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Ethicon Media Monitoring 9/19/2018
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J&J Cut Corners, Pelvic Mesh Jury Hears At Philly Trial's End
Sep 19, 2018 | Law360
By Matt Fair
A trial over a Johnson & Johnson unit’s pelvic mesh product came to a close Tuesday as jurors heard the closing arguments. The woman in the trial, Susan McFarland, has been in chronic pain and unable to have sex after receiving an implant a decade ago. -
Grieving son who lost mother to mesh set to meet health secretary
Sep 19, 2018 | The Scotsman
By Kevan Christie
The son of the first woman in Scotland to have mesh listed as an underlying cause of death is to meet with health secretary Jeane Freeman tomorrow to discuss his mother’s case. -
Surgical mesh failure rates unacceptably high, expert says
Sep 19, 2018 | The Irish Times
By Kevin O'Sullivan
A review by Trinity College Dublin professor of materials engineering David Taylor concludes that surgical mesh failure rates are unreasonably high and that more should have been done to evaluate the use of mesh in such circumstances. -
Irish professor's research finds failure rate of some vaginal mesh treatments 'unacceptably high'
Sep 19, 2018 | journal.ie
By Michelle Hennessy
A review by Trinity College Dublin professor of materials engineering David Taylor concludes that surgical mesh failure rates are unreasonably high and that more should have been done to evaluate the use of mesh in such circumstances. -
Patient accuses obstetrician of medical liability
Sep 19, 2018 | West Virginia Record
By Bree Gonzalez
Saleena F. Bowen filed a complaint in Cabell Circuit Court against Dr. Brenda Lee Mitchell, alleging she improperly installed a vaginal mesh, which caused complications after Bowen's medical procedure and was not immediately diagnosed and treated. -
Ethicon Physiomesh Case Bellwether Schedules Extended By 75 Days
Sep 19, 2018 | AboutLawsuits.com
By Irvin Jackson
The U.S. District Judge presiding over all federal Ethicon Physiomesh lawsuits has agreed to extend all pending discovery deadlines by 75 days, which may push the start of the first bellwether trial into early 2020.
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J&J Cut Corners, Pelvic Mesh Jury Hears At Philly Trial's End
Sep 19, 2018 | Law360
By Matt Fair
A trial over a Johnson & Johnsonunit’s pelvic mesh products came to a close Tuesday as jurors heard arguments that the company’s failure to properly study the device before it went to market resulted in defects that left a woman in chronic pain and unable to have sex after receiving an implant a decade ago.
Tracie Palmer, an attorney with Kline & Specter PC representing plaintiff Susan McFarland, told jurors during closing arguments that Ethicon had failed to thoroughly study the potential risks of its so-called TVT-O mesh product before it was put on the market in 2003, and instead had thrown millions of dollars in marketing the implant to physicians.
“There was nothing to stop them from doing a clinical trial except for greed,” she said.
Ethicon is hoping to reverse its fortunes as juries in five out of six prior trials over allegedly defective mesh in the Philadelphia County Court of Common Pleas have returned verdicts in favor of plaintiffs.
Total damages in the cases have topped $100 million.
McFarland’s suit stems from complications she says she suffered after receiving a TVT-O implant in April 2008 to treat stress urinary incontinence.
A year and a half later, however, McFarland reported that she was experiencing pain during sex, and doctors discovered that a portion of the implant had eroded through the wall of her vagina requiring surgery to remove.
Even after the revision surgery, McFarland has continued to suffer from frequent urinary tract infections that leave her bedridden, an inability to hold her bladder for more than an hour, and chronic pain.
The pain is so bad, Palmer told jurors on Tuesday, that she’s been left unable to have sex with her husband.
“For 10 years she hasn’t been able to have a normal sex life and she likely won’t for the rest of her life,” Palmer said.
She ultimately filed suit in July 2013, according to court records.
But Kathleen Gallagher, an attorney with Beck Redden LLP representing Ethicon, told jurors on Tuesday that McFarland had clearly known about complications from her implant within a year of receiving it, and thus had waited well beyond the two-year statute of limitations to sue.
Even if her suit was timely, Gallagher said, there was ample clinical evidence that TVT-O was safe and effective.
While Palmer seized on the last of any clinical trials in the run-up to TVT-O’s release, Gallagher said the product had simply been a new iteration of a prior product — known simply as TVT — that had been rigorously studied since it went to market in the late 1990s.
She said the product continues to be used by physicians today to treat urinary stress incontinence, and that it had been praised by industry groups including the American Urogynecologic Society and the Society for Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction.
“What the evidence shows is that TVT-O was the best when it came out on the market in 2003 and it remains the gold standard today,” Gallagher said.
Jurors are expected to begin deliberations in the case on Wednesday.
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/1084073/j-j-cut-corners-pelvic-mesh-jury-hears-at-philly-trial-s-end
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Grieving son who lost mother to mesh set to meet health secretary
Sep 19, 2018 | The Scotsman
By Kevan Christie
The son of the first woman in Scotland to have mesh listed as an underlying cause of death is to meet with health secretary Jeane Freeman tomorrow to discuss his mother’s case.
Mark Baxter will go to Holyrood with his sister Audrey and mesh campaigner Neil Findlay MSP to discuss the circumstances surrounding the death of their mother Eileen who passed away on 27 August.
"I want to know what she’s going to do about this for the other women that are going to be worried they could suffer the same fate as my mother," Mark Baxter.
Mrs Baxter, a great-grandmother, who was married to 79-year-old Chic, had multiple organ failure listed as directly leading to her death after being admitted to the Royal Infirmary of Edinburgh, with internal bleeding, sickness and diarrhoea.
The 75-year-old also had a perforated bowel that may have been linked to sacrocolopexy mesh repair surgery that she had five years previously. Last week the health secretary told parliament that the use of transvaginal mesh repair implants has been immediately halted in NHS Scotland. The move came after The Scotsman revealed Mrs Baxter’s death.
However, this does not include other procedures such as transabdominal mesh surgery which Mrs Baxter underwent for a pelvic organ prolapse but these will be subject to “high vigilance” procedures.
Mr Baxter said he was “looking for answers” to a number of questions that he planned to ask Ms Freeman. He added: “The first question I’ll be asking Jeane Freeman is will there be an inquest into my mum’s case?
“I want to know if I can become a member of the NHS risk management panel that is looking into the use of mesh, this would provide transparency.
“I also want to know if there was a risk assessment put in place before my mother’s operation? “I want to know how there was a tear in my mother’s bowel.
“Normally this kind of thing happens during an operation and I’m going to ask what the mesh device was called and who were the manufacturers?
“I want to know if my mum had any underlying bowel condition that could have been recognised as a risk and was she ever asked if they could remove the mesh?
“I’m going to say to Jeane Freeman that she’s responsible for protecting and promoting public health and providing welfare for others and I want to know what she’s going to do about this for the other women that are going to be worried they could suffer the same fate as my mother.”
Labour MSP Neil Findlay, said Mr Baxter “deserves answers” from the health minister over his mother’s death.
He added: “Seeing mesh listed as one of the underlying causes of Eileen Baxter’s death was confirmation of what many have known all along – mesh should not be implanted inside human beings.
“This substance has left thousands of women across the world debilitated, in chronic pain and unable to walk or live their lives as they previously did.
“Some have lost organs, many have witnessed the end of their careers, their relationships and some have lost their homes.”
A Scottish Government spokesperson said: “The Health Secretary wants to hear first-hand the experiences and views of Ms Baxter’s family following this tragic case.
“Health boards were last week instructed to immediately halt the use of transvaginal mesh altogether in cases of both pelvic organ prolapse and stress urinary incontinence, pending the implementation of a new restricted use protocol that will ensure procedures are carried out only in the most exceptional circumstances and subject to a robust process of approval and fully informed consent.”
https://www.scotsman.com/news/uk/grieving-son-who-lost-mother-to-mesh-set-to-meet-health-secretary-1-4801952 -
Surgical mesh failure rates unacceptably high, expert says
Sep 19, 2018 | The Irish Times
By Kevin O'Sullivan
Failure rates in some treatments using “surgical mesh” products are unacceptably high and as a result many women have been condemned “to a lifetime of pain and discomfort”, according a Trinity College Dublin materials expert .
In recent years, a large number of patients – mainly women – have been implanted with pieces of mesh to correct urinary incontinence and prolapse of organs such as the vagina, which occurs frequently after childbirth.
Surgical mesh is a fabric-like material which has been used successfully for more than 50 years for repair of hernias. However, in recent years medical companies developed new products using this same mesh, for operations involving organs in the pelvic region.
A review by TCD professor of materials engineering David Taylor concludes more should have been done to evaluate the use of mesh in such circumstances.
“More experiments should have been conducted to properly assess how surgical mesh would behave in some of the bodily environments in which it has recently been used, such as the vagina and urinary system,” he said.
“Many of these women have been condemned to a lifetime of pain and discomfort because the mesh has caused damage to surrounding organs and tissues, and it cannot be removed,” he said.Banned
As a result, the use of these products has been banned or restricted in many countries including the United States, UK, Australia and New Zealand.
In Ireland “we have been slow to realise the extent of the problem”, he said.
In July this year Minister for Health Simon Harris announced “a pause had been placed on the use of these products pending a full investigation into their use and the risks involved”.
The review article by Prof Taylor considers the findings of a wide variety of scientific and medical sources, from material test reports to clinical case studies. It has been published the Journal of the Mechanical Behaviour of Biomedical Materials.
“The use of surgical mesh to treat pelvic organ prolapse and urinary incontinence seems to provide another example in which new products have been developed that expand the use of existing materials without conducting the necessary experiments to properly understand the material, and how it will react in its new application,” Prof Taylor said.
“Very severe consequences can result from mesh erosion, when the mesh material damages the surrounding tissues. The prolapse products caused mesh erosion in over 10 per cent of cases, rising to almost 30 per cent in some studies, which I concluded was unacceptably high,” he said.
“In the case of urinary incontinence products, erosion occurs less often, around 2 per cent to 3 percent, so my opinion is that patients should be given more information to allow them to make an informed decision about the risks involved, “ he added.Technique
Chemical degradation of the material due to bacterial infection, and poor surgical technique are two potential reasons for the failures, Prof Taylor said, “but further work is needed – especially the examination of failed mesh products – to properly determine the underlying causes of this problem.”
In a statement, the Department of Health said the HSE had paused the use of mesh products. It said the chief medical officer has been asked to complete a paper on the clinical and professional issues involved to ensure the use of mesh implants was in line with international best practice.
“A programme of work has commenced in the HSE to advance priority recommendations relating to mesh products including patient information and consent, surgical professional training, collection of appropriate data concerning use of mesh implants and the development of aftercare services for women suffering from complications,” a spokeswoman for the department said.
https://www.irishtimes.com/news/health/surgical-mesh-failure-rates-unacceptably-high-expert-says-1.3633571
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Irish professor's research finds failure rate of some vaginal mesh treatments 'unacceptably high'
Sep 19, 2018 | journal.ie
By Michelle Hennessy
NEW RESEARCH BY a Trinity College professor has concluded the failure rate in some surgical mesh treatments is ‘unacceptably high’ and further experiments should have been conducted to properly assess how these products behave in the body.
Professor of Materials Engineering David Taylor conducted a review of around 20 studies – involving thousands of patients – on vaginal mesh devices and associated complications. There has been controversy around these devices in several countries, including Ireland, as women have reported life-changing complications like recurrent infections and chronic pain.
Mesh devices, which are made of polypropylene – a type of plastic – are used in procedures to address pelvic organ prolapse and stress urinary incontinence, conditions women can suffer from after natural childbirth and in their later years. It is known now that the devices, most commonly used in a tape form, can move inside the body and become embedded in other organs or tissue.
“Many of these women have been condemned to a lifetime of pain and discomfort because the mesh has caused damage to surrounding organs and tissues, and it cannot be removed,” Taylor notes in his article on the topic, published in the Journal of Mechanical Behaviour of Biomedical Materials.
The use of vaginal mesh devices has been suspended in Ireland pending a review by the Chief Medical Officer.
This new academic review considered the findings of a variety of scientific and medical sources, from material test reports to clinical case studies.
“The use of surgical mesh to treat pelvic organ prolapse and urinary incontinence seems to provide another example in which new products have been developed that expand the use of existing materials without conducting the necessary experiments to properly understand the material, and how it will react in its new application,” Taylor said.
Source: Michelle Hennessy/TheJournal.ie
Surgical mesh has been used for over 50 years in the repair of hernias and surgical sutures are made from the same type of material. But it is only since the 90s that medical companies expanded the use of this material to products for the pelvic region.Very severe consequences can result from mesh erosion, when the mesh material damages the surrounding tissues. The prolapse products caused mesh erosion in over 10% of cases, rising to almost 30% in some studies, which I concluded was unacceptably high.In the case of urinary incontinence products, erosion occurs less often, around 2% to 3%, so my opinion is that patients should be given more information to allow them to make an informed decision about the risks involved.
Speaking to TheJournal.ie, Taylor said even with a 3% complication rate for stress incontinence procedures, there should be a discussion around “what is acceptable risk”.
“Take for example different products for hip replacements. There is an understanding that, if in ten years, failure rates are less than 10%, that’s considered to be reasonable. It’s not nice if it fails and you are in pain and have to get another operation to replace it again,” he explained.
“With mesh, a person considering this urinary incontinence procedure could be told it’s only a 2% failure rate and think that’s fine. But what happens if the risk is that they could be in pain the rest of their lives?”
He said his main message is that patients need to be given all of the information before they have these procedures so that they can make an informed decision.
In January, Taylor took part in a presentation at Leinster House to brief politicians about the research around these devices. He said some women only had slight incontinence problems before they had the procedure and they now have life-changing complications.
“If they were told beforehand of the potential consequences, they might have felt that actually they could live with it for a while, maybe not take the risk and look at surgery later down the line if it got worse.”
Professor Taylor said he will be continuing his research in this area and he is now hoping to establish the reason the devices are failing – something he said he was not able to find in any of the studies he looked at.
“Lots of the clinical studies involved a patient with a problem, so the surgeon took out the mesh and there was no further follow-up to investigate why it happened, the mesh just went in the bin.”
He said it is possible these devices are reacting differently in the pelvic area because it has a different chemical environment.
“We have one piece from a patient and we are hoping to get more so we can do tests to compare them to new pieces of mesh and find out if they are broken and how they came to be.”
Treatment pathways
In July this year, Minister for Health Simon Harris asked the Chief Medical Officer to review the use of these devices here.
Documents released to TheJournal.ie through a Freedom of Information Request revealed some of the initial findings of this review. They include:There is no set description for consultants of what constitutes appropriate patient selection, appropriately trained personnel, or appropriate facilities;There are also no systematic approaches in place to make sure patients have the full information about risks and complications before they give their consent;No information is collected about patient outcomes;There are no agreed treatment pathways for women who suffer complications.
The review also found that no clinicians have reported complications to the Health Products Regulatory Authority.
A representative group for surgeons working in this area said members will not have submitted reports as the rate of serious complications they were seeing among their patients was not higher than the expected rate deduced from prior studies.
Dr Susmita Sarma, president of the Continence Foundation of Ireland said their “evidence based” position on the use of these procedures is that “alternative surgical treatments, which date back 60 years, are more invasive procedures associated with more complications and are less effective”.
http://www.thejournal.ie/vaginal-mesh-8-4241810-Sep2018/
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Patient accuses obstetrician of medical liability
Sep 19, 2018 | West Virginia Record
By Bree Gonzalez
A Prichard woman is suing an obstetrician and gynecologist, alleging medical professional liability.
Saleena F. Bowen filed a complaint in Cabell Circuit Court against Dr. Brenda Lee Mitchell, alleging she improperly installed a vaginal mesh, which caused complications after Bowen's medical procedure and was not immediately diagnosed and treated.
According to the complaint, between Dec. 16, 2015, Bowen underwent a robot-assisted laparoscopic hysterectomy and bilateral salpingo-oophorectomy and was discharged a day after the procedure. The suit says Bowen complained of persistent pain and other complications, which were a result of a vaginal mesh tightly implanted by Mitchell and the plaintiff needed to undergo another surgical procedure to remove the mesh.
The plaintiff alleges Mitchell breached the standard of care when she negligently performed the December 2015 procedure. Additionally, the suit says, Mitchell failed to promptly diagnose and/or treat Bowen's post-surgical complications.
Bowen seeks trial by jury, damages in excess of the jurisdictional minimums of the court and sufficient to fully compensate for her injuries, plus attorney fees, court costs, expenses and all other proper relief. She is represented by attorneys Brian J. Headley and Jonathan K. Matthews of Headley Ballard LLC in Mount Pleasant.
Cabell Circuit Court case number 18-C-373
https://wvrecord.com/stories/511563573-patient-accuses-obstetrician-of-medical-liability
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Ethicon Physiomesh Case Bellwether Schedules Extended By 75 Days
Sep 19, 2018 | AboutLawsuits.com
By Irvin Jackson
The U.S. District Judge presiding over all federal Ethicon Physiomesh lawsuits has agreed to extend all pending discovery deadlines by 75 days, which may push the start of the first bellwether trial into early 2020.
There are currently at least 1,417 product liability lawsuits pending against Johnson & Johnson & it’s Ethicon subsidiary in the federal court system, each raising similar allegations that problems with the hernia mesh resulted in painful complications and the need for additional surgery to remove the Physiomesh after it failed.
Given similar questions of fact and law raised in the complaints, the federal litigation is centralized before U.S. District Judge Richard Story in the Northern District of Georgia, as part of an MDL, or multidistrict litigation. To reduce duplicative discovery into common issues in the cases, avoid conflicting rulings from different courts and to serve the convenience of parties, witnesses and the judicial system, cases filed in U.S. District Courts nationwide are consolidated before Judge Story for pretrial proceedings and a series of early “bellwether” trials.
To help the parties gauge how juries may respond to certain evidence and testimony that is likely to be presented throughout the litigation, Judge Story established a bellwether process, where a small group of claims are going through case-specific discovery to select representative cases for trial, the first of which was previously expected to begin in September 2019.
In an Order (PDF) issued on September 11, the Court announced that all pending deadlines were being extended for two and a half months, which may delay the start of the first Ethicon Physiomesh trial dates until the end of 2019 or early 2020.
Earlier this year, the parties each selected a group of cases to go through preliminary discovery, including the exchange of Plaintiff Fact Sheets providing information about each claim. This initial discovery pool was expected to be narrowed down to a total of 20 cases by December 1, but that selection process will be delayed until mid-February 2019.
Following the recent extension of all deadlines, each side is now required to submit a proposal regarding the manner of trial, order of selection of plaintiffs and specific timing of trials by mid-July 2019. The court will then consider challenges to the admissibility of expert witness testimony in late 2019, as well as any dispositive motions before the first case goes before a jury.
While the outcome of these early bellwether trials is not binding on other plaintiffs involved in the litigation, the cases are being closely watched, as they may influence eventual negotiations to resolve claims.
Johnson & Johnson’s Ethicon unit introduced Physiomesh in March 2010, containing an absorbable film coating on each side of a polypropylene hernia mesh, which was designed to help the patch incorporate into the body and minimize inflammation. However, the hernia mesh was recalled last year, after a higher-than-expected number of individuals required revision surgery due to problems with the design.
Following the coordinated proceedings in the MDL, if Ethicon fails to reach hernia mesh settlements for individuals who had a Physiomesh patch fail, each individual complaint may be transferred back to the U.S. District Court where it originally would have been filed for a future trial date.
https://www.aboutlawsuits.com/ethicon-physiomesh-case-deadlines-149212/
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