NuvaRing Lawsuit Alleges Device Caused Death

A new NuvaRing lawsuit, initiated by the estate of a woman who died using the contraceptive, claims the device led to a fatal blood clot, wrote The Associated Press (AP). The lawsuit was filed yesterday in U.S. District Court in Omaha, said the AP.

The woman, Ann Tompkins, a 43-year-old mother of two, died last year after having been using <"">NuvaRing for five months, wrote the AP. According to the AP, the lawsuit is seeking damages from several pharmaceutical firms that sold or manufactured the contraceptive at one time, such as Merck & Co., which acquired Schering-Plough—a prior manufacturer—last year. Also involved are Organon BioSciences NV, its U.S. divisions, and Akzo Nobel NV, its parent company, which were all were purchased in 2007 by Schering-Plough, explained the AP.

A family friend found Ann Tompkins, dead in her home; the autopsy revealed that her cause of death was a blood clot in one of her lungs, reported the AP. The lawsuit accuses NuvaRing’s makers of over-promoting NuvaRing but not appropriately warning about the blood clot risk, among other issues, said the AP.

NuvaRing is a transparent, flexible vaginal ring that provides month-long birth control by emitting a continuous dose of estrogen and progestin for 21 days. The device releases a combination of ethinyl estradiol, a form of the hormone estrogen, and etonogestral. NuvaRing is marketed as providing the same efficacy as birth control pills but with the convenience of month-long protection.

NuvaRing lawsuits allege that because the device delivers a constant stream of hormone unmediated by the digestive system or the liver, patients end up receiving higher doses than they do from older pills. Of note, high estrogen doses create a greater risk of blood clots, which can be fatal.

Generally, complaints allege that the defendants failed to adequately test NuvaRing or warn about the potential for side effects, including an increased risk of stroke, heart attack, pulmonary embolism, deep vein thrombosis (DVT), and sudden death.

In 2003, the New England Journal of Medicine published two studies that concluded that the use of low-estrogen oral contraceptives containing the progestin desogestrel significantly increases the risk of venous thromboembolism, a potentially fatal type of blood clot, more than low-estrogen birth control pills containing levonorgestrel. In 2007, the consumer advocacy group Public Citizen asked federal regulators to ban oral contraceptives containing forms of desogestral because this dangerous progestin has been implicated in a higher risk of strokes, blood clots and other cardiovascular problems. NuvaRing releases approximately 120 micrograms of etonogestral, an active desogestral metabolite, per day, a relatively high dose of this hormone.

In 2009, NuvaRing lawsuits pending in federal courts nationwide were consolidated in a multidistrict litigation U.S. District Court for the Eastern District of Missouri. Attorneys for plaintiffs and defendants selected an initial pool of 13 cases, from which the first “bellwhether” or test trials will be selected. NuvaRing was also named in some 300 product liability lawsuits, all claiming NuvaRing caused plaintiffs to suffer serious, life threatening blood clots. In addition to the mulitdistrict litigation, NuvaRing lawsuits in New Jersey State court are pending, as well as this case, in Omaha.

Some legal experts believe thousands of NuvaRing lawsuits could eventually be filed.

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