Surgical Mesh: Harm-for-Profit Crimes Against Women

Mesh Lawsuits

$57.1 Million Verdict Against Johnson and Johnson

$57.1 million was awarded against Johnson & Johnson and Ethicon to Ella Ebaugh, who was implanted with TVT-Secur transvaginal mesh that eroded through her urethra, caused her internal injuries and permanently damaged her urinary system leaving her incontinent. The jury verdict included $7.1 million in compensatory damages and $50 million in punitive damages. The Philadelphia Court of Common Pleas verdict was delivered September 7, 2017, marking the fifth TVM verdict against the mesh manufacturers.

$20 million was awarded to a woman who suffered after multiple surgeries to remove a TVT-Secur mesh implant. On April 28, 2017, the Philadelphia Common Pleas Court jury awarded  $2.5 in compensatory damages and $17.5 million in punitive damages. Plaintiff, Peggy Engleman’s mesh failed within a month of implantation causing pain as the mesh eroded into her tissues leaving shreds of mesh in her body. On May 26, 2017, Sharon Beltz was awarded $2.16 million for injuries caused by Ethicon’s Prolift implanted in 2006. Johnson and Johnson vows to appeal both cases to a higher court.

Transvaginal mesh bellwether trials and settlements are updated as follows:

MDL No. 2327 | In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation – Cases are being prepared for trials, dismissals or remands. Total Cases: 38,956 Total Closed: 7718  Past verdicts and settlements include:

• Mullins, et al. v. Ethicon, Inc., et al., 2:12-cv-02952 (37 TVTs) trial continued
• Edwards v. Ethicon, Inc., et al., 2:12-cv-09972-  Dismissed
• Dianne Bellew v. Ethicon, Inc. (Prolift) settled March 6, 2015
• Carolyn Lewis v. Ethicon, et al. Defense Judgment
• Huskey v. Ethicon, et al. $3.27 Million Verdict for Plaintiffs
• Brenda Lehrer v. Ethicon, Inc., et al. (Prolift) Dismissed

MDL No. 2325 | In Re American Medical Systems, Inc., Pelvic Repair System Products Liability Litigation – Settlement announced for all remaining mesh lawsuits in the MDL. Total Cases: 21,127  Total Closed: 17,248

MDL No. 2187 | In Re C. R. Bard, Inc., Pelvic Repair System Products Liability Litigation–  Cases are being prepared for trials, dismissals or remands. The court ordered Mandatory Settlement Conferences for unsettled Covidien LP, Sofradim and TSL plaintiffs.  Total Cases: 15,491  Total Closed: 10,452  Past verdicts and settlements include:

• Wise, et al. v. C. R. Bard, Inc. – Settled
• Donna Cisson v. Bard, Inc.  – $2 Million Verdict
• Wanda Queen v. Bard, Inc. 2:11-cv-00012  – Settled
• Carolyn Jones v. Bard, Inc. 2:11-cv-00114 – Settled

MDL No. 2326 | In Re Boston Scientific Corp. Pelvic Repair System Products Liability Litigation – Settlements in process with no trials scheduled. Total Cases: 25,029   Total Closed: 15,101   Past verdicts include:

• Jeanie Blankenship – $4.25 million +  $1 million punitive damages
• Chris Wilson – $3.75 million +  $1 million punitive damages
• Carol Campbell – $3.25 million + $1 million  punitive damages
• Jacquelyn Tyree  – $3.25 million + $1 million punitive damages
• Juana Betancourt – $6.5 + million
• Mania Nunez – $6.7 + million; and
• Margarita Dotres – $6.7 + million;
• Amal Eghnayem – $6.7 + million

MDL No. 2440 | In Re Cook Medical, Inc., Pelvic Repair System Products Liability Litigation – No trials have been scheduled. The following cases were dismissed: Ailey v. Cook Inc., Watkins v. Cook Inc., et al. Hovey v. Cook Inc., et al.  Total Cases: 629 Total Closed: 123

MDL No. 2387 | In Re Coloplast Corp. Pelvic Support Systems Products Liability Litigation – . There are no bellwether trials scheduled and the judge is conducting settlement conferences. Total Cases: 2610 Total Closed: 2397

MDL No. 2511 | In Re Neomedic Pelvic Repair System Products Liability Litigation – There are no bellwether trials scheduled. Settlement Program entered 11/2015. Total Cases: 137 Total Closed: 125

Transvaginal Mesh Verdicts 

A chronology of the verdicts, settlements, manufacturers, products, and jurisdictions follows:

1. 7/12: $5.5 million – Christine Scott – C.R. Bard Avaulta Plus –  CA
2. 2/13: $11.11 million – Linda Gross – Ethicon/JJ Prolift – NJ
3. 8/13: $2 million – Donna Cisson – C.R. Bard Avaulta – MDL WV
4. 2/14: $0 – Carolyn Lewis – Ethicon/JJ TVT-O – MDL WV
5. 4/14: $1.2 million – Linda Batiste – Ethicon/JJ TVT-O  – TX
6. 7/14: $0 – Diane Albright – Boston Scientific Pinnacle – MA
7. 8/14: $0 – Maria Cardenas – Boston Scientific Obtryx – MA
8. 9/14: $3.27 million – Jo Huskey – Ethicon/JJ TVT-O – MDL WV
9. 9/14: $73.465 million – Martha Salazar – Boston Scientific Obtryx – TX
10. 11/14: $6.7+ million – Amal Eghnayem – Boston Scientific Pinnacle – MDL FL
11. 11/14: $6.7+ million – Margarita Dotres – Boston Scientific Pinnacle – MDL FL
12. 11/14: $6.7+ million – Mania Nunez – Boston Scientific Pinnacle – MDL FL
13. 11/14: $6.5+ million – Juana Betancourt – Boston Scientific Pinnacle – MDL FL
14. 11/14: $5.25 million – Jeanie Blankenship – Boston Scientific Obtryx –  MDL WV
15. 11/14: $4.75 million – Chris Wilson – Boston Scientific Obtryx – MDL
16. 11/14: $4.25 million – Carol Campbell – Boston Scientific Obtryx – MDL
17. 11/14: $4.25 million – Jacquelyn Tyree – Boston Scientific Obtryx – MDL
18. 2/15: Settled – Wise v. Bard in the MDL
19. 3/15: Settled  – Bellew v. Ethicon (Prolift) in the MDL;
20. 5/15: Settled – Sanchez v. Boston Scientific (Pinnacle) – CA
21. 3/15: $5.7 million – Coleen Perry – Ethicon/JJ Abbrevo sling – CA
22. 5/15: $100 million – Deborah Barda v. Boston Scientific Pinnacle and Advantage Fit – DL
23. 10/15: $0 – Carol Cavness v. Ethicon/JJ Prosima –  TX
24. 10/15: $0 – Martha Carlson v. Boston Scientific Uphold – NC
25. 12/15: $12.5 million – Hammons v. Ethicon/JJ (Prolift) –  PA
26. 2/16: $0 – Sherrer v. Boston Scientific Solyx and Bard Align – MO
27. 2/16: $13.5 – Carlino v. Ethicon/JJ (TVT)  – PA
28. 4/17:  $20.0 million – Engleman v. Ethicon/JJ (TVT Secur) – PA
29. 5/17: $2.16 million – Betz v. Ethicon/Prolift – PA
30. 9/17: $57.1 million – Ebaugh v. Ethicon/JJ (TVT-Secur) – PA

TVM Verdicts and Trials

On February 10, 2016, $13.5 million was awarded by a Philadelphia jury in Carlino v. Ethicon. $10 million of that award was for punitive damages. The plaintiff suffered through three TVT sling revision and removal mesh surgeries following her Ethicon/Johnson and Johnson implant. 

This follows a $12.5 million jury verdict in a transvaginal mesh lawsuit against Johnson and Johnson’s Ethicon division on December 22, 2015. A Philadephia jury found that Patricia Hammons suffered injuries from a Prolift pelvic mesh implant, which was removed from the medical device market in 2012. The $12.5 million award included $7 million in punitive damages as the jury heard evidence of Ethicon’s document destruction. 

On February 2, 2016, a Kansas City, Missouri jury awarded nothing to the plaintiff in a Boston Scientific Solyx and C.R. Bard Align case. On October 16th,  2015, the jury awarded nothing to the plaintiff in Martha Carlson v. Boston Scientific in Statesville, North Carolina. On October 5th, 2015, the jury awarded nothing for the plaintiff in Carol Cavness v. Ethicon/ Johnson and Johnson in Dallas, Texas.  

As of August 3rd, 2016, eighteen (18) transvaginal mesh plaintiffs have won trials and the defendants have won six (6). Following the failed status conferences, TVM trials moved forward, resulting in two plaintiffs’ verdicts ranging from $100 Million to $5.7 Million and numerous confidential settlements.  Boston Scientific, Coloplast, AMS and Bard have begun offering settlements. 

A  California jury awarded $5.7 million to Coleen Perry, who was implanted with an Abbrevo sling device. Ms. Perry experienced pain after surgery, but the sling could only be partially surgically removed  because the mesh had grown into the tissues. The jury unanimously awarded $5 million in punitive damages finding Ethicon acted with malice.

Trial began March 2, 2015 in Bellew v. Ethicon in the MDL and settled March 6, 2015 for an undisclosed amount. This case involved removal of a Prolift mesh, a product which had been taken off the medical device market. 

Bard Bellwether Case Settles Before Trial

Wise v. Bard, the bellwether case set for trial February 18, 2015, was settled right before trial for a confidential amount.  On February 12, 2015,  Judge Goodwin appointed Ellen Reisman as Special Master to facilitate settlement negotiations in the Bard MDL. Christine Scott, the first Bard Avaulta Plus plaintiff who endured nine mesh revision surgeries stated, “Thank God, we can finally get the word out to women.”

$26.7 Million and $18.5 Million Verdicts Against Boston Scientific 

$26.7 million and $18.5 million verdicts against Boston Scientific were awarded in two transvaginal mesh MDL trials. On November 13, 2014, a Miami, Florida jury awarded $26.7 million to four women implanted with Boston Scientific’s Pinnacle mesh devices. On November 20, 2014,  a Charleston, West Virginia jury awarded  $18.5 million to four women implanted with Boston Scientific’s Obtryx mid-urethral slings. The Obtryx verdict included $4 million in punitive damages, with $1 million awarded to each plaintiff.

The women in the Florida Pinnacle trial were each awarded between $6.5 million and $6.7 million. Boston Scientific’s Pinnacle mesh devices were implanted during pelvic organ prolapse surgeries and are no longer on the market. The individual awards for the women in the Pinnacle mesh trial include: 

1. Amal Eghnayem – $6.7 + million;
2. Margarita Dotres – $6.7 + million;
3. Mania Nunez – $6.7 + million; and
4. Juana Betancourt – $6.5 + million

The women in the West Virginia Obtryx sling trial were each awarded between $3.25 million to $4.25 million, plus an additional $1 million each for punitive damages. The Obtryx sling devices are implanted during stress urinary incontinence surgeries and are still on the market. The individual awards for the women in the Obtryx sling trial include: 

1. Jeanie Blankenship – $4.25 million +  $1 million punitive damages;
2. Chris Wilson – $3.75 million +  $1 million punitive damages;
3. Carol Campbell – $3.25 million + $1 million  punitive damages;
4. Jacquelyn Tyree  – $3.25 million + $1 million punitive damages

Transvaginal Mesh Adverse Events

Click the TVM video link which contains medical legal animation, diagrams and warnings about TVM implants and the transvaginal mesh litigation. Failed Transvaginal Mesh Injury Lawsuit Podcast with Howard L. Nations

Transvaginal mesh and vaginal sling products have been linked to thousands of reported serious, life-threatening side effects or adverse events from seven surgical mesh manufacturers. The complications are associated with surgical mesh devices used to repair Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI). The mesh devices are typically placed transvaginally for minimally invasive placement. Complications include:

• erosion through the vaginal tissue
• mesh contraction
• mesh extrusion
• inflammation
• fistula
• infection and abscess
• pain
• blood loss
• chronic and acute nerve damage
• pudendal nerve damage
• pelvic floor damage
• scar tissue
• chronic pelvic pain
• urinary problems and/or incontinence
• recurrence of prolapse
• bowel, bladder, and blood vessel perforation
• dyspareunia or pain during sexual intercourse

Treatment of the complications includes additional surgical procedures to revise or remove the mesh, blood transfusions, drainage of hematomas, drainage of abscesses from infection, IV medication, pain injections, botox injections, physical therapy, among other treatments to alleviate the complications. 

In July 1, 2012, Bard stopped selling the Avaulta Mesh in the United States because the FDA required additional clinical trials and testing.

On June 4, 2012: Johnson and Johnson/Ethicon withdrew four mesh products from the US Market, including its controversial Gynecare Prolift, Prolift+ M, TVT Secur and Prosima systems.

History of Warnings

Surgical mesh is a metallic or polymeric screen surgically implanted to reinforce and support weakened soft tissue or bone. On the market since the 1950s for use in abdominal hernias, gynecologists in the 1970s began using surgical mesh to reinforce vaginal tissue to treat pelvic organ prolapse. In the 1990s, surgeons began using surgical mesh to treat stress urinary incontinence in women.

Transvaginal mesh was approved for sale through the 510(k) process simply by comparing it to the kind of mesh used to treat abdominal hernias. Most transvaginal mesh products on the market today are based on Boston Scientific Corp.’s ProteGen mesh, which the FDA approved in 1996 as the first surgical mesh to treat stress urinary incontinence. Two years later, the FDA approved Johnson & Johnson’s Gynecare TVT mesh through the 510(k) process after the company claimed the mesh was substantially equivalent to ProteGen.

However, in October, 1999, the FDA recalled Boston Scientific’s ProteGen sling due to the large number of complications experienced by women, including erosion of the vaginal tissues. The complete irony is that a majority of the transvaginal mesh are based upon this recalled defective device.

On October 20, 2008, the U.S. Food & Drug Administration (FDA) issued an urgent public health notification to physicians and patients regarding serious complications associated with transvaginal placement of surgical mesh in repair of Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI).

On May 16, 2011, the New England Journal of Medicine (NEJM) Study on Transvaginal Mesh Complications confirmed that the use of surgical mesh to treat pelvic organ prolapse carries the risk of serious side effects including bladder perforation and pelvic hemorrhaging.

On July 13, 2011, FDA issued an updated safety communication warning that surgical placement of transvaginal mesh to repair POP may expose patients to a greater risk of side effects than other treatment options. In addition to the increased risk of side effects, the FDA stated that vaginal mesh offers no greater clinical value or improved quality of life over other surgical methods.

On August 25, 2011, Public Citizen called on FDA to recall the vaginal mesh in response to a high number of reports linking vaginal mesh products to erosion, pain, bleeding and urinary incontinence.

Transvaginal Mesh Products & Manufacturers 

Ethicon

• Secure
• Prolift
• Prolift +M
• Gynemesh/Gynemesh PS
• Prosima
• TVT
• TVT-Obturator (TVT-O)
• TVT-SECUR (TVT-S)
• TVT-Exact
• TVT-Abbrevo

C. R. Bard

• Align
• Avaulta Plus™ BioSynthetic Support System
• Avaulta Solo™ Synthetic Support System
• Faslata® Allograft
• Pelvicol® Tissue
• PelviSoft® Biomesh
• Pelvitex™ Polypropylene Mesh
• PelviLace
• InnerLace
• Uretex

American Medical Systems 

• SPARC®
• Mini-Arc
• Apogee
• Elevate
• Monarc
• In-Fast
• BioArc

Boston Scientific

• Obtryx® Curved Single
• Obtryx® Mesh Sling
• Obtryx Transobturator Mid-Urethral Sling System
• Prefyx Mid U™ Mesh Sling System
• Prefyx PPS™ System
• Uphold Vaginal Support System
• Pinnacle Pelvic Floor Repair Kit
• Advantage Transvaginal Mid-Urethral Sling System
• Advantage Fit System
• Solyx SIS System

Coloplast

• T-Sling-Universal Polypropylene Sling
• Aris-Transobturator Sling System
• Supris-Suprapubic Sling System
• Novasilk-Synthetic Flat Mesh
• Suspend-Tutoplast Processed Fascia Lata
• Exair-Prolapse Repair System
• Axis-Tutoplast Processed Dermis
• Restorelle
• Smartmesh
• Omnisure
• Minitape

Cook 

• Surgisis

http://www.carolynstclair.com/trucking-accidents/practice-areas/transvaginal-mesh/

Douglas Kohrs, AMS (American Medical Systems), Endo: Criminals Go To Jail - Executives Pay 'Settlements'

Transvaginal Mesh Settlement News: Endo ENDP Agrees to Resolve “Virtually All” Remaining Pelvic Mesh Claims, Sets Aside Additional $775 Million

Published on August 8, 2017 by Laurie Villanueva  FiDA Highlight

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.

____________________________________________________________________

https://seekingalpha.com/article/4096349-endo-international-plc-endp-q2-2017-results-earnings-call-transcript?page=2   

Earnings conference call today with global banks and investors

Paul V. Campanelli - Endo International Plc

Yesterday, the company announced that it reached agreements to resolve virtually all known U.S. mesh product liability claims. Beginning in the second quarter of 2017, we aggressively executed a settlement strategy in connection with Endo's mesh litigation. We believe that these efforts which include global resolution with all key plaintiff attorneys; case management orders issued by courts overseeing mesh cases, and our goal of having additional orders entered by other courts; our decision to stop selling mesh products in March of 2016; settlements recently entered into by other mesh manufacturers and the corresponding decrease in attorney advertising, as well as the continued running of statutes of limitations will collectively deter future filings.

Importantly, we believe these actions will assist most mesh claimants to move forward with their lives and permit Endo to move forward with an even greater focus on executing against our core strategic priorities. We increased our mesh liability accrual by $775 million in the second quarter, which is expected to cover approximately 22,000 U.S. mesh claims subject to a claims validation process for all resolved claims as well as all of the known international mesh claims and other mesh-related matters. I'll let Blaise address this more fully as he discusses our financial performance.

Blaise Coleman - Endo International Plc

Moving to slide 11, on the mesh litigation settlements, Paul already discussed we've reached agreements to resolve virtually all known U.S. product liability claims relating to the transvaginal mesh products sold by Endo's AMS subsidiary. As to the financials, in the second quarter 2017, Endo recorded a $775 million mesh product liability charge, reflecting an estimate for the expected future payments related to the resolved U.S. mesh product liability claims, the small portion of known unresolved U.S. claims and all of the known international mesh product liability claims and all other mesh related matters.

As of June 30, 2017 the mesh liability accrual was approximately $1,295 million, with $359 million in the qualified settlement funds, leaving approximately $935 million to be paid into qualified settlement funds. We expect to pay approximately $160 million to $185 million into the qualified settlement funds or directly to plaintiffs during the second half of 2017, with the remaining payments into the qualified settlement funds continuing through the fourth quarter of 2019.

Question-and-Answer Session

Operator

Yes, sir. First question comes from Liav Abraham of Citibank. Your line is now open.

Liav Abraham - Citigroup Global Markets, Inc.

Good morning. A couple of questions.  

And then secondly, on your settlement on mesh, congrats for closing this out. Just a couple of clarifications. The settlement amount that you announced, is this a post-tax amount or pre-tax? I assumed it was pre-tax, so what would the tax shield be on that? And I also noticed that the number of claims covered by the agreement that was announced yesterday of 22,000 was a lot higher than what was disclosed in Q1 of 10,500. So, was this just a significant step-up in the number of new claims in the recent past few months? Thank you.

Paul V. Campanelli - Endo International Plc

Thank you. So, I'll take the environment question, then I'll talk a little bit about the increase in claims to 22,000 and Blaise will talk a little bit about your financial question. 

Regarding the mesh update in terms of the increase from 10,000 to 10,500 to 22,000, the starting point was is when I was asked to take over as CEO in late September and early October, it took me a period of time to evaluate the current strategy that Endo was pursuing.

And then after careful consideration, looking at where we're heading in terms of looking at this for a series of years, looking at – opining with internal and external counsel, as you know, we made some disclosures early in the, I guess, mid to late second quarter would probably be better way that we disclosed at that period of time, that there was approximately 10,500 claims that had been filed or asserted or that we believed that were likely to be filed or asserted.

And that was our starting point. However, later in that period of time, we did change our strategy. I got closer involved and we had an opportunity to meet with private plaintiffs and we started to negotiate. At that point in time, we received more information that we did not have earlier in that period of time. And we learned a lot more about unfiled claims that totaled approximately 22,000 claims. So we had to make a business decision. We looked at where the company was headed, we were looking at distraction; we were looking at the amount of time that we were investing into resolving the mesh claims.

So at that point in time, we looked at the number of claims and we negotiated to $775 million accrual. And we view this as an inflection point for the company. So while it was a difficult negotiation, we are now moving forward as a company. We're focused on operational execution and we can focus on our business.

So with that, I'll pass it over to Blaise and can talk a little bit about the financial aspect.

Blaise Coleman - Endo International Plc

Yeah, sure. So, just in terms of the pre- and post-tax question, just as a remainder, as we've previously discussed, one really needs to model taxes at a total enterprise level. So as we said for 2017, we expect to be in a net tax cash receipt position of $15 million. And for modeling purposes for 2018 and 2019, we're providing a range that our cash taxes paid will be between $15 million and $30 million at a total company level. And that would obviously include everything including the mesh payments that are new here that we'll have in 2018 and 2019.

Liav Abraham - Citigroup Global Markets, Inc.

Great, thank you.

Young Min Lee - Raymond James

Good morning. This is Lucas Lee in for Elliot. Thank you for taking our questions. So, as a follow-up to the dialogue around resolution of mesh litigation claims, understand that this resolves the vast majority of known and potential cases. But assuming there could still be some emerging cases, could you help us frame what the cap on liability is, potential liability is? We're just trying to get a sense of how many patients ultimately used the mesh product and then how many of those have turned into claims. Thank you.

Paul V. Campanelli - Endo International Plc

Yeah. So no, Lucas, we're not going to be able to quantify that for you. What you have to understand is the 22,000 that we disclosed is virtually all known claims. Now, moving forward, what we've done is we've talked about things that have occurred and what we've put in place to deter, and I mentioned this in my opening comments, right? What's in place to deter the assertion of weak or meritless case, right? The sheer nature of having the CMO in place, the case management order at the MDL level and also having a case management order in the state of Minnesota, whereby that is the home state of AMS, that in itself is going to deter, again, weak or meritless cases, right? So, there is a process in order to move cases forward.

The CMO in itself is a deterrent of having mass tort cases coming forward. So, that's one component. You've got to recall that we stopped shipping and selling the product in Q1 of 2016, so you have a timing issue. You also have the statute of limitations. That ranges state by state in a range of two to three and up to six years, but the bottom line is is you have a statute of limitations.

When you look at all of these components, I think we have positioned ourselves in a good place to move forward and away from mesh. So I hope I answered your question, Lucas.

Young Min Lee - Raymond James

All right. Thank you.

Ann-Hunter Van Kirk - BMO Capital Markets (United States)

Good morning. This is Ann-Hunter Van Kirk on for Gary. Thanks for taking our questions. What are your expectations for leverage over the next couple years in light of the mesh payment and are you considering any additional cost cuts to help pay down debt?

Paul V. Campanelli - Endo International Plc

Thanks. So Blaise you'll take this?

Blaise Coleman - Endo International Plc

Yeah. So thanks, Ann, for the question. I think as we told you for 2017, we expect to be in the high 4 times range from a leverage perspective. And as we've previously communicated, we do continue to aspire to leverage down over time back into the 3 times to 4 times range. In terms of timing of when we'll be able to achieve that leverage goal, although today's announcement around mesh removes one of the near-term uncertainties we've been facing in terms of developing a path and timeframe in order to achieve that goal, we're just not going to able to provide any specific timeline today, as there continues to be a number of key uncertainties, both in the near-term and mid-term that could impact the timing of delevering. But again, we will, as we talked about when we come to 2018 guidance, we'll certainly provide what our expectations are, both from a cash flow perspective and from a leverage perspective for 2018.

Paul V. Campanelli - Endo International Plc

On the cost-cutting side, and I think you've seen that we've made some very difficult decisions over the last 10 months.

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https://www.bizjournals.com/philadelphia/morning_roundup/2016/02/endo-shutting-down-astora-womens-health-division.html

Endo shutting down its women's health division

Feb 29, 2016, 4:04pm EST Updated Feb 29, 2016, 4:33pm EST

John George

Senior Reporter

Philadelphia Business Journal

Endo International said Monday it is winding down its Astora Women’s Health division after failing to find a buyer for the business.

The company said it will cease business operations for Astora, based in Eden Prairie, Minn, by March 31 in part to “reduce the potential for product liability related to future mesh implants.”

Endo (NASDAQ: ENDP) and other medical manufacturers who make vaginal mesh products have been sued by patients allegedly injured by the makers of such products used to treat a variety of medical conditions including urinary incontinence and pelvic organ prolapse.

The company's stock closed down 21 percent to $41.81 per share Monday.

In August, Endo said it had set aide $1.53 billion for potential litigation and settlement costs, and the company said Monday it took an additional $834 million pre-tax charge during the fourth quarter related to vaginal mesh cases.

Endo, which is based in Dublin, Ireland, and has its U.S. headquarters in Malvern, said it will work with physicians to support their transition to alternative products.

The company, as part of its strategy to focus on global sales of its branded and generic pharmaceutical products, sold off its men’s and prostate health business last year to Boston Scientific in a deal valued at up to $1.65 billion.

Endo entered the urology device market in 2011 when it bought American Medical Systems Holding Inc. for $2.9 billion in 2011.

Last year, Endo bought rival generic drug manufacturer Par Pharmaceutical Holdings Inc. for $8 billion.

John George covers health care, biotech/pharmaceuticals and sports business.

International #MeshAwarenessDay #LiveLifeMeshFree May 1, 2017

Caz Chisholm recognised for campaign supporting women pelvic mesh victims

Joanne McCarthy

1 May 2017, 10:23 a.m.

A WOMAN who launched a campaign to support women victims of pelvic mesh and hold Australian health regulators to account has won two awards for consumer health advocacy.

Australian Pelvic Mesh Support Group founder Caz Chisholm received the Western Australian Health Consumers Council health consumers award and the Rosemary Caithness Award for outstanding service to health consumers after a campaign, supported by the Newcastle Herald, for a Senate inquiry into pelvic mesh.

Winner: Australian Pelvic Mesh Support Group founder Caz Chisholm with two health consumer awards received for her work since 2014 campaigning for victims of pelvic mesh.

Ms Chisholm’s group jumped from 39 members in early 2015 to more than 600 by Thursday when she received the awards, only days before International Mesh Awareness Day on Monday, May 1. The day was initiated by mesh support groups in countries including Australia, America, New Zealand, Great Britain and European countries including the Netherlands. In America alone more than 125,000 women have initiated legal action against mesh manufacturers after they were implanted with transvaginal mesh (surgery through the vagina rather than the abdomen) after post-childbirth complications.

An American woman on Friday was awarded $20 million compensation for complications after mesh surgery in 2007 using a Johnson & Johnson transvaginal mesh. In Australia 450 women have joined a class action against Johnson & Johnson, another 350 women have joined a class action against a second American device manufacturer, and more than 1000 women in total have complained of serious injuries after mesh surgery.

Ms Chisholm said she was “thrilled and honored to receive these awards as this represents the acknowledgement of all women suffering from the devastating effects of mesh”.

“What we seek first and foremost is recognition of our pain and suffering because most of us have been ignored by doctors, and when we do present with complications we are told they are caused by anything other than mesh,” Ms Chisholm said.

“Yet when women join the support group and they read about the same complications as others, they breathe a sign of relief and often cry because finally they have the recognition that they are not imagining their pain and they are not going crazy.

“They realise their pain is real and their pain is from mesh.”

Western Australian Health Consumers Council executive director Pip Brennan said Ms Chisholm’s double win of the two most prestigious consumer health awards recognised her tireless advocacy for mesh victims and outstanding work on giving them a voice.

“The use of mesh is now the subject of a federal Senate inquiry, which is taking submissions until May 31, and the inquiry’s title is ‘Number of women in Australia who have had transvaginal mesh implants and related matters’. This highlights that we simply don’t know how many women have had these implants, and how many of them have suffered complications,” Ms Brennan said.

“Caz Chisholm has spent significant time and energy raising awareness for women about the issue and providing essential peer support. She was also directly responsible for ensuring that the Senate inquiry was successfully advocated by Senator Derryn Hinch.”

In 2016 Australia’s peak health regulator for medical devices, the Therapeutic Goods Administration, quietly placed on its website a list of at least 30 known complications following pelvic mesh surgery, after TGA executives met with Ms Chisholm and other support group members.

The complications include punctures of vessels, nerves, structures or organs including the bladder, urethra or bowel; foreign body response including erosion of mesh into the vagina, bladder or bowel; chronic infections; acute or chronic pain; pain during intercourse; temporary or permanent inability to void via the lower urinary tract; bleeding; chronic pain in the groin, thigh, leg or abdomen; atypical vaginal discharge; exposed mesh may cause pain to the patient’s partner during intercourse and abscess.   

Catastrophically harmed by surgical mesh? Justice in settlements?

Progress Continues TowardSettling Coloplast Mesh Lawsuits: Report

By: Austin Kirk | Published: June 25th, 2014

As hundreds of Coloplast mesh lawsuits continue to move forward through the federal court system, the parties are continuing to make progress in settlement negotiations to resolve the litigation, according to a recent court update.

Coloplast Corp. currently faces nearly 1,500 federal transvaginal mesh and bladder sling lawsuits, which have all been consolidated for pretrial proceedings before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia as part of an MDL, or multidistrict litigation.

All of the complaints involve similar allegations that women suffered severe and debilitating complications after receiving Coloplast mesh for surgical repair of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI), where the mesh eroded through the vagina, caused infections or other injury.

According to a pretrial order (PDF) issued by Judge Goodwin on June 16, “substantial progress” has been made toward settling the Coloplast cases and a follow up status conference has been scheduled for August 7, at which time the parties will meet with Judge Goodwin in chambers to provide an updated report.

In March, it was reported that a Coloplast mesh settlement was reached to resolve about 400 cases for $16 million.

In addition to lawsuits against Coloplast, Judge Goodwin is also presiding over thousands of similar cases brought against manufacturers of other transvaginal mesh products, including C.R. Bard, American Medical Systems (AMS), Ethicon, Boston Scientific, Cook Medical and Neomedic.

Endo Health Systems reported last month that it has agreed to pay $830 million to settle AMS mesh lawsuits brought by about 22,000 women, making it the largest settlement reported to date in the litigation.

C.R. Bard has also reached a number of individual settlements involving cases that were scheduled to come up for trial, but no global settlement agreement has been reached.

Vaginal Mesh Litigation Update

According to the latest case list (PDF) released by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on June 16, Judge Goodwin is currently presiding over 17,812 AMS mesh lawsuits, 18,176 Ethicon mesh lawsuits, 12,004 Boston Scientific mesh lawsuits, 8,555 Bard Avaulta mesh lawsuits, 1,468 Coloplast mesh lawsuits, 195 Cook Medical mesh lawsuits and about 52 Neomedic mesh lawsuits.

The combined total of 58,262 vaginal mesh claims pending in the federal court system represents a nearly 35% increase in the number of cases pending since March 2014, when the U.S. JPML reported that a combined total of 43,173 cases were centralized before Judge Goodwin. In addition, thousands of other cases are pending in various state court systems throughout the country.

As part of the coordinated pretrial proceedings in federal court, Judge Goodwin has scheduled a series of early trial dates involving several of the manufacturers. Known as “bellwether” cases, such test trials are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation.

In August, a trial involving a lawsuit filed against Ethicon by Jo Huskey is scheduled to go before a federal jury. Huskey alleges that she suffered injuries after receiving an Ethicon TVT-O bladder sling for stress urinary incontinence.

Later this year, a combined trial involving 11 Boston Scientific mesh cases is set to go before a jury starting in October 2014. That case involves women who experienced problems after receiving a Boston Scientific Obtryx sling for repair of stress urinary incontinence.

Last year, a series of three Bard Avaulta trials were set for trial in the MDL, with the first case going before a federal jury in July 2013, involving a lawsuit filed by Donna Cisson. That trial resulted in a $2 million damage award against Bard, including punitive damages designed to punish the company for the actions during the manufacture and sale of the product. The second and third trials were each settled shortly before they were set to begin, with terms of the deals withheld.

Given the lack of progress towards settling additional cases by some manufacturers, Judge Goodwin recently ordered that a second wave of Bard Avaulta cases and Boston Scientific mesh cases be prepared for trial, with hundreds of cases going through case-specific discovery over the remainder of this year so that they can be trial-ready by early 2015.

If the manufacturers fail to reach vaginal mesh settlements to resolve the majority of cases against them, they could face hundreds of individual trial dates scheduled throughout the country next year.

Related Articles

            Coloplast Mesh Settlement Reached To Resolve 400 Lawsuits: Report (3/6/2014)

            Ethicon Prolift Mesh Lawsuits To Be Selected For MDL Trial in Aug. 2014 (9/11/2013)

            Trials for AMS, Ethicon & Boston Scientific Mesh Cases to Begin Dec 2013 (12/11/2012)

            Additional Bellwether Trial Dates Set for Vaginal Mesh Implant Lawsuits (9/5/2012)

            Coloplast Pelvic Mesh Lawsuit Consolidation Sought in W.V. MDL (7/5/2012)

Tags: Bladder Sling, Coloplast, Transvaginal Mesh, Vaginal Mesh, West Virginia

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