In re Pelvic Repair System Products Liability Litigation (Transvaginal Mesh MDLs) Lawsuit

In re Pelvic Repair System Products Liability Litigation (Transvaginal Mesh MDLs)

• Type: Products liability mass tort (medical devices / pelvic mesh)

• Country: United States

• Court: U.S. District Court for the Southern District of West Virginia (Huntington)

• Dockets: MDL Nos. 2187, 2325, 2326, 2327, 2440, 2511

• Resolved: 2017 (global settlements); MDLs terminated 2019–2021

• MDL status: Terminated

Product and manufacturers

Transvaginal mesh is a net-like surgical implant placed through the vaginal wall to reinforce weakened pelvic tissue. It was used to treat two conditions: pelvic organ prolapse (POP), in which the bladder, uterus or rectum sags into the vagina, and stress urinary incontinence (SUI), where a sling beneath the urethra supports the bladder neck during activities that raise abdominal pressure. Devices for these indications were made by several major medical-device companies: Ethicon (a subsidiary of Johnson & Johnson), Boston Scientific, C.R. Bard, American Medical Systems, Cook Medical and Neomedic. The first SUI- and POP-specific meshes received FDA clearance as class II moderate-risk devices in 1996 and 2002, and by the mid-2000s mesh was used in a substantial share of prolapse repairs performed in the United States.

Alleged harm

Patients reported a cluster of complications that were severe, persistent and, in their frequency, unexpected: mesh erosion or exposure through the vaginal wall, chronic pelvic, groin and sexual pain, infection, urinary problems, and recurrent prolapse. Erosion was the most commonly reported complication, affecting a significant share of patients within a year of POP repair, and many affected women required additional surgery to remove part or all of the implant. A small number of deaths associated with bowel perforation and bleeding were recorded in the 2008–2010 period, and over the following decade approximately one patient in fifteen who had received transvaginal mesh required a removal procedure. The FDA's own evaluation concluded that the safety and effectiveness of transvaginal mesh for POP had not been scientifically established; on April 16, 2019, the agency banned the sale of POP mesh products in the United States, with midurethral slings for SUI excluded from the ban.

Course of the litigation

Injury claims were filed in federal and state courts across the country by tens of thousands of women. The federal cases were centralized in the U.S. District Court for the Southern District of West Virginia (Huntington) as six related multidistrict litigations, one per major manufacturer: MDL 2187 (C.R. Bard), MDL 2325 (American Medical Systems), MDL 2326 (Boston Scientific), MDL 2327 (Ethicon / Johnson & Johnson), MDL 2440 (Cook Medical) and MDL 2511 (Neomedic). The first pretrial orders, issued between 2010 and 2014, show that Judge Joseph R. Goodwin presided over all six MDLs from their centralization; Chief Judge Frank W. Volk handled the later phase of the proceedings, including the 2019–2021 terminations.

Resolution

In 2017, Johnson & Johnson (through its Ethicon subsidiary) and Boston Scientific agreed to global settlements that covered the bulk of the claims in the MDLs. The MDLs were formally terminated in 2019–2021, after qualified settlement funds were established to process and pay eligible claims. State-level resolutions followed: in 2019 the New York Attorney General reached a settlement with Johnson & Johnson over the marketing of the company's mesh products, and in 2022 a multi-state settlement with Johnson & Johnson resolved further state claims. The litigation extended beyond U.S. borders as well: a class of roughly 700 Australian women sued the mesh manufacturer there, and more than 100,000 mesh-related lawsuits in the United States, Australia and the United Kingdom are attributed to the products as a whole.

Aftermath

The mesh MDLs became one of the defining mass-tort devices cases of the 2010s. The 2019 FDA ban on POP mesh, the termination of the MDLs, and the subsequent state settlements closed out the principal federal and state proceedings, while the regulatory history — from class II clearance in the 1990s to reclassification as a class III high-risk device in 2016 — is frequently cited in discussions of post-market surveillance for gynecologic surgical mesh.