Julie DEMAHY, Plaintiff-Appellant, v. SCHWARZ PHARMA, INCORPORATED; Actavis, Incorporated, Individually and as Successor in Interest of Purepac Pharmaceutical Company; Wyeth, Individually and as Successor-in-Interest of A.H. Robins Company, Incorporated, Defendants-Appellees.
No. 11-31073.
United States Court of Appeals, Fifth Circuit.
Oct. 25, 2012.
700 F.3d 177
Before BENAVIDES, OWEN and SOUTHWICK, Circuit Judges.
PER CURIAM:
In this case, Plaintiff-Appellant Julie Demahy (“Demahy“) appeals the district court‘s denial of two motions: a motion for relief from judgment as to Defendants-Appellees Wyeth, Inc. (“Wyeth“) and Schwarz Pharma, Inc. (“Schwarz“), makers of the prescription drug metoclopramide under the brand name Reglan, and a motion to set aside judgment as to Defendant-Appellee Actavis, Inc. (“Actavis“), a manufacturer of a generic version of metoclopramide. We find that the district court was correct in denying the motions and, accordingly, we affirm.
FACTUAL AND PROCEDURAL HISTORY
This case stems from Plaintiff-Appellant Demahy‘s use of generic metoclopramide. The Food and Drug Administration (“FDA“) approved Reglan for use in 1980 and generic metoclopramide has been produced by a number of generic manufacturers since 1985, including by Actavis. Wyeth acquired the rights to name-brand Reglan in 1989 and it manufactured Reglan until 2001, when it sold the rights to Schwarz. Schwarz manufactured name-brand Reglan until 2008, when it sold the rights to Alaven Pharmaceutical LLC.
In 1985, the FDA required that metoclopramide‘s label be updated to include a warning about the risk of tardive dyskinesia, an often irreversible neurological disorder, and Actavis updated its label to include these warnings. In 2004, the FDA approved the name-brand manufacturer‘s requested change to the Reglan label, adding a warning that Reglan should not be used for more than twelve weeks. In 2009, the FDA issued a black-box warning—its strongest warning—stating that treatment with metoclopramide can cause tardive dyskinesia, and treatment “for longer than 12 weeks should be avoided in all but rare cases.” Pliva, Inc. v. Mensing, --- U.S. ----, 131 S.Ct. 2567, 2573, 180 L.Ed.2d 580 (2011) (quoting Physician‘s Desk Reference 2902 (65th ed. 2011)).
On April 28, 2008, Demahy filed the current suit in state court for damages against Wyeth, Schwarz, and Actavis. The complaint sought damages that Demahy allegedly suffered due to her use of generic metoclopramide from 2002 to 2007, asserting a variety of tort claims under Louisiana law. Demahy alleges that her use of metoclopramide manufactured by Actavis caused her to develop tardive dyskinesia. On June 2, 2008, the Defendants-Appellees removed the case to the Eastern District of Louisiana based on diversity of citizenship.
On July 25, 2008, Demahy, Wyeth, and Schwarz jointly moved to dismiss the claims against Wyeth and Schwarz without prejudice, and the district court granted the motion on July 28, 2008. On July 29, 2008, Actavis filed a motion to dismiss all
On June 23, 2011, the Supreme Court reversed this Court‘s decision, holding that state laws that would require generic manufacturers to change a drug‘s label are preempted by federal law based on impossibility preemption, which asks “whether the private party could independently do under federal law what state law requires of it.” Mensing, 131 S.Ct. at 2579. Specifically, because federal law requires generic drug labels to be the same as name-brand labels, state laws requiring generic metoclopramide manufacturers to attach a safer label to their product are preempted by the federal law. Id. at 2578. Justice Thomas, writing for the majority, recognized that the Court‘s decision dealt the plaintiffs an “unfortunate hand,” because if they had taken Reglan, “their lawsuits would not be pre-empted. But because pharmacists, acting in full accord with state law, substituted generic metoclopramide instead, federal law pre-empts these lawsuits.” Id. at 2581. The Supreme Court remanded the case to this Court, and this Court remanded the case to the district court with instructions to enter judgment in favor of Actavis. On August 30, 2011, the district court entered judgment in favor of Actavis and dismissed Demahy‘s suit with prejudice.
After the entry of judgment, Demahy filed two motions before the district court. First, on September 28, 2011, Demahy filed a motion under
STANDARD OF REVIEW
This Court reviews an order denying a motion for relief under
ANALYSIS
In her appeal of the district court‘s denial of her
1. Claims Against Wyeth and Schwarz (Name-Brand Defendants)1
Because it was filed within the relevant time period, we consider Demahy‘s
The only ground for amending the judgment under
In deciding whether an amendment to the judgment is warranted, we must therefore determine whether the decision in Mensing altered Louisiana tort law as it applies to the claims against Wyeth and Schwarz. Demahy argues that Louisiana cases holding that her claims against name-brand manufacturers cannot be brought have been overruled by the Supreme Court‘s decision in Mensing. According to Demahy, Mensing undermined the logic of the Fourth Circuit‘s decision in Foster v. American Home Products Corp., 29 F.3d 165 (4th Cir.1994), which she argues is a foundation of the Louisiana decisions ruling that a party cannot be liable for damages resulting from use or consumption of a product they did not manufacture. See, e.g., Stanley v. Wyeth, Inc., 991 So.2d 31, 34 (La.App. 1 Cir.2008) (favorably citing Foster and other cases).
In Foster, the Fourth Circuit, construing Maryland law, rejected the argument “that a name brand manufacturer‘s statements regarding its drug can serve as the basis for liability for injuries caused by another manufacturer‘s drug.” 29 F.3d at 170. The Foster court rejected claims nearly identical to those brought in this suit, holding that the duty of care does not extend to third parties. Id. at 171. The court also stated in dicta that plaintiffs could sue the generic manufacturers who the court believed were “also permitted to add or
We do not view Mensing as overruling Foster because the court in Foster did not reach its holding by relying on the ability of a plaintiff to sue generic manufacturers. Instead, the court‘s holding was based on its interpretation of Maryland law and the conclusion that a name-brand manufacturer has no duty of care to consumers that are not using the manufacturer‘s product. Foster, 29 F.3d at 171-72; see also Smith v. Wyeth, 657 F.3d 420, 423-24 (6th Cir. 2011) (following Foster‘s conclusion that name-brand manufacturers have no duty to generic-brand consumers). The Foster court‘s opinion in dicta on the viability of suits against generic manufacturers was proved wrong, but this fact does not impose on name-brand manufacturers a duty of care to customers using generic products. Likewise, decisions that relied upon Foster to create a similar rule in Louisiana remain valid.
Moreover, even were we of the view that Mensing undermined Foster, the implicit reversal of a Fourth Circuit decision about Maryland law would have no effect on Louisiana law. See Morris, 2011 WL 4975317, at *1-3 (stating that Foster‘s continued validity has no effect on Louisiana law because “any finding that Mensing upsets Foster would apply [only] to Maryland state law claims“). This Court is bound by Louisiana law and we cannot create a new remedy. Solomon v. Walgreen Co., 975 F.2d 1086, 1089 (5th Cir.1992) (per curiam) (stating that the court is bound to apply state law “as it currently exists[ ] and may not change that law or adopt innovative theories of recovery“). Thus, because the Supreme Court‘s decision in Mensing had no effect on Louisiana state law, the district court‘s denial of Demahy‘s motion to amend the judgment under
2. Claims Against Actavis (Generic Defendant)
Regarding the district court‘s dismissal of her claims against Actavis and its denial of her
Demahy argues that Actavis‘s appeal of the district court‘s denial of Actavis‘s July 29, 2008 motion to dismiss “was limited only to consideration of failure to warn claims that required a manufacturer to provide a warning that was different or in addition to the warnings appearing in the label for the brand-name version of the drug.” Br. of Pl.-Appellant Julie Demahy at 16 (Feb. 6, 2012) [hereinafter Appellant Br.]. She therefore states that her other claims “could not have been encompassed within this Court‘s direction to the lower court to enter judgment in favor of Actavis.” Id. at 17 (emphasis and quotation marks omitted).5 Consequently, she argues that “the district court committed reversible error when it dismissed all of plaintiff‘s claims under its interpretation of the mandate.” Id. at 17.
As set out above in the factual history, Actavis‘s July 29, 2008 motion to dismiss sought “to dismiss all of Plaintiff‘s claims asserted against it based on federal conflict preemption principles.” Mot. to Dismiss of Def. Actavis Inc. at 1, Demahy v. Wyeth Inc., 2011 WL 5056987 (E.D.La. Oct. 14, 2011) (No. 08-3616) (emphasis added). The district court granted Actavis‘s motion as to Demahy‘s fraud-on-the-FDA claim, but denied it as to her failure-to-warn claims. Demahy v. Wyeth Inc., 586 F.Supp.2d 642, 662 (E.D.La.2008). Therefore, it is clear that the district court viewed Demahy as having asserted only two types of claims. This Court affirmed the district court‘s denial of Demahy‘s motion to dismiss the failure to warn claims, Demahy, 593 F.3d at 449, but the Supreme Court reversed, finding that state-law failure-to-warn claims against generic drug manufacturers are preempted by federal law, Mensing, 131 S.Ct. at 2581. This Court then vacated the district court‘s order denying in part the motion to dismiss, and it remanded for the entry of judgment in favor of Actavis. Demahy v. Actavis, Inc., 650 F.3d 1045, 1046 (5th Cir.2011). Accordingly, the district court granted “judgment in favor of Defendant, Actavis, Inc. and against Plaintiff, Julie Demahy, dismissing the Plaintiff‘s suit with prejudice[.]” Demahy v. Wyeth, Inc., No. 08-3616, 2011 WL 5505399, at *1 (E.D.La. Aug. 30, 2011).
Demahy argues that the mandate addressed only her failure-to-warn claims, and states that “[n]o court has considered the arguments raised in Plaintiff‘s Rule 59 Motion[.]” Appellant Br. at 25 (emphasis omitted). While it is true that the mandate addressed only her failure-to-warn claims, that is simply because, at the time this Court issued the mandate, Demahy‘s only remaining claims had been characterized by the district court, this Court, and the Supreme Court as failure-to-warn claims. The mandate plainly vacated the district court‘s order allowing Demahy‘s
Since we hold that the mandate was not in error6 and the district court correctly followed the mandate, we need not reach the merits of Demahy‘s allegedly non-failure-to-warn claims. Nonetheless, even if we were to find that these claims survived the mandate, or if we were to accept Demahy‘s assertion that the mandate was “erroneous,” Mem. of Law in Supp. of Pl.‘s Mot. to Amend and/or Alter J. at 1, Demahy v. Wyeth Inc., 2011 WL 5056987 (E.D.La. Oct. 14, 2011) (No. 08-3616), we would still affirm the district court insofar as the claims are, at base, failure-to-warn claims, which would be preempted in light of Mensing. Based on Demahy‘s complaint, the only claims that are arguably not failure-to-warn claims are those for breach of express warranty, R. at 524, and for design defect, R. at 526. Since her express warranty claim names only Wyeth, the only possible non-failure-to-warn claim Demahy has stated against Actavis is for design defect. Post-Mensing, however, a seeming majority of federal district courts to consider other state-law tort claims have found them to be preempted based on the fact that the plaintiffs’ claims are failure-to-warn claims under different names.7 In addition, other courts have specifically held plaintiffs’ design defect claims against generic metoclopramide manufacturers to be preempted based on Mensing.8 The result is that, with few exceptions, see, e.g., Cooper v. Wyeth, Inc., No. 09-929-JJB, 2012 WL 733846, at *1 (M.D.La. Mar. 6, 2012), courts have held that state-law tort claims against generic drug manufacturers, including design defect claims, are preempt-
CONCLUSION
For the foregoing reasons, we AFFIRM the district court‘s denial of Demahy‘s motion to set aside judgment as to Actavis and her motion for relief from judgment as to Wyeth and Schwarz.
AFFIRMED.
