United States District Court, N.D. Alabama, Southern Division
DAVID PROCTOR UNITED STATES DISTRICT JUDGE.
matter is before the court on Defendants' Motion to
Dismiss Plaintiff's First Amended Complaint. (Doc. # 44).
In their motion and accompanying memorandum of law (Doc. #
45), Defendants argue that Plaintiff's Amended Complaint
is due to be dismissed in its entirety. Defendants'
motion is fully briefed. (Docs. # 45, 51, 52). For the
reasons stated below, Defendants' Motion is due to be
granted in part and denied in part.
engage in the distribution, marketing, and sale of the drug
known as LIALDA. (Doc. # 41 at ¶ 8). In November 2013,
Plaintiff was prescribed LIALDA for treatment of his
Crohn's disease. (Id. at ¶ 39). Plaintiff
took LIALDA, as prescribed, from November 2013 until February
2015. (Id.). In September 2015, Plaintiff was
diagnosed with Stage IV renal failure and severe chronic
interstitial nephritis. (Id. at ¶ 45).
Plaintiff contends that LIALDA causes toxicity to build up in
the kidneys over time, and he alleges that his kidney
injuries were a direct result of his continued use of LIALDA.
(Id. at ¶¶ 43-47).
asserts that LIALDA's label contained a defect, which was
present both in January 2007 (when LIALDA was initially
approved by the FDA), and in November 2013 (when Plaintiff
was first prescribed LIALDA). (Id. at ¶¶
17, 18). He contends that LIALDA's defective label caused
his injuries. (Id. at ¶¶ 36, 47).
LIALDA's label warned of the possibility that a consumer
may develop kidney damage from use of the product. Indeed,
the LIALDA label in use at the time Plaintiff was prescribed
the drug warned that “[r]enal impairment,
including minimal change nephropathy, acute and chronic
interstitial nephritis, and rarely, renal
failure, has been reported in patients given products
such as LIALDA that contain mesalamine or are converted to
mesalamine.” (Id. at ¶ 18) (emphasis
added). Accordingly, Plaintiff does not contend that
Defendants failed to warn that use of LIALDA may result in
he takes issue with the following language, also from
LIALDA's label: “[i]t is recommended that patients
have an evaluation of renal function prior to initiation of
LIALDA therapy and periodically while on therapy.”
(Id.). Plaintiff alleges that this recommended
“periodic” evaluation constitutes a defective and
unsafe instruction for use of LIALDA. (Id. at ¶
22). He contends that the term “periodic, ” as
generally used in drug labels, refers to either semi-annual
or annual testing. (Id.). However, he asserts that
an appropriate LIALDA label should include instructions
recommending “evaluation of renal function by a simple
serum (blood) test of creatinine levels on a monthly basis
for the first three months after initiation of therapy and
then on a quarterly basis for at least one year.”
(Id. at ¶ 25). Plaintiff asserts that
Defendants' recommendation of only “periodic”
testing, as opposed to the more specific testing regimen
detailed in his Amended Complaint, proximately caused his
kidney injury. (Id. at ¶ 26). Plaintiff asserts
claims for failure to warn under the Alabama Extended
Manufacturers Liability Doctrine (“AEMLD”),
fraud, suppression and concealment, and breach of express
Standard of Review
Federal Rules of Civil Procedure require only that the
complaint provide “a short and plain statement of the
claim showing that the pleader is entitled to relief.”
Fed.R.Civ.P. 8(a)(2). Still, the complaint must include
enough facts “to raise a right to relief above the
speculative level.” Bell Atlantic Corp. v.
Twombly, 550 U.S. 544, 555 (2007). Pleadings that
contain nothing more than “a formulaic recitation of
the elements of a cause of action” do not meet Rule 8
standards, nor do pleadings suffice that are based merely
upon “labels and conclusions” or “naked
assertion[s]” without supporting factual allegations.
Twombly, 550 U.S. at 555, 557. In deciding a Rule
12(b)(6) motion to dismiss, courts view the allegations in
the complaint in the light most favorable to the nonmoving
party. Watts v. Fla. Int'l Univ., 495 F.3d 1289,
1295 (11th Cir. 2007).
survive a motion to dismiss, a complaint must “state a
claim to relief that is plausible on its face.”
Twombly, 550 U.S. at 570. “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.”
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).
Although “[t]he plausibility standard is not akin to a
‘probability requirement, '” the complaint
must demonstrate “more than a sheer possibility that a
defendant has acted unlawfully.” Id. A
plausible claim for relief requires “enough fact[s] to
raise a reasonable expectation that discovery will reveal
evidence” to support the claim. Twombly, 550
U.S. at 556. The Supreme Court has recently identified
“two working principles” for a district court to
use in applying the facial plausibility standard. First, in
evaluating motions to dismiss, the court must assume the
veracity of well- pleaded factual allegations; however, the
court does not have to accept as true legal conclusions when
they are “couched as . . . factual
allegation[s].” Iqbal, 556 U.S. at 678.
Second, “only a complaint that states a plausible claim
for relief survives a motion to dismiss.” Id.
of the facial plausibility standard involves two steps. Under
prong one, the court must determine the scope and nature of
the factual allegations that are well-pleaded and assume
their veracity; and under prong two, the court must proceed
to determine the claim's plausibility given the
well-pleaded facts. That task is context specific and, to
survive the motion, the allegations must permit the court
based on its “judicial experience and common sense . .
. to infer more than the mere possibility of
misconduct.” Id. If the court determines that
well-pleaded facts, accepted as true, do not state a claim
that is plausible, the claims are due to be dismissed.
brief in support of their Motion to Dismiss makes a number of
arguments which purport to establish bases to dismiss
Plaintiff's Amended Complaint. The court will address
Defendants' arguments in turn.
axiomatic that “[u]under the Supremacy Clause, state
laws that require a private party to violate federal law are
pre-empted and, thus, are ‘without effect.'”
Mutual Pharm. Co. v. Bartlett, 133 S.Ct. 2466, 2470
(2013) (quoting Maryland v. Louisiana, 451 U.S. 725,
746 (1981)). However, “[i]n all pre-emption cases, and
particularly in those in which Congress has
‘legislated… in a field which the States have
traditionally occupied, ' … we ‘start with
the assumption that the historic police powers of the States
were not to be superseded by the Federal Act unless that was
the clear and manifest purpose of Congress.'”
Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (quoting
Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230
(1947)). Here, Defendants argue that Plaintiff's state
law claims, which allege that LIALDA's label is
inadequate under state law, are preempted by federal law
related to the labelling of prescription drugs. (Doc. # 45 at
Plaintiff alleges that Defendants had a duty under Alabama
state law to issue adequate testing requirements and warnings
(see Doc. # 41 at ¶ 150), federal law imposes
more complex drug labeling requirements. See PLIVA, Inc.
v. Mensing, 564 U.S. 604, 612 (2011). Under the Federal
Food, Drug, and Cosmetic Act (“FDCA”), drug
manufacturers must gain approval from the United States Food
and Drug Administration (“FDA”) before marketing
any drug in interstate commerce. Mut. Pharm. Co. v.
Bartlett, 133 S.Ct. 2466, 2470 (2013); see 21
U.S.C. § 355(a). This premarket approval of a new drug
application (“NDA”) requires FDA approval of the
exact text contained in the drug's proposed label.
See 21 U.S.C. § 355; 21 C.F.R.
§314.105(b). The FDA may approve of an NDA only if the
drug in question is “safe for use” under
“the conditions of use prescribed, recommended, or
suggested in the proposed labelling thereof.” 21 U.S.C.
“a manufacturer may only change a drug label after the
FDA approves a supplemental application.” Wyeth v.
Levine, 555 U.S. 555, 568 (2009); 21 C.F.R. §
314.70. However, there are certain instances in which a drug
manufacturer may unilaterally make changes to a drug's
label without the FDA's prior approval. Under the
“changes being effected” (“CBE”)
regulation, a manufacturer may unilaterally change the label
of its drug to “add or strengthen a contraindication,
warning, precaution, or adverse reaction” without
waiting for FDA approval. § 314.70(c)(6)(iii)(A).
those instances when state and federal law conflict, and it
is “impossible for a private party to comply with both
state and federal requirements, ” state law is
preempted. Freightliner Corp. v. Myrick, 514 U.S.
280, 287 (1995) (internal quotation marks omitted). Given
their obligations under the FDCA, Defendants argue that it
would be impossible for them to comply with federal ...