Randy Marcus et al v. Forest Pharmaceuticals, Inc. et al
Filing
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Judge Nathaniel M. Gorton: ORDER entered. MEMORANDUM AND ORDER: "Accordingly, defendants' motion to dismiss (Docket No. 16 / Master Docket No. 243 ) is ALLOWED. So ordered." Associated Cases: 1:09-md-02067-NMG, 1:13-cv-11343-NMG(Moore, Kellyann)
United States District Court
District of Massachusetts
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CELEXA AND LEXAPRO MARKETING AND )
SALES PRACTICES LITIGATION
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RANDY MARCUS and BONNIE MARCUS, )
on behalf of themselves and all )
persons similarly situated,
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Plaintiffs,
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v.
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FOREST LABORATORIES, INC. and
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FOREST PHARMACEUTICALS, INC.,
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Defendants.
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In re:
MDL No.
09-2067-NMG
Civil Action No.
13-11343-NMG
MEMORANDUM & ORDER
GORTON, J.
This case arises out of the marketing and sales of the
anti-depressant drug Lexapro by defendants Forest Laboratories,
Inc. and Forest Pharmaceuticals, Inc. (“defendants” or,
collectively, “Forest”).
Plaintiffs Bonnie and Randy Marcus
(“plaintiffs”) allege that defendants violated California’s
Consumer Legal Remedies Act, Unfair Competition Law, and False
Advertising Law by misrepresenting and concealing material
information about the efficacy of Lexapro in treating major
depressive disorder in pediatric patients.
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Pending before the Court is defendants’ motion to dismiss
or in the alternative to stay the case under the primary
jurisdiction doctrine.
For the reasons that follow, the motion
will be allowed and the case will be dismissed.
I.
Background
Celexa and Lexapro are closely-related selective serotonin
reuptake inhibitor (“SSRI”) antidepressants.
Forest obtained
the approval of the Food and Drug Administration (“FDA”) to
market Celexa (citalopram) for adult use in 1998 and to market
Lexapro for adult use in 2002.
It later sought to market both
drugs for use in treating major depressive disorder (“MDD”) in
children and adolescents.
A.
FDA approval process
In order to obtain FDA approval to market Celexa and
Lexapro as effective for pediatric and adolescent use, Forest
was required to make a sufficient showing to the FDA that the
drugs would be more effective than placebos in treating MDD in
pediatric or adolescent patients.
The FDA typically requires
parties to submit at least two “positive” placebo-controlled
clinical trials supporting such use.
Drug studies are deemed “positive” if they show
statistically significant improvements for patients who are
administered a drug rather than a placebo.
In contrast, a
“negative” study is one that indicates no statistically
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significant difference in outcomes between patients who are
administered the drug and those who receive a placebo.
Plaintiffs assert that the FDA sets a low bar for approving
drugs for a particular use because it does not require a showing
of clinically significant improvement over placebo.
To
determine clinical significance, one must examine whether the
observed benefit of a drug outweighs the risks associated with
the drug when compared to alternative, less risky treatments.
Thus, a drug with dangerous side effects could, in theory, be
proven to be statistically superior to a placebo but not
clinically superior.
Drug manufacturers submit the results of such trials to the
FDA as part of “new drug applications” (“NDAs”).
Through an
NDA, a manufacturer may also request FDA approval of use of the
drug to treat a specific condition which is known as an
“indication”.
A manufacturer may only market and sell the drug
for an approved indication.
If it wishes to obtain FDA approval
for a new use, it must submit a separate NDA for that
indication.
B.
Clinical studies and FDA approval of an adolescent
indication for Lexapro
Forest arranged for researchers to conduct four doubleblind, placebo-controlled studies on the efficacy of Celexa and
Lexapro in treating pediatric and adolescent depression.
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The
first two studies, which examined the efficacy of Celexa, were
completed in 2001.
Of those studies, “Celexa Study 18” produced
“positive” results whereas “Celexa Study 94404” produced
“negative” results.
Plaintiffs claim that Forest fraudulently
“doctored” the data of Celexa Study 18 to make the results
appear positive and also suggest that flaws in the study design
may have made patients aware of whether they were receiving
treatment or a placebo.
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 Celexa Study 94404 was a clearly negative study.
Two studies of Lexapro’s efficacy produced similar results
to the earlier Celexa studies.
Lexapro Study 15, which was
completed in 2004, produced negative results, whereas Lexapro
Study 32 was positive.
Plaintiffs contend that there are
several problems with the design of Lexapro Study 32 that cast
doubts upon its positive results.
In 2008, Forest submitted the results of those studies and
the earlier Celexa studies to the FDA in a supplemental NDA.
Based on 1) the fact that Celexa Study 18 and Lexapro Study 32
were both positive for efficacy in adolescents and 2) the
chemical similarities between Celexa and Lexapro, the FDA in
2009 permitted Forest to market Lexapro as safe and effective in
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treating MDD in adolescents.
Forest never obtained FDA approval
to market Celexa for such use.
C.
Lexapro’s labeling
Plaintiffs allege that the drug label for Lexapro, which
was approved by the FDA in March, 2009, is misleading and
inadequate.
A section of the label titled “Pediatric Use”
states that
Safety and effectiveness of Lexapro has not been
established in pediatric patients (less than 12 years
of age) with Major Depressive Disorder. Safety and
effectiveness of Lexapro has been established in
adolescents (12 to 17 years of age) for the treatment
of major depressive disorder....
The label goes on to describe the two positive clinical studies
that formed the basis of FDA approval for the adolescent
indication and describes both studies as showing “statistically
significant greater mean improvement”.
The label also states
that two studies did not demonstrate efficacy.
D.
Plaintiffs’ purchase of Lexapro
In April, 2009, plaintiffs’ son, who was 17 years old at
the time, was prescribed Lexapro by his physician to treat his
ongoing depression about one month after Lexapro was approved
for treating MDD in adolescents.
Plaintiffs and their physician
were both allegedly misled into believing that Lexapro was more
effective at treating adolescent MDD than it actually was.
Plaintiffs allege that they read the drug label before
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purchasing Lexapro for their son and relied on the
representations therein.
They claim to have spent approximately
$495 on purchases of Lexapro between April, 2009 and April,
2011.
E.
Procedural history
Plaintiffs filed their Complaint in the Central District of
California in May, 2013, and the case was transferred to this
Court by the Judicial Panel on Multidistrict Litigation in June,
2013.
Defendants moved to dismiss in July, 2013.
The Court
heard oral argument on that motion in September, 2013, and took
the matter under advisement.
II.
Defendants’ motion to dismiss
Plaintiffs allege that defendants have misrepresented and
concealed material information about the efficacy of Lexapro in
treating major depressive disorder in pediatric patients.
Their
Complaint asserts claims under several California consumer
protection statutes including the Consumer Legal Remedies Act
(“CLRA”), Cal. Bus. & Prof. Code §§ 1770(a), 1780; the Unfair
Competition Law (“UCL”), Cal. Bus. & Prof. Code § 17200; and the
False Advertising Law (“FAL”), Cal. Bus. & Prof. Code §§ 1750017509.
Forest has moved to dismiss on the grounds that
plaintiffs’ claims are barred by 1) the federal preemption
doctrine and 2) California’s safe harbor rule.
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In the
alternative, defendant urges the Court to remand the case to the
FDA under the primary jurisdiction doctrine.
A.
Legal standard
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.” 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. Langadinos v.
Am. Airlines, Inc., 199 F.3d 68, 69 (1st Cir. 2000).
The Court,
however, need not accept legal conclusions as true. Ashcroft v.
Iqbal, 129 S. Ct. 1937, 1949 (2009).
B.
Application
The Court finds that, as a matter of law, plaintiffs’
claims are barred by the California safe harbor provision.
As a
result, it need not consider defendants’ preemption or primary
jurisdiction arguments.
1.
California’s safe harbor rule
The California safe harbor doctrine bars certain claims
brought under California’s unfair competition laws.
For the
doctrine to apply,
another
clearly
may not
actions
provision must actually “bar” the action or
permit the conduct.... In other words, courts
use the unfair competition law to condemn
the legislature permits.
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Cel-Tech Comm’c’ns, Inc. v. L.A. Cellular Tel. Co., 973 P.2d
527, 541-42 (Cal. 1999).
Courts have subsequently applied the
safe harbor doctrine to bar claims brought under the CLRA, FAL
and UCL based upon federal statutes and regulations. See, e.g.,
Davis v. HSBC Bank Nev., 691 F.3d 1152, 1165-66 (9th Cir. 2012)
(affirming dismissal of UCL claim based on federal regulations);
Pom Wonderful LLC v. Coca-Cola Co., No. 08-06237, 2013 WL
543361, at *5 (C.D. Cal. Feb. 13, 2013) (finding that compliance
with FDA labeling regulations insulated juice manufacturer from
liability under the UCL and FAL).
2.
Analysis
Forest argues that the safe harbor bars plaintiffs’ claims
because the FDA is required by statute to decline to approve a
new drug application if
there is a lack of substantial evidence that the drug
will have the effect it purports or is represented to
have under the conditions of use prescribed,
recommended, or suggested in the proposed labeling
thereof [or] based on a fair evaluation of all
material facts, such labeling is false or misleading
in any particular....
21 U.S.C. § 355(d); see also 21 C.F.R. § 314.125(b)(6)
(requiring FDA to reject application when proposed labeling is
“false or misleading in any particular”).
Moreover, it asserts
that the FDA’s “voluminous” regulations concerning prescription
drug labeling provide further support for its argument that FDA
approval of a drug label protects Forest from liability under
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state consumer protection law for statements or omissions within
that label. See 21 C.F.R. §§ 201.56, 201.57 (describing labeling
requirements with respect to, inter alia, efficacy information,
safety information and approved uses).
Plaintiffs respond that Forest would be entitled to safe
harbor protection only if federal law
specifically allowed Forest to conceal material
information about a drug’s efficacy from consumers and
prescribers.
They contend that federal law in fact provides the exact
opposite because it prohibits Forest from distributing drugs
that are labeled in a false or misleading way.
That argument
misstates the relevant inquiry: the safe harbor provision, in
essence, reflects a judgment by the California Supreme Court
that California’s unfair competition law should not be employed
to second guess legislative judgments. See Cel-Tech, 973 P.2d at
541-42 (explaining that the policy underlying the safe harbor
rule is that “courts may not use the unfair competition law to
condemn actions the legislature permits”).
Where, as here, Congress has entrusted the FDA to determine
1) whether there is a substantial evidence of efficacy for a
particular indication and 2) whether a proposed label is false
or misleading in any way, and the FDA approves a label for a
certain indication, the safe harbor provision applies to bar a
claim that the label was false or misleading.
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Furthermore,
neither of the two potential exceptions to the safe harbor rule
applies.
First, this case is distinguishable from cases involving
FDA regulation of food and homeopathic remedies in which courts
have held that the safe harbor provision did not apply. See,
e.g., Delarosa v. Boiron, Inc., 818 F. Supp. 2d 1177, 1189-90 &
n.8 (C.D. Cal. 2011) (declining to apply safe harbor provision
after reasoning that “unlike with non-homeopathic [over-thecounter] drugs, the FDA has not set up a comprehensive process
to evaluate the safety or efficacy of homeopathic [over-thecounter] remedies”); Von Koenig v. Snapple Beverage Corp., 713
F. Supp. 2d 1066, 1075-76 (E.D. Cal. 2010) (holding that
informal FDA policy “cannot be accorded the weight of federal
law for purposes of the safe harbor rule”).
In contrast to the
insufficient regulatory frameworks in those cases, the
prescription drug industry is subject to comprehensive
regulations promulgated by the FDA. Bober v. Glaxo Wellcome PLC,
246 F.3d 934, 942 (7th Cir. 2001).
Second, this case is distinguishable from cases in which
plaintiffs argued that the practice in question violated federal
law.
For instance, in Prohias v. Pfizer, Inc., 490 F. Supp. 2d
1228 (S.D. Fla. 2007), the court addressed whether safe harbor
provisions of the consumer protection statutes of Massachusetts
and Florida barred claims against the drug manufacturer Pfizer
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based on advertisements that claimed that the drug Lipitor
reduced the risk of coronary heart disease. Prohias, 490 F.
Supp. 2d at 1232-35.
The court found that the safe harbor
provisions barred claims arising after the FDA approved the use
of Lipitor to reduce the risk of heart disease in some patients
because, at that point, the FDA specifically authorized such
advertising by approving the use for which Lipitor was
advertised. Id. at 1233-34.
It found, however, that the safe
harbor provisions did not bar claims based on advertisements
that pre-dated FDA approval because such advertisements were not
expressly authorized by the FDA. Id. at 1234-35.
Here, where
plaintiffs base their claims entirely on the marketing and sales
of Lexapro after the FDA approved Forest’s application for an
adolescent indication and a proposed label, the safe harbor
applies to bar such claims.
Finally, the Court is not persuaded that Wyeth v. Levine,
555 U.S. 555 (2009) calls into doubt the viability of safe
harbor provisions in state consumer protection statutes.
Wyeth
held that FDA approval of a drug label does not necessarily
preempt state-law failure to warn claims.
Plaintiffs provide no
justification to extend that holding to preclude state safe
harbor defenses to claims arising under state consumer
protection law and this Court has found no authority permitting
it to do so.
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ORDER
Accordingly, defendants’ motion to dismiss (Docket No. 16/
Master Docket No. 243) is ALLOWED.
So ordered.
/s/ Nathaniel M. Gorton
Nathaniel M. Gorton
United States District Judge
Dated March 5, 2014
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