Last July we discussed a rare event, a preemption win for an innovator drug under the  Wyeth v. Levine, 555 U.S. 555 (2009), “clear evidence” standard.  However, that case, In re Fosamax Products Liability Litigation, 951 F. Supp.2d 695 (D.N.J. June 27, 2013), occurred in the peculiar context of a preemption motion granted after the defendant won a trial of the same case.  Given that the plaintiff was extremely likely to lose anyway, given the verdict, that case was never appealed.  

Now the Fosamax preemption ruling has been extended to other, similarly situated cases in the MDL.  See In re Fosamax (Alendronate Sodium) Products Liability Litigation, No. 3:08-cv-00008-JAP-LHG, slip op. (D.N.J. March 26, 2014).  The court disposed of the MDL plaintiffs (mostly) procedural arguments against preemption and applied its earlier ruling to all cases in the MDL with injury dates before Sept. 14, 2010 – when the FDA last reaffirmed its position that it did not have enough evidence of a causal association to allow a warning change.  Slip op. at 7.

The court found no reason not to apply its preemption ruling to other similarly situated plaintiffs because: (1) the case in question had been selected as a bellwether; (2) preemption had been thoroughly briefed; and (3) plaintiffs had been repeatedly instructed to come forward with all their preemption related evidence.  Slip op. at 9-13.  The “newly discovered” evidence that the plaintiffs predictably asserted after they lost didn’t change anything.  It was an expert opinion based on the same facts that existed when the court decided the original bellwether preemption motion.  Slip op. at 15.  Further, all the expert testimony in the world about what might have happened, did not change the undisputed regulatory facts about what actually did happen.  Slip op. at 19-20.  The court pointed out (with a useful collection of cases) that preemption had repeatedly been addressed in similar fashion in other MDLs.  Slip op. at 16-17.

Plaintiffs attempted to claim that design defect claims were different and couldn’t be preempted.  The court again disagreed. There was no way to change the chemical composition of Fosamax, so the “design” claims were merely warning claims in disguise.  Slip op. at 21-22.

After disposing of various arguments rehashing what had already been decided, the court disposed of the plaintiffs’ final argument that “if fully informed” the FDA might have acted differently.  That claim was merely warmed over fraud on the FDA:

[T]o the extent that Plaintiffs claim that [defendant] withheld information from the FDA and clear evidence does not exist as to whether the FDA, if fully informed, would have rejected a stronger label, this does not defeat Defendant’s showing that it is entitled to judgment as a matter of law on preemption grounds. . . .  [E]ven assuming [defendant withheld information], Plaintiffs have failed to show that providing such information to the FDA would have changed the FDA’s conclusion that a Precaution was not warranted.  Instead, Plaintiffs’ contention appears to be a fraud-on-the-FDA theory which was rejected by the Supreme Court in [Buckman], or alternatively, is based largely on speculation and cannot defeat summary judgment.

Slip op. at 29 (citations omitted).

So this time, it appears, there is likely to be a Fosamax preemption appeal.  As we pointed out in our first post, the regulatory facts supporting preemption look quite strong.  Thus, another avenue for eventual reconsideration of Levine – or at least some of its loopier aspects – appears to be presenting itself.

Thanks to Terry Henry at Blank Rome for sending this decision along to us.