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March 20, 2009

Supreme Court Ruling Allows Woman’s Case Against NuvaRing

Drug maker Organon, now merged with Shering-Plough, is currently under fire concerning its birth control device NuvaRing. Kristina Buckner is a healthy young woman whose life was in the balance three years ago. After using NuvaRing, she suffered potentially fatal blood clots, a side effect listed on the label. She is part of a class action lawsuit against the drug maker along with 200 other plaintiffs that include 6 deaths associated with the product. Buckner’s suit was on hold waiting for a response from the U.S. Supreme Court concerning drug preemption in another case. Organon/Shering-Plough was trying to use drug preemption as its defense, saying that if a product has been approved by the FDA, than it is deemed safe and company cannot the be held accountable to difficulties experienced by patients who use their product. The drug preemption claim was spurred by a similar case concerning a Vermont woman, Diana Levine, who lost her arm below the elbow due to complications experienced by a medication from Wyeth that was administered to her. In much relief, “The Supreme Court just held that even if the Food and Drug Administration has approved a label, it doesn't stop people from suing,” says Shaun Martin, Professor of Law at the University of San Diego. “The Supreme Court said that there are eleven thousand different drugs on the market, and the ability of the FDA to effectively make sure that all of the labels are adequate is minimal,” Martin said. After the Supreme Court ruling, NuvaRing's maker dropped its petition to dismiss Buckner's lawsuit under the same FDA shield argument that didn't work for Wyeth. Buckner's case is now moving forward.

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