Court Upholds TVT Pelvic Mesh Verdict Against Ethicon
A $13.4 million verdict issued against Johnson & Johnson’s Ethicon unit will stand, a Philadelphia judge ruled. The award was handed down February 2016 in Pennsylvania state court. Jurors considered a lawsuit filed on behalf of a woman implanted with Ethicon’s Tension-free Vaginal Tape (TVT), alleging that the device caused serious complications and resulted in multiple surgeries. Philadelphia Court of Common Pleas Judge Kenneth J. Powell, Jr. refused to hear post-trial arguments from J&J, upholding the transvaginal mesh verdict.
The personal injury and product liability attorneys 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 lawsuit.
Jurors awarded $3.25 million in compensatory damages to the plaintiff, $250,000 to the plaintiff’s husband for loss of consortium, $10 million in punitive damages and $239,119 in delay damages.
The plaintiff was implanted with Ethicon’s TVT pelvic mesh device in 2005. The transvaginal mesh was implanted to treat her stress urinary incontinence, a condition that causes the involuntary release of urine during normal, everyday activities such as sneezing or laughing. According to her lawsuit, she suffered from pain after the mesh was implanted. Her physician discovered that a portion of the mesh was exposed in her vagina. Doctors performed two operations to remove the mesh. The plaintiff suffered from pain during sexual intercourse, or dyspareunia. She alleges that the complications were caused by transvaginal mesh complications and that Ethicon failed to warn the plaintiff and her physician about the risks.
The judge found that Ethicon “deceptively withheld important information about the risks of undergoing a TVT implant procedure,” and that “the jury was free to determine that Ethicon provided warnings so deliberately misleading as to warrant the imposition of punitive damages.”
During the trial, three Ethicon executives testified that Ethicon was aware of the risks associated with transvaginal mesh but did not adequately warn patients or the medical community.
Ethicon is facing numerous pelvic mesh lawsuits, including 164 in Philadelphia courts and over 31,000 in the federal multidistrict litigation (MDL) consolidated before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia.
In January 2016, Ethicon agreed to settle 2,000 to 3,000 lawsuits for $120 million. The company has also been hit with other pelvic mesh verdicts, including awards of $3.27 million and $1.2 million in 2014. Recently, the New Jersey Supreme Court upheld an $11.1 million pelvic mesh verdict handed down in 2013. The verdict stemmed from a bellwether lawsuit alleging injuries from the Gynecare Prolift pelvic mesh. The plaintiff, implanted with the transvaginal mesh in 2006, underwent 18 surgeries to remove the mesh. According to her lawsuit, mesh injuries ended her nursing career and interferes with her ability to enjoy life. Ethicon stopped selling the Prolift in 2012.
Transvaginal Mesh Lawsuit MDLs
Parker Waichman notes that numerous lawsuits have been filed over transvaginal mesh implants, against various mesh manufacturers. Several MDLs have been established before Judge Goodwin. In an MDL, similar lawsuits are transferred to one court before one judge. These types of mass torts are created to make large, complex litigations proceed more quickly. Lawsuits remain separate in an MDL, as opposed to a class action in which one lawsuit represents numerous plaintiffs.
Pelvic mesh lawsuits have been filed against several different manufacturers, including C.R. Bard, Boston Scientific and American Medical Systems (AMS). Plaintiffs similarly allege that the pelvic mesh caused injuries such as mesh erosion, pain and bleeding. Device makers are accused of knowing about the risks and failing to warn consumers.
A number of verdicts and settlements have resulted from transvaginal mesh litigation. C.R. Bard, for instance agreed to settle 3,000 transvaginal mesh lawsuits for $200 million in August 2015. Two Bard cases that went to trial yielded verdicts of $2 million and $5.5 million. In 2014, Judge Goodwin took the unusual move of urging the company to settle. “I can’t imagine a corporation facing potentially billions of dollars in verdicts wouldn’t find it advisable to try to achieve a settlement for a much lesser sum,” he said, according to a transcript of a Dec. 9, 2014 hearing.
“I base that billions of dollars business on some of the rather large verdicts that we’ve had.”
Pelvic mesh lawsuits have also been filed against Endo Pharmaceuticals, a unit of American Medical Systems. In June 2013, the company settled an undisclosed number of pelvic mesh lawsuits. Another settlement was announced in May 2014; AMS agreed to pay $830 million to settle 20,000 mesh injury claims.
Transvaginal mesh verdicts have been issued against Boston Scientific as well. In November 2014, two transvaginal mesh plaintiffs were awarded a total of $45 million in verdicts. In September of that year, a Boston Scientific mesh plaintiff won a verdict of $73 million. Recently, Judge Goodwin upheld a $14.4 million mesh verdict handed down against the company.
Some 4,000 Coloplast pelvic mesh lawsuits were settled for $16 million in 2015. Each mesh plaintiff would be awarded $40,000 under the settlement.
Transvaginal Mesh Background: FDA Warnings
The U.S. Food and Drug Administration (FDA) approved transvaginal mesh implants for pelvic organ prolapse and stress urinary incontinence. The mesh is intended to support sagging pelvic organs and muscles associated with these conditions, which become more common after childbirth. Pelvic organ prolapse is when organs in the pelvis drop or prolapse from their normal place.
Transvaginal mesh implants were cleared through 510(k), a route that does not require clinical testing for safety or efficacy.
In 2008, the FDA warned that transvaginal mesh complications were serious, but rare. The agency later amended this in 2011 to state that complications were “not rare”. The agency has said the most common injuries reported with transvaginal mesh include:
• Mesh erosion
• Urinary problems
• Recurrence of prolapse
There have also been reports of perforation in the bowels, bladders and blood vessels, regulators said.
In its 2011 safety alert, the FDA said that pelvic mesh does not appear to have clear benefits for POP patients compared to non-mesh methods and may carry additional risks.
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).