Four Bellwether Cases Chosen for AMS Mesh Lawsuits
The judge overseeing pretrial coordination of federal AMS mesh lawsuits has selected four cases to serve as bellwether trials. The cases were identified by Judge Joseph R. Goodwin in the U.S. District Court for the Southern District of West Virginia. The first bellwether trial involving AMS pelvic mesh is scheduled for December 2013.
Vaginal mesh lawsuits consolidated in MDLs
Multidistrict litigation has been established in this court for vaginal mesh lawsuits involving the following manufacturers; American Medical Systems (AMS), Boston Scientific, C.R. Bard, Cook Medical, Coloplast, and Ethicon. All of the MDLs are presided over by Judge Goodwin. Coordination of federal cases was established to streamline early trial proceedings and prevent duplicate discovery and conflicting opinions in different courts.
AMS mesh lawsuits were selected for bellwether trials the same month bellwether trials for cases involving C.R. Bard devices is scheduled to begin. Proceedings have begun for the first of four bellwether trials involving Bard Avaulta – a lawsuit filed by Donna Cisson, which was selected earlier this year. These initial cases are an important part of the legal process, since they provide insight as to how juries might respond to testimony and evidence presented. These cases might also enable negotiations for vaginal mesh lawsuit settlements in the future.
FDA warnings could prompt lawsuit filings
Surgical mesh implants were approved by the FDA to treat stress urinary incontinence and pelvic organ prolapse. However, reports of serious transvaginal mesh complications prompted the agency to issue a safety communication in July, 2011. The communication stated that complications stemming from these devices are not rare, as originally thought. The agency also advised women and their medical providers that vaginal mesh may not be more effective for treating POP than traditional surgical procedures.
In 2012, the FDA ordered a number of mesh manufacturers to conduct further studies on the safety and effectiveness of their products. The agency has continued to receive adverse event reports from consumers that including complications like mesh erosion and extrusion, persistent abdominal pain and recurring infections. These events could be prompting additional lawsuit filings, since many states have a two-year statute of limitations that begins when the plaintiffs could have reasonably discovered a defective product led to their injuries.
Bellwether cases proceed amid jury awards and settlement speculations
Currently, there are 8,614 AMS mesh lawsuits pending in the federal MDL. There has been some speculation that AMS may attempt to settle at least some of those cases before the first trial begins in December. An SEC filing recently disclosed that the company reached a settlement of approximately $54.5 million to settle lawsuits pending against them.
Plaintiffs who have filed lawsuits against other manufacturers of vaginal mesh devices have had positive rulings in the courtroom. A California court awarded $5.5 million to a plaintiff who had multiple surgeries to correct the complications caused by her Bard Avaulta mesh device. And a New Jersey jury awarded damages totaling $11.1 million to a woman who alleged injuries from the Gynecare Prolift implant, manufactured by Ethicon.
The four bellwether cases selected for the AMS MDL include the following:
- Lisa Fontes, et al. v. American Medical Systems, Inc.
- Joann Serrano v. American Medical Systems, Inc., et al.
- Debbie K. Jilovec v. American Medical Systems, Inc.
- Mary Weiler, et al. v. American Medical Systems Inc.
Judge Goodwin will choose two of those cases to be ready for trial on December 3, 2013. One of the cases will be determined as the lead case. Judge Goodwin will follow the same process for the second set of cases scheduled for May 6, 2014.
- U.S. District Court, Southern District of West Virginia, Pretrial Order #71 http://www.wvsd.uscourts.gov/MDL/amsinc/pdfs/PTO_71.pdf
- U.S. District Court, Southern District of West Virginia, MDL No. 2325 http://www.wvsd.uscourts.gov/mdl2325/caseviewlist.aspx
- FDA, 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