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June 11, 2014

As far as birth control methods go, few have been as simultaneously popular and controversial as the NuvaRing. The vaginal ring, which slowly releases hormones into a woman’s bloodstream over the course of about three weeks, racked up about $686 million in 2013 alone for its manufacturer Merck. Around this same time, and after about 1,000 formal complaints to the FDA and a damaging study in the British Medical Journal, 700 women claiming to have been harmed by the device also began a class action lawsuit. By this year, the number of filed and unfiled cases against NuvaRing has jumped to 3,800–and the Daily Mail reports that 224 deaths have been linked to the device. It seems Merck, as of this month, is finally ready to settle, though it insists this is not an admission of any wrongdoing on its part.

Many of the women involved in these cases suffered painful blood clots; others were the victims of an embolism, which occurs when part of a blood clot breaks off and is carried to the heart, lungs, or brain. This may lead to an increase in pressure in any of these organs, which may in turn lead to labored and painful breathing, heart palpitations, rapid heartbeat, and even sudden death. The Daily Mail report also states that the device has been connected to strokes, heart attacks, breast cancer, and cancer of the reproductive organs.

Providing further support for these women’s claims is the British Medical Journal study mentioned above, whose authors conclude, “Women who use transdermal patches or vaginal rings for contraception have a 7.9 and 6.5 times increased risk of confirmed venous thrombosis [a blood clot that forms within a blood vessel] compared with non-users of hormonal contraception of the same age.” Though this study led to a labeling change mentioning this increased health risk in Canada, the U.S. Food and Drug Administration (FDA) has done nothing.

After announcing in February of this year that they are willing to settle existing NuvaRing lawsuits for $100 million, Merck’s offer was approved by a New Jersey Superior Court judge earlier this month. Were every patient to accept the offer, this would result in an estimated average $60,000 payout per case; though every plaintiff’s exact settlement amount will vary based upon a committee review. Despite this offer, the families of several victims who blame Merck for their loved ones’ deaths are unwilling to sign on.

The Langhart family, for example, lost their 24-year-old daughter Erika to a heart attack months before she was to begin law school at Georgetown University. Her father Rick insists that the drug’s packaging should include language telling women that using NuvaRing could be fatal, and he argues that Merck “has control over the FDA. We think [Merck executives] have undue influence within the FDA.” He went on to say, “It was never about the money. It was about trying to hold Merck responsible.”

This is yet another tragic example of the failure of the FDA to provide proper post-market research into drugs it has already approved. It is remarkable that, even in light of these patients’ reports and empirical research, the FDA has not yet called for stricter labeling standards. This is emblematic of federal regulation in this country and again proves the point that the civil justice system is often the only thing standing between self-interested corporations and government agencies seemingly in the business of keeping them profitable.

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