DePuy Pinnacle Hip Lawyer Probes J&J Execs about Safety Studies
Johnson & Johnson’s DePuy Orthopaedics unit adequately assessed the safety of an all-metal hip replacement allegedly tied to metal ion poisoning and other complications, the company said Monday during trial for a DePuy Pinnacle hip lawsuit.
According to Reuters, an executive for the medical device manufacturer told Dallas jurors on September 15th that “no human study” involving the health effects of metal debris shed from an all-metal version of the Pinnacle Hip Replacement had been conducted before 2001. A lawyer for the plaintiff countered this claim, pointing to research beginning in 1974 that linked metal-on-metal devices to an increased risk for serious complications. A week earlier, DePuy officials were questioned about documents from a Los Angeles surgeon who consulted with the company on its hip replacements, and advised the company in 2001 that more safety data was needed to properly assess risks of the metal-on-metal Pinnacle. The current hip trial involves the first of more than 6,000 cases now filed in a federal multidistrict litigation (MDL) underway in the U.S. District Court, Northern District of Texas.
DePuy Pinnacle Lawsuit Alleges Elevated Cobalt Levels
Not unlike other claims filed in Texas federal court, the plaintiff in this DePuy Pinnacle hip lawsuit alleges serious injuries that necessitated removal of the implant. The 58-year old woman from Montana filed her case in 2012 after the two Pinnacle hips she received three years earlier allegedly led to levels of cobalt in her bloodstream that eventually reached 85 times the normal level. Although the all-metal device from DePuy Orthopaedics has not been recalled, the company stopped selling this and several other metal-on-metal implants in 2013. At the time, Johnson & Johnson and its subsidiary cited declining sales as a primary reason for this decision, which they said was not driven by safety concerns. In January of that year, the U.S. Food and Drug Administration (FDA)’s proposed stricter regulations for approving metal-on-metal hip replacements, which are more likely to fail prematurely than any other type.
A DePuy spokeswoman said in a recent statement that safety issues involving the Pinnacle were properly analyzed before its entrance into the market, via a comprehensive scientific and clinical information review.
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