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Ethicon Media Monitoring 11/5/2018
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Vaginal 'rejuvenation' using lasers 'takes an uncertain treatment too far', say doctors
Nov 5, 2018 | Newcastle Herald
By Joanne McCarthy
Vaginal “rejuvenation” laser treatments introduced to Australia without clinical trials could be the next major women’s health scandal, say specialists and academics in an extraordinary warning comparing the risks of vaginal laser treatments with the pelvic mesh scandal. -
Plaintiffs Lawyers Fight to Keep $4.7B Talc Verdict, Citing J&J's 'Perfect Storm' of Misconduct
Nov 2, 2018 | Law.com
By Amanda Bronstad
Johnson & Johnson’s refusal to warn consumers its baby powder might cause ovarian cancer, despite four decades of knowing about the risk, created a “perfect storm of highly reprehensible conduct” that warranted a $4.7 billion verdict in Missouri. -
Scottish Legal Review: Can we settle out of court?
Nov 1, 2018 | The Scotsman
By Sarah Devine
A hot topic of conversation among Scotland’s litigators over the last year has been the Civil Litigation (Expenses and Group Proceedings) Bill, which was passed by the Scottish Government in May, with secondary legislation yet to be enacted.
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Vaginal 'rejuvenation' using lasers 'takes an uncertain treatment too far', say doctors
Nov 5, 2018 | Newcastle Herald
By Joanne McCarthy
Vaginal “rejuvenation” laser treatments introduced to Australia without clinical trials could be the next major women’s health scandal, say specialists and academics in an extraordinary warning comparing the risks of vaginal laser treatments with the pelvic mesh scandal.
Doctors have been warned to “consider the potential medico-legal consequences” of using laser treatments because of the lack of evidence supporting their use for “vulvovaginal atrophy”, and the Urological Society of Australia and New Zealand has asked health regulator the Therapeutic Goods Administration to review the treatments, said an article in the Medical Journal of Australia on Monday.
Queensland University urogynaecologist Christopher Maher, who sounded the alarm on pelvic mesh more than a decade before it became an Australian and global scandal, said the rise of carbon dioxide laser therapy to treat vaginal atrophy “causes some anxiety for me”.
“We have been through all this within the past 10 years with transvaginal meshes and we’re still going through it,” Associate Professor Maher said.
“Everyone wishes we had done things differently (with transvaginal mesh) but we are just repeating the same problems again.”
Monash University Professor of Women’s Health Susan Davis said the rise of laser therapy to treat menopausal symptoms was “extremely concerning”.
“While the jury is out, I believe that using this treatment in the community, at a cost to the individuals, is taking an uncertain treatment too far,” Professor Davis said.
The laser treatments are being offered in specialist, general practice and cosmetic medicine settings. The MJA article said the procedure costs more than $500 per treatment, with three initial treatments followed by annual treatments. It is unknown how many are being performed in Australia because they cannot be tracked by a specific Medical Benefits Schedule item number. A Senate inquiry into the pelvic mesh scandal heard evidence the number of women receiving mesh could not be determined for the same reason.
NSW gynaecologist Dr Richard Reid, who retired before he was deregisteredin September after multiple women experienced serious complications following pelvic mesh surgery by him, promoted “vaginal ageing” laser procedures in 2016 while under investigation by the NSW Health Care Complaints Commission.
Dr Reid was suspended in America in the 1990s after findings of incompetence involving women’s pelvic laser surgery.
In the MJA article on Monday Professor Davis, University of Melbourne Professor of Obstetrics and Gynaecology Martha Hickey, and Queensland gynaecologist Dr Melissa Buttini said the increasing use of laser therapy to treat menopausal syndromes was extremely concerning.
The TGA cleared laser therapy for “incision, excision, vaporization and coagulation of body soft tissues” during oral surgery, dermatology, ear, nose and throat surgery and gynaecology, but it was not specifically listed to treat menopausal syndromes. The TGA advised the Newcastle Herald in 2016 that medium or medium-high risk laser devices were approved on the basis of European certification.
Professor Davis called on the Royal Australian College of Obstetrics and Gynaecology (RANZCOG) to update its position on laser treatments for vaginal atrophy after the American Food and Drug Administration in July said it had “serious concerns” over the use of carbon dioxide laser therapy for “vaginal rejuvenation”.
RANZCOG’s website notes there is little high-quality evidence that laser therapy is effective, enhances sexual function or improves self-image. Complications included scarring, adhesions, permanent disfigurement, infection and difficult or painful sexual intercourse.
Professor Hickey said it was premature to offer women vaginal laser treatment for dryness or any other symptom until there was evidence to show it worked and was safe, and she had current ethical concerns about use of the treatment, the MJA article said.
“Currently we do not have this evidence,” she said.
The MJA article noted a trial of the MonaLisa Touch laser treatment at the Royal Hospital for Women at Randwick.
Until results of the trial and others outside Australia are known “it seems foolish to be using a technique that has the potential to do harm”, Professor Hickey said.
“For women who do require treatment, the best evidence we have currently, is that low dose oestrogen is the most effective treatment for vaginal dryness and is safe for the great majority of women.”
She warned that clinicians who had purchased expensive equipment to perform laser therapy had a conflict of interest in recommending it.
In August the Urological Society of Australia and New Zealand backed the American FDA’s warning about “deceptive health claims” relating to lasers and their use for reshaping vaginal tissue, menopause and improving sexual function.
“While the devices have been approved for use in the treatment of serious conditions such as the destruction of abnormal or pre-cancerous cervical or vaginal tissue as well as genital warts, the safety and effectiveness of these devices has not been evaluated for ‘vaginal rejuvenation’,” the society said.
“There have been reported cases of burns, scarring and pain associated with the use of the devices.”
Society special advisory group leader on female urology Associate Professor Vincent Tse said urologists were concerned by patients being referred to manage complications after ‘vaginal rejuvenation’ procedures.
“This is a technology for which there is limited scientific data to support its use for claims associated with vaginal atrophy or incontinence and the FDA has acted wisely. We would encourage the TGA to also review claims made in Australia regarding this technology,” Associate Professor Tse said.
The TGA was contacted for comment.
https://www.theherald.com.au/story/5739378/vaginal-laser-therapy-risks-being-the-next-pelvic-mesh-scandal-doctors-warn/?cs=12
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Plaintiffs Lawyers Fight to Keep $4.7B Talc Verdict, Citing J&J's 'Perfect Storm' of Misconduct
Nov 2, 2018 | Law.com
By Amanda Bronstad
Johnson & Johnson’s refusal to warn consumers its baby powder might cause ovarian cancer, despite four decades of knowing about the risk, created a “perfect storm of highly reprehensible conduct” that warranted a $4.7 billion verdict in Missouri.
That’s according to the plaintiffs’ attorneys, who filed court documents Wednesday seeking to uphold the July 13 award, the largest verdict over talcum powder. Eric Holland, partner at Holland Law Firm in St. Louis, noted in his opposition to a motion for new trial on damages that while rare, “all factors support a large punitive damage award.”
“Defendants knew there was asbestos in what they marketed as ‘baby’ powder, but they deliberately targeted mothers and women in general with advertising misrepresenting the safety of their talc product,” Holland wrote.
Johnson & Johnson has moved to toss the award, calling it unconstitutional and excessive. It also alleges misconduct against the plaintiffs’ lead trial counsel, Mark Lanier. Among other things, the company claims Lanier referenced stillborn babies in his opening statement, changed words on his website in midtrial and showed the jury a drawing of a woman pushed over a ledge into ovarian cancer by Johnson & Johnson’s asbestos-containing baby powder.
“It is hard to conjure a more emblematic example of inflammatory and prejudicial statements at trial than statements about dead babies,” wrote Johnson & Johnson attorney Beth Bauer, a partner at HeplerBroom in Edwardsville, Illinois, in a Sept. 20 motion for a new trial. “The image of defendants pushing a woman off a cliff served one purpose only: to inflame the jury.”
Bauer was joined in the motions by Orrick, Herrington & Sutcliffe and Shook, Hardy & Bacon. Johnson & Johnson also filed a motion for a new trial on damages and a motion for a judgment notwithstanding the verdict.
It’s not the first time Johnson & Johnson has gone head-to-head against Lanier. In April, the U.S. Court of Appeals for the Fifth Circuit reversed a $502 million hip implant awardagainst its subsidiary, DePuy Orthopaedics, in part due to Lanier’s “unequivocally deceptive” conduct.
“Such deceptive tactics have no place in a courtroom and further warrant new trials of each plaintiff family’s claims,” Bauer wrote.
Lanier, in the plaintiffs’ responses on Wednesday, acknowledged he mistakenly referred to stillborn babies in his opening statement but did so only in reference to a study, not to allude that Johnson & Johnson’s baby powder caused their deaths. The plaintiffs’ lawyers also defended the drawing, over which Johnson & Johnson never objected during trial.
“Such attacks are typical for these defendants, and they have launched them repeatedly in the media against both the court and the jury,” Holland wrote in opposing a motion for a new trial, joined by The Lanier Law Firm and Gray Ritter & Graham in St. Louis. “Defendants’ repetitive and vindictive ad hominem attacks on Mr. Lanier are a PR stunt and do not advance the litigation. Litigants who lose and disapprove of opposing counsel’s trial tactics are not for that reason entitled to a new trial.”
A St. Louis jury awarded $550 million in compensatory damages and $4.05 billion in punitive damages. The trial was the first talcum powder case for Lanier and the first ovarian cancer award in a case alleging Johnson & Johnson’s talcum powder contained asbestos, a known carcinogen.
Johnson & Johnson’s posttrial motions argued that the plaintiffs’ attorneys failed to provide sufficient evidence that its baby powder caused ovarian cancer or that it caused the disease in each individual plaintiff. They criticized the testimonies of the plaintiffs’ experts and said the plaintiffs’ attorneys misconstrued Missouri’s law on causation, an allegation opposed on Wednesday.
In its motion for a new trial on damages, Johnson & Johnson suggested that the compensatory damages be no more than $3 million per plaintiff. The company also challenged the use of a coordinated trial of 22 women because it was “inherently unfair” and “highly prejudicial,” an approach borrowed from its arguments in the hip implant verdicts.
Six plaintiffs died from ovarian cancer, several had spouses with additional claims, and each differed in their talcum powder use and prognoses.
“The proof is in the results: After five hours of jury instructions, the jury deliberated for only eight hours—less than 20 minutes per plaintiff,” Bauer wrote in the new trial motion. “Each family received the same $25 million in total compensatory damages, without any apparent regard for the individual circumstances of any particular plaintiff. The excessive and unconstitutional $4.14 billion punitive damage award highlights the combined effect of these rulings. Simply put: The trial was not fair, and the court should grant new trials for each individual plaintiff family.”
In responding, the plaintiffs’ lawyers turned to the U.S. Court of Appeals for the Eleventh Circuit’s 2017 ruling upholding a $27 million verdict in a consolidated trial of four women against Boston Scientific Corp. over its pelvic mesh products.
The $4.7 billion verdict came in the first talcum powder trial since the U.S. Supreme Court’s decision in Bristol-Myers Squibb v. Superior Court of California, which made it harder for nonresident litigants to pursue claims in lawsuits with multiple plaintiffs.
In its motion for a judgment notwithstanding the verdict, Johnson & Johnson, based in New Jersey, continued to site Bristol-Myers, noting that 17 of the 22 plaintiffs were not from Missouri. The plaintiffs’ attorneys wrote on Wednesday that a Missouri talc supplier had established jurisdiction.
https://www.law.com/2018/11/02/plaintiffs-lawyers-fight-to-keep-4-7b-talc-verdict-citing-jjs-perfect-storm-of-misconduct/?slreturn=20181005023454
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Scottish Legal Review: Can we settle out of court?
Nov 1, 2018 | The Scotsman
By Sarah Devine
A hot topic of conversation among Scotland’s litigators over the last year has been the Civil Litigation (Expenses and Group Proceedings) Bill, which was passed by the Scottish Government in May, with secondary legislation yet to be enacted. It aims to add clarity over legal expenses and sets a cap on success fee agreements.
It also introduces qualified one-way cost shifting, meaning that pursuers of a personal injury action may no longer face legal costs if they are unsuccessful. An increased work flow for litigators is anticipated as a result.
“This will take away some of the financial risk from pursuers in court cases,” believes Stephen Goldie, head of litigation at Brodies.
“We are active in the insurance and risk sector so we have a number of insurance and risk clients that we act for. If you take away the cost risk for the pursuer, then it may lead to an increase in the number of cases, where people otherwise might think twice about starting the claim.
“At the moment, the situation is that if you are the pursuer and you start a case and you lose it, you have to pay the defender’s legal expenses.
“With this qualified one-way cost shifting, it is going to take away that financial risk from the pursuer.
“So if you factor things like that in to the current climate, then I think we could see an increase in litigation.”
It has been a busy year for the dispute resolution and litigation team at Brodies, particularly with constitutional Brexit-related issues.
Litigation partner and chair of the firm Christine O’Neill acted as junior counsel in the Scottish Government’s legal team in July, when the UK Government challenged Holyrood’s Brexit Continuity Bill.
The team’s other areas of focus have been health and safety, contentious construction and regulatory issues.
Meanwhile Gary Moffat, litigation partner at Burness Paull, is focused on the legislation’s creation of group proceedings, similar to the US’s class-actions which have the aim of reducing legal costs for individuals.
He points to the firm’s acting on behalf of the manufacturers of allegedly dangerous mesh implants and hip replacements, which have been widely reported on.
He says: “The way [these kinds of cases] run at the moment is that you have every individual who has been impacted by the issue raising one action, so if you have 100 people then 100 separate processes have to go through. Under a class action you would group together into one big case. That is the biggest change we will see coming out of it and we are doing that already.”
Moffat’s team also reports a busy year for 2018 and, with four significant fraud cases worth a total of £10 million running, there are no signs of business slowing down.
He predicts health and safety will be a driver of growth for 2019 as his team are involved in separate upcoming fatal accident inquiries into helicopter crashes at the Clutha Bar, in Glasgow, and off Sumburgh, in Sheltand, which both occurred in 2013.
While litigation involves court, mediation is a quicker, private alternative form of dispute resolution and is something John Sturrock QC, senior mediator and chief executive of Core Solutions, predicts will be used increasingly in the near future.
He says it “enables the key players, the real decision makers, to confidentially explore the legal, commercial and technical points and negotiate agreements, usually in one day.”
The key, according to Sturrock, is that the people affected can retain control over the outcome instead of a third party making a decision on their behalf.
At the beginning of October, the Scottish Parliament published a report entitled “I Won’t See You in Court: Alternative Dispute Resolution in Scotland” and called for increased use of alternative dispute resolution methods, including mediation.
Sturrock says that the courts are now thinking differently about litigation as a last resort. He adds: “I think that the awareness of the benefits of mediation is growing among the institutions and businesses that traditionally might have used litigation.
This seems to herald a real change in culture and attitude in use of mediation. “There is a worldwide movement away from litigation, Scotland has been part of that and we progress quite quickly sometimes.
“But around the world people are using mediation much more as an alternative to litigation to speed up dispute resolution. I think that is going to continue.”
https://www.scotsman.com/business/companies/scottish-legal-review-can-we-settle-out-of-court-1-4821348
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