No Surprise -- But The Fosamax® MDL Is Now Essentially All Over.

We have covered this for over a decade, as well. These atypical femur fracture cases. . . are (as of Tuesday) at an end, in reliance on Wyeth-style pre-emption.

Here is that opinion, and a bit:

. . .Based on clear and convincing evidence, the Court finds that Defendant fully informed the FDA of the justifications for its proposed warning, which was adequate under state law and encompassed the injury Plaintiffs allege here. The FDA, in turn, informed Defendant that it would not approve changing the Fosamax label to include that warning in the CRL.

Because the basis for the FDA’s rejection was insufficient evidence of a causal link between Fosamax and atypical femoral fractures, the Court is satisfied that the evidence is clear and convincing that the Agency would not have approved a differently worded warning no matter how Defendant attempted to submit one. Plaintiffs’ state law failure-to-warn claims are therefore preempted, and Defendant’s Motion for Summary Judgment is GRANTED. . . .

So ends yet another chapter, with 'Nova notching a solid win, tonight. . . grin -- off, to the museums with the baby girl tomorrow!

नमस्ते