Friday, October 19, 2012
I’m sure many of us are talking about the contaminated steroid injections which have spread a fungal form of meningitis Exserohilum rostratum across the country. The CDC, which as is usually the case is doing an excellent job of providing clear and current information, reports that as of “October 17, 2012, a total of 47 patients have laboratory-confirmed fungal meningitis.” They offer some reassuring information—that “this form of fungal meningitis is not contagious” and some scary information—that there are 257 cases and ten deaths in 15 states and that incubation periods last up to a month.
The most recent legal news is that the pharmacy was visited
earlier this week by the FDA’s criminal investigative unit and that the first law suit has already been filed in Minnesota Federal District Court by a woman who received a vaccine from the pharmacy but who does not know yet if she has meningitis.
The incident provides an opportunity to watch these two agencies work quickly with local health departments in reaction to a crisis. The FDA estimates “that approximately 14,000 patients may have received injections with medication from three implicated lots of methylprednisolone and nearly 97% of these patients have been contacted for further follow-up.” This is a copy of the letter they have received.
Since I don’t teach Public Health Law until next semester, I’ve used the event as an in-class exercise in Torts. I showed a brief video clip on the story and asked the students to consider what kinds of information they could collect to prove standard of care should they be hired by either a patient or the pharmacy. I was very pleased that they developed a list
that included things like consulting pharmacists who might be expert witnesses as well as researching the existence of laws controlling lab safety.
This story is, of course, a moving target and is likely to serve as a rich source of teaching material as details emerge. In the larger picture, it should raise awareness about the growing problem of both adulteration and contamination of pharmaceuticals. The Economist publisheda very interesting piece this week, Bad Medicine, The World’s Drug Supply Is Global. Governments Have Failed To Keep Up, that puts the issue in a global context.
JSBStarting with the statistic that “In America 80% of drugs’ active ingredients come from abroad (drug imports there more than doubled from 2002 to 2010, accounting for 40% of finished medicine)” it tells a very interesting, if frightening, story of how countries around the world are addressing, and not addressing, the dangers inherent in not just compounding but manufacturing.
Some of the things we teach in Health Law courses are far from our students' experiences, but I found that all my students were not only aware of this story, they were quite familiar with the concept of getting a steroid injection for pain from a sports or other injury.