A plaintiff’s lawyer yesterday pushed the executive in charge of Johnson & Johnson‘s (NYSE:JNJ) global clinical research to admit that the medical device company failed to perform critical safety tests on the DePuy Pinnacle hip implant.
Worldwide clinical research vice president Pamela Plouhar was the 2nd J&J executive to face a grilling from Mark Lanier, the lawyer for plaintiff Kathy Herlihy-Paoli in the 1st lawsuit to go to trial over the Pinnacle implant.
Lanier put former DePuy president Andrew Ekdahl on the hot seat Sept. 4, accusing him of helping to conceal the risk that the metal-on-metal hips could cause serious injury. Ekdahl, now chairman of J&J’s DePuy Synthes franchise, denied the allegations.
Yesterday Lanier sought to show that DePuy neglected to gather enough safety data on the devices, particularly regarding the risk of metal debris reaching the bloodstream, suggesting that research showed as early as 1974 that there were problems with the metal-on-metal implants, Reuters reported.
Citing emails between J&J employees and metal-on-metal hip pioneer Dr. Thomas Schmalzried, a DePuy consultant, Lanier said Johnson & Johnson knew as early as 2001 of the potential for metallosis, or high levels of heavy metal ions in the bloodstream. Plouhar denied that any study considered the effects of metal debris from the Pinnacle device before 2001, according to the news service.
Last November, Johnson & Johnson settled a raft of lawsuits over its DePuy ASR metal-on-metal implant for $2.5 billion. In February of this year, Biomet agreed to settle 1,000 lawsuits over its metal-on-metal M2A Magnum implants. Zimmer (NYSE:ZMH) has also faced litigation over its Durom MoM device, as has Stryker‘s (NYSE:SYK) Trident and Rejuvenate devices. Potential plaintiffs are also lining up for Smith & Nephew (FTSE:SN, NYSE:SNN), which blazed the MoM trail with its Birmingham line of MoM devices.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.