Preview Newsletter
Ethicon Media Monitoring 1/22/2018
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Back to all news Peter Finamore, MD: Pressing Urogynecology Needs, Treatments
Jan 22, 2018 | MD Magazine
By Kevin Kunzmann
The most pressing area of development in urogynecology is the development of a registry for our patients. -
Canadian Courts Gearing up for Pelvic Mesh Litigation
Jan 22, 2018 | Mesh Medical Device Newsdesk
In Canada, there is no multidistrict litigation like there is in the U.S. where many pelvic mesh product liability cases are filed in one federal court for resolution. -
Teaching assistant is SUSPENDED over a magazine interview about how 'designer vagina' treatment boosted her sex life - but insists she was raising awareness of medical issues
Jan 22, 2018 | The Daily Mail
By Siofra Brennan
... Ms Hanson claims she's only received a positive reaction to the article, and said that she was eager to make other women aware of the treatment options available to them after the recent scandal over vaginal mesh implants. -
Transvaginal Mesh Collateral Damage Too High for TVM Settlement
Jan 22, 2018 | Lawyers and Settlements
By Jane Mundy
“The Transvaginal Mesh settlement offered by Boston Scientific isn’t enough to cover the collateral damage my family has suffered.”
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Back to all news Peter Finamore, MD: Pressing Urogynecology Needs, Treatments
Jan 22, 2018 | MD Magazine
By Kevin Kunzmann
Where are the most pressing areas of development in urogynecology?
The most pressing area of development in urogynecology is the development of a registry for our patients. Traditionally, the treatment for urogynecologic conditions has been carried out by general gynecologists, as well as same generally urologists. In about the last 10 to 15 years, we've developed subspecialty fellowships in this area to really kind of train surgeons how to deal with these issues in a more specific way. A registry would allow us to really kind of track these patients, track the success of some of these surgeries and some of the risks of complications, and hopefully guide better patient care by allowing us to follow the surgeons and the particular operations, and really develop a better way to care for our patients. So I think that would be very helpful to those of us who practice urogynecology.
What therapies, technologies, or practices are in development for the field?
One of the most important things that we've been working in a new area of research in urogynecology is the use of trans-vaginal mesh for prolapse. We've been using mesh for many years in urogynecology and in general surgery for a variety of different reasons. Several years ago people started to use trans-vaginal mesh to help lift some of these prolapsed organs — if a woman had a dropped bladder or prolapsed uterus, people were putting mesh vaginally to help cure that problem.
In 2011 the FDA issued a public health notification about trans-vaginal mesh, and it's become quite controversial. There are a lot of studies that have been going on since that point, where we're kind of trying to figure out the details of this. Is there a type of mesh that would work well for this type of operation, is there a patient that would benefit more from a trans-vaginal mesh.
I'm kind of anxiously waiting some of the research that's been going on for the last several years regarding trans-vaginal mesh to see if there is a potential role in our treatment for the condition of prolapse.http://www.mdmag.com/medical-news/peter-finamore-md-pressing-urogynecology-needs-treatments
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Canadian Courts Gearing up for Pelvic Mesh Litigation
Jan 22, 2018 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, January 19, 2018 ~ In Canada, there is no multidistrict litigation like there is in the U.S. where many pelvic mesh product liability cases are filed in one federal court for resolution.
The Canadian system of justice concerning pelvic mesh litigation leads the injured to join a class action or to file for an individual settlement.
Is your case individual or a class action?
Even with no multidistrict (MDL) litigation in Canada, the thousands of defective product pelvic mesh cases are moving toward resolution.
Compare that to the U.S, where 105,000 are filed in one court in Charleston, WV, with thousands more pelvic mesh cases filed around the country – New Jersey, Philadelphia, and Los Angeles – for example, in Canada there are only about 2,000 defective product cases filed against five mesh manufacturers.
Since Canada has a considerably larger land mass than the US, with only about one-tenth the population, a general guideline is it will have about one-tenth of any number in the U.S.
If so, that means there are many more pelvic mesh cases waiting to be filed.Class Action Cases
Because there is no MDL system in Canada, a couple thousand women are currently enrolled in class actions, personal injury pelvic mesh lawsuits against AMS (American Medical Systems), Boston Scientific, Coloplast, Cook and Covidien.
Johnson & Johnson (Ethicon) is waiting to be certified as a class following a procedural motion.
Siskinds law firm of London, Ontario has one of the largest inventories of pelvic mesh cases filed in a class, approximately 1,000 pelvic mesh cases.
Attorney, Jill McCartney, a partner with Siskinds, tells MND that some issues, which are common to the class, can be decided at a common issues trial for the whole group.
“There are common issues that can be decided for the whole group at a common issues trial, such as breaches of the standard of care, including defective design and failure to warn, and general causation. Then the litigation would proceed to individual trials for each class member on specific causation of their individual mesh related injuries and damages, for example, ‘Ms. Brown had her mesh implanted on a certain date and subsequently it caused erosion with infections,’ ….”
Those injuries must also be quantified, she adds.
McCartney says they use a class to promote access to justice since it’s a better vehicle for inclusion of all women with mesh products. For litigation outside of the class action, the class member must have an individual action and may need a trial on all issues for each plaintiff.
“A cost benefit analysis must be undertaken and in Canada the cost benefit analysis may not make sense for an individual action in all mesh implant cases depending on the circumstances and facts of the individual and the potential case.”
That means Siskinds, as class counsel represents the common interests of everyone in the class unless a woman chooses to opt out and pursue her own individual litigation.
Read more about how these cases are conducted here in a MND previous interview with Daniel Bach of Siskinds.
McCartney adds that the legal fees to cover individuals in the class action generally range from 20 to 33% depending on a number of factors in a case, including the risk, the complexity, and the amount of time the firm puts into the case.
In Canada, class action counsel fees must be approved by the Court.
In the U.S., law firms lining up cases to settle are charging clients as much as 40% plus additional expenses and a contribution of 5% into the common benefit fees.
See NYT here on fees in Vioxx litigation of 2007.
Individual Pelvic Mesh CasesPaul Miller files individual transvaginal pelvic mesh cases. Miller joined Toronto’s Howie, Sacks & Henry LLP as a partner one year ago. Previously he was at Will Davidson.
He also represents the estate of the late Chrissy Brajcic who lost her life last November 30th after repeated infections and antibiotic treatment. She had just started another round of antibiotics, “the strong stuff,” she said in one of her last posts, when her death was announced.
Miller tells MND that the cause of death has not yet been established and autopsy results are pending. Read MND story here.
Presently he has about 260 clients who have filed pelvic mesh actions with 200 having settled. Those who opt out may be able to go to trial, though there have been no cases that have gone to trial so far.
And just like the U.S., some clients are unhappy with how settlement dollars pale in comparison to huge jury verdicts at trial.
But even at trial, Miller says pain and suffering is capped in Canada, currently at $367,000, which goes up slightly with the cost of living index.
“By reading the trial verdicts and the big numbers they have to be educated on the law in Canada. We have a cap on pain and suffering and non-pecuniary damages (pain and suffering) that Americans do not. We have almost like a cap on punitive damages. So far the highest amount the Supreme Court has allowed is one million dollars.”
With caps on damages how then is a wrongdoer held accountable for injuries, particularly if there is evidence the mesh manufacturer knew, or should have known, that users of the product would suffer injuries?
Miller says, “That’s a question you have to ask the judges. It’s a serious injustice for those who have serious or catastrophic injuries. Whether its transvaginal mesh or a horrible car accident or slip and fall, and there are catastrophic damages, I don’t get it but I don’t care about the wrongdoer, I care about my client.”
“When I went through my settlements I had one week where I was calling woman after woman and having to repeat the cap and it really made an impact on me. When you talk about it occasionally, that’s the law, but when you speak to 10 15 women a day for a week and keep telling them, Oh my God! You know what their injuries are, it’s horrific and it’s nothing I can change. The Supreme Court has dealt with it so it’s not changing.”
To add to settlement dollars, Miller sometimes get a nurse or occupational therapist involved to assess the future care costs.
Ontario has a loser pay system (it differs in each province), where the plaintiff could be on the hook for the defendants’ court fees if the plaintiff loses her case before a jury. Miller advises that before clients go to trial they take out adverse cost insurance to cover any possible losses.
His firm is no longer taking mesh cases. After 6.5 years, Miller says it’s time to move on once they are settled.
And the plaintiff must understand that by signing a settlement she is forever releasing the company from future liability.
Miller says, “That’s no different than the person who breaks his ankle and settles it and has future problems. There is an end to litigation. I’ve had that discussion with many clients. People may not like defendants but they are entitled to having their litigation come to an end.”
There is another distinction between Canadian and US courts, for example, what about those wigs?
“No, not wigs but we do have to wear the robes,” says Miller. ###
https://www.meshmedicaldevicenewsdesk.com/canadian-courts-gearing-pelvic-mesh-litigation/
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Jan 22, 2018 | The Daily Mail
By Siofra Brennan
· Kim Hanson, 37, from Manchester was a teaching assistant to Years 4 and 5
· Was suspended from St Clement's Catholic Primary School in Runcorn
· Gave an interview to this week's Closer magazine about £500 Nu-V treatment
· Insists there was nothing graphic about article and school's treatment is sexist
A single mother-of-four has been left devastated at being suspended from her teaching assistant job after giving an interview to a magazine about having vaginal rejuvenation.
Kim Hanson, 37, from Manchester received a call from headteacher Mark Parker at St Clement's Catholic Primary School in Runcorn at 7.30pm last night to say she was being suspended on full pay pending investigation.
Ms Hanson, who is a teaching assistant for Years 4 and 5, appeared in this week's edition of Closer, detailing how she underwent £500 Nu-V treatment at The Women's Health Clinic to tighten the inside and outside of the vagina.
In the article entitled 'I dumped my husband and got a designer vagina' she revealed the treatment had cured her stress incontinence and boosted her sex life, which is now 'amazing'.
'It was a medical procedure because of stress incontinence,' Ms Hanson told FEMAIL saying she felt sexism was behind the decision.
'If it was a man in a magazine talking about testicular cancer or erectile dysfunction nobody would mind. I wasn't embarrassed about it There was the shock value of the headline to get people's attention, but I thought it was more an informative article.'
She claimed headteacher Mark Parker had told her he was 'shocked and disgusted' by the piece 'because the article says things about my sex life and my vagina.'
St Clement's Catholic Primary School declined to comment when contacted by MailOnline.
Ms Hanson claims she's only received a positive reaction to the article, and said that she was eager to make other women aware of the treatment options available to them after the recent scandal over vaginal mesh implants.
Made from synthetic polypropylene, a type of plastic, the implants are intended to repair damaged or weakened tissue in the vagina wall, but have left some in constant abdominal and vaginal pain
'I know someone who had to be off work for six weeks. She wasn't aware of laser treatment.
'Everyone I've mentioned it to said "I wet myself on the trampoline or when I sneeze". But it's not talked about, it's a taboo subject.
She added: 'All the people I've spoken to about it think it's really positive. I was quite happy to put it out there.'
Prior to the article, Ms Hanson insists she had no issues in the workplace and was not aware of any clauses in her contract banning media interviews.
'I didn't think they would be happy about it, but I feel I've been badly treated - to throw that on me on a Thursday night when I'm at home with four children.
'They've blown it out of proportion. I wasn't in Playboy or doing a topless photoshoot.
I've gone through the menopause and suffer from depression. I'm on antidepressants and don't have family support around me. I'm totally devastated.'
A spokesperson for The Women’s Health Clinic said: 'No-one should be treated badly for speaking out about their own medical issues.
We believe if women had more information about their bodies and what is "normal" then this type of information would not be taboo in the first place. It’s why we’ve launched a campaign for more information on women’s health from school upwards.'
http://www.dailymail.co.uk/femail/article-5288359/Teaching-assistant-SUSPENDED-designer-vagina-interview.html
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Transvaginal Mesh Collateral Damage Too High for TVM Settlement
Jan 22, 2018 | Lawyers and Settlements
By Jane Mundy
“The Transvaginal Mesh settlement offered by Boston Scientific isn’t enough to cover the collateral damage my family has suffered.”
Houston, TXAlthough Jordan will receive compensation from Boston Scientific for transvaginal mesh injuries, she says the settlement cannot cover the collateral damage suffered not only by her injuries but also by her family.
Jordan suffered from pelvic organ prolapse after childbirth back in 2007 so upon her doctor’s advice, she had the transvaginal mesh implanted. (Most women suffer some degree of prolapse after giving birth, typically corrected with simple pelvic floor exercises.) Jordan’s doctor, like most health professionals about a decade ago, was likely “sold a bill of goods” by medical device manufacturers like Boston Scientific, promising that transvaginal mesh was the next best thing to sliced bread. But no doctor could guarantee to their patients that the mesh wouldn’t come with complications.
“I am worse off now than I was before getting it. I’ve lived in pain for the past 10 years, so long that I can’t imagine life free of pain,” says Jordan. “But that’s only part of it. My husband and I can no longer have sex and it’s a wonder that we’re still together. And I can’t lift anything more than about 10 pounds, including my son. I can’t play soccer with him like I did with his brother; I couldn’t pick him up when he cried. Did Boston Scientific and all the attorneys on both sides take collateral damage into account when they agreed on this settlement?”
Boston Scientific Settlement
Boston Scientific last October announced a settlement to resolve an aggregate of about 44,000 transvaginal mesh cases and claims. In its filing with the U.S. Securities and Exchange Commission, the medical device maker said that “approximately 15,500 [of those cases and claims] have met the conditions of the settlement and are final. All settlement agreements were entered into solely by way of compromise and without any admission or concession by us of any liability or wrongdoing.” The company said 48,500 product liability claims had been filed involving its TVM device. (Boston Scientific first reached an agreement to settle more than 25,000 vaginal mesh lawsuits nationwide for about $119 million in April 2015.)
British Medical Journal transvaginal mesh Review
A recent review in the British Medical Journal (December 2017) found that many transvaginal mesh products were approved with little, if any, clinical testing. The study concluded that, “Transvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence over the last 20 years. Devices have inherited approval status from a few products. A publicly accessible registry of licensed invasive devices, with details of marketing status and linked evidence, should be created and maintained at the time of approval.”
Although the FDA in 2016 labeled the transvaginal mesh products “high risk” and found that there was “no evidence that transvaginal mesh provides any additional benefits when compared to more traditional surgery for treatment of pelvic organ prolapse,” its warnings came too late and the agency failed to protect thousands and thousands of women like Jordan. Rather than spend money to study the safety of its devices, many mesh manufacturers chose to stop making the devices. Meanwhile, the FDA has been accused of being asleep at the wheel and it has been accused of failing to:· adequately evaluate the safety and efficacy of medical devices and procedures;
· establish a comprehensive register of mesh products and procedures;
· provide adverse reporting systems to accurately represent health consumer outcomes;
Details of the transvaginal mesh settlements have not been disclosed. Jordan thinks she will wind up with less than $100,000. That amount doesn’t even compensate for loss of wages – she was unable to return to work full-time and her insurance company denied her long-term disability benefits. “I’m hopeful that some of this money will pay for surgery to get all of this mesh removed once and for all,” says Jordan. “I’ve already gone through one surgery that was unsuccessful. “Maybe one day I’ll be able to get my life back. And my husband’s, and my son’s…”
https://www.lawyersandsettlements.com/articles/transvaginal-mesh-tvt-sling/interview-transvaginal-mesh-lawsuit-6-22819.html
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