Fleming v. Janssen Pharmaceuticals, Inc. et al

Filing 55

ORDER granting 18 Motion to Dismiss for Failure to State a Claim; granting 18 Motion to Dismiss for Lack of Jurisdiction. Signed by Judge Jon Phipps McCalla on 6/6/2016. (McCalla, Jon)

IN THE UNITED STATES DISTRICT COURT
FOR THE WESTERN DISTRICT OF TENNESSEE
AT JACKSON

WARDELL FLEMING,
Plaintiff,
v.
JANSSEN PHARMACEUTICALS, INC.,
JOHNSON & JOHNSON, and MITSUBISHI
TANABE PHARMA CORP.,
Defendants.

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ORDER GRANTING JANSSEN PHARMACEUTICALS, INC. AND
JOHNSON & JOHNSON’S MOTION TO DISMISS

Before the Court is Defendants Janssen Pharmaceuticals,
Inc. and Johnson & Johnson’s (“Defendants”) Motion to Dismiss,
filed February 12, 2016.

(ECF No. 18).

For the following

reasons, Defendants’ Motion to Dismiss is GRANTED.

Accordingly,

the Court dismisses all claims against Johnson & Johnson with
prejudice; dismisses Plaintiff’s design defect claims with
prejudice; dismisses Plaintiff’s Tennessee Consumer Protection
Act (“TCPA”) claims with prejudice; and dismisses Plaintiff’s
Tennessee Product Liability Act (“TPLA”) claims without
prejudice.

Plaintiff is permitted to re-plead his TPLA claims

with specificity within thirty (30) days of the entry of this
order, up to and including July 6, 2016.

I.

BACKGROUND
A.

Factual History

Plaintiff Wardell Fleming (“Plaintiff”), a Tennessee
resident, brings suit against Defendants Janssen
Pharmaceuticals, Inc. (“Janssen”), a Pennsylvania corporation;
Johnson & Johnson, a New Jersey corporation; and Mitsubishi
Tanabe Pharma Corp. (“Tanabe”), a Japanese corporation, for
injuries and damages caused by Invokana, a diabetes drug.
(Compl. ¶¶ 1-3, 7-10, 18-23, ECF No. 1.)

Plaintiff alleges that

Defendants Tanabe and Johnson & Johnson collaborated to design
and develop Invokana.

(Id. ¶ 18.)

Defendant Janssen, a

wholly-owned subsidiary of Johnson & Johnson, acquired marketing
rights to the drug in North America and marketed, advertised,
distributed, and sold Invokana in states including Tennessee.
(Id. ¶ 19.)

Invokana was approved by the FDA for the treatment

of type 2 diabetes.

(Id. ¶ 21.)

Invokana, an SGLT2 inhibitor,

was the first drug of its kind approved by the FDA.

(Id. ¶ 23.)

The FDA has since received a significant number of reports
of diabetic ketoacidosis and kidney infection from Invokana
users.

(Id. ¶ 26.)

On May 15, 2015, the FDA issued a Public

Health Advisory regarding a link between SGLT2 inhibitors and
diabetic ketoacidosis.

(Id. ¶ 27.)

Plaintiff alleges that,

despite the reported adverse events, Defendants have continued
to fail to warn patients about diabetic ketoacidosis as a risk
2

of taking Invokana.

(Id. ¶¶ 28-30.)

On December 4, 2015, the

FDA updated Invokana’s warning label to include a warning about
ketoacidosis and serious urinary tract infections which can
develop into kidney infections.

(Id. ¶ 31.)

Plaintiff alleges that Defendants knew of the risk that
severe injury could be caused by Invokana.

(Id. ¶ 33.)

Plaintiff began taking Invokana in or about November 2013.
¶ 35.)

(Id.

Plaintiff suffered kidney failure, kidney damage, and

reduced kidney function after taking Invokana; in addition to
physical injuries, Plaintiff also alleges emotional injuries,
loss of enjoyment of life, and economic loss.

(Id. ¶¶ 40, 48.)

Plaintiff asserts that his injuries were a reasonably
foreseeable consequence of Defendants’ conduct and Invokana’s
defects.

(Id. ¶ 43.)

Plaintiff asserts he would not have used

Invokana if he had been properly warned.

(Id. ¶ 45.)

Plaintiff

asserts that there are several safer alternative products
available.
B.

(Id. ¶ 32.)
Procedural History

On December 14, 2015, Plaintiff Wardell Fleming filed a
complaint against Defendants Janssen Pharmaceuticals, Inc.,
Johnson & Johnson, and Mitsubishi Tanabe Pharma Corp. in the
Western District of Tennessee.

(ECF No. 1.)

On February 12,

2016, Defendants Janssen and Johnson & Johnson (“Defendants”)
filed a motion to dismiss for failure to state a claim and for
3

lack of jurisdiction over Johnson & Johnson.

(ECF No. 18.)

Plaintiff responded in opposition on March 14, 2016.
33; see also ECF No. 31.)
2016.

(ECF No.

Defendants filed a reply on April 1,

(ECF No. 36.)

The Court held a telephonic scheduling conference on March
17, 2016.

(Min. Entry, ECF No. 34.)

On April 6, 2016, the

Court held a second scheduling conference and a hearing on the
instant motion.

(Min. Entry, ECF No. 38.)

On April 22, 2016, Defendant Tanabe filed a motion to
dismiss.
II.

(ECF No. 42.)

This motion remains pending.

LEGAL STANDARD
A.

Motion to Dismiss for Lack of Personal Jurisdiction

A court may dismiss a claim for “lack of personal
jurisdiction.”

Fed. R. Civ. P. 12(b)(2).

“The plaintiff bears

the burden of making a prima facie showing of the court’s
personal jurisdiction over the defendant.”

Intera Corp. v.

Henderson, 428 F.3d 605, 615 (6th Cir. 2005).

A plaintiff “can

meet this burden by ‘establishing with reasonable particularity
sufficient contacts between [a defendant] and the forum state to
support jurisdiction.’”

Neogen Corp. v. Neo Gen Screening,

Inc., 282 F.3d 883, 887 (6th Cir. 2002) (quoting Provident Nat’l
Bank v. Cal. Fed. Sav. Loan Ass’n, 819 F.2d 434, 437 (3d Cir.
1987)).

When the court does not conduct an evidentiary hearing

on the issue, it must “not consider the facts proffered by the
4

defendant that conflict with those offered by the plaintiff, and
will construe the facts in the light most favorable to the
nonmoving party.”
B.

Id. (citation omitted).

Motion to Dismiss for Failure to State a Claim

A court may dismiss a claim for “failure to state a claim
upon which relief can be granted.”

Fed. R. Civ. P. 12(b)(6).

“To survive a motion to dismiss, a complaint must contain
sufficient factual matter, accepted as true, to ‘state a claim
to relief that is plausible on its face.’”

Ashcroft v. Iqbal,

556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly,
550 U.S. 544, 570 (2007)).
A complaint must contain a short and plain statement
of the claim showing that the pleader is entitled to
relief. . . . A claim is facially plausible when the
pleaded factual content allows the court to draw the
reasonable inference that the defendant is liable for
the misconduct alleged. . . . [T]he court need not
accept as true allegations that are conclusory or
require unwarranted inferences based on the alleged
facts.
Newberry v. Silverman, 789 F.3d 636, 640 (6th Cir. 2015)
(citations and internal quotation marks omitted).

“Plausibility

is not the same as probability, but it requires ‘more than a
sheer possibility that a defendant has acted unlawfully.’”
v. Fed. Home Loan Mortg. Corp., 743 F.3d 149, 157 (6th Cir.
2014) (quoting Iqbal, 556 U.S. at 678).

A court must

“construe[] the complaint in a light most favorable to the

5

Mik

plaintiff.”

HDC, LLC v. City of Ann Arbor, 675 F.3d 608, 611

(6th Cir. 2012).
III. ANALYSIS
A.

Personal Jurisdiction as to Johnson & Johnson

Defendants Janssen and Johnson & Johnson assert that all
claims against Johnson & Johnson should be dismissed because
Plaintiff has failed to establish personal jurisdiction as to
Johnson & Johnson.

(ECF No. 18-1 at 4-8.)

Plaintiff argues

that personal jurisdiction exists because Johnson & Johnson
purposefully availed itself of this Court when it designed
Invokana and, along with Janssen, a subsidiary, placed Invokana
in the stream of commerce in Tennessee.

(ECF No. 33 at 5

(citing Daimler AG v. Bauman, 134 S. Ct. 746, 759 n.13 (2014)).)
The Court finds that Johnson & Johnson does not have minimum
contacts with Tennessee such that personal jurisdiction exists.
“Personal jurisdiction can be either general or specific,
depending upon the nature of the contacts that the defendant has
with the forum state.”
Cir. 2002).

Bird v. Parsons, 289 F.3d 865, 873 (6th

The Court examines only specific jurisdiction

because Plaintiff focuses on specific jurisdiction in his
response to the instant motion.

(See ECF No. 33 at 3 n.1

(“Plaintiff does not claim that Johnson & Johnson is subject to
general jurisdiction in Tennessee, but instead asserts specific
jurisdiction.”).)
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To determine whether specific jurisdiction exists, the
Court employs the following three-part test:
First, the defendant must purposefully avail himself
of the privilege of acting in the forum state or
causing a consequence in the forum state. Second, the
cause of action must arise from the defendant’s
activities there.
Finally, the acts of the defendant
or consequences caused by the defendant must have a
substantial enough connection with the forum state to
make the exercise of jurisdiction over the defendant
reasonable.
Devault-Graves Agency, LLC v. Salinger, No. 2:15-cv-02178STA-tmp, 2015 WL 6143513, at *4 (W.D. Tenn. Oct. 19, 2015)
(quoting S. Mach. Co. v. Mohasco Indus., Inc., 401 F.2d 374, 381
(6th Cir. 1968)).

In analyzing purposeful availment, the Sixth

Circuit uses a “stream of commerce plus” approach that requires
more than simply “[t]he placement of a product into the stream
of commerce” to prove purposeful availment in the forum state.
Bridgeport Music, Inc. v. Still N the Water Publ’g, 327 F.3d
472, 479-80 (6th Cir. 2003) (per curiam) (alteration in
original) (internal quotation marks omitted).

“The ‘stream of

commerce plus’ test is not met when the ‘defendant was “merely
aware” of the fact of national distribution, but the choice to
distribute was ‘pretty much out of [its] hands.’”
Devault-Graves, 2015 WL 6143513, at *5 (alteration in original)
(quoting Palnik v. Westlake Enter., Inc., 344 F. App’x 249, 251
(6th Cir. 2009)).

Factors to consider for the “stream of

commerce plus” test include “(1) the defendant’s direction or
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control over the flow of the product into the forum; (2) the
quantity of the defendant’s particular product regularly flowing
into the forum; and (3) the distinctive features of the forum
that connect it with the product in question.”

One Media IP

Ltd. v. S.A.A.R. SrL, No. 3:14-cv-0957, 2015 WL 4716813, at *8
(M.D. Tenn. Aug. 7, 2015) (citing Eaves v. Pirelli Tire, 2014 WL
1883791 (D. Kan. May 12, 2014)).
Plaintiff has not alleged facts to satisfy the “stream of
commerce plus” test.

First, Plaintiff has not alleged that

Johnson & Johnson controlled the flow of Invokana into
Tennessee.

Plaintiff asserts that Johnson & Johnson “‘designed

and developed’ Invokana in collaboration with Mitsubishi
Tanabe.”

(ECF No. 33 at 5 (quoting Compl. ¶ 18).)

Defendant

asserts that Johnson & Johnson is a holding company 1 that “plays
no role in the manufacture and sale of Invokana.”
at 3 & n.4.)

(ECF No. 18-1

This factual dispute must be construed in the

light most favorable to Plaintiff, Neogen, 282 F.3d at 887, but
Plaintiff has failed to allege facts that connect the design and
development of Invokana to the flow of Invokana in Tennessee.
Second, Plaintiff has not asserted a quantity of the
product regularly flowing into Tennessee.

Although Plaintiff

1
Other courts have found that because Johnson & Johnson is a holding
company, it is not subject to specific jurisdiction where it has not availed
itself of the laws of the particular state. See, e.g., Order Granting Mot.
to Dismiss at 18, 33, Brazil v. Janssen Research & Dev., No. 4:15-CV-0204-HLM
(N.D. Ga. Mar. 24, 2016), ECF No. 20; Androphy v. Smith & Nephew, Inc., 31 F.
Supp. 2d 620, 622 (N.D. Ill. 1998).

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asserts that Johnson & Johnson has derived a substantial amount
of revenue from Tennessee because Johnson & Johnson reported
$890 million in U.S. sales of Invokana in the first nine months
of 2015 alone (ECF No. 33 at 4 & n.2), Plaintiff fails to
specify the sales related to Tennessee.

Third, Plaintiff has

failed to connect any distinctive features of Tennessee to
Invokana.

The record does not indicate that Johnson & Johnson

has purposefully availed itself of the laws of Tennessee, and
thus, the first part of the specific jurisdiction test is not
met. 2
The Court, therefore, need not reach the second and third
parts of the specific jurisdiction test.

Even if the first part

were satisfied, Plaintiff has not satisfied the second by
showing that Johnson & Johnson’s actions in Tennessee caused the
injuries he asserts.

The record does not indicate that Johnson

& Johnson acted in Tennessee to cause Plaintiff’s alleged
injury.

While Plaintiff asserts that he was prescribed,

purchased, and used Invokana in Tennessee (Compl. ¶ 7),
Plaintiff’s own actions in the forum state are not sufficient to
establish specific jurisdiction.

See Devault-Graves, 2015 WL

2

While there is case law to support Plaintiff’s argument that Johnson &
Johnson’s nationwide sales and marketing activities indicate that Johnson &
Johnson has minimum contacts with Tennessee, see, e.g., In re DePuy
Orthopaedics, Inc. Pinnacle Hip Implant Prods. Liab. Litig., MDL Docket No.
3:11-MD-2244-K, 2014 WL 3557392 at *2 (N.D. Tex. July 18, 2014), the Sixth
Circuit standard of “stream of commerce plus” is controlling in the instant
case.

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6143513, at *6.

Although the third part might be satisfied 3 when

considering the factors of burden to Defendants and Plaintiff’s
interest, id., it alone cannot establish specific jurisdiction.
Accordingly, because specific jurisdiction cannot be
established over Johnson & Johnson, the Court GRANTS Defendants’
motion to dismiss Plaintiff’s claims against Johnson & Johnson.
B.

Preemption of Design Defect Claims

Defendants assert that Plaintiff’s design defect claims
(Counts I and IX), which are premised on the proposition that
Defendants should have designed Invokana differently, are
preempted by federal law.

(ECF No. 18-1 at 15.)

Plaintiff

argues that a case Defendants rely on, Mutual Pharmaceutical Co.
v. Bartlett, 133 S. Ct. 2466 (2013), is distinguishable because
it applied to generic drugs, not branded drugs like Invokana.
(ECF No. 33 at 6-10.)

Plaintiff also asserts that the focus of

his claims is on design defects before FDA approval, not
Defendants’ failure to redesign after FDA approval.

(Id. at 8.)

The Court finds that Plaintiff’s design defect claims are
preempted based on Yates v. Ortho-McNeil-Janssen
Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015), and

3
Plaintiff must show that “Tennessee has an interest in resolving the
conflict such that jurisdiction over the defendant is reasonable.”
Devault-Graves, 2015 WL 6143513, at *6 (citing Mohasco, 401 F.2d at 384).
Plaintiff is a Tennessee resident (Compl. ¶ 7), which suggests that the state
has an interest in resolving the conflict in Tennessee; and Johnson & Johnson
would likely not face a significant burden by litigating in Tennessee.

10

therefore grants Defendants’ motion to dismiss the design defect
claims.
Several Supreme Court cases provide guidance as to whether
the design defect claims are impossible as a matter of law:
Wyeth v. Levine, 555 U.S. 555 (2009), PLIVA, Inc. v. Mensing,
564 U.S. 604 (2011), and Bartlett.

In Levine, the Supreme Court

held that state claims were not preempted when Wyeth, a drug
manufacturer, could comply with both state and federal law
obligations.

555 U.S. at 581.

In that case, the Court found

that the FDA’s 2006 preamble which Wyeth relied on was contrary
to “the FDA’s own longstanding position” of recognizing state
law remedies.

Id. at 577, 580-81.

In Mensing, by contrast, the

Supreme Court found impossibility when generic drug
manufacturers could not comply with state-law duties to provide
adequate warning labels because federal statutes and regulations
required the manufacturers to use the same labeling as the
drug’s branded counterparts.
claims were thus preempted.

564 U.S. at 610-11.

The state

Similarly, citing Mensing, the

Supreme Court found in Bartlett that state-law design defects
claims were preempted by federal law preventing generic drug
manufacturers from changing the chemistry of their drugs or
changing the labels of their drugs.

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133 S. Ct. at 2475-76.

Under Tennessee law,
[w]arnings concerning prescription drugs generally are
adequate when they contain a full and complete
disclosure of the potential adverse reactions to the
drug.
A reasonable warning not only conveys a fair
indication of the dangers involved, but also warns
with the degree of intensity required by the nature of
the risk.
Pittman v. Upjohn Co., 890 S.W.2d 425, 428-29 (Tenn. 1994).
“Tennessee law thus appears to track the laws of Louisiana and
Minnesota discussed in Mensing, which impose a similar duty on
the manufacturer to warn of known dangers associated with its
product.”

Strayhorn v. Wyeth Pharms., Inc., 737 F.3d 378, 393

(6th Cir. 2013).
The Sixth Circuit clarified that impossibility preemption
is not limited to generic drugs.

Yates, 808 F.3d at 296.

Accordingly, in Yates, the design defect claims against the
manufacturers of a branded product were preempted.

Id. at

293-300.
Defendants argue that it would have been impossible for
Janssen to redesign Invokana under state law without violating
federal law prohibiting such a design change without prior FDA
approval.

(ECF No. 18-1 at 19-20.)

Plaintiff argues that the

issue is not Defendants’ duty to redesign the warning label
after FDA approval but rather Defendants’ duty to design the
drug differently before FDA approval.

(ECF No. 33 at 9-10.)

The Sixth Circuit, however, found this type of argument to be
12

“too attenuated” and “speculat[ive]” because it requires several
assumptions as to FDA approval and a patient’s selection of and
medical reaction to the alternative design.

Yates, 808 F.3d at

299-300 (“Defendants could not have complied with whatever
pre-approval duty might exist without ultimately seeking the
FDA’s approval prior to marketing [the branded drug], and
certainly prior to [plaintiff’s] use of the drug.”)

The Court

finds that in the instant case, Defendants could not comply with
both state law and federal law with regard to Invokana.
Other district courts have also determined that claims
against branded drugs are subject to preemption.

See, e.g.,

Batoh v. McNeil-PPC, Inc., --- F. Supp. 3d ---, No.
3:14-cv-01462 (MPS), 2016 WL 922779 (D. Conn. Mar. 10, 2016),
appeals docketed, No. 16-1060 (2d Cir. Apr. 7, 2016), No. 161288 (2d Cir. Apr. 25, 2016).

But see, e.g., Order Granting

Mot. to Dismiss at 79-82, Brazil, No. 4:15-CV-0204-HLM
(discounting the persuasiveness of Yates and finding in another
Invokana case that the plaintiff’s design defect claims were not
preempted).

Unlike in Brazil in the Northern District of

Georgia, Yates is controlling authority in the instant case.
The Court finds that Plaintiff’s design defect claims are
preempted by federal law because preemption can apply to both
generic and branded drugs and because it would have been
impossible for Defendants to comply with both state and federal
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law.

Thus, Defendants’ motion to dismiss is GRANTED as to the

design defect claims.
C.

Damages Under the Tennessee Consumer Protection Act
(“TCPA”)

Defendants assert that Plaintiff cannot recover damages
under the Tennessee Consumer Protection Act (“TCPA”) because he
“has failed to allege an ascertainable loss of money or property
as required under the statute.”

(ECF No. 18-1 at 8.)

Plaintiff

argues that he suffered economic damages from purchasing
Invokana.

(ECF No. 33 at 10.)

Plaintiff asserts that his

economic damages are “separate and distinct” from damages
resulting from his personal injury.

(Id.)

The Court disagrees

and finds that Plaintiff has failed to state a claim under the
TCPA.
The TCPA allows for recovery by “[a]ny person who suffers
an ascertainable loss of money . . . or thing of value wherever
situated, as a result of the use or employment by another person
of an unfair or deceptive act or practice described in
§ 47-18-104(b) and declared to be unlawful by this part.”
Code Ann. § 47-18-109(a)(1).

Tenn.

The alleged “consumer injury must

be more than trivial or speculative.”

Waggin’ Train, LLC v.

Normerica, Inc., No. 1:09-cv-01093, 2010 WL 145776, at *4 (W.D.
Tenn. Jan. 8, 2010) (quoting Tucker v. Sierra Builders, 180
S.W.3d 109, 117 (Tenn. Ct. App. 2005)).

14

“A TCPA claim must be

dismissed where a plaintiff ‘seeks to recover for injuries to
his person resulting from [a defendant’s] alleged violation of
the TCPA.’”

Riddle v. Lowe’s Home Ctrs., Inc., 802 F. Supp. 2d

900, 909 (M.D. Tenn. 2011) (quoting Birdsong v. Eli Lilly & Co.,
No. 3:10-01182, 2011 WL 1259650, at *3 (M.D. Tenn. Mar. 31,
2011)).
Plaintiff argues that the economic damages he suffered due
to Defendants’ violation of the TCPA are based on “the purchase
price of the drug that he would not have purchased but for
Defendants’ wrongful conduct.”
¶¶ 89, 200).)

(ECF No. 33 at 10 (citing Compl.

These damages are speculative, however, since

there is nothing in the record that indicates Plaintiff’s
expenditures from purchasing Invokana.
Further, the record does not support Plaintiff’s assertion
that the economic damages are “separate and distinct” from his
personal injury.

The “medical and related expenses” Plaintiff

asserts are directly related to the alleged injuries suffered
after using Invokana.

(Compl. ¶ 227.)

Plaintiff also suggests

that his economic damages could have been avoided if he had not
been injured by Defendants’ alleged TCPA violation.
Compl. ¶¶ 89-91.)

(See, e.g.,

The asserted damages, therefore, do not

“exist[] independently of the personal injuries that he
suffered.”

Riddle, 802 F. Supp. 2d at 909.

15

Because Plaintiff has failed to state a claim under the
TCPA, Defendants’ motion to dismiss is GRANTED as to Plaintiff’s
TCPA claims.
D.

Sufficiency of Pleading Under the Tennessee Product
Liability Act (“TPLA”)

Defendants assert that Plaintiff provides only conclusory
allegations about the defectiveness or dangerousness of Invokana
and thus fails to state a claim under the Tennessee Product
Liability Act (“TPLA”).

(ECF No. 18-1 at 10-11.)

Plaintiff

argues that he has sufficiently stated a claim for design
defects (Counts I and IX) under the TPLA because he has alleged
that Invokana’s design causes excess glucose excretion by the
kidneys (Compl. ¶ 24) and because the FDA issued an advisory
regarding Invokana and ketoacidosis and later required a change
in the labeling of Invokana (id. ¶¶ 27, 31).
13.)

(ECF No. 33 at

The Court finds that Plaintiff fails to state a claim

under the TPLA and must re-plead with specificity any TPLA
claims he wishes to pursue.
The TPLA states that: “A manufacturer or seller of a
product shall not be liable for any injury to a person or
property caused by the product unless the product is determined
to be in a defective condition or unreasonably dangerous at the
time it left the control of the manufacturer or seller.”
Code Ann. § 29-28-105(a).

Tenn.

“[U]nder Tennessee law, establishing

16

a prima facie products-liability claim requires that the
plaintiff must show: (1) the product was defective and/or
unreasonably dangerous, (2) the defect existed at the time the
product left the manufacturer’s control, and (3) the plaintiff’s
injury was proximately caused by the defective product.”

Sigler

v. Am. Honda Motor Co., 532 F.3d 469, 483 (6th Cir. 2008)
(internal quotations marks omitted).

As to unreasonable

dangerousness, a plaintiff can demonstrate either that the
product’s performance did not meet consumer expectations or that
the manufacturer was not prudent.

Id. at 483-84 & n.6.

A plaintiff must, at the pleading stage, allege facts that
indicate how the alleged defect(s) caused his injuries.

Brewer

v. Mr. Heater, Inc., No. 13-1330, 2014 WL 1364825, at *2 (W.D.
Tenn. Apr. 7, 2014).

The complaint in Brewer was dismissed

because the facts set forth were, save for one allegation
describing an insufficient component of the allegedly defective
device, “nothing but ‘labels and conclusions’ or ‘formulaic
recitation[s] of the elements’ of various causes of action.”
Id. at *3 (alteration in original) (quoting Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 555 (2007)).
Similarly, in the instant case, Plaintiff’s complaint
consists largely of legal conclusions, and the Court cannot make
a reasonable inference of Defendants’ liability from the facts
alleged.

The only assertion as to how the product design was
17

defective is a description of how the class of products works.
(See Compl. ¶ 24 (“SGLT2 inhibitors . . . are designed to
inhibit renal glucose reabsorption with the goal of lowering
blood glucose.

As a result, excess glucose is not metabolized,

but instead is excreted through the kidneys of a population of
consumers already at risk for kidney disease.”).)

The Court

cannot reasonably infer from the generic description of SGLT2
inhibitors’ mechanism of action that Invokana was defective or
unreasonably dangerous.
The facts are also insufficient as to the alleged defect as
the cause of Plaintiff’s injuries.

Plaintiff asserts, for

example, that “[a]s a direct and proximate result of Defendants’
negligence, wrongful conduct, and the unreasonably dangerous and
defective characteristics of INVOKANA, Plaintiff suffered severe
and permanent physical and emotional injuries.”

(Compl. ¶ 48.)

Under Rule 12(b)(6), such “unadorned, the-defendant-unlawfullyharmed-me accusation[s]” are insufficient to state a claim.
Iqbal, 556 U.S. at 678.
Plaintiff’s claims for warning defects also fail for
similar reasons.

“To plead a ‘failure to warn’ claim, Plaintiff

must allege facts for the Court to infer that the Device was
‘unreasonably dangerous’ within the meaning of T.C.A. § 29–28–
102(8).”

Maness v. Boston Sci., 751 F. Supp. 2d 962, 970 (E.D.

Tenn. 2010) (footnote omitted).

Plaintiff has made only
18

conclusory statements as to the failure of Defendants to warn
about the dangers of Invokana.

(See, e.g., Compl. ¶ 76

(“INVOKANA contained warnings insufficient to alert consumers,
including Plaintiff, to the dangerous risks and reactions
associated with INVOKANA, including the development of
Plaintiff’s injuries.”).)
Plaintiff’s other claims for breach of warranties,
misrepresentation, concealment, and fraud are encompassed within
the scope of actions under the TPLA.

See Tilden v. Gen. Elec.

Co., No. 3:11-CV-628, 2012 WL 1023617, at *2 & n.4 (E.D. Tenn.
Mar. 26, 2012) (citing Tenn. Code Ann. § 29-28-102(6)).

Because

Plaintiff has not stated a sufficient claim under the TPLA for
product liability, all remaining claims must be dismissed.

See

Tenn. Code Ann. § 29-28-102(6); see also Strayhorn, 882 F. Supp.
2d at 1028.
Accordingly, the Court GRANTS Defendants’ Motion to Dismiss
on the ground of failure to state a claim under the TPLA.
Plaintiff’s TPLA claims are dismissed without prejudice, and
Plaintiff is permitted to re-plead these claims with specificity
within thirty days.
IV.

CONCLUSION
For the reasons stated above, Defendants’ Motion to Dismiss

is GRANTED.

Plaintiff is permitted to re-plead with specificity

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any claims dismissed without prejudice within thirty days, up to
and including July 6, 2016.
IT IS SO ORDERED, this 6th day of June, 2016.

/s/ Jon P. McCalla
JON P. McCALLA
UNITED STATES DISTRICT JUDGE

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