Merck & Co. has agreed to pay $100 million to resolve all product liability claims in US federal and state courts alleging the drugmaker's transvaginal contraceptive NuvaRing (etonogestrel/ethinyl estradiol) causes potentially fatal venous thromboembolic (VTE) events. The proposed settlement agreement, which would also affect certain claims filed in the future, was presented at court hearings on Friday in Missouri and New Jersey, where most of the NuvaRing cases have been consolidated.
The company denied any wrongdoing as part of the deal, which must be accepted by 95 percent of the approximately 3800 eligible patients involved in cases pending in federal and state courts. "We stand behind the research that supported the approval of NuvaRing, and our continued work to monitor the safety of the medicine," Merck stated, adding that "there is substantial evidence to support the safety and efficacy" of the device.
The lawsuits alleged that Merck and its Organon subsidiary did not properly design and test NuvaRing, which combines oestrogen and progestin, and failed to provide adequate warnings on the device's label about higher VTE risk. In court filings, plaintiffs noted there are almost a dozen studies showing that the type of progestin used in the device is twice as likely to cause blood clots. However, Merck contended that it fully disclosed all known risks, including the possibility of blood clots, in its packaging and labeling. The product, which was linked in a 2011 FDA report to a higher risk for VTE, was approved in the US in 2001.
More than 1500 NuvaRing cases have been consolidated in St. Louis, Missouri, and over 200 were also consolidated in New Jersey state court. In 2013, the judge presiding over the New Jersey cases dismissed seven NuvaRing lawsuits that had been scheduled as the first to go to trial in that state after determining the plaintiffs could not show the device caused their injuries.
In December, Actavis announced that it filed for US regulatory approval to market a generic version of NuvaRing, making it the first company to do so.
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