Ethicon Pelvic Mesh Trial Underway in Philadelphia Exposes Document Destruction by J&J
Mesh News Desk, December 8, 2015 ~ OPENING ARGUMENTS
Opening arguments got underway for Philadelphia’s first pelvic mesh trial last week.
Patricia Hammons, 64, filed her product liability action against Johnson & Johnson and its subsidiary Ethicon over her Prolift pelvic mesh implant, used to treat a condition known as bladder prolapse. Initially filed in multidistrict litigation in Charleston, WV, it was remanded to court in Philadelphia two years ago.
Patricia L. Hammons v Secant Medical, Ethicon, in the Philadelphia Court of Common Pleas, Case No. 2:13-cv-04086. Secant is the maker of a component of the polypropylene mesh implant.
Attorney Shanin Specter (Kline & Specter, Philadelphia) said the Prolift pelvic mesh implant has too much mesh which causes scar tissue, mesh contraction and erosion. The amount of mesh could stretch across two-and-a half football fields, he said. Hammons suffers mesh erosion into her bladder and “excruciating” pain during sex or dyspareunia. The mesh was found to have folded under her bladder and repeated surgeries have caused a shortened vagina.
This case was filed in the Philadelphia Court of Common Pleas and is being heard before Judge Mark I. Bernstein. Attorney Adam Slater of Mazie Slater is also trying the case. Slater won the first Prolift case ever tried in Atlantic City in 2013. Linda Gross was awarded $11.1 million. That case is still under appeal.
Hammons is from Indiana and works at Wal-Mart as a stocker. She alleges her product was negligently designed and that J&J failed to warn doctors about the risk of the Prolift. She was implanted in 2009 after which she had numerous surgeries to fix her prolapse after the Prolift reportedly failed. The mesh has reportedly adhered to her bladder and cannot be removed after numerous attempts.
Specter showed the jury the blue and white mesh that comes in a box pre-cut along with its stainless steel hooks or trocars used for implantation. He also criticized the mesh for having pores too small that cause excess scarification or scar growth. Scar tissue tends to contract and can take with it nerves, causing chronic pain. Ethicon had no idea how to remove the mesh if it caused complications, Specter told jurors.
This is the first of 181 cases filed in that venue, according to The Legal Intelligencer (here). Ethicon is facing additional cases filed in state courts around the country including New Jersey, California and Missouri as well as 30,163 product liability cases filed in the consolidated multidistrict litigation court in Charleston, WV. See the case list here.
Talking to the jurors for Ethicon was attorney Susan M. Robinson of Thomas, Combs & Spann. She said Ethicon brought the mesh to market on the advice of doctors and there are risks associated with any of these pelvic mesh products. She insists the mesh is not defective and it worked properly.
The attorney blamed pain during sex on the plaintiff’s hysterectomy she underwent in 2009 and additional prolapsing of her small bowel and uterus. Prolift had nothing to do with the fact she later developed the bowel prolapse, she said.
This trial has been limited to two weeks by Judge Mark I. Bernstein.
DOCUMENT DESTRUCTION REVEALED
Those who follow coverage of the pelvic and hernia mesh issue remember that two years ago, the court determined Johnson & Johnson had destroyed thousands of pages of documents that were under a litigation hold in preparation for this product liability litigation. See the MND story here and here.
The outcome was inconclusive with WV Chief Magistrate Cheryl Eifert saying that spoliation (document destruction) had occurred but no adverse instructions would be given for every trial, in part, because no one could be identified as the perpetrator. See PTO#100 Doc #1069, Feb. 4, 2014.
It was deemed to be a setback for the plaintiffs’ attorneys who had to piece together portions of discovery. Part of what was lost were inner-office emails, personal computers of J&J executives as they were moved to new positions within the company, the potential conflict of interest payments to mesh inventor Drs. Ulmsten and Nilsson who retrofitted hernia mesh to fit a woman’s pelvis. See MND story on what else was lost December 8, 2014 here.
The issue was never raised again.
James P. Mittenthal was the designated corporate representative to testify on the subject. In the Philadelphia courtroom, his 2014 deposition was played. Under questioning by attorney Adam Slater, Mittenthal admitted ten-thousand documents had been destroyed by the company. J&J did it’s best to preserve documents and the destruction was unintentional, he said.
His deposition was taken for Lewis v. Ethicon, but never appeared to jurors before the trial ended in a directed verdict for the defense. See Lewis V. Ethicon MND coverage here.
LEWIS CASE – DO NOT DESTROY DOCUMENTS
In the Lewis case, Slater showed Mittenthal a document entitled Johnson & Johnson law department document preservation notice not to destroy specified documents.
It said “Do not discard, destroy, or alter in any way any of the documents, electronic or paper, described below.” The notice was issued May 22, 2003 by the Johnson & Johnson law department to preserve papers and documents in connection with current or future litigation.
A company-wide hold notice for mesh documents was issued April 30, 2007. Mr. Mittenthal said actually since 2003 there had been a defined policy. The employee is provided with a checklist and, along with their manager, they go through it to make sure “the departing employee’s obligations are complied with prior to his or her leaving the company, and that includes records retention or obligations.”
The policy has now been revised to take into account technology, he said. “
For my last question,” said Slater, “… you don’t expect people to actually tell you they did that (destroy documents) in direct violation of a policy right?”
A: I ask at every interview if information was destroyed. I have spent several years now looking at this company and have understood the climate by which information is managed, the information, the systems in place, and the general attitude and demeanor of the employees. And I have no reason to believe that anyone has withheld information from me or been false with me.”
Q: “There’s no way for you to know, for you to know what happened, right?”
A: “There’s no way for me to be absolutely certain. I would agree with you.”
PROLIFT OFF THE MARKET
Prolift, and three other pelvic meshes made by Ethicon, were quietly removed from the market in mid-2012 shortly after the U.S. Food and Drug Administration required mesh manufacturers to begin conducting three-years of post- approval studies on mesh products.
Philly.com (here) reports there have been 16 mesh verdicts totaling $247 million and ultimately the exposure for J&J and the six other mesh makers could be in the billions. The news outlet also reports that Philadelphia juries are “deemed sympathetic to plaintiffs.”
The first Prolift trial was that of Linda Gross of South Dakota and conducted by attorney Slater in state court in New Jersey. The $11.1 million jury verdict is still on appeal. The trial of another woman implanted with a Prolift mesh, Joan Budke, was settled just before it went to the jury in January of this year. Mrs. Budke died of mesh-related infections. #
Law 360 on loss of Key Documents, December 2013