Leonard Cottrell v. Alcon Laboratories , 874 F.3d 154 ( 2017 )

PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
___________
No. 16-2015
___________
LEONARD COTTRELL; SANDRA HENON; WILLIAM
REEVES; GEORGE HERMAN; SIMON NAZZAL; CAROL
FREBURGER; JACK LIGGETT; PATRICIA BOUGH;
MACK BROWN; DOLORES GILLESPIE; DEBORAH
HARRINGTON; ROBERT INGINO; EDWARD ROGERS,
JR.; DEBORAH RUSIGNULOLO; DOROTHY STOKES;
JOSEPHINE TROCCOLI; HURIE WHITFIELD; THOMAS
LAYLOFF; CAROLYN TANNER; PATSY TATE; JOHN
SUTTON; JESUS RENTERIA; GLENDELIA FRANCO;
NADINE LAMPKIN, on behalf of themselves and all others
similarly situated,
Appellants
v.
ALCON LABORATORIES; ALCON RESEARCH LTD;
FALCON PHARMACEUTICALS LTD; SANDOZ INC.;
ALLERGAN INC, RP; ALLERGAN USA INC;
ALLERGAN SALES LLC; PFIZER INC; VALEANT
PHARMACEUTICALS INTERNATIONAL; BAUSCH &
LOMB INC; ATON PHARMA INC; MERCK & CO INC;
MERCK SHARP & DOHME CORP; PRASCO LLC;
AKORN INC
_________________________________
On Appeal from the United States District Court
for the District of New Jersey
(D.C. Civil Action No. 3-14-cv-05859)
District Judge: Honorable Freda L. Wolfson
____________________________________
Argued: January 24, 2017
Before: CHAGARES, RESTREPO, and *ROTH, Circuit
Judges
Filed: October 18, 2017
____________
LEAH M. NICHOLLS, ESQ. [ARGUED]
Public Justice, P.C.
1620 L. St. N.W., Suite 630
Washington, DC 20036
RICHARD S. CORNFELD, ESQ.
Law Office of Richard S. Cornfeld
1010 Market St., Suite 1720
St. Louis, MO 63101
JOHN G. SIMON, ESQ.
KEVIN M. CARNIE, JR., ESQ.
The Simon Law Firm, P.C.
*
Judge Roth participated via video conference.
2
800 Market St., Suite 1700
St. Louis, MO 63101
JEFFREY W. HERRMANN, ESQ.
Cohn Lifland Pearlman Herrmann & Knopf LLP
Park 80 West-Plaza One
250 Pehle Ave., Suite 401
Saddle Brook, NJ 07663
BRIAN S. WOLFMAN, ESQ.
600 New Jersey Ave. N.W., Suite 312
Washington, DC 20001
Counsel for Appellants
ROBYN E. BLADOW, ESQ. [ARGUED]
AUSTIN C. NORRIS, ESQ.
Kirkland & Ellis LLP
333 South Hope Street, 29th Floor
Los Angeles, CA 90071
Counsel for Appellee Pfizer, Inc.
LIZA M. WALSH, ESQ.
ELEONORE OFOSU-ANTWI, ESQ.
Walsh Pizzi O’Reilly & Falanga LLP
One Riverfront Plaza
1037 Raymond Boulevard, Suite 600
Newark, NJ 07102
Counsel for Appellees Pfizer, Inc., Valeant
Pharmaceuticals International, Inc., Bausch & Lomb
Incorporated, and Aton Pharma, Inc.
3
ROGER B. KAPLAN, ESQ.
Greenberg Traurig, LLP
200 Park Avenue
Florham Park, NJ 07932
GREGORY E. OSTFELD, ESQ.
Greenberg Traurig, LLP
77 W. Wacker Drive, Suite 3100
Chicago, IL 60601
LORI G. COHEN, ESQ.
Greenberg Traurig, LLP
3333 Piemont Road NE, Suite 2500
Atlanta, GA 30305
Counsel for Appellees Alcon Laboratories, Inc., Alcon
Research Ltd., Sandoz Inc. and Falcon Pharmaceuticals, Ltd.
CHARLES B. CASPER, ESQ.
Montgomery McCracken Walker & Rhoads, LLP
LibertyView, Suite 600
457 Haddonfield Road
Cherry Hill, NJ 08002
STEPHEN G. STRAUSS, ESQ.
TIMOTHY J. HASKEN, ESQ.
Bryan Cave LLP
211 N. Broadway, Suite 3600
St. Louis, MO 63102
Counsel for Appellees Merck & Co., Inc., Merck Sharp
& Dohme Corp., and Prasco, LLC.
4
ROBERT J. MCGUIRL, ESQ.
Law Offices Of Robert J. McGuirl, LLC
295 Spring Valley Road
Park Ridge, NJ 07656
Counsel for Appellees Allergan, Inc., Allergan USA,
Inc., and Allergan Sales, LLC
JAMES P. MUEHLBERGER, ESQ.
LORI A. MCGRODER, ESQ.
Shook Hardy & Bacon LLP
2555 Grand Blvd.
Kansas City, MO 64108
Counsel for Appellees Allergan, Inc., Allergan USA,
Inc., Allergan Sales, LLC, Valeant Pharmaceuticals
International, Inc., Bausch & Lomb Incorporated, and Aton
Pharma, Inc.
WALTER H. SWAYZE, III, ESQ.
MEGAN E. GROSSMAN, ESQ.
KYLE G. EVERLY, ESQ.
Segal Mccambridge Singer & Mahoney, Ltd.
15 Exchange Place, Suite 1020
Jersey City, NJ 07302
JOHN M. KILROY, JR., ESQ.
Polsinelli PC
900 W. 48th Place, Suite 900
Kansas City, MO 64112
5
J. STANTON HILL, ESQ.
Polsinelli PC
1355 Peachtree Street, N.E., Suite 500
Atlanta, GA 30309
Counsel for Appellee Akorn, Inc.
JULIE NEPVEU, ESQ.
AARP Foundation Litigation
Room B4-245
601 E Street, N.W.
Washington, DC 20049
Counsel for Amicus AARP & AARP Foundation, in
support of Appellants
RICHARD A. DEAN, ESQ.
Tucker Ellis
950 Main Avenue
Suite 1100
Cleveland, OH 44113
Daniel J. Kelly, ESQ.
Tucker Ellis LLP
One Market Plaza, Steuart Tower Suite 700
San Francisco, CA 94105
Benjamin C. Sasse, ESQ.
Tucker Ellis LLP
950 Main Ave., Suite 1100
Cleveland, OH 44113
6
Counsel for Amicus Generic Pharmaceutical
Association, in support of Appellees
JEFFREY S. BUCHOLTZ, ESQ.
PAUL A. MEZZINA, ESQ.
King & Spalding
1700 Pennsylvania Avenue, N.W.
Suite 200
Washington, DC 20006
Counsel for Amicus Chamber of Commerce of the
United States of America, American Tort Reform Association,
Pharmaceutical Research and Manufacturers of America,
and National Association of Manufacturers in support of
Appellees
ANITA HOTCHKISS, ESQ.
Goldberg Segalla
902 Carnegie Center
Suite 100
Princeton, NJ 08540
Counsel for Amicus Product Liability Advisory
Council, in support of Appellees
Michael J. Quirk, ESQ.
Williams Cuker Berezofsky, LLC
1515 Market Street, Suite 1300
Philadelphia PA 19102-1929
National Association of Consumer Advocates
7
___________
OPINION OF THE COURT
RESTREPO, Circuit Judge
In this putative class action, consumers of prescription
eye medication allege that manufacturers and distributors of
the medication packaged it in such a way that forced them to
waste it, violating the consumer protection statutes of their
home states. The District Court dismissed the entire action for
lack of jurisdiction, finding the consumers’ allegations of
injury in fact insufficient to confer standing. For the reasons
that follow, we will reverse the dismissal, and remand the case
for further consideration.
I1
1
“When reviewing an order of dismissal for lack of
standing, we accept as true all material allegations of the
complaint and construe them in favor of the plaintiff.”
Danvers Motor Co., Inc. v. Ford Motor Co., 432 F.3d 286, 288
(3d Cir. 2005) (quoting Conte Bros. Auto., Inc. v. Quaker
State–Slick 50, Inc., 165 F.3d 221, 224 (3d Cir. 1998)). We
therefore will review the facts as alleged by Plaintiffs in their
operative complaint. See id.
8
Defendants are manufacturers and distributors of
generic and brand-name prescription eye drop medications that
are approved by the Food and Drug Administration (“FDA”)
to treat serious medical conditions such as glaucoma, a leading
cause of blindness.2 Defendants sell these prescription
medications in fluid form and package the fluid in plastic
bottles. Bottles are pre-packaged with a fixed volume of
medication (e.g., 5.0 mL) sold at set prices. Labeling on the
bottles does not indicate how many doses or days of treatment
a patient will be able to extract from the bottle.
Medication is dispensed from the plastic bottles into
patients’ eyes in drop form. The dimensions of the bottle’s
dropper tip dictate the size of the drop dispensed from that
bottle. In effect, the larger the bottle dropper tip, the larger the
drop dispensed. There is no reasonable way for a patient to
instill less than one full drop into his or her eye.
A plethora of scientific research conducted over the last
four decades has examined the drop size of Defendants’
medications; some of the studies conducted were, in fact,
sponsored and published by Defendants. According to these
2
As detailed in the District Court’s opinion, the
defendants in this case include both brand-name and generic
pharmaceutical manufacturers and their distributors. The
brand name companies include: Alcon Laboratories, Inc.,
Alcon Research, Ltd., Allergan, Inc., Allergan USA, Inc.,
Allergan Sales, LLC, Pfizer Inc., Valeant Pharmaceuticals
International, Inc., Bausch & Lomb, Inc., Aton Pharma, Inc.,
Merck & Co., Inc., and Merck, Sharpe & Dohme Corp. The
generic companies are Falcon Pharmaceuticals, Ltd., Sandoz
Inc., Prasco LLC, and Akorn, Inc.
9
studies, a normal adult’s inferior fornix – the area between the
eye and the lower eyelid – has a capacity of approximately 7 to
10 microliters (“µLs”) of fluid.3 If a drop of medication
exceeding that capacity is placed into an adult patient’s eye,
excess medication is expelled. Expelled medication may run
down a patient’s cheek, providing no pharmaceutical benefit to
the patient whatsoever. This medication is “entirely wasted”
by the patient. App. 182. Expelled medication also may flow
into a patient’s tear ducts and move into his or her bloodstream.
Medication entering a patient’s bloodstream may increase a
patient’s risk of experiencing certain harmful systemic side
effects.
These studies conclude that eye drops should be 5 to 15
µLs in order to maximize the amount of the medication
entering the inner eye – the site of action for the medication.
Drop sizes within this range minimize overflow “waste” and
also minimize the risk of side effects.
Despite the scientific consensus on drop size, all of
Defendants’ products at issue emit drops that are considerably
larger than 15 µLs. In fact, a 2008 study showed that each
Defendant’s drop size was more than two to three times the 15
µL maximum recommended size. Several Defendants sold
products with drop sizes of 50 µL. To put these data in
perspective, at least half of every drop of medication dispensed
from any one of Defendants’ product bottles goes to waste on
a patient, and may put the patient at risk of side effects.
3
It can hold 20 to 30 µLs of fluid only for a moment,
until the individual blinks.
10
Plaintiffs in this litigation are individuals who paid for
Defendants’ eye drop medication. They allege that Defendants
have control over the design and dimensions of the bottle
dropper tip, and thus could reduce the size of drops emitted
from their product bottles, but have chosen not to do so.
Plaintiffs do not purport to have personal knowledge as to why
no defendant has reduced their products’ drop sizes. However,
Plaintiffs include in the Amended Complaint allegations that
senior executives at Defendant Alcon explained to a consultant
working with them that they were unwilling to reduce drop
sizes because if they did, the company “would sell less product
and make less money.” App. 244.
Plaintiffs aver that Defendants’ practices of selling
medication in bottles that emit such large drops caused them
“substantial” economic injury. App. 214. Specifically,
Plaintiffs allege, “If the sizes of Defendants’ prescription eye
drops were limited to the maximum effective size of 15 µL . .
. the medication in the bottles would last longer and [Plaintiffs]
would spend substantially less on their therapy than they do
with larger, substantially wasted, eye drops.” App. 214.
Plaintiffs illustrated this point in their Amended Complaint
with an example provided in a 2008 scientific study:
[T]he average drop size for
Allergan’s glaucoma drug
Alphagan P . . . in a 5 mL bottle
was 43 μL . . . . At the
recommended dose of one drop in
each affected eye three times daily,
a 5 mL bottle would last a patient
with bilateral glaucoma 20 days.
That patient would go through
11
18.25 bottles in a year. In July
2013, a 5 mL bottle of Alphagan P
. . . cost $104.99. A year’s course
of treatment would therefore cost
approximately $1,915. However,
approximately 65% of the
medication, the amount over 15
μL, would be wasted. If the drops
had been only 15 μL, the patient
would have needed only 6.46
bottles a year, or 7.0 bottles if the
drops had been 16 μL . . . . The
unneeded medication would cost
the patient more than $1,100 a
year.
App. 215-216 (emphasis added). Plaintiffs also quantified
their individual economic injuries in charts attached to the
Amended Complaint.
Plaintiffs claim they could not have avoided these
economic injuries; they were “compel[led] [by Defendants’
practices] to spend more money on their therapy than if the
drops were 15 µL.” App. 214. They had no non-
pharmaceutical alternative treatments for their conditions.
And there were no alternative products to Defendants’; “all
prescription eye drops are substantially larger than 15 µL and
therefore lead to wastage.” App. 217. Their only alternative
was to forgo treatment and risk blindness or worsening
eyesight.
II
12
In September 2014, Plaintiffs filed a putative class
action complaint, on behalf of themselves and other similarly
situated parties, in the United States District Court for the
District of New Jersey. Plaintiffs asserted violations of the
consumer protection laws of their respective home states: the
New Jersey Consumer Fraud Act (“NJCFA”), N.J.S.A. § 56:8-
1, et seq.; the California Unfair Competition Law (“UCL”),
Cal. Bus. Prof. Code § 17200, et seq.; the Florida Deceptive
and Unfair Trade Practices Act (“FDUTPA”), Fla. Stat. §
501.201, et seq.; the Illinois Consumer Fraud Act (“ICFA”),
815 ILCS 505/1, et seq.; the North Carolina Unfair and
Deceptive Trade Practices Act (“NCUTDPA”), N.C.G.S. § 75-
1.1, et seq.; and the Texas Deceptive Trade Practices Act
(“DTPA”), Tex. Bus. & Com. Code § 17.41, et seq. Plaintiffs
claimed Defendants’ practices in manufacturing and selling
prescription eye drop medication violated the statutes’
prohibitions on unfair or unconscionable trade practices. The
District Court dismissed Plaintiffs’ original complaint for lack
of standing, without prejudice to Plaintiffs’ ability to amend
the complaint and cure the standing deficiencies.
In June 2015, Plaintiffs filed an Amended Complaint,
asserting claims of unfair or unconscionable practices under
the same six state consumer protection statutes.4 Plaintiffs
4
Specifically, Plaintiffs claim that Defendants’
practices were: (1) “unconscionable commercial practice[s]”
under the NJCFA; (2) “unlawful” and “unfair” practices under
the UCL; (3) “unfair acts or practices” under the FDUTPA; (4)
“unfair acts or practices” under the ICFA; (5) “unfair . . . acts
or practices” under the NCUDTPA; (6) and “unconscionable
act[s]” under the DTPA. App. 266-73 (internal quotation
marks and citations omitted).
13
supported their allegations of unfair or unconscionable
practices with: (a) scientific literature opining on costs savings
occasioned by utilizing smaller drop sizes; and (b) charts
showing each Plaintiff’s expenses. The charts detailed
Plaintiffs’ medication purchases and the out-of-pocket
expenses they incurred for their purchases. Using these charts
and information about each product’s drop size, Plaintiffs
calculated their total out-of-pocket payments on “wasted”
medication. These totals ranged from a few dollars to a few
hundred dollars.
In August 2015, Defendants moved to dismiss
Plaintiffs’ Amended Complaint for lack of standing, federal
preemption, and failure to state a claim. The District Court
granted Defendants’ motions, finding that Plaintiffs had not
pleaded an injury in fact necessary to confer standing. As a
result, the court did not reach Defendants’ arguments on
preemption and the sufficiency of Plaintiffs’ claims under
Federal Rule of Civil Procedure 12(b)(6). Plaintiffs then filed
this timely appeal.
III
The District Court had jurisdiction pursuant to the Class
Action Fairness Act (“CAFA”), 28 U.S.C. § 1332(d), because
at least one member of the Plaintiff class is diverse from at least
one of the Defendants, the putative class is composed of at least
100 people, and the amount in controversy exceeds five million
dollars. We have jurisdiction over the District Court’s
dismissal of the case pursuant to 28 U.S.C. § 1291.
We exercise plenary review over a dismissal for lack of
standing. In re Schering Plough Corp. Intron/Temodar
14
Consumer Class Action, 678 F.3d 235, 243 (3d Cir. 2012).
IV
Article III of the United States Constitution limits the
power of the federal judiciary to “cases” and “controversies.”
U.S. Const. art. III. For a federal court to exercise jurisdiction
under Article III, plaintiffs must allege – and eventually prove
– that they having “standing” to pursue their claims. See Lujan
v. Defenders of Wildlife, 504 U.S. 555, 560-61 (1992). The
doctrine of standing emerged from “the traditional
understanding of a case or controversy” in order “to ensure that
federal courts do not exceed their [constitutional] authority” by
“unsurp[ing] the powers of the political branches.” Spokeo,
Inc. v. Robins, 136 S. Ct. 1540, 1547 (2016) (quoting Clapper
v. Amnesty Int’l USA, 133 S. Ct. 1138, 1146 (2013)). “The
doctrine limits the category of litigants empowered to maintain
a lawsuit in federal court to seek redress for a legal wrong.” Id.
The plaintiff, “as the party invoking federal
jurisdiction,” bears the burden of establishing the minimal
requirements of Article III standing: “(1) . . . an injury in fact,
(2) that is fairly traceable to the challenged conduct of the
defendant, and (3) that is likely to be redressed by a favorable
judicial decision.”5 Id. In assessing whether a plaintiff has
carried this burden, we separate our standing inquiry from any
assessment of the merits of the plaintiff’s claim. To maintain
5
“In the context of class actions, Article III standing ‘is
determined vis-a-vis the named parties.’” McCray v. Fidelity
Nat. Title Ins. Co., 682 F.3d 229, 243 (3d Cir. 2012) (quoting
Krell v. Prudential Ins. Co. of Am., 148 F.3d 283, 306 (3d Cir.
1998)).
15
this fundamental separation between standing and merits at the
dismissal stage, we assume for the purposes of our standing
inquiry that a plaintiff has stated valid legal claims. Info.
Handling Servs., Inc. v. Defense Automated Printing Servs.,
338 F.3d 1024, 1029 (D.C. Cir. 2003) (citing Warth v. Seldin,
422 U.S. 490, 500 (1975)). While our standing inquiry may
necessarily reference the “nature and source of the claim[s]
asserted,” Warth, 422 U.S. at 500, our focus remains on
whether the plaintiff is the proper party to bring those claims,
The Pitt News v. Fisher, 215 F.3d 354, 360 (3d Cir. 2000);
White Tail Park, Inc. v. Stroube, 413 F.3d 451, 460-61 (4th Cir.
2005).
A
This case centers on the “[f]irst and foremost” of the
three standing elements, injury in fact. Spokeo, 136 S. Ct. at
1547 (quoting Steel Co. v. Citizens for Better Env’t, 523 U.S.
83, 103 (1998)). The purpose of the injury-in-fact requirement,
the Supreme Court has explained, is “to distinguish a person
with a direct stake in the outcome of a litigation – even though
small – from a person with a mere interest in the problem.”
United States v. Students Challenging Regulatory Agency
Procedures (SCRAP), 412 U.S. 669, 689 n.14 (1973). Put
differently, the requirement serves to filter out those “with
merely generalized grievances” who are “bringing suit to
vindicate an interest common to the entire public.” Friends of
the Earth, Inc. v. Gaston Copper Recycling Corp., 204 F.3d
149, 156 (4th Cir. 2000). The injury-in-fact requirement is
“very generous” to claimants, demanding only that the
claimant “allege[ ] some specific, ‘identifiable trifle’ of
injury.” Bowman v. Wilson, 672 F.2d 1145, 1151 (3d Cir.
16
1982) (quoting SCRAP, 412 U.S. at 686-90 & 689 n.14). It “is
not Mount Everest.” Danvers, 432 F.3d at 294.
To allege injury in fact sufficiently, a plaintiff must
claim “that he or she suffered ‘an invasion of a legally
protected interest’ that is ‘concrete and particularized’ and
‘actual or imminent, not conjectural or hypothetical.’” Spokeo,
136 S. Ct. at 1548 (quoting Lujan, 504 U.S. at 560). Typically,
a plaintiff’s allegations of financial harm will easily satisfy
each of these components, as financial harm is a “classic” and
“paradigmatic form[]” of injury in fact. Danvers, 432 F.3d at
291, 293. Indeed, we have explained that where a plaintiff
alleges financial harm, standing “is often assumed without
discussion.” Id. at 293; see also Carter v. HealthPort Techs.,
LLC, 822 F.3d 47, 55 (2d Cir. 2016) (“Any monetary loss
suffered by the plaintiff satisfies [the injury-in-fact] element;
‘[e]ven a small financial loss’ suffices.” (quoting Nat. Res. Def.
Council, Inc. v. U.S. Food & Drug Admin., 710 F.3d 71, 85 (2d
Cir. 2013))); Cent. Ariz. Water Conservation Dist. v. U.S.
E.P.A., 990 F.2d 1531, 1537 (3d Cir. 1993) (“Pecuniary injury
is clearly a sufficient basis for standing.” (internal quotation
marks and citation omitted)).
Although the District Court provided a detailed
recitation of standing law in its opinion, including the
components of injury in fact, it did not apply those individual
components to Plaintiffs’ allegations. Rather, it framed its
injury-in-fact analysis around broader principles and theories
of standing, as did the parties in their briefing to this Court.
This approach has some persuasive appeal. But where the
court or litigants cast aside the essential components of injury
in fact in favor of more generalized, abstract discussion, they
risk improperly, if inadvertently, crossing over in their analysis
17
from standing to merits. So we take a different tack; we will
address in turn each component of injury in fact.
1
The first component of the injury-in-fact test offered by
Spokeo – “legally protected interests” – warrants the most
discussion in this case. The Supreme Court has not defined the
term “legally protected interest” as it pertains to Article III
standing, nor has it clarified whether the term does any
independent work in the standing analysis. The Court first
introduced the term in Lujan. 504 U.S. at 560; see Judicial
Watch, Inc. v. U.S. Senate, 432 F.3d 359, 363 (D.C. Cir. 2005)
(Williams, J., concurring). And it appeared – without
elaboration – as recently as last year in Spokeo in the Court’s
recitation of Lujan’s injury-in-fact test. 136 S. Ct. at 1548.
Between Lujan and Spokeo though, it has not appeared with
regularity in Supreme Court opinions addressing standing. A
host of the Court’s standing opinions have omitted the term
altogether,6 and it has rarely been applied. See Judicial Watch,
6
See, e.g., Clapper, 568 U.S. at 409 (stating “an injury
must be concrete, particularized, and actual or imminent”
(internal quotation marks omitted)); Monsanto Co. v. Geertson
Seed Farms, 561 U.S. 139, 149 (2010) (“Standing under
Article III of the Constitution requires that an injury be
concrete, particularized, and actual or imminent . . . .”);
Massachusetts v. U.S. E.P.A., 549 U.S. 497, 517 (2007)
(formulating the Lujan injury-in-fact test as requiring “a
litigant [to] demonstrate that it has suffered a concrete and
particularized injury that is either actual or imminent”);
Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc.,
528 U.S. 167, 180 (2000) (“In Lujan[, 504 U.S. at 560-61], we
18
432 F.3d at 363 (Williams, J., concurring). This may suggest
that “legally protected interest” is simply a reformulation of the
other components of injury in fact. Id.
However, if we assume arguendo that the term “do[es]
some work in the standing analysis,” Initiative & Referendum
Inst. v. Walker, 450 F.3d 1082, 1093 (10th Cir. 2006) (en banc),
we can discern a number of guideposts from the Supreme
Court’s standing jurisprudence about what it may – and may
not – require that bear on this case. The most important is this:
in this context, whether a plaintiff has alleged an invasion of a
“legally protected interest” does not hinge on whether the
conduct alleged to violate a statute does, as a matter of law,
violate the statute. Were we to conclude otherwise, we would
effectively collapse our evaluation under Federal Rule of Civil
Procedure 12(b)(6) for failure to state a claim into an Article
III standing evaluation. Every losing claim would be
dismissed – without prejudice7 – for lacking standing in the
first place. Id. at 1092; White Tail Park, 413 F.3d at 460-61;
held that, to satisfy Article III’s standing requirements, a
plaintiff must show (1) it has suffered an ‘injury in fact’ that is
(a) concrete and particularized and (b) actual or imminent, not
conjectural or hypothetical . . . .”); Steel Co., 523 U.S. at 103
(describing an injury in fact as “a harm suffered by the plaintiff
that is concrete and actual or imminent, not conjectural or
hypothetical” (internal quotation marks and citation omitted)).
7
Because the absence of standing leaves the court
without subject matter jurisdiction to reach a decision on the
merits, dismissals “with prejudice” for lack of standing are
generally improper. See Korvettes, Inc. v. Brous, 617 F.2d
1021, 1024 (3d Cir. 1980).
19
Claybrook v. Slater, 111 F.3d 904, 907 (D.C. Cir. 1997); see
also In re Special Grand Jury 89-2, 450 F.3d 1159, 1172 (10th
Cir. 2006) (observing that the Supreme Court “has made clear
that a plaintiff can have standing . . . even though the interest
would not be protected by the law in that case”). And we
would “thwart a major function of the standing doctrine – to
avoid premature judicial involvement in resolution of issues on
the merits.” Judicial Watch, 432 F.3d at 364 (Williams, J.,
concurring).
Second, the Supreme Court has repeatedly recognized
that financial or economic interests are “legally protected
interests” for purposes of the standing doctrine. See Vermont
Agency of Nat. Resources v. United States, 529 U.S. 765, 772-
77 (2000); Clinton v. New York, 524 U.S. 417, 432 (1998);
Sierra Club v. Morton, 405 U.S. 727, 733-34 (1972); see also
Cent. Ariz. Water, 990 F.2d at 1537 (stating that “pecuniary or
economic injury is generally a legally protected interest,” so
long as that economic injury meets the remaining requirements
of the injury-in-fact test); Erwin Chemerinsky, Federal
Jurisdiction § 2.3, at 76 (7th ed. 2016) (noting that the Supreme
Court has deemed economic harms sufficient injuries for
standing).
Third, “legally protected interests” may arise from the
Constitution, from common law, or “solely by virtue of
‘statutes creating legal rights, the invasion of which creates
standing.’” Lujan, 504 U.S. at 576-78 (quoting Warth, 422
U.S. at 500). Both federal law and state law – including state
statutes – “can create interests that support standing in federal
courts.” Cantrell v. City of Long Beach, 241 F.3d 674, 684
(9th Cir. 2001) (citing FMC Corp. v. Boesky, 852 F.2d 981,
992 (7th Cir. 1988)).
20
Fourth, the interest asserted must be “related to the
injury in fact”; it cannot be “merely a ‘byproduct’ of the suit
itself.” Vermont Agency, 529 U.S. at 772-73. To illustrate, a
qui tam relator who is entitled to a portion of a recovery if his
suit under the False Claims Act is successful has a legally
protected interest in the outcome of the suit. Id. at 772. An
individual who has simply placed a wager on the outcome does
not. Id.; see also Steel Co., 523 U.S. at 107 (“[A] plaintiff
cannot achieve standing to litigate a substantive issue by
bringing suit for the cost of bringing suit.”).
With these guideposts in mind, we look to Plaintiffs’
Amended Complaint. Plaintiffs claim economic interests:
interests in the money they had to spend on medication that
was impossible for them to use. They seek monetary
compensation for Defendants’ conduct that they allege caused
harm to these interests. Plaintiffs’ claimed interests arise from
state consumer protection statutes that provide monetary relief
to private individuals who are damaged by business practices
that violate those statutes. These claims fit comfortably in
categories of “legally protected interests” readily recognized
by federal courts. See Cantrell, 241 F.3d at 684.
We acknowledge that the Seventh Circuit held
otherwise in a recent case concerning materially identical
allegations against many of the same defendants. Eike v.
Allergan, Inc., 850 F.3d 315 (7th Cir. 2017). In reviewing the
defendants’ appeal from the district court’s grant of class
certification, the Seventh Circuit concluded that plaintiffs had
failed to allege a “legally protected interest,” and therefore,
lacked standing. Id. at 318. The Court noted that the Plaintiffs’
pleading “lack[ed] . . . any suggestion of collusion . . . or any
21
claim” of misrepresentation or deception by defendants. Id. at
317. From the absence of fraud-based allegations, the court
went on to reason that the plaintiffs’ claims were necessarily
“based simply on [their] dissatisfaction” with the defendants’
products or their prices. Id. at 317. We decline to adopt the
Court’s rationale.
This reasoning fails to recognize a category of business
practices entirely separate from practices that are fraudulent,
deceptive, or misleading – “unfair” business practices –
prohibited under the state consumer protection statutes
invoked. The plaintiffs in Eike explicitly alleged that the
defendants’ practices in manufacturing and selling eye
medication were “unfair” under the Illinois Consumer Fraud &
Deceptive Practices Act (“ICFA”) and the Missouri
Merchandising Practices Act (“MMPA”). See Eike v.
Allergan, Inc., 2014 WL 1040728, at *1 (S.D. Ill. Mar. 18,
2014), vacated, 850 F.3d 315 (7th Cir. 2017).8 The Court was
8
Under the ICFA, “[a] plaintiff is entitled to recovery .
. . when there is unfair or deceptive conduct” and “may allege
that conduct is unfair . . . without alleging that the conduct is
deceptive.” Siegel v. Shell Oil Co., 612 F.3d 932, 935 (7th Cir.
2010) (emphasis added). Under the MMPA, “[t]he act . . . by
any person of any deception, fraud, false pretense, false
promise, misrepresentation, unfair practice or the
concealment, suppression, or omission of any material fact in
connection with the sale . . . of any merchandise . . . is declared
to be an unlawful practice.” Mo. Rev. Stat. § 407.020
(emphasis added). The definition of “unfair” under the MMPA
is “unrestricted, all-encompassing, and exceedingly broad.”
Conway v. CitiMortgage, Inc., 438 S.W.3d 410, 416 (Mo.
2014) (citation omitted).
22
obliged to take these allegations as true for purposes of the
standing inquiry. Yet nowhere in its opinion does the term
“unfair” even appear. See generally Eike, 850 F.3d 315.
Even setting aside the difference between “deceptive”
and “unfair” practices under the state consumer protection
statutes, the Court in Eike blended standing and merits together
in a manner that the Supreme Court has exhaustively cautioned
courts against. The Seventh Circuit seemed to begin its
standing analysis with a determination that the plaintiffs had
“no cause of action.” Id. at 317-18. Because they had no cause
of action, the Court reasoned, they had no injury. Id. at 318.
Because they had no injury, they had no standing to sue. Id.
This logic flips the standing inquiry inside out,
morphing it into a test of the legal validity of the plaintiffs’
claims of unlawful conduct. But as we have already
emphasized, a valid claim for relief is not a prerequisite for
standing. Steel Co., 523 U.S. at 96 (explaining that “the
nonexistence of a cause of action was no proper basis for a
jurisdictional dismissal” and highlighting the “fundamental
distinction between arguing” that plaintiffs have no cause of
action and arguing that they do not have Article III standing);
see also Bond v. United States, 564 U.S. 211, 218-19 (2011)
(noting the distinction between whether a plaintiff has a “cause
of action” and whether he or she has “standing”). Indeed, the
Seventh Circuit has acknowledged as much in other cases. For
instance, in Bruggeman ex rel. Bruggeman v. Blagojevich, 324
F.3d 906 (7th Cir. 2003), it faulted the district court for finding
that the plaintiffs had no standing to pursue their claims against
state officials for violations of a federal statute. Id. at 908-09.
There, it explained:
23
The district judge ruled that none
of [the relevant statutory
provisions] entitled the plaintiffs
to what they were seeking and that
therefore the plaintiffs had not
been injured by a violation of the
statute and so lacked standing to
sue. This is a misunderstanding of
standing. A plaintiff has standing
to sue – that is, he can invoke the
jurisdiction of the court – if he is
tangibly, materially, injured by the
conduct of the defendant that he
claims is unlawful . . . . [I]f the
consequence [of his claim lacking
merit] were that he lacked
standing, then every decision in
favor of a defendant would be a
decision that the court lacked
jurisdiction, entitling the plaintiff
to start over in another court.
Id. at 909.
The District Court here, like the Seventh Circuit, cast
the Plaintiffs’ allegations as mere grumblings that Defendants’
products were priced too high or packaged inefficiently,
because the allegations lacked notes of fraud, deception, or
misrepresentation. But as in Eike, the absence of fraud
allegations in the Amended Complaint was purposeful;
Plaintiffs claim that Defendants’ practices were unfair and
unconscionable, not deceptive or fraudulent. And like the
statutes at issue in Eike, the statutes enumerated in Plaintiffs’
24
Amended Complaint prohibit business practices that are
“unfair” or “unconscionable” in addition to practices that are
fraudulent, deceptive, or misleading; these terms are defined
separately and differently in the text of the statutes and in
relevant case law interpreting them.9 Therefore, the District
9
See Rubio v. Capital One Bank, 613 F.3d 1195, 1203
(9th Cir. 2010) (“A business act or practice may violate the
[UCL] if it is either unlawful, unfair, or fraudulent. Each of
these three adjectives captures a separate and distinct theory of
liability.” (internal quotation marks and citation omitted));
Siegel, 612 F.3d at 935 (7th Cir. 2010) (stating that “[a]
plaintiff is entitled to recovery under [the] ICFA when there is
unfair or deceptive conduct” and “may allege that conduct is
unfair . . . without alleging that the conduct is deceptive”);
PNR, Inc. v. Beacon Property Mgmt., Inc., 842 So. 2d 773, 777
(Fla. 2003) (defining an “unfair practice” under the FDUTPA
as “one that offends established public policy and one that is
immoral, unethical, oppressive, unscrupulous or substantially
injurious to consumers” and noting a separate definition for
“deception” (internal quotation marks and citation omitted));
Cox v. Sears Roebuck & Co., 647 A.2d 454, 462 (N.J. 1994)
(explaining that an unconscionable practice can qualify as
unlawful under the NJCFA, “even if no person was in fact
misled or deceived thereby”); Lon Smith & Assocs., Inc. v. Key,
2017 WL 3298391, at *11 (Tex. Ct. App. Aug 3, 2017) (“The
DTPA defines ‘[u]nconscionable action or course of action’ as
‘an act or practice which, to a consumer’s detriment, takes
advantage of the lack of knowledge, ability, experience, or
capacity of the consumer to a grossly unfair degree.’” (quoting
Tex. Bus. & Comm. Code Ann. § 17.45(5))); Melton v. Family
First Mortg. Corp., 576 S.E.2d 365, 368 (N.C. Ct. App. 2003)
(“A practice is unfair [under the NCUDTPA] when it offends
25
Court’s characterization of Plaintiffs’ claims as “sound[ing] in
fraud” was inaccurate, and the conclusion that Plaintiffs were
without standing due, in part, to the absence of theories of
injury “normally attendant to consumer fraud claims,” App. 23,
misses the mark. Moreover, the District Court’s chain of
reasoning – that because Plaintiffs made no allegations of
fraud, they suffered no injury, and therefore had no standing to
sue – blends standing with merits in the same manner as Eike.
For these reasons, we conclude that Plaintiffs have
sufficiently alleged “legally protected interests.”
2
We turn to the next component of injury in fact:
concreteness. For an injury to be “concrete,” it must be “real”
and “actually exist”; it cannot be “abstract.” Spokeo, 136 S.
Ct. at 1548 (internal citations omitted). Bare procedural or
technical violations of a statute alone will not satisfy the
concreteness requirement. Id. at 1549; see also Allen v. Wright,
468 U.S. 737, 754 (1984) (“[A]n asserted right to have the
Government act in accordance with law is not sufficient,
standing alone, to confer jurisdiction on a federal court.”),
abrogated on other grounds by Lexmark Int’l, Inc. v. Static
Control Components, Inc., 134 S. Ct. 1377 (2014). Here,
Plaintiffs do not simply allege that Defendants’ practices
violated state consumer protection statutes. They allege that
established public policy as well as when the practice is
immoral, unethical, oppressive, unscrupulous, or substantially
injurious to consumers” and offering a separate definition for
“deceptive” practices (internal quotation marks and citations
omitted)).
26
those violations caused each of them tangible, economic harm.
This satisfies the concreteness requirement.
3
An injury must be both concrete and particularized;
these are distinct components of injury in fact. Spokeo, 136 S.
Ct. at 1548. “For an injury to be ‘particularized,’ it ‘must affect
the plaintiff in a personal and individual way.’” Id. at 1548;
see also In re Schering Plough, 678 F.3d at 245 (noting that the
party seeking review must be “himself among the injured”
(quoting Lujan, 504 U.S. at 560)); The Pitt News, 215 F.3d at
360. Although “[g]eneralized grievances” common to the
public will not suffice, Knick v. Twp. of Scott, 862 F.3d 310,
318 (3d Cir. 2017), “[t]he fact that an injury may be suffered
by a large number of people does not of itself make that injury
a nonjusticiable generalized grievance,” Spokeo, 136 S. Ct. at
1548 n.7. Requiring a plaintiff to allege facts establishing he
is personally injured by a defendant’s conduct places “the
decision as to whether review will be sought in the hands of
those who have a direct stake in the outcome.” Sierra Club v.
Morton, 405 U.S. 727, 740 (1972). Here, each Plaintiff alleges
financial harm that he or she has personally incurred in
purchasing medication that was impossible for him or her to
use. There can be no dispute that this harm is particularized.
4
Finally, we must determine whether Plaintiffs’ alleged
injuries are “actual or imminent” rather than merely
“conjectural or hypothetical.” Spokeo, 136 S. Ct. at 1548. This
component of injury-in-fact is designed to separate those
plaintiffs who have alleged “that [they] ha[ve] been or will in
27
fact be perceptibly harmed by the challenged [defendants’]
action” from those who claim only that they “can imagine
circumstances in which [they] could be affected by the
[defendant’s] action.” SCRAP, 412 U.S. at 688-89. Plaintiffs’
“pleadings must be something more than an ingenious
academic exercise in the conceivable.” Id.
Plaintiffs attempt to measure their financial harm by
way of two “theories” outlined in their Amended Complaint:
(1) the cost differential between what they would have paid for
their course of medication from smaller tipped bottles and what
they actually paid for the larger tipped bottles (the “pricing
theory”); or (2) the total overflow from each drop administered
that was impossible for them to use (the “reimbursement
theory”). These are two ways of calculating the same thing:
the cost of “wasted” medication that Plaintiffs allege they were
compelled to purchase but could not use. Under both theories,
the total financial harm works out to be the same. And under
both theories, Plaintiffs’ claimed financial harm has already
occurred, it is not merely possible, or even probable. So there
is no question of adequate imminence in this case. See
Adarand Constructors, Inc. v. Pena, 515 U.S. 200, 210 (1995)
(noting that the plaintiff “of course” had standing to seek
damages for alleged past economic injury, as opposed to
alleged risks of future injuries); Lewert v. P.F. Chang’s China
Bistro, Inc., 819 F.3d 963, 966-97 (7th Cir. 2016); Maya v.
Centex Corp., 658 F.3d 1060, 1069 (9th Cir. 2011)
(“Allegedly, plaintiffs spent money that, absent defendants’
actions, they would not have spent . . . . This is a quintessential
injury-in-fact.”).
Despite this, the District Court rejected Plaintiffs’
“pricing theory” of “actual” harm as too speculative to support
28
standing in this case. The District Court interpreted Plaintiffs’
pricing theory to rely on two critical presumptions: (a)
Defendants would have reduced the volume of medication in
each bottle to correspond with the lower volume of medication
needed for a patient’s course of therapy; and (b) Defendants
would have reduced the price of a bottle of medication in
accordance with the reduction in volume. It rejected the
second premise, because it had “no way of knowing whether
Defendants would price their products [based on volume],
particularly since the pricing of pharmaceuticals is complex.”
App. 20-21.
We might be inclined to agree with the District Court
that the pricing theory was too speculative if it, in fact, had
depended on these presumptions. But it did not. Plaintiffs
alleged under the pricing theory that smaller tipped bottles
would lower the cost of their medication treatment regimen.
Treatment costs could have been lowered in several ways, only
one of which involved lowering the actual price of the bottle of
medication. Alternatively, Plaintiffs would have paid less for
their course of medication if they were able to extract more
doses of medication – at least twice as many doses, according
to the allegations – out of the same bottle, without any changes
from the status quo in bottle pricing, physicians’ prescribing
practices, or the volume of medication in each bottle.
Plaintiffs illustrated in the Amended Complaint how
smaller tipped bottles would reduce the number of bottles
needed for a one-year therapy regimen, and the resulting cost
savings, by referencing an example in a 2008 scientific study,
29
as detailed supra.10 Plaintiffs also supported this iteration of
the pricing theory by citing to numerous other scientific studies
in the Amended Complaint. See, e.g., App. 240 (noting that
“[o]bviously a smaller drop size would mean that more doses
could be dispensed from each bottle of medication, providing
cost savings to patients and managed care providers” (quoting
Richard Fiscella et al., Efficiency of Instillation Methods for
Prostaglandin Medications, 22 J. Ocular Pharmacology and
Therapeutics 477, 478 (2006))). This alternative iteration of
the pricing theory is far less speculative than the iteration of
the pricing theory that the District Court understood Plaintiffs
to be advancing. It is also far less speculative than the theory
of financial harm we rejected in Finkelman v. Nat’l Football
League, 810 F.3d 187 (3d Cir. 2016), the primary case on
which the District Court relied here.
In Finkelman, one plaintiff alleged that the National
Football League’s (“NFL”) policy on distributing Superbowl
tickets forced him to pay more for his ticket in the resale market
than he otherwise would have. Id. at 190-91, 199-200. Under
the NFL Superbowl ticket policy, 99% of the game tickets were
distributed to NFL insiders, rather than sold to the public at-
10
Further, Plaintiffs clearly articulated this theory in
their briefing to the District Court opposing Defendants’
motion to dismiss. They explained that their claims “ha[d]
nothing to do with whether Defendants would ever reduce the
prices of their bottles of medication. The reason patients would
save money is that they would not need to buy so many bottles”
at the same price, because their bottles “would have lasted
longer” and ultimately “their therapy would [have] cost them
less.” D.N.J. Civ. Case No. 14-5859, Doc. No. 91, at 20-21.
30
large. The plaintiff claimed that this policy reduced the
number of tickets available in the resale market. Id. Under the
basic economic principle of supply and demand then, the
policy resulted in an inflated ticket price in the resale market,
according to the plaintiff. Id. at 199-200. We rejected
plaintiff’s theory, as the plaintiff pled no facts to support their
assertion that the NFL’s policy would actually reduce the
number of tickets in the resale market, since League insiders
had the same incentives to resell their tickets for a large profit
as the public at-large. Id. at 200-02.
The alternative iteration of Plaintiffs’ pricing theory
does not depend on a comparable presumption essential to their
allegations of financial harm. As explained, the reduced size
of the bottle dropper tip is the only change from the status quo.
Accordingly, we find the pricing theory sufficient to satisfy the
injury-in-fact requirement.
Even if we had agreed that the pricing theory was too
speculative to confer standing, the District Court did not appear
to have the same concern about the reimbursement theory.
Rather, the District Court rejected the reimbursement theory
because it was not a theory of injury that previously had been
recognized in fraud cases. Fraud cases, and the theories of
injury recognized in those cases, are inapposite here for the
reasons explained above. Plaintiffs’ allegations concern
unfairness and unconscionability. Therefore, under either
theory, Plaintiffs’ harm is “actual” and satisfies this final
component of injury in fact.
* * *
31
Having found Plaintiffs to sufficiently allege in their
Amended Complaint the “‘invasion of a legally protected
interest’ that is ‘concrete and particularized’ and ‘actual or
imminent, not conjectural or hypothetical,’” Spokeo, 136 S. Ct.
at 1548 (quoting Lujan, 504 U.S. at 560), we hold that
Plaintiffs have alleged an injury in fact sufficient to confer
Article III standing to challenge Defendants’ allegedly unfair
business practices under the enumerated state consumer
protection statutes. Of course, it could be that the District
Court’s legal interpretation of those statutes will not protect
against the complained-of business practices and thus will not
provide Plaintiffs with the relief they seek. But that question
goes to the merits of Plaintiffs’ claims under the law, and
should be tested through Defendants’ motion to dismiss for
failure to state a claim pursuant to Federal Rule of Civil
Procedure 12(b)(6).11
11
The Dissent suggests that Plaintiffs have not
established standing because their “alleged economic injury”
is “overly speculative.” Diss. Op. at 7. It discusses in some
detail Plaintiffs’ theory of economic injury, which our
colleague regards as unreasonable. Our learned colleague also
cites to Dominquez v. UAL Corp., 666 F.3d 1359 (D.C. Cir.
2012), for the proposition that too-speculative economic
injuries cannot confer standing.
Three years after Dominquez, the D.C. Circuit
considered a case which a District Court had dismissed for lack
of standing on the purported basis of “an attenuated,
speculative chain of events that relies on numerous
independent actors.” Osborn v. Visa Inc., 797 F.3d 1057, 1063
(D.C. Cir. 2015). In reversing the District Court, the D.C.
Circuit specifically rejected the lower court “demanding proof
32
The District Court did not reach Defendants’ Rule
12(b)(6) arguments in this case. So that question is for another
day. For the reasons already discussed, we will not require
Plaintiffs to prove Defendants’ business practices are unfair
under state consumer protection statutes in order to find that
they have standing to level those attacks in the first place. La.
Energy and Power Authority v. Fed. Energy Regulatory
Comm’n, 141 F.3d 364, 368 (D.C. Cir. 1998).
B
Defendants Falcon, Sandoz, and Akorn, the generic
manufacturers, contend that even if we find that Plaintiffs have
standing to pursue their claims, we should affirm the dismissal
of their Amended Complaint on an alternative ground: because
their claims are preempted by federal law. Specifically, these
Defendants contend they cannot unilaterally make changes to
their products’ bottle droppers without FDA approval, because
of an economic theory that was not required in a complaint,”
id., and differentiated between cases decided at later stages
(such as summary judgment) and dismissals on the basis of
lack of standing. Id. at 1064. “A Rule 12(b)(1) motion . . . is
not the occasion for evaluating the empirical accuracy of an
economic theory.” Id. at 1065-66. In its discussion of the
merits of Plaintiffs’ theory of economic injury—partly by
reference to out-of-record material, Diss. Op. at 7, fn. 24-25—
the Dissent engages in just that type of evaluation. Whether
Plaintiffs defeat motions to dismiss for failure to state a claim
and for summary judgment, or can convince a jury, the facts
alleged “pass muster for standing purposes at the pleadings
stage.” Osborn, 797 F.3d at 1066.
33
a change to the dropper would be considered “major,” and all
“major” changes require FDA approval to take effect.
Therefore, they argue, federal impossibility preemption is
appropriate, since they could not simultaneously comply with
FDA requirements and with state consumer protection laws
that required them to manufacturer bottles with smaller tips.12
Further, these Defendants argue that claims against generic
manufacturers should be preempted because FDA regulations
require generic products to have the same bottle design as their
brand name equivalents.
Plaintiffs argue in response that some manufacturers
have changed their drop volumes over time without FDA
approval, which suggests FDA approval is unnecessary.
Plaintiffs also argue that there is no same-size-drop
equivalence requirement between brand name and generic
manufacturers, as reflected by the fact that drop sizes differ
between these manufacturers already.
The District Court did not reach preemption in this case,
having found that Plaintiffs lacked standing to pursue their
claims. We decline to address it in the first instance on appeal,
as the record before us is not adequately developed to evaluate
the parties’ arguments.
V
12
Impossibility preemption, one of several types of
preemption, applies “when it is ‘impossible for a private party
to comply with both state and federal requirements.’” In re
Fosamax (Alendronate Sodium) Products Liability Litig., 852
F.3d 268, 282 (3d Cir. 2017) (quoting PLIVA, Inc. v. Mensing,
564 U.S. 604, 618 (2011)).
34
For the foregoing reasons, we will reverse the District
Court’s dismissal of this action and remand for further
proceedings consistent with this opinion.
35
ROTH, Circuit Judge, dissenting.
Article III of our Constitution is a strict master,
preserving constitutional strictures imposed on courts through
the requirement that only true cases and controversies be
heard. The Majority today, however, erodes these strictures
by allowing the plaintiffs here to manufacture a purely
speculative injury in order to invoke our jurisdiction. They
assert that the defendants could have manufactured a more
efficient product, which in turn could have lowered plaintiffs’
overall treatment costs. Because this approach ignores both
clear precedent from the Supreme Court and the complexities
of pricing in the pharmaceutical industry, I respectfully
dissent.
I
I begin by defining the exact nature of the harm that
the plaintiffs claim to have suffered as a result of the
defendants’ conduct. The plaintiffs are the users of
prescription eye drops for various visual ailments. The
defendants manufacture and sell the eye drops used by the
plaintiffs in bottles containing a fixed volume of fluid. The
bottles have dropper tips, which dispense more fluid than is
medically necessary to treat the plaintiffs’ ailments, causing
some portion of each drop to be wasted. While the plaintiffs
and the Majority note that exposing one’s eyes to too much of
the fluid can have negative side effects, no plaintiff in the
purported class alleges to have suffered harmful medical
consequences. The plaintiffs’ sole injury, therefore, is the
money spent on that portion of a single eye drop which
1
exceeds the medically necessary volume.1 The plaintiffs do
not argue that they were charged more than the market price
for eye drops; rather, they argue that the defendants could
manufacture a hypothetical eye dropper that would dispense
the exact amount of fluid needed to maximize efficacy
without waste. Were the defendants to produce such a
dropper, they continue, the effective lifespan of each bottle of
medicine would increase, reducing the plaintiffs’ long-term
treatment costs by reducing the number of bottles each
plaintiff would have to purchase. Notably, their case depends
on the assumption that no other changes would occur in the
market to prevent them from capturing the additional value of
each bottle at no extra cost. It is the strength of this
assumption that we must evaluate.
II
As the Majority recognizes, constitutional standing has
three core elements: (1) an injury in fact, (2) causation, and
(3) redressability.2 A complaint must adequately plead all
three elements to invoke federal court jurisdiction.3 In
reviewing the adequacy of a complaint’s assertion of
standing, we employ the familiar standards used in evaluating
motions to dismiss for failure to state a claim; we accept all of
1
While the plaintiffs and the Majority discuss two separate
theories explaining how to arrive at this figure—the “pricing
theory” and the “reimbursement theory”—both depend on the
critical assumption that pricing was based on volume, not on
effective doses. I find this assumption untenable, and
therefore I will not address the theories separately.
2
Hassan v. City of N.Y., 804 F.3d 277, 289 (3d Cir. 2015).
3
Id.
2
the plaintiff’s factual allegations as true, reject conclusions,
and assess the plausibility of the plaintiff’s standing in light
of the well-pleaded allegations.4 In this evaluation, however,
we may make only reasonable inferences in support of the
plaintiff’s claim to standing.5
This case turns on whether the plaintiffs have
adequately alleged the “[f]irst and foremost”6 of the
“irreducible constitutional minimum”7 of standing: injury in
fact. Such injury must be sufficiently concrete; “that is, it
must actually exist.”8 As such, the Supreme Court has
repeatedly expressed “reluctance to endorse standing theories
that rest on speculation about the decisions of independent
actors.”9 Complaints alleging such abstract and speculative
injuries have been rejected, both by our Court and by the
Supreme Court for failing to give rise to a reasonable
inference of injury in fact.10 While the Majority properly
4
In re Schering Plough Corp. Intron/Temodar Consumer
Class Action, 678 F.3d 235, 243 (3d Cir. 2012).
5
In re Horizon Healthcare Servs. Inc. Data Breach Litig.,
846 F.3d 625, 633 (3d Cir. 2017).
6
Steel Co. v. Citizens for Better Env’t, 523 U.S. 83, 103
(1998).
7
Spokeo, Inc. v. Robins, 136 S. Ct. 1540, 1547 (2016).
8
Id. at 1548.
9
Clapper v. Amnesty Int’l USA, 568 U.S. 398, 414 (2013).
10
See, e.g., Summers v. Earth Island Inst., 555 U.S. 488, 495-
96 (2009); Whitmore v. Arkansas, 495 U.S. 149, 157 (1990);
City of L.A. v. Lyons, 461 U.S. 95, 101 (1983) (“Abstract
injury is not enough.”); Knick v. Township of Scott, 862 F.3d
310, 319 (3d Cir. 2017); Miller v. Nissan Motor Acceptance
Corp., 362 F.3d 209, 225 (3d Cir. 2004).
3
notes these governing principles of constitutional standing,11
it ignores clear law cautioning against recognizing Article III
standing based on the types of conjectural allegations that the
plaintiffs advance here. Further, the Majority’s reasoning
ignores the complex nature of pharmaceutical markets as they
currently operate, relying on an unreasonable set of
assumptions to reach its desired outcome. I address both
issues in turn.
A
Just last year, in Finkelman v. National Football
League, we reaffirmed that “[p]laintiffs do not allege an
injury-in-fact when they rely on a chain of contingencies or
mere speculation.”12 I believe that Finkelman all but decides
this case. There, a plaintiff brought suit against the NFL,
alleging that the NFL’s practice of withholding approximately
99% of Super Bowl tickets for certain insiders artificially
inflated the price of tickets available via the resale market.
The plaintiff argued that he suffered an economic injury
because he was forced to buy a ticket on the secondary
market for $2,000, which was $1,200 more than the face
11
I take no issue with the Majority’s conclusion that actual
economic injuries are generally invasions of legally protected
interests, or that the alleged injury here would be
particularized to purchasers of the eye drops. I disagree,
however, with the Majority’s conclusion that the plaintiffs’
alleged economic injuries “actually exist.” Spokeo, 136 S. Ct.
at 1547.
12
Finkelman v. Nat’l Football League, 810 F.3d 187, 193 (3d
Cir. 2016) (internal quotation marks omitted).
4
value of the ticket.13 We held that this allegation was
insufficiently concrete, and declined to recognize his standing
to sue. We properly recognized that markets operate in
complex ways. First, we noted that insiders faced the same
incentives to sell their tickets on the secondary market as did
the general public. Second, we noted that, given the insiders’
potential profit margins, insiders were more likely to sell on
the secondary market at lower prices, suggesting that the
withholding could have no effect, and potentially even a
positive one, on secondary market prices. Taken together,
these two propositions made clear that any potentially
unlawful conduct by the NFL did not necessarily result in
higher prices to the plaintiff; we concluded that “we have no
way of knowing whether the NFL’s withholding of tickets
would have had the effect of increasing or decreasing prices
on the secondary market.”14
While Finkelman spoke primarily about market
unpredictability in the context of third party action, it relied
heavily on the Court of Appeals for the District of Columbia
Circuit’s opinion in Dominguez v. UAL Corp.,15 which
involved no intervening third parties. There, a plaintiff
sought to challenge a policy by United Airlines that prevented
resale of tickets, arguing that allowing a secondary market
would bring down prices in the aggregate. Much like the
plaintiffs here have done by attaching scientific studies to
their Amended Complaint, Dominguez introduced expert
evidence demonstrating that, holding all other forces being
equal, a change in United Airlines’s policy would result in
13
Id. at 197-98.
14
Id. at 200.
15
666 F.3d 1359 (D.C. Cir. 2012).
5
lower overall prices for consumers. The D.C. Circuit rejected
this argument, reasoning that it “assume[d] that United would
continue to offer the same types of tickets that it does now”
without accounting for the possibility that United “would
need to alter its pricing strategy, which may very well result
in higher average ticket prices . . ..”16 Because this attempt to
“pile[] speculation atop speculation” fell short of
Dominguez’s obligations under Article III, the D.C. Circuit
held that Dominguez lacked standing to bring the action.17
Taken together, Finkelman and Dominguez make clear
that, for purposes of analyzing economic injuries in the
context of marketwide effects, we cannot do precisely what
the plaintiffs here ask of us: isolate and change one variable
while assuming that no downstream changes would also
occur. These cases are not outliers; rather, they reflect courts’
skepticism about plaintiffs’ ability to satisfy the case or
controversy requirement of Article III by relying on such
imaginative economic theories.18 Thus, contrary to the
Majority’s assertion,19 the plaintiffs’ pricing theory does in
fact depend on exactly the sort of presumption rejected by us
and by other courts—namely, the presumption that no other
16
Id. at 1364.
17
Id.
18
See, e.g., DaimlerChrysler Corp. v. Cuno, 547 U.S. 332,
344-45 (2006) (finding an alleged injury too conjectural for
failing to account for “how [other actors] respond to a
reduction in revenue . . .”);
19
Maj. Op. at 27 (distinguishing Finkelman on the grounds
that “Plaintiffs’ pricing theory does not depend on a
comparable presumption essential to their allegations of
financial harm”).
6
aspects of the market would change once the defendants’
conduct did. It is true that we “credit allegations of injury
that involve no more than application of basic economic
logic.”20 However, Finkelman makes clear that this principle
distinguishes “between allegations that stand on well-pleaded
facts and allegations that stand on nothing more than
supposition.”21 As other courts have noted, this distinction is
critical at the pleading stage for a simple reason: assumptions
about basic economic logic are susceptible to proof at trial.22
The plaintiffs here ask more: they ask us to assume certain
facts about other actors’ behavior—exactly the sort of
assumption that cannot be proven at trial. Accordingly, I
would reject the plaintiffs’ alleged economic injury as overly
speculative and untenable under existing precedent.23
B.
Although the speculative nature of the plaintiffs’
alleged injury would likely be fatal regardless of the nature of
the product, it is worth noting that their theory is a
particularly bad fit for the market for pharmaceuticals,
20
Finkelman, 810 F.3d at 201 (internal quotation marks
omitted).
21
Id.
22
Osborn v. Visa Inc., 797 F.3d 1057, 1064-65 (D.C. Cir.
2015) (finding basic economic assumptions sufficient to
satisfy injury requirement where plaintiffs’ “sorts of
assumptions [we]re provable at trial”).
23
See United Transp. Union v. I.C.C., 891 F.2d 908, 912
(D.C. Cir. 1989) (“When considering any chain of allegations
for standing purposes, we may reject as overly speculative
those links which are predictions of future events (especially
future actions to be taken by third parties) . . ..”).
7
undercutting the reasonableness of the assumptions they ask
us to make and the inference of economic harm they ask us to
draw in their favor. The plaintiffs essentially ask us to
assume that the defendants price their medication by volume;
thus, in the plaintiffs’ view, changing the eyedropper size
would not change the price of the medicine, while extending
the useful lifespan of each bottle, driving down their
aggregate costs. This assumption is unreasonable, given the
unique nature of markets for medical goods and services.
Pharmaceutical companies have, for some time now,
recognized that “unit-based pricing[] is too one-dimensional
for the marketplace’s current needs.”24 Increasingly,
throughout the United States and the world, manufacturers
engage in “value-based pricing” which deemphasizes the
overall volume of medicine received by the patient in favor of
an assessment of the value—measured in part by effective
doses—received by a patient.25 Amici raise this point
24
Ellen Licking & Susan Garfield, A Road Map To Strategic
Drug Pricing, IN VIVO, March 2016, at 1, 3, available online
at http://www.ey.com/Publication/vwLUAssets/ey-in-vivo-a-
road-map-to-strategic-drug-prices-subheader/$FILE/ey-in-
vivo-a-road-map-to-strategic-drug-prices-subheader.pdf.
25
DELOITTE CENTER FOR HEALTH SOLUTIONS, VALUE-BASED
PRICING FOR PHARMACEUTICALS: IMPLICATIONS OF THE SHIFT
FROM VOLUME TO VALUE 3 (2012), available online at
http://deloitte.wsj.com/cfo/files/2012/09/ValueBasedPricing
Pharma.pdf. Pricing in the medical services sector is unique
in this regard, as the standard economic forces that set prices
for consumer goods do not apply to prescription drugs. This
is in part due to the disjunction between the source of
payment for services (insurers) and the end users of services
8
effectively in their briefing, noting that “patients demand
treatment, not fluid volume, so demand for defendants’
products is properly measured in doses, not in milliliters.”26
Thus, alternative pricing models have begun to take hold in
pharmaceutical markets across the world.27 Some of the
plaintiffs’ own studies confirm this, noting that the cost of the
plaintiffs’ therapy “may be based on several factors
[including drop size].”28 The net effect of this shift is to sever
the link between volume and price upon which the plaintiffs’
alleged injury depends. As amici argue, therefore, it is likely
that the defendants “priced their products based on how many
therapeutic doses (not how many milliliters of fluid) they
contained, so that improvements in the products’ efficiency
would not have saved the plaintiffs any money.”29
The plaintiffs, in the same breath in which they accuse
the District Court of misunderstanding their pricing theory,
misunderstand the importance of such countervailing market
forces. As the District Court observed, the studies provided
by the plaintiffs all tend to “assume[] as true that
manufacturers of eye drops would price their medication
solely based on the volume of the fluid contained in the
(patients). See Licking & Garfield, A Road Map To Strategic
Drug Pricing, at 3.
26
Amicus Br. of the Am. Tort Reform Assoc., U.S. Chamber
of Commerce, Nat’l Assoc. of Mfrs., & Pharma. Research &
Mfrs. of Am. (hereafter, “ATRA Br.”) at 11.
27
Licking & Garfield, A Road Map to Strategic Drug
Pricing, at 7.
28
Am. Compl. ¶ 192.
29
ATRA Br. at 9.
9
bottled.”30 The reason for this observation is not to suggest
that the defendants would lower their prices in response to a
new dropper design; rather, it is to suggest that the price of
each bottle could actually increase if each bottle provided
more doses.
At its core, therefore, the plaintiffs’ Amended
Complaint asks us to make an assumption about the effects of
changing the size of the defendants’ eye droppers which does
not reflect market conditions and pressures in the
pharmaceutical industry. As such, the plaintiffs ask us to
speculate about a theoretical eye dropper design, then draw an
unreasonable inference about the downstream consequences
of such an innovation. Because the realities of the
pharmaceutical industry make such inferences unreasonable,
the Majority errs by accepting them at face value. The
plaintiffs have failed to plausibly allege standing.
III
I am sympathetic to the difficulties in demonstrating
marketwide injuries in class action litigation. The difficulty
of such a showing, however, is not an excuse to treat
jurisdiction lightly; “jurisdiction is a strict master.”31 Today’s
ruling flouts this principle, allowing class action plaintiffs to
ignore “the exacting federal standing requirements”32 by
offering nothing more than speculation about complex and
industry-specific pricing models. On a practical level, the
Majority also invites judges—rather than industry experts,
30
JA 17.
31
State Nat’l Ins. Co. v. Cty. of Camden, 824 F.3d 399, 411
(3d Cir. 2016) (internal quotation marks omitted).
32
Goode v. City of Phila., 539 F.3d 311, 318 (3d Cir. 2008).
10
market forces, or agency heads—to second-guess the efficacy
of product design even in the most opaque of industries.
Because I am troubled by both the legal and practical
ramifications of the Majority’s decision, I respectfully
dissent.
11