Preview Newsletter
Ethicon Media Monitoring 8/19/2017
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For Plaintiffs Bar, Taking on J&J Means Battling a Shadow Foe
Aug 18, 2017 | Law.com
By Amanda Bronstad
Pay attention to mass torts litigation and it’s hard not to notice a certain feedback loop between Johnson & Johnson’s products liability docket and the tort reform agenda of the U.S. Chamber of Commerce. -
J&J Unit Looks To Block Damages After Pelvic Mesh Win
Aug 18, 2017 | Law 360
By Matt Fair
A Johnson & Johnson unit has launched an appeal challenging a Pennsylvania judge's order reviving a woman's bid for damages over injuries she claims she suffered after receiving a pelvic mesh implant, despite a recent jury verdict clearing the company of liability. -
Ethicon Appeals Post-Defense Verdict Move to Damage Hearing in Pelvic Mesh Case
Aug 17, 2017 | The Legal Intelligencer
By Max Mitchell
Ethicon, the main defendant in the pelvic mesh mass tort in Philadelphia, is appealing a judge's decision to revive a suit that initially ended in a win for the manufacturer. -
At least 10 women a DAY are seeking help from lawyers as they demand compensation for the damage caused to their bodies by controversial vaginal mesh implants
Aug 21, 2017 | The Daily Mail
By Stephen Matthews And Alexandra Thompson
At least 10 women each day are approaching lawyers demanding compensation for the life-changing damage caused to their bodies by controversial vaginal mesh, it has emerged. -
The Vaginal Mesh Scandal: Why Hundreds Of Women Are Suing Over Treatment
Aug 18, 2017 | Elle
By Louise Donovan
NHS figures show one in 15 women fitted with the vaginal mesh implants will require surgery to extract it -
Informed Consent – What We Are Learning
Aug 18, 2017 | Mesh Medical Device Newsdesk
What are we learning about Informed Consent? Almost all medical bodies agree informed consent, sharing information about pros and cons of a procedure to educate a patient, is important! -
Johnson & Johnson, Ethicon Appeal Decision Granting Transvaginal Mesh Lawsuit Plaintiff New Damages Hearing
Aug 21, 2017 | RX Injury Help (blog)
By Sandy Liebhard
Johnson & Johnson and Ethicon, Inc. have appealed a decision by a Pennsylvania judge to order a new hearing on damages in a transvaginal mesh lawsuit that went to trial earlier this summer.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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For Plaintiffs Bar, Taking on J&J Means Battling a Shadow Foe
Aug 18, 2017 | Law.com
By Amanda Bronstad
Pay attention to mass torts litigation and it’s hard not to notice a certain feedback loop between Johnson & Johnson’s products liability docket and the tort reform agenda of the U.S. Chamber of Commerce.
The Chamber likes to use real-world stories of lawsuits run amok to fuel its advocacy, and it’s got no shortage of examples, thanks to Johnson & Johnson. The group often points to J&J cases when it lobbies to tighten venue rules, limit plaintiffs bar advertising and curb third-party litigation funding.
Meanwhile J&J raises alarm bells about the very same issues in its court fights, echoing the Chamber’s agenda and creating courtroom sideshows that air the group’s pet issues but have little apparent effect in those suits.
And then there’s John Beisner, chairman of the mass torts practice at Skadden, Arps, Slate, Meagher & Flom, who’s a top lawyer to both.
While coordination between companies and trade associations is a common litigation and lobbying strategy, the J&J-Chamber ties are notable for their closeness, constancy and for being unusually reciprocal. Typically, it’s an association that carries water for the industry but J&J is also a champion for the Chamber and boosts the organization’s broader tort reform positions.
It can make it hard to tell where J&J’s advocacy ends and the Chamber’s begins. Whether the dynamic is intentionally choreographed or borne of aligned interests, plaintiffs lawyers going up against the New Jersey-based conglomerate have come to expect that Beisner’s arguments in court will echo the Chamber’s advocacy.
“They’ve got the same mouthpiece,” said Texas plaintiffs attorney W. Mark Lanier. “They’ve got the same source of money, they’ve got commonality of directors, and they parrot the same mission.”
Michael Krauss, a professor at George Mason University’s Antonin Scalia Law School who teaches about legal ethics and torts, said the Chamber likely sees the flood of suits against Johnson & Johnson as a proxy for its tort reform fights. J&J is like the “canary in the coal mine” for the Chamber, said Krauss.
“If J&J gets crushed, a lot of its other members get crushed,” he said. “The Chamber sees the world the same way that Johnson & Johnson sees the world.”
Beisner did not respond to a request for comment. But in an earlier interview, he denied the existence of any “special relationship.”
The Chamber files “numerous amicus briefs every year in support of a wide array of companies and comment on various things,” he said. Johnson & Johnson, he said, is “a member, but there are a lot of other members, hundreds of members.”
There’s no doubt the Chamber’s advocacy on behalf of one industry player can pay wider dividends. A significant win on tort reform this past year came in a fight for a different drugmaker, Bristol-Myers Squibb Co. Yet the U.S. Supreme Court’s decision in that case, deemed a game-changer for mass torts, prompted a Missouri judge to immediately halt a talcum powder trial against J&J.
In addition to Beisner’s dual role, Johnson & Johnson general counsel Michael Ullmann was a board member of the Chamber’s Institute for Legal Reform as of 2015, according to the most recent publicly available information. Chamber officials refused to provide more recent data or confirm whether he was still a board member.
In an emailed statement, Harold H. Kim, executive vice president of the Chamber’s Institute for Legal Reform, said that the group “has advocated for reforms to the country’s civil justice system on behalf of the entire business community,” not just Johnson & Johnson. “Lawsuit abuse adversely affects our national economy and stifles innovation and job creation,” Kim wrote. “We will continue to be a voice for commonsense legal reforms.”LITIGATION OVERDRIVE
Johnson & Johnson is fending off tens of thousands of products liability lawsuits over talcum powder products, its transvaginal mesh devices, hip implants and widely used prescription medications including antipsychotic Risperdal and blood thinner Xarelto. (A description of ongoing legal proceedings in the company’s most recent quarterly report filed with the U.S. Securities and Exchange Commission goes on for more than 10 pages.)
A host of law firms in addition to Beisner’s Skadden have been involved in those cases. Among them: Drinker Biddle & Reath and Shook, Hardy & Bacon.
“No company is facing as much mass tort litigation as Johnson & Johnson,” said Shanin Specter, of Philadelphia’s Kline & Specter, which has won jury verdicts against J&J over pelvic mesh and Risperdal. “They are facing over 100,000 product liability suits in 22 separate product lines.”
Many of those cases involve J&J subsidiaries, such as Janssen Pharmaceuticals Inc., Ethicon Inc. and DePuy Orthopaedics Inc. But Stephen Sheller, who has partnered with Kline & Specter on Risperdal trials, said they follow a predictable pattern: Litigation “to the nth degree.”
The Chamber is “just one more bullet in their gun,” he said.
“If they can get a nonprofit to do their bidding, and do their thing, it saves them a lot of money,” said Sheller, founding partner of Sheller PC in Philadelphia. “You can contribute to the nonprofit and deduct a lot of those expenses as contributions.”
The connection doesn’t go unnoticed by plaintiffs attorneys suing J&J. They said they often find themselves fighting broad policy arguments that go beyond just their case at hand.
Sheller said those peripheral legal fights, over issues such as third-party funding or attorney advertising, delay cases against J&J. They also find their way into court cases brought against other companies facing similar products liability litigation.
“A common denominator is John Beisner, and it would be no surprise then that you’ll see consistent arguments from the Chamber or other tort reform groups he’s involved with and J&J,” said Leigh O’Dell, a principal at Beasley, Allen, Crow, Methvin, Portis & Miles in Montgomery, Alabama, who is co-lead plaintiffs attorney in the federal talcum powder litigation against Johnson & Johnson.
“And you might argue that John and others that defend or represent J&J are involved in the strategy making, and that proliferates through defendants in pharmaceutical litigation.”
In February, Lanier cited the Chamber’s “intimate relationship” with Johnson & Johnson to argue that the Chamber and three other organizations should not be allowed to file amicus briefs before the U.S. Court of Appeals for the Fifth Circuit in the appeal of a $502 million hip implant verdict.
Lanier claimed the groups were essentially alter egos of Johnson & Johnson, making their amicus filings a cheat to allow the company to bypass page limitations on its briefs. The Chamber was represented by Mayer Brown partner Andrew Pincus in its proposed amicus brief, and Beisner was on Johnson & Johnson’s appellate team.
A Fifth Circuit judge granted Lanier’s request as to the three other tort reform groups—two of which had Johnson & Johnson executives on their boards—but, without addressing its reasons, allowed the Chamber to file its brief.
Many of Lanier’s arguments about the overlap between the Chamber and J&J rested on Beisner, who serves “their common interests in litigation and legislative endeavors.” He also said that J&J historically had held leadership roles for both the Chamber and its affiliates, specifically referencing one executive who serves as the Chamber’s co-chairman of global health and the economy and one who is an advisory board member to the Chamber’s foundation. No Johnson & Johnson executives serve on the Chamber of Commerce board or the board of its litigation center, the division that handles amicus briefs.WHO’S IN THE DRIVER’S SEAT?
A flood of litigation over the blood thinner Xarelto, made by Johnson & Johnson subsidiary Janssen, could be seen as a case study in the synergistic interests and advocacy of J&J and the Chamber.
With more than 16,000 cases over Xarelto pending in federal court in New Orleans, the litigation has become the Chamber’s poster child in a fight to curb what it sees as rampant plaintiffs attorney advertising.
Last August when Lisa Rickard, president of the Institute for Legal Reform, wrote an opinion articlecalling for more regulation of attorney ads, she cited a report funded by Janssen and co-authored by a Janssen employee and a consultant for Janssen.
The report, submitted to the U.S. Food and Drug Administration, found at least 30 people suffered strokes, heart attacks and other serious medical problems when they stopped taking Xarelto after seeing a lawsuit commercial. Two people died.
The report was also referenced by Virginia Republican U.S. Rep. Bob Goodlatte, chairman of the House Judiciary Committee and a Chamber ally on tort reform, during this year’s tort reform pushin the U.S. House of Representatives.
Later that month, the report turned up again. This time it was referenced in Johnson & Johnson court filings ahead of the first Xarelto jury trial. Plaintiffs attorneys had filed motions to bar the defense from referring to TV ads concerning Xarelto. In an April 12 response, lawyers for Johnson & Johnson and Bayer cited the report in countering that complaints about the drug were “driven by pervasive and aggressive attorney advertising.”
U.S. District Judge Eldon Fallon of the Eastern District of Louisiana granted the plaintiffs’ requests, and the advertising issue never became part of the trial.
Another big issue for the Chamber, third-party litigation financing, has come up in cases against Johnson & Johnson. In Xarelto litigation pending in the Philadelphia Court of Common Pleas, lawyers for Bayer and Johnson & Johnson filed a motion in April that, if granted, would force plaintiffs attorneys to disclose litigation financing of their cases. Johnson & Johnson also asked for that information last year in federal cases over talcum powder, but U.S. District Judge Freda Wolfson in New Jersey denied the request.
Then there’s Missouri, where Johnson & Johnson has suffered losses totaling more than $300 million in suits over talcum powder and where the Chamber has aggressively pushed bills that would make it harder to bring products liability cases there.
The lawsuits allege Johnson & Johnson’s baby powder and Shower to Shower products have caused women to get ovarian cancer. In its first appeal, J&J’s lawyers criticized Missouri’s standards for allowing scientific experts at trial. They also challenged a jurisdictional rule that allowed out-of-state plaintiffs to join talcum powder cases in Missouri state court.
The Chamber has lobbied on both issues, and in late March, Missouri Gov. Eric Greitens, a Republican, signed a bill that would change the expert evidence standard.
The Chamber’s Rickard immediately praised the move: “Missouri is turning the corner on legal reform,” she said in a statement. The law becomes effective on Aug. 28.
http://www.law.com/sites/almstaff/2017/08/18/for-plaintiffs-bar-taking-on-jj-means-battling-a-shadow-foe/?slreturn=20170721014634
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J&J Unit Looks To Block Damages After Pelvic Mesh Win
Aug 18, 2017 | Law 360
By Matt Fair
Law360, Philadelphia (August 18, 2017, 5:33 PM EDT) -- A Johnson & Johnson unit has launched an appeal challenging a Pennsylvania judge's order reviving a woman's bid for damages over injuries she claims she suffered after receiving a pelvic mesh implant, despite a recent jury verdict clearing the company of liability.
Ehticon Inc. said Wednesday that it would ask the Pennsylvania Superior Court to weigh in after a judge agreed that a jury had been inconsistent in its conclusion that, while a mesh implant received by a plaintiff had been defectively designed, it was not the cause of injuries that were acknowledged by both sides.
“At trial, the jury decided in favor of Ethicon and determined that the company’s product did not cause the plaintiff’s injuries,” spokeswoman Kristen Wallace said. “We have filed an appeal to the Superior Court solely regarding the granting of a new hearing on damages, because we believe that it was not right to set aside what the jury decided.”
A jury concluded in June that Ethcion’s so-called TVT Secur pelvic mesh — which Kimberly Adkins had implanted in July 2010 to treat her urinary stress incontinence — had been defectively designed, and that the company had failed to provide adequate warnings about its risks.
They declined, however, to back claims that the Ohio resident had suffered any injuries as a result of the implant.
Adkins argued in post-trial motions that three doctors who testified in the case — her treating physician, a plaintiff’s expert and a defense expert — all acknowledged that the mesh caused injuries including bleeding during sex and that, as a consequence, it needed to be removed.
Adkins filed suit in July 2013 seeking damages after a portion of the TVT Secur implant eroded into her vaginal canal and left her in significant pain. The mesh erosion resulted in her undergoing surgery to remove a portion of the implant in September 2012.
In addition to claiming that the jury had returned an inconsistent verdict in concluding the mesh had not been a factor in her injuries, post-trial motions Adkins filed in the case also called for upending a finding that the woman’s implanting physician had been properly warned about the risks of the product.
But the judge stopped short of reversing that ruling. Nor did he assent to overturn the results of the trial on the grounds that one of the jurors worked with polypropylene mesh in her position as a medical engineer for GlaxoSmithKline.
Ethicon’s victory at the trial came after losses in four prior mesh-related cases dating back to December 2015 that have left the company facing nearly $50 million in damages.
An attorney for Adkins did not immediately return a message seeking comment on Friday.
Adkins is represented by Bryan Aylstock, Daniel Thornburgh and James Barger of Aylstock Witkin Kreis & Overholtz PLLC, Benjamin Anderson of Anderson Law Offices, and Lee Balefsky, Christopher Gomez and Christine Clarke of Kline & Specter PC.
Ethicon is represented by Kimberly Bueno of Scott Douglass & McConnico LLP, William Gage, Chad Hutchinson and Jordan Walker of Butler Snow LLP; and Kenneth Murphy, D. Alicia Hickok, Melissa Merk and Andrew Reeve of Drinker Biddle & Reath LLP.
The case is Kimberly Adkins v. Ethicon Inc. et al., case number 130700919, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
--Additional reporting by Dan Packel. Editing by Philip Shea.https://www.law360.com/articles/955799/j-j-unit-looks-to-block-damages-after-pelvic-mesh-win
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Ethicon Appeals Post-Defense Verdict Move to Damage Hearing in Pelvic Mesh Case
Aug 17, 2017 | The Legal Intelligencer
By Max Mitchell
Ethicon, the main defendant in the pelvic mesh mass tort in Philadelphia, is appealing a judge's decision to revive a suit that initially ended in a win for the manufacturer.
A common pleas court judge in July determined the case, captioned Adkins v. Ethicon, should move to a damage hearing, even though a jury handed up a defense verdict in June. The Johnson & Johnson subsidiary, which is facing more than 100 lawsuits in Philadelphia over its pelvic mesh products, filed a notice Wednesday stating it plans to appeal that decision to the Pennsylvania Superior Court.
The four-page notice, which was filed by Drinker Biddle & Reath attorney Alicia Hickok, said the appeal is interlocutory, and only deals with the decision to reinstate the case.
In an emailed statement, a spokeswoman for Ethicon noted that the jury determined the product did not cause Kimberly Adkins' injuries.
"We have filed an appeal to the Superior Court solely regarding the granting of a new hearing on damages, because we believe that it was not right to set aside what the jury decided," spokeswoman Kristen Wallace said in the statement.
Adkins' attorney, Bryan Aylstock of Aylstock, Witkin, Kreis & Overholtz in Pensacola, Florida, said in an emailed statement that, given that the jury initially determined the mesh had been defectively designed, he was disappointed by the immediate appeal.
"This interlocutory appeal could further delay justice for Ms. Adkins," he said. "That said, we intend to vigorously oppose this appeal so that the jury can award Ms. Adkins the appropriate amount of damages for the harm and disfigurement that she has suffered as a result of the implantation of the defective TVT-Secur mesh device.
On June 9, a Philadelphia jury had handed up a defense verdict in the case. It was the fifth pelvic mesh case to be tried out of Philadelphia's pelvic mesh mass tort program, and the only case to have ended in a defense win.
Philadelphia Court of Common Pleas Judge Michael Erdos' one-page order filed July 19 granted plaintiff Adkins' post-trial motion contending that the jury's findings were inconsistent on the issue of whether the alleged design defect caused the injuries, and said the case should proceed to a damages hearing.
Adkins' motion, which was filed June 19, argued the jury's determination that the product had been defectively designed but not the cause of the plaintiff's injuries was against the weight of the evidence.
The defense win in Adkins' case came about two months after another Philadelphia jury awarded a woman $20 million, including $17.5 million in punitive damages. In May, a jury awarded another plaintiff $2.1 million over similar claims.
The first case to hit trial out of Philadelphia's pelvic mesh mass tort ended with a $12.5 million award in December 2015. Soon after, the second pelvic mesh case came to a $13.5 million award, with the jury awarding $10 million in punitive damages.
As part of her post-trial arguments in the wake of the defense verdict, Adkins noted the testimony of defense expert Dr. John Wagner, who, she argued, had admitted the mesh caused her initial injuries and only disputed whether her current complaints were mesh-related.
Adkins also contended that she should have been allowed to strike one of the jurors off the case because that juror was a biopharmaceutical engineer with GlaxoSmithKline. The motion noted some comments the juror made suggesting the injuries often claimed in pelvic mesh cases stem from pre-existing injuries, and said the outcome of the case could potentially have an economic impact on the juror, given the juror's employer.
Erdos, however, denied that portion of the post-trial motions.
http://www.thelegalintelligencer.com/id=1202795828831/Ethicon-Appeals-PostDefense-Verdict-Move-to-Damage-Hearing-in-Pelvic-Mesh-Case?slreturn=20170721014706
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Aug 21, 2017 | The Daily Mail
By Stephen Matthews And Alexandra Thompson
· Floods of affected women have made contact with London firm Wedlake Bell
· In recent weeks it has been inundated with requests from outraged women
· Wedlake has had to set-up an email inbox dedicated to dealing with new cases
At least 10 women each day are approaching lawyers demanding compensation for the life-changing damage caused to their bodies by controversial vaginal mesh, it has emerged.
Following cries for the scandal-hit procedure to be halted, backed by MailOnline, floods of affected women who have had their lives destroyed by such devices have sought help from Wedlake Bell.
The leading London-based legal firm have been inundated with desperate requests from outraged women seeking answers and action since it launched an email inbox dedicated to dealing with those afflicted.
The alarming figures follow our revelations that the NHS has chosen to ignore damning studies that showed the vaginal mesh complication rates to be significantly higher than officials are willing to admit.
Thousands of British women are known to have been left suicidal, unable to have sex and plagued with infections as a result of the controversial procedure - but those responsible are trying to sweep the issue under the carpet.
David Golten, partner at Wedlake, spoke of his grave concerns towards the surgery and has backed campaigns to call for an end to brittle vaginal mesh implants, which erode inside women and leave them in a lifetime of pain.
He told MailOnline: 'Our dedicated email address for people to communicate with us only went up around two months ago. In the last few weeks we are getting 10 new approaches a day.'
Mr Golten added: ‘The Mail has a history of successful campaigns. We hope that it will reach out to the women whose lives have been ruined by these devices and encourage them to join the efforts to get it banned.
‘Media campaigns are so important because the more women there are, the stronger their [those affected women] voice is.' He said such media attention applies pressure on the Government and on the NHS to take action to stop using the devices.
But these are figures are just the tip of the iceberg and are from just Wedlake, who specialise in taking action on vaginal mesh. It is unknown how many other women affected requested legal help from other firms.
Wedlake hand out questionnaires to all new members of Sling The Mesh, a campaign group dedicated in fighting for an end to the practice which has seen its member count double to 2,600 since April - when the scandal first came to light.
New women are asked if they want to obtain legal help for their life-changing side effects. So far that 250 have returned them with clear indications that they are happy to proceed in seeking action from lawyers.
But Mr Golten added that ‘there are lots more’, probably in the region of 10,000 across England and Wales, who have yet to realise the true extent of damage that the mesh may have done to their body.
Mr Golten said he suspects the true rate of adverse effects to be much closer to the 10 per cent mark, in line with various medical journals, despite the NHS and MHRA stating it to be 1 to 3 per cent.
Earlier this week, MailOnline reported on a host of evidence that clearly shows adverse effects of the surgery to strike up to 40 per cent of women. Others suggest it could be as high as 75 per cent.
Such studies encouraged doctors to suspend the procedures in three US states, with the device being considered high-risk across America for nearly a decade, as officials accept that up to 40 per cent of women may experience injury.
Senior doctors have already called for a public inquiry into its use in Britain, saying it could be akin to the thalidomide scandal. The procedure, used to treat childbirth problems, has seen more than 800 women sue the NHS and device manufacturers.
Figures estimate that more than 92,000 women in England underwent vaginal mesh procedures between 2006 and 2016.
http://www.dailymail.co.uk/health/article-4775826/10-women-DAY-seeking-help-lawyers-vaginal-mesh.html
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The Vaginal Mesh Scandal: Why Hundreds Of Women Are Suing Over Treatment
Aug 18, 2017 | Elle
By Louise Donovan
NHS figures show one in 15 women fitted with the vaginal mesh implants will require surgery to extract it
Let's start the beginning. What the hell is a vaginal mesh implant? If you've never given birth, there's a high chance you'll have no knowledge of this fairly common procedure.
The implants are used to treat pelvic organ prolapse and incontinence after childbirth, and are less invasive than traditional surgical approaches.
A plastic mesh is inserted into the vagina, or vaginal wall, and left there to help support the womb.
'This allows the angle between the urethra and the bladder to be a better shape to allow the woman to be continent rather than incontinent,' consultant gynecologist and obstetrician Dr Amed Ismail, from Queensway Gynecology Clinic, told The Huffington Post UK.
According to a 2012 government report, the procedure is performed on about 15,000 women in the UK per year. For the majority of women, the operation is successful, but concerns are increasingly mounting over large numbers of patients suffering severe complications.
New NHS figures show that one in every 15 women fitted with the vaginal mesh implant in the past ten years has had it removed. These figures only contribute to the growing controversy around the use of vaginal mesh, after the BBC's Victoria Derbyshire show revealed in April that more than 800 women are suing either the NHS or the device manufacturers, after experiencing complications.
In other words, the problems are much more widespread than previously acknowledged.
At the moment, according to the Independent, 500 patients in Britain are embroiled in legal action against mesh manufacturers, and up to 2,000 are planning to sue.
The side effects can range from chronic pain and loss of sexual function, to major complications like the implant protruding, and bursting, through the bladder or bowels.
Complications are usually caused by the mesh eroding and breaking down into smaller pieces, which can potentially move around in the body. To remove one fully can require hours of surgery and can risks damage to nerves and nearby organs.
Senior doctors are referring to it as the most serious women's health scandal since thalidomide - the 'risk-free' sedative designed to combat morning sickness in pregnant women that led to a dramatic global spike in the birth of deformed babies in the late 1950s.
Many women who've experienced problems have spoken out about experiencing intense pain, sometimes leaving them unable to walk, work or have sex.
Carolyn Churchill, 57, told the Guardian she was 'in absolute agony, but [the doctors] wouldn't listen to me and made me feel like some sort of baby, and that it was normal.'
'If I could have walked to the A&E that night, I would've begged them to take it out.'
Churchill underwent the procedure because she was 'bothered' by stress incontinence, which affects roughly 10% of women. She experienced 'ripping, burning' pains in her side and legs, and the soles of her feet often went numb.
She was 'horrified' to discover the mesh had eroded the wall of her vagina.
The doctors, she says, were reluctant to blame the mesh implant and instead offered her hip X-rays, physiotherapy - 'which made the pain worse' - and mental health counselling.
In 2015, Kath Sansom, a journalist and campaigner, had the procedure to treat occasional stress incontinence. Severe symptoms began to kick in 10 weeks after, including constant pain in her legs, feet, groin and private parts 'burning so badly it's like someone has poured a bottle of chilli sauce inside it,' she told The Independent.
IF I COULD HAVE WALKED TO THE A&E THAT NIGHT, I WOULD'VE BEGGED THEM TO TAKE IT OUT
'For some women 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.'
Sansom started the Sling the Mesh campaign to try and raise awareness about the risks involved in what is perceived as a common practise procedure. The mesh treatment has been the centre of a suspicion and controversy after NHS meeting minutes, obtained by the Press Association from 2016, revealed bosses plotted to 'avoid media attention' about potential complications.
When the minutes were published, authorities were accused of covering up the real risks of treatment.
The whole thing stinks of sexism and a devaluation of both a woman's comfort and sexual fulfilment.
If the sexual desires or genitalia functioning of hundreds of men was being affected by a medical procedure, would said procedure still be in use by the NHS? Highly doubtful.
'I think the government should take responsibility,' says Churchill. 'When there was all the problems with breast implants they stood up and said it would never happen again. And all that time, it was already happening to thousands of us. I want someone to stand up and say sorry for what they've done to us.'
http://www.elleuk.com/life-and-culture/culture/news/a37893/vaginal-mesh-scandal-why-women-suing/
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Informed Consent – What We Are Learning
Aug 18, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, August 18, 2017 ~ What are we learning about Informed Consent? Almost all medical bodies agree informed consent, sharing information about pros and cons of a procedure to educate a patient, is important!
But what is informed consent when it comes to pelvic and hernia mesh?
What do people wish they had heard before the procedure? The list is long and growing.
We hear the term “Informed consent” in the context of mesh implants. Patients, whether hernia or pelvic mesh patients, are owed an explanation of the potential downfalls of their mesh implant.Informed consent is not only information about your treatment options, from your medical provider, but it is the pros and cons of a procedure, drug or device that helps you make an informed decision.
Ideally, the language is in a written form you can take home and study before making a decision that’s right for you, rather then when you are on a gurney ready to be wheeled into surgery.
There is a world of difference among professionals, marketers, scientists, consumers, and doctors as to what informed consent should look like. And any information based on marketing alone is hardly informed consent.
In a March 2017 report (here), it finds that two in 10 GPs didn’t understand surgery for incontinence or pelvic organ prolapse and almost half did not believe that complications could be mesh-related.
In the U.S., at the last session of the American Urogynecologic Society, those who brought to light their mesh complications were denigrated and called part of the “Anti-Mesh Movement” by the group’s president.
So how can there be agreement on transvaginal or hernia informed consent when there is so much disagreement?We can listen and we can learn from those mesh-injured about what they wish they knew before their mesh implant including:
Mesh is a permanent implant and may not be able to be removed.
Mesh placement is a blind procedure using stainless steel trocars that resemble a hook. They too can cause injuries, so much so, that they have been upgraded to a high risk status, Class III, by the FDA.
Pelvic and hernia mesh was never tested in humans before it was marketed.
You have some chance of being harmed sexually, also known as dyspareunia. Many women report they can no longer have sexual relations after their mesh implant. Many men have pain after a mesh implant. Testicle loss is a possibility.
Biofilm infections are possible, which cannot be treated with antibiotics.Autoimmune issues have been reported including pain, aches, fibromyalgia, rheumatoid arthritis, Lupus, rashes, brain fog, dental problems, among others.
Your doctor may have been trained in a weekend cadaver clinic and may be a preceptor or consultant for the company that makes the mesh he is using. What is his/her training?
Mesh placement is a blind procedure using stainless steel trocars that resemble a hook. They too can cause injuries, so much so, that they have been upgraded to a high risk status, Class III, by the FDA.
Pelvic and hernia mesh was never tested in humans before it was marketed.
You have some chance of being harmed sexually, also known as dyspareunia. Many women report they can no longer have sexual relations after their mesh implant. Many men have pain after a mesh implant. Testicle loss is a possibility.
Biofilm infections are possible, which cannot be treated with antibiotics.
Autoimmune issues have been reported including pain, aches, fibromyalgia, rheumatoid arthritis, Lupus, rashes, brain fog, dental problems, among others.
Your doctor may have been trained in a weekend cadaver clinic and may be a preceptor or consultant for the company that makes the mesh he is using. What is his/her training?
You may experience a return of incontinence or prolapse after your mesh surgery.
You may face repeated surgeries to remove the mesh or to reconstruct your pelvic region.
Surgical injury to the bladder, colon, and pudendal nerve has been reported during pelvic mesh placement or removal surgery.
There are more than 150,000 defective product lawsuits filed against seven mesh manufacturers around the world. Hernia mesh lawsuits are consolidating in multidistrict litigation.
Many pelvic meshes have been quietly removed from the market.
Some resin is suspected to have been smuggled into the U.S. is low-grade and adulterated polypropylene resin from China.
A number of devices, still on the market, have been found to be defectively designed.
Pelvic mesh should never be implanted in a woman who may become pregnant, who has a pre-existing condition; a heart-lung patient; in a patient with diabetes; in a woman who exercises regularly; in a patient with a pacemaker; or into someone who can’t undergo anesthesia.
According to the FDA in a July 2011 Safety Communication, the FDA reported that complications are “not rare” and that in most cases, pelvic organ prolapse (POP) can be successfully treated without pelvic mesh.FDA- Mesh used in transvaginal POP repair introduces risks not present in traditional non-mesh surgery for POP repair.
FDA – Mesh placed abdominally for POP repair appears to result in lower rates of mesh complications compared to transvaginal POP surgery with mesh.
FDA- There is no evidence that transvaginal repair to support the top of the vagina (apical repair) or the back wall of the vagina (posterior repair) with mesh provides any added benefit compared to traditional surgery without mesh.
FDA- While transvaginal surgical repair to correct weakened tissue between the bladder and vagina (anterior repair) with mesh augmentation may provide an anatomic benefit compared to traditional POP repair without mesh, this anatomic benefit may not result in better symptomatic results.
https://www.meshmedicaldevicenewsdesk.com/informed-consent-learning/
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Aug 21, 2017 | RX Injury Help (blog)
By Sandy Liebhard
Sandy Liebhard is an Senior Partner at Bernstein Liebhard LLP
Johnson & Johnson and Ethicon, Inc. have appealed a decision by a Pennsylvania judge to order a new hearing on damages in a transvaginal mesh lawsuit that went to trial earlier this summer.
The case, Adkins v. Ethicon, was decided in June when a jury in the Philadelphia Court of Common Pleas ruled for the companies. Even though jurors determine that Ethicon’s TVT-Secur mesh was defectively designed and found that the company had failed to warn plaintiff Kimberly Adkins about the implant’s risks, they denied her damages after concluding the transvaginal mesh device was not responsible for her injuries.
Adkins quickly motioned for a new damages hearing, arguing that the verdict was inconsistent with the evidence. The Court agreed and granted her motion in late July.
According to a report published today by The Legal Intelligencer, Johnson & Johnson and Ethicon have appealed that decision to the Pennsylvania Superior Court.
“We have filed an appeal to the Superior Court solely regarding the granting of a new hearing on damages, because we believe that it was not right to set aside what the jury decided,” one of the company’s attorneys told The Legal Intelligencer.
Transvaginal Mesh Litigation
Ethicon is the main defendant in a mass tort program currently underway in Philadelphia that includes more than 100 transvaginal mesh lawsuits. Women pursuing these cases claim that vaginal mesh implants marketed by Ethicon and other defendants to treat stress urinary incontinence and pelvic organ prolapse were defective and erode in the vagina, leading to chronic pain, scarring, adhesions, infections, and other life-changing and permanent complications.
The Adkins’ verdict was the first time a Philadelphia jury had found in favor of Johnson & Johnson and Ethicon in a transvaginal mesh lawsuit. The companies had been ordered to pay damages of $2.16 million, $12.5 million, $13.5 million and $20 million at the conclusion of four previous trials.
More than 54,000 women are currently pursuing pelvic mesh lawsuits against Johnson & Johnson and Ethicon in courts nationwide. Tens of thousands of additional cases have been filed against Boston Scientific Corp., C.R. Bard, Inc., and other device makers.
Transvaginal Mesh Complications and Warnings
The U.S. Food & Drug Administration (FDA) has issued several warnings regarding the use of transvaginal mesh devices, after the agency received thousands of adverse event reports involving the implants. In 2011, the FDA said it no longer considered complications associated with transvaginal prolapse repair to be rare, and expressed doubts that these devices offer any additional benefits over traditional, non-mesh methods of prolapse repair.
Most recently, the FDA issued new regulations that made transvaginal mesh indicated for prolapse repair ineligible for the agency’s 510(k) clearance protocols, which allowed the devices to come to market without the benefit of human clinical trials.
While it has never conducted a transvaginal mesh recall, Ethicon announced in 2012 that it would end sales of TVT-Secur mesh and three implants. In doing so, the company cited commercial concerns rather than safety reasons. However, the FDA had previously ordered Ethicon and other vaginal mesh manufacturers to conduct further research into the risks associated with their products.
http://www.rxinjuryhelp.com/news/2017/08/18/johnson-johnson-ethicon-appeal-decision-granting-transvaginal-mesh-lawsuit-plaintiff-new-damages-hearing/
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