This afternoon, Judge Keenan published his memorandum opinion on the topic of whether generic manufacturers of alendronate sodium (the compound that Merck has branded as Fosamax®) will be completely excused from the ongoing Fosamax ONJ MDL — under the preemption principles set down by the Supremes in Wyeth v. Levine.
This will not likely directly impact Merck’s overall fortunes — except insofar as Merck might be able to assign some of the damages it ultimately ends up paying (to the extent an MDL settlement is reached) for payment, by the generic manufacturers.
Now — to make the background theory here a little clearer — if a generic simply copies a branded drug, in general, the generic may rely on the labels and warnings provided by the branded drug manufacturer (here Merck), verbatim — in the generic’s own inserts, all as approved by FDA, to escape liability from various plaintiffs’ claims under the theory of federal preemption of state law claims.
Judge Keenan generally agreed with that idea — but ruled (full 15 page PDF here) that if the generic companies did not promptly update the label copy for alendronate sodium as Merck revised it, with FDA concurrence over the years, the generics may be held seperately liable for not promptly warning doctors and their patients about the emerging risks. In sum, then, this clearly opens the door at least a bit — to Merck’s making the generics kick in to the proposed settlement funding.
. . . .For the reasons stated above, the Generic Defendants’ motion to dismiss is granted with respect to the design defect claims. The motion to dismiss is also granted as to the failure to warn claims, except to the extent that plaintiffs may claim that the Generic Defendants failed to timely update their labels after Merck updated the Fosamax label. . . .
Separately, we are reliably informed that Judge Keenan expressed displeasure today about the lack of progress on a mediated settlement — for about 300 of the ONJ (or osteonecrosis of the jaw) cases. I think there will be a renewed effort, even though the parties report that talks have foundered — because the able judge is suggesting that both sides have a lot to lose, if all 300 proceed to trial. That said, this opinion may ultimately increase the probability of the settlement being funded adequately — and thus allow the two sides to close the gap, whatever that might be.