Fullington v. Pfizer Inc et al
OPINION AND ORDER: Joyce Fullington's 110 second amended complaint is dismissed with prejudice. Signed by Judge J. Leon Holmes on 2/28/2014. (ks)
IN THE UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF ARKANSAS
No. 4:10CV00236 JLH
PLIVA, INC., formerly known as
Pliva USA, Inc.; and MUTUAL
PHARMACEUTICAL COMPANY, INC.
OPINION AND ORDER
This Court previously dismissed all of Joyce Fullington’s claims with prejudice. On appeal,
the United States Court of Appeals for the Eighth Circuit affirmed the dismissal of all claims except
Fullington’s nonwarning design defect and breach of implied warranty claims, and with respect to
those claims, the court remanded for further proceedings. Fullington v. Pfizer, Inc., 720 F.3d 739,
747 (8th Cir. 2013). The Eighth Circuit remanded Fullington’s implied warranty claims “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 745 (quotation marks
omitted). The Eighth Circuit remanded the design defect claims for further consideration in light
of the opinion of the United States Supreme Court in Mutual Pharmaceutical Co., Inc. v. Bartlett,
133 S. Ct. 2466, 186 L. Ed. 2d 607 (2013). Fullington, 720 F.3d at 746-47.
After remand, the Court directed Fullington to file a short and concise statement of the claims
that she believes survive as a result of the opinion of the Eighth Circuit, after which the Generic
Defendants moved for judgment on the pleadings as to those claims. In response, Fullington filed
a brief arguing that her causes of action for strict liability design defect, breach of the implied
warranty of merchantability, and breach of the implied warranty of fitness for a particular purpose
remain viable. The Court then ordered Fullington to file a second amended complaint, alleging her
claims for strict liability design defect, breach of the implied warranty of merchantability, and breach
of the implied warranty of fitness against the Generic Defendants, omitting all allegations that relate
to parties and claims that had previously been dismissed with prejudice. After Fullington filed her
second amended complaint, the Court gave the parties one final opportunity to brief the issues and
directed Fullington to explain in her brief specifically what the Generic Defendants could have done
to comply with Arkansas law, as well as how doing so would not have violated federal law. Those
final briefs have been filed, and the issues that the Eighth Circuit directed this Court to consider on
remand are now ripe for decision.
The Generic Defendants have not argued, following remand, that Fullington’s breach of
implied warranty claims fail to state claims upon which relief may be granted under Arkansas law.
Upon review of the second amended complaint, the Court is satisfied that Fullington’s claims for
breach of implied warranty meet the pleading standards of the Federal Rules of Civil Procedure and
state claims upon which relief could be granted under Arkansas law. Consequently, the issue to be
decided is whether Fullington’s breach of implied warranty and design defect claims are preempted,
and that issue requires the Court to consider the scope of the Supreme Court’s decision in Bartlett.
In remanding for further consideration in light of Bartlett, the Eighth Circuit explained:
[T]he 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, 133 S. Ct. at 2476-78. 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 2474-75. 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., 147 N.H. 150, 784 A.2d 1178,
1181 (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 drug’s ‘risk-utility’ profile—and thus . . . escape liability—was to
strengthen” the drug’s warning label. Id. at 2475-76. As [PLIVA, Inc. v. Mensing,
131 S. Ct. 2567, 180 L. Ed. 2d 580 (2011)] 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, 317 Ark. 58, 875 S.W.2d 843, 847 (1994); Berkeley
Pump Co. v. Reed-Joseph Land Co., 279 Ark. 384, 653 S.W.2d 128, 133 (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.
Fullington, 720 F.3d at 746-47.
The Fourth Circuit has recently issued an opinion that decides the issue regarding Bartlett
that the Eighth Circuit directed this Court to consider. Drager v. PLIVA USA, Inc., __ F.3d __, 2014
WL 292700 (4th Cir. Jan. 28, 2014). Drager, like this case, presented a situation in which long-term
use of generic metoclopramide resulted in permanent injuries. Id. at *1. The plaintiff alleged statelaw claims of negligence, breach of warranty, fraud and misrepresentation, strict liability, and failure
to warn under Maryland law. Id. The plaintiff’s strict liability claim included a claim that generic
metoclopramide was defective in design. Id. at *5. There, as here, the plaintiff contended that
Bartlett did not control because Maryland, like Arkansas, assesses the reasonableness of the danger
of a product using a consumer-expectations test, in contrast to New Hampshire, the state whose tort
laws were at issue in Bartlett, which uses a risk-utility approach. Id. Rejecting that argument, the
Fourth Circuit explained:
To the extent that there is a difference in approach between the two states, it is
immaterial. The Court in Bartlett did not determine that the New Hampshire law was
preempted because it applied the risk-utility approach. Instead, it concluded that
there was no action that the defendant could take under that approach to increase the
safety of its product without violating the restrictions of the [Food, Drug, and
Cosmetics Act, 21 U.S.C. §§ 301 et seq.]. We have no trouble concluding that the
same is true under either the risk-utility or the consumer-expectations approach in
Maryland. PLIVA cannot be required to stop selling its product, but at the same time
it is prohibited from making any changes to the product itself or the accompanying
warnings. Regardless of the way in which Maryland assesses the unreasonableness
of a product’s risks, if PLIVA’s metoclopramide is unreasonably unsafe, there is no
apparent action that PLIVA can take in compliance with FDCA restrictions to avoid
Id. (footnotes omitted). The Fourth Circuit is correct: whether a state follows the risk-utility
approach or the consumer-expectations approach does not affect the application of Bartlett.1
In Bartlett, the Supreme Court noted that the Food, Drug, and Cosmetics Act 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. Bartlett, 133 S. Ct. at 2475. Consequently,
a generic drug manufacturer cannot change the design of the drug to comply with state law. Id. Nor
can a generic drug manufacturer change the label. Id. at 2476. Hence, if a generic drug is
defectively designed, the only action the manufacturer can take to comply with both state and federal
In a footnote, the Fourth Circuit observed that Maryland has used both approaches. Id. at
n.2 (citing Halliday v. Sturm, Ruger & Co., 368 Md. 186, 792 A.2d 1145, 1153 (2002)). Arkansas
likewise has used both approaches. Compare West v. Searle & Co., 305 Ark. 33, 40-41, 806 S.W.2d
608, 612-13 (1991) (adopting Comment k to § 402A of the Restatement (Second) of Torts and
applying a risk/benefit analysis to a strict liability claim relating to a pharmaceutical product) with
Fullington, 720 F.3d at 746 (citing Arkansas cases using the consumer-expectations approach).
law is to withdraw the product from the market, but Bartlett rejects that as an option that avoids
impossibility preemption. Id. at 2477. It is therefore impossible for a manufacturer of a generic drug
that violates state design-defect laws to comply with both federal and state laws—which leads to the
conclusion that the state laws are preempted by the FDCA. Id. at 2478. None of this reasoning
depends on the distinction between the risk-utility approach and the consumer-expectations
The same logic applies to claims of breach of an implied warranty. Again, the Fourth Circuit
Because PLIVA was not permitted to change its warnings or formulation, it could not
have avoided liability for breach of these implied warranties except by exiting the
market. Therefore, to the extent that implied warranties of merchantability or fitness
for a particular purpose can arise in this context under Maryland law, they are
preempted by the requirements of the FDCA.
Drager, 2014 WL 292700 at *6. The same is true here.
In the Court’s order directing final briefing, the Court directed Fullington to explain what the
Generic Defendants could have done to comply with Arkansas law without violating federal law.
Her brief argues, first, that the defendants could have refrained from selling metoclopramide and,
second, that the defendants could have conducted post-marketing surveillance. As noted, Bartlett
overruled the first argument. Bartlett, 133 S. Ct. at 2477. As to the second argument, Fullington
does not explain how a failure to conduct post-marketing surveillance constitutes a design defect or
breaches one of the implied warranties, nor does she explain how the defendants could have avoided
liability on her design defect and implied warranty claims by conducting post-marketing surveillance.
In addition to the implied warranty and design defect claims discussed above, Fullington
argues that she has a state-law misbranding claim that parallels a federal misbranding claim and thus
is viable notwithstanding Bartlett. Her brief does not specify which factual allegations in the second
amended complaint support a misbranding claim, and the only factual allegations that appear to
support such a claim are allegations that PLIVA failed to update its warnings to conform to the FDA
approved label after 2003. Those allegations were also included in her first amended complaint and
were dismissed with prejudice by this Court. On appeal, the Eighth Circuit affirmed the dismissal
of those claims, albeit for reasons other than those stated by this Court. Fullington, 720 F.3d at 747.
Hence, Fullington’s misbranding claims were dismissed with prejudice, and that dismissal became
the law of the case when the Eighth Circuit affirmed and issued its mandate. United States v.
Castellanos, 608 F.3d 1010, 1016-17 (8th Cir. 2010).
If Fullington is alleging misbranding claims that were not alleged in her first amended
complaint, those claims still fail. Although this Court directed Fullington to file a second amended
complaint alleging only her strict liability design defect and breach of the implied warranty claims,
the Court did not give, nor did Fullington seek, leave to allege new claims. If Fullington is alleging
new claims, she has violated Rule 15, which provides that a party may amend its pleadings only with
the opposing party’s written consent or leave of court. Fed. R. Civ. P. 15(a)(2). Furthermore, the
Court’s scheduling order provided that leave to amend pleadings had to be sought no later than
January 17, 2012. “If a party files for leave to amend outside of the court’s scheduling order, the
party must show cause to modify the schedule.” Popoalii v. Correctional Med. Servs., 512 F.3d 488,
497 (8th Cir. 2008). Fullington has not shown cause to modify the scheduling order. Cf. Bell v.
Kansas City Police Dept., 635 F.3d 346, 347 (8th Cir. 2011) (finding no abuse of discretion in the
denial of leave to amend where the plaintiff failed to show good cause for modifying the pretrial
scheduling order to allow an untimely amendment of the complaint).
Either Fullington’s misbranding claims were presented in her first amended complaint, in
which case they were dismissed with prejudice, and that dismissal is the law of the case by virtue
of the Eighth Circuit’s mandate; or they are new claims that she has not obtained leave to assert.
For the reasons stated, Joyce Fullington’s second amended complaint is dismissed with
prejudice. Document #110.
IT IS SO ORDERED this 28th day of February, 2014.
J. LEON HOLMES
UNITED STATES DISTRICT JUDGE
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