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Plaintiffs Lawyers Urge Settlements After $100 Million Pelvic Mesh Verdict
Jun 3, 2015 | Delaware Law Weekly
By Gina Passarella
A $100 million verdict handed up in a Wilmington courtroom last week in a transvaginal mesh case is the latest in a string of high-dollar verdicts that has plaintiffs lawyers saying the defendants should see these as clear reasons to settle. -
Delaware Jury Awards $100 million to Pelvic Mesh Patient
Jun 2, 2015 | The National Law Review
The litigation against manufacturers of pelvic mesh devices continues to increase nationwide. A pelvic mesh implant is a synthetic material implanted and tied to ligaments or bone to lift and support internal organs. -
Pelvic Organic Prolapse Procedures With Mesh Increase, Leading to Age-based Complications
Jun 2, 2015 | Cornell Chronicle
Despite FDA warnings that a synthetic mesh used to treat a weakening of the female pelvis's walls can cause infection, pain, and disease recurrence, surgeons are increasing their use of the device -
Mesh injured victims rally to resolve cases filed in federal court
Jun 2, 2015 | West Vriginia MetroNews
By Carrie Hodousek
Women injured by pelvic mesh devices rallied in front of the federal courthouse in Charleston Tuesday in an effort to resolve thousands of cases filed against the procedure. -
**New** Women in Solidarity Over Mesh Injuries Listen to Court Proceedings
Jun 2, 2015 | Mesh Medical Device News Desk
By Jane Akre
...Attorneys for Johnson and Johnson, which has the most cases filed here (26,200), told the judge it has three trials scheduled for later this year, one in August in this Charleston courtroom and a case scheduled for July in Bergen, New Jersey... -
**NEW** Pelvic Mesh-Injured Women Rally in WV to Call for End to Mesh Implants
Jun 2, 2015 | Mesh Medical Device News Desk
By Jane Akre
...Mesh makers with cases consolidated in this multidistrict litigation include Johnson and Johnson (Ethicon), Boston Scientific, C.R. Bard, Cook Medical, Covidien, Coloplast and Neomedic...
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Plaintiffs Lawyers Urge Settlements After $100 Million Pelvic Mesh Verdict
Jun 3, 2015 | Delaware Law Weekly
By Gina Passarella
A $100 million verdict handed up in a Wilmington courtroom last week in a transvaginal mesh case is the latest in a string of high-dollar verdicts that has plaintiffs lawyers saying the defendants should see these as clear reasons to settle.
A Delaware Superior Court jury awarded May 28 $100 million to a woman who experienced complications from transvaginal mesh implants made by Boston Scientific Corp.
The verdict, according to attorneys for plaintiff Deborah Barba, was composed of $25 million in compensatory damages and $75 million in punitive damages.
Barba's attorneys, Fred Thompson III and Fidelma Fitzpatrick of Motley Rice, said in a statement that the punitive damages award sends a message and, they hope, will cause Boston Scientific and other pelvic mesh manufacturers to settle other cases quickly.
Barba's case is one of thousands faced by manufacturers of pelvic mesh who have been sued over plaintiffs' complications from the mesh implants. Those complications have included pain, urinary problems, bleeding and organ perforation. Barba had to undergo two surgeries to repair her failed implant, but portions of the mesh still remain "painfully embedded" with little hope of being fully removed, her attorneys said.
A Boston Scientific spokeswoman said in an emailed statement, "At Boston Scientific, patient safety is of the utmost importance and we dedicate significant resources to deliver safe, high-quality products. We strongly disagree with the jury's finding and intend to appeal based on the strength of our evidence."
There are nearly 17,000 cases that have been part of In re Boston Scientific Pelvic Repair System Products Liability Litigation, a multidistrict litigation in the Southern District of West Virginia. About 200 of those cases have been resolved. None originated from Delaware, while more than 400 have been brought into the MDL from the neighboring Eastern District of Pennsylvania. Several other state court cases are pending across the country. Between federal and state court actions, Boston Scientific was facing more than 25,000 pelvic mesh suits, including eight putative class actions, as of February, according to its filings with the U.S. Securities and Exchange Commission.
In its 2014 annual report, filed in February, Boston Scientific said, "We intend to vigorously contest the cases and claims asserted against us; however, the final resolution is uncertain and could have a material impact on our results of operations, financial condition and/or liquidity. Initial trials involving our transvaginal surgical mesh products have resulted in both favorable and unfavorable judgments for us. We do not believe that the judgment in any one trial is representative of potential outcomes of all cases or claims related to our transvaginal surgical mesh products."
Boston Scientific announced in late April that it allotted $119 million to settle close to 3,000 of the cases against it. They represented the full inventories of cases of several plaintiffs lawyers, including a Texas state court action for which a $35 million judgment was rendered and on appeal.
"The settlement and the distribution of settlement funds to participating claimants are conditioned upon, among other things, achieving minimum required claimant participation thresholds," Boston Scientific said in an April 28 SEC filing. "If the participation thresholds are not satisfied, the company may terminate the agreement."
While Boston Scientific intends to appeal the Barba ruling and has said one case doesn't foreshadow the outcome of other cases, plaintiffs lawyers say the writing is on the wall.
Thomas R. Kline of Kline & Specter is involved in his firm's representation of more than 2,000 transvaginal mesh patients across several jurisdictions, including several in Philadelphia state court.
"The [Barba] verdict is a loud message that will resound among the manufacturers of mesh products that the strategy of trying cases in the face of punitive damages was an unsound strategy doomed to fail," Kline said in an emailed statement. "The string of plaintiffs' seven-, eight-, and nine-figure jury verdicts, including this punitive verdict, is a predictor of more to come—all based upon a defective product that caused devastating injuries to women. Our firm looks forward to the seven TVM trial listings in Philadelphia [Court of Common Pleas] beginning in December."
Fitzpatrick said in a statement that she hoped mesh manufacturers took note of the verdict and resolved "all pending cases swiftly."
"The punitive damages the jury awarded in this verdict speak very boldly for themselves," Thompson said in a statement about Barba. "With all the evidence we presented, the jury chose the damages according to the irresponsible behavior it thought Boston Scientific demonstrated. We are pleased that Boston Scientific may finally be receiving the message about the dangers of its transvaginal mesh where it hurts most, its wallet."
According to Fitzpatrick and Thompson, the jury in Barba found Boston Scientific negligently designed and manufactured its Pinnacle and Advantage Fit devices and also failed to warn doctors and patients of the products' risks.
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Delaware Jury Awards $100 million to Pelvic Mesh Patient
Jun 2, 2015 | The National Law Review
The litigation against manufacturers of pelvic mesh devices continues to increase nationwide. A pelvic mesh implant is a synthetic material implanted and tied to ligaments or bone to lift and support internal organs. The implants were introduced over a decade ago, and can serve as an alternative to a hysterectomy. Thousands of women, who were allegedly uninformed about the dangers involved with the mesh implants, have since complained of injuries, including severe pain, infections and bleeding that often require follow-up surgeries.
A Delaware jury ordered Boston Scientific to pay $100 million to a woman that was injured by a pelvic mesh device. The trial took two weeks to finish. It took the jury only seven hours to conclude that Boston Scientific had negligently designed the devices and also failed to warn patients and doctors about potential risks. Many of the more than 70,000 pelvic mesh cases remain pending in federal court before U.S. District Judge Joseph Goodwin. Judge Goodwin continues to push the manufacturers to consider settling their cases.
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Pelvic Organic Prolapse Procedures With Mesh Increase, Leading to Age-based Complications
Jun 2, 2015 | Cornell Chronicle
Despite FDA warnings that a synthetic mesh used to treat a weakening of the female pelvis's walls can cause infection, pain, and disease recurrence, surgeons are increasing their use of the device. What's more, when compared to not using mesh, younger patients who undergo surgery with mesh for pelvic organ prolapse (POP) are more likely to have a repeat surgery the following year, and older patients are more likely to have complications while they're in the hospital, according to new research from Weill Cornell Medical College.
POP occurs when a woman's uterus or vaginal walls weaken and descend, causing bleeding, incontinence and other painful symptoms. The condition affects about 40 percent of women after childbirth, according to a 2002 study in the American Journal of Obstetrics and Gynecology.
Using data from the New York State Department of Health Statewide Planning and Research Cooperative System (SPARCS), which records every incidence of surgery in the state, the researchers found that POP repair using mesh increased from 21 percent in 2008 to 30 percent in 2011, despite multiple FDA warnings beginning in 2008.
The researchers broke the patients into two age groups, discovering that younger patients who received mesh had a 66 percent higher risk of experiencing another intervention within one year when compared to those who had repair without mesh. Mesh use was associated with 36 percent higher risk of developing in-hospital complications such as urinary retention among older patients. The study was published June 2 in BMJ.Dr. Bilal Chughtai
Photo credit: Weill Cornell Art and Photography"This study is addressing the real-world, population-based application of mesh as a medical device, and it yields a different profile for its safety — that mesh is not as safe as people believe it is," said senior author Dr. Art Sedrakyan, an associate professor of healthcare policy and research in cardiothoracic surgery at Weill Cornell.
Mesh is frequently used for POP because it's relatively inexpensive and provides an easier solution for physicians than the alternative, such as more time-consuming and skillful repair of damaged tissue. Previous research investigated the safety and efficacy of mesh, but the studies were small and yielded conflicting results, the authors say.
This study is the first to investigate mesh use in POP surgeries on a major population level like New York State and to employ such an extensive data set. The large number of surgeries allowed the researchers to evaluate safety by different age groups. The researchers also used propensity matching, an advanced statistical technique that ensures that the patient groups being examined are truly comparable and therefore yield reliable results.
Importantly, the researchers emphasize that mesh is not always dangerous and caution against extreme interpretation of the findings. In some instances mesh use might be needed and women should discuss with their physicians which form of POP surgery would be most effective for them personally, taking into account benefits and harms as well as factors such as anatomy, age and medical history.
The researchers' ability to glean insights based on age, a patient-specific characteristic, highlights the need for and the potential of a comprehensive registry of mesh-based surgical procedures and their outcomes, added lead author Dr. Bilal Chughtai, an assistant professor of urology at Weill Cornell. Such a registry would provide a powerful tool for personalized treatment recommendations, based on data from previous patients with similar characteristics and medical histories who underwent surgeries.
"With a registry we could potentially identify the correct procedure for the correct patient, and in turn, minimize harm and maximize benefits for patients," Dr. Chughtai said.
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Mesh injured victims rally to resolve cases filed in federal court
Jun 2, 2015 | West Vriginia MetroNews
By Carrie Hodousek
Women injured by pelvic mesh devices rallied in front of the federal courthouse in Charleston Tuesday in an effort to resolve thousands of cases filed against the procedure.
As of last week, seven mesh manufacturers are facing nearly 80,000 product liability cases against transvaginal and hernia mesh slings, consolidated before Judge Joseph Goodwin in the U.S. District Court of the Southern District of West Virginia.
The net-like implant is used to treat pelvic organ prolapse (POP) and urinary incontinence problems in women, but the product design contributes to serious complications causing chronic pain and infections.
“It has killed women. It has had women commit suicide. The mesh migrates through your body, it breaks, it goes through organs. It has crippled a lot of women. There’s a lot of divorces,” said Tammy Jackson, of Kentucky, whose had surgery complications. “We’re here to bring awareness, so this product will be recalled off the market.”
Judge Goodwin ordered all manufacturers of mesh to come together Tuesday, to hear both sides and eventually reach a settlement agreement.
According to the U.S. Food and Drug Administration, the permanent medical device was not supposed to be used in women. Manufacturers bypassed it, without FDA testing or approval of the device.
Jackson said her case has been filed for nearly five years. Since then, she said thousands of women have undergone numerous surgeries.
Lisa Mason, of Florida, said she hopes a settlement can be reached to help cover her surgery costs since she currently does not have insurance.
“One, we want it off the market, so no more women get hurt and two, we want the manufacturers to be responsible for the surgeries that we have to have,” said Mason.
Since the first implementation in the late 1990s, the FDA noted, in 2011, mesh complications rose and that it was “not rare” the complications could be life-altering and permanent.
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**New** Women in Solidarity Over Mesh Injuries Listen to Court Proceedings
Jun 2, 2015 | Mesh Medical Device News Desk
By Jane Akre
By Tuesday afternoon, women who gathered for a status hearing on their pelvic mesh cases began filtering into Judge Joseph Goodwin’s Charleston, WV courtroom.
Judge Goodwin is overseeing more than 76,000 product liability cases in the U.S. District Court of the Southern District of West Virginia. He had called for a status hearing from five manufacturer, which brought attorneys from both sides to Charleston. Here is the status conference order.
Tammy Jackson, a mesh-injured participant from Kentucky tells MND that they listened as Judge Goodwin called up each manufacturer to account for what each was doing to bring these mass tort proceedings forward to some resolution.
One plaintiff attorney told a woman present he wanted a T-shirt like the one she was wearing with a slash through the word “Mesh”.
Attorneys for Johnson and Johnson, which has the most cases filed here (26,200), told the judge it has three trials scheduled for later this year, one in August in this Charleston courtroom and a case scheduled for July in Bergen, New Jersey. J&J vows to continue with litigation until it is vindicated in court.
“It went real quick,” says Jackson as lawyers for each of the five manufacturers present spoke before Judge Goodwin.
Women have filed defective product actions against manufacturers claiming the mesh is defectively designed and manufactured and that instructions to end users (doctors) are defective and inadequate. Without informing doctors, their female patients can never receive true informed consent. Several jury trials have ended up in excess of $200 million in compensatory awards and a designation that the pelvic mesh was defective. Still, most meshes remain on the market.
Outside, about 20 mesh-injured woman and their families chanted “No More Mesh” as lawyers arrive at the federal courthouse. One husband held up a sign to passing motorists. Another woman had an image of Alex Gorsky, the CEO of J&J, behind bars.
Jackson says plaintiffs’ attorneys would stop, smile and give the thumbs up, while attorneys representing defendants would ignore the crowd or shoot them a disapproving look.
The Department of Homeland Security, which oversees courthouse safety, made the group feel welcome offering them restroom and water breaks. “We were treated very well.,” says Jackson who added the camaraderie of the group was emotionally overwhelming.
“We hugged each other, it was beautiful. It’s a sisterhood we don’t forget,” she said, vowing to return.
This story is in production as the court files and update on the status hearing. Judge Joseph Goodwin has said the federal court was never designed to deal with such a large number of product liability cases, the largest mass tort ever filed in one court.
Pelvic mesh, made of polypropylene, remains on the market and is still used by doctors to treat pelvic organ prolapse and incontinence, even though the U.S. Food and Drug Administration has said that complications are “not rare”.
As a result, some manufacturers have quietly removed their most problematic mesh products, those associated with the most injuries.
Patients need to ask if the mesh is made of polypropylene, which, when implanted transvaginally, seems to cause life-altering complications in about one-third of the recipients.
Hernia mesh patients are also experiencing pain, mesh shrinkage, chronic infections, and autoimmune reactions. #
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**NEW** Pelvic Mesh-Injured Women Rally in WV to Call for End to Mesh Implants
Jun 2, 2015 | Mesh Medical Device News Desk
By Jane Akre
A rally by mesh-injured women gathered in Charleston, West Virginia today as lawyers from both sides of the issue converged for a status conference before the judge overseeing more than 76,000 defective product cases.
Mesh Awareness Movement brought about 20 women, their husbands and friends from Kentucky, Ohio, Pennsylvania, Florida and beyond to join in solidarity and send a message that pelvic mesh should not be allowed to continue to injure unsuspecting women and that mesh manufacturers need to financially care for the women they’ve harmed.
Pelvic mesh, used to shore up pelvic organs, was never approved for safety or efficacy by the U.S. Food and Drug Administration. Instead it was approved by the FDA 510(k) approval process that does not require any clinical trials.
Beginning in the late 1990’s, pelvic mesh was fashioned from hernia mesh and the polypropylene was marketed by seven manufacturers who are facing defective product lawsuits consolidated in this federal court. There are more than 76,000 cases here before The Honorable Judge Joseph Goodwin. Manufacturers are facing more than 100,000 cases nationwide.
“Exciting” is what women told Mesh News Desk today. All of the television stations were here and we will be featured on their noon news. Finally we are getting the attention we deserve and the message is getting out,” said organizer Lisa Mason.
The women tell MND that lawyers representing plaintiffs fave a thumbs up as they filed into the building for a status conference called by Judge Goodwin who wants these cases settled. Lawyers for manufacturers gave a thumbs down to the crowd which numbered around 20. One woman had her surgery scheduled for today but opted to be in Charleston instead.
Here are some of the images from today.
Catch the news coverage on the local ABC and CBS television stations in Charleston, WV.
Background
Pelvic mesh, made of polypropylene, is still used by many doctors as a first line treatment to treat pelvic organ prolapse (POP) or stress urinary incontinence (SUI) though it is falling out of favor, doctors tell MND, because many doctors are being sued for medical malpractice. The FDA in 2012 said complications from mesh are “not rare” after a five fold increase in adverse event reports to the agency.
In trials conducted so far, the failure to adequately inform the doctor about the risks of mesh have seen the doctor side with the plaintiff. Many meshes have been found to be defectively designed and the risks underplayed in trials so far.
Boston Scientific was ordered to pay a mesh-injured woman $100 million dollars in a Delaware trial concluded just last week.
Today’s status conference before Judge Goodwin will be held in open court with individual manufacturers negotiating behind closed doors with Judge Goodwin.
Mesh makers with cases consolidated in this multidistrict litigation include Johnson and Johnson (Ethicon), Boston Scientific, C.R. Bard, Cook Medical, Covidien, Coloplast and Neomedic.
American Medical Systems has begun the settlement process with plaintiffs though some awards after legal fees range around $20,000. #
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