Tina Johnson v. Teva Pharmaceuticals USA, Inc., et al

Filing

PUBLISHED OPINION FILED. [12-31011 Affirmed ] Judge: JES , Judge: JLD , Judge: SAH. Mandate pull date is 08/01/2014; denying motion to certify question filed by Appellant Ms. Tina Johnson [7284880-2] [12-31011]

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IN THE UNITED STATES COURT OF APPEALS
FOR THE FIFTH CIRCUIT
United States Court of Appeals
Fifth Circuit

No. 12-31011

FILED
July 11, 2014
Lyle W. Cayce
Clerk

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

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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, 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
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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
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.
1

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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 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
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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.

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).
2

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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 18081. 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, 3435 (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

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.
3

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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

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”).
1

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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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