Coney v. Mylan Pharmaceuticals, Inc. et al

Filing 54

ORDER granting 36 Motion for Summary Judgment. Coney's claims against Mylan Bertek Pharmaceuticals Inc., Mylan Laboratories, Inc., and Mylan Pharmaceuticals, Inc. are dismissed. Signed by Judge B. Avant Edenfield on 1/19/2012. (loh)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF GEORGIA
STATESBORO DIVISION
THEOTIS CONEY,
Plaintiff,
v.

6:11-cv-35

MYLAN PHARMACEUTICALS, INC.,
et al.,
Defendants.
ORDER
I. INTRODUCTION
Plaintiff Theotis Coney (“Coney”) filed
a complaint, individually and as personal
representative of the estate of his wife,
Bertha Coney (“Bertha”), seeking to
“recover damages for loss of consortium
damages sustained by Theotis Coney related
to the wrongful death of his wife.” See Doc.
1-3 at 14.
Bertha developed a severe skin rash
following her treatment with a prescription
drug called “Dilantin.” See id. at 19. Bertha
died of these complications a month later.
See id. Coney alleged nine counts: (1) strict
liability for failure to warn; (2) strict liability
for defective design/manufacture; (3)
negligence; (4) fraudulent concealment; (5)
breach of implied warranty; (6) gross
negligence; (7) joint and several liability; (8)
punitive damages; and (9) loss of
consortium. See id. at 21-37.
Defendants Pfizer, Inc., Warner-Lambert
Company LLC, and Pfizer Pharmaceuticals
LLC (“collectively, Pfizer”) removed this
case from the State Court of Screven

County, alleging diversity jurisdiction and
claiming fraudulent joinder of Georgia
resident Defendant Ross Drugs, Inc.
(“Ross”). See Doc. 1. The Court agreed
that Ross Drugs, Inc. was fraudulently
joined. See Doc. 29 at 4.
All Defendants filed motions to dismiss.
See Docs. 6 (motion to dismiss filed by
Pfizer); 8 (motion to dismiss filed by Mylan
Bertek Pharmaceuticals Inc., Mylan
Laboratories,
Inc.,
and
Mylan
Pharmaceuticals, Inc. (collectively,
“Mylan”) (with Pfizer and Ross,
“Defendants”); 15 (motion to dismiss filed
by Ross). The Court dismissed all of
Coney’s claims against Ross, as well as
Coney’s claim of loss of consortium based
on breach of implied warranty against Pfizer
and Mylan. See Doc. 29.
Now before the Court is Mylan’s
“Motion for Summary Judgment Based on
the Doctrine of Federal Preemption.” See
Doc. 36.
II. FACTS
In November 2007, Bertha was
hospitalized for treatment of seizures
associated with her breast cancer after it
metastasized to her brain. See Doc. 29 at 1.
Her treating physician prescribed and
administered Dilantin. See id.
Dilantin is the brand name under which
Pfizer markets the drug Phenytoin Sodium.
See id. Mylan distributes a generic form of
Dilantin (hereinafter, “Phenytoin”). See id.
Bertha’s physician wrote her a prescription
for Dilantin upon her discharge from the
hospital. See id. at 2. She filled that
prescription at Ross. See id. Ross filled the
prescription with Phenytoin. See id.

Real Prop. in Greene & Tuscaloosa Cntys.,
941 F.2d 1428, 1437 (11th Cir. 1991).

Bertha developed a severe skin rash in
February 2008. See id.. On February 22,
2008, physicians diagnosed her with
Stevens-Johnson Syndrome (“SJS”) and
Toxic Epidermal Necrolysis Syndrome
(“TENS”), potentially fatal diseases known
to develop in African-American patients on
Dilantin. See id. Bertha died on March 21,
2008 as a result of these diseases. See id.

“The moving party bears ‘the initial
responsibility of informing the . . . court of
the basis for its motion, and identifying
those portions of the pleadings, depositions,
answers to interrogatories, and admissions
on file, together with the affidavits, if any,
which it believes demonstrate the absence of
a genuine issue of material fact.’” Four
Parcels, 941 F.2d at 1437 (quoting Celotex
Corp. v. Catrett, 477 U.S. 317, 323 (1986))
(internal quotation marks removed).

Coney filed this suit on March 2, 2011
See Doc. 12 at 3.
III. ANALYSIS

Mylan has moved for summary
judgment, alleging that Coney’s claims are
preempted by federal law. See Doc. 36; see
also PLIVA, Inc. v. Mensing, 131 S. Ct.
2567 (2011). Mylan also argues that
Coney’s design defect claims are
inadequately pled. See Doc. 45 at 5. The
Court accordingly construes Mylan’s motion
for summary judgment as one for judgment
on the pleadings in the alternative. See F ED.
R. C IV. P. 12(h)(B); see also Strategic
Income Fund, L.L.C. v. Spear, Leeds &
Kellogg Corp., 305 F.3d 1293, 1295 n.8
(11th Cir. 2002).

The nonmoving party then “may not rest
upon the mere allegations or denials of the
[nonmoving] party’s pleadings, but . . . must
set forth specific facts showing that there is
a genuine issue for trial.” Gonzalez v. Lee
Cnty. Hous. Auth., 161 F.3d 1290, 1294
(11th Cir. 1998). “A factual dispute is
genuine ‘if the evidence is such that a
reasonable jury could return a verdict for the
nonmoving party.’” Four Parcels, 941 F. 2d
at 1437 (quoting Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 248 (1986)). A fact is
material only if it might affect the outcome
of the suit under governing law. See
Anderson, 477 U.S. at 248.

A. Standards

Courts may consider all materials in the
record, not just those cited by the parties.
F ED. R. C IV. P. 56(c)(3).

“The court shall grant summary
judgment if the movant shows that there is
no genuine dispute as to any material fact
and the movant is entitled to judgment as a
matter of law.” F ED. R. C IV. P. 56(a). In
ruling on summary judgment, the Court
views the facts and inferences from the
record in the light most favorable to the nonmoving party. See Matsushita Elec. Indus.
Co. v. Zenith Radio Corp., 475 U.S. 574,
587 (1986); United States v. Four Parcels of

“Rule 12(c) permits judgment on the
pleadings when there are no material facts in
dispute and judgment may be rendered by
considering the substance of the pleadings
and any judicially noticed facts.” Scottsdale
Ins. Co. v. Pursley, 2012 WL 48035, at *1
(11th Cir. Jan. 10, 2012). In the context of a
motion to dismiss that has been converted
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into a motion for judgment on the pleadings,
the Court must determine whether the
complaint states a claim for relief. See
Strategic Income Fund, L.L. C. v. Spear,
Leeds & Kellogg Corp., 305 F.3d 1293,
1295 n.8 (11th Cir. 2002). Thus, the
pleading standard established in Bell Atl.
Corp. v. Twombly is also relevant in this
case. 550 U.S. 544 (2007).

relief survives a motion to dismiss.” Id. at
1950.
B. PLIVA, Inc. v. Mensing

In Mensing, the Supreme Court
considered whether federal drug regulations
preempted state law failure to warn claims
against generic drug manufacturers. See 131
S. Ct. at 2572.
Warning labels for the drug at issue in
Mensing, metoclopramide, had been
strengthened and clarified several times.
See id. at 2572. Ultimately, the labels were
updated to warn of the risk of “tardive
dyskinesia, a serious movement disorder that
is often irreversible.” Id. at 2573. Before
the label reflected the true risk of
contracting tardive dyskinesia, the Mensing
plaintiffs had received prescriptions for and
had taken generic metoclopramide. See id.
The plaintiffs sued, alleging that the
generics’ manufacturers were liable under
state law failure to warn theories. See id.

“Factual allegations must be enough to
raise a right to relief above the speculative
level.” Twombly, 550 U.S. at 555; see also
Ashcroft v. Iqbal, 129 S. Ct. 1937, 1949
(2009) (claim must have “facial
plausibility”); Edwards v. Prime, Inc., 602
F.3d 1276, 1291 (11th Cir. 2010).
The Iqbal Court further explained the
required level of specificity:
A claim has facial plausibility
when the plaintiff pleads factual
content that allows the court to draw
the reasonable inference that the
defendant is liable for the
misconduct alleged. The plausibility
standard is not akin to a probability
requirement, but it asks for more
than a sheer possibility that a
defendant has acted unlawfully.

The Supreme Court held that these
claims were preempted. See id. at 2577.
The Court first identified the duties owed by
generics’ manufacturers under state and
federal law. See id. at 2573-77. The Court
concluded that liability in state tort law
imposes a duty “to use a different, stronger
label than the label they actually used.” Id.
at 2577.

129 S. Ct. at 1949 (internal citation and
quotation omitted).
In order to assess the plausibility of a
complaint, a court must be mindful of two
principles. “First, the tenet that a court must
accept as true all of the allegations contained
in a complaint is inapplicable to legal
conclusions.” Id. “Second, only a
complaint that states a plausible claim for

On the other hand, “[fJederal drug
regulations, as interpreted by the FDA,
prevented the Manufacturers from
independently changing their generic drugs'
safety labels.” Id. Thus, federal law
required “sameness” of labeling between
brand-name and generic drugs. See id. at
2575.
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on Phenytoin’s label, that claim is
preempted.

The Court then went through
Supremacy Clause analysis, noting “that
state and federal law conflict where it is
‘impossible for a private party to comply
with both state and federal requirements.’”
Id. at 2577. (quoting Freightliner Corp. v.
Myrick, 514 U.S. 280, 287 (1995).

Coney attempts to circumvent Mensing
by arguing that his failure to warn claim
targets not Mylan’s failure to include
information not contained on the FDAapproved labeling, but Mylan’s failure to
include warnings that were included on the
FDA-approved label. See Doc. 41 at 3.

The Court found impossibility. See id.
“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 to ask for FDA assistance, they
would not have satisfied the requirements of
state law.” Id. at 2577-78.

Coney’s argument is unavailing. This
distinction does not appear in Coney’s
complaint. See Doc. 1-3 at 21-23. Thus,
this variation of the claim is not facially
plausible, due to the lack of any supporting
factual allegations in the complaint.

C. Coney’s Claims

Coney next claims that Mylan had a duty
to communicate the warnings on
Phenytoin’s label. See Doc. 41 at 4. Coney
asserts that this duty could have been
accomplished through a “Dear Doctor”
letter, training programs, continuing
education, patient access programs,
specialized packaging, and “Changes Being
Effected” (“CBE”) procedures. See id. at 45.

Coney currently has strict
liability/failure to warn, strict product
liability/defective design or manufacture,
negligence, fraudulent concealment, and
gross negligence claims pending against
Mylan. See Docs. 1-3 at 14; 29. Mylan
moves to dismiss all of these claims,
asserting that all of these claims are founded
upon failure to warn reasoning. See Doc.
36. Mylan also asserts that Coney’s product
defect claims are inadequately pled. See
Doc. 45 at 23. The Court takes each of
Coney’s claims up in turn.

Coney once again attempts to articulate a
claim in a manner unsupported by his
complaint. Coney’s complaint indicates that
Phenytoin “was sold without adequate
warnings regarding the risk of serious skin
reactions, exfolliative dermatitis, toxic
epidermal necrolysis, Steven-Johnson
Syndrome and other risks associated with its
use.” See Doc. 1-3 at 22 (emphasis added);
see also id. at 18-19 (“Defendants
represented its product Phenytoin as a drug
to control seizures, but failed to include
adequate information in its label, package
insert, and sales literature regarding the

1. Strict Liability Failure to Warn
Mensing established that failure to warn
claims against generics manufacturers who
satisfied federal law’s abbreviated drug
application requirements were preempted
because they conflicted with federal law.
Mensing, 131 S. Ct. at 2577-78. To the
extent that Coney alleges failure to warn
premised on the lack of additional warnings

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serious and potentially fatal side effects
related to its use.”). Hence, Coney’s
complaint does not allege that Mylan failed
to communicate warnings that had already
been adequately detailed on the warning
label; Coney alleged that any warning
attached to Phenytoin was per se inadequate.
Coney’s complaint simply does not support
the argument he is now espousing.
Accordingly, Coney’s pleadings do not
sufficiently take this configuration of his
claim beyond the realm of mere possible
liability.

timely modify its label or track label
changes for branded Dilantin.” See Doc. 41
at 5. Coney never asserted this theory in his
complaint. See Doc. 1-3 at 18-19, 21-23.
Accordingly, this claim is barred as
implausible based on his pleading.
Coney next argues that Mylan could
have simply chosen to take Phenytoin off
the market. See Doc. 41 at 7. Other courts
have considered and rejected this argument.
See, e.g., Mensing v. Wyeth, Inc., 658 F.3d
867 (8th Cir. 2011); Fullington v. PLIVA,
Inc., 2011 WL 6153608, at *6 (E.D. Ark.
Dec. 12, 2011). Finding that state law
prohibits Mylan from doing what federal
law explicitly requires Mylan to do would
be tantamount to conferring supremacy upon
the state law. See City of Detroit v. Comcast
of Detroit, Inc., 771 F. Supp. 2d 781, 790
(E.D. Mich. 2011); see also United States v.
State, 2011 WL 446994, at *45 (N.D. Ala.
Sept. 28, 2011).

Coney cites Brasley-Thrash v. Teva
Pharms. USA, Inc. for the proposition that
failure to disseminate Dear Doctor letters
can still result in post -Mensing liability. See
2011 WL 4025734, at *3 (S.D. Ala. Sept.
12, 2011). Coney, however, ignores the
facts of Brasley-Thrash. In that case, the
FDA had already approved a label change to
the drug Reglan. See id. at * 1. The plaintiff
attempted to amend her claims to include a
charge of failing to send a Dear Doctor letter
reflecting the approved changes. See id.
The court decided that the amendment was
not futile because the claim was not
preempted by federal law. See id. at *3.
The court noted that manufacturers at the
time would not have needed federal
government involvement to take the steps
the plaintiff alleged were needed. See id.
Thus, the plaintiff had actually attempted to
amend her complaint to include a claim
premised upon the failure to send a Dear
Doctor letter containing FDA-approved
language. Coney has not properly alleged
such a claim in this case.

Finally, Coney asks the Court to
postpone preemption of his failure to warn
claim against Mylan until the Court
evaluates the adequacy of Pfizer’s warning.
See Doc. 41 at 8. Preemption of Coney’s
claims against Mylan, however, is not based
on Pfizer’s actions; if Coney’s claims
against Mylan are preempted, it is because
Mylan could not act in accord with both
state and federal law. See Mensing, 131 S.
Ct. at 2579 (“The question for
“impossibility” is whether the private party
could independently do under federal law
what state law requires of it.” (emphasis
added)). But see Foster v. Am. Home Prods.
Corp., 29 F.3d 165, 170 (4th Cir. 1994)
(stating in pre-Mensing dicta that generics’

Coney next argues that discovery might
show that Mylan breached its duty “to
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manufacturers could be liable for negligent
misrepresentations on labels the
manufacturers merely adopt because “[t]he
statutory scheme governing premarketing
approval for drugs simply does not evidence
Congressional intent to insulate generic drug
manufacturers from liability for
misrepresentations made regarding their
products, or to otherwise alter state products
liability law”).

and are based upon Mylan’s duty not to sell
the drug at all. See Doc. 41 at 10.
The Court finds that Coney has
inadequately pled this claim. The Georgia
Code states:
The manufacturer of any
personal property sold as new
property directly or through a dealer
or any other person shall be liable in
tort, irrespective of privity, to any
natural person who may use,
consume, or reasonably be affected
by the property and who suffers
injury to his person or property
because the property when sold by
the manufacturer was not
merchantable and reasonably suited
to the use intended, and its condition
when sold is the proximate cause of
the injury sustained.

Finding Mylan liable for replicating, as
required by federal law, the FDA-approved
warnings used by Pfizer for Dilantin simply
because a third party (Pfizer) or the Federal
Government might bring about conditions
that enable Mylan to comply with both state
and federal law would eviscerate the
Supremacy Clause. See Mensing, 131 S. Ct.
2579. Accordingly, the Court will not hang
Mylan’s fate on Pfizer’s liability.
Because Coney’s failure to warn claim is
either preempted or improperly pled, it is
DISMISSED.

O.C.G.A. § 51-1-11(b)(1). Georgia law
utilizes a cost-benefit analysis to determine
whether a product is defective; a product’s
utility must outweigh the product’s risk in
order for the product to be effective. See
Bryant v. Hoffman-La Roche, Inc., 262 Ga.
App. 401, 406 (2003).

2. Defective Design and
Manufacture
Mylan argues that Coney’s defective
design and manufacture claim claims are
actually founded upon a failure to warn
theory and must also be preempted. See
Doc. 36-1 at 3. In the alternative, Mylan
argues that Coney’s defective design and
manufacture claims are impliedly preempted
under the frustration of purpose doctrine.
See Doc. 45 at 18-23. Mylan also insists
that Coney’s design defect claim is
inadequately pled. See Doc. 45 at 23.
Coney asserts that these claims are
independent of his failure to warn claims

The existence of a defect is an essential
element of both
strict liability and
negligence product defect claims. See
Udoinyion v. Michelin N. Am., Inc., 2011
WL 6091218, at *2 (Ga. App. Dec. 8, 2011).
Thus, a complaint is deficient if it fails to
allege a specific design or manufacturing
defect. See Moore v. Mylan Inc. f/k/a/
Mylan Labs. Inc., No. 1:11-cv-03037, at 13
(N.D. Ga. Jan. 5, 2012).

6

Coney has failed to allege a specific
design or manufacturing defect. See Doc. 13 at 23-26. Furthermore, “because the
complaint is silent as to a design or
manufacturing defect, the Court cannot draw
the reasonable inference that a design or
manufacturing defect caused the decedent's
injuries.” Moore, No. 1:11-cv-03037, at 13;
see also Hall v. Scott USA, Ltd., 198 Ga.
App. 197, 200 (1990) (noting that proximate
cause is a “necessary element” under either
a strict liability or negligence theory of
products liability).

The following elements are essential to a
negligence claim in Georgia:
(1) A legal duty to conform to a
standard of conduct raised by the law
for the protection of others against
unreasonable risks of harm; (2) a
breach of this standard; (3) a legally
attributable causal connection
between the conduct and the
resulting injury; and (4) some loss or
damage flowing to the plaintiff's
legally protected interest as a result
of the alleged breach of the legal
duty.

Because Coney fails to allege a plausible
defective design or manufacture claim
against Mylan, Coney’s defective design and
manufacture claims against Mylan are
preempted and DISMISSED.

Dixie Grp., Inc. v. Shaw Indus. Grp., Inc.,
303 Ga. App. 459, 466-67 (2010).
As stated supra, the existence of a defect
is an essential element of both strict liability
and negligence product defect claims. See
Udoinyion, 2011 WL 6091218, at *2.
Coney failed to allege a specific defect in
Phenytoin that would support his negligence
claim. See Doc. 1-3 at 26-29. The Court is
thus unable to draw the inference that a
defect proximately caused the decedent’s
injuries. See Moore, No. 1:11-cv-03037, at
13. Thus, Coney fails to adequately plead
negligence claims to the extent that they are
based on Phenytoin’s design and
manufacture.

3. Negligence and Gross Negligence
Claims
Coney contends that his negligence
claims survive because they are focused on
Phenytoin’s design, development, and
manufacturing, not labeling. See Doc. 41 at
12.
Coney’s complaint alleges that Mylan
was negligent in part because it provided
inadequate warnings on Phenytoin’s label.
See Doc. 1-3 at 26-27. For the reasons
stated supra, Coney’s negligence claim is
preempted to the extent it relies on Mylan’s
purported failure to warn. See supra Part
III . C. 1.

Because Coney’s negligence claims are
either preempted or insufficiently pled, those
claims are DISMISSED.

Insofar as Coney’s negligence claims
focus on Phenytoin’s design and
manufacture, those claims are inadequately
pled.

4. Fraudulent Concealment
Coney’s fraudulent concealment claim
must also be dismissed. Coney asserted that
Mylan fraudulently failed to disclose test
7

results showing the risks of Phenytoin,
failed to include warnings about potential
risks, provided false or misleading
information regarding Phenytoin’s risks, and
concealed known incidents of adverse
reactions to the drug. See Doc. 1-3 at 30.

both state and federal law, Coney’s
fraudulent concealment claim, to the extent
it is premised on Phenytoin’s warning label,
is also preempted.
Insofar as Coney alleges fraudulent
concealment premised on materials outside
of the label and already approved by the
FDA, Coney has pled these claims
inadequately. Fraud claims are subject to
heightened pleading requirements. See F ED.
R. C IV. P. 9(b). Rule 9(b) requires a
complaint to set forth:

“The tort of fraud has five elements: (1)
a false representation or omission of a
material fact; (2) scienter; (3) intention to
induce the party claiming fraud to act or
refrain from acting; (4) justifiable reliance;
and (5) damages.” ReMax N. Atlanta v.
Clark, 244 Ga. App. 890, 893 (2000). Thus,
finding Mylan liable for fraudulent
concealment means finding that Mylan
falsely omitted a material fact.

(1) precisely what statements were
made in what documents or oral
representations or what omissions
were made, and (2) the time and
place of each such statement and the
person responsible for making (or, in
the case of omissions, not making)
same, and (3) the content of such
statements and the manner in which
they misled the plaintiff, and (4)
what the defendants obtained as a
consequence of the fraud.

To the extent that Coney alleges
fraudulent concealment claims based on
omissions on Phenytoin’s warning label or
Mylan’ s communications with health
providers, his claim is preempted. “Any
claim based on the errors in the label—or
omissions in labeling or communications
with health providers—is pre-empted by the
FDA regulations for the same reason that
failure-to-warn claims are pre-empted.”
Grinage v. Mylan Pharm., Inc., 2011 WL
6951962, at *7 (D. Md. Dec. 30, 2011); see
also Fisher v. Pelstring, 2011 WL 4552464,
at *20 (D.S.C. Sept. 30, 2011). Mylan was
forced to comply with federal law in
determining what warnings and other
written materials to communicate. See
Mensing, 131 S. Ct. at 2576; see also 21
U.S.C. § 321(m); 21 C.F.R.§ 201.100(d)(1);
21 C.F.R.§ 202.1( l)(2). Finding Mylan
guilty of fraudulent omission would indicate
that Mylan had a state-law duty to issue
more detailed warnings. Because it would
be impossible for Mylan to comply with

Mizzaro v. Home Depot, Inc., 544 F.3d
1230, 1237 (11th Cir. 2008) (quoting Tello
v. Dean Witter Reynolds, Inc., 494 F.3d 956,
972 (11th Cir. 2007)).
With regards to fraudulent omissions
outside the context of Phenytoin’s warning
label, Coney has failed to identify the time
and place of Mylan’s omissions, the content
omitted and the manner in which the
omissions misled Coney, and what Mylan
obtained as a result of its omissions. See
Doc. 1-3 at 29-30. Accordingly, Coney’s
complaint fails to articulate the factual
allegations necessary to meet the Rule 9(b)
pleading standard.
8

Because Coney’s fraud claim is either
preempted or insufficiently pled, the claim
must be DISMISSED.
IV. CONCLUSION

Mylan’s motion for summary judgment,
see Doc. 36, is GRANTED. Coney’s claims
against Mylan Bertek Pharmaceuticals Inc.,
Mylan Laboratories, Inc., and Mylan
Pharmaceuticals, Inc. are DISMISSED.

This 19th day of January 2012.

49 EDENFIELØ, I- 4^111
,
R AVANT
JUDGE
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF GEORGIA

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