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Ethicon Media Monitoring 3/21/2019
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Women in Limbo Update
Mar 20, 2019 | Mesh Medical Device Newsdesk
By Jane Akre
Most do not know what their future holds and how much money they can expect from a pelvic mesh settlement. When you signed with your law firm you signed a retainer agreement. That may hold the clue to how much the firm plans to take. -
Woman alleges attorney, practice mishandled pelvic mesh case
Mar 20, 2019 | Southeast Texas Record
By John Suayan
A local attorney and his practice are accused in a Plano woman’s state district lawsuit of mishandling her pelvic mesh case. -
Elaine Is One Amazing Woman!
Mar 20, 2019 | Glasgow South and Eastwood Extra
A Newton Mearns woman has been recognised at the the No.1 Amazing Women Awards in Glasgow. -
NSF offers grant to improve treatment approaches for pelvic organ prolapse
Mar 21, 2019 | News Medical Life Sciences
By James Ives
Is it normal to pee a little when you laugh? It's a simple question many women ask, and as a symptom of pelvic floor dysfunction, urinary incontinence in women is surprisingly common. However, it can also accompany a related and more debilitating disorder known as pelvic organ prolapse (POP)... -
Behavioural Therapy Is Often More Effective Than Drugs for Urinary Incontinence in Women, Finds Review
Mar 18, 2019 | British Medical Journal
By Susan Mayor
Behavioural therapy to strengthen the pelvic floor or to change behaviour influencing bladder function, with or without other treatment, is generally more effective than drugs in treating stress or urgency urinary incontinence in women, a review of randomised trials has found.
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Mar 20, 2019 | Mesh Medical Device Newsdesk
By Jane Akre
Most do not know what their future holds and how much money they can expect from a pelvic mesh settlement. When you signed with your law firm you signed a retainer agreement. That may hold the clue to how much the firm plans to take.
Are they taking 40% for their efforts, even a settlement. Is there a lesser amount the law firm will take if you were never worked up for trial?
Why is the settlement taking so long? Unfortunately, the mesh makers have had a heavy hand in the final settlements. They are not quick to offer up adequate monies, quite the opposite. There has been a slow response to settlement demands. And lien resolution companies must trudge through many cases to resolve any liens before monies can be issued.
This is done en masse, not on an individual basis. That at least partially explains why things take so long.
Attorney Michael Monheit, talks to MND editor, Jane Akre.
Monheit: “In an ideal world, I wish we could turn back time and explain this litigation so you would have realistic expectations. Whatever you were told in the beginning, every mass tort contains some realities. For example, at least one-hundred thousand women were injured by pelvic mesh – that is a fact. Some law firms signed up thousands of cases, some just a few. Some may have intended to settle those cases and perhaps never take one to trial. Others planned to select a few for trial as “bellwether” cases to help determine or estimate of their worth for settlement purposes.
My frustration is there are hundreds of women in the same boat saying, “I don’t want to settle.”
Akre: What will happen to those women?
Monheit: “I’m afraid most of them will end up as dismissed cases.
“It is unlikely you will find another attorney as rarely will an attorney want to represent someone who already rejected a settlement. And you likely can’t spend a couple hundred thousand to go forward alone. What that results is injustice upon injustice. Thus, going it alone is not much of an option.”
Akre: Doesn’t a lawyer have an obligation to represent you until the end?
Monheit: “Most firms have within their fee agreement the right to withdraw from a case, and thus have informed clients of this possibility. Some might argue this is unfair to clients, others might even argue it is not ethical.”
“However, the motion to withdraw would be approved by the Court, so it is unlikely that this will result in any ethical issue for the lawyers seeking to withdraw from the case.”
Akre: But you understand most women want their day in court.
Monheit: “Yes, Your story deserves to be heard. Often the other women who have gone to court have received favorable awards, even though they will have to wait years to see any money as the appellate process plays out.
“But let’s look at the numbers.
“If all of these cases actually went to trial, or consider even 30,000 cases, (there are many more) and you gave 10 judges 3-thousand cases each, if those judges could try six cases a year, it would take those ten judges 500 years to get through! You can see the impossibility of having each case litigated.
“Your attorney may advise you to settle your case since there are so few they can take forward to litigate.
“It is highly unlikely that new firm would want to step into a case where you have indicated you would not settle.
“We have limited time in life and must choose our battles carefully. I urge you to consider this for yourself as well.
“Ask yourself – What is your goal? If the goal is to be part of a movement that in the aggregate is holding the defendants accountable, then you are likely accomplishing that with your claim. If your goal is to receive what feels like full compensation for your injuries, then I doubt it is likely you will achieve that goal.”
kre: We know that firms settling cases must agree to about 95% of their clients agreeing to a settlement. Defendants require that. Why is that so important?
Monheit: “Manufacturers want to know that they are obtaining a certain degree of resolution, or otherwise may as well keep paying their attorneys to defend the cases.
“To achieve these percentages, in order then to help the vast majority of their clients who may want to settle, even if not for as much as they would like, the attorneys may need to withdraw from most cases where clients do not want to settle.
“Put another way, imagine if you are the client who wants to settle. Your lawyer may not be able to settle your case because of clients who insist on going to trial.
“Coming back to the issue of finding other counsel, you are likely to encounter the same issues. These firms you are reaching out to are likely to already have other clients. Thus, it is not likely that this lawyer would be willing take on a client who has already demonstrated an unwillingness to settle their claim, as the law firm does not want to jeopardize the ability to settle the claims of clients that they already represent and who have expressed a willingness to settle their claims.”
Akre: MND has told a story of a women who is going it alone, Pro Se, after she asked her two law firms to drop her. Does she have any chance of representing herself in court?
Monheit: “While I admire and honor her determination to see this through, my common sense tells me that she is facing a battle that is almost meaningless to the mesh makers and their team of high powered attorneys and difficult for her.
“It is distressing to know that this world has wrongs that at least in our time or in ways we can see don’t make sense and don’t seem to be righted. They are like weeds that keep growing. They are wicked who prosper and may be cut down later, but often not in our time. The underlying sense or purpose of this is simply not revealed to us for now.
“For each injured mesh victim, your story deserves to see the light of day, but I think that there are easier ways to tell your story about any mesh maker than putting yourself through a Pro Se litigation process.
“Here are some things to consider…
You are going to be to a certain degree outside the typical benefits of the MDL process – it will not be tailored to your needs. Rather, you are going to have to fit into your life to the court’s deadlines and requirements. Do not expect that the judge make any exception for you, the Pro Se plaintiff. The system is the same for everyone. That is why people hire lawyers who know the system – because the process is complex.
If it does not work out, you don’t get to do it again. While lawyers can survive if one case doesn’t work out, because they are working on many and can spread the risk, you only have your one chance at your one case. And it is so much more so the defendants, who have thousands of these cases and can afford to win some and lose some.
It is unlikely defendants will want to settle with a Pro Se plaintiff. They know that you are not coming at the case from a position of strength. They know that they can make this very hard for you.
The MDL work product may not be shared with a Pro Se claimant, since you did not pay for it. That may mean you have to create on your own, essentially duplicate, what has been accomplished by the MDL.
As far as the costs – Depositions – you will have to figure out how to prepare for them (know the science) and will need to compensate medical experts. Typically this could cost more than $10,000 for each physician. To testify is $1,000 an hour on average.
Travel – There are costs to get to the deposition and retain a videographer and court reporter. You will need a location, a hotel and airfare.
I would think the above could cost $100,000 – $200,000 to prepare a case and take it to trial.
Will your doctors agree to testify? If not, are you prepared to file the motions in court to compel them to do so? Will they cooperate with you and your questioning?
How will you present yourself as a witness?”
Akre: So it doesn’t sound hopeful? How can these women give up and take a small settlement?
Monheit: “Defendant manufacturers are corporations and as such do not have feelings. Their attorneys will get paid win or lose. They want to win as much as you do. They have more resources than you do. The company likely sees this as a cost of doing business. Companies don’t have souls. They make money. They don’t apologize.
“Your story is important and deserves to be told. Every mesh story is tragic and deserves to be told. Thousands of them! The question for me is do you get the most benefit and do the most good in this Pro Se fight, or is there a better use of your time and energy to tell your story and impact the world and your life going forward in a positive manner.”
Akre: What might she do to direct her energies to right this wrong if going Pro Se isn’t an option?
Monheit: “Lawsuits are a part of the picture, as in the aggregate they create a significant financial penalty on the manufacturer. But a Pro Se plaintiff has little chance of moving the company into action.
“Things we can do as individuals include the following: get active in the political process, organize lobby days, petition Congress, run for office, find a media outlet to target, march on insurance companies, organize boycotts, change the laws. These are all places where energy could be focused so we can change the law and insist on medical coverage for harm from devices, paid for by device manufacturers, since they got you here in this difficult situation in the first place.
“As the laws stand now, there is not enough regulation of these devices and we need people to continue to speak out.”
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https://www.meshmedicaldevicenewsdesk.com/women-in-limbo/
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Woman alleges attorney, practice mishandled pelvic mesh case
Mar 20, 2019 | Southeast Texas Record
By John Suayan
A local attorney and his practice are accused in a Plano woman’s state district lawsuit of mishandling her pelvic mesh case.
Sharyn Joy Teitelbaum initiated litigation against Howard L. Nations and Howard Nations, P.C., doing business as The Nations Law Firm, on Mar. 13 in the Harris County 165th District Court.
Teitelbaum hired the defendants in October 2014 after she experienced problems with bleeding and cramping in connection with the mesh implant manufactured by Coloplast.
According to the 10-page original petition, the respondents worked with other counsel without obtaining the plaintiff’s prior consent. The attorney-client contract between Teitelbaum and NLF purportedly stated that the latter would receive a 40 percent contingent fee while 60 percent went to a firm named Levin Papantonio Thomas Mitchell Rafferty & Proctor, PA.
Teitelbaum says that Levin Papantonio notified her after the execution of the contract it could not represent her, which left NLF as her lone counsel.
Court filings further accuse NLF of making a secret arrangement with the firm Motley Rice, LLC to lump the complainant’s case “together with 749 other cases to attempt to negotiate a settlement on behalf of the plaintiff and other unidentified clients.” Teitelbaum insists that she was not consulted about “these negotiations or offers.”
Consequently, the plaintiff seeks unspecified monetary damages and a jury trial.
She is represented by Cris Feldman of the law firm Feldman & Feldman P.C. in Houston.
Harris County 165th District Court Case No. 2019-18460
https://setexasrecord.com/stories/512300572-woman-alleges-attorney-practice-mishandled-pelvic-mesh-case
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Mar 20, 2019 | Glasgow South and Eastwood Extra
A Newton Mearns woman has been recognised at the the No.1 Amazing Women Awards in Glasgow.
Elaine Holmes won the Amazing Lifetime Inspiration Award alongside Renfrew-based, Olive McIlroy who both founded the Scottish Mesh Survivors campaign group.
Surgical vaginal mesh implants have been used to treat conditions such as Stress Urinary Incontinence and Pelvic Organ Prolapse.
Many women in Scotland are known to have suffered life-changing injuries after mesh surgery and last September, an immediate halt to mesh procedures was announced at the Scottish Parliament by the Cabinet Secretary for Health and Sport.
Eastwood MSP, Jackson Carlaw and East Renfrewshire, MP Paul Masterton passed on their congratulations.
Elaine said: “As a constituent of Jackson and Paul, my husband Jeff and I cannot thank them enough for their empathy and support for mesh victims everywhere.”
https://www.glasgowsouthandeastwoodextra.co.uk/lifestyle/elaine-is-one-amazing-woman-1-4892684
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NSF offers grant to improve treatment approaches for pelvic organ prolapse
Mar 21, 2019 | News Medical Life Sciences
By James Ives
Is it normal to pee a little when you laugh?
It's a simple question many women ask, and as a symptom of pelvic floor dysfunction, urinary incontinence in women is surprisingly common. However, it can also accompany a related and more debilitating disorder known as pelvic organ prolapse (POP), a condition characterized by the abnormal descent of the female pelvic organs.
Though not life-threatening, pelvic organ prolapse affects half of all women over the age of 50 and is notoriously difficult to treat; surgery is often the only viable option, but success rates are low, with 30 percent of women requiring additional procedures. Many of these pelvic reconstructive surgeries also utilize surgical mesh, a controversial material that comes with its own set of problems.
With a new grant from the National Science Foundation, Virginia Tech researcher Raffaella De Vita hopes to address those problems - and improve overall treatment approaches and outcomes for pelvic organ prolapse.
An associate professor in the Department of Biomedical Engineering and Mechanics within the College of Engineering, De Vita will use animal models to study both the passive and active properties of the uterosacral ligaments, a group of tissues and structures that are predominantly responsible for supporting a woman's uterus, cervix, and vagina. Yizheng Zhu, an assistant professor in the Bradley Department of Electrical and Computer Engineering, will also serve a key role on the grant by developing imaging systems to quantify ligament cell and tissue deformation under various load conditions.
"Before we can address issues with current pelvic organ prolapse treatments, we first need to take a closer look at healthy uterosacral ligament tissue," said De Vita. "What are the mechanical properties of these tissues when they're functioning normally within the body?"
That knowledge will help researchers develop new tissue models that can dramatically transform prolapse prevention and treatment, leading to the development of new stretching routines (known as Kegel exercises), surgical reconstruction guidelines, and even responsive mesh grafts that can be used in POP repair.
The team also hopes to raise awareness about the need for further research on the disorder - and ease lingering public stigma associated with the condition.
"Pelvic organ prolapse is extremely overlooked," said Alyssa Huntington, an engineering mechanics doctoral student who studies cellular-level aspects of the project. "The proportion of the population that's affected by it versus the proportion of research being conducted on it is vastly different."
In women who suffer from pelvic organ prolapse, damaged uterosacral ligament tissues and structures cause the reproductive organs to fall out of place. In severe cases, this descent can even cause the vagina or uterus to protrude outside of the body. Daily symptoms include discomfort and heaviness in the vagina, pain during sexual intercourse, difficulty using the restroom, and the onset of other symptoms associated with pelvic floor dysfunction (such as urinary and fecal incontinence).
And that's just the half of it.
"Pelvic organ prolapse carries a lot of physical considerations, but it's more debilitating psychologically," said De Vita. "It comes with a lot of anxiety and this idea of not feeling good about your body, and many women suffering from this condition also experience depression. It diminishes a woman's overall quality of life."
Physicians and researchers don't know exactly what causes pelvic organ prolapse, but they can point to a set of risk factors. Older women and those who have given birth to three or more children tend to experience POP at higher rates, and smoking, obesity, and heavy weightlifting can also increase the risk.
However, researchers can't quite explain why some women develop pelvic organ prolapse and others don't.
"We hope our research can produce objective criteria that rely on evidence," said De Vita. "Can we say that based on what we know about mechanical properties of healthy ligaments, certain women are more likely to develop prolapse, and then give appropriate recommendations for prevention?"
One important focus of De Vita's research will be the development of surgical mesh that can be used effectively in pelvic reconstructive surgeries. Because traditional mesh grafts don't expand and contract alongside organs and tissue, they often cause serious problems within the body, including pain, infection, and even organ perforation.
Eventually, the team would like to create an active mesh for pelvic organ prolapse that's patient-specific, one that not only moves along with internal tissues but could also accommodate different mechanical properties depending on the needs of different women.
It's that real-world impact and the avoidance of a one-size-fits-all approach that first attracted biomedical engineering doctoral student Kandace Donaldson to the project - and to Virginia Tech.
"I'm definitely passionate about this area, and when I was looking at graduate schools and labs I wanted to work with, I was focused on social impact," said Donaldson, who works on tissue-level aspects of the project.
"The proportion of the population that stands to be helped by this research is just huge," she said.
https://www.news-medical.net/news/20190321/NSF-offers-grant-to-improve-treatment-approaches-for-pelvic-organ-prolapse.aspx
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Mar 18, 2019 | British Medical Journal
By Susan Mayor
Behavioural therapy to strengthen the pelvic floor or to change behaviour influencing bladder function, with or without other treatment, is generally more effective than drugs in treating stress or urgency urinary incontinence in women, a review of randomised trials has found.
Urinary incontinence affects nearly one in five (17%) non-pregnant women, and the prevalence increases with age, particularly after the menopause. The most common types are stress or urgency urinary incontinence, or a mix of both types.
A range of non-pharmacological and drug treatments are available, with evidence supporting their use either alone or in combination compared with no intervention. They differ greatly, however, in their potential adverse events.
To compare the efficacy of available non-surgical treatments for urinary incontinence in more detail researchers carried out a systematic review and network meta-analysis of randomised clinical trials reporting clinical outcomes.1
The study, reported in Annals of Internal Medicine, identified 84 trials evaluating 14 categories of interventions, most commonly behavioural therapies, anticholinergics, and neuromodulation.
Researchers assessed the strength of evidence using the Agency for Healthcare Research and Quality measures for grading a body of evidence, including the number of studies, the designs of studies, the consistency of results, likelihood of bias, and limitations.
Results analysing clinical outcomes showed that behavioural therapy was statistically significantly more effective than anticholinergics in achieving cure or improvement of urgency urinary incontinence (high strength of evidence). Both neuromodulation and onabotulinum toxin A were more effective than no treatment (high strength of evidence).
For stress incontinence, behavioural therapy was more effective than either α-agonists or hormones in achieving cure or improvement (moderate strength of evidence).
“Behavioural therapy, alone or combined with other interventions, is generally more effective than other first and second line monotherapies for both stress and urgency urinary incontinence,” said the researchers, led by Ethan Balk, from Brown University School of Public Health in Providence, Rhode Island, USA.
They added, “Besides being less effective than behavioural therapy . . . pharmacological treatments, when used alone, are associated with non-serious but bothersome adverse events, such as dry mouth, nausea, and fatigue.”
But they cautioned, “Large gaps remain in the literature regarding comparisons of individual interventions and subgroup analyses.”
Overall, the researchers noted that their study, which was funded by the US Agency for Healthcare Research and Quality and the Patient-Centered Outcomes Research Institute, showed that most active interventions were better than sham or no treatment, with the possible exception of hormones or periurethral bulking agents.
https://www.bmj.com/content/364/bmj.l1223
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