NuvaRing Users File Lawsuits Against Contraceptive Maker Merck

NuvaRing is a prescribed hormonal contraceptive composed out of a flexible plastic vaginal ring and is designed to slow-release low doses of progestin and estrogen. NuvaRing delivers 120 µg or 0.120 mg of etonogestrel (progestin) and 15 µg or 0.015 mg of ethinyl estradiol (estrogen) each day of use and has been found to be as effective as taking birth control pills in preventing pregnancy.

The contraceptive device, manufactured by Merck & Co. (formerly Schering-Plough), was approved for use in the US by the US Food and Drug Administration (FDA) in October 2001 and was marketed to the public the following July. At last estimates, the ring had been utilized by approximately 1.5 million women worldwide.

The makers of the NuvaRing boasted benefits of ease and infrequent incidences of side effects such as nausea and irregular bleeding when compared to oral birth control. Several clinical trials, however, found the use of the NuvaRing contributed to vaginitis, headaches, track infections, and weight gain – and as with other birth control methods utilizing hormones, cautioned users to the possibility of increased risks for stroke, heart attack, and blood clots (venous thrombosis or phlebothrombosis) especially in smokers.

In March 2008, an initial lawsuit was filed against the manufacturers, distributors, and marketers of NuvaRing alleging they willfully concealed the health risks associated with using the device, which had been blamed for deaths. The plaintiffs argued the advertising had severely downplayed the product risks regarding life-threatening blood clots.

Several studies, including a recent one funded by the FDA, found that women taking contraceptives like NuvaRing – which contains a third-generation progestin that is directly introduced into the bloodstream – are 1.4 to four times more likely to develop blood clots than those taking contraceptives with second-generation progestin.

Now more than 1,000 women are suing Merck & Co. in a federal district court in Missouri, according to Yahoo News. The victims allege that the company’s device caused them to suffer blood clots — in some cases, fatal ones — heightened risks of which they say they were inadequately forewarned about and insufficiently tested for prior to allowing the product onto the market.

Similar lawsuits have been filed against other hormonal contraceptive makers in recent years. Ortho McNeil, a Johnson & Johnson subsidiary, paid out millions to thousands of women after studies revealed a higher blood clot risk associated with the Ortho Evra patch. Bayer, the maker of Yaz and Yasmin, set aside more than $1.5 billion to settle claims after more than 10,000 negligent suits were filed.

Many of the cases against Merck will face trial in the federal court system starting this October.