Last week we were going through the regulatory record of a drug
that is now the subject of mass tort litigation. This effort is
central to assembling, per the SCOTUS Wyeth v. Levine
case, "clear evidence" that the FDA would not have
approved whatever label change the plaintiffs are advocating. Then
we remembered something. It was even worse than remembering that we
left the stove on, or that we left the garage door open, or that we
root for the Phillies. We remembered that our case would be
governed by Third Circuit precedent, and that the Third Circuit had
done its best in the Fosamax case to make it impossible to
get summary judgment on preemption.
As we
blogged back in March, the Third Circuit in Fosamax
reversed summary judgment for the manufacturer and held that it is
a question for the jury whether the manufacturer had proved with
clear and convincing evidence that the FDA would have disapproved
the exact warning suggested by the plaintiffs. Throwing what
