According to court documents, over 5,600 DePuy Pinnacle lawsuits are pending in an MDL which is currently underway in the Northern District of Texas, U.S. District Court. These lawsuits allege injury from the metal-on-metal version of the DePuy Pinnacle hip implant which utilizes the Ultamet metal-on-metal Pinnacle liner. Plaintiffs are questioning whether the DePuy Pinnacle should have been recalled along with the DePuy ASR, which was recalled in August, 2010. The first federal trials for the Pinnacle are expected to begin in September, 2014.
FDA Alert Issued Regarding the DePuy Pinnacle Hip Implant, But No Recall
Although the Pinnacle hip device has not been recalled, the FDA issued an alert in January, 2013, cautioning all those who had received a metal Pinnacle to undergo metal ion blood testing should they experience any adverse medical symptoms related to the device such as symptoms of chromium and cobalt poisoning and DePuy Pinnacle metallosis. Court documents claim that the all-metal design (when used with the Ultamet metal-on-metal liner) can lead to dangerous amounts of microscopic metal ion debris being released into the body.
Adverse Health Issues Associated With the DePuy Pinnacle Hip Implant
When the metal shards enter the hip tissue, inflammation, pain in the hip, groin and thigh, deterioration of bone and tissue and the failure of the hip implant are possible. The metal ions entering the bloodstream can cause chromium and cobalt poisoning and can be responsible for the following: vision and hearing loss, gastrointestinal disorders, neurological, cardiovascular, renal and thyroid issues, depression, anxiety, irritability, reproductive disorders, the alteration of DNA, the development of pseudo-tumors, rashes, vertigo and certain types of cancer.
Was DePuy Aware of the Problems Associated With the Pinnacle?
Despite known issues with the DePuy Pinnacle hip implant, there was no recall; DePuy merely discontinued the metal liner in mid-2013. Over 1,300 adverse event reports were submitted to the FDA regarding harm suffered from the Pinnacle, yet DePuy steadfastly maintains there is no defect in the design of the Pinnacle. More than one DePuy lawsuit alleges DePuy was well aware of the safety hazards of the Pinnacle, yet concealed the defects, misrepresenting to patients that the implant was both safe and effective.
Is the Pinnacle as Dangerous as the ASR?
Court records indicate about 140,000 U.S. citizens are recipients of the Pinnacle hip implant, which received FDA approval in 2000. The FDA recommended stricter regulations for all metal-on-metal hip implants, including requirements that the manufacturers of the all-metal hip implants conduct more safety studies, if they intend to continue selling their metal-on-metal hip implants. Although both the DePuy Pinnacle and the ASR hip implant have caused significant amounts of harm to patients implanted with the devices, the Pinnacle has been on the market much longer.
The DePuy Pinnacle hip implant uses a separate liner—metal or plastic—which was not included in the FDA approval. The Pinnacle is attached with screws, unlike the ASR which uses a porous coating. Both the ASR and the DePuy Pinnacle hip implant have failure rates of at least 12% by the end of the first five years after surgery. If you are the recipient of a DePuy Pinnacle hip implant which utilized an Ultamet metal-on-metal Pinnacle liner, it could be to your advantage to speak to a DePuy Pinnacle hip lawyer.