This isn't about FDA regulations[1] or tort law[2]. It's about the American medical system being a corrupt racket. 1. The FDA will approve nearly anything. For

This isn't about FDA regulations[1] or tort law[2]. It's about the American medical system being a corrupt racket. 1. The FDA will approve nearly anything. For example, very flexible user-managed insulin pumps. 2. A jury of retards will convict if the plaintiff is sufficiently pathetic. Assuming you have reasonably good intentions and reasonably clear documentation, tort liability is just a roll of the dice.