IN THE UNITED STATES COURT OF APPEALS

FOR THE FIFTH CIRCUIT

No. 12-31011

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

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 brandname 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 

United States Court of Appeals

Fifth Circuit

FILED

July 11, 2014

Lyle W. Cayce

Clerk

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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 

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claims against Generic Defendants pending the Supreme Court’s decision in

PLIVA, Inc. v. Mensing, —U.S.—, 131 S.Ct. 2567 (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 

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.

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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 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 

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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 

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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.

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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 678-

79; 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 

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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’ 

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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.

III. Claims Against Brand Defendants 

Johnson next contends that the district court erred in dismissing her 

claims against Brand Defendants under Rule 12(b)(6). Johnson alleges that 

Brand Defendants are liable for providing false and misleading information 

and failing to warn medical providers as to the risks associated with long-term 

use of Reglan. Brand Defendants respond that Johnson’s claims are barred by 

the Louisiana Products Liability Act (“LPLA”) because Johnson never ingested 

Reglan manufactured by Brand Defendants, only generic metoclopramide. 

In dismissing Johnson’s claims, the district court reasoned that the 

LPLA provides the exclusive remedy against manufacturers in products 

liability suits under Louisiana law, and that Johnson could not maintain 

claims against Brand Defendants under the LPLA because Brand Defendants

did not manufacture the generic metoclopramide that caused Johnson’s 

injuries. The district court further reasoned that Johnson’s claims also fail 

because “brand name drug manufacturers do not owe a continuing duty to 

consumers of the generic drug equivalent.”

“We review a district court’s decision on a 12(b)(6) motion de novo, 

accepting all well-pleaded facts as true and viewing those facts in the light 

most favorable to the plaintiff.” Stokes v. Gann, 498 F.3d 483, 484 (5th Cir. 

2007). To avoid dismissal, a plaintiff must plead “enough facts to state a claim 

to relief that is plausible on its face.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 

570 (2007).

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As a preliminary matter, Johnson moves to certify to the Louisiana 

Supreme Court the question of whether a brand-name manufacturer can be 

held liable for injuries caused by a plaintiff’s ingestion of a generic product that 

was neither manufactured nor distributed by the brand-name manufacturer. 

We may certify a determinative question of Louisiana law to the Louisiana 

Supreme Court if there is “no clear controlling precedent” of that court. La. 

Rev. Stat. Ann. § 13:72.1. However, “[a]s a general proposition we are chary 

about certifying question of law absent a compelling reason to do so.” Jefferson 

v. Lead Indus. Ass’n, Inc., 106 F.3d 1245, 1247 (5th Cir. 1997). Standing alone, 

“the absence of a definitive answer from the state supreme court on a 

particular question is not sufficient to warrant certification.” Id. “Neither is 

certification a proper avenue to change our binding precedent.” Id. 

Furthermore, “[t]he court should be slow to honor a request for certification 

from a party who chose to invoke federal jurisdiction.” Id. at 1248 (quoting

17A C. Wright, A. Miller, & E. Cooper, Federal Practice and Procedure § 4248 

(2d ed. 1988)). 

We conclude that certification is not warranted in this case. Our 

conclusion is informed by a number of considerations, including this court’s 

prior decision in Demahy v. Schwarz Pharma, Inc., 702 F.3d 177 (5th Cir. 

2012), cert. denied, 134 S.Ct. 57 (2013); the numerous other decisions 

interpreting Louisiana law on this subject;2 Johnson’s decision to file suit in 

federal court; and the text of the LPLA.

2 See, e.g., Whitener v. PLIVA, Inc., No. 10-1552, 2014 WL 1276489, at *6-7 (E.D.La. 

Mar. 27, 2014); Cooper v. Wyeth, Inc., No. 09-CV-929, 2010 WL 4318816, at *2-3 (M.D.La. 

Oct. 26, 2010); Craig v. Pfizer, Inc., No. 3:10-00227, 2010 WL 2649545, at *2-4 (W.D.La. May 

26, 2010); Washington v. Wyeth, Inc., No. 3:09-CV-01343, 2010 WL 450351, at *2 (W.D.La. 

Feb. 8, 2010); Morris v. Wyeth, Inc., No. 09-0854, 2009 WL 4064103, at *2-5 (W.D.La. Nov. 

23, 2009); Stanley v. Wyeth, Inc., 991 So. 2d 31, 35 (La. Ct. App. 2008).

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Turning to the merits of Johnson’s appeal, our prior decision in Demahy

resolves Johnson’s claims against Brand Defendants. In Demahy, we 

addressed nearly identical claims brought by a consumer of generic 

metoclopramide against brand-name manufacturers, including claims for 

misrepresentation, fraud, and violation of LUTPA. Demahy, 702 F.3d at 180-

81. Demahy appealed the district court’s denial of her Rule 59(e) motion for 

relief from the district court’s dismissal of her claims against the brand-name

manufacturers in light of the Supreme Court’s decision in Mensing. Id. at 182. 

We affirmed the district court’s ruling. In doing so, we reasoned that prior to 

Mensing, Louisiana law did not provide liability against brand-name

manufacturers for injuries caused by a plaintiff’s ingestion of a generic product, 

and that nothing in Mensing altered this conclusion. Id. at 182-84. We wrote: 

The Louisiana Products Liability Act (“LPLA”) provides that it is 

the exclusive remedy for products liability suits, stating that “[a] 

claimant may not recover from a manufacturer for damage caused 

by a product on the basis of any theory of liability that is not set 

forth in this Chapter.” La. Rev. Stat. Ann. § 9:2800.52. Under the 

LPLA, recovery is not available against a manufacturer if the 

manufacturer did not produce the offending product. Thus, 

according to pre-Mensing Louisiana caselaw, Demahy’s claims 

against [the brand-name manufacturers] fail because they did not 

manufacture the medication she actually consumed.

Id. at 182-83 (internal quotation marks and citations omitted). We further 

explained that “the Supreme Court’s decision in Mensing had no effect on 

Louisiana state law.” Id. at 184. 

Following Demahy, we conclude that Johnson’s claims against Brand 

Defendants are foreclosed by the LPLA. Brand Defendants, like the brandname manufacturers in Demahy, are “manufacturers” within the LPLA’s 

exclusivity provision. See La. Rev. Stat. Ann. § 9:2800.52 (“A claimant may not 

recover from a manufacturer for damage caused by a product on the basis of 

any theory of liability that is not set forth in this Chapter.”); see also La. Rev. 

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Stat. Ann. § 9:2800.53 (defining “manufacturer” as, inter alia, “a person or 

entity who is in the business of manufacturing a product for placement into 

trade or commerce”). Johnson argues that Brand Defendants are not 

“manufacturers” under the LPLA because they did not manufacture the 

product Johnson consumed. However, we rejected this same argument in 

Demahy. See Demahy, 702 F.3d at 183 n.4 (“Demahy argues that the LPLA . . 

. does not apply to her claims because Wyeth and Schwarz are not 

‘manufacturers,’ given that they have no connection to the product she actually 

consumed. This argument is unavailing. The vast majority of decisions have 

held that the LPLA broadly applies to all suits involving injuries from 

products, and these decisions rejected the argument that common law tort 

claims can still be brought for injuries stemming from products under facts 

nearly identical to those in the current case.”); see also Lashley, 750 F.3d at 

477 (“This argument fails because brand defendants are, indeed, 

manufacturers—and were they not, there would be no relationship on which 

to presume liability (since they did not design the drug).”). 

As a result, the LPLA provides Johnson’s exclusive remedy against 

Brand Defendants, and Johnson’s non-LPLA claims are barred. See Demahy, 

702 F.3d at 183. To the extent that Johnson’s complaint can be construed as 

bringing claims against Brand Defendants under the LPLA, these claims fail 

because “recovery is not available under LPLA against a manufacturer if the 

manufacturer did not produce the offending product.” Id. at 182; see also Stahl 

v. Novartis Pharms. Corp., 283 F.3d 254, 260-61 (5th Cir. 2002); Jefferson, 106 

F.3d at 1252. Therefore, consistent with Demahy, we hold that Johnson’s 

claims against Brand Defendants fail under Louisiana law because Brand 

Defendants did not manufacture the medication Johnson consumed. 

Also consistent with Demahy, we conclude that, even if the LPLA did not 

apply, Johnson has not established that Brand Defendants owed Johnson a 

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duty of care. See Demahy, 702 F.3d at 183 n.4 (“[E]ven if the LPLA did not 

apply, Demahy’s tort claims would fail since [the brand-name manufacturers] 

did not manufacture the generic product giving rise to Demahy’s claims, and 

thus owed Demahy no duty of care.”); Stanley v. Wyeth, Inc., 991 So. 2d 31, 34-

35 (La. Ct. App. 2008) (“[A] name brand drug manufacturer owes no legal duty 

to the consumer of a generic equivalent of its drug.”); Fricke v. Owens-Corning 

Fiberglas Corp., 618 So. 2d 473, 475 (La. Ct. App. 1993); see also Solomon v. 

Walgreen Co., 975 F.2d 1086, 1089 (5th Cir. 1992) (“This court is Erie-bound to 

apply state law as it currently exists, and may not change that law or adopt 

innovative theories of recovery.”). Thus, to the extent that Johnson’s claims 

rely on a duty of care, these claims fail for an additional reason as well.3 

Accordingly, we perceive no error in the district court’s dismissal of 

Johnson’s claims against Brand Defendants.

IV. Conclusion 

For the foregoing reasons, we AFFIRM the district court’s grant of 

Generic Defendants’ motion for judgment on the pleadings, grant of Brand 

3 Our decision is consistent with other circuit decisions that have held (under the laws

of several different states) that brand-name manufacturers are not liable for injuries caused 

by a plaintiff’s ingestion of generic products. See Eckhardt, 751 F.3d at 681-82; see, e.g., 

Lashley, 750 F.3d at 476-78 (finding no liability under Mississippi and Texas law); Guarino 

v. Wyeth, LLC, 719 F.3d 1245, 1252 (11th Cir. 2013) (same under Florida law); Schrock v. 

Wyeth, Inc., 727 F.3d 1273, 1282-85 (10th Cir. 2013) (same under Oklahoma law); Strayhorn 

v. Wyeth Pharm., Inc., 737 F.3d 378, 401-06 (6th Cir. 2013) (same under Tennessee law); Bell 

v. Pfizer, Inc., 716 F.3d 1087, 1092-93 (8th Cir. 2013) (same under Arkansas law); Smith v. 

Wyeth, Inc., 657 F.3d 420, 423-24 (6th Cir. 2011) (same under Kentucky law), cert. denied, 

132 S.Ct. 2103 (2012); Foster v. Am. Home Prods. Corp., 29 F.3d 165, 170-71 (4th Cir. 1994) 

(same under Maryland law). But see Kellogg v. Wyeth, 762 F. Supp. 2d 694, 705-09 (D. Vt. 

2010); Wyeth, Inc. v. Weeks, —So.3d—, 2013 WL 135753, at *19 (Ala. Jan. 11, 2013), reh’g 

granted (June 13, 2013); Conte v. Wyeth, Inc., 85 Cal. Rptr. 3d 299, 311-18 (Cal. Ct. App. 

2008).

Additionally, to the extent that Johnson makes an argument on appeal based on the 

Louisiana Constitution, Article I, Section 22, Johnson waived this argument by failing to 

raise it in the district court. See AG Acceptance Corp. v. Veigel, 564 F.3d 695, 700 (5th Cir. 

2009). We decline to consider this substantive argument for the first time on appeal. 

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Defendants’ motion to dismiss, and denial of leave to amend. We further 

DENY Johnson’s motion for certification. 

AFFIRMED. 

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JAMES L. DENNIS, concurring in part, dissenting in part: 

Although I concur in the majority opinion’s disposition of PlaintiffAppellant Tina Johnson’s claims against the generic manufacturers, I 

respectfully dissent from the resolution of Johnson’s claims against the brandname drug manufacturers because I would grant Johnson’s motion to certify 

the question of state law to the Louisiana Supreme Court. Johnson seeks 

certification to the Louisiana Supreme Court of the question whether, under 

Louisiana law, a brand-name drug manufacturer may be held liable for harm 

caused by a consumer’s use of the generic manufacturer’s equivalent product—

a drug that was not directly manufactured by the brand-name pharmaceutical 

corporation but, as the Supreme Court has explained, must contain labeling 

and warnings identical to that of the brand-name product under the “duty of 

sameness.” PLIVA Inc. v. Mensing, 131 S. Ct. 2567, 2574-75 (2011). The 

question of whether Louisiana law imposes such liability should be certified to 

the Louisiana Supreme Court because it implicates significant public policy 

concerns with potentially grave ramifications, is dispositive as to Johnson’s 

claims against the brand-name defendants, and there is no Louisiana Supreme 

Court case law available to guide our analysis and only scant lower state court 

authority that is called into doubt by Mensing. See In re Katrina Canal 

Breaches Litig., 613 F.3d 504, 509 (5th Cir. 2010) (“[C]ertification may be 

advisable where important state interests are at stake and the state courts 

have not provided clear guidance on how to proceed.” (quoting Free v. Abbott 

Labs., Inc., 164 F.3d 270, 274 (5th Cir. 1999))); see also Jesco Const. Corp. v. 

NationsBank Corp., 278 F. 3d 444, 448 (5th Cir. 2001) (“We have [certified a 

question] in the past when we determined that the issue carried ‘tremendous 

consequences’ . . . [or] widespread ramifications . . . .”) (internal citations 

omitted). 

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The Louisiana Supreme Court has never addressed the extent of brandname manufacturers’ liability to consumers of the generic equivalents. There 

is only one Louisiana Court of Appeals case on point and it’s questionable 

whether its reasoning stands today. In Stanley v. Wyeth, Inc., 991 So. 2d 31 

(La. App. 1st Cir. 2008), the Court of Appeal of Louisiana, First Circuit, held 

that the plaintiff failed to state a claim against the brand-name manufacturers 

for negligent misrepresentation because brand defendants do not owe a duty 

to consumers of the generic equivalent. Id. at 33. In holding that brand-name 

defendants owe no duty to consumers of the generic equivalent, the Stanley 

court reasoned that “a manufacturer cannot reasonably expect that consumers 

will rely on the information it provides when actually ingesting another 

company’s drug.” Id. at 34. The court in Stanley therefore based its holding 

on pre-Mensing assumptions: that consumers of generic drugs do not rely upon 

the brand-name manufacturer’s representations or warnings as to the risks of 

harm to consumers, and that a generic manufacturer’s “acceptance” of the 

brand-name manufacturer’s label, is something of a choice. Id. Such reasoning 

is belied by Mensing’s holding that, under federal law, a generic 

manufacturer’s label and communications must be the same as the brandname equivalent, and the generic manufacturer is prohibited from unilaterally 

communicating to consumers any message different than that communicated 

by the brand name manufacturer. Thus, it is perfectly foreseeable, if not 

inevitable, that, post-Mensing, consumers of generic drugs and their 

physicians will rely exclusively upon the brand-name manufacturer’s label to 

assess the safety risks of the generic drug equivalent. Mensing thus calls 

Stanley—the sole Louisiana Court of Appeal decision on this issue—into 

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question.1 Accordingly, the majority’s Erie guess that, under Louisiana law, a 

brand-name manufacturer is not liable to a consumer of the generic equivalent 

for failure to warn rests primarily on a single Louisiana Court of Appeals case, 

that, after Mensing, is questionable, if not erroneous. There is absolutely no 

post-Mensing state law authority on the current state of Louisiana law. 

Without any authoritative guidance from Louisiana courts, the 

majority’s opinion completely closes the courthouse doors to Louisiana 

consumers injured by inadequately labeled generic pharmaceutical products. 

By declining to certify the question to the Louisiana Supreme Court and 

affirming the district court’s decision below, both generic and brand-name 

pharmaceutical companies are essentially immunized from private suits by 

consumers of generic drugs, who make up an overwhelming majority of 

pharmaceutical consumers. Today, “nearly 8 in 10 of prescriptions are filled 

with generic drugs. The use of generic drugs is expected to grow over the next 

few years as a number of popular drugs come off patent through 2015.” See

Facts About Generic Drugs, U.S. FOOD AND DRUG ADMINISTRATION, 

http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesaf

ely/understandinggenericdrugs/ucm167991.htm (last visited July 9, 2014). 

The threat of private suits for damages provides substantial incentives to 

pharmaceutical manufacturers to effectively warn consumers of the safety 

risks associated with consumption of their products. The majority eviscerates

1 I acknowledge that, as discussed in Part III of the majority opinion, our court has 

previously rejected an argument that Mensing altered Louisiana law. Demahy, 702 F.3d at 

183. The Demahy decision, however, relies upon our court’s and federal district courts’ 

opinions interpreting Louisiana law and nowhere cites any authoritative Louisiana Supreme 

Court case. Id. (citing, inter alia, Stahl v. Novartis Pharms. Corp., 283 F.3d 254, 260-61 (5th 

Cir. 2002), and Possa v. Eli Lilly & Co., No. 05-CV-1307, 2006 WL 6393160 (M.D. La. May 

10, 2006), for the proposition that “recovery is not available against a manufacturer if the 

manufacturer did not produce the offending product”). 

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this incentive for brand-name manufacturers, who control the content of the 

warning labels and communications to the public for both brand and generic 

drug equivalents, and thus will have “tremendous consequences” for the health 

and safety of consumers of pharmaceutical products in Louisiana. Jesco, 278 

F.3d at 448. 

Tort claims against the manufacturer of drugs that allegedly 

inadequately warn the consumer as to potential risks are common. Given the 

nature of the parties involved,—Louisiana has many consumers of generic 

drugs but is home to few, if any, drug manufacturers—cases raising this issue 

will invariably be litigated in federal court, pursuant to diversity jurisdiction. 

See 28 U.S.C. §§ 1332, 1441. Therefore, by denying Johnson’s motion to certify 

the question to the Louisiana Supreme Court, the majority ensures that federal 

courts facing the issue will continue down this uncharted path of attempting 

to interpret a true “creature of state law,” Rubino v. Lynaugh, 845 F.2d 1266, 

1275 (5th Cir. 1988), in the absence of any authoritative precedent, effectively 

barring the Louisiana Supreme Court the opportunity to articulate the 

meaning of its own tort law relating to the health and protection of Louisiana 

citizens, and thereby offending basic principles of comity. 

Lastly, as Johnson notes in her motion to certify, an identical question 

was recently certified to the Alabama Supreme Court by the United States 

District Court for the Middle District of Alabama. Despite federal precedent 

interpreting Alabama law as precluding liability for brand-name defendants, 

once the question was certified, the Alabama Supreme Court concluded, contra 

to the earlier federal court decisions, that brand-name defendants are liable to 

consumers of the generic equivalent product for failing to provide adequate 

warnings. The Alabama Supreme Court discussed Mensing and its 

implications in concluding that under Alabama law, “a brand-name drug 

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company may be held liable for fraud or misrepresentation (by misstatement 

or omission), based on statements it made in connection with the manufacture 

of a brand-name prescription drug, by a plaintiff claiming physical injury 

caused by a generic drug manufactured by a different company.” Wyeth, Inc. 

v. Weeks, No. 11-01397, 2013 WL 135753 (Ala. Jan. 11, 2013), reh’g granted 

(June 13, 2013). The Alabama Supreme Court’s answer to the certified 

question rejected federal courts’ contrary decisions applying Alabama law, 

which had “held that Alabama law does not allow a person who consumed a 

generic version of a brand-name drug to sue the brand-name manufacturer 

based on fraudulent misrepresentation.” Id. at *9-10 (discussing and rejecting, 

for example, Overton v. Wyeth, Inc., No. CA 10-0391, 2011 WL 1343392 (S.D. 

Ala. 2011) (unpublished), because the Overton court’s “conclusion that a 

generic manufacturer becomes responsible for its own warning label . . . is 

incorrect” in light of Mensing). The Louisiana Supreme Court should be 

afforded the same opportunity, particularly given the lack of a state Supreme 

Court case and the significant impact that this panel’s decision will have on 

Louisiana citizens’ ability to seek redress for serious bodily injury caused by 

the consumption of an allegedly inadequately labeled generic drug. 

In conclusion, because there is no precedent from the Louisiana Supreme 

Court on this case-dispositive issue, the prior Louisiana case law is based on 

reasoning now undermined by Mensing, and the question implicates 

significant public policy concerns with potentially severe ramifications for the 

people of Louisiana, I respectfully dissent from the majority opinion’s 

resolution of Johnson’s claims against the brand-name manufacturers and 

would grant Johnson’s motion to certify the question to the Louisiana Supreme 

Court. 

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