United States District Court, D. Massachusetts
In re CELEXA AND LEXAPRO MARKETING AND SALES PRACTICES LITIGATION
FOREST LABORATORIES, INC. and FOREST PHARMACEUTICALS, INC., Defendants. PAINTERS AND ALLIED TRADES DISTRICT COUNCIL 82 HEALTH CARE FUND, Plaintiff, DELANA S. KIOSSOVSKI and RENEE RAMIREZ, Plaintiffs,
FOREST LABORATORIES, INC. and FOREST PHARMACEUTICALS, INC., Defendants.
MEMORANDUM & ORDER
Nathaniel M. Gorton United States District Judge.
cases arise 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, “the Kiossovski
plaintiffs”) and plaintiff Painters and Allied Trades
District Council 82 Health Care Fund (“Painters”)
(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.
§§ 1962(c) and (d), 2) were unjustly enriched, 3)
violated the Washington Consumer Protection Act
(Kiossovski) and 4) violated the Minnesota Consumer
Fraud Act and Minnesota Unfair Trade Practices Act
before the Court are (1) Painters' motion for partial
summary judgment on Forest's statute of limitations
affirmative defense (Painters) (Docket No. 662), (2)
Forest's cross-motion for summary judgment on all claims
(Painters) (Docket No. 676) and (3) Forest's
motions for summary judgment on all claims (Painters
and Kiossovski) (Docket Nos. 797 and 798). For the
reasons that follow, this Court will deny as moot
Painters' motion for partial summary judgment, allow, in
part, and deny as moot, in part, Forest's cross motion
for summary judgment and allow Forest's motions for
summary judgment on all claims.
Court heard oral argument on the pending motions on January
Background and procedural history
and Lexapro are closely related selective serotonin reuptake
inhibitor (“SSRI”) anti-depressants sold by
Forest. 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”).
FDA Approval Process
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” placebo-controlled 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
and Lundbeck, the Danish pharmaceutical company that
developed the drugs and licensed them to Forest, conducted
four double-blind, placebo-controlled studies on the efficacy
of Celexa and Lexapro in treating pediatric depression. The
first two studies examined the efficacy of Celexa, were
completed in 2001 and were submitted to the FDA in 2002. 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.
The other two studies addressed the efficacy of Lexapro.
Lexapro Study 15 (“MD-15”) was completed in 2004
and produced negative results but Lexapro Study 32
(“MD-32”), completed in 2007, produced
statistically significant, and therefore positive, results.
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.
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 ages
12-17. Forest did not seek similar FDA approval for Celexa.
Delana Kiossovski and Renee Ramirez
July, 2001 to February, 2002, Kiossovski bought Celexa for
her daughter, who was then 13 years old, based upon the
recommendation of her daughter's psychiatrist, Dr.
Stephen Barnett. A short time later, Kiossovski's
daughter developed a rash and stopped ingesting Celexa for
approximately two months. She resumed taking the medication
in October, 2001. In March, 2002, Kiossovski's daughter
attempted suicide. Shortly after her attempted suicide,
Kiossovski's daughter was diagnosed with bipolar disorder
by psychiatrist Dr. Carola Bosenberg. Dr. Bosenberg
discontinued the prescription of Celexa for use by
Kiossovski's daughter and prescribed other medication.
Thereafter the daughter stopped using Celexa. Kiossovoski
became aware in 2014 that the efficacy of Celexa for
pediatric use was unproven when it was prescribed for her
February, 2003 to April, 2004, Ramirez purchased Celexa for
her eight-year-old son and from May, 2004 to December, 2006
she bought Lexapro. Ramirez continued to fill her son's
Lexapro prescriptions until March, 2010. Dr. Michael Saito, a
neurologist, treated Ramirez's son from March, 2001 to
September, 2010. During that time, the son was diagnosed with
several disorders including autism and anxiety. Dr. Saito
prescribed Celexa and Lexapro to treat symptoms of autism.
Painters and Allied Trades District 82 Council Health Care
is a third-party payor (“TPP”) that provides
medical benefits, including prescription drug coverage, to
its insured beneficiaries, who are employees of unionized
commercial painting companies. Painters retains a pharmacy
benefit manager (“PBM”), Prime Therapeutics
(“Prime”), that administers Painters'
prescription drug benefit program. Painters delegated to
Prime responsibility for 1) determining which drugs to
include on the approved drug formulary, 2) negotiating
rebates with pharmaceutical manufacturers, and 3) imposing
limitations on coverage, if necessary. A drug formulary lists
medications that will be reimbursed by the insurer or TPP, in
this case, Painters.
January, 1999 and October, 2004, Painters reimbursed 72
Celexa prescriptions for 16 of its pediatric insureds, at a
total cost of $4, 210. Between August, 2002 and January,
2015, Painters reimbursed 234 prescriptions for Lexapro for
31 of its pediatric insureds, at a total cost of $20, 262.
Painters and another TPP initiated this action in the
District of Minnesota on behalf of two putative nationwide
TPP classes in November, 2013. The case was transferred to
this Court pursuant to a multi-district litigation assignment
in December, 2013. Plaintiffs filed a first amended complaint
in February, 2014, asserting violations of RICO (Counts I and
II) and three Minnesota consumer protection statutes (Counts
III, IV and V) on behalf of the two putative nationwide
classes of TPPs and two putative Minnesota classes of TPPs
and consumers. This Court dismissed Count V and all claims
brought by TPP Allied Services Division Welfare Fund and New
Mexico UFCW Union's and Employers' health and Welfare
Trust Fund in December, 2014.
moved for class certification in February, 2016 and that
motion was denied in June, 2016. In December, 2016, the First
Circuit Court of Appeals denied Painters' Fed.R.Civ.P.
23(f) petition seeking permission to appeal this Court's
order denying class certification. Painters filed its second
motion for class certification in February, 2017. Forest has
not opposed that motion but instead sought a stay of
consideration of that motion until the motions for summary
judgment have been resolved.
August, 2014, former plaintiff Marlene LoConte and Kiossovski
commenced an action in the United States District Court for
the Western District of Washington 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. The case
was transferred to this Court pursuant to a multi-district
litigation assignment in October, 2014.
June, 2015, this Court 1) allowed defendants' motion to
dismiss the action 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.
February, 2016, defendants moved to dismiss the amended
complaint which this Court denied in June, 2016. In March,
2017, the Kiossovski plaintiffs moved for class certification
which defendants opposed. This Court denied the Kiossovski
plaintiffs' motion for class certification in August,
Motions for Summary Judgment
role of summary judgment is “to pierce the pleadings
and to assess the proof in order to see whether there is a
genuine need for trial.” Mesnick v.
Gen. Elec. Co., 950 F.2d 816, 822 (1st Cir. 1991).
The burden is on the moving party to show, through the
pleadings, discovery and affidavits, “that there is no
genuine dispute as to any material fact and that the movant
is entitled to judgment as a matter of law.”
Fed.R.Civ.P. 56(a). A fact is material if it “might
affect the outcome of the suit under the governing
law.” Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 248 (1986). A genuine issue of
material fact exists where the evidence with respect to the
material fact in dispute “is such that a reasonable
jury could return a verdict for the nonmoving party.”
moving party has satisfied its burden, the burden shifts to
the non-moving party to set forth specific facts showing that
there is a genuine, triable issue. Celotex Corp.v.Catrett, 477 U.S. 317, 324 (1986). The
Court must view the entire record in the light most favorable
to the non-moving party and indulge all reasonable inferences
in that party's favor. O'Connorv.Steeves, 994 F.2d 905, 907 (1st Cir. 1993). Summary
judgment is appropriate if, after viewing the record in the
non-moving party's favor, the Court ...