Preview Newsletter
Ethicon Media Monitoring 3/13/2018
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Mesh surgeon removed ovaries without prior consent
Mar 13, 2018 | BBC News
A surgeon under NHS investigation removed a patient's ovaries without prior consent as they were "in the way". -
Johnson & Johnson’s Ethicon loses $35m pelvic mesh lawsuit
Mar 13, 2018 | Mass Device
By Brad Perriello
An Indiana jury hit Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon with a $35 million verdict in a product liability lawsuit brought over its Prolift pelvic mesh. -
Jury Hits J&J with $35M Verdict in Transvaginal Mesh Case
Mar 12, 2018 | Drugwatch
By Michelle Llamas
An Indiana jury this month awarded $35 million to a woman in a transvaginal mesh case. The jury found Johnson & Johnson and its subsidiary Ethicon negligent in the design and marketing of the Prolift transvaginal mesh device. -
Ind. Federal Jury Awards $35 Million to Plaintiff in Prolift Transvaginal Mesh Action
Mar 12, 2018 | HarrisMartin Publishing
An Indiana federal jury has awarded $35 million to a woman who alleged her Ethicon Prolift transvaginal mesh device was defectively designed and that Ethicon Inc. failed to provide her surgeon with adequate warnings as to the device's risks. -
Jury awards $35M in mesh implant case
Mar 12, 2018 | Chicago Daily Law Bulletin
A federal jury in Indiana has returned a $35 million verdict in favor of a woman who alleges she was injured by a vaginal mesh implant. -
Indiana Woman Awarded $35 Million for Defective Prolift Mesh, as Johnson & Johnson Loses Another Transvaginal Mesh Lawsuit
Mar 13, 2018 | RX Injury Help
By Laurie Villanueva
An Indiana woman has been awarded $35 million, after the federal jury hearing her transvaginal mesh lawsuit found that Johnson & Johnson and its Ethicon, Inc. subsidiary committed negligence in designing and marketing Prolift mesh implants for the treatment of pelvic organ prolapse.
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Mesh surgeon removed ovaries without prior consent
Mar 13, 2018 | BBC News
A surgeon under NHS investigation removed a patient's ovaries without prior consent as they were "in the way".
Tony Dixon helped to pioneer the use of mesh in bowel surgery to fix prolapses and relieve constipation.
Lucinda Methuen Campbell, who recently died, said she had not consented to the removal before the operation in 2014.
Mr Dixon said he could not comment on specific allegations due to patient confidentiality.
Mrs Methuen Campbell had lengthy consultations with Mr Dixon before the operation.
He told her her problems were complex involving surgery not just on her bowel but also her womb.
Mrs Methuen Campbell was first told shortly after the operation that her ovaries had been removed.International reputation
At the time of the surgery, Mrs Methuen Campbell lived near Swansea and later found that she struggled to get treatment in England.
She told the BBC that she was desperate for a solution to the pain she continued to experience and had seen other doctors.
Mrs Methuen Campbell was found dead at home in January. The coroner is currently investigating the cause of death.
Mr Dixon built up an international reputation for using mesh rectopexy to fix bowel problems, often caused by childbirth, but is currently suspended from performing this surgery at two hospitals in Bristol.
The General Medical Council (GMC) has stopped him from performing another form of corrective surgery, known as a Starr procedure (stapled transanal resection of the rectum), until November 2018.
North Bristol NHS Trust is investigating the consultant, who worked at Southmead Hospital and at the private Spire Hospital in Bristol.
The BBC has been contacted by scores of women after an Inside Out expose last year, supporting revelations that their surgery did not work and they were left in severe pain.
Mrs Methuen Campbell suffered complex problems with her bowels and womb prior to seeing Mr Dixon.'In the way'
She had the mesh in 2014, when she was 54, to try to avoid a hysterectomy.
She said that the removal was never mentioned before the surgery, and if it had she would have been "vaguely prepared".
"He said he thought he'd done me a favour. And he said: 'I thought you know, a woman of your age wouldn't really need her ovaries.'
"I said 'Why did you remove them?' and he just said 'They were in the way'."
"My life is absolutely ruined but you know, I can't say that it's Mr Dixon's ruined my life."
Mr Dixon has previously said all operations can have problems but his are done in good faith and the majority are successful.
Dr Sohier Elniel, a gynaecologist, said she had seen an increase in demand for mesh removal since the BBC first raised the issue in October.
The body can react against mesh, which can also erode and become infected.
She said: "A lot of patients are aware perhaps all the symptoms they've had for many years may be related to this mesh and complications of mesh so they've come to seek help.
"We had at the beginning two or three a month and now we are getting one mesh complication patient every third or fourth day."
Surgeons say they only started to recognise complications from mesh procedures in the last few years.
The Pelvic Floor Society (PFS) says up to 2.5% of women who have bowel mesh surgery will suffer complications, but it can bring life-changing benefits for the majority.
North Bristol NHS Trust said that the welfare and safety of patients was an "absolute priority".
A spokeswoman said: "We would like to re-assure patients affected by this that we are taking this very seriously and our investigations are continuing.
Dr JJ de Gorter, group medical director at the Spire, said it suspended Mr Dixon from surgery in July 2017 and was reviewing the care he had provided.
He said: "This was followed by a full suspension of his practising privileges in early November 2017, which means he is no longer working at the hospital."
Watch the full investigation on Inside Out on BBC One West on Monday, 12 March at 7.30pm and for seven days afterwards on the iPlayer.
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Johnson & Johnson’s Ethicon loses $35m pelvic mesh lawsuit
Mar 13, 2018 | Mass Device
By Brad Perriello
An Indiana jury hit Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon with a $35 million verdict in a product liability lawsuit brought over its Prolift pelvic mesh.
Barbara Kaiser and her husband Anton Kaiser sued Ethicon in March 2012, after learning that the Prolift mesh her doctor implanted in 2009 to treat her pelvic organ prolapse might be causing her low pelvic pain.
The lawsuit accused J&J and Ethicon of concealing the problems with Prolift, which allegedly include high failure, injury, and complication rates and “frequent and often debilitating re-operations,” according to the Kaiser’s complaint. Prolift “caused severe and irreversible injuries, conditions, and damage to a significant number of women, including plaintiff,” according to the complaint.
“Defendants have consistently underreported and withheld information about their Prolift’s propensity to fail and cause injury and complications, and have misrepresented the efficacy and safety of the products through various means and media, actively and intentionally misleading the medical community, patients, and the public at large,” the Kaisers alleged. “Defendants actively and intentionally misled and continue to mislead the public, including the medical community, health care providers, and patients, into believing their Prolift is safe and effective, leading to the prescription for, and implantation of, their Prolift into plaintiff, Barbara Kaiser, and numerous other women.”
The U.S. District Court for Northern Indiana jury March 8 awarded Barbara Kaiser $10 million in damages and $25 million in punitive damages but gave nothing to Anton Kaiser, according to court documents.
“Ethicon defended an indefensible product and the jury stood up for Barbara Kaiser,” her attorney, Thomas Plouff, told Scotland’s Sunday Post. “They were asked to send a message to Ethicon to deter future wrongdoing, and they did.”
Johnson & Johnson plans to appeal the verdict, spokeswoman Mindy Tinsley told MassDevice.com via email, “as we believe it contradicts the evidence that the product was properly designed and that the company appropriately informed surgeons of pertinent complications.”
“Pelvic organ prolapse is a serious and debilitating condition with limited treatment options. Scientists from around the world who have conducted and reviewed independent research on pelvic mesh agree it is an important treatment option for some women. All surgeries to treat pelvic organ prolapse have risks. While we empathize with those who have experienced complications, many women with pelvic mesh see an improvement in their day to day lives,” Tinsley told us. “Ethicon stands by, and will continue to defend, our pelvic mesh products in litigation.”
https://www.massdevice.com/johnson-johnsons-ethicon-loses-35m-pelvic-mesh-lawsuit/
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Jury Hits J&J with $35M Verdict in Transvaginal Mesh Case
Mar 12, 2018 | Drugwatch
By Michelle Llamas
An Indiana jury this month awarded $35 million to a woman in a transvaginal mesh case. The jury found Johnson & Johnson and its subsidiary Ethicon negligent in the design and marketing of the Prolift transvaginal mesh device.
Barbara Kaiser and her husband filed a lawsuitagainst J&J and Ethicon after Kaiser received a Prolift mesh implant during prolapse repair surgery.
Kaiser suffered severe pelvic pain, among other “severe and irreversible injuries,” according to her 2012 complaint.
On March 8, 2018, the Indiana jury ruled in favor of Kaiser and her husband after a nine-day trial.“Ethicon defended an indefensible product, and the jury stood up for Barbara Kaiser,” Kaiser’s attorney Thomas Plouff told Scotland’s Sunday Post. “They were asked to send a message to Ethicon to deter future wrongdoing, and they did.”
The jury awarded the Kaisers $10 million for pain, suffering and monetary damages. Jurors also awarded the couple $25 million in punitive damages for wanton disregard of Kaiser’s safety.
J&J and Ethicon knew the device had a high risk of complications and failure, Kaiser said in her lawsuit. But, the device maker failed to warn the public of the risks.
Kaiser’s surgeon testified that he was unaware of the Prolift’s safety risks.
J&J spokeswoman Mindy Tinsley told MassDevice.com that the company intends to appeal.
“All surgeries to treat pelvic organ prolapse have risks. While we empathize with those who have experienced complications, many women with pelvic mesh see an improvement in their day-to-day lives,” Tinsley told MassDevice.com via email. “Ethicon stands by, and will continue to defend, our pelvic mesh products in litigation.”
This verdict comes two days after J&J lost its bid to overturn a $15 million verdict for Elizabeth Hyrmoc. Hyrmoc’s trial took place in November 2017 in New Jersey.
J&J and Ethicon still faced more than 13,600 mesh lawsuits as of Feb. 15, 2018.
https://www.drugwatch.com/2018/03/12/jury-hits-jj-35m-verdict-transvaginal-mesh-case/
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Ind. Federal Jury Awards $35 Million to Plaintiff in Prolift Transvaginal Mesh Action
Mar 12, 2018 | HarrisMartin Publishing
HAMMOND, Ind. - An Indiana federal jury has awarded $35 million to a woman who alleged her Ethicon Prolift transvaginal mesh device was defectively designed and that Ethicon Inc. failed to provide her surgeon with adequate warnings as to the device's risks.
In a March 8 verdict, the jury sitting in the U.S. District Court for the Northern District of Indiana awarded plaintiff Barbara Kaiser $10 million in compensatory damages and $25 million in punitive damages. Kaiser's husband was awarded nothing on his loss of consortium claim, however.
Judge Philip P. Simon presided over the trial, which began on Feb. ...
Access to full text unavailable – subscription required. For full story: https://harrismartin.com/article/23278/ind-federal-jury-awards-35-million-to-plaintiff-in-prolift-transvaginal-mesh-action/
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Jury awards $35M in mesh implant case
Mar 12, 2018 | Chicago Daily Law Bulletin
A federal jury in Indiana has returned a $35 million verdict in favor of a woman who alleges she was injured by a vaginal mesh implant.The jury on Thursday directed Johnson & Johnson and a subsidiary to pay $10 million in actual damages and $25 million in punitive damages to Barbara Kaiser of Valparaiso, Ind.The jury found Johnson & Johnson and Ethicon Inc. negligently designed a transvaginal mesh device and then …
Access to full text unavailable – subscription required. For full story: http://www.chicagolawbulletin.com/articles/2018/03/12/35m-mesh-implant-injury-3-12-18
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Mar 13, 2018 | RX Injury Help
By Laurie Villanueva
Laurie Villanueva is an attorney with Bernstein Liebhard LRX Injury Help
An Indiana woman has been awarded $35 million, after the federal jury hearing her transvaginal mesh lawsuit found that Johnson & Johnson and its Ethicon, Inc. subsidiary committed negligence in designing and marketing Prolift mesh implants for the treatment of pelvic organ prolapse.
According to her 2012 filing in the U.S. District Court, Northern District of Indiana, Plaintiff Barbara Kaiser has experienced chronic pelvic pain ever since undergoing prolapse repair surgery in 2009. Among other things, she claimed that Johnson & Johnson and Ethicon were aware that Prolift was associated with high rates of failure and complications, yet never warned doctors and patients about these issues.
“Defendants actively and intentionally misled and continue to mislead the public, including the medical community, health care providers, and patients, into believing their Prolift is safe and effective, leading to the prescription for, and implantation of, their Prolift into plaintiff, Barbara Kaiser, and numerous other women,” the lawsuit states.
During her 9-day trial, Kaiser’s surgeon testified that he would not have used Prolift had he been aware of its risks.
Kaiser was awarded $10 million in compensation for her injuries, as well as $25 million in punitive damages for the defendants’ wanton and reckless disregard for her safety.Ethicon Transvaginal Mesh Litigation
Johnson & Johnson and Ethicon are facing more than 55,000 product liability claims involving Prolift and other transvaginal mesh implants used to treat pelvic organ prolapse and stress urinary incontinence.
The companies have lost more than a half-dozen trials, with other verdicts ranging from $2.16 million to $20 million. Some juries have found for the defendants, while other cases have settled out-of-court.Transvaginal Mesh Complications
Since 2008, the U.S. Food & Drug Administration has (FDA) issued several safety communications regarding transvaginal mesh devices, after the implants were tied to hundreds of injuries and complications, including many that proved permanent and life-changing. In 2011, the agency warned that transvaginal mesh complications associated with prolapse repair were not rare, a reversal of its previous position on the subject.
In 2016, the FDA reclassified mesh implants indicated for prolapse repair as Class III (high risk) medical devices, which among other things, barred such product from the FDA’s 510(k) approval program. This program allowed Prolift and similar mesh devices to come to market without the benefit of human trials because their manufacturers were able to convince the FDA that they were “substantially equivalent” to implants that had already gone through the agency’s stricter pre-market approval process.
In June 2012, Ethicon announced it would no longer market several transvaginal mesh implants in the United States, including the Prolift, Prolift+M, TVT Secur and Prosima devices. The company has never announced a transvaginal mesh recall, and indicated that the decision to stop selling the implants was made for commercial reasons, rather than safety concerns.
https://www.rxinjuryhelp.com/news/2018/03/12/indiana-woman-awarded-35-million-for-defective-prolift-mesh-as-johnson-johnson-loses-another-transvaginal-mesh-lawsuit/
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