A plaintiff who won a $2 million jury verdict against C.R. Bard Inc. in the first vaginal mesh bellwether trial over alleged defects in its vaginal mesh implants has asked the Fourth Circuit to uphold the verdict, saying that the lower court correctly excluded  regulatory evidence.

Plaintiff Donna C., to whom a West Virginia federal jury awarded $1.75 million in punitive damages and $250,000 in compensatory damages in August 2013, told the Fourth Circuit that Bard’s argument that the court wrongly excluded evidence relating to an FDA rule requiring device makers to notify the agency 90 days before marketing a medical device rests on a faulty premise.

She also asked the appeals panel to rule as unconstitutional a Georgia state law that requires prevailing product liability plaintiffs to pay 75 percent of their punitive damages to the state.

According to Donna C., Bard, the manufacturer of vaginal mesh devices, contends that the district court’s exclusion was based on a misunderstanding of the FDA’s process and argues that the process is designed to ensure that a medical device is safe and effective before it can be marketed.

Donna further claims that Bard’s argument that a material safety data sheet that had accompanied the material used to manufacture the Avaulta Plus vaginal mesh device should have been excluded as hearsay is “legally and factually flawed.”

The vaginal mesh lawsuit was the first to go to jury trial within the seven vaginal mesh multidistrict litigations. Donna claimed she experienced “significant mental and physical pain and suffering” after being implanted in May 2009 with the Avaulta Plus Posterior Biosynthetic Support System manufactured by Bard to treat pelvic organ prolapse.

Vaginal Mesh Complications

Vaginal mesh is used in vaginal reconstructive surgeries to alleviate the pain related to pelvic organ prolapse (POP) and stress urinary incontinence (SUI). The FDA has reported thousands of cases in which pelvic mesh products created adverse events. Patients have reported problems ranging from feeling intense mesh pain in the implant area to mesh erosion.

It has been determined that the design and materials used do not allow surrounding tissue to receive oxygen and nutrients. Patients have suffered through pain, repeat mesh surgery, infections, loss of sexual enjoyment, blood transfusions and more.

The industry faces over 11,000 vaginal mesh lawsuits in the United States from harm caused by allegedly defective transvaginal mesh. Litigation increased dramatically after the FDA released an updated warning about pelvic mesh devices in July 2010. After reviewing thousands of reports, the agency stated, contrary to its last notification in 2008, vaginal mesh complications are not rare.

Furthermore, the announcement stated that transvaginal mesh may be posing a greater risk over other treatments for POP because no clinical evidence exists to demonstrate an advantage of vaginal mesh.

Several vaginal mesh products have been approved under an FDA rule that requires no human testing as long as the product is deemed similar enough to another device already on the market. This approval led to a chain of additional approvals for other vaginal mesh brands.

The Vaginal Mesh Lawsuit is Case No. 15-1102 in the U.S. Court of Appeals for the Fourth Circuit.