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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Implanted transvaginal mesh is a bad idea: you think!

Tempers Flare at First FederalTransvaginal Mesh Trial

Posted July 31st, 2013  FiDA highlight

By Doug Allen

CHARLESTON, W.Va. – Physicians dominated the second day of testimony Tuesday in the country’s first federal trial to determine if a transvaginal mesh manufacturer is responsible for injuries to a patient. A doctor who consulted for C.R. Bard Inc. testified that the company knew the resin used to manufacture the mesh should not be permanently implanted in the human body but refused to disclose that to surgeons.

Cisson v. C.R. Bard Inc. is a bellwether case for the more than 23,000 cases involving transvaginal mesh combined in the U.S. District Court for the Southern District of West Virginia. Judge Joseph R. Goodwin is overseeing all of the cases.

In 2009, Dr. Brian Raybon implanted Bard’s Avaulta Plus device into Donna Cisson, the patient at the center of the lawsuit. He spent several hours on the witness stand Tuesday, describing Cisson’s condition and the steps he took to treat it.

Cisson suffered from symptoms like involuntary loss of gas and urine and was diagnosed with pelvic organ prolapse and stress urinary incontinence, Raybon said. He recommended the Avaulta Plus, and Cisson, a nurse, agreed.

“I liked it,” said Raybon, referring to the mesh device. “I felt like it was a good system at that time, and I thought it was appropriate for Mrs. Cisson.”

The urogynecologist from Georgia said he felt confident in the mesh product based on the information he had at the time. He had consulted with Bard on the Avaulta brand for several years, and gained notoriety as the first surgeon to implant an Avaulta product in a patient in the United States.

Concern Grows over Complications

It was only after patients began showing up with complications requiring multiple surgeries to remove the mesh that Raybon discovered the company that manufactured the resin used to make the mesh told Bard it was not to be permanently implanted in the human body.

“How could (Bard) use it with that (warning)?” he asked, when pressed by Cisson’s attorneys. “That’s the part that really concerns me about this. I was astounded when I saw (the warning).”

Under cross-examination, lead defense attorney Lori Cohen pressed Raybon on his failure to contact Bard to ask about the warning, which was disclosed on a Chevron Phillips Material Safety Data Sheet (MSDS) for the resin, once he found out about it.

The jury of four men and four women listened intently as Raybon became visibly agitated and raised his voice while explaining why Bard’s lack of disclosure of the MSDS sheet caused him great concern.

“As someone who spent four or five years at Bard teaching other physicians (about Bard products), and there‘s this MSDS sheet around,” he said. “I’m really concerned I’ve put something in these patients that shouldn’t have been put in. I’m sorry … it was a little irritating to work with someone four or five years, and they didn’t tell me.”

‘Transvaginal Mesh is a Bad Idea’

Late in the afternoon, Dr. Lennox Hoyte, whose response to a question from an attorney caused the first trial to end in a mistrial, returned to the witness stand. Hoyte is a professor of urogynecology and pelvic reconstructive surgery at the University of South Florida, and the chief of urogynecology and robotic surgery at Tampa General Hospital

After being recognized by the court as an expert witness in female pelvic medicine and reconstructive surgery, Hoyte demonstrated how prolapse affects women, using a 3-D model of a woman’s pelvis and a sock.

Hoyte said 50 to 60 percent of women who deliver a baby vaginally will develop some sort of pelvic organ prolapse over time. He also said that he’s performed more than 400 mesh repair operations since 2009, and about 100 of those involved Bard’s Avaulta line.

The net-like device at the heart of the lawsuit includes small mesh “arms” that extend from the device to help hold it in place. Hoyte said he believes the arms are the problem.

“It’s dangerous to go after the arms (during revision surgery) because of the location,” he said.

The mesh implant allows fatty tissue, nerves, blood vessels and muscles to grow through and around it, and Hoyte said it’s not easy to remove. Hematomas (collections of blood) can form, and the vaginal flesh becomes ingrown so tightly around the mesh that surgical removal can destroy so much tissue that the vagina can be difficult to reconstruct.

“Armed transvaginal mesh is a bad idea,” he said. “It never made sense to me. … I always had a feeling the mesh would shrink and cause pain to patients.”

Testimony continues today, with defense attorneys cross-examining Hoyte on Day 3 of what is scheduled to be a 12-day trial.

Doug Allen is a freelance reporter based in Aspen, Colo. His work has appeared in local and national print and radio outlets, including The Washington Post and Aspen Public Radio.

Last modified: July 31, 2013  Drugwatch.com