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)
- Judge Settles Hundreds Of Transvaginal Mesh Suits Naming C.R. Bard (June 21, 2017)
- Has AMS Paid All Transvaginal Mesh Claims? (May 27, 2017)
- Boston Scientific Plans Mass Pelvic Mesh Settlements (May 9, 2017)
- Mesh Trials Ahead With No Prospect Of Settling (April 18, 2017)
- J&J Settles Third Round Of Pelvic Mesh Cases (March 28, 2017)
- Judge Approves $12 Million Settlement In Caldera Transvaginal Mesh Claims (January 31, 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)
- Caldera Medical – Take $11.7 Mill Mesh Settlement or Nothing! (February 22, 2016)
- Johnson & Johnson Offers First Transvaginal Mesh Settlement $120 Million (January 27, 2016)
- Will Caldera Medical Ever Settle Its Mesh Claims? (January 3, 2016)
- Settlement Dollars Are Slow In Coming In Transvaginal Mesh Claims (November 5, 2015)
- Mesh Maker Covidien Agrees To Settle 11,000 Claims (June 30, 2015)
- Boston Scientific Offers First Settlement To 3,000 Pelvic Mesh-Injured Women (April 28, 2015)
- Anatomy of an AMS Settlement – 692 Pelvic Mesh Injury Claims to be Resolved? (April 20, 2015)
- $1.6 Billion Master Settlement Reached To Resolve AMS Pelvic Mesh Claims (September 30, 2014)
- 100-Thousand Mesh Defective Product Cases Now Filed As Mesh Makers Assure Shareholders (September 28, 2014)
- Legal Thoughts On The AMS Transvaginal Mesh (TVM) Settlement (May 22, 2014)
- Endo Offers $850 Million To Settle 20K AMS Pelvic Mesh Lawsuits (April 30, 2014)
- Coloplast Reported To Offer $16 Million To Settle Transvaginal Mesh Lawsuits (March 4, 2014)
- Attorney Harry Bell On Mesh Lawsuit Settlements (July 4, 2013)
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. ###
Judge Settles Hundreds Of Transvaginal Mesh Suits Naming C.R. Bard
Mesh Medical Device News Desk, June 21, 2017 ~ Judge Joseph Goodwin is overseeing more than 103,659 (as of today) product liability cases involving transvaginal mesh.
Three hundred product liability cases naming C.R. Bard have been dismissed just since Monday.
Earlier this year Judge Goodwin told lawyers he would like to have the cases filed against seven mesh manufacturer resolved this year.
Just since Monday, Judge Goodwin made good on that promise, at least as far as Murray Hill, New Jersey mesh maker, C.R. Bard is concerned.
The judge has issued 20 orders moving nearly 300 pending cases against C.R. Bard toward resolution.
These appear to be cases represented by law firms that are not on the steering committees and may have a limited number of product liability cases naming Bard over its transvaginal mesh.
Once resolved, they are then taken off the trial docket, where as of today, there are 15,459 product liability cases filed against Bard (with 9,660 closed).
Bard has the fourth highest number of cases behind Ethicon, Boston Scientific, and AMS (American Medical Systems).
Look up cases using PACER in Bard 2:10-md-2187.
Judge Dismisses Hundreds Of Settled Cases
Filed since Monday, June 19 are:
- Document #4001 is an order which grants the motion to dismiss all claims, cross claims, counter claims and third party claims for 75 plaintiffs. These cases are now dismissed with prejudice, meaning they cannot ever be filed again.
The orders name as defendants both Bard and Tissue Science Laboratories Limited, Sofradim Production and Covidien LP, who have reportedly all agreed to a settlement model.
Sofradim Production SAS is the French biotechnology company affiliated with Covidien medical device maker headquartered in Dublin, Ireland. Sofradim manufactures implants used for hernias and weaves polymers to create mesh.
Tissue Science Laboratories is a privately held British medical device company, which is a division of Medtronic.
- Another order on the same date, #Bard 3996 , dismisses three cases with prejudice against Bard, filed by three law firms with one case each.
- In Document #Bard 4002, 133 plaintiffs agreed to settlement with Sofradim Production SAS, Tissue Science Laboratories, Covidien and C.R. Bard.
- Another Motion to Dismiss, Doc #4003, says defendants, including Sofradim Production SAS, Tissue Science Laboratories Limited, Covidien and CR Bard, have agreed to settle three claims, however, the claims which include Cook Medical will be transferred to that court.
- In Doc #4005, (see it #Bard 4005), Sofradim, Covidien, Tissue Science Labs and Bard, agreed to a settlement model for two plaintiffs. The court will not conduct further proceedings on these two cases.
- Document #4004 dismisses one Bard case with prejudice provided she accepts the settlement by October 31, 20017. After that time if a settlement is not finalized the Court will have a hearing to determine the case’s future. See it here. #Bard 4004.In the meantime, it’s on the inactive docket.
- Document #4000, lists 33 plaintiffs, who along with defendants – Bard, Covidien, Tissue Science and Sofradim, have settled all claims and jointly move the court to dismiss Bard and Covidien as defendants.Other defendants, including Ethicon, will remain in these actions and plaintiffs will continue to prosecute these actions. Within 14 days of the motion, they are required to file an amended short form complaint against the remaining defendant, Ethicon and they will be transferred to the Ethicon MDL 2327.
- Document #Bard 3997 also dismisses the usual suspects but nine plaintiffs have an additional action against AMS and will continue with those claims and are required within fourteen days to file an amended short form complaint in the AMS (American Medical Systems) MDL 2325.
- Docket #3998, filed June 19, has the 21 plaintiffs dismissed with prejudice Sofradim, Tissue Science and Covidien, presumably because they have reached a settlement.
Often a law firm will represent to the court it has reached a settlement before the final resolution with its client. Clients still have the option to decline a settlement if they have not committed in writing to accept it.
- Doc #3999 is a joint motion filed June 19, 2017, to dismiss defendants with prejudice including Sofradim Production, Tissue Science Laboratories and Covidien as settlement has been reached. The parties move to dismiss with prejudice and terminate the cases from the docket of this MDL. Three plaintiffs are named.
- Doc #3995 joint motion to dismiss certain defendants with prejudice and plaintiffs’ motion to transfer MDLs, in this case Boston Scientific Corp, which remain in the action. After 14 days they must file a short form complaint in the BSC MDL 2187 that no longer include Bard and Covidien entities. Seven cases are included here.
Including June 19 are six proposed orders by Judge Goodwin.
- Docket #3994 involves one plaintiff represented by a smaller law firm saying Bard has agreed to a settlement with the plaintiff therefore it is unnecessary to conduct further proceedings or to keep the case on the active docket. Both parties have until September 30, 2017 to finalize a settlement and submit a dismissal order.
- Docket # 3993, gives both sides until December 31, 2017 to submit a settlement and dismissal order concerning one case. Again, it says both sides have agreed to a settlement model with regard to Bard.
- Doc #3992 is the same giving a deadline of on or before December 31, 2017 to finalize the settlement and submit a dismissal order for one case.
- Docket #3991 also gives until the end of the year for a settlement to be finalized for one case.
- Docket #3990, again until December 31, one case to settle.
- Docket #3989 is given until the end of the year to finalize a settlement and submit dismissal orders for one case.
The Friday before, June 16, there is a rash of orders dismissing cases from the C.R. Bard docket as well.
Bard’s Settlement History So Far
So far, Bard has settled 149 cases which were dismissed in April, while 3,000 lawsuits were part of a 2015 settlement of $200 million.
Earlier this year, C.R. Bard removed its pelvic meshes from the market as it is in the process of being sold to Becton Dickinson for $24 billion.
Last November, Judge Goodwin asked both plaintiff and defendant sides to come up with 50 cases each to prepare for trial.
$2 Million Verdict Upheld
Donna Cisson’s $2 million verdict against Bard in 2013 was upheld by an appellate court a year ago.
During that trial, in an unusual move, Judge Goodwin noted that Bard attempted to hide its identity in purchasing raw polypropylene resin from the supplier.
“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 which 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 the Mesh News Desk story here.
Christine Scott’s Bard pelvic mesh case also survived appeal and the company was on the hook for $3.6 million to the plaintiff resulting from her July 2012 trial in Bakersfield, California. ###
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
Mesh Trials Ahead With No Prospect Of Settling
Mesh Medical Device News Desk (MND), April 18, 2017~Protracted transvaginal mesh (TVM) litigation has many law firms moving onto the next attractive Mass Tort and clearing out their inventory.
What remains when the dust settles?
The online ad for the publisher Harris Martin promises an upcoming legal education conference on hernia mesh, Benicar, Xarelto, testosterone drugs, and Bair Hugger – all the latest, shiniest Mass Torts that promise to deliver litigation lightning while reducing risk to the bottom line of plaintiffs’ law firm. Plaintiffs should make something too.
Meanwhile transvaginal mesh litigation, with about 150,000 U.S. plaintiffs, and thousands others overseas, lingers with the largest mesh makers the longest holdouts to the settlement table.
That was supposed to be the aim of the multidistrict litigation (MDL) where the bulk of transvaginal mesh cases, filed against seven manufacturers, are consolidated.
Try a few cases, see which way juries will decide and have that serve as a basis to approach some reasonable settlements in these defective product cases. But that hasn’t happened.
“The primary strategy by Ethicon and by C.R. Bard is to basically say you need money more than we do, you have no prospect unless you take what we offer now, and that’s offensive to me,” says New Jersey attorney Adam Slater.
He is based near the Bergen County court where transvaginal mesh cases will be heard in succession beginning at the end of this year and into next.
Slater says he is insulted by the offers.
“I won’t sit at a table with anyone who says that to me. They have to be reasonable, and what they’ve done is very serious, or else I will continue to prepare to ultimately get reasonable offers for my clients.”
Mazie Slater is one of the law firms still taking transvaginal mesh cases filed by women who claim a lifetime of injuries from the polypropylene implants used to treat incontinence and pelvic organ prolapse.
Slater says he doesn’t see an end to the litigation and adds, “I’m not going to stop.”
Here is a MND story on law firms that remain in TVM litigation.
For the remaining trial lawyers, litigating pelvic mesh cases will continue for years.
The next trial for C.R. Bard is in Bergen County, New Jersey by October 30th, and possibly sooner.
Slater says he is in full scale litigation against Bard with no prospects for settlement.
“Bard said you will never get to trial. I said “Watch me.””
Philadelphia’s Court of Common Pleas has 190 transvaginal mesh cases in line to be tried against defendants Boston Scientific and Ethicon/ Johnson & Johnson. Currently the Engleman v. Ethicon trial is underway.
April 18th, a Pelvic Mesh Meeting was scheduled.
**Update 11 new cases were set for trial as a result of yesterday’s meeting. All but two name Ethicon/ J&J, the other two name Boston Scientific as a defendant. See the schedule here.
In Philadelphia, six cases against Ethicon have a trial date certain. One naming Defendant Boston Scientific is set for March 2018. See the Pelvic Mesh Case list here.
Ethicon/ Johnson & Johnson, has proven to be a holdout, offering a smattering of settlements, particularly on individual cases just before trial. Instead, it quietly took its most troubling meshes off the market.
Boston Scientific too has proven to be tough defendant to bring to the negotiating table.
Mostyn Law is planning a trial against Boston Scientific to be heard in Los Angeles Superior Court, July 31, 2017. Six plaintiffs’s cases may be heard among the possible 247 filed. See JCCP 4733 here.
Another Ethicon/ Johnson & Johnson case is set for trial in Bergen Co. November 27, 2017 with a November 13th date set for jury selection.
Slater says his position with Ethicon is the same – No Prospect of Settling!
“I’m aware of the numbers offered. No way would I ever offer that to my clients,” he tells MND.
With 102,000 product liability cases naming seven mesh makers filed in Charleston, WV, consolidated in multidistrict litigation, there are an additional 1,000 cases naming C.R. Bard filed in New Jersey and another 9,000 naming Ethicon/ Johnson & Johnson in the same court. Some of those have settled.
AMS (American Medical Systems), sold to Endo International in 2011 and stopped making pelvic mesh one year ago. AMS/Endo agreed to a mass settlement of its transvaginal mesh cases. Because of that move, there was no discovery required to prepare for trial, therefore little evidence on which to base litigation.
Caldera Medical has offered about 2,700 women a dwindling amount of insurance money, about $11.75 million, the amount that remained after legal wrangling with its insurance carrier.
Those settlement packets of approximately $4,000 per plaintiff are currently being sent out. It does not include legal fees and expenses, which will cut the settlement dollars roughly in half.
When Settling Makes Sense
The harsh truth is that most of the 102,000 cases filed in multidistrict litigation will never pass the threshold of the courtroom.
Many plaintiffs refuse to accept the amount of dollars offered in a settlement. When they retained a law firm it was often with the promise of a “million dollar case.”
That is a red flag as no one can promise you the outcome of your case. There are far too many variables, such as a jury, for example. But still, emotions run high when a promise made isn’t kept.
Of the cases tried, most have resulted in jury awards compensating them for pain and suffering, for past and future medical care, and punitive damages.
Then the appeals process begins, which can take years. About four cases that won at the trial level, have exhausted the appeals process and been paid to the plaintiff. Gross v. Ethicon, the first New Jersey case against Johnson & Johnson, is on the eve of paying its $11.1 million jury award after nearly four years of appeals by J&J.
So when do you accept a settlement? For many women settlements make a lot of sense.
If you have a mesh in place and for the present time, are still able to function, a settlement might make sense. A lawyer can structure an annuity so the money is doled out for a longer time and it’s tax free.
There is no waiting years for the appeals process to wind through the court.
There is an immense downside in going to trial that many plaintiffs do not consider. A woman’s life is on display including her most intimate pelvic problems, she lives away from home, maybe for months, must be deposed by lawyers for the mesh makers and probed in a pelvic exam done by doctors for defense. There is always some degree of public humiliation about her weight, or preexisting conditions or her sex life. And there is no telling what a jury will do.
But if you think you have no options but stay with your current law firm, think again.
“I’m hearing stories of women being threatened by their attorney that they will face a penalty if they talk to another law firm. It is unethical to make that threat under New Jersey law. The client owns the case, not the lawyer,” he tells Mesh News Desk. ###
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 Medical Device News Desk, January 31, 2017 ~ On Monday, Caldera Medical received final approval of its proposed settlement to end all of its pelvic mesh litigation.
Those women who claim permanent injuries from Caldera transvaginal mesh, will receive the smallest settlement dollars among all seven manufacturers, under $5,000.
At a hearing Monday in a Los Angeles courtroom, California-based Caldera Medical faced bankruptcy as one option to finally resolve its 3,800 pending claims.
After once denying the proposed Caldera Medical settlement of $11.75 million, Judge Stephen V. Wilson of U.S. District Court for the Central District of California, on Monday agreed to the proposed settlement, ending Caldera Medical’s transvaginal mesh litigation. The monies will be distributed to women who were implanted with one of Caldera Medicals transvaginal mesh products – the T-Sling, the Desara, Ascend, Hydrix, and the pelvic organ prolapse mesh, Vertessa.
Depending on her degree of injury, each woman will receive somewhere under $5,000 after legal fees and expenses are paid, making it among the smallest compensation settlement for the 100,000 women who claim injuries by transvaginal mesh made by seven manufacturers.
Bankruptcy was one option for California-based Caldera Medical, which has been in protracted litigation over its insurance coverage, the cost of which reduced the settlement dollars from $35 million to $11.75 million.
The afternoon hearing before Judge Wilson was a renewed motion for attorney’s fees and the renewed motion for settlement approval of the Caldera class of injured women.
Dozens of women had objected to the initial offer made by Caldera Medical.
**Late Add** One women, who has pursued Caldera Medical pro se, that is without representation, Samantha, is barred from filing any future claims within the federal judiciary, per an email she received by RR Johnson, Senior Counsel Locke Lord LLP, an attorney for Federal Insurance Company.
He sent an email to Samantha, (not her real name) saying her objections were specifically mentioned to the Judge before he granted final settlement approval. “Any and all claims that you may have had against any of the released parties, including Caldera, are now barred any released.”
No reason was given.
“Overwhelming,” was all she had to say to Mesh News Desk.
Attorney Lee Balefsky (Kline Specter) who appeared before Judge Wilson, on behalf of 36 claimants, said Judge Wilson did not offer an opinion but it should be published shortly.
“In our view it’s a sad day for women who have been injured by this company’s products,” ~ Lee Balefsky.
You may recall that last year Caldera Medical said it was insolvent after the litigation between Caldera and Federal Insurance (Chubb). The $11.75 million would be a final offer, there were no opt-outs, no chance to go to trial for women seeking compensation due to their transvaginal mesh injuries. Take it or leave it.
Some attorneys for the women agreed to the proposal while Balefsky and others asked Caldera to be dissolved to determine its true value.
Last February, while insisting on the limited settlement, Caldera announced it was partnering with IVUMed to “eradicate the incapacitation and suffering of women with stress urinary incontinence and prolapse organ prolapse.”
The one million women who would allegedly have their suffering eradicated were from Third World countries.
Then in October 2016, Caldera Medical spent thousands as one sponsor of the 2016 American Urogynecologic Association (AUGS) annual meeting. One of the company directors told me there that they were fully solvent.
Where did you hear they were insolvent? she asked, “From a trial attorney,” she glared at me.
Caldera Medical says it is dedicated to “improving the quality of life for women.”
Samantha, a Caldera mesh “victim” as she calls herself, said a bankruptcy would have been a good option for the company to determine its true value.
“The federal trustee could then determine the level of federal fraud between Caldera Medical and Chubb Insurance Company and American Medical System (AMS) and determine if the stockholder and the patent holders and the board of directors will also have to contribute to the damages for victims,” she said before the agreement was announced.
Samantha, like others damaged by the Caldera pelvic mesh believe that AMS should also be tapped for its insurance coverage since it provided the surgical tools used in the mesh kits that Caldera sold.
She believes all of the mass tort attorneys wanted out of this litigation so they agreed to a settlement that was not in their client’s best interest.
“If you are hit by a drunk driver, that’s what this is like. There was no informed consent. I find out who the parties are who have damaged me. I called them and was given a claim number with no investigation at all. You wouldn’t allow this in a hit-and-run. They know there are multiple policies and they know I’m outside their policies.”
She was implanted with a Caldera mesh in 2004, outside of the Caldera Medical insurance coverage period of 2008-2012. In 2004, the FDA had not cleared Caldera Medical pelvic meshes for use, in fact, the FDA had no notice Caldera pelvic mesh was being used by select doctors, according to Samantha, who was the first patient to receive a T-Sling. She says she did not sign an agreement to be part of a clinical trial.
Caldera Medical, while technically not insured at that time, claims that “tail insurance” will cover Samantha and others outside of the coverage period. Samantha calls that insurance fraud.
“They said that’s all the money for the Caldera women and that’s not true,” she says.
Did Caldera operate for a decade without any life science or general liability insurance?
That question also has never been litigated. ###
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
Caldera Medical – Take $11.7 Mill Mesh Settlement Or Nothing!
Women implanted with a Caldera Medical pelvic mesh product have until May 2, 2016 to submit a claim to a limited settlement that is being offered by the company. A cash settlement fund of $11.75 million is intended to settle thousands of defective product claims over the Caldera pelvic mesh products.
The settlement was just announced by The Settlement Alliance of Southlake, Texas which is the claims administrator. It was reached by the Federal Insurance (a subsidiary of Chubb Insurance Group here) interpleader and the Levin Simes law firm.
See it here.
Why the settlement for the Agoura Hills, California company?
Basically, Caldera Medical claims it is insolvent. At the same time, it admits it did nothing wrong in launching its brand of pelvic mesh.
“The claimants assert that Caldera manufactured, marketed, sold, and distributed TVM devices that it knew or should have known were hazardous and dangerous to patients who were implanted with them. Caldera denied and continues to deny that it did anything wrong. The principle reasons for the Class Settlement are to maximize the share of Caldera’s limited resources that are paid to claimants, and to eliminate the expense, uncertainty and risk of further litigation.”
“Attorneys for claimants have investigated the facts and applicable law regarding the Transvaginal Mesh Medical Product Claims against Caldera and Caldera’s defenses. The attorneys also have pursued extensive litigation, including litigation relating to the actions entitled In Re Transvaginal Mesh Litigation, Los Angeles Superior Court Case No.: JCCP 4733 (the “JCCP Action”) and Federal Insurance Company v. Caldera Medical, Inc., U.S.D.C., Central District of California Case No. 2:15-cv-00393 (the “Interpleader Action”). In connection with the Interpleader Action, representatives for the Settlement Class, Caldera, and Caldera’s insurance company, Federal Insurance Company, engaged in lengthy negotiations and mediation.”
Caldera says the $11.75 million fund represents “virtually all of Caldera’s funds.” That comes to about $5,000 per claimant if there are an estimated 2,200 women implanted who have filed claims.
If you choose not to participate in the settlement you are forbidden from receiving any dollars or from even be a party to any lawsuit against Caldera in this case.
This is a Non-Opt Out settlement class, says the notice.
“You can tell the Court that you don’t agree with the Settlement or some part of it.”
The Court will hold a hearing, called the “Final Approval Hearing,” to decide whether to approve the Settlement and Class Counsel’s requests for fees and expenses. You may attend, but do not have to do so. You may be able to speak if you do not have an attorney. But you must request permission to speak at the Final Approval Hearing.
Signing the agreement releases Caldera from any future claims by the plaintiff or her estate. There is no admission of liability.
Caldera develops and markets surgical implants to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) including the T-Sling®, Desara®, Ascend®, Hydrix®, POPmesh®, and Vertessa®.
Caldera Medical Insolvent?
Caldera is a manufacturer often linked as a co-defendant with American Medical Systems litigation over pelvic mesh. See case here.
Earlier this month, Caldera Medical announced it was partnering with IVUmed to:
“eradicate the incapacitation and suffering of women with Stress Urinary Incontinence (SUI) and pelvic organ prolapse (POP). The two companies will go into third would countries and make quality urological care available to people worldwide.”
In other words, it is exporting its mesh products to Vietnam, Rwanda, Senegal among other countries and train local doctors on the use of its mesh products.
IVUmed will coordinate the “humanitarian “ trips and train local surgeons in workshops using American doctors as preceptors/trainers. See the news release here.
Caldera Medical launched the Desara SL, Mini and Blue at the American Urogynecologic Society meeting in October 2013. See press release here.
Caldera Medical says it is dedicated to “improving the quality of life for women.”
The Desara products can be placed with multiple approaches including transvaginally, suprapubic and transobturator. #
Caldera – Launch of the Desara, August 2013
Mesh News Desk, Caldera Medical among 33 mesh manufacturers to follow-up on complications. See story here:
Mesh News Desk, January 27, 2016 ~ Bloomberg News (here) reports Johnson & Johnson has agreed to pay $120 million to settle thousands of injury lawsuits filed by women implanted with the company’s transvaginal mesh.
The offer resolves anywhere from 2,000 to 3,000 lawsuits. The number represents $40,000 to $60,000 per case before legal fees and outstanding debt is settled.
This is the first time J&J has offered to resolve its product liability cases regarding mesh.
J&J and its Ethicon division is currently facing more product liability lawsuits than any other mesh maker, in excess of 40,000 actions. According to its fourth quarter SEC filing the company does not consider the financial risk from pelvic mesh to be material.
“From time to time we have appropriately agreed to resolve some cases,” Ernie Knewitz, a J&J spokesman, said in an e-mailed statement. “We will not discuss the terms, nor discuss our ongoing litigation strategy.”
J&J says it has spent $141 million in costs in total litigation expenses during 2015. That’s down from $1.2 billion in 2014, says J&J Investor News.
The J&J Fourth Quarter report says, “The number of pending product liability lawsuits continues to increase, and the Company continues to receive information with respect to potential costs and the anticipated number of cases.”
Besides 30,665 cases filed in multidistrict litigation in Charleston, WV (here), a number of personal injury cases have been filed in Australia, Belgium, Canada, England, Israel, Italy, the Netherlands, Scotland and Venezuela seeking damages.
While other mesh manufacturers such as American Medical Systems and C.R. Bard have agreed to settle their outstanding product liability actions regarding pelvic mesh, J&J has not done so to date until the eve of a jury trial or, in one case, just as the case was about to go to the jury.
Any settlement requires at least 90 percent of qualified recipients agree to the terms of settlement.
J&J recently announced it was restructuring its medical device division and dismissing 3,000 employees after disappointing sales figures. #
Mesh Medical Device News Desk, January 3, 2016 ~ Caldera Medical’s pelvic mesh cases are apparently nowhere near being settled, despite multiple tries. Is the company insolvent or not? Meanwhile, the approximately 3,800 women, allegedly injured by the Caldera Medical pelvic mesh products, remain in limbo.
Caldera Medical of Agoura Hills, California announced last February that it was insolvent and because it was broke, would offer a limited settlement to women who alleged its gynecological mesh products injured them. The amount came to about $3,000 per mesh-injured woman, more or less depending on the degree of injury.
By March 2016, Caldera proposed a $11.75 million settlement for then 2,000 women. Seethe published settlement notice here.
The final approval hearing was set in June of last year in Los Angeles before U.S. District Judge Stephen V. Wilson.
Caldera claimed it did not have enough medical insurance to cover injuries. The initial insurance pool of $25 million was whittled down by legal fees to pay lawyers representing Federal Insurance Company and Caldera. The issue was whether or not Caldera had insurance coverage between 2008 and 2011 and how much coverage there was.
(See 2:15-cv-00393-SVP-PWJ Federal Insurance Company v. Caldera Medical, Inc. et al United States District Court Central District of California.)
So with a pool of $11.75 million remaining, for the 2,000 to 4,000 women involved, there would be no opting out. It would be a “take it or leave it” settlement. (This was always a separate matter from multidistrict litigation centered in West Virginia with nearly 100,000 cases amassed in one federal court.)
But here we are, one year later, and the Caldera Medical settlement has not happened.
Women wanted evidence of the actual value of the company if it were liquidated.
Attorney Lee Balefsky (Kline Specter) said last June an independent audit was the only way to determine the actual value of Caldera Medical. Balefsky and Kline Specter represented 36 women implanted with Caldera medical mesh at the time. Caldera argued it had already produced financial records.
Kline Specter objected to the final settlement approval again this last November citing that the liquidated value expert designated by Caldera was not an expert and had worked with company employees to issue his report. See Nov 7 2016 Kline Specter Objection to Settlement.
Judge Wilson asked why was Caldera still in business if they were cash poor and only had a small amount of insurance to settle claims.
CALDERA CASH POOR?
When Caldera announced it was insolvent and had only half of the original $25 million remaining to settle defective product claims, Caldera announced it was partnering with IVUMed to “eradicate the incapacitation and suffering of women with stress urinary incontinence and pelvic organ prolapse.”
In a humanitarian-sounding gesture, the company said it had plans to implant one million women in third would countries and to train doctors on the use of its mesh products. See Mesh News Desk coverage, Feb. 2016 here.
Mesh News Desk has asked the company for an update on the IVUMed partnership but no call was returned by publishing time.
In June 2015, the company launched Vertessa Lite- a polypropylene mesh designed to be lighter, stronger and with larger pores than previous models to treat pelvic organ prolapse. See the Mesh News Desk story here.
And as further evidence of its solvency, last October, Caldera Medical paid thousands to be a sponsor of the American Urogynecologic Association (AUGS) annual conference where a company representative told your editor that the company was fully solvent.
Caldera products include in the settlement include the T-Sling, the Desara, Ascend, Hydrix, and the pelvic organ prolapse mesh, Vertessa.
Caldera Medical says it is dedicated to “improving the quality of life for women.”
CALDERA TANGLES WITH AMS, COLOPLAST
Just last month, American Medical Systems (AMS) lost a bid to have Caldera’s insurance cover its losses in pelvic mesh litigation. See it here.
AMS said Caldera made use of its novel surgical instruments for treating incontinence, but the district court decided that Federal Insurance had no duty to defend AMS because it was not insured under the Caldera Medical Policy. The U.S. Court of Appeals for the Ninth Circuit affirmed.
In another legal entanglement, this time with the Danish company, Coloplast, Coloplast charged Caldera medical infringed on three of its patents. The evidence was the Vertessa Lite transvaginal pelvic mesh which infringed on three Coloplast patents, according to Coloplast, which demanded a jury trial last May. See the filing here.
CALDERA’S CEO NEW VENTURES
Meanwhile Caldera CEO Bryon L. Merade appears to be venturing out into other holdings.
Merade is associated with four companies according to CorporationWiki (here) – Vidamed, Inc where he is listed as the President, Caldera Medical, also the President, Auslo Holdings, a member since 2016 and Xmed Holdings LLC where he has been a member since 2016.
Here is Judge Stephen v Wilson’s court, 2:15-cv-00393
Mesh News Desk coverage, Feb 2016
MND, Nov. 5, 2015~ Your editor recently sat down at the Mass Torts Made Perfect session on multidistrict litigation (MDL) to hear the latest on the settlements purported to be in the works concerning transvaginal mesh.
Attorney Henry Garrard told the crowd that four of five mesh manufacturers are in the settlement mode.
It started with American Medical Systems (AMS). Judge Goodwin who heads the multidistrict litigation (MDL) in Charleston, West Virginia, has praised AMS for setting forth the first settlement model, though many complain it is short in compensation dollars, certainly not enough for a lifetime of medical management.
AMS – MDL 2325 ~ In April 2014, AMS, now part of Endo Health Solutions, announced $830 million to settle 20,000 product liability lawsuits. That number was upped to $1.6 billion by September to resolve about 25,000 mesh injury claims. See the story here.
The settlements vary and are reached by individual law firms, some working together to hammer out an agreement. The agreements may not all be the same, but regardless, they have been slow in coming. Many women report to MND they have their paperwork yet no dollar amount has been specified.
The higher “Tiers” of injury are worked out individually. The lower Tiers may represent no compensation after a 40% legal fee is removed, along with any outstanding liens or medical bills.
Remember, when you agree to a settlement, you forever give up your right to seek redress through the courts as do your family members. You do have the option to refuse the settlement and insist your law firm take your case to court. At that point you may get pushback from your firm. It’s easier for the law firm to settle and move on, but it may not be in your best interest. They are officers of the court who must act in your best interest! Check with your state Bar Association to see if you can be dropped as a client if you refuse a settlement!
A June 2013 agreement specifies $54,500,000 as a Settlement Fund held in escrow. It requires 95% of claimants to participate. There is no admission of liability by the company in offering the millions to women implanted with the Perigee, Apogee and Elevate transvaginal mesh implants. See the Master Settlement here.
Endo Health Solutions took over AMS in 2011 for $2.9 billion and in doing so acquired more than 22,000 lawsuits claiming the polypropylene mesh is defective and doctors were not adequately warned about the complications associated with the mesh.
Boston Scientific – MDL 2326 ~ Boston Scientific announced it would pay $119 million to settle 2,970 cases back in April of this year. According to Garrard, Boston Scientific is working with national settlement counsel of the Sedgewick firm of New Jersey, specifically Mike Tenanbaum. See him here.
At least 130 cases may be sent back to their own District Courts in the state where they originated in an effort to reduce the load on the MDL in Charleston, WV.
Boston Scientific says it has over 27,000 product liability cases. More than 2,700 claims have been assigned to one judge in state court in Massachusetts. In its August 2015 SEC filing (here), the company says last April it entered into a master settlement agreement with certain plaintiffs’ counsel. It will provide $119 million to resolve 2,970 cases including the federal court in Dallas County, Texas. The company has also entered into a Master Settlement, without admitting any guilt or liability, regarding 1,627 pending cases.
Boston Scientific says it plans “to vigorously contest the cases and claims asserted against us.”
C.R. Bard – MDL 2187 ~ Bard is less than forthcoming about the number of lawsuits it’s currently facing and settling in its October SEC report. The good news, according to Garrard, is that Nina Gussack, a partner with the Pepper Hamilton LLP law firm of Philadelphia (here), a settlement firm is helping things along says Garrard and they are about to settle 60 percent of the docket.
Bard was reported to be prepared to settle 500 product liability pending actions for $21 million last year. See the MND story here.
Bard’s October 2015 SEC report (here) says there are about 90 pending claims in federal and state courts involving the Composix Kugel hernia repair products.
Additionally, the company says its reached agreements with 6,470 Women’s Health Product Claims agreeing to pay Medtronic $121 million toward these potential settlements. These are claims not included in the 12,850 claims presently in the MDL, making the actual number of product liability lawsuits murky in this report.
Bard says two subsidiaries of Medtronic (as a successor to Covidien plc) supplied the company its mesh products and therefore has an obligation to defend and indemnify Bard from product defect liability. Bard has reached agreement with 6,470 claims agreeing to pay Medtronic $121 million toward these potential settlements.
While Bard continues to talk to Plaintiff law firms regarding potential resolutions and “intends to vigorously defend the Women claims that do not settle, including through litigation, it cannot give any assurances that the resolution of these claims will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.”
Covidien – MDL 2187 ~ The company based in Ireland is now part of Medtronic and two subsidiaries of Covidien supplied pelvic mesh products to C.R. Bard, which is named in the litigation. According to Garrard, they are reaching settlement with Williams and Connolly’s Joseph Petrosinelli (here).
In July of last year, Covidien announced it planned to take $180 million from its third quarter profits to pay the costs associated with pending lawsuits. In July 2015 Covidien and Bard agreed Bard would pay Covidien $121 million toward the settlement of those claims while other claims remain unsettled ( see the Bard story above). Law firms represent about 11,300 claimants and as of September, Covidien has reached agreements to settle about 2,300 of those claims.
See the Corporate 10-Q September 9, 2015 filing here.
See PTO #181 (here), June 23, 2015. Cathy Yanni was appointed the Special Mater for administration of the settlement reached between Blasingame, Burch, Garrard & Ashley P.C., and Covidien. By September, Blasingame, Burch, Garrard & Ashley, P.C. set up an Escrow Agreement account with Wells Fargo bank. Law firms Motley Rice and Beasley Allen also filed motions to establish a qualified settlement fund.
Coloplast – MDL 2387 ~ The Danish company has been in the settlement mode since day one, according to Garrard, but they’ve not had much discussion of settlement with Plaintiffs’ lawyers. Now they are reported to be in a speed- up mode. See Coloplast Pretrial Order #77 (here).
Judge Joseph Goodwin, who oversees the MDL, says if significant progress is not made in the MDL he will put a half docket in the fast track for work up. It would be on the trial dockets in early 2016. A Minnesota judge working up PSI order in 15 days and pushing discovery. The judge in Minnesota is pushing those cases.
In September, Coloplast announced it would increase its mesh legal budget by $448 million for a total of about $727 million. The company had settled 400 lawsuits last year for $16 million. Coloplast is facing 2,323 lawsuits filed in the MDL and likely more claims globally. Since it is not a U.S. company, there is not SEC report filed. See the announcement here.
Ethicon – MDL 2327 ~ Is the ten thousand pound elephant in the room. A trial is set for December for 30 Plaintiffs implanted with the TVT (transvaginal tape) which will be a product defect case only. There are no individual cases. As a sterile design defect the trial is a disadvantage to the Plaintiff, however if they are successful with the TVT trial, it will represent a major problem for Ethicon, a division of Johnson & Johnson.
Ethicon is facing 44,400 personal product liability cases, according to an October SEC report. See it here.
Also set were 200 cases for November addressing the oldest filed Ethicon cases. These are good for the Plaintiff because many of the older cases are the better cases. Recently Judge Goodwin sent out a notice to Plaintiffs’ firms to work up another 200 cases and have that to him by November 9. That process puts pressure on the Defendant.
The problem with Ethicon it says it will not settle TVT and TVT-O cases with a product in place and a non-surgical outcome because there is no demonstration of injury, says Ethicon. We are exploring how to deal with that said Garrard.
See Pretrial order #203 which dismisses without prejudice the 87 Plaintiffs listed in Exhibit A attached to PTO #199. That means then can be filed in the District Court closest to the Plaintiff, in this case North Texas. Here is the list of Plaintiffs.
According to Garrard, the mass advertising campaign currently seen on late night television is not helpful to get the Ethicons of the world resolved, largely because these cases dilute the better cases.
Ironically, not five minutes after a conversation with Mr. Garrard, I got a call on my cell phone from “Steve” of Medical Healthcare Center. He told me medical compensation might be offered if I had bladder sling surgery in the past, which I have not. #
Mesh Medical Device News Desk, June 30, 2015 ~ Covidien will settle some of the 11,000 pelvic mesh claims it has pending in federal court, Reuters reports citing court documents.
There is no word on the amount of settlement dollars being offered and no specificity on the number of outstanding product liability claims that will be included in the settlement.
This would be the third pelvic mesh maker that has entered into settlement discussions to end a number of product liability claims naming its products. Covidien makes transvaginal mesh and bladder slings that are sold by different companies, particularly C.R. Bard.
The majority of the 100,000 pelvic mesh product liability claims remain pending, many in U.S. District Court in the So. District of WV.
Last July, Covidien announced plans to take $180 million from its third quarter profits to pay the costs associated with lawsuits. Covidien also agreed to indemnify the maker from certain claims. See the Mesh News Desk story here.
Indemnify means to compensate the party for its losses or to guarantee it will cover damages in the future. See the legal definition here.
The $180 million charge reportedly came after discussions with plaintiff attorneys, Henry Garrard and Blasingame, Burch, Garrard & Ashley, P.C.
In a a pretrial order, Judge Joseph Goodwin writes Covidien has appointed Special Master Cathy Yanni (PTO #181) to resolve the claims related to its product.
C.R. Bard is facing 11,656 product liability claims in this federal court. This is the fourth highest number of claims among seven defendant companies. See. So District of WV website here.
Covidien was born of the business conglomerate Tyco International before being sold to Medtronic Inc. for $43 billion in a deal that merged two of the world’s largest implant and medical supply companies.
Minneapolis-based Medtronic then moved its base to Dublin where a more favorable tax burden is found, reports Marketwatch however technically Covidien is run from Mansfield, Mass.
Judge Goodwin presides over 75,000 cases against seven mesh manufacturers including American Medical Systems, C.R. Bard, Ethicon (J&J) Boston Scientific, Coloplast, Cook Medical and Neomedic. Covidien is not named as a defendant but is named in some cases as a co-defendant (See Carolyn Jones 2:11-cv-00114, for supplying mesh to C.R. Bard).
In the Jones case, C.R. Bard is named as a defendant along with Covidien Inc. D/B/A Sofradim Production, a Delaware corporation with business located in Mansfield, Massachusetts. Bard and Covidien designed, manufactured, marketed, packaged, labeled and sold the product. In her case (Jones) the mesh was the Avaulta Synthetic Support System. Bard and Covidien also make Avaulta Solo and Avaulta Plus meshes used to “restore normal vaginal structure after a pelvic organ prolapse.”
Settlements So Far
The Covidien announcement is the third mesh maker to announce mass settlements to the many pending plaintiffs, women injured by the polypropylene mesh implants. So far American Medical Systems (Endo) has agreed to set aside $1.6 billion to settle about 40,000 claims. Recently, Boston Scientific announced it planned to settle some of its pending transvaginal mesh claims.
Johnson & Johnson has settled individual claims either preceding or during litigation (See Budke case here) but otherwise has announced no settlement plans. Cook, Neomedic, Coloplast have not offered any settlements to women.
Judging from the SEC filings of the various companies involved there are in excess of 100,000 pelvic mesh product liability claims globally. #
Covidien SEC Report, July 11,2014
So District of WV, PTO # 182 (2:10-md-2187, Bard MDL filing number)
So District of WV PTO #181- Entered June 23, 2015
Medtronic SEC Report, June 23, 2015 – on indemnification
PTO #180 Qualified Settlement Fund, entered June 23, 2015
Mesh Medical Device News Desk, September 30, 2014 ~ This afternoon Endo International announced a master settlement has been reached that will resolve the lawsuits facing the vaginal mesh maker and its subsidiary AMS (American Medical Systems).
The press release says the settlement in no way admits any liability or fault. In its most recent SEC report from July, AMS tells shareholders it is facing 25,000 defective mesh cases.
Endo CEO, Rajiv De Silva announced “We are very pleased to resolve substantially all of the remaining U.S. vaginal mesh litigation claims facing our AMS business.” The settlement will allow AMS to continue to grow and focus on its medical device division, he says in the news release here.
Initially the company estimated a pre-tax product liability reserve of about $1.2 billion but settling the additional cases, both present and in the future, increased the settlement amount to approximately $1.6 billion. Payments will be settled during this year and through 2017. So far Endo/AMS has paid out about $200 million in settlement claims.
Back in May the company announced it would pay out about $830 million to resolve 20,000 pelvic mesh lawsuits.
The Wall Street Journal reported last month that Endo has put AMS on the auction block even though it delivers 19 percent of Endo’s revenue. The company is valued at about $2 billion today. Three years ago Endo purchased AMS for $2.9 billion.
Endo’s top priority is the safety and efficacy of its subsidiaries’ products and supporting the patients and physicians who use them, says the company. Endo continues to support the FDA’s recommendations that physicians be well trained and patients fully understand the risks associated with the use of mesh products.
The company says in its news release it remains committed to the safety and efficacy of AMS transvaginal mesh and plans to continue growing the women’s health division “so that women have appropriate access to innovative, safe and effective therapies.”
AMS is headquartered in Minnetonka, Minnesota. Endo International is based in Dublin, Ireland with U.S. headquarters in Malvern, PA.
Endo/AMS products include:
ElevateTM Anterior and Posterior Pelvic Floor Repair System. Our AMS segment offers the Elevate® transvaginal pelvic floor repair system, for the treatment of pelvic organ prolapse, which may be caused by pregnancy, labor, and childbirth. Using an anatomically designed needle and self-fixating tips, Elevate®allows for safe, simple and precise mesh placement through a single vaginal incision, avoiding an external incision. Elevate® revenue accounted for approximately 1% of our total revenues in both 2013 and 2012.
Monarc® Subfascial Hammock. The Monarc® subfascial hammock is our leading device to treat female stress urinary incontinence, which generally results from a weakening of the tissue surrounding the bladder and urethra which can be a result of pregnancy, childbirth and aging. It incorporates unique helical needles to place a self-fixating, sub-fascial hammock through the obturator foramin. Monarc® revenue accounted for approximately 1% of our total revenues in both 2013 and 2012.
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. #
Including the numbers from the mesh makers latest Securities and Exchange Filings with the federal government, the number of defective mesh cases now hovers at the 100-thousand lawsuit mark.
Even with 67,322 cases filed in federal court in West Virginia, more than any other Mass Tort amassed in one court, the media coverage remains quiet with the exception of large jury verdicts.
The latest numbers come from the SEC 10-Q report filed by Boston Scientific (23,000), Johnson & Johnson (33,000), AMS/Endo (25,000) and C.R. Bard (12,445). Add those number to the number of cases filed by Cook Medical, a privately held U.S. company which is facing 330 cases filed in the federal court in West Virginia and an unknown number around the country; Coloplast, a Danish company, facing at least 1,777 actions filed in the MDL; and Neomedic, a mesh maker from the U.K., which has 72 federal cases filed in federal court in the U.S.
These numbers do not include the cases filed with the MDL over the last two months and recently added to state courts. Typically, the federal multidistrict litigation has been adding one to two-thousand product liability pelvic mesh lawsuits per month.
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Your Editor, Jane Akre
Recently, Endo Pharmaceuticals announced that it had reached a settlement in principle with four law firms representing plaintiffs in the transvaginal mesh litigation pending before Judge Goodwin in federal district court in West Virginia (MDL 2325). The Press Release issued by Endo states that it expects to pay over time “an aggregate pre-tax amount of $830 million in connection with the resolution of 20,000 claims relating to vaginal mesh products sold by Endo’s subsidiary, AMS.”
As an attorney who has represented women in pharmaceutical and medical device litigation for over thirty years, including DES, fen-phen and breast implants, and who currently represents women injured by transvaginal mesh, I was not surprised to learn that Endo and some of the plaintiff firms had arrived at a mass settlement. After all, in this type of litigation—known as mass torts—mass settlements are not unusual as they can resolve a large number of cases quickly and efficiently.
Of course, the goal of prompt resolution must not trump the plaintiff’s right to be fairly compensated for her injuries. Considering the harm caused by these devices, including organ perforation, urinary and bowel problems, mesh erosion, vaginal scarring, severe pain, sexual problems, and revision surgeries, this proposed settlement, averaging $41,500 for each woman who had an AMS pelvic mesh device, made me pause.
I did not participate in the settlement discussions and none of my clients are included in this settlement. In other mass settlements I have participated in, plaintiffs were compensated based on the severity of their injuries. Here, it is likely that women who underwent revision surgeries would receive more than the average amount for their case, while others who only underwent implantation, may receive less than that amount. Still, it is reasonable to ask whether the terms of the settlement are adequate in light of the suffering caused by transvaginal mesh.
In assessing settlement value, it is important to recognize that the initial trials have gone exceedingly well for the plaintiffs:
- A $3.6 million verdict against Bard in California state court in 2012 (the implanting physician was held responsible for another $1.9 million in damages).
- An $11.1 million verdict against J&J/Ethicon, including $7.76 million in punitive damages, in New Jersey state court. The jury in that case found that defendants failed to warn of the risks of transvaginal mesh.
- A $2 million verdict in the first Bard case tried last year before Judge Goodwin in federal court, including $1.75 million in punitive damages, with a finding that the mesh was defective and contained inadequate warnings. Soon after, Bard settled a second case before trial.
- A $1.2 million verdict against J&J/Ethicon in Texas state court last month. The jury found that the mesh was defectively designed.
To my knowledge, the sole defense victory was a case where J&J/Ethicon obtained a directed verdict in their favor before the case got to a jury. In that case, though, the plaintiff was not allowed to present evidence on the inadequate warnings provided by the defendant.
Juries understand these cases and recognize the harm caused by defective mesh used for pelvic organ prolapse and stress urinary incontinence. The verdicts reflect that understanding–close to $18 million in compensatory and punitive damages in just four cases, with only one loss in a circumscribed case decided by a judge. While the jury system is inherently unpredictable and any trial is risky, these results underscore the strength of transvaginal mesh cases. Overall, this extraordinary track record in court enhances the settlement value of the cases.
It is important to remember that transvaginal mesh devices were never approved for safety and efficacy by the FDA. Rather, the mesh manufacturers relied upon the 510(k) process to quickly get devices marketed in the United States. The 510(k) process determines only whether a new device is “substantially equivalent” to a legally marketed “predicate” device.
As I discussed in another article, the 510(k) process is fundamentally flawed. Transvaginal mesh devices were marketed based on claims of substantial equivalence to predicate mesh devices that were never reviewed for safety and effectiveness. Any settlement negotiations must start with the recognition that the device manufacturers have never convincingly established safety and efficacy. The jury verdicts are consistent with this fact.
Hopefully, the settlement will be clarified for the thousands of women it affects as well as the plaintiffs whose cases will remain in the MDL. Transvaginal mesh devices have caused immense suffering for women and any settlement must fairly compensate each woman for her injuries. We owe it to our clients to vigorously defend their rights, and fight for fair and just compensation for their injuries.
Dan C. Bolton is Of Counsel in the Los Angeles office of Keller, Fishback & Jackson LLP. The firm represents plaintiffs nationwide in pharmaceutical and medical device cases, including transvaginal and hernia mesh litigation. Mr. Bolton oversees the pharmaceutical and medical device practice.
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
In a regulatory filing (here), Boston Scientific Corp announced today it’s reached a settlement of $119 million to resolve 2,970 product liability cases concerning pelvic mesh.
That would amount to an average award of just $40,000 per claim. Claims are generally awarded based on the degree of injury resulting from a pelvic mesh implant so an award could amount to more or less than that number.
This does not resolve the bulk of the 25,000 cases filed in U.S. and federal state courts but it would include the Martha Salazar case which resulted in a $35 million award against the company last year.
There is no admission of liability or wrongdoing if an agreement is reached reports Reuters. The funds could be set aside in an escrow account by October 1.
*New* The timing is interesting. In a recent ruling, Judge Joseph Goodwin, who is overseeing the federal cases against pelvic mesh manufacturers, allowed to stand punitive damage claims in one of its pending product liability claims. See story here.
Here is the portion of the SEC report:
ITEM 8.01. OTHER EVENTS
On April 28, 2015, the Company announced that it reached an agreement with certain plaintiffs’ counsel to settle substantially all of their inventories of product liability cases and claims pending against the Company related to transvaginal surgical mesh products designed to treat stress urinary incontinence and pelvic organ prolapse. This settlement has been memorialized in a Master Settlement Agreement (the “Agreement”), which was entered into solely by way of compromise and does not constitute an admission or concession by the Company of any liability or wrongdoing. The Agreement provides that the Company will pay approximately $119 million to resolve 2,970 cases and claims, including a case in the District Court of Dallas County (TX) for which there is a judgment of approximately $35 million that is currently subject to appeal. Under the terms of the Agreement, the Company will make two payments into a settlement fund held in escrow with full funding to be completed on or before October 1, 2015. The Agreement establishes a procedure for claimants to participate in the settlement. The settlement and the distribution of settlement funds to participating claimants are conditioned upon, among other things, achieving minimum required claimant participation thresholds. If the participation thresholds are not satisfied, the Company may terminate the Agreement.
Mesh News Desk, June 21, 2013, Endo Agrees to Settle Some AMS Vaginal Mesh cases for $55 Million here
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.
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.
This morning Mesh News Editor, Jane Akre, received a call that even revealing any specifics of the settlement agreement by AMS will discourage others from making any offers to settle outstanding pelvic mesh cases. AMS is watching this column and cites the confidentiality agreement that is in place. Although no individual settlement has been revealed, the company does not want the specifics disclosed. As a result, this story has been revised.
Because it has always been the focus of Mesh News Desk to do what is in the best interest of the injured community, for both transvaginal and hernia mesh victims, this story is being altered. The specifics of the settlement will not appear. Consult with your individual law firm about which “Tier” of injury you fit into.
What we can say is that there are currently 19,712 AMS defective product lawsuits consolidated in one federal court in Charleston, West Virginia, not including those filed in various state courts.
AMS litigation represents the second highest number of product liability lawsuits filed in this court behind Ethicon (Johnson & Johnson). AMS admits no fault in offering any settlement. Judge Joseph Goodwin has cited AMS as the leader in offering settlement dollars to those women injured by transvaginal mesh. He has encouraged other companies who are holding out and opting for protracted litigation to follow the lead of AMS.
AMS- are you watching? As you know, your settlement dollars will never be enough. They don’t begin to make whole women damaged by your product, which at best, was experiment and highly speculative. Clearly the product is not working in a large number of patients and should not ever be a “Gold Standard” for anything. The collateral damage is just too high. No one can predict who will be adversely affected. No expert doctor can assure a woman she will not have complications.
AMS- will you offer an apology to those injured? It might go a long way to admit you made a mistake.
Other law firms are trying to work out details of a settlement and MND does not want to impede that progress. Clearly it is preferable over beating up an already injured woman in court, though the jury may decide she deserves millions, it will be a long time before she sees that award.
What we can say is that there are 692 AMS claimants who will be the recipients of this settlement, overseen by the Laminack, Pirtle & Martines LLP law firm of Houston. AMS has agreed to a settlement amount to which there must be at least 90 percent agreement by claimants. Additional reserve monies are being set aside in case there is any change in an individual’s settlement category.
You are encouraged to discuss your specific injuries with your law firm to see which “Tier” you fit into.
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.
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 System and 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. #
Pelvic Mesh Litigation- Is AMS Watching?
AMS Master Settlement Reached, Mesh News Desk, September 2014
March 4, 2014 ~ Coloplast is one of the smaller manufacturers of transvaginal meshes and is one of six companies facing the 53,000 cases consolidated in federal court in West Virginia. Now Coloplast A/S is said to be willing to settle its outstanding lawsuits for $16 million.
The Danish company will offer about $40,000 for each claimant, reports Bloomberg, to settle about 400 product liability lawsuits. To women who have had their life damaged by migrating and infected polypropylene mesh, that amount is hardly enough to regain their lives much less cover the future surgeries they will need for removal and treatments.
Coloplast was entered into multidistrict litigation in August 2012. Mesh News Desk did a story on the products it made at that time here.
There are currently 1,356 Coloplast lawsuits filed in the So. District of W.V. here.
Other manufacturers include Ethicon, a division of Johnson & Johnson, American Medical Systems (a unit of Endo health), Boston Scientific, C.R. Bard and Cook.
J&J has refused to discuss settlements vowing to try each case on its own merits. That is what it said about the DePuy metal–on-metal defective hips that left so many in need of a revision while causing pain and toxic metal poisoning, before it made a settlement offer of $2.7 billion that is expected to grow as more cases come forward.
These are product liability lawsuits that claim the defective transvaginal mesh products should never had been made and certainly should never have been released on an unsuspecting public without clinical trials.
The meshes used to treat incontinence and to hold up sagging pelvic organs, are approved under a safety loophole of the Food and Drug Administration known as the 510(k) approval process. There are at least 60,000 lawsuits filed around the country in state courts with the majority filed in federal court in Charleston, West Virgina.
Business Week story is here.
MDND talked to Charleston, WV attorney Harry Bell about how cases are settled with defendants.
On the eve of four back-to-back cases against C.R. Bard in West Virginia and the recent settlement of some American Medical System cases, it’s important to understand what could be next. Too many losses and a defendant, in this case a mesh manufacturer, may decide to offer a settlement to the injured. Many plaintiffs say it will never be enough to retrieve a lost life. ~ J. Akre
“Every lawyer who represents their client has the highest obligation to their client to take care of them. It’s the defendant’s choice whether they want to enter into settlement negotiations or not. A defendant will sometimes say they will try every single one of these cases in a mass tort. That’s the message being sent and the Court, such as we see here, is moving things along both in discovery and by setting bellwether trial cases.
If at some point Ethicon, AMS or any other defendant, would want to enter into settlement negotiation they can do that in a myriad of different ways.
Making A Business Decision
One way is to think from a corporate standpoint. That is a smart, overall business decision which is in the best interest of the company. You may find the defense counsel want to keep litigation going as it becomes a ‘cash cow’ for a defense firms billable hours but as defendants recognize, just as plaintiffs do, litigation is very expensive for all sides with uncertainties as to outcomes. Somebody at the corporate level asks ‘What are we spending and do we have problems?’ and ‘Let’s make a business decision.’
These high level discussions involve senior management who are used to dealing with large critical decisions such that, at some point, a defendant’s corporate strategy will evolve where it becomes obvious to the litigants and the Courts.
What do we think it’s going to cost; are we going win or lose every case? What’s our range? There are big picture things to consider. If at some point they want to resolve the litigation, oftentimes a defendant will utilize different strategies, one is ‘We want to buy our peace and we’re done totally and want to resolve it and resolve all claims against us.’
A proposal is made and negotiations go back and forth and at some point, you may have a large grid format of a settlement agreement. Let’s say a defendant wants to resolve all cases in state and federal court.
The way it’s sometimes done in mass torts is the defendant will come up and negotiate with the leadership on the plaintiff’s side and if a successful template is reached, they present it to the MDL Court.
Settlement may also depend on a certain percentage of claimants accepting the settlement grid. The actual numbers of plaintiffs willing to settle may be less than needed so it can fail and the parties continue litigation.
Another strategy defendants sometimes employ is look at who is suing them and look at the universe of cases and say ‘I’m going to settle some of those selectively and others, we will hear out at trial in a ‘scorched earth’ policy.’
Depending upon whether you may be in a venue known for high verdicts, or in an area that’s conservative in its jury findings can also affect settlement strategy. As a defendant, you may turn around and settle cases that present a high exposure. Conversely, the defendant can say we are going to try cases if they are getting feedback that it is a conservative jury area.
There are numerous other strategies defendants can employ to get out of this litigation and eventually, all cases will be resolved either by trial, settlement or dismissal. Much like many complex things in life, expect the process to take awhile. There are excellent teams of attorneys, on all sides, with wise, fair and very astute Judges involved. People should have confidence in our Judicial system to assist them in resolving matters in a Court of record.”
MDND: Does a law firm have to get approval before a settlement is agreed to on your behalf?
“Absolutely, the sign off involves approvals. If you have other mass torts what happens, mesh aside, let’s say pharmaceutical products, how long has the plaintiff suffered from a medical condition? Then there is a grid worked out. Here is the proposal subjected to 80 plus filing claims. Where do you fall in the grid?”
MDND: Like the Kugel Mesh settlement that had tiers of injury? Some say they were strong armed into settling for very little money.
“A lawyer’s job is to tell the client what they need to hear, not what they want to hear. Oftentimes clients are not the best to determine what’s in their best interest because of their emotional investment in the issue. To the extent if a client was hesitating and wanted to do something not in their best interest, the lawyer has options. Sometimes clients use their hesitation to extract money by getting a change in the fee agreement. You might have one lawyer end up giving away his fees to get them to sign because they thought it was in their best interest to sign. Those are rare as certainly clients would be upset if the attorney suggested the agreement should be changed for the attorney to get more. Honor your agreement is the best policy for all.”
MDND: Can Ethicon say I’m going to settle the claims of the XYZ law firm alone?
“Yes, they can do that if they want to. A defendant may say ‘We’re going to offer you x amount of dollars for your clients only were not going to offer to anyone else.’ That lawyer has an obligation to confer to his clients, and if that lawyer is appointed in a leadership position, he or she has an obligation to inform the Court at some point. As an Attorney, I have an obligation to advise my clients. As a practical matter if you have things like that and the Court sees the defendant picking off and trying to get people to settle to get leaders off the leadership positions – that’s happened before in the mass tort world – The Court will have to appoint new leadership to move the litigation along. I would suspect that Judges would not be real happy at defendants who try that tactic to ‘gut’ the plaintiff leadership structure, but that could be a strategy a defendant may employ.”
MDND: If I’m a corporation, I’m going to pick the less reputable attorneys to settle. Is that a strategy?
“The bottom line for clients is choose your representation wisely. Ask – Is it in writing you must approve a settlement? Ask what is their experience; why is this in my best interest; how many cases have you tried; have all the depositions been taken? There are a lot of questions before you. If my lawyer says she’s taken over 70 depositions over 2-3 years and has reviewed 34 million pages of documentation and has her own experts retained and she recommends you settle, you’ll feel better than hearing that from a lawyer who says I’ve not participated in any depositions and not looked at any expert reports.
Just be sure you understand what is at stake. I certainly am of the opinion there is a tremendous amount of experience and resources devoted by many plaintiff’s counsel in mesh litigation and clients are being very well represented.”