LoConte et al v. Forest Laboratories, Inc.

Filing 62

Judge Nathaniel M. Gorton: ENDORSED MEMORANDUM & ORDER entered denying 53 Motion to Dismiss for Failure to State a Claim (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.,
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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
related anti-depressant drugs Celexa and Lexapro by defendants
Forest Laboratories, Inc., Forest Laboratories, LLC and Forest
Pharmaceuticals, Inc. (“defendants” or, collectively, “Forest”).
Plaintiffs Delana Kiossovski (“Kiossovski”) and Renee Ramirez
(“Ramirez”) allege that defendants engaged in a fraudulent
marketing scheme designed to induce consumers to purchase Celexa
and Lexapro for pediatric use.

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Pending before the Court is defendants’ motion to dismiss
and/or to strike certain claims in the amended complaint (Docket
No. 548).

For the reasons that follow, that motion will be

denied.
I.

Background and procedural history
The background and early procedural history are set forth

in this Court’s earlier Memorandum & Order addressing
defendants’ motion to dismiss the initial complaint (Docket No.
572).

The relevant factual allegations for the purposes of the

pending motion are summarized below.
Celexa and Lexapro are closely-related selective serotonin
reuptake inhibitor (“SSRI”) anti-depressants.

Forest sought to

market both drugs for treating major depressive disorder (“MDD”)
in children and adolescents and, to that end, conducted four
sets of efficacy studies.

Celexa Study 94404 and Lexapro Study

15 produced negative results while Celexa Study 18 (“MD-18”) and
Lexapro Study 32 produced arguably positive results.

The FDA-

approved labels for both drugs prior to 2005 stated that
“[s]afety and effectiveness in pediatric patients have not been
established”.

Forest revised the labels in 2005 to include

descriptions of the efficacy studies.
In March, 2009, the FDA reviewed the positive results in
MD-18 and Lexapro Study 32, noted the chemical similarities
between Celexa and Lexapro and approved Lexapro as safe and

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effective in treating MDD in adolescents.

Forest did not seek

similar FDA approval for Celexa.
In August, 2014, former plaintiff Marlene LoConte
(“LoConte”) and plaintiff 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 and
adolescent use of Celexa and Lexapro despite knowing that the
drugs did not provide any clinically significant benefit over
placebos in treating MDD.

The case was transferred to the

District of Massachusetts pursuant to a multi-district
litigation assignment to this Court in October, 2014.
In June, 2015, this Court 1) allowed defendants’ motion to
dismiss the complaint with respect to the Racketeer Influenced
and Corrupt Organizations Act (“RICO”), the 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 (“CPA”) and unjust enrichment claims brought by Kiossovski.
Plaintiffs amended the complaint in January, 2016 by
replacing LoConte with Ramirez as the second plaintiff and
putative class representative.

The amended complaint raised two

RICO claims by Kiossovski and Ramirez, an unjust enrichment
claim by both plaintiffs and a CPA claim by Kiossovski.

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II.

Motion to dismiss
Defendants move to dismiss Ramirez’s individual claims and

the putative class action claims relating to Lexapro and
adolescent use.
A.

Legal standard

To survive a motion to dismiss, a complaint must contain
sufficient factual matter to state a claim to relief that is
plausible on its face. Bell Atl. Corp. v. Twombly, 550 U.S. 544,
570 (2007).

The Court must accept all factual allegations in

the complaint as true and draw all reasonable inferences in the
plaintiff's favor. Santiago v. Puerto Rico, 655 F.3d 61, 72 (1st
Cir. 2011).

Threadbare recitals of the legal elements,

supported by mere conclusory statements, do not suffice to state
a cause of action. Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009).
A complaint does not state a claim for relief where the wellpled facts fail to warrant an inference of any more than the
mere possibility of misconduct. Id. at 679.
B.

Application
1.

Ramirez’s RICO claims

Defendants first move to dismiss Ramirez’s RICO claims for
failure to state a claim.

They assert that her claims are time-

barred under the statute of limitations.
The statute of limitations for civil RICO claims is four
years after the plaintiff discovers or should have discovered

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the injury. See Rotella v. Wood, 528 U.S. 549, 553 (2000). The
limitations period commences when the plaintiff “knew or should
have known of his injury.” Lares Grp., II v. Tobin, 221 F.3d 41,
44 (1st Cir. 2000).
The amended complaint alleges that Ramirez purchased Celexa
for her eight-year-old son starting in February, 2003 and
continuing through April, 2004 but that Celexa did not
effectively treat his pediatric depression.

Ramirez also

asserts that she purchased Lexapro for her son from May, 2004
through his twelfth birthday in January, 2007.

She continued

buying Lexapro for her son until he stopped using it in 2011 due
to side effects such as muscle spasms and difficulty
concentrating in school.

The amended complaint declares that

Ramirez first learned in February, 2014 that “Lexapro had not
been proven effective for children” and first realized, “[w]ith
the benefit of hindsight”, that this was consistent with her
prior observations that Lexapro was ineffective for her son.
Plaintiffs allege that Ramirez did not discover, and had no
reason to discover, her RICO injury until 2014.
Defendants respond that Ramirez’s RICO claims are timebarred because she first became aware that Lexapro was
ineffective with respect to her son in January, 2007.

They

argue that she thus discovered her RICO injury more than four
years before the initiation of this action in 2014.

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They assert

that the doctrine of fraudulent concealment does not toll the
statute of limitations because the amended complaint fails to
allege that Ramirez diligently investigated the potential
inefficacy of Lexapro by reading, for instance, either the
Lexapro drug label or any of the numerous public announcements
of Lexapro’s inefficacy.
Plaintiffs respond that, although Ramirez believed that
Lexapro was ineffective for her son in 2007, she did not know,
and had no reason to know, that Lexapro was ineffective in
children generally until she learned about the negative efficacy
studies in 2014.

They contend that the doctrine of fraudulent

concealment tolls the statute of limitations because the amended
complaint alleges that 1) defendants wrongfully concealed their
fraudulent marketing practices, 2) Ramirez did not discover her
RICO injury within the limitations period and 3) she acted
diligently and did not have reason to discover her RICO injury,
see Berkson v. Del Monte Corp., 743 F.2d 53, 55 (1st Cir. 1984).
The first step for the Court is to identify the nature of
Ramirez’s asserted RICO injury.

The amended complaint alleges

that defendants’ misrepresentations prevented her from making an
informed decision which caused her to buy Lexapro that she
otherwise would not have bought for her son.

Plaintiffs clarify

in their opposition memorandum that Ramirez’s injury stemmed
from her belief that Celexa and Lexapro were effective with

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respect to children in general, not a belief that they would be
effective for her son specifically.
The asserted injury, therefore, consists of payments for
prescriptions of Celexa and Lexapro that she made for pediatric
use as a result of defendants’ alleged misconduct which
precluded her from making an informed decision as to efficacy.
Her injury qualifies as a RICO injury because she claims that
1) she bought Celexa and Lexapro as a result of defendants’
misrepresentations of efficacy, 2) Lexapro was ineffective for
her son and thus 3) she bought products with undisclosed risks
that actually materialized with respect to her son. See In re
Celexa & Lexapro Mktg. & Sales Practices Litig., 2015 WL
3751422, at *6 (D. Mass. June 15, 2015) (“LoConte”)(“Because
LoConte does not contend that Lexapro was ineffective as to her
son, her alleged RICO injury is inadequate because it is akin to
a lack of informed decision before purchasing a product with
undisclosed risks that never appear.”).
The inquiry before this Court is whether, taking all of the
factual allegations in the amended complaint as true, plaintiffs
have pled facts sufficient to support a finding that Ramirez did
not discover, or have reason to discover, her RICO injury, i.e.,
payment for drugs that had no pediatric efficacy, before the
accrual of the limitations period.

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After considering the allegations in the light most
favorable to plaintiffs, the Court is satisfied that plaintiffs
have set forth facts sufficient to support a finding that
Ramirez, as a consumer, did not discover her RICO injury until
2014 and had no reason for discovering it sooner.

The Court

declines to make a factual determination as to whether Ramirez
actually discovered, or reasonably should have discovered, her
RICO injury prior to 2014. See id. at *5 (finding that “the
running of the [statute of limitations] is usually a question
for the jury”); In re Celexa & Lexapro Mktg. & Sales Practices
Litig., 65 F. Supp. 3d 283, 289 (D. Mass. 2014)(“Painters
I”)(“[T]he Court will leave the determination of whether
plaintiff should have discovered its injury as of 2005 to the
finder of fact.”).
Accordingly, the motion to dismiss Ramirez’s RICO claims as
time-barred will be denied.
2.

Ramirez’s unjust enrichment claim

Defendants move to dismiss Ramirez’s claim for unjust
enrichment on the ground that she “fails to state a viable RICO
claim, or any other actionable wrong”.

That argument is

inapposite in light of the finding that her RICO claims survive
dismissal with respect to the statute of limitations.
Accordingly, defendants’ motion to dismiss her unjust
enrichment claim will be denied.

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3.

Putative Lexapro class action claims with respect
to adolescent use

Defendants seek to dismiss the putative class action claims
that Lexapro was ineffective with respect to patients between
the ages of 12 and 17.

They contend that the amended complaint

“concedes” that the FDA approved Lexapro as effective for
adolescent use in 2009 which precludes plaintiffs from plausibly
alleging that Lexapro is medically ineffective for adolescent
patients.

Defendants move to dismiss those putative class

action claims for failure to state a claim.
The Court finds that argument unpersuasive.

Plaintiffs

allege that 1) Ramirez bought Lexapro for her son as a result of
defendants’ misconduct, 2) her son used Lexapro both before and
after he turned 12 years old and 3) Lexapro was ineffective at
treating her son’s depression.

Such allegations are sufficient

to plead a RICO injury in support of a RICO claim.

That

conclusion is in line with an earlier finding by this Court that
former plaintiff LoConte could not allege a RICO injury because
she admitted that the FDA approved Lexapro as effective for
adolescents in 2009 without also contending that Lexapro was
ineffective as to her own child. See LoConte, 2015 WL 3751422,
at *6.

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Defendants advance no other arguments for dismissing the
putative class action claims with respect to the adolescent use
of Lexapro.
The putative class action claims that Lexapro was
ineffective for adolescent use thus survive dismissal.

The

Court will leave to the jury the task of weighing the totality
of the evidence which in this case includes an FDA determination
that Lexapro is effective for adolescent use and Ramirez’s
observations that Lexapro was ineffective for her son.
Likewise, the Court declines to evaluate or review the validity
of the FDA’s decision that certain clinical studies established
the efficacy of Celexa and Lexapro for adolescent use. See In re
Celexa & Lexapro Mktg. & Sales Practices Litig., 2016 WL
3102004, at *11 (D. Mass. June 2, 2016)(“Painters II”) (citing
In re Celexa & Lexapro Mktg. & Sales Practice Litig., 779 F.3d
34, 41 (1st Cir. 2015) (“Marcus”)).
Accordingly, the Court will deny defendants’ motion to
dismiss the putative class action claims alleging that Lexapro
was ineffective for patients between the ages of 12 and 17.
III. Motion to strike class allegations
Defendants move to strike all of the Celexa and Lexapro
class allegations pursuant to Fed. R. Civ. P. 12(f) and
23(d)(1)(D).

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A.

Legal standard

Rule 12(f) permits a court to strike class allegations from
the complaint if it is “obvious” from the pleadings that “the
proceeding cannot possibly move forward on a classwide basis”.
Manning v. Boston Med. Ctr. Corp., 725 F.3d 34, 59 (1st Cir.
2013).

Striking class allegations under Rule 12(f) is a drastic

remedy that is disfavored in practice because
it requires a reviewing court to preemptively terminate
the class aspects of . . . litigation, solely on the
basis of what is alleged in the complaint, and before
plaintiffs are permitted to complete the discovery to
which they would otherwise be entitled on questions
relevant to class certification.
Id.

The more typical course is to “await the development of a

factual record” before deciding whether to allow the case to
proceed as a class action. Id.
Rule 23 authorizes a court to issue orders requiring “that
the pleadings be amended to eliminate allegations about [the]
representation of absent persons”. Fed. R. Civ. P. 23(d)(1)(D).
B.

Application

Defendants seek to strike the class allegations now, before
plaintiffs move for class certification, because they claim that
plaintiffs will not be able to satisfy the predominance
requirement in Fed. R. Civ. P. 23(b)(3).

They assert that the

case cannot proceed on a class-wide basis because resolution of
the issues concerning the statute of limitations, injury and

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causation will require individualized determinations that
overwhelm the class-wide issues.

They also point out that the

parties in the multi-district litigation have engaged in seven
years of discovery and the Court has already denied the
certification of multiple consumer classes in those related
cases.
The Court concludes that striking the class allegations at
this preliminary stage would, however, be premature.

The Court

will consider the propriety of allowing the litigation to
proceed as a class action after plaintiffs have had an
opportunity to submit their anticipated motion for class
certification.
Accordingly, defendants’ motion to strike the class
allegations will be denied.

ORDER
For the foregoing reasons, defendants’ motion to dismiss
and/or to strike certain claims in the amended complaint (Docket
No. 548) is DENIED.
So ordered.
/s/ Nathaniel M. Gorton
Nathaniel M. Gorton
United States District Judge
Dated June 9, 2016

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