Monday, July 8, 2013, marks the beginning of a Transvaginal Mesh Implant bellwether case, with jury selection and opening arguments set to take place. The trial against Defendant C.R. Bard, also named Bard Urological, a division of C.R. Bard, Inc., is being tried at the Federal Courthouse in Charleston, West Virginia. This case is only the first of nearly 6,000 cases filed against C.R. Bard in the multidistrict litigation (MDL) which have been consolidated into the West Virginia. Five additional manufactures of Mesh Implants are named as defendants in about 27,000 other cases filed in this same Court.
The plaintiff in the case, Ms. Donna Cisson, was implanted with C.R. Bard’s Avaulta Plus Posterior BioSynthetic Support System in May of 2009. As a result of her surgery to implant the Avaulta Plus Posterior BioSynthetic Support System, Cisson has endured both physical and mental pain, sustaining permanent injury along with permanent and substantial physical deformity. Additionally, Cisson’s need undergo costly corrective surgeries and her loss of present and future lost wages has amounted to a significant economic loss for her family. Moreover, Cisson has suffered from impaired physical relations with her husband Dan, a co-plaintiff in the case, who himself has suffered a loss of his wife’s consortium and companionship.
The Plaintiffs allege negligence and failure to warn on the part of C.R. Bard. Bard had the duty to design, make and market, label, package and sell a safe product. Unfortunately, the design and manufacturing defects of C.R. Bard’s Avaulta Plus Posterior BioSynthetic Support System caused Cisson’s injuries, pain, losses, emotional distress, and other damages.
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 very assurances are what Donna Cisson and her healthcare providers relied upon in making the decision to have her implanted with C.R. Bard’s Avaulta Plus Posterior BioSynthetic Support System in the first place.
A spokesman for Bard informed Bloomberg News that the Avaulta Mesh is a “safe and effective treatment for pelvic organ prolapse when used in accordance with its instructions.” However, and in contrast to, unsealed case documents show that Bard executives were aware and understanding 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 Polyproylene Material. Background story found 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, emails between C.R. Bard executives reveal intent not to tell anyone the raw material is intended for a medical device according to the court documents. Consequently, C.R. Bard could face significant damages.
As material developments occur we will strive to update them on this blog.