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Ethicon Media Monitoring 3/14/2019
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Retrial Jury Hears J&J Mesh Not To Blame For Woman's Pain
Mar 13, 2019 | Law 360
By Matt Fair
After jurors deadlocked six months ago on whether defects in a Johnson & Johnson unit’s pelvic mesh product left a Pennsylvania woman suffering from chronic pelvic pain, a new jury in the case heard opening arguments in Philadelphia on Wednesday blaming the injuries on menopause-related symptoms. -
Multidistrict Surgical Mesh Lawsuit Awards and Settlements Approach $11 Billion
Mar 13, 2019 | Lawyers and Settlements
By Anne Wallace
As the nation’s largest mass tort product liability lawsuit winds to a close, those who have suffered from surgical mesh complications and their attorneys are pausing to take stock. Not everyone is happy. -
Connah's Quay resident raising awareness of potential health complications caused by surgical mesh implants
Mar 13, 2019 | The Leader
By Joe Robinson
A Flintshire woman is campaigning to raise awareness of severe complications caused by surgical mesh implants used to quell problems following pregnancy. -
Health Canada starts releasing protected drug and medical device data
Mar 13, 2019 | CBC News
By Vik Adhopia
Nonie Wideman said a plastic mesh she had surgically implanted to support her bladder gave her debilitating health problems. Health Canada rejected her multiple requests to see the clinical evidence the department used to approve the mesh for use in Canada. -
Left inside: Drill bits among items left in patients
Mar 14, 2019 | New Zealand Herald
By Nicholas Jones
...That was demonstrated by the use of surgical mesh, which was removed from supply for some gynaecological procedures in December 2017, following problems including infection and chronic pain.
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Retrial Jury Hears J&J Mesh Not To Blame For Woman's Pain
Mar 13, 2019 | Law 360
By Matt Fair
After jurors deadlocked six months ago on whether defects in a Johnson & Johnson unit’s pelvic mesh product left a Pennsylvania woman suffering from chronic pelvic pain, a new jury in the case heard opening arguments in Philadelphia on Wednesday blaming the injuries on menopause-related symptoms.
Susan McFarland claims that a defective TVT-O pelvic mesh sling she received more than a decade ago to treat her urinary stress incontinence sawed through the soft tissue of her vagina, causing scarring and chronic pain.
But an attorney for J&J subsidiary Ethicon Inc., pointing to testimony from McFarland’s doctors, told jurors on Wednesday that another cause was to blame: the natural atrophying of vaginal tissue, which can occur with menopause.
“In a court of law, belief is not enough. Belief is not evidence,” Beck Redden LLP partner Kate Skagerberg said. “What is evidence is the testimony of Ms. McFarland’s own doctor, who will tell you that vaginal atrophy is the reason for the concerns that she complains about in this lawsuit.”
Ethicon managed to avoid liability in the case in September, but the jurors — even though they agreed the company's so-called TVT-O product had been negligently designed — deadlocked on a question over whether the implant had been the cause of McFarland's injuries.
The deadlock brought an uncertain end to what was then the seventh pelvic mesh trial that Ethicon had faced in Philadelphia.
Since then, however, an eighth mesh trial has resulted in a $41 million verdict against the company.
In total, six trials in Philadelphia have produced nearly $150 million in damages for recipients of Ethicon mesh implants.
McFarland’s case centers on an implant she received in 2008 to relieve symptoms of stress urinary incontinence.
A year-and-a-half later, however, McFarland reported that she was experiencing pain during sex, and doctors discovered that a portion of the implant had eroded through the wall of her vagina requiring surgery to remove.
Even after the revision surgery, McFarland has continued to suffer from frequent urinary tract infections that leave her bedridden, an inability to hold her bladder for more than an hour, and chronic pain.
But Skagerberg argued on Wednesday that the thinning and drying of McFarland’s vaginal walls as a result of menopause had been the reason the mesh eroded into her vagina.
Tracie Palmer, an attorney with Kline & Specter PC representing McFarland, countered that it was clear from scarring inside her client’s vagina that the mesh had been a substantial factor in the injuries at issue in the case.
“Why is a woman’s body being blamed for doing what it’s supposed to do when there’s a piece of plastic permanently implanted in it?” she asked.
She said Ethicon’s rush to get the product on the market in 2008 had resulted in the company failing to conduct a single clinical trial to ensure TVT-O’s safety.
“They put profits before patients, and women like Mrs. McFarland are the ones who’ve had to pay the price,” Palmer said. “They acted unreasonably as the manufacturer of a medical device meant to remain in a woman’s body forever.”
McFarland and her husband are represented by Tracie Palmer, Braden Lopinto, Shanin Specter and Lee Balefsky of Kline & Specter PC.
Ethicon is represented by Kate Skagerberg of Beck Redden LLP, Adam Spicer, Paul Rosenblatt and Jordan Walker of Butler Snow LLP and D. Alicia Hickok, Kenneth Murphy and Melissa Merk of Drinker Biddle & Reath LLP.
The case is Susan McFarland et al. v. Ethicon Inc. et al., case number 130701577, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
https://www.law360.com/articles/1117133/retrial-jury-hears-j-j-mesh-not-to-blame-for-woman-s-pain
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Multidistrict Surgical Mesh Lawsuit Awards and Settlements Approach $11 Billion
Mar 13, 2019 | Lawyers and Settlements
By Anne Wallace
As the nation’s largest mass tort product liability lawsuit winds to a close, those who have suffered from surgical mesh complications and their attorneys are pausing to take stock. Not everyone is happy.
The majority of cases filed in the seven multidistrict litigations (MDLs) consolidated in the Southern District of West Virginia have now been resolved. At one point, that included more than 100,000 individual lawsuits. In the cases that have settled or reached a verdict after trial, roughly $7.25 billion has gone to plaintiffs to compensate them for their injuries, and another $3.75 billion will likely be awarded in the near future.
On the other hand, plaintiffs are left to live with permanent and painful injuries. Some are dissatisfied with the settlement amounts they ultimately received after costs were netted out. In an unusual move intended to address this inequity, plaintiffs’ lawyers have sought to reduce the legal fees awarded to common benefit counsel. Lawyers fighting lawyers over money is bound to get nasty.
NINE YEARS, VERY COMPLEX ISSUESWhat began in 2010 with 36 plaintiffs suing C. R. Bard, Inc. over injuries attributable to Avaulta pelvic organ prolapse repair devices, ultimately mushroomed into seven MDLs involving 104,000 plaintiffs suing many defendants who manufactured many different pelvic mesh products. Individual plaintiffs were often implanted with different products manufactured by multiple defendant manufacturers, so their cases crossed several different product lines.
Along the way, both plaintiffs’ and defendants’ cases depended on expert information about urology, surgery, materials, chemistry, and other specialties. Bellwether trials finally brought many cases to settlement.
From a process point of view, the district court was clearly very pleased with the management of the lawsuit.
SMALL SETTLEMENTS, BIG JURY VERDICTSThe gross amount of settlement payments may seem quite large to the casual observer. Seven medical device manufacturers, including Boston Scientific and Johnson & Johnson, alone, will pay nearly $8 billion to resolve pelvic mesh claims.
The injured parties’ perspective, however, can be quite different. Although settlement amounts vary with individual circumstances, the average settlement is less than $60,000, according to the New York Times. One woman, who suffered pain and discomfort during sex because of her pelvic mesh implant, had hoped to use her settlement amount to pay for its removal. But after lawyers’ fees and other expenses, her $12,000 payout was reduced to only $3,500 – too little to pay for corrective surgery. In another situation recounted by the Times,, fees and other expenses reduced a comparatively generous $140,000 award to merely $50,000.
Consider, as well, that these MDL settlements occur against a background of far larger jury verdicts. In 2018, a jury in Bergen County New Jersey, awarded a woman who had been injured by her pelvic mesh implant and her husband a total of $68 million in compensatory and punitive damages. A Philadelphia jury recently awarded $41 million to another woman who suffered pelvic mesh injuries.
Even considering the differences in individual circumstances and the possibility that the cases involving more serious injuries may have been more likely to go to trial, the disparity between settlement amounts and jury awards is hard to ignore.
LAWYER V. LAWYERTo mitigate the harm caused by overly modest settlement amounts, attorneys for the MDL plaintiffs sought to reduce the percentage of the total settlement amount that was to be paid to the group of lawyers charged with the task of developing common resources for litigants. They argued for a reduction from five to two-and-a-half percent, but were ultimately unsuccessful.
LIVING WITH THE DAMAGEMeanwhile, the harm caused transvaginal mesh implants continues for many women. Between 3 and 4 million women worldwide have had mesh implanted to treat urinary incontinence and prolapse. About 5 percent of those have complications, including chronic pelvic pain, erosion of mesh into the vagina, incontinence, obstruction, pain in the groin, hip and leg, and pain during intercourse.
The complications can be hard to treat. Some doctors have compared the difficulty of removing mesh that has scarred into place to trying to remove bubble gum from hair or rebar from concrete. Scarring that occurs as a result of chronic inflammation may damage a woman’s vagina, bladder and urethra beyond complete repair.
Vaginal mesh is no longer being used in Australia, Ireland and Scotland. In July, the United Kingdom instituted a temporary ban while long-term damage is assessed. It’s a lesson not lost on American women. In the absence of more effective healthcare regulation, the best defense may be the most aggressive legal posture possible.https://www.lawyersandsettlements.com/legal-news/mesh-complications/multidistrict-surgical-mesh-lawsuit-awards-settlements-approach--23057.html
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Mar 13, 2019 | The Leader
By Joe Robinson
A Flintshire woman is campaigning to raise awareness of severe complications caused by surgical mesh implants used to quell problems following pregnancy.
Maxine Cooper, 56, has been undergoing treatment for four years following major health complications after she received a surgical mesh implant after pregnancy in 2010.
Mesh is a generic name for metallic or polymeric (plastic) implantable surgical devices used as a scaffold to reinforce weaknesses in tissue or bone throughout the human body.
There are several common conditions which it is used to treat, which include hernia, prolapse, stress urinary incontinence and breast reconstruction. They are implanted into men, women and children.
Ms Cooper, from Connah’s Quay, has been laid off work for two years now, and is doubtful she will be able to work again after being left with nerve damage.
She said: “I was working happily in the Flintshire youth justice service but have been on benefits for two years now as I have been unable to work.
“With the extent of the complications and nerve damage I have sustained, and the fact I’m not getting any younger, I’m not sure if if I’ll get back to work.”
Following experiencing stress incontinence after pregnancy nine years ago, she received a surgical mesh implant to deal with the problem.
However, after numerous fruitless doctor’s appointments after experiencing extreme pain and general discomfort, the problems she feared were finally revealed four years later after she received a conclusive second opinion from a specialist in London.
Following scans, it became clear the mesh had sliced through intimate areas of her body and had embedded in the urethra area of her bladder. She was unable to walk for two years, and has received two lots of major major surgery to have the mesh removed.
Because the complications are so complex, only a handful of surgeons across the country are able to conduct the surgery. This means Ms Cooper has had to continually travel to London for consultations and operations.
A number of complications can arise after having mesh implanted. Patients can suffer from internal injuries to neighbouring organs, blood vessels and nerves, which in turn can leave people with severe illnesses and disabilities. These are life altering conditions and in the worst-case scenario may result in death.
Ms Cooper said: “It’s just been an absolute nightmare, it’s completely ruined my life, the mesh has left me disabled and yet I haven’t received any form of care support or compensation.
“I’ve just been left to fend for myself. My niece is also undergoing treatment, and I know of a woman from Mold who is bed bound because she is so ill following the complications, and several others across Flintshire.
“I just want to raise awareness of this issue and warn women of the potential problems they may face, as otherwise they will walk blindly into the operation and could unwittingly become victims.”
Ms Cooper has organised a charity evening to raise money for support charity Mesh UK and Nightingale House hospice in Wrexham.
On Friday, March 29, at 7.30pm, acclaimed psychic medium and clairvoyant James Byrne will be in Connah’s Quay Navy Club for a night of supernatural communication.
Mr Byrne has in the past sold out the London Palladium and has put on more shows than any other psychic medium in the UK.
Tickets are priced at £10 with proceeds after expenses going to the charity. They can be bought from the navy club on Chapel Street in Connah’s Quay, or by calling 07532320779.
https://www.leaderlive.co.uk/news/17496707.connahs-quay-resident-raising-awareness-of-potential-health-complications-caused-by-surgical-mesh-implants/
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Health Canada starts releasing protected drug and medical device data
Mar 13, 2019 | CBC News
By Vik Adhopia
Data about medical devices and drugs that used to be carefully guarded by Health Canada is starting to be posted online. The information includes clinical trials and other submissions provided by companies that Health Canada uses when it considers approving medications and medical devices.
Up until now, the full data was not publicly available and restricted to particular researchers.
In a news release, the department wrote: "Canadians want greater access to credible information that will enable them to make well-informed decisions about their health and that of their families."
It went on to state the move is one of the transparency measures introduced under Vanessa's Law, which was passed in 2014, and is supposed to protect Canadians from unsafe drugs.
The Clinical Information Portal will include clinical trial information that shows the effectiveness of any new drug or device and whether there were any documented side effects.
The portal is off to a modest start, as there are only two records posted of the thousands of drugs and devices approved for use in Canada. But once regulations are finalized on March 20, Health Canada promised data for all new drugs and devices approved will be posted.Empty website a good analogy
University of Toronto medical researcher Dr. Nav Persaud is underwhelmed by the portal. "This empty website is a good analogy for Health Canada's approach to transparency," he said.
Persaud was involved in a years-long struggle with Health Canada to obtain clinical trial information used to approve a controversial morning sickness drug. He filed multiple requests and some of the data was eventually released, albeit heavily redacted, after he was forced to sign a confidentiality agreement. Persaud said he continues to wait for other data.
The physician said the public should have a right to this information, but that up until now it was "practically impossible".
"Health Canada continues to treat the results of clinical trials as confidential business information even though the clinical effects of a medication people are taking is clearly not," he said.'Upon request' for drugs, devices already on the marketHealth Canada said it will also now make any information about the medications and devices already on the market available "upon request" and then add the data to the portal.
The recent joint CBC News investigation, The Implant Files, revealed how patients who rely on medical devices are not entitled to see the clinical evidence used to approve the device implanted inside them.
In one case, a B.C. woman's request to see the clinical trial information used to approve the pelvic mesh that was breaking apart inside her was rejected by Health Canada because she was not considered a qualified researcher.
In response, the federal Health Minister Ginette Petitpas Taylor announced an action plan in December 2018 which promised to provide Canadians with more information on medical devices, such as clinical trial information and access to an adverse events database.
The move also brings Canada in line with the European Union's plans for greater transparency surrounding medical devices.
Health Canada has also launched a separate database of adverse reactions to drugs or medical devices. This information was previously not public until CBC News filed access to information requests and posted the data online.
https://www.cbc.ca/news/health/health-canada-drug-device-database-1.5054838
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Left inside: Drill bits among items left in patients
Mar 14, 2019 | New Zealand Herald
By Nicholas Jones
Swabs, bandages and drill bits have been left in patients after recent surgeries - and women undergoing gynaecological procedures are particularly affected.
Health boards have reported 63 incidents over the past three years where materials or surgical items were mistakenly left in patients too long.
In one case, a surgical drill bit snapped and a piece was left in a patient's jaw. It was removed later after a more senior surgeon reviewed the case and thought it could cause damage.
Another person suffered repeat infections after a drainage tube was left in their chest for three years.
A Herald survey of adverse event reports for each of the country's 20 DHBs shows about a third of cases happened when swabs, gauze and bandages were left inside women after childbirth or gynaecological procedures. That number may be higher, given many DHBs don't specify what surgery was carried out when listing "retained foreign object" incidents.
Health boards have policies to stop retainment of materials, including making sure every item in theatre is checklisted before and after a surgery. However, in some cases policies weren't in place, or weren't followed. Staff under pressure and poor equipment design were also cited as factors.
At Counties Manukau, a vaginal pack was left in a patient after the pack's "tail" wasn't secured to a leg. Gauze was left in another woman after being taken from a trolley after the final equipment count was done.
Whanganui DHB filed a report in 2015-2016, after a woman who had a routine gynaecological surgery went to ED a few days later because of pain and other symptoms. Six weeks later she was back at ED, in even worse shape. A CT scan showed a surgical clip was blocking a duct connecting the kidney to bladder.
"The patient required further multiple surgeries and unfortunately continues to have problems requiring treatment at another DHB," the report states.
Sue Claridge, coordinator of the Auckland Women's Health Council, said women often bore the brunt of medical mishap.
That was demonstrated by the use of surgical mesh, which was removed from supply for some gynaecological procedures in December 2017, following problems including infection and chronic pain.
The reported cases of retained objects were low, Claridge said, but could be the "tip of the iceberg", given research had shown adverse events were generally underreported.
Doctors were human and mistakes happened, she said. The response was crucial.
"How seriously are they taking patients when they complain something's not right, and what systems and process are being put in place to ensure it doesn't happen again?"
Adverse events are monitored by the Health Quality & Safety Commission, which has circulated documents advising how to guard against mishaps. It also supports simulation training, and promotes the use of a safety checklist, including a count of items such as instruments and sponges.
A spokeswoman for the commission said existing systems were effective in preventing mistakes, and research had proven the effectiveness of the surgical safety checklist.
"International literature suggests only a small portion of adverse events are reported. In New Zealand, DHBs seek to create a culture where staff feel safe to report adverse events, and we are seeing this reflected in the increase in numbers of reported events to the commission."
A change in July 2017 required DHBs to always report "retained foreign object" events, even if there was minimal or no harm. That tweak explained a nearly 60 per cent increase in reported events in 2017/18.
DHBs must review each incident and outline findings and changes made as a result. Most cases involve material such as swabs, but a few incidents involved surgical equipment.
Wellington's Capital & Coast DHB in 2015/16 reported the tip of an instrument used to position the uterus during surgery had come off and been left in a patient.
Drill bits remained in patients in two cases. In one instance at Counties Manukau, the wrong drill guide was used during a jaw operation.
"Excessive bending of the drill led to drill bit snapping," the DHB summarised in its 2015/16 report. "It was initially thought that the drill was flush with the bone, but later review by a senior doctor identified the need to remove retained drill bit due to the potential damage to surrounding tissue.
"Supervision for junior doctors needs to be congruent with level of experience and capability."
https://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=12211549
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