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Ethicon Media Monitoring 8/16/2018
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Federal judge cuts vaginal mesh punitive award; Woman must take lesser amount or go through new trial
Aug 15, 2018 | Legal NewsLine
By John Sammon
An Indiana federal judge on Aug. 8 gave a choice to a woman who won a case that alleged the pelvic mesh device made by Johnson & Johnson caused her severe injury. -
Hospital stops mesh implants
Aug 15, 2018 | Jersey Evening Post
By Lucy Stephenson
The use of pelvic mesh implants has been suspended in Jersey following a decision in the UK after concerns were raised about possible complications which campaigners say have left thousands of women around the world in agony. -
The Bleeding Edge Is 2018’s Best Horror Film
Aug 16, 2018 | The Cut
By Melissa Dahl
I only made it 11 minutes into The Bleeding Edge, Netflix’s terrifying new documentary about the medical-device industry, until I had to hit pause to compose myself.
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Aug 15, 2018 | Legal NewsLine
By John Sammon
An Indiana federal judge on Aug. 8 gave a choice to a woman who won a case that alleged the pelvic mesh device made by Johnson & Johnson caused her severe injury. She could submit to a lesser amount of punitive damages or face a new punitive damages trial, the judge ruled.
Judge Philip P. Simon's ruling in favor of Barbara Kaiser is one of thousands of lawsuits J&J and its New Jersey subsidiary Ethicon face over their pelvic implant device, called “Prolift.”
Kaiser sued Johnson & Johnson and Ethicon, a maker of surgical tools and medical closure devices, for the pelvic mesh implant installed into her groin region in January 2009 at the Community Hospital in Munster, Indiana. The device was intended to prop up a sagging bladder.
Instead in September 2011, Kaiser said she learned from her doctor the acute pain she was experiencing in her vaginal area could be caused by the implant.
Prolift is a device made of pre-cut pieces of polypropylene called “Gynecare Gynemesh” manufactured by Ethicon. The mesh has four connecting and securing arms.
On July 13, 2011, the U.S. Food & Drug Administration (FDA) issued a warning about the use of mesh devices that “serious complications associated with surgical mesh for transvaginal repair are not rare.”
The warning further stated it is not clear if transvaginal mesh devices are more effective than traditional non-mesh repairs (sutures) for patients with prolapse conditions, and could subject the patients to greater risk.
Kaiser’s lawsuit of March 28, 2012, alleged mental and physical pain and suffering, permanent injury requiring corrective surgery, financial loss from medical bills and loss of physical relations with her husband and co-plaintiff Anton Kaiser.
The U.S. District Court for the Northern District of Indiana on March 8 awarded the woman $10 million in damages and $25 million in punitive damages after a jury agreed Johnson & Johnson and Ethicon had misled the public about the risks of the mesh implant. The verdict said the companies failed to establish proper safety procedures for removal of the mesh in case of failure and failed to perform adequate research and pre-testing of the device.
The allegations contended the defendants had also provided incomplete, insufficient and misleading training and information on the implantation of the devices to doctors who would install them, to increase sales of the mesh devices.
“Despite defendants’ knowledge of similar catastrophic injuries, complications and conditions caused by their Prolift, the defendants have and continue to manufacture, market and sell the products, while continuing to inadequately warn, label, instruct and disseminate information regarding the product, both prior to and after the marketing and sale of the product implanted into the plaintiff (Kaiser),” the suit read.
Johnson & Johnson contested the verdict and moved to overturn it. The company also sought a new trial or at least a reduction in the damages award.
Judge Simon denied overturning the judgment and a request for a new trial, finding the presentation of the evidence made a judgment in favor of Kaiser reasonable. However, the judge said the punitive damage award had been set too high.
Simon said the jury erred in setting a punitive damage amount based on a percentage of J&J’s $70 billion total net worth, rather than the company’s profits selling the Prolift device in Indiana, calculated at a mere $150,000.
He maintained the $25 million punitive amount was 166 times the relevant amount of profits earned by the defendants J&J and Ethicon. Simon ruled instead for a $10 million punitive award.
Kaiser is to decide if she will accept a reduced punitive amount and receive a total $20 million in damages instead of $35 million. If she refuses, the judge will order a new punitive damages trial.
According to a report by the Saunders & Walker law firm on March 13, Johnson & Johnson and Ethicon still face more than 13,000 mesh lawsuits and 55,000 product liability claims across the country. The two companies have lost more than a half-dozen trials with verdicts from $2.16 million to $20 million.
https://legalnewsline.com/stories/511529753-federal-judge-cuts-vaginal-mesh-punitive-award-woman-must-take-lesser-amount-or-go-through-new-trial
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Aug 15, 2018 | Jersey Evening Post
By Lucy Stephenson
The use of pelvic mesh implants has been suspended in Jersey following a decision in the UK after concerns were raised about possible complications which campaigners say have left thousands of women around the world in agony.
In a statement, a spokesman for the Health Department said that the decision followed a recommendation adopted by the NHS. He said procedures would be suspended until further updated advice was received and he reassured patients that the recent findings only related to vaginal mesh surgery.
Mesh implants are made of polypropylene plastic and are used to treat incontinence or prolapse, often suffered following pregnancy and childbirth weakening pelvic floor tissue.
Last month, NHS England accepted a recommendation to temporarily suspend the use of vaginal mesh implants until March 2019 after concerns were raised about some cases in which the implants had moved, twisted and even degraded inside the body.
However, the suspension did not cover the Channel Islands, promoting campaign group ‘Sling the Mesh’ to warn that it was potentially ‘a significant region affected by this women’s health scandal’.
However, the Health Department confirmed it had now followed the lead of the UK, where an independent review is currently underway.
In a statement it said: ‘The NHS has temporarily suspended all use of mesh in the vagina for pelvic organ prolapse and stress urinary incontinence. Jersey’s Health and Community Services Department has therefore followed this recommendation and stress urinary incontinence procedures using mesh have been suspended until further updated advice is received. Other surgical procedures are available in Jersey and any women suffering from urinary incontinence are encouraged to seek assessment from their GP and referral to the hospital if required. It is important to reassure patients who have had other types of mesh surgery (eg for a hernia) that the recent report and findings only reflect vaginal mesh surgery.’
It added: ‘The department will continue to review recommendations by the National Institute of Health and Care Excellence to ensure the delivery of safe and evidenced-based healthcare services that meet the needs of Islanders.’
Kath Sansom from the Sling the Mesh campaign group said she was aware of women in Jersey suffering complications following the procedure.
‘The pain this procedure can cause is indescribable. I’ve been in contact with women in Jersey who are suffering serious complications from vaginal mesh implants. This procedure is being promoted as a “quick fix” for urinary stress incontinence – but the plastic can twist, move and degrade inside the body.
‘It can attach and slice through organs causing paralysis, chronic pain, sepsis, loss of sex life and even organ failure. Women contact our group feeling suicidal from the pain vaginal mesh implants have caused them. If you, or a loved one, have been experiencing complications following the procedure, then I urge you to share your story with the government’s independent review.’
https://jerseyeveningpost.com/news/2018/08/15/hospital-stops-mesh-implants/
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The Bleeding Edge Is 2018’s Best Horror Film
Aug 16, 2018 | The Cut
By Melissa Dahl
I only made it 11 minutes into The Bleeding Edge, Netflix’s terrifying new documentary about the medical-device industry, until I had to hit pause to compose myself. “Blood exploded out of me,” the woman on screen was saying (until I made her stop). “It looked like a horror scene. There were large splats all over the floor.”
She was describing the gruesome side effects she suffered as a result of Essure, a surgically implanted permanent birth-control device, and she was making me feel a little faint as she did so. Fellow Cut staffer Emily Sundberg tells me she actually did faint during this scene. The documentary is rough on those of us prone to vasovagal reactions, as it feels like a horror film pretty much all the way through. Consider:
• The man who tells the filmmakers about the time his wife’s recently inserted vaginal mesh cut his penis, while the two were having sex.
• The doctor who recalls losing his mind in a hotel room, grabbing a ball point pen and scribbling all over the walls and ceiling. It was a symptom, he now believes, of metal poisoning from his hip replacement. (When his surgeon went in to remove the device, he discovered that it had been leaking toxic “sludge” into his bloodstream.)
• The woman who describes the aftermath of a hysterectomy performed via robotic surgery: “I go to the restroom and I felt something emerge from my vagina,” she says. “I had three feet of my colon fall out.”
So much gore and so much trauma, and yet the detail I can’t stop thinking about is sort of boring by comparison: It seems I am now obsessed with the flimsy process by which the FDA approves medical devices. As it is now, this process is often already irresponsible — and, as the filmmakers point out, it is likely to get so much worse under the Trump administration.
Currently, many devices — even high-risk ones — aren’t thoroughly tested before they go on the market, due to a kind of loophole in the system: “[B]ecause so many new devices are brought to market, including new iterations of already approved devices, some medical companies argue that it’s too expensive to send each device through massive amounts of clinical testing,” explains Time health reporter Alexandra Sifferlin. Enter said loophole, called the 510(k) pathway, through which a medical-device manufacturer only has to prove that their product is “substantially equivalent” to a device already on the market. Even if that “equivalent” device was itself not tested thoroughly. Even if that device was later deemed dangerous. Even if that device was later recalled.
And then there’s this: I missed the reports about it last fall — “Cat Person” had just been published, you see, and I was distracted — but in November, the FDA proposed a loophole for the existing loophole. The proposed plan would be a way to fast-track approval of medical devices without requiring manufacturers to name an “equivalent,” also called a “predicate,” product. The current copy-of-a-copy system is seriously flawed, but at least it requires some pre-market testing of some version of the device. This proposal, as a Reuters reporter noted at the time, would “[shift] safety monitoring from the pre-approval to the post-market setting, [and] would essentially turn patients into guinea pigs.”
It’s all so bleak. The documentary ends, and you feel helpless. Hopeless. And then, at the last possible moment, a bit of optimism appears. Did you ever hear about Get Out’s alternate ending? The original was deemed a “downer,”so they decided to change it to something slightly more hopeful. I thought about that at the end of The Bleeding Edge, which gets an alternate ending, too, kind of. In a late addition to the film, a title card was added just before the credits, and it tells us this: “Shortly after the premiere of this film, Bayer announced it would stop selling Essure in the U.S. at the end of 2018.”
https://www.thecut.com/2018/08/the-bleeding-edge-is-2018s-best-horror-film.html
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