Opinion ID: 2683270
Heading Depth: 1
Heading Rank: 2

Heading: Claims Against Generic Defendants

Text: On appeal, Johnson contends that the district court erred in granting Generic Defendants’ Rule 12(c) motion for judgment on the pleadings. Johnson further contends that the district court abused its discretion in denying her leave to amend her complaint. We review a district court’s ruling on a Rule 12(c) motion for judgment on the pleadings de novo, using the same standard applicable to a Rule 12(b)(6) motion to dismiss. Gentilello v. Rege, 627 F.3d 540, 543-44 (5th Cir. 2010). “To avoid dismissal, a plaintiff must plead sufficient facts to state a claim for relief that is plausible on its face.” Id. at 544 (internal quotation marks and citation omitted). Additionally, we review a district court’s ruling on a motion to amend for abuse of discretion. Briggs v. Mississippi, 331 F.3d 499, 508 (5th Cir. 2003). A district court does not abuse its discretion in denying leave to amend if amendment would be futile. Id. a. Failure-to-Warn Claims In her original complaint, Johnson brought a claim against Generic Defendants for inadequate warning under La. Rev. Stat. Ann. § 9:2800.57. Johnson alleges that generic metoclopramide was “unaccompanied by proper warnings regarding the serious risks associated with ingestion of the drug.” The district court concluded that Johnson’s claim is preempted by federal law in light of Mensing. 3 Case: 12-31011 Document: 00512696002 Page: 4 Date Filed: 07/11/2014 No. 12-31011 In Mensing, the Supreme Court held a similar failure-to-warn claim against generic manufacturers of metoclopramide preempted by federal law. Mensing, 131 S.Ct. at 2572. The Court reasoned that federal law demands that “generic drug labels be the same at all times as the corresponding brand-name drug labels.” Id. at 2578. This is known as the “duty of sameness.” Id. at 2576. “This duty of sameness is overlaid with the agency’s pronouncement that ‘Dear Doctor’ letters (or other forms of warnings) from a generic manufacturer constitute labeling.” Lashley v. Pfizer, Inc., 750 F.3d 470, 474 (5th Cir. 2014). Because federal law requires generic drug labels to be the same as brand-name labels, any state-law duty that requires generic manufacturers to use safer labels conflicts with the federal “duty of sameness” and is preempted by federal law. Mensing, 131 S.Ct. at 2577, 2578 (“Where state and federal law ‘directly conflict,’ state law must give way.”); Morris v. PLIVA, Inc., 713 F.3d 774, 77677 (5th Cir. 2013) (“Whether a warning is placed on the label on the bottle or in letters to distributors, any state law duty requiring generic manufacturers to act unilaterally in this area is preempted by federal law.”); see also Eckhardt v. Qualitest Pharm., Inc., 751 F.3d 674, 678 (5th Cir. 2014); Lashley, 750 F.3d at 747. The crux of Johnson’s failure-to-warn claim alleged in her original complaint appears to be that the warnings accompanying generic metoclopramide were inadequate and that Generic Defendants should have provided stronger warning labels. Because Generic Defendants were unable to provide stronger warnings as a matter of federal law, Johnson’s failure-towarn claim is preempted. See Mensing, 131 S.Ct. at 2578. Accordingly, the district court did not err in granting Generic Defendants’ motion for judgment on the pleadings for this claim. Johnson also requested leave to amend her complaint to add two additional failure-to-warn claims. First, Johnson requested leave to add a 4 Case: 12-31011 Document: 00512696002 Page: 5 Date Filed: 07/11/2014 No. 12-31011 claim alleging that Generic Defendants failed to adequately communicate the information contained in the FDA-approved label. In 2004, the FDA approved a label change to warn that “[t]herapy should not exceed 12 weeks in duration.” Mensing, 131 S.Ct. at 2572. Johnson alleges that Generic Defendants are liable for failing to send “Dear Doctor” letters or similar communications to alert medical providers to the 2004 label change. This claim is controlled by Morris and Lashley, in which we held nearly identical claims preempted by federal law. See Morris, 713 F.3d at 777; Lashley, 750 F.3d at 474-75. In Morris, we wrote: 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. 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 [the generic manufacturer] to comply with both the state law duty to warn and the federal law duty of sameness. Morris, 713 F.3d at 777 (internal citations omitted). In this case, Johnson acknowledges that no brand-name manufacturer sent a warning based on the 2004 label change. Accordingly, Generic Defendants were not at liberty to do so. See id.; Lashley, 750 F.3d at 474-75; see also Guarino v. Wyeth, LLC, 719 F.3d 1245, 1249 (11th Cir. 2013). But see Teva Pharm. USA, Inc. v. Superior Court, 158 Cal. Rptr. 3d 150, 161-64 (Cal. Ct. App. 2013). Following controlling precedent, we conclude that Johnson’s 5 Case: 12-31011 Document: 00512696002 Page: 6 Date Filed: 07/11/2014 No. 12-31011 proposed claim is preempted by federal law, and the district court did not abuse its discretion in denying Johnson leave to add this claim. Second, Johnson requested leave to add a claim alleging that generic manufacturer Teva failed to incorporate the 2004 label change into its label until 2005. This claim is also controlled by Morris. See Morris, 713 F.3d at 777; see also Lashley, 750 F.3d at 475. In Morris, we observed that “it is logically incoherent to conclude that [the generic manufacturer] had a duty to apply the 2004 warning label when Appellants also assert repeatedly that no labels predating 2009 were adequate. Tort liability does not arise for failure to attach an inadequate label.” Morris, 713 F.3d at 777. We further concluded that “a claim that [the generic manufacturer] breached a federal labeling obligation sounds exclusively in federal (not state) law, and is preempted.” Id. In light of Morris, we hold that the district court did not abuse its discretion in denying Johnson leave to add this claim. 1 b. Design-Defect Claim In her original complaint, Johnson also brought a claim against Generic Defendants for design defect under La. Rev. Stat. Ann. § 9:2800.56. Johnson alleges that “the foreseeable risks of serious harm posed by the drug far outweigh its alleged benefits.” To establish a design-defect claim under Louisiana law, a plaintiff must show: (1) There existed an alternative design for the product that was capable of preventing the claimant’s damage; and (2) The likelihood that the product’s design would cause the claimant’s 1 Johnson’s proposed failure-to-update claim fails for an additional reason: Johnson does not plausibly allege that Teva’s one-year delay in updating its label caused her injuries. Johnson acknowledges that Teva updated its label in July 2005 and that she continued to take metoclopramide until March 2009. Thus, Johnson’s doctors continued to prescribe, and she continued to ingest, the drug for almost four years after Teva updated its label. Johnson does not allege any facts indicating that her doctors would not have continued to prescribe, and she would not have continued to consume, metoclopramide had Teva updated its label in 2004 instead of 2005. 6 Case: 12-31011 Document: 00512696002 Page: 7 Date Filed: 07/11/2014 No. 12-31011 damage and the gravity of that damage outweighed the burden on the manufacturer of adopting such alternative design and the adverse effect, if any, of such alternative design on the utility of the product. La. Rev. Stat. Ann. § 9:2800.56. The second prong involves a risk-utility analysis. See Krummel v. Bombardier Corp., 206 F.3d 548, 551 (5th Cir. 2000). Louisiana law instructs courts, in conducting this risk-utility analysis, to consider whether the product contains an “adequate warning.” See La. Rev. Stat. Ann. § 9:2800.56. For the reasons articulated in Bartlett, Johnson’s design-defect claim is preempted by federal law. See Mut. Pharm. Co., Inc. v. Bartlett, —U.S.—, 133 S.Ct. 2466 (2013) (holding a New Hampshire design-defect claim against generic manufacturers preempted by federal law). Federal law requires a generic drug to have the same chemical composition and labeling as its brandname counterpart. Id. at 2471, 2475 (“[T]he FDCA requires a generic drug to have the same active ingredients, route of administration, dosage form, strength, and labeling as the brand-name drug on which it is based.”). Johnson’s state-law claim that Generic Defendants should have designed metoclopramide’s composition or labeling differently conflicts with these federal requirements. See id. at 2475-77. Because Generic Defendants were unable to change metoclopramide’s design as a matter of federal law, Johnson’s design-defect claim is preempted. See id.; see also Eckhardt, 751 F.3d at 67879; Lashley, 750 F.3d at 475-76. Johnson contends that her design-defect claim is not preempted because Generic Defendants could have complied with their duties under both federal and state law by declining to sell metoclopramide. The Supreme Court rejected this “stop-selling” rationale in Bartlett as “incompatible with our pre-emption jurisprudence.” Bartlett, 133 S. Ct. at 2477. “Our pre-emption cases presume 7 Case: 12-31011 Document: 00512696002 Page: 8 Date Filed: 07/11/2014 No. 12-31011 that an actor seeking to satisfy both his federal and state-law obligations is not required to cease acting altogether in order to avoid liability.” Id. Johnson further contends that her design-defect claim is distinguishable from those that courts have previously found preempted because Louisiana law allows liability for a design defect under the theory that there exists a safer alternative product, not just a safer alternative design. Even assuming this to be the case, Johnson’s argument does not save her claim. Johnson did not allege the existence of a safer product in her complaint. Nor did Johnson move to amend on this ground. For the reasons above, the district court did not err in finding that Johnson’s design-defect claim, as alleged in her complaint, is preempted by federal law. The district court properly granted judgment on the pleadings for Generic Defendants on this claim. c. Express-Warranty Claim Finally, Johnson brought a claim against Generic Defendants for breach of express warranty under La. Rev. Stat. Ann. § 9:2800.58. Johnson alleges that the metoclopramide manufactured by Generic Defendants was unreasonably dangerous because it did not conform to their express warranties about the product. As discussed above, federal law prohibited Generic Defendants from unilaterally altering the drug’s composition or labeling. See Bartlett, 133 S.Ct. at 2471, 2475. Any modified or supplemental warranties by Generic Defendants would have run afoul of the “duty of sameness” identified in Mensing. “Any state law-based holding that the generic manufacturers should have acted differently with respect to warnings or should have ceased manufacturing these products because of insufficient warnings not only violates the duty of sameness but conflicts with FDA’s exclusive authority to approve drugs and drug labels.” Morris, 713 F.3d at 778 (“A breach of warranty claim that goes directly to the sufficiency of the generic manufacturers’ 8 Case: 12-31011 Document: 00512696002 Page: 9 Date Filed: 07/11/2014 No. 12-31011 labeling is clearly unacceptable.”); see also Eckhardt, 751 F.3d at 680; Lashley, 750 F.3d at 475-76; Drager v. PLIVA USA, Inc., 741 F.3d 470, 479 (4th Cir. 2014); Schrock v. Wyeth, Inc., 727 F.3d 1273, 1287-89 (10th Cir. 2013). Accordingly, the district court did not err in finding Johnson’s breach-ofwarranty claim preempted by federal law, and in granting judgment on the pleadings on this claim.