Ethicon Mesh Injury Lawsuits Drawing Nearer to Long-Awaited Trial Dates
Over the past several years, over 70,000 lawsuits have been filed in federal district court regarding the alleged dangers of vaginal mesh products. These lawsuits, which have been consolidated before U.S. District Court Judge Joseph Goodwin, involve allegations against multiple mesh manufacturers, including C.R. Bard, Boston Scientific, and Johnson & Johnson’s Ethicon brand – the latter of which has allowed thousands of cases to languish on the docket without a settlement in sight.
Judge renews concern over languishing vaginal mesh cases
Renewing his frustrations with the glacial pace of vaginal mesh litigation, Judge Goodwin entered a pretrial order on August 19, 2015 directing Johnson & Johnson to begin case-specific discovery for the 200 oldest cases naming Ethicon and/or Johnson & Johnson as the defendant. Procedurally speaking, this order requires the parties to make strides toward trial by engaging in the mutual exchange of non-privileged information for purposes of determining whether to engage in a settlement or continue to trial.
However, recent Bellwether trials resulted in multi-million dollar verdicts in favor of injured mesh plaintiffs, which prompted several manufacturers to settle nearly all of their remaining claims. Only Ethicon/Johnson & Johnson remain as the vaginal mesh defendant with nearly all of its outstanding vaginal mesh injury lawsuits still unresolved.
Most likely, at the conclusion of the pre-trial discovery period, the unresolved cases will be transferred back to their district court of origin for placement on the docket. This will inevitably result in multiple, contemporaneous trial dates across the United States – which will undoubtedly create additional difficulty for the defendant should it opt to forgo a negotiated vaginal mesh settlement.
Discovery in the cases must be completed within six months, at which point parties may file dispositive motions and/or challenges to the admissibility of certain evidence revealed during the pre-trial discovery phase.
Problems with the Ethicon vaginal mesh product
Vaginal mesh devices are commonly prescribed by gynecologists to treat the symptoms of pelvic organ prolapse (POP) or stress urinary incontinence (SUI) in patients experiencing a weakening of the pelvic floor. The conditions are often caused by the stress placed on the pelvic floor as a result of childbirth, and the vaginal mesh device is used to fortify and strengthen these muscles to avoid the pain and discomfort of a weakened pelvic area.
The device is essentially “sewn” into the pelvic floor using minimally-invasive techniques, and is often completed in the gynecologist’s office. However, shortly after its introduction to the U.S. market, the patients began reporting adverse events associated with the device. Most notably, vaginal mesh users reported to the FDA that the implant began eroding through the vaginal epithelium, causing excruciating pain, infection, urinary problems and the return of prolapse.
Moreover, Johnson & Johnson reportedly marketed and sold the Ethicon Gynecare Prolift device before it received official approval from the FDA. Reportedly, the company sought approval for a similar device known as the Gynecare Gynemesh in 2008, along with the Prolift version. It received approval for both devices, and asserted that – since both are similar – there should be no problem with the pre-approval marketing of the Gynecare Prolift.
- Bloomberg.com, Johnson & Johnson sold vaginal mesh implant without U.S. regulatory approval, http://www.bloomberg.com/news/articles/2012-03-21/j-j-sold-vaginal-mesh-implant-without-u-s-regulatory-approval
- FDA.gov, Public health notification:Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence, http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PublicHealthNotifications/ucm061976.htm
- Huffingtonpost.com, Thousands of women sue over vaginal mesh complications, http://www.huffingtonpost.com/2013/02/08/pelvic-mesh-lawsuits-surgical_n_2647435.html