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Ethicon Media Monitoring 4/25/2017
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C.R. Bard Sold $24 Billion, Transvaginal Mesh Maker With 15k lawsuits
Apr 24, 2017 | Mesh Medical Device Newsdesk
Sunday it was announced that Becton Dickinson (BD) and Company (NYSE BDX) will acquire C.R. Bard for $317.00 per common share in cash and stock. The agreement totals $24 billion. -
Cisson Case Tests Georgia’s Punitive Damages
Apr 24, 2017 | Mesh Medical Device Newsdesk
The Cisson v. C.R. Bard case resulted in a windfall for Georgia’s state treasury, not for Cisson. -
Why does the medical establishment fail to take women in pain seriously?
Apr 24, 2017 | New Statesman
By Anjuli Shere
Claire Cooper’s voice wavered as she told the BBC interviewer that she had thought of suicide, after her mesh implant left her in life-long debilitating pain. “I lost my womb for no reason”, she said, describing the hysterectomy to which she resorted in a desperate attempt to end her pain. She is not alone, but for years she was denied the knowledge that she was just one in a large group of patients whose mesh implants had terribly malfunctioned. -
Vaginal mesh implants: why over 800 women are suing the NHS over ‘barbaric’ treatment
Apr 24, 2017 | Lexology
By Kingsley Napley
News broke this week that hundreds of women were suing the NHS and the manufacturers of vaginal mesh implants after facing serious health complications. Women have been left unable to walk, work or have sex as a result of the treatment, with many sufferers claiming they were never informed of the potential dangers before having the mesh fitted. -
Vaginal tape scandal: 800 women take legal action against NHS
Apr 24, 2017 | Shemazing
Over 800 women in the UK are to take legal action against the NHS and the makers of the vaginal mesh implants used by the health service. -
The Round Up: Immigration Appeals, Vaginal Mesh, and Farage and Defamation
Apr 24, 2017 | UK Human Rights Blog (blog)
By Sarah Janeewart
More than 800 women are involved in suits over the product liability of vaginal mesh, a surgical implant used to treat prolapse and incontinence.
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C.R. Bard Sold $24 Billion, Transvaginal Mesh Maker With 15k lawsuits
Apr 24, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, April 24, 2017 ~ C.R. Bard to be sold for $24 billion.
Sunday it was announced that Becton Dickinson (BD) and Company (NYSE BDX) will acquire C.R. Bard for $317.00 per common share in cash and stock. The agreement totals $24 billion.
As was the case when AMS was sold to Endo International, the acquiring company generally buys the liability or outstanding lawsuits as well.
In this case, C.R. Bard is facing 15,363 lawsuits (with 8,747 closed) over allegedly defective transvaginal mesh products, filed in multidistrict litigation MDL #2187. (Here)
Additionally there is a New Jersey state MDL with 130 remaining cases on the docket, according to a status report (here) issued in April. (Master Docket No. BER-L-17717-14, Superior Court of New Jersey, Bergen Co.)
The New Jersey Pelvic Mesh Cases are listed here and includes thousands of cases filed against another New Jersey company, Johnson & Johnson (Ethicon).
Becton Dickinson, a Franklin Lakes, N.J.- based medical device giant, offers products to treat diabetes, anesthesia care and diagnostics. BD announced it would improve its ability to offer products that reduce the chance of hospital-acquired infections. Bard offers devices in urology, oncology and vascular.
The deal should be closed this fall and USA Today reports, after regulatory and shareholder approval. This is the fourth largest acquisition of the year and the largest in the U.S.
Together the companies have about $16 billion in annual revenues and 65,000 employees. BD hopes to accelerate growth into China and internationally.
Bard’s CEO will join BD’s board of directors.
OUTSTANDING LIABILITIES
C.R. Bard faced its first bellwether case in August 2013 with the D. Cisson trial. MND story here.
Cisson was awarded $2 million by a Charlest0n, WV jury. That case was precedent setting because it was the first in a decade to allow the state of Georgia to collect 75% of the punitive damage award of $1.75 million. In 1987, Georgia added that provision as part of tort reform in 1987, to discourage lawsuit.
On January 20, 2015, Judge Goodwin denied the plaintiffs’ motion to declare that Georgia’s law regarding punitive damages unconstitutional. ion of 1987.
Bard also wanted punitive damages reduced from $1.7 million to $250,000. That too was denied.
In 2015, Bard agreed to settle 3,000 mesh cases for $200 million. In 2014, Bard agreed to a $21 million settlement to resolve 500 defective product lawsuits.
Bard, based in Georgia, manufactures various medical devices including:
Avaulta Plus™ BioSynthetic Support System
Avaulta Solo™ Synthetic Support System
Faslata® Allograft
Pelvicol® Tissue
PelviSoft® Biomes
Pelvitex™ Polypropylene Mesh
**This story is in production and will be altered as information comes in**
http://www.meshmedicaldevicenewsdesk.com/c-r-bard-sold-24-billion-transvaginal-mesh-maker-15k-lawsuits/
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Cisson Case Tests Georgia’s Punitive Damages
Apr 24, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, April 24, 2017 ~ The Cisson v. C.R. Bard case resulted in a windfall for Georgia’s state treasury, not for Cisson.
Tort reform came in Georgia in 1987. The Georgia Tort Reform Act was launched by Big Business, such as tobacco and asbestos, to curtail plaintiff victories in court.
The Daily Record (here) reports tort form in Georgia led to an act that would curtail the awarding a punitive damages, known as the split-recovery law.
Georgia has the highest split-recovery laws in the country.
Cisson was implanted with a Bard Avaulta pelvic mesh. In August 2013, a jury in Charleston, West Virginia awarded her $2 million in August 2013. That included $250,000 in compensatory damages and $1.75 million in punitive damages.
Under state statute, anyone who received compensatory and punitive damages, set to punish the company for bad behavior, would have to share 75% of the punitive damages with the state. It was the first time in 10 years, the split-recovery statute was enacted.
Georgia’s Treasury received nearly $800,000, the portion of punitive damages minus the costs of litigation and attorney’s fees.
The Daily Record reports the verdict was appealed by both sides, with Cisson arguing that the provision requiring her to relinquish 75 percent of the punitive damages to the state amounted to an unconstitutional taking.
“Cisson contends that she has a vested property interest in the entire punitive damages award, but, in the scant briefing she has provided to this Court on the issue, she has failed to articulate a viable theory in support of that contention,” said the Jan. 14 opinion.
In a case decided in January, Senior Assistant Attorney General Julie Adams successfully defended the law’s constitutionality in the Fourth Circuit Court of Appeals.
In the last 30 years, a dozen states have adopted split-recovery statutes.
A variation of split-recovery is “curative damages” where a portion of the punitive recovery is distributed to some charity.
Both sides the statute encourages both sides to settle. The company found liable does not want to have punitive damages on its record and plaintiffs do not want to hand over a chunk of money to the state.
But that didn’t happen in the Cisson case, which was paid earlier this year, becoming just one of four cases that has gone to trial and survived an appeal. ###
http://www.meshmedicaldevicenewsdesk.com/cisson-case-tests-georgias-punitive-damages/
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Why does the medical establishment fail to take women in pain seriously?
Apr 24, 2017 | New Statesman
By Anjuli Shere
Claire Cooper’s voice wavered as she told the BBC interviewer that she had thought of suicide, after her mesh implant left her in life-long debilitating pain. “I lost my womb for no reason”, she said, describing the hysterectomy to which she resorted in a desperate attempt to end her pain. She is not alone, but for years she was denied the knowledge that she was just one in a large group of patients whose mesh implants had terribly malfunctioned.
Trans-vaginal mesh is a kind of permanent “tape” inserted into the body to treat stress urinary incontinence and to prevent pelvic organ prolapse, both of which can occur following childbirth. But for some patients, this is a solution in name only. For years now, these patients – predominantly women – have been experiencing intense pain due to the implant shifting, and scraping their insides. But they struggled to be taken seriously.
The mesh implants has become this month's surgical scandal, after affected women decided to sue. But it should really have been the focus of so much attention three years ago, when former Scottish Health Secretary Alex Neil called for a suspension of mesh procedures by NHS Scotland and an inquiry into their risks and benefits. Or six years ago, in 2011, when the US Food and Drug Administration revealed that the mesh was unsafe. Or at any point when it became public knowledge that people were becoming disabled and dying as a result of their surgery.
When Cooper complained about the pain, a GP told her she was imagining it. Likewise, the interim report requested by the Scottish government found the medical establishment had not believed some of the recipients who experienced adverse effects.
This is not a rare phenomenon when it comes to women's health. Their health problems are repeatedly deprioritised, until they are labelled “hysterical” for calling for them to be addressed. As Joe Fassler documented for The Atlantic, when his wife's medical problem was undiagnosed for hours, he began to detect a certain sexism in the way she was treated:
“Why”, I kept asking myself, when reading his piece, “are they assuming that she doesn’t know how much pain she’s feeling? Why is the expectation that she’s frenzied for no real reason? Does this happen to a lot of women?”
This is not just a journalist's account. The legal study The Girl Who Cried Pain: A Bias Against Women in the Treatment of Pain found that women report more severe levels of pain, more frequent incidences of pain, and pain of longer duration than men, but are nonetheless treated for pain less aggressively.
An extreme example is “Yentl Syndrome”. This is the fact that half of US women are likely to experience cardiovascular disease and exhibit different symptoms to men, because male symptoms are taught as ungendered, many women die following misdiagnosis. More often than should be acceptable, female pain is treated as irrelevant or counterfeit.
In another significant case, when the news broke that the most common hormonal birth control pill is heavily linked to a lower quality of life, many uterus-owning users were unsurprised. After all, they had been observing these symptoms for years. Social media movements, such as #MyPillStory, had long been born of the frustration that medical experts weren’t doing enough to examine or counter the negative side effects. Even after randomised trials were conducted and statements were released, nothing was officially changed.
Men could of course shoulder the burden of birth control pills - there has been research over the years into one. But too many men are unwilling to swallow the side effects. A Cosmopolitan survey found that 63 per cent of men would not consider using a form of birth control that could result in acne or weight gain. That’s 2 per cent more than the number who said that they would reject the option of having an annual testicular injection. So if we’re taking men who are afraid of much lesser symptoms than those experienced by women seriously, why is it that women are continually overlooked by health professionals?
These double standards mean that while men are treated with kid gloves, women’s reactions to drugs are used to alter recommended dosages post-hoc. Medical trials are intended to unearth any potential issues prior to prescription, before the dangers arise. But the disproportionate lack of focus on women’s health issues has historically extended to medical testing.
In the US, from 1977 to 1993, there was a ban on “premenopausal female[s] capable of becoming pregnant” participating in medical trials. This was only overturned when Congress passed the National Institutes of Health (NIH) Revitalisation Act, which required all government funded gender-neutral clinical trials to feature female test subjects. However, it was not until 2014 that the National Institutes of Health decreed that both male and female animals must be used in preclinical studies.
Women’s exclusion from clinical studies has traditionally occurred for a number of reasons. A major problem has been the wrongful assumption that biologically women aren’t all that different from men, except for menstruation. Yet this does not take into account different hormone cycles, and recent studies have revealed that this is demonstrably untrue. In reality, sex is a factor in one’s biological response to both illness and treatment, but this is not as dependent on the menstrual cycle as previously imagined.
Even with evidence of their suffering, women are often ignored. The UK Medicines and Healthcare Regulatory Agency (MHRA) released data for 2012-2017 that shows that 1,049 incidents had occurred as a result of mesh surgery, but said that this did not necessarily provide evidence that any device should be discontinued.
Yes, this may be true. Utilitarian thinking dictates that we look at the overall picture to decide whether the implants do more harm than good. However, when so many people are negatively impacted by the mesh, it prompts the question: Why are alternatives not being looked into more urgently?
The inquiry into the mesh scandal is two years past its deadline, and its chairperson recently stepped down. If this isn’t evidence that the massive medical negligence case is being neglected then what is?
Once again, the biggest maker of the problematic implants is Johnson&Johnson, who have previously been in trouble for their faulty artificial hips and – along with the NHS – are currently being sued by over 800 mesh implant recipients. A leaked email from the company suggested that the company was already aware of the damage that the implants were causing (Johnson&Johnson said the email was taken out of context).
In the case of the mesh implants slicing through vaginas “like a cheese-wire”, whether or not the manufacturers were aware of the dangers posed by their product seems almost irrelevant. Individual doctors have been dealing with complaints of chronic or debilitating pain following mesh insertions for some time. Many of them just have not reported the issues that they have seen to the MHRA’s Yellow Card scheme for identifying flawed medical devices.
Shona Robison, the Scottish Cabinet Secretary for Health and Sport, asked why the mesh recipients had been forced to campaign for their distress to be acknowledged and investigated. I would like to second her question. The mesh problem seems to be symptomatic of a larger issue in medical care – the assumption that women should be able to handle unnecessary amounts of pain without kicking up a fuss. It's time that the medical establishment started listening instead.
http://www.newstatesman.com/politics/feminism/2017/04/why-does-medical-establishment-fail-take-women-pain-seriously
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Vaginal mesh implants: why over 800 women are suing the NHS over ‘barbaric’ treatment
Apr 24, 2017 | Lexology
By Kingsley Napley
News broke this week that hundreds of women were suing the NHS and the manufacturers of vaginal mesh implants after facing serious health complications. Women have been left unable to walk, work or have sex as a result of the treatment, with many sufferers claiming they were never informed of the potential dangers before having the mesh fitted.
The BBC’s Victoria Derbyshire program ran an exclusive feature on the legal action, sharing the stories of many women that have been left in permanent, debilitating pain. As clinical negligence solicitors, we find it extremely encouraging to see high profile coverage of this important issue. It not only spreads awareness of the dangers of mesh implants to a wider audience, but we hope talking about these issues will help dispel the stigma surrounding injuries of this kind.
So, what is a vaginal mesh implant?
A vaginal mesh is a purely synthetic net material used in the placement of a weak connective tissue or ligaments, suspending the vagina and the uterus. The treatment is common in the UK, with more than 92,000 women receiving a vaginal mesh between April 2007 and March 2015 in England alone. The implants are used by surgeons to treat pelvic organ prolapse and incontinence in women, two conditions which commonly occur after childbirth.
As discussed in our previous blog on ‘Stopping the Stigma of Childbirth injuries,’ many women find it difficult to talk about the injuries they incur in childbirth and complications with vaginal meshing is no different. Many can feel too uncomfortable or embarrassed to find out what might be causing their symptoms.
Unfortunately, even those who did seek help from medical professionals found that they were not being listened to. One sufferer, who began to experience pain three years after giving birth to her first child, had her womb removed at the age of 39 after doctors believed it to be the source of her pain. When she went back to her GP after the operation with continuing pain, she was told she was ‘imagining it.’ The severity of the pain, coupled with the lack of understanding and support, resulted in the woman having suicidal thoughts. She told the BBC “This stuff breaks up marriages. I wouldn’t at all be surprised if there are mesh-injured women that have taken their own lives and didn’t know what the problem was.”
Despite data collected by the Medicines and Healthcare products Regulatory Agency (MHRA) showing more than 1,000 adverse incidents related to the mesh had been reported in the last five years, the regulator continued to say that ‘the figures did not necessarily indicate a fault with any device.’ While they claimed to ‘sympathise’ with women who had suffered complications, none of the 100 different types of vagina mesh implants available on the NHS have been recalled.
Lawsuits in the US have seen around £2 billion being paid out to women affected by vaginal mesh implants. If the women in the UK are successful in their legal action, experts have anticipated the NHS could have to pay out tens of millions of pounds of compensation. However, this alone will not address the issue and cannot reverse the pain and suffering that so many women have gone through. Many women remain unsure what symptoms to expect after the procedure, it is vital that women are aware of the risks and should not hesitate to seek help if they experience any pain or discomfort.
http://www.lexology.com/library/detail.aspx?g=4bb2fe88-3781-4ec9-9035-b1a0d05f817a
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Vaginal tape scandal: 800 women take legal action against NHS
Apr 24, 2017 | Shemazing
Over 800 women in the UK are to take legal action against the NHS and the makers of the vaginal mesh implants used by the health service.
Transvaginal tape is a plastic mesh used by the NHS to treat women who suffer from stress incontinence (unintentional loss of urine) and pelvic organ prolapses, symptoms often suffered by women post child birth.
The mesh strip is cut to size and placed through the vagina or abdomen during a supposedly simple 20-minute procedure. 92,000 women underwent the surgery in the UK between April 2007 and March 2015.
For a lot of women the experience is positive and the insert works to alleviate those taboo symptoms with no adverse side effects.
However, the same can’t be said for every woman. According to the BBC, 800 women in the UK are suing the NHS and the manufactures of the inserts after they experienced chronic pain following the procedure.
Struggling to urinate, plastic cutting through the virginal wall and an inability to have sex or use tampons were just some of the symptoms reported by these women.
One of these women, Kath Sansom, spoke to the-pool.com about her experience saying, “If this hadn’t happened to me, and someone told me about it, I’m not sure I would have believed them. It’s like a bizarre horror story.”
Before having the surgery, Kath was and extremely active diver and cyclist.
However, the intense pain that Kath has suffered as a result, left her unable to run or even kneel down for any extended period of time.
Despite having the device removed, she is still unable to live the active lifestyle she was so fond of before entering the operating theatre that day.
According to Kath, the problem with the mesh insert is that it shrinks and erodes once inside the body.
“It should remain the same until the patient dies. But there are studies which show this fabric can shrink, and twist and the edges can fold, it can degrade and have fragments drop off, and it can go brittle or really hard.”
She also claimed that women are often ill-informed about the potential risks of the procedure, and believes no one will take the issue seriously.
“Still surgeons are purporting that the surgery is more beneficial than risky. But what we should be doing, instead of rushing women into procedures like this, which are obviously not working well enough, is looking towards preventative measures. ‘’
Of course, Kath’s story is just one of many.
The scandal involves over 800 effected women who will take legal action against the NHS in an effort to have the mesh tape banned for good.
http://www.shemazing.net/vaginal-tape-scandal-sees-800-women-take-legal-against-the-nhs/
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The Round Up: Immigration Appeals, Vaginal Mesh, and Farage and Defamation
Apr 24, 2017 | UK Human Rights Blog (blog)
By Sarah Janeewart
VAGINAL MESH
More than 800 women are involved in suits over the product liability of vaginal mesh, a surgical implant used to treat prolapse and incontinence. The campaign group Sling the Mesh says that the procedure takes an average of twenty minutes, and is unusual in that it is performed ‘blind’, without the use of key hole cameras. Women have been left in life-changing agony, the Guardian reports, unable to have sex, with one woman reportedly considering suicide. The problem has been that in some such cases surgeons have been unable to operate to remove the tape, owing to its proximity to the nerve. Campaigners say that this is an unacceptable risk.
The scandal intensified this week when minutes were released from a meeting between the Medicines and Healthcare Products Regulatory Agency and NHS England in October 2016, showing that efforts were being made to ‘avoid media attention’ on the vaginal mesh.
Lawsuits over the implant have amassed billions of dollars in the US. The product was retracted from use in Scotland in 2014 but has been recently reinstated, and India has just started using it in procedures. Leigh Day is investigating a potential suit here.
https://ukhumanrightsblog.com/2017/04/24/the-round-up-immigration-appeals-vaginal-mesh-and-farage-and-defamation/
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