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Ethicon Media Monitoring 4/11/2019
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Pa. Justices To Mull Standing For Out-Of-State Mesh Patients
Apr 10, 2019 | Law 360
By Matt Fair
The Pennsylvania Supreme Court agreed on Wednesday to hear arguments over whether out-of-state residents should be allowed to bring claims in Philadelphia County over a Johnson & Johnson unit’s allegedly defective pelvic mesh products. -
Mesh: NHS trusts in Oxfordshire warned after new NICE guidelines
Apr 10, 2019 | Oxford Mail
By Harrison Jones
NHS Trusts across Oxfordshire are being told that they will be acting unlawfully if they fail to enforce ‘high vigilance restrictions’ in the use of mesh implants, after new guidance sparked outrage. -
Anger over new guidelines on controversial surgical mesh surgery
Apr 11, 2019 | Gazette & Herald
By David Mackie
A Ryedale campaigner who is fighting to end controversial surgical mesh procedures has said she is “angry and upset” at new guidelines on the surgery - but will continue to campaign until authorities “listen and act”. -
Campaigners welcome move for ‘mesh survivors’
Apr 11, 2019 | The Gazette
Recommendations on how to improve care for women who have experienced complications from mesh procedures are to be made in early autumn. -
Vaginal mesh: the evidence
Apr 10, 2019 | Lexology
By Peter Rudd-Clarke
Last week, NICE (the National Institute for Health and Care Excellence) published new guidelines on the use of vaginal mesh.
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Pa. Justices To Mull Standing For Out-Of-State Mesh Patients
Apr 10, 2019 | Law 360
By Matt Fair
The Pennsylvania Supreme Court agreed on Wednesday to hear arguments over whether out-of-state residents should be allowed to bring claims in Philadelphia County over a Johnson & Johnson unit’s allegedly defective pelvic mesh products.
The appeal, which represents the latest development in a long-running effort by J&J subsidiary Ethicon Inc. to boot mesh cases from non-Pennsylvanians out of a mass tort program, stems from a case brought by an Indiana woman, Patricia Hammons, that resulted in a nearly $13 million verdict.
But implicated in the appeal are more than $45 million in damages that jurors have awarded to three different out-of-state plaintiffs, including Hammons, in mesh cases in the Philadelphia County Court of Common Pleas.
Meanwhile, dozens of other cases from non-Pennsylvanians remain pending as part of a mass tort program in the court.
In granting the appeal, the justices agreed to consider whether due process protections and state procedural rules preclude Pennsylvania “from asserting personal jurisdiction over two New Jersey companies in a case brought by an Indiana resident asserting claims under the Indiana Product Liability Act.”
Hammons alleged that design defects in Ethicon’s pelvic mesh product, which she received to treat her urinary stress incontinence, made it prone to sawing through the soft tissue around the implantation area.
The result, Hammons said, was parts of her mesh became implanted in her bladder.
While a jury returned $5.5 million in compensatory damages and $7 million in punitive damages, Ethicon argued on appeal that the U.S. Supreme Court’s recent decision in Bristol-Myers Squibb Co. v. Superior Court of California meant that it should not have been forced to face Hammons' claims in Philadelphia.
In the Bristol-Myers decision, which was handed down two years ago, the justices ruled that the company did not have sufficient business contacts in California to confer courts there with jurisdiction over some 600 lawsuits brought by out-of-state plaintiffs over injuries allegedly caused by the blood-thinner Plavix.
But the Pennsylvania Superior Court upheld the Hammons verdict in June after finding that Ethicon had clear and substantial business links with Pennsylvania sufficient to give the state jurisdiction over the claims.
The court pointed in particular to J&J’s reliance on a Philadelphia-area company, Secant Medical Inc., to manufacture the mesh.
Shanin Specter, an attorney with Kline & Specter PC representing Hammons, said he believed the justices would ultimately allow the cases to move forward in Pennsylvania.
“I think it’s wise for the Pennsylvania Supreme Court to provide guidance to the lower courts in the wake of the U.S. Supreme Court’s recent decision in BMS,” he said. “I’m confident that our Supreme Court will affirm the Superior Court given Ethicon’s relevant contacts in Pennsylvania.”
A spokesperson for Ethicon did not immediately return a message seeking comment.
Ethicon is represented by D. Alicia Hickok of Drinker Biddle & Reath LLP, Stephen Brody of O'Melveny & Myers LLP, and Julie Callsen of Tucker Ellis LLP.
Hammons is represented by Shanin Specter, Lee Balefsky, Charles “Chip” Becker, Kila Fickes and Ruxandra Laidacker of Kline & Specter PC.
The case is Patricia Hammons v. Ethicon Inc. et al., case number 7 EAP 2019, before the Pennsylvania Supreme Court.
https://www.law360.com/articles/1148804/pa-justices-to-mull-standing-for-out-of-state-mesh-patients
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Mesh: NHS trusts in Oxfordshire warned after new NICE guidelines
Apr 10, 2019 | Oxford Mail
By Harrison Jones
NHS Trusts across Oxfordshire are being told that they will be acting unlawfully if they fail to enforce ‘high vigilance restrictions’ in the use of mesh implants, after new guidance sparked outrage.
Earlier this week, the Oxford Mail reported on a Wallingford mum hitting out at her vaginal mesh surgery, blaming it for two miscarriages and her new reliance on a mobility scooter.
Now, campaign group Sling the Mesh and Thompsons Solicitors argue that new National Institute of Clinical Excellence (NICE) guidance cannot be seen as a ‘green light’ for mesh use - and that doing so would be unlawful.
Sling the Mesh director Kath Sansom said: “We have many women in Oxfordshire who have been affected by mesh.
"They tell us how risks were not explained to them before they had the mesh operation, and how they were ignored when they went back to their surgeons for help. Sadly, in the South East, women tell us it feels like they have suffered an institutional betrayal.
"We expect Baroness Cumberlege [who is leading a review into mesh] to reach a different conclusion to NICE. We have taken advice from Thompsons Solicitors and to make sure that no more patients are put at risk letters are going to every hospital Trust in the South East, making clear that the new guidelines are not a green light to restart the use of mesh, and that the July 2018 restrictions remain in place."
In the letter, to NHS England and all NHS Trusts, Sling the Mesh and Thompsons suggest that the NICE guidelines ignore the vast majority of the evidence-based views that led to an original restriction in July 2018.
They argue that the NICE guidelines can only come into effect when all the conditions in restriction have been satisfied.
Ms Sansom added: “NHS Trusts can easily avoid legal action, they simply have to confirm that, as we are absolutely confident is the case, having not met any or all of the six conditions attached to the July 2018 restriction, they will not be restarting use of mesh.”
https://www.oxfordmail.co.uk/news/17564435.mesh-nhs-trusts-in-oxfordshire-warned-after-new-nice-guidelines/
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Anger over new guidelines on controversial surgical mesh surgery
Apr 11, 2019 | Gazette & Herald
By David Mackie
A Ryedale campaigner who is fighting to end controversial surgical mesh procedures has said she is “angry and upset” at new guidelines on the surgery - but will continue to campaign until authorities “listen and act”.
Jackie Cheetham, of Allerston, near Pickering, was responding to new guidelines and patient leaflets released by the National Institute for Health and Care Excellence (NICE) on April 2.
The guidelines cover “assessing and managing urinary incontinence and pelvic organ prolapse in women”, but also covers complications associated with mesh surgery for these conditions.
This controversial surgery involves plastic polypropylene implants, sometimes called “sling implants”, given to women to support organs in the pelvis.
The NICE guidelines, which can be read at nice.org.uk, are aimed at healthcare professionals, but also the patients themselves. The guidelines state: “There is public concern about the use of mesh procedures. There is some evidence of benefit, but limited evidence on long-term effectiveness and adverse effects.”
Upon publication, they were criticised by campaigners in the Sling the Mesh movement but also MP Owen Smith, who said that though he was pleased the guidance had been issued, “the guidelines appear to disregard mesh-injured women’s experiences by stating that there is no long-term evidence of adverse effects.”
Mrs Cheetham, who has herself been through an agonising ordeal with the procedure, said that the guidelines miss out on key data and should have waited until a high-profile review, led by Baroness Cumberlege, reports later this year.
She said: “Every day on our support group, we see women suffering severe pain, some losing their bowels and bladders, all thanks to mesh surgery.
“Surgeons who take their guidance from NICE, need to be more honest with women in the first instance and they need to stop covering up the true risks.
“We will continue to campaign until they listen and act.”
https://www.gazetteherald.co.uk/news/17560474.anger-over-new-guidelines-on-controversial-surgical-mesh-surgery/
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Campaigners welcome move for ‘mesh survivors’
Apr 11, 2019 | The Gazette
Recommendations on how to improve care for women who have experienced complications from mesh procedures are to be made in early autumn.
An expert group was announced by Health Secretary Jeane Freeman last month following a meeting with women who have suffered as a result of vaginal mesh implants.
The medical devices are used by surgeons to treat pelvic organ prolapse and incontinence in women – conditions that can commonly occur after childbirth.
However, they were banned across the UK last year due to safety concerns, with hundreds of Scottish women suffering chronic pain from the implants.
Among those whose lives have been devastated by mesh operations are Olive McIlroy and Elaine Holmes, who have campaigned tirelessly to raise awareness of the issue.
Olive, from Renfrew, and Elaine, from Newton Mearns, were jointly awarded the Amazing Lifetime Inspiration prize at this year’s No.1 Amazing Women Awards in recognition of their efforts.
Ms Freeman has now written to campaigners, MSPs and the Scottish Parliament’s Health and Sport Committee to set out details of the work to be carried out to improve care.
The group, made up of senior clinical managers, medical directors and other key specialists, is expected to submit its findings to health board chief executives in the early autumn.
To ensure the work takes into account the views of patients, a clinician will also be nominated to give further views.
In its remit, the group will examine the needs of patients and the course of care provided for those who suffer complications following vaginal mesh surgery.
It will also consider what additional steps could be taken to offer choice to women who want – and are clinically suitable for – removal of mesh.
Alex Neil MSP, who served as Scotland’s Health Minister from 2012 to 2014, described the Scottish Government’s announcement as “an important step towards improving the lives of some of the women who have suffered from the devastating effects of mesh implants.”
He added: “It’s important the group works quickly to progress these recommendations while taking into account the personal experience of patients who have been affected.
“This move will be welcomed by campaigners, sufferers and politicians alike.”
The Scottish Mesh Survivors group can offer support to those affected by mesh implants.
https://www.the-gazette.co.uk/news/17561863.campaigners-welcome-move-for-mesh-survivors/
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Apr 10, 2019 | Lexology
By Peter Rudd-Clarke
Last week, NICE (the National Institute for Health and Care Excellence) published new guidelines on the use of vaginal mesh. The guidelines have been published at a time when litigation concerning mesh products has been well documented and the period of “high vigilance restriction” announced by the Government in 2018 remains in place, pending the results of a review by Baroness Cumberlege.
Against this backdrop, the following points set out by NICE regarding the evidence of the risks and benefits associated with mesh products may be particularly relevant for parties defending claims, whether manufacturers, hospitals or their insurers:
There is evidence of benefits associated with mesh procedures, but limited evidence on the long-term adverse effects
The true prevalence of long-term complications is unknown
Discussion with patients should refer to the uncertainty surrounding the long-term adverse effects for all procedures, including those involving mesh materials
There is limited evidence regarding the benefits of partial or complete removal of mesh products, compared with choosing not to remove such products
Equally, there is limited evidence of the long-term effectiveness and complications for some alternatives to surgical procedures
NICE supports the use of a national registry to provide more reliable evidence than is available currently on the use of mesh procedures in England and Wales, and their long-term effects
It is well known that large numbers of women in the UK are reported to have experienced serious side effects as a result of surgery involving mesh products. There have been many reports of the impact these complications have had on the lives of the patients involved. Patients and their families, as well as hospitals and manufacturers, will study the Cumberlege report in detail when it is published later this year. In the meantime, the NICE guidelines published last week do not add anything of significance to what was already known, but they do at least offer a starting point for the debate about the evidence regarding mesh products and the extent to which the benefits outweigh the associated risks.
https://www.lexology.com/library/detail.aspx?g=759f392d-565d-4f27-81d2-c462d2beef95
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