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ethicon feb 23
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Bard To Settle Avaulta Mesh Suit Ahead Of Trial
Feb 20, 2015 | Law360
By Sindhu Sundar
...In the MDL against Johnson & Johnson unit Ethicon Inc., Judge Goodwin earlier this month scheduled a trial for July 13 in a case by plaintiff Tonya Edwards, who targeted its Gynecare TVT Obturator, TVT-O device... -
Mesh surgery scandal: 166
operations AFTER Government urged health boards to stop them
Feb 22, 2015 | Daily Record and Sunday Mail
By Marion Scott
166 of the controversial operations have taken place since former health secretary Alex Neil said further mesh procedures would be “highly unacceptable”. -
Mesh Operations Continue in Scotland Despite Suspension
Feb 22, 2015 | Mesh Medical Device News Desk
By Jane Akre
Journalist Marion Scott is leading the way again with her reporting on the mesh surgery scandal in Scotland. -
Bard Execs Sell Off Stock, Make No Promises to Investors
Feb 22, 2015 | Mesh Medical Device News Desk
By Jane Akre
...Besides transvaginal mesh, C.R. Bard of Murray Hill, NJ makes surgical, diagnostic and medical devices... -
Scleroderma Patient Has Pig Intestine Mesh Inserted Into Vagina To Help Make Sex Possible
Feb 20, 2015 | Medical Daily
By Dana Dovey
...Mesh augmented vaginal reconstruction is an operation typically used on women who experience vaginal relapse due to childbirth or a hysterectomy...
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Bard To Settle Avaulta Mesh Suit Ahead Of Trial
Feb 20, 2015 | Law360
By Sindhu Sundar
C.R. Bard Inc. and a plaintiff targeting its pelvic mesh devices in the federal multidistrict litigation in West Virginia on Wednesday indicated plans to settle their dispute, ahead of a trial in the case that was scheduled to start this month.
Plaintiff Debra Wise and Bard have a "pending settlement," according to a court filing that U.S. District Judge Joseph Goodwin signed off on in ordering the case off the active docket in the litigation. Their dispute had been scheduled to begin trial in February.
Wise had originally filed her suit in West Virginia state court in the Circuit Court of Cabell County, before her suit moved to the federal MDL. Her suit targeted the Avaulta Plus devices, which she had implanted in 2007 to treat pelvic organ prolapse.
Bard had argued in a past motion for summary judgment in the case that many of the gynecological problems that she attributed to the devices, including pelvic pain and dyspareunia, a medical condition that causes sexual intercourse to be painful, pre-dated that surgery.
An attorney for Wise could not immediately be reached for comment Friday.
A total of seven MDLs have been assigned to U.S. District Judge Joseph Goodwin over transvaginal surgical mesh devices used to treat pelvic organ prolapse and stress urinary incontinence.
Those MDLs contain more than 70,000 cases that are currently pending, including roughly 10,000 in the Bard MDL, according to court documents.
In the MDL against Johnson & Johnson unit Ethicon Inc., Judge Goodwin earlier this month scheduled a trial for July 13 in a case by plaintiff Tonya Edwards, who targeted its Gynecare TVT Obturator, TVT-O device. The device includes a mechanism used to place a mesh tape, or sling, under the urethra to provide support to treat stress urinary incontinence, according to court documents.
Last February, J&J won the first bellwether case the first bellwether case against it in the multidistrict litigation over alleged transvaginal mesh injuries, in a five-day trial that concluded when Judge Goodwin granted the defendants’ motion for judgment.
In the current case, Wise is represented by Henry G. Garrard, Gary B. Blasingame, Andrew J. Hill, James B. Matthews and Josh B. Wages of Blasingame Burch Garrard Ashley PC.
Bard is represented by Lori G. Cohen and R. Clifton Merrell of Greenberg Traurig LLP and Michael K. Brown of Reed Smith LLP.
The case is Wise et al v. C. R. Bard Inc., case number 2:12-cv-01378, part of MDL 2187, in the U.S. District Court for the Southern District of West Virginia. -
Mesh surgery scandal: 166 operations AFTER Government urged health boards to stop them
Feb 22, 2015 | Daily Record and Sunday Mail
By Marion Scott
166 of the controversial operations have taken place since former health secretary Alex Neil said further mesh procedures would be “highly unacceptable”.101 Shares166 of the controversial operations have taken place since former health secretary Alex Neil said further mesh procedures would be “highly unacceptable”.
HEALTH boards have ignored a government request to halt mesh procedures until after a safety review.
The Sunday Mail can reveal 166 of the controversial operations have taken place since former health secretary Alex Neil said further mesh procedures would be “highly unlikely and highly unacceptable”.
He won plaudits from campaigners around the world after announcing a nationwide suspension in June 2014.
Neil said he was moved to action after hearing the testimony of hundreds of Scottish women who suffered crippling injuries as a result of mesh ops for pelvic and bladder problems.
But since then more than 160 have taken place as eight Scottish NHS boards have ignored the suspension.
Officials at NHS Greater Glasgow and Clyde, who have carried out 56 ops, claim patients have insisted on going ahead despite the risks.
An NHS Glasgow spokeswoman said: “At their initial outpatient appointment, all patients who are assessed and require mesh procedures have the opportunity to fully discuss the risks and benefits of treatment options with their consultant before they are listed for surgery.
“In addition they are given the patient information booklet provided by the Scottish Government.”
Other health boards that have continued with the ops include Lothian, Fife and Forth Valley.
NHS Aberdeen and NHS Orkney have signed up 24 patients for a clinical trial comparing the effectiveness of the tape compared with the TVT-O device twice found defective in a US court.
Six health boards have observed the suspension and not carried out a single operation – Tayside, Orkney, Shetland, Highland, Western Isles and Ayrshire and Arran.
Lothians MSP Neil Findlay, who has represented campaigners, said: “Hundreds of thousands of women around the world have been crippled.
“It’s outrageous health boards are disregarding the suspension and playing Russian roulette with the lives of those patients.
"There have been settlements of over £1.5billion in the US, and countries like Australia are deregistering mesh implants because of safety concerns.”
Mesh campaigner Elaine Holmes, 50, from Newton Mearns, said: “We’re appalled health boards are arrogantly flouting the suspension.”
More than 400 injured women are suing the NHS and mesh manufacturers.
Medical negligence lawyer Cameron Fyfe said: “Given everything we now know about the level of injuries that can be caused by mesh implants, any health board would have the gravest difficulty defending itself if any of new patients made a claim.”
Neil’s successor as Health Secretary Shona Robison will meet mesh victims tomorrow before a public petitions committee meeting at Holyrood on Tuesday.
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Mesh Operations Continue in Scotland Despite Suspension
Feb 22, 2015 | Mesh Medical Device News Desk
By Jane Akre
Journalist Marion Scott is leading the way again with her reporting on the mesh surgery scandal in Scotland.
According to her article in the Daily Record and Sunday Mail, ever since the government urged the country to stop using transvaginal mesh in that country, there have been 166 operations.
Scott reports eight health boards have ignored the suspension.
Read her story here.
The NHS Great Glasgow and Clyde, reportedly said patients wanted mesh placed, despite the risks. It is the board with the most – 56 operations. Meanwhile six health boards have performed no mesh surgeries and have observed the suspension.
Scotland has a publicly funded healthcare system, NHS. There are 14 regional NHS Boards in Scotland.
Included in scheduled future operations is a clinical trials on 24 patients who will test a TVT tape versus a TVT-O (transvaginal tape obturator) which has already been found to be defective in two U.S. courts.
Elaine Holmes testifying to Parliament
Mesh campaigners, including Scottish Mesh Survivors’ Elaine Holmes says she is “appalled health boards are arrogantly flouting the suspension.”
Last June, former health secretary Alex Neil announced a nationwide suspension on procedures after mesh-injured campaigners petitioned a committee of parliament to share their stories of horrendous mesh injuries.
Like in the U.S., litigation is underway in Scotland where more than 400 mesh-injured woman have filed lawsuits against the mesh makers and the NHS. #
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Bard Execs Sell Off Stock, Make No Promises to Investors
Feb 22, 2015 | Mesh Medical Device News Desk
By Jane Akre
Sleek Money reports (here) that the Chief Operating Officer for C.R. Bard, John H. Weiland sold off 13,616 shares of company stock on Tuesday, February 17. With the stock selling at $174.51 a share, it brought Mr. Weiland $2,376,128.16, according to the report. The sale was disclosed in a SEC filing. See it here.
John Weiland, COO Bard
The COO currently owns 87,822 shares with an approximate value of $15,325,817.22.
52-week low for the stock is $132.81 and the high is $180.35.
According to the article, several analysts reiterated a “hold” rating on the stock.
Meanwhile WKRB News reports C.R. Bard VP John P. Groetelaars sold 4,566 shares of the company on Thursday, February 19th. The value of the transaction was approximately $3,520,839.42 with an average price of of $175.14.
Besides transvaginal mesh, C.R. Bard of Murray Hill, NJ makes surgical, diagnostic and medical devices.
According to a transcript from a 3Q conversation on earnings in October 26,2011, transvaginal mesh makes up 1-2% of the company’s profits.
Cartoon courtesy JadeR
Legal Proceedings – Women’s Health Products
According to its SEC filing released Feb. 18, 2015 (see it here), concerning women’s health products, “as of February 9, 2015, product liability lawsuits involving individual claims by approximately 14,090 plaintiffs have been filed against the company in various federal and state jurisdictions alleging personal injuries associated with the use of certain of the company’s surgical continence products for women. In addition, five putative class actions in the United States and four putative class actions in Canada have been filed against the company (all lawsuits, collectively, the “Women’s Health Product Claims”). The Women’s Health Product Claims generally seek damages for personal injury resulting from use of the products. ”
In July 2012, the Christine Scott case naming the Bard Avaulta resulted in a judgment against the company of approximately $3.6 million. That survived an appeal in November 2014. The company has since filed to have the Scott case heard before the California Supreme Court. The Cisson case in July 2013 resulted in a $2 million award, which has been appealed.
“During the third quarter of 2013, the company settled one MDL case and one New Jersey state case. In addition, during the third quarter of 2013, one MDL case was voluntarily dismissed with prejudice.”
Judge Joseph Goodwin
Bard was ordered by Judge Joseph Goodwin, who heads multidistrict litigation in his federal courtroom in Charleston, WV, to prepare 200 then 300 additional cases for trial. In its SEC filing, the company warns investors these orders resulted in significant addition litigation-related costs to the company.
During the second quarter of 2014, Bard agreed to a settlement with two plaintiffs’ law firms concerning 500 cases. It settled an MDL case scheduledfor May 2014. At the end of 2014, a settlement was reached concerning 25 cases. Most recently the Debra Wise case was settled by Bard for an undisclosed amount. A state court trial is scheduled for April, 2015 in Missouri.
Meanwhile, there are 1,800 pending claims which have not yet been filed.
“While the company continues to engage in discussions with other plaintiffs’ law firms regarding potential resolution of unsettled Women’s Health Product Claims and intends to vigorously defend the Women’s Health Product Claims that do not settle, including through litigation, it cannot give any assurances that the resolution of these claims and the related litigation with Covidien will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.”
Covidien is a supplier for the company.
Hernia Mesh
At present there are “about 80 federal and 45 state lawsuits involving individual claims by approximately 125 plaintiffs, as well as three putative class actions in the United States are currently pending against the company with respect to its Composix® Kugel® and certain other hernia repair implant products (collectively, the “Hernia Product Claims”). The company voluntarily recalled certain sizes and lots of the Composix® Kugel® products beginning in December 2005.”
The Composix® Kugel® lawsuits were transferred into one Multidistrict Litigation (“MDL”) for coordinated pre-trial proceedings in the United States District Court for the District of Rhode Island.
“In June 2011, the company announced that it had reached agreements in principle with various plaintiffs’ law firms to settle the majority of its existing Hernia Product Claims. Each agreement was subject to certain conditions, including requirements for participation in the proposed settlements by a certain minimum number of plaintiffs. In addition, the company continues to engage in discussions with other plaintiffs’ law firms regarding potential resolution of unsettled Hernia Product Claims, and intends to vigorously defend Hernia Product Claims that do not settle, including through litigation.”
NuVia SI Pelvic Floor Repair Kit
According to a conversation on earnings Q3 2011 (here) Bard planned to introduce its newest pelvic floor repair kit, the NuVia SI single incision by 2012 to the U.S. in 2012. That never happened. Instead, Bard launched the transvaginal mesh kit in Europe.
The National Law Journal reports the larger pore, lightweight mesh kit was developed under something called the Web/WebTO project. Plaintiffs’ firms have launched discovery into the project which resulted in the development of mesh products to be used overseas. Bard has objected to the discovery request, reports the journal.
The company states the lighter weight mesh products were not designed to correct any alleged design flaws with the Avaulta line of products, which have since been taken off the market. #
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Scleroderma Patient Has Pig Intestine Mesh Inserted Into Vagina To Help Make Sex Possible
Feb 20, 2015 | Medical Daily
By Dana Dovey
A condition known as scleroderma caused a Czech woman’s vagina to become so narrow that doctors were not even able to complete a gynecological exam. In a first-of-its-kind procedure, the woman’s vagina was surgically widened using a mesh made from pig intestines. Although still in the recovery stages, doctors believe that the operation will allow the woman to enjoy something that’s been robbed of her for years: a full and active sex life.
Mesh augmented vaginal reconstruction is an operation typically used on women who experience vaginal relapse due to childbirth or a hysterectomy. The operation usually involves using synthetic mesh, but this time a team of doctors at the University Hospital in the town of Plzen, Czech Republic, chose to take a new approach to the fairly common procedure and use organic pig intestines to construct their vaginal mesh.
Pig intestines were chosen for their genetic similarity to human DNA, the Daily Mail reported. The team of doctors was inspired to use pig material after observing the success of past operations that re-grew human leg muscles using implants made of pig bladder tissue.
Scleroderma is an umbrella term for a group of conditions which involve the hardening and tightening of the skin and connective tissues. In most cases it only affects the skin, but in some individuals, such as the Czech patient, the condition can affect internal organs. The patient was given a variety of medications to help treat her condition, but none provided her with relief.
To repair the hardened vaginal tissue, the doctors cut inside of the patient and inserted the mesh made from the pig intestines into her vaginal wall. The material was about 1 millimeter thick, and over time the pig intestines will be absorbed into the woman’s body, replaced by new human tissue.
The entire surgery lasted about an hour, and the patient was allowed to return home after a five-day stay in the hospital.
“The patient is very happy now. The gynecological examinations are not painful anymore,” Dr. Vladimir Kalis, head doctor of the gynecological-obstetrical clinic at the hospital, toldCEN, the Daily Mail reported.
The patient is still recovering and at the moment has been advised to not engage in sexual activity, but Kalis expects her to make a full recovery in about two years.
The surgical team believes they are the first to have conducted a mesh augmented vaginal reconstruction using pig intestines and are planning on publishing the results of their surgery in an effort to bring awareness to the condition.
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