United States District Court, N.D. Mississippi, Greenville Division
MEMORANDUM OPINION AND ORDER
M. BROWN UNITED STATES DISTRICT JUDGE.
products liability action is before the Court on the motions
to dismiss of: (1) Bristol-Myers Squibb Company, and
AstraZeneca Pharmaceuticals LP, Doc. #7; and (2) AstraZeneca
AB, AstraZeneca LP, and AstraZeneca PLC, Doc. #20.
April 27, 2016, Kamilah Young filed a complaint in the
Circuit Court of Sunflower County, Mississippi, against
Bristol-Myers Squibb Company, AstraZeneca PLC, Astrazeneca
LP, AstraZeneca Pharmaceuticals LP, and AstraZeneca AB. Doc.
#2. In her complaint, Young seeks to recover for injuries and
damages caused by her ingestion of Farxiga, a drug
researched, developed, sold, and/or marketed by the various
31, 2016, Bristol-Myers Squibb Company and AstraZeneca
Pharmaceuticals LP (“Removing Defendants”)
removed the state court action to this Court. Doc. #1.
Approximately one week later, on June 7, 2016, the Removing
Defendants filed a motion to dismiss Young's complaint
under Rule 12(b)(6) of the Federal Rules of Civil Procedure.
Doc. #7. Young responded in opposition to the motion to
dismiss on June 21, 2016, Doc. #17; and the Removing
Defendants replied on June 29, 2016, Doc. #18.
7, 2016, AstraZeneca AB, AstraZeneca LP, and AstraZeneca PLC
(“Non-Removing Defendants”), filed a document
“join[ing] and rely[ing] on” the Removing
Defendants' motion to dismiss and reply. Doc. #20. Young
responded in opposition to this filing on July 21, 2016, Doc.
#29; and the Non-Removing Defendants replied on August 1,
2016, Doc. #32.
To survive a motion to dismiss [for failure to state a
claim], a complaint must contain sufficient factual matter,
accepted as true, to state a claim to relief that is
plausible on its face. 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.
Where a complaint pleads facts that are merely consistent
with a defendant's liability, it stops short of the line
between possibility and plausibility of entitlement to
Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009)
(internal citations and punctuation omitted) (citing Bell
Atl. Corp. v. Twombly, 550 U.S. 544, 555-58 (2007)).
Under this standard, a court must “accept all
well-pleaded facts as true, viewing them in the light most
favorable to the plaintiff.” New Orleans City v.
Ambac Assurance Corp., 815 F.3d 196, 199-200 (5th Cir.
2016) (internal quotation marks omitted). However, “a
plaintiff's obligation to provide the grounds of his
entitlement to relief requires more than labels and
conclusions, and a formulaic recitation of the elements of a
cause of action will not do so.” Twombly, 550
U.S. at 555.
Farxiga Development and Effects
point before 2014, Bristol-Myers Squibb and the AstraZeneca
Defendants were involved in the research, development, and
testing of Farxiga, a sodium-glucose cotransporter 2
(“SGLT-2”) inhibitor designed to treat type-2
diabetes. Doc. #2 at ¶¶ 3-16, 23-24. SGLT-2
inhibitors inhibit renal glucose reabsorption with the goal
of lowering blood glucose. Id. at ¶ 32. When
taken, SGLT-2 inhibitors cause the kidneys to excrete, rather
than metabolize, glucose. Id.
Farxiga, like other SGLT-2 inhibitors, prevents absorption of
glucose, the “body's primary fuel, ” the
bodies of patients on the medication break down fat instead.
Id. at ¶ 33. When fat is broken down, acids
called ketones are introduced into the body's blood
stream, creating the potential for acidosis (excessive blood
acidity). Id. at ¶ 33. Generally, to maintain
blood-acid balance, the body excretes excess ketones through
urination. Id. at ¶ 35. Accordingly, a patient
suffering from ketoacidosis (excessive blood acidity caused
by ketones) will generally report high blood-glucose levels
and frequent urination. Id. at ¶ 34. However,
“because Farxiga places the kidneys under duress by
expelling significant amounts of glucose that has not been
metabolized through the urinary tract, Farxiga users are
often unable to obtain blood-acid balance without medical
intervention.” Id. at ¶ 35.
general population, ketoacidosis is rare for type-2 diabetics
and “much more common” in type-1 diabetics.
Id. at ¶ 38. This discrepancy is caused by the
fact that type-1 diabetics, like Farxiga patients, are unable
to metabolize glucose. Id.
Farxiga Approval and Marketing
January 8, 2014, the United States Food and Drug
Administration approved Farxiga for treatment of type-2
diabetes. Id. at ¶ 23. Following approval, the
defendants each participated in the manufacturing, marketing,
distribution, and sale of Farxiga. Id. at ¶ 28.
Although Farxiga was indicated for only glycemic control in
adult type-2 diabetics, the defendants marketed Farxiga for
other purposes, including weight loss and blood pressure
reduction. Id. at ¶ 37.
15, 2015, the FDA issued a Public Health Advisory linking
SGLT-2 inhibitors, including Farxiga, to diabetic
ketoacidosis, a condition which can result in organ failure
and death. Id. at ¶ 39. On December 4, 2015,
the FDA, which had also received reports linking Farxiga to
kidney injuries, including renal failure, required the
defendants to change the Farxiga warning label to warn of
ketoacidosis and urosepsis. Id. at ¶¶
40-41. Before and after the FDA's advisories, the
defendants “aggressively promote[d] Farxiga” and
“did nothing to alert United States consumers, and
health care professionals of the risks associated with
Farxiga.” Id. at ¶¶ 42-43.
Young's Use of Farxiga
about May 2015, Young was prescribed Farxiga and began taking
it as prescribed. Doc. #2 at ¶ 49. On or about May 31,
2015, Young fell ill with ketoacidosis. Id. at
¶ 54. On June 22, 2015, Young suffered renal failure and
was hospitalized for approximately ten days. Id. at
¶¶ 54-55. This action followed.
complaint, Young asserts ten causes of action against the
defendants based on: (1) strict liability (Count One); (2)
manufacturing defect (Count Two); (3) design defect (Count
Three); (4) failure to warn (Count Four); (5) negligence
(Count Five); (6) breach of express warranty (Count Six); (7)
breach of implied warranty (Count Seven); (8) negligent
misrepresentation (Count Eight); (9) fraud (Count Nine); and
(10) “violation of consumer protection laws”
Common Law Claims (Counts One, Five, Seven, Eight, and
initial matter, the defendants argue in their motion that the
Mississippi Products Liability Act subsumes Young's
common law claims so as to require dismissal of the claims
based on strict liability, negligence, breach of implied
warranty, negligent misrepresentation, and fraud. Doc. #8 at
MPLA, which applies “in any action for damages caused
by a product, including, but not limited to, any action based
on a theory of strict liability in tort, [and] negligence or
breach of implied warranty, except for commercial damage to
the product itself” provides, in relevant part:
The manufacturer, designer or seller of the product shall not
be liable if the claimant does not prove by the preponderance
of the evidence that at the time the product left the control
of the manufacturer, designer or seller:
(i) 1. The product was defective because it deviated in a
material way from the manufacturer's or designer's
specifications or from otherwise identical units manufactured
to the same manufacturing specifications, or
2. The product was defective because it failed to contain
adequate warnings or instructions, or 3. The product was
designed in a defective manner, or 4. The product breached an
express warranty or failed to conform to other express
factual representations upon which the claimant justifiably
relied in electing to use the product; and
(ii) The defective condition rendered the product
unreasonably dangerous to the user or consumer; and
(iii) The defective and unreasonably dangerous condition of
the product proximately caused the damages for which recovery
Miss. Code Ann § 11-1-63(a). Though the defendants argue
that Young's claims for strict liability, negligence,
breach of implied warranty, negligent misrepresentation, and
fraud should be dismissed as subsumed by the MPLA, dismissal
is not required merely because a claim falls under the
express terms, the MPLA applies to “any action for
damages caused by a product.” Miss. Code Ann. §
11-1-63(a). Although “[t]he statute clearly
contemplates suits may be brought under the statute, ”
the MPLA “does not preclude or bar an action, although
it clearly creates what some may argue to be formidable
obstacles for a plaintiff to overcome in order to
prevail.” R.J. Reynolds Tobacco Co. v. King,
921 So.2d 268, 273 (Miss. 2005). Accordingly, common law
claims based on damages caused by a product are subsumed by
the MPLA and must be analyzed under the statute. Elliott
v. El Paso Corp., 181 So.3d 263, 269 (Miss. 2015).
Common law claims for damages caused by a product which seek
to impose liability outside the MPLA's framework must be
dismissed for failure to state a claim. See id.
(“Plaintiffs' negligence and strict-liability-based
products-liability claims against CPChem, Tri-State, and TGP
must be analyzed under the MPLA. To the extent that
Plaintiffs purport to make common-law negligence or
strict-liability claims based on damages caused by odorant
fade, we find that those claims fail as a matter of
where a common law claim is subsumed by the MPLA and is
brought alongside products liability claims based on the same
theory of recovery, the proper course is to dismiss the
common law claim to the extent it is duplicative of the
parallel products liability counts. See, e.g.,
Cross v. Laboratories, No. 1:05-cv-170, 2014 WL
11430933, at *3 (N.D. Miss. May 12, 2014)
(“Plaintiffs' claims for negligence and
warranty/misrepresentation are duplicative and subsumed by
the MPLA and are dismissed. All claims under the MPLA shall
remain viable at this juncture ....”); Arnoult v.
CL Med. SARL, No. 1:14-cv-271, 2015 WL 5554301, at *3
(S.D.Miss. Sep. 21, 2015) (“Plaintiff's negligence
claims against Uroplasty are governed by the MPLA, and Count
3 of the Complaint is subsumed by Counts 1 and 2.”)
(internal citation omitted). To the extent a subsumed common
law count is asserted “as an independent tort claim
outside the scope of the MPLA, ” the count must be
dismissed for failure to state a claim.” Id.
(“The Court grants Uroplasty's motion to dismiss
Count 3 insofar as it is asserted as an independent tort
claim outside the scope of the MPLA.”).
Strict Liability (Count One)
is no dispute that a claim for strict liability based on
damage caused by a product is subsumed by the MPLA. Miss.
Code Ann § 11-1-63(a). Young's claim for strict
liability includes allegations regarding: (1) defective
design; (2) failure to warn; and (3) defective manufacture.
Doc. #2 at ¶¶ 73-74, 81-82. In this regard, her
strict liability claim in Count One is subsumed by Count Two
(manufacturing defect), Count Three (design defect), and
Count Four (failure to warn). Accordingly, Count One will be
dismissed as duplicative of Young's product liability
claims. To the extent Count One attempts to impose liability
on other grounds, it will be dismissed for failure to state a
Negligence (Count Five)
for negligence are also subsumed by the MPLA. Miss. Code Ann
§ 11-1-63(a). Young's claim for negligence includes
allegations regarding: (1) defective design; (2) failure to
warn; and (3) defective manufacture. Doc. #2 at ¶¶
135, 138-40. In this regard, the claim is subsumed by Count
Two (manufacturing defect), Count Three (design defect), and
Count Four (failure to warn). Accordingly, to the extent
Young's negligence claim in Count Five is subsumed by the
product liability claims, Count Five will be dismissed as
duplicative. To the extent Count Five attempts to impose
liability on other grounds, it will be dismissed for failure
to state a claim.
Breach of Implied Warranty (Count Seven)
for breach of implied warranty are subsumed by the MPLA.
Miss. Code Ann. § 11-1-63. Young's claim for breach
of implied warranty in Count Seven alleges that the
defendants breached the implied warranties of merchantability
and fitness for particular purpose because Farxiga “was
unduly dangerous and caused undue injuries ....” Doc.
#2 at ¶ 174. In this regard, the claim is subsumed by
Count Three (design defect). Accordingly, to the extent the
claim is subsumed by the product liability claims, Count
Seven will be dismissed as duplicative. To the extent Count
Seven attempts to impose liability on other grounds, it will
be dismissed for failure to state a claim.
Negligent Misrepresentation (Count Eight) and Fraud (Count
products liability action, negligent misrepresentation and
fraud claims are subsumed by the MPLA unless the claims are
“unrelated to the [product's] alleged
defects.” Elliott, 181 So.3d at 269. Young,
citing this provision, contends that her “claims for
Fraud and negligent misrepresentation are governed by the
common law, not the MPLA.” Doc. #17 at 18. However,
both claims seek to recover for damages caused by the
allegedly defective Farxiga and, therefore, fall within the
MPLA's ambit. See Doc. #2 at ¶¶ 195,
214. In this regard, the claims are subsumed by Count Three
(design defect) and Count Four (failure to warn) and must be
dismissed as duplicative. To the extent Counts Eight and Nine
attempt to impose liability on other grounds, they will be
dismissed for failure to state a claim.
common law claims for strict liability, negligence, breach of
implied warranty, negligent misrepresentation, and fraud are
subsumed by the MPLA. To the extent these common law claims
are duplicative of Young's product liability claims, the
common law claims must be dismissed as duplicative. To the
extent the common law claims are asserted as independent
torts, they must be dismissed for failure to state a claim.
Design Defect (Count Three)
defendants argue that Young's claim for defective design
must fail because Young has failed to plead a feasible design
alternative and because federal law preempts the design
the doctrine of federal preemption, a federal law supersedes
or supplants an inconsistent state law or regulation.”
United States v. Zadeh, 820 F.3d 746, 751 (5th Cir.
2016). Under the doctrine of conflict preemption, federal law
will supersede or supplant state law “when compliance
with both [the] state and federal law is impossible.”
Id. “Federal preemption is an affirmative
defense that a defendant must plead and prove.”
Fisher v. Halliburton, 667 F.3d 602, 610 (5th Cir.
2012).” Accordingly, “[u]nless the complaint
itself establishes the applicability of a federal-preemption
defense - in which case the issue may properly be the subject
of a Rule 12(b)(6) motion - a defendant should ordinarily
raise preemption in a Rule 12(c) motion for judgment on the
pleadings or a Rule 56 motion for summary judgment.”
Id. (internal footnotes omitted).
defendants argue that federal law preempts Young's design
defect claims because Young “alleges that Defendants
should have designed Farxiga differently. ... [B]ut,
critically, federal law prohibits Defendants from changing
the design of Farxiga in a meaningful way without prior FDA
approval.” Doc. #8 at 21.
pharmaceutical design defect claims are evaluated primarily
against the framework set forth in Mutual Pharmaceutical
Co., Inc. v. Bartlett, under which a court begins by
identifying a defendant's state and federal law duties
and then asks whether it is possible to comply with both
duties. 133 S.Ct. 2466, 2475-77 (2013). In Bartlett,
the United States Supreme Court considered whether a design
defect claim brought under New Hampshire state law against a
generic drug manufacturer was preempted by federal law. The
Supreme Court held that, under New Hampshire state law, a
manufacturer must “ensure that the products they
design, manufacture, and sell are not ‘unreasonably
dangerous.'” Id. at 2474. It further noted
that under the risk-utility approach used in New Hampshire, a
manufacturer could satisfy this duty “either by
changing a drug's design or by changing its
labeling.” Id. Because federal law prevents a
generic drug manufacturer from changing the drug's design
or its label, the Supreme Court concluded that federal law
preempted the plaintiff's state law claims. Id.
State Law Duties
Mississippi law, a manufacturer has a duty to manufacture a
product which is not defective and “unreasonably
dangerous.” Miss. Code Ann. § 11-1-63. “In
most cases, the unreasonable danger presented by a
product's design is the factor that makes the design
defective.” Williams v. Bennett, 921 So.2d
1269, 1274 (Miss. 2006). Unreasonable danger, in turn, is
determined under the risk-utility approach utilized by most
courts in the country. See Smith v. Mack Trucks,
Inc., 819 So.2d 1258, 1262-64 (Miss. 2002).
Under the risk-utility theory, a plaintiff may recover for
any injury as a result of the use of a dangerous product,
provided that the utility of the product is outweighed by its
danger. In balancing a product's utility against the risk
of injury it creates, the factors to be considered are:
(1) The usefulness and desirability of the product-its
utility to the user and to ...