NuvaRing is the first birth control to use a vaginally inserted ring to prevent pregnancy. The device was initially made by Organon, a Dutch medical and pharmaceutical company, but eventually the rights to NuvaRing were sold to Merck. The device works by releasing hormones throughout a three week period, after which the ring is removed and a new one inserted a week later.
Although NuvaRing has been hugely popular because it provides a more convenient form of birth control as compared to the pill, it comes with some serious and even life-threatening complications. A small percentage of women using NuvaRing will develop dangerous blood clots. NuvaRing lawsuits have numbered in the thousands and Merck has already settled some of them. These women believe they were not adequately warned about the risk of clots and some have even called to have the device banned.
A More Effective Contraceptive
NuvaRing was an exciting development for many women. The effectiveness of oral contraceptives suffers because a woman has to take the pill every day around the same time for it to be fully effective at preventing pregnancy. Any mistake can lower that effectiveness and put her at risk for an unplanned pregnancy.
NuvaRing on the other hand is simply inserted at the beginning of the menstrual cycle and left in place for three weeks. Instead of a daily pill for three weeks, a woman can simply insert the device and forget about it until it’s time to remove it. For the fourth week, just as with oral contraceptives, she has her period. She then inserts the new ring at the start of the next cycle.
The U.S. Food and Drug Administration (FDA) first approved NuvaRing in 2001.When Merck took over the manufacture and sale of the device from Organon it proved to be a big seller, making hundreds of millions for the company. In addition to the improved effectiveness, NuvaRing is appealing because it does not need to be inserted in a doctor’s office like long-term intrauterine device contraceptives.
Third Generation Contraceptives
As with oral contraceptives, NuvaRing works by providing hormones that mimic the natural hormones regulating the menstrual cycle and pregnancy. A synthetic estrogen in the device, ethinyl estradiol prevents ovulation, while the synthetic progesterone, etonogestrel, acts to thicken the cervical mucus and changing the lining of the uterus to prevent fertilization and implantation of an egg. It is a combination contraceptive because it contains the two hormones.
NuvaRing is also one of the third generation contraceptives, those that contain a newer version of synthetic progesterone. They also contain lower amounts of hormones, which is supposed to reduce side effects without lowering effectiveness.
The problem with NuvaRing, and with most other third-generation contraceptives, and the issue that has led to a number of lawsuits, is that the newer progesterone hormones have been linked to a significantly increased risk for the formation of dangerous blood clots, also known as deep vein thrombosis, or DVT.
A DVT is a clot of blood that typically forms in the legs. Certain people are at risk for developing them, including those with certain genetic factors and people who have just had surgery. A blood clot is very serious because from the leg it can easily move to the lungs, the heart, or the brain and cause a blockage. When a clot moves to the lungs it is called a pulmonary embolism. In the heart or brain a clot may cause a heart attack or stroke. All three potential outcomes can quickly become fatal.
Although it came out on the market in 2001, it took time for evidence of this increased risk while using NuvaRing to come to light. If it can be determined that Merck knew about the risk all along, it could help plaintiffs win their cases against the company. There was no official warning about blood clots from the FDA until 2011 after numerous individual reports and data from studies showed that there was a definite risk.
Studies Show NuvaRing Poses Risk
When the FDA issued its warning in 2011 it stated that it was still waiting to draw a conclusion from research. The agency funded a study that investigated 800,000 women using birth control between 2001 and 2008. The results of that study showed that by using NuvaRing, a woman’s risk of developing a blood clot was up to 56 percent greater than in those women using another type of birth control.
In 2012 a study from Denmark that looked at more than one million women over 15 years found that the risk was even greater. Women using the device had their risk increased 6.5 times over other types of birth control. Other third generation oral contraceptives were also found to have an increased risk. The FDA made the decision to not include this large study’s results when it updated the NuvaRing warning label in 2013. It included only Merck’s own clinical data and the FDA’s 2011 study data.
Petition to Ban NuvaRing
While the research shows a clear connection between the device and an increased risk of developing blood clots, many believe that the FDA has not done enough to protect women. Many doctors, patients, and patient advocates think that all third generation contraceptives, including NuvaRing should be banned and recalled.
A Public Citizen petition made the rounds in 2007 getting more than 100,000 consumers to sign and call for the ban of these harmful drugs and devices. While the petition was not successful, it did help bring awareness to the issue and may have spurred the FDA to investigate NuvaRing in the 2011 study.
NuvaRing Lawsuits End in Settlements for Plaintiffs
Thousands of women have been adversely affected by NuvaRing and have filed lawsuits against Merck and Organon. They claim that Organon knew about the risks of blood clots and successfully resisted the FDA’s suggestions to include a specific warning about blood clots in the packaging information. These women are also making the case that Organon and Merck have sold a defective medical device, that they have misrepresented the risks it poses and that they have failed to warn the public about the extent of the risk of blood clots.
There are so many stories of the women who suffered after using NuvaRing. Just one of these tragic incidents left a young woman paralyzed and ultimately dead because of a blood clot. The woman, named Lyndsey Agresta, was just 27 when she complained of terrible migraines, which led her to the emergency room in the middle of the night. A blood clot had caused bleeding in her brain, followed by a massive stroke. She had several surgeries, but ended up paralyzed and died six months later.
This woman’s mother filed a lawsuit on her daughter’s behalf, along with more than 1,500 other women or their loved ones. While many are still pending, Merck agreed in 2011 to settle many of these cases. The company agreed to pay out $100 million, which resulted in approximately $58,000 per plaintiff. Merck still refuses to recognize any wrongdoing, but may end up paying even more in settlements as women continue to make the case that they were harmed by a drug and were not warned about that possibility.