TVT Pelvic Mesh Plaintiff Awarded $20M in Most Recent Verdict
Following a recent transvaginal mesh trial in Philadelphia, a jury handed down a $20 million pelvic mesh verdict against Johnson & Johnson. The lawsuit was filed on behalf of a 56-year-old New Jersey woman implanted with the trans-vaginal tape (TVT)-Secur device. Like thousands of other transvaginal mesh plaintiffs, she alleged that the device is defective and caused serious injuries. The lawsuit alleges that J&J and its subsidiary Ethicon failed to warn of the risks.
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.
Law360 reports that the lawsuit was filed in 2013. The plaintiff was implanted with the pelvic mesh in 2007 to treat stress urinary incontinence, a condition that causes the involuntary release of urine during everyday activities such as coughing or exercise. The plaintiff alleges that the transvaginal mesh stopped working within a month, causing her condition to return. The lawsuit states that the plaintiff subsequently experienced mesh erosion, a transvaginal mesh complication where the device moves through the tissues of the vagina.
According to the lawsuit, the plaintiff underwent three surgeries to address pelvic mesh complications but doctors were unable to completely remove the mesh. The plaintiff says she now suffers from chronic vaginal pain, pelvic floor spasms and permanent urinary dysfunction, allegedly due to the defective nature of the TVT-Secur. Ethicon introduced the device in September 2006.
The transvaginal mesh verdict consisted of $2.5 million in compensatory damages and $17.5 million in punitive damages. The trial last for three weeks, Law360 reports.
According to Law360, this the third eight-figure pelvic mesh award in a row against J&J in Philadelphia County court’s mass tort program. The previous two trials produced verdicts totaling around $26 million. There are still 183 cases pending in Philadelphia’s mass tort program. The litigation is underway in the Philadelphia Court of Common Pleas. The next pelvic mesh trial is slated for May 8, 2017.
Last year, a New Jersey woman suing over pelvic mesh was awarded $13.5 million. In 2015, a jury handed down a verdict of $12.5 million to an Indiana woman.
Transvaginal Mesh Litigation
Parker Waichman notes that transvaginal mesh litigation has been massive in the United States. Thousands of pelvic mesh injury claims have been filed against numerous manufacturers.
Recently, the Fourth Circuit Court of Appeals upheld a $3.27 million transvaginal mesh verdict handed down against Ethicon in 2014. The lawsuit alleged injuries from 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 verdicts have been issued against the company producing verdicts of $1.2 million, $11.1 million, and $13.7 million.
A Pennsylvania judge upheld the $13.7 million verdict earlier this year, refusing to toss the award. The verdict was handed down in February 2016. The plaintiff in that case alleged that the pelvic mesh caused painful sex, among other things.
Court records indicate that Ethicon faces some 31,000 transvaginal mesh lawsuits in a multidistrict litigation (MDL) consolidated before Judge Joseph R. Goodwin in the U.S. District Court for the Southern District of West Virginia. Several other MDLs have also been created for pelvic mesh litigation against other device makers.
MDLs are a type of mass tort where similar lawsuits are grouped together in one court before one judge. Consolidating cases in this manner makes litigation more efficient. In the transvaginal mesh MDL, plaintiffs similarly allege that the mesh is defective and that the device maker failed to warn about the risks.
Other companies have been involved in transvaginal mesh litigation. In January, Judge Stephen V. Wilson of the U.S. District Court for the Central District of California gave final approval for a Caldera pelvic mesh settlement. The company agreed to pay $12.5 million to settle claims regarding its transvaginal mesh.
Transvaginal Mesh Approval and FDA Warnings
The U.S. Food and Drug Administration (FDA) approved transvaginal mesh devices to treat stress urinary incontinence and pelvic organ prolapse. These mesh devices were intended to provide structural support for sagging pelvic organs and muscles. Transvaginal mesh products are now controversial, in light of safety concerns.
In 2008, the FDA said the most common transvaginal mesh complications include:
• Mesh erosion
• Urinary problems
• Recurrence of prolapse
Pelvic mesh was also associated with reports of bowel, bladder and blood vessel perforation. At the time, regulators said adverse events were serious but rare. The FDA amended this in 2011, warning that transvaginal mesh complications were in fact, “not rare”. Additionally, the agency said there was inadequate evidence to support the use of transvaginal mesh over non-mesh methods for treating pelvic organ prolapse. Mesh devices can even pose additional risks, regulators said.
Transvaginal mesh plaintiffs and safety advocates have noted that the devices were approved through an expedited FDA review process called 510(k). When products are cleared through 510(k), manufacturers are not required to conduct clinical testing to show that the device is safe and effective. This contrasts to the agency’s premarket approval (PMA) process, which does mandate clinical testing.
The 510(k) process only requires that devices are “substantially equivalent” to a previously approved device. This means that the new product is at least as safe as the older one, known as a predicate. The use of 510(k) for certain products is now debated, given that it was used to approve transvaginal mesh as well as other controversial devices such as metal-on-metal hip implants.
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 stricter PMA route.
Filing a Transvaginal Mesh Lawsuit
If you or someone you know suffered injuries related to the use of transvaginal mesh implants, you may have valuable legal rights. Our transvaginal mesh lawyers offer free, no-obligation case evaluations. For more information, fill out our online form or call 1-800-YOURLAWYER (1-800-968-7529).