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Ethicon Media Monitoring 5/9/2017
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J&J Opens 4th Pelvic Mesh Trial In Philadelphia
May 8, 2017 | Law 360
By Dan Packel
Attorneys litigating against Johnson & Johnson in Pennsylvania state court over allegedly defective pelvic mesh implants manufactured by the company look to keep a winning streak going as the fourth trial in Philadelphia’s mass tort program opened Monday. -
Boston Scientific Looks To Dodge Mo. Pelvic Mesh Cases
May 8, 2017 | Law 360
By Emily Field
Boston Scientific Corp. on Monday sought to avoid claims brought by more than 75 women in 33 different states alleging they were harmed by faulty pelvic mesh products, saying that a Missouri federal court doesn’t have jurisdiction since most of the women don’t have ties to that state. -
Vaginal mesh implant destroyed my life: Perth mum speaks out
May 9, 2017 | WA Today (also in Esperance Express)
By Emma Young
A Perth woman has described the "total destruction" of her life as a mesh implant, intended to treat post-childbirth prolapse, slowly disintegrates inside her.
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J&J Opens 4th Pelvic Mesh Trial In Philadelphia
May 8, 2017 | Law 360
By Dan Packel
Law360, Philadelphia (May 8, 2017, 2:22 PM EDT) -- Attorneys litigating against Johnson & Johnson in Pennsylvania state court over allegedly defective pelvic mesh implants manufactured by the company look to keep a winning streak going as the fourth trial in Philadelphia’s mass tort program opened Monday.
Kline & Specter PC attorney Tom Kline told a jury that a Prolift mesh implant made by J&J subsidiary Ethicon Inc. left Pennsylvania resident Sharon Beltz with unremitting discomfort, pain that is amplified when she attempts to have sex with her husband.
“We’ll show you how her life changed so much for the worse after this instrument was put into her body without having been properly tested,” he said.
Three previous trials over the company’s implants in Philadelphia have all gone in favor of plaintiffs and have led to a total of $46 million in damages against J&J. After a gap of over a year in the trial schedule, the third concluded at the end of April with the biggest verdict yet: a $20 million award that included $17.5 million in punitive damages.
Kline accused the company of rushing Prolift, which he said was initially designed to treat hernias, to the market in 2005 because a competitor had a rival product available. He asserted that it had only been tested on 175 women, and two studies had revealed complication rates of 10 to 14 percent. Ethicon stopped selling the product in 2012.
Kline said that the 45-year-old Beltz had the product implanted in 2006 to treat pelvic organ prolapse and stress urinary incontinence following four pregnancies. But he said the urogynecologist who recommended the implant was being trained by a doctor who received $1.75 million from J&J to advocate for the product, adding that she herself received $100,000 from the company.
Beltz was kept in the dark about these relationships and the risks of the implant, Kline contended.
“No one told Sharon Beltz: ‘You’ll have pain with sex all through your life,’” he said. “She’ll tell you: ‘If I know that, I’d never put this in my body.’”
Kline added that there were alternatives to the product available, including a separate mesh produced by the company.
Beck Redden LLP attorney Kat Gallagher, arguing for J&J, responded by detailing the seriousness of the ailments faced by Beltz and asserting that her doctor had outlined the risks of the mesh implant, including some that were specific to sexual intercourse.
And she noted that the 2006 surgery and a follow-up implant of a different mesh product in 2011 had served their purpose, pointing out that Beltz had been seated without any interruption for nearly 90 minutes of oral arguments. Gallagher said that Beltz would not have been able to do so before receiving the implant.
“The mesh has done what it’s supposed to do,” she told jurors.
Immediately afterward, Kline asked Philadelphia Court of Common Pleas Judge Kenneth Powell for a directed verdict on two of the three claims in Beltz’s lawsuit — misrepresentation and failure to warn — asserting that Gallagher had not addressed them in her opening.
“I may not have said it in the way Mr. Kline would like to hear, but the substance was there,” she responded.
Judge Powell said he would need to review the transcript and evaluate Pennsylvania law before reaching a conclusion.
The trial is expected to last approximately two weeks.
“We are always concerned when a patient experiences adverse medical events. We empathize with Mrs. Beltz’s medical situation, along with those of all women suffering from pelvic organ prolapse, a condition that can be serious and debilitating,” Ethicon spokeswoman Kristen Wallace said in an email. “The evidence will show that Ethicon acted appropriately and responsibly in the research, development and marketing of its Prolift device for the treatment of pelvic organ prolapse.”
The case is being presented for Beltz by Tom Kline of Kline & Specter LLP.
The case is being presented for J&J by Kat Gallagher of Beck Redden LLP.
The case is Beltz v. Ethicon Women’s Health and Urology et al, case number 130603835, in the Philadelphia County Court of Common Pleas.
--Editing by Christine Chun.https://www.law360.com/trials/articles/916094/j-j-opens-4th-pelvic-mesh-trial-in-philadelphia
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Boston Scientific Looks To Dodge Mo. Pelvic Mesh Cases
May 8, 2017 | Law 360
By Emily Field
Law360, New York (May 8, 2017, 7:40 PM EDT) -- Boston Scientific Corp. on Monday sought to avoid claims brought by more than 75 women in 33 different states alleging they were harmed by faulty pelvic mesh products, saying that a Missouri federal court doesn’t have jurisdiction since most of the women don’t have ties to that state.
In the suit, 84 women claim that they were injured by one of a number of different Boston Scientific pelvic mesh products, implanted by different doctors in different medical facilities on different dates ranging from 2001 to 2013, according to its motion to dismiss. The company is seeking to ax the claims brought by women outside of Missouri; only five of the plaintiffs are Missourians.
For one thing, the court doesn’t have personal jurisdiction over Boston Scientific regarding the non-Missourians’ claims, the company said.
And regarding general jurisdiction, the U.S. Supreme Court in its Daimler AG v. Bauman ruling said that it could only be exercised over a corporation in states where it can be considered “at home," the company said.
“Here, Boston Scientific is incorporated in Delaware and maintains its principal places of business in Massachusetts, and there are no other facts sufficient to render Boston Scientific at home in Missouri in order to support the exercise of general jurisdiction,” the company said.
The women's complaint establishes that the non-Missourians’ claims have no ties to that state, since they don’t claim they live there, were implanted with the pelvic mesh there or that they experienced complications in that state, the company said.
“Because the non-Missouri plaintiffs’ claims do not arise from any in-state activities of the defendant, specific jurisdiction over Boston Scientific as to these claims is a non-starter,” the company said.
The women argue that Missouri courts have personal jurisdiction over the non-residents’ claims, Boston Scientific said.
“But the United States Supreme Court recently granted certiorari to answer that very question in a case where the California Supreme Court found that specific personal jurisdiction did exist under facts substantially similar to those here,” the company said.
Boston Scientific is referring to the high court’s decision in January to hear Bristol-Myers Squibb Co.’s appeal of a California high court decision that allowed almost 600 out-of-state residents to sue the drugmaker over alleged injuries from blood-thinner Plavix because of the company’s ties to the state.
In upholding a lower court’s ruling, the Golden State’s high court said that because of the company’s contacts with the state — such as its marketing and distribution of the drug and research and development facilities located there — the state courts have specific personal jurisdiction over the nonresidents’ claims.
The justices have also agreed to hear another jurisdiction-related appeal, BNSF Railway Co. v. Tyrrell, Boston Scientific said. That one centers around a Montana Supreme Court decision that found that the railroad company’s business operations in the state allowed two out-of-state injured workers to bring claims there.
The women’s suit was filed in Missouri state court in October and removed to the federal court in early May.
Counsel for the parties didn’t immediately respond to requests for comment on Monday.
Boston Scientific is represented by Beth A. Bauer and Gerard T. Noce of HeplerBroom LLC.
The women are represented by Eric Jackstadt of Napoli Shkolnik PLLC.
The case is Gathright et al v. Boston Scientific Corp. et al., case number 4:17-cv-01437 in the U.S. District Court for the Eastern District of Missouri.
--Editing by Kelly Duncan.https://www.law360.com/articles/921744/boston-scientific-looks-to-dodge-mo-pelvic-mesh-cases
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Vaginal mesh implant destroyed my life: Perth mum speaks out
May 9, 2017 | WA Today (also in Esperance Express)
By Emma Young
A Perth woman has described the "total destruction" of her life as a mesh implant, intended to treat post-childbirth prolapse, slowly disintegrates inside her.
Women from across Australia are emerging to tell their stories as a Senate inquiry gathers evidence into what Senator Derryn Hinch described as "one of the greatest medical scandals and abuses of mothers in Australia's history".
Stella Channing suffered from pelvic organ prolapse in her late forties after having three children. A surgeon recommended surgery involving a 'small amount of tape' between her rectum and vagina, requiring an overnight stay in hospital and a few weeks off her full-time retail job.
She woke with two bodies of mesh – Johnson & Johnson Ethicon Prolift, now removed from sale – between her rectum and vagina. She was in hospital for eight days.
One week after discharge, the mesh had begun to erode. She began experiencing bleeding, and pain in her buttocks and legs. Her surgeon could not recommend any solution.
She could not go back to work for three months and when she did, she could not stay on her feet. Her employers created a position as a customer service officer, so she could sit on a cushion in the office.
By 14 months after surgery, after dipping for a time, the pain returned full force, in her buttocks, rectum, vagina and thighs. She began experiencing transient ischaemic attacks, or 'mini strokes'.
She was forced to drop work to part-time, then two days a week. She had to leave her job despite her employers' efforts to accommodate her, being unable now to sit down on an office chair.
The mesh had continued to erode and shrink, she said, shrinking her vagina and hardening her rectum, trapping and scarring the pudendal nerves running through the rectum and legs, damaging the flesh and muscles throughout the pelvis.
It was now close to piercing her rectal wall and causing blood poisoning.
She described her feelings in words that echoed those of other mesh-injured women now going public.
"The nerve pain is like petrol burning inside me," she said.
"The raw pain of the erosion is like broken glass in your rectum and vagina. As we speak I am losing blood from my rectum and vagina and the pain is unbearable.
"This has totally destroyed my life
"It sounds dramatic - and I can only say that it is."
Ms Channing cannot walk around the supermarket without a cane and must lie almost continuously on her side in a hammock-like bed. She cannot pick up her grandchildren, or even play with them.
The memory of her past life mocks the present one. As well as working towards a management position in retail, Ms Channing had been doing certificate courses to qualify as a personal trainer.
"I was a gym junkie. I would exercise every day. I wouldn't even sit till to watch a movie. I was active, busy and social. I was someone who looked after my appearance," she said.
"All that has been stolen. I am financially ruined. I lie down all day. I am isolated. Sometimes I cannot shower because the pain flare will be so great it will take days to recover."
Some days, she tried to pick herself up and give herself a talking to. She would get up, do her hair, put makeup on and go to see her grandchildren.
Afterwards she would be rewarded with pain so unbearable it was like a punishment for her effort.
Ms Channing's older sons and grandchildren felt her absence from their lives keenly, she said, as did her ageing mother, who she couldn't fly to Adelaide to visit.d, her 23-year-old daughter who still lives with her.
She brought her daughter up prizing health. The 10-year-old would amuse herself with colouring-in books at the gym waiting for her mother to finish a workout. As she grew older, they began to go together.
Now, her daughter does these rituals alone.
"She feels the burden of looking after me," Ms Channing said.
"The other day she got back from a walk and just said, 'Mum, we should be doing these things together'. I can't go for walks with her, or to the gym, even out to breakfast. So she is missing out on having a mother who is involved in her life.
"I become depressed, hopeless, knowing I must live with this for the rest of my life.
"Some days, I wake up and don't know why I have bothered waking up.
"Sometimes I think it would be better if I just didn't."
The meshes are not designed with removal in mind, so removal is a complex business. No Australian surgeon was trained to do it, Ms Channing said.
Her previous urogynaecologist suggested "having a dig around" and attempting partial removal but it would be too dangerous to attempt to remove the 'arms' of the mesh in her buttocks or groin. It would still be life-threatening surgery and would mean removing her rectum, leaving her with a colostomy.
"It doesn't inspire confidence. I know partial removals make it worse – more scar tissue, more nerve damage. Fortunately I have done my research of women worldwide, because I have been going through this for long enough and I know what will make it worse," Ms Channing said.
"I know you wait for full removal."
One surgeon in America, a country flooded with lawsuits over mesh injuries, has performed thousands of removals, which cannot return women to original health but can at least halt the damage.
But Ms Channing, unable to sit on a plane or buy a ticket on a disability pension, has no hope of going overseas. She can only hope the surgeon will one day travel to Australia as the scandal here grows.
She said she might have already taken her own life were it not for the support of her GP, pain psychologist and occupational therapist, "three strong women" who fight her corner.
But no medical specialist is overseeing her case since the urogynaecologist's offer to "dig around".
Ms Channing is one of more than 200 women to report a mesh-related "adverse event" to the Therapeutic Goods Administration.
The TGA approved use of pelvic mesh in Australia in 2005 following 2002's USA approvals, without clinical trials. It later conceded the approval was "not mature" and lacked rigour.
In 2011 the USA Food and Drug Administration announced serious complications were "not rare" and that the overall increase in serious adverse event reports was cause for concern.
In 2012 Johnson and Johnson notified all regulators they would cease supply globally of their urogynaecological meshes.
But other meshes are still being used.
They are now the subject of a federal Senate Inquiry, whose title "Number of women in Australia who have had transvaginal mesh implants and related matters" highlights the lack of information on how many Australian women have the mesh and how many have complications, thanks to inadequate records of mesh use.
The Project's special report said state health complaint agencies refused to disclose the number of complaints received.
A support group for mesh-injured women, begun with 27 members in 2014, now has nearly 700.
But women experiencing pain and mesh erosion are not told by doctors of this growing community.
"So many women are told to get test after test and don't know the mesh is causing their hip problem, their bleeding, their other complaints," Ms Channing said.
"I don't even want to go and see a new gynaecologist or colorectal surgeon because I just feel it's downplayed, they say you are the only one."
One Perth mother, who preferred not to be named, had vaginal mesh inserted in 2016 to treat prolapse but has since experienced further vaginal and rectal prolapses, severe bowel problems and vaginal bleeding.
She had very recent surgery to remove an eroding portion of mesh that had burrowed through the wall of her vagina, and the bleeding has stopped, but doctors failed to tell her there was a current Senate inquiry she could give evidence to, or that she could report an adverse event to the TGA.
"I have been struggling to try to get help. I have obviously Googled it and I am aware of the problems in America and I saw also the people in Australia," she said.
"But no one had told me about this. It has always been minimised.
"It's more like 'everything is perfect and good.'
"I was told it was no problems, a stitch hadn't healed, that it was the tiniest bit of mesh coming through and they were pleased with the results.
"I just don't know. You don't have any choice but to trust them to sort out these problems that have been extremely disabling for me. It's quite a horrible area to have a problem in."
Health consumers councils across Australia have united to help host a Facebook Page to ensure women's voices are at the heart of their Senate inquiry submission.
They are running an anonymous survey for women and their families to provide feedback to inform the submission.
In just three weeks 1250 women have completed the survey. Nearly 58 per cent say they have been adversely impacted, citing problems such as chronic incontinence, abdominal pain and pain during intercourse.
One-quarter said the impact had led to a breakdown of their marriage or personal relationships.
Of those who sought remedial medical assistance, slightly over 10 per cent reported this made things better; 40 reported no difference and 11 per cent that it made matters worse.
The remaining 39 per cent were told that nothing could be done for them.
The page will be active until the submissions deadline of May 31.
http://www.watoday.com.au/wa-news/vaginal-mesh-implant-destroyed-my-life-perth-mum-speaks-out-20170508-gw0fpx.html
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