Preview Newsletter
Ethicon Media Monitoring 4/29/2019
-
U.S. bans mesh as pressure mounts on British regulators
Apr 28, 2019 | The Sunday Post
By Marion Scott
US medical regulators have banned mesh implants for pelvic organ prolapse after manufacturers failed to prove they were safe. -
Pelvic mesh lawyers pressured clients to dismiss cases to avoid costs of trial
Apr 26, 2019 | Legal News Line
By Daniel Fisher
A law firm representing thousands of pelvic mesh plaintiffs gave some of its clients two days to decide whether to dismiss their lawsuits and accept a proffered settlement from Johnson & Johnson, or risk incurring substantial costs preparing for trial. -
Philadelphia jury levies $120M verdict on pelvic mesh manufacturers Johnson & Johnson, Ethicon
Apr 26, 2019 | The Pennsylvania Record
By Nicholas Malfitano
A Philadelphia jury has handed down a $120 million verdict in favor of a plaintiff who claimed she suffered pain, incontinence and an inability to have sexual intercourse with her husband, after being implanted with pelvic mesh manufactured by Johnson & Johnson and its subsidiary, Ethicon, Inc. -
The End Game – Pelvic Mesh Cases Pushed to Resolve or to Trial
Apr 26, 2019 | Mesh Medical Device News Desk
By Jane Akre
Is the end in sight for pelvic mesh litigation, at one time the largest consolidation of injury cases filed in one court? The resolution of your case may depend on just how seriously you were injured but settlement or trial appears to be on the horizon. -
Johnson & Johnson forced to pay $9.9 million over role in vaginal mesh scandal
Apr 26, 2019 | Woman&Home
By Samantha Simmonds
NICE sparked outrage when it ruled that the NHS could resume its use of vaginal mesh earlier this month, but over in the US, campaigners are celebrating a big win. -
Submit report on any adverse reaction to pelvic mesh, J&J told
Apr 27, 2019 | The Hindu
By Bindu Shajan Perappadan
Days after the U.S. Food and Drug Administration (FDA) banned surgical pelvic meshes — used to support the abnormal descent of the pelvis in women — following reports of adverse reactions, the Union Health Ministry has written to pharmaceutical giant Johnson & Johnson seeking information on the import, sale and stock of the product in the last three years.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
U.S. bans mesh as pressure mounts on British regulators
Apr 28, 2019 | The Sunday Post
By Marion Scott
US medical regulators have banned mesh implants for pelvic organ prolapse after manufacturers failed to prove they were safe.
The ban puts more pressure on UK watchdog NICE after it decided the controversial implants could safely be reintroduced in England.
Dr Jeffrey Shuren, director of the US Food and Drug Administration’s Centre for Devices and Radiological Health, said: “Patient safety is our highest priority, and women must have access to safe medical devices.”
Compensation paid to mesh victims in the States has already topped £10 billion.
Campaigner Elaine Holmes of Scottish Mesh Survivors said the FDA move was “too long overdue” and criticised NICE for “even suggesting this product should be brought back”.
Ms Holmes said: “Hundreds of thousands of women around the world have suffered life-changing injuries. How many more must die and how many more families will be left to pick up the shattered pieces before our medical regulators do the right thing?”
NICE made the announcement that it supports the continued use of pelvic organ prolapse mesh by specialist surgeons once a register is set up linking adverse incidents to the Medicines and Healthcare Products Regulatory Agency (MHRA).
It previously supported the withdrawal of pelvic organ mesh, and a change of heart sparked outrage among campaigners.
Mesh implant use is currently suspended across the whole of the UK pending an inquiry by Baroness Cumberlege who has been outspoken about the injuries suffered by thousands of women.
Politicians in Scotland say they will continue to back the campaign against the reintroduction of mesh.
MSP Neil Findlay said: “This a major move by the FDA.
“This should send a message to health regulators across the world that mesh should not be used in women’s bodies.”
An MHRA spokeswoman said: “We are aware of the FDA’s decision and we will closely monitor the situation and consider what action, if any, is needed.”
A NICE spokesman said: “At the time of publication NICE’s updated guideline, the high vigilance restriction is still in place and, until it is ends, professionals should continue to follow its requirements.”
https://www.sundaypost.com/fp/u-s-bans-mesh-as-pressure-mounts-on-british-regulators/
-
Pelvic mesh lawyers pressured clients to dismiss cases to avoid costs of trial
Apr 26, 2019 | Legal News Line
By Daniel Fisher
A law firm representing thousands of pelvic mesh plaintiffs gave some of its clients two days to decide whether to dismiss their lawsuits and accept a proffered settlement from Johnson & Johnson, or risk incurring substantial costs preparing for trial.
The letter from Aylstock, Witkin, Kreis & Overholtz put women who claim injuries from mesh implants in a tough spot, said Elizabeth Burch, a professor at the University of Georgia Law School. Unless they informed the law firm of their decision by April 24, the letter said, Aylstock, Witkin would dismiss their cases without prejudice, meaning they could be refiled. If they refused to dismiss their cases, the law firm warned clients they could be liable for costs of pretrial discovery, travel and other expenses.
“The letter was dated April 23, so women had one day to make a major, potentially life-changing decision or their case would be automatically dismissed,” said Burch, who obtained a copy of the letter as part of her research into how mass tort multidistrict litigation is administered.
“That’s what I find most worrisome.”
Aylstock Witkin didn’t respond to a request for comment. Burch, who described the incident in a blog post, said she spoke with a lawyer at the firm who said the apparent take-it-or-leave-it offer was part of a well-advanced settlement effort. Women are being informed in separate letters about their settlement offers, which are confidential, and they can appeal to a special master if they think their offer is too low.
Johnson & Johnson and other mesh manufacturers have offered more than $8 billion to settle lawsuits although they still face more than 100,000 cases. This week, a Philadelphia jury ordered Johnson & Johnson to pay $120 million in a mesh implant case.
Aylstock Witkin attributed the need to move quickly to “aggressive deadlines” set by U.S. District Judge Joseph Goodwin in West Virginia, who is overseeing the mesh MDL.
“The imposition of these deadlines creates a problem – complying with them will require significant time and significant expense which, in turn, will make settling your Ethicon claim in the near future more difficult,” Aylstock Witkin said in its letter to mesh clients.
Judge Goodwin’s last significant order on deadlines came on February 4, however, when he threatened to move thousands of cases from the “inactive docket” onto an active schedule for trial. Plaintiffs were required to submit paperwork supporting their claims by Feb. 15, written discovery requests by March 25 and their expert witnesses were to be disclosed by May 24.
Given the judge informed parties of his deadlines months ago, Burch said, “I don’t see the urgency.”
The episode illustrates the tensions and outright conflicts that can arise between mass-tort plaintiffs and their lawyers, especially when lawyers negotiate settlement deals with defendants that require a certain level of participation to go forward. Lawyers have an incentive to get the deal done so they can collect their fees and move on to the next mass tort. But individual plaintiffs might get a better offer if they maintain the threat of going to trial, Burch said.
In conversations with some of the mesh plaintiffs who received the letter, she said, the women said they felt pressured to drop their cases. One woman said a person at Aylstock Witkin told her she’d have to pay her own travel expenses to attend depositions if she proceeded toward trial.
Normally plaintiffs in mass tort cases like the mesh MDL are represented under contingency fee contracts in which their lawyers front the costs of litigation in exchange for a percentage of any winnings. While litigation expenses are also deducted from any recovery, it would be unusual for contingency fee lawyers to require their clients to pay any costs up front.
Mesh litigation has generated other examples of aggressive tactics by plaintiff lawyers. In an expose last year, the New York Times reported how some women were pressured into having unnecessary surgery to remove their implants in order to increase the settlement value of their cases. The Food and Drug Administration advises women not to undergo surgery if they don’t have complications or symptoms.
Millions of women have received transvaginal mesh implants to repair pelvic problems including prolapse, but the product is also associated with injuries including bleeding, infection and damage to the vagina. The FDA this month ordered Boston Scientific and another company to take their mesh products off the market pending a review of their safety and effectiveness.
https://legalnewsline.com/stories/512455904-pelvic-mesh-lawyers-pressured-clients-to-dismiss-cases-to-avoid-costs-of-trial
-
Philadelphia jury levies $120M verdict on pelvic mesh manufacturers Johnson & Johnson, Ethicon
Apr 26, 2019 | The Pennsylvania Record
By Nicholas Malfitano
A Philadelphia jury has handed down a $120 million verdict in favor of a plaintiff who claimed she suffered pain, incontinence and an inability to have sexual intercourse with her husband, after being implanted with pelvic mesh manufactured by Johnson & Johnson and its subsidiary, Ethicon, Inc.
The verdict, comprised of $20 million in compensatory damages and $100 million in punitive damages, is the seventh result delivered in favor of pelvic mesh plaintiffs in Philadelphia courts and more than double the formerly-largest jury award for a pelvic mesh trial in Philadelphia, $57 million.
It brings the total amount of damages awarded to pelvic mesh plaintiffs in Philadelphia to more than $270 million.
Tracie Palmer of Kline & Specter, a member of counsel for plaintiff Susan McFarland, issued a statement on the trial result.
“This verdict speaks volumes. This is a product still on the market and the jury’s message to Johnson & Johnson is take this product off the market for the health and safety of America’s women,” Palmer said.
A spokeswoman for Ethicon explained the company intends to appeal the verdict.
“While Ethicon empathizes with women who experience medical complications, this verdict and the damages awarded are inconsistent with the science, Ethicon’s actions, and previous verdicts related to our TVT-O product, which continues to be the gold standard of treatment for stress urinary incontinence,” Mindy Tinsley said.
“We believe the evidence showed Ethicon’s TVT-O device was properly designed and that Ethicon acted appropriately and responsibly in the research, development and marketing of the product. We respect the legal process, but we want to reiterate that jury verdicts are not medical, scientific or regulatory conclusions about a product and Ethicon will appeal this verdict.”
In 2008, McFarland, an Altoona resident, was suffering from pelvic floor-related medical issues and was subsequently implanted with the defendants’ Gynecare TVT-O pelvic mesh implant device. The mesh is used to counteract the effect of pelvic organ prolapse, a condition in which organs sometimes drop due to age or injury and which can result in urinary incontinence.
However, McFarland said the mesh malfunctioned and damaged her pelvis’ soft tissue before puncturing her vagina. She explained this required her to undergo revision surgery to remove broken pieces of the implant, but she allegedly suffered chronic and lasting pain preventing her from sexual contact with her spouse.
Counsel for McFarland argued the defendants rushed the mesh device to market without conducting proper testing to determine if it was safe for patient use.
McFarland’s case initially resulted in a mistrial last September, with the jury firmly deadlocked on the liability of the mesh product in causing her injuries. A retrial began in March before ending this week in the large jury verdict.
The verdict arrives only days after the Food & Drug Administration ordered pelvic mesh product manufacturers to immediately cease sales of their products, as there was no “reasonable assurance” that they were safe.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair pelvic organ prolapse. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
“Patient safety is our highest priority, and women must have access to safe medical devices that provide relief from symptoms and better management of their medical conditions. The FDA has committed to taking forceful new actions to enhance device safety and encourage innovations that lead to safer medical devices, so that patients have access to safe and effective medical devices and the information they need to make informed decisions about their care.”
Earlier this month in a separate case, a jury found in favor of Johnson & Johnson and Ethicon in a similar pelvic mesh trial.
https://pennrecord.com/stories/512455002-philadelphia-jury-levies-120m-verdict-on-pelvic-mesh-manufacturers-johnson-johnson-ethicon
-
The End Game – Pelvic Mesh Cases Pushed to Resolve or to Trial
Apr 26, 2019 | Mesh Medical Device News Desk
By Jane Akre
Is the end in sight for pelvic mesh litigation, at one time the largest consolidation of injury cases filed in one court? The resolution of your case may depend on just how seriously you were injured but settlement or trial appears to be on the horizon.
The Facebook message came from a woman who had just received a letter from her law firm. Sounding panicked she asked what it meant.
I reminded her I’m not a lawyer (if I had a dollar or every time I’ve said that I could fund Mesh News Desk (MND) – LOL) and she sent the letter for me to read.In a nutshell it said:They wanted her to dismiss her Ethicon case without prejudice (meaning it can be refiled after a year), a move Ethicon had agreed to.
The move was to save her money since Judge Goodwin was now fast-tracking the remaining pelvic mesh cases on the docket into Wave 11 aiming for a fall 2019 trial. That meant trial preparation – hiring experts and discovery. By dismissing, she no longer had to comply with the deadlines set by the judge. She had to let them know immediately. Meanwhile settlement process would continue including talks with the Special Master who is negotiating the final numbers.But she had refused her settlement.
It felt like a heavy-handed way to force her to accept the Ethicon settlement or else she could be on the hook for tens of thousands of dollars in the “costs” of preparing her case for trial. Not much of a choice.
On the other hand, if she was prepared to eventually take a settlement, but the number still being negotiated, why spend tens of thousands of dollars on experts and the cost of discovery? (travel, depositions etc.) And her statute of limitations would not be effected if she dismissed without prejudice.
Still it felt like a power move, she said, forcing us to settle.
The last part was especially troubling, especially since she was given 48 hours to make a decision.
“Unless you direct us not to, we will be dismissing your claim against Ethicon without prejudice. If you do not want us to dismiss your claim without prejudice in accordance with the above, you must contact us by April 24, 2019, and tell us the same.”
So What’s Going On?
The truth is Judge Joseph Goodwin who has overseen the largest personal injury multidistrict litigation (MDL) consolidated into one courtroom, wants to clear out the docket. He is way past retirement age and has been at this pelvic mesh MDL since early 2012.
Last year he closed the MDL to any new cases after it swelled to more than 104,000.
Then in February of this year, Judge Goodwin issued PTO #328 (here) which says basically – Move it Along!
Get off the “Inactive Docket” Goodwin said to 7,000 mesh injured women. They have resided there as early as July 2017 and have either been settled or are in a settlement mode.
To push things ahead, Judge Goodwin said he had no option but to place the cases back on the active docket and subject them to a vigorous schedule heading toward a fall 2019 trial that would become Wave 11 (Waves are cases consolidated and tried together).
Essentially, he instructed law firms to get your cases ready for trial and be prepared to meet the deadlines he set for trial preparation.
That move is what sparked the letter from AWKO to its clients.
Aylstock Anxious to Try Cases
Bryan Aylstock told Mesh News Desk he has several dozen cases he is “anxious to take to trial” and will wait until they are remanded back into federal court in the woman’s district.
The letter only went out to women who had indicated they would like to consider a settlement, he said.
That comes as news to the woman who called MND.
She had rejected her settlement and talked to a “very condescending” woman in Aylstock’s office.
“If she’s rejected the settlement the letter will not apply,” Aylstock told MND.
Call our office, he said. Nobody is abandoning clients.
Valuable Cases
The truth is every woman believes her case is valuable. She has been violated in her most personal places and often abused and abandoned by her doctor.
The truth is, despite her feelings of violation, some cases are considered more valuable than others, and those will be the cases moving forward.
You can blame Ethicon. Its partially-funded medical society AUGS, still calls TVT (Tension free vaginal tape) the Gold Standard and and fully promotes its use.
Ethicon has clearly stated that in the future it will not pay any settlements to a woman with a TVT or a TVT-O (obturator) mesh in place, even though TVT-O has been found defective in a court of law.
And trial lawyers understand a sacrocolpopexy (abdominal placement of mesh) is not as good a case to bring to trial in terms of value as a Prolift POP mesh with serious injuries.
At the end of the day, lawyers want those valuable cases with a number of removal surgeries.
Aylstock says he is flying lawyers around the country taking depositions and spending money in preparing cases for trial.
Vigna Preparing for Trial
Greg Vigna, MD, JD who is active in the Wave discovery process for women with neurological injuries including pudendal neuralgia for Ethicon and Boston Scientific injuries, says he too is ready for trial.
He believes the move by Judge Goodwin is good news for women experiencing severe neurological injuries. They should have their day in court, he tells MND. The year given if one dismisses without prejudice will provide the time necessary for expert reports and life care plans to get them ready for trial.
Vigna, who is a doctor and a lawyer, will also be particular about the cases he takes forward. Because of his background, is getting cases referred from other law firms.
“I’ve been a pudendal nerve expert and I know catastrophic woman when I talk to one. They have complex regional pain syndrome, severe dyspareunia, and severe injuries. A TVT-O with pudendal neuralgia, obturator neuralgia, Prolift devices, Uphold devices, Align devices – We are handling catastrophic neurological complications from all devices. My team and I will be doing these until the devices are removed off the market!”
Referring to the FDA’s recent decision to stop the sale of POP mesh devices, Vigna believes the next thing off the market is the transobturator (TVT-O) devices and the mini-sling.
“Finally, it will be the retropubic slings,” he said referring to devices that the AUGS still calls the Gold Standard.
https://www.meshmedicaldevicenewsdesk.com/the-end-game-pelvic-mesh-cases-pushed-to-resolve-or-to-trial/
-
Johnson & Johnson forced to pay $9.9 million over role in vaginal mesh scandal
Apr 26, 2019 | Woman&Home
By Samantha Simmonds
NICE sparked outrage when it ruled that the NHS could resume its use of vaginal mesh earlier this month, but over in the US, campaigners are celebrating a big win.
Women who have had the devices, which are made of polypropylene mesh, implanted to treat pelvic organ prolapse or urinary issues like incontinence have reported complications including chronic pain and infections, and even permanent nerve damage.
Johnson & Johnson, who made the surgical mesh devices, were due to stand trial in Washington this week, after Attorney General Bob Ferguson accused them of misrepresentation and failure to disclose serious risks in their instructions and marketing materials.
But rather than go to trial, the medical giant opted to settle out of court, paying out a whopping $9.9 million.
In a deposition, the company’s Global Head of Medical Affairs, Piet Hinoul, admitted that Johnson & Johnson knew about serious risks including chronic pain and pain with sexual intercourse ‘from day one’, but didn’t disclose them to patients.
Ferguson announced that the payment would go towards helping women who’d had pelvic mesh implants. The Attorney General’s Office estimates that hundreds of Washington women have suffered life-altering complications from vaginal mesh surgery.
One woman reported that she was housebound and suffering from depression and loneliness as a result of chronic urinary tract infections, leg cramps and back pain.
Others flagged up how tough it was to remove the mesh in the event of complications, with one woman going through three rounds of surgery for pain and incontinence to remove just part of the device. Another woman revealed that her doctor had told her that trying to remove the mesh was like ‘trying to remove chewing gum from hair’.
In some cases, the consequences are irreversible. One doctor told Johnson & Johnson that their patient’s vagina was ‘permanently destroyed’ due to vaginal mesh in 2009.
“Johnson & Johnson’s knowing deception caused women to suffer in deeply personal ways,” Ferguson declared. “I’m proud of my team for holding a powerful interest accountable for its egregious conduct.”
Kath Sansom, of Sling the Mesh, who campaign on behalf of the women affected by pelvis mesh implants, has recently spoken out about more action needs to be taken against the scandal – and fast.
“The FDA was so concerned for women’s safety that it banned vaginal prolapse mesh. The move came just two weeks after UK health watchdog NICE unbanned this type of mesh, having banned it 18 months earlier in December 2017,” she told woman&home. “The move makes a mockery of NICE guidelines. If we cannot trust them to get it right on vaginal prolapse mesh how can we trust them to get it right on guidelines for incontinence mesh slings and abdominal prolapse mesh.”
“All women’s pelvic mesh has the potential to cause serious, life changing, irreversible damage to women. The longer the time goes on the more women will start coming forward suffering as mesh has the potential to sit like a ticking time bomb for years. Sling The Mesh demands a 20 year retrospective audit to work out the true scale of this horrendous women’s health scandal.”
https://www.womanandhome.com/health-and-wellbeing/health-wellbeing-news/johnson-johnson-mesh-scandal-319655/
-
Submit report on any adverse reaction to pelvic mesh, J&J told
Apr 27, 2019 | The Hindu
By Bindu Shajan Perappadan
Days after the U.S. Food and Drug Administration (FDA) banned surgical pelvic meshes — used to support the abnormal descent of the pelvis in women — following reports of adverse reactions, the Union Health Ministry has written to pharmaceutical giant Johnson & Johnson seeking information on the import, sale and stock of the product in the last three years.
“We have also requested for information/report on any adverse reactions,’’ said a senior health official.
The Ministry is also looking at the fact that the company’s licence to import it expired in March 2019 and it hasn’t come up for renewal yet.
While the Indian manufactures claim that they aren’t making vaginal mesh, an official added that other international mesh makers — Boston Scientific and Coloplast — were not registered for the import of mesh in India.
Seeking an immediate ban on the use of the product, Rajiv Nath, forum coordinator of the Indian Medical Device Industry, said: “Our regulators approve import of notified medical devices on the basis of the USFDA and other such regulatory approval so when these countries ban specific devices, Indian regulators too need to automatically cancel import licences and impose the same restrictions. It is distressing when these reputed overseas manufactures continue to sell in India suspect quality batches of products that they have recalled or been asked to recall by their regulatory authority abroad.’’
Explained Malini Aisola, health researcher, co-convenor of the All India Drug Action Network (AIDAN): “As per AIDAN’s analysis, a number of mesh products for use in hernia repair, urinary incontinence and prolapse repair have been approved in India. Given the horrific adverse events associated with the pelvic mesh in Western countries which has led to the ban, the Indian regulatory body must take immediate measures to protect patients — by initiating local investigations and issuing show cause notices on the way to ordering mandatory withdrawal of these products.’’
She added that it was tragically ironic that the Indian regulator willingly relies on the decisions of foreign regulatory authorities to grant companies access to the market, but was reluctant to act on the decisions of those same agencies to protect patient safety.
https://www.thehindu.com/news/national/submit-report-on-any-adverse-reaction-to-pelvic-mesh-jj-told/article26968041.ece
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested