Nevertheless, the court finds that amendment would be futile because Ms. Johnson cannot state a plausible claim for relief based on the Generic Defendants’ delay in adopting the 2004 labeling changes. The proposed amendment is wholly inconsistent with the allegations of Ms. Johnson’s original complaint. The original complaint includes an allegation that the FDA-approved warning label for Reglan remained “inadequate” until the FDA issued a “boxed warning” in 2009. Essentially, therefore, Ms. Johnson seeks leave to amend her complaint to assert a claim that the Generic Defendants are liable for failing to update their label to one that was still inadequate.
This, however, is merely another way of stating that the Generic Defendants failed to provide adequate warnings about the risks associated with the long term-use metoclopramide. As explained above, Mensing forecloses any such claim. The FDCA prohibits generic manufacturers from employing any labeling that contains information that differs from that contained in the labeling used by brand-name manufacturers. Under the FDCA, “labeling” includes any written material accompanying the product. Accordingly, there was no alternative packaging design available to the Generic Defendants that could have conveyed stronger or different warnings about metoclopramide’s side effects.