Johnson v. Teva Pharms. United States, Inc.

• Decision Date: 11 July 2014
• Docket Number: No. 12–31011.,12–31011.
• Citation: 758 F.3d 605
• Parties: Tina JOHNSON, Plaintiff–Appellant v. TEVA PHARMACEUTICALS USA, INCORPORATED; Qualitest Pharmaceuticals, Incorporated; Wyeth, L.L.C.; Schwarz Pharma, Incorporated; Alaven Pharmaceutical, L.L.C.; Generics Bidco I, L.L.C., doing business as Qualitest Pharmaceuticals, Incorporated, Defendants–Appellees.
• Court: U.S. Court of Appeals — Fifth Circuit

758 F.3d 605

Tina JOHNSON, Plaintiff–Appellant

v.TEVA PHARMACEUTICALS USA, INCORPORATED; Qualitest Pharmaceuticals, Incorporated; Wyeth, L.L.C.; Schwarz Pharma, Incorporated; Alaven Pharmaceutical, L.L.C.; Generics Bidco I, L.L.C., doing business as Qualitest Pharmaceuticals, Incorporated, Defendants–Appellees.

No. 12–31011.

United States Court of Appeals,Fifth Circuit.

July 11, 2014.

Terrence J. Donahue, Jr., Esq. (argued), McGlynn Glisson & Mouton, Baton Rouge, LA, William B. Curtis, Curtis Law Group, Dallas, TX, for Plaintiff–Appellant.

David Michael Gold, Esq., Attorney, Christopher Joseph Aubert, Esq., Aubert Law Firm, Covington, LA, Richard Anthony Oetheimer, Esq. (argued), Goodwin Procter, L.L.P., Boston, MA, Jonathan I. Price, Goodwin Procter, L.L.P., New York, N.Y., William F. Sheehan, Esq., Attorney, Goodwin Procter, L.L.P., Washington, DC, Stanton E. Shuler, Jr., Esq., Lauren Fajoni Bartlett, Attorney, Leake & Andersson, L.L.P., New Orleans, LA, Tammara N. Tukloff, Morris Polich & Purdy, L.L.P., San Diego, CA, Kannan K. Shanmugam (argued), Williams & Connolly, L.L.P., Washington, DC, David Michael Melancon, Esq., Irwin Fritchie Urquhart & Moore, L.L.C., New Orleans, LA, Henninger Simons Bullock, Mayer Brown, L.L.P., New York, N.Y., Andrew Jonathan Calica, Attorney, Mayer Brown, L.L.P., New York, N.Y., Megan Haggerty Guy, Gregory Fortier Rouchell, Adams & Reese, L.L.P., New Orleans, LA, Mark Cheffo, Quinn Emanuel Urquhart & Sullivan, LLP., New York, N.Y., for Defendants–Appellees.

Appeal from the United States District Court for the Western District of Louisiana.

Before SMITH, DENNIS, and HIGGINSON, Circuit Judges.

HIGGINSON, Circuit Judge:

Tina Johnson filed this products liability suit against generic and brand-name manufacturers of the prescription drug metoclopramide. Johnson alleges that her long-term use of generic metoclopramide caused her to develop a neurological disorder known as tardive dyskinesia, and that manufacturers provided misleading and inadequate warnings as to the risks associated with long-term use of the drug. The district court dismissed Johnson's claims against the brand-name manufacturers under Rule 12(b)(6), granted judgment on the pleadings for the generic manufacturers under Rule 12(c), and denied Johnson leave to amend her complaint. Because all of Johnson's claims are either preempted by federal law, not viable under Louisiana law, or otherwise fail to state a claim, we AFFIRM the district court's orders.

I. Background

Metoclopramide is a prescription drug approved by the Food and Drug Administration (“FDA”) and available in both brand (“Reglan”) and generic formulations. From July 2002 until March 2009, Johnson consumed generic metoclopramide to treat digestive problems. In prescribing metoclopramide, Johnson's physicians relied on the drug's warning labels, including the information contained in the drug's package inserts and the Physicians' Desk Reference. Johnson alleges that, as a result of her long-term use of generic metoclopramide, she developed tardive dyskinesia.

In March 2010, Johnson filed this suit against generic and brand-name manufacturers of metoclopramide, including Teva Pharmaceuticals, USA, Inc.; Qualitest Pharmaceuticals, Inc.; and Generics Bidco I, LLC (“Generic Defendants”), and also Wyeth, LLC; Schwarz Pharma, Inc.; and Alaven Pharmaceuticals, LLC (“Brand Defendants”). Johnson alleges that both Generic and Brand Defendants provided inadequate, misleading, and false warnings as to risks associated with long-term use of the drug. Johnson brought claims against Generic Defendants under the Louisiana Products Liability Act (“LPLA”) for inadequate warning, design defect, and breach of express warranty. Johnson brought claims against Brand Defendants for breach of warranty, misrepresentation, fraud, and violation of the Louisiana Unfair Trade Practices Act (“LUTPA”).

The district court granted Brand Defendants' motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) on the ground that Brand Defendants did not manufacture the generic metoclopramide consumed by Johnson. After dismissing the claims against Brand Defendants, the district court stayed the claims against Generic Defendants pending the Supreme Court's decision in PLIVA, Inc. v. Mensing, ––– U.S. ––––, 131 S.Ct. 2567, 180 L.Ed.2d 580 (2011). Following Mensing, the district court granted Generic Defendants' motion for judgment on the pleadings under Rule 12(c), holding that Johnson's claims against Generic Defendants are preempted by federal law. The district court further denied Johnson's request to amend her complaint to add two additional claims and denied Johnson's motion for reconsideration. Johnson timely appealed.

II. Claims Against Generic Defendants

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 Defendantsfor 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.

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, 776–77 (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 474.

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-to-warn 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 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,...