Preview Newsletter
Ethicon Media Monitoring 5/1/2018
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Florida AG aware of pelvic mesh allegations, currently reviewing
Apr 30, 2018 | Florida Record
By John Breslin
Florida Attorney General Pam Bondi is reviewing allegations that lawyers, lenders and doctors may have been involved in a scheme that led to women being enticed into corrective pelvic mesh implant surgery. -
‘The Bleeding Edge’: Not Even Doctors Know How Medical Devices Are Regulated
Apr 30, 2018 | Daily Beast
By Neel V. Patel
Angie Firmalino, a mail carrier in upstate New York, was like thousands of women trying to take control of her birth control. Instead of popping a daily pill, she wanted a simpler system, an implant that would help prevent an unplanned pregnancy. -
Sure, Kate Middleton Looks Great — But Let’s Talk About What Giving Birth Really Does To Women’s Bodies
Apr 30, 2018 | WBUR
By Chloe Axelson
Seven hours after giving birth to her third child in less than five years, Kate Middleton, the Duchess of Cambridge, stood before the media — in heels and a cherry red Jenny Packham dress -- cradling her darling new prince. -
May 1 Worldwide Mesh Awareness Day
May 1, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
May first is the worldwide Mesh Awareness Day, a tern coined by the Mesh Awareness Movement, though recognized in the past. -
Weber Gallagher Adds 5 Wilson Elser Attys To Med Mal Group
Apr 30, 2018 | Law 360
By Jeannie O'Sullivan
Five attorneys from Wilson Elser Moskowitz Edelman & Dicker LLP have left the international firm to join Weber Gallagher Simpson Stapleton Fires & Newby LLP's medical malpractice team in its Bedminster, New Jersey, office, the latter firm announced on Monday.
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Florida AG aware of pelvic mesh allegations, currently reviewing
Apr 30, 2018 | Florida Record
By John Breslin
Florida Attorney General Pam Bondi is reviewing allegations that lawyers, lenders and doctors may have been involved in a scheme that led to women being enticed into corrective pelvic mesh implant surgery.
An article published by the New York Times detailed allegations that doctors practicing in the state, and companies based here, are part of the scheme.
"We are aware of this article and currently reviewing the allegations," Kylie Mason, press secretary for Attorney General Pam Bondi, told the Florida Record.
More than 100,000 women claim they have been damaged by mesh implants, with manufacturers setting aside $3 billion to cover settlements, according to the Times story.
But it is claimed, in court documents and by individuals, that some women have been enticed into corrective surgery, paid for by third party funders after being contacted by cold calling marketers, all as a way to increase the amounts expected to be awarded following lawsuits.
American Medical Systems manufactures pelvic meshes and is being sued.
In court documents reviewed by the Florida Record, filed in federal court in West Virginia, AMS asked for a preservation order so as to allow the company to forensically examine the electronic devices belonging to Surgical Assistance and Wesley Blake Barber.
Surgical Assistance and Barber, both based in Florida, are named as non-parties in a case taken against AMS. The motion was denied.
In its pre-trial order, the court said that the claim was that the mesh was defective, causing harm to the body and leading to complications, such as chronic pain and scarring. Some plaintiffs have undergone surgery to revise the implanted mesh or remove it altogether.
Magistrate Judge Cheryl Eifert further stated, "In the course of discovery, AMS learned that a portion of the plaintiffs had their corrective surgeries arranged and funded through third-party funding companies."
She wrote, "According to AMS, these arrangements were frequently complex, often expensive, and occasionally unnecessary, as some of the plaintiffs receiving the funding had health insurance to cover similar procedures.
"AMS was stymied in its efforts to discover the details of the funding arrangements from the plaintiffs, who seemed to know little more about them than AMS. Confronted with a lack of transparency regarding a key element of damages.
"AMS began seeking information from non-parties, including Surgical Assistance and Barber, about the third-party funding of corrective surgeries. At issue were both the cost and the medical necessity of the procedure."
In its story, the New York Times stated that lawyers building such cases sometimes turn to marketing firms to drum up clients.
"The marketers turn to finance companies to provide high-interest loans to the clients that have to be repaid only if the clients receive money from the case," the reporters wrote.
"Those loans are then used to pay for surgery performed by doctors who are often lined up by the marketers.
"Interviews with dozens of women, lawyers, finance executives and marketers, as well as a review of court records and confidential documents, indicate that hundreds, perhaps thousands, of women have been sucked into this assembly-line-like system. It is fueled by banks, private equity firms and hedge funds, which provide financial backing."
Barber, in a deposition found by the Times, stated that his company found doctors in Florida and Georgia to perform the surgery.
In one online ad, an actor in a white lab coat assures women suffering from their mesh implants that relief is near, the Times report states. They can call a toll free number and will be connected to "qualified surgeons" without need for upfront payments.
Women were then flown to Florida and Georgia, put up in motels and sent to walk-in clinics, according to court filings. The women spoken to by the Times generally didn’t meet the doctors who would be operating on them until shortly before the procedure. .
Each procedure typically cost about $21,000, according to lawsuits brought by women against the mesh manufacturers, the Times reported. Of that, doctors pocketed roughly $3,500 per surgery; most of the rest went to the medical centers where the surgery took place.
Asked for her opinion after reading the article, Mary Terzino, an attorney with expertise of the legal lending business, said,"My thought was that this article describes a racket in which lenders, lawyers and doctors are combining forces to prey on the vulnerable. It is an appalling abuse of the civil justice system."
https://flarecord.com/stories/511402102-florida-ag-aware-of-pelvic-mesh-allegations-currently-reviewing
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‘The Bleeding Edge’: Not Even Doctors Know How Medical Devices Are Regulated
Apr 30, 2018 | Daily Beast
By Neel V. Patel
Angie Firmalino, a mail carrier in upstate New York, was like thousands of women trying to take control of her birth control. Instead of popping a daily pill, she wanted a simpler system, an implant that would help prevent an unplanned pregnancy.
So Firmalino turned to Essure, a birth-control implant meant to prevent pregnancy with 99 percent efficacy.
What was supposed to be a straightforward procedure turned into a nightmare for Firmalino, which she described in vivid detail in The Bleeding Edge, a new documentary that premiered at the TriBeCa Film Festival in New York City and is set to be released on Netflix this summer.
In the documentary, Firmalino described the intense pain and bleeding that resulted from the procedure as looking like “a horror scene.” She goes on to form a group for people who’ve experienced negative health problems after Essure implantation, and tens of thousands of women join to tell their stories and demand action from Bayer (the company who manufactures and sells Essure), Congress, and the FDA.
To the film’s directors, Essure is emblematic of the immense unchecked power of the $400 billion-a-year medical device industry. Seventy million Americans have a medical device implanted within their body. "When it comes to medical devices, we built a system that doesn't work," David Kessler, the former FDA commissioner, said in The Bleeding Edge.
The disturbing truth is that, despite so many people relying on such implants, the medical device industry is very weakly regulated. Companies can manufacture and sell devices based on previous iterations that may already have been recalled. Sometimes, these products haven’t even been tested for the purpose they’re sold. And more often than not, they haven’t even been tested in the patient population they’re supposed to serve. If they have, the effects might not have been studied for more than a few months before they are marketed to the general public.
And many doctors have virtually no clue how badly regulated these products are when companies are hawking them. Companies have learned how to exploit a host of loopholes, especially in 510(k) and Premarket Approval routes for FDA approval, for getting medical devices on the market at just a fraction of the stringent rules required.
This isn’t just a problem local to a few devices; rather, it’s a systemic problem. “It’s everyone who is exposed to devices, from birth to death,” producer Amy Ziering told The Daily Beast. “If you’ve ever had an x-ray, or you wear contact lenses to see, this is for you. Devices are us, and our world will continue to use more of these. There’s an issue here that actually puts our lives in peril.”
While there are countless examples of shoddy medical devices harming patients in some way, a 99-minute documentary can only focus on a few big examples. One compelling example is that of Dr. Stephen Tower, a surgeon from Alaska. Tower received what he thought was a standard hip replacement. But immediately afterwards, he began to suffer a mental breakdown when the cobalt metal in his new hip implant degraded, giving him cobalt poisoning. Tower worked backwards to figure out the problem—all while his mental health was in shambles. Tower is only able to salvage his mental health when he receives a new, non-metallic hip replacement, virtually eradicating his symptoms.But Tower realizes there are countless others who are being misdiagnosed for Parkinson’s, Alzheimer's, and dementia—all because of the cobalt in their new hips.
Another story the film tells is of a vaginal mesh which received approval for use in 2002 in gynecological surgeries despite virtually no testing that demonstrates it’s fit for such a use. The mesh went on to create more problems than it solves in several women—even cutting a woman’s husband’s penis when the couple attempt to have sex. Johnson & Johnson suffered $300 million in lawsuits in the ensuing decade as a result.
When you consider that the company made $683 billion in the same time frame, as Ziering emphasized, there’s little financial incentive for these companies to properly test their devices for safety.
The medical device industry has become a daisy chain of faulty and harmful products. And companies know they can get away with it.“Part of the problem is that people don’t know about this because they think it’s too complicated, so they just trust their doctors,” said Kirby Dick, the director of the film. “That’s a mistake, since doctors don’t even know how these things are sometimes regulated.”
Indeed, one particularly powerful scene pits Essure protesters against physicians visiting a medical conference. Many of the doctors balk at what the women who’ve suffered Essure-related complications allege. Dick saw some of the skepticism expressed by doctors before they’d seen the film, though he’s been encouraged that most of them leave the theater realizing how much they have yet to learn. “I think one of the biggest lessons of this film is that doctors are victims too,” he said. Case in point: Dr. Tower, the surgeon with the hip replacement.
At its core, The Bleeding Edge wants viewers to be suspicious of buzzwords like “new” or “innovative.” The name of the documentary itself comes from a phrase describing emerging technologies that are so risky for early adopters to use, and could create a slew of problems in the long run. “In so many cases, something that’s new is untested, and it’s much riskier than things that have been around for decades,” Dick said.
https://www.thedailybeast.com/the-bleeding-edge-not-even-doctors-know-how-medical-devices-are-regulated
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Apr 30, 2018 | WBUR
By Chloe Axelson
Seven hours after giving birth to her third child in less than five years, Kate Middleton, the Duchess of Cambridge, stood before the media — in heels and a cherry red Jenny Packham dress -- cradling her darling new prince.
The internet exploded. Some women pronounced the Duchess superhuman. Others offered blunt comparisons to their own postpartum conditions. Mercifully, most seemed to realize Kate’s seemingly supernatural ability to bounce back is not normal. But by focusing so much on her flawless appearance, we are distracted from the real trauma, physical and emotional, that is the childbirth experience.
I have three kids: twins the first time (one born vaginally, the second, four hours later, by Cesarean section) and a singleton (also by Cesarean section) after 16 hours of labor and two hours of unsuccessful pushing.
My pregnancies, apart from the unplanned C-sections, were normal and uneventful. And I went through all the things the vast majority of postpartum women experience (Kate too, probably): vaginal bleeding, uterine cramps, engorged breasts, raging hormones, soreness, exhaustion, constipation and the general condition of feeling as if you’ve been run over by a truck.
But we don’t like to talk about these things. And we definitely don’t like to talk about the longer term physical struggles many postpartum women endure: urinary and fecal incontinence, acute pelvic pain, back pain, muscle tears, hairline fractures, prolapsed bladder, pain during sex (if one can even summon the desire: low sex drive is another unpleasant side effect) and the “mummy tummy” (medically known as diastasis recti), what happens when a woman’s abdomen stretches and separates to accommodate a growing fetus, but fails to knit itself back together. Many of these symptoms don’t appear immediately, and because these topics are not often talked about, women often assume symptoms are just the new normal.
Women’s health is the most popular of political footballs (to some people, it’s still a pre-existing condition to be a woman), and it’s also the most stigmatized. The female genitalia, in particular, is a gray area, a taboo even, something referred to as “down there” or “private parts” or, if you’re Oprah, “vajayjay.” The pelvic floor — the hammock of muscles that hold a woman’s bladder, bowel and uterus where they belong — isn’t visible, like a quad muscle, and it can be hard for women to pinpoint areas of discomfort. Most people don’t even know what a pelvis looks like, apart from a skeleton they’ve seen during Halloween.
But a significant number of women, more than half by some counts, experience pelvic injury or dysfunction as a result of childbirth.
Think about the women you know who joke about wetting their pants just a little bit when they laugh (one in three report urinary incontinence after childbirth), or resign themselves to pain during sex (that’s about one-third of all women too), or just assume a lumpy tummy — as my kids so lovingly called mine — is part of motherhood.
Not enough women know they can resolve some, if not all, of these issues with physical therapy.
After the birth of my third child, I was eager to get back to my regular running routine. When my OBGYN gave me the ‘all clear’ at my postpartum appointment, I vowed to start back slowly, running for a minute, then walking for a minute, to regain my strength and stamina.
After a few jogs, I was hobbling around, worried that my insides might fall out and splatter against the pavement.
I called my doctor, the very one who gave me the green light. She recommended a couple of places for women’s specific physical therapy, but the waitlist at Mt. Auburn Hospital, where I delivered, was 45 names long — so long they weren’t even willing to add my name to the queue. I was eventually able to get an appointment with an outstanding women’s health therapist at Marathon Sports in Newton, but I had to wait six weeks for my first appointment.
My experience isn’t uncommon. There are more women who need help than specialists who can provide care. (At Marathon, the average wait is four to six months.) Part of the scarcity of care has to do with the extensive clinical training pelvic floor specialists need to do internal pelvic exams. My PT, Donna Chiao, completed seven years of education beyond high school, not including all the continuing education courses she had to take after receiving her doctorate. She told me that anything regarding the pelvic floor is rarely taught as part of the standard physical therapy curriculum, even in doctoral degree programs.
In the end, I was lucky. My complication — pain in the cartilage joint that connects my pubic bones, known as pubic symphysis pain -- was resolved with strength training and lots of foam rolling. But I was incensed that my OBGYN gave me the go-ahead to start exercising without a thorough evaluation. She saw me through my pregnancy, but bore no responsibility to treat me in its aftermath.
In France, all postpartum women are prescribed 10 visits with a pelvic floor physical therapist as a standard of care. And have been since 1985.
The good news is there are inklings that the way our culture talks about women’s health — and childbirth — may be changing. Samantha Bee did a hilarious bit on the history of women’s pain. Gwen Jorgensen, the Olympic triathlon champion- turned-marathoner, talks openly about her postpartum pelvic floor rehabilitation. Abby Norman and Lena Dunham have written about their harrowing experiences with endometriosis. Meghan O’Connell’s new book, “And Now We Have Everything” talks about early motherhood with a compelling rawness: “My entire middle section … looked like a balloon that had been deflated but also, somehow, was full of wet dough.”
Maybe frank conversations in popular culture can help to change the way women’s bodies are perceived and treated medically.
For now, though, I hope the Duchess of Cambridge is home, resting, in giant mesh underwear and support leggings, sipping tea in between appointments with her women’s health specialist.
http://www.wbur.org/cognoscenti/2018/04/30/kate-middleton-postpartum-cloe-axelson
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May 1 Worldwide Mesh Awareness Day
May 1, 2018 | Mesh Medical Device Newsdesk
By Jane Akre
May first is the worldwide Mesh Awareness Day, a tern coined by the Mesh Awareness Movement, though recognized in the past.
Since there are so many injuries recorded globally, awareness is growing though very slowly, at least in the U.S. In the States, mesh is still used, at least the “sling” as it’s termed, and one medical society even still refers to mesh slings for incontinence as the Gold Standard,” despite all of the reports of injuries.
Worldwide Mesh Awareness Day
May 01, 2018
FOR IMMEDIATE RELEASE
Albany, GA April 24, 2018 – Mesh Awareness Movement announced their Worldwide Mesh Awareness Day Campaign, a mission which aims to educate women and men about the hazards associated with the use of transvaginal and hernia mesh implants.
The campaign will target women and men in an effort to raise awareness of mesh injuries and decrease the number of people being injured by mesh implants daily. Even at this early stage, many are planning various ways to bring awareness to the issues caused by these implants. Women and Men Worldwide are continuing to support and assist in the Mesh Awareness Campaign.
At the Tribeca Film Festival this past Saturday a film titled “The Bleeding Edge” was premiered. This film is a documentary about failed medical implants and includes a section on an injured woman sharing her story about how she and her family have been affected by a transvaginal mesh implant.
Interested parties can learn more about Mesh Awareness by visiting the internet and searching mesh. There users will find numerous groups that will help support the movement and educate on the dangers of mesh. In the U.S. the purple ribbon has been recognized for Mesh Awareness.
Mesh Awareness Movement and other groups have been online for several years to bring awareness and support to those that have been damaged by mesh.
We hope to reach those that have been injured by mesh, educate the public regarding the complications with mesh and support all involved with the fight on mesh.
https://www.meshmedicaldevicenewsdesk.com/may-1-worldwide-mesh-awareness-day/
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Weber Gallagher Adds 5 Wilson Elser Attys To Med Mal Group
Apr 30, 2018 | Law 360
By Jeannie O'Sullivan
Five attorneys from Wilson Elser Moskowitz Edelman & Dicker LLP have left the international firm to join Weber Gallagher Simpson Stapleton Fires & Newby LLP's medical malpractice team in its Bedminster, New Jersey, office, the latter firm announced on Monday.
Partner Kenneth Brown joins Weber Gallagher along with associates Peter Espey, Jennifer Suh, Duncan Francis and Anna Kitsos Papamarkos, a defense team that firm chairman Paul M. Fires said has built a reputation that is "beyond reproach."
"Expanding our medical malpractice group gives us a stronghold in the health care industry in New Jersey and bolsters our already established Pennsylvania practice," Fires said.
The additions bring the 10-office firm's medical malpractice team to 21 attorneys, according to a firm spokeswoman. The firm's roughly 100 lawyers serve clients in the mid-Atlantic region.
On his move from Wilson Elser, an 800-attorney firm with 35 offices in the U.S. and London, Brown said Weber Gallagher's regional focus is a better fit for his practice. Brown defends medical professionals in court and before New Jersey state licensing boards and has also defended clients in mass torts stemming from the heartburn drug Reglan, gadolinium toxicity and pelvic mesh.
Weber Gallagher's focus on individualized relationships, as well as its resources and technology platform, were a draw, according to Brown. Medical malpractice lawyers in New Jersey are tackling challenging cases, Browns said, thanks to the state's affidavit of merit statute requiring medical malpractice litigants to back their claims with an expert's opinion. The law, implemented in 1995, has allowed courts to vet the cases more carefully.
"Although the number of cases might be down, the level of severity in terms of the injury is way up. [The cases] require a lot of more work," Brown told Law360.
Espey defends health care professionals and medical groups and Suh's clients call on her for help with medical, nursing and legal malpractice, insurance defense and general liability matters, the firm said.
Francis and Papamarkos both focus on medical malpractice matters, according to the firm.
The newcomers represent a growth spurt for the firm that included the opening of a New Castle, Delaware, office in January led by partner Stephen F. Dryden, who brings extensive experience defending clients in multidistrict litigation, the firm said.
--Editing by Stephen Berg.https://www.law360.com/articles/1038747/weber-gallagher-adds-5-wilson-elser-attys-to-med-mal-group-
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