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Ethicon Media Monitoring 7/26/2017
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Judge Reverses J&J's Win In Philly Pelvic Mesh Mass Tort
Jul 25, 2017 | Law 360
By Dan Packel
A Pennsylvania state court judge has overturned part of a jury verdict that gave Johnson & Johnson its first win in five pelvic mesh trials in Philadelphia, ordering the company to face damages from allegations that an implant was defectively designed. -
Consolidated Trials Drawing Fire From Defense as Unfair
Jul 26, 2017 | The National Law Journal
By Amanda Bronstad
In a trial involving four women suing over an allegedly defective transvaginal mesh device, a Miami jury was faced with an assortment of claims. -
Pennsylvania Transvaginal Mesh Plaintiff Says Johnson & Johnson Verdict Was Inconsistent with Evidence, Wins Damages Hearing
Jul 26, 2017 | RX Injury Help
By Laurie Villanueva
A transvaginal mesh lawsuit plaintiff has been granted a damages hearing, less than two months after the Pennsylvania jury hearing her claim returned a verdict for Johnson & Johnson and its Ethicon, Inc. -
Vaginal implants: Report recommends recording complications
Jul 25, 2017 | BBC
An NHS England report on vaginal mesh implants has recommended better support and communication between patients and doctors over the devices. -
Women damaged by surgical mesh to treat incontinence are furious at report rejecting calls for a ban
Jul 26, 2017 | The Daily Mail
By Lois Rogers
Women damaged by surgical mesh used to treat post-childbirth incontinence have reacted with fury to a Government report investigating the problem. -
‘So many women are being left traumatised by these implants’
Jul 25, 2017 | Banbridge Leader
A Banbridge woman who suffered 12 years of pain after having a vaginal mesh implant fitted is leading the fight for a moratorium on the use of the devices in Northern Ireland.
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Judge Reverses J&J's Win In Philly Pelvic Mesh Mass Tort
Jul 25, 2017 | Law 360
By Dan Packel
Law360, Philadelphia (July 25, 2017, 3:28 PM EDT) -- A Pennsylvania state court judge has overturned part of a jury verdict that gave Johnson & Johnson its first win in five pelvic mesh trials in Philadelphia, ordering the company to face damages from allegations that an implant was defectively designed.
Philadelphia Court of Common Pleas Judge Michael Erdos on July 19 ruled in favor of plaintiff Kimberly Adkins on one facet of her post-trial motions. Adkins had contended the jury had been inconsistent in its conclusion that while the mesh she received was defectively designed, it was not the cause of injuries that were acknowledged by both sides.
“We are grateful that the court recognized this inconsistency and ordered a new trial on damages so that justice could be served and an appropriate amount [of] damages awarded to Ms. Adkins for her injuries and for JNJ’s malicious conduct in putting these defective mesh products on the market,” her attorney, Bryan Aylstock, said in an email.
The judge did not issue an opinion outlining his reasoning for the reversal.
Jurors in the trial that concluded in June agreed that J&J subsidiary Ethicon Inc. had defectively designed its so-called TVT Secur pelvic mesh, which Adkins was implanted with in July 2010 to treat her urinary stress incontinence, and had failed to provide adequate warnings about its risks. But they declined to back claims that the Ohio resident had suffered any injuries as a result of the implant.
Adkins argued in post-trial motions that three doctors who testified in the case — her treating physician, a plaintiff’s expert and a defense expert — all acknowledged that the mesh caused injuries including bleeding during sex and that, as a consequence, it needed to be removed.
Adkins filed suit in July 2013 seeking damages after a portion of the TVT Secur implant eroded into her vaginal canal, causing significant pain. The mesh erosion resulted in her undergoing surgery to remove a portion of the implant in September 2012.
After the trial, Adkins also argued that the jury’s finding that her implanting physician had been properly warned about the risks of the product should be set aside. She said that the jury ruling that the mesh implant did not cause her injuries precluded them from finding there was a failure to warn.
But Judge Erdos stopped short of reversing that ruling. Nor did he assent to overturn the results of the trial on the grounds that one of the jurors worked with polypropylene mesh in her position as a medical engineer for GlaxoSmithKline.
Ethicon’s victory at the trial came after losses in four prior mesh-related cases dating back to December 2015 that have left the company facing nearly $50 million in damages.
"At trial, the jury decided in favor of Ethicon and determined that the company’s product did not cause the plaintiff’s injuries. We are considering our next legal options in this case in light of this decision," Ethicon spokeswoman Kirstin Wallace said in an email. "We empathize with women suffering from stress urinary incontinence, which can be a serious and debilitating condition. 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."
Adkins is represented by Bryan Aylstock, Daniel Thornburgh and James Barger of Aylstock Witkin Kreis & Overholtz PLLC; Benjamin Anderson of Anderson Law Offices; and Lee Balefsky, Christopher Gomez and Christine Clarke of Kline & Specter PC.
Ethicon is represented by Kimberly Bueno of Scott Douglass & McConnico LLP; William Gage, Chad Hutchinson and Jordan Walker of Butler Snow LLP; and Kenneth Murphy, Melissa Merk and Andrew Reeve of Drinker Biddle & Reath LLP.
The case is Kimberly Adkins v. Ethicon Inc. et al., case number 130700919, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
--Additional reporting by Matt Fair. Editing by Alyssa Miller.https://www.law360.com/lifesciences/articles/947908/judge-reverses-j-j-s-win-in-philly-pelvic-mesh-mass-tort
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Consolidated Trials Drawing Fire From Defense as Unfair
Jul 26, 2017 | The National Law Journal
By Amanda Bronstad
In a trial involving four women suing over an allegedly defective transvaginal mesh device, a Miami jury was faced with an assortment of claims. Some of the women felt like they had a ball between their legs. Some had pain during sex, while others didn't. They all went to different doctors, at different times, for different surgeries. But the jury's verdict showed little difference. Each woman got more than $6.5 million.
Access to full text unavailable – subscription required. For full story: http://www.nationallawjournal.com/id=1202793913228/Consolidated-Trials-Drawing-Fire-From-Defense-as-Unfair?slreturn=20170626020506
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Jul 26, 2017 | RX Injury Help
By Laurie Villanueva
Laurie Villanueva is an attorney with Bernstein Liebhard LLP
A transvaginal mesh lawsuit plaintiff has been granted a damages hearing, less than two months after the Pennsylvania jury hearing her claim returned a verdict for Johnson & Johnson and its Ethicon, Inc. subsidiary.Jury Finds Ethicon TVT-Secur Mesh Defectively Designed
Kimberly Adkins’ complaint was among dozens filed against Johnson & Johnson and Ethicon in a mass tort program currently underway in the Philadelphia Court of Common Pleas. The Ohio woman was implanted with Ethicon’s TVT-Secur mesh to treat stress urinary incontinence in July 2010, and claims that the device eroded into her vagina, resulting in chronic pain.
Her case was the fifth Ethicion pelvic mesh lawsuit to go to trial in Philadelphia. Jurors returned a verdict for the defense on June 9th, after concluding that TVT-Secur was not responsible for Adkins’ injuries. However, they did find that the device was defectively designed and agreed that Ethicon had failed to warn doctors and patients about its potential risks.
The verdict was the first time a Pennsylvania jury had found in favor of Johnson & Johnson and Ethicon in a transvaginal mesh lawsuit. The companies had been ordered to pay damages of $2.16 million, $12.5 million, $13.5 million and $20 million at the conclusion of four previous Philadelphia trials.
Adkins filed a post-trial motion for a damages hearing on June 19th, arguing that the jury’s findings were inconsistent.
“Even if the jury disbelieved plaintiff’s testimony, found the testimony inconsistent or concluded plaintiff was exaggerating her injuries, the jury was not free to reject the undisputed consensus of both sides’ experts and the treating physician that plaintiff suffered some injury from the implantation of mesh,” the motion said.
According to The Legal Intelligencer, Philadelphia Court of Common Pleas Judge Michael Erdos granted Adkins’ motion last week.Transvaginal Mesh Warnings & Litigation
Transvaginal mesh implants are intended to treat women suffering from pelvic organ prolapse and stress urinary incontinence. However, reports linking the devices to thousands of serious injuries and complications have prompted the U.S. Food & Drug Administration (FDA) to issue several warnings regarding their use. In fact, the agency no longer considers complications associated with transvaginal prolapse repair to be rare, and has expressed doubts that these devices offer any additional benefits over traditional, non-mesh methods of prolapse repair.
In 2012, Ethicon announced it would end sales of TVT-Secur mesh and three other transvaginal mesh devices, citing commercial concerns rather than safety reasons. However, the FDA had previously ordered Ethicon and other vaginal mesh manufacturers to conduct further research into the risks associated with their products.
More than 54,000 women are currently pursuing transvaginal mesh lawsuits against Johnson & Johnson and Ethicon in courts nationwide. Tens of thousands of additional cases have been filed against Boston Scientific Corp., C.R. Bard, Inc., and other device makers.
http://www.rxinjuryhelp.com/news/2017/07/25/pennsylvania-transvaginal-mesh-plaintiff-says-johnson-johnson-verdict-was-inconsistent-with-evidence-wins-damages-hearing/
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Vaginal implants: Report recommends recording complications
Jul 25, 2017 | BBC
An NHS England report on vaginal mesh implants has recommended better support and communication between patients and doctors over the devices.
The Mesh Oversight Group report also said complications caused by the implants should be recorded so that experts fully understood the risks.
Vaginal mesh implants are used to treat stress urinary incontinence and pelvic organ prolapse.
But some women said they left them in permanent pain and unable to walk.
The research - seen exclusively by the BBC's Victoria Derbyshire programme - aims to address concerns over the use of mesh devices.
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Prof Keith Willett, who wrote the foreword to the report, said it contained three key recommendations:Improving patient-doctor consultation, so patients have a better understanding of what they are signing up toThe provision of specialist units for advice if clinical problems occur subsequentlyRecording incidences of complications to help the Medicines and Healthcare products Regulatory Agency (MHRA) understand the risks.
The report says: "Adverse events involving mesh as a medical device must be reported and clinicians must bear this responsibility."
It also says surgeons undertaking surgery for stress urinary incontinence "must be able to demonstrate they are performing these operations regularly".
It says that where a mesh is being used to treat pelvic organ prolapse "this should not be offered routinely for the first surgical intervention".'Safe' for majority
The plastic meshes are made of polypropylene - a material also used to make certain drinks bottles - and are manufactured by many different companies.
They are used to ease incontinence and to support organs such as the vagina, uterus, bowel, bladder or urethra which have prolapsed after childbirth.
The MHRA says, for the majority of women, the use of vaginal mesh implants is safe and effective.
But some can cut into the vagina, causing severe discomfort.
Currently in the UK, there are around 100 types of vaginal mesh implants.
http://www.bbc.com/news/health-40709784
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Women damaged by surgical mesh to treat incontinence are furious at report rejecting calls for a ban
Jul 26, 2017 | The Daily Mail
By Lois Rogers
· At least 7,800 women say they’ve suffered lacerations and nerve damage because the mesh has broken into tiny fragments
· The report, which is the result of a three-year investigation by NHS England, confirms many more women have complained of injuries than suggested
· But it did not look at the safety of the mesh and rejects calls for a ban
Women damaged by surgical mesh used to treat post-childbirth incontinence have reacted with fury to a Government report investigating the problem.
At least 7,800 women say they’ve suffered lacerations and nerve damage because the mesh has broken into tiny fragments.
The report, which is unpublished but has been seen by Good Health, is the result of a three-year investigation by NHS England. It confirms that many more women have complained of injuries than previously suggested and calls for a helpline to support victims.
But it did not look at the safety of the mesh and rejects calls for a ban. Instead, it says hospitals should ensure that surgeons be trained to implant it; at the moment any gynaecologist can perform the procedure.
The report stops short of demanding a register of all implant operations, which injured women had called for, but suggests women use the ‘yellow card’ reporting system, used by the Medicines and Healthcare Regulatory Agency (MHRA), where patients and doctors can report reactions to treatments.
‘More independent rigour [needs to be] brought to discussions,’ says the report.
Campaigners are furious about the report’s tenor and findings.
‘All the doctors I’ve seen think this material should be banned,’ says Teresa Hughes, 66, who has been battling for recognition of the injuries she suffered after she had the mesh implanted in 2006.
‘We wanted a proper register of how many meshes were implanted, how many were removed and mandatory reporting of problems to get a scale of the problem.
‘This inquiry and the way we have been dealt with has been utterly disgraceful, and whitewash is the only word for this report.’
Teresa, a former auditor and mother of two from St Helens, Lancashire, has had surgery to retrieve the mesh shards that penetrated her bladder, urethra and surrounding tissues.
‘A lot of it is still there,’ she says. ‘I can hardly walk because of nerve damage. I have pains shooting down my legs. There are so many women like me, yet surgeons continue to use this stuff.’
Teresa is one of seven representatives from victims’ groups invited to give evidence to the NHS-led Mesh Oversight Group, which produced the new report. The year after the group was formed in July 2014, the representatives and a number of doctors involved stopped receiving invitations to meetings and received no further communication from the group.
The mesh, introduced 20 years ago, was promoted as a quick, cheap alternative to complex surgery for incontinence and which did not require specialist training to implant. More than 10,000 women a year have the mesh procedure. This week the MHRA insisted the mesh is safe, despite its use being recently suspended in Scotland, pending a ‘review of a review’ of the safety concerns.
Suzy Elneil, a urogynaecologist who specialises in removing mesh fragments, was invited to join the inquiry but was dropped from the committee 18 months ago.
‘I had no idea until now the meetings were even continuing,’ she told Good Health. ‘I think they [the NHS and the MHRA] think this is a problem that will go away.
‘They insist the complications are only 1 to 3 per cent, but that’s ignoring data showing complications averaging up to 40 per cent in some studies.’
Kath Sansom, of the campaign group Sling the Mesh, said she had questioned the complication rate cited by the Department of Health. ‘They ignored their own evidence showing 14 to 15 per cent of women couldn’t have sex after having this tape inserted.’
Meanwhile campaigners have raised questions about potential conflicts of interest affecting the Mesh Oversight Group.
A database of implants run via the British Society of Urogynaecology who have been involved in the inquiry, was funded by manufacturers and was reported to have recorded only 27 per cent of operations.
British Association of Urological Surgeons (BAUS) events also receive funding from manufacturers and Roland Morley, a former BAUS chairman who has been on the Mesh Oversight Group, has had research funded by mesh manufacturers.
‘I make every effort not to be influenced,’ he said. ‘I have never knowingly been influenced in the use of any surgical appliance.’
Campaigners believe fear of litigation means the NHS will be reluctant to take further action.
Catherine Lee, 43, a former university lecturer from Hebden Bridge, West Yorkshire, is disabled following a mesh operation a year after the birth of her son Charlie, now nine. Last week she received £375,000 compensation from Calderdale and Huddersfield NHS Foundation Trust, the first in the country to receive such a payout.
Suzy Elneil believes this will open the floodgates for more claims: ‘Even if the NHS delays the litigation by continuing to deny there’s a problem, the claims are still going to come in.’
http://www.dailymail.co.uk/health/article-4726704/Women-damaged-surgical-mesh-furious-report.html#ixzz4npSnCAUF
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‘So many women are being left traumatised by these implants’
Jul 25, 2017 | Banbridge Leader
A Banbridge woman who suffered 12 years of pain after having a vaginal mesh implant fitted is leading the fight for a moratorium on the use of the devices in Northern Ireland.
Drawing on her own painful experience, Jackie Harvey has set up an online support group to offer help and advice to local women about mesh implants, and raise awareness about the complications associated with them.
The implants are used by surgeons in an operation to treat pelvic organ prolapse and urinary incontinence, which can be common after childbirth. But following reports of many women being left in agonising pain, there have been calls for the procedure to be banned, or at least suspended until the long-term safety of the implants can be evaluated.
At the age of 36, a gynaecologist recommended that Jackie have a vaginal mesh implant fitted as a way of alleviating the urinary incontinence problem she’d been left with after having her second child.
In March 2005 she underwent surgery and it worked well. She recovered quickly, but unfortunately the plastic implant soon started to cause her problems.
“After a year or two I noticed the tops of my legs were getting really painful and stiff and I just thought I must be getting old, though I was only 38 at the time,” she explained
“I went to doctors various times about the pain in my legs and got x-rays, but they didn’t really show anything. In 2009 I stopped doing any sort of impact exercise. I couldn’t run. I couldn’t really walk very far without getting pain in my legs, my feet and hips. I kept going back to the doctor and nothing was showing. In 2013 I was really struggling and I went to rheumatologist who told me that I didn’t have arthritis. I went to an orthopaedic consultant who told me he couldn’t see anything wrong with me. And then by 2015 I had seen an article online where a woman called Kath Sansom had started a campaign group called ‘Sling The Mesh’ and she was suffering from very similar complications to me, and it was just like a lightbulb going off in my head - this was 10 years after I’d had it put in.”
Jackie, who claims she wasn’t told about the risks so couldn’t make an informed decision about getting the implant, says the pain she suffered as a result of the device ruined 12 years of her life.
Jackie, who claims she wasn’t told about the risks so couldn’t make an informed decision about getting the implant, says the pain she suffered as a result of the device ruined 12 years of her life.
“It had a really detrimental impact on my life. I was struggling to walk and I was in pain and exhausted every single day of my life. I felt about 90. I was stiff, sore and I just felt ill. For me to go to a doctor and my issues not to be recognised or accepted was just horrendous.”
Jackie was referred to a gynaecologist who told her the implant wasn’t causing her problems, but she refused to accept that was the case. She decided she had no other option but to challenge the doctor’s findings, and eventually had to pay for specialist treatment in England.
The 49-year-old office worker had a scan in London which showed that her implant was in the wrong place and was causing her pain. She finally underwent surgery at a hospital in Oxford in March this year to have her mesh removed.
“As soon as I woke up the difference was amazing,” she said. “I’m still not perfect, but I’m an awful lot better than I was.”
Through the UK-wide ‘Sling The Mesh’ group, Jackie heard many stories of women from Northern Ireland who are suffering similar problems to those she experienced. So, in a bid to help them, she decided to set up her own local support group on Facebook, and it already has around 200 members.
“This is a repeated story across the UK, not just in Northern Ireland,” she continued. “These ladies are going to their surgeons and they are being told ‘It’s not the mesh that’s causing your problems’, or ‘It’s all in your head’. It’s almost like they’re reading off a script.
“These women are in pain, some of them are constantly getting infections, others are on antibiotics every day.
“Their lives are a misery, they have no sex lives, their marriages have broken down, some have lost their jobs, they can’t enjoy their life, it’s just horrendous. That’s what spurred me on to push for some sort of recognition that there is an issue in Northern Ireland and something has to be done.”
While the NHS says “the majority of women treated with mesh respond well to the treatment”, it acknowledges that “the Medicines & Healthcare products Regulatory Agency (MHRA) has received reports of complications associated with vaginal meshes - mostly regarding persistent pain, sexual problems, mesh exposure through vaginal tissues and occasionally injury to nearby organs, such as the bladder or bowel.”
Jackie, who was the first woman to report her implant to the Northern Ireland Adverse Incident Centre at Stormont, is campaigning for the use of vaginal mesh implants to be suspended.
“In Scotland there was a moratorium put on the use of mesh in 2014, by the Scottish government, and it doesn’t make sense that in the rest of the UK women aren’t afforded the same protection,” she said.
“We want the use of mesh suspended whilst there is a review ongoing. We want the same protection that they have in Scotland. We also want a national register to register how many mesh complications there actually are.
“So many women are being left traumatised by this. They are going to doctors for help and are just basically being fobbed off. It’s appalling. I hear the same story day in, day out from women looking for help and there’s nobody there to help them. Where do these women go for help? They are being left on the scrapheap and that’s just heartbreaking.”
Jackie is urging women who need help and advice about vaginal mesh implants to contact her via her Facebook page ‘TVT(O) POP Mesh Problems N Ireland’ or by email: meshgirlni@icloud.com
http://www.banbridgeleader.co.uk/news/so-many-women-are-being-left-traumatised-by-these-implants-1-8070613
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