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Ethicon Media Monitoring 10/25/2018
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NJ Law Applies In Bard Pelvic Mesh Multicounty Litigation
Oct 24, 2018 | Law 360
By Jeannie O'Sullivan
A New Jersey judge has ruled that Garden State law will apply to multicounty litigation over adverse effects of C.R. Bard’s pelvic mesh products, citing recent state Supreme Court precedent involving a mass tort over the acne drug Accutane. -
Industry Paints Rosy Picture About Vaginal Mesh and its Future
Oct 24, 2018 | Mesh Medical Device News Desk
By Jane Akre
Industry White Papers continue to point to a bright future for polypropylene mesh implants despite the number of patient injuries and the unanswered mysteries as to why they exist.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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NJ Law Applies In Bard Pelvic Mesh Multicounty Litigation
Oct 24, 2018 | Law 360
By Jeannie O'Sullivan
A New Jersey judge has ruled that Garden State law will apply to multicounty litigation over adverse effects of C.R. Bard’s pelvic mesh products, citing recent state Supreme Court precedent involving a mass tort over the acne drug Accutane.
Ruling on one woman’s case against the New Jersey-based medical device company, Bergen County Superior Court Judge Rachelle L. Harz issued an order Monday saying that New Jersey law would govern the “substantive issues” in all cases in the Bard multicounty litigation.
The ruling came in response to the briefing Judge Harz had requested the parties produce about the impact of the New Jersey Supreme Court’s Oct. 3 decision toppling 532 cases against Hoffmann-LaRoche Inc. The justices found that the drug company’s Accutane label warnings were adequate under New Jersey law, and that only Garden State law applies.
The choice-of-law ruling is “very significant,” said attorney Adam Slater, who represents plaintiffs Sandra and Ernest Rios, whose case against Bard is going to trial in January.
“Judge Harz did exactly what the Supreme Court intended, giving clear guidance so all parties know what law will apply," Slater told Law360.
Representatives for Bard didn't immediately respond to requests for comment.
As of Sunday, there were 132 pelvic mesh cases against C.R. Bard and 9,214 against Johnson & Johnson’s medical device unit Ethicon Inc. pending in New Jersey state court, according to the state judiciary’s latest MCL figures. The C.R. Bard products at issue in the MCL are Avaulta Solo, Align TO, Avaulta Plus, Avaulta Classic and Align R, Slater said.
According to the Rioses’ suit, Sandra Rios was implanted with a pelvic mesh product that caused severe pain when it eroded and contracted. She alleged she had to undergo surgery to remove the device and now experiences chronic pain. The complaint was filed in 2014 and lodges claims of design defect, failure to warn and negligence.
The Rioses’ lawsuit marks the second bellwether trial in the Bard MCL. In April, a jury slammed Bard with a $68 million judgment in two separate verdicts on punitive and compensatory damages. The verdicts were a victory for Mary McGinnis, whose claims against Bard were similar to those in the Rioses’ lawsuit.
On Oct. 11, Superior Court Judge James DeLuca denied Bard’s bid for a new trial.
The Rioses are represented by Adam Slater of Mazie Slater Katz & Freeman.
C.R. Bard is represented by Melissa A. Geist, Michael Brown and Eric Alexander of Reed Smith LLP.
The case is Sandra Rios and Ernest Rios v. C.R. Bard et al., case no. BER-L-018689-14, in the Superior Court of New Jersey.https://www.law360.com/articles/1095215/nj-law-applies-in-bard-pelvic-mesh-multicounty-litigation
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Industry Paints Rosy Picture About Vaginal Mesh and its Future
Oct 24, 2018 | Mesh Medical Device News Desk
By Jane Akre
Industry White Papers continue to point to a bright future for polypropylene mesh implants despite the number of patient injuries and the unanswered mysteries as to why they exist.
MESH INDUSTRY PROSPECTS
“Vaginal Mesh is Booming” the market research report promises.
White Papers or market research frequently forecast a rosy future for a certain sector’s growth. In this case, ResearchVector in its White Paper looks ahead to 2025 to predict pharmaceutical companies such as Johnson & Johnson and its Ethicon division, Boston Scientific, Endo, Coloplast, Covidien, Cook Medical, Neomedic and C.R. Bard are likely to benefit from renewed vaginal mesh sales.
The mesh manufacturers named are currently involved in defective product litigation and settlements.
Interestingly, as transvaginal placement of pelvic mesh is the subject of more than 100-thousand product liability lawsuits in the U.S. and globally, the report mentions only transabdominal mesh placement.
The meshes in this report are polypropylene (PP), the same material- polypropylene, a polymer used for indoor-outdoor carpets and Tic-Tac boxes.
The forecast predictions are global in reach, though the UK, Australia and New Zealand currently have suspended the use of PP mesh or recommend it as a last resort.
The White Paper can be obtained for $4,900. MND has asked for the report.
Among the promises:
Growth in the Vaginal Mesh market has increased the demand for Vaginal Mesh. The higher profit growth have increased the demand for {Products} in the Vaginal Mesh market. Other factors that are driving the growth of Vaginal Mesh market are:
Growing population
The rise in technological advancements
The total market size
Key market drivers
Major players in the market
The growing disposable income
Mesh News Desk has already written about an effort by a former executive for American Medical Systems, John Nealon, who wants to rebrand the company calling it UroCure and bring back polypropylene pelvic mesh.
American Medical Systems folded and was sold to Endo International, which relaunched AMS products as Astora Women’s Health. That company dissolved its women’s health division in 2016.
See MND background story here.
UroCure raised $2.5 million to fund creating of the urethral slings. It has goals of raising upward of $3.5 million. The slings will rely on the same patented technology used to create the AMS slings such as Sparc and Monarc to treat stress urinary incontinence.
Nealon says the new company plans to “build on the long-standing market leadership position,” said Nealon.J&J ROSY FORECAST
In its recent SEC report (8K report Oct 16) Johnson and Johnson reports Worldwide medical device sales were $6.6 billion and growing, according to an earning’s call.
This represents an acceleration over the first half of 2018. J&J and its Ethicon division also has a vision division as well as sales in catheters, atrial fibrillation procedures and prosthesis. The Women’s Health division at $3 million is the same as 2017 but down $1 million internationally and worldwide.
“We are pleased with our strong third-quarter performance, which reflects continued above-market growth in our Pharmaceutical business, accelerating sales momentum in our Consumer business and consistent progress in our Medical Devices business,” said Alex Gorsky, Chairman and Chief Executive Officer. “I’m confident that with our collaborative and inspired J&J colleagues around the world, unique broad-based business model and strategic investments in innovation, we are well positioned for success today and into the future.”
MESHES STILL ON THE MARKET
Johnson & Johnson (Ethicon) still markets:TVT – Tension Free vaginal tape. Also known as a “tape” or “hammock”. It is made of polypropylene. In some cases doctors tell patients that this is a “NEW” product or “Not the same one the subject of lawsuits.” Ask- Is it made of polypropylene?
TVT-O Tension free vaginal tape- Obturator (put through the obturator space). Also made of polypropylene, but placed through the obturator opening in the body. Nothing new here. This is classified as moderate risk with the FDA even though it has been found to have been defectively design at trial.
TVT-Abbrevo mini sling, Implanted transobturator is still on the market. See the product here.Gynemesh, used for pelvic organ prolapse, as Artisyn. The polypropylene mesh is used during sacrocolpopexy surgery used to treat prolapse.TVT-Exact – A Polypropylene sling mesh kit used to treat stress urinary incontinence. See product here. Boston Scientific still Markets:
Advantage Fit– mid-urethral sling to support the urethra made of polypropylene. This is a mesh sling and permanently implanted.Lynx Suprapubic – mid-urethral sling- polypropyleneObtryx Transobturator – mid-urethral sling, another polypropylene product woven through the obturator space to treat incontinenceSolyx a single incision sling for treating incontinenceC.R. Bard:
In June, 20017, C.R. Bard was sold to Becton Dickinson for $24 billion, its meshes are off the market.
See Mesh News Desk story here.American Medical Systems
AMS sold its gynecological device division to Endo International which shuttered its Astora Women’s Health division in 2016. A former AMS executive wants to bring back to the market AMS polypropylene meshes.
See MND story here and here.
Caldera Medical
Not to be deterred from the market Caldera offers six meshes to treat stress urinary incontinence, all made of polypropylene and similar to the meshes it’s always had on the market.
Caldera was severely under-insured it was discovered in litigation, and offered mesh-injured patients less than $4,000 each.
Here are their products today including Desara, Desara SL, Desara Blue, Desara TV and Vertessa Lite.
https://www.meshmedicaldevicenewsdesk.com/industry-paints-rosy-picture-about-vaginal-mesh-and-its-future/
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