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Ethicon Media Monitoring 4/11/2018
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Women in a landmark pelvic mesh case have sought strong future warnings for devices
Apr 11, 2018 | Newcastle Herald
By Joanne McCarthy
JOHNSON & Johnson should only sell pelvic mesh devices in Australia with warnings that injuries to women are not rare and occur regardless of a surgeon’s skill, that some women’s chronic pain “may not be able to be treated”, and device removal “may be practically impossible”, a class action by hundreds of women against the company has told a Federal Court judge. -
Former C.R. Bard VP said company 'chose not to remind' resin maker over use of resin in medical products
Apr 10, 2018 | Legal Newsline
By John Sammon
A former C.R. Bard vice president told a jury April 6 that the use of a resin substance in pelvic implant devices had not been communicated to a supplier of the resin because if the supplier found out its resin material was being used for medical purposes, it might prohibit its availability.
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Women in a landmark pelvic mesh case have sought strong future warnings for devices
Apr 11, 2018 | Newcastle Herald
By Joanne McCarthy
JOHNSON & Johnson should only sell pelvic mesh devices in Australia with warnings that injuries to women are not rare and occur regardless of a surgeon’s skill, that some women’s chronic pain “may not be able to be treated”, and device removal “may be practically impossible”, a class action by hundreds of women against the company has told a Federal Court judge.
Johnson & Johnson and device manufacturers Ethicon have until May 31 to respond to an application by the women to amend a statement of claim against the companies and seek an injunction preventing the supply or promotion of the devices without “proper warning” of alleged consequences.
The women have also sought a declaration that by marketing, promoting, distributing and supplying the devices without the “proper warning”, Ethicon engaged in misleading or deceptive conduct.
The application came after the end of evidence in February in a six-month legal class action case launched by more than 800 women alleging injuries caused by nine Ethicon devices sold by Johnson & Johnson in Australia.
It also came after Johnson & Johnson withdrew all pelvic mesh devices from the market in January, including its “gold standard” TVT midurethral mesh sling for incontinence, after new regulatory requirements for stronger warnings about adverse effects.
In a decision on Monday Federal Court Justice Anna Katzmann allowed more women to join the case until a cut-off date of July, 2017 after Shine Lawyers, for the women, argued it would be a “harsh and unjust outcome” if a large number of women were shut out from a class action initiated in 2012, after evidence of serious complications years after surgery.
Justice Katzmann rejected an application that women be allowed to join the case up until her judgment, which is not expected until early 2019, or any possible settlement between the parties before that date.
The TGA does not have an exclusive role in protecting the safety of consumers.Federal Court Justice Anna Katzmann
Justice Katzmann rejected the companies’ argument that the “proper warning” injunction sought by the women in their amended statement of claim was the job of the regulator, the Therapeutic Goods Administration.
“The TGA does not have an exclusive role in protecting the safety of consumers,” Justice Katzmann said.
An injunction could serve a public interest purpose to prevent and deter “undesirable trade practices” or “mark the court’s disapproval of a contravener’s conduct”, she said.
Lawyers for the women flagged the injunction issue in final submissions and the companies made no submissions against the application, she said.
The “proper warning” should include that polypropylene pelvic mesh devices cause chronic inflammatory response in all patients for as long as the implant is in the body; that it is not possible to predict the severity of the response in any patient; that severe chronic pain could have life-altering consequences including “psychiatric injury” and that the long term safety of implants “has not been studied and is unknown”, the women said in a submission to the court.
Justice Katzmann also gave the companies until May 31 to respond to a proposed amendment to the women’s statement of claim alleging women, patients and treating hospitals were not warned that pelvic mesh devices were not recommended for women with auto-immune and connective tissue disorders.
http://www.theherald.com.au/story/5335537/court-told-pelvic-mesh-pain-may-be-untreatable/
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Apr 10, 2018 | Legal Newsline
By John Sammon
HACKENSACK, N.J. (Legal Newsline) – A former C.R. Bard vice president told a jury April 6 that the use of a resin substance in pelvic implant devices had not been communicated to a supplier of the resin because if the supplier found out its resin material was being used for medical purposes, it might prohibit its availability.
“That could be one of the outcomes - it could be difficult to source the material,” said Roger Darois, former vice president of research and advanced technologies at C.R. Bard, during the trial at the New Jersey Superior Court in Bergen County.
Streaming video coverage of the trial was provided to Legal Newsline by Courtroom View Network.
However Darois, today retired, said there had been no wrongdoing.
“You were asked a number of questions about hiding information from Phillips Sumika (Polypropylene Co.) about C.R. Bard’s use of the resin,” said Cliff Merrell of Greenberg Traurig, attorney for C.R. Bard. “Is that an accurate characterization?”
“No,” Darois responded. “Hiding implies something wrong. We actually chose not to remind them (Phillips). We had no reason to contact them that we were still using their resin (for medical), we were buying it from a distributor, there was no way they could prevent us from buying this product legally.”
Phillips Sumika was a Woodlands, Texas-based supplier and marketer of polypropylene resins used for many purposes, including medical implants - particularly those involved in the repair of hernias. The Chevron Phillips website states Phillips Sumika "has permanently shut down its manufacturing facilities and is no longer involved in the production, sale or marketing of polypropylene."
Darois appeared as a witness for C.R. Bard in the lawsuit filed by Mary McGinnis of North Carolina. McGinnis sued C.R. Bard of New Jersey in New Jersey Superior Court over the pelvic mesh implanted into her groin region in 2009 for bladder prolapse. She alleges the device was unsafe and caused inflammation and scar tissue, resulting in intense pain.
The mesh, a spider web-shaped clear polypropylene device with connecting arms that comes in a box kit, had to be removed from McGinnis over subsequent surgeries.
In addition to pain, medical bills and quality of life damage, McGinnis also alleged C.R. Bard went ahead and marketed its Avaulta and Align implant devices beginning in 2007 knowing there were health concerns and without properly warning patients and doctors about possible complications.
Adam Slater of Mazie, Slater, Katz & Freeman in Roseland, New Jersey, attorney for McGinnis projected on a screen a medical caution statement titled "Material Safety Data Sheet" (MSDS), required by the Occupational Safety and Health Administration (OSHA) and that accompanies resin shipments.
The statement read, “Do not use this Chevron Phillips Chemical Co. material (resin) in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”
Another statement advised not to use the material for “Brief or temporary implantation unless provided under an agreement which acknowledges the contemplated use.”
Darois agreed he had written a 2004 email that suppliers would likely not be interested in medical applications of the polypropylene product because of liability concerns. He also later advised company officials “Ensuring an ongoing supply of polypropylene is critical to achieving the 2008 revenue and there is currently insufficient inventory on-hand to accomplish this.”
Shakespeare Monofilaments, a company that had supplied C.R. Bard with polypropylene monofilament for use in hernia and pelvic mesh devices, declined to provide more monofilament because of liability concerns over medical use. Slater said an offer had even been made to indemnify the monofilament producer against potential lawsuits brought by people for harm caused them by the products, but the offer was turned down as well.
“They (Shakespeare) still said 'Nothing doing; we won’t do it under any circumstances,' correct?” Slater asked.
“That’s correct,” Darois said.
Darois indicated the greatest good was to acquire the material so medical implant devices for hernias and pelvic problems could continue to be produced for the people who depended on them. He said the devices had a history of successful use.
“If we can’t get the material, there are a million surgical patches used each year,” Darois said. “Half of the hernias in the U.S. use them. To cut this off would be irresponsible unless we had data. The devices continue to be successfully used even after the caution.”
https://legalnewsline.com/stories/511385239-former-c-r-bard-vp-said-company-chose-not-to-remind-resin-maker-over-use-of-resin-in-medical-products
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