COTTRELL et al v. ALCON LABORATORIES, INC. et al

Filing 82

OPINION filed. Signed by Judge Freda L. Wolfson on 6/24/2015. (eaj)

*NOT FOR PUBLICATION*
UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY
_______________________________
:
LENOARD COTTRELL, et al.,
:
Civ. Action No.: 14-5859(FLW)
:
Plaintiffs, :
:
v.
:
:
OPINION
ALCON LABORATORIES, INC.,
:
et al.,
:
:
Defendants. :
_______________________________:
WOLFSON, District Judge:
In this putative consumer class action, in- and out-of-state
plaintiffs 1

accuse

defendant

pharmaceutical

manufacturers

and

distributors 2 of engaging in unfair and illegal business practices

These plaintiffs include: Leonard Cottrell, Sandra Henon,
William Reeves, George Herman, Simon Nazzal, Carol Freburger, Jack
Liggett, Patricia Bough, Mack Brown, Dolores Gillespie, Deborah
Harrington,
Robert
Ingino,
Edward
Rogers,
Jr.,
Deborah
Rusignulolo, Dorothy Stokes, Josephine Troccoli, Hurie Whitfield,
Thomas Layloff, Carolyn Tanner, Patsy Tate, John Sutton, Jesus
Renteria, Glendelia Franco and Nadine Lampkin (collectively,
“Plaintiffs”).
1

Plaintiffs name as defendants both brand-name and generic
pharmaceutical manufacturers and their distributors.
The brand
name companies include: Alcon Laboratories, Inc., Alcon Research,
Ltd., Allergan, Inc., Allergan USA, Inc., Allergan Sales, LLC,
Pfizer Inc., Valeant Pharmaceuticals International, Inc., Bausch
& Lomb, Inc., Aton Pharma, Inc., Merck & Co., Inc., and Merck,
Sharpe & Dohme Corp. (collectively, the “Brand Name Defendants”).
The generic companies are Falcon Pharmaceuticals, Ltd., Sandoz
Inc., Prasco LLC, Akorn, Inc. (collectively, the “Generic
Defendants”). All defendants will be collectively referred to as
“Defendants.”
2

1

by marketing prescription eye medications that allegedly deliver
unnecessarily

large

eye

drops,

which

results

purchasing more medication than they require.
have

brought

various

against Defendants.
separately

to

state

law

consumer

in

consumers

These Plaintiffs

fraud-related

claims

The Generic and Brand Name Defendants move

dismiss

Plaintiffs’

Complaint

on

the

following

grounds: (1) lack of standing; (2) preemption; and (3) failure to
state a claim.

For the reasons set forth herein, the Court GRANTS

Defendants’ motions on the basis that Plaintiffs lack standing to
bring suit, and therefore, all of Plaintiffs’ claims are dismissed
without prejudice.

However, Plaintiffs are given leave to amend

their Complaint within thirty-days (30) from the date of the Order
accompanying this Opinion.
BACKGROUND
For

the

purposes

of

these

motions,

I

will

only

recount

relevant facts from Plaintiffs’ Complaint and take them as true.
Defendants are brand name and generic pharmaceutical companies
that “perform selling, marketing and distribution activities . .
. for [various] prescription eye drop products.”
These

eye

drops,

pharmaceuticals,”

are

also

known

prescribed

as
for

Compl., ¶ 43.

“topical
serious

ophthalmic

diseases

and

conditions such as glaucoma, allergies, infections, inflammations,
[and] pre- and post-operative conditions . . . .”

Id. at ¶ 2.

Defendants “sell their prescription eye drop products as fluid in
2

plastic bottles.

They sell a given volume of medication (e.g.,

2.5 or 5.0 mL) for a certain price.”

Id. at ¶ 3.

According to Plaintiffs, scientific literature from the past
decades “establishes that these bottles, which also serve as
dispensers, emit drops so large that they exceed the capacity of
the fornix, the area between the eye and the lower eyelid.”
at ¶ 5.

Id.

Consequently, the excess fluid “can cause allergy or

pigmentation, or drains into their nasolacrimal drainage systems
and from there into the bloodstream where it can create a risk of
toxic side effects.”

Id.

Plaintiffs submit that, according to

certain scientific studies, “[s]maller size drops on the order of
15 µL have an efficacy and bioavailability equivalent to larger
drops.”

Id. at ¶ 8. “Yet Defendants’ eye drops are uniformly much

larger than 15 µL. Some are more than three times that size.”
at ¶ 9.

Id.

Plaintiffs allege that as a result of Defendants’ design,

“the excess product cannot be used, is entirely wasted, [and]
provides no pharmaceutical benefit.”
Indeed,
“Defendants

the
have

gravamen

of

persisted

Id. at ¶ 5.

Plaintiffs’
in

their

Complaint
unfair,

is

that

unethical,

unconscionable, and unlawful practices of selling prescription
ophthalmic medicine in dispensers that emit much larger eye drops.
As a result, consumers use more medication than they should, run
out of medicine before they should, and have to buy additional
bottles at great expense, providing increased . . . profits for
3

Defendants.”
that

“there

Id. at ¶ 11.
is

no

In that regard, Plaintiffs complain

legitimate

supplied smaller eye drops.

reason

why

Defendants

have

not

As they have long known, the size of

the drop is determined by a factor under their control, the
dimensions of the plastic dropper tip.”

Id. at ¶ 10.

Instead,

Plaintiffs claim that Defendants “would not reduce the drop size
of [their] products because it would mean that patients would be
able to use the bottles longer and [Defendants] would therefore
sell less product.”

Id. at ¶ 6.

Importantly, as to damages,

Plaintiffs base their claims on the allegation that “patients are
entitled to receive full use and therapeutic benefit of the entire
product they purchase.

Yet because of the Defendants’ illegal

schemes to increase their profits at consumers’ expense, patients
are compelled to purchase larger quantities that, through no fault
of their own, go to waste, and as a result they and their thirdparty payor pay much more than they should for the treatment they
need.”

Id. at ¶ 3.

Plaintiffs further allege certain facts regarding the role of
the Food and Drug Administration (“FDA”) in approving the size of
eye drops.

Plaintiffs aver that “a reduction in eye drop size to

15 µl would not have a substantial potential to have an adverse
effect on the identity, strength, quality, purity, or potency of
the drug product as these factors may relate to the safety or
effectiveness of the drug product.”
4

Id. at ¶ 153.

Therefore,

Plaintiffs, in their Complaint, claim that a reduction in eye drop
size would not be a “major change” requiring prior FDA approval.
See Id.

Moreover, Plaintiffs explain that because the FDA does

not “regulate the economics of drug use . . . the FDA does not
require or specifically permit Defendants [] to make their eye
drops so large that it leads to waste of medication.”

Id. at ¶

155.

In further support of their position that the FDA plays no

role

in

this

respect,

Plaintiffs

cite

to

certain

anecdotal

evidence. For example, Plaintiffs point out that defendant Alcon’s
drug, Travatan Z, had a 25 µL when the FDA conducted its initial
approval review.

Id. at ¶ 156.

Nevertheless, Plaintiffs allege

that just a few years later, a scientific study determined that
“the size of Travatan Z drops [was] 30 µL.”
according

to

Plaintiffs,

“the

FDA’s

Id. at ¶ 157.

website

And,

contains

no

applications for, or approvals of, the above changes in drop size
. . . . Thus, [the] FDA approval of those changes was apparently
not required.”

Id. at ¶ 158.

In the Complaint, twenty-five causes of action are asserted
against

Defendants.

Plaintiffs

seek

to

bring

these

claims

individually, and on behalf of classes of consumers and thirdparty payors who have paid all or part of the purchase prices of
prescription eye drops manufactured and sold by Defendants. More
specifically, each of the named plaintiffs asserts consumer fraud
related claims applicable in the state in which he/she resides.
5

Those state laws include: New Jersey Consumer Fraud Act, California
Unfair

Competition

Law,

Florida

Deceptive

and

Unfair

Trade

Practices Act, Illinois Consumer Fraud Act, North Carolina Unfair
and

Deceptive

Trade

Practices

Act

and

Texas

Deceptive

Trade

Practices Act.
On

these

current

motions,

the

Brand

Name

and

Generic

Defendants move separately to dismiss all of Plaintiffs’ claims
based on standing, preemption and failure to state a claim. 3
Because standing is a threshold question of jurisdiction, I turn
to that issue first. See Steel Co. v. Citizens for a Better
Environment, 523 U.S. 83, 109-10 (1998) (finding that a plaintiff's
Article III standing is a prerequisite for the federal courts to
decide the merits of a suit); Ballentine v. United States, 486
F.3d 806, 810 (3d Cir. 2007).

To date, similar claims against Defendants have been brought
in three other federal jurisdictions: Florida, Missouri, and
Illinois. In the Florida action, Freburger v. Alcon Labs., No.
13-24446 (S.D. Fla.), plaintiffs voluntarily dismissed the lawsuit
before oral argument on a pending motion to dismiss.
In the
Illinois case, Eike v. Allergan, Inc., No. 12-1141 (S.D. Ill.),
the court there denied defendants’ motion to dismiss based on
similar grounds to those asserted here.
However, the district
court in the Eastern District of Missouri dismissed plaintiffs’
claims on identical arguments raised by Defendants in this matter.
See Thompson v. Allergan USA, Inc., 993 F. Supp. 2d 1007 (E.D. Mo.
2014),
3

6

DISCUSSION
I.

Standing
Article III of the Constitution limits the scope of the

federal

judicial

"controversies."

power
U.S.

to

the

Const.

adjudication

art.

III,

§

of

2.

"cases"

This

or

“bedrock

requirement,” see Valley Forge Christian Coll. v. Ams. United for
Separation of Church & State, Inc., 454 U.S. 464, 471 (1982),
protects the system of separation of powers and respect for the
coequal branches by restricting the province of the judiciary to
"decid[ing] on the rights of individuals." Marbury v. Madison, 5
U.S. 137 (1803). Indeed, “‘[n]o principle is more fundamental to
the judiciary's proper role in our system of government than the
constitutional limitation of federal-court jurisdiction to actual
cases or controversies.’” Raines v. Byrd, 521 U.S. 811, 818 (1997)
(quoting Simon v. E. Ky. Welfare Rights Org., 426 U.S. 26, 37
(1976)).
Courts

have

developed

several

justicability

doctrines

to

enforce the case-or-controversy requirement, and “perhaps the most
important of these doctrines” is the requirement that “a litigant
have ‘standing’ to invoke the power of a federal court.”

In re

Schering-Plough Corp. Intron/Temodar Consumer Class Action, 678
F.3d 235, 244 (3d Cir. 2012)(quoting Allen v. Wright, 468 U.S.
737, 750 (1984)). The seminal standing question is “whether the
plaintiff has alleged such a personal stake in the outcome of the
7

controversy as to warrant his [or her] invocation of federal-court
jurisdiction and to justify exercise of the court's remedial powers
on his [or her] behalf.”

Id. (internal quotations and citations

omitted).
Of

course,

a

plaintiff

bears

the

burden

of

meeting

the

"irreducible constitutional minimum" of Article III standing by
establishing three well-settled elements:
First, the plaintiff must have suffered an injury in
fact—an invasion of a legally protected interest which
is (a) concrete and particularized and (b) actual or
imminent, not conjectural or hypothetical.
Second, there must be a causal connection between the
injury and the conduct complained of—the injury has to
be fairly traceable to the challenged action of the
defendant, and not the result of the independent action
of some third party not before the court.
Third, it must be likely, as opposed to merely
speculative, that the injury will be redressed by a
favorable decision.
Lujan

v.

Defenders

of

Wildlife,

504

U.S.

555,

560-61

(1992)

(internal quotations, alterations, and citations omitted).
The Third Circuit has stressed that of the three required
elements of constitutional standing, “the injury-in-fact element
is often determinative.”

Toll Bros., Inc. v. Twp. of Readington,

555 F.3d 131, 138 (3d Cir. 2009).

To satisfy this requirement,

the alleged injury must be “particularized,” such that it “must
affect the plaintiff in a personal and individual way.” Lujan, 504
U.S. at 560 n.1.

Indeed, an injury-in-fact also “must be concrete

8

in both a qualitative and temporal sense. The complainant must
allege

an

injury

to

himself

that

is

distinct

Whitmore v. Arkansas, 495 U.S. 149, 155 (1990).

and

palpable.”

And, the injury

must not be abstract or subjective. See Id.; Laird v. Tatum, 408
U.S. 1, 13-14 (1972). Allegations of a potential future injury, or
the

mere

possibility

of

a

future

injury,

will

not

establish

standing. See Whitmore, 495 U.S. at 158; Employer's Ass'n of New
Jersey v. New Jersey, 601 F. Supp. 232, 238 (D.N.J. 2003), aff'd
774 F.2d 1151 (3d Cir. 1985). While economic injury is one of the
paradigmatic forms of standing, see Danvers Motor Co., Inc. v.
Ford Motor Co., 432 F.3d 286, 291 (3d Cir. 2005), a demand for
damages, by itself, will not establish an injury-in-fact. See
Rivera

v.

Wyeth-Ayerst,

283

F.3d

315,

320

(5th

Cir.

2002);

Koronthaly v. L'Oreal USA, Inc., No. 07-5588, 2008 U.S. Dist. LEXIS
59024, at *13 (D.N.J. Jul. 29, 2008).
Moreover, “the 'injury-in-fact' test requires more than an
injury to a cognizable interest. It requires that the party seeking
review be himself [or herself] among the injured." Id. at 563
(quoting Sierra Club v. Morton, 405 U.S. 727, 734-35 (1972)). The
injury must also be "an invasion of a legally protected interest."
Id. at 560.

In other words, the injury-in-fact requirement exists

to assure that litigants have a “personal stake” in the litigation.
See The Pitt News v. Fisher, 215 F.3d 354, 360 (3d Cir. 2000). By
ensuring that litigants present actual cases and controversies,
9

courts can keep the judicial branch from encroaching on legislative
prerogatives, thereby preserving the separation of powers. See
Valley Forge v. Americans United for Separation of Church and
State, 454 U.S. 464, 473-74 (1982).
“[T]he standing inquiry requires careful judicial examination
of a complaint's allegations to ascertain whether the particular
plaintiff is entitled to an adjudication of the particular claims
asserted." Allen, 468 U.S. at 752.

In that regard, at the pleading

stage, "[a]lthough general factual allegations of injury resulting
from the defendant's conduct may suffice, the complaint must still
'clearly and specifically set forth facts sufficient to satisfy'
Article III.”

Reilly v. Ceridian Corp., 664 F.3d 38, 41 (3d Cir.

2011) (quoting Lujan, 504 U.S. at 561); Whitmore, 495 U.S. at 155;
see, e.g., Anjelino v. N.Y. Times Co., 200 F.3d 73, 88 (3d Cir.
2000) ("Standing is established at the pleading stage by setting
forth specific facts that indicate that the party has been injured
in fact or that injury is imminent, that the challenged action is
causally connected to the actual or imminent injury, and that the
injury may be redressed by the cause of action.").
In this case, although Plaintiffs assert numerous claims and
allege a variety of scientific studies relating to the designs of
Defendants’ eye drop bottles, their only theory of economic harm
is relatively straightforward: Plaintiffs were injured because
they did not receive the full use and therapeutic benefit of the
10

entire product they purchased due to Defendants’ design of their
bottles to dispense larger than necessary eye drops, which led to
waste.

Simply stated, Plaintiffs maintain that their losses

resulted from overpaying for wasted drops that they were not able
to use.

Moreover, while Plaintiffs allege that physical harm can

result from an excessive dose of the medications, none of the named
Plaintiffs have alleged that they suffered any side effects from
the use of the eye drops.

Thus, Plaintiffs, themselves, may not

premise standing on a theory of physical injury.
Defendants posit that Plaintiffs have not shown a concrete
injury-in-fact because Plaintiffs received the benefit of their
bargain; that is, Plaintiffs were able to use the prescribed eye
medications that they purchased.

Plaintiffs, in response, contend

that standing is easily established in this case based on the
standards set forth by § 5(a) of the Federal Trade Commission
(“FTC”) Act.

Plaintiffs’ argument relies on a FTC statement,

entitled “Policy Statement on Unfairness” (“Policy Statement”).
Pursuant to the Policy Statement, “[a]n act or practice [in the
context of consumer fairness] is ‘unfair’ . . . if it causes or is
likely to cause substantial injury to consumers which is not
reasonably avoidable by consumers themselves and not outweighed by
countervailing benefits to consumers or competition.”

11

See FTC

Policy Statement on Unfairness (Dec. 17, 1980). 4

Substantial

injury, according to the Policy Statement, may involve “monetary
harm . . . when sellers coerce consumers into purchasing unwanted
goods and services.”

Id.

Based on these standards, Plaintiffs

allege, in part, that “Defendants’ practices cause substantial
consumer injury because Defendants have . . . [compelled] consumers
into

purchasing

unwanted

Compl., ¶ 189.

amounts

of

prescription

eye

drops.”

The Court does not find Plaintiffs’ theory of

economic damages sufficient to confer standing.
At the outset, while Plaintiffs rely on standards set forth
in

the

Policy

Statement,

an

alleged

violation

of

the

Policy

Statement, by itself, is not sufficient to show an injury-in-fact
for standing purposes. See Polanco v. Omnicell, Inc., 988 F. Supp.
2d 451, 469 (D.N.J. 2013) (“merely asserting violations of certain
statutes is not sufficient to demonstrate an injury-in-fact for
purposes of establishing standing under Article III . . . .”); Doe
v. Nat'l Bd. of Med. Exam'rs, 199 F.3d 146, 153 (3d Cir. 1999)
(observing that it is “incorrect" to “equate[] a violation of a
statute

with

an

injury

sufficient

to

confer

standing"

and

Plaintiffs argue that the Policy Statement is critical to the
standing analysis because they have based their claims in large
part on the standards set forth in the Policy Statement, which
certain states -- namely, Florida, Illinois and North Carolina -have adopted as a part of their consumer fraud statutes.
See
Compl., ¶¶ 210, 216, 220(citing Fla. Stat. § 501.204(2); 815 ILCS
505/2; N.C.G.S. § 75-1.1(a)).
4

12

explaining that “[t]he proper analysis of standing focuses on
whether the plaintiff suffered an actual injury, not on whether a
statute

was

violated.”);

see

also

Rivera

v.

Wyeth-Ayerst

Laboratories, 283 F.3d 315, 319-20 (5th Cir. 2002) (finding that
plaintiffs could not prevail by establishing that Wyeth violated
a legal duty owed to consumers; instead, the injury must be
personal).

Rather, each Plaintiff must allege that he or she

personally suffered some actual economic damage as a result of
using Defendants’ medications.
There are typically two theories of economic harm associated
with consumer fraud actions: benefit-of-the-bargain and out-ofpocket expenses.

The former relates to economic damages caused by

a product failing to perform as advertised, and therefore, the
consumer would not have received the benefit of his/her bargain.
See, e.g., Koronthaly v. L'Oreal USA, Inc., 374 Fed. Appx. 257,
259 (3d Cir. 2010) (“[a]bsent any allegation that [plaintiff]
received a product that failed to work for its intended purpose or
was worth objectively less than what one could reasonably expect,
[plaintiff] has not demonstrated a concrete injury-in-fact.”).
The latter encompasses any expenses that a plaintiff incurred as
a result of purchasing the defective product, e.g., replacement
costs.

See, e.g., Marcus v. BMW of N. Am., LLC, 687 F.3d 583,

606 (3d Cir. 2012); Dicuio v. Brother Intern. Corp., No. 11-1447,
2012 U.S. Dist. LEXIS 112047, at *7 (D.N.J. Aug. 9, 2012) (“The
13

out-of-pocket rule applies when a plaintiff can demonstrate that
he paid money, and is now, out-of-pocket.”).

It is important to

point out that Plaintiffs do not premise their standing on either
of these two theories; indeed, Plaintiffs have neither alleged
that

Defendants

somehow

induced

Plaintiffs

to

purchase

the

medications by misrepresenting or concealing any information, nor
do Plaintiffs claim that the medications were ineffective for their
prescribed use and that they paid a premium for the medications.
Instead, Plaintiffs claim that they were precluded from using
the wasted eye drops because of Defendants’ design of the bottle
tip.

But, what Plaintiffs do not allege, is that they were

promised a specific number of doses or drops of the medications by
Defendants and that they failed to receive those amounts.
any

promises,

unsupported

Plaintiffs’

conclusion

theory

concerning

of

damages

Absent

merely

“an

alleged

[their]

is

loss,”

see

Lieberson v. Johnson & Johnson Consumer Cos., 865 F. Supp. 2d 529,
541 (D.N.J. 2011); Plaintiffs do not allege what specific economic
loss they have suffered.
the

costs

associated

First, Plaintiffs do not allege any of

with

the

products

at

issue,

and

while

Plaintiffs claim that the wasted drops have some economic value,
they

have

failed

to

quantify

that

value.

Put

differently,

Plaintiffs theorize that if the bottles were designed to dispense
with smaller doses of eye drops, that fact would somehow produce
a savings to them.

Plaintiff’s injury-related allegations amount
14

to nothing more than conjecture since Plaintiffs have neither
alleged any comparable cheaper products that they would have
purchased,

nor

have

they

alleged

that

Defendants

would

manufacture, or have manufactured, less expensive products based
on a different design.
Notwithstanding those deficiencies, as to costs, Plaintiffs
aver that “evidence” exists to establish that the medications at
issue would be less expensive if the eye drops were made smaller.
Plaintiffs cite to a 2006 article co-authored by an Allergan
employee, which states that “smaller drops would be preferable to
minimize systemic exposure and spilled or wasted medication” and
reducing eye drop size would “provid[e] cost savings to patients
and managed care providers.”

Compl., ¶ 7.

Aside from the fact

that this article presumably only pertains to Allergan’s products,
it is also cited out of context.

The article discusses the

possibility that patients might be able to dispense smaller drops
from their existing bottles of medication by holding the bottle at
a different angle.

Crucially, there is no indication in the

article that any of the defendants would manufacture products that
produce smaller eye drops at a less expensive price. 5

Hence,

Nor can Plaintiffs base their injury-in-fact on a statement
that reducing drop size would result in Alcon selling fewer bottles
of medication. Compl. ¶¶ 6, 79. Plaintiffs allege that such a
statement was made by an unidentified Alcon marketing executive at
an unspecified time for an unknown reason. But, this allegation
does not meet the Rule 12(b)(6) standard as it is conclusory in
5

15

allegations based on this article are not sufficient to establish
an injury-in-fact.
In

sum,

absent

sufficient

allegations

as

to

injury,

Plaintiffs are left with their bald assertion that they overpaid
for effective eye medications that would have been less expensive
if they were designed according to Plaintiffs’ specifications.
Such a conclusory theory is simply too remote and abstract to
qualify as a concrete and particularized injury under Article III
standing.

See, e.g., Koronthaly, 374 Fed. Appx. at 259 (“[a]bsent

any allegation that [plaintiff] received a product that failed to
work for its intended purposes or was worth objectively less than
what one could reasonably expect,” the plaintiff had not suffered
Article III injury-in-fact); Medley v. Johnson & Johnson Consumer
Cos., No. 10-2291, 2011 U.S. Dist. LEXIS 4627, at *5-7 (D.N.J.
Jan. 18, 2011) (plaintiffs lacked Article III standing because
“the product worked as intended.”); Thompson, 993 F. Supp. 2d at
1009 (rejecting claims similar to those raised here on the basis
that plaintiffs failed to allege that the eye drop products are
“anything other than what [they have] always purported to be” and
received the “benefit of the bargain.”); Carter v. Alcon Labs,
Inc., No. 13-997, 2014 U.S. Dist. LEXIS 32381, at *12-13 (E.D. Mo.

nature. More importantly, this statement alone does not allege
how it would impact Alcon’s discretion, much less the discretion
of the thirteen other Defendants, in setting the prices of
redesigned products.
16

Mar.

13,

2014)(“even

if

Defendants

sold

bottles

with

less

medication, Plaintiff has not suggested there is anything to
preclude them from charging what they now charge for the bottles
currently available for purchase.”); Dominguez v. UAL Corp., 666
F.3d 1359, 1364 (D.C. Cir. 2012)(finding no Article III standing
when plaintiffs’ theory regarding United Airlines ticket prices
required “pil[ing] speculation atop speculation” as to how United
would price its tickets in the future); Bowman v. RAM Med., Inc.,
10-4403, 2012 U.S. Dist. LEXIS 75218, at *7-10 (D.N.J. May 31,
2012); Waldron v. Jos. A. Bank Clothiers, Inc., No. 12-2060, 2013
U.S. Dist. LEXIS 189191, at *15 (D.N.J. Jan. 18, 2013); Coghlan v.
Wellcraft Marine Corp., 240 F.3d 449, 455 n.3 (5th Cir. 2001);
Medley v. Johnson & Johnson Consumer Cos., No. 10-2991, 2011 U.S.
Dist. LEXIS 4627, at *4-6 (D.N.J. Jan. 18, 2011). 6
Because Plaintiffs lack standing to bring suit, it deprives
this Court of subject matter jurisdiction.

6

See Ballentine, 486

To be fair, I recognize that the court in Eike v. Allergan,
Inc., found that plaintiffs there, who brought claims similar to
those asserted in this case, have sufficiently alleged an actual
injury. 2014 U.S. Dist. LEXIS 34894, at *10-11 (S.D. Ill. Mar. 18,
2014). But, the Eike Court’s analysis in that regard was confined
to violations of the Illinois Consumer Fraud & Deceptive Business
Practice Act, not Article III standing.
More fundamentally,
however, for the reasons expressed here, I am not persuaded by
that court’s conclusion. In fact, although I need not address the
merits of Plaintiffs’ claims, I note that the lack of Article III
standing may be fatal to Plaintiffs establishing an ascertainable
loss or injury in each of their state-law based consumer fraud
claims.
17

F.3d at 810.

Absent jurisdiction, it is well-settled that the

Court is without authority to address the parties’ remaining meritbased arguments. See Adams v. Ford Motor Co., 653 F.3d 299, 304
(3d

Cir.

2010)

(“[i]f

plaintiffs

do

not

possess

Article

III

standing, both the District Court and this Court lack subject
matter jurisdiction to address the merits of plaintiff's case.”).
Nevertheless, because the Court finds that Plaintiffs have not
sufficiently alleged standing, they are given leave to amend their
Complaint to cure the deficiencies consistent with the dictates of
this Opinion.

Thus, I am not addressing the parties’ arguments on

the merits of Plaintiffs’ case. 7

7

I will nonetheless take this opportunity to highlight the
issue of preemption should this litigation proceed farther – in
the event the Complaint is amended and motion practice follows.
Both Generic and Brand Name Defendants contend that Plaintiffs
brought state law consumer fraud related claims in order to “force”
the manufacturers to redesign their federally approved droppers to
dispense smaller drops; doing so, Defendants submit, conflicts
with federal law regulating manufacturers of prescription drugs.
In the context of pharmaceutical regulations and specifically
labeling, the Supreme Court in Wyeth v. Levine, 555 U.S. 555
(2009), held that the plaintiffs’ labeling claims under state tort
laws against brand name drug companies are not preempted by the
FDCA. Id. at 578. However, in both PLIVA, Inc. v. Mensing, 131
S. Ct. 2567 (2011) and Mutual Pharmaceutical Co. v. Bartlett, 133
S. Ct. 2466 (2013), the Supreme Court held that state tort claims
against generic companies – including labeling and design claims
– are preempted because of the doctrine of “sameness.” See Mensing,
131 S. Ct. at 2574-75; Bartlett, 133 S. Ct. at 2474-76. In so
doing, the Supreme Court in these decisions made clear the
distinction between generic and brand name products. It is, thus,
incumbent upon the parties, here, to address any distinctions in
future motion practice regarding preemption.
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CONCLUSION
For the reasons set forth above, Defendants’ motions to
dismiss are GRANTED as Plaintiffs lack standing to bring suit.
Plaintiffs are given leave to amend their Complaint within 30 days
from the date of the Order accompanying this Opinion.

DATE:

June 24, 2015

/s/
Freda L. Wolfson
United State District Judge

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