NuvaRing (ethinyl estradiol+ etonogestrel, Organon/Merck)
Many women concerned about the convenience and safety of oral birth control pills turned to an insert-able birth control device called NuvaRing. NuvaRing was marketed by Merck as equally safe or safer than oral birth control pills. However, Merck did not disclose that NuvaRing contains the same third-generation hormone which is considered problematic in oral contraceptives. New evidence reveals that NuvaRing may cause more disabling and life-threatening pulmonary embolisms than other forms of birth control.
NuvaRing is a small, flexible plastic ring that is inserted into the vagina once a month to prevent pregnancy. For three weeks, the ring releases two hormones into a woman’s body: ethinyl estradiol (a synthetic form of the hormone estrogen), and etonogestrel (a metabolite of desogestrel, a form of the hormone progestin). A woman then suspends NuvaRing use for a week before initiating the process again over the next four-week cycle.
In combination, estrogen and progestin prevent pregnancy by interrupting the release of eggs from a woman’s ovaries, and prompting changes in the lining of the cervix and uterus so that a fertilized egg is not able to attach. These two hormones are the basic ingredients of popular oral contraceptives.
Added Dangers of NuvaRing
While all hormone-containing birth controls are capable of causing clotting injuries, there seem to be additional factors that may make NuvaRing even more dangerous than oral birth control pills:
- NuvaRing releases these hormones into a woman’s body at a higher level than most birth control pills – in fact, possibly in doses even higher than stated in NuvaRing’s promotional literature.
- NuvaRing’s method of delivery seems to be unable to maintain consistent levels of the dosage.
- The form of progestin in NuvaRing – desogestrel – has proven capable of causing an abnormally high incidence of blood clotting disorders that can lead to lung collapse, heart attacks, strokes, and death.
An estimated 15% of sudden deaths are attributed to pulmonary embolism, a blockage of the main artery of the lungs caused by a blood clot. Usually the clot has traveled from some other part of the body – often from deep veins in the legs, a condition that is called venous thromboembolism.
Desogestrel is directly related to pulmonary embolisms and venous thromboses because it disrupts the body’s normal blood coagulation process. Desogestrel changes the balance between pro-coagulant proteins and anti-coagulant proteins. Medical scientists know that changes in a woman’s hormone status – such as pregnancy, hormone replacement, or taking oral contraceptives – can increase pro-coagulant activity. Desogestrel appears to create resistance to anti-coagulants, enabling blood clots to form more easily.
The Problem Explained
It now appears that NuvaRing manufacturer N.V. Organon, a subsidiary of Merck, never disclosed to the FDA the risks NuvaRing, nor did the company warn prescribing physicians or consumers of these risks. Instead, after gaining FDA approval in 2001, NuvaRing marketers emphasized the relatively low dose of estrogen to distract from their product’s dangerously high level of desogestrel.
Organon/Merck’s failure to disclose well-documented risks of desogestrel is puzzling from the perspective of public safety, but not surprising from the standpoint of market appeal and profitability. Desogestrel was developed in the 1980s as the antidote to the embarrassing side effects of other progestin-containing products, such as acne and excess body and facial hair. More important to Organon/Merck, the company held the patent on desogestrel – making this formula for NuvaRing less expensive to produce than if other, safer forms of progestin were used.
Advertising for NuvaRing used words such as “favorable safety profile,” “low side effects,” “low hormones,” and “low estrogen” misleading millions of women in light of already-documented risks of desogestrel.
Your Florida product liability lawyers know that as far back as 1995, there was evidence of a two-fold risk of venous thromboembolism with products containing desogestrel.
- Three case-control studies revealed in 1995 that the incidence of venous thromboembolism in women taking third-generation progestins such as desogestrel was at least twice that of women taking earlier forms.(See Jick, Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with different progestagen components; Bloemenkamp, Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestagen; and Farley, Effect of different progestagens in low oestrogen oral contraceptives on venous thrombo-embolic disease.)
- Two letters from the FDA in 1998 warned Organon to cease its false and misleading advertising of oral contraceptives Mircette and Desogen. These tablets contained the same two hormones – ethinyl estradiol and desogestrel – that subsequently were incorporated into NuvaRing. Yet the same misleading claims of safety and superiority became the core messages for NuvaRing.
- By 2001, two meta-analyses (Kemmeren,et al; Hennessy, et al) corroborated earlier findings that oral contraceptives containing desogestrel increased the risk of venous thrombosis more than oral contraceptives containing second generation progestins.
- Armed with this ammunition, in 2007 Public Citizen, a non-profit organization focused on consumer safety, petitioned the FDA to ban third generation oral contraceptives containing desogestrel because of the increased risk of venous thrombosis.
Organon/Merck was not deterred by research, FDA warnings or consumer groups. With full knowledge of the growing body of evidence linking desogestrel with pulmonary embolisms and other serious thrombotic events, the company continued to market NuvaRing to unsuspecting women.
The first lawsuits based on deaths and injuries caused by NuvaRing were filed in July 2007. In August 2008, with 11 NuvaRing lawsuits in federal courts, a NuvaRing multi-district litigation (MDL) designation centralized cases in the Eastern District of Missouri. Although each case remains a unique, individual claim with distinct damages, it is consolidated for pretrial proceedings and discovery (such as depositions and document production) relating to generic liability and issues of cause common to all the cases.
These defective drug lawsuits allege that, in designing, manufacturing, and marketing NuvaRing, Organon and Merck failed to:
- Design this birth control device in a safe manner, free of defects and dangerous propensities
- Inspect and test NuvaRing for safety and effectiveness
- Warn about serious risks
- Monitor uses for dangers that are exposed
- Revise labeling to reflect dangers as soon as known
While victims and their families are seeking recourse for injuries caused by NuvaRing, women who are considering birth control options should know that they should NOT use NuvaRing if they have any of the following conditions:
- History of heart attack or stroke
- History of blood clots in the legs, lungs, or eyes
- History of blood clots in deep veins of the legs
- Chest pain (angina pectoris)
- Severe high blood pressure
- Diabetes with complications of the kidneys, eyes, nerves, or blood vessels
- Headaches with neurological symptoms
- Breast cancer or cancer of the lining of the uterus, cervix, or vagina
- Unexplained vaginal bleeding
- Yellowing of whites of the eyes or skin (jaundice) during pregnancy or when using any kind of hormonal birth control
- Liver tumor
- Heart valve or heart rhythm disorder associated with blood clots
- Requirement for long period of bed rest after surgery
- Are pregnant, or planning to be pregnant
- Acute liver disease or abnormal liver function tests
- Hypersensitivity or allergy to any of the components of NuvaRing
Searcy Denney defective medical device lawyers remind women now taking NuvaRing should be especially alert to warning signs that could indicate a pulmonary embolism:
- Shortness of breath
- Rapid breathing
- Rapid heartbeat
- Chest pain
- Coughing up blood
- Blue lips and fingers
- Circulatory instability
- Sudden collapse
In addition, women taking NuvaRing should watch for symptoms of venous thrombosis:
- Redness in the affected area
No method of birth control is completely safe. Before choosing any form of birth control, women should do their own research and talk with their doctors about the various options and relative risks of each form of birth control considered. If you or a loved one is suffering serious side effects, contact a Florida product liability attorney at Searcy Denney immediately.