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Ethicon 11/9
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Texas Court Kills $1.2M Pelvic Mesh Verdict Against J&J
Nov 6, 2015 | Law360
By Jess Davis
A Texas appellate court on Thursday reversed a $1.2 million judgment against Johnson & Johnson’s Ethicon unit for defectively designing a pelvic mesh product, with the court holding there wasn’t evidence the plaintiff’s injuries were caused by the allegedly defective design. -
Dallas appeals court tosses $1.2 million surgical-mesh payout to cancer victim who sued Johnson & Johnson
Nov 6, 2015 | The Dallas Morning News
By Naheed Rajwani
A Dallas appeals court has sided with Johnson & Johnson in a landmark case about surgical mesh, throwing out a jury’s verdict that would have forced the company to pay $1.2 million to a Dallas woman who claimed the mesh was defective. -
$1.2 Million Batiste Pelvic Mesh Case Overturned by Texas Appellate Court
Nov 6, 2015 | Mesh Medical Device ENws Desk
By Jane Akre
The brief story was reported Friday in the Dallas News – the $1.2 million verdict against Johnson & Johnson and in favor of mesh-injured Linda Batiste has been overturned by a three-judge Texas appellate court. The decision was published Thursday from the Fifth District Court of Appeals in Dallas. -
Firms draw huge profits with third-party assisted litigation
Nov 8, 2015 | Houston Chronicle
By Mike Tolson
...The lawsuits, which at one point numbered far more than Charleston's population of 50,000, arose from the use of a product called transvaginal mesh... -
GAO study finds 510(k)-cleared devices account for 94% of unplanned postmarket safety studies
Nov 6, 2015 | Fierce Medical Devices
By Varun Saxena
...The vast majority of the surveillance studies (354, to be precise) were for orthopedics, devices used in general and plastic surgery, as well as those used in obstetrics and gynecology procedures, reflecting the well-documented safety issues of two sets of 510(k)-cleared devices: metal-on-metal hips and implantable vaginal mesh... -
C.R. Bard Pays $3.6 million in Precedent Setting Scott Pelvic Mesh Case
Nov 5, 2015 | Mesh Medical Device News Desk
By Jane Akre
In July 2012, Plaintiff Christine Scott went to trial against C.R. Bard over her Bard Avaulta Plus mesh kit in a Bakersfield, California courtroom. It would be the first trial to be held naming a major mesh manufacturer. -
Settlement Dollars are Slow in Coming in Transvaginal Mesh Claims
Nov 5, 2015 | Mesh Medical Device News Desk
By Jane Akre
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.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Texas Court Kills $1.2M Pelvic Mesh Verdict Against J&J
Nov 6, 2015 | Law360
By Jess Davis
A Texas appellate court on Thursday reversed a $1.2 million judgment against Johnson & Johnson’s Ethicon unit for defectively designing a pelvic mesh product, with the court holding there wasn’t evidence the plaintiff’s injuries were caused by the allegedly defective design.
The Fifth Court of Appeals in Dallas stripped the damages award from plaintiff Linda Batiste, holding she didn’t offer legally sufficient evidence that identified any alleged defect in J&J’s TVT-O pelvic mesh as the cause of her injuries, as compared with the device itself being the producing cause of her injuries. The court said it’s undisputed that implantation of the TVT-O device can cause a number of complications and that it’s undisputed Batiste suffered from those complications, but the law of products liability doesn’t guarantee a product will be risk-free.
The court said it’s possible that Batiste’s pelvic and groin pain and other complications were caused by implantation of the mesh itself, and that she didn’t have scarring beyond what you might expect from the removal of a foreign device from the body. The court held she did not prove her pain was caused by any of the alleged defects in the TVT-O device, like alleged degradation of the product or the fact it used a heavyweight mesh.
“While proving causation may be difficult, that does not excuse the plaintiff from introducing some evidence of causation, “ the court said. “Although Batiste alleged the TVT-O was defective based on its use of mechanically cut, heavyweight, small-pore mesh that was subject to degradation and particle loss, she failed to produce more than a scintilla of evidence that any of these alleged defects caused her injuries.”
Batiste’s case was the first in the U.S. to hold Ethicon responsible for the bladder sling product used to treat stress urinary incontinence. After a 12-day trial in Dallas district court, a jury awarded her $1.2 million in compensatory damages, but declined to award punitive damages.
During oral argument before the Fifth Court of Appeals, Batiste defended the win against what she called a “kitchen sink approach” from J&J, and said the company was asking the appeals court to reweigh evidence already considered by the jury. J&J argued to the court Batiste had presented only speculative evidence that injuries could have been caused by defective pelvic mesh, without reaching the necessary threshold of showing her injuries were actually caused by its product.
“We respectfully disagree with the court's holding and intend to seek relief from the Texas Supreme Court,” Tim Goss of Freese & Goss PLLC, who represented Batiste, said. “We remain committed to litigating these cases and seeking relief for the thousands of women injured by these defective products.”
Ethicon spokesman Matthew Johnson said Friday that the company believes the appellate court’s decision reflects the facts of the case.
“Ethicon’s TVT-O pelvic mesh was properly designed, and Ethicon has acted appropriately and responsibly in the research, development and marketing of our TVT-O device,” Johnson said. “Ethicon’s TVT devices are considered by many to be the gold standard for the treatment of stress urinary incontinence.”
Johnson & Johnson is represented by Stephen Brody and Charles Lifland of O’Melveny & Myers LLP and Scott Stolley of Cherry Petersen Landry Albert LLP.
Batiste is represented by Peter de la Cerda of Edwards & de la Cerda PLLC, Richard A. Capshaw of Capshaw & Associates, Tim Goss and Sara Turman-Vedral of Freese & Goss PLLC and David P. Matthews of Matthews and Associates.
The case is Johnson & Johnson et al. v. Batiste, case number 05-14-00864-CV, in the Texas Court of Appeals for the Fifth District. -
Nov 6, 2015 | The Dallas Morning News
By Naheed Rajwani
A Dallas appeals court has sided with Johnson & Johnson in a landmark case about surgical mesh, throwing out a jury’s verdict that would have forced the company to pay $1.2 million to a Dallas woman who claimed the mesh was defective.
The woman, Linda Batiste, died of cancer in August at age 65. Her lawsuit, filed in 2012, was the first mesh case in Texas to be heard by a jury.
The U.S. Food and Drug Administration issued warnings in 2011 about the implants, used to treat incontinence and other problems. Between 2008 and 2010, the FDA said it received about 2,900 complaints about complications related to surgical mesh devices.
Batiste claimed she experienced severe pelvic and vaginal pain after a doctor implanted a mesh sling device known as a TVT-Obturator, to treat “life-altering” urinary incontinence, court records state.
She alleged the device was defective because it used “mechanically cut, heavyweight, small-pore mesh that was subject to degradation and particle loss,” according to court records.
The jury sided with Batiste and ordered Johnson & Johnson and its subsidiary, Ethicon Inc., to pay her $1.2 million.
“I have pelvic pain,” the woman said in a 2014 interview with WFAA-TV (Channel 8). “It actually does feel like a scouring pad in your body. You can feel in your women parts, what it is. It’s there.”
On Thursday, however, an appeals court acknowledged the device can cause complications, but said Batiste did not cite a specific defect in the device that could have caused her injuries.
“She failed to produce more than a scintilla of evidence that any of these alleged defects caused her injuries,” the court wrote in its ruling.
Batiste’s attorney was not available for comment Friday.
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$1.2 Million Batiste Pelvic Mesh Case Overturned by Texas Appellate Court
Nov 6, 2015 | Mesh Medical Device ENws Desk
By Jane Akre
The brief story was reported Friday in the Dallas News – the $1.2 million verdict against Johnson & Johnson and in favor of mesh-injured Linda Batiste has been overturned by a three-judge Texas appellate court. The decision was published Thursday from the Fifth District Court of Appeals in Dallas.
The Batiste case was the first mesh case to go to trial in Texas. The jury decided Johnson & Johnson’s (J&J) TVT-Obturator (TVT-O), made by Ethicon, a division of J&J, was defective in its design and awarded Ms. Batiste $1.2 million.
Ms. Batiste, 65, died of cancer in August.
In her four-week trial in April of last year, she alleged the TVT-O caused her severe pelvic and vaginal pain, even years after it was implanted in January 2011.
“It actually does feel like a scouring pad in your body. You can feel in your women parts, what it is. It’s there,” she told WFAA-TV in an 2014 interview (here).
The TVT-O remains on the market and is used as a treatment to stop incontinence in women who leak urine during daily activities.
WHAT THE APPELLATE COURT SAID
During the trial, lawyers for Ms. Batiste showed the jury the Prolene mesh, also used for hernia repair, was considered a heavyweight mesh, too heavy for the pelvic region. It was mechanically cut with a small-pore that encouraged infection. The mesh would erode and degrade, the jury was told.
While the three-judge panel agreed the device can cause complications, such as erosion and pain, and agreed Ms. Batiste suffered from those conditions, it wrote:
“Rather, to recover on her product liability claim based on an alleged design defect in the TVT-O, Batiste was required to prove a specific defect in the TVT-O, and not simply the device itself, was the producing cause of her injuries.”
In other words, the Plaintiff must introduce evidence of causation, which clearly Plaintiffs’ attorneys felt that exactly was what they spent weeks presenting as acknowledged further in the decision:
“Although Batiste alleged the TVT-O was defective based on its use of mechanically cut, heavyweight, small-pore mesh that was subject to degradation and particle loss, she failed to produce more than a scintilla of evidence that any of these alleged defects caused her injuries. Accordingly, the evidence is legally insufficient to support the jury’s verdict.”
With that, the panel reversed the trial court’s judgment.
The Opinion is written by Justice Robert M. Fillmore, who was joined by Justices Lang and Whitehill.
A check of the Fifth Appellate District website shows Judge Fillmore was appointed by Gov. Rick Perry in 2009. Before that he worked for a Dallas law firm representing the corporate world in energy, utilities and antitrust litigation. Justices Lang and Whitehill worked for a Dallas firm that specializes in the aviation, chemical and energy industries, commercial litigation and white-collar defense.
TAKE NOTHING
Their decision specifically says they “render judgment that Batiste take nothing on her product liability claim against appellants based on a design defect in the TVT-O.”
The appellate judges had the option to remand the Batiste case back to court to be retried or to reduce the jury award.
There is no word this evening on whether Ms. Batiste’s attorneys plan any further appeals.
Ms. Batiste is represented by the law firms Freese & Goss, Capshaw & Assoc. , Matthews Law firm, Wagstaff, Cartmell and Edwards de la Cerda. The case is Johnson & Johnson et al. v. Batiste, case number 05-14-00864-CV, in the Texas Court of Appeals for the Fifth District.
ARGUMENTS
The appellate justices noted that Ms. Batiste suffered from a number of medical conditions. Although they acknowledged her pain, they said specifically the witness, Dr. Tom Margolis failed to address a number of potential causes of Batiste’s symptoms:
“such as diabetic neuropathy, which could be a source of her pelvic pain, and the possibility she suffers from interstitial cystitis, which could explain her pelvic and groin pain……Margolis failed to rule out the passage or the placement of the sling, as opposed to any defect in the sling, as being the cause of Batiste’s groin or pelvic pain.”
In its backup position of requesting a new trial, J&J said that the trial judge erred by excluding all evidence referencing the FDA including clearance of a medical device and any position statements by medical societies and by admitting evidence of other lawsuits of a similar nature.
Johnson & Johnson recently received its first favorable jury ruling in the October Dallas trial ofCavness v. Ethicon. Prior to that verdict, and the Batiste case, other product liability actions against J&J over its pelvic mesh include Jo Huskey ($3.57 million), Linda Gross ($11.1 million) and Coleen Perry ($5.7 million).
J&J has recently settled a number of other mesh cases before they went to the jury (Budke) or trial (Wicker) as well as a few cases in Missouri.
So far, two juries have found the TVT-O was defective in its design.
Ethicon, a division of J&J, is facing 44,400 personal product liability cases over its transvaginal mesh, according to an October SEC report. #
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Firms draw huge profits with third-party assisted litigation
Nov 8, 2015 | Houston Chronicle
By Mike Tolson
In the West Virginia courtroom of U.S. District Judge Joseph Goodwin, lawsuits that have been lingering for several years in America's largest-ever medical mass tort may be heading toward a comprehensive settlement. The judge said earlier this year the two sides should work out a deal on the cases that have not yet been settled, and what federal judges want, they usually get.
The lawsuits, which at one point numbered far more than Charleston's population of 50,000, arose from the use of a product called transvaginal mesh. The implanted mesh was manufactured by several companies to help women with a variety of pelvic problems, but because of the potential for post-surgical complications, it was the subject of a 2008 alert by the Food and Drug Administration.
The companies insisted the product was safe. But blood was in the water, and soon plaintiff lawyers around the country, including most of the heavy hitters and big names, had rounded up plenty of clients - some 70,000 by one estimate. Massive advertising campaigns made sure of that.
Curiously, the firm that advertised the most was one few other lawyers had heard of. Houston's AkinMears, a tiny operation with only seven lawyers listed on its website, reportedly spent around $25 million in a sweeping TV blitz, cutting across channels from gardening to golf to get viewers to call a toll-free number.
Yet, with no star attorneys in its stable, AkinMears took no part in the crucial "bellwether" trials that were intended to establish the value of the cases.
In truth, it spends little time in the courtroom. Its main partner, Truett Akin IV, is still better known as a former University of Houston football player than a lawyer, though in fairness he has finally earned some headlines. Just not the kind he wanted.
'Bushels of wheat'
A breach-of-contract lawsuit filed by a former AkinMears employee at the end of September raced through the legal grapevine like a greyhound. In colorful language obviously intended for a broad audience, the suit by a banker-turned-lawyer named Amir Shenaq opened a rare window into a shadowy world where clients exist only as case numbers, and large chunks of them are bought and sold with outside money and without their knowledge - in the words of one critic, like "bushels of wheat."
Shenaq had been hoping to strike it rich as the mesh litigation headed toward conclusion. His job had been to arrange financing that would allowed AkinMears to quietly acquire thousands of cases at a discount, right before Judge Goodwin pushed through the final remaining settlements.
The money, according to the suit, came from a private investment firm that bankrolls lawsuits in exchange for a portion of the returns. Shenaq claimed that he was fired because the firm did not want to pay him $4 million it owed him.
The suit was settled last week with the terms undisclosed. The attorney for Shenaq did not respond to requests for comment. AkinMears declined to comment on the suit or the settlement.
If publicity was Shenaq's initial aim, he succeeded. There both in the flamboyant text and between the lines of an otherwise routine complaint of a fired employee was raised the specter of a different type of law firm that does not have to do very much to get a piece of the action.
"AkinMears is not run like a traditional plaintiff's law office, and the firm's lawyers do not do the types of things that regular trial lawyers do," the lawsuit states. "AkinMears is nothing more than a glorified claims processing center, where the numbers are huge, the clients commodities, and the paydays, when they come, stratospheric."
Corrupted interests
Making it all possible, in this case, was one of the private equity firms that have sprung up in recent years to invest in litigation, which they see as promising higher returns than other investments. It had taken only weeks for Shenaq to interest one such firm, Gerchen Keller Capital, and line up about $100 million, to be couched as loans.
For experienced lawyers on both sides of the divide and pretty much anyone who keeps up with the high-stakes world of bigtime civil litigation, it was not hard to imagine a future of many such firms, all of them quietly using other people's money - and lots of it, rather easily obtained - to build a juggernaut of lawsuits that in theory could threaten the foundation of the American civil justice system.
The defense bar, which represents corporations that are often targeted in so-called mass torts, found the glimpse into the Houston firm's inner workings predictably chilling. Lisa Rickard, president of the U.S. Chamber of Commerce's Institute for Legal Reform, said the revelations about AkinMears shows how "litigation financing perverts the justice system and puts the interests of lawyers and financiers ahead of actual plaintiffs."
Growing alarm
The American Association for Justice, the trial lawyers' group, defended access to third-party funding as a necessity when consumers face corporations with unlimited resources
"The world of litigation funding is complicated," the advocacy group said in a statement. "But, when done ethically, (it) can help balance the playing field for those who have been harmed and ensure that wrongdoers can be held accountable,"
The AAJ did not define what constitutes ethical financing or address the AkinMears legal practice directly. But some veteran plaintiff lawyers are displeased by the notion of law firms as tools of investment bankers.
"I find the whole thing incredibly distasteful and borderline reprehensible," said Mark Lanier, a nationally known trial lawyer from Houston. "I am a capitalist, and I believe in the capitalist system. I believe in the civil justice system. But there are appropriate business models and models that are inappropriate. I find this one ghastly."
Shenaq's lawsuit claims AkinMears was not satisfied with the results, despite all the money it spent on advertising. Leads from a call center were too iffy.
"Akin ... wanted to aggressively grow his business, including a significant change of course," the lawsuit states. "Rather than buying non-stop advertisements and acquiring clients in a random, unpredictable manner, he wanted to start making direct investments in ongoing mass tort litigation. Akin mentioned a goal of closing on $100 million worth of cases in 2015 alone."
Long established in other countries, third-party funders like Gerchen Keller provide backing for lawyers involved in expensive lawsuits. Typically these litigation finance operations are private equity funds that may couch their help as loans but are in essence investing in the outcome of the lawsuits. The one constant is that the "loans" are non-recourse, meaning they do not have to be repaid if the lawsuit is unsuccessful.
The rise of litigation finance firms in the U.S. has taken place in the last decade. And as their numbers have increased and the scope of the litigation they invest in broadened, both lawmakers and business interest groups have expressed alarm. Shenaq's lawsuit provided one more bit of ammunition.
Mass profits
So far, the bulk of third-party assisted litigation has been in one-off lawsuits, often in complex business matters such as patent disputes. Gerchen Keller, with around $800 million in its litigation portfolio, has publicly said it will shy away from class-actions and personal-injury cases. Its apparent willingness to invest heavily in AkinMears, however, is part of a more recent strategy of finding "late-stage" litigation where the promise of a good return is quick. The subject matter mostly is irrelevant.
Gerchen Keller declined to comment on Shenaq's lawsuit or its business practices, citing client confidentiality.
According to Shenaq's calculations, the 14,000 transvaginal mesh cases AkinMears was intending to buy from a Washington, D.C., firm would net attorney's fees of $14,000 to $16,000 per case, according to the lawsuit. The cost of each case, however, was less than $3,600. Even if some of the cases fizzled out on further inspection, the profits would be immense.
"Akin was now on the cusp of acquiring this massive docket without a nickel coming out of his own pocket," the suit says, adding that the total net value to the firm could be an estimated $100 million. All of that without having to try a single case.
"This is not the way a civil justice system is supposed to work," said Bryan Quigley, ILR spokesman. "The outside money will ... introduce other players that have no stake in it. It will expand litigation and flood courts with useless lawsuits. There is a bias toward settlement in mass tort cases, once the tort has been established."
Buying a case
For the plaintiff bar, the coming of litigation finance is a mixed blessing. It may help small firms or firms that have little track record because one of the biggest obstacles to getting into mass tort litigation is removed: money. But less receptive are the established firms, for so long public enemy number one to business groups.
As they see it, the top plaintiff lawyers will still have to do the hard work and risk their own money to begin litigation that may or may not evolve into a big mass tort. Meanwhile, the big-lot commodity lawyers merely sit on the sidelines and watch, they say.
"There is a difference between using outside money to put into a case and using it to buy a case," Lanier said.
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GAO study finds 510(k)-cleared devices account for 94% of unplanned postmarket safety studies
Nov 6, 2015 | Fierce Medical Devices
By Varun Saxena
Industry and the FDA are striving toward faster approval times counterbalanced by increased postmarket monitoring as they aim to optimize med tech regulation.
Because in order to achieve its vision of protecting patient safety while getting innovative devices to market faster (as exemplified by new initiatives like the Expedited Access Pathway for accelerated approval of critical devices) the FDA needs to improve its use and collection of postmarket data.
A study in The Journal of the American Medical Association concluded that only one of 223 postapproval studies between 2005 and 2011 resulted in any action other than a change in labeling. No warning letters were issued as a result of the studies. An optimist might say that this reflects the strength of the premarket review process, but periodic safety scares like the controversy around power morcellation and metal-on-metal hip debacle show that some unsafe devices inevitably slip through the cracks.[
The GAO study, issued at the request of Rep. Rosa DeLauro (D-CT), analyzed the 313 postapproval market studies and 392 postmarket surveillance studies conducted between 2007 and February 2015. The FDA often requires specified postapproval studies be conducted as a condition of marketing approval, and can order surveillance studies lasting as long as three years at any time in order to inspect possible safety issues.
Among postmarket studies, 94% were ordered to monitor devices approved via the stringent PMA approval process. Among surveillance studies, 94% were ordered to monitor devices cleared via the less-stringent 510(k) process. The dichotomy reflects the lower data collection requirements for 510(k) devices during premarket review, and nearly demonstrates the interaction between the pre- and postmarket regulatory regimes.
The Pew Charitable Trust's medical device initiative pointed out in an email toFierceMedicalDevices that the GAO report claims patient enrollment often delays postapproval studies, and said the use of Unique Device Identifiers (UDI) and data registries can help fill the gaps in studies with small sample sizes or inadequate enrollment. In fact, one-third of the FDA postapproval studies analyzed relied on registries.
Pew and other think tanks like the Brookings Institution are advocating for a public-private partnership to strengthen the postmarket data registry network and increase their use further.
Meanwhile, GAO says that out of the 313 postmarket approval studies analyzed, 176 (56%) were for heart valves and stents. Almost 70% were observational prospective cohort studies--or studies in which a group using a particular device was compared to a second group not using the device for time frame as along as 10 years. An additional 7% were randomized clinical trials and 6% were bench or lab studies.
Finally almost three-fourths of studies are ongoing, 20% are completed and 8% were withdrawn because the study was revised, or the PMA submission withdrawn, among other reasons.
The vast majority of the surveillance studies (354, to be precise) were for orthopedics, devices used in general and plastic surgery, as well as those used in obstetrics and gynecology procedures, reflecting the well-documented safety issues of two sets of 510(k)-cleared devices: metal-on-metal hips and implantable vaginal mesh.
A surprising 88% of the studies were deemed inactive. That's because several such studies (31%) had been consolidated into a larger study of the same device type, while 28% were terminated due to a change in the device's indication for use. And in an additional 38% of those inactive studies, the device was withdrawn or redesigned.
The FDA's device arm is increasingly talking about the importance of postmarket data surveillance, and it is taking action too. In June it issued a safety warning to cardiologists based on troubling postmarket data among patients on theSynCardia Systems' Total Artificial Heart Companion 2 Driver System who underwent certain preimplant interventions.
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C.R. Bard Pays $3.6 million in Precedent Setting Scott Pelvic Mesh Case
Nov 5, 2015 | Mesh Medical Device News Desk
By Jane Akre
It largely slipped by unnoticed, until now.
In July 2012, Plaintiff Christine Scott went to trial against C.R. Bard over her Bard Avaulta Plus mesh kit in a Bakersfield, California courtroom. It would be the first trial to be held naming a major mesh manufacturer.
In a precedent setting decision, the jury found the company was negligent and awarded the Scotts $5.5 million which included $500,000 for loss of consortium for her husband. The surgeon charged with 40% of the fault.
That left the company to appeal its $3.6 million judgment, which it did. See the story here.
Bard, of Murray Hill, N.J., has now exhausted its appeals and the amount was paid on Marc 20, 2015. The information is contained in the company’s 10-Q quarterly report to the Securities and Exchange Commission (SEC) issued October 23, 2015. See it here.
See the Opinion as posted here. It’s a good summary of the case.
The implanting physician Dr. Tillaikaransi Kannappan who had received a one day training lab on the Avaulta taught by Susan Tate, a urogynecologist. Dr. Kannappan was not told Avaulta should not be used in women who are sexually active or for mild prolapse. Scott had incontinence while participating in sports and mild pelvic prolapse of the bladder and rectum. As a treatment, in January 2008 Dr. Kannappan implanted a mesh sling and two Avaulta Plus mesh kits one for anterior one for posterior. Dr. Kannappan says she did not read the instructions for use on the Avaulta plus but did watch a DVD on the surgical technique about a week before Scott’s surgery.
In an interview with KGET-TV 17 in Bakersfield, attorney Elaine Houghton said that the TVM product was tested on “16 rats, 12 rabbits, four sheep and, by their own researcher’s admission, the next living being this product went into was women.”
On appeal the decision was affirmed by the appellate court in November 2014. Then Bard filed a petition to have the issue go before the California Supreme Court. That was denied in February of this year.
This is not only the first trial over transvaginal pelvic mesh, but the first one to be paid following a jury trial and not a settlement. Her attorneys were Houghton and Gene Lorenz of Bakersfield.
The Cisson case followed. It was the first bellwether trial naming Bard in multidistrict litigation also over its Avaulta Plus. See the story here. In August 2013, Cisson was awarded $2 million, but the company filed an appeal. The next two cases to be heard in Charleston, Vigil and Queen, received settlements before they went to trial.
Bard is facing in excess of 21,000 product liability lawsuit over its Women’s Health Product (transvaginal mesh). As of this week, there are 12,735 of those cases filed in multidistrict litigation (MDL) in federal court in Charleston, WV. The Master Complaint was filed in the MDL in July 2012. See it here.
Upon winning her lawsuit, Scott was quoted as saying “Thank you God. We can finally get the word out to women.” See the story here.
Bard stopped selling the Avaulta in July 2012 right after the U.S. Food and Drug Administration requested three-years of post approval monitoring.
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Settlement Dollars are Slow in Coming in Transvaginal Mesh Claims
Nov 5, 2015 | Mesh Medical Device News Desk
By Jane Akre
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.
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