Dallas Federal Court on Depuy Trials. The bellwether trial over the metal-on-metal version of the Pinnacle hip implant continues in Dallas federal court. On Monday, Depuy worldwide vice president of clinical research Pamela Plouhar was questioned about safety studies regarding the risks of the implant, Reuters reports. The outcome of the trial can determine the course of the litigation for the remaining 6,000 lawsuits.
The lawsuit being tried alleges that the metal-on-metal version of the Pinnacle released metal debris into a 58-year old Montana woman, who received two of the implants in 2009. Her lawsuit, filed in 2012, alleges that the cobalt in her blood jumped up to 85 times the normal level as a result. DePuy failed to warn about the risks of the Pinnacle and marketed them as safe, the lawsuit alleges.
The Montana woman’s attorney asked Plouhar what studies the company did to assess the safety of the implant
The Montana woman’s attorney asked Plouhar what studies the company did to assess the safety of the implant. She responded that there was “no human study that looked at” the health consequences of metal debris for the Pinnacle before 2001. The attorney said that research has linked metal-on-metal hips to safety issues since as early as 1974, Reuters reports. Plouhar claims that DePuy followed industry standards and conducted the “necessary studies” on the metal debris issue to show that the hips were safe.
Last week, the Montana woman’s attorney cited documents showing that DePuy ignored doctors’ concerns about the Pinnacle. According to Reuters, the attorney pointed to documents showing that Dr. Thomas Schmalzried, a Los Angeles surgeon who consulted with Depuy, raised concerns about the hips in 2001, stating additional information was necessary to determine the risk of metal-debris in the implant.
The Pinnacle has an unacceptably high rate of failure at over 14 percent in seven years, the suit alleges. Although Depuy has not recalled the device, the metal liner is no longer being sold.
DePuy set aside $2.5 billion last year to settle more than 7,000 lawsuits over its ASR metal-on-metal hip implants. The hips were recalled August 2010 due to a high rate of failure, and have since fueled safety concerns over all-metal devices.