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Ethicon Media Monitoring 5/2/2017
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J&J's Ethicon hit with $20 million verdict in mesh case
May 1, 2017 | Reuters WestLaw
By Nate Raymond
A state court jury in Philadelphia has order Johnson & Johnson to pay $20 million to a New Jersey woman who said she suffered injuries after receiving a pelvic mesh implant made by the company's Ethicon unit. -
Why is the NHS STILL failing to help women maimed by post baby surgery? Mother, 28, is forced to spend £4,500 to remove bladder-controlling mesh implant after two years of agony
May 1, 2017 | Daily Mail
By Lois Rogers
Within days of an operation to insert a mesh support to improve her bladder function after childbirth, Kimberley Vallis, knew something was very wrong. -
J&J hit with $17.5M in damages in defective product suit
May 1, 2017 | NJ.com
By Kathleen O'Brien
Pharmaceutical giant Johnson & Johnson has lost another trial over its pelvic surgical mesh, a product that triggered nearly 55,000 lawsuits against the company, Bloomberg News reports. -
Cinnaminson woman awarded $20 million in pelvic mesh lawsuit
May 1, 2017 | Burlington County Times
By Crissa Shoemaker
Johnson & Johnson must pay $20 million to a Cinnaminson woman for injuries she received from a medical device implant the company manufactured, a Philadelphia jury has ruled. -
J&J hit with $20M verdict in Philadelphia vaginal mesh case
May 1, 2017 | FierceBiotech
By Amirah Al Idrus
A jury in Philadelphia has awarded $20 million in damages to a plaintiff who claimed that her pelvic mesh implant, made by J&J’s Ethicon unit, failed and caused her injury. -
Johnson & Johnson loses $20m verdict in 3rd pelvic mesh bellwether
May 1, 2017 | MassDevice
By Brad Perriello
A Pennsylvania state court jury dealt a $20 million blow to Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon last week in the 3rd pelvic mesh bellwether to go to trial in Philadelphia.
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J&J's Ethicon hit with $20 million verdict in mesh case
May 1, 2017 | Reuters WestLaw
By Nate Raymond
A state court jury in Philadelphia has order Johnson & Johnson to pay $20 million to a New Jersey woman who said she suffered injuries after receiving a pelvic mesh implant made by the company's Ethicon unit.
The verdict on Friday marked the third multimillion-dollar verdict for a plaintiff in the mass tort litigation in the Philadelphia Court of Common Pleas over its pelvic mesh implants. J&J faces thousands of similar lawsuits nationally.
To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/2qxjRZh
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May 1, 2017 | Daily Mail
By Lois Rogers
Within days of an operation to insert a mesh support to improve her bladder function after childbirth, Kimberley Vallis, knew something was very wrong.
She couldn’t move her left leg properly — ‘I had to use my hand to move it’ — and lumps, caused by blood clots, started to appear in her groin, recalls the 28-year-old former estate agent from Yate, near Bristol.
It was the start of two years of agony and urinary tract infections that culminated, she says, in her next pregnancy ending in a miscarriage. Kimberley had had a ‘foreign body response’ to the plastic mesh.
‘I kept asking them to take the mesh out, but they wouldn’t,’ she says.
‘Eventually I had a miscarriage. The baby died at six weeks, though I didn’t actually miscarry until 12 weeks. I’ve no doubt this was because of the infection set up by the mesh implant.’
Her nightmare only ended when she spent £4,500 on private surgery to remove the surgical mesh ‘ribbon’.
‘I just couldn’t bear the pain and constant infections,’ says Kimberley who gave birth to her second son, Adam, 11 weeks ago.
She believes she was a victim of a procedure to tackle a taboo problem: the fact that many women never regain full bladder control after childbirth.
The stigma around incontinence has meant vast numbers of women suffer in embarrassed agony because of the disintegration of the polypropylene material used to support the bladder or womb after childbirth.
Fragments of the mesh, which is inserted like a hammock to support the bladder, can burrow deep into tissue like tiny shards of glass, causing excruciating pain and infection that has left some women unable to walk or even facing kidney removal. Others report pain during sex.
Studies have shown that the longer the mesh is left in, the more likely it is to ‘erode’, embedding itself into tissue in a way that it cannot be removed.
A study published in The Lancet last December showed women given mesh implants were roughly three times more likely to suffer complications and twice as likely to need follow-up surgery compared with the traditional version of the surgery, where stitches are used to provide support.
Last week Johnson & Johnson which produces Ethicon, one of the best-selling meshes, was ordered to pay more than £16 million in damages to a woman injured by the mesh.
It has also been ordered to pay £10 million in two other cases, and is facing a further 35,000 lawsuits in the U.S., with claims from at least nine other countries including class actions from Australia and New Zealand.
At least 800 women in England are taking legal action, it was reported by the BBC last week. But despite cases first coming forward back in 2011, authorities in the UK have so far insisted there is no problem.
In fact there are concerns about the current, official investigations. Last month an inquiry in Scotland published its report on over 1,500 women who have been affected, concluding that despite the problems, the mesh should still be available.
However before the report’s publication, four of the 20-strong inquiry team resigned, including chairman and leading public health specialist Lesley Wilkie, Wael Agur another top clinical lecturer from Glasgow University, and patient representatives, Elaine Holmes and Olive McIlroy.
Meanwhile, an NHS England investigation has dispensed with input from five other patients and reformulated itself as a mesh ‘oversight group’ dominated by officials.
In the meantime, countless women in the UK have been left with dreadful side-effects.
An estimated 13,500 women in Britain have received a mesh implant and two million worldwide. It was first introduced in the mid-Nineties as a cheaper, quicker way for less experienced doctors to do pelvic repairs which previously involved highly skilled stitching.
As the Mail first highlighted five years ago, problems with nerve damage, pain, infection and sexual difficulties were initially reported to the Medicines and Healthcare Products Regulatory Agency (MHRA) in 2011.
NHS England set up an investigation in 2014, but it has yet to produce a final report and none of the five patient representatives originally invited to participate has been invited to recent meetings Good Health has discovered.
Leaked minutes from its meeting last October discussed the need to ‘avoid media attention on mesh’. An MHRA spokesman told Good Health this referred to a need to ensure balanced reporting. He insisted that the mesh is safe but refused to comment further, bizarrely citing pre- election purdah.
Olive McIlroy, 60, and Elaine Holmes, 52, the two patient representatives who resigned from the Scottish investigation, have expressed fury about the report. Elaine had the mesh inserted in 2011, waking after surgery in excruciating pain as the mesh had sliced through her urethra. She can no longer walk or drive.
Olive had the operation in 2008 and two years later woke up unable to move because of apparent nerve damage. Neither was well enough to talk to Good Health, but in a joint statement said vital evidence and safety warnings had been ignored, and they were ‘dismayed and disgusted the Scottish government has seen fit to publish this tainted report’.
Kath Sansom, 49, a journalist in Cambridgeshire, set up Sling the Mesh, a campaigning group for victims, two years ago after she, too, was left with nerve damage by the procedure in 2015. She now has 1,600 members demanding the mesh is banned.
‘The Government just isn’t listening to patients. The Scottish report is clearly a whitewash and we fear the NHS England one will be similar,’ she told Good Health. An NHS England spokesman said: ‘Many women have been treated successfully using transvaginal mesh implants, however, we do recognise that a number of women have suffered complications or poor outcomes.
‘We have listened carefully to their concerns . . . and made a number of recommendations in December 2015 to improve the quality of care and information available. Strong progress has been made in completing these recommendations, and a final report setting out the action taken will be published later this year.’
The women who have been affected fear many others will suffer before the medical establishment recognises the level of damage caused.
Sallie Booth, of solicitors Irwin Mitchell, represents nine women who have claims against Johnson & Johnson. ‘It’s an embarrassing, awful condition,’ she says. ‘It’s difficult to gauge how many there are because for a long time people haven’t realised that the awful effects are shared by others.’
Part of the problem is that many women are still being told by doctors their problems are unique. Teresa Hughes, 65, from St Helen’s, Lancashire, whose case was among the first to be highlighted by Good Health, was told the pains in her legs and lower body were ‘nothing to do with the mesh’ she had implanted in 2006.
‘Then I was told I was among a handful of unlucky people the product didn’t suit,’ she says. ‘I had no idea there were thousands of women with the same problem.’
Sohier Elneil, a gynaecologist at University College Hospital in London, who has developed an expertise in removing fragments of mesh, says the material was given a licence ‘on the basis it’s similar to hernia mesh’.
‘Over a period of seven years, this mesh fragment removal work has gone from 10 per cent to 60 per cent of my practice,’ she says.
Another gynaecologist, speaking on condition of anonymity, said the mesh was being promoted to save money. ‘It costs about £1,000 to do a surgical repair but a mesh procedure is £268 cheaper,’ he said.
‘That may not sound much, but if you’re doing thousands of operations a year, it adds up. They’re trying to keep the lid on it because of the possibility of the terrifying cost of litigation: claims could run into many millions.’
A spokesperson for Johnson & Johnson said: ‘Ethicon is vigorously defending litigation concerning the use of our pelvic mesh products. We believe the evidence shows the devices are safe.’
Kimberley says one thing is clear: ‘We’ve got to get the message out that incontinence is pretty normal and there are other less risky ways of dealing with it.’
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J&J hit with $17.5M in damages in defective product suit
May 1, 2017 | NJ.com
By Kathleen O'Brien
Pharmaceutical giant Johnson & Johnson has lost another trial over its pelvic surgical mesh, a product that triggered nearly 55,000 lawsuits against the company, Bloomberg News reports.
This latest verdict, reached Friday in Philadelphia, hits the company with punitive damages of $17.5 million on top of the $2.5 million awarded to the Cinnaminson woman who brought the lawsuit.
The hefty punitive damage means jurors were convinced of the woman's argument that the company knew its mesh, which had been used without issue in hernia repairs, caused problems in women.
The mesh kits were sold until 2012 as a way for surgeons to help bolster the pelvic walls against sagging pelvic organs. Instead, many women found the mesh implant contracted, shifted around, or broke in pieces, according to the lawsuits.
Ethicon, the J&J subsidiary based in Somerville, faces three upcoming trials in Philadelphia, according to Bloomberg News, as well as two "bellwether" trials in Bergen County this fall, according to Adam Slater, designated as one of the lead attorneys for the thousands of pelvic mesh cases filed in New Jersey.
While J&J has reportedly settled some cases on an individual basis, the company and the major tort attorneys involved in the issue have not reached any broad settlements that would avoid thousands of trials.
An Ethicon spokeswoman indicated the company intended to appeal this most recent Philadelphia verdict.
The company withdrew its product from the market after the U.S. Food and Drug Administration decided it should carry a higher level of warning to patients, as well as be subjected to more formal safety studies.
The company is also being sued by state attorneys general in Kentucky, California and Washington, who claim J&J misled both women and their surgeons about the implant's true risks.
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Cinnaminson woman awarded $20 million in pelvic mesh lawsuit
May 1, 2017 | Burlington County Times
By Crissa Shoemaker
Johnson & Johnson must pay $20 million to a Cinnaminson woman for injuries she received from a medical device implant the company manufactured, a Philadelphia jury has ruled.
The decision last week is the third judgment against the company for a pelvic mesh implant made by subsidiary Ethicon. Two earlier verdicts in Philadelphia resulted in awards of $12.5 million and $13.5 million. Hundreds of other cases are pending.'
In this case, Peggy Engleman of Cinnaminson sued Johnson & Johnson in 2013, claiming that its TVT-Secur device was defective and that Johnson & Johnson and Ethicon failed to warn users of the risks. Engleman had the device implanted in 2007 to relieve stress urinary incontinence, but the device failed within a month and the mesh began to erode inside her body. She had multiple surgeries but physicians have been unable to remove all the shards of mesh in her abdomen.
Following a three-week trial in Philadelphia Common Pleas Court, Engleman was awarded $2.5 million in compensatory damages and $17.5 million in punitive damages.
"Through this stunning verdict, the jury has unequivocally shown that Johnson & Johnson will have to pay a high price if their products are defective and harmful as well as their marketing practices unethical," Engelman's attorney, Martin P. Schrama of Stark & Stark, said in a statement.
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J&J hit with $20M verdict in Philadelphia vaginal mesh case
May 1, 2017 | FierceBiotech
By Amirah Al Idrus
A jury in Philadelphia has awarded $20 million in damages to a plaintiff who claimed that her pelvic mesh implant, made by J&J’s Ethicon unit, failed and caused her injury.
On Friday, a Philadelphia Common Pleas Court jury awarded the plaintiff, Peggy Engleman, $20 million in damages, including $17.5 million in punitive damages, the Philadelphia Inquirer reported. It is the third eight-figure verdict for pelvic mesh cases in Philadelphia.
Engleman received a TVT-Secur device in 2007 to treat urinary incontinence, the Inquirer reported. But the mesh failed, eroded inside her body and caused pain and discomfort. Engleman has since undergone multiple surgeries to remove it, but her surgeons were unable to remove all of the mesh.
Her lawyers argued that the device was defective and that J&J and Ethicon hid the risks of the product, the Inquirer said.
"We believe the evidence showed Ethicon’s TVT-Secur device was properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and TVT-Secur was not the cause of the plaintiff’s continuing medical problems,” Ethicon said, as quoted by the Inquirer. The company believes it has “strong grounds” for appeal.
In 2012, as hundreds of lawsuits piled up, the company stopped marketing four of its vaginal mesh products, including the TVT-Secur. But this hasn’t stopped the flood of lawsuits from women claiming the devices caused them injury.
And early last year, J&J set aside more than $120 million to settle thousands of lawsuits from women alleging chronic pain and organ damage as a result of the company’s pelvic mesh devices. This will scarcely put a dent in the company’s pelvic mesh woes—the funds will resolve between 2,000 and 3,000 lawsuits out of more than 40,000 cases J&J is facing over the devices.
Pelvic mesh isn’t the only device that’s got J&J in hot water—the company is also facing lawsuits from plaintiffs claiming injury from its Pinnacle metal-on-metal hip implants, which it stopped selling in 2013.
In December, a Dallas jury ordered J&J to fork over $1 billion to six plaintiffs who reported injuries such as tissue death and bone erosion as a result from the implant. The jury found that the devices were “defectively designed” and that the company and its DePuy subsidiary did not warn consumers of the risk. But a federal judge halved the penalty due to “constitutional considerations” that limit punitive damages.
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Johnson & Johnson loses $20m verdict in 3rd pelvic mesh bellwether
May 1, 2017 | MassDevice
By Brad Perriello
A Pennsylvania state court jury dealt a $20 million blow to Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon last week in the 3rd pelvic mesh bellwether to go to trial in Philadelphia.
The verdict, including a $17.5 million punitive damages award, was handed up April 28 in the Philadelphia Court of Common Pleas. Plaintiff Peggy Engleman alleged that the TVT-Secur mesh she was implanted with to treat her stress urinary incontinence caused her injuries as it eroded inside her body after just 2 months. Engleman, who according to court documents eventually underwent 3 surgeries to remove the TVT-Secur mesh, alleged that the product was defective and accused Johnson & Johnson of putting it on the market despite knowing of its risks.
The company countered that Engleman had no evidence that Ethicon “failed to warn of risks not within the common knowledge of pelvic floor surgeons.”
“Under New Jersey law, a manufacturer has no duty to warn of risks that are within the common knowledge of physicians,” according to the documents.
Engleman’s attorney, Benjamin Anderson of Cleveland’sAnderson Law Offices, told Delaware Law Weekly that he believes the case turned for the plaintiff when a former J&J consultant learned on cross-examination of an internal study warning of the erosion risk.
“Their punitive damages award is a reflection, we believe, of how despicable this conduct was, how offensive this was,” Anderson told the newspaper.
“We believe the evidence showed Ethicon’s TVT-Secur device was properly designed, Ethicon acted appropriately and responsibly in the research, development and marketing of the product, and TVT-Secur was not the cause of the plaintiff’s continuing medical problems. Therefore, we are disappointed with today’s verdict and feel we have strong grounds for appeal,” an Ethicon spokeswoman said in prepared remarks.
A jury in Philadelphia awarded plaintiff Sharon Carlino $3.5 million in compensatory damages and $10 million in punitive damages in February 2016, finding that the Ethicon transvaginal polypropylene tape implanted during a 2005 hysterectomy was defective and that the company failed to adequately warn of its risks. Like Engleman, Carlino eventually needed 3 revision surgeries to remove the eroded mesh. A Pennsylvania state judge in January upheld the verdict.
In December 2015, a jury in the same court added $7 million in punitive damages to the $5.5 million in compensatory damages it leveled against Ethicon in the 1st of the mass tort cases to go to trial in Philly.
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