We’ve been informed by counsel that the Dobbs litigation – the case that brought us Dobbs v. Wyeth Pharmaceuticals, 797 F. Supp.2d 1264 (W.D. Okla. 2011), has been settled while on appeal before the Tenth Circuit. That means that there is no longer any reasonable prospect of getting the best branded drug preemption facts that we know of, those involving adult suicide warnings on SSRI anti-depressants, before the Supreme Court in the foreseeable future.
The SSRIs, longtime readers will recall, had been the subject of a lengthy dispute over whether they (as opposed to the underlying depression they are intended to treat) caused increased suicides or suicide attempts/thinking. Time and time again the FDA rejected proposals to place suicide warnings on SSRIs as scientifically baseless. Although the FDA eventually allowed such a warning in teens/young adults (the cut off was 25 yo or thereabouts), it still has refused any warnings about suicide in older adults taking SSRIs.
The SSRI/suicide cases were what propelled the FDA onto the preemption battlefield in the first place, leading to the 2006 preemption preamble that ultimately was shot down by the Supreme Court in Wyeth
555 U.S. 555 (2009).
That preemption battlefield is what initially prompted us to found this blog.
Levine established a “clear evidence” standard for branded drug preemption, that is, “clear evidence” that the FDA would have rejected the warning proposed by the plaintiff. If any pharmaceutical regulatory history constituted such “clear evidence,” it was SSRI/suicidality, and that is precisely what the district court held in Dobbs.
We are certain that Dobbs was the only case post-Levine to have reached that felicitous conclusion. We are unaware of any other adult suicide cases in which the preemption issue is currently pending (that doesn’t mean that there aren’t any, but if so they’re being kept awfully quiet). Thus, the settlement in Dobbs effectively means that no appellate vehicle currently exists for even possibly bringing the best fact preemptive pattern before the Supreme Court.