Johnson & Johnson (J&J) and its subsidiary Ethicon, one of seven manufacturers of transvaginal mesh implant devices subject to pending state and federal mass tort litigation, have been named in over 33,000 lawsuits alleging damages from use of J&J vaginal mesh products.
Ethicon introduced the Gynecare Prolift onto the market in March 2005, after J & J filed a 510(k) application for U.S. Food and Drug Administration approval.
Transvaginal mesh systems are surgically inserted into the vagina to treat conditions including pelvic organ prolapse (POP) and stress urinary incontinence. POP occurs when the structures that hold the pelvic organs become so weak or stretched that the organs move from their original position and prolapse into the vagina. Various mesh product issues, such as shrinking, are alleged to cause serious adverse physical effects in implant patients, including:
Patients who experience complications from a failed vaginal sling often require revision surgery to remove the defective product and multiple excision surgeries may not result in complete removal of the mesh.
The FDA received more than 4,000 adverse event reports related to transvaginal mesh implants between 2005 and 2010. In 2008, the FDA issued a public health notification titled “Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence.” In 2011, the FDA issued a Safety Communication and detailed white paper addressed to doctors and patients warning that the use of a mesh in POP surgeries increased complication risks without any symptomatic benefits over non-mesh operations. Mesh erosion or contraction was the most frequent complication cited in the FDA reports.….” The FDA advised doctors to “recognize that in most cases, POP can be treated successfully without mesh, thus avoiding the risk of mesh-related complications.” After the FDA issued postmarket surveillance study orders (“522 orders”) to all manufacturers of urogynecologic surgical mesh products in January 2012, some mesh manufacturers withdrew certain products from the market. On May 10, 2012, J&J and Ethicon notified the FDA that they would discontinue marketing and selling four vaginal mesh implant systems:
· Gynecare Prolift Pelvic Floor Repair System;
· Prolift MTM;
· TVT Secur; and
J&J and Ethicon requested FDA approval to continue to sell its Gyencare Gynemesh system, with an updated label.
Approximately 75,000 of the over 100,000 mesh product liability claims filed against mesh manufacturers are currently pending before Chief Judge Joseph R. Goodwin in Multidistrict Litigation No. 2187 (MDL) established in 2012 in the U.S. District Court for the Southern District of West Virginia.
In February 2013, a New Jersey Superior Court jury returned a $11.1 million verdict ($3.35 million for compensatory damages and $7.76 million for punitive damages) in a J&J/Ethicon transvaginal mesh lawsuit claiming damages from medical complications (including 18 post implant surgeries) from a Gynecare Prolift implant. The jury found that Ethicon fraudulently misrepresented the safety of the device in its marketing materials and failed to warn physicians about the medical risks. On appeal, Judge Carol E. Higbee upheld the verdict, ruling that the evidence presented at trial was sufficient to support the patient’s claim that Ethicon had withheld warnings of the risks of the Gynecare mesh, despite knowing that there were problems with it. Judge Higbee noted that the substantial size of the verdict was not excessive because the jury could have granted additional damages. In September 2014, the second Ethicon case to go to trial in the MDL awarded $3.27 million to a patient, finding Ethicon sold faulty devices and failed to warn patients and their doctors of the side effects risks.