The plaintiff in the lead case, Marianna Prather, began using the NuvaRing in August 2003 when she was 33-years-old. Within a month, she was afflicted with deep vein thrombosis and pulmonary embolism, potentially fatal side effects of this method of contraception. She filed her lawsuit in 2008.
The number of lawsuits with similar claims against NuvaRing have skyrocketed over the last two years, increasing from just over 700 in April 2011 to 1,163 in May 2013.
Prather and other plaintiffs charge Merck’s subsidiary, Organon, the maker of NuvaRing, with negligence in investigating the device’s side effects, failure to warn users of health risks, falsely marketing the product as “safe” and “effective,” and inadequate design, testing, and manufacturing methods.
The NuvaRing is a flexible ring that is inserted in the vagina, where it releases fertility suppressing hormones over the course of three weeks. It is then removed for a week to stimulate a menstrual period.
NuvaRing’s contains a third-generation type of progestin, rather than the second-generation progestin, as well as the timing of the release of the different hormones from the device.
Third-generation progrestin has been found to pose a greater risk of venous thromboembolism (VTE). VTE side effects include deep vein thrombosis and pulmonary embolism, the symptoms the plaintiffs filed suit over.
Because it does not always successfully prevent ovulation and sometimes prevents implantation after fertilization has occurred, NuvaRing is considered an abortifacient capable of inducing a chemical abortion.
NuvaRing generated over $600 million in 2011, the last year for which numbers are available.
The FDA approved the device in 2001. Its sale continues despite the impending lawsuits.
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Prather's trial will be held on October 21 in the Eastern District of Missouri.
If she should win this bellwether lawsuit, it may nudge the more than one-thousand other lawsuits against NuvaRing to trial, or it may convince that the company to consider a settlement.
Merck acquired the NuvaRing in 2009 when the company merged with pharmaceutical giant Schering-Plough Corp.