Legal: NuvaRing lawsuit for no warnings about dangers of blood clots

A lawsuit was settled in 2014 against the pharmaceutical companies that developed and market the NuvaRing, Merck, Organon and Schering-Plough.

The plaintiffs accuse the companies of failing to disclose dangerous side-effects and say the active drug in the NuvaRing, etonogestrel, wasn’t tested adequately prior to release.

A number of lawsuits were eventually combined into a class action, in which Merck was reported to have settled for US$100 million, with 1,700 former NuvaRing users.

The NuvaRing contains hormones in a plastic ring that is inserted into the vagina, to secrete hormones slowly over the month, in a ‘once-a-month’ contraceptive option. NuvaRing secretes 15 micrograms of ethinyloestradiol and 120 micrograms of etonogestrel, a third-generation progestin hormone used in hormonal contraception.

The case

Merck, Organon and Schering-Plough are alleged to have been reckless and negligent in their marketing and in the final release of the NuvaRing. They are alleged to have hidden dangerous side-effects by focusing more on minor side-effects like headaches, and missing more dangerous complications like blood clots that can travel throughout the body, causing death.

The lawsuit accuses the companies of failing to adequately disclose known safety hazards, specifically from etonogestrel, particularly considering the typically administration of this drug is via mouth in oral contraceptives. This resulted in accusations of deceptive marketing, carelessness with warnings, defective manufacturing and design, and misrepresentation of the product.

Research has shown a link between hormonal contraceptives and blood clots, heart attack and stroke, some by up to three times normal risks. Those at higher risk are women who smoke, are over age 45, and anyone with high blood pressure.

So is the NuvaRing unsafe?

The pharmaceutical companies did not admit any wrongdoing, despite settling. The ring may be safe for many women, but it’s advisable if you smoke, are older than 35, and have high blood pressure to choose another non-hormonal contraceptive.

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Jessica Lloyd - Vulvovaginal Specialist Naturopathic Practitioner, BHSc(N)

Jessica is a degree-qualified naturopath (BHSc) specialising in vulvovaginal health and disease, based in Melbourne, Australia.

Jessica is the owner and lead naturopath of My Vagina, and is a member of the:

  • International Society for the Study of Vulvovaginal Disease (ISSVD)
  • International Society for the Study of Women's Sexual Health (ISSWSH)
  • National Vulvodynia Association (NVA) Australia
  • New Zealand Vulvovaginal Society (ANZVS)
  • Australian Traditional Medicine Society (ATMS)