Most product liability lawsuits end in settlement. Transvaginal and hernia mesh cases are no different. Most of these cases never reach a jury; instead, they’re resolved through negotiated agreements brokered by attorneys. And, while many mesh victims look forward to the end of litigation, settlement can easily become a thorny topic for personal injury survivors and their loved ones.
Transvaginal & Hernia Mesh Settlements
On this page, you’ll find a number of helpful articles from your editor on handling the settlement process from the plaintiff’s point of view. You’ll also get all the latest updates on mesh settlement announcements. To skip straight to a story, click on one of the links below:
- Hard Lessons Learned From Mesh Settlements (April 27, 2016)
- Endo To Resolve All U.S. Pelvic Mesh Product Liability Claims (August 8, 2017)
- Has AMS Paid All Transvaginal Mesh Claims? (May 27, 2017)
- Boston Scientific Plans Mass Pelvic Mesh Settlements (May 9, 2017)
- J&J Settles Third Round Of Pelvic Mesh Cases (March 28, 2017)
- Mesh Settlements & Internet Gossip (October 17, 2016)
- J&J Offers Second Major Settlement To Pelvic Mesh Injured Women (September 9, 2016)
- Caldera Denied Settlement & Quick Exit To Pelvic Mesh Litigation (July 26, 2016)
- 90,000 Pelvic Mesh Lawsuits Burden Court, Judge Dismisses 140 Bard Cases (April 27, 2016)
- Endo Offers $850 Million To Settle 20K AMS Pelvic Mesh Lawsuits (April 30, 2014)
Hard Lessons Learned From Mesh Settlements
Mesh Medical Device News Desk, April 27, 2016~
The following is an Op-Ed written by your editor who has covered the pelvic mesh issues for more than five years. I am not a doctor or a lawyer and am not providing any professional advice.
I am sharing observations of the evolution of mesh settlements and how, in many cases, they are not in any way coming close to making an injured woman whole.
In the vast majority of cases, law firms are walking away with settlement monies than their injured clients.
After waiting many months, American Medical Systems (AMS) is beginning to pay out a promised $1.6 billion settlement to resolve about 25,000 product liability cases filed by women who alleged they were permanently injured by the company’s pelvic mesh. See background story here.
Master Settlement Offers
On September 30, 2014, American Medical Systems, a division of Endo International, announced the master settlement which was designed to resolve substantially all of its remaining U.S. vaginal mesh litigation. As AMS was the first mesh manufacturer to agree to settlements, some women are now receiving their offers in writing.
Remember, the AMS settlement required around 90 percent participation so oddly, the injured women plaintiffs held some power over the settlement at that time, whether they knew it or not.
Interpreting Your Settlement Agreement
The contract you signed with your law firm contains the details. It should be understood, preferably before it is signed. If you wait until after you sign it, the news may not be welcome.
Did you file for bankruptcy? Do you get disability? Did you take out a loan? Do you owe a hospital or doctor?
Bankruptcy Chain Could Threaten Plaintiffs’ Fund
Unfortunately, what women are now finding is that the firm can go back into past bankruptcies, even if they are a dozen years old, to satisfy creditors. In that case, a woman with a $30,000 settlement gives half to her law firm (40% plus expenses) and $10,000 to the creditors and is left with $5,000. Some injured women are left with nothing.
Whatever the fine print says will prevail. Those entities will have to be paid before a mesh-injured woman receives her settlement. Your attorney or the Special Master may be able to negotiate downward any outstanding debt.
When Will The Money Arrive?
When you receive your check is another question. Women call me screaming they do not have their money. Again, the language of the contract will prevail.
Does it say payout will be in a “reasonable time” or some other wiggly language? “Reasonable” means nothing while language that says “payout in the form of an overnighted check must be received by plaintiff within 30 days of signature of this settlement agreement otherwise it is null and void” is much stronger language, which you may or may not have the option to add to your contract.
Your attorney should be able to advise you on this option.
The Fine Print
Multidistrict Litigation is supposed to streamline the process and avoid redundancy. One firm can rely on the discovery received by another so they do not have to reinvent the wheel, theoretically reducing billable hours and saving the client the cost of working up her case. But that may not be what’s happening in real time.
Attorneys’ Fees Rack Up
What the AMS settlements are showing is that law firms frequently charged 40% for their services. Some even added expenses to that 40%. However, many firms did not specifically work up a case for trial.
However, other law firms spent in excess of $1 million to work up an individual case for trial. This is the true definition of gambling. There are no assurances you will win a case. If you lose at trial, so does your law firm.
Common sense dictates if a lawsuit is won, that firm should expect to be repaid for the investment it made in your case.
Medicaid, Bankruptcy & Liens
Those outstanding debts will be subtracted from your settlement dollars. One woman tells MND after Medicaid and her lawyer were paid, she got absolutely nothing. Another woman reports the law firm went back into a 12-year-old bankruptcy to satisfy creditors.
Those interest-accruing loans will also have to be paid back as well. A $3,000 loan just to get by, can amount to $15,000 by settlement day.
Will Settlement Threaten Government Benefits?
Another interesting note, government benefits may be affected by accepting a settlement. Medicaid and disability could adjust downward without a Special Needs Trust, see story here.
To add insult to injury, many law firms will not take your call or will rush you off the phone. Some have paralegals who make promises that cannot be kept such as giving you a time you will receive your check that does not come true. #
Endo To Resolve All U.S. Pelvic Mesh Product Liability Claims
Mesh Medical Device News Desk, August 8, 2017 ~ Endo International has set aside $775 million to bring to a close its outstanding pelvic mesh U.S. and international claims, according to the Dublin, Ireland-based company.
Endo International, which owns the American Medical Systems (AMS) pelvic mesh lawsuits, has agreed to settle the 22,000 unresolved pelvic mesh product liability lawsuits that have been lingering in court, according to a press release (here) the Wall Street Journal.
$775M Settlement Fund
The company will set aside $775 million to resolve the last lawsuits, bringing to a total of more than $3.58 billion paid to settle lawsuits filed by women who claim they were injured by the allegedly defective devices made by AMS.
Endo will make installment payments beginning in the fourth quarter of 2017 and continuing through the fourth quarter of 2019, according to a company statement. The press release says it will resolve both U.S. “as well as all known international mesh product liability claims and other mesh-related matters.”
See Endo statements here.
MDL Holds Tens Of Thousands Of Cases
At the present time there are 21,127 defective product cases amassed against Endo, filed in federal court in Charleston, West Virginia.
Johnson & Johnson is facing almost 39,000 alone in Charleston and thousands more in New Jersey as well as cases filed around the country. The other large mesh maker, Boston Scientific, has 25,029 cases consolidated in the federal court in Charleston, West Virginia.
Judge Joseph Goodwin had announced to lawyers earlier this year that he wanted to resolve all 104,000 cases before him in multidistrict litigation in WV.
“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,” said Chief Executive Paul Campanelli in prepared remarks.
The company said it is in talks to resolve the remaining known U.S. claims at “reasonable values” reports the WSJ.
AMS: No More Settlements!
One woman, Samantha, who had a Caldera claim filed against AMS over its patented surgical tools used in the Caldera mesh kit. The law firm overseeing AMS/Endo’s $1.6 billion Qualified Settlement Fund told her, in a series of emails, that no more settlements would be paid.
See the MND background story here.
This is good news for mesh-injured claimants like Suzanne (not her real name), who was implanted with an AMS TVT-O in 2012. Because there have been no trials involving AMS transvaginal mesh, she is one of thousands who are lingering, awaiting an offer from the company to settle.
Read her MND story here.
AMS/Endo Settlements To Date
In April 2014, AMS/Endo agreed to an $830 million settlement fund to resolve about 20,000 claims. One year earlier, AMS/Endo announced a $54.5 million settlement to resolve pelvic mesh lawsuits.
In September 2014, AMS/Endo announced a master settlement of $1.6 billion to resolve the lawsuits.
Valued at $2 billion, Endo purchased American Medical Systems urology products for $2.9 billion in 2011. See the story here.
Mesh Litigation ENDED Endo’s Women’s Health Division
In March 2015, Endo International announced it sold the urology division to Boston Scientific for up to $1.65 billion. The women’s health division was renamed as Astora Women’s Health.
Astora Women’s Health was closed by Endo in March 2016 due to litigation costs. Astora announced it had suspended all commercial activity and is no longer making or distributing any women’s health products. See the MND story here.
Apogee Vaginal Mesh Removed From Market
AMS made the Apogee and Perigee Systems, ElevateTM Anterior and Posterior Pelvic Floor Repair System and IntePro Y sling to treat pelvic organ prolapse. The MiniArc, RetroArc, Monarc, In-Fast, BioArc and SPARC slings all treat stress urinary incontinence.
Since it took Apogee off the market, AMS no longer has to conduct FDA mandated three years of post approval monitoring on those models of pelvic mesh products.
The company reported second-quarter revenues of $876 million, a 5% decrease from the same time period of 2016. The loss of its opioid drug, Opana ER, withdrawn from the market, cut sharply into revenues. ###
Has AMS Paid All Transvaginal Mesh Claims?
Mesh Medical Device News Desk, May 27, 2017 ~ American Medical Systems/ Endo International says they are settling NO MORE CLAIMS, reports “Samantha” after a conversation with the national settlement firm.
Samantha has vigorously pursued AMS for its patented surgical tools used in the Caldera mesh kit that injured her.
Samantha was implanted with the T-Sling made by Caldera in 2004, before it was even cleared for experimental use, at HealthSouth in Birmingham, Alabama. Her implanting surgeon was one of the co-inventors, she says, something she was not told at the time but which she discovered later.
AMS Dead Set Against Further Settlements, Survivor Says
“If you believe you will obtain a settlement from AMS you might want to know that it is most likely not going to happen. They are on defensive now that the novel surgical tools are identified and are a new viable set of claims against their national settlement funds,” she tells MND.
Samantha, who is not represented legally but may be in the future, prefers not to be identified. She spoke with the law firm overseeing the AMS/Endo $1.6 billion Qualified Settlement Fund (QSF) March 17.
In response to clarification, whether AMS/Endo was ending transvaginal mesh settlements, Rohe wrote MND, “The statements in your email are incorrect.”
Pro Se Plaintiff Pushes Forward
Negotiations between plaintiffs’ lawyers and the company are reportedly still resulting in some case resolution, but Samantha is proceeding Pro Se, after she fired he law firm. With no one representing her interests, and being implanted outside of the years Caldera Medical had insurance coverage, Samantha is further disadvantaged in this litigation.
What’s unclear is whether future claims may be filed against the $1.6 billion QSF or whether the pending mesh product liability cases will be satisfied.
Settlement Limitations & Restrictions
There are already limitations to covered claims. The QSF does not pay for future injuries and there is a cut-off date of December 31, 2016 for applying for a supplemental settlement amount.
At one time, Judge Goodwin, overseeing pelvic mesh litigation, heralded AMS as the example the other six mesh manufacturers should follow to the settlement table. Now that progress has reportedly stalled.
AMS Settlement Hits Major Setbacks
Older AMS cases are lingering after dollar amounts were rejected by the mesh-injured plaintiffs, and according to Endo, an additional 9,700 product liability pelvic mesh claims have been filed.
The pelvic mesh litigation that was supposed to be the first resolved has failed to do so.
Is the AMS/Endo Settlement Near the End?
In 2011, Endo Pharmaceuticals agreed to acquire American Medical Systems for $2.9 billion in cash for its urology medical devices. The AMS deal would be a bad one for Endo. The merger resulted in Astora Women’s Health, which closed its doors one year ago due to the mounting cost of pelvic mesh litigation.
In September 2014, AMS/Endo announced it was committing $1.6 billion into the Qualified Settlement Fund to close its pelvic mesh cases.
Endo Liability Nears $2 Billion
In its latest securities filing for 2016, Endo International, based in Dublin, Ireland, shows cash payments to mesh-related product liability and other litigation matters in excess of the $1.6. billion QSF. The mesh-related activities include cash payments to claimants in 2016 of $1.1 billion and $676 million for 2015. See the Endo SEC 10-K here and here.
According to the filing, AMS/Endo settled 49,000 filed and unfiled mesh claims with, no admission of liability or fault as of December 31, 2016.
The SEC filing says, “It is currently not possible to estimate the number or validity of any such future claims.” The company no longer has product liability insurance to cover the claims in connection with the mesh-related litigation settlement.
Is it accurate to say then that Endo payments into the settlement fund, for the time being, have been satisfied? I asked Amy Rohe for a second time.
“That is not correct. My client has no additional comments with respect to settlements at this time,” writes Rohe in an email.
The settlement is a drain on a company already in a steep decline.
Last June, Endo stock plummeted and by December, Fierce Pharma reported Endo planned to cut loose 375 sales reps and staffers.
Endo Stock Tanks
Today Endo International plc is near its lowest point in a year, closing up today at $10.50 USD. The week of January 31, 2017, Endo was the worst performing stock in the S&P 500, in fact, twice in one week.
Adding insult to injury, last week two FDA advisory panels said that Endo’s moneymaker opioid, OPANA and OPANA ER do not provide more benefit than risk. The extended release, which was supposed to be an improved version, might be even more dangerous than the original, concluded Public Citizen.
It will be up to the FDA to decide whether to require label changes, restrict prescriptions or take OPANA off the market. For the present time, OPANA remains on the market with additional warnings.
Endo continues to pay hundreds of thousands of dollars in legal fees to defend all of its problematic products but appears to have given a green light to lawyers pursing a mesh-related alleged”scheme” to undergo additional surgeries for additional settlement dollars.
According to recent filings in the federal multidistrict litigation in Charleston WV, AMS/ Endo is pursuing Broward Outpatient Medical Center and Beth Israel Surgical Center to provide medical records on 32 plaintiffs, women implanted with AMS transvaginal mesh. To date, the hospital had not complied with the subpoenas requested by AMS attorneys on or about November 23, 2016. See PTO # 236 here.
Endo Accuses Women Of Undergoing Surgeries For Extra Cash
Attorneys for Reed Smith law firm representing AMS/Endo believe mesh-injured women are willing to undergo additional pelvic surgeries to increase their settlement dollars. The Tier system used to gauge injury and compensation is based on the number of mesh-removal surgeries a woman undergoes. See MND Pain for Profit story here.
The alleged “lured into needless surgeries” scheme has been reported numerous times by Reuters and is repeated in this recent column.
As if there was not enough litigation to go around, Reed Smith, is facing accusations of questionable practices of its own, as reported by ReedSmithWatch.com. The website says partners bill upwards of $700 an hour.
Samantha Urges Caldera Mesh Implanted To Pursue AMS / Endo
For Samantha, her argument is that the surgical tools included in the Caldera T-Sling were patented and owned by AMS, therefore she believes have value to her case.
Samantha continues, ” My journey has been long and difficult. All Caldera Medical Inc. victims should file a short form in the American Medical System MDL and demand payment from the national fund. I have an open insurance claim against AMS/Endo. I filed with ACE Chubb Group after locating the general liability policy through an insurance agent, Marsh U.S.A. I opened my claim on March of 2016 which is based in my injuries by the predevelopment use of AMS patent US6911003.
“The patent is for the helical introducer, inside-out introducer, hook introducer for the transobturator procedure are instruments whose use and IP method have injured me.
“After more than a year of communicating with an adjuster, my claim was directed to American Medical Systems National Settlement law firm and attorney Amy Rhoe.”
The context of the communication was as follows:
“It is my hope you are able to authorize a settlement offer as Astro / Endo Reached Master Settlement Agreement to Resolve Substantially All Remaining AMS Mesh Litigation Claims, in September of 2014. I was implanted with an assembly kit which contained the AMS novel surgical tools during the window of time where AMS was infringing upon Mentor and AMS and Caldera Medical, Inc. agreed to a royalty agreement for the novel surgical tools.
I was an unethical human experiment 22 months before the FDA was aware of the Caldera mesh assembly kit. It should be of concern to you as to how AMS was involved with HealthSouth in participating in my harm. Funds are set aside for settlement and ACE Chubb’s insurance adjuster directed me to contact Endo directly because all proceeds from the general liability policy had been paid into the fund. You can authorize the payment of my claim.
I am asking you authorize a settlement from the fund for my claim. My harm has never been denied by the insurance company. Life Science policies do not cover for harm outside of clinical trials of which I was not. Clinical trials did not begin until 2006. If Endo is unaware of the unethical human experimentation that American Medical Systems used to bring products to market, that should be addressed internally I, however, should be compensated for my harm.
I do not have legal representation because Multidistrict Litigation attorneys operate within collusive private deals which have hidden the criminal unethical human experimentation surrounding my harm, the Stark’s Law and False Claims violations and avoid prosecution so they can take their monies for legal fees and commissions while ignoring the predevelopment unethical human experiment that brought devices to market.
When I had initial contact with you, I indicated that I had information that you might not be aware of. That information concerns this question.
Do you know how American Medical Systems helical passer needles were used in the assembly kit use to implant me on April 20, 2004, at HealthSouth Alabama, 22 months before the FDA was aware of the implant?
Please review all 42 images of the patent, it will provide images for my harm. Here is the patent for Transobturator surgical articles and methods. My claim is based upon Patent 6911003 B2 CLAIMS (14) (here).
I look forward to our phone conversation today. Please review all 42 images of patent, I have provided image 11.
Again, I ask you to authorize a settlement offer from the current 2014 settlement fund.”
Boston Scientific Plans Mass Pelvic Mesh Settlements
Mesh Medical Device News Desk, May 9, 2017 ~ According to its quarterly federal filing, Boston Scientific, one of seven medical device manufacturers facing thousands of product liability cases over its pelvic mesh, plans to settle 37,000 cases with certain plaintiff attorneys without admitting any fault.
Quarterly reports that shareholders read are always enlightening as to how a company deals with allegedly defective products. In its latest quarterly report (10-Q), filed with the Securities and Exchange Commission (SEC) May 3, Boston Scientific (BSC) says whether patent infringement, intellectual property rights or product liability, lawsuits are a “normal course of business.”
BSC Lets Settlement Plan Slip In SEC Filings
But extraordinary within its pages is the admission that 37,000 of a pending 43,000 product liability cases filed against BSC will be resolved. Of those approximately 12,000 have met the condition of settlement and are final.
BSC likes to point out that the settlements came about through compromise “without any admission or concessions by us of any liability or wrongdoing.”
The cost of legal matters was $2 billion as of the last day of December. Another $1.75 billion, including the estimated costs of settlement, damage and defense, has been accrued by March 31, 2017.
The 10-Q filing does not specify how much has been set aside specifically for transvaginal mesh settlements.
Millions In Litigation Expenses
“We recorded $3 million of litigation-related charges during the first three months of 2017 and $10 million of litigation-related charges during the first three months of 2016.”
BSC says it has put aside money for these and future cases and claims which it believes is adequate but, “changes to this accrual may be required in the future as additional information becomes available.”
International Class Actions
The pending cases are filed in both state and federal courts and include eight class actions filed in Canada (one certified and three potential class actions) and fewer than 25 class claims in the UK.
These are claims for design and manufacturing defects, a failure to warn, breach of warranty, fraud, violations of state consumer protection laws and loss of consortium.
The SEC filing specifically points to Teresa Stevens, who in January 2016 filed a RICO claims against BSC on behalf of women who allegedly received mesh made from counterfeit or adulterated resin products imported (smuggled) from China.
RICO stands for Racketeer Influenced and Corrupt Organizations Act, charges of which are usually reserved for organized criminal activity.
FDA Leaves Counterfeit Mesh Plastic To BSC
On January 26, 2016, the Court issued an order staying the case and directing the plaintiff to submit information to allow the FDA to weigh in. The FDA deferred to Boston Scientific to determine if its resin from China implants were substantially different from resin sources in the U.S. There’s been no update from BSC.
The 10-Q continues, “In addition, we are in contact with the United States Attorney’s Office for the Southern District of West Virginia and are responding voluntarily to their requests in connection with that office’s review of the allegations concerning the use of mesh resin in the complaint.”
Another complaint alleging RICO violations was filed February 27, 2017 in the U.S. District Court for the Middle District of Florida, Orlando Division against Boston Scientific. Carolyn Turner also alleges violations of the Racketeer Influenced and Corrupt Organizations Act (RICO) and heads a class alleging she was harmed by vaginal mesh made from counterfeit resin brought in from China. This was served against the company April 7, 2017.
“We deny the plaintiff’s allegations and intend to defend ourselves vigorously.”
BSC says it has put aside money for these and future cases and claims which it believes is adequate, “changes to this accrual may be required in the future as additional information becomes available.”
In the federal court in Charleston West Virginia, May 5 the court entered PTO Order #160 appointing Cathy Yanni as special master for private settlement agreements between BSC and certain plaintiffs’ counsel, among them Skikos, Crawford, Skikos & Joseph LLP.
Trials So Far
Trial results have been both favorable and unfavorable but BSC says it does not believe that is an indicator of potential outcomes of all cases related to transvaginal mesh.
There are more than 3,100 cases filed in state court in Massachusetts and certain state attorneys general are also considering actions and have filed discovery requests on BSC.
TVM Cases Consolidated In West Virginia Court
The Southern District of West Virginia is the federal home of the bulk of transvaginal mesh claims against Boston Scientific. As of today there are 24,751 cases filed with 9,190 that claim to be closed. This includes cases filed as early as May 2011.
The Charleston, West Virginia court is where multidistrict litigation (MDL) assembled more than 102,000 claims against six manufacturers. Boston Scientific is MDL 2326.
New BSC Mesh Case Updates
On March 1, 2017, at the eve of a product liability trial, Sullivan v. Boston Scientific settled. See MND story.
A Mass. appeals court decided last September that the Albright case against Boston Scientific should receive a new trial because of information omitted by the Massachusetts trial court judge. See MND coverage here.
A RICO case was filed last June in federal court in Charleston, WV alleging Boston Scientific purchased counterfeit Marlex to make its pelvic mesh from a Chinese counterfeiter. See MND coverage here.
A North Carolina jury found for Boston Scientific and its Uphold mesh in the trial of Carlson v. Boston Scientific, October, 2015. See MND coverage here.
In September and again in November 2014, Boston Scientific lost two trials, one in Miami and another in Charleston, West Virginia that represented four plaintiffs each. The Eghnayem trial in Miami concerned BSC’s Pinnacle and resulted in a award total of $26.7 million. See MND coverage here.
In the Tyree case, which involved BSC’s Obtryx pelvic mesh, the litigants were awarded a total of $18.5 million. See MND coverage here.
The largest mesh award so far went to plaintiff Martha Salazar who was implanted with the Boston Scientific Obtryx. A Texas jury awarded her $73.46 million, which was later reduced by the trial court judge to $34.6 million under tort reform restrictions. See MND coverage here.
Still On The Market
Boston Scientific still sells mid-urethral slings – the Advantage Fit, Advantage, Lynx, Obtryx II, Solyx, according to its website here.
The Pinnacle, pelvic organ prolapse mesh has been removed from the market. The only other pelvic floor mesh includes the Repliform, a human dermal graft, Uphold LITE Vaginal support System, and Upsylon Y-Mesh.
Boston Scientific Strengthens Mesh Warning Label
A year ago Boston Scientific bolstered its pelvic mesh warning label. See the MND story here.
The notice also makes changes to the label on the BSC Pinnacle LITE pelvic floor mesh, not current available in the Boston Scientific U.S brochure, but the label changes for the international community indicate it is still being used overseas. Boston Scientific surgical mesh made after 2012 may be made from counterfeit resin smuggled to the U.S. from China. See the background here.
Michael Mahoney, CEO Of Boston Scientific
Michael Mahoney is CEO who reaped a total of $35.7 million in total compensation in 2016, according to bizjournals Boston.
Mahoney was hired away from Ethicon/ Johnson & Johnson in September 2011, (See MND story here) where he worked in sales and marketing selling nuclear medicine cardiology systems to small hospitals in the Carolinas.
While at J&J he worked alongside the president of DePuy Orthopaedics. In 2007, he was promoted to J&J’s knee and hip joint business. By August 2010, the DePuy ASR XL acetabular hip replacement was recalled because it was failing in the patients it was supposed to help. Marketed as an alternative hip replacement for the younger, athletic patient, the metal-on-metal prosthesis led to metal poisoning and repeated revisions. J&J did not warn physicians or patients and J&J paid out nearly $1 billion in legal costs and settlements.
Instead of losing his job, Mahoney was promoted within J&J to the head of J&J’s medical device and diagnostics group.
In 2011, J&J insisted on enforcing a non-compete clause to keep Mahoney from joining Boston Scientific, but then relented allowing the transition if Mahoney agreed not to work in any competing business to J&J such as stents or implantable defibrillators. ###
Mesh News Desk, Boston Scientific Must Pay Salazar $73.5 Million, September 8, 2014
See Mesh winners and losers so far
J&J Settles Third Round Of Pelvic Mesh Cases
Mesh Medical Device News Desk, March 28, 2017 ~ J&J (Johnson & Johnson) has been the last company to come to the settlement table, but an unopposed motion announces a third settlement for an unknown number of pelvic mesh women.
We don’t know how many women are involved or the dollar amount, but J&J has agreed to settle an unknown number of pelvic mesh cases.
Ethicon Reaches Settlement With Fleming, Nolen & Jez
According to Pretrial Order #250, filed in multidistrict litigation in Charleston, WV, Fleming, Nolen & Jez are the plaintiffs’ firm that has reached the Qualified Settlement Fund with Ethicon, a division of Johnson & Johnson.
The settlement has reportedly been in the works for some time, say sources. It occurred as the Susan Smith case (here) was being prepared for trial in Bergen County, New Jersey before Judge Rochelle Hartz.
Smith v. Ethicon trial was initially set for November 2016 then moved to January of this year.
Unopposed Motion Creates Ethicon Settlement Fund
Filed Monday, March 27, PTO#250 is a Motion establishing the Qualified Settlement Fund. The unopposed motion is granted by Judge Joseph Goodwin, overseeing multidistrict litigation in his Charleston, WV court.
Ethicon, a subsidiary of Johnson & Johnson has consistently had the largest number of product liability cases filed in this federal court. As of today, there are 38,035 cases filed with 5,547 cases closed. That number represents the lowest number of closed cases proportionately.
As of today there are 102,133 cases filed against seven manufacturers in this MDL where nationwide cases have been consolidated.
Since November first, 4,840 additional product liability cases, naming all seven manufacturers,have been filed in Charleston, WV court.
J&J Settlement Details
Scott Freeman of The Settlement Alliance of Houston is appointed as the fund administrator. The settlement will be deposited in J.P. Morgan Chase Bank which will serve as the Escrow Agent. The Master Settlement Agreement must also pay into the MDL No. 2327 Fund.
The Settlement Alliance offers Structured Settlement Trusts to provide tax-free payments.
The Houston-based Nolan law firm had several hundred transvaginal mesh cases. It is unclear how many are included in this settlement. George Nolan has a reputation of taking care of his clients and making sure they receive a just amount, says an unnamed source.
This would be the third settlement offer by J&J, which has been the firm least likely to come to the settlement table. In January, J&J made an offer to settle up to 3,000 lawsuits for $120 million to resolve up to 3,000 transvaginal mesh cases.
Last September, J&J offered settlements to an undisclosed number of clients of Blasingame, Burch, Garrard & Ashley. See the Mesh News Desk story here. ###
Mesh Settlements & Internet Gossip
Op-Ed, by Jane Akre, Editor, Mesh Medical Device News Desk, October 17, 2016 ~ Mesh Settlements are coming in and if you are a mesh-injured woman most likely you’ve heard from your law firm – Please do not read anything on the internet. It is unreliable and gossip.
That is what most law firms tell women injured by transvaginal mesh. Lawyers know women talk and social media is how they do it. Women like to talk to each other, especially when they’ve been made to feel they are the “only one.”
It brings comfort when few things do.
Are Mesh Settlements In Best Interest Of Injury Survivors?
It’s been years since litigation began in transvaginal mesh cases and after much wrangling and legal positioning, settlements are now coming in from the mesh manufacturers.
I’m reminded that Hulk Hogan recently won a privacy case for $140 million in his lawsuit against Gawker Media, bankrupting the company. You would have been better off having your privacy invaded rather than your pelvis.
The mesh settlements that are quietly underway are not designed to bankrupt any company, quite the contrary.
The Tier System
They are based on your degree or “Tier” of injury.
Women who did not have surgeries to remove a problematic mesh generally receive less. They may not have had insurance coverage or the cash on hand to afford a surgery. The fewer surgeries, the lower her Tier of Injury, generally speaking, further disadvantaging women who are not of means.
Doctor’s reports are important in determining a settlement amount. But what if the doctor writes a woman is a “hypochondriac?” What if that doctor is in deep denial that he may have caused her injury? Is that the report that goes to the Special Master to determine your settlement amount?
Some doctors at a recent urogynecologic society meeting, opined that women went out to submit their most private parts to additional surgeries, with anesthesia and a hospital stay, just to up their settlement dollars.
Federal Judge Pushes MDL Toward Settlement
With 96,000 cases filed in one federal court in Charleston, WV, (multidistrict litigation) would take decades to try all of these cases, so Judge Joseph Goodwin early on called for both sides to settle. That’s where we are now.
The following is from a mesh injured woman who we’ll call Anna.
“Anna” Sounds Off On Coward Attorneys
Anna says law firms claim they are out hundreds of thousands of dollars a case and really want to be paid now.
“REALLY?! So basically what you’re telling me is; “We milked it as long as we could and we racked up our $30 BILLION and now you victims need to accept the crumbs offered to you because time is running out (unless you want to wait many more years) OH and even if you do go to trial, know that “these conditions” that you women are blaming on mesh are also conditions that women without mesh deal with so hey, who’s to say……”
“How absolutely disrespectful and demeaning?!
“This is completely unacceptable behavior by both the Justice system and the Attorneys! Not only are we victims of our mesh implants, we are being victimized again by the Attorneys and the Justice System. And everyone else continues to profit from our tragedies. Something is truly wrong with our system.
“The Justice System is no longer about Justice, It’s about making money and making excuses.”
What You Can Do
So, if you have received a settlement offer, what can you do?
The following is not legal advice, which should come from a licensed legal professional, but opinion that is gathered by a journalist from more than five years of coverage of this issue including interviewing licensed professionals and mesh-injured women and their families.
Check out the terms of your agreement with your law firm. Do they have the right to settle on your behalf without your agreement? The terms of the agreement prevail.
- Does your law firm have all of your medical records? Is there disparaging language about you in any of them?
- Is your law firm taking 40% AND a 5% assessment fee? Lawyers must pay 5% into assessment which are common benefit hours set by the court in multidistrict litigation. (1% is the lawyer’s cost and 4% is his time) Will your law firm take 36% and contribute the 4% (to equal 40%) to the Common Benefit fund OR does the 4% also come out of your settlement? This could be called double dipping.
- Do you have a life care plan or know what your future medical costs will be? Have you lost your job, your home, your husband? What has that cost you?
- Might a plaintiff tally up these costs to come up with a more accurate compensation that comes more closely to Made Whole, which is a legal term related to insurance coverage. See the Doctrine here and here.
- Are legal fees reasonable? Can you get the actual out of pocket costs the law firm spent on your behalf? Did it include first class airfare and hotels and the cost of a jet, or were the fees “reasonable,” that is, what you would spend on such things.
Lawyers do work hard, however, and that should be taken into consideration. Traveling 8 hours to get to a deposition might warrant a stay in a nicer hotel.
The Contract Prevails
If you agreed to the terms of your settlement, it is the contract that prevails which includes a confidentiality clause as to the amount you received. Also, note* your manufacturer will admit no liability.
Just some random thoughts and internet gossip. Please seek reliable information from a licensed attorney before you consider agreeing to any settlement. ##
*Note to Readers * Please do not reveal any settlement amounts or your last name. But do share your experiences in bringing an end to this massive litigation. Thank you and I’m sorry!
J&J Offers Second Major Settlement To Pelvic Mesh Injured Women
Mesh Medical Device News Desk, September 9, 2016 ~ Healthcare giant offers second settlement to resolve pelvic mesh injury cases.
Motions have been flying this week in the Johnson & Johnson Pelvic Mesh litigation filed in federal court in West Virginia.
Undisclosed Settlement Approved By MDL Judge
Johnson & Johnson has agreed to its second settlement to resolve an undisclosed number of lawsuits filed by women injured by its vaginal mesh implants.
J&J and its Ethicon division has come to agreement with Athens, Georgia law firm Blasingame, Burch, Garrard & Ashley (BBGA).
Mesh News Desk has an inquiry into J&J for comment.
Settlement Amount Not Yet Finalized
While settlement amounts are confidential, last April a $5 million settlement was revealed in New Jersey court documents in a private agreement with one injured woman. In January of this year, J&J agreed to a $120 million settlement, to resolve 2,000 to 3,000 pelvic mesh cases, its first big mesh settlement announced. The latest settlement is reported by sources to be close to that amount to resolve fewer cases.
“The exact allocation among and distribution to covered claimants, or any other persons or entities asserting a claim of subrogation or reimbursement, has not been finalized at this time.”
J&J is the last of seven manufacturers to offer settlements to resolve claims of injury and infection. As of today, the healthcare giant faces 34,535 product liability cases filed in federal court in West Virginia, where pelvic mesh cases are consolidated in multidistrict litigation (94,265 total), as well as 8,931 cases filed in New Jersey, Internationally, cases have been filed by law firms representing injured women in Canada, Australia, Israel, among other countries.
Women who have filed lawsuits claim the mesh shrank, caused organ damage, constant pain and infection. In many women, the permanent implants cannot be removed.
How The New J&J Settlement Will Work
In Pretrial Order #237, filed September 7, Judge Joseph Goodwin, who is overseeing multidistrict litigation in WV, approved the Confidential Settlement Agreement with Ethicon. Judge Goodwin also appointed (PTO #236) Special Master Cathy Yanni to allocate and divide the settlement payouts. A woman’s medical condition, the number of surgeries she has had to endure as a result of her pelvic mesh implant will all be considered. Any outstanding liens, whether medical or to a lending company, will be negotiated as well.
The Special Master will receive $300 per claim plus $10,000 per calendar quarter and $2,000 per appeal.
Seasoned Mediator Appointed To Preside Over Settlement
Ms. Yanni has mediated over 10,000 matters over the past 17 years and has been appointed by Judge Joseph Goodwin to act as the Special Master for certain settlement agreements between Covidien, C.R. Bard, Boston Scientific and Coloplast and certain Plaintiffs’ counsel.
She has also mediated DePuy Orthopaedics Inc ASR Hip Implant Products Liability Litigation, another company owned by Johnson & Johnson, as well as Medtronic Infuse litigation and Gadolinium Contrast Dyes product liability litigation, Bextra and Zicam litigation.
In another filing, Ethicon, moves to have Dr. Anne Weber excluded as an expert in some upcoming pelvic mesh trials.
In PTO #235, Judge Goodwin announces a September 13 and 14, 2016 status hearing to access the progress made by both sides in settling this massive MDL, the largest ever filed in one court.
In February, 2015, Judge Goodwin predicted a “Rocky Path” if both sides did not meet some agreements. See MND story here. ##
Caldera Denied Settlement & Quick Exit To Pelvic Mesh Litigation
Mesh Medical Device News Desk, July 26, 2016 ~ Late Tuesday morning, the Judge overseeing a proposed settlement involving Caldera Medical denied the company claim it is insolvent and only has pennies to settle with women injured by its pelvic mesh.
That means Caldera Medical must face hundreds of defective product pelvic mesh cases filed in a Los Angeles court or declare bankruptcy.
“The decision prevents a company still selling defective mesh from doing so and to get out of litigation for peanuts,” said attorney Lee Balefsky of Kline & Specter to MND. The law firm is one that had argued against the settlement before Judge Wilson.
Caldera Says It’s Insolvent
California based- Caldera Medical announced it was insolvent last February and had about $25 million in insurance coverage (Federal Insurance, a subsidiary of Chubb) remaining to settle defective mesh claims by 2,100 women. There would be no opt out, according to the company.
Caldera claimed the ongoing litigation had exhausted half of the $25 million and to continue would mean the claimants would receive nothing, according to the May 16th Joint Motion for Final Settlement and Approval of Class Certification.
Last June, the company sought final approval of its proposed settlement before Judge Stephen v. Wilson U.S. District Judge for the Central District of California. Here is a background story. An estimated 46 women filed objections to the settlement including “Samantha” who filed a story with MND here.
Kline & Specter represented 36 of those women.
Federal Judge Questions Caldera’s Insolvency
In today’s decision in Federal Insurance Co V. Caldera Medical, Judge Wilson denied the motion for final settlement approval and class certification and denied a motion for attorneys’ fees as moot. There is no “definitely ascertained” limited fund he writes that has been placed into the settlement sum.
Additionally, “Given that Caldera remains a solvent, operational business, without evidence regarding Caldera’s potential liquidated value, it is not clear that the Policies are the only available funds to contribute to the settlement. “
At the time it announced its insolvency, Caldera Medical said it had signed an agreement with IVUmed
to have its pelvic mesh implanted in women in third world countries and had committed $1 million to that effort. See the background story here.
In June of last year, Caldera Medical Introduced the Vertessa Lite, a pelvic mesh abdominally placed and introduced through the Food and Drug Administration’s 510(k) approval process. See the MND story here.
Caldera makes the T-Sling®, Desara®, Ascend®, Hydrix®, and POPmesh®.
Judge William F. Highberger is overseeing a state multidistrict litigation in the Superior Court of the State of California (JCCP No. 4733), where hundreds of product liability cases are filed against the major mesh manufacturers. ##
90,000 Pelvic Mesh Lawsuits Burden Court, Judge Dismisses 140+ Bard Cases
Mesh Medical Device News Desk, April 27, 2016 ~ Judge Joseph Goodwin Monday dismissed 149 product liability lawsuits naming mesh maker C.R. Bard, ending the plaintiffs’ ability to file another pelvic mesh product liability lawsuit against the manufacturer ever again.
He wrote, “all claims have been compromised and settled.”
Medtronic and Covidien supplied the mesh to Bard and they were also named in the dismissal, which presumably followed an undisclosed settlement amount.
Judge Goodwin dismissed them with prejudice meaning they cannot be filed again.
TVM MDL Is Largest Ever
The multidistrict litigation involving pelvic mesh made by seven manufacturers before Judge Goodwin is the largest ever amassed in one court which, as of today, numbers 90,131 cases.
To lighten the untenable load, numerous cases have been remanded back to state courts across the country or settled and removed from the list.
Settlements & Trials
Last year, C.R. Bard said it would offer more than $200 million to settle 3,000 cases filed by pelvic mesh injured women. Still ahead and filed in Judge Goodwin’s court are 13,429 cases naming mesh maker Bard and claiming injury from its defective product.
The only other major manufacturer which has promised to settle cases is AMS, (American Medical Systems) owned by Endo International. Ethicon/Johnson & Johnson still plans to resolve the remainder of its 40,000 cases through litigation.
There are also cases naming C.R. Bard filed in numerous states and there are 1,541 cases naming CR Bard consolidated in New Jersey. See that here.
Bard Loses Two Major Court Cases
The first two product liability trials naming Bard were lost by the company.
In 2012, Christine Scott was awarded $3.6 million against the company by a Bakersfield, California jury. Donna Cisson was awarded $2 million by a Charleston, WV jury in 2013.
Bard filed an appeal on the amount which included $1.75 million in punitive damages but in January, an appeals court upheld the jury’s award.
The appeals court denied Cisson’s challenge to Georgia’s split-recovery statute. It requires the state to retain 75 percent of punitive damages with the remainder going to Cisson. The Scott case has been paid.
The appeals court also agreed with Judge Goodwin’s decision at trial, specifically that he was right not to allow evidence of the Food and Drug Administration’s 510(k) approval process that allowed mesh to be sold without assurances for safety and efficacy.
Judge Goodwin Strikes Out At Bard’s “Reprehensible Conduct”
During the Cisson trial, Judge Goodwin described Bard’s attempt to hide its identity in purchasing raw polypropylene resin:
“This secretive conduct in an effort to sidestep the MSDS warnings suggests reprehensible conduct, weighting against remittitur.”
The MSDS is the Material Safety Data Sheet accompanying the raw resin and clearly says:
“Do not use this Phillips Sumika Polypropylene Company material in medical applications involving brief or temporary implantation in the human body or contact with internal body fluids or tissues unless the material has been provided directly from Phillips Sumika polypropylene Company under an agreement which expressly acknowledges the contemplated use.”
See story here.
Cisson and Scott had both been implanted with a Bard Avaulta pelvic mesh, made with polypropylene provided by Phillips Sumika.
Bard is expected to report first quarter earnings Wednesday at 5 pm when it hosts a conference call. Based in Murray Hill, New Jersey, C.R. Bard (BCR) designs, manufactures and distributes medical, surgical, and patient care devices worldwide.
Join in the conference call here.
In February, Bard enjoyed one of the few trial victories in the case of Eve Sherrer in Kansas City, Missouri. Voting 10-2, jurors rejected the contention that the Bard Align and the Boston Scientific Solyx were defective. Sherrer had sought $28 million. This was the longest pelvic mesh product liability trial to be conducted stretching one month over the holiday season.
In February 2015, Bard settled with Debra Wise on the eve of trial. See story here.
Bard is facing in excess of $7 million in jury awards to six plaintiffs. In October 2014, the company offered to settle 500 cases for $21 million.
February 2015 – Wise v CR Bard, Settlement offered to Wise, terms not disclosed, Implanted with Avaulta Plus Anterior and Posterior BioSynthetic Support System, Charleston WV
October 2014 – Bard offers to settle 500 cases for $21 million
October 2013- Rizzo v Bard, Case is dropped by the plaintiff and Bard wants $14,000 in court costs from her. Charleston WV
September 2013 – Vigil v CR Bard, case settled by Bard for undisclosed amount. Vigil had Avaulta Suburethral Plus. Atlantic City, NJ
August 2013 – Queen v CR Bard, case settled by Bard. She received the Avaulta Solo. Charleston, WV
July 2013 – Cisson v. CR Bard, $ 2 million for Cisson. Implanted with Avaulta Plus. Includes $175,000 in punitive damages. Charleston WV bellwether
July 2012- Scott v. CR Bard, $5.5 million for Scott,($3.6 million against company, remainder her physician), Implanted with Bard Avaulta Plus, Bakersfield California
Endo Offers $830 Million To Settle 20K AMS Pelvic Mesh Lawsuits
Mesh Medical Device News Desk, April 30, 2014 ~ Late this afternoon, Endo Health Solutions announced it had reached an agreement with several law firms to settle in principle about 20,000 defective pelvic mesh lawsuits sold by its subsidiary American Medical Systems.
Here is Endo’s news release.
Here is Exhibit A: Resolution Framework:
MR press release about the settlement here:
That would amount to an average of $40,000 per case before legal fees are subtracted. Settlements of a mass tort are usually organized in “Tiers” of injury resulting in a range of compensation. In this case, women will be required to provide their medical records and a majority of women, or their estate, must agree to the settlement.
Endo Settlement Offer Is Insufficient
For women hoping to get back on their feet after the physical and financial losses associated with the injuries from pelvic mesh, or for those seeking removal or reconstruction surgeries, that amount of money is too little too late.
“I think this is Pure BS” says one Mesh News Desk reader.
Women have been encouraged not to speak to the media if they are involved in litigation. They spoke to MND on the condition of anonymity.
Joanna C. told MND “I’m disgusted, I’m angry. I will not accept this small amount of money absolutely not! I will fight this until the end. I’m sick.”
Rene B. said “Women have been injured. There is no way they’d accept that if it’s in their mother or sister. Do they think women are stupid?”
The settlement, if approved, would resolve the majority of the lawsuits. There are still about 5,000 cases facing Endo/AMS, some of which are consolidated in federal court in West Virginia.
The four law firms behind the agreement are Motley Rice LLC, Blasingame, Burch Garrard & Ashley, PC, Levin Simes LLP and Clark, Love & Hutson, G.P
Soaring Attorneys’ Fees
With legal fees beginning at 40%, the settlement would result in approximately $332 million for the law firms involved.
There will be no admission of liability by the company and women who sign are typically expected to sign a confidentiality agreement. In the past, there must be a majority of the plaintiffs willing to agree to any settlement numbers.
Last June, Endo Health Solutions Inc. agreed to pay $54.5 million to settle some outstanding lawsuits that have been filed by women who were implanted with the Perigee, Apogee and Elevate transvaginal mesh implants. See the Master Settlement here.
Last month, the company announced it had put aside $520 million to cover the cost of litigation or settlement. Endo also recorded a pretax charge of about $316 million at the end of 2013 which brought its product liability fund to about $520 million.
In its SEC filing, Endo Health Solutions Inc. said that an estimated 500 million women worldwide may suffer from urinary or fecal incontinence and around 400,000 surgeries are performed around the world annually to correct some form of pelvic organ floor prolapse.
Endo Under Investigation by AG Office
Then last month in its annual report released by the Securities and Exchange Commission, Endo admitted it had received subpoenas from several states investigating overpayments for its pelvic mesh products. The California Attorney General’s office is one of those states which issued a subpoena last November.
Legal Case Load
As of April 30, 2014, Endo/AMS is facing 17,369 lawsuits consolidated in federal court in West Virginia, just behind Ethicon at 17,790 cases. This does not include product liability cases filed in state courts around the country.
The company is still required by the FDA to conduct post-approval monitoring on the rates of organ damage and complications among the women implanted with its pelvic and transvaginal meshes. See background story here.
AMS originally received received 19 orders in January 2012 but, according to the SEC filing, that has been reduced to 16 orders “for various commercial reasons” says its filing.
When AMS took its Apogee and Perigee pelvic organ transvaginal mesh (TVM) off the market, it was relieved of complying with the studies.
“AMS is continuing to work with the FDA to comply with these outstanding orders,”says the filing. #
Bloomberg News, Endo Pay $830 Million to Resolve Vaginal Mesh Suits, April 30, 2014 here
Reuters, Endo Agrees to $830 million to Settle Vaginal Mesh Cases, April 30, 2014 here
Mesh News Desk– Endo/ AMS set aside $520 Million to Settle, February 2014 here
Master Settlement, SEC filing, $54.5 Million, Freese & Goss, Matthews & Associates and AMS here
Mesh News Desk, June 21, 2013, Endo Agrees to Settle Some AMS Vaginal Mesh cases for $55 Million here