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McGinnis v. C.R. Bard – What We Know from Past TVM Trials
Mar 21, 2018 | Mesh Medical Device News Desk
C.R. Bard, of Murray Hill, New Jersey has been the defendant in a number of transvaginal mesh trials. Here is what some of the evidence from those past trials has shown. -
Mum-of-four battles for urgent treatment in England
Mar 21, 2018 | Cambrian News
By Julie McNicholls Vale
A CEREDIGION woman has “given up hope of getting better” after the health board refused to fund treatment which is only available in England. -
Former American Medical Systems exec's startup raises $2.5M to revive device
Mar 21, 2018 | Minneapolis/St.Paul Business Journal
By Katharine Grayson
A device developed and once sold by American Medical Systems may get a second life through a startup launched by former AMS executive John Nealon.
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McGinnis v. C.R. Bard – What We Know from Past TVM Trials
Mar 21, 2018 | Mesh Medical Device News Desk
C.R. Bard, of Murray Hill, New Jersey has been the defendant in a number of transvaginal mesh trials. Here is what some of the evidence from those past trials has shown.
While MND is not in the courtroom this week for the McGinnis trial in Bergen Co, New Jersey, the evidence presented in this product liability case is reminiscent of other product liability trials conducted against C.R Bard.
Courtroom View Network is covering the trial and live feeds are available with a subscription here.
Mary McGinnis was implanted with a Bard Avaulta Support system to treat pelvic organ prolapse (POP) and also the Align transobturator sling to treat stress urinary incontinence (SUI).
Donna Cisson has the same meshes implanted in her.
Cisson sued C.R. Bard of Murray Hill, New Jersey, in July 2013, contending that the Bard Avaulta mesh used to treat pelvic organ prolapse (POP) was defective in design. She was represented by Henry Garrard of Blasingame Burch Garrard.
After a mistrial, the case of Cisson v. C.R. Bard began in July 2013 with Lori Cohen defending Bard. She is the same attorney representing Bard again in the McGinnis trial.
Lori Cohen
Your editor watched as Cohen made herself known during the Cisson jury selection, smiling, greeting and shaking hands with almost everyone on the defense half of the courtroom.
According to Law 360 when Cohen walks into a courtroom, she owns it.
“Her ability to befriend everyone, from the bailiff to the opposition’s witnesses, coupled with her focus on out-preparing the competition, have led to 55 straight trial victories and landed her a spot among Law360’s Top Female Trial Attorneys.”
However, Henry Garrard marred Cohen’s record and won the Cisson trial with his client being awarded $250,000 in compensatory damages and $1,750,000 punitive damages.
Since Cisson is from Georgia, the state was entitled to 75% of the punitive damages under state law.
Material Safety Data Sheet (MSDS)
Garrard opened the trial with the Material Safety Data Sheet.
The MSDS accompanies raw materials that workers come in contact with during the manufacturing process.
Enclosed in the MSDS was a warning the resin is not to be used in medical devices that are permanently implanted in the human body.
The evidence showed Bard knew about the warning and didn’t want supplier Phillips Sumika to know that’s exactly what it was doing.
Evidence showed emails from Roger Darois, VP of Research for Bard Davol who wrote about supplier Phillips Sumika:
“IMPORTANT.. these suppliers will likely not be interested in a medical application due to product liability concerns.” It was important the PP resin be purchased“through a 3rd party, not the resin supplier to avoid a supply issue once the medical application is discovered.”
As a diversion, Bard created a wholly-owned subsidiary Red Oak Sales Company that purchased resin from Phillips Sumika “without creating suspicion about its use.”
“We need to keep this proprietary,” writes Darois.
“Assuring an ongoing supply of PP is critical to achieving the 2008 revenue and there is currently insufficient inventory on-hand at Secant to accomplish this.”Secant is a textile manufacturer.
Sheerer Case
Eve Sherrer was implanted with both a Boston Scientific pelvic mesh and a Bard Align.
Represented by Tom Cartmell in the December 2015 trial in Kansas City, Missouri he told jurors a medical device manufacturer must make sure its device is reasonably safe before it is sold. To do that adequate testing is required, especially if this is a permanent implant. And there should be adequate warnings about the risks and dangers associated with the device.
Cartmell told jurors heavyweight and small pore mesh was first used in the 1960’s for hernia repair. After seeing the potential for expansion, manufacturers were in a race to re-purpose hernia mesh to be used in women and placed transvaginally, that is, through the vagina.
Johnson & Johnson was first with its TVT, marketed in the U.S. in 1998, and soon other “sling in a box” products were developed.
After C.R.Bard purchased the rights to the Uretex mesh, actually a knockoff of TVT, the company began selling it in 2002. But it was considered small pore mesh, less than 1 cm and could produce a hardened scar plate that contracted and encapsulated nerves.
Bard knew this but did nothing to make a larger pore pelvic mesh of 3 cm or more.
Doctors, who are considered the end users of transvaginal mesh, were not told the mesh had a potential to shrink from 30 to 50%, due to scarring. They were not told about the MSDS and its warning not to use the raw polypropylene resin for implantable medical devices.
At the Sherrer trial, Lori Cohen of Greenberg Traurig said the Align is the “Gold Standard” for pelvic mesh products.
Sheerer lost her case at the hands of the jury.
https://www.meshmedicaldevicenewsdesk.com/mcginnis-v-c-r-bard-know-past-tvm-trials/
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Mum-of-four battles for urgent treatment in England
Mar 21, 2018 | Cambrian News
By Julie McNicholls Vale
A CEREDIGION woman has “given up hope of getting better” after the health board refused to fund treatment which is only available in England.
Heather Hamlin-Brewer used to spend her days working in Tesco in Aberystwyth, walking her dogs and riding her motorbike, but the 61-year-old is virtually house-bound now, which she says is as a result of complications from mesh, implanted during surgery for pelvic organ prolapse.
The mother-of-four says Hywel Dda refuses to give her cross-border funding to see a specialist in England, and there is no-one in Wales who can help.
“I am a victim of surgical mesh, fighting to get the treatment I desperately need,” she told the Cambrian News.
“In the meantime my condition deteriorates. I have gone from an active person walking, hiking, horse riding, motorbike-riding to shuffling with the aid of a walking stick between bed and sofa.
“I am about to lose my job and I am practically housebound as I can no longer drive and car journeys are too painful to attempt other than for hospital appointments.”
In 2010 Heather, who used to live in south Wales, had surgery for a prolapse at the Prince of Wales Hospital, Bridgend.
She had to have the operation again in 2011, but her health continued to deteriorate.
Despite that, Heather and her partner Steve moved to Ceredigion three years ago, settling between Blaenpennal and Bronant. She registered with Tregaron Surgery who investigated her problems and discovered the probable cause.
“It was like a light bulb moment when I found out,” she said. “All the problems I’ve had over the years are all symptomatic of the mesh.
“It feels like having broken glass in your stomach. I also get a stabbing pain in my groin and my leg gives way.
The health board said it was unable to comment.
http://www.cambrian-news.co.uk/article.cfm?id=119763&headline=Mum-of-four%20battles%20for%20urgent%20treatment%20in%20England§ionIs=news&searchyear=2018
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Former American Medical Systems exec's startup raises $2.5M to revive device
Mar 21, 2018 | Minneapolis/St.Paul Business Journal
By Katharine Grayson
A device developed and once sold by American Medical Systems may get a second life through a startup launched by former AMS executive John Nealon.
In 2015, the startup, UroCure Inc., purchased intellectual property covering two products that treat urinary incontinence from Endo International, which inherited the devices through its 2011 acquisition of a division of Twin Cities-based AMS.
Now Minneapolis-based UroCure has raised about $2.5 million in funding from angel investors to pursue regulatory clearances for modified versions of the products, Nealon said. The devices will be branded as ArcTV and ArcSP.
The products are implantable “sling” devices that support urethras in women, reducing the risk that urine will leak from the bladder. The broader market for sling devices took a hit about five years ago, when lawsuits mounted against big playerswho made the products. The Food and Drug Administration warned in 2011 that mesh used as part of the procedures could erode and cause complications.
However, those safety concerns largely centered around the devices’ use in treating a condition called pelvic organ prolapse, Nealon said. In 2016, the FDA reclassified the device as riskier for the treatment of prolapse, but didn't do so for incontinence.
“Our belief is that these products belong on the market and doctors want to have them as options in the treatment of patients,” Nealon said.
Nealon was a long-time AMS executive and served as senior vice president and general manager of its women’s health business from 2008 through 2013. Malvern, Penn.-based Endo paid $2.9 billion for AMS in 2011. It shut down the company’s women’s health business, which was based in Eden Prairie, two years ago after it failed to find a buyer for the unit. AMS at one point had hundreds of employees in the metro area.
Nealon said it’s too early to say whether UroCure will seek to become a large, standalone business, or eventually sell its devices to a larger medical-device player.
“Our intent is to get these products back onto the market and into the hands of physicians,” he said. “We’ll look at all the avenues for accomplishing that.”
Nealon declined to disclose the size of the company’s workforce.
Among the startup’s board members and advisers is Doug Kohrs, a med-tech veteran who sold a startup to Medtronic two years ago and previously served as CEO of orthopedics company Tornier.
https://www.bizjournals.com/twincities/news/2018/03/21/former-american-medical-systems-execs-startup.html
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