A judge has set the first trials in the much-publicized transvaginal mesh litigation for late next year. The trials are scheduled to take place before a jury in New Jersey Superior Court.
Judge Carol E. Higbee is presiding over more than 350 cases filed against Ethicon Gynecare, which were centralized in her district to allow for easier preparation and trial by the parties.
The first of these cases are set to begin in November 2012, with all pre-trial procedures completed by October 5, 2012.
The cases were filed by women who have experienced side effects after receiving the Gynecare Prolift mesh, Gynecare Gynemesh, Gynecare Prolene mesh, Gynecare TVT sling or other pelvic mesh products manufactured by Ethicon.
Vaginal mesh devices, sometimes called bladder slings, are intended to help repair pelvic organ prolapse, a condition in which the organs of the abdomen sink through stretched or weakened pelvic muscles. The condition affects 1 in 10 women flowing pregnancy.
Studies have shown that of the hundreds of thousands of women who received a transvaginal implant of the devices, more than 15% could face serious complications. This summer, the FDA issued a warning about the risk of side effects, saying the transvaginal mesh devices were no more effective than other repair methods.
The warning, the second from the FDA, came after they received more than 4,000 reports of post-surgical complications by vaginal mesh patients between 2005 and 2011.
Complications involving transvaginal mesh often include infection, bleeding, organ puncture, pain or mesh erosion through vaginal tissue.
The lawsuits contain similar claims that Ethicon parent company Johnson & Johnson had knowledge that the devices were unreasonably dangerous for the repair of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI), but continued to sell them regardless.
Early cases such as these, known as bellwether cases, are used to help the sides determine how juries will likely respond to evidence that will be presented in later cases. Although it has no authority over later cases, it can aid in transvaginal mesh settlement discussions.
Transvaginal mesh lawyers are also investigating potential lawsuits for those patients injured by mesh devices from other companies, including American Medical Systems (AMS), Boston Scientific, C.R. Bard and others.