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Endo settles more than 350 vaginal mesh suits
Apr 20, 2015 | Fierce Medical Device
By Emily Wasserman
...Johnson & Johnson ($JNJ) is also facing legal pushback for its vaginal mesh devices, battling it out with plaintiffs or in some cases, settling claims... -
*New* Anatomy of an AMS Settlement – 692 Pelvic Mesh Injury Claims to be Resolved?
Apr 20, 2015 |
By Jane Akre
...Those claimants refusing its terms may opt to go back to court where there are presently 19,712 lawsuits consolidated in one federal court in Charleston, West Virginia, not including those filed in various state courts. AMS litigation represents the next highest number of product liability lawsuits filed in this court behind Ethicon (Johnson & Johnson)... -
*New* Scottish Mesh Survivors Erect Website for Mesh-Injured
Apr 20, 2015 | Mesh Medical Device News Desk
By Jane Akre
The Scottish Mesh Survivors has a newly erected website to solidify the unity of women who are part of the mesh-injured community in Scotland.
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Endo settles more than 350 vaginal mesh suits
Apr 20, 2015 | Fierce Medical Device
By Emily Wasserman
Endo International's ($ENDP) American Medical Systems (AMS) subsidiary is settling more than 350 suits over allegedly defective vaginal mesh implants, a turning point as the company shifts away from medical devices and casts its eye toward diversification to generate growth.
The Dublin-based company told U.S. District Judge Joseph Goodwin that it had "compromised and settled all claims" in about 360 cases in 12 joint motions to dismiss, including 30 cases that raised claims against other companies manufacturing similar devices including Boston Scientific ($BSX) and C.R. Bard ($BCR), Law360reports. Endo in October said it would add $400 million to its $1.2 billion liability reserve to resolve "substantially all" suits related to vaginal mesh implants sold by AMS. The company will fund the payments through 2017, settling more than 10,000 suits for an average of $48,000 apiece.
"These settlements will allow us to continue to invest in the growth of our business segments and pursue accretive M&A opportunities. We believe these settlements will also allow the AMS business to continue its return to growth and enhance focus on the operations and profitability of this leading medical device franchise," Endo CEO Rajiv De Silva said at the time.
And the company could be well on its way to reviving its slumping fortunes, shedding noncore assets and striking deals to generate some upward momentum. In January 2014, Endo announced that it would sell the remainder of its unwanted urology device business HealthTronics to Altaris Capital Partners in a deal worth up to $130 million. In June, Endo bought Dava Pharmaceuticals for up to $600 million to expand its generic drug portfolio.
The company lightened its load further in March, selling a chunk of its AMS device unit to Boston Scientific for $1.6 billion. The deal, which handed Boston Scientific products for men's health and prostate health, helped Endo diversify away from devices and furthered the company's push toward becoming a global specialty pharma company.
Meanwhile, other med tech outfits continue to deal with a slew of vaginal mesh-related claims. In November, a federal jury ordered Boston Scientific to pony up $18.5 million in damages to four women who claimed the company's devices caused them constant pain and injuries. In January, C.R. Bard lost a bid to delay a product liability trial over its vaginal mesh products.
Johnson & Johnson ($JNJ) is also facing legal pushback for its vaginal mesh devices, battling it out with plaintiffs or in some cases, settling claims. In January, the company said it would settle more than 100 product liability lawsuits regarding pelvic mesh products sold by its Mentor subsidiary. But a California jury in March ordered J&J to pay $5.6 million in the first trial over one of its mesh devices, adding to the company's mixed bag of rulings. J&J and its Ethicon unit still face more than 36,000 lawsuits in state and federal courts over the devices, including consolidated cases before U.S. District Judge Goodwin in West Virginia.
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*New* Anatomy of an AMS Settlement – 692 Pelvic Mesh Injury Claims to be Resolved?
Apr 20, 2015 |
By Jane Akre
American Medical Systems (AMS) has sent a settlement letter to 692 women who claim mesh-related injuries. These are women represented one of the settlement counsel.
There are at least 100 law firms representing injured women who have been encouraged by Judge Joseph Goodwin, who oversees the federal cases, to reach a settlement.
Here are the specifics:
The AMS settlement is voluntary and applies to those procedures documented in your medical records on or before December 12, 2014, the date the settlement was reached.
Those claimants refusing its terms may opt to go back to court where there are presently 19,712 lawsuits consolidated in one federal court in Charleston, West Virginia, not including those filed in various state courts. AMS litigation represents the next highest number of product liability lawsuits filed in this court behind Ethicon (Johnson & Johnson).
If your law firm will continue to represent you, you will be assigned to litigation along with 19,0020 other individuals. A settlement at least guarantees the issue will be over. You will not be able to sue the company again. You are also forbidden from talking about the settlement amounts with anyone.
The aggregate settlement covers 692 AMS claimants. The company will pay a total of $93,848,000 to settle all of the claims and there must be at least 90 percent of claimants to agree or it is taken off the table. $89,890,000 will be distributed at this time with a remaining $3,958,000 set aside in a reserve for any changes in an individual’s settlement category.
Judge Joseph Goodwin
The settlement agreement was reached with the help of a Special Master, the Honorable Susan S. Soussan. Judge Soussan has been a district court judge, special master in mass tort cases, a mediator an arbitrator.
Last May Judge Joseph Goodwin assigned Judge Marina Corodemus to be the Special Master between AMS and certain plaintiffs’ counsel (ie Motley Rice, Levin Simes, Blasingame, Burch). See the order here.
The job of a Special Master is to help resolve disputes that arise from the categorization and processing of any claims based on the facts and circumstances of an individual’s situation.
The amount each claimant receives depends on their evaluation.
Injuries are divided into five “Tiers” of injury with the first being a mesh implant in place with the medical management of symptoms. Those cases with a pelvic organ prolapse (POP) mesh receive $60,000. Stress urinary incontinence mesh (SUI) implant plaintiffs receive $50,000. This does not include any monies due the law firm representing the women or any outstanding debt. It is possible the woman is left with very little or nothing when that is satisfied.
The next, Tier II – included a mesh in place with an in office surgical treatment for symptoms. For POP mesh, the settlement is $110,000 and for SUI mesh the amount is $100,000.
Tier III – At least one revision surgery under general anesthesia. POP mesh $280,000 and SUI mesh $270,000.
Tier IV – Two revision surgeries under general anesthesia, POP mesh $380,000 and SUI mesh $375,000.
Tier V – Three or more revision surgeries under general anesthesia $425,000 and up for both.
Consider though that women who are under medical management may be unable to afford surgery of any kind. For those women the settlement dollars are the smallest, though their need may be as great as Tier 5.
Claimants are informed there is a strict confidentiality agreement in place when one signs off on the settlement, restricting anyone from discussing the contents of the settlement with anyone other than their attorney or immediate family members.
Claimants must agree to cover costs such a filing fees, medical records, depositions etc, which amounts to 5% of the gross value of the settlement. This is considered a Multi-District Litigation (MDL) fee. There is also a “Holdback for Potential Medicaid Lien” required by law before the settlement is complete.
Look for a Special Needs Trust to be set u so the monies are not considered an asset and are protected from Medicaid and disability reimbursement.
In February, Boston Scientific announced it would buy Endo’s AMS medical device unit for $2 billion. Endo acquired AMS for $2.9 billion in 2011. Last April, the company announced it had reached $830 million settlement to resolve a number of pelvic mesh cases.
AMS is headquartered in Minnetonka, Minnesota. Endo International is based in Dublin, Ireland with U.S. headquarters in Malvern, PA.
Endo/AMS products include the ElevateTM Anterior and Posterior Pelvic Floor Repair Systemand the Monarc® Subfascial Hammock.
In January, 2012, the Food and Drug Administration ordered AMS to conduct post-approval studies on women who had received the pelvic organ prolapse and mini-sling implants to monitor them for complications. AMS received 19 orders but has honed that down to sixteen “for various commercial reasons” says its filing.
AMS took its Apogee and Perigee pelvic organ transvaginal mesh (TVM) off the market and in doing so it relieved them of the FDA mandated post-market monitoring. #
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*New* Scottish Mesh Survivors Erect Website for Mesh-Injured
Apr 20, 2015 | Mesh Medical Device News Desk
By Jane Akre
The Scottish Mesh Survivors has a newly erected website to solidify the unity of women who are part of the mesh-injured community in Scotland.
Check it out here.
Elaine Holmes and Olive McIlroy are featured. They are two of the leaders of the group who petitioned their Scottish Parliament to hold a hearing on the number of pelvic mesh implants in their country and the high number of life-altering complications.
Not only did they raise awareness to the country as a whole, but lawmakers decided to suspend sales of pelvic mesh in the country until an inquiry could determine the number of injured and how this was happening.
National Health Service records show implants could range from 3,000 to as many as 10,000 in the small country.
See Mesh News Desk background stories on the suspension last June here. Last September,Sunday
Marion Scott, Daily Record and Sunday Mail, Reporter/ Journalist of the Year 2015
Mail journalist Marion Scott reported the use of mesh implants was continuing despite the Health Secretary’s suggestion the use be suspended. Scott reports eight health boards have ignored the suspension. She just won Reporter of the Year for her coverage of the mesh calamity. Yeah Marion!
Read her story here and here.
In February, New Jersey attorney Adam Slater addressed the Parliament on the latest goings on with Ethicon, the largest maker of polypropylene mesh implants. See story here.
Adam Slater
Reporter Marion Scott has long made the public aware of the mesh mess by her exhaustive coverage of the issue.
Congratulations to Scottish Mesh Survivors and Marion Scott for their efforts as an amazing organization that is making things happen!
The Petition, dated May 1, 2014, “Hear Our Voice” asks the government to suspend the use of polypropylene transvaginal mesh procedures and initiate a public inquiry on the use of mesh devices from around the world. They also ask for mandatory reporting of all adverse events by health professionals and to set up an implant register so AE can be tracked. Read more at the Petition here.
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