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Another generic drug manufacturer picked off a preemption victory today.
In Mensing v. Wyeth et al., 562 F. Supp.2d 1056 (D. Minn. June 17, 2008) (here’s a link to the slip opinion), Gladys Mensing sued both the pioneer and generic manufacturers of Reglan, prescribed to treat her diabetic gastroparesis, when she developed tardive dyskinesia.
Two generic manufacturers, Actavis and Pliva, moved for summary judgment on the ground of preemption. The court granted the motion.
The court reasoned, first, that generic manufacturers have no ability to change their package inserts unilaterally. The CBE regulation does not apply to generic manufacturers, and there is no other way for generic manufacturers unilaterally to change their labeling. Mensing, slip op. at 11-16. (The court’s discussion here is quite powerful. If you represent a generic manufacturer and want to run a preemption argument, read this stuff.)
Second, the court found “no legal duty requiring a generic manufacturer to propose revised labeling.” Id. at 17. Indeed — helpfully for both generic manufacturers and pioneers — even if the manufacturer had made such a request, “The outcome of any such request to make a revision is uncertain and would require speculation as to what the FDA might have done.” Id.
Finally, the “regulatory scheme . . . does not allow for [generic] manufacturers to send ‘Dear Doctor’ letters,” so there’s no possible loophole to preemption there. Id. at 18.
Put today’s win on top of the generic’s win in Gaeta on Friday, and the generics are on quite a roll.
The Hatfields give a bow to the McCoys.
And we thank Linda Maichl of Ulmer & Berne for alerting us to this decision.