Legal Loss Over Transvaginal Mesh Implants Jurors Award $20M to Woman Implanted with Transvaginal Mesh Johnson & Johnson and its subsidiary Ethicon suffered its most recent legal loss over transvaginal mesh implants in Philadelphia Common Pleas Court, where a jury returned a $20 million verdict against the companies. The product liability lawsuit was filed on behalf of a 56-year-old New Jersey woman implanted with the Trans-vaginal tape (TVT)-Secur mesh. This is the third-time in a row that J&J has been hit with an eight-figure pelvic mesh verdict in Philadelphia’s mass tort program.
The transvaginal mesh lawyers at Parker Waichman LLP are well-versed in transvaginal mesh litigation. The firm, which has decades of experience in medical device litigation, continues to offer free legal consultations to individuals with questions about filing a transvaginal mesh lawsuit.
The jury awarded the plaintiff $2.5 million in compensatory damages and $17.5 million in punitive damages. Like thousands of other transvaginal mesh lawsuits pending in courts across the country, the plaintiff alleges she suffered injuries due to the defective nature of the mesh. The suit alleges that J&J failed to warn of the risks.
According to the complaint, the plaintiff was implanted with pelvic mesh in 2007 to treat stress urinary incontinence. This condition, which is more common among women after childbirth, causes the involuntary release of urine during everyday activities such as coughing or exercise. Transvaginal mesh is intended to treat this condition by providing additional strength to the pelvic walls. However, many lawsuits allege that the device only caused complications. In this lawsuit, the plaintiff states that the pelvic mesh failed within only a month and her condition returned. Furthermore, she suffered from a transvaginal mesh complication called mesh erosion. This occurs when the mesh migrates through the tissues of the vagina, becoming deeply embedded. The eroded mesh can cause injuries to other surrounding organs.
The plaintiff underwent three surgeries to remove the mesh, but pieces of the device remain within her body, the suit states. According to her lawsuit, pelvic mesh defects left her with chronic vaginal pain, pelvic floor spasms and permanent urinary dysfunction. She filed a product liability lawsuit against J&J and Ethicon in 2013 seeking damages related to her transvaginal mesh injuries.
The trial lasted for three weeks before jurors handed down a $20 million verdict, Law360 reports.
The TVT-Secur was approved in September 2006. Like other pelvic mesh implants, it was approved to treat stress urinary incontinence and pelvic organ prolapse.
Previously, two pelvic mesh awards against J&J totaled $26 million. There are still 183 pelvic mesh injury claims pending in Philadelphia County Court’s mass tort program. The next transvaginal mesh trial is scheduled for May 8, 2017.
Last year, jurors awarded $13.5 million to a New Jersey woman who suffered transvaginal mesh injuries. An Indiana woman was awarded a $12.5 million verdict in 2015.
Pelvic Mesh Makers Face Litigation, Verdicts, Settlements
Parker Waichman comments that transvaginal mesh implants have become controversial in their time on the market. Thousands of lawsuits have been filed against a number of pelvic mesh makers, alleging that the devices are defective and caused serious injuries such as mesh erosion. Transvaginal mesh litigation has led to settlements and verdicts. Johnson & Johnson alone is facing more than 54,000 pelvic mesh claims. Bloomberg reports that the company is working on settlement negotiations.
Recently, the Fourth Circuit Court of Appeals upheld a $3.27 million transvaginal mesh verdict awarded in 2014. The lawsuit was filed on behalf of a woman implanted with the Tension-Free Vaginal Tape-Obturator (TVT-O).
Ethicon agreed to pay $120 million to settle 2,000 to 3,000 transvaginal mesh lawsuits in January 2016. Other pelvic mesh awards against J&J total $1.2 million, $11.1 million, and $13.7 million.
The $13.7 million verdict was returned last February. The plaintiff in that case alleges that her pelvic mesh injuries caused painful sex and other complications. A Pennsylvania judge refused to toss the verdict earlier this year.
Pelvic mesh lawsuits against several device makers, including J&J, have been consolidated into a federal multidistrict litigation (MDL) in the Southern District of West Virginia before Judge Joseph R. Goodwin. MDLs are a type of mass tort created by the U.S. Judicial Panel on Multidistrict Litigation (JPML) when there are a significant number of lawsuits with common factual allegations. MDLs transfer similar lawsuits to one court before one judge; this is helpful for complex litigation because it streamlines the legal process and eliminates the need for duplicate pretrial proceedings, such as the discovery phase.
In January, Judge Stephen V. Wilson of the U.S. District Court for the Central District of California gave final approval for a $12.5 million transvaginal mesh settlement.
Transvaginal Mesh Background
The U.S. Food and Drug Administration (FDA) approved transvaginal mesh for stress urinary incontinence and pelvic organ prolapse, two conditions that become more common following childbirth. Pelvic organ prolapse is when the organs of the pelvis prolapse, or drop, from their intended location and bulge into the vagina. In 2008, the FDA said the most common transvaginal mesh complications include:
- Mesh erosion
- Urinary problems
- Recurrence of prolapse
Adverse event reports also mentioned bowel, bladder and blood vessel perforation. At the time, regulators called transvaginal mesh complications serious, but rare. The FDA updated this communication 2011, and clarified that transvaginal mesh complications are in fact “not rare”. The agency also said there was inadequate evidence to support the use of transvaginal mesh over non-mesh methods for treating pelvic organ prolapse, and mesh inserts may pose additional risks.
The FDA approved transvaginal mesh through 510(k), a fast-track review process that clears devices without clinical testing for safety or efficacy. Unlike drugs and devices approved through the stricter premarket approval (PMA) process, manufacturers only need to show that their product is “substantially equivalent” to a previously approved device, referred to as a predicate.
Due to safety concerns, the FDA has since reclassified transvaginal mesh devices from “moderate-risk” to “high-risk”, meaning the products can no longer be approved through the 510(k) process. They must be cleared through the more-rigorous PMA route.