LoConte et al v. Forest Laboratories, Inc.

Filing 196

Judge Nathaniel M. Gorton: ENDORSED ORDER entered. MEMORANDUM AND ORDERFor the foregoing reasons, plaintiffs motion to certify a class (Docket No. 137) is DENIED. So ordered. Associated Cases: 1:09-md-02067-NMG, 1:14-cv-13848-NMG(Caruso, Stephanie) Modified on 8/15/2017 (Caruso, Stephanie).

United States District Court
District of Massachusetts
)
)
)
CELEXA AND LEXAPRO MARKETING AND )
)
SALES PRACTICES LITIGATION
)
)
DELANA S. KIOSSOVSKI and
)
RENEE RAMIREZ,
)
)
Plaintiffs,
)
)
v.
)
)
FOREST LABORATORIES, INC.,
)
FOREST LABORATORIES, LLC and
)
FOREST PHARMACEUTICALS, INC.,
)
)
Defendants.
)
)
In re:

MDL No.
09-02067-NMG

Civil Action No.
14-13848-NMG

MEMORANDUM & ORDER
GORTON, J.
This case arises out of the marketing and sales of the
anti-depressant drugs Celexa and Lexapro by defendants Forest
Laboratories, Inc., Forest Laboratories, LLC and Forest
Pharmaceuticals, Inc. (collectively, “defendants” or “Forest”).
Plaintiffs Delana Kiossovski and Renee Ramirez (collectively,
“plaintiffs”) allege that defendants 1) engaged in a fraudulent
marketing scheme designed to induce consumers to purchase Celexa
and Lexapro for pediatric use in violation of the Racketeer
Influenced and Corrupt Organizations Act (“RICO”), 18 U.S.C.

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§§ 1962(c) and (d), 2) were unjustly enriched and 3) violated
the Washington Consumer Protection Act, RCW § 19.86.010 et seq.
Plaintiffs’ motion for class certification (Docket No. 137)
is currently pending before the Court.

For the reasons that

follow, that motion will be denied.
I.

Background and procedural history
Celexa and Lexapro are closely related anti-depressants.

Forest obtained approval from the Food and Drug Administration
(“FDA”) to market Celexa for adult use in 1998 and Lexapro for
adult use in 2002.

It later sought to market both drugs to

treat pediatric major depressive disorder (“MDD”).
A.

FDA Approval Process

To obtain FDA approval to market Celexa and Lexapro for
pediatric use, Forest had to show that the drugs would be more
effective than placebos in treating MDD in pediatric patients.
The FDA typically requires at least two “positive” placebocontrolled clinical trials before approval.

A “positive” drug

study shows statistically significant improvements for patients
who are administered the drug rather than a placebo while a
“negative” study indicates no statistically significant
difference.

Drug manufacturers submit trial results to the FDA

as part of their “new drug applications” (“NDAs”).
Forest conducted four double-blind, placebo-controlled
studies on the efficacy of Celexa and Lexapro in treating

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pediatric depression.

The first two examined the efficacy of

Celexa and were completed in 2001.

The Celexa Study 18 (“MD-

18”) produced results that the FDA determined were positive
(although plaintiffs dispute that finding).

On the other hand,

Celexa Study 94404 (“Lundbeck Study”) produced negative results.
Forest submitted the results of the two Celexa studies to the
FDA in a supplemental NDA in 2002.

The FDA denied Forest’s

application for a pediatric indication for Celexa after finding
that the Lundbeck Study was negative.
addressed the efficacy of Lexapro.

The other two studies

Lexapro Study 15 produced

negative results but Lexapro Study (“MD-32”) produced
statistically significant, and therefore positive, results.
Before 2005, the FDA-approved labels for both drugs stated
that “[s]afety and effectiveness in pediatric patients have not
been established”.

In February, 2005, Forest revised Celexa’s

label to include a description of MD-18 and the Lundbeck Study
and Lexapro’s label to describe the negative study.
In 2008, Forest submitted study results to the FDA in a
supplemental NDA.

The following year, the FDA reviewed the

positive results in MD-18 and MD-32, noted the chemical
similarities between Celexa and Lexapro and approved Lexapro as
safe and effective in treating MDD in adolescents.
not seek similar FDA approval for Celexa.

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Forest did

B. Delana Kiossovski and Renee Ramirez
The proposed class representatives both purchased Celexa
and/or Lexapro for their children and both assert that they were
mis-led to believe that those drugs effectively treated
pediatric depression.

From July, 2001 to March, 2002,

Kiossovski bought Celexa for her daughter, who was then 12 years
old, based upon the recommendation of her daughter’s
psychiatrist, Dr. Stephen Barnett.
daughter attempted suicide.
Celexa.

In 2002, Kiossovski’s

After that, she stopped using

Kiossovoski became aware that the efficacy of Celexa

for children was unproven in 2014.

From February, 2003 to

April, 2004, the eight-year-old son of Ramirez used Celexa for
his depression and from April, 2004 to January, 2007 he used
Lexapro.

His physician, Dr. Michael Saito, recommended both

drugs.
C. Procedural history
In August, 2014, former plaintiff Marlene LoConte and
Kiossovski commenced this action in the Western District of
Washington by filing a complaint on behalf of themselves and
putative consumer classes.

They alleged that Forest

fraudulently promoted the pediatric use of Celexa and Lexapro
despite knowing that the drugs did not provide any clinically
significant benefit over placebos in treating MDD.

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The case was

transferred to this Court pursuant to a multi-district
litigation assignment in October, 2014.
In June, 2015, this Court 1) allowed defendants’ motion to
dismiss with respect to the RICO, Massachusetts Consumer
Protection Act, M.G.L. c. 93A (“Chapter 93A”) and unjust
enrichment claims brought by LoConte and 2) denied the motion
with respect to the RICO, Washington Consumer Protection Act and
unjust enrichment claims brought by Kiossovski.

Plaintiffs

amended the complaint in January, 2016 by replacing LoConte with
Ramirez as the second putative class representative.

The

amended complaint raises two RICO claims by Kiossovski and
Ramirez, an unjust enrichment claim by both plaintiffs and a
Washington Consumer Protection Act claim by Kiossovski.
In February, 2016, defendants moved to dismiss the amended
complaint which this Court denied in June, 2016.

In March,

2017, plaintiffs moved for class certification which defendants
opposed.

This Court convened a hearing on the motion for class

certification and that motion is the subject of this memorandum
and order.
II.

For the reasons that follow, it will be denied.

Motion to Certify Class
Plaintiffs request the certification of the following

nationwide RICO classes and subclasses:
Damages Class. All persons, in the United States of
America and its territories, who, for purposes other than
resale, (1) paid or incurred costs for the drug Celexa

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prescribed for use by an individual under 18 years of age;
and/or (2) paid or incurred costs on or before March 19,
2009, for the drug Lexapro prescribed for use by an
individual under 18 years of age.
Plaintiffs also propose the following sub-classes because
there is no study demonstrating that Celexa and/or Lexapro are
effective for children 12 or younger and MD-32 was not submitted
to the FDA in a supplemental NDA until March, 2008:
Child Subclass. All persons, in the United States of
America and its territories, who, for purposes other than
resale, (1) paid or incurred costs for the drug Celexa
prescribed for use by an individual under 13 years of age;
and/or (2) paid or incurred costs on or before March 19,
2009, for the drug Lexapro prescribed for use by an
individual under 13 years of age.
MD-32 Subclass. All persons, in the United States of
America and its territories, who, for purposes other than
resale, (1) paid or incurred costs for the drug Celexa
prescribed for use by an individual under 18 years of age;
and/or (2) paid or incurred costs on or before March 11,
2008, for the drug Lexapro prescribed for use by an
individual under 18 years of age.
Plaintiffs alternatively seek to certify a “liability-only
class” that is the same as the proposed damages class under Fed.
R. Civ. P. 23(c)(4).

Plaintiffs also move for the designation

of Kiossovski and Ramirez as class representatives and to
appoint Christopher L. Coffin of Pendley, Baudin & Coffin,
L.L.P. and Michael Baum of Baum, Hedlund, Aristei & Goldman,
P.C., along with their respective law firms, as class counsel.
Plaintiffs further request certification of classes of
Washington residents for the unjust enrichment and Washington

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Consumer Protection Act claims.

Kiossovski is the putative

class representative for those claims.
A.

Class Certification Pursuant to Fed. R. Civ. P. 23(b)

A court may certify a proposed class only if it satisfies
all of the requirements in Fed. R. Civ. P. 23(a) and one of the
requirements in Fed. R. Civ. P. 23(b). See Smilow v. Sw. Bell
Mobile Sys., Inc., 323 F.3d 32, 38 (1st Cir. 2003).

Here,

plaintiffs seek to certify a class under Rule 23(b)(3).
Although a court must conduct a “rigorous analysis” before
certifying a class, id., it should inquire into the merits of
the action only “to the extent that the merits overlap the Rule
23 criteria,” In re Boston Sci. Corp. Sec. Litig., 604 F. Supp.
2d 275, 281 (D. Mass. 2009)(quoting In re New Motor Vehicles
Canadian Export Antitrust Litig., 522 F.3d 6, 24 (1st Cir.
2008)).

If there are disputed factual or legal premises,

however, the court may “probe behind the pleadings to formulate
some prediction as to how specific issues will play out”. In re
New Motor Vehicles, 522 F.3d at 20 (citations omitted).
Rule 23(a) contains requirements of numerosity,
commonality, typicality and adequacy:
(1)

the class is so numerous that joinder of all
members [as individual plaintiffs] is
impracticable;

(2)

there are questions of law or fact common to the
class;

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(3)

the claims or defenses of the representative
parties are typical of the claims or defenses of
the class; and

(4)

the representative parties will fairly and
adequately protect the interests of the class.

Fed. R. Civ. P. 23(a).

Rule 23(b)(3) requires that 1) common

questions of law or fact “predominate” over those affecting
individual class members and 2) a class be the “superior” method
for fair and efficient adjudication. Fed. R. Civ. P. 23(b)(3).
B.

Application of the Rule 23(a) Requirements
1.

Numerosity

It is undisputed that the proposed class includes numerous
consumers who purchased Celexa or Lexapro for minors, rendering
joinder impractical. See In re Relafen Antitrust Litig., 218
F.R.D. 337, 342 (D. Mass. 2003).
2.

Commonality

In assessing commonality, the court should inquire into
“the capacity of a classwide proceeding to generate common
answers apt to drive the resolution of the litigation.” Wal-Mart
Stores, Inc. v. Dukes, 564 U.S. 338, 350 (2011).

The plaintiff

must show that there is a common contention capable of classwide resolution such that
determination of its truth or falsity will resolve an
issue that is central to the validity of each one of the
claims in one stroke.

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Id.

Plaintiffs assert that their “claims all originate with

Forest’s common course of unlawful conduct”, i.e. promoting offlabel, pediatric prescriptions of Celexa and Lexapro.
Plaintiffs satisfy the commonality requirement.
3.

Typicality

To meet the typicality prerequisite, the injuries of the
named plaintiff must arise from the same events or course of
conduct and be based upon the same legal theory as the injuries
and claims of the class. Swack v. Credit Suisse First Boston,
230 F.R.D. 250, 260 (D. Mass. 2005).

The named plaintiff is not

typical of the class if his or her claim may be “subject to
unique defenses that would divert attention from the common
claims”. Id.
Plaintiffs contend that their injuries and the injuries of
the other members of the putative class arise from the same
conduct: purchasing Celexa and/or Lexapro for a child based upon
the belief that the drugs would treat pediatric depression.
Defendants counter that the named plaintiffs will be subject to
individualized defenses based upon the unique medical histories
of their children.

Specifically, defendants highlight that

Kiossovski’s daughter twice attempted suicide, but was the
victim of sexual assault before the second attempt, and that
Ramirez’s son had multiple symptoms and is autistic.

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Defendants’ assertion that the named plaintiffs are not
typical is unavailing.

Plaintiffs have the “essential

characteristics” of the class: they purchased the drugs for
their minor children.

Therefore, the focus of the litigation

will be the alleged injury from that purchase, not the unique
medical situations of their children. See Barry v. Moran, No.
CIV. A. 05-10528-RCL, 2008 WL 7526753, at *11 (D. Mass. May 7,
2008) (internal quotation and citation omitted).

Plaintiffs

meet the typicality requirement.
4.

Adequacy

Adequacy requires that the class representative will
“fairly and adequately protect the interests of the class.” Fed.
R. Civ. P. 23(a)(4).

The named plaintiff must show that 1) its

interests align with the class interests and 2) its counsel is
qualified to litigate the claims vigorously. See Andrews v.
Bechtel Power Corp., 780 F.2d 124, 130 (1st Cir. 1985).
Plaintiffs claim that their interests align with those of
the proposed class because, along with the members of the class,
they have a strong interest in establishing that defendants
fraudulently promoted the use of Celexa and/or Lexapro for
minors and caused damages.

They also submit that this Court has

already determined that their counsel is qualified to represent
classes in this MDL.

Defendants respond that the unique medical

situations of the children of plaintiffs prevent them from

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meeting the adequacy requirement.

This Court agrees with

plaintiffs that they share common interests with the putative
class members and their counsel can adequately represent the
proposed class.
C.

Thus, the adequacy requirement is met.

Application of the Rule 23(b)(3) requirements
1.

Predominance

The crux of the dispute between the parties is whether
plaintiffs satisfy the predominance requirement that
questions of law or fact common to class members
predominate over any questions affecting only
individual members.
Fed. R. Civ. P. 23(b)(3).

The purpose of the requirement is to

assess whether the proposed class is “sufficiently cohesive” to
warrant class adjudication. Amchem Prods., Inc. v. Windsor, 521
U.S. 591, 623 (1997).
The predominance requirement is “far more demanding” than
the commonality requirement in Rule 23(a), id. at 623-24, but it
does not require that each element of the claims is susceptible
to class-wide proof. In re Nexium Antitrust Litig., 777 F.3d 9,
21 (1st Cir. 2015).

The plaintiff need only prove that

individualized questions will not “overwhelm” the common ones.
Id.

Thus, the “need for some individualized determinations”

will not defeat class certification. Id.
A plaintiff with a RICO claim must establish 1) conduct
2) of an enterprise 3) through a pattern 4) of racketeering

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activity such as violations of the mail and wire fraud statutes
located at 18 U.S.C. §§ 1341 and 1343. Giuliano v. Fulton, 399
F.3d 381, 386 (1st Cir. 2005).

The parties do not dispute that,

in this case, the four elements are susceptible to common proof.
Instead, the parties contest whether 1) plaintiffs can establish
causation, injury and damages through common proof and
2) defendants’ statute of limitations defenses will require
individualized determinations that overwhelm the common ones.
The first set of disputes arise from the civil damages
provision of the RICO statute which allows “[a]ny person injured
in his business or property by reason of a [RICO violation]” to
recover damages. 18 U.S.C. § 1964(c).

The term “by reason of”

refers to both proximate and but-for causation. In re Neurontin
Mktg. and Sales Practices Litig., 712 F.3d 21, 34 (1st Cir.
2013)(“Neurontin I”)(citation omitted).
a.

Proximate causation

For RICO claims, proximate causation depends upon the
“directness” of the causal chain and the application of three
functional factors. Neurontin I, 712 F.3d at 36.

Directness

refers to both the foreseeability of the injury and the
directness of the causal relationship between the plaintiff’s
injury and the defendant’s misconduct. Id. at 35.
The second part of the assessment involves three functional
factors which implicate 1) concerns about proof, given that the

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less direct an injury, the more difficult it is to calculate
damages, 2) concerns about administrability and avoidance of
multiple recoveries and 3) the societal interest in deterring
unlawful conduct and the issue of whether directly injured
victims would be likely “to vindicate the law as private
attorneys general”. Id. at 35-36.
Plaintiffs contend that proximate cause can be demonstrated
through common evidence showing that there was a fraudulent
scheme and that they were the intended and foreseeable victims.
Defendants state that they will not argue about proximate
causation “[g]iven the Court’s ruling in Painters II”.
This Court agrees with plaintiffs that class-wide proof of
a fraudulent scheme through which defendants intended to obtain
payments from consumers can be used to establish directness and
a favorable balance of the three factors, just as the plaintiffs
did in the Neurontin cases. See Neurontin I, 712 F.3d at 37-40.
Therefore, plaintiffs satisfy the predominance requirement with
respect to proximate causation.
b.

But-for causation

The inquiry with respect to but-for causation asks whether
the plaintiff would have suffered the injury absent the alleged
misconduct. Neurontin I, 712 F.3d at 34.

The plaintiff must

show that it “suffered the sort of injury that would be the
expected consequence of the defendant’s wrongful conduct” but

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need not affirmatively “prove a series of negatives” or exclude
every other possible cause of injury. Id. at 45.

If the

plaintiff succeeds, the burden shifts to the defendant to rebut
the causal inference. Id.
Plaintiffs contend that they can show but-for causation by
having the jury resolve the factual question of whether a
reasonable parent would give a child a drug “that is not better
than a sugar pill but has significant side effects”.

Defendants

reply that but-for causation must be resolved on an individual
basis by examining whether physicians and consumers were exposed
to the off-label promotions.
This Court agrees that whether physicians were exposed to
off-label promotions must be examined on an individual basis.
The individualized nature of the inquiry is highlighted by the
fact that, at the class certification hearing, plaintiffs stated
that that Dr. Saito felt misled by “studies that were not
brought to [his] attention during the marketing blitz”.
Conversely, plaintiffs admitted that Dr. Barnett “didn’t recall
ever being exposed to . . . a sales representative”, let alone
an off-label promotion.
Plaintiffs’ contention that the reaction of a “reasonable
consumer” can be used to show but-for causation is also
unavailing.

They cite no cases in support of such an approach

and conceded at oral argument that they “do not know of a

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specific case that talks about the reasonable-consumer
standard”.
In fact, the only cases cited in their arguments as to butfor causation are Neurontin I and In re Neurontin Mktg. & Sales
Practices Litig., 712 F.3d 60, 67 (1st Cir. 2013) (“Neurontin
III”).

Those decisions recognize that but-for causation may be

proved through a “combination of aggregate evidence and the
circumstantial evidence”. Neurontin III, 712 F.3d at 68; see
also Neurontin I, 712 F.3d at 40.

Neither opinion, however,

refers to a “reasonable consumer” standard for but-for causation
and plaintiffs do not provide any aggregate or circumstantial
evidence in support of but-for causation.

Thus, plaintiffs have

failed to show that common issues predominate with respect to
but-for causation.
c.

Injury

Plaintiffs claim that their injury arises from common
experience of parents purchasing Celexa and/or Lexapro for their
children based upon the incorrect belief that the drugs were
effective.

Defendants retort that assessing the purported

injuries will require individualized determinations as to
1) whether the drug was ineffective and 2) whether class members
would have paid more for an alternative drug.
In support of their argument, plaintiffs “incorporate[] by
reference” a 30-page memorandum filed in support of their second

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motion for class certification in the related case In re Celexa
& Lexapro Mktg. & Sales Practice Litig., No. 14-13848-NMG
(“Painters II”).

Plaintiffs specifically incorporate the

argument that no clinical studies for Celexa or Lexapro were
positive.

The Court notes that incorporating a 30-page

memorandum violates the page limits set by the Court.

In the

interest of efficiency, however, it will address the argument
incorporated by plaintiffs and the response by defendants.
Plaintiffs contend that the two positive studies, MD-18 for
Celexa and MD-32 for Lexapro, do not actually show efficacy.
With respect to MD-18, plaintiffs proffer that, because pink
pills labeled “FP” and “20mg” were accidently used instead of
the “blinded” white, unbranded pills for some patients, the
study was “unblinded” for eight patients.

Plaintiffs also

suggest that, in communicating the issue to the FDA, defendants
used misleading language.

Finally, according to plaintiffs,

defendants improperly included the participants who received the
pink pills in the results reported to the FDA.

That had a

substantial effect: when the patients who received the pink
pills were included there were statistically significant results
but when they were excluded the study was negative.
Defendants vigorously refute that version of events.
state that they reported the error to the FDA in 2000 and
specifically mentioned that it “had the potential to cause

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They

patient bias” and that there were “eight potentially unblinded
patients”.

In April, 2002, according to defendants, they

submitted the MD-18 study report to the FDA.

That report

mentioned the error five times, disclosed that the primary
efficacy analysis had possibly unblinded subjects and also
provided an analysis that excluded those subjects.

The FDA

still determined that MD-18 was a positive study.
Plaintiffs also contest the effectiveness of MD-32 but
their main objection appears to be that the study was
statistically significant but not clinically meaningful.
Plaintiffs’ arguments are underwhelming.

In the first

place, because the FDA is the “exclusive judge of safety and
efficacy”, In re Celexa & Lexapro Mktg. & Sales Practice Litig.,
779 F.3d 34, 38 (1st Cir. 2015), this Court will not question
its determination that MD-18 and MD-32 established the efficacy
of Celexa and Lexapro for use by patients between the ages of 12
and 17.

Moreover, although it would, perhaps, be permissible to

question the FDA’s conclusion if there were evidence that it was
unaware of the supposedly unblinded participants, see id. at 4243, as defendants point out, the information was disclosed to
the FDA in both a letter and the MD-18 report.

The information

is not new simply because its disclosure was not made in
language most appealing to plaintiffs.

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At oral argument, plaintiffs pointed out that Dr. Laughren,
who was employed by the FDA at the time it examined MD-18 and
helped review that study, stated that internal Forest
conversations as to how to disclose the purported unblinding to
the FDA is “probably new information”.

Yet plaintiffs do not

explain how the fact that some participants were given pink
pills during the study constitutes new information when that
fact was already disclosed to the FDA at the time it found MD-18
to be a positive study.

Furthermore, as defendants noted at the

hearing, Dr. Laughren also testified that, even with the socalled new evidence, he would have viewed MD-18 as a positive
study.
Moreover, the Neurontin findings on efficacy and injury do
not apply here because the Neurontin Court expressly limited its
findings on efficacy to cases with the same “mix” of evidence as
was present in the Neurontin cases. Neurontin I, 712 F.3d at 48
(“We need not address what the standard for efficacy would be if
there were no DBRCTs [double-blind randomized controlled trials]
in existence, or if the results of DBRCTs were equivocal, or if
there were a different mix of DBRCT and non-DBRCT evidence.”).
Here, the results of the clinical studies are “equivocal” in
that two studies yielded positive results for Celexa and Lexapro
and two yielded negative results.

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Because the class-wide evidence in this action is
“equivocal”, adjudication of the efficacy issues will likely
require individualized assessments of the utility of Celexa
and/or Lexapro for each patient.

For instance, both of the

physicians of the children of the representative plaintiffs have
testified that Celexa and Lexapro were beneficial for their
patients.

Those patient-specific determinations will overwhelm

the class-wide determinations.

The Court will, therefore, deny

the motion for class certification on that additional ground.
See In re Celexa & Lexapro Mktg. & Sales Practices Litig., 2014
WL 108197, at 9 (D. Mass. Jan. 10, 2014)(“Jaeckel II”)
(“[P]laintiffs [argue] that they purchased a product that Forest
misrepresented as effective but that was not, in fact,
effective.

Forest correctly maintains that individualized

inquiries would predominate over common issues because there
would be a question of whether or not Celexa or Lexapro actually
helped each class member's minor child.”).
d.

Damages

To satisfy the predominance requirement with respect to
damages, plaintiffs must “present a damages model that directly
reflects and is linked to an accepted theory of liability.” In
re Nexium (Esomeprazole) Antitrust Litig., 297 F.R.D. 168, 183
(D. Mass. 2013).

Plaintiffs rely on expert reports from Drs.

Rosenthal and Baum to estimate that the Celexa class suffered

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$140.7 million in damages and the Lexapro class $160.5 million.
Dr. Rosenthal reached those estimates by using Dr. Blum’s
regression models, simulating “but-for scenarios” to predict the
value of prescriptions induced by Forest’s misconduct.
Defendants respond that the damages calculations are flawed
because they fail to consider the difference between what a
consumer paid for the drug and the cost of an alternative
medication and assume that 1) all physicians were subject to
off-label promotion, 2) the drugs were ineffective and 3) all
sales were the result of fraudulent promotions.
This Court agrees that, given the individualized questions
that predominate with respect to but-for causation and injury,
individualized questions also overwhelm the question of damages.
e.

Statute of limitations

The statute of limitations for civil RICO claims is four
years after the plaintiff discovers or should have discovered
the injury. See Rotella v. Wood, 528 U.S. 549, 553 (2000); see
also Lares Grp., II v. Tobin, 221 F.3d 41, 44 (1st Cir. 2000).
Defendants state that they plan to challenge the timeliness
of each consumer’s claim.

For instance, defendants allege that

the claims of the named plaintiffs are untimely because they
filed suit more than 12 years after they first purchased the
drugs, nine years after the labels were edited and five years
after the qui tam suit was publicly available and other

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consumers filed suit.

Plaintiffs respond that common questions

can predominate even if there are individualized affirmative
defenses.

Again incorporating arguments from the memorandum in

the related case, they further proclaim that, because Forest
first publicly admitted to off-label promotion in 2010, no
reasonable consumer would have suspected injury before then.
Plaintiffs’ bald assertion that no reasonable consumer
would have suspected fraudulent promotion before 2010 is belied
by the fact that other plaintiffs discovered their injuries in
2009.

Although the public disclosure of the off-label promotion

in 2010 makes it more likely that consumers would have
discovered their injury, the fact that other consumers
discovered their injuries before then supports an individualized
approach to the statute of limitations defense. See Waste Mgmt.
Holdings, Inc. v. Mowbray, 208 F.3d 288, 296 (1st Cir. 2000).
Accordingly, Plaintiffs have not shown that common issues
predominate with respect the statute of limitations defenses.
2.

Superiority

The superiority criterion requires that class action be
“superior to other available methods for fairly and efficiently
adjudicating the controversy.” Fed. R. Civ. P. 23(b)(3).

In

evaluating superiority, courts consider 1) the interests of
class members in individually litigating separate actions,
2) the extent and nature of existing litigation, 3) the

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desirability of concentrating the litigation of the claims in a
one forum and 4) the difficulty in managing a class action. Id.
Plaintiffs submit that a class action would be superior
because 1) the cost of litigating the action individually would
“eclipse any possible recovery”, 2) the Judicial Panel on
Multidistrict Litigation has already determined that the
litigation will be concentrated in this Court, 3) a class action
would be more efficient and 4) there are no issues of
manageability.

Defendants respond that, because but-for

causation and injury require individualized proof, resolution of
the claims through a class action would result in a quagmire of
unmanageable individual interests.
This Court agrees that resolution of the claims will
require an individualized assessment of whether the drugs would
have been prescribed but-for the off-label promotions and
whether the drugs were effective.

Because resolving this case

as a class action would present serious issues of manageability,
plaintiffs have not satisfied the superiority requirement
pursuant to Fed. R. Civ. P. 23(b)(3).
The Court thus declines to certify the nationwide RICO
class and subclasses because Plaintiffs have not satisfied the
Fed. R. Civ. P. 23(b)(3) requirements of predominance with
respect to but-for causation, injury, damages and the statute of
limitations defenses or superiority.

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D.

Class Certification Under Fed. R. Civ. P. 23(c)(4)

An issue class may be certified if there are common issues
with respect to liability. In re McKesson Governmental Entities
Average Wholesale Price Litig., 767 F. Supp. 2d 263, 269 (D.
Mass. 2011).

Plaintiffs move to certify an “issue class”

pursuant to Fed. R. Civ. P. 23(c)(4) for the following issues:
1) Whether Celexa or Lexapro are effective in treating
pediatric depression, i.e., can they significantly or
clinically outperform placebo;
2) Whether Forest promoted Celexa and/or Lexapro for
pediatric use;
3) Whether Forest’s promotion of Celexa and/or Lexapro was
fraudulent;
4) Whether Forest’s promotion of Celexa and/or Lexapro was
part of an Enterprise;
5) Whether Forest’s promotion of Celexa and/or Lexapro
involved conduct indictable under federal wire or mail
fraud statutes; and
6) Whether Forest’s conduct violated RICO.
Plaintiffs contend that, if the above issues are resolved on a
class-wide basis, causation and damages can be easily resolved
individually, for instance with
a declaration by the consumer . . . that they would not
have purchased the drugs for their child if they had known
about the fraud.
Defendants maintain that the certification of an issues class is
inappropriate because liability issues, such as whether the
drugs were promoted for pediatric use and whether they were

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effective, require individual analyses.

This Court agrees.

Thus, the motion to certify an issue class will be denied.
E. Proposed State Law Classes
In their reply memorandum, plaintiffs briefly argue that
classes of residents of Washington State should be certified to
pursue the state claims.
enrichment.

The first state law claim is unjust

To show unjust enrichment, a plaintiff must prove

that a defendant has “retain[ed] money or benefits which in
justice and equity belong to another.” Bailie Commc'ns, Ltd. v.
Trend Bus. Sys., Inc., 810 P.2d 12, 18, amended sub nom. Bailie
Commc'ns, Ltd v. Trend Bus. Sys., Inc., 814 P.2d 699 (Wash. Ct.
App. 1991).

This Court agrees with defendants that

individualized issues as to justice and equity, such as whether
off-label promotion caused the purchase of the drugs,
predominate, preventing certification of a class for the unjust
enrichment claim. See In re Actiq Sales & Mktg. Practices
Litig., 307 F.R.D. 150, 168–69 (E.D. Pa. 2015).
Plaintiffs also contend that a class should be certified
for the Washington Consumer Protection Act (“WCPA”) claim. RCW
§ 19.86.010 et seq.

With respect to a WCPA claim, a plaintiff

must show:
(1) an unfair or deceptive act or practice, (2) occurring
in trade or commerce, (3) affecting the public interest,
(4) injury to a person's business or property, and (5)
causation.

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Panag v. Farmers Ins. Co. of Washington, 204 P.3d 885, 889
(Wash. 2009).

Plaintiffs assert that, similar to the Missouri

class that this Court certified in Jaeckel II, 2014 WL 108197, a
WCPA class is appropriate because 1) the WCPA allows claims
based upon informational injuries and 2) reliance is not
required.

Defendants counter that the injury and causation

issues that adversely affect the certification of a RICO class
also apply to a WCPA class.
Plaintiffs correctly contend that the WCPA permits claims
based upon informational injuries.

To bring a claim under that

statute, “the injury need not be great, or even quantifiable”
but a plaintiff must show that their property or business was
harmed. Ambach v. French, 216 P.3d 405, 407 (Wash. 2009).

An

“informational injury” may meet the injury requirement. Torres
v. Mercer Canyons Inc., 835 F.3d 1125, 1135–36 (9th Cir. 2016).
Yet in contending that, like the Missouri statute in
Jaeckel II, the WCPA does not require reliance, plaintiffs fail
to account for the causation requirement of that statute.
Defendants are correct that the Washington Supreme Court has
“firmly rejected the principle that reliance is necessarily an
element” of a WCPA claim. Schnall v. AT & T Wireless Servs.,
Inc., 259 P.3d 129, 137 (Wash. 2011).

That Court has also

recently held, however, that proximate cause is required to show
causation under WCPA and determined that

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[for] the causation analysis for a [WCPA] claim, a
plaintiff would have to establish that but for the
defendant's unfair or deceptive act or practice the
plaintiff's injury would not have occurred.
Indoor Billboard/Washington, Inc. v. Integra Telecom of
Washington, Inc., 170 P.3d 10, 21 (Wash. 2007).
Thus, the WCPA is distinguished from the Missouri statute
which
does not require an individualized showing that Forest's
alleged misrepresentations caused consumers to purchase
Celexa or Lexapro.
Jaeckel II, 2014 WL 108197, at *7.

Because individual issues as

to but-for causation persist, the predominance requirement is
not satisfied and WCPA class will not be certified.

ORDER
For the foregoing reasons, plaintiffs’ motion to certify a
class (Docket No. 137) is DENIED.
So ordered.
/s/ Nathaniel M. Gorton_____
Nathaniel M. Gorton
United States District Judge
Dated August 15, 2017

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