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Defective medical devices causing fatal blood clots, lawsuit says

Women in Ohio may be among those around the U.S. who sued pharmaceutical giant Merck during the past ten years over its NuvaRing contraceptive device. The company was accused of hiding information about potentially deadly blood clotting during the device's Food and Drug Administration approval process. NuvaRing was approved in 2001, and Merck began marketing it in 2002. The product is similar to oral birth control pharmaceuticals using progestin and estrogen together to decrease the chance that a woman will become pregnant.

NuvaRing is meant to be inserted into the vagina. It releases an estrogen variant as well as a third-generation progestin over time to prevent ovulation. However, claimants in the lawsuits against Merck claim that the device occasionally releases doses of estrogen so high that it increases the chance of users developing blood clots. They say that the company did not warn them that this was a potential problem. It was claimed that Merck marketed NuvaRing both to users and to doctors even though they were aware of its inherent risks.

All of the companies named as defendants in the lawsuits owned patent rights to the device. Organon USA and its subsidiaries Akzo Nobel, McKesson Corp., Merck & Co. and Schering-Plough were alleged in the legal actions as claiming their product was as effective as birth control pills but more convenient since it was meant to last for a month at a time. One woman suing over NuvaRing said that Merck used the same warnings for the device as it did for oral contraceptives despite knowing their dangers were quite different.

Defective medical devices can cause suffering, injury and death. The Food and Drug Administration may miss or not have been told about certain risks inherent to these devices during its approval process.

Source: Courthouse News Service, "NuvaRing: a Big Headache for Women & Merck", Philip A. Janquart, February 06, 2014

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