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Transvaginal Mesh Lawsuits

US-Supreme-CourtWith over 50,000 lawsuits filed in the past few years, litigation surrounding transvaginal mesh implants has grown to record-breaking proportions.  Serious complications are alleged by thousands of women who have filed a transvaginal mesh lawsuit, many of whom live with chronic pain or infections, cannot urinate or have sexual relations normally, or have been forced to undergo multiple surgeries in an attempt to regain their lives.

Plaintiffs contend that defendants produced a defective product without adequate testing or monitoring and a growing number have achieved victory in court.

Complications described by plaintiffs

Plaintiffs in transvaginal mesh (or TVM) lawsuits describe a number of painful or debilitating side effects associated with mesh implants, which were designed to treat conditions such as pelvic organ prolapse (POP) or stress urinary incontinence (SUI).

Instead of alleviating problems, many women found that they suffered the following mesh complications after being implanted with mesh devices.

  • Mesh erosion
  • Organ perforation
  • Recurrence of POP
  • Urinary incontinence
  • Chronic abdominal and/or pelvic pain
  • Vaginal bleeding
  • Vaginal scarring
  • Chronic infections
  • Pain during sexual intercourse

The FDA received close to 4,000 adverse event reports listing such complications between 2005 and 2010, noting in a July 13, 2011 communication that they were “not rare”.  The scale of mesh lawsuits filed thus far would seem to confirm this assessment.

Some women have been forced to undergo multiple revision surgeries to extract pieces of the eroded mesh or repair organ damage; Linda Gross, who was awarded a jury verdict against a TVM defendant in 2013, endured 18 such surgeries.  Even after many procedures, side effects continue to trouble some patients.

Allegations in transvaginal mesh lawsuits

Plaintiffs in TVM lawsuits filed have made the following allegations against defendants:

  • Negligence in creating and designing their products
  • Failure to adequately test or inspect products prior to distribution
  • Failure to warn of or disclose possible safety risks posed by products
  • Fraud and concealment; providing false or misleading information about products

Plaintiffs typically sue for the following damages that they have incurred due to TVM complications:

  • Medical expenses (past, present, future)
  • Loss of income or earning ability
  • Pain and suffering
  • Diminished quality of life
  • Loss of consortium

A spouse of a woman who has endured TVM complications can also be a plaintiff in a case, given that mesh complications can have a negative impact on the sexual and emotional relationship of a couple and their quality of life together.

A spouse can sue for:

  • Loss of consortium
  • Therapeutic assistance and support

Defendants in transvaginal mesh cases

The following seven manufacturers were named as the major defendants in transvaginal mesh lawsuits:

  • American Medical Systems (AMS)
  • Boston Scientific
  • Coloplast
  • Cook Medical
  • R. Bard
  • Ethicon (a subsidiary of Johnson & Johnson)
  • Neomedic

The defendant with the largest number of currently pending cases is Ethicon.

Multidistrict litigations established for TVM cases

A separate multidistrict litigation (MDL) was set up for each defendant in the U.S. District Court for the Southern District of West Virginia, all under presiding Judge Joseph R. Goodwin.  Each transvaginal mesh MDL shares a consolidated discovery phase in order to expedite the legal process and Judge Goodwin has overseen the process whereby preliminary (“bellwether”) cases are selected in order to establish precedent and encourage wide scale settlements.

Such litigation processes are designed to facilitate the resolution of the unprecedented number of defective medical device lawsuits filed over mesh products (in federal MDLs and at the state level), which would overwhelm the courts for years if each were to receive a separate trial.

Individual TVM jury verdicts of note

Several plaintiffs have won jury verdicts or negotiated settlements against the defendants listed above.

Notable examples include:

  • In July of 2012, a $5.5 million jury verdict was awarded to Christine Scott and her husband in a California   court over complications she experienced from the Avaulta Plus mesh implant (manufactured by C.R. Bard), including lacerations, infections, the need for a urinary catheter, disruptions to sexual relations with her husband, and the need for nine revision surgeries.
  • Linda Gross, the plaintiff cited above who underwent 18 different revision surgeries to correct TVM complications, won a $11.1 million verdict in February of 2013 when a jury in New Jersey Superior Court determined that Ethicon had misrepresented the level of safety of their product (the Gynecare Prolift) and failed to warn about its risks. $7.76 million of the award was for punitive damages. Ethicon’s bid for an appeal was denied.
  • A plaintiff in a Dallas, TX state court received a $73 million jury verdict against Boston Scientific, including $23 million in compensatory damages and $50 million in punitive damages in September of 2014.  The award was later reduced to $34 million, due to a cap on punitive damages in Texas.

Large-scale vaginal mesh settlements

TVM defendants have been slow to agree to large-scale settlements.  Only one has currently reached a settlement to resolve all of its cases: AMS paid a $54.5 million settlement to resolve its pending cases in July of 2013

Other large-scale, if partial, settlements have also been reached:

  • Coloplast agreed to pay $16 million to resolve 400 cases in March of 2014
  • Boston Scientific announced a $119 million settlement to resolve 2,970 of its more than 25,000 cases in May of 2015 after losing two federal level cases as well as the case in Dallas that ultimately resulted in a $34 million judgment against the company.

While other defendants are rumored to be engaged in settlement negotiations, the defendant with the largest number of cases, Ethicon, has not made any announcement concerning major settlement agreements at this time.

  1. FDA, FDA Safety Communication: UPDATE on Serious Complications Associated with Transvaginal Placement of Surgical Mesh for Pelvic Organ Prolapse

  2. FDA, Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse

  3. Obstetrics & Gynecology, Vaginal Mesh for Prolapse: A Randomized Controlled Trial

  4. NY Times, Women Sue Over Device to Stop Urine Leaks

  5. JPML US Courts, MDL Statistics Report - Distribution of Pending MDL Dockets

  6. Bloomberg, J&J Owes $7.76 Million in Punitives in Vaginal Mesh Case