More Witnesses Show Up In Hearings. Jurors continue to hear testimony from DePuy witnesses, as the first trial over the metal-on-metal version of the DePuy Pinnacle hip implant continues. The jury is comprised of 9 people (5 women and 4 men). The trial began on September 2nd in the U.S. District Court for the Northern District of Texas in Dallas. U.S. District Judge Ed Kinkeade is presiding over the case.
The lawsuit being tried was filed on behalf of Kathleen Herlihy-Paoli, who was implanted with the metal-on-metal version of the Pinnacle in 2009. Soon afterwards, she complained of pain 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 design of the metal hip implant is flawed
The design of the metal hip implant is flawed, causing metal debris to be released into the bloodstream and nearby tissues, the suit alleges. The lawsuit also alleges that the defect caused an infection and prompted the need for removal. During the trial, J&J was accused of marketing the Pinnacle hip implant 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.
Andrew Ekdahl, former DePuy President, took the stand on September 3rd. Testimony through video deposition has also been given by Polly Cary, Product Director of Marketing, and Matt Reimink, a manager of the Hip Project Division Group. Former Marketing Director Paul Berman, who left DePuy in 2010, has also been called to take the stand.
There have been substantial safety concerns regarding metal-on-metal hip implants, particularly after J&J recalled 93,000 ASR hips worldwide in August 2010. J&J said that 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 pay $2.5 billion to settle 8,000 ASR lawsuits
Last year, J&J agreed to pay $2.5 billion to settle 8,000 ASR lawsuits. The settlement resolves allegations that the devices caused complications such as metal poisoning, pain, dislocation that forced the need for surgical removal. Pinnacle lawsuits were not included in the settlement.
J&J halted sales of the metal-on-metal version of the Pinnacle hip implant after the U.S. Food and Drug Administration (FDA) said it would require device makers to go through a stricter approval process to get metal-on-metal hips onto the market. Up until this point, manufacturers have been getting metal hips onto the market without any clinical testing. The FDA is now requiring that the devices go through pre-market approval, which mandates clinical testing to show the products are safe and effective.