By Laura V. Yaeger, J.D., LL.M, July 10, 2013
Breaking News: The Bard trial ended with a mistrial this afternoon. Bard’s defense lawyer argued that a doctor’s testimony that the product was no longer available to buy ran afoul of the court’s evidentiary ruling. A new trial has been set for July 29.
Lawyers concluded their opening statements in the Cisson v. Bard trial on Tuesday. Donna Cisson, the 54-year-old plaintiff, had a Bard Avaulta transvaginal mesh implanted to treat pelvic organ prolapse and has since had two surgeries to repair the damage done by the mesh.
Plaintiff’s counsel told the jury — five women and three men — why Bard was responsible for the plaintiff’s injuries:
- Bard knew of the risks associated with Bard Avaulta transvaginal mesh and failed to inform doctors.
- Bard did not do clinical testing or studies to learn the risks of Bard Avaulta transvaginal mesh.
- Bard did not study how to remove Bard Avaulta transvaginal mesh.
- Bard marketed and sold Bard Avaulta transvaginal mesh despite knowing the material used to make it, Marlex, was not designed to implant in the human body.
- Bard did not tell doctors that Bard Avaulta transvaginal mesh was not fit for human use.
Bard fought to keep evidence related to Marlex, the material used to manufacture Bard Avaulta transvaginal mesh, from being heard by the jury. Before the trial, Bard filed an extensive motion in limine to exclude this evidence. However, the Honorable Judge Goodwin denied Bard’s motion.
Bard’s internal documents show that it knew that Marlex resin was not designed to use in the human body. The Material Safety Data Sheet for Marlex states:
“Do not use this … material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”
Bard ignored this directive. It used the material to manufacture Bard Avaulta transvaginal mesh and now thousands of women suffer various complications ranging from pelvic pain, mesh erosion, organ perforation, pain with intercourse, infections, bleeding and the need for additional surgeries.
Bard’s strategy in opening is to confuse the jury by focusing on the safety and efficacy of the product and any other possible cause of the plaintiff’s injuries. Bard’s attorney, much like Bard’s executives, claimed that the product is safe and effective for treating plaintiff’s pelvic organ prolapse when it is used in accordance with its instructions. She continued to claim that the Plaintiff and her doctors were fully informed of all the risks.
Bard manufacturers Avaulta synthetic surgical mesh, Avaulta BioSynthetic, Avaulta Plus and Avaulta Solo, as well as pelvic repair meshes, including PelviSoft, PelviLace, Pelvitex, Uretex, Align, Acellular Collagen Matrix, Faslata Allograft and Pelvicol. Recently, after the successful transvaginal mesh trial in New Jersey against Ethicon, a Johnson & Johnson company, Bard chose to remove all Avaulta transvaginal mesh products from the market.
Currently, thousands of cases against Bard are pending in the federal court in West Virginia. Tens of thousands more are pending against other manufacturers of transvaginal mesh – Johnson & Johnson, American Medical Systems, Boston Scientific, Coloplast and Cook Medical.
The trial continues today in the U.S. District Court of the Southern District of West Virginia.
Laura V. Yaeger is a contributing writer for Drugwatch.
The views and opinions expressed here do not necessarily represent those of Drugwatch.