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Ethicon Media Monitoring 6/20/17
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Bard Settles 75 More Suits In Pelvic Mesh MDL
Jun 20, 2017 | Law 360
By Rachel Graf
A West Virginia federal judge agreed Monday to toss dozens of suits against medical technologies manufacturer C.R. Bard Inc. in multidistrict litigation over injuries allegedly caused by pelvic mesh implants, saying all the claims have been “compromised and settled” for an undisclosed amount. -
Incontinence: not such a wee problem for women
Jun 19, 2017 | Irish Times
By Danielle Barron
There’s a short clip to be found on YouTube entitled “If female incontinence ads were honest”. The supplanting of the typical motivational messages of conventional advertisements for incontinence pads with brutal honesty about the reality of their use is mildly amusing, maybe especially so for those of you who have to fork out for these products and retain a sense of humour. -
J&J Granted Mistrial in Latest Talc Case in MO.
Jun 19, 2017 | Mesh Medical Device Newsdesk
Johnson & Johnson has been granted a mistrial in its latest multi-plaintiff talcum powder/ ovarian cancer trial.
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Bard Settles 75 More Suits In Pelvic Mesh MDL
Jun 20, 2017 | Law 360
By Rachel Graf
Law360, New York (June 19, 2017, 5:39 PM EDT) -- A West Virginia federal judge agreed Monday to toss dozens of suits against medical technologies manufacturer C.R. Bard Inc. in multidistrict litigation over injuries allegedly caused by pelvic mesh implants, saying all the claims have been “compromised and settled” for an undisclosed amount.
U.S. District Judge Joseph R. Goodwin dismissed with prejudice 75 suits, the latest round of dismissals after thousands of cases claiming Bard sold defective mesh products were consolidated in West Virginia.
Bard is just one of several companies that have been sued for allegedly making mesh surgical products for stress urinary incontinence and pelvic organ prolapse that caused severe injuries. Thousands of suits have been filed against companies including Johnson & Johnson’s Ethicon unit and Boston Scientific as well.
Bard was hit with a $2 million verdict in August 2013 in a suit brought by Donna Cisson, who alleged that its Avaulta Plus Posterior BioSynthetic Support System caused serious internal injuries. The jury awarded her $1.75 million in punitive damages on top of a $250,000 compensatory award, holding that the device maker had shown a conscious indifference to patient consequences in developing the product.
Bard also failed to convince the jury that Cisson knew and understood the dangers of having the Avaulta Plus product implanted when she consented to the procedure and knowingly assumed those risks, according to the verdict reached after a 13-day trial.
The company appealed the decision to the Fourth Circuit, which sided with Cisson in 2016, saying the trial court appropriately determined which evidence to exclude.
The U.S. Food and Drug Administration has reclassified pelvic mesh devices like those at issue in the suits as high-risk devices that must undergo the agency's most stringent safety evaluation before being put on the market.
Counsel for Bard and the women didn’t respond Monday to requests for comment.
Bard is represented by Richard B. North Jr. of Nelson Mullins Riley & Scarborough LLP.
The women are represented by Anne M. Tarvin of Bartimus Frickleton and Robertson PC, Andrew J. Cross, Jeffrey J. Lowe and Sarah Shoemake Doles of Carey Danis & Lowe, M. Brandon Smith and C. Andrew Childers of Childers Schlueter & Smith LLC and Joel L. Dilorenzo of The Dilorenzo Law Firm LLC, among others.
The case is In Re: C.R. Bard Inc. Pelvic Repair Systems Product Liability Litigation, case number 2:10-md-02187, in U.S. District Court for the Southern District of West Virginia.
-- Additional reporting by Emily Field and Andrew Scurria.https://www.law360.com/articles/936214/bard-settles-75-more-suits-in-pelvic-mesh-mdl
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Incontinence: not such a wee problem for women
Jun 19, 2017 | Irish Times
By Danielle Barron
There’s a short clip to be found on YouTube entitled “If female incontinence ads were honest”. The supplanting of the typical motivational messages of conventional advertisements for incontinence pads with brutal honesty about the reality of their use is mildly amusing, maybe especially so for those of you who have to fork out for these products and retain a sense of humour. Just allow yourself a grim smile though – a hearty chuckle may cause problems.
The market is booming for adult incontinence products, and marketers say a big reason for this is the huge spike in sales among women aged between 30 and 50. Stateside, manufacturers are even dropping their elderly spokespeople for models in their 40s, having developed more discreet products for what they see as a more physically active generation in need of protection. In fact, some estimates suggest the market for adult incontinence garments could equal that of babies’ nappies within just a decade.
Estimates put the proportion of Irish women who suffer with at least some leakage at more than 50 per cent, and it is thought that at least a third of younger women are affected at some stage, typically after childbirth. As we become an increasingly overweight society, obesity is also becoming a major cause of urinary incontinence among younger women.
And yes, it’s a sexist problem; women are thought to be up to six times more likely to experience bladder leaks than men. The effect of this on quality of life should not be underestimated.
Perhaps unsurprisingly, a recent US study published in the journal Sexual Medicine found that women with urinary incontinence were more likely to be sexually abstinent than continent women. “Women with urinary incontinence showed less sexual desire, sexual comfort, and sexual satisfaction than their counterparts, despite having a similar frequency of sexual activity,” according to the researchers.
Many women will accept that some degree of leakage is normal, particularly after childbirth. For older generations, the problem simply wasn’t discussed, meaning many women suffered in silence.
Yet this taboo is slowly being broken, says physiotherapist Maeve Whelan. Whelan is a specialist chartered physiotherapist in private practice in Dublin with over 25 years’ experience in treating women’s health conditions, such as bladder and bowel dysfunction, pelvic organ prolapse, and overactive pelvic floor disorders. She tells Health Plus that women are finally opening up about their pelvic floor problems and learning that there are a plethora of treatment options, from lifestyle changes to surgery.
“I think women are standing for less, and that has a lot to do with there being more openness. It’s not like our grandparents’ time, when issues like this would have been kept very much to themselves. The younger generation are much more open about sexuality and body issues. Women are egging each other on not to just put up with symptoms and to go and see someone or do something about it.”Hectic pace
Another factor is the hectic pace of modern life, and Whelan says today’s women are far too busy to tolerate the inconvenience of leaking when they laugh.
“Women don’t have time to have this problem. In addition, lots of women are really into exercise now and they don’t want this to stop them exercising. They know they need to exercise for their mental and physical health and they just aren’t willing to take it anymore.”
Pregnancy, menopause and obesity are all conditions that can lead to some form of urinary incontinence. Yet this doesn’t cover everyone – Whelan says she has helped treat girls in their teens and 20s who have been lifelong sufferers. And exercise comes into play again – ironically, some younger women are presenting with the problem due to overtraining.
“They are doing too much boot camp-type exercise, and overdoing pilates, and overdoing it to the point where their pelvic floor muscles are just far too tight and that over activity also leads to problems,” she explains.
And while an increasing number of women are aware of their pelvic floor, up to 50 per cent of women are doing the exercises incorrectly or sub-optimally, says Whelan. “The research has shown that, and this can instead be completely detrimental to the whole continence process.”Pelvic floor training
Proper pelvic floor training can take four to six months to complete, but results will be seen much sooner than that. “We teach women what we call “the knack”, where they learn the right way to contract when they are sneezing or coughing, or lifting their child, or anything that increases intra-abdominal pressure, improvements in continence will begin to take place immediately. This has been borne out in the research.”
This means it is essential to assess a woman in order to ascertain whether she is doing the exercises (or able to do them) correctly. Whelan explains that this may necessitate an internal vaginal examination to assess the level of pelvic floor contraction. “There are grades of strength; grade 1 is that you can just about feel a flicker, 2 is that they can actually contract, but not against gravity, 3 is they can contract against gravity, 4 is that they can squeeze against gravity and resistance, while 5 is the maximum squeeze,” she outlines, adding that a programme of pelvic floor exercises is then given to women to be carried out multiple times each day.
“However, if there is nothing happening, if a woman is at grade 1 or 2, then there is no point giving them such a programme as it can be soul-destroying for the women to work hard at this with no results. At this stage they need additional help.”
That’s where electrical stimulation devices come in, Whelan says. “These can be hugely helpful for these women, where an external or internal unit can passively make the muscles contract and thus strengthen them. This will get the muscles going and they can get on with their strengthening exercises then at a later stage.”
There are two main types of urinary incontinence; stress incontinence, where abdominal pressure will cause leakage, and urge incontinence, where there is over activity of the bladder muscle itself. If pelvic floor training and/or electrical stimulation do not work for stress incontinence, then surgery may have to be considered, says Whelan. “This known as TVT [trans vaginal tape] surgery, and it acts like a sling for the urethra. It’s a short procedure and many surgeons in Ireland are carrying this out successfully but obviously it is surgery, and not everyone will want to go down that route.”Effective drugs
She also advises that there are now effective drugs available for urge incontinence. “If someone has been suffering from urge incontinence, with a strong feeling of urgency of having to go to the toilet the whole time, then these medications can be life changing. We would always advise some lifestyle changes in conjunction with this, such as watching coffee and water intake. Bladder training is also key, where they learn to delay trips to the toilet by using relaxation or distraction techniques.”
Yet what if all this doesn’t work for sufferers of urge incontinence? Whelan advises that there are some “end-of-the-line” treatments that can then be employed. One of these is sacral nerve stimulation, which involves the implantation of a programmable device into the buttock. “This delivers a kind of calming effect to the bladder, and can be hugely helpful for people with incontractable bladder urge.”
Back to the booming market for female incontinence products. Surely these aren’t an ideal solution? Whelan says she believes the growth in sales is due to the number of women not willing to forgo their exercise regime. “I am seeing women coming in from their teens to their 80s and they don’t want to stop exercising, even if it is just going for a walk. In this case, the only solution may be to buy pads while they are waiting for other treatment options to kick in. I have had so many women tell me that when they’ve finished their physiotherapy, or had surgery, or taken medication, the biggest satisfaction for them is never having to walk down the supermarket aisle where the incontinence pads are ever again.”
https://www.irishtimes.com/life-and-style/health-family/incontinence-not-such-a-wee-problem-for-women-1.3114009
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J&J Granted Mistrial in Latest Talc Case in MO.
Jun 19, 2017 | Mesh Medical Device Newsdesk
Mesh News Desk, June 19, 2017 ~ Johnson & Johnson has been granted a mistrial in its latest multi-plaintiff talcum powder/ ovarian cancer trial.
This story is breaking and more information will become available. In St. Louis, Johnson & Johnson requested a mistrial be declared in its latest talcum powder trial. Judge Rex M. Burlison agreed and granted the defense motion late this afternoon.
The case was entering its seventh day in the 22nd Circuit Court for the City of St. Louis. In this case, several plaintiffs, all users of Johnson & Johnson’s talcum powder in their genital area, were diagnosed with ovarian cancer.
The prior cases in this venue have been single plaintiff.
Johnson & Johnson has insisted that there is not enough evidence to link the use of its Shower-to-Shower powder and Baby Powder to ovarian cancer. Plaintiff content the company knew and failed to warn users of the potential.
The event that sparked this mistrial is this morning’s U.S Supreme Court decision on jurisdiction.Johnson & Johnson had lost five trials in this St. Louis court over its talcum powder products.
J&J wanted to change this defendant-unfriendly venue. In the case of Jacqueline Fox and Gloria Ristesund, who were awarded $72 million and $55 million respectively, J&J claimed they were not residents of Missouri and had not used any of the products in Missouri. They were from Alabama and South Dakota. j&J argued that a Missouri court lacked personal jurisdiction for the non-resident plaintiffs who claimed manufacturing defect and design defect..
The counter argument is that if Johnson & Johnson didn’t want to be held liable for injuries in Missouri, it should never have sold its products in Missouri.
St. Louis University Law Journal has more on the legal aspects here.
The Supreme Court today agreed with J&J and slapped limits on where injury lawsuits may be filed, a move sure to impact plaintiffs’ lawyers nationally.
The St. Louis Post-Dispatch here reports in the 8-1 ruling, the justices overturned a lower court ruling that allowed out of state plaintiffs suing Bristol-Myers Squibb over its Plavix to sue the company in California. The justices ruled state courts cannot hear claims where the alleged injury did not occur or where the company defendant is not based.
Interesting in this case is that St. Louis Circuit Judge Rex Burlison declared the mistrial even though one of the plaintiffs is a St. Louis area man, who was suing on behalf of his late wife.
The newspaper reports the high court ruling could wipe out six previous verdicts from trials held in St. Louis, which resulted in more than $300 million in verdicts for plaintiffs.
This story is in production.
BACKGROUND
Mesh Medical Device News Desk, June 5, 2017 ~ The first trial involving multiple plaintiffs over J&J’s talcum powder and its link to ovarian cancer begins today in a St. Louis courtroom.
J&J is back in a St. Louis courtroom today, reports DrugWatch, facing three plaintiffs defending itself against charges that long-term use of its talcum powder causes ovarian cancer.
This is the first multi-plaintiff trial in St. Louis over the risks of using talcum powder and will be covered by Courtroom View Network.
The three plaintiffs are Michael Blaes (on behalf of his wife), Savanna Crews and Darlene Evans, all of whom died from ovarian cancer. Plaintiffs contend that long term use of Johnson & Johnson’s talcum powder, both baby powder and/ or Shower to Shower caused their ovarian cancer.
A pre-trial conference will be held Monday, June 5, and depending on the outcome, jury selection will begin Tuesday.
This same courthouse has been the venue for five unsuccessful talcum powder trials for Johnson & Johnson.
May 2017- Jury award of $110 million in compensatory and punitive damages. Lois Slemp, 62 of Virginia used baby powder and Shower to Shower for more than 40 years. Her ovarian cancer, diagnosed in 2012, has spread. See MND coverage here.
March 2017 – Jury ruled in favor of J&J. Plaintiff Nora Daniels, 55, was awarded nothing. MND coverage here.
October 2016 – Johnson & Johnson paid nearly $70 million to Deborah Giannecchini, 63, co-defendant ordered to pay $2.5 million. She was diagnosed with stage 4 ovarian cancer. One jurors told Bloomberg Newsabout J&J, “It seems like they didn’t care.” An appeal is planned. See MND coverage here.
May 2016 – J&J ordered to pay $55 million in compensatory and punitive damages to Gloria Ristesund. She used J&J powder for feminine hygiene for about 40 years. J&J should have put a warning on this product, said one juror.
February 2016 – Jackie Fox, 62, was awarded $72 million. She died of ovarian cancer in 2015. MND story here.
J&J insists the research on the link between ovarian cancer and talcum powder is inconclusive. There are more than 1,000 similar lawsuits filed around the country.
Beasley Allen law firm had headed the litigation on behalf of plaintiffs.
Courtroom View Network will cover the trial.
The pending Missouri trial is captioned Swann, et al. v. Johnson & Johnson, et al., No. 1422-CC09326-01, in Missouri’s 22nd Circuit Court in St. Louis.
http://www.meshmedicaldevicenewsdesk.com/jj-granted-mistrial-latest-talc-case-mo/
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