Litigation surrounding the NuvaRing birth control device is moving ahead, with more women filing lawsuits alleging the contraceptive device caused serious injuries, including blood clots. Later this month, litigants in the NuvaRing multidistrict litigation currently underway in the U.S. District Court for the Eastern District of Missouri will meet to discuss possible settlement plans for those NuvaRing lawsuits.
NuvaRing, known generically as an etonogestrel/ethinyl estradiol vaginal ring, is marketed by its manufacturers as a convenient, equally effective alternative to daily birth control pills. The device consists of a flexible ring that is inserted into the vagina, and provides month-long birth control by emitting a continuous, low dose of estrogen and progestin for 21 days.
The progestin released by NuvaRing, etonongestrel, is active metabolite of desogestrel, a third generation form of the hormone. In 2007, the consumer advocacy group Public Citizen petitioned the U.S. Food & Drug Administration (FDA) to ban oral contraceptives containing desogestrel, citing among other things a statement issued by the agency in 1995 that noted “new studies indicate about a two-fold increase in the risk of venous blood clots associated with products containing desogestrel.”
Last October, the FDA published a study comparing different methods of hormonal birth control that found NuvaRing raised the risk of blood clots, including deep vein thrombosis (DVT) and pulmonary embolism (PE), by 56% when compared to older birth control pills. The FDA study noted that combined hormonal contraceptives, including the etonogestrel/ethinyl estradiol vaginal ring, “potentially result in higher sustained exposure to estrogen and hence, increased thromboembolic risk.”
Back in 2009, a growing number of NuvaRing lawsuits prompted the U.S. Judicial Panel on Multidistrict Litigation to consolidate all federally filed complaints in a multidistrict litigation in the Eastern District of Missouri. The lawsuits pending in that litigation allege that Merck and its Organon Pharmaceuticals subsidiary failed to properly research the device or adequately warn about the risk of blood clots from NuvaRing. The plaintiffs filing the lawsuits also claim to have suffered serious injuries, including deep vein thrombosis (DVT), pulmonary embolism, heart attacks and strokes, because of the device.
The NuvaRing litigation recently entered an important phase, and attorneys for both sides are preparing cases for its first test trials. Last month, U.S. District Judge Rodney W. Sippel, who is overseeing the litigation, ordered both plaintiff and defense counsels to submit proposed plans for alternative dispute resolution, which could help guide the cases to settlement. Plaintiffs’ counsel did so, and proposed that a Special Master be assigned to supervise negotiations. But attorneys for the defense have maintained that it is too early to move in that direction. Nevertheless, Judge Sippel has scheduled a hearing for February 28 for preliminary discussion of an alternative dispute resolution plan.
Even as the NuvaRing multidistrict litigation moves ahead, women continue to file lawsuits alleging they were injured by the device. Most recently, a Pennsylvania woman filed a complaint in federal court in New Jersey, alleging she suffered a stroke on February 5, 2010 because of her use of NuvaRing. According to her February 3 filing, Aimee L. Flynn used the NuvaRing contraceptive from October 2008 through February 2010. It’s likely that Flynn’s NuvaRing lawsuit will be transferred to that the Easter District of Missouri, to be included in the multidistrict litigation.