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Ethicon Media Monitoring 9/29/2017
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Risk on All Sides as 4,800 Women Sue Over Johnson’s Baby Powder and Cancer
Sep 28, 2017 | The New York Times
By Tiffany Hsu
... Another 55,500 cases concern pelvic mesh for women, which attorneys general in Washington and California said caused urinary dysfunction, loss of sexual function, constipation and other complications. -
Mesh patients say they were 'duped'
Sep 28, 2017 | BBC
Mesh survivor Elaine Holmes said she and fellow patient Olive McIlroy were kept on the Scottish group to make its final report appear "less biased". -
BBC Radio: Reporter Scott on Transvaginal Mesh and Parliament
Sep 28, 2017 | Mesh Medical Device Newsdesk
Scotland’s Sunday Mail journalist, Marion Scott, talks to BBC Radio this morning about the transvaginal mesh issues that will be presented to a Parliamentary Petitions Committee today. -
Woman who sued Johnson & Johnson for £42,500,000 describes horrific pain of vaginal mesh implant
Sep 28, 2017 | Metro.co.uk
By Nicole Morley
A woman who sued Johnson & Johnson for £42,500,000 has spoken out about the horrific pain caused by a faulty mesh implant. Ella Ebaugh, 51, was forced to undergo three surgeries after the mesh eroded into her urethra. -
Mesh implant patients claim they were ‘cynically used’ to balance report
Sep 28, 2017 | Press Association ( In Evening Express)
Two patients who were part of the review group looking at the safety of mesh implants in Scotland have told MSPs they were “cynically used” to make its final report appear “less biased”. -
Ethicon Hernia Mesh Lawsuits Move Forward, As Court Approves Use of Short Form Complaint in Federal Physiomesh Litigation
Sep 28, 2017 | RX Injury Help
By Laurie Villanueva
The federal court overseeing dozens of hernia mesh lawsuits involving Ethicon, Inc.’s Physiomesh products has approved the use of a Short Form Complaint, which will greatly streamline the process of filing new cases in the multidistrict litigation now underway in the U.S. District Court, Northern District of Georgia.
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Risk on All Sides as 4,800 Women Sue Over Johnson’s Baby Powder and Cancer
Sep 28, 2017 | The New York Times
By Tiffany Hsu
Thousands of women across the country are suing the consumer goods giant Johnson & Johnson over its baby powder, claiming that talcum particles in the popular product caused their ovarian cancer.
The plaintiffs, however, are not working as a team. They are taking the company to court one at a time.
In many product liability complaints, class action status is difficult to win, given the various ways the product can be sold and used. Such cases often end up being individually litigated with the expectation that there will eventually be a mass payout.
This approach can be effective, according to plaintiffs’ lawyers. Each successive verdict, they say, sends a signal about how much plaintiffs can expect to be paid if, and when, a company agrees to settle.
“You can’t get to a global settlement until both sides have a really clear sense of the strengths and weaknesses and value of these claims,” said Nora Freeman Engstrom, a professor at Stanford Law School. “And the only way to test that is on the battlefield, which is trial.”Continue reading the main story
But going to court is expensive and risky — for both sides.
The tally of damages from verdicts against Johnson & Johnson is already in the hundreds of millions of dollars. And the harm to the company is not just financial: Its reputation could suffer if baby powder, one of its longest-standing products, is seen by the public as unsafe.
The cases are emotionally compelling.
Many of the plaintiffs — 4,800 as of July 2 — are extremely ill. In addition to seeking restitution, they are asking that Johnson & Johnson add a warning to its baby powder label or replace the product entirely with a similar one formulated with cornstarch.
Class action status “ends up taking the individuality out of the cases,” said Allen Smith, a lawyer who has represented plaintiffs in all of the cases to go to trial. And, he said, each victim “deserves the opportunity to have her day in court as fast as possible.”
But the safety concerns are based on inconclusive science.
Talcum powders contain talc, which includes moisture-absorbing particles of oxygen, magnesium and silicon. Asbestos, a known carcinogen that sometimes appears in natural talc, was stripped from all commercially used talc in the 1970s, according to the American Cancer Society.
Plaintiffs in the talc cases, citing studies from 1971 on, said that talc in baby powder can be absorbed by the reproductive system and cause inflammation in the ovaries when applied for feminine hygiene purposes.
But the National Cancer Institute said on its website that “the weight of evidence does not support an association between perineal talc exposure and an increased risk of ovarian cancer.”
As for sending a signal, the cases are mixed at this point.
Johnson & Johnson has lost six of the seven cases decided so far. A New Jersey state court judge dismissed two other complaints last year before they reached trial, ruling that the plaintiffs lacked credible scientific evidence.
Johnson & Johnson, which is appealing the verdicts that favored plaintiffs, said in a statement last month that it was “guided by the science.” It did not comment on whether it planned to pursue a global settlement.
“Ovarian cancer is a devastating diagnosis and we deeply sympathize with the women and families impacted by this disease,” said Carol Goodrich, a spokeswoman for the company. “We are preparing for additional trials in the U.S. and will continue to defend the safety of Johnson’s Baby Powder.”
The company is no stranger to enormous legal challenges.
As of early July, Johnson & Johnson faced lawsuits stemming from its blood thinner Xarelto, which 20,000 plaintiffs said caused uncontrollable bleeding. Another 55,500 cases concern pelvic mesh for women, which attorneys general in Washington and California said caused urinary dysfunction, loss of sexual function, constipation and other complications.
The first talc trial was in 2013 in Federal District Court in South Dakota. A jury found Johnson & Johnson negligent in a complaint filed by a Sioux Falls resident, Deane Berg, 60, but did not award her damages.
Ms. Berg, who used the company’s baby powder for 40 years and developed ovarian cancer in 2006, said she had turned down a $1.3 million settlement offer from the company. She instead wanted, but failed to force, the company to put warning labels on the product or to remove it from shelves.
Ms. Berg said she had endured “brutal” chemotherapy for six months and had also sustained permanent hearing loss, nerve damage, anemia and depression. Her cancer is in remission.
“It would be better to put all of these cases together and go after Johnson & Johnson for the whole thing,” she said.
So far, pretrial procedures in nearly 900 talc cases have been consolidated into what is known as a multidistrict litigation, or MDL. Complaints filed in different federal courts are being transferred to a single bundle in Federal District Court in New Jersey, where Johnson & Johnson is based and where many of its employees would probably serve as witnesses.
MDLs tend to reduce costs and time. Only one set of expert witnesses needs to be called. Lead lawyers chosen for each side oversee the process.
More consistency from the courts could mean a smaller legal bill for Johnson & Johnson.
By 2007, three years after the drugmaker Merck removed its Vioxx pain medication from pharmacy shelves, the company had paid more than $1 billion in legal fees over nearly 20 trials before agreeing to spend $4.85 billion to settle 27,000 lawsuits. Plaintiffs claimed, and evidence showed, that the drug increased the risk of heart attacks and strokes.
For Johnson & Johnson, which recorded $806 million in net litigation expenses for the 2016 fiscal year and at least $400 million during the second quarter of fiscal 2017, the most painful blow in the talc litigation came on Aug. 21.
That was when a jury in Los Angeles County Superior Court awarded Eva Echeverria, 63, of California, $417 million in her case against the company.
The decision included $347 million in punitive damages, which are awarded in only 5 percent of civil trials in which plaintiffs are successful, according to government data. Juries typically tack on punitive damages to a standard compensatory award when they deem a defendant’s behavior to be especially harmful.
“To me, that’s a very prudent, reasonable award, to be honest,” said Mr. Smith, one of Ms. Echeverria’s lawyers.
Clients must wait out the appeals process before receiving a payout, Mr. Smith said. Not that Johnson & Johnson, which recorded $16.5 billion in profits last year, would appear to be too worried about the money.
“In the history of major litigation cases against big pharma, there’s only been a few that really raise the bar to impacting the stock, but we haven’t seen those in a long time,” said Damien Conover, an analyst at Morningstar. “There’s a lot of room for a company like Johnson & Johnson to digest legal costs.”
https://www.nytimes.com/2017/09/28/business/johnson-and-johnson-baby-talcum-powder-lawsuits.html?_r=0
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Mesh patients say they were 'duped'
Sep 28, 2017 | BBC
Mesh survivor Elaine Holmes said she and fellow patient Olive McIlroy were kept on the Scottish group to make its final report appear "less biased".
Ms Holmes appeared before Holyrood's Public Petitions Committee.
They called for MSPs to ensure the current suspension of mesh procedures "remains firmly in place".
Transvaginal mesh implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women, conditions that can commonly occur after childbirth.Severe complications
Over the past 20 years, more than 100,000 women across the UK have had transvaginal mesh implants - including more than 20,000 in Scotland.
But some have suffered painful and debilitating complications.
There are more than 400 women currently taking legal action against Scottish health boards and manufacturers as a result of mesh implant surgery.
In 2014, former Scottish Health Secretary Alex Neil called for the suspension of such procedures, and an independent review group was set up to look at safety issues.
Ms McIlroy, from Renfrew, and Ms Holmes, from East Renfrewshire, who both suffered severe complications following mesh implant surgery, were patient representatives on the independent review group.
They quit earlier this year claiming that the final report had been watered down.
Ms Holmes told the Holyrood committee the report was a "whitewash".
"We were cynically used to make the report appear less biased to the public and to those of you here today," she said. "We were duped, used.
"We are not politicians, doctors or statisticians, we are ordinary women horrified by failure rates of an operation and the severity of injuries that can be life-changing and life-threatening."'Not in our name'
Ms Holmes said they went to Health Secretary Shona Robison before the report was published to ask her to delay publication until their concerns were investigated.
"It was to no avail. She accepted the final report and its conclusions, ignoring our concerns and publishing the final report just 11 days after our meeting. Any hope we had for change was completely dashed," she said.
Ms Holmes said the final report was "not in our name".
Public Petitions Committee convener Johann Lamont later said the evidence raised a range of "very concerning" issues about the process that produced the report.
She said a "lack of respect and credence" appeared to have been given to patients' views and experiences.
The Labour MSP said a debate had been secured in the Scottish Parliament chamber and she had written to the health secretary.
Catherine Calderwood, the Scottish government's chief medical officer, said "The patient representatives are the reason this review was carried out.
"They bravely came forward to tell their stories so it's extremely disappointing to hear that they do not feel they've been listened to.
"I've met with them several times and I certainly have heard their concerns and the harm they suffered with mesh."
During her evidence, Ms Holmes also attacked medical watchdogs MHRA (Medicines and Healthcare products Regulatory Agency).
She said it was "toothless and far too close" to manufacturers of medical devices.
"We need new health watchdogs who will insist on proof to show that devices and medicines are safe and effective," she added.Less than satisfied
Committee member Alex Neil, who dealt with issue when he was health secretary, said this was the third scandal in the past few years where the MHRA's role had been "less than professional or helpful".
He said: "One of my concerns is that part of the funding does come from manufacturers of the device.
"I don't see how you can be independent regulator if you are, even partially, funded by the people who are being regulated. The independence of the MHRA is partly the problem."
The SNP MSP said he was less than satisfied when dealing with the regulator.
"I don't think they are a very professional organisation, I don't think they are a very caring organisation, I don't think they care at all about Scotland and I don't think they have got patient care as their number one priority," he said.
An MHRA spokesman said the watchdog protected the health of millions of people every day through the "effective regulation of medical devices and medicines, underpinned by science and research".
He denied that its role was "to protect industry interests" and said 90% of its funding came from the Department of Health.
He said patient safety was "our highest priority" and said the organisation sympathised with women who had suffered complications after surgery.
"We have undertaken work to assess the findings of studies undertaken by the clinical community over many years, as well as considering the feedback from all sources in that time," he said.Cheaper than alternatives
He added that evidence supported the use of the devices in the UK for treatment of incontinence and organ prolapse in appropriate circumstances.
"In common with other medical device regulators worldwide, none of whom have removed these devices from the market, we are not aware of a robust body of evidence which would lead to the conclusion these devices are unsafe if used as intended," he said.
When the review was published in March, it concluded mesh implant procedures must not be offered routinely to women with pelvic organ prolapse, that patients should be offered a range of treatments - mesh and non-mesh - and they must be given the information to make "informed choices".
Dr Wael Agur, a clinician who also resigned from the review group, said the report had "left the door slightly open" for some procedures to be performed.
He told MSPs that mesh should only be used in exceptional circumstances due to the risks.
Dr Agur also told the committee that mesh tape procedures were cheaper than the alternatives, saving the NHS "significant amounts of money".
He called for the report to be opened up to a public consultation process.
The report is currently being independently reviewed by Alison Britton, a professor of healthcare and medical law.
http://www.bbc.com/news/uk-scotland-41427983
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BBC Radio: Reporter Scott on Transvaginal Mesh and Parliament
Sep 28, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, September 28, 2017 ~ Scotland’s Sunday Mail journalist, Marion Scott, talks to BBC Radio this morning about the transvaginal mesh issues that will be presented to a Parliamentary Petitions Committee today.
Eight minutes into this interview, the presenters review why an expert contributor to a Scottish official report on transvaginal mesh, Dr. Wael Agur, resigned. His key evidence was removed and buried in footnotes, he says.
Here is his Petition.
About 60 survivors were planning to appear at Scotland’s Parliament, the Palace of Holyroodhouse.
Scottish Mesh Survivors wants to continue the suspension on polypropylene mesh procedures in women until the manufacturers can assure safety.
They call the official report a whitewash.
In 2013, the country became the first to stop the use of polypropylene mesh implants as the standard treatment for stress urinary incontinence (SUI) and pelvic organ prolapse (POP). The official recall recommends to lift the suspension.
With more than 400 women filing lawsuits in that country, both against manufacturers and against the health service, former health minister, Alex Neil has called for a global summit on the mesh mess.
Women without problems are extremely lucky, says Scott in this interview.BBC Radio, Sept. 28, 2017 – Interviews Reporter, Marion Scott, start – 8 min in:
28/09/2017, Good Morning Scotland – BBC Radio ScotlandThe Petitions Committee is influential says Scott and has the power to hold inquiries, commission reports require government ministers and public servants to give evidence and answer questions. It has the power to recommend changes.
The Petitions Committee will examine what relationship the officials who produced the report have to mesh manufacturers, what monies they have received and why that issue was not made more transparent. ###
https://www.meshmedicaldevicenewsdesk.com/bbc-radio-reporter-scott-transvaginal-mesh-parliament/
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Woman who sued Johnson & Johnson for £42,500,000 describes horrific pain of vaginal mesh implant
Sep 28, 2017 | Metro.co.uk
By Nicole Morley
A woman who sued Johnson & Johnson for £42,500,000 has spoken out about the horrific pain caused by a faulty mesh implant. Ella Ebaugh, 51, was forced to undergo three surgeries after the mesh eroded into her urethra.
Vaginal mesh, also known as pelvic mesh, is implanted into women who suffer with pelvic organ prolapse or urinary problems by surgeons. Ms Ebaugh was awarded her pay out after a jury in Philadelphia found that Johnson & Johnson had been negligent and its product – a mesh implant – was defectively designed, CBS News reports.
She was fitted with Johnson & Johnson’s Ethicon vaginal mesh to treat urinary incontinence after having five children.
Ms Ebaugh described the immense pain: ‘I’m in excruciating pain. When I’m standing it hurts, when I’m sitting it hurts. ‘I will suffer for the rest of my life. ‘My urethra is mangled. I feel like I’m on fire, you know, down there.’ Despite three surgeries to remove the implant, part of it remains.
Ms Ebaugh’s isn’t alone, Johnson & Johnson now face more than 1,000 lawsuits from women who say they are experiencing problems. Johnson & Johnson stopped selling four of its mesh inserts five years ago, though medical experts still claim vaginal implants are safe and effective for women with urinary problems. Ethicon plans to appeal the court’s decision.
http://metro.co.uk/2017/09/28/woman-who-sued-johnson-johnson-for-42500000-describes-horrific-pain-of-vaginal-mesh-implant-6962116/
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Mesh implant patients claim they were ‘cynically used’ to balance report
Sep 28, 2017 | Press Association ( In Evening Express)
Two patients who were part of the review group looking at the safety of mesh implants in Scotland have told MSPs they were “cynically used” to make its final report appear “less biased”.
Mesh survivors Elaine Holmes and Olive McIlroy quit the group, claiming its final publication was a “whitewash” with “vital evidence ignored, deleted or hidden”.
They called on Holyrood’s Public Petitions Committee to use its influence to ensure the suspension of mesh procedures “remains firmly in place”.
The pair’s appearance before the committee followed evidence from Dr Wael Agur, a clinician who also resigned from the review group, stating he believed the report’s conclusions could have done more to ensure the safety of women considering mesh procedures.
Ms Holmes told the committee: “We are hear today to state clearly that justice was not done, our voices were drowned out, stifled by the pro-mesh lobby which did their best to silence and marginalise Olive and I.
“The proposed final report exposed women to unnecessary risks, it bore no resemblance to the interim report which had achieved group consensus.”
She added: “The final report is certainly not in our name, it is nothing more than a whitewash.
“We were cynically used to make the report appear less biased to the public and to those of you here today. We were duped, used.”
Ms Holmes continued: “We ask you today to use the power you have to ensure that the mesh suspension remains firmly in place.
“You have the power to make the changes that are needed to protect patients once and for all and to change the system so that nothing like this ever happens again to other patients.”
She said medical watchdogs were “toothless and far too close” to manufacturers of medical devices.
“We need new health watchdogs who will insist on proof to show that devices and medicines are safe as we as effective,” she added.
Ms Holmes and Ms McIlroy also called for ” proper registers and mandatory recording of data as well as mandatory reporting of adverse incidents”.
Synthetic transvaginal tapes and meshes are used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).
Thousands of women in Scotland have been treated using the implants but some have suffered painful and debilitating complications.
In June 2014, then health secretary Alex Neil asked health boards to suspend their use.
The subsequent review, published in March, concluded mesh implant procedures must not be offered routinely to women with pelvic organ prolapse, that patients should be offered a range of treatments – mesh and non-mesh – and they must be given the information to make ”informed choices”.
However Dr Agur, a consultant urogynaecologist, said key data he believed was crucial to inform the recommendations was removed from the body of the report into an appendix and an annexe.
He said the report had “left the door slightly open” for some procedures to be performed.
He told MSPs that mesh should only be used in exceptional circumstances due to the risks.
Dr Agur has called for the report to be opened up to a public consultation process.
The report is currently being independently reviewed by Alison Britton, a professor of healthcare and medical law.
https://www.eveningexpress.co.uk/news/scotland/mesh-implant-patients-claim-they-were-cynically-used-to-balance-report/
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Sep 28, 2017 | RX Injury Help
By Laurie Villanueva
Laurie Villanueva is an attorney with Bernstein Liebhard LRX Injury Help
The federal court overseeing dozens of hernia mesh lawsuits involving Ethicon, Inc.’s Physiomesh products has approved the use of a Short Form Complaint, which will greatly streamline the process of filing new cases in the multidistrict litigation now underway in the U.S. District Court, Northern District of Georgia.
More than 80 Physiomesh lawsuits are now pending in the Northern District of Georgia, all of which were filed on behalf of patients who claim to have suffered serious complications due to Ethicon’s allegedly defective hernia patches. The multidistrict litigation was established earlier in June to allow all federally-filed hernia mesh lawsuits involving Ethicon Physiomesh to undergo coordinated pretrial proceedings.
The Court directed all future plaintiffs to file via the Short Form Complaint in an Order dated September 22nd. Plaintiffs who already have hernia mesh lawsuits pending in the litigation are also required to file a Short Form Complaint with the Court.
In addition to streamlining the filing process, the Short Form Complaint provides a standardized method of collecting information from all plaintiffs. It will allow each individual plaintiff to outline the specific allegations they are adopting from the litigation’s Master Complaint and provide information as to when and where their hernia mesh was implanted.Ethicon Hernia Mesh Lawsuits: What’s the Problem?
Ethicon brought its Physiomesh products to market in 2010. Like other hernia mesh patches, Physiomesh devices are constructed from non-absorbable polypropylene (plastic) filaments that are woven into fabric. Each side of the mesh is then covered with an absorbable film coating, which is intended to help the patch incorporate into the body and reduce inflammation.
However, plaintiffs pursuing Physiomesh lawsuits claim that this multilayer construction actually hinders incorporation and increases the risk that patients will develop serious complications, including adhesions, perforations, infections, mesh erosion, hernia recurrence, and the need for hernia mesh revision surgery.Ethicon Hernia Mesh Market Withdrawal
Ethicon announced it was withdrawing Physiomesh Flexible Composite Mesh from the worldwide market in May 2016, after unpublished data from two hernia databases in Europe suggested that the product was associated with higher average recurrence and revision rates compared to other meshes used in laparoscopic ventral hernia repair.
“Based on the currently available data, Ethicon believes the higher rates to be a multifactorial issue (including possible product characteristics, operative and patient factors), but has not been able to fully characterize these factors,” the company’s notification stated.
Ethicon has indicated that the Physiomesh products listed in the notification will not be returning to the market.
https://www.rxinjuryhelp.com/news/2017/09/28/ethicon-hernia-mesh-lawsuits-move-forward-as-court-approves-use-of-short-form-complaint-in-federal-physiomesh-litigation/
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