U.S. District Court, Charleston, W.V.
July 7, 2013~ The Donna Cisson bellwether case is set for jury selection and opening arguments July 8th in a Charleston, West Virginia federal courthouse. Defendant C.R. Bard is named along with Bard Urological, a division of C.R. Bard, Inc. that designed, manufactured, marketed, packaged, labeled and sold the product in question - the Avaulta Plus Posterior BioSynthetic Support System.
Donna Cisson, 54, was implanted May 8, 2009 at Stephens County Hospital in Toccoa, Georgia. Dr. Brian Raybon performed her surgery to treat pelvic organ prolapse.
As a result of her surgery, Cisson experienced mental and physical pain, suffering permanent injury, permanent and substantial physical deformity. She has undergone corrective surgeries which has led to an economic loss for her family for medical services and expenses, present and future lost wags and impaired physical relations with her husband and co-plaintiff Dan Cisson, says the complaint.
The plaintiffs allege negligence - that Bard had a duty to design, make and market, label, package and sell a safe product which was the cause of Donna Cisson's injuries, pain, losses, emotional distress and other damages. Plaintiffs allege a design and manufacturing defect which caused her damages. Additionally, C.R. Bard failed to warn plaintiff Cisson, which led to her injuries.
The defendants made assurances to the general public, hospitals and healthcare professionals that the Bard Avaulta mesh was safe and effective for its intended purpose. Those assurances are what Donna Cisson relied upon to make her decision to have the implant placed. Her husband Dan also has suffered a loss of his wife's consortium and companionship as a result of her injuries and his damages are another count.
C.R. Bard could face punitive damages. This is the first of almost 4,000 cases against Bard consolidated in this federal court in West Virginia in multidistrict litigation (MDL). Five other manufacturers are named in about 25,000 cases filed in the same court.
More than $7 million was awarded Linda Gross in her trial against Ethicon in a New Jersey state court last February. Christine Scott was awarded $3.6 million in the first trial against C.R. Bard in California state court in June of last year. She was implanted with the Bard Avaulta Solo mesh. Shortly after that decision the Avaulta line was taken off the U.S. market.
A spokesman for Bard told Bloomberg News that Avaulta mesh is a "safe and effective treatment for pelvic organ prolapse when used in accordance with its instructions."
Unsealed documents in the case show that Bard executives understood that the plastic resin that makes up the polypropylene mesh material was not designed to be implanted in the human body. that information was contained in a "Material Safety Data Sheet" filed with the federal government by a unit of Chevron Phillips Chemical Company concerning the Marlex polypropylene material. Background story is here.
“Do not use this Phillips Sumika Polypropylene Co. material in medical applications involving brief or temporary implantation in the human body or contact with internal body fluids or tissues unless the material has been provided directly from Phillips Sumika Polypropylene Co. under an agreement that expressly acknowledges the contemplated use,” according to the warning.
Despite the warning, the emails between company executives reveal not to tell anyone the raw material is intended for a medical device, according to court documents.
Here is Marlex warning filed with the Occupational Safety and Health Administration.