Mistrial Declared in First Bard Avaulta Mesh Lawsuit
A mistrial has been declared in the first Bard Avaulta mesh lawsuit to be presented before a jury. The judge presiding over the case, and all transvaginal mesh lawsuits in multidistrict litigation, declared the mistrial on the second day of the vaginal mesh trial.
Cisson v. Bard
U.S. District Judge Joseph R. Goodwin is overseeing the lawsuit filed by Donna Cisson against Bard Avaulta. Cisson, 54, alleges that the vaginal mesh implant used to treat her pelvic organ prolapse resulted in significant pain and injury, as well as two subsequent revision surgeries in an effort to correct the damage. Cisson claims she has suffered pain, bleeding, and bladder spasms, which she directly attributes to complications from the mesh product manufactured by Bard Avaulta.
Cisson’s Bard Avaulta mesh lawsuit was chosen by Judge Goodwin to be the first of four bellwether trials. Bellwether trials are used to gauge jury response to testimony and evidence for other lawsuits to follow. Cisson’s trial began with opening statements that ended on July 9.
“A bell that cannot be unrung”
After opening statements, a gynecological expert took the stand and mentioned the Bard Avaulta mesh has been removed from the market since the time it was implanted into Cisson. This testimony was in direct conflict with pre-trial rulings that such information would be excluded, because it could bias the jury. Judge Goodwin called the mistrial in response to the testimony, calling it “a bell that cannot be unrung.”
Judge Goodwin also said this was the first civil mistrial he had declared in his 20 years on the bench – to the best of his recollection. The Bard Avaulta lawsuit is expected to restart later this month before a new jury. The Bard Avaulta mesh lawsuit will be followed by three other bellwether trials as planned. All four of the lawsuits have accused Bard of improper testing of their vaginal mesh devices, failing to disclose the risks as soon as they were known, and advertising their devices as safe and effective, despite the known risks.
Vaginal mesh complications lead to thousands of lawsuits
Vaginal mesh devices have received plenty of attention recently, as complications from devices manufactured by C.R. Bard, American Medical Systems, Johnson and Johnson, and others have been reported. Women who have had these devices implanted to treat pelvic organ prolapse and stress urinary incontinence may experience side effects that are even more uncomfortable than the original condition. Reported transvaginal mesh complications from the devices include mesh erosion and extrusion, persistent pain and bleeding, and recurrent infections.
In July, 2011, the FDA issued a safety communication regarding risks associated with vaginal mesh devices. At the time, the agency stated that complications with these devices were not rare. They also stated there did not appear to be any significant benefit of using the vaginal mesh implants, rather than traditional surgical procedures. In 2012, the agency also sent letters to manufacturers of these devices, ordering them to conduct additional studies on the safety of their products.
Many women have now filed lawsuits against the manufacturers of the devices, claiming the companies knew of the injury risks and failed to alert the medical community and general public. Many of these lawsuits have now been coordinated into multidistrict litigation in U.S. District Court for the Southern District of West Virginia. Multidistrict litigation is established when there are multiple cases with similar complaints, for the purpose of making early trial proceedings more efficient.
Currently, there are more than 4,000 cases pending against C.R. Bard, with thousands more waiting trial against Johnson and Johnson, American Medical Systems, Boston Scientific, Coloplast and Cook Medical. Many are watching this first bellwether trial to determine how much of this litigation might be resolve in the future.
- United States District Court, Southern District of West Virginia, MDL No. 2187 C.R. Bard, http://www.wvsd.uscourts.gov/MDL/2187/
- The State, Mistrial in Surgical Mesh Case in West Virginia, http://www.thestate.com/2013/07/15/2862980/mistrial-in-surgical-mesh-case.html
- FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm262435.htm