Organon Knew of Increased Side Effects Even Before NuvaRing’s 2001 FDA Approval

By Rheingold Giuffra Ruffo & Plotkin LLP

As our firm prepares to conduct the first NuvaRing trial in the nation, our pre-trial briefs shine a light on what was known about NuvaRing’s dangers before it was sold to unsuspecting women. Our client is Tiffany Barrow, who suffered from a pulmonary embolism in 2007 while she was living in Colorado and in college. She had no pre-existing conditions for causing the clot in her lungs, and we expect that at trial Organon will in fact agree the pulmonary embolism was caused by the NuvaRing, a plastic vaginal ring using third generation hormones.

Our firm’s legal submissions to Judge Martinotti in Bergen County include evidence that in 1995 Organon hired consultant Dr. Herschel Jick who had published a medical study finding twice the risk of clot injuries in users of third generation birth control, such as NuvaRing. Three women in Organon’s premarket clinical tests suffered from venous thrombolic events, yet Organon made efforts to keep this information from warnings for doctors and patients. In fact, it will be argued that the injury information was not timely reported to the FDA. All that was stated was that the risk with third generation hormones was “unknown,” even though Organon had calculated the risk was now twice as much.

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