IN RE: CELEXA AND LEXAPRO MARKETING AND SALES PRACTICES LITIGATION
FOREST PHARMACEUTICALS, INC.; FOREST LABORATORIES, INC.; FOREST LABORATORIES, LLC, successor in interest to Forest Laboratories, Inc., Defendants, Appellees, PAINTERS AND ALLIED TRADES DISTRICT COUNCIL 82 HEALTH CARE FUND; DELANA S. KIOSSOVSKI; RENEE RAMIREZ, on behalf of herself and all others similarly situated; MARLENE T. LOCONTE, Plaintiffs, Appellants, MARTHA PALUMBO, individually and on behalf of all other persons similarly situated; PETER PALUMBO, individually and on behalf of all other persons similarly situated; JAYNE EHRLICH, individually and on behalf of all other persons similarly situated; ANNA MURRET, individually and on behalf of all other persons similarly situated; UNIVERSAL CARE, INC.; ANGELA JAECKEL; MELVIN M. FULLMER, on behalf of himself and all others similarly situated; NEW MEXICO UFCW UNION'S AND EMPLOYER'S HEALTH AND WELFARE TRUST FUND, on behalf of itself and all others similarly situated; ALLIED SERVICES DIVISION WELFARE FUND, on behalf of itself and all others similarly situated; TARA JOHNDROW, individually and on behalf of all others similarly situated; BRIAN ANSON, individually and on behalf of all others similarly situated; SCOTT A. WILCOX, on behalf of himself and all others similarly situated; MUNICIPAL REINSURANCE HEALTH INSURANCE FUND; RANDY MARCUS; BONNIE MARCUS; RUTH DUNHAM; TANYA SHIPPY; JILL POWELL, Plaintiffs, PFIZER, INC.; WARNER LAMBERT COMPANY, Defendants.
APPEALS FROM THE UNITED STATES DISTRICT COURT FOR THE
DISTRICT OF MASSACHUSETTSHON. NATHANIEL M. GORTON, U.S.
Brent Wisner, with whom Michael L. Baum, Baum, Hedlund,
Aristei & Goldman, P.C., Christopher L. Coffin, and
Pendley, Baudin & Coffin, LLP were on brief, for
J. Ceresney, with whom Edwin G. Shallert, Kristin D. Kiehn,
J. Robert Abraham, Debevoise & Plimpton LLP, John G.
O'Neill, and Sugarman, Rogers, Barshak & Cohen, P.C.
were on brief, for appellees.
Howard, Chief Judge, Torruella and Kayatta, Circuit Judges.
KAYATTA, CIRCUIT JUDGE.
consolidated appeals arise out of two so-called
"off-label" prescription-drug-marketing cases
aggregated for pretrial proceedings in the District of
Massachusetts by order of the multidistrict litigation panel.
Plaintiffs claim that the defendants, Forest Pharmaceuticals,
Inc. and Forest Laboratories, Inc. (collectively
"Forest"), engaged in fraud to push their
antidepressant drugs on unsuspecting minors for whom the FDA
had not approved the use of these medications. As we will
explain, we reverse the dismissal of the claims brought by
two of the four plaintiffs, and we vacate the denial of
plaintiffs' motion to compel the production of additional
documents by Forest. We otherwise affirm the challenged
district-court rulings, including the denial of class
begin by summarizing the relevant statutory and regulatory
framework and by reciting the facts relevant to the
plaintiffs' summary-judgment appeal in the light most
favorable to the plaintiffs. See Boudreau
v. Lussier, 901 F.3d 65, 71 (1st Cir.
Federal Food, Drug, and Cosmetic Act ("FDCA")
requires drug manufacturers to obtain approval from the U.S.
Food and Drug Administration ("FDA") before
marketing a drug for a particular medical use. 21 U.S.C.
§ 355(a); see also Mut. Pharm. Co., Inc.
v. Bartlett, 570 U.S. 472, 476 (2013). To
secure that approval, the drug manufacturer must submit to
the FDA either a new-drug application ("NDA") or a
supplemental new-drug application ("sNDA"), and the
manufacturer must demonstrate the drug's efficacy for the
indicated use in at least two double-blind,
randomized-controlled trials ("DBRCTs"). See In
re Neurontin Mktg. & Sales Practices Litig.
(Kaiser), No. 04-cv-10739-PBS, 2011 WL 3852254, at
*5 (D. Mass. Aug. 31, 2011), aff'd, 712 F.3d 21
(1st. Cir. 2013); see generally 21 C.F.R. §
314.105. The FDCA creates both civil and criminal penalties
for drug manufacturers that promote the use of approved drugs
for unapproved uses (referred to here as
"off-label" uses). See 21 U.S.C.
§§ 331(d), 333(a), 355(a); Lawton ex rel.
United States v. Takeda Pharm. Co.,
842 F.3d 125, 128 n.4 (1st Cir. 2016). The FDCA, however,
does not prohibit doctors from prescribing drugs for
off-label uses. Lawton ex rel. United States, 842
F.3d at 128 n.4.
manufactures and markets prescription drugs, including the
antidepressant medications Celexa and Lexapro. Celexa and
Lexapro are chemically similar selective serotonin reuptake
inhibitors ("SSRIs"), a class of antidepressants
that affect a patient's mood by blocking the reabsorption
of the neurotransmitter serotonin in the brain, Eli Lilly
& Co. v. Teva Pharm. USA, Inc.,
No. 05-1044, 2005 WL 1635262, at *1 (Fed. Cir. July 13,
2005). The FDA approved Celexa and Lexapro for the treatment
of major depressive disorder ("MDD") in adults
(i.e., individuals aged eighteen or over) in 1998
and 2002, respectively. Drug manufacturers, including Forest,
had difficulty demonstrating that SSRIs were also effective
in treating depression in children and adolescents. As of
2005, only Fluoxetine -- commercially known as Prozac -- had
gained FDA approval for the treatment of pediatric
depression. In 2009, the FDA approved Lexapro for the
treatment of depression in adolescents (i.e.,
individuals of ages twelve through seventeen). The FDA has
never approved Celexa for any pediatric use nor has it
approved Lexapro as a treatment for depression in children
(i.e., individuals under the age of twelve). The
record in this case nevertheless strongly suggests that
Forest engaged in a comprehensive off-label marketing scheme
from 1998 through 2009 aimed at fraudulently inducing doctors
to write pediatric prescriptions of Celexa and Lexapro when
Forest had insufficient reason to think that these drugs were
effective for the treatment of depression in children and
adolescents. Plaintiffs have pointed to substantial evidence
that Forest sought to achieve this illicit aim by: (1)
promoting Celexa's efficacy for the treatment of
pediatric depression at medical conferences, at
continuing-medical-education programs, and in press releases;
(2) concealing negative clinical studies concerning
Celexa's efficacy and safety; and (3) directly
encouraging physicians to prescribe Celexa and Lexapro for
the treatment of pediatric depression.
years, Forest nevertheless denied that it was engaged in the
off-label promotion of these drugs. Forest Laboratories'
Executive Vice President, Dr. Lawrence Olanoff, testified
before Congress in 2004 that "because the FDA has not
approved pediatric labeling for our products, Forest has
always been scrupulous about not promoting the pediatric use
of our antidepressant drugs, Celexa and Lexapro. That is the
law, and we follow it." Publication and Disclosure
Issues in Antidepressant Pediatric Clinical Trials: Hearing
Before the Subcomm. on Oversight & Investigations of the
Comm. on Energy & Commerce, 108th Cong. 82 (2004)
(statement of Dr. Lawrence Olanoff).
before Dr. Olanoff assured Congress of Forest's
scrupulousness, a whistleblower had commenced a qui tam
action, alleging that Forest had violated the False Claims
Act ("FCA"), 31 U.S.C. § 3729(a), by
fraudulently marketing and promoting Celexa and Lexapro for
the off-label treatment of depression in pediatric patients.
Complaint, Gobble v. Forest Labs.,
Inc., No. 03-10395-NMG (D. Mass. Mar. 4, 2003), ECF No.
1. The United States later intervened in that suit, and, in
February 2009, the district court unsealed the United
States' complaint. Order Granting Motion to Unseal,
United States ex rel. Gobble, No. 03-10395-NMG (D.
Mass. Feb. 24, 2009), ECF No. 64. The evidence belying Dr.
Olanoff's assurances to Congress turned out to be quite
substantial. Ultimately, in September 2010, Forest paid a $39
million fine in connection with pleading guilty to criminal
violations of the FDCA for its off-label promotion of Celexa
between 1998 and 2002 and an additional $149 million to the
United States to settle civil claims that Forest illegally
promoted Celexa and Lexapro for pediatric use in 2002 through
the following four years, over a dozen consumers and entities
who paid for prescription drugs filed the lawsuits that led
to this appeal. Initially, four plaintiffs joined in the
notice of appeal. Only two, Renee Ramirez and the Painters
and Allied Trades District Council 82 Health Care Fund
("Painters") have presented any argument on appeal.
We refer to these two collectively as
"plaintiffs." Ramirez purchased Celexa and Lexapro
for her young son from February 2003 through March 2010 on
the recommendation of her son's neurologist. Painters has
reimbursed its pediatric insureds for off-label prescriptions
of Celexa and Lexapro since early 1999. Plaintiffs together
seek recovery under the Racketeer Influenced and Corrupt
Organizations Act ("RICO"), 18 U.S.C. §
1962(c)-(d), the Minnesota Consumer Fraud Act, Minn. Stat.
§ 325F.69, and the Minnesota Unfair Trade Practices Act,
Minn. Stat. § 325D.13, and for unjust enrichment.
2016, the district court denied Painters' motion to
certify two nationwide classes of similarly situated
health-insurance companies and health plans that had paid for
or reimbursed off-label pediatric prescriptions of Celexa or
Lexapro. In re Celexa & Lexapro Mktg. & Sales
Practices Litig. (Painters I), 315 F.R.D. 116,
131 (D. Mass. 2016). In rejecting class certification, the
court reasoned that while Painters had satisfied the Rule
23(a) numerosity, commonality, typicality, and adequacy
requirements, Painters had failed to establish that common
questions of fact or law predominated over individual issues
as required by Rule 23(b)(3). Id. at 123-31.
in March 2017, a dispute arose as a result of Forest's
apparently belated production of two internal memoranda in
advance of a deposition conducted by agreement after
discovery had otherwise closed. The two documents contained
details regarding a study of Celexa's effectiveness.
Forest revealed that it had not sought any responsive
documents from its Clinical Supply Group in responding to
Painters' discovery requests. The district court
nevertheless denied Painters' motion to compel
Forest's supplemental production of documents from this
group, concluding that any such production would be
cumulative. In re Celexa & Lexapro Mktg. & Sales
Practices Litig. (Painters II), 288 F.Supp.3d
483, 486-87 (D. Mass. 2018).
course, after deeming discovery complete and ruling on
various interim motions, the district court entered summary
judgment for Forest on plaintiffs' RICO claims, holding
that neither Painters nor Ramirez could demonstrate injury.
In re Celexa & Lexapro Mktg. & Sales Practices
Litig. (Painters III), 289 F.Supp.3d 247,
253-56 (D. Mass. 2018). The court then proceeded to dismiss
plaintiffs' state-based allegations as deriving from
their noncognizable RICO claims. Id. at 258-59. This
appeal by Painters and Ramirez followed.
judgment is appropriate "if the movant shows that there
is no genuine dispute as to any material fact and the movant
is entitled to judgment as a matter of law."
Fed.R.Civ.P. 56(a). In granting summary judgment dismissing
all of plaintiffs' claims, the district court concluded
that plaintiffs had no competent proof that either Celexa or
Lexapro was ineffective for treating depression in children
or adolescents. We review this conclusion de novo.
Martinez v. Petrenko, 792 F.3d
173, 179 (1st Cir. 2015).
on a RICO claim requires proof of an economic injury.
See 18 U.S.C. § 1964(c) ("Any person
injured in his business or property by reason of a violation
of section 1962 of this chapter may sue therefor.").
Plaintiffs allege injury in the form of payments made for
ineffective drugs. The district court therefore turned its
attention to determining whether plaintiffs had enough
evidence to allow a jury to find Celexa and/or Lexapro
ineffective for treating pediatric depression. See
Painters III, 289 ...