Preview Newsletter
Ethicon Media Monitoring 7/28/2017
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The vaginal mesh scandal is the 'new thalidomide' – so where is the outcry?
Jul 27, 2017 | The Independent
By Harriet Marsden
This week, the final report was published on the controversial use of vaginal mesh implants to treat incontinence and prolapse after childbirth. The report is, ultimately, a failure -
Women injured by mesh implants are furious at an NHS report that rejects calls for a ban
Jul 28, 2017 | Cambs Times
By Kath Sansom
A three year report into surgical mesh, that treats problems often caused by childbirth, has been slammed by an MP and branded a whitewash by women across the UK. -
Ethicon has favourable court ruling overturned for mesh devices
Jul 27, 2017 | Medical Plastics News
By Reece Armstrong
Johnson & Johnson subsidiary Ethicon has had its favourable court ruling overturned for a trial over its pelvic mesh devices. -
Despite Growing Lawsuits and Injuries, the Hernia Mesh Market is Expected to Grow
Jul 27, 2017 | The Ring of Fire Network
By KJ McElrath
As of July 17th, there were no fewer than 84 lawsuits pending against Johnson & Johnson subsidiary, Ethicon, Inc., citing injuries caused by its Physiomesh hernia repair products as the cause of action. That number represents an increase of nearly 20% over the previous month. -
Class action begins against maker of vaginal mesh implants
Jul 28, 2017 | Lexology
By Russell Kennedy
Shine Lawyers has commenced a class action against Johnson & Johnson Medical Pty Ltd and Ethicon in the Federal Court for faulty vaginal mesh implants which were used to treat weakened or damaged pelvic floor tissue. -
Philadelphia Mesh Verdicts Favoring Plaintiffs
Jul 27, 2017 | The Legal Examiner
By Roopal Luhana
In April 2017, a Philadelphia Court of Common Pleas jury awarded $20 million to a woman from Burlington County, New Jersey. The woman brought a lawsuit against Ethicon and parent company Johnson & Johnson (J&J), claiming that its transvaginal mesh product was defective and caused her to suffer serious injuries. This was the third consecutive case loss for the defendants in Philadelphia’s mass tort mesh litigation. -
Plaintiff's Expert's Opinions Trimmed Post-Remand in Mesh Litigation
Jul 27, 2017 | Mondaq
By Michelle Yeary
There is always a level of uncertainty when a case gets remanded from an MDL. New judge; new interpretations of prior rulings; new rulings
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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The vaginal mesh scandal is the 'new thalidomide' – so where is the outcry?
Jul 27, 2017 | The Independent
By Harriet Marsden
This week, the final report was published on the controversial use of vaginal mesh implants to treat incontinence and prolapse after childbirth. The report is, ultimately, a failure
The Mesh Oversight Group Report, in response to a 2015 interim paper and in conjunction with a March independent review in Scotland, came out this week – to address what’s being referred to by senior doctors as the most serious women’s health scandal since thalidomide: transvaginal mesh procedures.
And yet, barely a whisper in the headlines. And ultimately, a devastating blow to campaigners and victims. And a threatening precedent to women’s health in general.
The Mesh scandal
The transvaginal mesh implant (TVM) is a widely prescribed treatment for common complications following childbirth, such as urinary incontinence leaks with coughing or sneezing – or pelvic organ prolapse, where the internal organs can bulge into the vagina. A plastic mesh is blindly inserted into the vagina, or vaginal wall, with a set of hooks, and left there to support the womb. Functioning rather like a canvas grocery bag, and made of the same material that’s used to make drinks bottles.
According to a 2012 government report on concerns – and yes, this has been on the radar a long time – the procedure is performed on about 15,000 women in the UK per year. Side effects can range from chronic pain and loss of sexual function, to major complications like the implant protruding through the bladder, or bowels, even necessitating removal of organs ensnared in the mesh. It can shrink inside your body, slicing through nerve endings, tissue and organs.
The Medicines and Healthcare products Regulatory Agency (MHRA), the government medical devices watchdog, has received more than a thousand complaints, but continue to maintain that there is only a 1-2 per cent risk. But Professor Carl Heneghan, director of the Centre of Evidence Based Medicine (CEBM), tells me that the real number of re-admissions is closer to 19 per cent, depending on the procedure. Dr Sohier Elneil, a consultant in utogynaecology at University College Hospital, suggests that unpublished research by her team puts the number at 9 per cent re-admission, for meshes to treat incontinence. And that’s for serious complications alone.
Kath Samson, a journalist and campaigner, had the procedure to treat minor and occasional stress incontinence in 2015, and began suffering severe symptoms 10 weeks afterwards. She tells me that the procedure was marketed as “a very simple and quick fix, perfect for busy working mums to be back at their desks in a week, with the risks very much downplayed”. She tells me of the constant pain: in legs, feet, groin, bruising – and private parts “burning so badly it’s like someone has poured a bottle of chilli sauce inside it”.
“For some women,” she says, the mesh “literally slices clean through their vaginal walls – so not only does that hurt, but it cuts their partners during sex. Want to know what surgeons give to try and fix this? Ovestin cream – what a joke.”
Kath began to research the procedure, and stumbled upon a huge swathe of fellow victims. In response, she started the Sling the Mesh campaign, to try and raise awareness of the risks. At the moment, 500 patients in Britain are in legal action against mesh manufacturers, and up to 2,000 are planning to sue: particularly Johnson & Johnson, a high-profile manufacturer of the device.
In America, there are over 100,000 women currently in litigation. Over there, it’s been upgraded to a higher-risk device, after the FDA issued a public health notification on serious complicationsall the way back in 2008, citing that the hooks can cause injury to up to 40 per cent of women. Politicians in Scotland, including the former Scottish Health Minister, called for operations to be suspended all the way back in 2014. And yet, there were no such calls in England, Ireland or Wales.
There are around 100 different types of mesh implants are still available on the NHS; to date, not a single one has been recalled. MHRA has found “insufficient evidence” to justify a ban.
So the report: two years in the making; 10 years in the campaigning; eagerly awaited by politicians and medical professionals who called for a public inquiry, and desperately anticipated by thousands of women suffering chronic pain, serious physical and sexual complications, as well as loss of quality of life. And the official proclamation from the NHS on the use of “barbaric” transvaginal mesh on women – which offers no hint of change in medical policy, admittance of culpability or offering of apology.
In response to its publication, Labour MP Owen Smith has publicly stated that women will be “extremely disappointed by the outcomes of the final review, which seem to have made little progress since its interim report came out over a year ago. The only people pleased with this report will be the medical device companies who marketed mesh so diligently, and who now fear mass litigation.”
There are so many facets to this story: commercialisation of the medical device market that financially incentivises procedures, and poor regulation that allows untested devices on the market in the first place. Shame, stigma, sexism, and a lack of value on female sexuality – that the loss of sexual function for women isn’t even considered as a side effect. How was this allowed to happen?
The report effectively whitewashes the most important issue: the lack of proper knowledge of psychosexual side effects of vaginal surgeries in general – and the inherently misogynistic devaluation of a woman’s sexual fulfilment. Simply put: sexual damage to women is not really known about as a side effect of surgery; it's also not considered to be a serious one.
The Background
Professor Heneghan, also a GP and an expert in device regulation, explains how the mesh made it on to the market in the first place – without extensive trialling or long-term clinical data. The protogen was brought out in 1996, and approved with some short-term trialling. In 1998, serious concerns emerged, so they withdrew it from the market; however, during that two-year time period, several other similar devices had been already approved, which were not withdrawn.
To get a medical device approved you can go to any notifying body across Europe and be given Conformité Européenne (CE) accreditation. Once the device is approved in one EU member state, it’s automatically approved across all of them. The process also allows you to use the concept of ‘'substantial equivalence'’ – if your device is similar to others already on the market, you can get approval without clinical trial data – just a literature review of existing evidence, and some animal testing.
And unlike a drug approval, which requires a phase 1, 2, and 3 randomised human trial to establish benefits and harms, there is no such regulation for medical devices.
Any clinical trial data is short term – three to six months, usually. Not enough time for a proper investigation into the long-term gynaecological implications of surgical procedures.
And in fact, Professor Heneghan says, most of the clinical trials follow after the device has been on the market for some time. “It’s the loophole everybody’s missing,” he says. “These devices are used prior to establishing they’re safe, and that’s where there’s been a catastrophic and complete failing of device regulation.”
To prove this, in 2015 Professor Heneghan participated in an investigation with The Sunday Times: he produced a fake report for a Dutch journalist about the advantages of netting used as a surgical aid – the kind of netting used to carry oranges. They were told there would be ‘'no problem'’ getting it approved.
There’s also a lack of funding or availability for more appropriate non-surgical treatments, such as pelvic floor physiotherapy, which in France is a standard after women have babies. It’s estimated that these could help 60-80 per cent of women, who would then not have to endure more invasive surgical procedures. Dr Elneil, Kath Samson and all the gynaecologists I spoke to reported women being encouraged towards quick fixes like the mesh over more time-consuming, traditional procedures like the burch colposuspension or the autologous sling, which can take up to four hours, followed by a few nights’ stay in the hospital.
Ultimately, says Professor Heneghan: “It boils down to baseline profits for the big medical corporations. Commercialisation is a huge issue – the amount of money being made by individuals or companies. Most of these women are starting asymptomatic, with a small prolapse. These devices are costing thousands pounds.”
The report
In response to the report, the MHRA released this statement from John Wilkinson, director of devices: “In common with other medical device regulators worldwide, none of whom have removed these devices from the market, we are not aware of a robust body of evidence which would lead to the conclusion these devices are unsafe if used as intended.”
Not aware. Therein lies the crucial point that the report has missed: the lack of proper data for physical side effects. It uses evidence of rates from Hospital Episode Statistics, but the problem with using HES data is that if a woman has complications, and she goes to her GP but not the hospital, then she is not included in the stats. Many side effects which are reported, aren’t included in the report.
And what of those who were ignored? Women, such as the 100 that attended the parliamentary meeting on 18 July to discuss the issue, have spoken of “not being listened to” and feeling “consistently dismissed”. As Dr Elneil says: “There’s definitely a gender issue about it: a lot of women are just expected to carry on; many are told that it’s nothing serious.”
There are also potential conflicts of interests at play: some of the surgeons in some studies may have been paid by Johnson & Johnson with a research or fellowship grant. Other studies focus on the immediate success of operations, rather than on long-term effects. For many women, these procedures do work to treat prolapse or incontinence. As Samson says: “We’re not debating efficacy. But my God, it has some hideously catastrophic impacts on quality of life.”
And what of those side effects which aren’t reported? Shame, stigma, ignorance, lack of self-care or awareness of what’s normal...these are all issues surrounding women’s health in general, and the vagina in particular. Many women still feel too embarrassed to discuss sexual problems in any medical capacity, or even admit them to themselves.
Twenty years ago, speaking about incontinence and prolapse was taboo. “It’s only recently sexual function is something we discuss face to face on a regular basis,” says Dr Elneil: ”It’s the last of the taboos coming to the fore.”
“For women generally there’s a tendency – especially with issues regarding sexual function and the vaginal area – to be told to just get on with it. Think back to mothers and grandmothers – it was expected that you would have incontinence and prolapse when you have children, and you should just live with it.
“Also, there’s a tendency for women being busy people in life – they put themselves at the back of the queue. It’s usually their children first and husbands after that. Then they get to a certain stage in life when they feel their responsibilities for others have been addressed, and they can address their own issues. By that time, they will have suffered in silence for years. And there’s a thought that if there’s nothing horribly wrong, they’ll ignore it. More sinister like chronic discharge or bleeding will make them go to the doctor, but pain or discomfort during sexual intercourse – they’ll tend to forgo.”
It seems that the report shares this mentality. Nowhere on the included leaflet about improved guidelines is there any mention of the psychological side effects and damage to sex life that women can experience. But Samson tells me: “Half the women I spoke to [who had received a mesh] said they felt they been sexually neutered.”
Trialling on animals certainly wouldn’t have taken into account any effect on sexual fulfilment. A rabbit, sheep or dog can’t tell you that they’ve lost sexual function.
The other surgeries
This has far wider implications for vaginal and gynaecological surgeries. Mr Amer Raza, a consultant gynaecologist at the Lister Hospital, tells me: “In my experience, many women suffer with consequences of vaginal surgery (be there choice such as plastic surgery or unpreventable perineal tear in vaginal delivery) silently for a long time.”
Any operation, be that hymen repair procedures, episiotomies, or any other vaginal surgery, is associated with some post-operative pain. The problem is, any surgery in that area also has a psychological and anxiety-related relevance, which can result in long-term sexual dysfunction. That’s not a side effect that is ever discussed.
Memory of trauma to the area, even after the pain has worn off, has the potential to result in the serious condition of vaginismus - the involuntary tightening of the pelvic floor muscles as a result of psychological anxiety. It makes penetrative sex extremely painful, if not impossible. It’s thought that roughly two in 1,000 women suffer from the condition, which is notoriously difficult to treat, as a result of the combination of physical and psychological elements.
Sometimes, doctors prescribe botox injections into the vaginal walls: a short-term, little known process that is designed to temporarily weaken the vaginal walls, allowing the patient to break the cycle of anxiety and trauma and achieve penetrative sex, as well as plastic dilators and vaginal pessaries of anaesthetic gel, to numb the area. What’s not offered is psychosexual counselling to address the underlying psychological distress. Because it’s not available on the NHS.
Dr Elneil was part of the team that first developed the use of botox in the bladder for overactivity, where trials were able to show good efficacy and safety. “But for the use of botox in treating vaginismus,” she tells me, “there’s not much evidence to suggest it’s a good long-term therapy, and therefore more robust trials should be done.”
And what of episiotomies – slicing between the vagina and the anus, to aid childbirth? Delivery is high speed and panicked; any prior discussions of long-term side effects are, by default, unlikely. Mrs Pisal wonders: “Is loss of sexual pleasure considered an acceptable risk? Good question. I don’t think it is discussed well with patients as a long-term risk. I don’t think patients are well informed about what can result. There really isn’t much of a choice anyway – you either have to do an episiotomy, or a tear.”
And yet, many women suffer for decades following an episiotomy with chronic pain and sexual dissatisfaction.
And what about the psychological trauma of sexual dysfunction? Self-hate, shame, disgust, fear that a partner will never find you acceptable, fear of being unloved, trauma to relationships...the list goes on and on.
As Samson says: “It’s so embarrassing for a woman to talk about loss of sex life, and it’s almost as if medical professionals know that women will be too embarrassed to talk about it. Therefore, it can be massively downplayed within the risks. If there was the chance of a man losing their sex lives, there’d be absolute outrage.”
In 2017, is a women’s sexual fulfilment really such a minor consideration? If this really is a scandal on the scale of thalidomide, where’s the national outcry? When women don’t report side effects, or side effects go ignored, and those side effects aren’t offered as health risks, how can you say due diligence is being taken?
When the deregulation of the medical industry – and nobody knows what will happen in that respect after Brexit – combines with commercialisation and funding cuts; when lack of understanding of long-term side effects collides with lack of importance of a woman’s sexuality, all in the most delicate, complex, stigmatised part of a woman’s body – we enter into a maelstrom of shame and pain, in which only women bleed.
https://www.independent.co.uk/news/long_reads/transvaginal-mesh-vaginal-procedure-surgery-tvt-gynaecology-thalidomide-womens-health-psychology-a7862126.html
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Women injured by mesh implants are furious at an NHS report that rejects calls for a ban
Jul 28, 2017 | Cambs Times
By Kath Sansom
A three year report into surgical mesh, that treats problems often caused by childbirth, has been slammed by an MP and branded a whitewash by women across the UK.
The English Mesh report took three years to conclude that more reporting of mesh complications is needed and women and GPs need better information about risks of mesh - that is being labelled the biggest health scandal of our time.
MP Owen Smith, shadow Northern Ireland secretary, who this month set up an All Party Parliamentary Group into mesh, said: “Mesh-injured women will be deeply disappointed by the outcomes of the final NHS England review, which seems to have made little progress since its interim report came out over a year ago.
“This was an opportunity for the NHS to take a lead and recommend a pause in the use of mesh until we know precisely how many women have been adversely affected by the product.
“Instead, they appear content to allow mesh to be widely used despite growing, international concerns about its potential ill effects.
“The only people pleased with this report will be the medical device companies who marketed mesh so diligently and who now fear mass litigation.
“Many companies have already taken their mesh products off the market, that alone should tell us something is not right with these devices.”
Seven patient representatives were not invited to meetings for the last 18 months of the review and four of them resigned saying they were not listened to during the review.
A leading mesh removal surgeon was also not invited to any mesh meetings for the last 18 months.
Yet Professor Keith Willett, chairman of the review, said: “it is right and proper for those who deliver, lead and regulate health care to listen to patients concerns and work with all parties to resolve them.
“Our collective vision is that future patients recognise they have been part of a shared decision making process experience fewer complications and where complications do occur they are recognised and treated promptly.”
Jill Lott, a patient rep who resigned, said: “Much of what we said fell on deaf ears. The report has been a protracted waste of time and money.”
Teresa Hughes, who ran one of the UK’s first mesh support group, Meshies United, said: “We were treated disgustingly, no communication for months. The report says it is still using a database funded by mesh companies. Surgeons are still not recording adverse incidents. We need a National Register.”
Kath Pease, who runs TVT Info, resigned because: “I could see they were not interested in examining safety of these devices.”
Patient rep Ingrid Hardacre, said: “I was not listened to and all information I brought to the table was not accepted. This report has changed nothing, it is still pro mesh and patients will continued to be harmed by dangerous, blind mesh procedures.”
Pelvic mesh has been used in the NHS for 20 years yet across the globe it is causing concern for causing major life changing injuries for women.
Latest NHS England hospital figures show at least one in 11 women have complications - but in reality that figure will be higher as it only records the numbers of women who go into hospital to have a procedure such as mesh removal.
Kath Sansom, of campaign group Sling The Mesh, said: “They might as well park an ambulance at the bottom of a cliff and wait for women to fall in - they should have looked at product safety, not at ways to fix women once things have gone wrong.
“How can a major study of mesh not look at mesh safety. It is a whitewash. The NHS paid lip service to patient reps.
“Mesh implants are the only operation done blind, using large hooks to put in plastic that can then shrink, twist or degrade inside the body. “But nobody has explored that. When mesh goes wrong it is a personal tragedy for the woman and her family.
“Until there is a national register, nobody has a clue of how great this scandal is.”
David Golten, partner and head of litigation at law firm Wedlake Bell, leading a group legal action for Sling The Mesh, said: “The suffering of women affected by surgical mesh implants is immense.
“They live not only with life-changing pain, but they also have to accept they will never again be the people they once were.
“The emotional impact of that for them and their families is appalling, and all for an operation that was supposed to improve their quality of life.”
Surgeon Wael Agur said: “If we cannot obtain accurate figures on the true risks in real life, we cannot continue offering these procedures in the future.”
Jemima Williams of Welsh Mesh Survivors support group said: “This is the tip of a huge global iceberg that needs to be addressed now. Mesh should be suspended until an investigation is made into the adverse effects.”
Jackie Harvey of Northern Irish mesh support group, said: “Over 200 mesh-injured women in Northern Ireland have joined the local support group within the past four weeks.
“Heartbreaking stories of going to seek help with pain and infection only for many of them to be fobbed off or told they are the only one.” Scottish Mesh Survivors support group said: “Patients should not have had to campaign for years to highlight the suffering mesh implants have caused and to get basic safety measures in place. It is no longer acceptable for surgeons to assume that if a device has made it onto an NHS shelf it is safe.
“We have been let down badly by pro-mesh health professionals who cannot fix us when serious complications occur, and we have been let down by the MHRA who regurgitates the claim that the ‘benefit of mesh outweighs the risk’ without having necessary data to back up this up.
“We need the Government to step up to the mark and take responsibility for what is arguably the biggest health scandal ever and stop these procedures now.”
Professor Keith Willett, Medical Director for Acute Care at NHS England, who chaired the programme said: “We are now providing more consistent information to women and their clinicians, better care and support in the way of 18 self-declared centres with the specialist experience and skills to assess women suffering from distressing complications and making improvements to data collection which will in turn lead to greater evidence on the safety and efficiency of devices.
“I am reassured that this momentum will continue due to the commitment from NICE to update and develop further guidance related to the care of women with SUI and POP. ”
John Wilkinson, Director of Devices at MHRA, said: “Patient safety is our highest priority and we sympathise with women who have suffered complications after surgery.”
• BAUS surgeons conference video discusses mesh issues from 1.23.37
http://www.cambstimes.co.uk/news/women-injured-by-mesh-implants-are-furious-at-an-nhs-report-that-rejects-calls-for-a-ban-1-5125158
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Ethicon has favourable court ruling overturned for mesh devices
Jul 27, 2017 | Medical Plastics News
By Reece Armstrong
Johnson & Johnson subsidiary Ethicon has had its favourable court ruling overturned for a trial over its pelvic mesh devices.
In 2013 Ethicon was taken to court over its TVT-Secur mesh device by Kimberly Adkins. The court ruled favourably for Ethicon, stating that the device did not cause Adkins’ injuries, but it was defectively designed and the company failed to warn of its risks.
However, earlier this month judge Michael Erdos reversed the win for Ethicon, ordering the company to face damages on the defective design claim, MassDevice reported.
The trial was the first win for Ethicon and Johnson & Johnson in the Philadelphia court. Out of five trials Ethicon has lost four and was previously ordered to pay millions in punitive and compensatory damages.
A range of court cases have been levelled against Johnson & Johnson across the world. In Australiaover 700 women are claiming that the company’s vaginal mesh implant not adequately tested and that patients and surgeons were not warned of the risks.
In the UK, senior doctors have called for a public enquiry into the use of the devices after women met with MPs in Westminster earlier this month.
http://www.medicalplasticsnews.com/news/medical-devices/ethicon-has-favourable-court-ruling-overturned-for-mesh-devi/
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Despite Growing Lawsuits and Injuries, the Hernia Mesh Market is Expected to Grow
Jul 27, 2017 | The Ring of Fire Network
By KJ McElrath
As of July 17th, there were no fewer than 84 lawsuits pending against Johnson & Johnson subsidiary, Ethicon, Inc., citing injuries caused by its Physiomesh hernia repair products as the cause of action. That number represents an increase of nearly 20% over the previous month.
Despite this increase in litigation, the number of hernia repair surgeries using mesh devices has been growing – and this growth is projected to continue. According to recent market research, synthetic mesh products such as the Physiomesh are expected to lead this trend. Last year, synthetic meshes accounted for nearly 64% of global sales, largely because “incredible clinical acceptance from surgeons and the government” – and their lower costs. Over 46% of hernia repair mesh devices are sold in the U.S. and Canada.
While the price of hernia repair mesh may be relatively low, it has proven to be very costly to many patients in terms of their health and well-being. In some cases, that cost has been the patient’s life.
Last December, the U.S. Food & Drug Administration reported ten fatalities associated with the Ethicon Physiomesh device. Among the injuries attributed to hernia mesh are severe chronic pain, perforated organs, infections and complications caused by erosion of the mesh. Although Ethicon issued a recall for the Physiomesh in April 2016, many of these devices remain implanted in patients because of the difficulty in removing them.
The Ethicon Physiomesh received FDA approval in 2010 through the highly questionable510(k) Pre-market Clearance process. Over the next six years, there were an estimated 300,000 patients who wound up receiving the device before it was finally recalled. Significantly, Ethicon’s “urgent” Field Safety Notice fails to note any deaths or injuries resulting from the product. All it says is that “recurrence/reoperation rates…using ETHICON PHYSIOMESH™ Composite Mesh were higher than the average rates of the comparator set of meshes among patients” in two selected European registries. The company “believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors.”
According to plaintiffs, the problem lies with the defective design of the Physiomesh. Similar to the pelvic mesh that was the cause of action in previous litigation, the Physiomesh is made from synthetic woven, non-absorbable polypropylene plastic filaments, which is then coated with an absorbable film coating. According to Ethicon, the purpose of the film coating is to ease incorporation of the mesh into the patient’s tissues, thereby reducing the rate of inflammation.
Instead, it has had the opposite effect. According to the complaint, when the device is implanted into the patient,
“...the impermeable multi-layer coating of the Physiomesh prevents fluid escape, which leads to seroma formation, and which in turn can cause infection, abscess formation and other complications…[providing] a breeding ground for bacteria in which the bacteria cannot be eliminated by the body’s immune response, which allows infection to proliferate.”
The case will be heard in the Northern District of Georgia, with the Honorable Judge Richard Story presiding. An initial conference is scheduled for August 1st.
https://trofire.com/2017/07/27/despite-growing-lawsuits-injuries-hernia-mesh-market-expected-grow/
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Class action begins against maker of vaginal mesh implants
Jul 28, 2017 | Lexology
By Russell Kennedy
Shine Lawyers has commenced a class action against Johnson & Johnson Medical Pty Ltd and Ethicon in the Federal Court for faulty vaginal mesh implants which were used to treat weakened or damaged pelvic floor tissue.
It is claimed that the mesh implants were not fit for their purpose, were not of merchantable quality and were not safe. Many women are claiming that they have suffered organ perforation, incontinence, pain, infection, bleeding and erosion of the vaginal wall or into nearby organs.
More than 700 women have joined the Australian class action, which alleges that Johnson & Johnson failed to properly test the devices and then played down their risk to both surgeons and patients. No randomised controlled trials were conducted, and it is alleged the testing that was conducted was too short term. The class action also accuses Johnson & Johnson of embarking on an “aggressive marketing campaign” to sell the implants as a quick, easy, and therefore a lucrative alternative to treatment options, such as native tissue repair.
On 13 July 2012 the FDA issued an update advising of the serious complications associated with transvaginal mesh for pelvic organ prolapse. The Senate is also conducting an inquiry into pelvic mesh implants.
More information can be found here.
http://www.lexology.com/library/detail.aspx?g=1e4801e3-61ae-4216-9e57-69bf5d3eea1b
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Philadelphia Mesh Verdicts Favoring Plaintiffs
Jul 27, 2017 | The Legal Examiner
By Roopal Luhana
In April 2017, a Philadelphia Court of Common Pleas jury awarded $20 million to a woman from Burlington County, New Jersey. The woman brought a lawsuit against Ethicon and parent company Johnson & Johnson (J&J), claiming that its transvaginal mesh product was defective and caused her to suffer serious injuries. This was the third consecutive case loss for the defendants in Philadelphia’s mass tort mesh litigation.
More recently in June, another jury in the same mass tort litigation awarded a woman from Pen Argyl, Pennsylvania, $2.16 million in her Prolift mesh case. This was the fourth mesh case to go to trial in this court, and marks a trend in juries favoring plaintiffs’ arguments that these mesh devices were defectively designed, and that manufacturers failed to adequately warn patients and doctors about the risks associated with them.Plaintiff Receives Mesh Implant to Address SUI
The plaintiff in the third case claimed that she was implanted with the mesh device in 2007. She suffered from stress urinary incontinence (SUI) at the time and went through a surgical procedure that included implantation of the mesh.
SUI is a condition in which urine leaks during periods of abdominal pressure that can occur from by coughing, laughing, sneezing, or exercise. It’s the most common type of urinary incontinence in women and often happens due to weakened pelvic muscles and tissues that can no longer properly support the bladder and urethra. This weakness may be caused by multiple pregnancies and childbirths, aging, or prior pelvic surgery.
Mesh may be used during a surgical procedure to address SUI as it can help lift and support the urethra and/or the bladder in their proper positions. Procedures with surgical mesh are typically less invasive than procedures without it and result in faster recoveries. But recent reports have shown that in many cases, the mesh only makes things worse.Jury Agrees with Plaintiff that Device was Defectively Designed
The plaintiff claimed just one month following her surgery she started to experience problems. Her symptoms of SUI returned and she suffered from pain and discomfort. She went back to her doctor and learned the mesh had started to erode inside her and had to undergo several additional surgeries to repair the problem. Even after all the surgical procedures, some of the mesh still remains in her body.
The plaintiff described the whole experience as a “nightmare” and claimed that the mesh was defectively designed. A number of other plaintiffs have made similar claims, and Ethicon faces thousands of lawsuits related to these products.
In the fourth case, similar to the third, the plaintiff from Pen Argyl claimed that her Prolift mesh caused her to suffer from chronic vaginal pain and painful intercourse. She alleged that manufacturer Ethicon failed to provide adequate warnings about the risks associated with its product. The jury agreed and awarded her compensatory damages totaling $2.16 million.
Two other cases have gone to trial in this Philadelphia mass tort. The jurors found in favor of the plaintiffs in both. The manufacturers face over 180 lawsuits in the Philadelphia mass tort litigation and thousands more around the country.FDA Warns of Dangers of Transvaginal Mesh
In July 2011, the FDA released a safety update on transvaginal mesh, in which they stated that “serious complications associated with surgical mesh for transvaginal repair of POP (pelvic organ prolapse) are not rare.” They added that it wasn’t clear that repair with mesh was more effective than traditional repair without it, and that it may expose patients to more risks.
Mesh complications reported to the FDA include mesh erosion through the vagina, pain, infection, bleeding, pain during sexual intercourse, organ perforation, and urinary problems. On January 4, 2016, the FDA strengthened requirements for transvaginal mesh, requiring manufacturers to address safety concerns. They also reclassified these devices from class II, which includes moderate-risk devices, to class III, which includes high-risk devices.
http://pittsburgh.legalexaminer.com/medical-devices-implants/philadelphia-mesh-verdicts-favoring-plaintiffs/
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Plaintiff's Expert's Opinions Trimmed Post-Remand in Mesh Litigation
Jul 27, 2017 | Mondaq
By Michelle Yeary
This post is from the non-Reed Smith side of the blog.
There is always a level of uncertainty when a case gets remanded from an MDL. New judge; new interpretations of prior rulings; new rulings. It can be the cause of much anxiety on both sides. And the biggest question is – what's left to be done? That might seem simple. The case was remanded for trial. But cases rarely go back completely trial ready. Legal issues that turn more on state law are often left to the remand court to decide, as are case specific evidentiary decisions. There are also often questions as to whether a particular issue was raised in the MDL or not. If so, what was the ruling? If not, was it waived? So, there is definitely wiggle room for remand judges to imprint their reasoning and conclusions on a case. And where you've made progress in the MDL, you certainly don't want to lose momentum post-remand.
Which was likely the thinking of defendants in Walker v. Ethicon, Inc., 2017 U.S. Dist. LEXIS 112738 (ND IL Jun. 22, 2017) when faced with expert reports that went beyond the scope of what was deemed permissible by the MDL court in the mesh litigation. In this case, plaintiff served an expert report from Dr. Shull, a gynecologic surgeon. Dr. Shull had previously been challenged by defendants in the MDL but certain issues were reserved for the remand court. Certain issues had also been ruled on by the MDL court in the context of other cases and other experts – in defendants' favor. Defendant here asked the court to apply those rulings. Generally speaking the remand court found plaintiff offered no justification not to.
First up was the expert's opinion that different surgical procedures – ones not involving the use of the product — were safer alternatives to the defendant's mesh product. Id. at *5. In addition to the vast body of case law holding that non-use is not an "alternative design" for the product, the mesh MDL court had so held in another case. Id. The remand court agreed. The remand court also considered the impact of Illinois state law because Illinois does not require plaintiff to prove the existence of a safer alternative design, but such evidence may be relevant. Id. at *7. Plaintiff tried to argue that because a product could be found unreasonably dangerous without evidence of a safer alternative design, it follows that a product could be found unreasonably dangerous with evidence of a safer alternative regardless of whether that was a different design or a different surgical procedure. Id. But that disregards that what is relevant but not required under Illinois law is evidence of a safer alternative design. Plaintiffs offered no support for interpreting "safer alternative design" in Illinois any differently than any other state. Nor did they explain how the alternative procedure was relevant to any element of any of plaintiff's claims. Without relevance, the testimony was excluded. Id. at *8.
Next were the doctor's opinion on the duties of medical device manufacturers – testing, pharmacovigilance, and training. The court excluded them all. Defendants challenged the opinion on adequacy of research and testing of the product on both the relevance and the doctor's qualifications and competence. This is one of the topics on which the MDL court provided guidance but ultimately left the decision to the remand court. On relevance, the MDL court found it doubtful, but was willing to leave the call to the trial court based on nuances in state law. Id. at *10. Pertinent to defendants' motion, the MDL court had also ruled that an expert "may not offer testimony that is solely a conduit for corporate information." Id. On the qualification challenges, the MDL court did not exclude an expert on those grounds if the request for exclusion did not provide "specific content or context." Id. at *11.
Applying those rulings to the specific case, the remand court found that defendants had properly challenged Dr. Shull's qualifications with enough specificity and so that challenge was not denied, but reserved for the remand court. Id. So, on qualifications, Dr. Shull "is not qualified to testify regarding the standard of care for medical device testing." Id. at *13. Plaintiffs, however, argued that they were only offering testimony from Dr. Shull regarding what testing defendants did or did not do – the extent of the testing rather than its adequacy. Id. at *12. The court took that as a concession, but went on to exclude that testimony as well. That is information found in company documents – don't need the expert for that. Id.
Plaintiffs also wanted Dr. Shull to testify about how the defendants monitored adverse events. They claimed he was not offering an opinion as to what systems defendants should have been using just that what they were doing was "woefully inadequate." The court found this was a "distinction without a difference." Id. at *14-15. Dr. Shull's experience as a surgeon does not give him the expertise to testify on the standard of care for adverse event reporting. Id. at *15. And, again if he planned to talk generally about adverse events, that's company documents and not an area for expert testimony.
Finally, Dr. Shull's report included an opinion on whether defendants appropriately trained physicians. On this point, the MDL court had already ruled that Dr. Shull could not testify about what should or should not be included in the Instructions for Use for the product – and that covers training of physicians. Dr. Shull could testify to the risks of the product and whether such risks were included in the product materials. Id. at *16. That's it.
We're not sure what remains in Dr. Shull's report, but we certainly agree that the above portions were appropriately trimmed away.
This article is presented for informational purposes only and is not intended to constitute legal advice
http://www.mondaq.com/unitedstates/x/614708/trials+appeals+compensation/Plaintiffs+Experts+Opinions+Trimmed+PostRemand+in+Mesh+Litigation
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