Preview Newsletter
Ethicon Media Monitoring 8/22/2018
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Criminal probe call over vaginal mesh ‘dangers’
Aug 22, 2018 | The National
By Kirsteen Paterson
Neil Findlay, Labour’s ex-shadow health secretary, has written to the head of Police Scotland, the country’s chief prosecutor and Justice Secretary Humza Yousaf urging investigators to open an inquiry into companies responsible for the devices. -
MSPs call on the Scottish Government to end the use of mesh implants
Aug 21, 2018 | The National
By Kirsteen Paterson
The women, who suffered severe complications after undergoing mesh procedures, petitioned the Scottish Parliament on behalf of other patients left with pain and mobility problems. -
Chief medical officer defends use of mesh implants
Aug 21, 2018 | STV News
Scotland's chief medical officer has said vaginal mesh implants should remain available for women undergoing "exceptional circumstances". -
Update on Surgical Meshes
Aug 21, 2018 | Lexology
By Taylor Wessing
In March 2018, we reported on an announcement by the UK Government to review three NHS treatments: the hormone pregnancy test Primodos, sodium valproate and the use of vaginal meshes. -
Jury Selection Underway for McFarland Pelvic Mesh Case in Philadelphia
Aug 21, 2018 | Mesh Medical Device News Desk
By Jane Akre
Four new pelvic mesh lawsuits will be heard in the coming months after a long lapse with no trial action. -
Part of pelvic-mesh case to be retried
Aug 21, 2018 | Missouri Lawyers Media
By Jessica Shumaker
A woman who became the first person nationally to bring product-liability claims against two pelvic-mesh manufacturers in one trial — and lost — will have a chance to retry part of her case following a ruling Tuesday in the Missouri Court of Appeals Western District.
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Criminal probe call over vaginal mesh ‘dangers’
Aug 22, 2018 | The National
By Kirsteen Paterson
Neil Findlay, Labour’s ex-shadow health secretary, has written to the head of Police Scotland, the country’s chief prosecutor and Justice Secretary Humza Yousaf urging investigators to open an inquiry into companies responsible for the devices.
More than 20,000 women have been fitted with the implants since the 1990s, with surgeons using them to treat conditions including pelvic organ prolapse and incontinence.
However, the procedure has led to debilitating pain for some, with those affected experiencing a range of problems like infections, bleeding and impaired mobility.
Although then-Health Secretary Alex Neil asked NHS boards to suspend the use of transvaginal mesh implants in 2014, hundreds more have been fitted with them.
Last year an independent review said the devices should not be “routinely” offered to women with pelvic organ prolapse.
However, campaigners, including Elaine Holmes and Olive McIlroy of the Scottish Mesh Survivors group, branded that report a “whitewash” and yesterday a cross-party group of MSPs called for mesh usage to end amidst “serious concerns” about the credibility, transparency and independence of the inquiry.
Johann Lamont, convenor of the Scottish Parliament’s Public Petitions Committee, urged the Scottish Government to “respond to our recommendations and the concerns of women”.
Now, in his letter to authorities, Findlay says answers are needed on the make-up, sale and use of the implants.
The letter refers to the situation in America, where papers filed in a court action reveal warnings about the plastic resin used in their manufacture were first made in the late 1990s.
Several challenges have been filed against a number of related companies.
Arguing that women’s health has been “endangered”, Findlay states: “Is this not a criminal offence?
“I hope that you will take immediate action to investigate what has gone on here and proceed against companies that have deliberately ignored these warnings.”
http://www.thenational.scot/news/16590061.criminal-probe-call-over-vaginal-mesh-dangers/
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MSPs call on the Scottish Government to end the use of mesh implants
Aug 21, 2018 | The National
By Kirsteen Paterson
The women, who suffered severe complications after undergoing mesh procedures, petitioned the Scottish Parliament on behalf of other patients left with pain and mobility problems.
The petition was lodged in April 2014 for the Scottish Mesh Survivors group’s Hear Our Voice campaign.
Today the Public Petitions Committee is calling on the SNPadministration to stop the use of mesh procedures over “serious concerns” about the final report of an independent review into the use of mesh.
It concluded the implants must not be offered “routinely” to women with pelvic organ prolapse.
But Holmes, McIlroy and other women branded the inquiry a “whitewash” and a review of those findings is due to report later this year.
Now the cross-party committee has criticised the continued use of the procedure despite the request for a moratorium.
The paper records “serious concerns” about the credibility, transparency and independence of the process so far, and warned of the potential for the final report to be used “to justify the lifting of bans on mesh in other jurisdictions” such as England and Northern Ireland.
Committee convener Johann Lamont said: “I am grateful to the petitioners, Elaine Holmes and Olive McIlroy, for bringing forward this petition and I commend their courage and commitment in the face of their trauma. Seeing and hearing the experiences of the many women we have heard from during our consideration of this petition was incredibly emotional, with the physical and mental impact plain to see.
“One of the most important things to come out of this report was the extent to which women were not believed when they were highlighting their concerns to the medical profession, ultimately resulting in there being no record of their concerns. Now that we have published this report, we urge the Scottish Government to respond to our recommendations and the concerns of women.”
Deputy convener Angus MacDonald said the committee expects a “positive response” from the Scottish Government.
http://www.thenational.scot/news/16587382.msps-call-on-the-scottish-government-to-end-the-use-of-mesh-implants/
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Chief medical officer defends use of mesh implants
Aug 21, 2018 | STV News
Scotland's chief medical officer has said vaginal mesh implants should remain available for women undergoing "exceptional circumstances".
Dr Catherine Calderwood spoke to STV as a parliamentary report recommended use of the implants should be banned in Scotland.
The report, from Holyrood's Public Petitions Committee, criticised the continued use of the procedure in Scotland despite the request for a moratorium.
Thousands of women in Scotland have been treated using the implants but some have suffered painful and debilitating complications as a result.
However, Dr Calderwood said in some cases the mesh implants were the only way to improve the quality of life for women with severe incontinence or pelvic organ prolapse.
She told STV: "We've heard from women with terrible life changing injuries following the use of mesh and we must prevent that happening in the future.
"What we do have is a small number of women with very, very debilitating symptoms from their incontinence, their prolapse and in whom there is no choice but to use mesh which will actually improve their quality of life."
In many cases, Dr Calderwood said, mesh is preferable to operations which can lead to their own complications, or be unsuitable for some patients.
"So we do offer women a choice," she added.
"We would only offer mesh in very exceptional circumstances and with fully informed consent so that the number of risks and complications are fully understood by people coming forward to have the procedures."
Dr Calderwood also said it was "unacceptable" that many women had been harmed by their implants, and she had consulted with campaigners against the process, whose stories she described as "very distressing".
She believes, however, that patients are now given more information about the process and possible side-effects, giving them the option of making their own decision about treatments.
"We have a very good safety record now around the very few operations that are going ahead," she said.
"Women are fully informed and given all the options and we will continue to have a high vigilance around complications, around readmission rates and making sure that we are only doing this in very, very few circumstances where we will be sure that they will make a difference."
According to Dr Calderwood, fewer than 50 procedures involving mesh were carried out across the whole of Scotland.
Following publication of the new report, she has now taken the decision to limit these procedures to just "two or three" specialist units covering the whole country.
"We are now in a situation where we must make sure that the surgeons are as experienced as possible," she said.
Dr Calderwood said this would further reduce the risk of complications around mesh, which a wide-scale study recently found to be around 6%.
She concluded: "For some women will fully informed consent, their symptoms of incontinence or prolapse will be worth it - for them - of a very small percentage risk of complications."
https://stv.tv/news/scotland/1428070-chief-medical-officer-defends-use-of-mesh-implants/
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Aug 21, 2018 | Lexology
By Taylor Wessing
In March 2018, we reported on an announcement by the UK Government to review three NHS treatments: the hormone pregnancy test Primodos, sodium valproate and the use of vaginal meshes.
Following an interim recommendation of the Independent Medicines and Medical Devices Safety Review, the UK government and NHS have paused the use of vaginally inserted surgical mesh.
The Government's announcement of 11 July 2018 says that the use of vaginally inserted surgical mesh for stress urinary incontinence will be paused until a set of conditions to reduce the risk of injury are met. Vaginally inserted meshes will only be used when there is no alternative and after close and comprehensive consultation between patient and clinician, with rigorous oversight and governance at all times.
It was also recommended that the pause should be extended to include vaginally inserted mesh to treat pelvic organ prolapse, and that the pause should be implemented through a high vigilance regime of restricted practice.
The press release continues "NHS England and NHS Improvement have written to providers to ensure that provider medical directors and nurse directors are equipped with advice and guidance to ensure that clinicians can support patients to make clear decisions about their treatment".1
The National Institute for Health and Care Excellence (NICE) said that it will work with NHS England to produce a shared decision making tool, to be available when NICE's guideline on urinary incontinence and pelvic organ prolapse publishes early next year.
https://www.lexology.com/library/detail.aspx?g=1eba8f21-0890-4edd-93e2-54ba38d4e288
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Jury Selection Underway for McFarland Pelvic Mesh Case in Philadelphia
Aug 21, 2018 | Mesh Medical Device News Desk
By Jane Akre
Four new pelvic mesh lawsuits will be heard in the coming months after a long lapse with no trial action. The Philadelphia Court of Common Pleas is the next venue.
Jury selection starts this week in the Philadelphia pelvic mesh case of McFarland v Ethicon, [1307-01577 Mcfarland Etal v Ethicon Women’s Health and Urology].
The case will be heard on Monday, August 27, in the Philadelphia Court of Common Pleas, which has been the venue for seven pelvic mesh cases so far.
On or about April 3, 2008 Ms. McFarland was implanted with Gynecare TVT-O by Dr. Liang R. Bartkowiak, MD at Altoona Hospital Campus – Main in Altoona, Pennsylvania.
See Dr. Bartkowiak, on Dollars for Doctors, a ProPublic Project. See the Vitals Reviews here.
Ms. McFarland has undergone one revision surgery.
As a result of the surgeries she, “has sustained permanent injury, undergone corrective surgery, and has experienced, and will continue to experience, significant mental and physical pain and suffering, financial or economic loss, including but not limited to,
obligations for medical services and expenses.”
The action names Ethicon, Inc. Ethicon Women’s Health and Urology of Ethicon, Inc. and Secant Medical, a corporation located in Perkasie, PA in business jointly with Defendant Prodesco, Inc. the venue is correct in that plaintiff and defendants live and/or have businessin the state of Pennsylvania.
The Complaint says J&J knew that its disclosures to the FDA were and are not complete and are misleading and that their pelvic mesh products “were and are causing numerous patients severe injuries and complication like those suffered …” by the plaintiff.
J&J “suppressed this information, and failed to accurately and completely disseminate or share this and other critical information with the FDA, health care providers, or the patients. “
In January 2012, the FDA ordered the Defendants to conduct randomized, controlled clinical testing of the pelvic mesh products and by June 2012 many defendants announced they were withdrawing some and or all of the pelvic mesh products from the market and would not be conducting randomized, controlled clinical testing ordered by the FDA.
The Complaint lists – defective manufacture and design; failure to warn; negligence; common law fraud; negligent misrepresentation; negligent infliction of emotional distress; breach of express warranty; breach of implied warranty; violation of consumer protection law; gross negligence; loss of consortium; signed by Lee Balefsky, on July 10, 2013.
Tracie Palmer will be the lead counsel. In September 2017, she along with Elia Robertson and Kila Baldwin (all of Kline Specter) represented Ella Ebaugh in her $57.1 million verdict against Ethicon. Of the seven cases tried so far in the Philadelphia Court of Common Pleas, Ebaugh remains the highest awarded case in pelvic mesh litigation in that venue.
Gynecare no longer exists Gynecare, Inc. was merged out of existence and into Ethicon, Inc. on January 3, 2000. Ethicon supplies Secant with spools of PROLENE polypropylene filament which it knits to produce large rolls of mesh per specifications.
One the PROLENE polypropylene filaments are knit into mesh, samples of the mesh are measured for width, courses, wales, thickness, areal density and elasticity and are then ball-burst tested. These measurements are taken and recorded to ensure that Secant has knit the filaments per Ethicon’s specifications, and Secant completes a Certificate of Conformance for each lot that attests to this.
Defendant, Ethicon, has been busy trying to eliminate experts on behalf of McFarland, Dr. Bruce Rosenzweig is among them along with regulatory expert, Peggy Pence, PhD. Dr. Uwe Klinge, an expert on mesh after its removed from the body, has appeared at other trials and submitted an expert report in McFarland as has Vladimir Iakovlev, MD, who heads a hernia explant lab in Toronto, and Mayo Clinics’ Dr. Daniel Elliott.
The motion to exclude Dr. Klinge was denied as was the defense motion to exclude Dr. Pence. The defense motion to exclude Dr. Iakovlev MD was denied as well.
Besides the Ella Ebaugh case, other cases heard in the Philadelphia court include the Atkins’ case on the TVT-Secur which yielded zero for Ms. Atkins; Ms. Beltz was awarded $2.16 million; Ms. Engleman was a $20 million verdict for the plaintiff; Ms. Carlino $13.5 million; and Ms. Hammons $12.5 million.
LAWSUITS ON THE HORIZON
In November in the same court the case of Emmett v Ethicon will be heard. 1307-01495 Emmett Etal vs Ethicon Women’s Health and Urology, Trial date: November 19, 2018. See docket here.
In Bergen County, New Jersey, two trials will be heard in Superior Court there with attorney Adam Slater representing the plaintiffs.
Oct 1, Catherine Burns v. Ethicon – Prolift Anterior and TVT-O, 013723-14, filed 2/2/2010
Oct 22 Sandra and Ernest Rios v. Bard – Avaulta Solo Anterior, 018689-14, filed 5/5/2014.
https://www.meshmedicaldevicenewsdesk.com/jury-selection-underway-for-mcfarland-pelvic-mesh-case-in-philadelphia/
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Part of pelvic-mesh case to be retried
Aug 21, 2018 | Missouri Lawyers Media
By Jessica Shumaker
A woman who became the first person nationally to bring product-liability claims against two pelvic-mesh manufacturers in one trial — and lost — will have a chance to retry part of her case following a ruling Tuesday in the Missouri Court of Appeals Western District.
Access to full text unavailable – subscription required.
Story can be found here: https://molawyersmedia.com/2018/08/21/part-of-pelvic-mesh-case-to-be-retried/
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