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Ethicon Media Monitoring 8/28/2017
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10th Circ. Affirms Toss Of Faulty Surgical Mesh Claims
Aug 25, 2017 | Law 360
By Rachel Graf
The Tenth Circuit on Friday upheld a lower court’s decision to toss claims over an allegedly defective surgically implanted mesh sling, saying the patient shouldn’t have waited to file the suit until more than five years after doctors informed her she needed an operation to remove parts of the sling. -
Ethicon wins another federal pelvic mesh trial on most counts
Aug 25, 2017 | Reuters
By Tina Bellon
A federal jury on Thursday cleared Johnson & Johnson subsidiary Ethicon of liability on most counts in the latest trial over allegations the company defectively designed its pelvic mesh and failed to warn of its risks. -
Johnson & Johnson Argues that Pelvic Mesh Cases Belong in New Jersey
Aug 25, 2017 | The National Law Review
By Martin P. Schrama, Craig S. Hilliard and Stefanie Colella-Walsh
The sixth pelvic mesh product liability trial against Ethicon, Inc., a Johnson & Johnson subsidiary, is underway in the Philadelphia Court of Common Pleas. -
Doctors who inserted pelvic mesh in women patients who were too much pain to have vaginal sex because of the controversial surgery 'told them to have anal sex instead'
Aug 28, 2017 | The Daily Mail
By Nic White
Pelvic mesh patients in too much agony to have sex were told by their doctors to just have anal sex instead, a Senate inquiry heard. -
Pelvic Mesh Patients Told To Deal With Sexual Dysfunction By Having Anal Sex
Aug 28, 2017 | Buzzfeed News
By Gina Rushton
Women who couldn't have vaginal sex due to ongoing sexual dysfunction from urogynaecological mesh "repeatedly" reported their doctors suggested having anal sex instead, a Senate inquiry into the devices has heard. -
Medic ‘aghast’ at sex advice given to pelvic mesh victims
Aug 26, 2017 | NEWS.com.au
A DOCTOR said she was “aghast” at sickening advice given to victims unable to have sex after the mesh surgery accused of brutally injuring hundreds of women. -
Doctor 'aghast' at anal sex advice to pelvic mesh victims
Aug 26, 2017 | Illawarra Mercury
By Joanne McCarthy
A Perth doctor was left speechless after Federal Senators at a pelvic mesh inquiry in Perth on Friday said women unable to have vaginal sex after mesh surgery "repeatedly" reported that their doctors suggested anal sex as an alternative.
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10th Circ. Affirms Toss Of Faulty Surgical Mesh Claims
Aug 25, 2017 | Law 360
By Rachel Graf
Law360, New York (August 25, 2017, 5:17 PM EDT) -- The Tenth Circuit on Friday upheld a lower court’s decision to toss claims over an allegedly defective surgically implanted mesh sling, saying the patient shouldn’t have waited to file the suit until more than five years after doctors informed her she needed an operation to remove parts of the sling.
The two-judge panel said Gerry Adams should have known that a mesh sling manufactured by American Medical System Inc. and surgically implanted in her pelvic area to treat stress urinary incontinence was defective, after she was told in 2007 she would need to undergo a second surgery to alleviate pain caused by the product. Since she didn’t file the suit until 2013, the claims are consequently time-barred and were appropriately tossed, according to the filing.
“Adams knew, or should have known, by November 2007 — when she was told she had to undergo a second operation to remove part of the mesh sling in order to remedy severe pain and bleeding — that she had been harmed by the sling,” the panel said in the filing.
Doctors surgically implanted a Desara mesh sling into Adam’s pelvic region in July 2007, according to the filing. Adams subsequently suffered “severe pain,” and doctors determined in November 2007 that a portion of the sling had moved and was “protruding into the vaginal canal.” A month later, Adams underwent surgery during which her surgeon excised almost 2 centimeters of the mesh sling, though she allegedly continued to suffer from complications including vaginal pain and bleeding, pain during intercourse and “severe infections.”
In February 2013, a new doctor found “two pieces of mesh protruding through [Adams’] vaginal roof” and recommended she have the sling removed, according to the filing. Adams then filed this suit in June 2013.
The panel said Friday that Adams was required to file the suit within two years of discovering “both the harm and its cause.”
Adams should have known by November 2007 that she was being harmed and that the sling was defective, according to the filing. Adams’ doctor told her that month that the implanted mesh had moved within her body and was causing her “severe pain and vaginal bleeding,” requiring a second surgery, the panel noted.
Even if the December 2007 surgery had alleviated her complications, Adams still would have been able to file a product liability suit after the operation, according to the filing.
Counsel for the parties didn’t respond Friday to requests for comment.
U.S. Circuit Judges Timothy M. Tymkovich and David M. Ebel sat on the panel for the Tenth Circuit.
Adams is represented by Diana J. Huntsman of Huntsman Lofgran.
American Medical Systems Inc. is represented by David E. Stanley and Lisa M. Baird of Reed Smith LLP.
The case is Gerry A. Adams v. American Medical System Inc. et al., case number 14-4057, in the U.S. Court of Appeals for the Tenth Circuit.
--Editing by Alyssa Miller.https://www.law360.com/articles/957889/10th-circ-affirms-toss-of-faulty-surgical-mesh-claims
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Ethicon wins another federal pelvic mesh trial on most counts
Aug 25, 2017 | Reuters
By Tina Bellon
A federal jury on Thursday cleared Johnson & Johnson subsidiary Ethicon of liability on most counts in the latest trial over allegations the company defectively designed its pelvic mesh and failed to warn of its risks.
A jury in the U.S. District Court for the Northern District of Illinois cleared the company on defective design and failure to warn counts, but awarded the plaintiff $55,000 for medical expenses on a negligent misrepresentation claim. The jury did not award other compensatory or punitive damages.
To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/2iy6yIy
https://www.reuters.com/article/ethicon-lawsuit-idUSL2N1LB1DV
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Johnson & Johnson Argues that Pelvic Mesh Cases Belong in New Jersey
Aug 25, 2017 | The National Law Review
By Martin P. Schrama, Craig S. Hilliard and Stefanie Colella-Walsh
Martin P. Schrama, Craig S. Hilliard and Stefanie Colella-Walsh are attorneys with Stark & Stark law firm
The sixth pelvic mesh product liability trial against Ethicon, Inc., a Johnson & Johnson subsidiary, is underway in the Philadelphia Court of Common Pleas. The lawsuit alleges that the plaintiff was injured by Ethicon’s TVT Secur pelvic mesh product, requiring her to undergo multiple corrective surgeries and removal of mesh fragments from her urethra. The plaintiff alleges that the defective pelvic mesh product has caused perforations to her urethra, incontinence, and pain. The complaint alleges design defect and a failure to warn.
Citing the recent United States Supreme Court decision in Bristol-Myers Squibb v. Superior Court of California (BMS), Ethicon, Inc. argued that the company’s lack of tangible links to Pennsylvania prevented the Philadelphia County Court of Common Pleas from hearing pelvic mesh cases. Ninety of the cases filed in the Philadelphia court that alleging injuries caused by defective pelvic mesh implants were filed by out-of-state residents.
Ethicon and Johnson & Johnson were incorporated and have their principal place of business in New Jersey. The nonresident plaintiffs received their mesh implants and related treatment outside of the Pennsylvania.
Ethicon Inc. argued that the BMS case limits a state court’s ability to assert specific jurisdiction over nonresident companies, and that in the case before the court, there was no evidence of a link between the company’s conduct, the nonresident plaintiffs’ alleged injuries, and the Commonwealth of Pennsylvania. Ethicon relied not only on the BMS case but also on BNSF Railway Co. v. Tyrell, which also limits the extent to which state courts can exercise general jurisdiction over nonresident companies.
Just a few weeks earlier, a Philadelphia County judge agreed to reconsider a two year old ruling allowing nonresident claims against Ethicon relating to the allegedly defective pelvic mesh to proceed.
Whether Ethicon’s contacts with the Commonwealth are sufficient to allow jurisdiction has become the key issue. The nonresident plaintiffs argued that Ethicon’s contract with Pennsylvania-based third-party manufacturer of plastic filaments used in Ethicon’s pelvic mesh product provided sufficient contacts with the Commonwealth.
Scar plate formation, chronic inflammation, erosion, and mesh migration are possible complications allegedly due to defective pelvic mesh. There are many types of pelvic mesh products that are manufactured by various companies. Approximately 54,000 women have filed pelvic mesh lawsuits against Johnson & Johnson and Ethicon nationwide. Additional cases have been filed other device manufacturers.
In cases already concluded in the Pennsylvania pelvic mesh mass tort litigation involving Ethicon transvaginal mesh lawsuits, four juries found in favor of the plaintiffs, who were awarded damages of $2.16 million, $12.5 million, $13.5 million and $20 million. One jury ruled in favor of Ethicon but the plaintiff was granted a new damages hearing after the judge found the verdict was inconsistent with the evidence.
https://www.natlawreview.com/article/johnson-johnson-argues-pelvic-mesh-cases-belong-new-jersey
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Aug 28, 2017 | The Daily Mail
By Nic White
· Thousands of women suffered severe complications from pelvic mesh implants
· They were unable to have sex, had to quit their jobs, and were in constant pain
· Harrowing tales from women around Australia presented to a Senate inquiry
· They said doctors told them to have anal sex if they couldn't do it vaginally
· 700 patients are also suing manufacturer Johnson & Johnson over the scandal
Pelvic mesh patients in too much agony to have sex were told by their doctors to just have anal sex instead, a Senate inquiry heard.
The startling advice stunned even experienced doctors who investigated the controversial surgery and warned of its serious complications.
'I'm truly shocked a colleague would say that to a woman. I am aghast. I feel awful,' urogynaecologist Michelle Atherton told the inquiry on Friday.
The medical expert who wrote one of the first research papers on the devices was asked by Senator Derryn Hinch if the advice made patients feel betrayed.
Inquiry chair Senator Rachel Siewert said patients 'repeatedly' relayed the advice to the panel during the ongoing hearings, accord to WAToday.
The mesh technology is also the subject of a class action lawsuit against manufacturer Johnson & Johnson by 700 Australian women.
The Australian-invented implants were designed to treat prolapse and incontinence but caused a global scandal with thousands of patients affected.
Senator Hinch said told parliament it was 'one of the greatest medical scandals and abuses of mothers in Australia's history' and compared it to the infamous drug Thalidomide.Numerous women testified to the harrowing complications of the surgery, which was dropped from sale in 2012, that made death seem preferable.
The hearing heard 90 per cent of patients were not warned of the serious possible complications and many were not even aware until after surgery that it had been fitted - and some not even until years later.
Women told the inquiry their doctors refused to refer them to specialists and refused to believe their complications were linked to the mesh.
'Women who have gone for consultations have been scoffed at, mocked, humiliated and disregarded by some of their doctors,' Australian Pelvic Mesh Support Group founder Caz Chisholm and director Stella Channing said.
'These comments are a total invalidation of a woman's lived experience. This demonstrates how the health system silences, shames and blames the victims.'
More than 150,000 women were fitted with the device in Australia, including 30,000 with the most problematic transvaginal variety.
Ms Channing suffered from pelvic organ prolapse in her late 40s after having three children, and had the mesh inserted between her vagina and rectum.
But just a week after her eight-day hospital stay, the mesh already began to fall apart and put her in unbearable pain and gave her ischaemic attacks, or 'mini strokes'.
She had to quit her job and was often unable to leave the house due to the intense pain, which made her contemplate suicide.
Sydney grandmother Louise King had the surgery in 2006 and was left in such chronic pain she couldn't have sex with her husband.
'I couldn't climb stairs, I couldn't drive, I couldn't get out of bed some days,' she said.
Jan Hawkins, 60, said she had to retire from her job as a primary school teacher after she developed severe complications from an implant she had inserted in 2007.
'It's like sandpaper inside you that every now and then rears its ugly head and pokes through organs and walls, which affects nerves and how they function,'she said.
'It's a terrible thing that rubs and creates a cheese grater effect.'
The three women are part of a 700-person class action launched last month alleging devastating complications after surgery.
'Many now live in excruciating pain, suffering terrible side effects that impact all aspects of their lives,' Shine Lawyers attorney Rebecca Jancauskas said.
'This class action is about righting the wrong against these women, who will suffer pain and complications for the rest of their lives,' she said.
The Australian class action comes after more than 100,000 women started legal action in the US and similar moves were taken in the UK and Canada.
http://www.dailymail.co.uk/news/article-4824880/Doctors-told-pelvic-mesh-patients-anal-sex.html
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Pelvic Mesh Patients Told To Deal With Sexual Dysfunction By Having Anal Sex
Aug 28, 2017 | Buzzfeed News
By Gina Rushton
"The feeling from the women is just overwhelming despair at what they have been told by doctors."
Women who couldn't have vaginal sex due to ongoing sexual dysfunction from urogynaecological mesh "repeatedly" reported their doctors suggested having anal sex instead, a Senate inquiry into the devices has heard.
"It has been told to us repeatedly," senator Rachel Siewert told a Perth public hearing on Friday for the inquiry, of which she is the chair.
Urogynaecological meshes, sometimes known as transvaginal meshes, are inserted into women as a treatment option for pelvic organ prolapse (when the connective tissue securing the vagina and uterus to the pelvis gives way after childbirth), or urinary incontinence.
In the submissions to the inquiry, women have listed many complications which they say arose after the insertion of the mesh, which is polypropylene, non-absorbable, and acts as a permanent implant.
These include: chronic and constant vaginal pain; visceral pain with bowel movements; dyspareunia (pain during sex); vaginal bleeding; the granulation of vaginal tissue; pain through the glutes; inflammatory reactions; "offensive discharge"; incontinence; leg weakness; and haemorrhages.
The reports that doctors were suggesting patients try anal sex to cope with painful sex indicative of "just how many doctors have been ignoring the issues women have had with mesh", Siewert told BuzzFeed News on Monday.
"How this has gone on for so long amazes me frankly," Siewert said.
"The feeling from the women is just overwhelming despair at what they have been told by doctors."
Siewert said patients had been told their ongoing symptoms were "all in their head" by doctors.
"This is women being told to just get over it," she said.
"It is really distressing sitting in the [public hearings] and watching the women having to get up and stand against the wall because they just can't sit for very long without pain."
Perth urogynaecologist Dr Michelle Atherton told the inquiry she was "truly shocked a colleague would [suggest anal sex as a solution to sexual dysfunction] to a woman".
"I am aghast. I feel awful," Atherton told the inquiry on Friday, the Illawarra Mercury reported.
The Australian Senate inquiry launched in February and will continue to hear from patients and medical experts in public hearings around the country.
It will also examine the Therapeutic Goods Administration's "knowledge of women suffering from health problems after having transvaginal mesh implants", and is expected to report back in November.
Meanwhile, a legal battle is taking place in the Federal Court in Sydney between hundreds of women and a pharmaceutical giant that manufactures the implants.
The class action, which involves more than 700 Australian women, is against Johnson & Johnson subsidiary Ethicon, which has sold more than 100,000 mesh and tape implants.
Shine Lawyers, representing the women, has said there could be upwards of 8,000 Australians who have been implanted with one of nine devices and suffered complications that may be entitled to join the action.
In the statement of claim, supplied to BuzzFeed News, patients have listed a raft of symptoms and complications they say they have suffered following the insertion of the nine Ethicon mesh devices.
https://www.buzzfeed.com/ginarushton/pelvic-mesh-patients-told-to-deal-with-sexual-dysfunction?utm_term=.hvyL748Bw#.mcXEBDRQy
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Medic ‘aghast’ at sex advice given to pelvic mesh victims
Aug 26, 2017 | NEWS.com.au
A DOCTOR said she was “aghast” at sickening advice given to victims unable to have sex after the mesh surgery accused of brutally injuring hundreds of women.
Women unable to have vaginal sex after having the mesh implanted “repeatedly” reported that their doctors suggested anal sex as an alternative, Federal Senators told an inquiry in Perth on Friday.
“I’m truly shocked a colleague would say that to a woman. I am aghast. I feel awful,” said urogynaecologist Dr Michelle Atherton, who wrote one of the first papers on the risks of the Australian-invented device, according to WA Today.
Senator Derryn Hinch had asked if that sort of response might explain why victims felt so betrayed after what he has dubbed Australia’s “biggest medical scandal”.
Many women who had the surgery to insert the Tissue Fixation System reported pain so extreme that even death was welcomed, the inquiry heard. Around 90 per cent of those surveyed said they were not warned of the serious risks of complications, and some had no idea it had even been put in until years later.
The public hearing in Perth follows another in Melbourne, which heard that 150,000 risky mesh devices had been sold in Australia.
More than 700 women have joined the class action against Johnson & Johnson Medical Australia and subsidiary companies Ethicon Inc and Ethicon Sarl to seek hundreds of millions in compensation, claiming they have suffered catastrophic injuries to their internal organs.
They say the surgical mesh approved by Australia’s medicine watchdog has disfigured and disabled them, caused chronic pain and destroyed their sex lives.
One consultant enlisted to conduct clinical trials for the implants wrote in an email read out to a Sydney court: “I would not like my wife to undergo this procedure.”
The controversial mesh implants have been used to treat urogynaecological issues typically caused by child birth in thousands of Australian women since 2000.
Medical reviews claim up to one in eight suffer complications including scarring, infection, bleeding, organ perforation, incontinence and recurrent prolapse. Several patients claim the mesh has eroded their organs and fused others together.
Primary school teacher Jan Hawkins, 60, said she was forced to retire after she developed severe complications from a pelvic mesh implant she had inserted in 2007.
“It’s like sandpaper inside you that every now and then rears its ugly head and pokes through organs and walls, which affects nerves and how they function,” Ms Hawkins told news.com.au.
“It’s a terrible thing that rubs and creates a cheese grater effect.”
Australia’s Therapeutic Goods Administration still allows surgeons to implant the mesh despite bans, warnings and withdrawals in other countries and more than 120,000 pending lawsuits in the US. However, some of the implants have been discontinued.
The inquiry continues.
http://www.news.com.au/lifestyle/real-life/news-life/medic-aghast-at-sex-advice-given-to-pelvic-mesh-victims/news-story/83e521c5b8a34f1cbdd84c2d1c6cd70b
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Doctor 'aghast' at anal sex advice to pelvic mesh victims
Aug 26, 2017 | Illawarra Mercury
By Joanne McCarthy
A Perth doctor was left speechless after Federal Senators at a pelvic mesh inquiry in Perth on Friday said women unable to have vaginal sex after mesh surgery "repeatedly" reported that their doctors suggested anal sex as an alternative.
"I'm truly shocked a colleague would say that to a woman. I am aghast. I feel awful," said urogynaecologist Dr Michelle Atherton, after Senator Hinch asked if that kind of response from doctors was why pelvic mesh victims felt so betrayed.
Dr Atherton, who wrote one of the earliest Australian research papers warning about serious complications in women implanted with the Australian-invented Tissue Fixation System (TFS) device, was stunned by the suggestion.
But inquiry chair Senator Rachel Siewert said: "It's been told to us repeatedly."
Adelaide-based TFS Manufacturing, owned by former Australian champion basketballer and Newcastle Falcons player Paul Zadow, has appealed to the Australian Administrative Appeals Tribunal against the device's cancellation in 2014. The hearing is set down for October.
The Senate inquiry on Friday heard devastating evidence from many women reporting pain so extreme that even death was welcomed, and a doctor saying some mesh victims were so desperate for relief they were "at the end of the road, like cancer".
The hearing was told 90 per cent of women surveyed had not been warned of the sometimes high risk of serious pelvic mesh complications, and many women had no idea they were implanted with mesh until waking from surgery, and sometimes not until many years later.
Many women reported doctors refusing to refer them to specialists and refusing to believe their complications were linked to mesh surgery.
"Women who have gone for consultations have been scoffed at, mocked, humiliated and disregarded by some of their doctors," Australian Pelvic Mesh Support Group founder Caz Chisholm and director Stella Channing said.
"These comments are a total invalidation of a woman's lived experience. This demonstrates how the health system silences, shames and blames the victims."
The pelvic mesh inquiry was established after the support group met with Senator Derryn Hinch, who later compared mesh with the drug Thalidomide, and told federal parliament it was "one of the greatest medical scandals and abuses of mothers in Australia's history".
A first inquiry public hearing day in Melbourne was told about 150,000 mesh devices for incontinence and prolapse have been sold in Australia, all classified from medium to high risk. This includes about 30,000 of the most problematic transvaginal – surgery via the vagina – prolapse mesh devices.
At the second public hearing day in Perth on Friday doctors described some pelvic mesh devices as a "catastrophe", and were highly critical of broader issues relating to medical device safety clearance in Australia, the lack of transparency about device registration processes, and concerns about a "silent, suffering cohort" of women who lived with the consequences of failed mesh surgery.
Urogynaecologist Dr Nicolas Tsokos said the pelvic mesh scandal flowed from the "disaster that has come out of implanting things that we then can't image", after evidence from doctors and women about how some implanted mesh and anchors could not be seen in scans when complications occurred.
"You cannot keep implanting things in people without being able to find them exactly," Dr Tsokos said.
"One of my senior colleagues suggested a long time ago to the TGA (Therapeutic Goods Administration) that every device that's permanently implanted in Australia should be imageable in some fashion, and easily imageable, because otherwise the same thing's going to happen with something else."
WA Health Minister Roger Cook was strongly criticised by women for a submission saying patients undergoing pelvic mesh surgery were "apprised of all their treatment options and of the risks and evidence base in relation to the use of transvaginal mesh".
A health researcher named Daisy was scathing of the suggestion that all women had given informed consent to mesh surgery, after saying she consented to a hysterectomy in December, 2015 but woke to find she had a mesh implant "which was not consented to and not warranted".
"As a therapist and mental health professional I am aware that the most debilitating form of violence against women is perpetrated by people women trust. The fact that domestic violence is perpetrated by a woman's partner is particularly traumatising. Likewise is that perpetrated by a medical practitioner against their own patient," Daisy said.
She felt "physically sick" reading a Newcastle Herald report confirming it was tests on 13 "mongrel dogs" in Perth that initiated an Australian pelvic mesh device which went on to be registered in America, and led to the global mesh scandal.
The lack of consent by women implanted with pelvic mesh devices was a "public health outrage", she said.
"Consent is based on info question and answer, with sufficient time to consider alternatives, none of which occured in my case. This is abuse and violence against women and it's a public health outrage."
The inquiry continues.
http://www.illawarramercury.com.au/story/4881034/doctor-aghast-at-anal-sex-advice-to-pelvic-mesh-victims/
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