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Ethicon Media Monitoring 3/6/2018
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J&J Unit Can't Shake $15M Pelvic Mesh Verdict In NJ
Mar 6, 2018 | Law 360
By Bill Wichert
A New Jersey state judge on Monday refused to disturb a $15 million verdict against Johnson & Johnson unit Ethicon in a lawsuit alleging that a pelvic mesh product left a woman in debilitating pain, citing evidence that the business did not warn about certain risks associated with the device. -
Can You Change Your Law Firm?
Mar 6, 2018 | Mesh Medical Device Newsdesk
This story was posted on September 26, 2017 but has been revised as time passes. Since so many people ask, “Can you change law firms if you are unhappy with your representation?” get your retainer agreement out and look at the fine print. -
7 million women suffer incontinence: Now, the UK’s top doctor has revealed her own ordeal to break the most embarrassing taboo of all
Mar 6, 2018 | The Daily Mail
By Lucy Elkins
'We women, after we’ve had babies, can be damaged so that we get incontinence and actually — I’ve never gone public about this — after my first child I could only go three yards before I peed my pants.'
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J&J Unit Can't Shake $15M Pelvic Mesh Verdict In NJ
Mar 6, 2018 | Law 360
By Bill Wichert
Law360, Hackensack, N.J. (March 5, 2018, 9:24 PM EST) -- A New Jersey state judge on Monday refused to disturb a $15 million verdict against Johnson & Johnson unit Ethicon in a lawsuit alleging that a pelvic mesh product left a woman in debilitating pain, citing evidence that the business did not warn about certain risks associated with the device.
Superior Court Judge Rachelle Lea Harz denied the company’s motion for judgment notwithstanding the verdict or a new trial, upholding a jury’s Dec. 14 decision that plaintiff Elizabeth Hrymoc’s injuries were caused by the defective design of Ethicon Inc.’s Prolift and its inadequate warnings.
The judgment is comprised of $10 million in punitive damages, compensatory damages of $4 million for Hrymoc, and $1 million for her husband and fellow plaintiff, Tad.
“The evidence presented before this jury was more than sufficient for them to conclude that the Prolift’s design defects were a cause of Ms. Hrymoc’s injuries,” Judge Harz said from the bench in her Hackensack, New Jersey, courtroom.
Hrymoc and her husband established that Ethicon provided “partial and vague warnings” regarding the extent and gravity of certain risks related to the Prolift, Judge Harz said. The judge rejected the company’s assertion that risks omitted from its warnings were commonly known to pelvic floor surgeons.
Judge Harz stressed that Hrymoc’s treating physician testified that he had not known about many such risks, even though he was serving as an Ethicon consultant at the time. The Hrymocs’ experts also testified that the omitted risks were not common knowledge, the judge said.
“This court finds that the testimony and evidence at trial established that pelvic floor surgeons did not have common knowledge of the unwarned-of risks related to the Prolift,” Judge Harz said.
The judge noted that Hrymoc’s physician ultimately said that if Ethicon had informed him of the potential risk that women would experience what she suffered, he would not have used the device.
Ethicon’s failure to advise the medical community about such risks was part of how the company acted with “willful and wanton disregard,” Judge Harz said in citing evidence that supports the punitive damages award.
“The jury heard substantial evidence from [Elizabeth Hrymoc] as to her physical and emotional suffering,” said Judge Harz, describing how “her problems affected her husband.”
Hrymoc is among thousands of women nationwide who have filed suits alleging Ethicon and J&J failed to fully disclose risks associated with its Gynecare Prolift pelvic floor support mesh product, which was on the market from 2005 through 2012.
The Hrymocs’ suit is just the second pelvic mesh suit against Ethicon to go to trial in New Jersey, where the company is headquartered. A state appeals court in March 2016 upheld a jury’s $11.1 million award to the plaintiffs in the first pelvic mesh trial, and the New Jersey Supreme Court later declined to review that decision.
Hrymoc said she had the Prolift implanted in 2008 to treat a pelvic prolapse, but it contained a design defect the defendants knew was risky, but kept this information from consumers. Hrymoc, who was 62 when she had the mesh implanted, said she has suffered vaginal pain and pain when having sex since then.
Hrymoc also said the defendants failed to warn of the risks associated with a second J&J medical device, Trans Vaginal Tape, known as TVT, which was implanted to treat her stress urinary incontinence. In their verdict, jurors found that the warnings for TVT were inadequate, but they did not find that those inadequate warnings contributed to her injury.
Among the issues raised in its motion, Ethicon asserted with respect to the design defect claim that the Hrymocs failed to establish a practical, effective and reasonably safe alternative to the Prolift. The company said their experts did not back up their alternative design opinions with empirical evidence.
As one of Ethicon’s attorneys, Kelly Crawford of Riker Danzig Scherer Hyland & Perretti LLP, put it during Monday’s hearing, “Safer must be proven with empirical evidence.”
But Judge Harz later rejected the defense argument that such empirical evidence is mandatory.
“That is not the law in the state of New Jersey,” the judge said.
Judge Harz found that the Hrymocs had established that there were feasible, safer alternative designs. For example, the judge cited evidence that Ethicon internally believed Ultrapro mesh — marketed as Prolift+M Pelvic Floor Repair System — to be a “safer alternative.”
A defense expert testified that she switched from the Prolift to the Prolift+M when that device became available and never used the Prolift again, the Judge Harz said. An Ethicon executive also testified that a reasonable argument could be made that the company never should have sold the Prolift, the judge said.
The company has pointed to testimony from Hrymocs’ experts that alternative designs were not safe, but that testimony “does not take away from the fact that these alternatives were safer than the Prolift,” said Judge Harz, adding: “That is what is required under New Jersey law.
“This court finds that there is sufficient evidence regarding alternative design to support the jury’s ... design defect verdict.”
For Hrymoc and her husband, the judge’s decision marked an important step in a process that will continue with Ethicon challenging the verdict in the state’s Appellate Division, one of their attorneys, Adam Slater of Mazie Slater Katz & Freeman LLC, told Law360 on Monday.
“They have a road ahead of them, because ... there’s going to be an appeal filed and it’s going to take time,” he said, adding that the Hrymocs are a “tough couple” and “they’ll wait until ... they get the appeal done.”
Ethicon did not immediately provide comment following the judge’s ruling on Monday.
The Hrymocs are represented by Adam Slater and Cheryll A. Calderon of Mazie Slater Katz & Freeman LLC.
The defendants are represented by Kelly Strange Crawford and Aran Thomas McNerney of Riker Danzig Scherer Hyland & Perretti LLP.
The case is Elizabeth Hrymoc et al. v. Ethicon et al., case number L-13696-14, in the Superior Court of the New Jersey, County of Bergen.
--Additional reporting by Daniel Siegal. Editing by Adam LoBelia.https://www.law360.com/trials/articles/1018325/j-j-unit-can-t-shake-15m-pelvic-mesh-verdict-in-nj
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Mar 6, 2018 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, March 5, ~ This story was posted on September 26, 2017 but has been revised as time passes. Since so many people ask, “Can you change law firms if you are unhappy with your representation?” get your retainer agreement out and look at the fine print.
That’s a good place to start.
This article is being reposted because so many of you call MND and complain about your law firm and the lackluster settlement dollars being offered to mesh injured plaintiffs.
When you research whether you can leave your law firm, most references are for attorneys. At least once in a career, a lawyer may want to change firms.
But what if you, the client, are not happy with your representation and want to shop for another law firm to take your case?
Is that allowed?
A TEAM
In an ideal world, you and your law firm form a “team” based on mutual trust and respect. That means you must provide the law firm with the information it asks for and stay in touch if you move.
You need to be honest. If you already have signed with a law firm, you can’at expect to sign with another. If you’ve had a bankruptcy, tell the firm. Also, you must always be reachable.
In turn, the law firm should be able to answer your questions and have someone appointed to be your liaison. This should be a paralegal, or someone familiar with the law.
Check out the American Bar Association’s Model Rules of Professional Conduct here.
Your law firm must provide you with your case number and where your case is filed so you can look it up and verify that it actually has been filed. In some cases, a law firm did NOT file your case. They save the $450 filing fee, but what does that get you? In line for settlement only? Please make sure it is filed and ask if it is NOT!
You editor is hearing lately of cases that were never filed with the court, instead, they were prepared for settlement. What sort of message does that send to the defense side? A case worked for trial indicates resources were put into the merits of the case, one that counsel was prepared to present to a jury. As readers know, those have resulted in multi-million dollar verdicts, with very few exceptions.
LEGAL REFERRAL SERVICES
Is your case with a trial lawyer? Many 800 #’s led the unsuspecting injured plaintiff to a legal referral center that sells or “refers” your case to another firm for a set amount or percentage.
Since one has to be a lawyer to head a legal referral service, you may think you signed up with a law firm (and you did) but they may have had no intention of keeping the case. Unless you know that, you may waste previous time asking the referral service for an update on your case.
Ask the person at the end of the #800 if they are a legal referral service and if not, who are the trial lawyers who will handle your case. You should be able to tell if you are getting a truthful alswer.
Some plaintiffs were promised theirs was a “million dollar case” when they signed up. That is a red flag. No one knows the value of a case. Based on that premise, you were charged 40% legal fees. Is that customary for a settlement phase only – not really.
You might want to structure an agreement that differentiates a percentage for settlement from trial preparation since they are very different skills, such as 33 and one-third % for the first $100,000 and 25% for the second, something like that. The language in the retainer agreement will prevail so the agreement you sign is a contract and very important. (This is not legal advice, just consumer advice.)
Mesh News Desk has heard from plaintiffs who only find out years later that the initial referral firm no longer has their case.
This is a formula for disaster. As a client you have not kept up your end of the deal either!
No communication can mean that cases fall by the wayside and the plaintiff forgets about it and goes on with their life. That’s what happened in the recent story Women Who Are Missing, who had their cases dismissed by the court when both sides failed to communicate with each other.
Is changing law firms even allowed? Remember – Your case belongs to you.
Read the fine print of your firm’s retainer agreement. That may contain language that will guide you if you are not happy with your current representation.
If the law firm wants to end the relationship, the replaced lawyer will file a notice of withdrawal with the court. They must return your original files and papers and property and refund any unused retainer.
Make sure you do not get into a battle over paying them before your files are turned over to the next firm.
The American Bar Association’s Model Rule 1.16(d) (here) says your firm must surrender papers and property as soon as the representation is terminated. There may be a similar rule in your state bar association
If the firm is owed fees, it will file a lien on whatever award you eventually receive from either a jury award or a settlement.
Make sure the fees and costs are “reasonable” and not excessive. Ask for an invoice with details on the expenditure in your case.
If you never receive anything in a settlement, do you still owe that law firm something? It’s in the fine print.
Give careful thought to firing your attorney. Are you on the eve of trial? Has the firm communicated with you but your real frustration is with the industry you are suing?
Understand that opting out with your law firm and trying to take a case forward with a new law firm will cost hundreds of millions of dollars, a risk many firms are not willing to take.
What are you expectations and are they realistic? That is the million dollar question when it comes to mesh litigation because the dollars being offered by the mesh industry do not consider a lifetime of pain and medical care, loss of consortium, lost wages, medical care mesh-related but that are not revisions, pain and suffering.
So what is realistic?
As yourself, is this firm acting in a professional manner and do they still have your trust?
A sit down meeting to air your grievances may answer your questions. ###
LEARN MORE:
From Martindale-Hubbell, How to fire your attorney here.
https://www.meshmedicaldevicenewsdesk.com/can-change-law-firm/
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Mar 6, 2018 | The Daily Mail
By Lucy Elkins
· 7 million UK women suffer urinary incontinence, including Dame Sally Davies
· The condition is ‘more embarrassing than depression or cancer,' study says
· It's also estimated to cost the National Health Service over £233 million a year
· Here, a special report investigates the most effective ways to help manage it
'We women, after we’ve had babies, can be damaged so that we get incontinence and actually — I’ve never gone public about this — after my first child I could only go three yards before I peed my pants.'
These are the words of Dame Sally Davies, England’s chief medical officer, who last week, revealed she’d been virtually housebound for six weeks after the birth of her first daughter Olivia, now 26.
Dame Sally also said that even after all this time the issue was not completely sorted: ‘I’m still not as I would wish to be.’
It was a brave admission from the most senior doctor in the country, and one that will have resonated with millions of women, many of whom live in silence with the shame of their condition. For Dame Sally’s comments have drawn the spotlight onto one of medicine’s last taboos.
‘It is a huge problem — around seven million women have some degree of incontinence — and it’s a hidden problem, because so many are too embarrassed to seek help,’ says Jeremy Ockrim, a consultant urologist at the Hospital of St John and St Elizabeth in London.
In fact, urinary incontinence is ‘considered significantly more embarrassing than depression or cancer, respectively’ according to a study in 2011 by the Medical University of Vienna in Austria.
It’s not just the embarrassment — incontinence can have a crippling impact on women’s lives. It doubles the risk of postnatal depression, reported the Journal of Obstetrics and Gynaecology in 2011.
In the same year a Norwegian study of more than 5,000 women aged 40 to 44 with incontinence found that a fifth had at least one major episode of depression in the previous year, according to the International Urogynecology Journal.
TOO ANXIOUS TO MAKE LOVE
‘I have seen women whose relationships have broken down as a result — who are so embarrassed they don’t have sex in case they leak,’ says Myra Robson, a senior pelvic health physiotherapist at the Lewisham and Greenwich NHS Trust.
‘I have treated women in their 30s who won’t go to their children’s school play or concert for fear of leaking.
‘Yet it is still such a taboo subject that women feel embarrassed asking for help.
‘I have had women in their 90s who’ve put up with it since they were 30 without seeking help or telling anyone about it.’
One UK-wide study found that nearly half of women surveyed at GP surgeries had urinary incontinence, but tellingly, only one in 20 with moderate or severe incontinence had sought help, reported the journal Family Practice.
Quite apart from the personal cost, urinary incontinence is estimated to cost the NHS over £233 million a year — on top of this are the many millions patients spend themselves, on products such as incontinence pads.
‘It destroys women’s lives and I find it so frustrating that we don’t do more to stop this happening in the first place,’ adds Myra Robson. Because much of this suffering is needless, as in a great many cases regular pelvic floor exercises can make incontinence entirely preventable.
‘We know that early intervention, where women start training early, helps prevent incontinence,’ says Jacque Gerrard, the Royal College of Midwives’ director for England.
This was confirmed by a review last year from the authoritative Cochrane research body that looked at 38 trials involving more than 900 women — the researchers concluded that offering women in early pregnancy a structured training programme of pelvic floor exercises (typically including the help of a physiotherapist) can help to prevent the onset of urinary incontinence.
MANY ARE JUST GIVEN A LEAFLET
The problem is that the level of instruction women are given about how to do pelvic floor exercises often falls woefully short.
‘At the moment what all too often happens is that new mothers are handed a leaflet as they leave hospital telling them to exercise their pelvic floor — at a time when they have a new baby and a hundred and one other things to consider,’ says Myra Robson.
‘But we have seen from studies that this is not effective — one found that 50 per cent of women doing pelvic floor exercise just from the instructions in a pamphlet were getting them wrong.’
And doing the exercises incorrectly can be almost as detrimental as not doing them at all, as it can cause even more incontinence, she says.
‘That’s because you may tense the muscles so much that the pelvic floor becomes hyperactive and puts too much pressure on the bladder.’
So how do we teach women to do it right? Myra Robson says ideally women would receive instruction during a consultation with a specialist physiotherapist: ‘but realistically there are just not the resources to make it happen.’
There is no doubt that actually being shown how to do the exercises helps. A 2010 study led by the University of Aberdeen found that pelvic floor training with either extra sessions or ‘biofeedback’ — where the woman’s muscles are tested electronically as she does the exercise, were the most effective treatment.
FRENCH MOTHERS GET MORE CARE
In France, six weeks after giving birth, women are routinely sent for checks with a physiotherapist who actually checks their pelvic floor, with follow-up appointments for weeks afterwards.
‘For us it is normal to check the pelvic floor and to talk about the importance of a strong pelvic floor — there is no embarrassment — whereas here that is not the case,’ says James Turgis, a French physiotherapist and director of Mummy’s physio, a private London-based chain.
Myra Robson suggests particular attention should be paid to women who are at greater risk of urinary incontinence after pregnancy — women who have lots of stretch marks or hypermobility (as they may have issues with their collagen, which gives the tissue its strength).
‘They need to do extra protective exercises to prevent them from developing incontinence.’ Obesity has an impact as well.
‘Those women should be sent to specialists like me for intensive work during their pregnancy to help train their pelvic floor, but unfortunately they aren’t always.
There are 6,000 births a year at the hospital where I work, and I work alone and part-time,’ she says. Indeed, a lack of specialist physio help is major problem.
The Uk was one of only three European countries to report a cut in the number of physiotherapists per 100,000 inhabitants between 2010 and 2015 according to Eurostat figures.
Under NICE guidelines published in 2015, women with incontinence should be offered three months of ‘supervised pelvic floor muscle training’ — ie, exercises with a physiotherapist.
At the time of publication NICE noted that women with incontinence ‘are often given a leaflet on pelvic floor muscle training but are not given additional support . . . As a result, many women who attend for specialist treatment have been incorrectly performing pelvic floor muscle exercises for many years with no improvement in their symptoms.’
Specialist pelvic physiotherapists will typically first check the strength of the pelvic floor — manually or using a probe — which is rated from 0 to 5. A score of less than three may lead to treatments to help to make pelvic floor exercises more effective (for instance using cones inserted into the vagina or electrical devices to help the muscles contract).
But in the UK there are only around 700 specialist pelvic physiotherapists (who’ve done postgraduate training in pelvic health). To put this in context there are more than 700,000 births in England and Wales each year — and one in three women will develop problems.
‘Specialist physiotherapy services make a huge difference to a woman’s health and quite simply, their quality of life, but access to them can be inconsistent,’ says Ruth ten Hove, head of research and development at the Chartered Society of Physiotherapy. ‘Some areas may provide good access whereas other areas may not provide enough.’
The reasons for this, they say, vary: in some places it will be due to a shortfall in the numbers of physios, whereas in others it may be due to a lack of awareness among GPs or women themselves that such services exist.
HELP OFTEN IN SHORT SUPPLY
The service offered to women can be hit and miss, adds specialist urologist Jeremy Ockrim. ‘GPs are overwhelmed trying to meet targets for heart disease and cancer, and incontinence has tended to get ignored as a low priority. In some areas doctors even have to limit the number of incontinence pads they give to these women — it’s an outrage really,’ he adds. Four years ago the Royal College of Midwives and the Chartered Society of Physiotherapists announced a joint venture to highlight the need for pelvic health to become ‘a key public health issue’.
They called for all women to be given accurate advice about pelvic floor exercises and an opportunity to discuss pelvic care with a healthcare professional — a midwife, physiotherapist or a GP. ‘Midwives doing antenatal checks and talking to a woman about her diet should be saying: “and are you doing your pelvic floor exercises,”’ says Jacque Gerrard.
But the message doesn’t seem to be getting through. Charity consultant Lyanne Nicholl, 37, was so scandalised by the lack of advice and care after having her son 2½ years ago that she’s organised a parliamentary roundtable discussion in May with the MP Rosie Duffield, health care professionals and charities to discuss the need to improve the postnatal care for women.
‘I got handed a leaflet after having my baby about pelvic floor exercises — when I hadn’t slept in days — and at that time it just didn’t mean anything.
‘I’ve been lucky in that I haven’t had a problem, but I have had friends who are leaking and accepting they are: it seems to be entrenched that yes we have babies and so we just have to put up with the incontinence, the painful sex, the mental health problems that can develop.
‘If men were in this situation and becoming incontinent far more would have been done by now,’ she says.
Adds Myra Robson: ‘We need to get the message out to women that incontinence is common but never normal.
‘We spend time telling women not to eat soft cheese during pregnancy but spend so little time warning them how important it is to care for their pelvic floor — and not doing so can have ramifications for the rest of their life.’
http://www.dailymail.co.uk/health/article-5465455/7-million-women-suffer-incontinence-embarrassing-taboo.html
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