Lawyer grills DePuy executive over safety studies for Pinnacle hips

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From REUTERS:
BY JESSICA DYE AND MARICE RICHTER
Sept 15 Mon Sep 15, 2014 8:25pm EDT

(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.

READ MORE ABOUT THE DEPUY PINNACLE TRIAL HERE

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