Preview Newsletter
Ethicon Media Monitoring 8/14/2018
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Fight for justice: “I want to die knowing other mesh victims might now be saved”
Aug 12, 2018 | The Sunday Post
By Marion Scott
A mesh victim is calling on Scotland’s Chief Medical Officer to order rigorous monitoring of implant patients after being told she is dying from cancer. -
Scottish Mesh Campaigners Ask for Criminal Charges
Aug 13, 2018 | Mesh Medical Device News Desk
By Jane Akre
Marion Scott, now with The Sunday Post, has done a tireless job on following the anti-mesh campaign in Scotland. -
*Just In* Wave 7 Ethicon Trial Postponed Until Next Year
Aug 13, 2018 | Mesh Medical Device News Desk
By Jane Akre
It was set to start tomorrow, but the mass trial of more than 100 plaintiffs has been reset as thousands of cases are purged from the Ethicon docket. -
Ethicon fights expanded class in vaginal mesh action
Aug 13, 2018 | Lawyerly
By Miklos Bolza
Ethicon told the Full Federal Court on Monday that the judge overseeing the marathon class action against it over allegedly defective vaginal mesh devices got...
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Fight for justice: “I want to die knowing other mesh victims might now be saved”
Aug 12, 2018 | The Sunday Post
By Marion Scott
A mesh victim is calling on Scotland’s Chief Medical Officer to order rigorous monitoring of implant patients after being told she is dying from cancer.
After being given just months to live when she was diagnosed with lung cancer, Marion McMillan has urged Dr Catherine Calderwood to launch proper health checks on women suffering crippling side effects from mesh.
The former childminder, 70, and mother of four from Paisley, Renfrewshire, said: “I want to die knowing other mesh women will be saved the devastating diagnosis I have just been given.
“My health started breaking down from the moment I was given a mesh implant.”
Marion’s plea is backed by a government expert who is calling for research into possible links between the controversial implants and cancer or other chronic inflammatory illnesses.
Consultant uorogynaecologist Wael Agur, who gave evidence about mesh implants to both the Scottish and UK parliaments, said: “We need to wake up and research whether there is any link between mesh, cancer and other inflammatory illness.”
The surgeon, who now teaches others to use native tissue rather than mesh, said: “What we do have is good evidence that mesh is linked to inflammatory reaction.
“We have evidence that chronic inflammation and persistent infection can lead to cancer changes in the body.
“And we have increasing reports of a possible link between the use of mesh and auto-immune disease.”
Diagnosed with lung cancer despite never smoking, drinking or eating junk food, Marion has been told doctors cannot prolong her life.
Medical studies involving patients with long-term infection have found that although synthetic meshes were considered non-carcinogenic, the inflammatory response caused by implants acts as a “constant aggression”.
Research has recognised chronic inflammation can cause cancer changes in the body.
Three years ago, the American Urogynaecological Society also heard experts presenting research which concluded women who experienced mesh complications suffered inflammatory responses that persisted for years following implantation.
Professor Jan Willem Cohen Tervaert, director of rheumatology at University of Alberta, is calling for further research into links between mesh and the development of such illnesses in patients suffering foreign body reaction to the implant.
He says a test must be developed to check if patients have allergies before they are given implants as they may be at greater risk of developing complications.
The professor said more research is required to see if there is a link between patients who have an allergy prone system and an increased risk in the development of other autoimmune illnesses and cancer.
“It is very important so screen patients before a mesh implantation is planned.”
https://www.sundaypost.com/fp/fight-for-justice-i-want-to-die-knowing-other-mesh-victims-might-now-be-saved/
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Scottish Mesh Campaigners Ask for Criminal Charges
Aug 13, 2018 | Mesh Medical Device News Desk
By Jane Akre
Marion Scott, now with The Sunday Post, has done a tireless job on following the anti-mesh campaign in Scotland. The group, Scottish Mesh Survivors and Scott testified to a Parliamentary Committee and obtained a stay on mesh implants in that country in 2014, the first in the world. Scott now reports that Scottish Mesh Campaigners are asking for criminal charges to be filed against mesh manufacturers for their alleged reckless disregard of human life.
Image: The Sunday Post, August 12, 2018
The story is reported in The Sunday Post, August 12, by reporter, Marion Scott who has brought readers news of a growing anti-mesh campaign in Scotland for nearly a decade.
After a number of deaths among Scottish women following their implants, Scottish anti-mesh campaigners are calling on criminal charges to be filed against mesh makers which includes, Ethicon (Johnson & Johnson,) C.R. Bard, Boston Scientific and American Medical Systems, now Endo International.
In “Memos reveal mesh firms were warned 21 years ago that material should not be used on humans,” Scott revisits the Material Safety Data Sheet (MSDS), that accompanies a raw material through its processing.
As far back as 1997, implant makers C.R. Bard and its subsidiary, Davol, were warned they should not use polypropylene resin to make surgical implants. Chevron Phillips, the supplier of the PP resin, Marlex, said it feared being sued if the product was being used that way.
“…that statement purported to warn against using the resin for certain medical applications, they did so only to avoid potential legal liability because they had not performed medical safety testing,” Scott quotes a spokesman from Boston Scientific.
“Do not use this Chevron Phillips Chemical company LP material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.” ~ 2004 warning from Chevron Phillips that accompanied its Marlex mesh.
That was the warning by Chevron Phillips about its Marlex plastic product. Mesh News Desk first reported on the MSDS during the Cisson trial in 2014. See background stories here and here.
That didn’t stop Bard from using Marlex for millions of hernia and pelvic meshes. In fact, to cover its tracks, Bard set up a third party, Red Oaks, to purchase the raw polymer.
The mesh manufacturers distributed their products globally including to the National Health Service in Scotland and to 11 health boards in that country.
Roger Darois said, “It is likely that they do not know of our implant application. Please do NOT mention Davol’s name in any discussions with thee manufacturers.”
Scott reports that decision has led to horrific internal injuries. She cites Michele McDougall, 55, from Edinburg, who died last May after suffering chronic infections following six mesh patches. She suffered vaginal cancer and was too ill for chemotherapy.
Claire Daisley, 48 is awaiting removal of both her bladder and bowel, following her mesh surgery.
Marion McMillan, 70, diagnosed with lung cancer, even though she never smoked, has called on Scotland’s Chief Medical officer to order rigorous monitoring of implant patients in that country. She tells The Sunday Post that her health started breaking down “from the moment I was given a mesh implant.”
Here is her story.
It’s estimated at least 1,800 Scottish women were implanted with polypropylene gynecological mesh every year to treat prolapse and incontinence, until its use was suspended in 2014.
Urogynecologist, Wael Agur, told both the Scottish and UK parliaments that, “We need to wake up and research whether there is any link between mesh, cancer and other inflammatory reaction. We have evidence that chronic inflammation and persistent infection can lead to cancer changes in the body.”
New Jersey lawyer, Adam Slater spoke to Scottish lawmakers at a parliamentary hearing and said “In my opinion, the mesh manufacturers were criminal reckless, and more. They knew women would be severely hurt but his this knowledge so they could profit.”
MSP Neil Findlay said: “Here we have yet more evidence of the outrageous lengths mesh companies will go to maximise their profits all at the expense of lives and well-being. What more evidence is needed to take forward a prosecution?”
BACKGROUND
In the U.S., the Occupational Safety and Health Administration or OSHA, requires that potential safety hazards accompany a material with the hopes that workers can be safe who handle the material.
In the case of raw polypropylene resin, a polymer that results from the petroleum industry, lawyers had crafted the MSDS that warns the material should never be made into an implantable medical device.
Lawyers for the petroleum industry wanted to cover any liability the deep-pocketed industry might face from devices gone wrong, so the language would offer cover, just in case the resin was going into the making of an implantable device.
https://www.meshmedicaldevicenewsdesk.com/scottish-mesh-campaigners-ask-for-criminal-charges/
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*Just In* Wave 7 Ethicon Trial Postponed Until Next Year
Aug 13, 2018 | Mesh Medical Device News Desk
By Jane Akre
It was set to start tomorrow, but the mass trial of more than 100 plaintiffs has been reset as thousands of cases are purged from the Ethicon docket.
WAVE 7 UPDATE
Image: Wave, WikiCommons
You’ve heard the term – a “Wave” of cases – that were set to begin Tuesday, August 14, 2018 where multiple plaintiffs, more than 100 at one time, all women from West Virginia who had suffered from TVT mesh implants, were to have their case against Ethicon ( J&J) heard in one mass trial.
The Wave is off as the court goes through a purging of cases in an attempt to have it dissolved.
Last May, it was announced that the Wave would be heard before Judge Joseph Goodwin. At the time he was overseeing more than 100,000 pelvic mesh cases before him representing seven mesh makers consolidated in one multidistrict litigation (MDL).
Since then, Ethicon asked, and Judge Goodwin agreed to clear the docket of non–revision TVT meshes, of women who have not had any surgical removals of Ethicon meshes from the TVT family (tension-free vaginal tape) family. That includes TVT Retropubic, or Abdominal, TVT Obturator, TVT Abbrevo, TVT Exact.
Four devices which are no longer marketed are also included such as Prolift, Prolift +M, Prosima and TVT-Secur. The TVT family also includes Gynemesh PS and Prolene, the proprietary name of Ethicon (J&J’s) polypropylene mesh.
See MND on what Ethicon was granted here.
Judge Goodwin has been busy removing those cases from the So. District of WV docket as law firms announce they have reached settlement with Ethicon on behalf of their clients.
Between dismissals and settlements, the 100 woman caseload of Wave 7 is now whittled down to one.
Sutphin v. Ethicon is scheduled to be heard April 22, 2019, before Judge Goodwin in Charleston, WV.
SUTPHIN V ETHICON
The West Virginia plaintiff was implanted with a TVT February 24, 2009 at Logan Regional Hospital in Logan, West Virginia by Dr. David Afram, MD, who now practices in Virginia.
The attorney on the complaint is Lee Balefsky and Michelle Tiger from Kline & Specter, while Kila Baldwin has tried many cases for the Philadelphia-based law firm.
JNJ WANTS 510(K) IN, PEGGY PENCE OUT – RECENT FILINGS IN SUTPHIN CASE
Filed this month in the Sutphin (2:14-cv-01379) case, Defendant Ethicon has objected to Plaintiff wanting to exclude the FDA 510(k) evidence.
Plaintiff says the defendants now attempt to introduce additional arguments that the 510(k) clearance of mesh means it is, “FDA cleared, safe and effective,” and without risk.
Kila Baldwin, the attorney for Sutphin, says the defendant has “cherry picked” from FDA language, “from case law and FDA determinations, made blanket assumptions, and have fully ignored the conclusions made both by the Courts and the FDA.”
The FDA’s 510(k) clearance to sell is not the same as a premarket approval or PMA which drugs must undergo.
To introduce the regulatory language by the FDA could be considered an attempt to go down the rabbit hole of FDA regulatory jargon, sure to take up time before a jury and serve to confuse and obfuscate exploration of the defective nature of the polypropylene mesh implant, used to treat incontinence.
Defendant corporations have tried, unsuccessfully in the past, to introduce the 510(k) issue.
Baldwin writes, “To ask this Court to now provide jury instructions implicitly stating that the FDA has determined that the TVT-O is safe and effective and/or that Defendants acted with “due care” because it is a Class II device, without mentioning the FDA’s litany of concern over the Device’s safety and efficacy is misleading and preposterous. “
Filed last March 5, 2018 was a defendant’s motion to exclude Peggy Pence, Ph.D from the Wave 7 trials.
As many readers are aware, Dr. Pence has testified about the FDA regulatory process, and is considered an expert in how drugs and devices are brought to market, development, regulatory affairs and labeling standards. Judge Goodwin said the expert opinions expressed early on in this MDL are identical to those offered today.
The court attached similar rulings from a 2016 Memorandum Opinion and Order ECF 2075 on Peggy Pence:
Denied – Ethicons’ challenge of Dr. Pence and her 40 years of accumulated knowledge about the adequacy of the IFU, Instructions for use.
Denied- The use of Dr. Pence to testify about premarket testing of medical devices.
“Accordingly, the court will refrain from engaging the extremely inefficient practice of continuously reexamining the qualifications, reliability, and relevance of dozens of experts and their numerous opinions.” Challenges to experts, known as Daubert challenges, not previously addressed to the court are reserved for trial, says Judge Goodwin writing August 7, 2018.
https://www.meshmedicaldevicenewsdesk.com/just-in-wave-7-ethicon-trial-postponed-until-next-year/
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Ethicon fights expanded class in vaginal mesh action
Aug 13, 2018 | Lawyerly
By Miklos Bolza
Ethicon told the Full Federal Court on Monday that the judge overseeing the marathon class action against it over allegedly defective vaginal mesh devices got...
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Story can be found here: https://www.lawyerly.com.au/ethicon-fights-expanded-class-in-vaginal-mesh-class-action/#
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