A recent article published by Reuters notes that medical device company Johnson & Johnson, the parent company of DePuy, is taking a hard line in dealing with allegations concerning its DePuy Pinnacle hip replacement failures. DePuy, the manufacturer of both the ASR XL and the Pinnacle, is embroiled in approximately 3,000 hip replacement lawsuits concerning the ASR XL but is disputing complaints about the Pinnacle hip. According to Reuters, “Legal experts say J&J is taking a harder line defending itself against Pinnacle metal-on-metal claims, hiring a top product liability defense firm and refusing to recognize patient complaints or pay for replacing the hip devices – known as revision surgery. It maintains the device performs better than other all-metal hip implants.
Paul Voorhorst, director of biostatistics and data management at DePuy, told an FDA advisory panel last month that the Pinnacle metal-on-metal device “is performing consistent with or better than other metal-on-metal products.”
Of course, Voorhorst’s testimony doesn’t square with the numerous Pinnacle hip patients who are returning to their surgeons with nearly identical complaints as those concerning the ASR XL. In fact, the FDA has determined that all metal-on-metal hip implants should be scrutinized and progress report programs submitted to the federal agency for review.
Reuters interviewed one such hip patient. “Harriett Bowen, 64, from Salisbury, Maryland, received the Pinnacle all-metal hip in 2008. She soon developed the same symptoms as Grisham: pain, limited mobility and elevated levels of cobalt and chromium in her blood. In July 2011, Bowen’s left hip fractured at the implant site, requiring more surgery.
Bowen’s doctor determined she had a cobalt and chromium count of 7 micrograms per liter (mcg/L), a level flagged by UK health authorities as worrying. “He said, ‘Look, we’ve got to get this thing out of you.’ It nearly scared me to death.”
Unlike Grisham, she has received no compensation for the repair from J&J. Bowen is suing J&J.