Preview Newsletter
Ethicon Media Monitoring 4/17/2018
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A truly disgusting legal-lending racket
Apr 16, 2018 | New York Post
Kudos to The New York Times for uncovering yet another grotesque abuse by the legal-lending industry — one that uses telemarketers to entice women into unnecessary and risky surgery. -
Growing trend coaxes women into often unneeded surgery in suits versus medical device makers
Apr 16, 2018 | ABA Journal
By Debra Cassens Weiss
An Arkansas woman who contends she scared into surgery to remove vaginal mesh to bolster her position in litigation has filed a lawsuit against her former law firm and the litigation funding company that financed the operation. -
Emma Hardy: The campaign for justice on surgical mesh will go on
Apr 16, 2018 | Politics Home
By Emma Hardy
Mesh surgery is a medical procedure used to treat incontinence and prolapse in women, frequently used for new mothers. -
Just one Northern Ireland MPs to attend key vaginal mesh debate in Commons
Apr 17, 2018 | Belfast Telegraph
By Lisa Smyth
Only one Northern Ireland MP has confirmed they will attend a crucial Westminster debate on the vaginal mesh scandal that has destroyed the lives of hundreds of people here. -
Jury Adds $35 Mill in Punitives Making McGinnis v CR Bard $68 Mil
Apr 13, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
Friday, April 13, became somewhat of a lucky day for mesh injured plaintiff, Mary McGinnis in her product liability pelvic mesh case against C.R. Bard. -
Appeal Planned in “Wanton” “Willful Disregard” $68 Mill Bard Mesh Case
Apr 16, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
CR Bard of Franklin Lakes, New Jersey plans to appeal the record McGinnis transvaginal mesh jury decision, the company has announced. -
New Jersey jury hits Bard with $68 mln in pelvic mesh trial
Apr 16, 2018 | Reuters
By Tina Bellon
A state court jury in New Jersey has ordered medical device maker C.R. Bard Inc to pay $68 million to a South Carolina woman and her husband, who claimed she suffered injuries after being implanted with Bard’s pelvic mesh devices. -
New Zealand urologists support mesh option for treatment of incontinence
Apr 17, 2018 | New Zealand Doctor Online
The Urological Society of Australia and New Zealand (USANZ) believes women should be allowed to have a full choice of options, that includes the mid urethral sling, for the treatment of stress urinary incontinence. -
Fletchers Solicitors representing numerous women left with traumatic complications by top UK surgeon
Apr 16, 2018 | Bdaily
The UK’s leading medical negligence and serious injury law firm, Fletchers Solicitors, has been instructed to handle a number of claims against Britain’s most influential pelvic surgeon, Anthony Dixon, after it’s claimed that he left hundreds of women with life changing complications.
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A truly disgusting legal-lending racket
Apr 16, 2018 | New York Post
Kudos to The New York Times for uncovering yet another grotesque abuse by the legal-lending industry — one that uses telemarketers to entice women into unnecessary and risky surgery.
Class-action lawsuits surrounding mesh implants are the new gold mine for the tort bar. Millions of women have gotten the implants to correct a condition called pelvic organ prolapse; some suffer side effects — and the legal sharks circle for a fat payday.
But the suits don’t bring big payouts unless the woman has had the implant removed. So lawyers encourage that surgery, though, it, too, can have side effects and honest doctors only recommend it in extreme cases.
The marketing outfits that talk women into the operations arrange the surgery, including travel, and hook them up with lawyers as well as with firms that make high-interest loans the women won’t have to repay unless their lawsuits prosper.
As the Times reports, the doctors who work in the medical mills doing the procedures can earn $14,000 a day, yet typically meet the patients only on the day of surgery. Nor are they around to help with complications (such as incontinence).
Meanwhile, the legal fees and high-interest loans can eat up most of whatever settlement the woman may win.
The Post has done its own exposés on LawCash and other legal-lending outfits that cost taxpayers millions a year by encouraging questionable lawsuits against the city by handing out quick cash advances to potential plaintiffs.
State Sen. Rob Ortt (R-Niagra Falls) and Assemblyman William Magnarelli (D-Syracuse) have a bill to license and regulate the legal-lending industry to rein in these abuses. It can’t pass fast enough.
https://nypost.com/2018/04/16/a-truly-disgusting-legal-lending-racket/
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Growing trend coaxes women into often unneeded surgery in suits versus medical device makers
Apr 16, 2018 | ABA Journal
By Debra Cassens Weiss
An Arkansas woman who contends she scared into surgery to remove vaginal mesh to bolster her position in litigation has filed a lawsuit against her former law firm and the litigation funding company that financed the operation.
Allegations in the suit by Jerri Plummer highlight how plaintiffs in suits against medical device makers are receiving money for removal surgeries, the New York Times reports.
Plummer says she received a phone call telling her the mesh implant supporting her bladder needed to be removed because it was defective, her lawsuit alleges. The caller allegedly told Plummer that she could die if she didn’t act quickly. The caller said Plummer’s surgery expenses would be covered, and a lawyer could help her sue the mesh manufacturer, the suit says.
Plummer had the surgery days later in a medical office in an Orlando, Florida, shopping mall. She says she has chronic incontinence as a result of the surgery and must wear diapers.
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Emma Hardy: The campaign for justice on surgical mesh will go on
Apr 16, 2018 | Politics Home
By Emma Hardy
Mesh surgery is a medical procedure used to treat incontinence and prolapse in women, frequently used for new mothers. The surgery, which usually takes less than half an hour, involves inserting a plastic mesh into the vagina to support the bladder, womb or bowel. It was sold to many women as a quick and easy fix to their problems.
Some estimates predict that between 10 and 20 per cent of people are injured by the procedure. Here are some other shocking statistics about the operation:4 in 5 women injured by surgical mesh suffer life changing pain.1 in 3 women injured by surgical mesh have had to give up work.Only 3 in 20 women who received treatment with surgical mesh were warned of the risks.
I led a Westminster Hall debate last October to raise the issue with the government. In that debate, we asked the government to do four things, these were:Commit to a full retrospective and mandatory audit of all interventions using mesh followed by a full public enquiry.Suspend prolapse and incontinence mesh operations while the audit is being carried out.Bring forward the NICE guidelines for mesh in stress related urinary incontinence from 2019 to 2018.Commit to raising awareness of the issue with doctors and patients alike.
Despite initial resistance from the government, the pressure that the Surgical Mesh APPG has put on has led to some really good results. In December, NICE issued new guidance ruling that evidence for the long-term efficacy of the treatment for Pelvic Organ Prolapse is “inadequate in quality and quantity”. While the NHS is not compelled to act on these guidelines, it will amount to a de facto ban. Then in January, the Government caved in to demands for a national audit on surgical mesh and in February came the announcement of the Cumberlege review into how the NHS addressed concerns about vaginal mesh devices.
Yet every achievement we have marked has brought to light other goals to fight for. Mesh has not yet been completely suspended and it remains possible for doctors to use it, especially in the case of Stress Urinary Incontinence. The audit ordered by Jeremy Hunt looks only at NHS hospital figures and misses off private patients and outpatients. There is also still no physiotherapy available as standard for new mothers, like there is in France, to stop these problems before they even arise.
And even if we were to suspend mesh, investigate every patient – public and private – and offer physio to all new mothers, we would still have the absolute scandal that these devices were aggressively marketed to doctors and then used in patients for whom they were unsuited. To stop this, we must have a Sunshine Payment Act, as there is in America, which lists all industry funding, sponsorship or grants received by GPs and surgeons to stop such aggressive marketing not just with mesh, but with all medical products in future.
And so, it seems our campaign continues. But when it seems difficult, I read the stories of those women who have suffered from their mesh inflicted injuries and remember, in particular, the woman who first brought it to my attention. She was advised to have the mesh fitted in her 30s after suffering incontinence following the birth of twins. The impact it has had on her quality of life is devastating. I remember listening to her telling me about this life changing experience and being completely shocked and horrified. It is for this woman, and others like her, that I will rise to speak this Thursday.
Emma Hardy is Labour MP for Kingston upon Hull West and Hessle. Her backbench business debate on surgical mesh is on Thursday 19 April.
https://www.politicshome.com/news/uk/health-and-care/house/house-magazine/94399/emma-hardy-campaign-justice-surgical-mesh-will-go
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Just one Northern Ireland MPs to attend key vaginal mesh debate in Commons
Apr 17, 2018 | Belfast Telegraph
By Lisa Smyth
Only one Northern Ireland MP has confirmed they will attend a crucial Westminster debate on the vaginal mesh scandal that has destroyed the lives of hundreds of people here.
The DUP's Emma Little Pengelly has said she will be present.
Fellow DUP MP Jim Shannon hopes to be there for some of the Commons backbench business debate. The party's health spokesman has to attend another event running at the same time so is unlikely to be able to remain for the entire debate.
North Down MP Sylvia Hermon, an independent, has a prior engagement and cannot attend, while Sinn Fein MPs refuse to take their Westminster seats.
The trauma experienced by women around the world after undergoing transvaginal mesh procedures has been described by some senior doctors as the "most serious women's health scandal since thalidomide".
Five members of campaign group Sling the Mesh NI are travelling to London to watch the debate. Jackie Harvey of the group expressed frustration at the lack of support from politicians here.
"We have hundreds of members, we have women who have ended up in wheelchairs, they can't walk, they have lost their bladders, their marriages have broken down," she said.
"It isn't too strong to say that lives have been ruined because of the use of vaginal mesh.
"I don't think it is too much to expect all of our MPs to attend the debate on Thursday."
Emma Little Pengelly said her party had written to health departments in Northern Ireland and England, raising concern over why the issue was not taken seriously for so long.
"We have had many discussions with campaigners and sufferers. Further research is needed into mesh procedures and adverse effects," she said.
"There needs to be an improved and more holistic approach to caring for women affected, with an updating of clinical guidance and standards."
https://www.belfasttelegraph.co.uk/news/northern-ireland/just-one-northern-ireland-mps-to-attend-key-vaginal-mesh-debate-in-commons-36813909.html
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Jury Adds $35 Mill in Punitives Making McGinnis v CR Bard $68 Mil
Apr 13, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
Friday, April 13, became somewhat of a lucky day for mesh injured plaintiff, Mary McGinnis in her product liability pelvic mesh case against C.R. Bard.
After deliberating most of today, the five men, three women jury added $35 million of punitive damages to her compensatory award of $33 million, delivered yesterday.
A punitive damage award is meant to send a strong message to the defendant, in this case C.R. Bard of Murray Hill, New Jersey, to punish it for its behavior. Jurors award punitive damages after they listen to the evidence. In a sense, it is their way to weigh in on what they’ve heard.
If allowed to stand, this becomes the largest compensatory and punitive award to any plaintiff so far in this transvaginal mesh litigation, after two other larger awards were reduced by the trial judge.
The punitive phase of the Mary McGinnis v Bard case was being deliberated in a Bergen Co. NJ courtroom where Thursday jurors decided both Avaulta and Align, used to treat incontinence and prolapse, were defective in their design.
Jurors also agreed that the warnings concerning possible risks with the devices were insufficient.
There are about 150 other product liability lawsuits naming CR Bard waiting to be heard in New Jersey.
As of January of this year, there were more than 15,000 defective product lawsuits against CR Bard filed in multidistrict litigation (MDL) in Charleston, West Virginia.
Bard tells Bloomberg it plans to appeal and is disappointed with the outcome.
Mary McGinnis and Thomas Walsh McGinnis v. C.R. Bard Inc., et al., case number BER-L-17543-14.
Punitive Phase in McGinnis
In previous pelvic mesh trials, often punitive damages awarded may be as high as two-thirds the amount of the compensation.
In the case of McGinnis, the jury decided to exceed her compensatory award of $33 million for pain and suffering from the two Bard-made polypropylene mesh implants and the effects she still lives with.
In trials so far, plaintiffs have received jury awards 25 times, versus 7 wins for the defense.
The highest amount any jury awarded an injured patient was $100 million to Deborah Barba, in her case against Boston Scientific over a Pinnacle and Advantage mesh implants in May 2015.
Soon afterward, in October 2015, a Delaware judge slashed the Barba verdict to $10 million saying it was “grossly disproportionate to the injuries suffered and shock the court’s conscience and sense of justice.” See MND story here.
So much for the jury system of justice.
Then $73.46 million was awarded to Martha Salazar over her Boston Scientific Obtryx by a Dallas jury in September 2014. That amount was later reduced by the judge due to tort reform caps to $34.6 million.
Of the original award, $50 million had been punitive damages. See MND story here.
Ella Ebaugh was awarded $57 million by a Philadelphia jury last September due to injuries from the TVT and TVT-Secur implants made by Ethicon.
See MND story here. Of that award, $7.1 was for compensatory damages and $50 million in punitive damages.
In December in Hrymoc v Ethicon was awarded $15 million with $10 million in punitive damages. See MND story here.
Of course, no mesh injured woman will tell you that any monetary compensation of any amount is worth her health.
https://www.meshmedicaldevicenewsdesk.com/punitive-awards-and-mesh-litigation/
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Appeal Planned in “Wanton” “Willful Disregard” $68 Mill Bard Mesh Case
Apr 16, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
CR Bard of Franklin Lakes, New Jersey plans to appeal the record McGinnis transvaginal mesh jury decision, the company has announced.
“We are disappointed with the outcome of the trial and we plan to appeal,” said Troy Kirkpatrick, a company spokesman to North Jersey.com.
“Any implantable medical device carries inherent risks as well as clinical benefits. While we appreciate that Mrs. McGinnis is dissatisfied with the outcome of her procedure, it is important to note that thousands of women over many years have benefited from these products and have improved lives because of them.”
Mary McGinnis was implanted with two meshes made by Bard- the Avaulta Solo mesh and Align transobturator. Both are now off the market.
Adam Slater (Mazie Slater), who represented Ms. McGinnis, tells Mesh News Desk,
“This is an important verdict that demonstrates after listening to the evidence presented by these injured women, the jury will award substantial verdicts and punitive damages to punish the manufacturers. Mary McGinnis said after the trial she did this not just for herself but for all the injured women and to help the thousands of other women who need justice as well.”
“I’ve very grateful,” Mary McGinnis, told Northjersey.com as she left the courtroom with her husband. “This case was fought for all the victims of mesh, whom I hold in my heart.”
It took the jury three hours to come up with the $35 million punitive damages award on Friday, which, when added to the $33 million compensatory award makes this the highest jury award so far in mesh litigation. (Other cases have initially been awarded more but in both cases, they were reduced due to tort reform. Read the stories here).
The jury found that Bard showed “malicious intent” or “wanton and willful disregard” for the plaintiffs’ health when they put the products on the market in 2008.
Defense attorney, Lori Cohen (Greenberg Traurig) in her closing said there was “no malicious intent, no evil minded act” on the part of the company.
In speaking directly to the jury, Slater said he didn’t hear the company say it would do things differently or be more careful in the future. To punish and to deter Bard he urged jurors to send a message, “You can do better.”
Slater encourages other lawyers to take their pelvic mesh cases to trial. And he is willing to help.
“For all the women who haven’t settled their cases yet, there is video available of the lead expert, if lawyers reach out for that information. Dr. Richard Bercik (ob-gyn) from Yale University, on general causation and defective design in Avaulta, Solo and Align transobturator. All exhibits, video and power point, opening and closings can be made available for other firms to take their cases to court.”~ Adam Slater
Slater has another multi-plaintiff trial facing Ethicon in May.
https://www.meshmedicaldevicenewsdesk.com/appeal-planned-in-wanton-willful-disregard-68-mill-bard-mesh-case/
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New Jersey jury hits Bard with $68 mln in pelvic mesh trial
Apr 16, 2018 | Reuters
By Tina Bellon
A state court jury in New Jersey has ordered medical device maker C.R. Bard Inc to pay $68 million to a South Carolina woman and her husband, who claimed she suffered injuries after being implanted with Bard’s pelvic mesh devices.
The jury in New Jersey Superior Court, Bergen County, awarded Mary and Thomas McGinnis $35 million in punitive damages on Friday and $33 million in compensatory damages on Thursday. The awards came in the company’s first pelvic mesh trial in Murray Hill, New Jersey-based Bard’s home state, where hundreds of similar lawsuits have been consolidated.
https://www.reuters.com/article/products-bard/new-jersey-jury-hits-bard-with-68-mln-in-pelvic-mesh-trial-idUSL1N1RT0FC
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New Zealand urologists support mesh option for treatment of incontinence
Apr 17, 2018 | New Zealand Doctor Online
The Urological Society of Australia and New Zealand (USANZ) believes women should be allowed to have a full choice of options, that includes the mid urethral sling, for the treatment of stress urinary incontinence.
Urologists treat women with stress incontinence, or urine leakage with activity, a condition that is common after childbirth. Nearly one in ten women will need surgery for stress incontinence by the time they reach 80. Incontinence is not normal and is associated with poor quality of life and greater care needs for ageing New Zealanders.
The condition affects around 17 percent of adult women in New Zealand. Incontinence costs New Zealand around $8.05 billion annually. The condition is both socially and emotionally debilitating, with strong links to depression.
Transvaginal mesh has been at the centre of class actions around the world and regulatory bodies in New Zealand and Australia have placed restrictions on its use for prolapse only. In Australia a Senate Inquiry has recommended that ‘transvaginal mesh be used as a last resort’.
“New Zealand urologists broadly support the Senate Inquiry’s recommendations to enhance safety and communication with relation to the mesh product and support their Australian colleagues’ view that that women in both Australia and New Zealand should be given the choice to have a mid urethral sling for treatment of their stress incontinence,” says New Zealand based, Urological Society Vice President, Dr Stephen Mark.
“The mid urethral sling is the most scientifically studied surgical procedure for stress incontinence in history and has substantially improved many thousands of women’s quality of life. Overwhelming clinical evidence shows that in the majority of cases patients have a durable, effective and safe outcome from sling surgery. There are other sound alternatives to the mid urethral sling but these have a higher morbidity and a longer recovery period, with the same potential risk of complications.
“Urologists recognise that some women have had significant, sometimes devastating adverse events in relation to the placement of mid urethral slings and we support improvements in relation to safety, communication and ongoing monitoring,” says Dr Mark.
“The difficulties some women have experienced in relation to mid urethral sling placement has not always been a result of the technology alone and Urologists are experienced in managing such complications,” says Dr Giovanni Losco, a urologist specialising in female incontinence.
“Being able to offer the mid urethral sling as an option for women is important. The mid urethral sling has allowed many older women to have safe, successful treatment of their incontinence. Shared decision making between a women and her surgeon remains paramount to the management of incontinence,” says Dr Losco.
Urologists are the only specialists able to offer a full range of non-mesh options for women who suffer from this debilitating condition. Surgeons treating stress incontinence should be able to offer patients a full range of options, including non-surgical management, natural tissue slings and injections of bulking agents as well as mid-urethral slings to ensure women are fully informed."
The mid urethral sling is still offered in the initial choice of surgeries in the NHS in the United Kingdom, many EU countries and the USA.
https://www.nzdoctor.co.nz/article/undoctored/new-zealand-urologists-support-mesh-option-treatment-incontinence
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Fletchers Solicitors representing numerous women left with traumatic complications by top UK surgeon
Apr 16, 2018 | Bdaily
The UK’s leading medical negligence and serious injury law firm, Fletchers Solicitors, has been instructed to handle a number of claims against Britain’s most influential pelvic surgeon, Anthony Dixon, after it’s claimed that he left hundreds of women with life changing complications.
Valerie Evans, 77, from Woolaston in Somerset, is just one of these claimants. She was referred to Mr Dixon in 2016 to treat a small internal rectal prolapse known as an intussusception (where part of the intestine folds into the section next to it).
Mr Dixon, a consultant colorectal surgeon based at both the Southmead and Spire Hospitals in Bristol, specialised in laparoscopic ventral rectopexy surgery, and recommended that this operation, together with an anterior resection, be carried out. Valerie underwent the surgery in October 2016.
But, following surgery, Valerie developed an anastomotic leak where her bowel had been rejoined, and subsequent pelvic sepsis - an infection caused by injury to organs and tissue - due to the mesh used for the rectopexy. She had to undergo further revision surgery to remove all the damaged tissue and now has to live with a permanent colostomy bag.
Valerie claims that Mr Dixon told her the issues must have been caused because her ‘insides were in the wrong place’. She said: “I felt like I was being blamed for the whole ordeal, as though there was something wrong with my body. He washed his hands of all responsibility or fault and offered no apology.
“But, the complications caused by Mr Dixon’s surgery have totally ruined my life on every level. I suffer in agonising pain every day now and I can never regain the life I had before this.”
After realising that mistakes had been made with her care, Valerie has been working with the medical negligence team at Fletchers Solicitors to bring a claim against the Trust that employed Mr Dixon.
Recognised as a pioneer of bowel repair surgery, Mr Dixon had built up a strong reputation in this field that saw patients travelling from around the UK and further afield to seek his expertise.
But complaints started to increase, with some patients claiming they were subjected to overly complicated procedures without being fully informed of all the risks.
Investigations into his practices, particularly around the mesh rectopexy and Stapled Transanal Resection of the Rectum (STARR) operations he performed are currently ongoing by NHS Bristol NHS Trust. In August 2017, the General Medical Council (GMC) also placed restrictions on his practice, preventing him from carrying out STARR procedures unitl November 2018.
In anticipation of many more legal claims being made against Mr Dixon, a novel protocol has been adopted by the NHS to co-ordinate the process. The protocol operates as a form of altnerative dispute resolution (ADR) and will see benefits on both sides. It will reduce the overall costs to the NHS of considering these claims, but will also ensure that claims are dealt with promptly, with clients expected to receive an initial decision on their case within a matter of months of notification. For claimants to take the benefit of the protocol, their claim must be notified by 4pm on 1 August 2018.
Amy Hughes, the litigation executive dealing with Valerie Evans’ case, said: “We are representing a number of clients, including Mrs Evans, in connection with treatment provided by Mr Dixon over a period of time, whilst he worked for both the NHS and as a private consultant at the Spire Bristol Hospital.
“Mr Dixon aimed to pioneer mesh rectopexy in the UK, but surgeries involving mesh have come under intense scrutiny due to the high number of complications associated with them. We are now investigating on behalf of our clients whether Mr Dixon’s recommendations to proceed to surgery, and the way his procedures were carried out, was appropriate, given the incredibly poor outcomes they have suffered.”
https://bdaily.co.uk/articles/2018/04/16/fletchers-solicitors-representing-numerous-women-left-with-traumatic-complications-by-top-uk-surgeon
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