ROBERT GUSTAVSEN; JOSEPH CUGINI; DEMETRA COHEN; JACKIE CORBIN; LEE WILBURN; MARY LAW; CECILIA BRATHWAITE, Plaintiffs, Appellants,
ALCON LABORATORIES, INC.; ALCON RESEARCH, LTD.; FALCON PHARMACEUTICALS, LTD.; SANDOZ, INC.; ALLERGAN, INC.; ALLERGAN USA, INC.; ALLERGAN SALES, LLC; PFIZER, INC.; VALEANT PHARMACEUTICALS INTERNATIONAL, INC.; BAUSCH AND LOMB, INC.; ATON PHARMA, INC.; MERCK & CO., INC.; MERCK, SHARP & DOHME (I.A.) CORP.; PRASCO, LLC; AKORN, INC., Defendants, Appellees.
FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF
MASSACHUSETTS [Hon. Mark L. Wolf, Senior U.S. District Judge]
M. Nicholls, with whom Public Justice, P.C., Richard S.
Cornfeld, Law Office of Richard S. Cornfeld, John C. Simon,
Kevin M. Carnie, Jr., The Simon Law Firm, P.C., Kenneth J.
DeMoura, DeMoura Smith LLP, Emily Lisa Perini, Perini-Hegarty
& Associates, P.C., and Brian Wolfman were on brief, for
Gregory E. Ostfeld, with whom David G. Thomas, Michael
Pastore, Christiana Jacxsens, Greenberg Taurig, LLP, Peter
Simshauser, Skadden, Arps, Slate, Meagher & Flom LLP,
Robyn E. Bladow, Austin Norris, Kirkland & Ellis LLP,
Joseph P. Crimmins, Posternak Blankstein & Lund LLP, John
M. Kilroy, Jr., J. Santon Hill, Polsinelli PC, W. Scott
O'Connell, Nixon Peadoby LLP, James P. Muehlberger, Lori
A. McGroder, Shook, Hardy & Bacon LLP, Stephen G.
Strauss, Bryan Cave LLP, David J. Volkin, Law Offices of
David J. Volkin, David B. Chaffin, and White and Williams LLP
were on brief, for appellees.
Jeffrey S. Bucholz, Paul Alessio Mezzina, King & Spalding
LLP, Peter Tolsdorf, and Manufacturers' Center for Legal
Action, on brief for American Tort Reform Association, The
Chamber of Commerce of the United States of America, The
National Association of Manufacturers, and Pharmaceutical
Research & Manufacturers of America, amici curiae.
R. Geiger, Kristyn M. DeFillip, and Foley Hoag LLP, on brief
for Product Liability Advisory Council, Inc., amicus curiae.
Thompson, Kayatta, and Barron, Circuit Judges.
KAYATTA, CIRCUIT JUDGE.
disposition of the merits of this appeal turns on a single
question: Can manufacturers of prescription eye drops change
the medication's bottle so as to alter the amount of
medication dispensed into the eye without first getting the
FDA's approval? Finding that federal law requires prior
approval for such a change, we hold that state law claims
challenging the manufacturers' refusal to make this
change are preempted. Our reasoning follows.
this appeal comes to us following the district court's
grant of a motion to dismiss, we draw the facts from the
operative complaint. SEC v.
Tambone, 597 F.3d 436, 438 (1st Cir. 2010) (en
in this case are companies engaged in the manufacturing,
marketing, and distribution of both brand name and generic
prescription eye drops. These drops treat a multitude of
ailments, including glaucoma, allergies, infections,
inflammation, and pre- and post-operative conditions. The eye
drop solutions are sold in plastic bottles shaped at one end
to form a plastic dispenser. To use the eye solution,
consumers must squeeze or tap the bottle, emitting a drop of
solution directly into the eye. Consumers cannot dispense
less than one drop at a time. And the dimensions of the
bottle's dispenser, rather than any factor under human
control, determine the size of each drop. Specifically, the
complaint explains, the volume of the drop dispensed varies
based on the "inner diameter or hole and the outer
diameter of the tip" of the dispenser. The bottles do
not disclose the size of the eye drops, nor do they reveal an
estimate of the number of drops or doses contained in each
complain that defendants deliberately designed their
dispensers to emit unnecessarily large drops, on the order of
24 to 52 microliters. This ploy, plaintiffs say, forces
patients to waste medication, to their detriment and to
defendants' gain. Plaintiffs marshal a body of scientific
literature to support their argument. The scientific
consensus, they say, is that the optimal size of drops rests
between 5 and 15 microliters. The reason is a matter of human
anatomy. The fornix, which is the area between the eye and
the lower eyelid, is only capable of absorbing a small
portion of the unnecessarily large drops dispensed by
manufacturers of prescription eye drops, plaintiffs say,
engage in this practice; there is no prescription eye
solution on the market that dispenses drops that are not
substantially larger than 15 microliters. Plaintiffs do not
allege, however, that this industry standard is the result of
conspiracy, or that defendants otherwise acted in concert.
Rather, they allege that defendants "separately engaged
in" the challenged conduct. And that conduct, plaintiffs
allege, harms patients in two ways.
it costs patients money. If the bottles dispensed smaller
drops, then each bottle would deliver more doses, and
patients would be able to purchase fewer bottles over any set
amount of time. By comparing the number of bottles a patient
would use if the bottles dispensed 15 microliter doses
against the number of bottles each patient is now required to
purchase, plaintiffs calculate that a patient, on a yearly
basis, could save upwards of $500, depending on the brand and
type of solution used.
calculations naturally rely on an assumption that a
manufacturer would not substantially increase the price of a
bottle that dispensed smaller drops. Support for this
assumption in the complaint comes in two forms. Plaintiffs
point out that defendants currently price the various sized
bottles proportionate to their volume. A bottle twice the
size costs approximately twice as much. The inference they
would have us draw is that, if only the drop size were to
change but the volume of solution in the bottle were to stay
consistent, the price of the bottle would stay constant too.
Plaintiffs also point to various statements in academic
studies that draw a connection between the drop size and cost
to plaintiffs. For example, in a study published by Allergen
(one of the defendants here), the authors say that "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." They
also allege that, following a study by scientists employed by
Alcon (another defendant here) that concluded that 16
microliter drops were as effective as 30 microliter drops,
Alcon's top marketing executive said that Alcon would not
make the change to its bottles because "patients would
use the bottles longer and Alcon would therefore sell less
product and make less money."
second alleged impact on patients is physical. Excess eye
drops that stream down the cheek can cause allergies and
pigmentation. The excess drops that enter the bloodstream do
so without first going through metabolic inactivation in the
liver. And without the liver's processes, say plaintiffs,
the eye solution can lead to decreased cardiovascular
response to exercise, lowered blood pressure, and emotional
and psychiatric side effects. Although plaintiffs allege an
increased risk of these consequences, they do not allege that
any named plaintiff did, in fact, experience any such side
with these grievances, the named plaintiffs filed suit in
federal court on their own behalf and on behalf of a putative
class of prescription eye solution purchasers. The named
plaintiffs are residents of either Massachusetts or New York
who purchased eye solution from at least one of the defendant
manufacturers during the four years preceding the filing of
their lawsuit. They allege two categories of violations.
they allege that defendants' practice is
"unfair" under Massachusetts state law and the laws
of twenty-five other states and the District of Columbia, all
of which adopt the meaning of "unfair" as applied
in section 5 of the Federal Trade Commission Act. 15 U.S.C.
§ 45(a)(1). Plaintiffs do not allege that
defendants' actions are deceptive.
under the laws of New York and sixteen other states,
plaintiffs allege claims for unjust enrichment and for
"money had and received." The basis for these
latter two causes of action is plaintiffs' contention
that defendants received excess profits from their actions to
which they are not entitled.
defendants moved to dismiss. They asserted first that the
court lacked subject-matter jurisdiction because plaintiffs
had failed to satisfy the "injury in fact"
requirement of Article III standing. Second, defendants
argued that plaintiffs' claims were preempted by Food and
Drug Administration regulations. Specifically, they contended
that changing the dispensers to reduce the size of the eye
drops -- the change plaintiffs claim state law mandates --
requires pre-approval from the FDA, thus implicating the