Preview Newsletter
Ethicon Media Monitoring 10/04/16
-
Boston Scientific Can't Escape $14.3M Mesh Defect Verdict
Oct 3, 2016 | Law 360
By Brandon Lowrey
A West Virginia federal judge on Monday rejected Boston Scientific Corp.'s bid to overturn a $14.3 million verdict awarded to three plaintiffs in a trial over injuries allegedly caused by its Obtryx pelvic mesh devices, saying the verdict was supported by evidence and law. -
Hundreds of women left with health in ruins after bladder mesh ops, so why is treatment still offered?
Oct 3, 2016 | Mirror
By Kelly Strange
When Kim Vallis was offered what she thought would be a quick and easy solution to the embarrassment of stress incontinence, she was delighted.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Boston Scientific Can't Escape $14.3M Mesh Defect Verdict
Oct 3, 2016 | Law 360
By Brandon Lowrey
A West Virginia federal judge on Monday rejected Boston Scientific Corp.'s bid to overturn a $14.3 million verdict awarded to three plaintiffs in a trial over injuries allegedly caused by its Obtryx pelvic mesh devices, saying the verdict was supported by evidence and law.
U.S. District Judge Joseph R. Goodwin's decision upholds the November 2014 verdict after Boston Scientific challenged it last year. Goodwin rejected the company's contentions, which included that the jury's decision went against the weight of the evidence and that flawed closing arguments and jury instructions tainted the verdict.
"Indeed, the remedies of a directed verdict or a new trial should be applied only in exceptional circumstances," the judge wrote. "[Boston Scientific] has failed to show that such circumstances exist here."
The decision upholds a 2014 jury verdict reached after 10 days of trial. Jurors sided with plaintiffs Jacquelyn Tyree, Carol Sue Campbell, Jeanie Blankenship and Chris Rene Wilson on their claims that Boston Scientific's Obtryx Transobturator Mid-Urethral Sling System was defectively designed and that its warnings about potential injuries arising from the devices were insufficient.
Boston Scientific ultimately settled Tyree's case but urged the court to grant it judgment or a new trial against the other three defendants.
Among the issues that Boston Scientific raised was the plaintiffs' counsel Scott Love's use of a "golden rule" argument during closing arguments. The attorney essentially urged jurors to put themselves in the plaintiffs' shoes, Boston Scientific argued.
Arguing for jurors to substitute sympathy for judgment is typically off-limits, and the defendants objected.
However, the court said that Love specifically framed his arguments in terms of himself, and not the jurors. For instance, he described the effects of the women's injuries on their love lives and added, "But it’s knowing that you can’t provide for that person the way that all of your friends do, the way that your neighbors do, the way that everybody else in this courtroom can," according to the order.
Love's use of the word "you" was not a specific reference to jurors, the judge said in his order.
"I find that Mr. Love used the word 'you' in an impersonal sense, which is not error," he wrote.
He added that the trial judge's jury instructions specified that verdicts must be based solely on evidence and the law.
The 2014 verdict wasn't the only heavy defeat that Boston Scientific suffered.
In October, Boston Scientific reached a deal with a couple who won a $34.5 million judgment in Texas state court holding the company liable for making defective pelvic mesh, as well as settling a “substantial number” of other pelvic mesh cases. Terms of the settlement were not disclosed. The couple, Martha and Felix Salazar, had won a $73 million jury verdict in 2014, including $50 million in punitive damages, that was reduced by the trial court in its final judgment.
Representatives for the parties could not immediately be reached for comment late Monday.
The plaintiffs are represented by Scott Love of Clark Love & Hutson and Doug Monsour of the Monsour Law Firm.
Boston Scientific is represented by Eric M. Anielak, Jon A. Strongman, Matthew D. Keenan and Robert T. Adams of Shook Hardy & Bacon LLP, and Lindsey M. Saad and Michael Bonasso of Flaherty Sensabaugh & Bonasso.
The case is Carol Sue Campbell et al. v. Boston Scientific Corp., case number 2:12-cv-08633, in the U.S. District Court for the Southern District of West Virginia.
--Additional reporting by Sindhu Sundar. Editing by Aaron Pelc.http://www.law360.com/articles/847744/boston-scientific-can-t-escape-14-3m-mesh-defect-verdict
-
Oct 3, 2016 | Mirror
By Kelly Strange
Kim Vallis is just one of the many women left with health problems after receiving the increasingly controversial surgery for stress incontinence
When Kim Vallis was offered what she thought would be a quick and easy solution to the embarrassment of stress incontinence, she was delighted.
Like a third of British women, the young mum had suffered a leaky bladder since the birth of her son, Haydon, six years ago. She hoped a treatment called transvaginal tape (TVT) – a plastic mesh inserted under the bladder that supports it like a hammock – would sort things.
But Kim now bitterly regrets her decision to go under the knife and says the operation almost destroyed her health.
“I ended up in agony for months and the pain nearly ruined my wedding day and my sex life,” says Kim.
The teaching assistant, 30, is not alone. She is one of hundreds of British women who say TVT surgery left them suffering chronic pain, repeat infections, nerve damage and poor urine flow.
Such is the controversy surrounding the mesh that NHS England has undertaken a working group review and several hospitals have stopped using it.
The surgery was suspended in Scotland by the Scottish government two years ago where 400 lawsuits are ongoing.
And in the USA and Canada around 100,000 lawsuits have been filed by TVT victims who have permanent disabilities.
However, it is still routinely offered to women in England and Wales suffering incontinence and pelvic organ prolapse – where the womb presses against the bladder – and there are no plans to stop the 13,000 operations taking place each year.
Kim and others are now campaigning for England to copy the Scottish move.
Kim, of Yate in Gloucestershire, says she was not warned of the risks when she was offered the treatment aged 27.
“I leaked when I coughed or sneezed and it was preventing me from doing things I wanted to with my son,” she says.
Using incontinence pads made her feel “like an old woman” so when her consultant told her TVT would be a quick and easy answer she was happy to go ahead.
But after the operation in January 2014 Kim woke in agony. The pain failed to ease and she struggled to pick up her son. She walked with a limp and a lump also appeared in her groin.
Partner Tony Vallis, 37, who Kim met a few months later, was understanding but she was in too much pain to have sex.
“I was madly in love with the man but sex was impossible. It was agony,” she says.
Still hoping things would get better the couple decided to marry in August 2015. But as the big day approached Kim begged doctors to investigate. She went back into hospital where further surgery revealed a 4cm piece of mesh had looped over, causing the lump and pain.
It was removed, but Kim’s pain got worse. She could not walk or drive. She then had more surgery to remove an egg-sized blood clot in her groin.
“People told me I should cancel the wedding but I refused. I said I would use a wheelchair if I had to,” she says.
In the end, to allow her some sort of normality on the big day, a doctor injected painkillers so she could walk pain-free down the aisle. But a honeymoon was out of the question.
Kim then discovered she was pregnant – but miscarried after 10 weeks. “Nobody could tell me if it was the mesh but I felt there was no question. My body was a wreck because of it.”
She turned to her family for help and together they raised enough money so Kim could have the mesh removed privately. After the procedure she was told by her specialist that it had been inserted incorrectly.
Sohier Elneil, a consultant urogynaecologist and uroneurologist at University College Hospital, London, believes TVT has been hugely overused.
Before the tape was introduced patients were offered physiotherapy. If that failed the next step could be a Burch colposuspension, a surgical procedure that involves lifting the front wall of the vagina and stitching it to the pubic bone. However, the procedure is more specialised than TVT.
“The scale of the (TVT) problem is not really acknowledged, but the complexity is, so much so that professional bodies are now coming together to try and standardise the care patients access,” says Miss Elneil.
Kim now belongs to a support group called Sling The Mesh, which is campaigning for a ban and a national register of complications. It was started by journalist Kath Samson after she had the surgery in March last year.
Kath says: “I had the usual bladder problems brought on by a big baby and found it embarrassing. I was very active and didn’t want to leak at the gym.”
But when pain after the operation failed to subside she did an internet search on ‘TVT gone wrong’ and her chin hit the floor when she saw the results.
“I was in complete shock. There were all these support groups for women injured by the mesh and it had been suspended in Scotland because it could break up inside the body and migrate into other tissue. I had gone into this operation without knowing any of this.”
Kath also had the mesh removed in September 2015 and says she is one of the “lucky ones” who returned to full health.
“The problem is that the operation is considered a success on the basis that it does stop incontinence,” she says.
“What those statistics don’t take into account is the fact it can destroy every other area of your life.”
Corinna Lincoln, a specialist clinical negligence solicitor at Taylor & Emmet in Sheffield, says the number of women affected is worrying.
“In many instances other options were not explored properly with patients and women were not informed clearly that once implanted, the mesh is intended to be permanent,” she says. “Removing it is extremely difficult and can result in even more harm and damage.
“As a result there are concerns women were not aware of the risks and were not able to make an informed decision.”
However, Natalia Price, the consultant gynaecologist and urogynaecologist who removed Kim’s botched mesh, stands by TVT as a treatment.
She argues it remains the “gold standard” operation for treating stress incontinence. “Complications can occur but the majority of patients get stress incontinence cured and experience no adverse outcomes,” she says.
Miss Price adds that mesh surgery to treat prolapse has a higher complication rate because the surgery involves a larger mesh, but despite that the surgery still offers considerable benefits.
She acknowledges she has seen an increase in women coming forward with concerns but believes some media reports about TVT have been misleading.
“It is very important that women receive evidence-based unbiased information on the risks and benefits. They can then make a fully informed decision,” she says.
While Kim can now walk, drive, and enjoy intimacy with her husband again, she remains angry and is considering legal action.
“Women like me have been to hell and back because of the TVT mesh,” she says.
“Scottish women are now safe so why is it still available elsewhere in the UK? We won’t stop until all women are safe and it is banned.”
http://www.mirror.co.uk/lifestyle/health/hundreds-women-left-health-ruins-8972042
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested