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Ethicon Media Monitoring 5/23/2019
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J&J ordered to pay $80 million in Pennsylvania pelvic mesh case
May 22, 2019 | Mass Device
By Nancy Crotti
A Philadelphia jury has awarded a woman $80 million for injuries caused by pelvic mesh manufactured by Johnson & Johnson’s Ethicon subsidiary, according to media reports. -
Jury Orders J&J to Pay Woman $80M in Vaginal Mesh Case
May 22, 2019 | Medical Device and Diagnostics Industry
By Omar Ford
A jury has ordered Johnson & Johnson to pay $80 million to a Philadelphia woman injured by its Ethicon subsidiary’s vaginal mesh implants, according to the Philadelphia Inquirer. -
J&J Ordered to Pay $80M to PA Woman in Vaginal Mesh Lawsuit
May 22, 2019 | Legal Scoops
By Jacob Maslow
Patricia Mesigian, a 75-year-old woman, won an $80 million lawsuit against a Johnson & Johnson subsidiary. Mesigian had an Ethicon Prolift mesh implanted in her in 2008, but the mesh led to infection, pain, scar tissue and inflammation after it eroded. -
The Lancet on Makers Told to Stop Selling POP Mesh
May 22, 2019 | Mesh Medical Device News Desk
By Jane Akre
The Lancet is one of the oldest medical journals in the world. Ed Holt writes for The Lancet about last month’s FDA decision to halt the sales of any POP mesh due to concerns about safety and efficacy. It is the final nail in the coffin on the largest mesh implants used to treat prolapse. -
The FDA Pulls (Most) Vaginal Mesh Products off the Market – Now What?
May 22, 2019 | LawyersandSettlements.com
By Jane Mundy
The FDA has finally ordered the last two medical device companies selling transvaginal mesh products to pull them from the market. The agency said it is “committed to patient safety” but hundreds of thousands of women –victims of surgical mesh--would disagree. And the lawsuits are still pouring in.
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J&J ordered to pay $80 million in Pennsylvania pelvic mesh case
May 22, 2019 | Mass Device
By Nancy Crotti
A Philadelphia jury has awarded a woman $80 million for injuries caused by pelvic mesh manufactured by Johnson & Johnson’s Ethicon subsidiary, according to media reports.
The award includes $50 million in punitive damages and $30 million in compensatory damages — the largest compensatory damages verdict to date in a pelvic mesh case, a company spokeswoman told Bloomberg News.
Patricia Mesigian, 75, of Media, Pa., had Ethicon’s ProLift mesh implanted in 2008 to treat pelvic organ prolapse. The mesh caused her pain, inflammation, infection and scar tissue, and surgeons could not fully remove it despite repeated procedures.
The jury deliberated two days before rendering its verdict.
“In this largest transvaginal compensatory jury verdict to date, this jury resoundingly found that Johnson & Johnson terribly injured another one of thousands of women implanted with its defective transvaginal mesh device, recognizing not only the severity of the injury but the abhorrence of the conduct,” Mesigian’s trial attorney, Thomas Kline, said in an emailed statement Saturday to the Philadelphia Inquirer.
Last week’s verdict resulted in the second major compensatory damages award rendered by a Philadelphia jury against Ethicon in a month. In April, a jury awarded an Altoona, Pa., woman $120 million, including $100 million in punitive damages, in a pelvic mesh case.
The company has said it plans to appeal both verdicts.
https://www.massdevice.com/jj-ordered-to-pay-80-million-in-pennsylvania-pelvic-mesh-case/
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Jury Orders J&J to Pay Woman $80M in Vaginal Mesh Case
May 22, 2019 | Medical Device and Diagnostics Industry
By Omar Ford
A jury has ordered Johnson & Johnson to pay $80 million to a Philadelphia woman injured by its Ethicon subsidiary’s vaginal mesh implants, according to the Philadelphia Inquirer.
The 75-year-old had Ethicon’s Prolift mesh implanted in 2008 and the device eroded causing her pelvic pain, infection, inflammation, and scar tissue, according to the suit. Physicians were not able to remove the device from her.
According to the Philadelphia Inquirer, the jury found that Ethicon’s Prolift vaginal mesh product was defective adding that J&J had failed to adequately describe the device’s risks when treating pelvic organ prolapse.
J&J has faced some hefty penalties in its vaginal mesh cases. In April, the New Brunswick, NJ-based company lost a lawsuit when another Philadelphia jury awarded a woman $120 million. The woman had mesh implanted to treat incontinence.
The Jury’s May decision comes nearly a month after FDA ordered Boston Scientific and Coloplast to stop selling surgical mesh intended for transvaginal repair of pelvic organ prolapse.
One of the first major transvaginal lawsuits MD+DI reported on occurred in 2012 and resulted in a in Bakersfield, CA awarding Christine Scott $5 million. Scott had been treated with C.R. Bard’s Avaulta mesh to treat a bladder problem.
https://www.mddionline.com/jury-orders-jj-pay-woman-80m-vaginal-mesh-case
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J&J Ordered to Pay $80M to PA Woman in Vaginal Mesh Lawsuit
May 22, 2019 | Legal Scoops
By Jacob Maslow
Patricia Mesigian, a 75-year-old woman, won an $80 million lawsuit against a Johnson & Johnson subsidiary. Mesigian had an Ethicon Prolift mesh implanted in her in 2008, but the mesh led to infection, pain, scar tissue and inflammation after it eroded.
She underwent numerous surgeries in an attempt to remove the mesh, but all of the surgeries failed.
Mesigian suffers from severe pelvic pain. It took jurors two days of deliberation to find Johnson & Johnson guilty of failing to warn Mesigian of the risks associated with the Prolift device.
Mesigian’s verdict included $50 million in punitive damages. The settlement is one of the largest in transvaginal compensation. The lawsuit is the second against Ethican in less than a month. The subsidiary lost a record lawsuit in April, with jurors awarding a woman $120 million in settlement money.
Johnson & Johnson claims that they will appeal the verdicts.
Pelvic mesh is one of the largest mass torts in history. Makers of these medical devices have paid almost $8 billion in settlements to more than 100,000 woman who have had the mesh implanted and suffered complications as a result.
The FDA halted sales of pelvic vaginal mesh in April. The immediate halt stopped the sale and distribution of surgical mesh products. The FDA banned products from Coloplast and Boston Scientific, stating that the companies have failed to demonstrate the effectiveness and safety of these devices.
The FDA claims that it was not possible to assure patients that the mesh would be effective and safe over the long-term.
Officials advise women that have had transvaginal surgical mesh implanted should continue with their routine check-ups and follow-up care to ensure that the mesh does not deteriorate. If the mesh and surgery remain intact and there are no other complications, the FDA claims that there is no further action to take.
https://www.legalscoops.com/jj-ordered-to-pay-80m-to-pa-woman-in-vaginal-mesh-lawsuit/
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The Lancet on Makers Told to Stop Selling POP Mesh
May 22, 2019 | Mesh Medical Device News Desk
By Jane Akre
The Lancet is one of the oldest medical journals in the world. Ed Holt writes for The Lancet about last month’s FDA decision to halt the sales of any POP mesh due to concerns about safety and efficacy. It is the final nail in the coffin on the largest mesh implants used to treat prolapse.
Published in The Lancet, a weekly peer-reviewed medical journal, April 27, 2019, Ed Holt reports that the two companies must stop selling all remaining surgical mesh products for pelvic organ prolapse repair. Here is the article.
The three meshes are made by Boston Scientific and Coloplast. There are not enough assurances of safety and efficacy reported the FDA to support a favorable benefit-risk profile. The companies failed to show a transvaginal mesh repair was more effective and as safe as a native tissue repair at 36 months.
“Cathryn Glazener, an emeritus professor at University of Aberdeen, (Scotland) who co-authored a study published by The Lancet in 2016 that compared native tissue prolapse repair, use of a synthetic mesh, and biological grafts during prolapse surgery, told The Lancet: “This raises the question of why someone having a first repair would undergo such a procedure when there is now mounting evidence of extra problems with mesh products.” “
The president of the American Urogynecologic Society told Holt that he was surprised by the announcement and complained that a mesh option will no longer be available for patients who have unsuccessful previous native tissue repair.
Within AUGS there are opposing thoughts about mesh, he said, though the society has in the past painted a united picture as being overwhelmingly pro-mesh.
https://www.meshmedicaldevicenewsdesk.com/the-lancet-on-makers-told-to-stop-selling-pop-mesh/
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The FDA Pulls (Most) Vaginal Mesh Products off the Market – Now What?
May 22, 2019 | LawyersandSettlements.com
By Jane Mundy
The FDA has finally ordered the last two medical device companies selling transvaginal mesh products to pull them from the market. The agency said it is “committed to patient safety” but hundreds of thousands of women –victims of surgical mesh--would disagree. And the lawsuits are still pouring in.
(Not all surgical mesh has been banned. The FDA ruling pertains only to transvaginal mesh for prolapse, not mesh placed abdominally for prolapse or slings for urinary stress incontinence. And transvaginal mesh is not the only option for pelvic organ prolapse (POP). It can also be treated with conservative management, pelvic floor physical therapy and other therapies.)
FDA TRANSVAGINAL MESH – MORE THAN 10 YEARS OF WARNINGS
In the FDA order (April 16, 2019), the two remaining transvaginal mesh manufacturers, Boston Scientific and Coloplast, did not show that their devices were “safe and effective long term”, which begs the question: How long is the FDA’s definition of “long term”?
Back in 1996, the very first pelvic mesh comprised a strip used as a sling to help support the bladder and treat stress urinary continence. From 2002 through 2013, over 100 transvaginal meshes were cleared (by the 510K pathway) for pelvic organ prolapses, or POP, even as adverse event reports were flooding in. Rather than take the product off the market, the FDA issued warnings, beginning in 2008, of mesh erosion, infection, pain and more.
By 2009 transvaginal mesh lawsuits were being filed. LawyersandSettlements reported complaints filed against Mentor Inc. for its ObTape vaginal sling. By 2011 health professionals were calling on the FDA to remove all surgical mesh products from the market. In an interview with LawyersandSettlements, medical consultant Lana Keeton said "Synthetic Surgical Mesh is a life-threatening device…It is toxic, over-engineered and degrades during manufacture, shelf life and in the human body following surgical implantation."
Keeton said that, “without a doubt”, the transvaginal mesh sling or TVT is inherently defective and the manufacturers basically sold doctors on a product that was never tested.
RECENT TRANSVAGINAL MESH COMPLAINTS
Jackie from Seattle says in an email that she was implanted with TVM for urinary incontinence. “It worked for about a year, then SUI returned with a vengeance, worse than before the TVM. I have lower abdominal pain when going to the bathroom. It is always diagnosed as a bladder infection or a yeast infection. Every time I am given antibiotics but never really goes away. It just didn't work the way it should have and now I have to live with it.”
Sally from Phoenix says she had TVM for bladder prolapse surgery. “About 10 years later I needed surgery again because of the mesh and now I am feeling pain again. I am sure I am having the same problem. After reading about women having complications I am worried about more complications in my future…when is the FDA ever going to ban this mesh permanently? They are treating women like guinea pigs.”
CURRENT TVM LAWSUITS AND SETTLEMENTS
Believed to be the biggest transvaginal mesh settlement was awarded just one week after the FDA order. It took a Philadelphia jury just three hours to decide its verdict, according to the The Philly Inquirer (April 25). Susan McFarland, age 68, was awarded $120 million, which includes $100 million in punitive damages. She had an Ethicon (subsidiary of Johnson & Johnson) TVT-O plastic mesh strip implanted in 2008 and has been suffering from pain and chronic urinary tract infections ever since. Surgery to remove the mesh failed to help, according to her lawsuit.
Johnson & Johnson also agreed last month to pay $9.9 million to avoid going to trial for failing to disclose risks in the instructions and marketing materials for surgical mesh devices, including those for incontinence.
https://www.lawyersandsettlements.com/legal-news/mesh-complications/fda-pulls-most-vaginal-mesh-products-off-market-now-what-intervi-23088.html
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