Preview Newsletter
Ethicon Media Monitoring 4/8/2019
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J&J's Mesh Appeal Nothing But A 'Trial Balloon,' 7th Circ. Told
Apr 5, 2019 | Law 360
By Cara Salvatore
An Indiana woman who won $20 million over life-changing pain blamed on a pelvic support mesh implant asked a Chicago federal appeals court on Thursday to uphold the award, criticizing Johnson & Johnson's claim that the case never belonged in front of a jury. -
Campaigners north of the border hit out as mesh implants cleared for use across England
Apr 7, 2019 | The Sunday Post
By Marion Scott
An announcement by a government health watchdog that mesh implants can be brought back has left injured women devastated. -
Experts to make recommendations on mesh implants
Apr 5, 2019 | Press Association (In The Daily Mail, The Sunday Post, Irvine Times, Isle of Wight County Press)
Recommendations on how to improve care for women who have experienced complications from mesh procedures will be made in early autumn. -
Bernstein Liebhard Objects to Its Share of Fees in Transvaginal Mesh Litigation
Apr 5, 2019 | Law.com
By Amanda Bronstad
A fourth law firm has objected to its share of common benefit fees in the transvaginal mesh litigation, insisting that lawyers tasked with distributing the $550 million fund failed to compensate it for work in a critical New Jersey trial. -
Pelvic mesh injury clinic, co-designed by women, set to open in Queensland
Apr 6, 2019 | ABC News.au
By Annie Gaffney
A clinic specialising in treating mesh-injured women is set to open in Australia this month.
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J&J's Mesh Appeal Nothing But A 'Trial Balloon,' 7th Circ. Told
Apr 5, 2019 | Law 360
By Cara Salvatore
An Indiana woman who won $20 million over life-changing pain blamed on a pelvic support mesh implant asked a Chicago federal appeals court on Thursday to uphold the award, criticizing Johnson & Johnson's claim that the case never belonged in front of a jury.
Valparaiso, Indiana, resident Barbara Kaiser is fighting to keep her award over the Prolift polypropylene mesh a doctor implanted in 2009 to counteract organ prolapse. It caused bladder spasms and pelvic pain, ended the possibility of vaginal intercourse, and prompted further surgery, an Indiana jury heard last March before awarding Kaiser and her husband $10 million in compensatory damages and $25 million in punitive damages.
A judge later reduced the punitive damages to $10 million.
Kaiser urged the Seventh Circuit on Thursday to reject an appeal from Ethicon, the maker of the Prolift mesh, and Johnson & Johnson, Ethicon's owner, saying federal law requiring device designs to get U.S. Food and Drug Administration approval preempts Indiana's design-defect tort law and should have blocked the case.
"Ethicon is sending up yet another 'trial balloon' on appeal" to try to get a ruling saying that federal law mandating devices be cleared for sale by regulators conflicts with state law requiring devices to be safe, Kaiser said. "Numerous courts have rejected Ethicon's argument because no actual conflict exists between federal regulations and state law."
To flip the jury's design-defect finding, "Ethicon must establish that the FDA's §510(k) market-clearance process preempts all state tort law — something no court has ever held," Kaiser said.
And on a failure to warn claim, which Kaiser also won, she told the Seventh Circuit there was ample trial evidence that the mesh's risks "were not generally known to surgeons or disclosed in the medical literature."
Ethicon had highlighted the preemption argument in its February appeal, saying redesigning the Prolift would have been illegal without FDA approval, and so there was no satisfying Indiana law without breaking federal law.
It also said Kaiser failed to make a necessary argument at trial, that there were some alternative Prolift design that would have been safer.
Exactly the opposite is true, Kaiser said Wednesday: The Indiana Supreme Court doesn't require a safer-alternative-design element, and the jury saw plenty of evidence of one regardless.
"Ethicon has an insurmountable hill to climb on appeal," Kaiser told the Seventh Circuit.
Kaiser's doctor in Munster, Indiana, first implanted the Prolift mesh in January 2009, to treat her pelvic organ prolapse.
In 2011, the U.S. Food and Drug Administration formally warned health care providers and patients that serious complications associated with surgical mesh for treating pelvic organ prolapse are not rare, the jury heard.
Later on, Kaiser claimed she learned from another doctor that her chronic pelvic pain was thanks to the mesh.
Ethicon said it was from a car accident. But the company allegedly knew from the get-go that the Prolift failed at an astonishing rate; in study after study, complication rates were more than 10%, Kaiser's lawyer Tom Plouff told the jury in opening arguments last spring.
"They let it go on the market in March of 2005. And just a little bit over a year later they're reporting moderate or severe retraction in almost 13% of patients," he said.
People who got the mesh entered "a new normal of chronic pain, pain with intercourse, degraded self-esteem and body image, constant coping," Plouff said. "They have to take it into account every day."
Kaiser underwent what's known as a revision surgery in November 2013 to try to get the mesh out. Only part of it could be removed.
Counsel and representatives for the parties were not immediately available for comment.
Kaiser is represented by Thomas Plouff of Costello McMahon Burke & Murphy Ltd., Jeffrey Kuntz of Wagstaff & Cartmell LLP, and Edward Wallace, Mark Miller and Timothy Jackson of Wexler Wallace LLP.
Johnson & Johnson and Ethicon are represented by R. Stanton Jones and William Perdue of Arnold & Porter, Stephen Brody and Jason Zarrow of O'Melveny & Myers LLP, and Amy Pepke of Butler Snow LLP.
The case is Kaiser et al. v. Johnson & Johnson et al., case number 18-2944, in the U.S. Court of Appeals for the Seventh Circuit.
https://www.law360.com/articles/1147109/j-j-s-mesh-appeal-nothing-but-a-trial-balloon-7th-circ-told
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Campaigners north of the border hit out as mesh implants cleared for use across England
Apr 7, 2019 | The Sunday Post
By Marion Scott
An announcement by a government health watchdog that mesh implants can be brought back has left injured women devastated.
NICE, which advises on treatment in England and Wales, said mesh implants should be available down south. But campaigners here say Scotland must stand firm against the move.
Mesh implants were used in Scotland to treat pelvic organ prolapse and bladder issues after childbirth.
Elaine Holmes of Scottish Mesh Survivors said: “We can only think that whoever made this decision [at NICE] must have been sleeping for the last seven years or that they are completely unaware of the women who have died or been maimed and crippled by these devices.
“We will not stand back and allow this carnage to continue to affect our daughters and granddaughters. Already far too many women and their families have been devastated by mesh.”
Neil Findlay MSP said: “Every truly independent piece of research has shown that the risks of mesh outweigh the benefits and that is why we do not want these implants brought back into Scottish hospitals.
“We will be standing firm on this despite NICE. I find it incomprehensible that anyone who has ever seen the devastating injuries, and deaths, from mesh implants can countenance their return.”
NICE say that once a register is established, surgeries should be carried out at specialist centres, and only offered after all other non-surgical options are considered.
https://www.sundaypost.com/fp/campaigners-north-of-the-border-hit-out-as-mesh-implants-cleared-for-use-across-england/
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Experts to make recommendations on mesh implants
Apr 5, 2019 | Press Association (In The Daily Mail, The Sunday Post, Irvine Times, Isle of Wight County Press)
Recommendations on how to improve care for women who have experienced complications from mesh procedures will be made in early autumn.
An expert group was announced by Health Secretary Jeane Freeman last month following a meeting with women who have suffered as a result of vaginal mesh implants.
The devices were banned across the UK last year due to safety concerns, with hundreds of Scottish women suffering chronic pain from the implants.
Ms Freeman has written to campaigners, MSPs and the Scottish Parliament’s Health and Sport Committee to set out details of the work to be carried out.
The group, made up of senior clinical managers, medical directors and other key specialists, will hold its first meeting on Friday and is expected to submit its findings to health board chief executives in the early autumn.
To ensure the work takes into account the views of patients, a clinician will also be nominated to give their views.
In its remit, the group will examine the needs of patients and the course of care provided for those who suffer complications following vaginal mesh surgery.
It will also consider what additional steps could be taken to offer choice to women who want – and are clinically suitable for – removal of mesh.
Ms Freeman said: “Last September, I announced a complete halt to all transvaginal mesh procedures, which will only be lifted when a new Restricted Use Protocol has been developed and fully implemented.
“However, I am also determined that women who have had complications from procedures get the best possible care and support.
“I have now written to the women I met last month to set out some more details of the expert group that will take this work forward.
“It is important that the group takes the views of women into account and I expect them to report their findings to health board chief executives in autumn.”
https://www.dailymail.co.uk/wires/pa/article-6890299/Experts-make-recommendations-mesh-implants.html
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Bernstein Liebhard Objects to Its Share of Fees in Transvaginal Mesh Litigation
Apr 5, 2019 | Law.com
By Amanda Bronstad
A fourth law firm has objected to its share of common benefit fees in the transvaginal mesh litigation, insisting that lawyers tasked with distributing the $550 million fund failed to compensate it for work in a critical New Jersey trial.
Bernstein Liebhard, based in New York, joins three other law firms that have objected to their allocation of common benefit fees, which are designed to compensate lawyers for work that had a “common benefit” to all the litigation over transvaginal mesh devices. More than 100,000 lawsuits were filed over the devices, most of them coordinated in multidistrict litigation in federal court in West Virginia. But one of the first trials in the nation was in New Jersey’s Atlantic County Superior Court, where one of the defendants, Johnson & Johnson’s Ethicon, lost an $11 million verdict in 2013.
In a March 29 objection, Bernstein Liebhard claims that the fee and cost committee in the multidistrict litigation, in recommending less than $1.4 million in fees, failed to account for the firm’s work in that trial. Under a 2012 agreement, attached to Bernstein Liebhard’s objection, the MDL leadership had agreed to have a representative of the New Jersey cases on the fee and cost committee.
“But the MDL made no effort to appoint a NJ firm to the FCC and even ignored an express request to do so,” wrote Bernstein Liebhard attorney Mike Hissam, of Hissam Forman Donovan Ritchie in Charleston, West Virginia, in the objection. “The NJ firms never served on the FCC. Now, the two NJ firms that expended the most effort for the MDL plaintiffs object to the fee allocation.”
Neither Hissam, nor Bernstein Liebhard name partners Stanley Bernstein and Sandy Liebhard, responded to a request for comment.
Henry Garrard, a shareholder at Blasingame, Burch, Garrard & Ashley in Athens, Georgia, who is chairman of the fee and cost committee, declined to comment but noted in an email that “it was up to the court as to membership on the FCC and the court did due deliberation determining his committee.”
The fee and cost committee’s responses to the objections are due on April 9.
In all, 94 plaintiffs law firms received common benefit fees in the mesh cases. On March 12, the fee and cost committee and Daniel Stack, a retired judge on the Madison County, Illinois, Circuit Court appointed to review the fee allocation process, issued their final recommendations on how to allocate the fees.
Three other firms have objected to their fees: Philadelphia’s Kline & Specter; Mazie Slater Katz & Freeman, based in Roseland, New Jersey; and Anderson Law Offices in Cleveland. Three of the four firms worked on the first mesh trial against Ethicon in the nation, which involved plaintiff Linda Gross, a South Dakota woman who had 18 surgeries to fix injuries caused by the Gynecare Prolift mesh implant.
In a March 26 objection over $6.02 million in fees, Mazie Slater partner Adam Slater raised concerns that some law firms on the fee and cost committee had resorted to self-dealing and bill padding to ensure they would receive the majority of the fees, citing comments that Stack made to him. Slater also referenced the 2012 agreement involving the New Jersey cases, noting that his firm was lead counsel in the first Ethicon trial.
Anderson Law Offices, which raised similar concerns, also worked on that trial.
Bernstein Liebhard, in its objection, said its partner “played a significant role” in both the New Jersey trial and the multidistrict litigation against Ethicon. That partner, Jeffrey Grand, now at Seeger Weiss in New York, did not respond to a request for comment.
Grand signed the 2012 agreement, along with Slater and Jillian Roman of Cohen, Placitella & Roth in Philadelphia. Two members of the fee and cost committee, Renée Baggett of Aylstock, Witkin, Kreis & Overholtz in Pensacola, Florida, and Thomas Cartmell of Kansas City, Missouri-based Wagstaff & Cartmell, co-lead counsel in the Ethicon MDL, also signed the agreement.
Roman, Baggett and Cartmell did not respond to requests for comment.
Under the agreement, the New Jersey firms agreed to share “work product and other good and valuable common-benefit work” with the leadership in the MDL against Ethicon. Such work, the agreement stated, would be “fairly compensated,” and the MDL leadership agreed to “use their best efforts to ensure that the MDL court fairly compensates the aforesaid common benefit work.” The MDL leadership also agreed to “recommend to the district court, and give their best efforts to ensure, that the fee committee include representation from the NJ litigation.”
Instead, Hissam wrote, the fee committee cut 455 of Bernstein Liebhard’s 4,407 billable hours from its final allocation.
Bernstein Liebhard attached a comparison of “blended” hourly rates in its allocation—about $352—and that of each of the eight firms on the fee and cost committee, such as Blasingame Burch, whose fee award comes out to $847 per hour. Bernstein Liebhard also based its fee request for $3.2 million on an “average blended hourly rate” of those eight law firms: About $730.
“Reviewing the blended rates awarded in the MDL shows that BL’s fee is patently unfair,” Hissam wrote. “Is a partner’s time as valuable as a paralegal or low-level document reviewing attorney? Of course not—but the recommended allocation gives no information to discern how comparable timekeepers or work is to be compensated.”
https://www.law.com/njlawjournal/2019/04/05/bernstein-liebhard-objects-to-its-share-of-fees-in-transvaginal-mesh-litigation/
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Pelvic mesh injury clinic, co-designed by women, set to open in Queensland
Apr 6, 2019 | ABC News.au
By Annie Gaffney
A clinic specialising in treating mesh-injured women is set to open in Australia this month.
Established in direct response to a 2018 Senate Inquiry into pelvic mesh products, Queensland Pelvic Mesh Service at Varsity Lakes, on the Gold Coast, will receive $3.14 million annually over the next three years.
Urogynaecologist Dr Malcolm Frazer, the clinical medical lead of the new service, said input from mesh-injured women was sought to help design the clinic.
"We wanted to make sure that we had a system that would fit their needs," Dr Frazer said.Like having a bullet in your body'
Among those referred to the service is Sunshine Coast woman Sandra Chapman, who has experienced complications from a transvaginal mesh implant procedure carried out in 2013.
She said she did not question her surgeon when he told her he would need to "mesh up" her bladder to correct a problem she was having going to the toilet.
"I went through with it because I had blind trust in him," she said.
"I have had four children and I was having a few troubles down there."
Her mesh implant procedure was done vaginally.
"They sling [the mesh] up there and there's spring-loaded anchors that are supposed to hold it up in place — in my case up around my bladder," she said.
"I've since found out through a specialist that my mesh quite possibly straight away fell down and then of course, I've got a foreign body response.
"It's like having a bullet in your body, which [causes] inflammation."
Ms Chapman said the mesh did not relieve her symptoms.
"If anything, I actually became incontinent after the operation, which I didn't really have beforehand," she said.
"I believe that is from the weight of the mesh."
Ms Chapman said she could no longer enjoy her love of cycling and power-walking.
"At the moment, my mesh is so low down that I am actually told not to cycle," she said.
"I'm not prepared to take that risk, and also it's very uncomfortable because of where it's sitting — I feel that."
Ms Chapman is fearful of what could happen if she attempted to have sex.
"Especially [with] any friction there, I'd be afraid that the mesh would come through," she said.'Canary in the coalmine'
Melissa Fox, the CEO of charity Health Consumers Queensland, said the independent body began receiving complaints from women with mesh implants in 2014.
"It really felt like a canary in the coalmine around medical devices and safety and quality," Ms Fox said.
She said the National Mesh Forum, which was held in Melbourne on Friday, was "the first time stakeholders have been able to come together from a consumer perspective to look at the issue."
Ms Fox said women are still not being told about the full range of complications they might experience.
"Unfortunately, there hasn't been a galvanising within the medical community around this issue", she said.
"We are starting to see some doctors demonstrate great empathy.
"They can see that they too were let down by our safety and quality systems."
Ms Fox believes the Queensland Pelvic Mesh Service could set a new standard.
"[It is] definitely the only one of its kind in Australia and we would say internationally," she said.'Serious and complex problems'
Dr Frazer said he and other specialists had visited various medical centres in North America to make sure they were offering a world-class service.
He said that in addition to up to five urogynaecologists, the service included psychologists, pelvic floor physiotherapists, occupational health and social workers, as well as nurses and other medical specialists.
Choosing the patients carefully is important, with estimates that anywhere between 7-20 per cent of women with transvaginal implants could have issues with the mesh.
"The best estimate would be that only about 50 per cent of women who have significant mesh removal surgery can expect real benefit in the management of their pain," Dr Frazer said.
Dr Frazer predicted that at least 123 women would need to access the Queensland Pelvic Mesh Service annually, and that the clinic had already started taking referrals.
"The vast majority of women who have had pelvic mesh for either the treatment of prolapse or incontinence will not having any issues or problems," he said.
"So we're dealing with a small percentage, but unfortunately we're dealing with people who have serious problems which are very complex."
The Therapeutic Goods Administration has banned transvaginal mesh implants used to treat pelvic organ prolapse, but some mesh products are still able to be used in Australia.
https://www.abc.net.au/news/2019-04-06/vaginal-mesh-clinic-set-to-open-queensland/10916696
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