The January issue of Vanity Fair has a long, important article about the dangers of the birth control device, NuvaRing, manufactured by Merck. The article tells the story of two women—one killed and one permanently injured—by NuvaRing. But, my best friend's sister died last year from pulmonary embolisms caused by NuvaRing, so I do not need this article to humanize this regulatory and personal disaster.
The article provides very useful information for consumers and non-lawyers about the regulatory and legal framework in which harmful drugs are introduced to market and in which attorneys struggle to seek justice for those who have been injured or killed by those drugs. If you are interested in understanding from a very real-world situation what "agency capture" or "mass tort" litigation looks like, this article is a must-read.
For the rest of you, please, ask every woman you know whether she is using Nuvaring and share this article with her.
While it is hard to find an exemplary pull quote from this long and excellent article, this quote demonstrates the extent to which drug companies will go to obscure science in search of ever-expanding profits.
In September 2001, as the F.D.A. was considering the approval of the completed application, court documents submitted by the plaintiffs claim, Organon scientists had become concerned with “the burst release” and what they called “out-of-spec results” in “large-scale NuvaRing batches.” One member of the regulatory-affairs team e-mailed a colleague, “This is a very serious issue, in that FDA is very sensitive to the ‘burst release’ phenomenon and release in general. Going to FDA to change these specifications is absolutely the LAST thing we should consider, i.e., that’s the worse possible scenario.”
I am angry all over again.
