The DePuy Pinnacle bellwether trial continues, as DePuy witnesses continue to testify. The trial, which began on September 2nd in the U.S. District Court for the Northern District of Texas in Dallas before U.S. District Judge Ed Kinkeade, is expected to last 6 to 8 weeks. Nine people, 5 women and 4 men, are on the jury.
Jurors heard the testimony of Andrew Ekdahl, former DePuy President, on September 3rd. Polly Cary, Product Director of Marketing, and Matt Reimink, a manager of the hip project division group have testified through video deposition. Former Marketing Director Paul Berman, who left DePuy in 2010, has also been called to testify.
The trial is considering a lawsuit filed on behalf of Kathleen Herlihy-Paoli, who was implanted with the metal-on-metal version of the Pinnacle in 2009. She experienced pain soon afterwards and the hips were surgically removed in 2011. According to court filings, testing done before the surgery showed that “implants had released dangerous levels of cobalt and chromium into her bloodstream…Tests indicated that Mrs. Paoli’s cobalt blood serum levels were 85 times higher than normal,” The release of metal debris allegedly caused an infection.
Herlihy-Paoli’s injuries were caused by the defective design of the metal hip implant and resulted in metal debris to being released into the bloodstream and nearby tissues, the suit alleges. The lawsuit alleges that the defect caused an infection and prompted the need for removal. During the trial, J&J was accused of marketing the Pinnacle in a way that was deceiving and dangerous. The company told doctors that the hip implant was successful “99.9 percent of the time” while ignoring evidence of its risks, Herlihy-Paoli’s attorney said.
J&J has already faced litigation over their metal-on-metal ASR hip, which was recalled in August 2010. The company said the devices failed at a rate of 12 percent in five years, but internal documents showed that the devices failed at a rate of 37 percent in 4.6 years, Bloomberg reports. In Australia, the failure rate is 44 percent in seven years. J&J agreed to settle 8,000 cases last year for $2.5 billion. Patients suing over the device alleged complications such as metal poisoning, pain and dislocation that forced the need for surgical removal. Pinnacle lawsuits were not included in the settlement.
Metal-on-metal hips were not clinically tested before they were approved, many lawsuits point out. Last August, the FDA sought to change this by requiring device makers to go through a stricter approval process to get metal-on-metal hips onto the market. J&J halted sales of the metal-on-metal version of the Pinnacle after this decision.