Newly Available Expert Analysis Of Confidential Drug Company Data Reveals That NuvaRing Estrogen Levels In Studies Were A Cause For Concern, And The Method Of Reporting Was Misleading
In the pending NuvaRing litigation a federal judge recently unsealed some significant documents previously protected under claims of confidentiality. These "new" documents are remarkable because they show that several drug companies responsible for the NuvaRing have done reports which were misleading and the results were a cause for concern.
As background, the NuvaRing birth control product was initially approved by the FDA in October 2001, when Organon USA Inc. was the responsible drug company. Since that time, first, Organon was acquired by Schering-Plough and, later, Merck took over Schering-Plough and Organon.
According to Merck, as of December 31, 2011, there were approximately 950 NuvaRing lawsuits filed by women who had suffered serious blood-clot side effects such as pulmonary embolism (PE) and deep vein thrombosis (DVT). Today there are reportedly more than 1000 cases, and that number will continue to grow as more women file these drug injury legal claims against Merck, Organon, and Schering-Plough.
The majority of these NuvaRing lawsuits are filed in the federal court NuvaRing MDL, which is situated in the U.S. District Court for the Eastern District of Missouri, with Judge Rodney Sippel presiding.
In early September 2012 Judge Sippel issued an Order that made public for the first time some significant findings in Organon records made by experts retained by Plaintiffs. This expert review information was unavailable until now due to confidentiality claims asserted by the Defendants. Those defense claims were denied by this Order about certain motions related to expert reports.
Contained in the newly released documents is information not publicly revealed before now about some studies which Organon did concerning the measure of estrogen in a small group of women in order to prove that the NuvaRing was safe.
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Set forth in the unsealed papers are a motion to exclude testimony by a pharmacologist, Shelley Ann Tischkau, Ph.D., who was selected by the plaintiffs to study internal reports from Organon. One of the studies she reviewed was #34128 -- which is the one and only study that Organon did to actually measure the levels of estrogen in women using the NuvaRing. In her expert report, as recounted on the motion to exclude her testimony, Dr. Tischkau pinpoints some important safety facts shown in the confidential Organon study which would have been of significant interest to the doctors who prescribe the drug.
Based on a review of these newly available Organon NuvaRing study-related documents, we have learned the following facts:
- In pharmacokinetics study #34128, Organon only tested the NuvaRing on 16 people to see how much estrogen got into their blood, but evidently only 5 were actually reported on, and she pronounced this misleading.
- When testing the NuvaRing, Organon found there were bursts of estrogen released, which was a cause of concern in that higher levels of estrogen increased the risk of clotting.
- There was striking and significant variability in the blood levels of estrogen in the subjects in this study, and an unusual discrepancy in the levels of the subjects of this study, and there was an unreasonable variability in the time for subjects to reach maximum blood levels of estrogen.
The reason these Plaintiff expert findings are significant to the NuvaRing litigation is because the higher the levels of estrogen or the more these estrogen levels vary from day to day, the greater the risk of a blood clot forming and, in turn, a deep vein thrombosis (DVT) and/or a pulmonary embolism (PE) developing in women using the NuvaRing.
NOTE TO LAWYERS (AND MARKETERS) WHO MAY THINK ABOUT COPYING THIS ARTICLE FOR USE ON THEIR SITE -- AND PASSING IT OFF AS THEIR INTELLECTUAL WORK: Some deliberately placed inaccuracies are in this article which, though not significant to potential clients reading this, will be telltale that you used this article without our permission and without doing your own analysis of these unsealed documents.
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