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. Schmalzried,
- 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.
Further Trial Updates
The trial continues, and additional witnesses have subsequently been called. These witnesses include:
- Dr. John Fisher, Defense tribologist – University of Leeds/England,
- Additional video testimony from Dr. Antoni Nargol (see above),
- Dr. Henrik Malchau, an orthopaedic surgeon and full professor at Harvard Medical School (including the showing of some video clips from plaintiffs’ revision surgery),
- Dr. Allmacher, the initial implanting surgeon,
- Additional video testimony from Paul Berman (see above),
- Plaintiff Kathy Paoli,
- Dan Bagwell, Certified Life Care Planner and Certified Disability Management Specialist,
- Dr. Altwell, Neurologist, Rehabilitation and life care planning expert,
- Scott Bayley, CPA, and
- Plaintiff’s husband John Paoli.
On Monday, September 29, 2014, Judge Kinkeade allowed the plaintiff to tell jurors about the 6,500 other cases pending in the multidistrict litigation that allege Pinnacle metal-on-metal hip implant defects, lifting an earlier order that barred discussion of the other plaintiffs. Judge Kinkeade said that DePuy had opened the door to the mention of the other pending cases that target its Pinnacle hip implant by calling the plaintiff’s case an “outlier” and suggesting the doctors who treated her were also outliers. The judge noted he had warned the defense about that line of argument after its opening statement but that DePuy continued to use it, meaning the plaintiff needed to be able to defend that characterization.
The judge further said his concern boils down to how far DePuy had gone in defending its metal-on-metal implants and that the company was going beyond just this case. “You want to try these cases one by one, but you want to defend the whole thing,” Judge Kinkeade said.
Monday, September 29 also marked the beginning of DePuy’s defense, as the company called its first witness. The plaintiff still has two witnesses reserved, but by an agreement of the parties and the court, will call them later in the trial.
The first witness for the defense:
- Scott Nelson, orthopedic pathologist
Earlier Monday, the judge denied DePuy’s second motion for a mistrial. According to court records, the company had asserted it was hit with unfair surprise during testimony from Herlihy-Paoli’s surgeons.
Trial Updates for October 2, 2014
On October 2, 2014, Dr. Nelson returned to the stand to continue his testimony. He was followed by defense witness Dr. Pat Campbell (UCLA Professor of Orthopedic Surgery), who returned on October 3rd to continue her testimony. She was followed by defense witness Dr. Matthew Heinrich (Orthopedist specializing in hip and knee replacement surgery). Dr. Heinrich’s testimony was interrupted for the calling of Dr. Vicki Colvin (Chemistry PhD/Nanoparticle Expert). Dr. Heinrich is expected to return later in the trial.
Trial Updates for the Week of October 6-10, 2014
The previous week’s testimony concluded with the defendants playing clips from the video depositions of Dr. Fehring and Dr. Wasielewski (design orthopedic surgeons). Subsequently, over the intervening weekend the defendants filed their third motion for mistrial.
On Monday October 6th, defendants called their regulatory expert, Timothy Ulatowski. His testimony occupied the entire day.
As the week continued, defendants recalled plaintiffs’ witness Dr. Schmalzried to the stand. Dr. Schmalzried’s testimony continued through Wednesday afternoon. Thereafter, Dr. Heinrich returned to the stand for the remainder of the day. On Thursday October 9th, defendants played the video depositions of:
- Cath Hardaker (26 year DePuy employee/ World-wide Tribology Manager);
- Richard Farrar (J&J Worldwide Director of Engineering Systems);
- James Lancaster (Former DePuy employee; mechanical engineer; alternate bearing project team); and
- Dr. William Griffin (design orthopedic surgeon)
Trial Updates for the Week of October 13-17, 2014
On Tuesday October 14th, defendants called Dr. Roger Emerson, an orthopedic IME. On the 15th, Dr. Emerson returned to the stand, followed by Dr. Math, an orthopedic radiologist. On Thursday, October 16th, with permission of the Court, Dr. Ekdahl returned to the stand via video deposition which was taken during trial. Dr. Ekhahl was followed by defense witness Ph.D. Lisa Pruitt, a mechanical and biomedical engineer specializing in fracture mechanisms who teaches at Berkeley. Dr. Pruitt’s testimony will resume on Monday, October 20th.
Trial Update October 20
Dr. Lisa Pruitt returned to the stand. Video designations of the Lancaster and Nargol plaintiffs were then played. Subsequent to that, both plaintiffs and defendants rested. This was followed by a Rule 50 Motion Practice and Jury Charge Conference. The defendants submitted 36 pages of objections to plaintiffs’ proposed charges.
Trial Update October 21
Closing arguments were presented by both sides. The case is now with the jury.
Final Trial Update
On October 23, 2014, the jury returned a verdict for the defendant. At the trial, J&J introduced evidence that the plaintiff’s implants had been improperly positioned, and the implants themselves were not to blame for her injuries.