Bard Avaulta Mesh Lawsuit Begins Anew After Mistrial

Earlier this week, the first of thousands of federal transvaginal mesh lawsuits returned to court after ending in a mistrial last month. The case is one of 24,000 product liability cases against six manufacturers pending in federal court dealing with allegedly defective transvaginal mesh products, or so-called bladder slings, used to surgically repair pelvic organ prolapse and female stress urinary incontinence.

In this case, 54-year-old Donna Cisson of Georgia is demanding compensation from transvaginal device maker Bard Avaulta, alleging that the manufacturer knew as early as 2002 that the synthetic mesh could degrade over time, erode patients’ vaginal tissue and cause infection but failed to disclose the risks  and continued advertising the device as safe and effective.

As a result, Cisson claims in her Bard Avaulta mesh lawsuit that she suffered extensive pain, bleeding and bladder spasms, and needed to undergo two additional surgeries in an attempt to correct the damage. Her personal injury claims mirror those in thousands of other transvaginal mesh lawsuits.

Bellwether trials and pelvic mesh multidistrict litigation

U.S. District Judge Joseph R. Goodwin of the United States District Court for the Southern District of West Virginia is presiding over the transvaginal mesh litigation including Cisson’s case, the first of four “bellwether” trials selected to help parties and legal experts gauge how juries will respond to the claims, since the same type of testimony and evidence put forth is likely to be presented in case after case.  The lawsuits are grouped together in multidistrict litigations in an effort to consolidate claims and avoid dozens of different courts handling related suits against the same six manufacturers. Of the 24,000 cases, 3,400 are Bard Avaulta mesh lawsuits.

Expert witness disregards pretrial ruling, causing mistrial

Cisson’s case first came to trial on July 9 and quickly ended the following day in a mistrial after a gynecological expert testified that the Bard Avaulta mesh had been removed from the market. Judge Goodwin – who had made a pretrial ruling that this testimony must be excluded since it could bias the jury – determined that a new jury would have to hear the case, calling the prejudicial testimony “a bell that cannot be unrung.” In other words, the first jury would not be able to discard the information after hearing it.

Thousands of transvaginal mesh lawsuits on deck

The number of transvaginal mesh lawsuits has grown quickly since 2011, when the FDA issued a safety communication warning that thousands of women had reported injuries related to vaginal mesh and that the benefits to utilizing the devices might not outweigh the risks, especially when safe and effective surgical alternatives exist.

The following year, the FDA sent a letter asking vaginal mesh manufacturers to conduct additional research trials to determine the safety and efficacy of these devices and establish whether they pose an unreasonably dangerous risk. Within a few months of receiving the 2012 letter, Bard Avaulta mesh was removed from the U.S. market.

Cisson and others argue in their transvaginal mesh lawsuits that these research trials should have been conducted and evaluated long before the products hit the market and allege that because the Bard Avaulta vaginal mesh was subsequently pulled off the market, the device maker knew all along of the dangers the product posed to patients. Judge Goodwin has decided, however, that the jury cannot hear testimony about the removal of the mesh from the market and witnesses in Cisson’s Bard Avaulta mesh lawsuit must abide by this ruling, or else risk causing a second mistrial.