Eleventh-Hour Settlement in Bard Avaulta Trial Set to Begin in Charleston Federal Court

Lori Cohen and team in Charleston, August 2013

Mesh News Desk has learned from two reputable sources connected to the court that a settlement was reached over the weekend in the federal trial of Debra Wise v. C.R. Bard. It was set to begin before Judge Joseph R. Goodwin of the U.S. District Court for the Southern District of West Virginia on Wednesday, February 18.

Case 2:12-cv-01378 was filed May 3, 2012 and the defective product litigation is one of more than 10,000 transvaginal mesh cases filed against this manufacturer.

Details of the settlement are always confidential. A settlement so close to trial could signal that the defense was not confident in its case and did not want the adverse publicity.

The reports are that settlement talks began Friday night and continued over the weekend in Charleston, WV.

Mesh News Desk has a story is in production. Below is the case as it was left before settlement talks.

Plaintiff Debra Wise was implanted with the Avaulta Plus Anterior and Posterior BioSynthetic Support System on July 16, 2007 at St. Mary’s Medical Center in Huntington, West Virginia by Dr. Mitchell E. Nutt, M.D. The polypropylene mesh implant was used to treat her pelvic organ prolapse.

Henry Garrard, attorney

The defendants are C.R. Bard Inc., Sofradim Production SAS and Tissue Science Laboratories Limited. Defense attorneys are Greenberg Traurig from Atlanta (Lori Cohen) and Reed Smith LLP of Los Angeles (Eric Alexander, Michael K. Brown).

Attorney Paul Farrell from Huntington, WV has been added to the plaintiffs’ team from Blasingame, Burch, Garrard & Ashley P.C. (Athens, Georgia).

Ms. Wise alleges negligence, strict liability for design defect, manufacturing defect, failure to warn, breach of express warranty, implied warranty and she has asked for punitive damages. Ronald Wise alleges loss of consortium. The plaintiff says she experiences vaginal spasms, damage to her ureter, vagina and rectum kidney, urinary tract infections, constipation, dyspareunia, lower pelvic pain, incontinence and kidney stones.

Thanks to Fonvielle Lewis Foote & Messer for their support of this trial coverage!

Cartoon courtesy JadeR

Trial Highlights

The Wise case will likely echo many of the expert witnesses and documents from the Donna Cisson Avaulta mesh case against Bard which was heard in the same court before Judge Joseph Goodwin in August 2013. Ms. Cisson was awarded $2 million which included $1.75 million in punitive damages against the company.

The last case against Bard in this courtroom was one year ago (Jones v. Bard, 2:11-cv-00114) that reportedly settled with no disclosure on specifics.

You may recall that the former medical director for Bard, Jim Ross, who appeared via videotape, proposed doing clinical trials of the Bard Avaulta, but the company declined largely because the tests would be outdated in the ever evolving field of transvaginal mesh medical devices.

The Material Safety Data Sheet was what could be called the closest thing to a smoking gun in the Cisson case. In the label that accompanied the raw resin used to make the medical device was this language:

“Do not use this Phillips Sumika Polypropylene Company material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”

Instead, in an effort to protect its supply source, company executives decided to form a dummy company to purchase the resin material to provide a layer of immunity to Bard. See the August 6 story on Mesh News Desk here.

Dr. Marshall Austin, M.D. PhD

Dr. Austin- Biocompatibility Expert

In a Feb. 11 order, Judge Goodwin held that Dr. Marshall Austin, M.D. Ph.D, an expert for the defense, may testify at the Wise trial as an expert in the biocompatibility of mesh. The judge said because Dr. Austin has examined hundreds of vaginal mesh explants over the past ten years and he is qualified to testify about biocompatibility issues but he may not testify whether Avaulta was defectively designed as that is outside of his expertise.

Judge Goodwin also allowed Dr. Austin to testify about the reaction between polypropylene mesh and tissue ingrowth, on the foreign body response and wound healing around mesh. His testimony on pore size is denied. He will be allowed to criticize the work of the plaintiffs’ pathology expert, Dr. Bernd Klosterhalfen.

Dr. Austin is a Professor of Pathology and Director of Cytopathology in the Gynecologic Pathology Division at Magee-Women’s Hospital at the University of Pittsburgh Medical Center. See link here.

Case Numbers Have Nearly Tripled

When the Cisson case was tried there were 27,602 lawsuits filed in this federal courthouse against six manufacturers claiming transvaginal mesh was defective.

At this writing there are 72,465 cases filed against seven mesh makers prompting Judge Goodwin last week to tell both sides to commence settlement talks. It is not possible for the court to handle this many cases in any timely fashion.

Bard, based in Georgia, manufactures various medical devices. It's mesh products included:

Avaulta Plus™ BioSynthetic Support System

Avaulta Solo™ Synthetic Support System

Faslata® Allograft

Pelvicol® Tissue

PelviSoft® Biomes

Pelvitex™ Polypropylene Mesh

The Bard litigation was consolidated in October 2010 in multidistrict litigation in the Southern District of West Virginia before Judge Goodwin..

The Avaulta was taken off the market in June 2012 after the FDA required mesh manufacturers to conduct a three-year post-approval monitoring of women already implanted with the mesh product to assess their condition. The company said it was making a business decision not to invest in the clinical trials for the Avaulta.

After removing Avaulta from the market the FDA no longer required the company to conduct those trials, despite the fact that thousands of women still live with the Avaulta mesh and its complications. #