More Pelvic Mesh Lawsuits Filed into MDL
Ethicon, a subsidiary of Johnson & Johnson, continues to be named in product liability lawsuits involving transvaginal mesh. Lawsuits continue to be filed into the J&J pelvic mesh multidistrict litigation (MDL), consolidated before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia. The MDL contains some 40,000 transvaginal mesh lawsuits alleging that the devices caused severe injuries, and that J&J 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.
According to court records, a new pelvic mesh lawsuit was recently filed on behalf of a North Carolina woman implanted with the Prolift in October 2008. Transvaginal mesh products are approved to treat stress urinary incontinence and pelvic organ prolapse. The plaintiff suffered adverse events, allegedly due to pelvic mesh defects. According to the complaint, J&J failed to warn her or her doctor about the risk of complications.
The Ethicon transvaginal mesh allegedly caused mesh erosion, infection, organ perforation and organ prolapse, inflammation, scar tissue, painful sex, urinary and fecal incontinence, and chronic nerve damage, the suit alleges. The plaintiff alleges that mesh complications caused her to lose control of her lower pelvic organs. Transvaginal mesh injuries caused her to undergo several operations, the plaintiff states.
Other plaintiffs in the transvaginal mesh MDL allege that the mesh inserts are defective and caused injury. An MDL is a type of mass tort where similar lawsuits are grouped together in one court before one judge. Consolidating cases in this manner streamlines the legal process and eliminates duplicate discovery and other pretrial proceedings.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) has created MDLs for other pelvic mesh product liability lawsuits before Judge Goodwin.
J&J Hit with 4 Pelvic Mesh Verdicts in a Row
Parker Waichman comments that jurors found for pelvic mesh plaintiffs in four consecutive transvaginal mesh trials. The cases were all part of a mass tort program underway in Philadelphia County’s Court of Common Pleas.
Most recently, jurors returned a verdict of $2.16 million in favor of the plaintiff. The suit was filed on behalf of a Prolift user who alleged painful intercourse and chronic vaginal pain. Unlike previous pelvic mesh trials, no punitive damages were awarded. Jurors did find, however, that the risks of the Prolift outweighed its benefits.
The previous trial produced a substantial $20 million verdict. The plaintiff in that case was a 56-year-old New Jersey woman who suffered injuries, allegedly due to the defective nature of Ethicon’s Trans-vaginal Tape (TVT)-Secur mesh. Her lawsuit alleges that the mesh was defective; in attempt to address complications, the plaintiff underwent three surgeries to remove the mesh from her body. She alleges that pelvic mesh defects left her with chronic vaginal pain, pelvic floor spasms and permanent urinary dysfunction.
The $20 million verdict included $17.5 million in punitive damages, which are awarded when jurors feel that the liable party’s actions warrant additional punishment.
The first two trials resulted in verdicts totaling about $26 million.
According to Law360, the pelvic mesh mass tort program in Philadelphia contains over 180 lawsuits. Cases began going to trial in December 2015.
Parker Waichman comments that transvaginal mesh litigation has become massive in the United States. Lawsuits have been filed against several different device makers. Some cases have produced sizeable verdicts and settlements.
Last year, a New Jersey woman was awarded $13.5 million for her transvaginal mesh injuries. A $12.5 million pelvic mesh verdict was handed down in 2015; the plaintiff was an Indiana woman.
In 2014, a pelvic mesh plaintiff was awarded $3.27 million. The award was recently upheld by the Fourth Circuit Court of Appeals. The suit was filed on behalf of a woman implanted with the Tension-Free Vaginal Tape-Obturator (TVT-O).
In January 2016, Ethicon agreed to pay $120 million to settle 2,000 to 3,000 transvaginal mesh lawsuits. Other pelvic mesh awards against J&J total $1.2 million, $11.1 million, and $13.7 million.
Transvaginal mesh plaintiffs allege that the devices caused serious injuries, and that they would not have agreed to undergo mesh procedures if they were fully informed the risks. A commonly alleged injury is mesh erosion, where the mesh moves through the tissues of the body and becomes deeply embedded, causing complications such as organ damage and severe pain.
Transvaginal Mesh Injuries and 510(k) Approval
The U.S. Food and Drug Administration (FDA) approved transvaginal mesh to treat pelvic organ prolapse and stress urinary incontinence. These conditions, which are more common in women following childbirth, are caused by the weakening of pelvic muscles and sagging organs.
Stress urinary incontinence is the involuntary release of urine during normal, everyday activities such as sneezing or laughing. Pelvic organ prolapse is when the organs of the pelvis prolapse, or drop, from their intended location and bulge into the vagina.
Pelvic mesh is supposed to treat symptoms of POP and SUI by providing additional strength to the pelvic walls.
Device makers obtained transvaginal mesh approval through 510(k), a fast-track review process that clears devices without clinical testing for safety or efficacy. This contrasts with the agency’s premarket approval (PMA) process, a route that mandates clinical data.
When devices are approved through 510(k), manufacturers only need to show that their product is “substantially equivalent” to a previously approved device, referred to as a predicate.
Transvaginal mesh has since been reclassified from “moderate-risk” to “high-risk”, meaning the products can no longer be approved through 510(k); they must be cleared through the stricter PMA route.
In 2008, the FDA said the most common transvaginal mesh complications include:
• Mesh erosion
• Urinary problems
• Recurrence of prolapse
According to the FDA, women also reported bowel, bladder and blood vessel perforation. The FDA initially said that transvaginal mesh complications were 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.
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).