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Ethicon Media Monitoring 8/9/2017
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Health bodies 'serious' on vaginal meshes
Aug 9, 2017 | BBC
By Catherine Smyth
At least three letters have been sent from various NI health bodies advising recipients of the health department's stance on vaginal mesh procedures. -
Endo settles bulk of remaining pelvic mesh cases for $775 mln
Aug 8, 2017 | Reuters
By Tina Bellon
Endo International PLC said it has reached an agreement to resolve "virtually all known U.S. mesh product liability claims," against it ending approximately 22,000 cases in a long-running multidistrict litigation. -
Struggling Endo's write-downs pass $5B for 2017 thanks to Opana, mesh, restructuring
Aug 9, 2017 | FeircePharma
By Carly Helfand
On Tuesday, the company reported $725 million in impairment charges, thanks largely to the restructuring of its manufacturing network and its pulling of pain med Opana ER from the market. -
Endo swings to Q2 loss on $775m pelvic mesh set-aside
Aug 8, 2017 | Drug Delivery Busines (Mass Device)
By Sarah Faulkner
Endo International (NSDQ:ENDP) posted a net loss in the second quarter of this year, citing charges like the $775 million it has set aside to resolve 22,000 remaining lawsuits relating to the company’s vaginal-mesh implants. -
Transvaginal Mesh Settlement News: Endo Agrees to Resolve “Virtually All” Remaining Pelvic Mesh Claims, Sets Aside Additional $775 Million
Aug 9, 2017 | RX Injury Help
By Laurie Villanueva
Endo International PLC has announced new agreements to settle “virtually all known” U.S. transvaginal mesh lawsuits involving devices manufactured by its American Medical Systems unit. -
Endo Will Pay $775M to End All Known AMS Vaginal Mesh Product Liability Claims
Aug 8, 2017 | Lawyers and Settlements
By Lucy Campbell
Santa Clara, CA: Endo International PLC has announced that it will settle “virtually all known” AMS transvaginal meshproduct liability lawsuits. This includes lawsuits in the US and internationally.
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Health bodies 'serious' on vaginal meshes
Aug 9, 2017 | BBC
By Catherine Smyth
At least three letters have been sent from various NI health bodies advising recipients of the health department's stance on vaginal mesh procedures.
They follow BBC reports that a number of women felt physically and mentally scarred after having the implants.
A support group for the women has welcomed the move, but said it was sad some women had to go public with their stories to get to this point.
The letters show health authorities are taking the issue extremely seriously.Vaginal mesh surgery advice issuedMesh led to 'excruciating pain'Hundreds suing NHS over vaginal implantsWhat's the issue with mesh implants?
The letters from the Department of Health, the Patient Client Council and the Health and Social Care Board advise staff on how to deal with complaints.
In July, the Health and Social Care Board wrote to every GP in Northern Ireland and all five health trusts about how to manage women experiencing complications following vaginal mesh surgery.
The Health and Social Care Board's Dr Brid Farrell said the issue had taught health authorities the importance of engaging with women early in the process.
"If we look back at how things happened in the past, perhaps when women were being offered surgery they didn't get the amount of information they should have gotten at the time.
"But I think now people realise the implications and significance of complications when they happen, and women are given more information than they would have been in the past." she said.Clinicians' workshop
The Patient and Client Council has written to one woman enclosing two copies of a draft letter of complaint to her health trust.
The permanent secretary Richard Pengelly has also written to the former SDLP MP Margaret Ritchie who raised the issue in Parliament.
He advised her that the recent focus of the Department of Health has been on addressing this issue.
Mr Pengelly also revealed that the Public Health Agency has commissioned a workshop with clinicians to consider how various aspects of care for this group of women might be improved, including consent.
Meanwhile, Susan McLarnon from the women's support group said they were receiving requests from people to join on a daily basis.
"They have been suffering in silence and when they reach us it is like a weight has been lifted from their shoulders," she said.
"This is a big, big issue."
http://www.bbc.com/news/uk-northern-ireland-40865087
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Endo settles bulk of remaining pelvic mesh cases for $775 mln
Aug 8, 2017 | Reuters
By Tina Bellon
Endo International PLC said it has reached an agreement to resolve "virtually all known U.S. mesh product liability claims," against it ending approximately 22,000 cases in a long-running multidistrict litigation.
Dublin-based Endo in a statement on Monday said the company has set aside $775 million to cover those claims.
To read the full story on Westlaw Practitioner Insights, click here: bit.ly/2vN9bME
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Struggling Endo's write-downs pass $5B for 2017 thanks to Opana, mesh, restructuring
Aug 9, 2017 | FeircePharma
By Carly Helfand
Back in February, Endo took a whopping $3.5 billion write-down—but that wouldn’t be it for the year.
On Tuesday, the company reported $725 million in impairment charges, thanks largely to the restructuring of its manufacturing network and its pulling of pain med Opana ER from the market.
And that announcement came just one day after the Dublin drugmaker said it would raise by $775 million the amount it’s paying to wrap up the vaginal mesh saga that has been plaguing it for years. Between this year’s Q4 and the end of 2019, it’ll make settlement payments expected to cover about 22,000 U.S. liability claims, as well as all the international claims it’s aware of.
All in all, it’s been an expensive year for Endo, which has struggled in the face of executive turnover, industry-wide generics pricing pressure and more. The FDA’s June request that Endo nix long-acting opioid Opana—a $160 million seller thrust into the spotlight by the opioid addiction crisis—didn’t help.
The company did manage to record a street-beating Q2, though, triumphing in the face of low expectations. Notably, the “strength came ... on the back of a beat in generics,” which generated $563 million versus analyst forecasts of $525 million, RBC Capital Markets analyst Randall Stanicky pointed out in a note to clients.
Still, “the reality is cash flow generation toward continued paydown of debt/mesh will remain the primary focus in the stock over the near-term,” he said.
Meanwhile, opioids continue to face scrutiny from all sides, with a U.S. cost watchdog taking aim Tuesday. The Institute for Clinical and Economic Review (ICER) published its final report on the effectiveness and value of abuse-deterrent versions of the highly addictive meds, determining that the safer products needed an average 41% discount to make them “cost-neutral” with their predecessors.
http://www.fiercepharma.com/pharma/struggling-endo-s-write-down-total-passes-5b-for-2017-thanks-to-opana-mesh-restructuring
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Endo swings to Q2 loss on $775m pelvic mesh set-aside
Aug 8, 2017 | Drug Delivery Busines (Mass Device)
By Sarah Faulkner
Endo International (NSDQ:ENDP) posted a net loss in the second quarter of this year, citing charges like the $775 million it has set aside to resolve 22,000 remaining lawsuits relating to the company’s vaginal-mesh implants.
The generic drugmaker faced other setbacks this quarter, including the FDA asking that Endo pull its painkiller, Opana ER, from the market. The regulatory watchdog said that the benefits of the abuse-deterrent drug no longer outweigh the risks.
The move marked the first time that the FDA has urged a company to remove an opioid painkiller due to concerns of abuse. Endo voluntarily withdrew the drug at the start of June.
The Dublin-based company posted a net loss of -$1.39 billion, or -$6.26 per share, on sales of $875.7 million for the 3 months ended June 30. During the same period last year, Endo posted a profit of $343.6 million.
Revenue fell -4.9% this quarter, but was ahead of consensus on The Street, where analysts were looking for sales of $836.4 million
Adjusted to exclude 1-time items, earnings per share were 93¢, ahead of estimates.
“We are very pleased to report another solid quarter of operating performance, with impressive contributions from our core growth areas. Sterile injectables and branded specialty products continue to perform well, as each unit again achieved strong double-digit growth,” president & CEO Paul Campanelli said in prepared remarks. “This performance provides evidence of the progress we are making on the strategic priorities we outlined earlier this year.”
“In addition to solid quarterly execution, we continue to make significant progress across an array of strategic initiatives, including settling mesh litigation, divesting Litha, signing a definitive agreement to divest Somar, and the restructuring of our manufacturing network. Through these actions, we continue to position Endo to compete and succeed in the future,” Campanelli added.
ENDP shares were trading at $9.38 apiece today in morning activity, up 0.7%.
http://www.drugdeliverybusiness.com/endo-swings-q2-loss-775m-pelvic-mesh-set-aside/
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Aug 9, 2017 | RX Injury Help
By Laurie Villanueva
Endo International PLC has announced new agreements to settle “virtually all known” U.S. transvaginal mesh lawsuits involving devices manufactured by its American Medical Systems unit.
In a statement issued yesterday, the company disclosed that it would reserve another $775 million to resolve the remaining U.S. claims. With the additional reserves, Endo will have now set aside more than $2.6 billion to cover costs associated with transvaginal mesh settlements.
“While it remains possible that additional claims will be filed, we believe today’s announcement will assist most mesh claimants to move forward with their lives and will permit Endo to move forward with an even greater focus on executing against our core strategic priorities,” said Paul Campanelli, Endo’s President and Chief Executive Officer.
Under the new agreements, Endo will begin making installment payments in the fourth quarter of 2017. The installments will continue through the fourth quarter of 2019.
Roughly 22,000 transvaginal mesh lawsuits remain pending in the American Medical Systems litigation, all of which were filed on behalf of women who allegedly suffered serious complications after the devices eroded into their vaginal wall. The majority of claims are pending in a federal multidistrict litigation now underway in the U.S. District Court, Southern District of West Virginia.Nationwide Transvaginal Mesh Litigation
Transvaginal mesh products were once widely-used to treat women suffering from pelvic organ prolapse and stress urinary incontinence. However, the U.S. Food & Drug Administration (FDA) has issued several public health alerts since 2008 detailing life-changing complications potentially associated with the implants, including mesh erosion, chronic pain, organ perforation, incontinence, scarring and adhesions, chronic infections, and more.
In 2011, the FDA reversed its previous position regarding the frequency of transvaginal mesh complications in pelvic organ prolapse repair, stating it no longer considered these adverse events to be rare. The agency also expressed doubt that such procedures offered any additional benefits compared to traditional non-mesh prolapse repair.
Last year, the FDA finalized new regulations that, among other things, reclassified transvaginal mesh intended for use in prolapse repair as a high-risk medical device. The new rules also made the implants ineligible for the agency’s 510(k) clearance program, which had previously allowed such products to come to market without first undergoing human clinical trial.
While it appears that most cases involving American Medical Systems will soon be resolved, the litigation surrounding transvaginal mesh is far from over. Johnson & Johnson and its Ethicon, Inc. subsidiary still face roughly 55,000 pelvic mesh claims now pending in state and federal courts around the country.
Other device makers involved in the massive transvaginal mesh litigation include Boston Scientific Corp., C.R. Bard, Inc., Coloplast Corp., Cook Medical, Inc. and Neomedic.
Ethicon and the other defendants have settled some pelvic mesh lawsuits, but thousands of cases remain pending.
http://www.rxinjuryhelp.com/news/2017/08/08/transvaginal-mesh-settlement-news-endo-agrees-to-resolve-virtually-all-remaining-pelvic-mesh-claims-sets-aside-additional-775-million/
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Endo Will Pay $775M to End All Known AMS Vaginal Mesh Product Liability Claims
Aug 8, 2017 | Lawyers and Settlements
By Lucy Campbell
Santa Clara, CA: Endo International PLC has announced that it will settle “virtually all known” AMS transvaginal meshproduct liability lawsuits. This includes lawsuits in the US and internationally.
In a statement issued by the Irish-based maker of transvaginal surgical mesh, Endo stated it will end the known US claims at "reasonable values" and will make installment payments starting in the fourth quarter of 2017 and continue making payments until the end of 2019. It will set aside $775 million to cover roughly US 22,000 mesh implant claims as well as all known international mesh product liability claims and other related matters.
The company stated that it at this time it isn’t aware of any claims that won’t be covered by the $775 million.
In April 2014, Endo said that it had reached settlements with several of the remaining plaintiffs suing American Medical Systems (AMS) Inc. over allegedly harmful vaginal mesh products, resolving “substantially all” of the claims in the case without admitting any liability or fault.
Then, in March 2016, Endo said it was winding down its Astora Women’s Health unit, formerly AMS Women's Health, to reduce the potential for product liability claims related to future mesh implants. At that time it was facing numerous lawsuits alleging health complications caused by a number of vaginal mesh devices. AMS, based in Minnesota, was a major manufacturer of transvaginal mesh medical devices, which are support systems designed to correct pelvic organ prolapse, (POP) and stress urinary incontinence (SUI).https://www.lawyersandsettlements.com/settlements/19567/endo-will-pay-775m-to-end-all-known-ams-vaginal-mesh.html
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