In re NuvaRing Products Liability Litigation Lawsuit

In re NuvaRing Products Liability Litigation

NuvaRing is a once-monthly vaginal contraceptive ring made by Merck. The ring delivers 120 micrograms of etonogestrel, a progestin, and 15 micrograms of ethinyl estradiol, an estrogen, each day of use. A user inserts the ring into the vagina for three weeks and removes it for one week per cycle, during which a menstrual period typically occurs; the device works primarily by suppressing ovulation. The etonogestrel/ethinyl estradiol combination was first approved in the Netherlands in early 2001, then in the European Union in mid-2001, and by the U.S. Food and Drug Administration in October 2001. United States marketing began in July 2002. The ring was promoted on the basis of its convenience, its low profile, and a lower estrogen exposure than combined oral contraceptive pills; as late as 2023, the combination remained among the most commonly prescribed medications in the United States.

The alleged harm

The claims grew out of the cardiovascular risks inherent in combined hormonal contraception. The ring carried the same class of contraindications as combined oral contraceptives — blood clots, heart attack, and stroke — with the risk substantially higher when combined with factors such as smoking, recent surgery, a history of cardiovascular disease, or older age. A large Danish cohort study published in 2012 reported that users of the ethinyl estradiol–etonogestrel ring had a sharply elevated risk of venous thromboembolism relative to non-users of hormonal contraception. That research led to a labeling change warning of the increased clotting risk in Canada, but not initially in the United States. Plaintiffs alleged that Merck and other defendants concealed or downplayed these health risks in their advertising and marketing, and that the device had caused injuries including death. The company denied the allegations.

The litigation

The first lawsuit was filed in March 2008 against the manufacturers, distributors, and marketers of NuvaRing; a subsequent wave of plaintiffs asserted similar claims concerning how the device was advertised and how its risks of injury and death were presented. The federal actions were centralized as MDL No. 1964 in the United States District Court for the Eastern District of Missouri, under docket 4:08-md-01964-RWS, with the consolidated proceedings assigned to Judge Rodney W. Sippel. As the case count grew past the thousand mark, a first bellwether trial — selected from the pool of federal lawsuits — was scheduled to begin in April 2014.

Outcome

In February 2014, before the bellwether trial began, Merck announced that it would settle the NuvaRing litigation. The settlement covered more than 1,850 lawsuits at the time and was subject to approval by 95 percent of claimants by March 2014; otherwise Merck could retract the offer. Judge Sippel approved the settlement in June 2014, and it was understood to be shared by approximately 3,800 claimants. The MDL is recorded as terminated, with the litigation resolved in 2014.