I almost forgot I had a blog.
Really. Some intereesting things have happened at work, but I forget to record them here. Busy busy busy. My blogshares are suffering terribly.
"King of Torts" comes to life
Yes, we've certainly received legal complaints based on Adverse Events before. But nothing like we're getting this year, for one particular drug.
A law firm in Massachusetts has sent us 7000 complaints, with individual patient identifiers, for one of our psycho-active drugs. Since each patient is named, that means we have to create a case in our safety database for each one. They are overwhelmingly described as having an unspecified illness, so these cases don't get reported anywhere, unless the patient has died. There's a handful of those. We have no idea how many more are coming.
We have a way of marking these cases in our database, so that they don't skew our statistics, which compare a particular instance of an individual event for a drug versus the background rate in the rest of our database. Basically, our database is a universe of patients, that can be used to find safety signals. Adding 7000+ meaningless cases to the database wouldn't help our statistical analyses.
I have absolutely no idea how we are planning to defend these, since no damages are specified, as far as side effect particulars are concerned. Just unspecified illnesses, wreaking havoc on patients' lives. If they named a particular ailment, it's probably on the label anyway. Then you'd be back to the restatement of torts again - unavoidably unsafe products, with warnings provided. They're going to have to provide specifics at some point. The co-morbidities of this patient population are extensive. I don't think this is going anywhere. Just giving our people busy-work.
This drug in particular was a target previously, because we had something listed on our Japanese label that was not listed anywhere else. Oh, the consternation! How dare we not warn the American people about problems that we are warning the Japanese about! Don't we care about Americans?
This went nowhere, because the Japanese label was mandated by the MHW, against our wishes. We didn't believe the Japanese label claim was justified, and we had the data on our side.