Merck & Co. [corporate website] agreed to pay $100 million to settle thousands of lawsuits concerning Merck's NuvaRing [official website] contraceptive device. The lawsuits allege [Bloomberg report] that NuvaRing potentially causes fatal blood clots. The settlement will provide an average payment of over $58,000 per case. This settlement is less than other contraceptive makers have had to pay in similar lawsuits. For example, last year Bayer AG [corporate website] paid more than $1.6 billion to settle claims related to Yasmin and Yaz contraceptive pills. A 2011 US Food and Drug Administration (FDA) [official website] report linked NuvaRing to a higher risk of blood clots, and the plaintiffs allege that are almost a dozen filings showing that the type of chemical progestin used in NuvaRing is twice as likely to cause blood clots than other types of progestin. The plaintiffs contend that Merck failed to provide proper warnings about the higher clot risk. The settlement agreement requires at least 95 percent participation from the 3,800 people eligible to participate. Merck denies fault [WSJ report] under the settlement, and the settlement would cover cases filed in both state and federal courts, as well as some unfiled claims.
The FDA has been in the legal news recently for their involvement in two ongoing controversies: lethal injection and contraceptives [JURIST backgrounder]. In June the FDA announced [JURIST report] that it has officially approved the brand-name emergency contraceptive Plan B One-step for all women of child-bearing potential without a prescription, regardless of age. This approval came following an order [JURIST report] issued the prior week by Judge Edward Korman of the US District Court for the Eastern District of New York [official website], who has been overseeing the Plan B litigation [JURIST news archive] for more than six years. JURIST Guest Columnist Alyson Schwartz argues that the FDA's actions with regard to emergency contraception has marked a turn away from political maneuvering [JURIST op-ed] and a return to their health-based mission.