Bell v. Wyeth, Inc. et al
MEMORANDUM OPINION AND ORDER granting 117 MOTION for Judgment on the Pleadings. Signed by Chief Judge William Keith Watkins on 8/3/2015. (wcl, )
IN THE UNITED STATES DISTRICT COURT
FOR THE MIDDLE DISTRICT OF ALABAMA
WYETH, INC., et al.,
CASE NO. 2:10-CV-973-WKW
MEMORANDUM OPINION AND ORDER
This lawsuit is one in a long line of actions alleging inadequate and illegal
conduct on the part of the various pharmaceutical companies that “innovated,
made, promoted, and sold” the prescription drug Reglan® or its generic
counterpart, Metoclopramide (“MCP”). (Doc. # 105, at 1.) Plaintiff Rosalyn Bell
contends that she ingested MCP in accordance with a prescription from her treating
physician and developed a severe and incurable neurological disorder as a result.
Ms. Bell alleges that her diagnosis is the proximate result of Defendants Wyeth,
Inc. (“Wyeth”),1 Pfizer, Inc. (“Pfizer”), Schwarz Pharma, Inc. (“Schwarz”),2 Pliva
As noted in Ms. Bell’s Amended Complaint, Pfizer acquired Wyeth in a cash and stock
merger on October 15, 2009. As a result of the merger, Pfizer acquired all of Wyeth’s assets and
assumed the full extent of Wyeth’s liabilities. Pfizer is named in Ms. Bell’s Amended Complaint
solely as the successor to Wyeth’s liability.
Schwarz entered an Asset Purchase Agreement with Wyeth on December 27, 2001,
whereby Schwarz purchased the rights and liabilities associated with Reglan subject to an
USA, Inc. (“Pliva”), Watson Laboratories, Inc. (“Watson Laboratories”), Watson
Pharmaceuticals, Inc. (“Watson Pharmaceuticals”), and Teva Pharmaceuticals
USA’s (“Teva”) dissemination of “inaccurate, misleading, materially incomplete,
false, and otherwise inadequate information concerning the potential effects of
exposure to Reglan/MCP.” (Doc. # 105, at 8.) She brings the following claims
against each Defendant: strict liability (Count I), negligence and wantonness
(Count II), breach of implied warranty (Count III), breach of express warranty
(Count IV), fraud by misrepresentation (Count V), fraud by concealment,
suppression, or omission of material facts (Count VI), and failure to adequately
warn (Count VII).
Presently before the court is Defendants Pliva and Watson Laboratories’
(“Generic Defendants”)3 Motion for Judgment on the Pleadings, in which they
argue that Ms. Bell’s claims against them are preempted by federal law. (Doc. #
The motion has been fully briefed.
(Docs. # 118, 133, 144.)
consideration of the parties’ arguments, the record, and the relevant case law, the
court finds that the Generic Defendants’ motion is due to be granted.
I. JURISDICTION AND VENUE
Subject-matter jurisdiction is proper pursuant to 28 U.S.C. § 1332. The
parties do not contest personal jurisdiction or venue.
Defendants Activis, Inc., f/k/a Watson Pharmaceuticals, and Teva – the other Generic
Defendants – did not join in the present motion.
The FDA approved Reglan® in 1980 as a short-term therapy4 for adults
suffering from gastroesophageal reflux who did not respond to conventional
therapy and to relieve the symptoms associated with acute and recurrent diabetic
gastric stasis. Simply put, Reglan® was designed to increase the speed at which
food travels through the digestive system. In 1985, pharmaceutical manufacturers
began producing MCP – a generic version of Reglan®. MCP is equivalent to
Reglan® in all therapeutically relevant aspects, including dosage, strength, and
Ms. Bell’s physician prescribed her MCP in 2005, and she took the drug for
approximately two years. In 2009, Ms. Bell was diagnosed with tardive dyskinesia
TD is a neurological disorder that commonly causes “involuntary,
repetitive movements of the extremities, lip smacking, grimacing, tongue
protrusion, teeth grinding, rapid eye movements or blinking, puckering and pursing
of the lips, and/or impaired and involuntary movement of the fingers.” (Doc. #
105, at 9.) Ms. Bell suffers from one or more of these symptoms. At present, there
is no known cure for TD, and its effects are rarely reversible.
Ms. Bell alleges that it was her prolonged ingestion of MCP that caused her
to develop TD. The active ingredient in MCP works to block the transfer of
Reglan® was never approved for use longer than twelve weeks.
dopamine within the brain, which in turn causes the brain to produce additional
dopamine receptors. Ultimately, prolonged MCP ingestion may lead the areas
within the brain that control movement to become hypersensitive to dopamine,
potentially resulting in the development of a neurological movement disorder.
“Studies have shown that up to 29% of patients who take [MCP] for several years
develop [TD].” PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2572 (2011).
In her complaint, Ms. Bell alleges that Defendants had actual knowledge that
the risk of developing TD or another neurological side effect from long-term use of
Reglan® or MCP was “approximately 100 times greater” than the risk that
Defendants disclosed to medical professionals. (Doc. # 105, at 10.) Ms. Bell
contends that Defendants failed to warn doctors and patients of the risks associated
with long-term use and even “encouraged long term use of the drug,” concealing
the drug’s “true risks and the true prevalence of side effects.” (Doc. # 105, at 10.)
Had her treating physician been warned of the true risks of MCP, Ms. Bell asserts
that her physician would have adjusted the prescription to avoid the risks
associated with long-term use or not prescribed the drug at all.
This case has a protracted procedural history. Ms. Bell filed her initial
complaint in November 2010. The Brand-Name Defendants5 responded with a
motion to dismiss. In the motion, they argued that Ms. Bell only ingested the
The Brand-Name Defendants are Wyeth, Pfizer, and Schwarz.
generic MCP, and accordingly, she could not maintain products-liability claims
against them as the manufacturers and sellers of Reglan®. After briefing the
motion to dismiss, the Brand-Name Defendants moved to stay the action to allow
the Eleventh Circuit to issue its opinion in Simpson v. Wyeth, Inc., No. 11-11197
(11th Cir.). The Brand-Name Defendants argued that Simpson presented the same
issue existing in this case – namely, whether brand-name drug manufacturers can
be held liable for harm caused by a generic drug manufactured and distributed by
an unrelated generic manufacturer. The motion to stay was unopposed, and the
court entered the stay on April 15, 2011.
Before the Eleventh Circuit issued its opinion, however, the Simpson
plaintiffs moved to dismiss their appeal. As a result, the Brand-Name Defendants
requested that this court certify the unresolved question to the Alabama Supreme
Court. However, in another action pending in this court in which an identical legal
issue was presented, the following question was certified to the Supreme Court of
Alabama: “Under Alabama law, may a drug company be held liable for fraud or
misrepresentation (by misstatement or omission), based on statements it made in
connection with the manufacture or distribution of a brand-name drug, by a
plaintiff claiming physical injury from a generic drug manufactured and distributed
by a different company?” Weeks v. Wyeth, Inc., No 1:10-CV-602-MEF, at 5 (M.D.
Ala. Aug. 25, 2011) (Order certifying question to the Alabama Supreme Court).
Accordingly, this court kept the April 15, 2011 stay in place pending the
conclusion of the certification process in Weeks.
On October 17, 2011, the Alabama Supreme Court agreed to answer the
question certified in Weeks. On January 11, 2013, the Alabama Supreme Court
issued its opinion, concluding that liability could extend to brand-name
manufacturers and developers for fraud or misrepresentations made in connection
with the manufacture and sale of a brand-name drug, by a plaintiff who was injured
by the generic drug manufactured and distributed by a different company. The
brand-name defendants in Weeks, however, timely moved for a rehearing, which
the Alabama Supreme Court granted.
On August 15, 2014, the Alabama Supreme Court withdrew its January 11,
2013 opinion and issued a new opinion. Despite the issuance of a new opinion, the
Alabama Supreme Court’s legal determination largely was the same. For a second
time, it concluded that liability could extend to brand-name manufacturers and
developers for fraud or misrepresentations made in connection with the
manufacture and sale of a brand-name drug, by a plaintiff who was injured by the
generic drug manufactured and distributed by a different company. The brandname defendants in Weeks again applied for rehearing, but the Alabama Supreme
Court denied their application, and on September 3, 2014, a certificate of judgment
was issued, making the determination as to the certified question final.
Upon the conclusion of the certification process in Weeks, the stay in this
case was lifted, and a new scheduling order was entered. Ms. Bell filed an
amended complaint on December 16, 2014.
After the pleadings closed, the
Generic Defendants responded with the now pending motion for judgment on the
III. STANDARD OF REVIEW
The Federal Rules of Civil Procedure provide that “[a]fter the pleadings are
closed—but early enough not to delay trial—a party may move for judgment on
the pleadings.” Fed. R. Civ. P. 12(c). A judgment on the pleadings is limited to
consideration of “the substance of the pleadings and any judicially noticed facts.”
Bankers Ins. Co. v. Fla. Residential Prop. & Cas. Joint Underwriting Ass’n, 137
F.3d 1293, 1295 (11th Cir. 1998). In evaluating a motion for judgment on the
pleadings, the court must review the factual allegations in the light most favorable
to the non-moving party. Cannon v. City of W. Palm Beach, 250 F.3d 1299, 1301
(11th Cir. 2001). However, the court need not credit a nonmoving party’s legal
contentions. See CompuCredit Holdings Corp. v. Akanthos Capital Mgmt., LLC,
661 F.3d 1312, 1314 (11th Cir. 2011). A judgment on the pleadings pursuant to
Rule 12(c) is appropriate when “no issues of material fact exist, and the movant is
entitled to judgment as a matter of law[,]” Ortega v. Christian, 85 F.3d 1521, 1524
(11th Cir. 1996), or when “the complaint lacks sufficient factual matter to state a
facially plausible claim for relief that allows the court to draw a reasonable
inference that the defendant is liable for the alleged misconduct.” Jiles v. United
Parcel Serv., Inc., 413 F. App’x 173, 174 (11th Cir. 2011) (citing Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 556, 570 (2007)).
The Generic Defendants’ motion for judgment on the pleadings is grounded
singularly upon an assertion that Ms. Bell’s state-law tort claims are preempted by
They specifically contend that the federal-labeling requirements
imposed on generic-pharmaceutical manufacturers directly conflict with state-tort
liabilities and that these conflicting obligations mandate the dismissal of Ms. Bell’s
claims against them on the basis of preemption. In response, Ms. Bell argues that
the preemption doctrine is not applicable because the Generic Defendants chose
not to comply with federal law. Because the Generic Defendants failed to comply
with the federal requirements, Ms. Bell asserts that they could have complied with
the state laws, avoiding true conflict and bringing this action outside the scope of
Federal Pharmaceutical Regulations
The labeling of pharmaceuticals is heavily regulated by federal law. Before
a pharmaceutical manufacturer may market any new drug to the public, it must
first acquire federal approval.
To acquire federal approval, the 1962 Drug
Amendments to the Federal Food, Drug, and Cosmetic Act require that a
manufacturer prove that the new drug “is safe and effective and that the proposed
label is accurate and adequate.” 21 U.S.C. §§ 301 et seq.; Mensing, 131 S. Ct. at
For a period of time, all manufacturers had to complete the same approval
process, whether the manufacturer was seeking to market an entirely new
pharmaceutical or merely a new, generic version of an existing drug. Mensing,
131 S. Ct. at 2574.
Because successfully completing the approval process
inherently required “costly and lengthy clinical testing” ill-suited to the
development of a thriving generic-pharmaceutical industry, in 1984 Congress
enacted the Drug Price Competition and Patent Term Restoration Act, commonly
known as the Hatch-Waxman Amendments, which drastically altered the approval
process for new generic pharmaceuticals. 21 U.S.C. § 355(j); Mensing, 131 S. Ct.
Pursuant to the Hatch-Waxman Amendments, manufacturers of brand-name
drugs and manufacturers of generic drugs face two different sets of obligations
when seeking federal approval of new pharmaceuticals.
manufacturers must prove that the proposed label is “accurate and adequate.” 21
U.S.C. § 355(b)(1), (d); Mensing, 131 S. Ct. at 2574. The manufacturers of
generic drugs, on the other hand, are not independently required to demonstrate the
accuracy or adequacy of their labels.
Rather, generic-drug manufacturers are
obligated to ensure that their proposed warning label is identical to the label of the
corresponding brand-name drug.
The Arguments of the Parties
It is upon this “sameness” requirement that the Generic Defendants rest their
federal-preemption argument. They contend that each of Ms. Bell’s claims is
grounded upon a theory that the Generic Defendant failed to adequately warn
and/or properly design MCP. The Generic Defendants argue, however, that they
were unable to strengthen MCP’s warning labels or alter the drug’s design without
violating federal law. In conclusion, the Generic Defendants assert that, because
the state-tort laws conflict with their federal-law obligations, the state laws are
preempted and Ms. Bell’s claims against them are due to be dismissed.
Ms. Bell counters the Generic Defendants’ arguments by contending that the
Generic Defendants cannot rely on federal preemption because they “chose not to
comply with the applicable federal law” when they failed to update their labels.
Because the Generic Defendants did not comply with the federal labeling
requirements, Ms. Bell asserts that they could have complied with Alabama’s tort
laws. Accordingly, she argues that there is no real conflict and, therefore, no
preemption defense available.
A defense of federal preemption is grounded upon the Supremacy Clause of
the United States Constitution. The Supremacy Clause states that “the Laws of the
United States . . . shall be the supreme Law of the Land . . . any Thing in the
Constitution or Laws of any State to the Contrary notwithstanding.” U.S. Const.,
art. VI, cl. 2. The Supreme Court has interpreted this constitutional mandate to
require any state law, including those creating state-tort duties, to give way when
the state law is in direct conflict with a federal law. Mensing, 131 S. Ct. at 2577.
(“Where state and federal law ‘directly conflict,’ state law must give way.”
(quoting Wyeth v. Levine, 555 U.S. 555, 583 (2009))). The Supreme Court has
explained that state and federal law directly conflict for preemption purposes when
it is “impossible for a private party to comply with both state and federal
requirements.” Freightliner Corp. v. Myrick, 514 U.S. 280, 287 (1995).
To be sure, this is not the first case in which a court has been tasked with
determining whether state-tort laws directly conflict with the federal laws
regulating pharmaceuticals. The Supreme Court addressed a similar preemption
defense brought on behalf of the generic manufacturers of MCP in 2011. In
Mensing, plaintiffs similarly situated to Ms. Bell alleged that the long-term use of
MCP had caused them to develop TD and that the generic manufacturers of MCP
were liable under state-tort laws “for failing to provide adequate warning labels.”
131 S. Ct. at 2573. Specifically, they contended that, “despite mounting evidence
that long term [MCP] use carries a risk of [TD] far greater than that indicated on
the label, none of the [m]anufacturers had changed their labels to adequately warn
of that danger.” Id. (internal quotation marks omitted).
The Mensing defendants countered the plaintiffs’ claims with a theory of
Like the Generic Defendants in the present action, the
Mensing defendants explained that “federal statutes and FDA regulations required
them to use the same safety and efficacy labeling as their brand-name
counterparts,” and, accordingly, it was impossible for them “to simultaneously
comply with both federal law and any state tort-law duty that required them to use
a different label.”
With these contentions in place, the Supreme Court
examined whether the Mensing defendants had an avenue by which they could
comply with both federal drug regulations and state-tort laws.
Relying heavily on the FDA’s interpretations of the federal requirements
imposed upon generic pharmaceutical manufacturers, the Supreme Court
determined that the Mensing defendants were without a viable means of complying
with both state and federal law. Specifically, the Supreme Court determined that
federal law prohibited the generic manufacturers from unilaterally changing their
labels via the “changes-being effected” process or providing heightened warnings
directly to physicians via “Dear Doctor” letters. Id. at 2575. Accordingly, the
Supreme Court concluded that federal law preempted the Mensing plaintiffs’
failure-to-warn state-tort claims.
Two years later, the Supreme Court extended its holding in Mensing,
concluding that federal pharmaceutical regulations also preempted state-tort claims
against generic manufacturers based upon design-defect theories. See Mut. Pharm.
Co. v. Bartlett, 133 S. Ct. 2466 (2013). The Supreme Court neglected the First
Circuit’s rationale that Mensing was distinguishable because the generic
manufacturer could have complied with state design-defect laws and federal
regulations simultaneously by choosing to not make the drug at all. It determined
that a “stop-selling” rationale was “incompatible with . . . pre-emption
jurisprudence.” Id. at 2477. The Court ultimately concluded that state-tort laws
that require generic manufacturers to “render a drug safer by either altering its
composition or altering its labeling are in conflict with federal laws” and
preempted accordingly. Id. at 2479.
Recently, the Eleventh Circuit applied the Supreme Court’s holdings in
Mensing and Bartlett. In Guarino v. Wyeth, LLC, 719 F.3d 1245 (11th Cir. 2013),
a plaintiff appealed from a district court’s dismissal of her claims in favor of a
generic manufacturer of MCP. The district court had explicitly relied upon the
Supreme Court’s decision in Mensing, and on appeal, the plaintiff argued that
Mensing was distinguishable because her negligence claim was based upon a
“failure to communicate” theory. Id. at 1247–48. Addressing the plaintiff’s artful
attempt to overcome federal preemption, the Eleventh Circuit spoke to the scope of
Mensing, explaining that any state law cause of action grounded upon a generic
manufacturer’s taking unilateral action is preempted because the federal law “duty
of sameness” makes generic manufacturers dependent upon brand-name
manufacturers. Id. at 1249.
The Generic Defendants argue that Mensing, Bartlett, and Guarino control
the entirety of Ms. Bell’s action against them. Ms. Bell asserts, however, that her
claims against the Generic Defendants are easily distinguishable from the claims
asserted in Mensing and the related cases. She argues that the Generic Defendants,
on their own, “prior to [her] ingestion of [MCP], chose not to fulfill federal law”
when they failed to update the package inserts to match the inserts that
accompanied the name-brand Reglan®. (Doc. # 133, at 8.) Accordingly, she
contends that by unilaterally deciding to ignore the federal duty of “sameness,” the
Generic Defendants should not now be able to cloak themselves in that duty for
preemption purposes. As support for this argument, Ms. Bell highlights the Sixth
Circuit’s analysis in Fulgenzi v. PLIVA, Inc., 711 F.3d 578 (6th Cir. 2013).6
In Fulgenzi, the Sixth Circuit was tasked with applying Mensing to facts
largely analogous to those presented in this case. Specifically, the plaintiff in
Fulgenzi argued that federal preemption was not available to the generic
manufacturer because it “failed to update its labels as required by federal law—
rendering compliance with both federal and state duties no longer impossible.”
711 F.3d at 580. Finding the plaintiff’s argument persuasive, the Sixth Circuit
concluded that the generic manufacturer not only could have acted unilaterally to
update its labeling to conform to that of the brand-name manufacturer, but it was
required to do so under federal law. Id. at 584. Accordingly, it held that the
The Eleventh Circuit addressed Fulgenzi when rendering its decision in Guarino. In a
footnote, the Eleventh Circuit explained that its decision “was not to the contrary” of the Sixth
Circuit’s holding in Fulgenzi. Guarino, 719 F.3d at n.2. Rather, it noted that the plaintiff in
Guarino had failed to allege that the generic manufacturer had not updated its label, as allowed
by federal law. Id.
plaintiff’s claims were allowed to go forward in a limited fashion. While the
plaintiff could not proceed as to any claims based upon the generic manufacturer’s
failure to act independently of the brand-name manufacturers, her claims
challenging the generic manufacturer’s warning survived “to the extent that [the
warning] did not include the language contained in the updated Reglan label from
While Ms. Bell hinges her opposition to the Generic Defendants’ motion for
judgment on the pleadings upon the Sixth Circuit’s reasoning in Fulgenzi, she fails
to appreciate the limited nature of Fulgenzi’s holding. The Fulgenzi court did not
conclude that federal preemption was inapplicable to the entirety of the plaintiff’s
claims. Rather, the Sixth Circuit determined that federal-preemption law did not
prohibit the plaintiff from pursuing a single, narrow state-tort law claim.
Specifically, the plaintiff was able to proceed on her claim that the generic
manufacturers violated state-tort law when they failed to provide a durational
warning on the labeling, as was allowed (even required) under federal regulations
because the brand-name manufacturers already had added the language to their
Accordingly, while Ms. Bell argues that the Generic Defendants’ failure to
comply with federal law should leave her claims entirely outside the scope of
federal preemption, the Supreme Court, the Eleventh and Sixth Circuits, and the
Supreme Court of Alabama all make clear that generic manufacturers cannot be
held liable for violating state-tort laws in failing to take unilateral actions that
would be prohibited by federal law. Mensing, 131 S. Ct. at 2577–78 (“We find
impossibility here. It was not lawful under federal law for the Manufacturers to do
what state law required of them.”); Guarino, 719 F.3d at 1249 (agreeing with the
Fifth Circuit, that “[w]hether 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” (quoting Morris v. PLIVA,
Inc., 713 F.3d 774, 776–77 (5th Cir. 2013))); Fulgenzi, 711 F. 3d at 588 (“Under
Mensing, [the plaintiff’s] claims are viable only to the extent [the generic
manufacturer’s] actions were permitted by federal law.”); Wyeth, Inc. v. Weeks,
159 So. 3d 649, 677 (Ala. 2014) (“The Supreme Court in [Mensing] held that it
would have been impossible for the generic manufacturers to change their warning
labels without violating the federal requirement that the warning on a generic drug
must match the warning on the brand-name version, preempting failure-to-warn
claims against generic manufacturers.”). Applying that principle, to the extent Ms.
Bell seeks to hold the Generic Defendants liable for actions that would have been
prohibited by federal law, her claims are due to be dismissed under a
straightforward application of Mensing.
This court is left with the singular task of determining whether Ms. Bell may
proceed on a claim that the Generic Defendants violated state-tort law when they
failed to provide a durational warning on the labeling. As discussed in Guarino,
such a claim could potentially survive Mensing and federal preemption because the
Generic Defendants were allowed (even required) under the federal regulations to
incorporate the durational warning since the brand-name manufacturers already
had added that language to their labeling. A close review of Ms. Bell’s Amended
Complaint, however, makes clear that, unlike the Guarino plaintiffs, Ms. Bell has
not pled a failure-to-update claim sufficiently narrow to escape federal preemption.
As Ms. Bell has acknowledged, preemption will attach when “it is
‘impossible for a private party to comply with both state and federal
Mensing, 131 S. Ct. at 2577 (quoting Freightliner Corp. v.
Myrick, 514 U.S. 280, 287 (1995)). Stated differently, if complying with a state’s
laws would require a “party to violate federal law,” then the state laws “are preempted and, thus, are ‘without effect.’” Bartlett, 133 S. Ct. at 2470 (quoting
Maryland v. Louisiana, 451 U.S. 725, 746 (1981)). In turn, to present a viable
state-tort claim that falls outside the scope of federal preemption, Ms. Bell would
have to allege that (1) the Generic Defendants violated their state-tort duties, and
that (2) the Generic Defendants could have taken actions in line with their federallaw obligations that would have also allowed them to discharge their state-law
duties. More specifically, she would have to allege that, if the Generic Defendants
had updated their labels in accordance with federal law to incorporate a durational
warning, then they would have been able to comply fully with their state tort-law
Ms. Bell, however, does not make such a claim. Rather, throughout her
Amended Complaint, Ms. Bell repeatedly asserts that the federally compliant
labeling, as implemented by the Brand-Name Defendants in 2004, failed to fully
comply with state law. As a result, Ms. Bell contends that, even if the Generic
Defendants had fulfilled their federal updating obligation, they would not have
satisfied state law. Because Ms. Bell’s claims, all of which are grounded upon
failure-to-warn and defective-design theories,7 allege state-law violations that the
Generic Defendants could not have remedied without violating federalpharmaceutical obligations, the claims are preempted. See Mensing, 131 S. Ct. at
2577 (“We find impossibility here. It was not lawful under federal law for the
Manufacturers to do what state law required of them. And even if they had
fulfilled their federal duty . . . , they would not have satisfied the requirements of
state law.”); Morris, 713 F.3d at 777 (“[I]t is logically incoherent to contend 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.”).
In responding to the Generic Defendants’ motion for judgment on the pleadings, Ms.
Bell clarifies that she is not seeking to hold the Generic Defendants accountable for failing to
comply with the federal law that requires generic manufactures to maintain the same labeling as
that of their brand-name counterparts. She repeatedly emphasizes that all of her claims are based
upon alleged violations of state law and that she is not pursuing a “failure-to-update” claim. Ms.
Bell explains that the Generic Defendants’ failure to update its labeling was discussed only
tangentially as a means of establishing why her claims were outside the reach of a preemption
Based on the foregoing analysis, it is ORDERED that Defendants Pliva and
Watson Laboratories’ Motion for Judgment on the Pleadings (Doc. # 117) is
DONE this 3rd day of August, 2015.
/s/ W. Keith Watkins
CHIEF UNITED STATES DISTRICT JUDGE
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