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Ethicon Media Monitoring 1/30/2018
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Vaginal mesh: Thousands of cases to be reviewed
Jan 29, 2018 | Sky News
By Charlotte Lomas-Farley
Complications from the implants have left women in chronic pain, but it is not known how many women have been negatively affected. -
Mother-of-six left unable to walk, use the toilet or have sex after botched mesh implant ripped her pelvic nerve - and the painkillers to treat it wiped memories of her children
Jan 29, 2018 | The Daily Mail
By Natalie Rahhal
After giving natural birth to six children, Amy Whitaker was no stranger to pain. -
How the Finance Industry Is Trying to Cash In on #MeToo
Jan 29, 2018 | The New York TImes
By Matthew Goldstein and Jessica Silver-Greenberg
For the past two decades, settlement-advance companies have been chasing the hottest — and most lucrative — trends in litigation. They have provided advances to victims of surgical vaginal mesh products; those suffering from ailments related to the Sept. 11, 2001, terror attacks; and former National Football League players with brain injuries. -
First Ethicon Physiomesh Lawsuit Headed to Trial in September 2019, as Federal Court Outlines Bellwether Case Selection Process
Jan 29, 2018 | RX Injury Help
By Laurie Villanueva
The federal court overseeing hundreds of hernia mesh lawsuits involving Ethicon, Inc.’s Physiomesh Flexible Composite Mesh implants has begun setting the stage for the litigation’s first bellwether trials.
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Vaginal mesh: Thousands of cases to be reviewed
Jan 29, 2018 | Sky News
By Charlotte Lomas-Farley
Complications from the implants have left women in chronic pain, but it is not known how many women have been negatively affected.
In a major win for campaigners against vaginal mesh implants, the Government has launched a full retrospective audit of all women who have had the surgery since 2005.
It will be the first comprehensive study into the scale of complications and will provide a definitive look at the number of women affected by mesh implants.
This comes after a series of meetings with an all-party parliamentary group set up by Owen Smith MP which looked into the safety of mesh devices.
NHS England estimates that more than 100,000 women have had vaginal mesh surgery to treat urinary incontinence, most often caused by childbirth.
The official complication rate for vaginal mesh surgery is between 1-3% but recent studies have shown it to be anything between 10-15%.
The announcement of an audit comes a few months after Australia and New Zealand banned the use of its mesh products for some pelvic surgery.
Chair of the APPG on Surgical Mesh Implants, Owen Smith MP, said: "Over the last two years I've been urging ministers to conduct an investigation to fully determine problems related to mesh surgery.
"I'm delighted that the Government has listened to my concerns and has now agreed to undertake this audit to get a better understanding of complications related to mesh surgery. I hope the audit will provide crucial answers about the proportion of women adversely affected."
Dr Sohier Elneil is a specialist in mesh removal and sat on the board of the UK health watchdog NICE for 10 years, advising on its use. She described the audit as a major step forward.
She said: "I'm absolutely over the moon about it because this is the one thing we were looking for - this was not about us pursuing anybody or pursuing any agency, it was about us getting to the truth and knowing what the problem was and how much of a problem it was.
"I think the complication rate is a minimum of 10%, I suspect it is much closer to 20-25% of all implants that have had a negative effect on women's lives.
"After the results of the audit we also need to make plans, on how to rectify the situation and how to start helping women. Not just on a one-on-one scale but on a global scale and that may impact, and should impact, on what actual product is available and when it could or should be used.
"So we need to revise the whole issue of insertions of tapes, meshes or prosthetic materials - it depends on what everybody calls them. But it's still the polypropylene product."
Julie Gilsenan, a paramedic from Liverpool, had vaginal mesh surgery last year to treat her mild incontinence brought on after childbirth.
She decided to have her mesh removed after it caused her chronic pain and she was barely able to walk. It is a highly dangerous procedure because mesh is designed to be permanent.
She said: "It absolutely ruined my life. I'm in a worse position now - I had mild stress incontinence and that's why I had the TVT operation performed in February. And I'm now more incontinent than I was before I had the surgery. So I'm facing the prospect of further surgery to try and correct that.
"That's just hideous to think that I've spent 12 months, being in pain and agony for 12 months, I had to take all kinds of painkillers, couldn't do my job. And I've had two operations and I'm now in a worse position than I was before I had that initial surgery.
"Would you take that risk if someone said that to you? There's absolutely no way. It's playing with people's lives and I just cannot believe that they still do this."
The results of the audit are expected to be announced in April after data is collected and analysed on patients' conditions and the type of surgery and subsequent hospital admissions.
The latest guidelines from the UK health regulator, the MHRA, is that vaginal mesh is an effective treatment for the majority of women and there is no evidence to suggest the device is inherently unsafe.
The news comes ahead of the latest APPG meeting on Tuesday in Parliament, where MPs from all political parties will meet with clinicians to discuss mesh.
https://news.sky.com/story/vaginal-mesh-thousands-of-cases-to-be-reviewed-11228531
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Jan 29, 2018 | The Daily Mail
By Natalie Rahhal
· Surgical mesh split a nerve in Amy Whitaker's pelvis in 2016
· Whitaker, 36, says the white hot, burning pain from the damaged nerve that carries sensation to the vagina and vulva left her feeling helpless and worthless
· While she suffered, her parents took out two mortgages to help Whitaker and her husband, a radiologist, care for their children
· For a year, she lived in constant pain, bedridden until her doctor convinced her to try the opioid, fentanyl, which eased the pain but robbed her of memories
· A stem cell treatment finally brought her some relief, and Whitaker weaned herself off painkillers, suffering through excruciating withdrawals
· She lost a third of her body weight, but, on a good day, can finally do basic activities like sitting at the movies and grocery shopping
After giving natural birth to six children, Amy Whitaker was no stranger to pain.
But when, aged 35, she woke up from a minor operation to remove a pelvic hernia she learned a new definition of the word.
'The minute I opened my eyes, I felt intense pain; it was instantaneous,' the mother from Atlanta, Georgia, told Daily Mail Online.
Instead of closing the surgical site inside her with stitches, Whitaker's doctor used a surgical mesh to 'stem' it.
It wasn't until months after the initial operation that Whitaker, now 36, found out the mesh had been placed just a bit too low, tearing into the nerve connecting her clitoris, anus, vulva and pelvis.
The excruciating pain forced her to outsource everything - from cooking to parenting - as she battled a rare condition called pudendal neuralgia. Her parents even took out two mortgages to support Whitaker, her husband and their children Aiden, 10, Rose, eight, Matthew, six, Nick, four, Eli, three and Lana, 21 months.
Whitaker’s next year was a blur of pain, prescription opioids, and endless doctors' consults - coupled with excruciating drug withdrawals to wean herself off the drugs which were wiping memories of her newborn daughter.
The intense, burning pain through her pelvis, vagina and vulva made the most basic human functions – like sitting, urinating and sex – impossible for a year.
Only the potent painkiller that has largely driven the opioid epidemic would 'make a dent' in her suffering - but that brought its own agony of weight loss, anxiety, and crushed her memories of her children.
All the while, her doctors insisted Whitaker's post-op pain was normal.
'I've had childbirth of a nine-and-a-half pound baby, so I can push through any pain if I know it's normal,' she says, but when she wasn't getting any better, she and her husband, James, a radiologist, spent 10 months looking for answers and being turned away over and over.
'That was really hard, because we were on our own with a new baby, no family around, and I was in so much agony, but they said 'go deal with that yourself,' and with no one sort of quarterbacking, it's really difficult,' Whitaker says.
James had an obscure hunch: his wife had a lot of symptoms of pudendal neuralgia, a condition that affects about one in every 100,000 people in the world. Few doctors know about it and even fewer treat it.
The condition arises from damage to pudendal nerve, which feeds sensory information to and from the pelvic floor muscles, the urethral and anal muscles and all of the skin between the clitoris (or the penis, in men) and the anus.
Nerve pain is not the dull persistent ache of muscles, or the sharp radiation of a break, but rather white hot burning.
After countless trips to specialists, Dr Brian Organ, a surgeon at Emory confirmed James's insistent suspicions.
'I was in so much pain at that point, I didn’t care if I lived or died…I wouldn't be here today if it weren't for my husband,' Whitaker says.
The mesh had split one of the nerve's branches in half. If Whitaker was ever to have more manageable pain level, the mesh would have to come out.
But even that was not a fix: 'Once you cut a nerve, it doesn't heal like bone does when you just put a cast on it,' Whitaker says.
Nerve blocks – local anesthetic injections – acted as the bandage on her break but wore off, and even getting those required long travel to get to doctors that would perform them.
In between injections, 'it was like someone poured gasoline inside my bodily orifices and then lit it on fire,' Whitaker says.
Her urethra hurt, her vagina hurt, her 'external bladder' hurt – 'you don't even know what that is until it hurts,' she says (it's the muscle group that surrounds the bladder).
'You take your basic bodily functions - like going to the restroom, having sexual relations with my spouse, sitting, drinking water – it's a whole new level of stress, and it's such an intimate area,' Whitaker says.
The pain was isolating, relegating her to her bed for more than a year because sitting and standing were too painful. Whitaker's parents moved to Atlanta, taking out two mortgages so they could help to raise her six children - including a baby she'd never known without pain.
'It's extra horrible because it's hard to talk about it with people,' because her pain comes from her genitals, she says.
After her doctor had her try the full gambit of pain management options, he coaxed Whitaker into trying fentanyl, despite her anxieties about using a drug so closely associated with the opioids epidemic.
'I was ashamed and nervous, terrified of pain medication, and thought, 'what if it ruins my life?' Whitaker says.
Together, fentanyl and a nerve pain drug called Lyrica gave her back a little sanity, but the pain and the drugs to treat it robbed Whitaker of other crucial parts of her life: a third of her body weight, memories and her sense of self-worth.
'I had to outsource parenting, cooking, my whole life. It was like being dead watching my life go by,' she says.
Later, she would see a picture of Lana at eight months old and be moved to tears. 'I don't remember what she looked like then. I lost her babyhood, and I'll never get that back,' Whitaker says, 'I remember the pain, but I don't remember her sweet face at that age.'
With so many of the 'productive' elements of her life out of reach, Whitaker says that only her faith gave her a definition of self-worth that she could live with.
'I realized that worth doesn't lie in how productive you are, or how much money you make. I redefined a person's worth as just who they are as a human, as a soul,' she says.
Finally, an injection of amniotic fluid – similar to a stem cell treatment – began to give Whitaker back her physical life, too, in late May of 2017.
The injections didn't eliminate the pain, but rather 'turned the volume down,' she says. In the relative calm, Whitaker felt clarity: she wanted off of the drugs.
Over the course of six weeks, Whitaker did her own at-home detox, slowly making her fentanyl patches smaller and smaller.
'Every symptom and side effect you've heard is true,' she says.
Though Whitaker never felt any euphoria from fentanyl – just less pain – she certainly felt the horrors of withdrawal.
'James said he'd always be with me and held my hand as I shook through withdrawals,' she remembers.
'The nausea was overwhelming, I had headaches and sweats, I was shaking. It's like you just want to pull your skin off,' she says.
She had to be fed through IVs because she couldn't keep solid food down.
At last, she emerged, and showed up to her pain doctor’s office with a bag of leftover painkiller patches.
'On Labor Day [of 2017], I turned in the last of my meds and said 'burn it.' I'll never forget his face, he said 'I think you're the only patient that's done this with fentanyl. He didn't know what to do with it,' Whitaker says proudly.
But through that horrific year, she learned empathy for those in pain, and especially for those struggling with addiction, that she had never had before.
'It opened my eyes to a world of suffering I didn't know existed, I was really naïve. There is not shortcut [to getting off painkillers], no easy way.
Whitaker has good days and bad ones. She is still fairly weak physically - down to 107lbs, at 5'5" - but is getting her strength back little by little. She takes pleasure in things she lost for a year, things like going to the movies, and sex.
She has celebrated the return of both: 'We took a picture of the movie, though not the sex,' she laughs.
'I had mourning periods, where I had to mourn the death of myself, raging that I wanted my life back,' and she has worried that she will never be able to pay anybody back.
'But the best I can do is show my children what perseverance looks like,' Whitaker says.
Whitaker wants to show that same quality - and the realities of her poorly-understood pain condition - to others too, and writes a blog called The Glass is Half Full, where she hopes other sufferers can come to find that they are not alone, and are understood.
http://www.dailymail.co.uk/health/article-5325265/Mother-six-battles-pain-condition-drug-withdrawals.html
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How the Finance Industry Is Trying to Cash In on #MeToo
Jan 29, 2018 | The New York TImes
By Matthew Goldstein and Jessica Silver-Greenberg
Accusations of sexual harassment have felled dozens of executives, but in one quiet corner of the financial world, the #MeToo movement looks like a golden opportunity.
Companies that offer money to plaintiffs in anticipation of future legal settlements are racing to capitalize on sexual harassment lawsuits.
That is setting off alarms in some quarters because the industry, like payday lenders, has a history of providing cash at exorbitant interest rates to customers who need the money for living and sometimes medical expenses.
The largely unregulated companies have operated with less public scrutiny than the rest of the litigation finance industry, which provides money to law firms to fund commercial lawsuits.
Historically, settlement-advance businesses have targeted personal injury and medical malpractice plaintiffs, many of them referred by their lawyers. But in recent months, lawyers say, more pitches are directed at women with sexual harassment claims.
For example, days after news broke of the Hollywood mogul Harvey Weinstein’s history of sexual harassment, LawCash, a settlement-advance company, was trying to cash in. “Sexual abuse is a crime #HarveyWeinstein,” read a LawCash tweet. The Brooklyn company offered cash upfront to sexual abuse plaintiffs “if you or someone you know is in need of financial help.”
The settlement-advance firms get paid back only if a plaintiff collects money from a lawsuit. They make money by charging interest rates as high as 100 percent, which they are able to do because technically the money is considered an advance — not a loan — and therefore is not subject to state usury laws.
Consumer groups call the industry predatory. The companies counter that they are providing a vital service to people without other options.
Legal and business experts said there are scores of firms providing advances to tens of thousands of plaintiffs each year. The largest firms make cash advances totaling up to $40 million a year, according to an unpublished 2014 report by Diligence, a business intelligence firm.
Legal Bay of Fairfield, N.J., is one of the settlement-advance firms trawling for sexual harassment clients.
In one October news release, Christopher R. Janish, its chief executive, said he had “set aside a large portion of their presettlement cash advance funding specifically for plaintiffs of sexual harassment cases.” The next month, the firm trumpeted its “special focus for victims of unwanted sexual advances.”
Mr. Janish said he did not know if the pitches had landed any clients. “It just really is more of a public awareness and branding thing,” he said.
The firms advertise on television and include hot-button search terms on their websites to lure traffic. That was how Heather Rothermund of Redding, Calif., learned of Nova Legal Funding in Los Angeles last summer. She had sued her employer, an adult care facility, for failing to discipline a co-worker who she said had groped her breasts and forced his hands down her jeans. Along with a state civil rights agency, she sought $250,000 in damages. The facility’s owner did not respond to a request for comment.
Ms. Rothermund, 41, said the alleged assault left her with bills for therapy and anxiety medications that she couldn’t afford. Her car was about to be repossessed when she came across Nova’s online advertisement. The company advanced her $2,000 against an anticipated future legal settlement, she said.
The money got her out of a financial hole and helped her avoid having to accept a lowball settlement offer. She said that if the case settled within the year she might owe $4,000 — double what she borrowed. If the case drags on, she will owe more.
“It is expensive, but it does help and it is available,” Ms. Rothermund said.
For the past two decades, settlement-advance companies have been chasing the hottest — and most lucrative — trends in litigation. They have provided advances to victims of surgical vaginal mesh products; those suffering from ailments related to the Sept. 11, 2001, terror attacks; and former National Football League players with brain injuries.
“There are some companies that are trying to ride that ‘me too’ thing, and we are not doing that,” said T. Thomas Colwell, chief executive of TriMark Legal Funding in Oregon. “That is just opportunistic.”
Mr. Colwell said his firm had been providing cash advances to women with sexual harassment claims for 15 years. He said many clients worked in less glamorous industries than Hollywood and needed money to cover basic living expenses.
Only a handful of states regulate or license the settlement-advance firms, and little more than a website is necessary to get into the business.
Mr. Janish formed Legal Bay in 2014, a few years after getting out of state prison in New York for orchestrating a $13 million stock manipulation scheme.
Legal Bay’s promotional materials don’t mention Mr. Janish’s past. He said his legal history wasn’t relevant to customers. “My only obligation is to disclose to them the terms of the money they seek,” he said.
Last year, the Consumer Financial Protection Bureau and the New York attorney general sued R. D. Legal, claiming the New Jersey firm took advantage of former N.F.L. players who expected to receive money in the league’s landmark concussion settlement. The authorities claimed that R. D. Legal had tricked the players “into costly advances on settlement payouts.”
Just last week, Colorado’s attorney general announced a $2 million settlement with LawCash and another settlement-advance firm, Oasis Financial, saying they charged personal injury plaintiffs “predatory interest rates.”
The industry says it charges high fees to compensate for the risk of not being repaid.
But the industry’s lucrative model has attracted mainstream financial institutions. The D. E. Shaw hedge fund, the private equity firms Parthenon Capital and Victory Park Capital, and Germany’s DZ Bank have either bought stakes in or lent money to settlement-advance firms. D. E. Shaw has sold its stake in Oasis Financial.
In addition to providing cash upfront to sexual harassment plaintiffs, some firms are pursuing the more traditional form of litigation finance, providing money to law firms in exchange for a cut of potential settlements.
Nova — the same company that advanced money to Ms. Rothermund — plans to announce that it will provide financing for lawyers pursuing Hollywood sexual harassment cases.
“We’re trying to level the playing field in cases against big Hollywood players,” said Ron Sinai, Nova’s founder.
And Legalist, a San Francisco litigation finance start-up, said that a Weinstein-related marketing pitch had attracted new clients, and that the company was now bankrolling three lawsuits against alleged sexual abusers.
The practices used by the settlement-advance industry have proved particularly controversial, uniting consumer groups and big business in opposition. Consumer activists argue that recipients don’t understand how quickly the costs accumulate. Business groups, including the U.S. Chamber of Commerce, argue that cash advances artificially drive up litigation costs.
“I would never recommend an individual finance his or her recovery,” said Robert Kraus, a New York employment lawyer. “It is inconsistent for a lawyer, if he believes in a client’s case, to recommend that he or she should limit their recovery.”
Some of the larger settlement-advance firms use lawyers to drum up business. The firms recruit lawyers in much the same way that pharmaceutical companies woo doctors: with perks such as holiday gift baskets and invitations to year-end parties.
At Oasis, one of the industry’s biggest players, employees who got a lawyer to send at least three clients in a year were celebrated as “hunters,” according to court documents in an employment dispute.
Oasis, which spends millions of dollars each year on TV advertising, said it had provided funds to 200,000 customers since it opened in 2003.
Michael Gibson, a former case manager at Oasis, said he had worked on up to 70 cases a day. The typical customer, he said, borrowed less than $2,000 but paid a fee that was the equivalent of an 80 percent annual interest rate.
“My personal opinion is that legal financings are predatory loans,” Mr. Gibson said.
Some customers say the cost is worth it.
Nickie Burdick, 28, had been unable to work for two years after she was injured in a car accident. Ms. Burdick, of Batavia, N.Y., said her attorney had suggested she take out a loan against a potential settlement in her case.
She knew the rates were steep, but she didn’t see another viable option, she said. She recently has been borrowing $2,000 a month from Oasis, accruing $220 in fees each time.
“It was either that or I lose my house and be homeless,” she said.
https://www.nytimes.com/2018/01/28/business/metoo-finance-lawsuits-harassment.html
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Jan 29, 2018 | RX Injury Help
By Laurie Villanueva
Laurie Villanueva is an attorney with Bernstein Liebhard LRX Injury Help
The federal court overseeing hundreds of hernia mesh lawsuits involving Ethicon, Inc.’s Physiomesh Flexible Composite Mesh implants has begun setting the stage for the litigation’s first bellwether trials.
Physiomesh Lawsuits to be Selected for Initial Discovery & Trial Pools
According to a Practice and Procedure Order issued in the U.S. District Court, District of Georgia, on January 19th, the first Physiomesh trial will be convened on September 16, 2019.
By May 15, 2018, the parties are to each select 12 cases for inclusion in an Initial Discovery Pool. Physiomesh lawsuits eligible for the pool include all of those currently pending in the litigation that were filed as of January 11, 2018.
Plaintiff Fact Sheet for the selected cases must be submitted to the Court by June 15th. Defendant Fact Sheets are due by July 31st.
Ten additional cases will be selected for the Initial Discovery Pool on June 22nd, with the parties each selecting 5 lawsuits from all claims pending in the litigation. Completed Plaintiff Fact Sheets are due on those cases by July 13th, while Defendant Fact Sheets must be submitted by August 21st.
Following fact discovery, Plaintiffs and Defendants will each select 5 cases from the Initial Discovery Pool for inclusion in the Trial Pool. Those selections are to be made on or before December 1st.
By May 1st, each side is to submit a memorandum in support of their proposed manner of trial, order of selection of plaintiffs for trial, and timing of trials. The parties may submit a response to the opposing party’s memorandum regarding by May 8th. The Court will rule on these matters by May 15th.Ethicon Physiomesh: What’s the Problem?
Ethicon brought the first Physiomesh products to market in 2010, via the U.S. Food & Drug Administration’s 510(k) clearance process. This program allows a new medical device to come to market without undergoing human clinical trials if a manufacturer can show that it is “substantially equivalent” to a device that had previously undergone the FDA’s more stringent premarket approval process.
Ethicon withdrew Physiomesh Flexible Composite Mesh from the worldwide market in May 2016, after unpublished data from two European hernia databases suggested that the product was associated with higher average recurrence and revision rates compared to other meshes used in laparoscopic ventral hernia repair.
While Physiomesh recalls were announced in several countries, no such action has been taken in the U.S.
The federal litigation currently includes more than 460 hernia mesh lawsuits, all of which were filed on behalf of individuals who suffered serious and debilitating complications, including infection, adhesions, chronic pain, and hernia recurrence, due to an allegedly defective Physiomesh Flexible Composite Mesh patch.
The Physiomesh bellwether trials will serve as test cases, and could provide some insight into how juries might decide similar hernia mesh claims.
https://www.rxinjuryhelp.com/news/2018/01/29/first-ethicon-physiomesh-lawsuit-headed-to-trial-in-september-2019-as-federal-court-outlines-bellwether-case-selection-process/
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