DePuy Executive Questioned regarding Safety Studies for DePuy Pinnacle™ Hips
Reuters reports that an executive at Johnson & Johnson’s DePuy Orthopaedics Inc. unit has testified in the first DePuy Pinnacle™ bellwether regarding the company’s assessment of safety risks associated with its Pinnacle™ hip implants. Pamela Plouhar, the DePuy executive and worldwide vice president of clinical research, was questioned about the studies DePuy performed on these hip implants in an attempt to demonstrate the company’s negligence in gathering clinical data before these devices were approved by the Food and Drug Administration (FDA).
The first bellwether trial in the DePuy Pinnacle™ Multidistrict Litigation (In Re: DePuy Orthopaedics, Inc., Pinnacle Hip Implant Products Liability Litigation, Case No. 3:11-md-02244, MDL No. 2244) began this month, as set forth in Case Management Order No. 8. The first trial involves cases filed by two plaintiffs: Kathleen Herlihy-Paoli and Toni M. Lay. Herlihy-Paoli alleges that her Pinnacle™ hip implant failed and turned black due to metallosis (metal poisoning), while Lay alleges that her doctor found high levels of cobalt and chromium in her blood and that her Pinnacle hip implant failed. Lay’s surgeon also determined that she suffered from soft tissue death surrounding the area of the device. According to the most recent report from the Judicial Panel on Multidistrict Litigation (JPML), there are currently 6,207 Pinnacle™ Hip Implant cases pending in the United States District Court for the Northern District of Texas before The Honorable Judge James Edgar “Ed” Kinkeade.
DePuy’s Pinnacle™ Hip Replacement System was approved by the U.S. Food and Drug Administration (FDA) in 2000. The Pinnacle metal-on-metal device was approved via Premarket Notification (PMN) clearance (also called the 510(k) process), which means the FDA found the device to be “substantially equivalent” to a predicate device—the Ultima Metal-On-Metal Acetabular Cup—already on the market. Recipients of both hip replacement systems sustained adverse complications from the devices. In mid-2013, DePuy discontinued the manufacturing and marketing of its metal liner.
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