[Drug and Device Law] Mensing - It's Not Just About Generics Anymore
We’ve been saying this for a while now – the impossibility preemption rationale created in Wyeth v. Levine, 555 U.S. 555 (2009), and weaponized by our side in PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013), isn’t just about generic drugs.
Bartlett made this crystal clear. “Once a drug − whether generic or brand-name − is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.’ “ 133 S. Ct. at 2471. We also pointed out that the FDA considers a whole bunch of things to be “major changes” that require Agency pre-approval. We also explained how any label changes concerning off-label use likewise require the FDA’s OK before being effectuated.
Now we have judicial confirmation that we aren’t baying at the moon. In Thompson v. Allergan USA, Inc., ___ F. Supp.2d ___, 2014 WL 308794 (E.D. Mo. Jan. 28, 2014), the plaintiff brought a consumer fraud claim class action alleging that the defendant was engaged in “overfilling” by putting more than a single dose of medication in single-use vials. The class claimed it was paying too much because it was being forced to buy more medicine than it needed. Id. at *1.
The fly in the litigation ointment?
The drug’s FDA approval set the dosage exactly the way it was being sold. And a dosage change is one of those pesky “major changes” that requires FDA pre-approval. The result: preemption under Mensing/Bartlett in a non-generic drug case - we hope, the first of many:
[I]f Defendants were unable, under federal law, to independently lower the volume in each vial of [their drug] to be in compliance with the state duties alleged by Plaintiff, Plaintiff’s state claims would be preempted. FDA regulations provide that once a drug, whether generic or brand-name, is approved, the manufacturer is prohibited from making any major changes to the “qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.”
The Court concludes that reducing the amount of medicine in each . . . vial is a major change requiring prior FDA approval. As noted above, FDA Guidelines from 2001 state that a “decrease in the fill volume” of a drug product “involves a change to the specifications and must be submitted in a prior approval supplement” for FDA approval. . . . [T]he Court agrees that a decrease in the fill volume of a drug product . . . involves a change to the specifications under the plain meaning of the statute.
2014 WL 308794, at *6 (citations and quotation marks omitted) (emphasis added). The plaintiff’s attack on the FDA-approved dosage of the drug is “therefore preempted under the Supremacy Clause.” Id.
Moreover, since neither Mensing or Bartlett required any further “clear evidence” beyond establishing the existence of an FDA pre-approval obligation, there was no need to speculate whether the FDA would have approved such a change. The requirement of pre-approval sufficed:
The Court does not find persuasive Plaintiff’s argument that . . . [their] claims are not preempted unless Defendants show by clear and convincing evidence that the FDA would have rejected such a change . . . . Applying this standard “would render conflict pre-emption largely meaningless because . . . [w]e can often imagine that a third party or the Federal Government might do something that makes it lawful for a private party to accomplish under federal law what state law requires of it.”
Id. (Mensing citations omitted). We hasten to add that the same argument preempts all design defect claims against FDA-approved products since all design changes require pre-approval.
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Posted By Bexis to Drug and Device Law at 2/03/2014 08:00:00 AM --
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