Catastrophically harmed by surgical mesh? Justice in settlements?

Progress Continues TowardSettling Coloplast Mesh Lawsuits: Report

By: Austin Kirk | Published: June 25th, 2014

As hundreds of Coloplast mesh lawsuits continue to move forward through the federal court system, the parties are continuing to make progress in settlement negotiations to resolve the litigation, according to a recent court update.

Coloplast Corp. currently faces nearly 1,500 federal transvaginal mesh and bladder sling lawsuits, which have all been consolidated for pretrial proceedings before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia as part of an MDL, or multidistrict litigation.

All of the complaints involve similar allegations that women suffered severe and debilitating complications after receiving Coloplast mesh for surgical repair of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI), where the mesh eroded through the vagina, caused infections or other injury.

According to a pretrial order (PDF) issued by Judge Goodwin on June 16, “substantial progress” has been made toward settling the Coloplast cases and a follow up status conference has been scheduled for August 7, at which time the parties will meet with Judge Goodwin in chambers to provide an updated report.

In March, it was reported that a Coloplast mesh settlement was reached to resolve about 400 cases for $16 million.

In addition to lawsuits against Coloplast, Judge Goodwin is also presiding over thousands of similar cases brought against manufacturers of other transvaginal mesh products, including C.R. Bard, American Medical Systems (AMS), Ethicon, Boston Scientific, Cook Medical and Neomedic.

Endo Health Systems reported last month that it has agreed to pay $830 million to settle AMS mesh lawsuits brought by about 22,000 women, making it the largest settlement reported to date in the litigation.

C.R. Bard has also reached a number of individual settlements involving cases that were scheduled to come up for trial, but no global settlement agreement has been reached.

Vaginal Mesh Litigation Update

According to the latest case list (PDF) released by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on June 16, Judge Goodwin is currently presiding over 17,812 AMS mesh lawsuits, 18,176 Ethicon mesh lawsuits, 12,004 Boston Scientific mesh lawsuits, 8,555 Bard Avaulta mesh lawsuits, 1,468 Coloplast mesh lawsuits, 195 Cook Medical mesh lawsuits and about 52 Neomedic mesh lawsuits.

The combined total of 58,262 vaginal mesh claims pending in the federal court system represents a nearly 35% increase in the number of cases pending since March 2014, when the U.S. JPML reported that a combined total of 43,173 cases were centralized before Judge Goodwin. In addition, thousands of other cases are pending in various state court systems throughout the country.

As part of the coordinated pretrial proceedings in federal court, Judge Goodwin has scheduled a series of early trial dates involving several of the manufacturers. Known as “bellwether” cases, such test trials are designed to help the parties gauge how juries may respond to certain evidence and testimony that may be repeated throughout the litigation.

In August, a trial involving a lawsuit filed against Ethicon by Jo Huskey is scheduled to go before a federal jury. Huskey alleges that she suffered injuries after receiving an Ethicon TVT-O bladder sling for stress urinary incontinence.

Later this year, a combined trial involving 11 Boston Scientific mesh cases is set to go before a jury starting in October 2014. That case involves women who experienced problems after receiving a Boston Scientific Obtryx sling for repair of stress urinary incontinence.

Last year, a series of three Bard Avaulta trials were set for trial in the MDL, with the first case going before a federal jury in July 2013, involving a lawsuit filed by Donna Cisson. That trial resulted in a $2 million damage award against Bard, including punitive damages designed to punish the company for the actions during the manufacture and sale of the product. The second and third trials were each settled shortly before they were set to begin, with terms of the deals withheld.

Given the lack of progress towards settling additional cases by some manufacturers, Judge Goodwin recently ordered that a second wave of Bard Avaulta cases and Boston Scientific mesh cases be prepared for trial, with hundreds of cases going through case-specific discovery over the remainder of this year so that they can be trial-ready by early 2015.

If the manufacturers fail to reach vaginal mesh settlements to resolve the majority of cases against them, they could face hundreds of individual trial dates scheduled throughout the country next year.

Related Articles

            Coloplast Mesh Settlement Reached To Resolve 400 Lawsuits: Report (3/6/2014)

            Ethicon Prolift Mesh Lawsuits To Be Selected For MDL Trial in Aug. 2014 (9/11/2013)

            Trials for AMS, Ethicon & Boston Scientific Mesh Cases to Begin Dec 2013 (12/11/2012)

            Additional Bellwether Trial Dates Set for Vaginal Mesh Implant Lawsuits (9/5/2012)

            Coloplast Pelvic Mesh Lawsuit Consolidation Sought in W.V. MDL (7/5/2012)

Tags: Bladder Sling, Coloplast, Transvaginal Mesh, Vaginal Mesh, West Virginia

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Boston Scientific follows product failure with belated $1 million clinical study

Vaginal Mesh Effectiveness Target of New Boston Scientific Study

By: Austin Kirk | Published: June 10th, 2013  (FiDA highlight)

Boston Scientific announced last week that it is working with the Pelvic Floor Disorders Network (PFDN) to study the effectiveness of treating uterine prolapse with vaginal mesh compared to traditional surgery.  

The company is contributing more than $1 million to the study, which will look at one form of pelvic organ prolapse (POP) and the available treatment options.

The announcement comes two years after the FDA found that there was no evidence that transvaginal mesh provides any additional benefits when compared to traditional surgery, yet it appears to carry a risk of serious complications.

Concerns about the safety of surgical mesh for treatment of pelvic organ prolapse and female stress urinary incontinence gained widespread attention in July 2011, when the FDA indicated that nearly 3,000 reports of problems with vaginal mesh were received by the agency between January 2008 and December 2010, including cases where the mesh eroded through the vagina, caused infections and other debilitating injuries.

In early 2012, the FDA sent a letter to several manufacturers of these products, ordering that they conduct additional studies and trials to evaluate the safety of transvaginal mesh products, looking for additional information to establish whether they pose an unreasonable risk of injury for women.

Concerns Over Safety and Effectiveness of Vaginal Mesh

The main manufacturers of vaginal mesh products sold in the United States are Boston Scientific, American Medical Systems (AMS), C.R. Bard, Johnson & Johnson’s Ethicon and Gynecare subsidiaries, Coloplast Corp. and Cook Medical.

Many of these products were approved through the FDA’s controversial 510(k) system, which allowed the manufacturers to begin selling the devices without conducting rigorous pre-market studies. Products were approved by the agency as long as the manufacturer could indicate that it was “substantially equivalent” to other products on the market.

As concerns have surfaced over the safety and effectiveness of vaginal mesh, many of the manufacturers have elected to cease marketing their products in an effort to avoid conducting the required studies.

The new study announced last week by Boston Scientific, the SUPeR clinical trial, is expected to enroll 180 women considering surgery to treat uterine prolapse who do not plan to have any more children. The women will either be implanted with the Boston Scientific Uphold LITE Vaginal Support System or they will be treated with more traditional surgery, including a vaginal hysterectomy.

The test subjects will be evaluated every six months for up to five years. Researchers will look at the safety, success, cost-effectiveness and other factors resulting from the surgery. The final results are expected in 2018.

Vaginal Mesh Lawsuits

About 20,000 women throughout the U.S. are currently pursuing a vaginal mesh lawsuit against the makers of these products, alleging that transvaginal surgical mesh is unreasonably dangerous and defective, carrying a severe risk of painful and debilitating health problems for women that outweighs any potential benefits.

The U.S. Judicial Panel on Multidistrict Litigation (JPML) has established separate consolidated proceedings in the federal court system for cases involving different manufacturers, with five Multidistrict Litigations (MDLs) centralized before U.S. District Judge Joseph Goodwin in the Southern District of West Virginia.

According to an updated case list (PDF) released on May 15, Judge Goodwin is currently presiding over at least 2,938 Bard Avaulta lawsuits, 6,028 AMS vaginal mesh lawsuits, 3,557 Boston Scientific pelvic mesh lawsuits, 5,763 Ethicon Gynecare mesh lawsuits and 320 Coloplast bladder slings lawsuits.

Several cases pending in state courts throughout the country have already gone to trial, with a California court awarding $5.5 million in damages to a woman who experienced complications with a Bard Avaulta mesh in July 2012, and a New Jersey state court jury awarded $11.1 million in damages in February, including both compensatory and punitive damages for problems with Ethicon’s Gynecare Prolift mesh.

In the federal court system, the first vaginal mesh trials are scheduled to begin next month, with a series of lawsuits involving the Bard Avaulta mesh set to begin on July 6. Later this year and early next year, a series of at least three additional trials will be held involving AMS mesh, Boston Scientific mesh and Ethicon mesh.

These early trial dates are designed to help the parties gauge how juries are likely to respond to certain evidence and testimony that may be offered throughout the vaginal mesh litigation. The preparation and any outcomes may help facilitate negotiations to reach vaginal mesh settlements in other cases.