Young v. Bristol-Myers Squibb Company et al
MEMORANDUM OPINION AND ORDER granting in part and denying in part 7 Motion to Dismiss; granting in part and denying in part 20 Motion to Dismiss for Failure to State a Claim. Signed by District Judge Debra M. Brown on 2/22/17. (tab)
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF MISSISSIPPI
BRISTOL-MYERS SQUIBB COMPANY;
LP; and ASTRAZENECA AB
MEMORANDUM OPINION AND ORDER
This 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.
On 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 defendants. Id.
On May 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.
On July 7, 2016, AstraZeneca AB, AstraZeneca LP, and AstraZeneca PLC (“NonRemoving Defendants”), filed a document “join[ing] and rely[ing] on” the Removing
Defendants’ motion to dismiss and reply.1 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,
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 relief.
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
The document is styled as a motion to dismiss but in substance only joins the Removing Defendants’ motion,
memorandum, and reply. See generally United States v. Campos-Guel, 245 F. App’x 743, 745 n.1 (10th Cir. 2007)
(“[Courts] review the substance of ... arguments and not ... title[s].”); Argueros v. Vargars, No. 07-cv-904, 2008 WL
4179452, at *2 (W.D. Tex. Sep. 5, 2008) (“It is not the title of the motion that governs its consideration, but the
substance.”). To the extent the Non-Removing Defendants merely join the Removing Defendants’ filings, Young’s
subsequent response, Doc. #29, amounts to an unauthorized sur-reply and the Non-Removing Defendants’
subsequent reply is an unauthorized sur-sur-reply. Neither document therefore has been considered for the purpose
of deciding the motion to dismiss. See generally Figueroa v. Gates, No. CV00-0415, 2001 WL 1182889, at *2
(C.D. Cal. Mar. 30, 2001) (“A conclusion that [a defendant] must separately file another motion to dismiss, where
arguments articulated in the already filed [motion] are inclusive, would be illogical, and would require the kind of
multiplication of effort it is best to avoid.”).
elements of a cause of action will not do so.” Twombly, 550 U.S. at 555.
A. Farxiga Development and Effects
At some 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.
Because 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.
In the 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.
B. Farxiga Approval and Marketing
On 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.
On May 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.”2 Id.
at ¶¶ 42–43.
C. Young’s Use of Farxiga
In or 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.
In July 2015, the defendants did, however, send warning letters to healthcare professionals in Canada and Australia
“warning of Farxiga’s ketoacidosis risk.” Doc. #2 at ¶ 43.
In her 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” (Count Ten).
A. Common Law Claims (Counts One, Five, Seven, Eight, and Nine)
As an 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 5–8.
The 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:
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 is sought.
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 MPLA’s purview.
By its 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 commonlaw negligence or strict-liability claims based on damages caused by odorant fade, we find that
those claims fail as a matter of law.”).
Practically, 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.”).
1. Strict Liability (Count One)
There 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 claim.
2. Negligence (Count Five)
Claims 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.
3. Breach of Implied Warranty (Count Seven)
Claims for breach of implied warranty are subsumed by the MPLA. Miss. Code Ann. §
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.
4. Negligent Misrepresentation (Count Eight) and Fraud (Count Nine)
In a 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.
Young’s 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.
B. Design Defect (Count Three)
The 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
“Under 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).
The 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.
Today, 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. at 2476–77.
a. State Law Duties
Under 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 the
public as a whole.
(2) The safety aspects of the product-the likelihood that it will cause injury, and
the probable seriousness of the injury.
(3) The availability of a substitute product which would meet the same need and
not be as unsafe.
(4) The manufacturer’s ability to eliminate the unsafe character of the product
without impairing its usefulness or making it too expensive to maintain its utility.
(5) The user’s ability to avoid danger by the exercise of care in the use of the
(6) The user’s anticipated awareness of the dangers inherent in the product and
their avoidability, because of general public knowledge of the obvious condition
of the product, or of the existence of suitable warnings or instructions.
(7) The feasibility, on the part of the manufacturer, of spreading the loss by
setting the price of the product or carrying liability insurance.
Id. at 1262–63. Under this standard, “[i]f an alternative design could have been practically
adopted at the time of sale, and if the omission of such an alternative design rendered the product
not reasonably safe, than a design is defective.” Williams, 921 So.2d at 1275.
b. Federal Law Duties
It is undisputed that, “[o]nce a drug—whether generic or brand-name—is approved, the
manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative
formulation of the drug product, including active ingredients, or in the specifications provided in
the approved application.’” Bartlett, 133 S.Ct. at 2471 (quoting 21 C.F.R. § 314.70(b)(2)(i)).
However, a brand name manufacturer, unlike a generic manufacturer, “may use the FDA’s CBE
regulation to unilaterally change its labeling without prior FDA approval.” Brazil v. Janssen
Research and Dev. LLC, No. 4:15-cv-204, 2016 WL 4844442, at * 16 (N.D. Ga. Mar. 24, 2016).
The defendants argue that Young’s design defect claims are preempted because there is a
conflict between federal law requiring FDA approval to change Farxiga and the Mississippi law
which “imposes a duty on a manufacturer, designer, or seller to adopt an alternative, safer design
if the failure to do so makes a product unreasonably safe.” Doc. #8 at 20–21. Young responds
that “Federal law does not prohibit brand-name drug manufacturers from designing a reasonably
safe drug before FDA approval, nor does it prohibit manufacturers from changing a drug’s
design post-approval to ensure it is reasonably safe.” Doc. #17 at 7. Young is both right and
i. Post-Approval Changes
As clearly stated in Bartlett, “[o]nce a drug—whether generic or brand-name—is
approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or
quantitative formulation of the drug product, including active ingredients, or in the specifications
provided in the approved application.’” 133 S.Ct. at 2471. Accordingly, contrary to Young’s
assertion, federal law prohibits brand name drug manufacturers from altering a drug’s design
after receiving FDA approval. Guidry v. Janssen Pharm., Inc., __ F.Supp.3d __, No. CV 154591, 2016 WL 4508342, at *14 (E.D. La. Aug. 29, 2016) (“[T]to the extent the plaintiff
contends that the defendants should have adopted a new design for Invokana after it was
approved by the FDA, her defective design claim is preempted.”) (emphasis omitted).
ii. Pre-Approval Changes
Courts are, however, split on whether federal law acts as a bar on claims based on a
contention that a brand name drug should have been designed properly before FDA approval. A
wide array of courts, focusing on a manufacturer’s wide discretion to submit proposals to the
FDA for approval, have held there is no conflict between a manufacturer’s state law duty to
produce a safe drug and its federal law duties to obtain approval. 3 However, the Sixth Circuit
and a smattering of district courts have rejected this theory as “too attenuated” and/or equivalent
to a “never-start selling rationale,” which was rejected in Bartlett. Yates v. Ortho-McNealJanssen Pharms., Inc., 808 F.3d 281, 299–300 (6th Cir. 2015).4
Specifically, the Sixth Circuit in Yates wrote:
To imagine such a pre-approval duty exists, we would have to speculate that had
defendants designed ORTHO EVRA® differently, the FDA would have approved
the alternate design. Next, we would have to assume that Yates would have
selected this method of birth control. Further yet, we would have to suppose that
this alternate design would not have caused Yates to suffer a stroke. This is
several steps too far. Even if New York law requires defendants to produce and
market a different design, the ultimate availability to Yates is contingent upon
whether the FDA would approve the alternate design in the first place ....
Yates's pre-approval claim fails for another reason. In Bartlett, the Supreme Court
held that “[t]he [First Circuit] Court of Appeals’ solution—that [the manufacturer]
should simply have pulled [the drug] from the market in order to comply with
both state and federal law—is no solution.” 133 S.Ct. at 2470. This “stop-selling”
rationale is “incompatible with ... preemption jurisprudence,” which “presume[s]
that an actor seeking to satisfy both his federal- and state-law obligations is not
See Guidry, 2016 WL 4508342, at *15 (“[T]he dispositive question presented here is simply: Can a drug
manufacturer independently design a reasonably safe drug in compliance with its state-law duties before seeking
FDA approval? The answer is yes.”); Estate of Cassel v. Alza Corp., No. 12-cv-771, 2014 WL 856023, at *5–6
(W.D. Wisc. Mar. 5, 2014) (“No federal law prohibited defendants from submitting a different design (or at least,
defendants have pointed to none). Similarly, defendants have offered no evidence that the FDA would have
exercised its authority to prohibit defendants from creating and submitting such a design for approval.”) (emphasis
omitted); Trahan v. Sandoz, Inc., No. 3:13-CV-350-J-34MCR, 2015 WL 2365502, at *6 (M.D. Fla. Mar. 26, 2015)
(“[I]n her Amended Complaint Trahan arguably states a claim that Sandoz breached its duty to design a reasonably
safe product when it initially selected the defective glass, prior to FDA approval. Complying with its state law duty
of care at that time was not ‘impossible’ in the absence of any federal law requiring Sandoz to utilize the allegedly
defective glass container.”) (emphasis omitted); Sullivan v. Aventis, Inc., No. 14-cv-2939, 2015 WL 4879112, at *6
(S.D.N.Y. Aug. 13, 2015) (“[C]ounsel has cited no federal law that restricts a brand-name drug manufacturer from
designing a reasonably safe product prior to FDA approval.”) (emphasis in original).
Utts v. Bristol-Myers Squibb Co., __ F.Supp.3d __, No. 16-cv-5668, 2016 WL 7429449, at *12 (Dec. 23, 2016)
(pre-approval duty too attenuated); Small v. Amgen, Inc., No. 2:12-cv-476, 2016 WL 4942078, at *2 (M.D. Fla. Jan.
25, 2016) (“[I]t is likely, even if Enbrel is capable of redesign, that any claim that Defendants should have changed
Enbrel's design before seeking FDA approval would likewise be preempted.”) (citing Yates); Fleming v. Janssen
Pharms., Inc., 186 F.Supp.3d 826, 833–34 (W.D. Tenn. 2016) (citing Yates).
required to cease acting altogether in order to avoid liability.” Id. at 2477. In
contending that defendants’ pre-approval duty would have resulted in a birth
control patch with a different formulation, Yates essentially argues that
defendants should never have sold the FDA-approved formulation of ORTHO
EVRA® in the first place. We reject this never-start selling rationale for the same
reasons the Supreme Court in Bartlett rejected the stop-selling rationale of the
In sum, both Yates’s pre-approval and post-approval design defect claims are
preempted by federal law.
808 F.3d at 299–300. In rejecting these arguments, United States District Judge Martin L.C.
Feldman of the Eastern District of Louisiana wrote:
Indeed, every defective design claim requires consideration of hypothetical
scenarios—what different steps could have been taken that may have prevented
the plaintiff’s injury. The only added assumption in the pharmaceutical context is
that the FDA would have approved the safer, hypothetical drug. It is not too
attenuated to assume that the FDA would approve a safer, alternative design of a
drug that it has already approved. Nor does the Court share the Sixth Circuit's
reservations about the so-called “never-start-selling” argument. Indeed, the raison
d’être of products liability litigation is to penalize manufacturers who design
unreasonably dangerous products in hopes that they never start selling them. State
products liability law functions as a compliment to federal drug regulations to
keep unreasonably dangerous drugs off the market.
Guidry, 2016 WL 4508342, at *15.
The Court finds Judge Feldman’s analysis largely persuasive but would add two
First, the impossibility aspect of conflict preemption requires that a state law duty conflict
with a federal law duty. If there is no state law duty, the state law cause of action must certainly
fail but there can be no conflict so as to justify preemption. Put differently, the absence of a state
law duty is fatal to a claim but not under the doctrine of conflict preemption. Here, the parties
have not argued whether Mississippi law recognizes a pre-approval claim, and the Court does not
reach the issue. Rather, for the purpose of addressing the defendants’ preemption argument, it is
sufficient to say that there is no conflict between Young’s pre-approval theory and the
defendants’ federal law duties.
Second, Yates misstates the “stop selling” rationale explained in Bartlett. In Bartlett, the
Supreme Court rejected an argument that a generic manufacturer could avoid a conflict with
federal and state law by “choosing not to make [the drug] at all.” 133 S.Ct. at 2477 (internal
alterations omitted). The Supreme Court held that such a doctrine was incompatible with
preemption cases which “presume that an actor seeking to satisfy both his federal – and state law
obligations is not required to cease acting altogether in order to avoid liability.” Id. The preapproval theory does not argue that a manufacturer should have stopped acting, just that it should
have acted differently. Accordingly, the Court concludes that the stop selling doctrine does not
preclude a pre-approval theory of recovery.5
2. Feasible Design Alternative
Under the MPLA:
Plaintiffs alleging a defective design must show ... that at the time the product left
the control of the manufacturer:
Although not raised by Young in her response, the Court notes that even if Young could not proceed on a preapproval theory, her design defect claim would still not be preempted. As explained above, Mississippi law
recognizes a risk-utility approach for determining whether a product was defectively designed. Under this approach,
a court considers the existence of suitable warnings or instructions. Smith, 819 So.2d at 1262–64. Because it is
undisputed that a brand name manufacturer has the ability to unilaterally change its warning labels, in risk-utility
jurisdictions, a plaintiff is not preempted from arguing that a product was defectively designed due to an insufficient
warning label. See Sikkelee v. Precision Airmotive Corp., 822 F.3d 680, 703 (3d Cir. 2016) (“[T]he Court has
distinguished between brand-name drugs and their generic equivalents, determining that at least some state law tort
claims may be brought against brand-name drug companies because such companies have the ability to make some
unilateral changes to their labels without additional regulatory preapproval.”) (emphasis omitted); Utts v. Bristol–
Myers Squibb Co., No. 16CV5668(DLC), 2016 WL 7429449, at *9 (S.D.N.Y. Dec. 23, 2016) (“If the claim
addresses newly acquired information and addresses a design or labeling change that a manufacturer may
unilaterally make without FDA approval, then there may be no preemption of the state law claim.”); Brazil v.
Janssen Research & Dev. LLC, No. 4:15-CV-0204-HLM, 2016 WL 3748771, at *10 (N.D. Ga. July 11, 2016)
(“Any claim by Plaintiff that Defendants should change the formulation of Invokana is preempted by FDA
regulations. Plaintiff, however, may argue that Defendants should be liable because a stronger warning would have
changed Invokana’s risk-utility profile to make it not unreasonable dangerous.”); Sullivan v. Aventis, Inc., No. 14CV-2939-NSR, 2015 WL 4879112, at *6 (S.D.N.Y. Aug. 13, 2015) (“Furthermore, even if redesign is not feasible,
there is no federal law that prevents a manufacturer from complying with its state-law duty by strengthening a
brand-name drug's warning label (pre- or post-approval).”).
(i) The manufacturer or seller knew, or in light of reasonably available knowledge
or in the exercise of reasonable care should have known, about the danger that
caused the damage for which recovery is sought; and
(ii) The product failed to function as expected and there existed a feasible design
alternative that would have to a reasonable probability prevented the harm. A
feasible design alternative is a design that would have to a reasonable probability
prevented the harm without impairing the utility, usefulness, practicality or
desirability of the product to users or consumers.
3M Co. v. Johnson, 895 So.2d 151, 165 (Miss. 2005) (quoting Miss. Code Ann. § 11-1-63)
(emphasis added). The defendants argue that Young’s design defect claim must fail because
“nowhere does Plaintiff identify with any specificity what alternative design is available.” Doc.
#8 at 17. The defendants further argue that Young’s allegations do not offer an alternative
design, but rather an alternative product, and that the proffered alterations would impair the
utility, usefulness, practicality or desirability of Farxiga. Id. at 19.
a. Conclusory Allegations
The defendants, citing to Austin v. Bayer Pharmaceuticals Corporation,6 argue that “[a]
conclusory allegation that there was an alternative available without any facts about what that
alternative design is does not state a claim under the MPLA.” Doc. #8 at 17. Young, citing
paragraphs 46, 109, and 110 of her complaint, responds that the “Complaint has adequately pled
a feasible alternative design.” Doc. #17 at 15–16.
The cited provisions of Young’s complaint allege:
46. Consumers, including Plaintiff, who have used FARXIGA for treatment of
diabetes, have several alternative safer products available for treatment. SGLT-2
inhibitors, including FARXIGA, are the only class of drugs which utilize the
mechanism of expelling significant quantities of unmetabolized glucose through
the kidneys to lower blood-glucose levels.
No. 5:13-cv-28, 2013 WL 5406589 (S.D. Miss. Sep. 25, 2013).
109. At the time FARXIGA left Defendants’ control it was both technically and
economically feasible to have an alternative design that would not cause renal
failure, renal impairment, renal insufficiency and ketoacidosis, or an alternative
design that would have substantially reduced the risk of these injuries.
110. It was both technically and economically feasible to provide a safer
alternative product that would have prevented the harm suffered by Plaintiff.
Doc. #2 at 8–9, 22.
This Court agrees that Rule 8 requires more than a bare assertion that safer alternative
products exist. See Varney v. R.J. Reynolds Tobacco Co., 118 F.Supp.2d 63, 70 (D. Mass. 2000)
(“Although the plaintiff states, in the sort of conclusory fashion that is insufficient, that safer
alternative designs for cigarettes were available, there is not the slightest description of what
those designs were or why they would have avoided causing harm to the plaintiff if adopted.”)
(internal citation omitted).
However, Young’s allegations go beyond a mere conclusory
statement, although by a narrow thread. Young in essence alleges that the defendants could have
designed their drug without using an SGLT-2 inhibitor.
While, as discussed below, this
allegation fails for another reason, it does not fail for lack of specificity.
Next, the defendants argue that any change from SGLT-2 would impair the utility,
usefulness, practicality or desirability of the product to users or consumers. Beyond pointing out
that SGLT-2 inhibitors have been approved by the FDA, the defendants offer no authority to
support their argument. Under these circumstances, the argument does not defeat Young’s
defective design claim.
c. Different Product
The defendants further argue that, even if Young’s allegations regarding non-SGLT-2
inhibitors are not conclusory, they refer to a different product, not an alternative design, and are
thus insufficient under the MPLA. Doc. #8 at 18; Doc. #18 at 4. Young responds that she
merely “alleges a different formulation of the root product (prescription diabetes medication).”
Doc. #17 at 16. As support for their respective positions, the parties argue over the meaning of
three cases: Elliott v. El Paso Corp., 181 So.3d 263 (Miss. 2015) (cited above); Phillips 66 Co.
v. Lofton, 94 So.3d 1051 (Miss. 2012); and Tersingi v. Wyeth, 817 F.3d 364 (1st Cir. 2016).
In Elliott, the Mississippi Supreme Court held that a design defect claim brought against
a natural gas odorant manufacturer failed “as a matter of law because no expert ... offered any
alternative chemical design for the allegedly defective odorant. Instead, [the alleged] alternative
design for odorant – requiring members of the affected public to buy gas detectors – is an
additional warning system.” 181 So.3d at 272. The court held that “[r]equiring an entirely
different warning system, or requiring the affected public to use gas detectors in their homes, is
not a feasible alternative design for natural-gas odorant.” Id. at 273.
In Lofton, the Mississippi Supreme considered whether a plaintiff had introduced
sufficient evidence of an alternative design for a viscosifier7 which contained asbestos. The
defendant argued that at the time the product left its control, “no other asbestos viscosifier was
formulated ... so as to not generate breathable fibers during use ....” 94 So.3d at 1061 (emphasis
in original). The Lofton court rejected the defendant’s argument and held the plaintiff satisfied
his burden by introducing evidence which “showed that alternative vi[s]cosifiers were available
which did not contain asbestos ....” Id. at 1062. In reaching this conclusion, the court noted that
evidence at trial revealed that “nonasbestos viscosifiers were available with similar
characteristics and purposes ....” Id.
In Tersingi, a plaintiff sued the developer and marketer of Pondimin, a weight loss drug,
A viscosifier is “used to increase the viscosity of (to thicken) drilling mud fluids” on oil and gas drilling rigs.
Lofton, 94 So.3d at 1056.
which caused primary pulmonary hypertension. 817 F.3d at 365. The plaintiff attempted to
argue that the defendant could be held liable “because, at the time Pondimin was marketed, there
were other, safer methods of weight loss available.” Id. at 368. The First Circuit rejected the
plaintiff’s argument as inconsistent with “the reasonable alternative design inquiry, which
requires the plaintiff to show that the product in question could have been more safely designed,
not that a different product was somehow safer.” Id.
Neither party has cited, and this Court has been unable to find, a Mississippi case
addressing, as Tersingi did, the alternative design/different product distinction in the context of
pharmaceuticals. However, courts throughout the country have held that a party may not show a
reasonable alternative design by pointing to the availability of a different drug available for the
same purpose. See, e.g., Brown v. Johnson & Johnson, 64 F.Supp.3d 717, 722 (E.D. Pa. 2014)
(“Defendants correctly argue that acetaminophen is not an alternative to ibuprofen but an entirely
different product.”); Salvio v. Amgen Inc., No. 2;11-cv-553, 2012 WL 517446, at *7 (W.D. Pa.
Feb. 15, 2012) (“Plaintiff has failed to allege any alternative ways in which Enbrel could have
been designed. Instead, he merely lists completely different drugs that Decedent could have
taken.”); Brockert v. Wyeth Pharms., Inc., 287 S.W.3d 760, 770–71 (Tex. Ct. App. 2009)
(“Brockert does not explain how Prempro could have been modified or improved; she instead
argues that progestin should not have been added to estrogen. In essence, Brockert argues that
the product Prempro should have been a different product: its predecessor Premarin.”); Massa v.
Genentech Inc., No. H-11-70, 2012 WL 956192, at *7 (S.D. Tex. Mar. 19, 2012) (“Massa's
argument that Raptiva could have been formulated with a number of alternative underlying
compounds is not an argument that Raptiva should have been safer; it is an argument that
Raptiva should have been a different product.”) (emphasis and internal quotation marks omitted).
The question of whether an “alternative design is in fact a different product is generally a
question of fact for the jury.” Keffer v. Wyeth, 791 F.Supp.2d 539, 549 (S.D.W.V. 2011);
Torkie-Tork v. Wyeth, 739 F.Supp.2d 895, 900 (E.D. Va. 2010). However, the issue may be
decided on a motion to dismiss where the allegations fail as a matter of law. Massa, 2012 WL
956192, at *6 (granting motion to dismiss based on conclusion that alternative design was a
Young attempts to satisfy her alternative design burden by pointing not just to a different
drug but to a different class of drugs (non SGLT-2 inhibitors) which do not “utilize the
mechanism of expelling significant quantities of unmetabolized glucose through the kidneys to
lower blood-glucose levels.” Doc. #2 at ¶ 46. Wherever Mississippi draws the line between an
alternative design and a different product, the Court has no trouble concluding that Young’s
allegations, which point to drugs which by their very nature perform a different function, fall
well on the latter side of such a line. Accordingly, the design defect claim must fail.
The Court concludes that Young’s design defect claim is not preempted by federal law.
However, as explained above, the claim must be dismissed for failure to plead a feasible
C. Failure to Warn (Count Four)
“A manufacturer is liable under a failure-to-warn theory if the product ‘failed to contain
adequate warnings,’ the inadequate warnings ‘rendered the product unreasonably dangerous to
the user or consumer,’ and the inadequate warning ‘proximately caused the damages for which
recovery is sought.’” Union Carbide Corp. v. Nix, Jr., 142 So.3d 374, 385 (Miss. 2014) (quoting
Miss. Code Ann. § 11-1-63(a)(i)–(iii)). However, a defendant will not be liable for failure to
warn unless the plaintiff proves “that at the time the product left the control of the [defendant, the
defendant] knew or in light of reasonably available knowledge should have known about the
danger that caused the damage for which recovery is sought and that the ordinary user or
consumer would not realize its dangerous condition.” Miss. Code Ann § 11-1-63(c)(i).
In their motion to dismiss, the defendants argue that the failure to warn claim must be
dismissed because: (1) the defendants provided an adequate warning for Farxiga’s risk of renal
impairment; (2) the claim seeks to recover for health risks Young did not suffer; and (3) the
defendants were not required to warn of the risks of ketoacidosis.
1. Renal Impairment Warning
An adequate product warning or instruction is one that a reasonably prudent
person in the same or similar circumstances would have provided with respect to
the danger and that communicates sufficient information on the dangers and safe
use of the product, taking into account the characteristics of, and the ordinary
knowledge common to an ordinary consumer who purchases the product; or in the
case of a prescription drug, medical device or other product that is intended to be
used only under the supervision of a physician or other licensed professional
person, taking into account the characteristics of, and the ordinary knowledge
common to, a physician or other licensed professional who prescribes the drug,
device or other product.
Miss. Code Ann. § 11-1-63(c)(ii). “The issue of a warning’s adequacy is factual and usually will
be resolved by the trier of the fact.” Union Carbide, 142 So.3d at 389 (internal quotation marks
The defendants argue that Young’s claims related to renal damage must fail because the
prescribing information for the drug warned prescribing physicians about impairment of renal
function. Doc. #8 at 25.
Of relevance here, the first page of the prescribing information, under a section titled
“WARNINGS AND PRECAUTIONS,” states “Impairment in renal function: Monitor renal
function during therapy. (5.2).”8 Section 5.2, in turn, reads:
WARNINGS AND PRECAUTIONS
Impairment in Renal Function
FARXIGA increases serum creatinine and decreases eGFR. Elderly
patients and patients with impaired renal function may be more
susceptible to these changes. Adverse reactions related to renal
function can occur after initiating FARXIGA [see Adverse Reactions
(6.1)]. Renal function should be evaluated prior to initiation of
FARXIGA and monitored periodically thereafter.
The referenced section 6.1 reads:
The following important adverse reactions are described below and elsewhere in
• Impairment in Renal Function [see Warnings and Precautions (5.2)]
Impairment of Renal Function
Use of FARXIGA was associated with increases in serum creatinine and
decreases in eGFR (see Table 3). In patients with normal or mildly impaired renal
function at baseline, serum creatinine and eGFR returned to baseline values at
Week 24. Renal-related adverse reactions, including renal failure and blood
creatinine increase, were more frequent in patients treated with FARXIGA (see
Table 4). Elderly patients and patients with impaired renal function were more
susceptible to these adverse reactions (see Table 4). Sustained decreases in eGFR
were seen in patients with moderate renal impairment (eGFR 30 to less than 60
Under the “learned intermediary doctrine,” “pharmaceutical companies are required to
A pharmaceutical’s prescribing information is a public record. In re Ariad Pharms., Inc., 98 F.Supp.3d 147, 174
(D. Mass. 2015), reversed on other grounds sub nom., In re Ariad Pharm., Inc. Sec. Litig., 842 F.3d 744 (1st Cir.
2016). “[I]t is clearly proper in deciding a 12(b)(6) motion to take judicial notice of matters of public record.”
Norris v. Hearst Tr., 500 F.3d 454, 461 n.9 (5th Cir. 2007). The prescribing information for Farxiga is available at:
warn only the prescribing physician of dangers inherent in its products because the prescribing
physician acts as a ‘learned intermediary’ between the manufacturer and the consumer.” Moore
ex rel. Moore v. Mem’l Hosp. of Gulfport, 825 So.2d 658, 662 n.6 (Miss. 2002). Accordingly, if
the prescribing information provided an adequate warning to a physician, then Young’s claim
must fail. See Deese v. Immunex Corp., 2012 WL 463722, at *4 (S.D. Miss. Feb. 13, 2012)
(“[U]nder Mississippi’s learned intermediary doctrine, the relevant question is whether
Defendants adequately warned Deese’s prescribing physician of the adverse effects of Enbrel,
not whether Deese himself was adequately warned.”).
In arguing that the warning is inadequate, Young contends that the prescribing
information does not “specifically warn of renal failure, but instead uses language designed to
downplay the association of renal failure and Farxiga.” Doc. #17 at 12–13 (emphasis omitted).
Young further argues that the warning does not “account for the numerous other forms of
communication about the risks and benefits of Farxiga which were provided to Plaintiff and her
physician, and which may have implications on the adequacy of the warning.” Id. at 12 (citing to
negligent misrepresentation claim).
Under the MPLA, to be adequate, a warning for a prescription drug must be one that “a
reasonably prudent person in the same or similar circumstances would have provided with
respect to the danger and that communicates sufficient information on the dangers and safe use
of the product, ... taking into account the characteristics of, ... and the ordinary knowledge
common to, a physician or other licensed professional who prescribes the drug, device or other
product.” Miss. Code Ann. § 11-1-63(c)(ii). Young has alleged that “[t]he warnings that were
given ... failed to properly warn physicians of the risks associated with FARXIGA.” Doc. #2 at ¶
124. Neither the prescription information nor the complaint itself offers any indication of the
adequacy of the warning in light of the ordinary knowledge common to a physician.
Accordingly, nothing in the prescription information or the complaint itself contradicts this
allegation. Therefore, the defendants’ argument regarding the adequacy of the warning must be
2. Additional Health Problems
The defendants argue that “to the extent the failure-to-warn claim is premised on alleged
risks that Plaintiff did not suffer – renal infection, urosepsis, or heart attack – the Complaint fails
to state a claim.” Doc. #8 at 26 (internal citation omitted). Young responds that she only alleges
two injuries in her complaint – ketoacidosis and renal failure. Doc. #17 at 11–12. To the extent
the defendants seek to dismiss claims not pled by Young, the motion will be denied.
The defendants argue that “the failure to warn claim relating to ketoacidosis should be
dismissed because the Complaint fails to allege any facts that would create a duty to warn about
that adverse event.” Doc. #8 at 27. Specifically, the defendants contend that Young “does not
allege sufficient facts to support a reasonable inference that Defendants knew about [the] risk at
the time they distributed the drugs.” Id. Young responds that “the Complaint has adequately
alleged a plausible duty to warn of ketoacidosis under two theories:” (1) “the Complaint alleges
Defendants ‘failed to investigate, research [and] study’ the risks of Farxiga;” and (2) the May 15,
2015, FDA public health advisory creates a “reasonable inference ... that at the time Plaintiff was
prescribed, purchased, and first used Farxiga, Defendants knew or should have known about
the risk of ketoacidosis.” Doc. #17 at 11–12. The defendants reply that Young “alleges no facts
showing that Defendants knew or should have known about the risk of DKA at the time Plaintiff
was prescribed Farxiga. She does not even allege the date she was prescribed Farxiga, and fails
to allege that Defendants had any knowledge of the FDA’s Safety Communication before it was
issued on May 15, 2015.” Doc. #18 at 2. The Court agrees that both of Young’s theories of
knowledge must fail.
As explained above, a defendant will not be liable for a failure to warn unless the plaintiff
proves “that at the time the product left the control of the [defendant, the defendant] knew or in
light of reasonably available knowledge should have known about the danger that caused the
damage for which recovery is sought and that the ordinary user or consumer would not realize its
Miss. Code Ann § 11-1-63(c)(i).
Young has not alleged that the
defendants had knowledge of the FDA communication before the Farxiga Young ingested left
their control. Furthermore, while Young argues that the defendants should have been aware of
the ketoacidosis risk through investigation, research, and study, she has not alleged that the facts
regarding ketoacidosis risk were reasonably available to the defendants through such
investigation. Under these circumstances, the defendants’ motion to dismiss will be granted to
the extent the failure to warn claim is based on injuries caused by ketoacidosis.
The defendants’ motion to dismiss: (1) will be denied to the extent it seeks dismissal of
the failure to warn claim based on Young’s renal failure, (2) will be denied as moot to the extent
it seeks dismissal of claims not pled by Young, and (3) will be granted to the extent it seeks
dismissal of the failure to warn claim based on Young’s ketoacidosis.
D. Manufacturing Defect (Count Two)
To sustain a claim for a manufacturing defect, a plaintiff must show that “[t]he 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.” Miss. Code Ann. § 11-1-63(a)(1).
In her complaint, Young alleges “FARXIGA was defective when it left Defendants’
control and was placed in the stream of commerce, in that there were foreseeable risks that
exceeded the benefits of the product and/or that it deviated from the product specifications and/or
applicable requirements, and posed a risk of serious injury and death.” Doc. #2 at ¶ 91. In their
motion to dismiss, the defendants argue that the manufacturing defect claim must fail because
“[t]he Complaint makes no factual allegations how the Farxiga ingested by Plaintiff ‘was
manufactured in a way which deviated from the design specifications.” Doc. #8 at 15. Young
responds that, “[a]t this early stage, Plaintiff is not privy to specific information which details the
ways in which Defendants manufacturing process deviated from specifications, because
Defendants are in sole possession of such information.” Doc. #17 at 17.
While it has been observed that “[c]ourts typically allow the pleader an extra modicum of
leeway where the information supporting the complainant’s case is under the exclusive control of
the defendant,” United States v. Baxter Intern., 345 F.3d 866, 882 (11th Cir. 2003), Young cites
no authority for the proposition that exclusive control of information totally excuses a plaintiff
from pleading more than a bare recitation of the elements of a cause of action, as she has done
here. Additionally, Young does not argue how knowledge of the allegedly defective pills she
took, which were ostensibly in her control, fall within the exclusive knowledge of the
defendants. Rather, and as pointed out by the defendants, courts routinely dismiss manufacturing
defect claims for failure to comply with Rule 8’s pleading standards.
See, e.g., Deese v.
Immunex Corp., No. 3:11-cv-373 2012 WL 463722, at *3 (S.D. Miss. Feb. 13, 2012) (dismissing
manufacturing defect claim because plaintiff “offer[ed] no indication of the particular grounds
supporting a manufacturing ... defect claim in an amended complaint”); Adams v. Energizer
Holdings, Inc., No. 3:12-cv-797, 2013 WL 1791373, at *3 (S.D. Miss. Apr. 19, 2013) (“Plaintiffs
purport to claim a manufacturing defect but do not allege how the subject product(s) deviated
from the manufacturers’ specifications or other units.”). Because Young has wholly failed to
plead how the Farxiga she took departed from the medication’s design specifications, her
manufacturing defect claim must be dismissed.
E. Breach of Express Warranty (Count Six)
To support liability for breach of express warranty under the MPLA, a plaintiff must
show that “[t]he 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.”
Miss. Code Ann. § 11-1-63(a)(i)(4). An express warranty “is any affirmation of fact or promise
which concerns the product and becomes part of the basis for the purchase of such a product.”
Forbes v. Gen. Motors Corp., 935 So.2d 869, 876 (Miss. 2006).
In her complaint, Young alleges:
Defendants expressly represented to Plaintiff, other consumers, Plaintiff’s
physicians, and the medical community, by and through statements made and
written material disseminated by Defendants or their authorized agents or sales
represents, that FARXIGA:
was safe and fit for its intended purposes;
was of merchantable quality;
did not produce any dangerous and life threatening side effects, and
had been adequately tested and found to be safe and effective for the treatment
Doc. #2 at ¶ 148. Young further alleges that she relied on these representations, and that Farxiga
did not conform to the representations. Id. at ¶¶ 153, 156.
The defendants argue that the claim must fail because Young “offers no specificity about
what specific statements either Defendant allegedly made about Farxiga that the plaintiff or her
prescribing physician relied upon.” Doc. #8 at 28–29.
As an initial matter, a claim for breach of express warranty “clearly is not” subject to
Rule 9(b)’s heightened pleading requirements. Schouest v. Medtronic, Inc., 13 F.Supp.3d 692,
709 n.9 (S.D. Tex. 2014). Thus, there is no need for a plaintiff to allege a specific time and place
of a warranty. Indeed, under Rule 8’s more relaxed pleading standards, courts have found
similar allegations to be sufficient to state a claim for express warranty. See, e.g., Huntley v. CL
Med. SARL, No. 2:14-cv-105, 2015 WL 5521796, at *3–4 (S.D. Miss. Sep. 16, 2015) (denying
motion to dismiss where “Plaintiff specifically noted CLMI’s website, which allegedly claims
that the ’I–STOP provides patients with a fast, effective and minimally invasive procedure,’ and
that it has ’superior characteristics in the clinical setting.’”); Rosenstern v. Allegran, Inc., 987
F.Supp.2d 795, 805 (N.D. Ill. 2013) (denying motion to dismiss based on similar allegations).9
In view of this authority and the lenient pleading standards of Rule 8, the Court concludes that,
while a close call, Young has alleged the express warranties with enough specificity to survive
the defendants’ motion.10
F. Fraud Based Claims (Counts Eight, Nine, and Ten)
Finally, the defendants argue that, even if not subsumed by the MPLA, Young’s claims
which sound in fraud must be dismissed for failure to satisfy the pleading requirements of Rule
9(b). Under Rule 9(b) of the Federal Rules of Civil Procedure, “[i]n alleging fraud or mistake, a
The defendants point to Deese, in which a district judge held insufficient an allegation that “Defendants ... through
their advertising, marketing and product labeling, expressly warranted that Enbrel was reasonably safe for use as a
prescription treatment for persons suffering from rheumatoid arthritis such as Deese.” 2012 WL 463722, at *6. The
Deese court held that such an allegation “fails to identify ... any express warranty or express factual representation
made by Defendants that they allegedly breached.” Id. The Court finds the allegations in this case to be more
specific than those in Deese.
In reaching this conclusion, the Court notes that, while not raised by the defendants, Young’s breach of express
warranty claim must fail to the extent it is based on alleged omissions in Farxiga’s prescribing information. An
omission is neither an affirmation of fact nor a promise. See generally Sidco Prods. Mktg. v. Gulf Oil Corp., 858
F.2d 1095, 1099 (5th Cir. 1988) (“Omissions, however, are not affirmative representations of any sort and thus
cannot support a warranty claim, because express warranties must be explicit.”) (applying Texas law).
party must state with particularity the circumstances constituting fraud or mistake. Malice, intent,
knowledge, and other conditions of a person’s mind may be alleged generally.” “Rule 9(b)
applies by its plain language to all averments of fraud, whether they are part of a claim of fraud
or not.” Lone Star Ladies Inv. Club v. Scholtzsky’s Inc., 238 F.3d 363, 368 (5th Cir. 2001). The
defendants argue, and Young does not dispute, that Rule 9(b) applies to Young’s claims for
fraud, negligent misrepresentation, and violations of Mississippi’s Consumer Protection Act, all
of which rely on allegations of fraudulent or deceptive behavior.11 Doc. #8 at 31.
“What constitutes ‘particularity’ will necessarily differ with the facts of each case. At a
minimum, Rule 9(b) requires allegations of the particulars of time, place, and contents of the
false representations, as well as the identity of the person making the misrepresentation and what
he obtained thereby. Put simply, Rule 9(b) requires ‘the who, what, when, where, and how’ to be
laid out.” Benchmark Elecs., Inc. v. J.M. Huber Corp., 343 F.3d 719, 724 (5th Cir. 2003)
(internal punctuation and citations omitted). With regard to the how, “[t]he Fifth Circuit ... and
other district courts within [the circuit] have either held or strongly suggested that Rule 9(b)’s
particularity requirement extends to allegations of actual reliance.” In re BP P.L.C. Sec. Litig.,
No. 4:12–cv–1256, 2013 WL 6383968, at *39 (S.D. Tex. Dec. 5, 2013) (collecting cases). “[A]t
a minimum, Rule 9(b) requires Plaintiffs to specify with particularity what actions [they took] or
forewent in reliance upon Defendants’ alleged misrepresentations.”
Id. at *41 (internal
punctuation and emphasis omitted).
See generally Benchmark Elecs., 343 F.3d at 723 (“Although Rule 9(b) by its terms does not apply to negligent
misrepresentation claims, this court has applied the heightened pleading requirements when the parties have not
urged a separate focus on the negligent misrepresentation claims. That is the case here, as Benchmark’s fraud and
negligent misrepresentation claims are based on the same set of alleged facts.”) (internal citations omitted); Frith v.
Guardian Life Ins. Co. of Am., 9 F.Supp.2d 734, 742 (S.D. Tex. 1998) (Rule 9(b) applied to allegations of fraud
brought under Texas Consumer Protection Act).
Here, Young alleges that the defendants made a number of misrepresentations and
omissions related to Farxiga’s safety and that “Defendants[‘] misrepresentations were made
through various methods, including but not limited to, FARXIGA’s published labeling and
medication guide, medical literature, promotional materials directed at consumers, promotional
materials directed at health care professionals, and documentation submitted in support of
FARXIGA’s NDA.” Doc. #2 at ¶ 204. These allegations fail for numerous reasons.
First, the complaint wholly fails to plead when these documents were published or how
Young herself relied on them. See Cooper v. Samsung Elec. Am., Inc., No. 07-3853, 2008 WL
4513924, at *8 (D.N.J. Sep. 30, 2008) (“Cooper asserts that he relied on unspecified marketing
and advertising materials related to the ... television he bought .... He does not, however, supply
any details with respect to the marketing or advertising materials in question, characterizing
instead their presumed effect upon a reasonable consumer. While such pleading may be
consistent with claims under Rule 8(a), it fails to provide the particularity required by Rule
9(b).”) (internal quotation marks and citation omitted); Asad v. Hartford Life Ins. Co., 116
F.Supp.2d 960, 963 (N.D. Ill. 2000) (“The complaint generically refers to ‘policy illustration,’
‘marketing materials,’ and ‘sales presentations’ but never identifies which particular items form
the basis of Hartford’s alleged fraud.”).
More importantly, Young makes no effort to identify specific documents or to link
specific misrepresentations (or omissions) to such documents.
Accordingly, this Court
concludes that Young has failed to plead her fraud claims with particularity. See House v.
Bristol-Myers Squibb Co., 2017 WL 55876, at *9 (W.D. Ky. Jan 4, 2017) (“She alleges that
Defendants committed fraud in unspecified labeling, advertising, marketing materials, detail
persons, seminar presentations, publications, notice letters, and regulatory submissions, without
identifying or referencing a single particular document or statement.... [T]he Complaint’s vague
allegations simply do not suffice under Rule 9(b) because they discuss the alleged practices only
at a high level of generality.”) (internal quotation marks omitted).
Leave to Amend
In response to the motion to dismiss, Young asks for an opportunity to conduct discovery
or for leave to amend her complaint. Doc. #17 at 21. However, under this Court’s Local Rules,
“[a] response to a motion may not include a counter-motion in the same document.” L.U. Civ.
R. 7(b)(3)(C). Nevertheless, “a plaintiff’s failure to meet the specific pleading requirements
should not automatically or inflexibl[y] result in dismissal of the complaint with prejudice to refiling.” 199 F.3d 239, 247 n.6 (5th Cir. 2000). Thus, “[a]lthough a court may dismiss [a] claim,
it should not do so without granting leave to amend, unless the defect is simply incurable or the
plaintiff has failed to plead with particularity after being afforded repeated opportunities to do
so.” Id. Upon consideration, the Court concludes that Young should be given an opportunity to
correct the pleading deficiencies identified by this order. Accordingly, the dismissal of Young’s
claims will be without prejudice to filing an amended complaint.
For the reasons explained above, the Removing Defendants’ motion to dismiss , which
was joined by the Non-Removing Defendants , is GRANTED in Part and DENIED in
Part such that:
Young’s common law claims for strict liability, negligence, breach of implied
warranty, negligent misrepresentation, and fraud are dismissed.
Young’s design defect claim is dismissed for failure to plead a feasible design
Young’s failure to warn claim based on Young’s ketoacidosis is dismissed.
Young’s manufacturing defect claim is dismissed.
Young’s breach of express warranty claim is dismissed.
To the extent dismissal was sought under Rule 9(b), Young’s claims for fraud,
negligent misrepresentation, and violation of the Consumer Protection Act are
The motion to dismiss is denied in all other respects on all other grounds.
Such dismissals described above shall be without prejudice to Young filing an
amended complaint within twenty-one (21) days of this order.
SO ORDERED, this 22nd day of February, 2017.
/s/ Debra M. Brown
UNITED STATES DISTRICT JUDGE
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