Defendants Had Sought To Keep Sealed Some Documents That Show NuvaRing Estrogen Levels Were Apparently Concealed Or Misrepresented By Organon
In a defeat for Defendants Organon USA Inc., Organon Pharmaceuticals USA Inc., and Organon International Inc. (“Defendants”), on October 22, 2012 New Jersey State Court Judge Brian R. Martinotti issued an Order that allows public access to documents for which Organon had sought to keep restricted access, only.
As background, in July 2012 the Defendants filed six motions to exclude certain testimony by Plaintiffs’ experts; all six motions included documents which Organon filed under seal, i.e., restricted access. Like similar motions filed in the federal court NuvaRing MDL, these NJ motions contained a discussion of both parties’ relevant expert reports and expert depositions, which were included as exhibits to the motions and designated as confidential pursuant to the Protective Order entered by U.S. District Court Judge Rodney Sippel, who is presiding over the NuvaRing MDL proceedings.
Whereas Judge Sippel ruled in September 2012 that only the expert motions and memorandums in support should be unsealed, i.e., public access, — as seen in “Disturbing Information About NuvaRing Safety Found In Motions On Experts Recently Unsealed By Federal Court MDL Judge” — Judge Martinotti went further and unsealed, in addition, the expert reports and expert depositions which were exhibits to those motions.
The fundamental basis for this October 2012 ruling by Judge Martinotti was an established public policy of New Jersey — specifically, there is a presumption that the public has a right of access to judicial proceedings, which includes the public’s right to inspect judicial records.
Among the unsealed documents is an expert report by a pharmacologist, Shelley Ann Tischkau, Ph.D., prepared for Plaintiffs in the NuvaRing litigation. As part of this work, Dr. Tischkau analyzed Organon’s Study #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 for the Plaintiffs, Dr. Tischkau pinpoints facts shown in the “confidential” Study #34128 which were concealed or misrepresented by Organon, to the doctors who prescribe the NuvaRing and in fact to the governmental bodies which supervise the safety of drugs.
Based on review of this newly available Tischkau expert report, we have learned that:
- In pharmacokinetics study #34128, Organon only tested the NuvaRing on 16 people to see how much estrogen got into their blood, and it was so high in two women that Organon dropped them out of the study report without disclosing this reduction in number.
- Organon presents a chart in the Prescribing Information which shows estrogen levels from day 1 – 21 but the drug company omits day on day zero (first 24 hours) which is much higher estrogen.
- When testing the NuvaRing, Organon found they had bursts of estrogen which they could not control, and ultimately decided they would just have to live with that situation.
- And related to that last point, before resigning themselves to the fact they could not control it, Organon applied for a patent for a way to avoid the estrogen bursts with new technology but did not follow through with it.
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.
In contrast to these expert findings above, and apparently in order to promote the NuvaRing, those drug companies have claimed that the NuvaRing provides the least amount of estrogen of any contraceptive and that, unlike, the birth control pill, this low amount of estrogen is steadily released into the woman user over the 21-days cycle.
As regards the more than 1000 NuvaRing lawsuits that have been filed to date in the NJ state court and federal court MDL litigations, these Plaintiff expert findings are significant 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 developing into a deep vein thrombosis (DVT) or pulmonary embolism (PE).
No wonder the Defendants’ lawyers argued to Judge Martinotti that the unsealing of these expert materials would be damaging to Organon’s reputation.
Fortunately, Judge Martinotti saw the NuvaRing litigation as a high public-interest case which involved both health and safety, such that he rejected this argument by the Defendants and pointed out any harm to Organon’s reputation is irrelevant. 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.