Multimillion-Dollar Award in Third Consecutive Lawsuit Against J&J/Ethicon Over TVT Pelvic Mesh Device. In the third consecutive eight-figure jury award against healthcare giant, Johnson & Johnson, a New Jersey woman, 56, was awarded $20 million over alleged injuries following a vaginal mesh implant. The case is part of a pelvic mesh tort being heard in Philadelphia County Court.
The woman was awarded $2.5 million in compensatory damages and $17.5 million in punitive damages following a three-week trial. The woman alleged that the Transvaginal Tape (TVT) Secur medical device manufactured by Johnson & Johnson subsidiary, Ethicon Inc., was defective and that both companies had failed to warn of its risks, according to Law360. The case is Engleman v. Gynecare et al, case number 140305384, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia.
The lawsuit was filed in 2013 and the device was implanted in 2007 to help correct the woman’s stress urinary incontinence (SUI). The SUI causes leakage when she coughed or exercised; however, she alleged that the TVT-Secur failed within one month and her SUI returned, according to Law360. The TVT-Secur mesh began eroding within the woman’s body and her surgeons were unable to remove the entire device after three additional surgeries, the woman alleged.
The plaintiff alleged chronic vaginal pain, pelvic floor spasms, and permanent urinary dysfunction, Law360 reported. “I’m happy I could be a voice for other women,” the woman said in a statement. “It’s been a nightmare, and I feel justice was truly served today.”
The TVT-Secur product was launched in September 2006; however, the woman’s attorneys said Johnson & Johnson had received a number of reports indicating high failure rates from countries worldwide, noted Law360.
Two prior trials in Philadelphia have resulted in damage awards against Ethicon that totaled approximately $26 million. A 2015 case led to a $12.5 million verdict for an Indiana woman and a 2016 case led to a $13.5 million for a New Jersey woman. The pelvic mesh mass tort has another 183 cases pending. The next case is scheduled for trial on May 8, according to Law360.
The transvaginal mesh lawyers at Parker Waichman LLP are well versed in transvaginal mesh litigation. The firm has decades of experience in medical device litigation and continues to offer free legal consultations to individuals who have questions concerning filing a transvaginal mesh lawsuit.
In the prior lawsuit the jury found in favor of the plaintiff in the amount of $13.5 million in February 2016. The woman in the second case alleged that she was in near constant pain and discomfort and was no longer able to have sex, Law360 wrote. The jury agreed that the Ethicon TVT product was not reasonably safe and that the plaintiff’s physician would never have implanted the TVT had he known of the risks.
The jury in the first case returned a $12.5 million verdict in December when it found that Ethicon’ Prolift pelvic mesh device was negligently designed and that the physician who implanted the device in the plaintiff in 2009 did not receive sufficient warnings concerning the device’s risks. In that case, according to Law360, the verdict included $10 million in punitive damages, $3.5 million in compensatory damages, and $250,000 to the husband for loss of consortium.
Allegations included that the TVT was defectively designed and that Ethicon and Johnson & Johnson did not provide sufficient warnings to the woman’s physician. That case is Carlino et al. v. Ethicon Inc. et al., case number 130603470, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia.
The woman was implanted in 2005 to treat her SUI. She began experiencing a sharp feeling in her vagina in 2007. Her physician discovered the mesh became exposed and that she had to undergo surgery to remove part of the implant. Three years later, she had to undergo another procedure when another exposed mesh patch led to additional pain. In 2012, she felt pulling sensations and pain due to scarring from the implant and related revision surgeries, noted Law360.
During closing arguments, it was brought up that the mesh suffers from various alleged defects. For one, the mesh’s pores are too small, which prevents the body’s tissues from appropriately growing through the mesh and instead lead to inflexible scar tissue, causing the vagina to contract. The mesh also allegedly changes shape and/or degrades when implanted, which leads to erosion, curling, and/or fraying. Also, when the tape is cut with a machine and not a laser, pieces of the device fall from the edges, becoming embedded in the vaginal tissue, according to Law360.
FDA Changes Transvaginal Mesh Classification, Issues Warnings
The U.S. Food and Drug Administration (FDA) issued warnings concerning transvaginal mesh implants in 2008 and 2011. In 2011, the federal regulator updated its prior notification to include that complications tied to transvaginal mesh were “not rare,” that transvaginal mesh does not appear to have any clear benefits for patients diagnosed with pelvic organ prolapse (POP) when compared to non-mesh methods, and that transvaginal mesh devices may also present additional risks that may include infection, incontinence, mesh erosion, pain, recurrence of prolapse, and urinary problems. Perforation of the bowels, bladder, and blood vessels were also associated with transvaginal mesh device implants.
Numerous transvaginal mesh plaintiffs have noted that the devices were cleared through the 510(k) route, which enables device makers to release devices to the market without clinical data for safety or efficacy. Devices approved through the 510(k) need only be shown to be “substantially equivalent” to a previously approved medical device, even if that product was voluntarily recalled or was never assessed for safety.
To address these concerns, the FDA reclassified transvaginal mesh from a moderate- to a high-risk device. This means that transvaginal mesh device makers must go through the agency’s stricter pre-market approval (PMA) process, which mandates medical device companies to submit data proving their devices are both safe and effective.