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Ethicon Media Monitoring 12/29/2017
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Woman Awarded $15M for Pelvic Mesh Injuries
Dec 27, 2017 | The Legal Reader (Blog)
By Jay W. Belle Isle
Earlier this month, a New Jersey jury found in favor of a woman who had been injured by pelvic mesh. The jury awarded Elizabeth Hrymoc, 71, $15M in her suit against Johnson & Johnson’s (J&J) subsidiary Ethicon, the mesh manufacturer. -
Large Awards and National Spotlight Highlight Phila. CP's 2017
Dec 28, 2017 | The Legal Intelligencer
By Max Mitchell
Philadelphia is no stranger to large verdicts and high-profile cases, but with record-breaking awards and a handful of moments in the national spotlight, 2017 was an especially busy year for the Philadelphia legal community. -
Cambs Times reporter named as one of 20 ground breaking women in 2017 by The Independent newspaper
Dec 27, 2017 | Cambs Times
By Harry Rutter
Kath joins actress Rose McGowan, who was among the first to speak out against disgraced director Harvey Weinstein, Chelsea striker Eni Aluko who campaigns against racism in football and the Women of the White Helmets peace movement in Syria. -
My vagina was badly injured after giving birth. Why was getting help so hard?
Dec 28, 2017 | The Guardian
By Christen Clifford
Every time I see a woman walking down the street with a newborn, all I can think is, “Does she have a traumatized vagina?” -
2017 health review: Cuts and a 'collapsing' care system
Dec 29, 2017 | BBC
By Marie-Louise Connolly
Adult social care, vaginal mesh implants and phantom health cuts - it takes all sorts to make it into an end of year BBC health review.
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Woman Awarded $15M for Pelvic Mesh Injuries
Dec 27, 2017 | The Legal Reader (Blog)
By Jay W. Belle Isle
Earlier this month, a New Jersey jury found in favor of a woman who had been injured by pelvic mesh. The jury awarded Elizabeth Hrymoc, 71, $15M in her suit against Johnson & Johnson’s (J&J) subsidiary Ethicon, the mesh manufacturer. The $15M verdict consisted of $4M for pain and suffering, $1M for loss of consortium (conjugal affection with her spouse), and $10M in punitive damages, meant to send the defendants a clear message that their behavior is unacceptable.
Mrs. Hrymoc was treated with Prolift, Ethicon’s polypropylene pelvic mesh. This type of implant is a common treatment for organ prolapse, typically caused when the vaginal walls begin to weaken with age. She was implanted in 2008 and soon after found herself dealing with chronic pain, painful intercourse, and urinary incontinence (ironically, another of the conditions the device was designed to treat). Mrs. Hrymoc was implanted with two Prolift mesh devices in 2008, and her case centered on the one that caused her injuries.
Pelvic mesh devices in general are also called slings and Prolift got the FDA’s stamp of approval in 2002. However, due to the number of complaints about the various brands, the FDA has told healthcare providers that pelvic mesh is now a “high-risk” treatment. Mrs. Hrymoc’s is one of thousands of lawsuits over such devices. According to her lawyer, Adam Slater of Mazie Slater Katz & Freeman, he has 240 active pelvic mesh cases himself.
As a note, J&J/Ethicon pulled the Prolift device from the market in 2012, citing financial reasons.
Mrs. Hrymoc’s claim was not just that the Prolift device was defective, but that she was also never warned of the risks involved with the device.
Shortly after the verdict was handed down, Mrs. Hrymoc said she was pleased with the outcome “but not just for myself. For the thousands of other women who have gone through this. I’m very pleased that justice was done, not just for me, but for all other women who were hurt.”
The jury, for its part, unanimously agreed with Mrs. Hrymoc. The testimony presented by expert witnesses and doctors was very technical and took 2.5 weeks to get through. With over 1M documents involved in her case, the four women/six men jury needed just six hours to reach two unanimous verdicts: the Prolift device was defective, and the risks were not adequately explained to Mrs. Hrymoc.
Many of the documents presented as evidence were internal from Ethicon and included memos and reports written by Ethicon’s researchers. Some of these documents openly expressed the researchers’ doubts that Prolift was actually safe. One such instance was the concern that the polypropylene mesh may contract once implanted. The researchers were concerned that it could erode the vaginal wall. It may not have been part of the internal documents, but in other cases, a contracted mesh device could also cause discomfort and painful intercourse.
Even facing those issues, Ethicon moved ahead with the Prolift device and it was introduced to the market without a clinical study. This often happens with medical devices that are substantially similar to devices that have already been studied and given FDA approval.
Despite pulling the product from the market in 2012, Ethicon still argued that it was safe. The company said its 50-person research team spent thousands of hours in product development and testing.
Mrs. Hrymoc’s lawyer, Mr. Slater, said that the team, and company executives, ignored many “red lights” during the process. He continued, saying that, while the case was quite complex, the evidence presented was clear.
He added, “We felt the case was very strong, and we felt the wrongdoing was clear.” He called Mrs. Hrymoc and her husband “incredibly brave” for tacking such a major player in the medical device field.
Of course, Ethicon immediately released a statement of its intent to appeal.
According to company spokesperson Mindy Tinsley, “Ethicon intends to appeal this verdict, as we believe that the evidence showed that the company appropriately informed surgeons of pertinent complications and that the products were properly designed and studied.”
https://www.legalreader.com/woman-awarded-15m-pelvic-mesh-injuries/
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Large Awards and National Spotlight Highlight Phila. CP's 2017
Dec 28, 2017 | The Legal Intelligencer
By Max Mitchell
Philadelphia is no stranger to large verdicts and high-profile cases, but with record-breaking awards and a handful of moments in the national spotlight, 2017 was an especially busy year for the Philadelphia legal community.
Here’s a look back at some of the top litigation from 2017.
Record-Breaking Salvation Army Settlement
The year began with what attorneys said was the largest personal injury settlement to come out of a Pennsylvania state court. In February, defendants in the Salvation Army building collapse litigation agreed to settle for $227 million.
The accord ended a five-month trial in the Philadelphia Court of Common Pleas, and came a week after the jury found the Salvation Army should bear the lion’s share of the responsibility for the 2013 collapse that killed seven and injured 12.
Along with the size of the settlement, the case was notable for its length. According to lead plaintiffs’ attorney Robert Mongeluzzi of Saltz Mongeluzzi Barrett & Bendesky, it was the longest civil trial in Philadelphia history, and included more than 100 days of depositions, 125 motions in limine and 43 motions for mistrial.
More than three months after the global settlement, an arbitrator allocated $95.6 million of the award to plaintiff Mariya Plekan, a Ukrainian immigrant who was shopping when the building collapsed, causing her to lose both legs and a portion of her abdomen, along with numerous other injuries. Plekan’s attorney, Andrew Stern of Kline & Specter, said at the time the award was the largest recovery for an injured individual in Pennsylvania history.Mass Tort Awards
Philadelphia courts continued to see large awards through the year, with several coming from the mass tort programs.
The largest was a $57.1 million verdict against Ethicon over allegations its pelvic mesh product was defective. The award, which broke down into $7.1 million in compensatory damages and $50 million in punitive damages, set a record for the largest verdict out of the pelvic mesh mass tort.
The record-setting amount wasn’t the only eight-figure verdict to come out of pelvic mesh mass tort program in 2018. In April, another jury awarded a plaintiff $20 million over similar claims against Ethicon, a Johnson & Johnson subsidiary.
Philadelphia’s busy Complex Litigation Center, which handles the city’s mass tort programs, also had its first Xarelto case come to trial. The trial was held after three straight defense wins in the consolidated litigation in federal court, but the case tried in Philadelphia,Hartman v. Janssen Pharmaceuticals, ended with a $27.8 million verdict in early December.National Spotlight
The Philadelphia legal community also found itself in the national spotlight in 2017, for good reasons and bad.
Beginning with the bad, the controversy around former District Attorney R. Seth Williams continued to mount, culminating with a federal indictment and guilty plea on a single count of bribery. The incident grabbed headlines in publications across the across the country, and roiled the city’s criminal justice community.
But, at the same time Williams’ controversial reign and criminal trial were unfolding, Philadelphia was thrust back into the spotlight over a controversial civil rights and criminal defense attorney running to succeed him as district attorney.
Larry Krasner, who went on to win a seven-way primary in May before winning the general election with nearly 75 percent of the vote, ran on a platform of criminal justice reform. Promising changes, such as revamping the city’s civil forfeiture and cash bail programs, never seeking the death penalty and seeking lesser sentences for nonviolent drug offenses, the race received a lot of media attention (and a few celebrity donations), fueled in large part by Krasner’s progressive platform.
The national spotlight returned to Philadelphia again over a lengthy prison sentence handed down to hip-hop star Meek Mill and the brash legal tactics of his defense counsel.
In November, Philadelphia Judge Genece Brinkley sentenced Mill, whose real name is Robert Williams, to a two- to four-year sentence for violating probation. The sentence was a surprise since neither prosecutors nor Williams’ probation officer were seeking jail time. But allegations Williams’ counsel made in the wake of that sentence were more eye-catching.
Williams’ attorney, New York lawyer Joe Tacopina, made statements to the press that Brinkley had imposed the harsh sentence because she was “enamored” with the hip-hop star, had asked him to change to a Philadelphia-based management company and had requested him to re-record a version of a Boyz II Men song with her name inserted into some of the lyrics. Subsequent filings also said the FBI investigated Brinkley regarding her handling of the case. A report from The Philadelphia Inquirer, however, said that, according to three sources familiar with the probe, Williams had brought the issue to the FBI’s attention and the “short-lived review” was shuttered after Williams refused to wear a wire.
Williams is appealing his sentence to the Superior Court.
https://www.law.com/thelegalintelligencer/sites/thelegalintelligencer/2017/12/28/large-awards-and-national-spotlight-highlight-phila-cps-2017/
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Cambs Times reporter named as one of 20 ground breaking women in 2017 by The Independent newspaper
Dec 27, 2017 | Cambs Times
By Harry Rutter
Kath joins actress Rose McGowan, who was among the first to speak out against disgraced director Harvey Weinstein, Chelsea striker Eni Aluko who campaigns against racism in football and the Women of the White Helmets peace movement in Syria.
Also in the final 20 are education for women campaigner Malala Yousafzai, shot by the Taliban at the age of 15 for the crime of going to school, Cambridge University professor Mary Beard who brings literature to the masses through a popular TV show and political philanthropist Gina Miller who took Brexit to court and won.
Kath was named after running Sling The Mesh campaign for two and a half years.
Starting with just a handful of women on the Facebook support page there are now more than 5,000 members who join for information and support on mesh implants used to fix prolapse, incontinence and hernias.
Kath said: “It is an honour to be among so many great women. This is testament to how one small person can make a big difference if you keep going in what you know is the right thing to do.”
Independent journalist Harriet Marsden, who compiled the list, said: “The past few years have seen the “biggest health scandal since thalidomide” blown wide open, and nobody has done more to expose the truth than Kath Sansom.
“In 2015, after she received a vaginal mesh implant to treat mild incontinence after babies, she suffered agonising pain and knew something was wrong.
“She began to do some research online, and stumbled into a world of pain and ignored suffering: what would become known as the vaginal mesh scandal.
“As she herself wrote: “It probably needed a journalist to be mesh injured, to provide the final media push needed for the issue to get to Westminster.”
Since major removal surgery and particularly this year, Kath has used her extensive research to bring the scandal to light, keeping it in the national news agenda and tirelessly campaigning, prompting a lobby, debate and now a specialist Parliamentary think tank on mesh for which she is the formal advisor.
Harriet said: “As her group gains more members by the day, Sansom has also used social media to act as a touchstone of comfort and advice for all the new “meshies”, as the community calls themselves.
“To the thousands of men and women injured by hernia and vaginal mesh implants, Sansom is more than a campaigner: she’s a lifesaver. And if her activism leads to a full ban on mesh implants, that’s exactly what she’ll be.”
http://www.cambstimes.co.uk/news/sling-the-mesh-kath-sansom-20-ground-breaking-women-2017-1-5335257
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My vagina was badly injured after giving birth. Why was getting help so hard?
Dec 28, 2017 | The Guardian
By Christen Clifford
Every time I see a woman walking down the street with a newborn, all I can think is, “Does she have a traumatized vagina?”
My vagina tore when I had my first child. Doctors I’d never met before sewed me up and refused to tell me how many stitches they’d put in. I healed, and when I had another child five years later, I tore in the same place.
My midwives sewed me up and told me everything looked fine, but I noticed certain changes: it was next to impossible to hold in flatulence. Constipation became a painful and humiliating constant. I leaked urine when I sneezed no matter how many kegels I did. And it felt like the physical angle of everything having to do with evacuation and intercourse had somehow shifted after childbirth in new and uncomfortable ways. I felt like my vag was broken. That something was wrong.
Five years later, I started seeing a new gynecologist, who listened, examined me, and said, “Oh, yep, you’ve got a little rectocele in there.”
A what?
She told me that a rectocele occurs when the muscle between the rectum and vagina is so worn and thin that the rectum kind of pops out into the vagina.
I felt angry. Why hadn’t a single health professional, many of whom had examined me thoroughly, bothered to diagnose it? “Well, it’s within the range of normal, so we usually don’t mention it.”
I went home and searched for more information. The National Institutes of Health says, “Rectoceles are common and involve a herniation of the rectum into the posterior vaginal wall that results in a vaginal bulge. Women with rectoceles generally complain of perineal and vaginal pressure, obstructive defecation, constipation, or the need to splint or digitally reduce the vagina to effectuate a bowel movement.”
Splinting? Digital reduction? These are the medical terms for what I knew through anecdotal evidence was common practice: one friend must insert a finger into her vagina to release the stool from her rectum every time she defecates. Another said she always pressed into her perineum when relieving herself. Another friend, with a rectocele and a cystocele, splints and takes vast quantities of psyllium seed husk to stay regular.
Me? Once, I was doubled over in pain, so dehydrated and constipated that I took the plastic gloves out of a box of Nice’N’Easy haircolor because, well, it wasn’t. After I had dug out the feces that had become trapped in the small pocket of my rectum that protruded into my vagina, I was shocked, silent, humiliated.
Even with my excellent health insurance, after giving birth the only medical attention I received was a quick six-week checkup. After learning about my rectocele, I went to see a pelvic floor specialist. She told me that because my rectocele was small and the risks were high, I was not a candidate for surgery.
She explained pelvic floor exercises, recommended I eat a lot of fiber and suggested “double evacuation” when urinating. Pee, then stand up and move from side to side, then urinate again so the bladder is completely emptied.
In France, where the republic wants to increase the population and the culture values sexuality, women may take vaginal rejuvenation classes or “rééducation périnéal”: 10 to 20 sessions of pelvic floor physiotherapy, paid for by the government. Here in the US, I learned about my condition 10 years after I first had symptoms.
A few weeks later, I was at my kids’ public school fundraiser, drinking and rage-telling the story of discovering the word rectocele. A woman I barely knew joined us, whisper-crying, “Stage four tearing. I’ll never be the same.” Women are suffering in silence, hurt and embarrassed. Shamed again.
The New York Times has devoted an admirable amount of editorial space to the women in Africa who suffer from fistulas, their dignity and daily routines compromised by bodies that leak urine or feces because of childbirth or assault.
What no one is talking about – not medical professionals, not educators, not mothers, not their partners – are the various states of post-partum prolapse that plague women after childbirth, causing a similar loss of control and dignity to that faced by fistula sufferers. The emotional and sexual ramifications of my situation included secrecy, shame and isolation.
We need to make the words rectocele and cystocele and urethrocele and enterocele, each a type of pelvic organ prolapse resulting most often from childbirth and ageing, part of the common vernacular of women’s health. The words are utterly absent, even to those of us who seek to learn more about these conditions and educate others.
According to the Mayo Clinic, prolapse means “to slip or fall out of place”. A rectocele is when the rectum bulges into the vagina. A cystocele is when the bladder bulges into the vagina. A urethrocele is when the urethra bulges into the vagina. An enterocele is when the small intestine bulges into the vagina. So basically, they are vag bulges.
The American Society for Colon and Rectal Surgeries estimates that 40% of women have a rectocele, yet most people don’t know the word. This needs to change. Harvard says that anywhere from 80% to 20% of women might have small rectoceles. Meanwhile, pharmaceutical companies spend and make millions of dollars to keep dicks in the air.
The medical industry is pushing vaginoplasty, labiaplasty, and Viagra for women, to keep women “young” and “tight” and looking like porn actors. I know our culture doesn’t make much room for older women, let alone our vaginas, but shouldn’t we be spending some of this time and money to care for the post-maternal vagina?
And I don’t mean surgery with the vaginal mesh that was recently banned in New Zealand. We need sexual education and respect for mother’s vaginas – vaginas that have been through a lot. We need to be talking about prolapse and non-surgical treatments like diet, hydration, biofeedback, electrical stimulation, and core strengthening exercises.
To be sure, some vaginas take a licking and keep on ticking. I have many friends who didn’t tear, who gave birth and kegeled their way to safe and healthy sexual lives.
My vagina has changed a lot in my 46 years. I loved exploring it for pleasure as a child. Then my vagina was injured when I was raped at 15 and didn’t tell. Later I had a lot of great sex and a lot of mediocre sex. I birthed two children through this space, a space that still holds potential for experience and love.
There is no equality without reproductive rights, there are no reproductive rights without knowledge of the female body, and there is no knowledge of the female body without acknowledgment of the post-maternal vagina. The lack of education and attention to my – and thousands of mothers’ – pelvic injuries is another sign of our country’s indifference to women’s rights and health.
We are, as a nation, in fits and starts, beginning to do better for women’s lives. I am thrilled, for example, to see longstanding silences broken. I am happy to see menstrual equity with states moving toward tax exemption for tampons and other feminine hygiene products.
So, how about we ask the medical and pharmaceutical communities to do better by mothers’ bodies – by acknowledging and treating the physical injuries caused by giving birth. By acknowledging our bodies as they are. By talking about maternal sexuality. By granting us language and autonomy. We can start conversations and healing.
And, how about we ask the mothers in our lives how their vaginas are doing? Hopefully, with the proper education, their answers won’t surprise us.
https://www.theguardian.com/us-news/commentisfree/2017/dec/28/vaginal-health-post-partum-maternity-rectocele
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2017 health review: Cuts and a 'collapsing' care system
Dec 29, 2017 | BBC
By Marie-Louise Connolly
Adult social care, vaginal mesh implants and phantom health cuts - it takes all sorts to make it into an end of year BBC health review.
Towards the end of 2017, adult social care was making headlines.
From patients experiencing lengthy waits for home-care packages, to those who deliver them comparing themselves to "work horses," we heard about a system that is overstretched and that, according to some, is at breaking point.
The issue was explored in a series of reports by BBC News NI.'Collapsing'
A number of questions were asked, including just how much the social care sector is valued, how much workers are paid and if their employment rights are being upheld.
A long-awaited report commissioned by the Department of Health which explored social care was published.
One of its findings was that the system is "collapsing in slow motion".
The report also called for a fundamental change in the way Northern Ireland delivers and funds social care.
Paying a living wage to care workers, introducing a new professional body, involving families and patients in care decisions - and even means testing care, were all among the recommendations.
A lack of nurses continues and in an unprecedented move, Northern Ireland's health regulator formally notified the Department of Health about a serious nursing shortage.
That followed a series of inspections which identified staffing levels as being a problem in almost every area, with respite and palliative care for children living in the Fermanagh area being suspended.
The Horizon West children's hospice service was opened in Enniskillen in 2012.
Nine paediatric nurses are required to operate the service.
The scandal around vaginal mesh implants in Northern Ireland broke after women told the BBC they had been left physically and mentally scarred after having the treatment.
There are claims of medical negligence and pleas for mesh to be banned.
Northern Ireland's abortion story moved to London where Supreme Court judges are being asked to consider whether the existing rules breach a woman's human rights. An outcome is expected shortly.
A year on from the Bengoa health review and little has been transformed. The public made their voices heard loud and clear during the pre-consultation on the reshaping of stroke services; a formal consultation begins in 2018.
The future of emergency departments is in the balance again, people power won over Daisy Hill Hospital in Newry, County Down, maintaining its ED status.
Despite it receiving a tick on the Department of Health's list of jobs done, the Royal College of GP's would argue that each GP practice has yet to have a named district nurse and health visitor.
GPs remain under tremendous pressure, however, at the end of the year the Department of Health allocated almost £4m to help improve the service.
Also, an additional £7m is being targeted at soaring hospital waiting lists.
The latest official figures tell us that more than 270,000 people are waiting for a hospital outpatient appointment - and it seems more are turning to the private sector.
While the system is creaking, some people argue it is not all about throwing more money at the problem.
What is required more, perhaps, is leadership.
Other questions posed this year include - will the Royal Victoria Hospital's critical care building miss another opening deadline? According to my sources, probably.
It was also a year of phantom health cuts - remember the sudden reversal over IVF treatment?
The performance of local emergency departments continues to dominate.
Four of Northern Ireland's health trusts were among the 10 worst emergency department performers in the UK.
In a UK-wide exercise, the BBC examined statistics dating back five years.
The Belfast, Northern, Western and Southern health trusts were named among the worst performers, alongside six English NHS trusts.
The ongoing political vacuum at Stormont and lack of transformation means this winter is very likely to be the most challenging yet in terms of NHS performance across the UK.'Ross the Boss'
But ending on a more positive note, we met GP Benny Glover who retired aged 78 from his practice in Glenarm, County Antrim.
There was also nine-year-old cancer survivor Ross Patterson.
Known to the nurses as Ross the Boss - in his own inimitable style he rocked our world at the opening of two new state-of-the-art isolation rooms at the Royal Belfast Hospital for Sick Children.
http://www.bbc.com/news/uk-northern-ireland-42364274
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