Drager v. Pliva United States, Inc.

Decision Date28 January 2014
Docket NumberNo. 12–1259.,12–1259.
Citation741 F.3d 470
PartiesArthur L. DRAGER, as personal representative for the Estate of Shirley Gross, Plaintiff–Appellant, v. PLIVA USA, INC., Defendant–Appellee, and Pfizer, Inc.; Wyeth, Inc.; Wyeth Pharmaceuticals, Inc.; Schwarz Pharma, Inc.; Teva Pharmaceuticals USA, Inc., Defendants.
CourtU.S. Court of Appeals — Fourth Circuit


ARGUED:Louis Martin Bograd, Center for Constitutional Litigation, PC, Washington, D.C., for Appellant. Michael David Shumsky, Kirkland & Ellis LLP, Washington, D.C., for Appellee. ON BRIEF:Terrence J. Donahue, Jr., McGlynn Glisson & Mouton, Baton Rouge, Louisiana, for Appellant. Joseph P. Thomas, Linda E. Maichl, Jeffrey Peck, Ulmer & Berne, LLP, Cincinnati, Ohio; Jay P. Lefkowitz, John K. Crisham, Kirkland & Ellis LLP, Washington, D.C., for Appellee.

Before SHEDD, DUNCAN, and DAVIS, Circuit Judges.

Affirmed by published opinion. Judge DUNCAN wrote the opinion, in which Judge SHEDD and Judge DAVIS joined.

DUNCAN, Circuit Judge:

Appellant Arthur Drager, as personal representative of the estate of Shirley Gross, seeks reversal of the district court's denial of Gross's request to amend her complaint and its dismissal of her state common law tort claims against appellee PLIVA USA, Inc. for injuries sustained as a result of her use of a drug it manufactured. Drager contends on appeal that the proposed amendments were not futile and that Gross's state tort claims are not preempted by the requirements of the Federal Food, Drug, and Cosmetics Act, 21 U.S.C. §§ 301 et seq., (“FDCA”). For the reasons that follow, we affirm.


In 2006, Gross was prescribed Reglan, a brand of metoclopramide, a drug used to treat gastroesophageal reflux disease and other ailments. Gross followed a ten-month course of generic metoclopramide, produced by appellee PLIVA, from March 2006 to January 2007. As a result of Gross's long-term use of metoclopramide, she developed permanent injuries including the movement disorders tardive dyskinesia and akathisia.

On January 15, 2010, Gross filed suit against PLIVA and brand-name Reglan producers, including Pfizer, Inc., alleging state law claims of negligence, breach of warranty, fraud and misrepresentation, strict liability, and failure to warn. Pursuant to Gross's stipulation that she ingested only PLIVA's generic metoclopramide, the district court dismissed her claims against the brand name manufacturers on November 9, 2010. The district court stayed further proceedings against PLIVA, the only remaining defendant, on April 7, 2011, pending the Supreme Court's decision in PLIVA, Inc. v. Mensing, –––U.S. ––––, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011).

After Mensing was decided, holding that FDCA labeling requirements preempted state failure-to-warn laws, see id. at 2577–78, the stay was lifted and PLIVA filed a motion for judgment on the pleadings. It contended that pursuant to Mensing, Gross's claims were preempted by the FDCA because of the impossibility of PLIVA'scompliance with both that statute and the alleged state law duties. In her response to PLIVA's motion, Gross requested that the district court allow her to amend her complaint to include allegations that PLIVA violated a state law duty by failing to update its warnings to include changes made by brand name manufacturers in 2004. On November 22, 2011, the district court granted PLIVA's motion, holding under the reasoning of Mensing that all of Gross's state law claims were preempted by FDCA requirements applicable to generic drug manufacturers. The district court also denied leave to amend on the ground that the proposed amendments would be futile under Maryland law. Gross filed a motion to alter or amend the judgment, which the district court denied on January 27, 2012. During the pendency of this action, Gross passed away and Drager continued the case on behalf of her estate. The district court's November 22 and January 27 orders form the basis of Drager's appeal.


We review de novo a district court's ruling on a motion for judgment on the pleadings under Federal Rule of Civil Procedure 12(c). Butler v. United States, 702 F.3d 749, 751 (4th Cir.2012). The standard of review for Rule 12(c) motions is the same as that under Rule 12(b)(6). Id. at 751–52. Therefore, a motion for judgment on the pleadings “should only be granted if, after accepting all well-pleaded allegations in the plaintiff's complaint as true and drawing all reasonable factual inferences from those facts in the plaintiff's favor, it appears certain that the plaintiff cannot prove any set of facts in support of his claim entitling him to relief.” Edwards v. City of Goldsboro, 178 F.3d 231, 244 (4th Cir.1999). A Rule 12(c) motion tests only the sufficiency of the complaint and does not resolve the merits of the plaintiff's claims or any disputes of fact. Butler, 702 F.3d at 752.

Under Federal Rule of Civil Procedure 15(a)(2), the ‘grant or denial of an opportunity to amend is within the discretion of the district court.’ Scott v. Family Dollar Stores, Inc., 733 F.3d 105, 121 (4th Cir.2013) (quoting Foman v. Davis, 371 U.S. 178, 182, 83 S.Ct. 227, 9 L.Ed.2d 222 (1962)). Consequently, we review the district court's denial of a motion to amend for abuse of discretion. Nourison Rug Corp. v. Parvizian, 535 F.3d 295, 298 (4th Cir.2008). A district court's denial of leave to amend is appropriate when (1) ‘the amendment would be prejudicial to the opposing party;’ (2) ‘there has been bad faith on the part of the moving party;’ or (3) ‘the amendment would have been futile.’ Scott, 733 F.3d at 121 (quoting Laber v. Harvey, 438 F.3d 404, 426–27 (4th Cir.2006)).

We may affirm on any ground supported by the record regardless of the ground on which the district court relied. United States v. Moore, 709 F.3d 287, 293 (4th Cir.2013).


Drager contends on appeal that the district court's denial of leave to amend was an abuse of discretion because Gross's proposed allegations would have stated a cause of action under Maryland law. However, Drager concedes that Gross never filed a motion to amend her complaint or a proposed amended complaint with the district court. Regardless of the merits of the desired amendment, a district court does not abuse its discretion “by declining to grant a motion that was never properly made.” Cozzarelli v. Inspire Pharms., Inc., 549 F.3d 618, 630–631 (4th Cir.2008)(finding no abuse of discretion where plaintiffs requested leave to amend in a response but did not file a motion to amend or a proposed amended complaint).

Consequently, we affirm the district court's denial of leave to amend and hold that none of Drager's claims regarding PLIVA's alleged failure to update its warnings are before us on appeal. Similarly, we find that the complaint did not allege any violation of the federal misbranding laws or parallel state duties. To the extent Drager makes those claims on appeal they are waived. United States v. Evans, 404 F.3d 227, 236 n. 5 (4th Cir.2005).


Drager also argues that the district court erred by finding Gross's state tort claims to be preempted by the FDCA because of the impossibility of PLIVA's simultaneous compliance with FDCA requirements and relevant Maryland law. Although one of Drager's objections to the district court's reasoning gives us pause, all of Gross's causes of action are indeed preempted by the FDCA. We therefore affirm the district court on all counts.


In Mensing, the Supreme Court reaffirmed the principle that [p]re-emption analysis requires [courts] to compare federal and state law.” 131 S.Ct. at 2573. To make this comparison, courts first “identify[ ] the state tort duties and federal ... requirements applicable” to the parties. Id. If the applicable federal statute does not include a statement that either expressly preempts or expressly preserves otherwise applicable state law duties, the court must determine if there is preemption by conflict. Id. at 2577 n. 5.

[S]tate law is naturally preempted to the extent of any conflict with a federal statute,” Crosby v. Nat'l Foreign Trade Council, 530 U.S. 363, 372, 120 S.Ct. 2288, 147 L.Ed.2d 352 (2000), because the federal Constitution provides that every federal enactment is superior to any state law or constitutional article, U.S. Const. art. VI, cl. 2. As a result, under the Supremacy Clause, [w]here state and federal law directly conflict, state law must give way.” Mensing, 131 S.Ct. at 2577 (internal quotation marks and citation omitted). The Supreme Court has held that state and federal law conflict when it is impossible for a private party to simultaneously comply with both state and federal requirements. Id. In such circumstances, the state law is preempted and without effect. By definition a party cannot state a claim for which relief may be granted pursuant to a law that has been “effectively repeal[ed] as it applies to a particular set of circumstances. Id. at 2579.

Mensing and another recent Supreme Court case, Mutual Pharmaceutical Co., Inc. v. Bartlett, ––– U.S. ––––, 133 S.Ct. 2466, 2471, 186 L.Ed.2d 607 (2013), address the preemptive effect of the FDCA on state tort laws as they apply to generic drug manufacturers. For a variety of policy reasons, under the Hatch–Waxman amendments, codified at 21 U.S.C. § 355(j), the FDCA imposes substantially different requirements on producers of name brand drugs and producers of non-branded, or generic, counterparts. In greatly simplified terms, manufacturers of generic medications gain authorization to market their products by demonstrating that those products are equivalent to the previously authorized name brand versions in a number of ways, including formulation and labeling. Generics must maintain this equivalence to maintain authorization. See generally21 U.S.C. § 355(j).

In Mensing, the Supreme Court made clear that under § 355(j) generic drug manufacturers are not entitled to unilaterally change their...

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