New Lawsuit Alleges Injuries from Ethicon Transvaginal Mesh

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Public Health Watchdog Breaking News
Public Health Watchdog Breaking News

Pelvic Mesh Litigation Filed Against Ethicon, Other Device Makers

A new pelvic mesh lawsuit has been filed against Johnson & Johnson’s Ethicon unit alleging injuries from a transvaginal mesh implant. As with other vaginal mesh lawsuits, the plaintiff alleges that the device caused adverse events and that the manufacturer failed to disclose the risks to her or her physician. Transvaginal mesh lawsuits have been filed against Ethicon and several other device makers.

The personal injury attorneys represent numerous clients in lawsuits alleging transvaginal mesh complications and other medical device injuries. The firm continues to offer free legal consultations to individuals with questions about filing a pelvic mesh lawsuit.

The plaintiff received a transvaginal mesh implant in March 2014 to treat stress urinary incontinence, or the involuntary release of urine during everyday activities such as laughing or sneezing. Pelvic mesh is supposed to provide additional support to the weakened pelvic floor. Stress urinary incontinence is more likely to occur following childbirth.

The lawsuit alleges that the mesh is prone to complications, such as erosion (where mesh moves through the vaginal tissues), organ damage, pain, bleeding and infection. The plaintiff alleges that Ethicon should have disclosed these risks and claims she never would have agreed to the procedure if she were fully informed.

Transvaginal Mesh Lawsuits, Settlements and Verdicts

Parker Waichman notes that transvaginal mesh litigation has become substantial, leading to settlements and verdicts against various pelvic mesh manufacturers. Thousands of transvaginal mesh plaintiffs allege that the mesh inserts caused complications, suing device makers. To consolidate the litigation, the U.S. Judicial Panel on Multidistrict Litigation (JPML) set up several multidistrict litigations (MDLs) in West Virginia before Judge Joseph Goodwin.
MDLs are established to streamline legal proceedings; they centralize similar lawsuits to one court before one judge to eliminate duplicate discovery and make litigation more efficient. Plaintiffs in the transvaginal mesh MDL allege that pelvic mesh devices were manufactured defectively and caused injuries. Device makers are accused of failing to warn patients or their doctors about the risks. Alleged injuries include difficulty urinating, painful sex, bleeding, organ perforation and recurrence of POP.

According to court documents, the largest number of pelvic mesh lawsuits have been filed against Ethicon. Plaintiffs allege complications from products such as the Gynecare TVT and Prolift. Ethicon offered to settle a large batch of cases for the first time in January. The company agreed to settle 2,000 to 3,000 transvaginal mesh lawsuits for $120 million. The settlement only resolves a fraction of the claims, however, as there are still another 42,000 pelvic mesh lawsuits pending. Throughout the course of the litigation, several transvaginal mesh lawsuits have gone to trial. In September 2014, jurors handed down a verdict of $3.27 million against Ethicon. Juries also found for plaintiffs in 2013 and 2014, issuing verdicts of $11 million and $1.2 million, respectively.

Other manufacturers have also been sued over transvaginal mesh injuries, including C.R. Bard. A verdict of $2 million was handed down against the device maker when the first transvaginal mesh lawsuit went to trial. The company was hit with another $5.5 million verdict in California. In light of several large transvaginal mesh lawsuit awards, Judge Goodwin urged Bard to settle mesh injury claims in December 2014; the move was unusual.
“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,” said Judge Goodwin, 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.” Bard offered to settle 3,000 vaginal mesh lawsuits in August 2015, agreeing to pay $200 million.

In June 2013, Endo Pharmaceuticals unit American Medical Systems (AMS) settled an undisclosed number pelvic mesh claims. The company agreed to an $830 million settlement in May 2014, resolving 20,000 transvaginal mesh lawsuits.
In November 2014, two transvaginal mesh verdicts were issued against Boston Scientific, totaling over $45 million. The company was also ordered to pay $73 million to a pelvic mesh plaintiff in September of that year. Also in 2014, a jury handed down a verdict of $14.3 million; the award was recently upheld by Judge Goodwin.

Coloplast has also been involved in pelvic mesh litigation, agreeing to pay $16 million to settle 4,000 transvaginal mesh lawsuits in 2015. According to Bloomberg, each plaintiff would receive roughly $40,000 under the settlement.

Pelvic Mesh Background, FDA Warnings

Transvaginal mesh devices were approved to treat stress urinary incontinence and pelvic organ prolapse, a sagging of the pelvic organs that most often occurs after childbirth. The FDA has issued warnings regarding pelvic mesh complications, one in 2008 and again in 2011.

In 2008, regulators said the most common injuries reported with transvaginal mesh include:

• Mesh erosion
• Infection
• Pain
• Urinary problems
• Recurrence of prolapse
• Incontinence

Adverse events also included perforated bowels, bladders, and blood vessels. At the time, the FDA said complications were serious, but rare.

In 2011, the FDA updated its previous warning. The agency said, contrary to what it said in 2008, complications associated with transvaginal mesh were “not rare”. Additionally, the agency cautioned that pelvic mesh does not appear to have clear benefits for POP patients compared to non-mesh methods and may carry additional risks.

Plaintiffs and patient safety advocates point out that mesh inserts were cleared through 510(k), which approved devices without clinical testing for safety or efficacy so long as the product is deemed “substantially equivalent” to a previously approved product. Following injury reports, transvaginal mesh and the 510(k) process came under increased scrutiny. In response to this, the FDA has reclassified transvaginal mesh from “moderate-risk” to “high-risk”. The new classification means that devices must be approved through the agency’s stricter premarket approval (PMA), which requires manufacturers to show that their products are both safe and effective before allowing them onto the market.

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).