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Ethicon 12/10
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Ethicon Pelvic Mesh Trial Underway in Philadelphia Exposes Document Destruction by J&J
Dec 9, 2015 | Mesh Medical Device News Desk
By Jane Akre
Opening arguments got underway for Philadelphia’s first pelvic mesh trial last week. -
Mesh News Desk Trial Coverage Cut For Being ‘Advocacy’ Organization
Dec 9, 2015 | Mesh Medical Device News
By Jane Akre
As editor of Mesh News Desk (MND), I cover trials either in person or remotely through a feed provided by Courtroom View Network (CVN). David Siegel who works there, has always been very friendly. We alert each other to upcoming trials.
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Ethicon Pelvic Mesh Trial Underway in Philadelphia Exposes Document Destruction by J&J
Dec 9, 2015 | Mesh Medical Device News Desk
By Jane Akre
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 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.
THE PLAINTIFF
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 andhere.
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 here.
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.
Until now.
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. SeeLewis 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 her attorney Adam Slater of Mazie Slater. Gross was awarded $11.1 million in 2013. That 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. Mrs. Budke died of mesh-related infections. #
LEARN MORE:
Law 360 on loss of Key Documents, December 2013
http://www.law360.com/articles/492626/j-j-unit-accused-of-losing-key-docs-in-vaginal-mesh-mdl -
Mesh News Desk Trial Coverage Cut For Being ‘Advocacy’ Organization
Dec 9, 2015 | Mesh Medical Device News
By Jane Akre
A funny thing happened on the way to covering a pelvic mesh trial.
As editor of Mesh News Desk (MND), I cover trials either in person or remotely through a feed provided by Courtroom View Network (CVN). David Siegel who works there, has always been very friendly. We alert each other to upcoming trials.
Lately CVN has impose restrictions on coverage – do not capture images from the court or show exhibits. Okay, I said. They are a for-profit company and I could see if, in the unlikely event, someone found our coverage, it could hurt the CVN business model. No problem. I appreciate the access (though courts require a “pool camera” to share with other media).
After covering approximately eight of these defective pelvic mesh trials, the expert witnesses are often the same, Peggy Pence PhD, Bruce Rosenzweig, MD, T. Michael Margolis MD, on and on, so their background is easily augmented by accessing past coverage.
And as is customary, readers of Mesh News Desk (MND) make comments under a story. That’s what happened on the second day of coverage (here) of the Eve Sherrer v. Boston Scientific and C.R. Bard trial in Kansas City. See MND coverage of opening arguments here.
The plaintiff had been implanted with two pelvic meshes to treat her prolapse. Most women receive only one and about one-third of them have problems with intense pain, shrinking mesh, nerve encapsulation, chronic infection etc.
This is the first time a trial has focused on two defendants at the same time, so it was an interesting case to follow.
On the second day of the trial, the defense criticized a world-renowned doctor who has now turned mesh removal expert. He caused the plaintiff’s injuries, at least partially, they claimed. As expected man comments praised Dr. Raz as a hero. I monitor comments for civility. Nothing stood out as particularly profane or inappropriate.
But the comments caught the eye of the defense team. Oral arguments were made before Judge Robert M. Schieber to disallow the camera in the court. This would not only hurt MND coverage but CVN as well.
CVN immediately hired a media attorney from Kansas City, Jean Maneke who filed a well thought-out motion and presented it to the judge on Sunday December 6, according to the docket.
Among the things she wrote, CVN could not be held responsible for content posted on a website over which it has no editorial control, according to a Missouri Lawyers Weekly story on the issue. Reader comments appear on newspaper and television websites regularly. Restricting access to the court, does nothing to prevent comments.
“Trials are inherently public events, and attorneys representing large, publicly traded corporations at a multi-million dollar product liability trial involving medical devices alleged to have injured thousands of women nationwide can and should expect to be the subject of news media coverage and public discussion, whether in print on social media sites or around the local coffeehouse counter, which may not always be flattering or may be potentially hostile.” ~ Attorney Jean Maneke.
She characterized comments in question as “inflammatory” but not threatening. Here Jean Maneke’s Motion for CVN.
Mesh News Desk had no representative in the courtroom. As editor, I had talked to the public information officer previously, given her my name, background (30 years in news, including a stint as an anchor/ reporter at KTVI in St. Louis. MO), assured her I’m not a legal referral service or work for a law firm but just a journalist who thinks this story deserves the light of day. She listened politely. We were cordial.
I asked if I should talk to the judge on Friday, December 4, as this all broke, to introduce myself. Thinking he might be a reasonable person, I’d have expected a speaker phone to listen to the proceedings and make my own case. That didn’t happen.
Judge Robert M. Scheiber decided to curtail the camera access to MND while CVN maintained its camera in the court. Split the baby in half as judges are inclined to do.
Today’s story in Missouri Lawyers Weekly on the issue says the basis for the judge’s decision is that MND is an “advocacy organization.” (I spoke to them looking for a law firm. They did a story instead. ) This is my first understanding of the objection to continuing coverage.
(Sorry there is a pay wall and I was asked not to share the story)
Interesting. MND is an “organization” of one. It is a for-profit publishing business. I alone own it. Just like newspaper and TV station websites, comments are allowed. There is no difference. Comments are monitored for civility and profanity, just like any media website.
Even if MND was an advocacy organization, there is nothing in the rules governing media access to Missouri courts that prevents access to the courts by anyone who is a member of an advocacyorganization. If the Susan Komen organization wanted access to the CVN feed for educational outreach to its members, would they be denied? Missouri Court Operating Rule 16 says no.
The story in Missouri Lawyers Weekly ends with your editor’s comment, “This isn’t just a private club that the defense gets to make a decision about what coverage they like and don’t like,” Akre said. “It’s ridiculous.” #
Bottom Line- About 5,000 daily readers of MND lose a resource to keep appraised of litigation involving two of the largest mesh manufacturers. MND is still attempting to reach out to the judge through legal means to regain access. Please allow the process to take its course!
LEARN MORE:
Jean Maneke – Motion, CVN camera in the courtroom
Web reporter shut out of trial after reader’s comment
http://molawyersmedia.com/category/local/By Scott Lauck
scott.lauck@molawyersmedia.com
“An online journalist remotely covering a major trial in Jackson County Circuit Court has been shut out of access to the proceedings after defense counsel objected to a reader’s comments posted on her website.
Jane Akre, the Florida-based editor of Mesh Medical Device News Desk, said she was trying to re-establish access to a privately maintained pool camera that provides a web feed of the trial. The case, which began last week, involves claims against companies Boston Scientific and C. R. Bard that make transvaginal mesh products that plaintiffs allege have injured women in whom they were implanted. It’s one of a series of such suits around the country.
Akre covered the first two days of the trial via a pool camera arrangement through Courtroom View Network, a private company that provides subscriptions to video coverage of trials nationwide that are of interest to legal professionals. According to court records, CVN applied in November to serve as the pool camera for the trial, providing online access for a number of traditional and trade media outlets, including Akre’s.
According to a court filing made by CVN, attorneys for the defense on Friday complained to the court about comments left by online readers on Akre’s website and asked that CVN’s coverage be suspended. The company successfully argued that it should be allowed to continue. CVN, however, terminated Akre’s access to its feed.
It was unclear if she would be able to regain access……”
MO COURT RULES OF OPERATION
Court Operating Rule 16
http://www.courts.mo.gov/courts/ClerkHandbooksP2RulesOnly.nsf/e2aa3309ef5c449186256be20060c329/8d8476459573196786256c240070a979?OpenDocumentMedia Coordinator, shall work with and through the appropriate media coordinator regarding all arrangements for media coverage.
“Pooling arrangements shall be the sole responsibility of the media coordinator, and the judge shall not be called upon to mediate any dispute as to the appropriate media representatives authorized to cover a particular judicial proceeding. Requests for copies of audio recording, video tape or photographs shall be directed to the pool representative only, who shall supply copies upon request to media representatives at a price not exceeding actual cost.”
http://www.courts.mo.gov/page.jsp?id=1441
“COR 16 does not affect the right of the public, including a member of the news media, to attend and observe any judicial proceeding which is otherwise open to the public. In other words, this Rule does not affect existing law under which reporters, sketch artists and others may attend judicial proceedings as members of the public.”JEAN MANEKE- Mo Gets ‘F’ Ranking in Sunshine Law, 2007
http://www.mopress.com/_lib/files/Manlaw712.pdf
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