- Pinnacle Hip Trial Update: J&J Allegedly Knew Hip Was Defective As Early As 2001
- September 22, 2014 | Author: Lexi J. Hazam
- Law Firm: Lieff, Cabraser, Heimann & Bernstein, LLP - San Francisco Office
In the first case to proceed to trial involving the Pinnacle hip replacement manufactured by DePuy, a subsidiary of Johnson & Johnson, evidence was introduced to show that J&J was aware as early as 2001 that the device could generate metal debris which enter the patient's bloodstream.
As reported by Bloomberg News, DePuy officials said that Dr. Thomas Schmalzried warned in 2001 that the potential release of metal ions was a significant issue for metal-on-metal hips implants like the Pinnacle hip replacement system.
Kathleen Herlihy-Paoli, a Montana woman, charges in her lawsuit the Pinnacle hips' flawed design produced cobalt and chromium material that leached into her body and required the implant to be surgically removed. Ms. Herlihy-Paoli is seeking damages for pain, suffering and intentional infliction of emotional distress.
In its marketing, DePuy claimed that metal-on-metal hip implants like the Pinnacle hip were still in use by 99.9 percent of patients after five years. Internal company files from 2012 however showed the metal Pinnacle hips had a 15 percent failure rate after five years of use.
A series of 2008 e-mails between DePuy executives and Dr. Schmalzried, an orthopedic design surgeon who entered into a consulting agreement with DePuy in the 1990's and was paid millions by the company, were introduced to the jury. Dr. Schmalzried had reviewed the case of a patient implanted with the Pinnacle hip who suffered extensive tissue damage. The e-mails recounted that Dr. Schmalzried had said the extent of the metal-hip patient's tissue damage was "alarming and concerning." In the e-mails DePuy executives stated that they planned to tell colleagues to "keep quiet for now" about the case Schmalzried highlighted.
Further evidence was introduced that Dr. John Irving, an orthopedic surgeon, repeatedly informed DePuy officials of the high failure rate his patients with Pinnacle metal hips were experiencing. In a 2010 letter, Dr. Irving said the wave of problems he'd seen with the metal devices "is an epidemic," and he considered it to be "borderline unethical to continue to market these products until the issues are elucidated. These products are harming patients."
Subsequently, plaintiff's counsel questioned:
- Polly Cary, DePuy's Product Director of Marketing,
- Matt Reimink, a manager of the hip project division group,
- Paul Berman, former Marketing Director who left DePuy in 2010,
- Dr. Antoni Nargol, an orthopedic surgeon from England who specializes in hip surgery, and
- Dr. Pam Plouhar, DePuy's Vice President of Clinical Research
During the trial, DePuy moved for the Court to declare a mistrial, which the Court denied.