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Ethicon Media Monitoring 1/31/2019
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J&J Pelvic Mesh Patient Endured 'Hell,' Pa. Jury Told
Jan 30, 2019 | Law 360
By Jeannie O'Sullivan
An attorney for a woman who claimed she experienced complications from pelvic mesh products manufactured by a Johnson & Johnson unit urged a Pennsylvania jury Wednesday to rule in his client's favor, saying in closing that she endured "hell"... -
Key Attys In Boston Scientific Pelvic Mesh MDL To Get $366M
Jan 30, 2019 | Law 360
By Mike Curley
West Virginia federal judge on Wednesday approved a bid to set aside 5 percent of proceeds from a massive multidistrict litigation accusing Boston Scientific Corp. of making defective pelvic mesh implants, granting attorneys that worked for the common benefit of the plaintiffs more than $336 million. -
Prolift Trial Moves into Closing Arguments
Jan 30, 2019 | Mesh Medical Device News Desk
By Jane Akre
The trial of Suzanne Emmet moves into closing arguments today in a Philadelphia courtroom after a lengthy trial that began before the holidays. *Please note, Emmet is spelled both ways in filed documents, with one “t” or two.
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J&J Pelvic Mesh Patient Endured 'Hell,' Pa. Jury Told
Jan 30, 2019 | Law 360
By Jeannie O'Sullivan
An attorney for a woman who claimed she experienced complications from pelvic mesh products manufactured by a Johnson & Johnson unit urged a Pennsylvania jury Wednesday to rule in his client's favor, saying in closing that she endured "hell" and the pharmaceutical giant knowingly put profits over patients.
Speaking in a voice that ranged from near shouting to a stage whisper, attorney Thomas Kline of Kline & Specter PC often motioned toward plaintiffs Suzanne Emmet and her husband, Michael, as he summed up about four weeks of testimony that had stretched over two months in the latest pelvic mesh trial held in the Philadelphia Court of Common Pleas.
“Hell” is how Emmet had described her experience due to the pelvic mesh products manufactured by J&J subsidiary Ethicon Inc., according to Kline, who said the ordeal left her “burned, scarred and eroded.” The products hadn’t been tested in clinical trials before women began using them, Kline said, because the company prioritized speed and money over safety.
“How dare they?” Kline hissed at one point.
Ethicon contends that the complications experienced by Emmet were well known to her implanting surgeon and had been clearly communicated. During Wednesday’s summations, Ethicon attorney Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP said the product’s components had been tested in clinical trials, and also doubled down on the company’s argument that the July 2013 lawsuit is barred by the two-year statute of limitations.
Emmet has maintained that she didn’t realize the possibility that her injuries might have been related to a defective implant until she saw an attorney advertisement in 2012. But Ethicon has countered that Emmet began experiencing complications shortly after her original implantation surgery, and that the frequency of the erosions she experienced should have made her realize by 2009 at the latest that there might be a problem with her mesh.
“The statute of limitations is not a technicality,” Ismail told the jury. “It’s the law of the commonwealth that everyone here has sworn to uphold.”
Ismail reminded the jury that the standard is “clear and convincing” proof, and that Emmet must prove Ethicon acted maliciously. Yet, it was significant that none of her doctors have corroborated her claim, Ismail said.
Emmet’s is the eighth case over the alleged defects in the Ethicon mesh products to go to trial in the Philadelphia County Court of Common Pleas; juries in five of the previous proceedings have returned verdicts in favor of plaintiffs.
Total damages in the five cases have topped $100 million.
Emmet's trial began in early December but was adjourned due to a juror's illness and resumed Jan. 7. Among those who testified were 10 Ethicon employees and three pelvic mesh removal surgeons, according to statements made in court Wednesday.
According to her lawsuit, Emmet experienced severe complications after receiving three mesh implants six years earlier to treat urinary stress incontinence and a condition in which both her bladder and rectum were sagging against her vagina.
In the weeks after receiving the implants in May 2007, Emmet began to experience complications as a portion of one of the devices eroded into her vagina.
Emmet underwent a corrective procedure in August 2007, but her doctor quickly realized that more of the mesh had made its way through her vaginal wall.
After another erosion two years later, Baldwin said, Emmet underwent another corrective procedure in which doctors chemically burned a portion of her vagina to try to scar over the exposed mesh. In all, Emmet underwent nine surgeries and almost a dozen chemical cauterizations to address 14 mesh erosions she experienced after being implanted, according to Baldwin.
Emmet’s husband was harmed by what felt like “barbed wire,” according to statements made in court Wednesday.
Emmet and her husband, Michael, are represented by Kila Baldwin, Thomas Kline, Elia Robertson and Thomas Bosworth of Kline & Specter PC.
Ethicon is represented by Anita Modak-Truran of Butler Snow LLP, Tarek Ismail of Goldman Ismail Tomaselli Brennan & Baum LLP, and Kenneth Murphy, D. Alicia Hickok, Melissa Merk and Molly Flynn of Drinker Biddle & Reath LLP.
The case is Suzanne Emmet et al. v. Ethicon Inc. et al., case number 130701495, before the Court of Common Pleas of Philadelphia County, Pennsylvania.
--Additional reporting by Matt Fair. Editing by John Campbell.https://www.law360.com/articles/1123643/j-j-pelvic-mesh-patient-endured-hell-pa-jury-told
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Key Attys In Boston Scientific Pelvic Mesh MDL To Get $366M
Jan 30, 2019 | Law 360
By Mike Curley
West Virginia federal judge on Wednesday approved a bid to set aside 5 percent of proceeds from a massive multidistrict litigation accusing Boston Scientific Corp. of making defective pelvic mesh implants, granting attorneys that worked for the common benefit of the plaintiffs more than $336 million.
U.S. District Judge Joseph R. Goodwin ruled in a memorandum and order that the attorneys, who worked to coordinate one of the largest MDL proceedings in the country’s history, made the more than $7 billion in wins so far possible by crafting legal theories and establishing strategies for the more than 104,000 individual plaintiffs involved in the suits.
“The fruits of this efficient process were made available to every plaintiff and their counsel,” Judge Goodwin wrote. “The court finds that every plaintiff benefited greatly from these efforts.”
What started with 36 plaintiffs more than nine years ago swelled to more than 104,000 across seven consolidated MDLs, Judge Goodwin wrote, requiring a plaintiff steering committee to lead the MDL and create a foundation that would streamline and consolidate the discovery, depositions and other concerns as much as possible.
“The common benefit work performed by leadership guaranteed that each plaintiff was the beneficiary of well-researched and briefed theories of liability with organized supporting factual resources and carefully vetted and developed expert opinion testimony,” Judge Goodwin wrote, adding the leadership’s efforts helped bridge the gap between the well-funded defendants and the less wealthy plaintiffs when it came to representation.
With more than $7 billion in verdicts and settlements for the plaintiffs so far, an amount that could grow to $11 billion when the rest of the cases are settled, the case’s Fee and Cost Committee asked the judge to award 5 percent of those awards.
Judge Goodwin found that the 5 percent was consistent with other “super-mega-fund” litigation, defined as litigation where recovery exceeds $1 billion, in which the percentage given to leadership counsel has ranged from 4.3 percent to 14.5 percent, with the higher percentages going toward smaller overall recovery.
The time and labor the leadership counsel put into the difficult and novel cases also justifies the award, the judge wrote, saying the risks and costs of the litigation have remained onerous.
Three plaintiffs’ firms — Kline & Specter PC, Sheller PC and Andrus Wagstaff PC — filed objections to the Fee and Costs Committee’s petition, though only Kline & Specter’s was submitted on time, Judge Goodwin wrote.
Kline & Specter had argued that the award should be reduced to 2.5 percent, saying that the lack of a global settlement is evidence that the leadership’s work didn’t benefit all the plaintiffs. Judge Goodwin ruled that the team’s efforts paid off in numerous ways for all the plaintiffs, such as developing expert testimony and theories of liability and reducing the defense’s bargaining power in settlement negotiations.
“Far from failing to provide a common benefit in the form of a global settlement, the plaintiffs’ leadership facilitated the settlement of tens of thousands of cases through its persistent efforts to weaken the defendants’ factual and legal standing compared to individual women across the country,” the judge wrote. “Plaintiffs’ leadership also provided the MDL plaintiffs with all the work product they created and educated individual plaintiff attorneys on how to prosecute a pelvic mesh case. These are global benefits.”
Judge Goodwin also overruled Kline & Specter’s objection that the Fee and Cost Committee emphasized its own members’ contributions and objections over the allocation, saying these arguments are premature. The motion is only on how much in total to award the attorneys, and how much each individual firm or attorney will get will come with a later order, the judge wrote.
As the other two firms did not get their objections in on time and didn’t file for extensions, Judge Goodwin overruled them without addressing the substance of their objections.
Representatives for Boston Scientific, the Fee and Cost Committee, Kline & Specter, Sheller and Andrus Wagstaff could not immediately be reached for comment Wednesday.
The products at issue are intended to treat stress urinary incontinence, which is the involuntary loss of urine during movement that puts pressure on the bladder, such as laughing, coughing or sneezing, and pelvic organ prolapse, which is the movement of the bladder or other organs.
The mesh can fix the problem, but can also lead to punctured organs, infections, bleeding, pain during sexual intercourse and urinary problems.
In November 2014, a Florida federal jury found Boston Scientific was negligent in manufacturing the Pinnacle Pelvic Floor Repair Kit and awarded some $27 million to four women who said they experienced infection, organ perforation, nerve damage, blood loss and chronic pelvic pain. The jury did not award punitive damages in the bellwether trial. The Eleventh Circuit upheld that decision in October 2017.
In July, Judge Goodwin denied joint motions from the plaintiffs and Boston Scientific Corp. to toss more than 800 cases from the present litigation but granted their requests to dismiss nearly 300 suits against the medical device maker.
Boston Scientific is represented by Jon A. Strongman of Shook Hardy & Bacon LLP.
The plaintiffs are represented by firms including Blasingame Burch Garrard & Ashley, Motley Rice LLC, Sanders Viener Grossman LLC, The Potts Law Firm, Fleming Nolen & Jez LLP, Bottar Leone PLLC, Kline & Specter PC, Sheller PC and Andrus Wagstaff PC among others.
The MDL is In re: Boston Scientific Corp. Pelvic Repair System Products Liability Litigation, case number 2:12-md-02326, in the U.S. District Court for the Southern District of West Virginia.
--Additional reporting by Tiffany Hu. Editing by John Campbell.https://www.law360.com/articles/1123849/key-attys-in-boston-scientific-pelvic-mesh-mdl-to-get-366m
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Prolift Trial Moves into Closing Arguments
Jan 30, 2019 | Mesh Medical Device News Desk
By Jane Akre
The trial of Suzanne Emmet moves into closing arguments today in a Philadelphia courtroom after a lengthy trial that began before the holidays. *Please note, Emmet is spelled both ways in filed documents, with one “t” or two.
Subscribers to Mesh News Desk receive filed documents for their support. Subscribe $38/ yr for individuals $52 month for law firms ($600 yr) here.
Image: Kila Baldwin, Kline Specter Law
Emmet was implanted with a Prolift pelvic mesh used to treat pelvic organ prolapse (POP).
The Prolift is made by Ethicon (Johnson & Johnson) as was the TVT-O she also received as a treatment for incontinence.
The trial began in November before Judge Kenneth Powell (Case No. 01495) in the Philadelphia Court of Common Pleas.
The allegations are negligence, defective design and failure to warn.
Emmet received the polypropylene mesh devices May 14, 2007, implanted by Dr. Patricia Reddy at Pinnacle Health in Harrisburg, PA. She had given birth to two large babies, which allegedly weakened and damaged her pelvic floor.
According to lawyer and blogger Deborah Silver (here) Dr. Reddy had five training sessions with Ethicon and “believes the risks of the mesh were temporary and could be treated.”
Since that time she has been treated for ten mesh erosions, had nine revision surgeries, several Botox injections and multiple applications of silver nitrate.
Her 2008 removal surgery was conducted by Dr. Vincent Lucente, of Allentown, PA, well known as a consultant to Ethicon. He removed a 3 by 1 cm piece of eroded mesh, also known a partial removal. Dr Lucente treated her for eight years.
Ms. Emmet claims her injuries are permanent, and she suffered mental and physical pain, an inability to have sexual relations, as well as economic loss. The mesh allegedly eroded into her vagina and left a scar plate and vaginal deformation. She experienced frequent and chronic urinary tract infection and inflammation.
She is represented by Kila Baldwin and Elia Robertson of Kline Specter.
Attorneys for Ethicon are Tarek Ismail, Anita Modak Truran and Joe O’Neil.
THE TRIAL
Dr. M. Tom Margolis was called as the first witness.
Margolis has appeared at many defective product trials. He is a pelvic floor surgeon and still does about 10 surgeries a week with many more requests for revision surgeries. He says he’s removed about 600 transvaginal meshes over the past 20 years.
He currently uses about 5 inches of suture material to treat a prolapsing vagina versus a mesh implant which contains 500 feet of mesh.
He testified that Prolift is defective and the risks outweigh the benefits. The same for Gynemesh and TVT-O.
Dr. Margolis did examine Ms. Emmet in his California office, a basis for his expert opinion and testimony.
He testified that a polypropylene medical device is not inert, the immune system recognizes it is there; scar tissue shrinks taking with it the mesh, nerves, muscles and surrounding tissue causing pain. The vagina cannot move when that happens.
He testified that Ms. Emmet had a “garden variety” prolapse, and no symptoms from her prolapse.
In Medieval times women suffering prolapse were hung upside down and Dr. Margolis opined that using Prolift is also barbaric. Prolift was voluntarily removed from the market in June 2012.
As is often the case, defense wants to show the jury that he is paid – Dr. Margolis charges $3,000 for a day of trial testimony and $400 an hour to review records. This is the standard exchange for experts on both sides of an issue. In the last ten years he reported earnings of $604,126.84 on pelvic mesh cases he has worked on but that represents 5% of his overall income.
He also spends time on self-funded trips to Uganda to provide medical services.
DANIEL ELIOTT UROLOGIST, PLAINTIFF EXPERT
Another expert for Emmet was Dr. Daniel Elliott, a urologist at Mayo Clinic in Rochester, MN and long-time opponent of the use of pelvic mesh. Dr. Elliott is board certified in urology, gynecology and reconstructive surgery.
He sees between 3-5 women a week suffering from complications. He used absorbable mesh sutures as part of his treatment.
Dr. Elliott signed onto the 2011 Public Citizen campaign to recall synthetic surgical mesh.
Dr. Elliott told jurors Prolift mesh was not needed, suture repairs can be used to repair prolapsed organs. He recounted the rate of erosion in mesh six to 12 % when using mesh to repair prolapse and there is a 21% erosion rate for the Prolift leading to the need to re-operate.
He called the concept of “tension-free” impossible in the human body which needs to be able to move.
Dr. Elliott disagrees with reports of native tissue repair failing 30-40% of the time.
The defense pointed out that Dr. Elliott never did a Prolift implant in any patient by choice and has not received any training in the procedure.
Looking for more trial testimony go to the blog of lawyer Deborah Silver on Dr. Lucente and Dr. Katrin Elbert, an engineer at Ethicon here.
PHILADELPHIA COURT OF COMMON PLEAS
The Philadelphia venue has been very favorable to mesh-injured plaintiffs in the past considering the jury verdicts so far including:
Hammons $12.5 million (Prolift), Dec. 2015
Carlino $13.5 million; (TVT), Feb 2016
Engleman $20 million, (TVT-S), April 2017
Beltz $2.16 million (Prolift), May 2017
Ebaugh $57 million (TVT and TVT-S), September 2017
McFarland, mistrial but set for a new trial, September 2018
https://www.meshmedicaldevicenewsdesk.com/prolift-trial-moves-into-closing-arguments/
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