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Ethicon Media Monitoring 2/26/2018
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U.K. health secretary mandates vaginal mesh safety audit
Feb 23, 2018 | Mass Device
By Brad Perrieilo
Jeremy Hunt, the U.K.’s health & social care secretary, this week ordered a National Health System safety audit of the use of plastic mesh implants to treat vaginal prolapse and female urinary incontinence. -
Welcome for proposals to rethink multiple claims
Feb 26, 2018 | The Scotsman
By Duncan Batchelor
The Civil Litigation (Expenses and Group Proceedings) (Scotland) Bill comes almost 40 years after lawmakers first considered multi-party litigation procedure. -
View From The House – 23rd February 2018
Feb 23, 2018 | Tamworth Informed (Blog)
There was another major review announced this week by the Health Secretary into how authorities responded to concerns over three major medical problems; namely the pregnancy test Primodos, vaginal mesh implants and epilepsy drug sodium valproate. -
Critical Mass: DOJ Begins to Choose Class Action Settlements for Scrutiny. Plus: New Trial for Risperdal Punitives
Feb 23, 2018 | Law.com
By Amanda Bronstad
... Meanwhile, pelvic mesh verdicts are routinely in the tens of millions of dollars, and the Xarelto mass tort recently came to a nearly $28 million verdict. -
US Female Urology expert says surgical experience reduces risk of adverse outcomes from mesh devices
Feb 26, 2018 | New Zealand Doctor
Leading United States Female Urology specialist, Professor Eric Rovneri, has expressed confidence in the use of a controversial female pelvic mesh product for stress urinary incontinence saying it is “an effective procedure” that has been “a boon for women’s health”. -
Janie Jarman, left in constant pain after vaginal mesh procedure, says government review is
Feb 25, 2018 | Dorset Echo
By Katie Williams
A mother left suffering with chronic pain after having a vaginal mesh implant has welcomed news that the government is to review the way authorities handled concerns over the procedure.
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U.K. health secretary mandates vaginal mesh safety audit
Feb 23, 2018 | Mass Device
By Brad Perrieilo
Jeremy Hunt, the U.K.’s health & social care secretary, this week ordered a National Health System safety audit of the use of plastic mesh implants to treat vaginal prolapse and female urinary incontinence.
Hunt said the review of vaginal mesh and two other products – the Primodos hormone-based pregnancy test and the anti-epilepsy drugsodium valproate – were prompted by “serious concerns … raised by patients and their families.”
Some of those complaints about vaginal mesh included calls for the products to be banned in the U.K. The health secretary said he asked NHS chief medical officer Dr. Sally Davies for advice on a ban.
“She has been clear that clinical experts here and abroad agree that, when used appropriately, many women gain benefit from this intervention, hence a full ban is not the right answer in the light of the current evidence available,” Hunt said during a Feb. 21 address to the House of Commons. “However, this is not to minimize the suffering many women have experienced, which is why today I can announce that we will be publishing a retrospective audit to investigate the links between patient-level data to explore outcomes, and investing £1.1 million [$1.5 million] to develop a comprehensive database for vaginal mesh to improve clinical practice and identify issues.”
The Primodos test led to miscarriages and birth defects during the 1960s and ’70s before it was withdrawn in 1978, he added, and sodium valproate was “definitively linked” to autism and learning disabilities in children when taken during pregnancy.
Hunt pledged to offer full genetic clinical evaluations to families in the Assn. for Children Damaged by Hormone Pregnancy Tests and to introduce a new warning label for sodium valproate packaging, updating national guidance on its use and push for it to be contra-indicated for women of childbearing potential not using contraception, among other things.
“Of course our first thoughts are with the individuals and families whose lives have been turned upside down by these issues,” Hunt said. “I pay particular tribute to those who have responded to such experiences not just with understandable anger, but with resolute determination to campaign for change on behalf of others.
“We must acknowledge that the response to these issues from those in positions of authority has not always been good enough,” he said. “To do better in the future, we need to ensure that patient voices are bought to the table as systematically and consistently as other voices in the system.”
Hunt said he asked Baroness Julia Cumberlege to review “what happened in each of these three cases, including whether the processes pursued to date have been sufficient and satisfactory, and to make recommendations on what should happen in future.”
https://www.massdevice.com/u-k-health-secretary-mandates-vaginal-mesh-safety-audit/
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Welcome for proposals to rethink multiple claims
Feb 26, 2018 | The Scotsman
By Duncan Batchelor
The Civil Litigation (Expenses and Group Proceedings) (Scotland) Bill comes almost 40 years after lawmakers first considered multi-party litigation procedure. Implementing recommendations of Lord Gill’s 2009 Scottish Civil Courts Review, it is driven by a policy to improve access to justice.
The stage one report has been published and there remain hoops for it to jump through, but personal injury lawyers and consumer groups support the bill becoming law. If it does, how will it impact litigation in Scotland?
Scotland currently has no formal procedure to deal with multiple claims as a group, with parties usually agreeing the solution of running one or two “test cases” to trial (proof), while the rest are paused (sisted). The pursuers still need to raise each case individually at considerable expense and a test case decision is not always binding on the rest. Depending upon the litigation, it may not be easy to reach consensus.
In larger or more complex group claims, the Court of Session has taken a more creative, ad hoc approach. For example, in the pelvic mesh and Vioxx litigations, both highly complex, the court set out bespoke procedures through a series of Practice Directions. However, the power of the court to proceed in that way has been questioned.
Evidence has shown that group procedure is widely welcomed in Scotland. Costs for pursuers would reduce, businesses would be deterred from harmful behaviour by the threat of mass litigation, and precious court time would be saved.
Does the bill match these ambitious aims? If it became law, group procedure in Scotland would look like this:
l Available only in the Court of Session.
l Minimum of two claims per group, but no maximum.
l “Opt-in” – relevant claims are not automatically included in the group.
l One representative party’s case, not necessarily a member, is heard on behalf of the group.
l A decision in the representative party’s case is binding on the group.
l The court must give permission to apply the procedure, which will only be granted if all of the claims “raise issues (whether of fact or law) which are the same as, or similar or related to, each other.”
Immediate questions arise. Why withhold this from sheriff courts? The All Scotland Personal Injury Court would be a more cost-effective forum to litigate many low-value claims. Sheriff courts might also be suited to considering low value human rights cases. Claimants using the Court of Session will pass higher costs on to defenders in any award of expenses if successful.
What about “opt-out” procedure, in which cases meeting defined criteria are automatically conscripted and must actively choose to leave the group? Imposing the step of opting-in risks outlier claims running alongside the group at additional expense. How would a decision in those claims affect the group?
How does a prospective claimant sign up to the group? Will they require to raise individual proceedings, or simply add their name to a list? What checks will be made to ensure that claims are genuine?
The courts will need to provide guidance on the proposal that “similar” or “related” claims could form a group. How does one define “similar” or “related”? Must all claims have the same defender, same legal basis, or rest on the same facts? In the US, a distinction is drawn between mass tort and class actions. In mass tort, every claimant is a member of a group but treated as an individual. In class actions, a representative who stands in for the rest of the class. All members of the class are treated as one claimant, not separately. A number of criteria have to be met for an action to proceed as a class action. There has been no attempt to draw such a distinction under the Scottish proposals.
It is not yet clear whether the one-size-fits-all procedure envisaged by the bill will be sufficiently flexible to deal with the various types of group litigation that could arise.
The devil may ultimately be in the detail, as specific court rules will be developed by the Scottish Civil Justice Council. For now, the bill passes to stage two for amendment… watch this space.
Duncan Batchelor is a partner with Clyde & Co
https://www.scotsman.com/news/opinion/welcome-for-proposals-to-rethink-multiple-claims-1-4695705
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View From The House – 23rd February 2018
Feb 23, 2018 | Tamworth Informed (Blog)
HELLO and welcome to my weekly View from the House for Tamworth Informed.
Over the last few weeks, I have been trying to compile a list of potholes around the area to send to Staffordshire County Council, the authority responsible for roads, so that their attention is brought to the problem. So far I have received a great response from residents from around the constituency getting in touch to highlight their roads. If you have any thoughts or know of any that you pass on the roads, please do let me know.
Last week as part of my usual meetings with teams at our local hospitals, I visited the Chief Executives at the Burton NHS Hospitals Trust who are responsible for the Sir Robert Peel Hospital. It was a really positive meeting and I was reassured to hear the plans to improve and provide new services at the hospital for many years to come.
Since the last election, there has been a lot of talk about the post-18 education system, for example cancelling student debt, lowering/zero tuition fees, and whether the current university system is a fair deal for students but also the taxpayer. This week the Prime Minister announced that a review will be taking place to look into the subject of post-18 education. The review is expected to take around a year.
The United Kingdom has a world-class higher education system. Sixteen of our universities are in the world’s top 100 and four are in the top 10. We have record numbers of young people entering university, including from disadvantaged backgrounds. Our student finance system removes up-front financial barriers and provides protections for borrowers so that they only have to contribute when they can afford to do so. A university degree provides significant financial returns to the individual: graduates on average benefit from their university education by over £100,000 over their lifetime.
However, despite this all these positive stories, it is clear there remains some unfairness in the system. The review will look at four key strands: choice and competition across post-18 education and training; value for money for graduates and taxpayers; accessibility of the system to all; and delivering the skills that our country needs now and in the future. This means identifying ways to help people to make the most effective choices between the options available at and after 18, so that they can make more informed decisions about their futures. It is also about ensuring that there is a more diverse range of options to choose from beyond the classic three-year or four-year undergraduate degrees.
There was another major review announced this week by the Health Secretary into how authorities responded to concerns over three major medical problems; namely the pregnancy test Primodos, vaginal mesh implants and epilepsy drug sodium valproate. The cases make for some upsetting reading.
In the case of Primodos, campaigners claim it caused birth defects in their children, such as blindness, deafness, spina bifida and heart and limb defects, as well as cleft palates.
It is claimed that babies exposed to valproate medicines in the womb have a 10% chance of developing physical abnormalities and a 40% chance of developing cognitive problems, such as learning disabilities and autism. Parents who have had babies born with disabilities say they were not sufficiently warned about the risks.
In the case of mesh implants, it is estimated that more than 100,000 women in the country have had a mesh fitted. Campaigners have reported the implants cutting into the body and women being left in permanent pain, unable to walk or work. Truly shocking.
After a long campaign by many, I’m very pleased to see the Health Secretary announce an independent review to look in to these matters which will aim to ensure that these problems will not be replicated by the NHS or any other authority in the future.
Today is what’s known as a ‘Sitting Friday’ where MPs debate Private Member’s Bills (PMBs). These Bills can be put forward by any MP and are always debated on intermittent Fridays. As I write we have just passed the Overseas Electors Bill which is a PMB to extend the basis on which British citizens outside the UK qualify to participate in Parliamentary elections. It will remove the ’15-year rule’ which prevents British citizens living overseas from registering to vote if they have lived abroad for more than 15 years. This is good news for those British citizens living abroad!
Have a great weekend.
Chris
http://www.tamworthinformed.co.uk/vfth-230218/
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Feb 23, 2018 | Law.com
By Amanda Bronstad
After Rachel Brand said in a speech that the U.S. Justice Department would use the Class Action Fairness Act to review settlements, it didn;t take long for a case to be brought under the microscope.
Welcome to Critical Mass, Law.com’s new briefing on class actions and mass torts. I’m Amanda Bronstad in Los Angeles. The DOJ wants to review class action settlements, but what’s it looking for? Also, a Pennsylvania appeals court issued another ruling that opens up possible punitive damages in Risperdal cases. And the 9th Circuit came out with a key ruling addressing Spokeo Inc. v. Robins.DOJ Sniffs Around Wine Buyers Class Settlement
One day after Associate Attorney General Rachel Brand hinted that the U.S. Department of Justice, under the Class Action Fairness Act, would get more involved in reviewing class action settlements, government lawyers filed a statement of interest in a false advertising case against a website that sold wine. Here’s the story from Law.com’s Cogan Schneier.
It’s not a surprising case for the DOJ to pick, said Burt Rublin of Ballard Spahr. He likened it to “shooting fish in a barrel.”
“They cherry-picked this case because it’s an obvious poster child for the kind of class action abuse that animated the enactment of CAFA way back when,” he said. In 2005, the big concern was coupon settlements. In the wine settlement, class members get vouchers of 20 cents to $2.25 on future bottles of wine.
But it’s not only coupon settlements the DOJ is looking at most closely. Akin Gump’s Anthony Pierce told me that the amount of monetary benefit, or injunctive relief, could be on the DOJ’s radar — as will plaintiffs attorney fees. Plaintiffs lawyers in the wine settlement are set to receive $1.7 million in fees.
“I’m looking for them to weigh in on cases where they don’t see great benefit to the consumer, or they see a substantial windfall, in their minds, in the fee request from the plaintiffs lawyers,” he said.A Redo for Risperdal Punitives
The Pennsylvania Superior Court has sent back a $1.75 million verdict in a Risperdal case for a possible new trial on punitive damages. The panel cited the court’s own decision last month that allowed plaintiffs to seek punitive damages under the laws of their own states, rather than in New Jersey, where Risperdal manufacturer Janssen is based and where punitive damages are not allowed in product liability cases. Law.com’s Max Mitchell has the story.
There are big ramifications for the Risperdal litigation. Max told me:
“The broader significance is that Janssen faces much higher stakes in the Risperdal litigation. For the most part, verdicts in Risperdal have stayed at around $1 million. Meanwhile, pelvic mesh verdicts are routinely in the tens of millions of dollars, and the Xarelto mass tort recently came to a nearly $28 million verdict. Both of those litigations have allowed punitive damages since the start.”Credit Card Data Exposure Made No Sound, 9th Circuit Rules
The 9th Circuit came out with another post-Spokeo decision this week — and it ruled for the defendant. Here’s my story. In the plethora of circuit court opinions addressing standing in light of the U.S. Supreme Court’s Spokeo Inc. v. Robins ruling in 2016, the 9th Circuit so far has come down more favorably for plaintiffs — including the one in the Spokeo case itself.
But not this time. The plaintiff, Steven Bassett, alleged he was at risk of identity theft after a parking garage operator printed the expiration date of his credit card on the receipt. But the panel, aligning with the 7th and 2nd circuits, disagreed.
Then it ended with this classic parting quote: “We need not answer whether a tree falling in the forest makes a sound when no one is there to hear it. But when this receipt fell into Bassett’s hands in a parking garage and no identity thief was there to snatch it, it did not make an injury.”Who Got the Work?
Intel isn’t the only chipmaker sued over security flaws in its processors. Advanced Micro Devices has been hit with at least four class actions – three by consumers, and one by investors. O’Melveny & Myers has stepped in to defend AMD. On Feb. 9, Los Angeles partner Richard Goetz, O’Melveny’s litigation co-chairman, made an appearance in a consumer case. And on Feb. 12, Los Angeles partner Matthew Close and counsel Brittany Rogersappeared in a securities case.
Here’s what else you need to know as we wrap up the week:
Emissions Case Accelerates: A ruling this week in Michigan allowing RICO claims to move forward against GM could drive other diesel emissions cases against automakers that were sued over alleged “defeat devices” in the wake of the Volkswagen scandal. Here’s my story. Plaintiffs attorney Steve Berman, who has brought cases against Mercedes, Fiat Chrysler and Ford, called it a “huge precedent.”
Baltimore Boost: A group of nine litigators from Miles & Stockbridge led by product liability attorney Michael Brown is opening an office in Baltimore for Nelson Mullins. Here’s the firm’s announcement, and the full story from Law.com. Nelson Mullins Managing Partner Jim Lehman said: “This group of litigators is strong in a number of our key practice areas, such as products liability; and in particular sectors such as the automotive, medical device, and pharmaceutical industries.”
Wynn Some, Lose Some: Casino magnate Steve Wynn’s legal troubles mounted this week when investors filed a class action alleging the failure of Wynn Resorts Ltd. to reveal its former CEO’s sexual misconduct led to stock losses. Here’s Law.com’s story. Jeremy Lieberman and J. Alexander Hoodof Pomerantz represent the investors.
PFC Practice: Philadelphia attorney Keith Smith has jumped to Greenberg Traurig after nine years at Eckert Seamans. A big reason for Smith’s move? Perfluorinated compounds. That’s right. According to this Law.com article, claims over the toxicity of perfluorinated compounds, or PFCs, have been a growing area of litigation — and Smith has nearly 20 cases dealing with the chemicals.
“With more than 80 class action lawyers at Greenberg Traurig … I knew I’d have the right team in place to take on the PFC litigation,” he told Law.com.
https://www.law.com/2018/02/23/critical-mass-doj-begins-to-choose-class-action-settlements-for-scrutiny-plus-new-trial-for-risperdal-punitives/?slreturn=20180126020926
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US Female Urology expert says surgical experience reduces risk of adverse outcomes from mesh devices
Feb 26, 2018 | New Zealand Doctor
Leading United States Female Urology specialist, Professor Eric Rovneri, has expressed confidence in the use of a controversial female pelvic mesh product for stress urinary incontinence saying it is “an effective procedure” that has been “a boon for women’s health”.
Prof Rovner is in Melbourne to speak at the Urological Society of Australia and New Zealand’s Annual Scientific Meeting this week.
The Urological Society of Australia and New Zealand says specialists have noted the adverse publicity over complications from female pelvic mesh devices has impacted patient’s confidence in the most common and effective treatments for urinary stress incontinence, the mid urethral sling.
Female pelvic mesh products are at the centre of a class action by Australian 700 women against manufacturer Johnson & Johnson and a Federal Parliamentary Senate Enquiry.
In December the TGA (Therapeutic Goods Administration) banned transvaginal mesh products for prolapse and single incision mini slings for stress urinary incontinence. New Zealand regulators have imposed similar restricctions.
The mid urethral sling (MUS) has not been removed, however anti-mesh campaigners are calling for it to be banned as well.
In January Johnson & Johnson withdrew its mid urethral slings from the Australian market but other manufacturers’ versions of the product remain available.
In the United States, pelvic mesh has been the subject of that country’s largest, single class action with $3billion to date appropriated to settle and litigate cases.
Professor Rovner says female pelvic mesh products have not been banned in the US, but the FDA has issued warnings about prolapse mesh and single incision slings (mini-slings) putting them under tighter scrutiny and mandating a review to be funded by the manufacturers.
Professor Rovner says it is still unclear whether the complications relate specifically to the mesh itself or the denominator effect of the increasing number of cases using the product.https://www.nzdoctor.co.nz/article/undoctored/us-female-urology-expert-says-surgical-experience-reduces-risk-adverse-outcomes
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Janie Jarman, left in constant pain after vaginal mesh procedure, says government review is
Feb 25, 2018 | Dorset Echo
By Katie Williams
A mother left suffering with chronic pain after having a vaginal mesh implant has welcomed news that the government is to review the way authorities handled concerns over the procedure.
Health Secretary Jeremy Hunt announced this week that Baroness Julia Cumberlege will lead a review into patient concerns about vaginal mesh, as well as hormone pregnancy test drug Primodos and sodium valproate.
The review will investigate how the NHS responds to safety concerns raised by patients about medicines or medical devices. It will also consider whether any further action is required, including whether a full investigation or a public inquiry is necessary.
Mr Hunt announced plans to invest £1.1 million to develop a database for vaginal mesh which could help identify safety issues.
Janie Jarman, a mother-of-three from Weymouth, had the mesh implant fitted in 2007 in a routine operation.
The Tension-free Vaginal Tape procedure (TVT) is often carried out to treat prolapse or incontinence after childbirth to provide support when repairing damaged tissue. The mesh is made of polypropylene, a type of plastic.
As reported by the Echo in September last year, Janie said the implant severely affected her life, leaving her suffering constant pain. As someone who previously enjoyed camping trips, Janie says she now struggles to walk very far and finds bending over uncomfortable.
Now Janie, who is a supporter of the Sling the Mesh campaign calling for the operation to be suspended in the UK, is “thrilled” that the voices of thousands of women who have suffered following the procedure are being listened to.
She said: “The audit, which will show a more accurate picture of the complication rate, is something we’ve all been fighting for. I welcome the statement made by Jeremy Hunt and hope that this will immediately lead to a comprehensive audit of not just vaginal mesh surgery, but all mesh surgery, which will highlight the severe, life changing damage we have experienced.
“One of the aims of Sling the Mesh Campaign is to get mesh surgery stopped pending further research. The statements made by Jeremy Hunt will hopefully be a step towards achieving this aim”
Mr Hunt said the response to the issues “has not always been good enough”. He added that the review will also consider the processes followed by the NHS and regulatory bodies after patients report their concerns - including how they communicate with patients.
He said: “From Primodos to mesh and sodium valproate, patients and their families have had to spend too much time and energy campaigning for answers in a way that has added insult to injury for many. I want to see if we can establish a fairer and quicker way of resolving these concerns.”
http://www.dorsetecho.co.uk/news/16044237.janie-jarman-left-in-constant-pain-after-vaginal-mesh-procedure-says-government-review-is-step-forward-for-suffering/
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