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Ethicon Media Monitoring 11/14/2017
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Pelvic Mesh Jury Sides With J&J Unit In Houston
Nov 13, 2017 | Law 360
By Emily Field
A federal jury in Houston has found in favor of Johnson & Johnson subsidiary Ethicon Inc. in a trial over a woman’s allegations that she was injured by a defective pelvic mesh device, which played a role in her divorce, finding there was no design defect. -
Australian Medical Association Reviews Evidence On Industry Funding
Nov 13, 2017 | Newcastle Herald
By Joanne McCarthy
THE Australian Medical Association is reviewing doctors’ relationships with industry after evidence showing an association between corporate funding and doctors’ prescribing behaviour, and revelations of undeclared financial relationships between doctors and pelvic mesh manufacturers. -
UK To Place Further Restrictions on POP Pelvic Mesh
Nov 13, 2017 | Mesh Medical Device Newsdesk
While Australia says it will consider all vaginally- placed mesh and surgical mesh as “high risk,” news from the UK says pelvic organ prolapse (POP) mesh may be made obsolete.
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Pelvic Mesh Jury Sides With J&J Unit In Houston
Nov 13, 2017 | Law 360
By Emily Field
Law360, New York (November 13, 2017, 4:38 PM EST) -- A federal jury in Houston has found in favor of Johnson & Johnson subsidiary Ethicon Inc. in a trial over a woman’s allegations that she was injured by a defective pelvic mesh device, which played a role in her divorce, finding there was no design defect.
A jury on Thursday found there was no design defect in the TVT-S pelvic mesh device that caused Cheryl Lankston’s alleged injuries. Ethicon had argued she lacked evidence that a specific design defect caused her alleged injuries, including urinary problems and vaginal pain, according to court filings, as her obstetrician gynecologist expert didn’t identify any specific design defect, but merely identified the TVT-S device as the source of Lankston’s alleged injuries.
Lankston also argued that the TVT-S should have been designed with a different material than prolene polypropylene, namely, a pelvic mesh called Ultrapro, according to court filings.
Ethicon, however, argued that she hadn’t shown in tests that TVT-S made with Ultrapro would have prevented or reduced her risk of injury, or that it wouldn’t have affected the pelvic mesh device’s utility.
“The jury’s decision in favor of Ethicon reflects the facts in this case. The evidence showed Ethicon’s TVT-Secur device was properly designed,” Ethicon spokeswoman Kristen Wallace said in a statement. “We empathize with all women suffering from stress urinary incontinence. Pelvic mesh has helped improve the quality of life for millions of women with serious, debilitating conditions.”
Lankston first started having stress urinary incontinence and pain during sex in 1996; after her hysterectomy that year, her urinary problems lessened until 2011, when she started a job that didn’t allow for frequent bathroom breaks, according to court documents.
She sought treatment and was implanted with the TVT-S device, but eight weeks later, she and her husband Michael both started experiencing pain during intercourse. Her stress urinary incontinence also returned, according to court filings.
Lankston eventually lost hope that she could find a solution to her medical problems, according to a Wednesday filing.
“This being the case, Ms. Lankston decided to suffer her stress urinary incontinence, urinary leakage, and dyspareunia in silence, gave up any hope of having a healthy romantic relationship again, and divorced her husband, Michael Lankston,” she said in the filing.
Lankston had argued that Ethicon knew that replacing the heavyweight small-pore prolene mesh with a lighter weight large-pore mesh, like Ultrapro, would likely improve the side effects associated with the TVT-S.
Ethicon countered that neither Lankston’s experts nor anyone else has ever made the TVT-S with such a mesh and tested it — not even in a cadaver.
Lankston also had no proof that Ultrapro was feasible or available when the TVT-S was made, since the U.S. Food and Drug Administration has never cleared Ultrapro for use in treating stress urinary incontinence, Ethicon argued.
"We are certainly very disappointed for Ms. Lankston that Ethicon’s internal documents acknowledging over the course of years the many failures and complications of the TVT-Secur device did not translate into a verdict for her injuries," David Augustus of The Spencer Law Firm, attorney for Lankston, told Law360 on Monday.
Ethicon is represented by Kathleen Gallagher and W. Curt Webb of Beck Redden LLP, Chad R. Hutchinson of Butler Snow LLP and Scott P. Stolley of Stolley Law PC.
Lankston is represented by David L. Augustus, Ashley M. Spencer and Loren M. King of The Spencer Law Firm.
The case is Lankston v. Ethicon, Inc. et al., case number 4:17-cv-00323 in the U.S. District Court for the Southern District of Texas.
--Editing by Orlando Lorenzo.
Update: This article has been updated to add comment from Lankston's attorney.https://www.law360.com/trials/articles/984502/pelvic-mesh-jury-sides-with-j-j-unit-in-houston
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Australian Medical Association Reviews Evidence On Industry Funding
Nov 13, 2017 | Newcastle Herald
By Joanne McCarthy
THE Australian Medical Association is reviewing doctors’ relationships with industry after evidence showing an association between corporate funding and doctors’ prescribing behaviour, and revelations of undeclared financial relationships between doctors and pelvic mesh manufacturers.
AMA president Dr Michael Gannon said a five-year review of the position statement on medical practitioners’ relationships with industry would consider “evidence around this important issue”, including a series of studies showing even cheap industry-funded meals were associated with increased prescribing by doctors.
Confirmation of the 2012 review comes after Dr Gannon in August said the AMA’s marketing of a pelvic mesh device more than a decade ago as an “Australian medical design breakthrough”, despite women’s reports of complications in Western Australian public hospital trials from as early as 1989, was “a long way from our proudest hour”.
The Australian-invented device helped spark a global pelvic mesh scandal after it was sold and registered for use in America in 2001 to treat prolapse, despite no evidence supporting that use.
It also comes after the Australian and New Zealand College of Obstetricians and Gynaecologists in September failed to declare substantial funding from pelvic mesh manufacturers and marketers for more than a decade to a Senate inquiry investigating pelvic mesh.
The college denied being influenced by health industry funding, but has been criticised by health advocates and some senior obstetricians and gynaecologists for being largely silent for a decade about the risks faced by women from pelvic mesh devices, despite evidence of severe complications in some women.
Dr Gannon said the AMA’s ethics and medicolegal committee, on which he sits, released a position statement in 2012 which did not specifically state that industry marketing influences prescribing behaviour. New research showing clear associations would inform the current review.
“Doctors should be aware of this influence and ensure their professional judgement is not compromised by industry relationships,” he said.
“At its heart the current policy states that doctors’ relationships with industry are for the public benefit so long as they are appropriately managed to put patients’ interests first and to maintain public trust and confidence in the profession.
“The AMA believes it is imperative that doctors’ relationships with industry should be open and transparent, able to withstand public and professional scrutiny, meet public and professional standards and expectations and adhere to relevant legislative and regulatory requirements.”
It was important that “doctors and industry work collaboratively to improve the quality of, and access to, health care” but “it’s essential that doctors manage such relationships appropriately to avoid real and perceived conflicts of interest which can undermine public confidence and trust in the medical profession”, Dr Gannon said.
The doctor’s primary duty is to act in patients’ interests, not the interests of doctors or industry.”
The AMA advocates that the overriding principle guiding doctors' relationships with industry is the primacy of patient care. The doctor's primary duty is to act in patients' interests (not the interests of doctors or industry);
The AMA’s current position statement said it was “ethically acceptable for industry to support meetings that contribute to doctors’ education” but the funding should be “untied, fully disclosed, at arms’ length to the organisation of the meeting”.
In a statement to the Newcastle Herald in August, after confirming the AMA’s direct links with progression of the global pelvic mesh scandal, Dr Gannon said that “to call this a tragedy is not overstating it at all”.
http://www.theherald.com.au/story/5048297/doctors-funding-under-review/
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UK To Place Further Restrictions on POP Pelvic Mesh
Nov 13, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, November 13, 2017 ~ While Australia says it will consider all vaginally- placed mesh and surgical mesh as “high risk,” news from the UK says pelvic organ prolapse (POP) mesh may be made obsolete.
In the United Kingdom (UK, Northern Ireland, Britain and Scotland), the National Institute for Health and Care Excellence (NICE) guidelines, due out in December, say POP mesh must only be used in a research context.
What may result, if this interim decision becomes a final guideline, is that unless there is upcoming research, POP mesh will not be able to be sold or used as a standard treatment for prolapsing pelvic organs.
The result – it’s highly unlikely that any doctor will any longer implant the controversial polypropylene product in a patient suffering from POP.
According to the founder of the Sling the Mesh Campaign in the UK, Kath Sansom, “This is a subtly brought-in ban on vaginally placed prolapse mesh and is excellent news, not just for UK women but campaigners globally as it sends a clear message to surgeons that it will not be tolerated unless it is in a research setting. I am glad that NICE has some sense.”
This news is a departure from the National Health Service working groups in England and Scotland that reported it was safe to use pelvic mesh as a last resort in a multi-disciplinary setting. A Mesh Oversight Group Report issued in July, encourages doctors to learn more about mesh implantation and for specialist centers to treat complications. It does not recommend any curtailing of the current use of mesh for POP and SUI.
Sansom says that many surgeons in the United Kingdom (as in the U.S.) believe transabdominally placed prolapse mesh is safe and will start pushing that procedure as an alternative.
“Yet it ends up in the same site in the body and has same problems of shrinkage, twisting at edges, degradation, erosion. Also, it all ends up in the vaginal vault and we know from seeing women in campaign groups globally that it all causes the same problems of excruciating pain and ruined quality of life.”
In the UK, final guidelines on the use of both stress urinary incontinence (SUI) and POP mesh will be published in 2019.
Meanwhile the National Health Service (NHS) continues to insist the risk of mesh complications is low, at 1-3%.
In January 2016, the U.S. Food and Drug Administration reclassified POP mesh, generally a larger piece of polypropylene, to class III or high risk. Manufacturers were given 30 months years to take POP mesh off the market or prove with clinical trials that the mesh is safe and effective.
See MND story here.
AUSTRALIAN ACTION
As Australia moves to reclassify all pelvic mesh devices from moderate to “high risk” over the next 24 months, see MND story here), women in that country suffering pelvic mesh complications want to hold accountable regulators assigned with protecting the public health.
See Herald story here.
Women from Western Australia (WA) implanted with the Intra Vaginal Sling (IVS) and Tissue Fixation System (TFS) have plans to sue, not just pelvic mesh manufacturers, but the state health systems and regulators that put the medical devices on the market.
Solicitor Adrian Barakat, of AJB Stevens Lawyers in Sydney, is bringing the action with a focus on Western Australian (WA) Health Department alleging a cover-up of mesh device surgical trials in public and private hospitals.
For example, two doctors from WA, who conducted clinical trials in WA hospitals claimed they had ethics committee approvals, which cannot be confirmed.
Mr Barakat told the Herald they are looking to sue health departments in each state in Australia. Also being considered, is action against the TGA, the Therapeutic Goods Administration for clearing devices with little or no evidence of safety and efficacy.
There are more than 1,350 Australian women involved in class action lawsuits naming mesh makers Johnson & Johnson (J&J), American Medical Systems.
There is currently a six-month trial involving 700 mesh injured plaintiffs being conducted in Sydney against defendant, J&J. ###
https://www.meshmedicaldevicenewsdesk.com/uk-place-restrictions-pop-pelvic-mesh/
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