Preview Newsletter
Ethicon Media Monitoring 5/10/2019
-
Nicola Sturgeon urged to intervene to ensure vaginal mesh patient gets surgery
May 9, 2019 | The Sunday Post
By Katrine Bussey
The First Minister has been urged to intervene to help a woman who needs urgent surgery to prevent her from losing her bladder and bowel as a result of vaginal mesh. -
The First Minister has been urged to intervene to help a woman who needs urgent surgery to prevent her from losing her bladder and bowel as a result of vaginal mesh.
May 9, 2019 | Press Association (In the Daily Mail)
The First Minister has been urged to intervene to help a woman who needs urgent surgery to prevent her from losing her bladder and bowel as a result of vaginal mesh. -
Mesigian Prolift Pelvic Mesh Trial Underway in Philadelphia
May 9, 2019 | Mesh Medical Device News Desk
By Jane Akre
The pelvic mesh trial of a Ms. Mesigian is currently underway in the Philadelphia Court of Common Pleas, which has seen a steady stream of plaintiff-friendly decisions amounting to hundreds of millions of dollars in this pelvic mesh litigation. -
Philly Jury Awards $120 Million in Transvaginal Mesh Lawsuit
May 9, 2019 | DrugWatch.com
By Michelle Llamas
A Philadelphia jury ordered Johnson & Johnson’s Ethicon unit to pay $120 million to Susan McFarland, a 68-year-old woman who said the company’s transvaginal mesh implant caused her pain, inability to have sex and chronic urinary tract infections, The Philadelphia Inquirer reported. -
Why are people protesting outside the Hilton today?
May 9, 2019 | Manchester Evening News
By Charlotte Dobson
Women whose lives have been ruined by vaginal mesh held a protest outside the Hilton hotel in Manchester. -
UCLH statement on mesh removal surgery
May 9, 2019 | University College London Hospitals
Until recently UCLH has had two teams working on mesh removal. One consists of a group of surgeons from urogynaecology, urology and colorectal services who form a multidisciplinary team (MDT) which is called the Urogynaecology and Pelvic Floor Unit.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Nicola Sturgeon urged to intervene to ensure vaginal mesh patient gets surgery
May 9, 2019 | The Sunday Post
By Katrine Bussey
The First Minister has been urged to intervene to help a woman who needs urgent surgery to prevent her from losing her bladder and bowel as a result of vaginal mesh.
Labour MSP Neil Findlay asked Nicola Sturgeon to step in and help Claire Daisley, telling MSPs the Greenock woman could lose the organs if she does not have a full mesh removal procedure carried out within the next two months.
Sharing her story in The Sunday Post last weekend, Ms Daisley appealed to health bosses to send her to the United States where specialist surgeons could remove the implant.
Ms Sturgeon said she would instruct Health Secretary Jeane Freeman to ensure that everything possible was being done “for that individual”.
The First Minister told him: “I will obviously not clinically intervene in any individual case but I will undertake to have the Health Secretary look into the case.”
She made the commitment after Mr Findlay raised the plight of women who have been left with debilitating medical problems after vaginal mesh was used to treat problems that resulted from pregnancy and childbirth.
The Lothian MSP said: “This week I have been contacted by constituents who are victims of mesh who do not want to be named.
“They have raised with me the issue of women being directed to so-called centres of excellence in Edinburgh and Glasgow for treatment, where many have received partial mesh removal, producing very poor and debilitating results.
“The belief is that clinicians at these centres do not have the required skill set to carry out full mesh removal using the latest techniques.”
He added: “One woman, who is not my constituent, who has broken her anonymity is Claire Daisley, who will lose her bowel and bladder if she doesn’t get a full mesh removal within the next two months.”
Pressing Ms Sturgeon at First Minister’s Questions, he continued: “Will the First Minister personally intervene in Claire’s case to ensure she gets the treatment she deserves and will she halt partial mesh removal at these centres until a full appraisal is carried out?”
As well as vowing to have the Health Secretary look into the case, Ms Sturgeon said the Scottish Government would help if any women wanted to speak to Ms Freeman about complications arising from the use of mesh in confidence.
The First Minister said: “I understand why some women would want to retain anonymity and privacy but if there are any individual women who Neil Findlay is aware of who want confidentially to speak to the Health Secretary or health officials we would be very happy and very keen to facilitate that on the assurance of protecting the privacy and anonymity of them.”
https://www.sundaypost.com/news/scottish-news/fm-urged-to-intervene-to-ensure-vaginal-mesh-patient-gets-surgery/
-
May 9, 2019 | Press Association (In the Daily Mail)
The First Minister has been urged to intervene to help a woman who needs urgent surgery to prevent her from losing her bladder and bowel as a result of vaginal mesh.
Labour MSP Neil Findlay asked Nicola Sturgeon to step in and help Claire Daisley, telling MSPs the Greenock woman could lose the organs if she does not have a full mesh removal procedure carried out within the next two months.
Ms Sturgeon said she would instruct Health Secretary Jeane Freeman to ensure that everything possible was being done “for that individual”.
The First Minister told him: “I will obviously not clinically intervene in any individual case but I will undertake to have the Health Secretary look into the case.”
She made the commitment after Mr Findlay raised the plight of women who have been left with debilitating medical problems after vaginal mesh was used to treat problems that resulted from pregnancy and childbirth.
The Lothian MSP said: “This week I have been contacted by constituents who are victims of mesh who do not want to be named.
“They have raised with me the issue of women being directed to so-called centres of excellence in Edinburgh and Glasgow for treatment, where many have received partial mesh removal, producing very poor and debilitating results.
“The belief is that clinicians at these centres do not have the required skill set to carry out full mesh removal using the latest techniques.”
He added: “One woman, who is not my constituent, who has broken her anonymity is Claire Daisley, who will lose her bowel and bladder if she doesn’t get a full mesh removal within the next two months.”
Pressing Ms Sturgeon at First Minister’s Questions, he continued: “Will the First Minister personally intervene in Claire’s case to ensure she gets the treatment she deserves and will she halt partial mesh removal at these centres until a full appraisal is carried out?”
As well as vowing to have the Health Secretary look into the case, Ms Sturgeon said the Scottish Government would help if any women wanted to speak to Ms Freeman about complications arising from the use of mesh in confidence.
The First Minister said: “I understand why some women would want to retain anonymity and privacy but if there are any individual women who Neil Findlay is aware of who want confidentially to speak to the Health Secretary or health officials we would be very happy and very keen to facilitate that on the assurance of protecting the privacy and anonymity of them.”
https://www.dailymail.co.uk/wires/pa/article-7010959/FM-urged-intervene-ensure-vaginal-mesh-patient-gets-surgery.html
-
Mesigian Prolift Pelvic Mesh Trial Underway in Philadelphia
May 9, 2019 | Mesh Medical Device News Desk
By Jane Akre
The pelvic mesh trial of a Ms. Mesigian is currently underway in the Philadelphia Court of Common Pleas, which has seen a steady stream of plaintiff-friendly decisions amounting to hundreds of millions of dollars in this pelvic mesh litigation.
The pelvic mesh case of Patricia and George Mesigian was filed in the Philadelphia court on February 5, 2014. Five years later, the Pennsylvania couple is currently having their day in court in this defective product case filed against Johnson & Johnson, its subsidiary Ethicon Women’s Health and Urology, Gynecare, and Secant medical, which sold mesh components. See Case ID: 140200399.
On or about September 25, 2008, Patricia Mesigian was implanted with a Gynecare Prolift during a surgical procedure by Dr. James Cosgrove at St. Francis Hospital in Wilmington, Delaware. She underwent the surgery to correct incontinence and pelvic organ prolapse.
In July of 2009 and again in September of 2013, she had corrective surgery to revise and/or remove the Prolift by Dr. James Cosgrove and Dr. Jose Maceda at St. Francis Hospital in Wilmington, Delaware and Chester/Crozer Hospital in Upland, Pa.
According to the Complaint – The plaintiff has “suffered permanent injury, will require future corrective surger(ies) and has experienced, and will continue to experience, significant mental and physical pain and suffering, financial or economic loss, including, not not limited to, obligations for medical services and expenses.”
Complications include irreversible injuries, dyspareunia, infection, mesh contraction, inflammation, scar tissue formation, organ perforation, pelvic floor damage, recurrent incontinence, and vaginal mesh erosion, says the Complaint.
The company knew of no way to remove the Prolift, even though it had a high failure rate and is one of the largest meshes in its family of products, yet it continued to mislead the medical community that their mesh were safe and effective, say lawyers for Mesigian.
Plaintiff law firm, Kline Specter has filed multiple counts – Negligence, failure to warn, defective manufacture and design, common law fraud, negligent misrepresentation, negligent infliction of emotional distress, breach of express warranty, breach of implied warranty, violation of consumer protection laws, gross negligence, and loss of consortium.
Mesigian is represented by Kila Baldwin, Charles Becker, Philip Pasquarello, Thomas Kline, and Michael Trunk, all of Kline Specter,
Butler Snow, Tucker Ellis, Drinker Biddle & Reath represent the defendant, J&J.Judge Daniel Anders received the case April 25, 2019.
Limit Destruction of Document Evidence says Defendant
Motions generally fly just before trial and that occurred in this case as well.
In a 109 page, April 1, 2019 filing, Reply of Defendant Ethicon and J&J Support of Defendants Motion in Limine No 5 to Exclude Evidence of PL Allegations of Spoliation, Ethicon calls evidence of the destruction of company documents in pending pelvic mesh litigation “highly prejudicial.”
That evidence is only allowed into court “where there is evidence of bad-faith destruction of materials that has interfered with an adversary’s ability to present his or her case.”
Ethicon wants the court to grant a motion in limine or limit and/or exclude any reference to allegations that Ethicon/ J&J destroyed documents that were on a pelvic mesh litigation hold, also known as spoliation.
Ethicon did not act willfully or intentionally, the defendant says.
In all, Ethicon destroyed more than 20,000 documents related to the development of the Prolift and other mesh devices, despite a preservation notice that was in effect for pelvic mesh litigation.
In the multidistrict litigation in West Virginia, Magistrate Judge Cheryl Eifert issued an 18-page opinion that rejected any sanctions based on spoliation, because the “evidence was negligent, not willful or deliberate.”
Ethicon claims that in September 24, 2009, a fire occurred inside the offsite facility destroying thousands of boxes including containing multi-center study research. See Doc #1022-4 under 2:12-md-02327.
In a March 26 letter from attorney Michael Trunk to Judge Arnold New, the plaintiffs note that defendants have omitted numerous examples of the destruction of documents that were relevant to this litigation.
“Ethicon either at best failed to preserve or at worst, knowingly destroyed, portions of the custodial files of several highly ranked employees, each of which undoubtedly contained pertinent information regarding the design and development of Ethicon’s transvaginal mesh devices.”
For its part, Ethicon requested the court follow the rulings in Emmet, Adkins, Beltz, Engleman, Carlino and Blockus pelvic mesh cases. Ethicon claims it had a procedure to review the legal files of departing employees and compare their electronic files against any Preservation Notices in effect,” according to James Mittenthal who worked for Ethicon.
However, due to “inadvertent oversight” electronic documents belonging to certain former employees that were subject to legal holds were not retained and neither were the hard drives. The motion blames the exiting employee who did not communicate to IT personnel that certain materials on the hard drive needed to be preserved.
On March 26, 2019 the Defendants Motion to exclude evidence of Spoliation was denied by Judge Arnold New.
The case of Dunfee v Ethicon is next in line in the Philadelphia court that has been seeing a steady stream of pelvic mesh cases tried since December 2015 t hat have yielded $266 million in verdicts for litigants.
Among those was the Emmett Prolift trial that concluded in January of this year where the jury reached a verdict of $41 million for the plaintiff.
https://www.meshmedicaldevicenewsdesk.com/mesigian-prolift-pelvic-mesh-trial-underway-in-philadelphia/
-
Philly Jury Awards $120 Million in Transvaginal Mesh Lawsuit
May 9, 2019 | DrugWatch.com
By Michelle Llamas
A Philadelphia jury ordered Johnson & Johnson’s Ethicon unit to pay $120 million to Susan McFarland, a 68-year-old woman who said the company’s transvaginal mesh implant caused her pain, inability to have sex and chronic urinary tract infections, The Philadelphia Inquirer reported.
The verdict includes $100 million in punitive damages intended to punish the company for especially harmful behavior.
“I’m so happy for Susan McFarland,” Tammy Jackson, a patient advocate and mesh survivor for over 12 years, told Drugwatch. “I believe the jury saw the truth about mesh. I hope other jurors do the same.”
McFarland received her TVT-O mesh implant in 2008. Most pelvic mesh implants are made of a plastic called polypropylene. They repair pelvic organ prolapse and treat stress urinary incontinence by providing support to weakened tissue.
According to McFarland’s lawsuit, the mesh eroded tissue in her pelvis and punctured her vagina. She had revision surgery to remove the mesh but continued to suffer complications.
This verdict is the largest pelvic mesh jury verdict against the company, Ethicon spokeswoman Mindy Tinsley told Bloomberg. She said the company would appeal.
Other manufacturers also face mesh lawsuits, but Ethicon has the most federal lawsuits pending against it with 10,415 cases. At one time, that number was 40,719, according to the U.S. Judicial Panel on Multidistrict Litigation.
On April 16, 2019, the FDA stopped all sales of pelvic mesh for prolapse because the agency could not “assure women that these devices were safe and effective long term,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in the agency’s press release.J&J to Pay $9.9 Million for Failing to Disclose Mesh Risks
In addition to individual mesh lawsuits, Johnson & Johnson also faces lawsuits from states that say the health care giant failed to disclose mesh risks.
Two days before Philadelphia jurors handed up the McFarland verdict, Johnson & Johnson had agreed to pay Washington state $9.9 million to avoid going to trial for “misrepresentations and failure to include serious risks in the instructions and marketing materials for surgical mesh devices,” according to the Washington State Office of the Attorney General.
Attorney General Bob Ferguson sued Johnson & Johnson in May 2016 on grounds that the company violated Washington’s Consumer Protection Act by failing to disclose mesh risks in materials for patients and doctors. According to Ferguson’s office, about 14,000 women in the state have had mesh implanted.
Johnson & Johnson Global Head of Medical Affairs Piet Hinoul said during a deposition that the company knew about the serious risks “from day 1” but did not inform patients of the risks.
Meanwhile, Tammy Jackson and fellow mesh sufferers in Kentucky helped Attorney General Andy Beshear file a similar lawsuit against Johnson & Johnson in 2016. California Attorney General Kamala D. Harris has also filed a lawsuit.
“Washington state’s attorney general did an amazing job getting $10 million for the ladies of Washington state. I hope more attorneys general do the same,” Jackson said. “I believe the truth about polypropylene mesh is coming to light.”
Ferguson has announced that the money from the settlement will go to help Washington women affected by mesh. Women can fill out a contact form on the state’s website for more information.
https://www.drugwatch.com/news/2019/05/09/philly-jury-awards-120-million-in-transvaginal-mesh-lawsuit/
-
Why are people protesting outside the Hilton today?
May 9, 2019 | Manchester Evening News
By Charlotte Dobson
Women whose lives have been ruined by vaginal mesh held a protest outside the Hilton hotel in Manchester.
Members of the 'Sling the Mesh' campaign health policy chiefs as they arrived for the The National Institute for Health and Care Excellence (NICE) annual conference on Thursday morning.
The protesters say they represent hundreds of women living with painful side effects of a procedure to treat incontinence or prolapse.
Some women have been left unable to walk, work or have sex after having the implants.
The campaign group are protesting against new NICE guidelines which they claim pave the way for future generations of women to be harmed.
Sling the Mesh want the Government to carry out a retrospective audit to track the outcome of every single woman who has had a mesh operation in the last two decades.
Joanne Lloyd, coordinator for the Sling the Mesh rally, said it would be 'morally wrong' for the NHS to carry on using mesh.
Speaking at the rally on Thursday, Joanne said: "We don't feel the guidelines issued in April were strong enough.
"We feel the mesh needs banning. We've all been injured by mesh and we're not going to happy until it's banned or used as a last resort.
"Personally, I had it fitted 15 years ago before having it removed last year. It has caused nerve injuries and even when it's been removed it leaves you damaged for life.
"We've got women in our group who are suicidal, their relationships have broken down or they've lost their jobs because they're unable to work.
"People have lost their homes, their quality of life and their hobbies. We're nearly all psychologically affected by it."
The use of vaginal mesh was halted across the UK last year amid safety concerns.
NICE said operations must be performed by specialist surgeons at specialist centres before their reintroduction.
All instances - and outcomes - of vaginal mesh operations should also be recorded on a national database "to help with future decision-making", it said.
The NHS is not compelled to act on the guidelines - which are for England only - and the "pause" on vaginal mesh surgery remains in place.
But services are expected to take NICE recommendations into account when planning and delivering care.
Some women at the rally spoke of being 'fobbed off' for years by doctors - despite complaining of pain and other debilitating side effects.
"So many women have been told it's all in their head by doctors', adds Joanne.
"We are women and some of this is down to misogyny. We do feel we've been gaslighted by a lot of men."
Jennifer Sigley, 43, is one of thousands of women who have had a vaginal mesh sling fitted to ease stress incontinence.
Before Jennifer had the procedure she enjoyed running half marathons and walking holidays in the Lake District with her family.
All that stopped when the implant moved and eroded, causing her pain she to a cheese wire cutting through her groin, vagina and bladder.
"I can't walk more than 50 feet without my stick now," explains Jennifer.
"I'm an office manager in Stockport and I'm on my feet all day and I have no other option but to carry on doing that.
"I would like doctors to understand the symptoms that women like us have.
"For ages I was sent to physio when all along the problem was being caused by the mesh."
Kath Sansom, of March, Cambridgeshire, founder of Sling The Mesh, said: "Today we are fighting for justice for every woman harmed by mesh and failed by the system.
"It has gone beyond institutional denial. It is institutional betrayal. The Government and NHS must step up to the mark and show proper leadership.
"First they said mesh was safe, then it wasn’t. Then they contradicted the head of their own independent inquiry by backing NICE guidelines which did nothing but muddy the water further. Then they robbed women of a vital life-line by suspending mesh removal surgeries.
"Working in partnership with Thompsons Solicitors, we’ve already written to every NHS Trust urging them to ignore NICE's recommendations to carry on using mesh or face legal action.
"This is to stem the tide of the crisis, and prevent further patients from being put at risk."
https://www.manchestereveningnews.co.uk/news/greater-manchester-news/people-protesting-outside-hilton-today-16248298
-
UCLH statement on mesh removal surgery
May 9, 2019 | University College London Hospitals
Until recently UCLH has had two teams working on mesh removal. One consists of a group of surgeons from urogynaecology, urology and colorectal services who form a multidisciplinary team (MDT) which is called the Urogynaecology and Pelvic Floor Unit. The other is Mrs Elneil who works as The Female Pelvic Medicine and Reconstructive Surgery Unit.The Urogynaecology and Pelvic Floor Unit recently obtained accreditation from the British Society of Urogynaecologists (BSUG). This unit offers a mesh removal service and its surgery lists have not been paused.
Mrs Elneil has a national reputation and is much sought after but her Unit has not received accreditation by BSUG. So UCLH has taken a decision to pause her mesh removal operations to help her manage her waiting list and to allow her the space and time to make the necessary improvements.
As a result she will be able to integrate her cases into the UCLH MDT process alongside the Urogynaecology and Pelvic Floor Unit, so that all surgical decisions are supported by UCLH's clinical governance, and so that she too can obtain BSUG accreditation.
This decision was not made lightly. It has affected 13 patients given provisional dates for surgery in May and we deeply regret the distress this has caused this group of patients who are living with a very difficult and complex condition. We have written to all of them offering them alternative options, including referral to one of the surgeons in the Urogynaecology and Pelvic Floor Unit qualified to carry out mesh removal.
Finally, UCLH is also trying to ensure that the service is in a good position to be selected as one of the new specialised services for women with complications of mesh inserted for urinary incontinence and vaginal prolapse.
This newly commissioned service will be out to tender shortly, and NHS England will be looking to commission between four and seven centres across the country. We very much want to be one of those centres.
https://www.uclh.nhs.uk/News/Pages/UCLHstatementonmeshremovalsurgery.aspx
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested