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The judge presiding over all federal Bard Avaulta vaginal mesh lawsuits has asked the parties to develop a list of potential bellwether cases, which would be prepared for early trial dates in the multidistrict litigation (MDL).
After meeting with attorneys from both sides earlier this month, Chief Judge Joseph R. Goodwin called for plaintiff and defense lawyers to identify eight cases each to be considered for early discovery. The list is due no later than March 2.
The Bard Avaulta cases are moving forward as vaginal mesh litigation continues to grow against a number of manufacturers who sell similar devices for repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI). The surgical mesh products have been linked to a risk of serious and debilitating complications, including erosion of the mesh into the vagina, recurrence of urinary problems, pain and disfigurement.
More than 250 lawsuits over C.R. Bard vaginal mesh filed in federal courts throughout the United States have been consolidated before Judge Goodwin for pretrial litigation as part of an MDL. While the litigation initially only included Bard Avaulta mesh products, it has since been expanded to include at least 29 other types of vaginal mesh made by C.R. Bard or their subsidiaries, including Pelvicol, PelviLace, PelviSoft, Pelvitex, Uretex and Align mesh.
In addition to lawsuits against C.R. Bard, a growing number of similar complaints have been filed against Boston Scientific, American Medical Systems (AMS) and Ethicon/Gynecare, which is a division of Johnson & Johnson.
On January 26, the U.S. Judicial Panel on Multidistrict Litigation is scheduled to hear oral arguements over whether the vaginal mesh lawsuits involving these other manufacturers should also be centralized as part of three separate MDLs before Judge Goodwin in the U.S. District Court for the Southern District of West Virginia for coordinated handling.
The number of complaints filed in courts throughout the country has increased in recent years, as public awareness about the risk of vaginal mesh problems increased following an FDA warning issued last year about an increasing number of adverse event reports associated with the products.
In July 2011, the FDA issued surgical mesh warning, indicating that they have been unable to find any evidence that transvaginal mesh kits used for repair of pelvic organ prolapse provide any benefit over other available means of treatment.
In September, an FDA advisory panel was convened to review the potential health risks with vaginal mesh products. At the panel hearing, a majority of surgical mesh manufacturers joined together to create a “Transvaginal Mesh Working Group”, making a joint presentation to the committee and presenting a unified voice and position at the hearing.
Earlier this month, the FDA mailed a letter to several device makers calling for more post-marketing studies into the rate of complications with vaginal mesh systems, which many believe is the beginning of tighter regulations aimed at protecting women from these serious and debilitating problems.
Tags: American Medical Systems (AMS), AMS Vaginal Mesh, Bard, Bard Avaulta, Boston Scientific, Boston Scientific Pinnacle Mesh, C. R. Bard, Ethicon, Gynecare, Gynecare Prolift, Transvaginal Mesh, Vaginal Mesh, Vaginal Sling