Preview Newsletter
Ethicon Media Monitoring 4/24/2017
-
Pa. Mesh Cases Won't Be Stayed For Jurisdiction Appeals
Apr 21, 2017 | Law 360
By Matt Fair
- A Pennsylvania state judge has rejected a bid by Boston Scientific Corp. and a Johnson & Johnson unit to use two pending U.S. Supreme Court appeals over jurisdictional issues to stay more than a hundred cases from out-of-state plaintiffs over injuries caused by allegedly defective pelvic mesh products. -
NHS and medical devices regulator tried to limit scandal over vaginal mesh implants
Apr 21, 2017 | The Guardian
By Denis Campbell and Carmen Fishwick
NHS bosses and the watchdog that oversees medical devices tried to limit public exposure of the scandal over vaginal mesh implants that have harmed hundreds of women. -
The NHS tried to DODGE media attention over the agonising vaginal mesh implants that left hundreds of women in constant excruciating pain
Apr 21, 2017 | The Daily Mail
By Alexandra Thompson
Minutes from an MHRA and NHS meeting show an agreement to 'take the press element out of' a campaign for women suffering complications from the device -
NHS bosses tried to 'avoid media attention' over women's vaginal mesh implants agony'
Apr 21, 2017 | Mirror
By Jane Kirby
The medical devices regulator and NHS England sought to "avoid media attention" on mesh implants, which have left women in debilitating pain, documents show. -
Advertising feature: Laparoscopy is offering an alternative in surgery to women suffering with pelvic problems
Apr 22, 2017 | The Herald
While so many women suffer in silence the discomfort and embarrassment of pelvic floor problems, others are seeking solutions; opting for the precision afforded through laparoscopy or key hole surgery, and avoiding the use of ‘mesh’.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Pa. Mesh Cases Won't Be Stayed For Jurisdiction Appeals
Apr 21, 2017 | Law 360
By Matt Fair
Law360, Lancaster, Pennsylvania (April 21, 2017, 2:39 PM EDT) -- A Pennsylvania state judge has rejected a bid by Boston Scientific Corp. and a Johnson & Johnson unit to use two pending U.S. Supreme Court appeals over jurisdictional issues to stay more than a hundred cases from out-of-state plaintiffs over injuries caused by allegedly defective pelvic mesh products.
Judge Arnold New in the Philadelphia County Court of Common Pleas issued an order on Tuesday rejecting arguments from BSC and Ethicon Inc. that the pending appeals, which center around personal jurisdiction over claims from out-of-state plaintiffs, could force the mesh cases out of Pennsylvania.
Judge New did not comment on the motions in his one-page order.
A spokeswoman for Ethicon told Law360 on Friday that the company respected the court's decision, while a representative from BSC did not immediately return a message seeking comment.
The companies had argued that decisions by the U.S. Supreme Court in BNSF Railway Co. v. Tyrell and Bristol-Myers Squibb Co. v. Superior Court of California could result in the Philadelphia County courts being unable to exercise jurisdiction over claims lodged by out-of-state plaintiffs.
The BNSF case, the first of the two jurisdiction-related appeals the justices announced in January that they would hear, centers around a Montana Supreme Court decision finding that the railroad company’s business operations in the state allowed two injured workers from out of state to bring claims there.
The Bristol-Myers case, which was accepted by the justices just days later, involves a California Supreme Court ruling that allowed almost 600 out-of-state residents to sue the drugmaker over alleged injuries from blood-thinner Plavix because of the company’s ties to the state.
Ethicon and BSC filed separate motions in the wake of the U.S. Supreme Court’s move to take up the appeals, claiming that the cases could impact whether the Philadelphia County courts, which established a mass tort program in February 2014 to handle a glut of mesh-related claims, could continue to exercise jurisdiction over out-of-state plaintiffs given the companies’ limited ties to the state.
Ethicon’s motion singled out 106 cases it’s facing from out-of-state plaintiffs, while BSC pointed to six cases from non-Pennsylvanians.
Two trials have already resulted in a pair of damage awards against Ethicon totaling some $26 million.
Ethicon is represented by Kenneth Murphy and Melissa Merk of Drinker Biddle & Reath LLP and Julie Callsen of Tucker Ellis LLP.
Boston Scientific is represented by Joseph Blum and Erin Loucks of Shook Hardy & Bacon LLP.
The plaintiffs are represented by Lee Balefsky and Michelle Tiger of Kline & Specter PC, Irene McLafferty of Messa & Associates, Laura Feldman of Feldman & Pinto PC, Clayton Clark of Clark Love & Houston, William Barfield of the Potts Law Firm, James Barger and Bryan Aylstock of Aylstock Witkin Kreis & Overholtz PLLC and Stefanie Colella-Walsh of Stark & Stark.
The case is In Re: Pelvic Mesh Litigation, case number 140200829, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
--Editing by Bruce Goldman.
Update: This story has been updated to include comment from Ethicon Inc.https://www.law360.com/articles/915669/pa-mesh-cases-won-t-be-stayed-for-jurisdiction-appeals
-
NHS and medical devices regulator tried to limit scandal over vaginal mesh implants
Apr 21, 2017 | The Guardian
By Denis Campbell and Carmen Fishwick
Minutes show NHS England and MHRA worked together to try to ‘avoid media attention’ of problems faced by women
NHS bosses and the watchdog that oversees medical devices tried to limit public exposure of the scandal over vaginal mesh implants that have harmed hundreds of women.
Minutes of a meeting held in October 2016 show that NHS England and the Medicines and Healthcare Products Regulatory Agency (MHRA) agreed to “avoid media attention” over the implants, despite the fact they were seeking to encourage patients to report any complications.More than 800 women sue NHS and manufacturers over vaginal mesh implants
Read more
The document, obtained by the Press Association, records an agreement to “take the press element out” of the “yellow card” campaign to record adverse reactions experienced by vaginal mesh patients, suggesting that it could be incorporated into a wider effort, “of which mesh is one element, to avoid media attention on mesh”.
The apparent cooperation between NHS England and the MHRA to minimise media focus on the debilitating problems increasingly associated with the implants appears to breach the NHS’s duty – reiterated regularly by the health secretary, Jeremy Hunt – to be open and transparent over patient safety failings.
NHS England and the Department of Health both refused to comment on the minutes of the meeting.
MHRA officials said the minutes were more than six months old and the conversation noted in them was one of many conversations held during one of many oversight meetings about the issue.
The campaign, when it begins, will aim to ensure that both women and healthcare professionals know that there is no time limit on reporting complications with mesh devices. It will include engagement with the media, officials stressed.
An MHRA spokeswoman said: “Patient safety is our highest priority and we are committed to help address the serious concerns raised by some patients. MHRA strongly encourages the reporting of issues related to all medical devices. When promoting reporting it is important to strike a balance between causing undue concern to patients who may benefit from a procedure and making sure they are aware of the potential complications.”
One possible reason for the NHS to want to limit exposure of the issue could be to reduce the number of potential lawsuits faced by the health service.
More than 800 women are suing the NHS and the manufacturers of the implants after suffering serious complications, it emerged this week. Some women reported that implants had cut into their vaginas, with one woman saying she was left in so much pain that she considered suicide. Others have been left unable to walk or have sex, according to the BBC.
Vaginal mesh implants are used to treat incontinence after childbirth or pelvic organ prolapse, where the womb or bladder bulge against the walls of the vagina. Between 2006 and 2016, more than 11,000 women in England were given the implants to treat prolapse or incontinence, NHS data shows.
About 11% to 12% of users have reported problems, while lawsuits in the US have already seen about $2bn (£1.5bn) paid to affected women.
Campaigners say that hundreds more women have come forward after learning of the group planning to sue.
Kath Sansom, who runs the campaigning website and Facebook group Sling the Mesh, says the number of women contacting her has risen from a few people a day to more than 200 in the past 24 hours.
“It’s always the same story,” she said. “There are so many women who were told it was just them, that they were a one-off. They can’t believe there are others out there. So many people are told it’s back pain, endometriosis, gall bladder pain, scar tissue. And so many of them accept it, you trust medical professionals.”
Data from the MHRA, which has been looking at the issue since 2011 after complaints from women, shows more than 1,000 adverse incidents have been reported in the past five years.
Despite the problems that have emerged the MHRA insists the best current evidence supports the continued use of the implants to resolve health conditions that could themselves cause serious distress to patients.
A report into the issue from a working party led by NHS England admits there is a huge lack of data on complications from the devices. Published studies on mesh implants do “not tell the whole story” and there are gaps in NHS knowledge about their safety, it added.
https://www.theguardian.com/society/2017/apr/21/nhs-vaginal-mesh-implants-scandal-suppress-media
-
Apr 21, 2017 | The Daily Mail
By Alexandra Thompson
Minutes from an MHRA and NHS meeting show an agreement to 'take the press element out of' a campaign for women suffering complications from the device
· A report by NHS England admitted a lack of understanding over their safety
· Kate Langley has been admitted to hospital 53 times to try and relieve the pain
· Since 2011, the MHRA has collected over 1,000 reports of complications
· Over 800 women are suing the NHS and mesh implant manufacturers
The NHS tried to dodge media attention over the vaginal mesh implants that left hundreds of women in agony.
The procedure cut into their vaginas and left many in discomfort so severe they have been left unable to work, walk or have sex.
It has now emerged the NHS actively sought to avoid courting headlines over the matter.
Minutes from an NHS meeting back in October show an agreement to 'take the press element out of' a campaign for women experiencing complications from the devices.
Over 800 women are suing the NHS and the implants' manufacturers, including Johnson & Johnson.
The meeting's minutes, seen by the Press Association, outline the Medicines & Healthcare products Regulatory Agency's (MHRA) yellow card campaign, which targets under-reporting of mesh complications.
Officials said they should 'look into taking the press element out of the mesh yellow card campaign' and 'investigate whether there can be a general yellow card campaign, of which mesh is one element, to avoid media attention on mesh'.
Between April 2007 and March 2015, over 92,000 women had vaginal mesh implants fitted in England. Of which, around one in 11 have experienced problems, according to NHS data from the Hospital Episodes Statistics.
An investigative report from a working party led by NHS England admits there is a huge lack of understanding over the devices' complications.
Since 2011, the MHRA has collected data showing over 1,000 reports of complications after the procedure.
A December 2015 interim report from the working group in England said the NHS is unable to collect accurate data on their use.
Yet, the report added there is an 'under-reporting' of complications to the MHRA
It said: 'Despite extensive efforts, the data and information group has found it difficult to gather information on mesh-related adverse incidents other than peer-reviewed publications in the medical literature, which the group feels does not tell the whole story with regard to adverse incidents.'
In a foreword to the report, Professor Keith Willett, medical director for acute care, NHS England, said: 'There is evidence that complications, when they do arise, can be very severe and life-altering.
'There is a lack of comprehensive data on complications, due to issues relating to data coding and incomplete data recording.
'This is coupled with a lack of data from safety reporting of adverse incidents and long-term population level surgical outcomes, meaning we do not currently know the true complication rates and cannot use data to gauge severity.'
Patients in England and Scotland have resigned from working groups set up to investigate the issue, describing them as a 'whitewash'.
Ann Bori, 61, from Lincolnshire, had a mesh implant in 2003 for incontinence but suffered debilitating pain when it 'eroded through' her urethra and 'destroyed it' eight years later.
She helps run the support group Sling The Mesh, which has 1,600 members.
Ms Bori said: 'I resigned because the group were not tackling the safety issue around mesh and were not willing to talk about it.
'They want to keep mesh on the market.'
Implant recipient Kate Langley has been admitted to hospital 53 times to try and relieve the pain.
Yet, the mesh is too close to her nerve to be completely removed, leaving her with nerve damage.
Ms Langley was forced to give up her childminder business because the pain left her unable to look after the children.
A spokeswoman for the MHRA said patient safety was its highest priority.
She said: 'MHRA strongly encourages the reporting of issues related to all medical devices.
'When promoting reporting, it is important to strike a balance between causing undue concern to patients who may benefit from a procedure and making sure they are aware of the potential complications.
'The evidence we have seen and continue to see is the greater proportion of the clinical community and patients support the use of these devices in the UK for treatment of the distressing conditions of incontinence and pelvic organ prolapse.
'We encourage anyone who suspects they have had a complication after having a mesh device implanted, to discuss this with their clinician and report to us via the Yellow Card scheme regardless of how long ago the implant was inserted.'
NHS England was unable to provide a comment.
http://www.dailymail.co.uk/health/article-4432344/The-NHS-tried-dodge-vaginal-mesh-implant-backlash.html
-
NHS bosses tried to 'avoid media attention' over women's vaginal mesh implants agony'
Apr 21, 2017 | Mirror
By Jane Kirby
The medical devices regulator and NHS England sought to "avoid media attention" on mesh implants, which have left women in debilitating pain, documents show.
Minutes from a meeting held between the Medicines and Healthcare products Regulatory Agency (MHRA) and NHS England officials in October show an agreement to "take the press element out of" a campaign for women reporting complications from the devices.
The document, seen by the Press Association, says officials should also "investigate whether there can be a general Yellow Card campaign, of which mesh is one element, to avoid media attention on mesh".
A report from a working party led by NHS England looking at the issue also admits there is a huge lack of data on complications from the devices.
It said published studies on mesh implants do "not tell the whole story" and there are NHS gaps in knowledge about their safety.
Hundreds of women are suing manufacturers and the NHS after suffering cuts, severe discomfort and inability to walk or have sex after having the implants.
Some 12% of users have reported problems, while lawsuits in the US have already seen around £2 billion paid out to affected women.
The implants are used to treat pelvic organ prolapse and incontinence after childbirth.
Data from the MHRA, which has been looking at the issue since 2011 following complaints from women, shows more than 1,000 adverse incidents have been reported in the past five years.
A December 2015 interim report from the working group in England said the NHS is unable to collect accurate data on their use.
It said: "The current coding does not allow the identification of the reason why the tape/mesh has been removed.
"If codes could be developed which indicate the type of removal and indicate the reason why, this would provide more information... about these procedures."
It said there was "under-reporting" of complications to the MHRA, adding: "Despite extensive efforts, the data and information group has found it difficult to gather information on mesh-related adverse incidents other than peer-reviewed publications in the medical literature which the group feels does not tell the whole story with regard to adverse incidents."
In a foreword to the report, Professor Keith Willett, NHS England's medical director for acute care, said: "There is evidence that complications, when they do arise, can be very severe and life-altering.
"There is a lack of comprehensive data on complications, due to issues relating to data coding and incomplete data recording.
"This is coupled with a lack of data from safety reporting of adverse incidents and long-term population level surgical outcomes, meaning we do not currently know the true complication rates and cannot use data to gauge severity."
A 2016 Lancet study from UK hospitals found 12% of women with a mesh implant for prolapse suffered a complication within two years.
It concluded: "Augmentation of a vaginal repair with mesh or graft material did not improve women's outcomes in terms of effectiveness, quality of life, adverse effects, or any other outcome in the short-term, but more than one in 10 women had a mesh complication."
It said longer-term follow-up on benefits or complications was "vital".
Patients in England and Scotland have resigned from working groups set up to look at the issue, describing them as a "whitewash".
Ann Bori, 61, from Lincolnshire, resigned from the England working group.
She had a mesh implant in 2003 for incontinence but suffered debilitating pain when it "eroded through" her urethra and "destroyed it" after eight years.
She helps run the support group Sling The Mesh, which has 1,600 members.
She said: "I resigned because the group were not tackling the safety issue around mesh and were not willing to talk about it.
"We were invited there so they were seen to be doing something but it was a lip service on their behalf for a pre-determined outcome. They want to keep mesh on the market."
A spokeswoman for the MHRA said patient safety was its highest priority.
She said: "MHRA strongly encourages the reporting of issues related to all medical devices.
"When promoting reporting, it is important to strike a balance between causing undue concern to patients who may benefit from a procedure and making sure they are aware of the potential complications.
"The evidence we have seen and continue to see is the greater proportion of the clinical community and patients support the use of these devices in the UK for treatment of the distressing conditions of incontinence and pelvic organ prolapse.
"We encourage anyone who suspects they have had a complication after having a mesh device implanted, to discuss this with their clinician and report to us via the Yellow Card scheme regardless of how long ago the implant was inserted."
NHS England said it was unable to provide a comment today.
http://www.mirror.co.uk/news/uk-news/nhs-bosses-tried-avoid-media-10270608
-
Apr 22, 2017 | The Herald
While so many women suffer in silence the discomfort and embarrassment of pelvic floor problems, others are seeking solutions; opting for the precision afforded through laparoscopy or key hole surgery, and avoiding the use of ‘mesh’.
Dr George Angus has been pioneering the technique of laparoscopic treatment for over 20 years, he believes that this minimally invasive surgery, not only offers a degree of precision unavailable through other techniques, but it works by returning the bodys’ tissue back to its native origin, giving longer lasting success.
“Unlike others that work from below the pelvic floor, key hole begins much higher up, ensuring that the native tissue is not just restored, it is repaired back into its normal position,” Dr Angus says.
This surgery is to use telescopes and instruments that are smaller than the diameter of your little finger. This means pain is reduced and time in hospital is as little as between 1 to 3 days.
“Most women feel great two weeks after surgery and there’s often a temptation to resume daily activities, while recovery is efficient, patients need to be sensible,”
While the surgery does pose some risk, patients can typically expect to resume to a normal lifestyle within 6 to 8 weeks, unless they have a rigorous routine which can take up to 10 weeks to return to.
With a success rate of between 95 to 98 per cent, Dr Angus says key hole techniques can give results for up to 15 years, with patients able to have more surgery if necessary in later years.
“The most important factor is to determine where and how many defects there are first, so that the treatment is the right treatment and carried out in the right area,”
The starting point for patients considering surgery is to first undergo a consultation with Dr Angus, where a 3-D, 4-D (dynamic) ultrasound is done to identify damaged areas.
“There’s little point in carrying out a procedure until we have seen the extent of the defects and using the dynamic ultrasound enables us to see, first hand, how the muscle performs when coughing for example,”
Once the ultrasound is complete, Dr Angus provides patients with details of recommended treatment to go away and consider and research.
“Not all instances will result in surgery. Some may be best starting with physiotherapy to train the muscles and improve symptoms. Women need to go away with information to digest, and to then make a decision to act on, or discuss further if need be.”
Dr Angus has been a practising Obstetrician/Gynaecologist for 20 years.
He is a graduate of The University of Sydney and completed his Specialty Training at Royal North Shore Hospital, U.K. and John Hunter Hospital.
http://www.theherald.com.au/story/4608642/laparoscopy-could-be-key/
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested