I just spent some Saturday morning time re-reading much of the Singer brief. I highly encourage anyone with heightened heebeejeebees after the FDA generic approval to do the same. A few things are "obvious":
- The brief is excellent. It is clear, direct, methodical, and devastating to the sloppy, biased conclusions that Judge Du drew from the trial.
- It is pretty clear, from the briefing, that Covington and team presented in substance all of the arguments that should have been compelling toward a finding for Amarin. What is clear, if you read Singer's briefing, is EXACTLY what he alleges. The Judge fell victim to hindsight, and then reverse engineered the support for that hasty and sloppy conclusion. It may well be the case that it made no difference who presented Amarin's case -- the trial was wired against Amarin due to Judge Du's sophomoric approach to the facts and overwhelming inclination to find for the defendants.
- It is also pretty clear that we are not solely dependent on the error in legal procedure. The offsetting of secondary considerations is a clear, crazy error. And the sequencing of prima facie vs secondary may be in error, but there is a debate there. I would say, however, that the pure factual errors are SO grotesque here that even if the procedural errors weren't out there, there is STILL a very compelling case for reversal. The defendants were so far from presenting clear and compelling prima facie evidence that we shouldn't even have needed any secondary conditions (although we had them -- in spades). Judge Du arrived at an extremely simplified and erroneous mental model of the clinical issue at hand, drew sweeping conclusions from that model, and took the defendants' framing hook, line, and sinker while summarily dismissing any contradictory evidence from Amarin's witnesses. It is just startling -- a level of bias, and burden shifting, that was breathtaking.
- We could get into an endless debate here about Du's qualifications, but her career isn't really a track record of terrible decisions or clear bias. It makes this decision bizarre. The decision is so sloppy and terrible, when compared with that track record, that one has to question real motivations here. At best, it was her contempt for the big-timing East Coast suits. At worst -- something more sinister.
At any rate -- worth some of your Memorial Day weekend time. It's a really good brief. And it makes clear just how bad this decision was.
“The trick is in what one emphasizes. We either make ourselves miserable, or we make ourselves happy. The amount of work is the same.” Carlos Castaneda
