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Ethicon Media Monitoring 3/21/2018
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Ethicon has been ordered to pay $35 million in compensation to a woman who claims to have suffered severe injuries due to the Prolift transvaginal mesh.
Mar 21, 2018 | The Legal Herald
By Laurence Banville
An Indiana federal jury has awarded $35 million in damages to Barbara and Anton Kaiser, a couple who claim to have suffered numerous damages due to Ethicon's Prolift transvaginal mesh product, the Sunday Post, a Scottish newspaper, reports. -
Woman left with PTSD after vaginal mesh left her unable to walk
Mar 20, 2018 | SWNS.com
By Laura Elvin
A mum is planning on suing the hospital that fitted her with a surgical mesh – because it left her unable to work and suffering from Post-traumatic Stress Disorder. -
New Jersey Set to Try First C.R. Bard Transvaginal Mesh Lawsuit
Mar 20, 2018 | RX Injury Help
By Sandy Liebhard
New Jersey is preparing to try its fist transvaginal mesh lawsuit involving products marketed by C.R. Bard, Inc.
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Mar 21, 2018 | The Legal Herald
By Laurence Banville
An Indiana federal jury has awarded $35 million in damages to Barbara and Anton Kaiser, a couple who claim to have suffered numerous damages due to Ethicon's Prolift transvaginal mesh product, the Sunday Post, a Scottish newspaper, reports. In its opinion, the jury found Ethicon, a subsidiary of Johnson & Johnson, had been negligent in designing and marketing Prolift, a polypropylene patch used to treat pelvic organ prolapse.
Prolift Mesh Lawsuit Ends In $35M Jury VerdictNearly 14,000 women have filed transvaginal mesh lawsuits against Ethicon and parent company Johnson & Johnson. Like Barbara Kaiser, many of these patients were being treated for pelvic organ prolapse, a medical condition in which organs in the pelvis drop and apply pressure on the vagina.
Pelvic organ prolapse is a serious disorder, but Kaiser and her fellow plaintiffs say the "solution" cooked up by Ethicon and similar companies, transvaginal mesh, is just as bad.
Transvaginal Mesh Blamed For Severe Pelvic PainIn her lawsuit, Kaiser claims to have received a Prolift mesh implant in 2009, but soon began to suffer debilitating pelvic pain.
Along with her husband Anton, she filed suit against Ethicon in 2012, arguing that her mesh device had been designed in a defective manner and, further, that the Johnson & Johnson subsidiary had failed to warn the public and medical community about the implant's risks.
Surgeon Says No One Warned Of RisksAfter three years of pre-trial proceedings, Kaiser's case went to court on February 28, 2018.
At trial, the woman's surgeon testified that, when he'd used the implant in Kaiser, he'd been unaware of Prolift's safety risks. If he'd known, the surgeon said, he would certainly have considered using a different product.
Kaiser's attorneys presented evidence to support the assertion that Ethicon has "consistently underreported and withheld information about [...] Prolift's propensity to fail and cause injury and complications."
Jury Holds Ethicon LiableNine days later, a jury for the US District Court for the Northern District of Indiana delivered its conclusion on the matter. Ethicon had placed an unsafe product into the stream of commerce, the jury decided, while failing to warn patients, including Barbara Kaiser, about the risks.
The jury ordered Ethicon to pay Kaiser $10 million in compensatory damages and $25 million in punitive damages, but refrained from awarding her husband, Anton, any money.
"Ethicon defended an indefensible product," according to Thomas Plouff, the plaintiffs' attorney who represented the Kaiser family, "and the jury stood up for Barbara Kaiser."
J&J Plans To AppealIn a statement emailed to MassDevice.com, Johnson & Johnson spokesperson Mindy Tinsley said the company intends to appeal the jury's decision "as we believe it contradicts the evidence that the product was properly designed and that the company appropriately informed surgeons of pertinent complications."
https://legalherald.com/indiana-jury-transvaginal-mesh/
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Woman left with PTSD after vaginal mesh left her unable to walk
Mar 20, 2018 | SWNS.com
By Laura Elvin
A mum is planning on suing the hospital that fitted her with a surgical mesh – because it left her unable to work and suffering from Post-traumatic Stress Disorder.
Theresa Bartram, 51, suffered so badly after having a trans-vaginal tape put in to lift her prolapsed bladder that she has been left with repeated infections, fibromyalgia and PTSD – usually seen in ex-servicemen.
The mum-of-one from Peacehaven, East Sussex, had been suffering from stress incontinence after having a baby when she had the Gynecare TVT sling fitted in 2007.
But the former health worker was forced to have it removed in 2015 after the device cut through her vaginal wall – slicing into her partner’s penis while they had sex.
Theresa, who is now barely able to walk, said: “I had the sling put in because I had a mild prolapse while giving birth standing up, and was told that it was the ‘gold standard’ for women like me.
“The doctor said the risks were minimal, it was fantastic, and there was only a one per cent chance of infection – I had no idea at all that it could cut through me.
“In 2010, it cut my partner during sex because it had perforated my vaginal walls after three years.
“I blew up – I was hugely swollen and looked eight months pregnant – so I went to A&E, but they said I was fine and to go home.
“Eventually it was found that they’d looked at someone else’s blood results and I had liver and pancreas problems, because my body was reacting so violently to the mesh.
“I felt so sick, I kept falling asleep in conversations and on the phone and was sleeping for 18 hours a day.
“I had swollen up all over and I spent five-and-a-half years going from doctor to doctor and they all told me I wanted to be ill and it was all in my head – they tried to give me anti-psychotic medication.
“Eventually in summer 2015, I was able to see a gynecologist, who admitted that the mesh was cutting through my vaginal wall.
“It smelt like I had leg ulcers and I didn’t know what was going on, it was only later that the penny dropped with the doctors that it was the mesh.
“I had been screaming it from the rooftops and no one listened – even my own family.”
Theresa finally had the sling removed at Eastbourne District General Hospital in November 2015, in a three-hour ‘very violent surgery’.
She says it took five months for the wound to heal, and she has even developed an allergy to five antibiotics since the mesh’s removal, meaning she struggles with any infection.
Theresa added: “I can’t work because of all the pain I’m in – I have a constant low level electrical buzz all over my body, I’m sore all over, with shooting pains in both ankles and my left elbow.
“Because my pelvic floor has been cut through, holding my body up is a struggle and I’m constantly incontinent.
“I’ve had sepsis even after the mesh was removed, which you don’t expect, and still now I’m having treatment for PTSD – which is difficult, because I’m still living in this trauma.”
Theresa, whose partner left her two months after the penis-slicing incident, is now hoping to take legal action against the hospital and the tape manufacturers, Johnson & Johnson.
In September, a 51-year-old woman in the US was awarded £42.5 million by the pharmaceuticals company.
Her case revealed that the implant was launched without a clinical trial, and then marketed for five years despite the company discovering it had a higher failure rate than two similar devices.
Theresa wants to instruct a solicitor, but is unable to access legal aid and is currently on benefits.
She said: “I’m going to get legal advice, but I have no money.”
Brighton and Sussex University Hospitals NHS Trust refused to comment on Theresa’s individual case.
A spokesperson said: “Ms Bartram’s consultant is no longer at BSUH.
“NICE issued new guidance on the use of vaginally inserted mesh for vaginal wall prolapse in December 2017.
“This was followed by a statement from the Royal College of Obstetricians and Gynaecologists and the British Society of Urogynaecology.
“The main change is that vaginal mesh is no longer being inserted at the Trust for vaginal wall prolapse.
“Since March 2016, we conducted eight vaginal wall prolapse treatments, for which one patient had recurrent prolapse and no patient had pain, infection or exposure. No mesh required removal.
“The guidelines do not apply to abdominally-inserted mesh, which has a much lower complication rate.
“The NICE guidelines also don’t apply to tapes used for urinary stress incontinence.
“The new National Institute for Health and Clinical Excellence (NICE) guideline on the management of urinary incontinence in women is due for release in March 2018.
“Mid-urethral tape slings remain the most commonly used surgical procedure for stress incontinence in the United Kingdom.
“Our data shows that our rate of mid-urethral tape slings removal for complications is around 2.4 per cent.
“Without being able to comment directly on Ms Bartram’s circumstances, we can’t really say much beyond offering the assurance that we are following the latest guidelines, all patients are followed up after prolapse surgery and assessed and if there are any patients who are not satisfied with the care provided, they can request a follow up assessment.”
https://stories.swns.com/news/woman-left-ptsd-vaginal-mesh-left-unable-walk-95612/
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New Jersey Set to Try First C.R. Bard Transvaginal Mesh Lawsuit
Mar 20, 2018 | RX Injury Help
By Sandy Liebhard
Sandy Liebhard is an Senior Partner at Bernstein Liebhard LLP
New Jersey is preparing to try its fist transvaginal mesh lawsuit involving products marketed by C.R. Bard, Inc.
According to CVN.com, jury selection for the case got underway in Bergen County Superior Court on March 15th. Opening statements will likely begin shortly after a jury is empaneled.
The case selected for trial was filed on behalf of Mary McGinnis, who received C.R. Bard’s Avaulta and Align implants in 2009 to treat stress urinary incontinence and pelvic organ prolapse. She claims that the devices were defectively designed and manufactured and caused her to suffer from chronic pain.
McGinnis further asserts that C.R. Bard knew that the material used to manufacture the transvaginal mesh devices could interact adversely with vaginal tissue but failed to warn doctors and patients of this risk.
C.R. Bard Transvaginal Mesh Verdicts
More than 100,000 women have filed suit in courts nationwide over injuries and complications allegedly caused by transvaginal mesh products marketed by C.R. Bard and other manufacturers, including American Medical Systems, Inc., Boston Scientific Corp., and Ethicon, Inc., among others.
While roughly 30 cases have gone to trial thus far, only three have involved New Jersey-based C.R. Bard:
· In 2012, a jury in California Superior Court awarded $5.5 million to another Avaulta plaintiff.
· A second Avaulta recipient was awarded $2.2 million by a West Virginia federal court jury in 2013.
· The defense prevailed in a 2016 Missouri case involving C.R. Bard’s Align and Boston Scientific’s Solyx implants.
In recent years, C.R. Bard has reached agreements to confidentially settle hundreds of additional transvaginal mesh claims involving its devices.
FDA Transvaginal Mesh Warnings
The U.S. Food & Drug Administration (FDA) began investigating an increasing number of reports linking transvaginal mesh to severe and life-changing complications in 2008. In July 2011, the agency warned that transvaginal mesh complications following prolapse repair were not rare, a marked change from its previous position on the issue.
In 2016, the FDA reclassified transvaginal mesh implants indicated for prolapse repair as Class III (high risk) medical devices, which among other things, made such products ineligible for the agency’s 510(k) clearance program. This program allowed the implants to come to market without the benefit of human clinical trials because manufacturers were able to demonstrate that that transvaginal mesh was “substantially equivalent” to “predicate” devices that had already been subjected to the FDA’s more stringent premarket approval process.
https://www.rxinjuryhelp.com/news/2018/03/20/new-jersey-set-to-try-first-c-r-bard-transvaginal-mesh-lawsuit/
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