More than 1,000 women who have been injured by the NuvaRing contraceptive device are suing the manufacturer, Merck, alleging that it has caused them to suffer blood clots.
The Daily Mail is reporting that the cases will be heard in a federal district court in Missouri beginning later this year. The plaintiffs allege that Merck did not adequately test or label the device before introducing it to the market in 2002.
Unlike other contraceptives, NuvaRing, a vaginal ring, delivers hormones directly into the bloodstream, stopping ovulation by releasing a combination of the hormones estrogen and progestin into the body. This delivery causes what expert witnesses call hormone “spikes” that make women more susceptible to blood clots.
In some cases, the blood clots were fatal.
According to an article appearing on Yahoo!News, 24 year-old Rachel Lietzke Payne, a NuvaRing user, was out to lunch with her father in 2010 when she suddenly fell ill and “spat up quarter-size chunks of blood onto the cement” outside the restaurant. The Orlando, Florida resident was 22 years-old and a healthy non-smoker at the time.
Payne was hospitalized for 10 days while doctors administered anticoagulants to thin her blood and try to determine the cause of her problem. They eventually agreed that the NuvaRing was the problem.
The NuvaRing Resource Center, a patient advocacy group, is reporting that the FDA has received over 1,000 reports of blood clot injury or death in patients using NuvaRing. In 2011, they released a report entitled, “Combined Hormonal Contraceptives (CHSs) and the Risk of Cardiovascular Disease Endpoints” which showed that vaginal ring contraceptives could increase the risk of blood clots as much as 56 percent.
In addition, they cite a Danish study published in the British Medical Journal on May 10, 2012 linking vaginal rings like NuvaRing to as much as a 90% increased risk of blood clots over oral contraceptives. On June 14, 2012, the New England Journal of Medicine also published a study finding vaginal ring contraceptives could relate to a 2.5 to 3-fold increased risk of blood clots.
Dozens of other studies, including recent research funded by the U.S. Food and Drug Administration (FDA) found that women taking contraceptives like Nuva Ring containing what are known as “third-generation” progestins are up to four times more likely to develop blood clots that those taking other forms of progestin.
Executives at Merck insist that their product is an effective and safe method of birth control.
“We are confident the company has provided appropriate and timely information about NuvaRing to consumers and the medical, scientific and regulatory communities,” said Lainie Keller, a spokeswoman for Merck, in a statement.
Some health experts have come out in support of Nuva Ring, with more than 20 researchers publishing a letter in the Journal of Family Health and Reproductive Planning earlier this month saying some of the studies conducted on the device failed to take into account other risk factors for blood clots such as obesity.
On April 19, New Jersey Federal Judge Brian Martinotti threw out seven suits by women alleging injury from the device, saying the plaintiffs failed to prove that NuvaRing was the cause of their injury.
Rochelle Rottenstein, principal of the Rottenstein Law Group, a firm representing the plaintiffs, said the ruling doesn’t mean their cases are doomed to fail, but that plaintiffs attorneys in upcoming cases will need to “reassess their strategies” before heading into court.
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