We’ve always thought that the FDA’s close regulation of SSRI’s (selective serotonin reuptake inhibitors) and the issue of suicide was among the best fact patterns for preemption. So did the FDA – it entered the preemption field to preserve its control over the labeling of these drugs.
If our side can’t win the preemption fight after Levine with this fact pattern, then it’s going to be difficult for us to do so anywhere. Today, we lost the first post-Levine appellate decision in this area, Mason v. SmithKline Beecham Corp., slip op. (7th Cir. Feb. 23, 2010). It’s not our best facts, as the suicide was a young adult (23 years old), and subject to an eventual FDA label change, but it’s not good either.
We haven’t had a chance to read it yet, but since it’s going to be published anyway, we thought we’d get it out there for our readers to know about it.