Not too long ago we saw a story in the legal press about a newly filed case in Minnesota where the plaintiff claimed that the FDA was going easy on the defendant because it approved “hundreds of premarket supplements” rather than requiring “a new PMA application.” Supposedly “[b]y utilizing the [premarket approval] supplement process instead of filing a new PMA application, [the defendant] avoided the rigorous scientific review, public comment and clinical trial requirements.”
That’s barnyard excrement. This plaintiff isn’t just wrong s/he is loud wrong – which, for plaintiffs, is unfortunately rather common.Continue Reading Supplemental Authority