What's up with Colacicco?

The last time we looked at the long-running Colacicco saga, the Third Circuit had vacated its 2007 decision and remanded the preemption issue back to the district courts. As to the Colacicco half, Judge Baylson has issued an order detailing how reconsideration of the preemption issue (and other issues) is to proceed. The court envisions discovery on preemption - which should eliminate any concerns over the completeness of the record - to be completed by the end of September, 2009. The order also provides a summary judgment schedule looking to a new preemption decision by the end of the year. That's not just our speculation. The order (¶6) actually states "The Court intends to rule on this issue before the end of the year."

There are a couple of other interesting things about this order. First, it mentions (¶1) that the pioneer manufacturer, which did not make the drug that the plaintiff took, is out of the case. That eliminates state-law issues concerning causation and product identification. Those are serious alternative state-law grounds for dismissal, as we have discussed before. The dismissal puts the preemption issue front and center.

Second, the court is quite explicit on the issue it is interested in deciding:

In preparing any motion on the preemption issue, counsel for Apotex shall keep in mind the narrow issue, as articulated by the Supreme Court in Wyeth v. Levine, 129 S. Ct. 1192 (2009), that the drug manufacturer bears the burden of showing by “clear evidence that the FDAwould not have approved a change to [the drug]’s label.” Id. at 1198.

Order ¶6. That proviso tells us that the court is interested narrowly in the issue of SSRI preemption - whether the administrative record demonstrates that the FDA had looked at SSRIs and suicide and already made up its mind what the warning was supposed to say. Conversely, the court does not seem interested in the issue of generic drug preemption, which as we've discussed on a number of occasions, focuses on whether the generic manufacturer has control over its own label, given the statutory requirement that generic labels be the "same" as pioneer labels.

Finally, while it's not reflected in the order itself, according to a report we received on the hearing, Judge Baylson indicated that he doesn't think Levine adversely affected his prior finding of preemption. We don't think so either.