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Ethicon Media Monitoring 8/31/2017
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Bollinger County man accuses Ethicon, Johnson & Johnson of developing defective mesh product
Aug 30, 2017 | St. Louis Record
By Noddy A. Fernandez
A Bollinger County man is suing the manufacturer and distributor of hernia repair mesh products, citing alleged breach of implied warranty. -
Johnson & Johnson Is Facing a Lawsuit from Women Left Unable to Have Sex
Aug 30, 2017 | Allure
By Macaela Mackenzie
After losing a lawsuit over a claimed connection with one woman's terminal case of ovarian cancer, Johnson & Johnson is facing a different legal battle in Australia — this one related to a product some women claim has left them in chronic pain and unable to have sex. -
Patients deserve better than this. Surgeon speaks of the ‘Absolute disaster’ of global approval systems for women’s pelvic mesh kits
Aug 31, 2017 | Cambs Times
By Kath Sansom
Warnings were given as long ago as 2009 about the dangers of surgical mesh and its implanting hooks by a respected surgeon who said the kits had everything to fix women’s pelvic health problems - except ethics and sound judgement. -
Godsend female surgery in jeopardy because of ‘hysterical bias’
Aug 31, 2017 | The Australian
By Caroline Overington
An experienced Sydney surgeon has expressed concern about "hysterical bias" in the campaign against the use of vaginal mesh, saying the operation is still the best option for many women. -
Hinch's Senate Diary: heartrending stories from pelvic mesh inquiry
Aug 31, 2017 | Crikey
By Derryn Hinch
It was a stark Perth image I will never forget. An attractive, white-haired woman, who was much younger than she looked and obviously discomforted, standing and leaning on a crutch in a meeting room at the Four Seasons hotel. -
Women’s pain is too often dismissed by doctors – why is that?
Aug 30, 2017 | iNews
By Imogen Robinson
Just months after the vaginal mesh scandal showed that women reporting debilitating symptoms are simply brushed off by medical professionals and pharmaceutical companies, another case in which women are being ignored when they report adverse side effects from procedures concerning their reproductive organs has come to light. -
The many women suing Johnson & Johnson
Aug 30, 2017 | Consumer Affairs
By Amy Martyn
Johnson & Johnson last week was hit with a $417 million verdict after a California jury sided with plaintiff Eva Echeverria, who charged that her daily application of the company’s talcum powder had caused her to develop ovarian cancer in 2007.
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Bollinger County man accuses Ethicon, Johnson & Johnson of developing defective mesh product
Aug 30, 2017 | St. Louis Record
By Noddy A. Fernandez
ST LOUIS — A Bollinger County man is suing the manufacturer and distributor of hernia repair mesh products, citing alleged breach of implied warranty.
Larry Jordan filed a complaint Aug. 11 in the U.S. District Court for the Eastern District of Missouri Southeastern Division against the Ethicon Inc. and Johnson & Johnson Inc., alleging the defendants failed their duty to use reasonable care in designing, testing, inspecting, manufacturing, packaging, labelling, marketing, distributing and preparing written instructions and warnings for Physiomesh product.
According to the complaint, on May 16, 2012, the plaintiff received a Physiomesh implant to repair a ventral hernia. The plaintiff claims he was forced to undergo a revision surgery to remove the implant because it adhered to the abdominal wall and caused other complications. As a result, Jordan claims he suffered personal injuries, financial loss and medical expenses.
The plaintiff holds Ethicon and Johnson & Johnson responsible because the defendants allegedly failed to design or manufacture products that are fit for their intended use and failed to provide adequate warnings and instructions concerning the risks of using the product.
The plaintiff requests a trial by jury and seeks judgment for compensatory and punitive damages in an amount not less than $75,000, as well as costs, attorney fees, interest or other relief he is entitled to receive. He is represented by James G. Onder, Williams W. Blair and Michael J. Quillin of Onder, Shelton, O'Leary & Peterson LLC in St. Louis.
http://stlrecord.com/stories/511187111-bollinger-county-man-accuses-ethicon-johnson-johnson-of-developing-defective-mesh-product
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Johnson & Johnson Is Facing a Lawsuit from Women Left Unable to Have Sex
Aug 30, 2017 | Allure
By Macaela Mackenzie
After losing a lawsuit over a claimed connection with one woman's terminal case of ovarian cancer, Johnson & Johnson is facing a different legal battle in Australia — this one related to a product some women claim has left them in chronic pain and unable to have sex.
As reported by the Australian Broadcast Corporation (ABC), a group of Australian women opened a class action suit against Johnson & Johnson earlier this summer after they alleged experiencing severe side effects from Johnson-&-Johnson-manufactured pelvic mesh. Mesh can be implanted to support damaged or weak tissue and treat pelvic floor disorders, which are often a complication from childbirth — but the woman involved in this suit claim that mesh implants left them in debilitating, chronic pain.
The prosecution is targeting Johnson & Johnson, as reported by The Guardian in July. According to arguments in court, they alleged that no randomized controlled trials were conducted, the device was aggressively marketed to doctors as a cheap, effective solution for women. “It was sell first, test later,” Barrister Duncan Graham of the Australian Supreme Court said, according to The Guardian. “The women who had them implanted were part of an experiment, they were guinea pigs,” he added.
As part of the court case, lawyers presented emails between a J&J marketing manager and French doctors treating women affected by the faulty mesh, which ABC obtained. One doctor's solution to the debilitating vaginal pain? Just try anal sex. “It is no less true that sodomy could be a good alternative!” he allegedly wrote in one email presented in court.
Women were understandably disgusted by this attitude. "The suggestion that women who are unable to have vaginal intercourse should practice anal instead completely devalues a woman’s right to a full and healthy sex life as an active, empowered and fulfilled participant,” one member of the Australian Pelvic Mesh Support Group commented to The Guardian. "Only a misogynist could think this way," another said.
"As a company, we are here to improve people’s health and wellbeing and our hearts go out to all women suffering pelvic organ prolapse and stress urinary incontinence — conditions which seriously impact a woman’s quality of life," a representative from Johnson & Johnson told Allure in a statement via email. "I can assure you that safety is our highest priority. We have full confidence in the safety and efficacy of our pelvic mesh products and have acted ethically and in compliance with all laws, regulations and industry codes of conduct in their research, development and supply." The company did not wish to comment on the emails while court proceedings are underway.
https://www.allure.com/story/doctor-suggests-women-can-just-have-anal-if-sex-hurts
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Aug 31, 2017 | Cambs Times
By Kath Sansom
Warnings were given as long ago as 2009 about the dangers of surgical mesh and its implanting hooks by a respected surgeon who said the kits had everything to fix women’s pelvic health problems - except ethics and sound judgement.
Professor Lewis Wall said his father was a gynaecologist before him and would be horrified at what has happened to his profession.
“Before the advent of mesh kits, there was little commercial interest in gynaecologic surgery aside from the sale of sutures or catheters, but now there are operation-specific kits, huge profits are on the table,” he said.
“Almost everything you need to operate - except good clinical judgment and technical skill - is right there, fresh out of the box.
“Patients deserve better than this.
“Surgeons wanted to fix all these problems with prolapse without having to train up for the more complex native tissue repairs that took years of experience and skill.
“Mesh kits involve inserting a synthetic mesh tape into a contaminated surgical field using trocars, done blind – it is asking for trouble.”
He continued: “It is not good enough to say that abdominal mesh has been proven safe for hernia repairs so it is OK to use it in the vagina; the vagina isn’t the same thing as the belly wall.
“Add in the absolute disaster of our approval system for surgical devices that only works to the advantage of shareholders.
“Mesh kits may make intellectual sense but is not the same as ethical sense.
“My father was a gynaecologist and would be horrified at what has happened to his profession.”
Approval systems around the world are flawed which means mesh being implanted into women without strong clinical trials to prove it is safe and effective, he added.
In 2009 Mr Wall and Douglas Brown wrote a report warning that commercial interests were reshaping gynaecology and the dangers of allowing industry to have too heavy a hand in medicine.
Unlike drugs, which must be shown by clinical trials to be both safe and effective prior to launch, if a device is “equivalent” to something that is already being implanted into patients, it is allowed to enter the market.
Independent trials are not needed.
It is how the PIP breast implant scandal – using mattress grade silicone instead of human grade – managed to happen.
Mr Wall said of mesh kits: “The procedures should be considered experimental and patients should consent to surgery with that understanding.
“Certainly in the early days of mesh kits I believe surgeons weren’t deliberately injuring women, but there were a lot of aggressive salesmen and a lot of naive doctors who believed the glossy marketing brochures and didn’t want to fall behind on surgical practice, so they jumped on the bandwagon before the evidence was in.
“There’s so much money and profits at stake its mind boggling,” he saied.
However, there’s a fundamental opposition between medicine and business - in business profitability comes first.
“In business you look at costs – if profits are $200b and you have to set aside $60b for compensation then it is $140b profit. So the product is a goer.
“In medicine the first priority must always be the best interests of the patients. Often there is a clash.”
“Mesh is less aggressively marketed now than it was but the real problem came in the first few years – once it was in the public arena it went crazy.”
• Read the report Commercial Pressures and Professional Ethics and a thread of discussion that followed in this link here.
• Lewis Wall is a professor of obstetrics and gynaecology at Washington University in St Louis, Missouri. Read his biography here.
http://www.cambstimes.co.uk/news/patients-deserve-better-than-this-surgeon-speaks-of-the-absolute-disaster-of-global-approval-systems-for-women-s-pelvic-mesh-kits-1-5169298
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Godsend female surgery in jeopardy because of ‘hysterical bias’
Aug 31, 2017 | The Australian
By Caroline Overington
An experienced Sydney surgeon has expressed concern about "hysterical bias" in the campaign against the use of vaginal mesh, saying the operation is still the best option for many women.
Jenny King, who is director of the Pelvic Floor Unit at Sydney’s Westmead Hospital, and chair of the Urogynaecological Society of Australasia, says vaginal mesh has “truly been a godsend for so many women”. She is alarmed by the “one-sided reporting on mesh”, some of which, she argues, has presented the operation as a dangerous, untested experiment on women.
Senator Derryn Hinch has become a champion of female patients, saying the use of mesh may well be Australia’s “biggest medical scandal”. The Senate has established a committee to inquire into the use of mesh; there is also a class action against the makers of mesh under way in the Federal Court in Sydney.
Vaginal mesh is used to treat incontinence, as well as prolapse of the pelvic organs, such as the bladder, bowel or uterus, which in serious cases can fall through, and hang out of the vagina. More than 150,000 women in Australia have had vaginal mesh inserted since the technology was introduced in the year 2000, and Dr King believes it has been effective ‘‘for 99 per cent of them’’.
‘‘Undeniably there are some women who have experienced really distressing complications from vaginal mesh (but) the reality is that any surgery, with or without mesh, carries a risk of chronic pain,’’ Dr King said. “My worry is that the adverse publicity, which has been almost hysterical in its bias, will mean many more women will suffer because they will be denied the option of a vaginal mesh repair which may be the only suitable procedure for them.”
Dr King says mesh is particularly suited to women over 75, “in whom we couldn't really perform major abdominal surgery, so they simply stayed wet (or incontinent). We can always go back to these more morbid abdominal operations for younger and fitter women if we have to, but this won't work for the elderly, the frail and the obese.
“Traditional repairs fail in easily one third of patients, so we need vaginal mesh available.
“I naively thought we just had to explain the real situation to the public, to the media and the Senate inquiry. Sensible decisions, based on the facts, would then be made. But this does not seem to be the case. I have tried to talk with multiple media outlets but quite honestly no one wants to hear about ladies who have had a good outcome. Why don't these patients matter?
“Many of my patients have made submissions to the Senate inquiry explaining their positive mesh experiences. To date, none of these individual letters have been published on the website. There are, of course, multiple letters from patients unhappy with mesh. I have queried this with the Senate staff who told me the senators had not finished reviewing all the submissions. I don’t want to sound paranoid but this is a little difficult to believe. I really despair over how we are going to be able to care for all of our patients without these mesh products.”
The Senate committee has posted a submission from a trio of specialists: urogynaecologist Hans Peter Dietz of the Nepean Hospital; gynaecologist Clara Shek from Liverpool Hospital; and urogynaecologist Vivien Wong, who is undertaking a PhD on prolapse.
Like Dr King, they argue that “as surgeons, we try to do the best by our patients, and the rapid uptake of mesh arose from an awareness that conventional surgery often simply doesn’t work”.
“If it did why should gynaecological surgeons go to the pains of learning new, sometimes difficult techniques. Banning mesh or impeding development of new surgical techniques in this field would perpetuate high failure rates.”
http://www.theaustralian.com.au/news/health-science/godsend-female-surgery-in-jeopardy-because-of-hysterical-bias/news-story/a23bde96fdc4ffab8a730e4797bfde7e
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Hinch's Senate Diary: heartrending stories from pelvic mesh inquiry
Aug 31, 2017 | Crikey
By Derryn Hinch
It was a stark Perth image I will never forget. An attractive, white-haired woman, who was much younger than she looked and obviously discomforted, standing and leaning on a crutch in a meeting room at the Four Seasons hotel. Across the room, past a woman in a wheelchair, another middle-aged woman leant against the wall.
Access to full text unavailable – subscription required. For full story: https://www.crikey.com.au/2017/08/31/hinchs-senate-diary/
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Women’s pain is too often dismissed by doctors – why is that?
Aug 30, 2017 | iNews
By Imogen Robinson
Just months after the vaginal mesh scandal showed that women reporting debilitating symptoms are simply brushed off by medical professionals and pharmaceutical companies, another case in which women are being ignored when they report adverse side effects from procedures concerning their reproductive organs has come to light.
The Victoria Derbyshire show reported that Essure, a form of permanent sterilisation used on the NHS, can cause severe side effects and complications. The small implant, made of nickel and polyester fibres, is inserted into the fallopian tubes where the resulting inflammation leads to a buildup of scar tissue, eventually blocking the tubes.
The Victoria Derbyshire show reported that Essure, a form of permanent sterilisation used on the NHS, can cause severe side effects and complications. The small implant, made of nickel and polyester fibres, is inserted into the fallopian tubes where the resulting inflammation leads to a buildup of scar tissue, eventually blocking the tubes.
The device reportedly left one woman suicidal due to the unbearable pain, and in another woman it perforated her fallopian tube and got dislodged, embedding itself elsewhere in her body. Despite the fact that more than 15,000 women with the device reported problems to the US Food and Drug Administration (FDA), their use was continued, with the manufacturer claiming the benefits outweigh the risks, according to the BBC.
The device reportedly left one woman suicidal due to the unbearable pain, and in another woman it perforated her fallopian tube and got dislodged, embedding itself elsewhere in her body. Despite the fact that more than 15,000 women with the device reported problems to the US Food and Drug Administration (FDA), their use was continued, with the manufacturer claiming the benefits outweigh the risks, according to the BBC.
Pain is ignored completely Vaginal mesh and sterilisation devices are not the only instances regarding sexual and reproductive health whereby women have had their pain ignored completely, with devastating results.
A 2015 report by Endometriosis UK revealed that it takes, on average, 7.5 years for a woman to get a formal diagnosis of endometriosis, which can leave women infertile. PMDD, an extreme form of PMS, affects 5-8% of women according to the National Association for Premenstrual Syndrome, yet few doctors are aware of the condition, which can leave women feeling suicidal. In 2016, researchers finally confirmed the long-suspected link between hormonal contraceptives and depression, and yet the only real long-term alternative available is the copper coil — which can cause longer, heavier, and more painful periods.
It doesn’t stop there. Studies show between 20 and 50% of women live with incontinence, yet an American study found that women wait 6.5 years after beginning to experience problems before they go and see a healthcare professional. An estimated 200,000 women experience the impacts of traumatic birth each year, and yet there is still stigma attached to childbirth, with pressure on women to go without pain relief or have the child vaginally, whatever the cost.
It doesn’t stop there. Studies show between 20 and 50% of women live with incontinence, yet an American study found that women wait 6.5 years after beginning to experience problems before they go and see a healthcare professional. An estimated 200,000 women experience the impacts of traumatic birth each year, and yet there is still stigma attached to childbirth, with pressure on women to go without pain relief or have the child vaginally, whatever the cost.
Why is female pain deemed simply imagined?
So why are women being overlooked or ridiculed when they seek help for health problems? What is it about female pain that means it is simply deemed imagined?
The reasons are manifold. Historically, women weren’t allowed to be doctors and scientists, so it is only relatively recently that there have been physicians with any sort of vested interest in women’s reproductive health. On top of that, women didn’t previously have a platform to speak out, so were brushed off as weak, or “hysterical”.
It wasn’t until 1994 that the US National Institutes of Health ruled that women and minorities should be included in any government-funded health research, despite the fact that it has long been known that women and men react differently to different drugs. Knowledge is still lacking on female-specific reproductive health issues, which means doctors are not adequately prepared to answer women’s needs. A shadow report from the UK CEFAW Working Group found that many women (in particular young, black, minority ethnic, or refugee women) feel judged by healthcare professionals.
Increasingly, too, we are seeing money directed away from crucial services, with the Local Government Association describing sexual health services as being at “tipping point” due to funding cuts, cuts which will adversely affect young women. In some areas there is also still a deeply-entrenched belief that women should not be allowed to control their own health needs, with thousands of women in Northern Ireland still having their health put at risk due to lack of access to a free, safe, and legal abortion.
Finally, there is still a considerable amount of stigma when it comes to discussing issues to do with our gynaecological health. Despite ubiquitous sexualised advertising and freely available porn, we still live in a very conservative society, one in which men are still terrified of tampons and a woman who is still childless in her thirties arouses suspicion. Many women refuse to go for potentially life-saving smear tests for fear of someone seeing their vulva, due to this lingering idea that privates, and all related matters should be, well, private.
Fortunately, things are slowly improving, but the process is still too slow. We need to shout about women’s health needs and continue eradicating stigma surrounding sexual and reproductive health. Pain that leaves you bed bound for days on end is not normal. Being forced to walk around with a device that is perforating your organs is not normal. Being told there are no alternatives is not normal. While women are waiting for research to catch up with their needs, they should not suffer in silence. And when they do speak up it’s time for them to stop being silenced.
https://inews.co.uk/author/imogen-robinson/
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The many women suing Johnson & Johnson
Aug 30, 2017 | Consumer Affairs
By Amy Martyn
Johnson & Johnson last week was hit with a $417 million verdict after a California jury sided with plaintiff Eva Echeverria, who charged that her daily application of the company’s talcum powder had caused her to develop ovarian cancer in 2007.
The court case leading to the record-breaking verdict tells yet another dramatic story about a pharmaceutical behemoth’s betrayal of its female customer base. It’s a story that is all too familiar to Johnson & Johnson.
The popular trend in medicine of “minimally invasive surgery” was bolstered in part by pharmaceutical companies selling devices that made certain new surgical techniques possible. A fast-track process called 510(k) allows companies to quickly get approval from the Food and Drug Administration to market new surgical tools, implants and other medical devices. The ease of this process has led critics and researchers to charge that devices do not get enough scrutiny from the Food and Drug Administration before landing in doctor’s hands.
Power morcellators would become a prime illustration for this concern.
For gynecologists, the benefits seemed clear. Doctors treating women afflicted with uterine fibroids, benign but painful growths on the uterus, used to cut their patients open to remove the growths. But using the power morcellator, doctors could remove fibroids laparoscopically. The morcellator works by literally morcellating -- or mincing, slicing and dicing -- the fibroids and the uterus into minuscule pieces inside the patient’s body. This allows doctors to then remove the organ through a much smaller incision.
It took pushback from an anesthesiologist-turned-activist and her outspoken husband, a heart surgeon, to question the wisdom of grinding up an unknown mass before it is removed from a patient.
“From a surgical perspective, it’s clear that indiscriminant morcellation of any tumor with malignant potential inside a patient’s body poses a prohibitive danger,” wrote Dr. Hooman Noorchashm, the heart surgeon married to activist Dr. Amy Reed.
Reed underwent what she was told would be a low-risk surgery to treat her uterine fibroids in 2013. Doctors did not discover until after they performed the procedure that Reed was not suffering from fibroids but from uterine cancer. The morcellation device had likely caused her cancer to spread and metastasize. Caused the cancer to spread
As she grappled with a devastating Stage 4 cancer diagnosis, Reed and her husband lobbied medical authorities, politicians and journalists to scrutinize the use of morcellators in uterine surgery. The Food and Drug Administration finally relented and agreed to study the safety of morcellators. The agency reported that the morcellators were spreading undiagnosed cancer in an estimated 1 in 350 women, a figure that was “much higher than previously suspected rates of 1 in 10,000,” the FDA acknowledged.
Johnson & Johnson subsidiary Ethicon was the most high-profile manufacturer of laparoscopic power morcellators, and the FDA’s warnings about the device put the corporation under pressure. The FBI launched an investigation into Johnson & Johnson after the discrepancies in safety data came to light, and the FDA subsequently issued a “black box” warning on power morcellators. About 100 patients filed lawsuits claiming that the company’s researchers were aware of the risk that uterine tumors could be misdiagnosed as fibroids.
Ethicon ultimately decided to pull its morcellator out of hospitals in 2014, explaining that “Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk.” Johnson & Johnson began settling the morcellator lawsuits last year.
But for Hooman Noorchashm, more work is yet to be done. The nation’s largest group representing gynecologists has cautiously continued endorsing the morcellation procedure, writing in a public statement that “we continue to believe that power morcellation has a role in gynecologic surgery.”
The morcellator used on Amy Reed was not developed by Johnson & Johnson but by competitor Karl Storz Endoscopy, whose morcellators have not been recalled. The couple battled the German device-maker in civil court and in an unusual strategy, announced that they would refuse to settle until Karl Storz takes its product off the market. That still hasn’t happened. Frustrated after Reed's death
Reed passed away from cancer in May 2017. Noorchashm, frustrated with a lack of a response from gynecologists, wrote an open letter to the American Society of Anesthesiologists on July 26, asking them to consider the death of their former colleague and to intervene in surgeries when gynecologists try to use morcellators. "It takes no amount of effort for any reasonable physician to understand that mincing up tumors with malignant potential inside a human body cavity is a prohibitively dangerous practice -- because it risks spreading or upstaging a deadly process,” he told the anesthesiology society.
Society of Anesthesiologists spokesman Theresa Hill writes to ConsumerAffairs that evaluating the safety of morcellation is outside their scope of expertise, but that their ethics committee is considering the general question of whether anesthesiologists “have an ethical duty to intervene regarding medical procedural decisions made by surgeons.”
Meanwhile, another device-maker last year won FDA approval to market its own version of the power morcellator. Olympus advertises that its new morcellator is equipped with a "containment device" that will supposedly stop "the escape of fluids, cells and tissue fragments."
Even though the new Olympus morcellator is already on the market, researchers point out that there is limited data proving that the containment bags actually work at preventing the spread of cancer cells. Researchers used morcellators equipped with containment bags to perform surgery on 76 women last year and found that the bags leaked in seven of those patients.
It is perhaps for that reason that Olympus is continuing to test its morcellators on patients, despite already having FDA approval. The company is currently planning to test its power morcellators on 140 women, in a study conducted by doctors at the University of North Carolina. Noorchashm has tried to put a stop to this research, arguing that it is "critically flawed" and unethical to test the morcellator on people.
Olympus responds that they simply want to improve on their products and keep their "commitment to continuing innovation." The practice of testing a device for safety after it has already been granted FDA approval “is common in the medical device industry,” Olympus spokesman Stephanie Sherry writes to ConsumerAffairs via email.
Pelvic mesh
The story behind the plastic netted implant marketed as pelvic mesh or TVT mesh has some striking similarities to the morcellator. Both were cleared under the 510(K) process, and both were supposed to allow for fast operations on women's reproductive organs, the difference with mesh being that the device itself was supposed to stay implanted in the patient permanently.
Treating women who had suffered from the common condition called pelvic organ prolapse used to require somewhat complicated gynecological surgery. Johnson & Johnson's TVT mesh was supposed to make that surgery easier when it was introduced in 2002. Ethicon sold gynecologists the mesh implant with the pitch, once again, that it allowed for minimally invasive surgery. Doctors could place the implant in the patient's organs without any cutting and a short recovery time.
Women who underwent the procedure said they were never informed of the specifics of what was actually being done to them. They said that doctors described the implant as a hammock of sorts that would gently hold their organs in place.
In reality, as patients would later learn, mesh is a plastic implant made of rough netted material and is attached to the pelvis with trocar hooks. Company documents revealed in courtrooms described ways in which the plastic netting could cause severe pain and complications. And should patients suffer from those complications, there is little recourse, as most doctors do not know how to remove the implant.
It took the complaints of thousands of patients describing unbearable pain, destroyed sex lives and other issues to get the FDA to reevaluate. Finally, in 2011, the FDA released a warning that complications from mesh used to treat pelvic organ prolapse were "not rare” after all, and they re-classified the device as high-risk.
Ethicon opted to stop selling mesh for pelvic organ prolapse the following year, though it never recalled the product, and Johnson & Johnson and others still sell mesh to treat other gynecological or urological conditions, such as incontinence caused from giving birth. For many patients, the new federal warnings were too little and too late. Doctors had been treating pelvic organ prolapse with Johnson & Johnson's mesh for nearly a decade before the FDA revised its stance on the device.
The regulators’ about-face opened the floodgates to personal injury attorneys, who put out aggressive advertising campaigns to find the mesh patients who had suffered complications. An estimated 54,000 women have filed lawsuits against Johnson & Johnson in the United States, and lawsuits against other mesh manufacturers brings that total to over 127,000, making mesh lawsuits the largest type of personal injury litigation since the asbestos lawsuits, according to Reuters.
So many women have filed lawsuits and have sought surgeries to have the mesh removed that a new cottage industry has developed in which medical lenders pay for plaintiffs’ mesh removal surgery upfront. The lenders then demand a stake of the financial reward should the patient secure a financial settlement. Patients who won mesh settlements describe being shocked to find their money gutted by medical liens, as Reuters reported in 2015. Attorneys have also reportedly been pressuring their clients to accept low settlement offers.
Litigation against Johnson & Johnson isn’t limited to the United States. In Australia, where approximately 700 women have joined a class action lawsuit against Johnson & Johnson, public officials and news media have given much more attention to complaints about the product. One lawmaker in Australia said that pelvic mesh is “the biggest medical scandal for Australian women since thalidomide in the 1950s and 1960s, when kids were born without arms and legs.”
According to testimony against Johnson & Johnson in the Australian courts, one of the company’s implanting physicians admitted that he would never perform the mesh procedure on his own wife. Salespeople reportedly incentivized doctors to perform the procedure by giving them Lamborghinis and ski trips to the Swiss Alps. Surgeons were also told, according to the court testimony, that they could insert four mesh devices “before lunch,” which would earn them $10,000 in a single morning.
Johnson & Johnson responded to the Austrian news media in a statement this month that though it could not comment on documents used in litigation, "we have confidence in the safety and efficacy of these mesh products, they are backed by scientific research."Talc
Smooth, absorbent talcum powder has for decades been marketed as an all-purpose hygiene product for both men and women of every age. Talc is present not just in baby powder but in makeup, medicine tablets and even food. But consumers in recent years have raised concerns that some cosmetic-grade talc may be contaminated with asbestos. Regulators banned the use of asbestos in cosmetic-grade talc in 1973, but cosmetics companies are not required to have their products independently tested by the FDA.
The FDA finally tested a selection of talc-based cosmetic products and in 2012 reported finding no traces of asbestos. Even then, the FDA warned, “the results were limited” because only four talc suppliers agreed to submit samples for testing.
Independently of asbestos concerns, questions of whether talc itself could cause ovarian tumors have been around since the 1980s, when Harvard researcher Dr. Daniel Cramer began reporting a link between talc use for feminine hygiene and ovarian cancer. The FDA maintains that research about the dangers of daily use is inconclusive.
Regardless, an estimated 5,000 people have sued Johnson & Johnson over its marketing of talcum powder. The women suing say that they developed ovarian cancer after using talc daily and argue that the company knew of a link between ovarian cancer and talc use for decades. Johnson & Johnson has already had to pay out a total of $307.6 million in damages to plaintiffs who won their cases. On August 21, jurors shattered that record with their $417 million judgement to Eve Echeverria.
“Ms. Echeverria is dying from this ovarian cancer," her attorney told CNBC, "and she said to me all she wanted to do was to help the other women throughout the whole country who have ovarian cancer for using Johnson & Johnson for 20 and 30 years."
Johnson & Johnson has pledged to appeal the verdict, as it has previous cases. The company has not yet returned inquiries from ConsumerAffairs about whether it is reevaluating its overall approach to gynecological health.
In response to the litigation, the company launched its own website to defend the safety of talcum powder. “Multiple scientific and regulatory reviews have determined that talc is safe for use in cosmetic products and the labeling on Johnson’s Baby Powder is appropriate,” Johnson & Johnson says in a statement.
https://www.consumeraffairs.com/news/the-many-women-suing-johnson-johnson-083017.html
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