Sometimes it’s funny how an issue that we all know is out there sits for a long time and then, all of a sudden, it comes back at us from several different directions at once. The recent flurry of interest in the question of whether “FDA experts” – usually former FDA employees – can offer
Less than three weeks ago (it seems a lot longer) we posted about the FDA’s position that expert witnesses shouldn’t be allowed to opine on the meaning of FDA regulations during trial. Such opinions, the Agency argued, were legal – not factual – opinions. Thus they were the province of the court to decide, and
Coming in at number 2 on our list of the top ten worst court decisions of 2007, was the Missouri opinion Strong v. American Cyanamid – for a lot of reasons, including the court’s allowance of thinly-disguised FDCA-based negligence per se claim contrary to Missouri law, and the court’s expansive reliance upon expert testimony on
We’re so used to adverse decisions out of the District of Minnesota – what with the defibrillator MDLs “distinguishing” Buckman into near oblivion, and the heart valve MDL persisting in certifying classes despite being told not to by the Eighth Circuit – that good news from that district is like a breath of fresh air.