Joyce Fullington v. Pfizer, Inc.

United States Court of Appeals
For the Eighth Circuit
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No. 12-2945
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Joyce Fullington

lllllllllllllllllllll Plaintiff - Appellant

v.

Pfizer, Inc.; Wyeth, LLC; Schwarz Pharma, Inc.; Pliva, Inc.; Alaven
Pharmaceutical, LLC; Mutual Pharmaceutical Company, Inc.

lllllllllllllllllllll Defendants - Appellees
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Appeal from United States District Court
for the Eastern District of Arkansas - Little Rock
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Submitted: March 14, 2013
Filed: July 15, 2013
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Before MURPHY, SMITH, and GRUENDER, Circuit Judges.
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GRUENDER, Circuit Judge.

Joyce Fullington filed a product liability suit against the manufacturers of the
prescription drug Reglan and its generic equivalent, metoclopramide. The district
court ruled that all of Fullington’s claims were either not viable under Arkansas law
or were preempted by federal law governing drug product labeling. We affirm in
part, reverse in part, and remand for further consideration.
 I. Background

From April 2008 through April 2009, Fullington ingested the prescription drug
metoclopramide. She subsequently developed a neurological disorder called tardive
dyskinesia, allegedly as a result of long-term use of metoclopramide. In response,
Fullington filed suit against two groups of pharmaceutical companies, asserting
causes of action under Arkansas law for negligence (including gross negligence),
strict liability, breach of the implied warranties of merchantability and fitness for a
particular purpose, misrepresentation, suppression of evidence, and fraud. One group
of defendants are companies that at some point, either directly or through
subsidiaries, were involved in the manufacture of Reglan: Pfizer, Inc.; Wyeth, LLC;
Schwartz Pharma, Inc.; and Alaven Pharmaceutical, LLC (collectively, “Brand
Defendants”). The second group of defendants, consisting of PLIVA, Inc. (“PLIVA”)
and Mutual Pharmaceutical Company (“Mutual”) (collectively, “Generic
Defendants”),1 manufacture generic versions of Reglan, known as metoclopramide.

Metoclopramide is not an exact duplicate of Reglan, but federal regulations
significantly constrain its contents and effects. Manufacturers of generic drugs are
required, as a condition to entering the market, to establish that their product is
“chemically equivalent” and “bioequivalent” to the reference listed drug they are
replicating—generally, as here, the brand-name drug. Mu. Pharm. Co. v. Bartlett,
570 U.S. --- (2013), 2013 WL3155230, at *4 (citing 21 U.S.C. § 355(j)(2)(A)).
Because generic drugs are so similar to their brand-name counterparts, many states,
including Arkansas, permit pharmacists to substitute generic drugs when filling a
prescription for a brand-name drug. See Ark. Code Ann. § 17-92-503. Such a
situation in fact occurred in Fullington’s case: although her physician wrote a
prescription for Reglan, her pharmacist filled her prescription with metoclopramide.

1
Fullington initially filed suit against Teva Pharmaceuticals USA, Inc. as well,
but she voluntarily dismissed her claims with prejudice against this defendant.

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 Reglan and metoclopramide have been the subject of extensive product liability
litigation. These suits have largely been brought by individuals, such as Fullington,
who developed tardive dyskinesia after using either or both versions of the drug.
Since Reglan and metoclopramide were first approved for sale in the 1980s, the
United States Food and Drug Administration (“FDA”) has occasionally required
manufacturers to update their product’s labeling to reflect greater understanding of
the risks of long-term use of Reglan/metoclopramide. For example, in 2004, the
FDA required the addition of a bolded warning stating that use “should not exceed
12 weeks in duration.” Five years later, the FDA mandated the inclusion of a black
box warning, which cautions that “Prolonged treatment (greater than 12 weeks) with
metoclopramide should be avoided in all but rare cases.”

When a manufacturer applies for FDA approval for a generic drug, it “is
responsible for ensuring that its warning label is the same as the brand name’s.”
PLIVA, Inc. v. Mensing, 564 U.S. ---, 131 S. Ct. 2567, 2574 (2011). The Supreme
Court in Mensing upheld the FDA’s interpretation of its regulations as requiring that
“the warning labels of a brand-name drug and its generic copy must always be the
same—thus, generic drug manufacturers have an ongoing federal duty of
‘sameness.’” Id. at 2574-75 & n.3. As a result of these constraints, a generic drug
manufacturer cannot unilaterally strengthen the warnings on its product’s labeling.
Id. at 2575, 2578. The Court in Mensing clarified that “impossibility” preemption
exists where a party cannot “independently do under federal law what state law
requires of it.” Id. at 2579. Accordingly, tort suits seeking to impose liability based
on a manufacturer’s failure to strengthen or modify a generic drug’s labeling are
preempted by federal drug regulations. Id. at 2576-81. The logical corollary of this
regulatory scheme is that certain design defect claims are preempted as well. As the
Supreme Court recently explained, because a generic drug manufacturer is prohibited
from unilaterally redesigning either its product’s labeling or design, a design defect
claim that would impose liability for a failure to undertake one of these two courses
of action is similarly preempted. Bartlett, 2013 WL 3155230, at *8-10. Moreover,

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a generic manufacturer is not obligated to leave the market when it is incapable of
complying with both federal and state obligations; imposing such a Hobson’s choice
would render impossibility preemption “all but meaningless.” Id. at *10 (quoting
Mensing, 131 S. Ct. at 2579).

The litigation in this case spans a time period both prior and subsequent to the
Court’s decision in Mensing, and it invokes the scope of claims preempted pursuant
to Mensing and now Bartlett. In September 2010, the district court granted the Brand
Defendants’ motion for summary judgment. The Brand Defendants argued that
because they neither manufactured nor distributed the metoclopramide that Fullington
ingested, Fullington’s product liability claim against them was not viable under
Arkansas law. The district court agreed, interpreting Arkansas law as requiring the
plaintiff to make a “product identification,” in other words “allege that the actual
product manufactured or distributed by the defendant caused the injury to the
plaintiff.”

While Mensing was pending, the Generic Defendants obtained a stay in these
proceedings. After the Supreme Court released its opinion, the district court granted
the Generic Defendants’ motion to dismiss. The district court concluded that all of
Fullington’s claims against the Generic Defendants were premised on “failure-to-
warn allegations” and, as such, were preempted pursuant to Mensing because it would
be impossible for the Generic Defendants to comply with both federal drug
regulations and the more rigorous warnings regarding long-term use that Arkansas
law allegedly required. The district court also ruled, in the alternative, that to the
extent Fullington pled product liability claims other than failure to warn, namely
manufacturing or design defect claims, her allegations failed to meet federal pleading
standards. See Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).

Fullington then sought and obtained leave to amend her complaint, citing
PLIVA’s recent disclosure that it had failed to update the labeling on the

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metoclopramide it produced, as required by 2003 and 2004 FDA-mandated changes
to Reglan’s labeling. Fullington did not amend her misrepresentation and implied
warranty claims, and the district court subsequently dismissed these claims based on
the analysis in its initial opinion. As to Fullington’s other, amended claims, the
district court determined that each was still premised on allegations of inadequate
warnings. The district court also concluded that Fullington’s design defect
allegations remained too conclusory to meet federal pleading standards. To the extent
any of Fullington’s claims invoked a new challenge to the adequacy of PLIVA’s
warnings,2 based on the failure to update its labeling as required by federal law
(“failure to update claim”), the district court ruled that such a claim was not viable.
The district court acknowledged reasonable arguments both for and against the
proposition that this claim was preempted under Mensing, but it elected not to decide
the issue. Instead, the district court dismissed the claims based on a perceived fatal
internal inconsistency between Fullington’s theory of liability and her allegations
regarding inadequate warnings. On one hand, Fullington claimed that the
Reglan/metoclopramide labeling was deficient until the addition of a black box
warning in February 2009; yet on the other hand she faulted PLIVA for failing to
incorporate the 2004 label change, a version of labeling that she insisted was still
inadequate to fully warn of the dangers of long-term use. In a motion for
reconsideration, Fullington argued that she had been pleading in the alternative, a
contention which the district court rejected.3

2
Fullington did not allege that Mutual failed to incorporate the 2003 and 2004
label changes onto its product’s labeling.
3
The district court determined that based on the complaint alone, Fullington’s
tort claim against PLIVA for use of metoclopramide between February 2009, when
the labeling supposedly became adequate with the addition of a black box warning,
and April 2009, when Fullington stopped ingesting the drug, could survive. The
district court converted PLIVA’s motion to dismiss into a motion for summary
judgment and offered Fullington fourteen days to present evidence that she had
ingested PLIVA-manufactured metoclopramide during this period. In her motion for

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 Fullington appeals the district court’s adverse grant of summary judgment to
the Brand Defendants and its dismissal of her claims with prejudice against the
Generic Defendants.

II. Claims Against the Brand Defendants

We review de novo the district court’s grant of summary judgment to the Brand
Defendants. Knutson v. Schwan’s Home Service, Inc., 711 F.3d 911, 913 (8th Cir.
2013). Fullington stipulated that she only ingested metoclopramide; at no point did
she ingest Reglan or any other product manufactured or distributed by one of the
Brand Defendants. Nonetheless, Fullington insists she can maintain a product
liability suit against the Brand Defendants. Although Fullington concedes that claims
based on strict liability or breach of warranty require a product identification, she
insists that Arkansas law does not require such a showing if the plaintiff’s product
liability claims are based on negligence, misrepresentation, suppression of evidence,
or fraud.

The Arkansas Product Liability Act (“APLA”) defines “product liability
action” as “all actions brought for or on account of personal injury, death, or property
damage caused by or resulting from the manufacture, construction, design, formula,
preparation, assembly, testing, service, warning, instruction, marketing, packaging,
or labeling of any product.” Ark. Code Ann. § 16-116-102(5). Not only do all of
Fullington’s claims fall within the plain meaning of this definition of “product
liability action,” but a recent decision by this court regarding nearly identically-pled
claims virtually compels the conclusion that Fullington’s claims are all “product

reconsideration, Fullington conceded that she could not do so. Accordingly, the
district court entered summary judgment in favor of PLIVA on Fullington’s surviving
claim that PLIVA’s warnings were inadequate after February 2009. On appeal,
Fullington does not argue that deficiencies in the warnings accompanying PLIVA’s
metoclopramide from February to April 2009 caused her tardive dyskinesia.

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liability actions” under Arkansas law. See Bell v. Pfizer, Inc., --- F.3d ---, 2013 WL
2661189, at *3 (8th Cir. June 14, 2013). As the court in Bell also held, Arkansas law
requires product identification for all product liability actions, and there is no
indication “the Arkansas Supreme Court would create an exception to the Arkansas
product identification requirement to allow [Fullington] to hold the [B]rand
[D]efendants liable for injuries caused by their competitor’s generic products.” Id.
at *4. We are not at liberty to contradict another panel’s interpretation of section 16-
116-102(5). See, e.g., United States v. Collins, 321 F.3d 691, 698 & n.5 (8th Cir.
2003). Fullington’s claims against the Brand Defendants are all “product liability
actions,” so they are only viable if she is able to make a product identification.
Because Fullington stipulated that she never used Reglan manufactured or distributed
by any of the Brand Defendants, she “cannot hold them liable under Arkansas law.”4
Bell, 2013 WL 2661189, at *4. The district court did not err in granting the Brand
Defendants’ motion for summary judgment.

4
Like the appellant in Bell, Fullington argues for the first time on appeal that
if a product identification requirement does apply to her claims against the Brand
Defendants, she has satisfied it because the Brand Defendants are “manufacturers”
of generic metoclopramide as that term is defined in the APLA. See Ark. Code Ann.
§ 16-116-102(3) (“‘Manufacturer’ means the designer, fabricator, producer,
compounder, processor, or assembler of any product or its component parts.”). Under
this theory, the Brand Defendants are “manufacturers” of the metoclopramide
Fullington consumed because they designed the drug upon which the generic version
is based, and they, in conjunction with the FDA, determine the labeling generic
manufacturers must reproduce on their own products. This claim contradicts
Fullington’s stipulation to the district court that her “causes of action against [the
Brand Defendants] are not based on any claim that [they] manufactured or sold the
Reglan/metoclopramide ingested by Joyce Fullington.” (Emphasis added.) We
decline, as the Bell court did, to address this novel argument for the first time on
appeal because there are no “exceptional circumstances” warranting departure from
the general rule that “we cannot consider issues not raised in the district court.” Bell,
2013 WL 2661189, at *3 n.1 (quoting Shanklin v. Fitzgerald, 397 F.3d 596, 601 (8th
Cir. 2005)).

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 III. Claims Against the Generic Defendants

“We review de novo a district court’s decision to grant a motion to dismiss,
accepting the complaint’s allegations as true.” Gomes v. Am. Century Cos., 710 F.3d
811, 815 (8th Cir. 2013). The outcome of this appeal is controlled in large part by
this court’s recent decision in Bell v. Pfizer, Inc. The appellant in that case, Shirley
Bell, also developed tardive dyskinesia following prolonged use of metoclopramide.
Bell, 2013 WL 2661189, at *1. Like Fullington, Bell brought a product liability
action under Arkansas law raising claims based on “negligence; strict liability; breach
of warranties; misrepresentation, suppression of evidence, and fraud; and gross
negligence.” Id. The district court allowed Bell to amend her complaint post-
Mensing but then dismissed her claims with prejudice, finding that they remained
preempted failure-to-warn claims and, to the extent her failure to update claim against
PLIVA was not preempted, it was barred by Arkansas’s application of the learned
intermediary doctrine. Id. at *6, 8. On appeal, this court “agree[d] with the district
court that the vast majority of Bell’s allegations in her amended complaint set forth
preempted failure to warn claims,” with the exception of her “design defect and
breach of implied warranty claims, other than those based on an inadequate warning
or labeling.” Id. at *7. The court in Bell reversed the dismissal of these latter claims
because the district court had incorrectly viewed them as preempted failure to warn
claims and had not analyzed whether these claims otherwise “state[d] viable claims
under Arkansas law.” Id. The court did not reach the issue of whether the holding
in Mensing preempted a failure to update claim, agreeing with the district court that
such a claim was in any case not viable given Arkansas’s adherence to the learned
intermediary doctrine. Id. at *8-9.

Like the amended complaint in Bell, the vast majority of the allegations in
Fullington’s amended complaint are premised on preempted failure to warn claims.
The exception, as this court determined in Bell, are her “non-warning design defect
and breach of implied warranty claims.” Id. at *7. Yet the district court in this case,

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just like the Bell district court, still categorized these latter claims as failure-to-warn
claims. The language in Fullington’s amended complaint regarding breach of implied
warranty claims is substantially similar to the analogous claims in Bell’s amended
complaint. Compare Fullington Compl. ¶¶ 7.09-7.12 with Bell Compl. ¶¶ 4.10-4.14.
Accordingly, we reverse the dismissal of Fullington’s non-warning breach of implied
warranty claims and remand for further consideration as to whether they “adequately
state viable claims under Arkansas law” and if so, whether the Generic Defendants
can nonetheless establish preemption. Id. at *7.

There is one notable distinction between this case and Bell. The district court
in this case made an alternative holding recognizing that, to the extent Fullington
articulated a design defect claim independent of a failure to warn claim, the claim did
not satisfy federal pleading standards. The district court later determined that
Fullington’s amended complaint failed to rectify the problem.

“To succeed on a design defect claim under Arkansas law, the plaintiff must
establish that the product was in a defective condition,5 that the defective condition
rendered the product unreasonably dangerous,6 and that the defect proximately caused
the complained-of injury.” Boerner v. Brown & Williamson Tobacco Co., 394 F.3d
594, 598 (8th Cir. 2005). We disagree with the district court’s conclusion that

5
“‘Defective condition’ means a condition of a product that renders it unsafe
for reasonably foreseeable use and consumption.” Ark. Code Ann. § 16-116-102(2).
6
“‘Unreasonably dangerous’ means that a product is dangerous to an extent
beyond that which would be contemplated by the ordinary and reasonable buyer,
consumer, or user who acquires or uses the product, assuming the ordinary
knowledge of the community or of similar buyers, users, or consumers as to its
characteristics, propensities, risks, dangers, and proper and improper uses, as well as
any special knowledge, training, or experience possessed by the particular buyer,
user, or consumer or which he or she was required to possess.” Ark. Code Ann. § 16-
116-102(7)(A).

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Fullington’s design defect allegations were too conclusory to survive a motion to
dismiss because her complaint includes “sufficient factual matter, accepted as true,
to state a claim for relief that is plausible on its face.” Hamilton v. Palm, 621 F.3d
816, 817 (8th Cir. 2010) (quoting Aschcroft v. Iqbal, 556 U.S. 662, 678 (2009)).
Furthermore, to the extent the district court found Fullington’s claims insufficient
because she failed to submit “factual allegations that PLIVA or Mutual, as opposed
to the brand-name manufacturers, actually designed metoclopramide,” such an
allegation is unnecessary under Arkansas law. See Boerner v. Brown & Williamson
Tobacco Corp., 260 F.3d 837, 841 (8th Cir. 2001) (explaining that Arkansas law
authorizes strict liability claims against the “supplier of a product” who “is engaged
in the business of manufacturing . . . or otherwise distributing the product.” (quoting
Ark. Code Ann. § 4-86-102(a))).

Nonetheless, the Supreme Court’s recent decision in Bartlett casts doubt on the
viability of Fullington’s design defect claim. In Bartlett, the Supreme Court held that
the plaintiff’s design defect claim, brought under New Hampshire law, was
preempted. Bartlett, 2013 WL 3155230, at *10. An “unreasonably dangerous”
product is an element of a design defect claim under both New Hampshire and
Arkansas state law. New Hampshire state courts use a “risk-utility approach” to
determining whether a product is unreasonably dangerous. Id. at *8. Under this
approach, New Hampshire courts tend to balance three factors in determining whether
the defendant supplied an unreasonably dangerous product: the product’s value to the
public, whether the supplier could reduce the product’s risks without major expense
or serious detriment to the product’s efficacy, and whether an alternate warning could
mitigate unreasonable risk of harm “from hidden dangers or from foreseeable uses.”
Id. (quoting Vautour v. Body Masters Sports Indus., Inc., 784 A.2d 1178, 1181 (N.H.
2001)). The first two factors, the Court determined, necessarily required generic drug
manufacturers unilaterally to redesign the composition of their drugs, which federal
law precludes generic drug manufacturers from doing. Id. As a result, the only
remaining mechanism by which a generic drug manufacturer could “ameliorate the

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drug’s ‘risk-utility’ profile—and thus . . . escape liability—was to strengthen” the
drug’s warning label. Id. at *9. As Mensing previously established, this, too, generic
drug manufacturers cannot independently do under federal law. The defendant
generic drug manufacturer in Bartlett, no less than in Mensing, was caught between
the devil and the deep blue sea: the only way to avoid state-law tort liability was to
take actions forbidden by federal law.

In contrast to New Hampshire’s risk-utility approach, Arkansas state courts
focus on consumer expectations in determining whether a product is unreasonably
dangerous. See Ark. Code Ann. § 16-116-102(7)(A) (defining “unreasonably
dangerous” in terms of the expectations of “the ordinary and reasonable buyer”);
Purina Mills, Inc. v. Askins, 875 S.W.2d 843, 847 (Ark. 1994); Berkeley Pump Co.
v. Reed-Joseph Land Co., 653 S.W.2d 128, 133 (Ark. 1983). Consequently, it is not
immediately clear whether Arkansas, unlike New Hampshire, offers generic drug
manufacturers an opportunity, consistent with federal obligations, to somehow alter
an otherwise unreasonably dangerous drug. Therefore, we reverse the dismissal of
Fullington’s design defect allegations and remand to the district court for further
consideration in light of Bartlett. See Bell, 2013 WL 2661189, at *6 n.2.

The only claim left to be considered is Fullington’s failure to update claim. The
court in Bell did not reach the question of whether Bell’s analogous claim was
preempted under Mensing because the court concluded it was not viable due to
Arkansas’s learned intermediary doctrine. Under this doctrine, “a drug manufacturer
may rely on the prescribing physician to warn the ultimate consumer of the risks of
a prescription drug.” West v. Searle & Co., 806 S.W.2d 608, 613 (Ark. 1991). A
manufacturer’s inadequate warning is not a proximate cause of a plaintiff’s harm so
long as the prescribing physician had independent knowledge of the risk that the
inadequate warning should have communicated. Bell, 2013 WL 2661189, at *8.
Bell’s physician, like Fullington’s, wrote a prescription for the reference listed drug,
Reglan, which a pharmacist then filled with metoclopramide. Bell admitted that her

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prescribing physician relied on information provided by the manufacturer of the
reference listed drug, which included the updated warning. As a result, Bell’s
prescribing physician had independent knowledge of the risk the updated
metoclopramide label would have communicated, and so this court determined that
Bell failed to articulate a causal link between her injury and PLIVA’s failure to
update its labeling. Id. at *9. Fullington also admits that “her prescribing doctor
relied upon information published in the package inserts and/or the Physicians’ Desk
Reference . . . or otherwise disseminated by the Reference Listed Drug Company.”
Arkansas’s learned intermediary doctrine applies, then, just as it did in Bell.
Although the district court relied on alternative reasoning, we can “affirm the district
court’s dismissal on any basis supported by the record.” Phipps v. FDIC, 417 F.3d
1006, 1010 (8th Cir. 2005). Accordingly, we affirm the district court’s dismissal of
Fullington’s claims against PLIVA for failing to update its labeling.

III. Conclusion

For the foregoing reasons, we affirm the grant of summary judgment in favor
of the Brand Defendants. With respect to the claims against the Generic Defendants,
we affirm the dismissal of Fullington’s failure to warn and failure to update claims
and reverse the dismissal of Fullington’s non-warning design defect and breach of
implied warranty claims and remand for further proceedings.

MURPHY, Circuit Judge, concurring.

I agree with the majority that this case is controlled by our previous opinion in
Bell v. Pfizer, Inc., 2013 U.S. App. LEXIS 12002 (8th Cir. June 14, 2013). I also
agree that we cannot consider Fullington's argument that the brand manufacturers
were "designers" of the generic drug because it was not raised in the district court.
See Dobrovolny v. Moore, 126 F.3d 1111, 1114 n.2 (8th Cir. 1997). If properly

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presented, however, such a claim may have merit given recent developments in the
Supreme Court's prescription drug liability jurisprudence.

The overwhelming majority of courts which have considered whether brand
manufacturers could be held liable for harms caused by their generic counterparts
have answered in the negative. These cases have generally been predicated on the
assumption that the generic manufacturers could independently safeguard and
strengthen their own labels. See, e.g., Foster v. Am. Home Prods. Corp., 29 F.3d 165,
170 (4th Cir. 1994); Mensing v. Wyeth, Inc., 588 F.3d 603, 612–14 (8th Cir. 2009),
rev'd in part on other grounds sub nom. Pliva, Inc. v. Mensing, 131 S. Ct. 2567
(2011). Since the brand and generic manufacturers were assumed to have separate
duties to ensure their labels and warnings were adequate, there was no reason for the
brand manufacturers to foresee that generic consumers would rely on representations
made on the brand drug's label. Foster, 29 F.3d at 170. Consequently we observed
in Mensing that the brand manufacturers did not owe a duty of care to generic
customers because these manufacturers "intended to communicate with their
customers, not the customers of their competitors." 588 F.3d at 613 n.9.

The Supreme Court's decisions in Mensing and Mutual Pharmaceutical Co. v.
Bartlett, 2013 U.S. LEXIS 4702 (June 24, 2013), severely eroded the foundation of
this analysis. These cases stripped any discretionary authority from the generic
manufacturers to ensure the safety of their products or the adequacy of their labels,
instead placing the burden entirely on the brand manufacturers. See Mensing, 131
S. Ct. at 2574. The privileged position accorded to the brand manufacturers may alter
their state law relationship to the generic drugs whose composition and labeling they
control, since at this point such a manufacturer is "the party that actually controls the
manufacturing and labeling of the product in question." Fields v. Wyeth, Inc., 613
F. Supp. 2d 1056, 1061 (W.D. Ark. 2009). With the brand manufacturers solely
responsible for the content and updating of a generic's labels, it can no longer be

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credibly argued that communications regarding the risks of their product are not also
directed at consumers of the generic bioequivalents.7

With these observations, I join in the majority opinion.

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7
That is particularly apparent in this case, as Fullington's doctor prescribed
Reglan, which was then substituted with generic metoclopramide by her pharmacist.

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