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Ethicon Media Monitoring 5/24/2017
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Latest J&J Pelvic Mesh Injury Case Kicks Off In Philly
May 23, 2017 | Law 360
By Matt Fair
The latest in a string of cases over a Johnson & Johnson unit’s allegedly defective pelvic mesh kicked off in Pennsylvania state court on Tuesday, as a jury heard arguments a woman had been left facing chronic pain after being implanted with one of the products nearly seven years ago. -
Patient alleges mesh used for hernia repair is defective
May 23, 2017 | Madison County Record
By Heather Isringhausen Gvillo
A patient is suing the manufacturers of a mesh intended for hernia repair after it allegedly caused damages and must be removed. -
Dr Richard Reid questioned about pelvic mesh implanted in woman
May 24, 2017 | Newcastle Herald
By Joanne McCarthy
A FORMER University of Newcastle associate professor who was suspended in Australia and America after surgery on women must tell a court what training he received from two American medical companies before implanting a NSW woman with high risk pelvic mesh in 2010 and 2011. -
Scottish Mesh Inquiry Blows-Up
May 23, 2017 | Mesh Medical Device Newsdesk
An official mesh inquiry has blown up in Scotland, falling short of protecting the public, claim campaigners.
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Latest J&J Pelvic Mesh Injury Case Kicks Off In Philly
May 23, 2017 | Law 360
By Matt Fair
The latest in a string of cases over a Johnson & Johnson unit’s allegedly defective pelvic mesh kicked off in Pennsylvania state court on Tuesday, as a jury heard arguments a woman had been left facing chronic pain after being implanted with one of the products nearly seven years ago.
Bryan Aylstock, an attorney with Aylstock Witkin Kreis & Overholtz PLLC, told a panel of Philadelphia County jurors that an Ethicon Inc. mesh product that Kimberly Adkins was implanted with in July 2010 to treat her incontinence had eroded into her vagina, causing significant pain and largely robbing her of the ability to have sex with her partner.
“The mesh itself actually saws through the tissue and erodes back into the vaginal cavity, causing severe pain,” Aylstock said. “You’re going to hear that’s what happened to Ms. Adkins.”
The case is the fifth to go to trial in Philadelphia over allegations of defects in various pelvic mesh products that Ethicon has marketed to treat incontinence in women, and is one of nearly 200 cases pending as part of a mass tort program in the court to deal with claims over the products.
Litigation over Ethicon mesh products in Philadelphia has resulted in several hefty verdicts against the company, including a $12.5 million award in December 2015 in the first case to go to trial, a $13.5 million award in a second case in February 2016 and a $20 million award handed down late last month.
The trial in a fourth case is ongoing in Philadelphia, with jurors expected to begin deliberations sometime in the second half of this week.
Aylstock said that Ethicon had rushed its so-called TVT Secur mesh product to market despite serious concerns about the potential for a high rate of failures and complications in women using the product to treat incontinence.
He said that internal documents showed the company had opted not to conduct a randomized clinical trial of the product before it went to market in September 2006.
Instead, he said Ethicon had tested the product in only 31 women, and that initial results received just a week before the device went to market showed a 30 percent failure rate, with 60 percent of the participants experiencing some form of complication.
“This product was a disaster from day one,” he said.
Kimberly Bueno, an attorney with Scott Douglass & McConnico LLP representing Ethicon, admitted to the jury that it would likely hear some unflattering things about the company’s handling of the product’s launch.
She stressed, however, that the case was not ultimately about Ethicon’s conduct but about the injures Adkin claims she suffered as a result of receiving the implant.
“I imagine there will be a lot of time spent on these issues in the coming days,” she said of the company’s problems with the product. “As you’re listening to the evidence you may be troubled by it, but I ask you to keep in mind that this case is about one person and one person only: Ms. Kim Adkins.”
She pointed to testimony that she said would come from two causation experts who had concluded that the pain Adkins experiences during sex was a result of vaginal atrophy, or a lack of natural lubrication due to a drop in estrogen levels that women can experience as they age.
And while Adkins did undergo a procedure in September 2012 to remove a portion of the mesh implant that had eroded into her vagina, Bueno said that exams conducted earlier this year by the two experts did not reveal any additional erosion.
Bueno said that erosion was a commonly understood risk with all pelvic mesh products, and that records shows that Adkins and her doctor, George Pettit, had discussed the possibility of complications before she agreed to the surgery.
“This is a commonly known risk of all pelvic mesh products, not just the TVT Secur,” she said. “Ethicon warned about this risk of erosion and exposure, Dr. Pettit knew about the risk of erosion, and, importantly, Dr. Pettit told Ms. Adkins about the risks before her surgery.”
Adkins is represented by Bryan Aylstock, Daniel Thornburgh and James Barger of Aylstock Witkin Kreis & Overholtz PLLC, Benjamin Anderson of Anderson Law OFfices, and Lee Balefsky, Christopher Gomez and Christine Clarke of Kline & Specter PC.
Ethicon is represented by Kimberly Bueno of Scott Douglass & McConnico LLP, Williams Gage, Chad Hutchinson and Jordan Walker of Butler Snow LLP, and Kenneth Murphy, Melissa Merk and Andrew Reeve of Drinker Biddle & Reath LLP.
The case is Kimberly Adkins v. Ethicon Inc. et al., case number 130700919, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
--Editing by Kelly Duncan.https://www.law360.com/lifesciences/articles/927276/latest-j-j-pelvic-mesh-injury-case-kicks-off-in-philly
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Patient alleges mesh used for hernia repair is defective
May 23, 2017 | Madison County Record
By Heather Isringhausen Gvillo
A patient is suing the manufacturers of a mesh intended for hernia repair after it allegedly caused damages and must be removed.
Gary Goodson filed the suit in the U.S. District Court for the Southern District of Illinois on May 22 against Johnson & Johnson and Ethicon Inc.
In his complaint, Goodson claims he was implanted with a Physiomesh device at Anderson Hospital in Maryville in an attempt to repair a recurrent ventral incisional hernia.
Goodson alleges that due to continuous complications with the implanted device, he requires revision surgery to correct the “dangerous and defective” Physiomesh.
The suit states that the Physiomesh incorporates give distinct layers, which is not used in any other hernia repair product sold in the U.S.
“The multi-layer coating was represented and promoted by the Defendants to prevent or minimize adhesion and inflammation and to facilitate incorporation of the mesh into the body, but it did not.
“Instead the multi-layer coating prevented adequate incorporation of the mesh into the body and caused or contributed to an intense inflammatory and chronic foreign body response resulting in an adverse tissue reaction including migration and damage to surrounding tissue in the form of sclerotic, granulomatous and/or fibrotic tissue and improper healing,” the suit states.
The plaintiff alleges the impermeable multi-layer coating prevents fluid escape and provides a “breeding ground for bacteria” which cannot be eliminated by the body’s immune response.
He also alleges the mesh cannot withstand normal abdominal forces and layers can become adhered to organs, causing damage.
The plaintiff alleges the defendants were responsible for the research, design, development, testing manufacture, production, marketing, promotion, distribution and sale of the device.
He also alleges the device was defectively designed, was not reasonably safe for its intended use in hernia repair, and the risks of the design outweighed any potential benefits associated with the design.
“Neither Plaintiff Gary Goodson nor his implanting physician were adequately warned or informed by Defendants of the defective and dangerous nature of Physiomesh,” the suit states.
Goodson seeks more than $75,000 in compensatory damages, plus court costs, pre- and post-judgment interest, punitive damages and any other relief the court deems just.
He is represented by John Carey, Jeffrey Lowe, Andrew Cross, Sarah Shoemake Doles and Alyson Petrick of Carey Danis & Lowe in Clayton, Mo.
U.S. District Court for the Southern District of Illinois case number 3:17-cv-540
http://madisonrecord.com/stories/511119086-patient-alleges-mesh-used-for-hernia-repair-is-defective
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Dr Richard Reid questioned about pelvic mesh implanted in woman
May 24, 2017 | Newcastle Herald
By Joanne McCarthy
A FORMER University of Newcastle associate professor who was suspended in Australia and America after surgery on women must tell a court what training he received from two American medical companies before implanting a NSW woman with high risk pelvic mesh in 2010 and 2011.
Gynaecologist Richard Reid used Boston Scientific and Cook Medical mesh devices during the procedures on a woman, 35, who took legal action after alleging Dr Reid was negligent and the surgery left her with serious injuries.
In the NSW Supreme Court last week the woman alleged Dr Reid was negligent in failing to obtain informed consent for the procedures, for the way he performed the procedures and for using mesh surgery when more conservative management was warranted.
The woman is one of five taking legal action against Dr Reid, after a sixth woman implanted with Cook Medical’s high risk Surgisis pig intestine mesh settled a case against him in January.
Dr Reid is also the subject of NSW Health Care Complaints Commission action in the NSW Civil and Administrative Tribunal. He retired from medical practice in January.
Justice Christine Adamson directed Dr Reid to answer pre-hearing questions put to him by the woman about the training, study and experience he had using polypropylene meshes before he implanted the woman with different meshes in 2010 and 2011.
Dr Reid must confirm if he received any training from Boston Scientific or Cook Medical before implanting the woman with the companies’ pelvic mesh devices.
In oral submissions to the court the woman’s barrister said she wanted to make a case that Dr Reid “overused particular products and used them for applications for which they were unsuited, and that this was what had happened in the present case”.
Dr Reid was a University of Newcastle associate professor between 2009 and January, 2012.
He was suspended in America in April, 1998 and fined $10,000 after the Michigan Board of Medicine found he violated his duty to safely and skilfully practise medicine, based on complaints from three American woman.
The NSW Medical Council suspended Dr Reid in 2014 but the decision was overturned by the NSW Civil and Administrative Tribunal. He was later placed on conditions.
http://www.theherald.com.au/story/4678433/patient-pursues-doctor-on-mesh/
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Scottish Mesh Inquiry Blows-Up
May 23, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, May 23, 2017 ~ An official mesh inquiry has blown up in Scotland, falling short of protecting the public, claim campaigners.
A story in the Sunday Post from reporter Marion Scott (here) says an independent inquiry will be conducted into conflicts of interest among authors of an official report that stopped short of banning most types of mesh implants.
Health Secretary Shona Robison has ordered a review of the official mesh implant inquiry.
In Scotland, estimates are that between the years 2000 and 2014, up to 1,500 women suffering from stress urinary incontinence, and 350 suffering from pelvic organ prolapse had synthetic mesh implant surgery using a polypropylene (PP) mesh medical device.
By comparison, there are more than 130,000 product liability lawsuits against seven mesh makers filed in U.S. courts. Visible appearances by anti-mesh campaigners and extensive media coverage have made the issue front-page news in Scotland and forced the inquiry.
The Scottish Government investigated pelvic mesh implants after hundreds of women came forward and spoke directly to a Parliamentary Committee
The Independent Review of Transvaginal Mesh Implants,published March 27, 2017 is here.
The Health Board banned the use of most mesh in that country in June 2014 until the release of the independent review.
But the official report followed the publication of an earlier interim report published in October 2015 so campaigners were especially disappointed when this final report fell short.
The campaigners, Scottish Mesh Survivors, wanted six points of a petition to be met including banning polypropylene transvaginal mesh procedures, requiring mandatory reporting of all adverse events and the establishment of a Scottish transvaginal mesh implant register.
While the Independent Review of Transvaginal Mesh Implants, said transvaginal mesh implants procedures must not be offered routinely, it stopped short of an outright ban that campaigners sought.
Also omitted was establishment of a central registry of all data about mesh implant clinical procedures that would be gathered in one place.
Four clinical experts on the 20-person panel have links to industry that makes mesh implants, say campaigners. Panelists were only required to declare any conflicts 12-months prior. Boston Scientific told the paper that any funding of educational sessions follows strict internal guidelines.
Three members of the panel resigned in protest of the removal of recommendations before the report was issued. Elaine Holmes who was a campaigner who resigned from the review said “Vital evidence was ignored by the review which hasn’t taken account of so many significant issues and safety warnings, we fear it will leave more women at risk.”
Like the U.S. Food and Drug Administration’s 510(k) clearance for medical devices, a hands-off fast-track get-to-market clearance, the United Kingdom has a CE Mark. That means the manufacturer met the minimum regulatory requirements and a CE Mark clears the device to sell. ###
http://www.meshmedicaldevicenewsdesk.com/scottish-mesh-inquiry-blow/
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