On Monday, a DePuy executive was questioned about whether or not the company properly analyzed the dangers of the metal-on-metal Pinnacle hip implant. According to Reuters, Depuy worldwide vice president of clinical research Pamela Plouhar took the stand in the bellwether trial.
There are over 6,000 Pinnacle lawsuits consolidated in Dallas federal court. The first to go to trial was filed on behalf of a 58-year old Montana woman who received two metal-on-metal versions of the Pinnacle hip implant in 2009. Her lawsuit, filed in 2012, alleges that the defective devices released cobalt into her bloodstream and caused it to jump up to 85 times the normal level.
The outcome of the trial can affect the rest of the litigation, and influence whether or not a settlement will arise.
The lawsuit alleges that DePuy failed to warn about the risks of the devices and touted them as safe. When the Montana woman’s attorney asked what studies the company conducted to assess the safety of the implant, Plouhar answered that there was “no human study that looked at” the adverse effects of metal debris for the Pinnacle prior to 2001. Research has suggested safety issues with metal-on-metal devices since as early as 1974, the attorney said.
Plouhar claims that DePuy followed industry standards and did the “necessary studies” on the metal debris risk to prove that the hips were safe.
Last week, the woman’s attorney cited documents showing that Dr. Thomas Schmalzried, a Los Angeles surgeon, raised concerns about the hips in 2001. Schmalzried, who worked as a consultant for the company, said that additional information was necessary to determine the risk of metal-debris in the implant.
The lawsuit being tried alleges that the failure rate is unacceptably high with the Pinnacle. In seven years, the failure rate is over 14 percent. The metal liner is no longer being sold, although the device has not been recalled thus far.
There have been major safety concerns over metal-on-metal hips. These concerns truly came to light in August 2010, when DePuy recalled 93,000 ASR hip implants worldwide due to a high rate of failure. The company agreed to settle over 7,000 lawsuits for $2.5 billion last year, Reuters reports.