Tens of thousands of transvaginal mesh (TVM) lawsuits have been filed against the makers of TVM devices. To date, two lawsuits pending against C.R. Bard Inc, the manufacturer of Avaulta, Faslata, Pelvicol and PelviSoft products have been settled.
In March 2013, an $11 million verdict was rendered for the Plaintiff in the first Ethicon trial (In re: Pelvic Mesh/Gynecare Litigation, No. 6341-10; In re: Pelvic Mesh Litigation/Bard, No. L-6339-10).
All the transvaginal mesh lawsuits allege the products are defective and have resulted in severe health issues ranging from pain during sex to erosion of vaginal tissue and infection to death.
Also known as transvaginal slings, the specific complications associated with TVM include the following:
• mesh erosion into the vagina, bladder, intestines and uterus
• infection
• pelvic pain
• urinary problems, including recurrence of prolapse and/or incontinence
• development of urinary retention
• bowel, bladder and blood vessel perforation during insertion
• vaginal scarring
• dyspareunia (pain with sexual relations),
• fistulas and recurrence of prolapsed organs
• neuropathic pain
Some women have undergone additional surgical procedures, often to remove the mesh, along with IV therapy, blood transfusions, and drainage of hematomas or abscesses.
Here we provide an update on Bard, Johnson & Johnson, and American Medical Systems TVM litigation.
Bard TVM Multidistrict Litigation (MDL)
•The Bard Avaulta litigation was consolidated in October 2010 as part of an MDL in the US District Court for the Southern District of West Virginia.
•A jury hearing the first Bard transvaginal mesh personal injury lawsuit has awarded the plaintiff $2 million in damages. In her lawsuit, Donna Cisson alleges that the mesh, one of the line of Avaulta transvaginal mesh products made by C.R. Bard Inc, which she had surgically implanted, caused her bleeding and pain.
• With thousands of transvaginal mesh lawsuits pending in a multidistrict litigation (MDL) in West Virginia, Cission’s case is a bellwether. The jury found that Bard indeed failed to issue warnings regarding the transvaginal mesh design defect. Consequently, they awarded Cisson $250,000 in compensatory damages and $1,750,000 in punitive damages.
• A second bellwether trial to go to federal court in a West Virginia was settled August 21 against Bard. The plaintiff, Wanda Queen, alleged her implanted Avaulta transvaginal mesh caused her injury and complications, forcing her to undergo six surgeries. Settlement terms between the company and the court were not released. Scott Lowry, a spokesman for C.R. Bard, said the settlement only covered this particular case, and not the thousands of pending lawsuits against the company.
• The implant cases against Bard and other manufacturers have been consolidated before U.S. District Judge Joseph Goodwin in Charleston for pretrial information exchanges. Two other trials are set for October, according to court dockets.
• The Bard consolidated cases are In re: C.R. Bard Inc. Pelvic Repair System Products Liability Litigation, 10-md-02187. Queen’s case is Queen v. C.R. Bard Inc., 11-cv-00012, U.S. District Court, Southern District of West Virginia (Charleston).
• An MDL is more practical for both the plaintiffs and the judicial system, as it allows for the trying of all cases on an individual basis. An MDL is a special federal legal procedure that speeds up the process of handling complex cases such as complex product liability lawsuits. An MDL can take place when civil actions involving one or more common questions of fact are pending in different districts. Additionally, MDLs reduce the likelihood of duplicative discovery and conflicting pretrial rulings from different judges.
• Bard also faces the first trial in state court coordinated litigation in Atlantic City, New Jersey, on September 23, the National Law Journal reports.
• Bard, based in Georgia, manufactures, distributes and markets numerous medical devices. Brand names of Bard’s transvaginal mesh patches include:
Avaulta Plus™ BioSynthetic Support System
Avaulta Solo™ Synthetic Support System
Faslata® Allograft
Pelvicol® Tissue
PelviSoft® Biomesh
Transvaginal mesh lawsuits involving Johnson & Johnson
• TVM lawsuits pending against J&J’s subsidiary Ethicon are also progressing in federal court in West Virginia, according to court documents.
• The next status conference, in which pretrial proceedings will be discussed, will be held at 10 a.m. on Sept. 19, according to court documents (In Re Ethicon, Inc., Pelvic Repair System Products Liability Litigation; MDL-2327, U.S. District Court for the Southern District of West Virginia).
Transvaginal Mesh Lawsuits Involving American Medical Systems
• Transvaginal mesh lawsuits filed against American Medical Systems, Inc. continue to move forward in a federal MDL also underway in U.S. District Court, Southern District of West Virginia.
• According to a Pretrial Order issued on July 29, the Court has granted the parties’ Joint Motion for an Agreed Order and Stipulation Regarding Third-Party Subpoenas.
• Court documents indicate that more than 8,860 vaginal mesh lawsuits are now pending against American Medical Systems in the federal litigation (In Re: American Medical Systems, Inc., Pelvic Repair Systems Products Liability Litigation - MDL No. 2325).
• All of the mesh lawsuits pending in the American Medical Systems litigation allege the company failed to provide adequate warnings regarding the risks associated with its transvaginal mesh devices.
• According to court documents, the first bellwether trial of an American Medical Systems vaginal mesh lawsuit is set to begin in December.
Other TVM Manufacturers
• Endo Health Solutions Inc, and Boston Scientific Corp face similar claims to Bard and J&J, specifically that their implants, threaded in place through vaginal incisions, shrink over time - a design defect that can result in severe health consequences.
•The FDA has also received many adverse reports regarding other transvaginal mesh devices, including the Gynecare TVT sling. TVT systems typically involve mesh tape with vaginal sling surgery, also known as a TVT sling procedure, which results in a transvaginal sling to correct urinary incontinence.
MDLs pending in West Virginia & Georgia
• The implant cases against Bard and other manufacturers have been consolidated before US District Judge Joseph Goodwin in Charleston for pretrial information exchanges.
• Two other trials are set for October, according to court dockets.
• To date, more than 20,000 mesh lawsuits have been filed against a number of other implant manufacturers in separate litigations: Mentor Corp.; MDL-2004, U.S. District Court for the Middle District of Georgia. C.R. Bard, American Medical Systems, Boston Scientific, Ethicon, Coloplast and Cook Medical; MDLs-2187, 2325, 2326, 2327, 2387, and 2440, U.S. District Court for the Southern District of West Virginia.
TVM History & Facts
• The US FDA approved the Avaulta transvaginal mesh device using a fast-track approval process known as 510(k) in 2005.
• The expedited process does not require formal review of a product’s safety, and has allowed many controversial products, which were later recalled, to be introduced to the market.
• Since the device was approved, the FDA has received over a thousand reports of complications associated with surgical mesh.
• In October 2008, the FDA issued an alert about complications associated with transvaginal placement of surgical mesh to treat pelvic organ prolapse (POP) and Stress Urinary Incontinence (SUI). At the time, the FDA noted that in the previous three years, it received more than 1,000 reports from nine surgical mesh manufacturers of complications associated with their surgical mesh devices.
• On July 13, 2011, the FDA issued a public notice regarding the use of transvaginal mesh (TVM) for the treatment of POP and SUI. Doctors and their patients are now advised to consider alternatives to TVM.