(Reuters) - An executive at Johnson & Johnson’s DePuy Orthopaedics Inc unit on Monday defended the company’s assessment of safety risks associated with metal-on-metal Pinnacle hip implants in a Dallas court from a lawyer who said the company had neglected to perform critical safety testing.
Pamela Plouhar, the worldwide vice president of clinical research at DePuy, was grilled by a lawyer for plaintiff Kathy Herlihy-Paoli during the first trial among more than 6,000 lawsuits over the Pinnacle hips that have been consolidated in Dallas federal court. The outcome of this so-called bellwether case could have an impact on DePuy’s decision to continue fighting the cases in court or consider a settlement.
Herlihy-Paoli and other plaintiffs claim the company failed to understand and warn patients and doctors about the device’s risks, instead marketing them as safe.
On Monday, Herlihy-Paoli’s lawyer, Mark Lanier, pressed Plouhar over what studies DePuy had performed on the implants, in an attempt to show jurors that the company had been negligent in gathering clinical data on the devices before they were approved by the U.S. Food and Drug Administration in 2000.
Plouhar said there was “no human study that looked at” the health effects of metal debris for the Pinnacle hips before 2001. Lanier said that research as early as 1974 suggested problems with the metal-on-metal devices.
During testimony last week, Lanier pointed to documents that showed that Thomas Schmalzried, a Los Angeles surgeon who had consulted with DePuy on the hips, said in 2001 that more information was needed to assess the risks of metal debris in Pinnacle devices.
On Monday, Plouhar insisted DePuy had followed industry standards. When asked by Lanier whether the company had done the “necessary studies” on the metal-ion issue to prove the hips were safe, she said they had.
The safety record of metal-on-metal implants and whether DePuy properly vetted the devices have been key themes so far during the trial, which entered its third week on Monday.
Herlihy-Paoli’s lawyers have said the failure rates for the implant were unacceptably high - more than 14 percent over seven years.
Herlihy-Paoli, a 58-year-old woman from Montana, received two Pinnacle hips in 2009, and said in her 2012 lawsuit that defects in the devices led the level of cobalt in her blood to skyrocket to 85 times the normal level.
While the Pinnacle implant has not been recalled, the company stopped selling metal liners for the devices last year.
In a statement, DePuy spokeswoman Mindy Tinsley said the company undertook a comprehensive review of scientific and clinical information on metal-on-metal hips before launching the Pinnacle metal-on-metal device, including two FDA-approved clinical trials, and continued to monitor the device’s safety after its launch.
Last year, DePuy agreed to pay $2.5 billion to settle more than 7,000 lawsuits over its ASR metal-on-metal hip systems, which were recalled in 2010.
Reporting by Jessica Dye in New York and Marice Richter and Lisa Maria Garza in Dallas; Editing by Alexia Garamfalvi and Lisa Shumaker