
Unfortunately, the metal-on-metal hip implant released toxic particles of chromium and cobalt, resulting in painful inflammation in her hip. Levels of cobalt skyrocketed to 85-times the normal level in her bloodstream, causing metal poisoning throughout her body.
Lawyers for grilled Pamela Plouhar, the worldwide vice president of clinical research at DePuy. During testimony, she was asked what studies DePuy performed to investigate the health effects of metal debris. She said there was “no human study that looked at” these side effects, but DePuy performed “necessary studies” to prove that the implants were safe.
Herlihy-Paoli’s attorneys argued that studies published as early as 1974 suggested problems with metal-on-metal hip implants. They argued that DePuy was negligent for failing to adequately asses the risk of metal debris from the Pinnacle.
The Pinnacle hip implant has not been recalled. However, last year, DePuy stopped selling the ULTAMET® metal-on-metal and COMPLETE™ ceramic-on-metal hip replacement liners. These liners were designed exclusively for use with the DePuy Pinnacle Acetabular Cup System. DePuy said the decision was made for business reasons and was not related to safety or efficacy.
DePuy has already settled about 8,000 lawsuits involving the ASR hip implant for about $2.5 billion. The ASR was recalled in 2010 and was linked to a 40% five-year failure rate. When the ASR was approved, the FDA did not require safety studies because it was “substantially equivalent” to the Pinnacle.
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