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Ethicon Media Monitoring 7/14/2017
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Mesh implants are like ‘skewering women with kebab sticks’ and there is no reliable system to log problems
Jul 14, 2017 | Cambs Times
By Kath Sansom
As few as four out of ten surgeons log problems. Among the reasons for not doing so are that they are “chaotic” or cannot work out how to use the system. -
The urgent fight to stop vaginal mesh tape implants harming UK women
Jul 13, 2017 | The Pool
By Zoë Beaty
Campaigners are taking their battle to ban "quick-fix" vaginal mesh tape implants to parliament next week -
Phila. Risperdal Docket More Than Doubles in First Half of 2017
Jul 13, 2017 | Law.com
By Max Mitchell
... The Xarelto mass tort grew by 210 cases, or 17 percent, from 1,214 to 1,424. The pelvic mesh litigation was the only other program to see any growth. It increased 7 percent, rising from 164 to 176.
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Jul 14, 2017 | Cambs Times
By Kath Sansom
Surgeons are not logging mesh implant problems which means thousands of women suffer in silence with no figures to prove it, it has been revealed.
As few as four out of ten surgeons log problems. Among the reasons for not doing so are that they are “chaotic” or cannot work out how to use the system.
The issue was discussed in a national conference where among logging fails one consultant said he was “frightened” to implant two types of pelvic mesh because it was like “skewering women with kebab sticks.” (53.4).
Campaigners have warned for years about the lack of long term monitoring, globally, which means nobody knows the true scale of what has been called the biggest health disaster since the morning sickness drug thalidomide by an Australian politician.
The revelation makes a mockery of a pledge by MP Norman Lamb in 2013 when he promised Parliament that the Department of Health was working to improve arrangements to report complications.
Chris Harding, urologist, said: “There are some surgeons, some units that don’t enter any data.
“From the NHS English mesh review, the thing that was really lacking in the literature - and we couldn’t find it when we went and looked - was long term data,” he said at the 2017 British Association of Urology Surgeons (BAUS) conference. (1:33:35)
He added that surgeons input their own results: “Which has got a significant risk of bias. This is not high level evidence.” (1:25)
One surgeon admitted he didn’t report as he was “chaotic” while another said he could not work out how to use the logging system. (1:26)
Another said: “When you look at the BSUG database there’ll be a few nervous gynaecologists, with all the tape cases coming to court.”
(1:32:30.
The BSUG wrote to surgeons in a newsletter in 2014 and said they must provide stress incontinence auditing from 2013 in response to concerns about lack of data.
Three years later in 2017, however, those figures have not been published.
The British Society of Urogynaecologists (BSUG) said less than four out of ten of their surgeons log outcomes.
The British Association of Urology Surgeons (BAUS) said around six out of ten of their members logged outcomes - but their database only follows women for three months, so if problems hit, for example, a year down the line, these patients will not show up in official records.
In December 2013, a Hansard report shows that MP Norman Lamb told Liverpool MP Luciana Berger: “We acknowledge there is considerable under reporting of complications.
“There are currently no plans in place to introduce mandatory reporting of medical device adverse incidents by health care professionals, however the situation is under constant review to ensure that appropriate systems are in place to facilitate the reporting of adverse incidents from all sources.”
In 2014 a Hansard report reveals that Mr Lamb told Easington MP Graeme Morris there was collaborative working to ensure better reporting of complications.
In 2017, campaigners say it appears those systems are still not in place.
• Sling The Mesh goes to Parliament on Tuesday July 18 in a lobby led by MP Owen Smith, shadow Northern Ireland secretary.
More than 80 women and their families are attending along with surgeons and a professor who went undercover to get orange fruit netting approved as a vaginal mesh implant to prove how weak the regulatory system is for medical devices.
http://www.cambstimes.co.uk/news/mesh-implants-are-like-skewering-women-with-kebab-sticks-and-there-is-no-reliable-system-to-log-problems-1-5105527
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The urgent fight to stop vaginal mesh tape implants harming UK women
Jul 13, 2017 | The Pool
By Zoë Beaty
Campaigners are taking their battle to ban "quick-fix" vaginal mesh tape implants to parliament next week
It’s just a few months since we reported on a then little-known scandal putting women’s bodies in peril: “simple” transvaginal mesh tape procedures, designed to help women recover from conditions often caused by childbirth, were leaving thousands of women suffering life-changing side-effects. Chronic pain, incontinence, the inability to have sex. Some women were facing bladder or bowel removal following the insertion of the mesh. Others said their lives had simply been irrevocably ruined.
“It felt like someone was cutting me, from the inside, with knives,” Kath Sansom, who leads a campaign to ban the implants – Sling The Mesh– told me at the time. She was speaking at speed, determined to be heard – or for the world to listen – about the procedure that she said made her “hang my head over the sink and sob” due to the pain. “If you thought I was talking fast last time we spoke,” she announced yesterday morning, almost three months later, as she picked up the phone, “I’m going to be a million miles an hour today – I’ve got a lot to tell you.”
She was being sincere. Since April, when the vaginal mesh tape scandal broke into mainstream news, there have been several developments, both here in the UK and globally. Most notably, Sansom’s campaign has made its way to parliament – or, at least, it will next week. On July 18, scores of experts, campaigners and survivors will lobby parliament, led by Owen Smith, MP for Pontypridd, and shadow secretary for Northern Ireland.
“It’s all a bit weird, but brilliant,” Sansom said, honestly. “We’ve created a real momentum on this issue. Now we’re launching a class action lawsuit as well as an urgent campaign, next week, to pressure parliament into suspending – and ultimately banning – the mesh tape devices. We’re making sure that we’re heard.”
The aim of the parliamentary campaign is to get England, Wales and Northern Ireland up to speed with Scotland who, Sansom says, are leading the way on this issue. In Scotland, the use of the mesh tape implants has been suspended since 2014 under health secretary Alex Neil. “That suspension would run until at least May 2018 – which is four years of protection for Scottish women,” Sansom explains. “Down in England and Wales and Northern Ireland? Nothing. They are still issuing these devices as standard.
“So next week we’re telling parliament that it’s morally wrong. How can Scottish women be afforded that protection, while the government ignores the rest of us?”
If you’re not familiar with the scandal, in a nutshell it is this: a polypropylene (plastic) tape was introduced in the 1990s as an effective way to treat women suffering from stress incontinence and pelvic organ prolapses. It is cut to size and inserted into the vagina via the abdomen. Defenders of the mesh argue that the majority of women find the 20-minute operation to be straightforward and less invasive than traditional surgeries to treat such conditions, which generally require a much longer time under general anaesthetic and a four-day stay in hospital.
These politicians have the power to put a suspension in place, to protect other women until we get more information
But critics – some surgeons, and many of the women who have undergone the procedure – say it’s nothing more than a cost-cutting exercise, and that the sometimes catastrophic effects of the operation (the plastic mesh tape has cut through the bladder, bowel and/or vaginal wall in some women, slicing flesh in a “cheese grater" effect, and caused a loss of activity and sex life, as well as many other ailments) are being ignored. There is also concern that the material shrinks and erodes once inside the body, causing debilitating effects even years after treatment. Once implanted it is incredibly difficult to remove – “like trying to get chewing gum out of hair”, Sansom says.
She argues that there should be a suspension of the implants until at least May next year, when an independent review, which hopes to verify the findings of this year's independent report, is published. “If we can get this suspension in place, I’ve worked out from looking at hospital episode statistics that we can save that at least 1,000 women from being harmed by this procedure in the time it will take for the report to be published.”
Elsewhere, women are gathering in several countries to take action against the use of mesh tape. In the US, the scandal resulted in an estimated 100,000 lawsuits – that’s the amount of people affected who have taken action, rather than the total number of people suffering – being taken against companies issuing the implants. In Canada, one settlement reached $2.4m. And in Australia, a class action suit against Johnson & Johnson Medical Australia and subsidiary companies Ethicon Inc and Ethicon Sarl, who produce the devices, has reached the Federal Court. Just last week a hearing began involving more than 700 women suing the companies for compensation after alleging the device left them with catastrophic injuries to their internal organs. An email written by a surgeon who was enlisted to conduct clinical trials for the implant for Johnson and Johnson was heard in court this week. “I wouldn’t like my wife to undergo this procedure,” he wrote. “... And I don’t think I’m alone.”
It has been dubbed the country’s “biggest medical scandal”, yet Johnson & Johnson deny the claims that their product has put women at unnecessary risk of harm, saying that “all devices have pros and all have cons. It's not defective if a device has a con.” Steven Finch SC, defending Johnson & Johnson, added: "The fact the device is associated with a rate of failure is simply one of its features.”
Sansom wholly disagrees. “I couldn’t believe what I was reading when I saw those comments,” she told me yesterday. She explained she feels that it’s just yet another example of women’s pain being dismissed, and of those in pain not being listened to. And she’s most certainly not alone.
The stories being told about this device only get more harrowing, and the scale of the issue – the hundreds of thousands of women fighting against it all over the world – is undeniably significant. Of course, many women have perfectly healthy and successful operations to fit the device – and if it works well, it appears to have a hugely positive effect on their lives. But the effects for those whose operations are not successful appear to be extreme. And, while there are so many question marks still hovering over the use transvaginal mesh tape – and so many women’s voices saying they are suffering, it feels odd that there is such a stubborn reluctance to address it.
“There is reluctance,” Sansom says, “but we’re not mucking around. These politicians have the power to put a suspension in place, to protect other women until we get more information. And we’re saying one thing: use it."
https://www.the-pool.com/news-views/latest-news/2017/28/zoe-beaty-transvaginal-mesh-tape-implant-scandal-update
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Phila. Risperdal Docket More Than Doubles in First Half of 2017
Jul 13, 2017 | Law.com
By Max Mitchell
The litigation over Risperdal has not only become the largest mass tort program in Philadelphia’s busy court system, it has also nearly tripled in size from about 2,000 cases at the start of the year to more than 5,500 as of June.
According to the latest statistics from the Philadelphia Court of Common Pleas, litigation over the anti-psychotic drug Risperdal jumped from being 31.4 percent of the Complex Litigation Center’s inventory as of Jan. 1 to 55.8 percent as of June 14. That number represents a 185 percent increase from the 1,945 at the start of the year, and is due to 3,617 new cases being filed in the mass tort since January. As of early June, 5,548 Risperdal cases were pending.
Attorney Thomas R. Kline, who, as part of a consortium of attorneys from Kline & Specter, Sheller P.C. and Arnold & Itkin, is handling approximately three-quarters of the Risperdal docket in Philadelphia, said the recent influx was caused mostly by a tolling agreement that was terminated last year.
Although he said the latest wave of cases is largely over, he anticipates the litigation will continue to grow in Philadelphia. In particular, he noted the recent jurisdictional ruling by the U.S. Supreme Court in Bristol-Myers Squibb v. Superior Court of California, the numerous issues on appealbefore the state Superior Court, and what Kline said is a lack of progress toward a “reasonable” global settlement.
“The significant influx of cases is a direct result of Johnson & Johnson’s actions,” he said, specifically referencing the termination of the tolling agreement.
A spokeswoman for Janssen, the Johnson & Johnson subsidiary that makes Risperdal, said the company plans to “continue to defend this litigation and will try cases where appropriate.”
“We do not have insight into plaintiffs’ choices regarding when and where they initiate lawsuits,” Janssen spokeswoman Jessica Castles Smith said in an emailed statement.
According to the statistics, 94 percent of the latest filings comes from outside Pennsylvania. That is the highest the court has seen since at least 2005.
Philadelphia has long been a hub for mass tort litigation, often attracting suits from plaintiffs who live outside Pennsylvania. Frequently finding itself on the American Tort Reform Foundation’s list of “judicial hellholes,” the court made some administrative changes to the program in 2012, in part to address a growing backlog.
Since the court began measuring the number of out-of-state filings in 2005, the percentage of cases filed by plaintiffs from outside Pennsylvania has mostly hovered between 85 and 89 percent. Last year saw the lowest percentage of out-of-state filings since 2005.
Kline said the plaintiffs hale from all over the country, and balked at the criticism that having plaintiffs from outside the Keystone State unfairly burdens Pennsylvania courts, specifically noting that Philadelphia is considered to be a home venue for Janssen.
“It’s like the [Pittsburgh] Pirates saying we would like to play all our games in Philadelphia,” he said. “We will play all the games here on your home court.”
According to Kline, eight to 10 trials are listed to take place through the rest of 2017 and the first half of 2018.
Although the largest mass tort that Philadelphia has seen was the Fen-Phen litigation, which involved about 15,000 cases, Judge Arnold New, supervising judge of the Complex Litigation Center, said the Risperdal mass tort is the largest he has seen since he began leading the center in 2012.
New said he had been anticipating significant growth in the Risperdal mass tort, and he has been asking the parties for more information about the cases in an effort to get a better understanding of the litigation for administrative purposes. For example, one recent ruling requires plaintiffs to submit more information about their prescribing doctors and their injuries when filing. But New added that information including where a plaintiff is from and their ages can also help the court to focus on handling cases that don’t involve issues up on appeal.
“As we’ve had this growth in cases, we’ve been trying to get more and more information from the lawyers to determine how to handle these cases, how try these cases, and when,” he said. “Risperdal really is overwhelmingly gynecomastia, but maybe if some claims arise over stroke, or heart attack, I want to know about it.”
The court, he said, is expecting more cases to be filed, particularly in the wake of the Bristol-Myers Squibb decision.
“That’s fine. We have a great court system that knows how to deal with mass torts as efficiently as possible in order to have all the parties reach a resolution that’s acceptable,” he said.
The Risperdal mass tort saw, by far, the largest growth out of the nine programs pending in Philadelphia.
The Xarelto mass tort grew by 210 cases, or 17 percent, from 1,214 to 1,424. The pelvic mesh litigation was the only other program to see any growth. It increased 7 percent, rising from 164 to 176.
The Yaz, Yazmin, Ocella mass tort, which came to a settlement agreement in 2015, fell 80 percent, from 109 to 22, and the asbestos docket dropped by 7 percent, from 595 to 554. Fen-Phen also dropped by 33 percent, but it started the year with only three cases pending.
Reglan also dropped by 74 cases, or 3 percent. But with 2,091 cases pending as of early June, it was the second largest mass tort in the Complex Litigation Center, making up 21 percent of the inventory.
http://www.law.com/sites/almstaff/2017/07/13/phila-risperdal-docket-more-than-doubles-in-first-half-of-2017/?slreturn=20170614015911
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