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Ethicon Media Monitoring 9/25/2018
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Jury Deadlock Ends Latest Philly Mesh Case
Sep 24, 2018 | Law 360
By Matt Fair
The latest trial over alleged injuries from a Johnson & Johnson unit’s pelvic mesh products ended Monday as a Philadelphia jury deadlocked over whether negligence they agreed had been involved in the design of the implant had contributed to a woman’s chronic pain and left her largely unable to have sex. -
*Just In* McFarland Jury Deadlock Results in Mistrial
Sep 24, 2018 | Mesh Medical Device News Desk
By Jane Akre
After four days of deliberation, jurors in the trasnsvaginal mesh case of Susan McFarland v. healthcare giant Johnson & Johnson (Ethicon) ended in a deadlocked jury. -
Women demand Federal Government response to Senate inquiry into pelvic mesh scandal
Sep 25, 2018 | Newcastle Herald
By Joanne McCarthy
Women have accused the Australian Government of standing by while devastated pelvic mesh patients are re-traumatised by a health system failing to acknowledge and respond to a national scandal.
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Jury Deadlock Ends Latest Philly Mesh Case
Sep 24, 2018 | Law 360
By Matt Fair
The latest trial over alleged injuries from a Johnson & Johnson unit’s pelvic mesh products ended Monday as a Philadelphia jury deadlocked over whether negligence they agreed had been involved in the design of the implant had contributed to a woman’s chronic pain and left her largely unable to have sex.
The Philadelphia County jury agreed that the Ethicon Inc. mesh had been negligently designed, but told a judge they were hung up on a question over whether the defects were the main factor in injuries suffered by Susan McFarland.
Judge Michael Erdos declared a mistrial Monday afternoon following four days of deliberations on the heels of closing arguments in the case Sept. 18.
“There seems no reasonable hope that a verdict of 10 jurors or more can be reached,” Judge Erdos said before dismissing the panel. “Everyone stood by their convictions and that’s the most we can ask of you.”
The jury had initially sent a note to Judge Erdos on Friday asking to be dismissed over its failure to agree on a verdict, but was instructed to put in one more day of deliberation in hopes of breaking the impasse.
The deadlock brought an uncertain conclusion to the seventh pelvic mesh trial Ethicon has faced in Philadelphia, five of which have resulted in verdicts for plaintiffs who have reaped more than $105 million in combined damages.
Several others cases have ended in settlement in advance of trial.
While acknowledging her disappointment with the outcome of the case, Tracie Palmer, an attorney with Kline & Specter PC representing McFarland, noted that the jury had managed to agree that there were latent problems with Ethicon’s so-called TVT-O mesh implant.
“We’re obviously very disappointed with the verdict; however, we acknowledge that, yet again, a jury has recognized these products were negligently designed, including those like the TVT-O that remain on the market today,” she said.
McFarland filed suit against Ethicon in July 2013 over alleged defects in a TVT-O implant she received five years earlier to hold her urethra in place to relieve her stress urinary incontinence.
Within a year and a half of receiving the implant, however, doctors discovered that a portion of the mesh had eroded through the wall of her vagina, requiring surgery to remove.
But even after the operation, McFarland has said she continues to suffer from frequent urinary tract infections that typically leave her bedridden for days, an inability to hold her bladder for more than an hour, and chronic pain that has prevented her from having a normal sex life with her husband.
McFarland argued that the mesh used in the TVT-O was too rigid and that it was prone to sawing through the soft tissue in and around the vagina.
She also said the company had failed to properly test the product, which is a version of a previously marketed implant, before it was offered for sale in 2003.
In fighting the claims, Ethicon argued that McFarland’s alleged injuries, including the pain she experienced during sex, could be pinned to natural atrophying of the tissue in her vagina, and the simple fact that some people’s bodies could react poorly to the implant.
“I am surprised they were hung up on that,” Palmer said. “I believe the evidence of causation that we presented was very strong.”
Ethicon also looked to dodge liability by arguing that McFarland had missed the two-year statute of limitations for her claims.
The jury did agree on that question as part of their deliberations, as at least 10 of the 12 jurists sided with arguments from McFarland that she hadn’t been aware of possible defects with the mesh until she saw a televised legal advertisement in late 2012.
As jurors continued their deliberations Monday morning, attorneys for McFarland and Ethicon sparred over whether the jury’s verdict on the statute of limitations should be taken by the court, or whether the issue should be included in any potential retrial.
Palmer said that including the issue in a second trial “entitles [Ethicon] to a second bite at the apple even though plaintiffs succeeded on it.”
Alicia Hickok, an attorney with Drinker Biddle & Reath LLP representing Ethicon, said that accepting the jury’s verdict on the lone issue of the statute of limitations would create a procedural morass on appeal because a new trial would result in the creation of a separate record.
“We can’t appeal a statute of limitations ruling that is a part of something that’s going to a new trial,” she said. “They might bring out different evidence in a new trial, we might bring out different evidence, and the adjudication of that question could be different.”
Ultimately, however, Judge Erdos decided from the bench Monday afternoon not to record a verdict on the statute of limitations.
The next mesh case in Philadelphia is scheduled to begin in November.
Palmer said it was unclear when McFarland’s case might be queued up again for trial.
Mindy Tinsley, a spokeswoman for Ethicon, defended the product in a statement Monday.
“There are various treatment choices for women with this condition seeking to improve their quality of life, including surgical treatment with implantable mesh, which is backed by years of clinical research and is considered by most doctors to be the gold standard treatment,” she said. “We believe the evidence showed Ethicon’s TVT-O device was designed with due care and that Ethicon acted appropriately and responsibly in the research, development and marketing of the product.”
McFarland is represented by Tracie Palmer, Elia Robertson, Braden Lepisto, Lee Balefsky and Shanin Specter of Kline & Specter PC.
Ethicon is represented by Kathleen Gallagher and Kate Skagerberg of Beck Redden LLP, Kenneth Murphy, D. Alicia Hickok, Melissa Merk and William Carr of Drinker Biddle & Reath LLP and Adam Spicer of Butler Snow LLP.
The case is Susan McFarland et al. v. Ethicon Inc. et al., case number 130701577, before the Court of Common Pleas of Philadelphia County, Pennsylvania.https://www.law360.com/articles/1085733/jury-deadlock-ends-latest-philly-mesh-case
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*Just In* McFarland Jury Deadlock Results in Mistrial
Sep 24, 2018 | Mesh Medical Device News Desk
By Jane Akre
After four days of deliberation, jurors in the trasnsvaginal mesh case of Susan McFarland v. healthcare giant Johnson & Johnson (Ethicon) ended in a deadlocked jury.
Judge Michael Erdos had no option but to call for a mistrial.
McFarland v Ethicon [1307-01577] opened August 27 in the Philadelphia Court of Common Pleas. Jurors had before them an option to declare that Ethicon negligently designed the polypropylene transvaginal mesh. They were also given the option to award punitive damages.
TVT-O is in the Ethicon family of meshes and designed to support the urethra and treat incontinence.
This was the seventh transvaginal mesh trial in the Philadelphia Court of Common Pleas. All but one have awarded plaintiffs compensation for their injuries as well as punitive damages totaling more than $105 million.
This is the first transvaginal mesh case in this jurisdiction concerning the TVT-O polypropylene mesh. TVT-O is run through the obturator space.
(This story is in production)
Lead counsel was Tracie Palmer (Kline Specter). In September 2017, she along with Elia Robertson and Kila Baldwin (all of Kline Specter) represented Ella Ebaugh in her $57.1 million verdict against Ethicon.
Two other product liability trials involving Ethicon’s TVT-O have concluded it was defectively designed. They include Jo Huskey v. Ethicon ($3.27 Million) in September 2014 (here), and Linda Batiste v. Ethicon, ($1.2 million) in a Dallas court in April 2014 (here).
In the Huskey trial, it was argued that the heavyweight laser-cut mesh led to mesh shrinkage and contraction and foreign body response near muscles and nerves, all contributing to pain.
BACKGROUND
Susan McFarland, 67, underwent the implantation of a Tension Free Vaginal Tape-Obturator system (TVT-O) by Liang R. Bartkowiak, M.D. on April 3, 2008.
Since then she has experienced vaginal pain, urinary tract infections which are frequent, dyspareunia, recurrent SUI, new onset urge incontinence and urinary frequency. Within the year she complained to Dr. Bartkowiak she could “feel something in her vagina” and she had vaginal bleeding and dyspareunia. She was identified with a “right periurethral TVT erosion through the vaginal vault.”
On September 29, 2009, Dr. Bartkowiak performed a revision surgery on Ms. McFarland. She removed “very tight adhesions of the tension-free vaginal tape on the right periurethral area” and “trimmed” the TVT-O.
Ms. McFarland continued to experience vaginal bleeding, dyspareunia, frequent urination and leakage as well as frequent and severe urinary tract infections. An appointment with another doctor, urologist, Henry C. Wong, M.D. and he performed a cystoscopy on Ms. McFarland and noted incomplete emptying with a recent increase in urinary tract infections and dyspareunia since implantation of the TVT-O device.
In August 2013, she was diagnosed with vaginal atrophy and dyspareunia and received a Premarin prescription.
A third doctor, urologist Stephen Yanoshak, D.O diagnosed her with “urinary frequency, nocturia, incomplete emptying of bladder, recurrent urinary tract infections and both SUI and urge incontinence.”
She continues to suffer from SUI and urge incontinence, urinary tract infections that are frequent and severe, dyspareunia so painful she rarely engages in intercourse and emotional and psychological injuries.
RUSHED TO MARKET
The plaintiffs claim TVT-O was rushed to market in 2001 without properly evaluating its safety or efficacy, and that it is defective in its design and unsafe for use in women, and that Ethicon continues to market and Sell the TVT-O without proper warnings, despite its knowledge of the defects. From Motion in Limine (here).
Both the TVT and TVT-O were cleared to market through the FDA’s 510(k) process which requires only to name a predicate device. In this case it was the ProteGen made by Boston Scientific. ProteGen was voluntarily recalled from the market because it did not perform as intended. The TVT-O was intended to be an improvement on the TVT and sales profits were estimated to exceed $34 million by 2010.
Feeling the pressure from competitors, Project Mulberry’s goal was to bring the TVT-O to market. Ethicon’s product development plan called for 24 months of review, which was shortened to eighteen month, then 12 months. Finally, considering the eroding TVT business, a revised timetable of just 9 months was settled upon.
“Project Mulberry is critical to GYNECARE’s success in the incontinence marketplace,” and “We MUST make this project happen in a short period of time,” said an email from Ronnie Toddywala to multiple recipients on June 24, 2003.~ Toddywala, Ethicon VP of Research & Development.
To meet the company goals of nine month before launch, defendants decided to forgo any clinical studies of the TVT-O, even though Dan Smith had suggested six months of clinical testing.
DEFECTIVE MESH/ v Negligent Design?
Plaintiffs in previous cases have determined the TVT-O is defective because
*Polypropylene is unsuitable for use in a woman’s vagina
*The transobturator insertion technique carries the risk of additional complications including injury to obturator nerve
*the mesh is machine cut making it excessively rigid, frays, degrades, rope and lose particles (laser cut mesh became available in the 4Q of 2006 for TVT products)
*the mesh degrades
*the mesh causes chronic foreign body reaction
*the mesh causes infections and the formation of bio-film
*the mesh incites fibrotic bridging leading to scar plate formation and mesh encapsulation
*the mesh shrinks and contracts
*toxicity testing reveals it is cytotoxic, meaning toxic to the body’s cells causing cell death or injury
Ethicon never studies what effect there might be on patients implanted with machine cut mesh, while Ethicon continued to market and sell TVT products with machine cut mesh, including the TVT-O.
SIX PRIOR CASES
Of the six cases tried so far in the Philadelphia Court of Common Pleas, Ebaugh remains the highest awarded case.
Others include:
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
The only favorable verdict for Ethicon was the Atkins case in June of 2017 (TVT-Secur). A new trial has been ordered in that case.
https://www.meshmedicaldevicenewsdesk.com/just-in-mcfarland-jury-deadlock-results-in-mistrial/
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Women demand Federal Government response to Senate inquiry into pelvic mesh scandal
Sep 25, 2018 | Newcastle Herald
By Joanne McCarthy
Women have accused the Australian Government of standing by while devastated pelvic mesh patients are re-traumatised by a health system failing to acknowledge and respond to a national scandal.
“Women have been left feeling like they’ve been raped by the health system and abused again when they’ve sought the help they were promised,” said mental health worker Justine Watson after seven years of pelvic mesh complications that included a suicide attempt and a trip to an American specialist in 2017 to remove the mesh.
“What is just not understood and acknowledged by governments is that women were implanted with mesh by doctors without giving informed consent, via the vagina, and have suffered devastating and permanent complications. It is why so many are suffering serious mental and physical harm. What women experienced is a kind of sexual assault and yet the services being provided are just not responding to that,” Ms Watson said.
She is one of three women to set up Mesh Injured Australia Incorporated to provide urgent support for thousands of women and men injured by surgical mesh implants. The association will also demand government action.
The group issued a media statement on Monday as prominent pelvic mesh gynaecologist Richard Reid was deregistered after leaving a trail of devastated women patients, including mesh-injured patients, across two countries and two Australian states. The five-year deregistration almost two years after he retired was an insult to women and a demonstration of the health system’s failure to protect the public, said Medical Errors Action Group founder Lorraine Long.
Ms Watson said mesh-injured women were appalled the Federal Government had not implemented urgent changes in treatment, monitoring and care and had not responded to the Senate inquiry into the pelvic mesh scandal six months after a final report was released.
The inquiry, initiated by Senator Derryn Hinch and headed by Greens Senator Rachel Siewert, identified failures across the health system leading to “catastrophic” results for an unknown number of women implanted with devices for more than three decades.
Mr Hinch described the implantation of high risk pelvic mesh devices in Australian women as “one of the greatest medical scandals and abuses of mothers in Australia’s history”.
The Senate inquiry final report called on the federal and state governments to commission an audit of all mesh devices and outcomes and establish specialist units across the country to assess and manage the long-term severe complications experienced by some women.
It recommended mandatory reporting of adverse events by doctors, a registry for all high risk implantable devices a more comprehensive monitoring scheme for devices approved for use in Australia after damning evidence of health system failures to respond to women’s complaints about pelvic mesh devices from as early as the 1990s.
It recommended pelvic mesh should be used as a “last resort” after evidence from women about the severe, permanent and disabling consequences of some mesh surgery to treat routine conditions after childbirth.
The final report also recommended a Department of Health-led review of “systems in place to prevent the payment of inducements to medical professionals and teaching hospitals” after Australia’s college of women’s health specialists failed to declare the full range of sponsorships from pelvic mesh device manufacturers to the Senate inquiry.
Ms Watson said a range of attempts had been made to secure Government support for services to mesh injured people across the country but “all to no avail”.
Instead support groups established by mesh-injured women were receiving constant reports of health authorities having little or no information or understanding of pelvic mesh injuries when women sought help, she said.
“There’s been no studies done, there’s no data and women are having to educate health workers about the complications they’re experiencing. It’s a re-traumatisation for them to have to explain what has happened, when it was the health system’s failures that led to their injuries,” Ms Watson said.
“We need patient-centred care facilities, co-designed with consumers, to be established in each state to accommodate women in particular who have experienced trauma, abuse and mesh complications. Those centres need to facilitate safe and full removal of surgical mesh if required.
“Every day shocking stories arise from mesh support groups that are real life stories, including women as young as 28 seeking medical attention and being faced with chronic gender discrimination, ignorance, complacency and negative and dismissive treatment.”
Ms Watson and mesh-injured women Andrea Walter and Kim Blieschke established a toll free national hotline, 1800 MESHED (1800 637 433), run by mesh-injured volunteers.
A spokesperson for Federal Health Minister Greg Hunt said the government will “soon respond” to the Senate report.
The Federal Department of Health did not respond to a Newcastle Heraldquestion about the provision of specific support for mesh-injured women, as recommended by the Senate inquiry.
A new regulatory framework requires all surgical mesh devices, including hernia mesh, to “meet higher evidentiary requirements” for use in Australia.
From December 1 manufacturers of all new implantable devices, including hernia mesh, will need to supply patient leaflets with “information about symptoms to be aware of and where to report adverse events”, a Department of Health spokesperson said.
https://www.theherald.com.au/story/5663756/like-weve-been-raped-mesh-injured-women-slam-governments/
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