PER CURIAM:
Appellants Penny and John Morris sued Appellees PLIVA, TEVA, and Actavis — generic drug manufacturers — for injuries related to use of the drug metoclopramide (brand-name Reglan). This case is yet another in the expanding cohort controlled by PLIVA, Inc. v. Mensing, ___ U.S. ___, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011), which held state law claims against generic manufacturers of Reglan preempted by FDA regulations. See also Demahy v. Actavis, Inc., 650 F.3d 1045 (5th Cir.2011) (per curiam). Accordingly, we AFFIRM the dismissal of this suit.
Penny Morris took metoclopramide from early 2006 to July 2008. Ingesting the drug for more than twelve weeks, however, has been contra-indicated on FDA-approved
Finding the Morrises' only factually supported claim — inadequate warning — to be preempted, the district court dismissed the complaint "pursuant to Rule 12(b)(6) and/or 12(c) of the Federal Rules of Civil Procedure." Appellants subsequently moved the district court under Rule 59(e) to amend its earlier ruling based on four theories: (1) Appellant PLIVA failed to comply with the 2004 FDA-approved label change; (2) the generic defendants failed to properly test their products and report that information; (3) breach of express warranty; and (4) Appellant TEVA may be held liable for a "failure to warn" because of its status as a reference listed drug ("RLD") holder.
Judgments on the pleadings are reviewed de novo; Rule 12(c) motions are governed by the same standard as Rule 12(b)(6) motions. Jebaco, Inc. v. Harrah's Operating Co., 587 F.3d 314, 318 (5th Cir. 2009). The fundamental question is whether the plaintiff states a claim on which relief may be granted. "To survive a Rule 12(b)(6) motion to dismiss, a complaint `does not need detailed factual allegations,' but must provide the plaintiff's grounds for entitlement to relief...." Cuvillier v. Taylor, 503 F.3d 397, 401 (5th Cir.2007) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 1964, 167 L.Ed.2d 929 (2007)). Alternatively, Rule 59 orders are reviewed for abuse of discretion and "cannot be used to raise arguments which could, and should, have been made before the judgment issued." Schiller v. Physicians Res. Grp. Inc., 342 F.3d 563, 567 (5th Cir.2003) (quoting Rosenzweig v. Azurix Corp., 332 F.3d 854, 863 (5th Cir.2003)).
Mensing held that federal law demands "generic drug labels be the same at all times as the corresponding brand-name labels." Mensing, 131 S.Ct. at 2578. This is known as the "duty of sameness." Whether a warning is placed on the label on the bottle or in letters to distributors,
Appellants first contend that Mensing did not dispense with claims concerning a failure to communicate approved warnings. They allege the generic defendants are liable for failing to convey FDA-approved information; information communicated by generic manufacturers that is consistent with the brand-name labeling does not violate the duty of sameness.
On the contrary, Mensing forecloses such claims because failure to "communicate" extends beyond just a label change. To avoid liability, the manufacturer must take affirmative steps to alert consumers, doctors, or pharmacists of changes in the drug label. Because the duty of sameness prohibits the generic manufacturers from taking such action unilaterally, they are dependent on brand-names taking the lead. Id. at 2576 ("[I]f generic drug manufacturers, but not the brand-name manufacturer, sent [additional warnings such as a `Dear Doctor' letters], that would inaccurately imply a therapeutic difference between the brand and generic drugs and thus could be impermissibly `misleading.'"). Under federal law, the inquiry is whether the brand-name manufacturers sent out a warning, not whether the proposed warning to be disseminated contains substantially similar information as the label. Because no brand-name manufacturer sent a warning based on the 2004 label change, the generic manufacturers were not at liberty to do so. As Mensing concluded, preemption is thus triggered since it would be impossible for PLIVA to comply with both the state law duty to warn and the federal law duty of sameness.
Appellants also fault PLIVA specifically for not adopting the 2004 FDA-approved warning label.
Appellants also argue that TEVA may be held responsible for a failure-to-warn claim notwithstanding that it is a generic manufacturer. TEVA's product was designated an RLD by the FDA, making it the equivalent of a brand-name manufacturer's metoclopramide. As the district court noted, the Fourth Amended Complaint did not raise this claim, which Appellants mislabeled in 2010 as "newly discovered." The information was available in the 2003 "FDA Orange Book." Yet even if an amendment were allowed, we agree with the district court's analysis, in rejecting
Appellants next argue that the generic defendants failed to test and inspect the product according to federal law. This claim fails for several reasons. First, the Federal Food, Drug, and Cosmetic Act ("FDCA") provides no private right of action for these violations. "[A]ll such proceedings for the enforcement, or to restrain violations of [the FDCA] shall be by and in the name of the United States." 21 U.S.C. § 337. Nor can a violation be used as evidence of a breach of duty. While any testing and reports could have been used to alert the FDA of the need to strengthen labels and warnings, the Supreme Court specifically addressed this argument in Mensing. A federal duty to ask for such help might have existed but state tort law "did not instruct the Manufacturers to communicate with the FDA about the possibility of a safer label." Mensing, 131 S.Ct. at 2578. Finally, any "useful" reporting — at least from the standpoint of those injured — would ostensibly consist of some sort of warning. This argument, then, is yet another attempt to circumvent disfavored failure-to-warn claims.
Appellants' final claim is for breach of express warranty based on the generic defendants' introducing a defective product into the stream of commerce.
For the foregoing reasons, we affirm both the district court's denial of Appellants' motion to alter or amend the judgment and the grant of Appellees' motion to dismiss.