United States District Court, E.D. Pennsylvania
IN RE SUBOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE) ANTITRUST LITIGATION
Indivior Inc. et al. Case No. 16-cv-5073 THIS DOCUMENT RELATES TO: Wisconsin, et al. STATE OF WISCONSIN By Attorney General Brad D. Schimel, et al. Plaintiffs,
INDIVIOR INC. f/k/a RECKITT BENCKISER PHARMACEUTICALS, INC., et al. Defendants. Civ. A. No. 16-5073
Defendants in this multi-district litigation-Indivior Inc.,
f/k/a Reckitt Benckiser Pharmaceuticals, Inc.; Reckitt
Benckiser Healthcare (UK) Ltd.; Indivior PLC, f/k/a/ Reckitt
Benckiser Group, plc; and MonoSol Rx, LLC-each play some role
in the manufacture, production, and/or sale of Suboxone, a
medication used for the treatment of opioid addiction.
Plaintiffs, a collection of states,  have brought suit against
these Defendants alleging violations of federal and state
antitrust statutes and state unfair trade and consumer
Reckitt Benckiser Healthcare (UK) Ltd. (“RBH”)
now moves to dismiss all claims against it, arguing that I do
not have jurisdiction and that the Amended Complaint does not
sufficiently allege any antitrust or state law cause of
action. While I disagree with RBH regarding lack of
jurisdiction, because a plausible antitrust claim has not
been pled, I will grant the motion in its entirety.
ALLEGATIONS IN THE AMENDED COMPLAINT
The Defendant Entities
Defendant RBH is a British company incorporated under the
laws of England and Wales. According to the Amended
Complaint, RBH is engaged in the development and manufacture
of pharmaceuticals, including Suboxone, as well as other
health care products made and sold subject to FDA approval.
RBH is a subsidiary of Reckitt Benckiser Group PLC (“RB
Group”), a non-party. (Am. Compl. ¶ 12.)
Group also previously owned Defendant Indivior, Inc.,
formerly known as Reckitt Benckiser Pharmaceuticals, Inc.
(“RBPI”). In December 2014, RB Group sold the
assets of RBPI to a British company known as Defendant
Indivior PLC (“I-PLC”). As a result, RBPI was
demerged from its prior parent, the RB Group, into I-PLC. By
the terms of the sale, the ownership of all assets and
operations related to the production of Suboxone was
transferred to I-PLC. (Id. ¶¶ 11, 13.)
According to the Certificate of Amendment from the State of
Delaware, RBPI simply changed its name to Indivior,
(Def. I-PLC's Mot. to Dismiss, ECF No. 139, Ex. 1.)
MonoSol Rx, LLC is a Delaware limited liability company with
its principal place of business in Indiana. (Am. Compl.
¶ 14.) MonoSol produces PharmFilm drug technology, which
allows pharmaceuticals to be converted into a sublingual film
form. (Id. ¶ 48.)
Conduct Underlying the Litigation
broad terms, the Amended Complaint alleges that Defendants
engaged in a “product hopping” scheme designed to
prevent or delay less expensive generic versions of its drug
Suboxone from entering the market. Plaintiff States assert
that the primary Defendant Indivior, faced with the impending
loss of exclusivity on its Suboxone tablet, developed a new
“film” version of Suboxone, which would not be
AB-rated, or pharmaceutically equivalent, with a generic
version of the Suboxone tablet. Plaintiffs claim that
Indivior, in conjunction with RBH and MonoSol, launched the
sale of the film in 2010, while simultaneously taking steps
to (a) convert the market's prescription base from
tablets to film and (b) delay the entry of generic tablets by
refusing to participate in a joint REMS safety program and
filing a baseless citizen petition. Ultimately, the FDA
approved the first generic alternatives to Suboxone tablets
in February 2013, and the generics were initially marketed to
the public in March 2013.
Reckitt Benckiser Healthcare (UK) Limited's
defendant at issue in the current motion is RBH. Plaintiffs
allege that RBH is responsible for some or all of the
antitrust conduct challenged in the Amended Complaint,
including the joint venture to create and manufacture
Suboxone film, establishment of the parameters for the timing
of the launch and formulation of Suboxone film, gathering and
investigating all consumer complaints as to Suboxone
products, trademarking the names for the financial programs
to encourage the switch from Suboxone tablets to film, and
obtaining patents with MonoSol related to Suboxone film
development. (Am. Compl. ¶ 12.) They further allege that
RBH monitored the taste and quality of Suboxone film,
prepared materials for regulatory approval of Suboxone film,
manufactured and supplied the ingredients for Suboxone film,
and provided grants for the study of Suboxone. Id.
2013, several putative classes initiated litigation against
Defendants alleging anticompetitive behavior with respect to
the marketing and sale of Suboxone. These cases were
consolidated into a multi-district litigation
(“MDL”) assigned to this Court. Among those cases
was the class action complaint brought by Direct Purchaser
Plaintiffs and End-Payor Plaintiffs alleging that Defendants
unlawfully delayed and impeded competition from generic
versions of Suboxone tablets, resulting in ongoing
overpayments by consumers. On December 3, 2014, I issued an
opinion dismissing one of the Direct Purchaser
Plaintiffs' stand-alone antitrust claims, a variety of
state law claims by the End-Payor Plaintiffs, and claims
against several of the other Defendant entities. In re
Suboxone, 64 F.Supp.3d 665 (E.D. Pa. 2014). I allowed
the remaining federal and state law claims to proceed.
December 23, 2015, Amneal Pharmaceuticals LLC
(“Amneal”), a generic manufacturer and competitor
of Indivior, filed a complaint regarding Indivior's
alleged anticompetitive conduct with respect to Suboxone.
That case was consolidated with the MDL currently before me.
On January 4, 2017, I dismissed part of Amneal's claims
that Indivior improperly delayed entry of generic tablets,
all claims against Reckitt Benckiser Pharmaceuticals, Inc.,
and all claims against Indivior PLC. In re Suboxone,
13-MD-2445, 2017 WL 36371 (E.D. Pa. Jan. 4, 2017).
September 22, 2016, the Plaintiff States initiated the
current litigation against Defendants, including RBH. The
States filed a First Amended Complaint on November 23, 2016,
setting forth five causes of action as follows: (1)
monopolization under the Sherman Act § 2 against
Indivior, Indivior PLC, and RBH; (2) attempted monopolization
under the Sherman Act § 2 against Indivior, Indivior
PLC, and RBH; (3) conspiracy to monopolize under the Sherman
Act § 2 against all Defendants; (4) illegal restraint of
trade under the Sherman Act § 1 against all Defendants;
and (5) individual state law claims against all Defendants.
On September 8, 2017, I denied Indivior's Motion to
Dismiss these claims. In re Suboxone, No. 16-5073,
2017 WL 3967911 (E.D. Pa. Sept. 8, 2017).
December 12, 2016, RBH filed a separate motion to dismiss the
Amended Complaint, arguing: (1) Plaintiffs failed to set
forth sufficient grounds for the exercise of personal
jurisdiction over RBH and (2) Plaintiffs failed to state a
claim against RBH. The States responded on January 30, 2017,
and RBH filed a reply brief on February 21, 2017.
MOTION TO DISMISS FOR LACK OF PERSONAL JURISDICTION
Standard of Review
to dismiss for lack of personal jurisdiction under Federal
Rule of Civil Procedure 12(b)(2) require the court to accept
as true the allegations of the pleadings and all reasonable
inferences therefrom, and to resolve all factual disputes in
favor of the plaintiff. Fed.R.Civ.P. 12(b)(2); see also
Pinker v. Roche Holdings Ltd., 292 F.3d 361, 368 (3d
Cir. 2002). The Rule, however, “does not limit the
scope of the court's review to the face of the
pleadings”; rather the court must also consider any
affidavits submitted by the parties. Scott v.
Lackey, No. 02-1586, 2005 WL 2035598, at *1 (M.D. Pa.
Aug. 11, 2005). “Where, as here, the Court resolves the
jurisdictional issue in the absence of an evidentiary hearing
and without the benefit of discovery, the plaintiff need only
establish a prima facie case of personal jurisdiction.”
Otsuka Pharm. Co., Ltd. v. Mylan Inc., 106 F.Supp.3d
456, 461 (D.N.J. 2015) (citing Avocent Huntsville Corp.
v. Aten Int'l Co., Ltd., 552 F.3d 1324, 1328-29
(Fed. Cir. 2008)). The court may always revisit the issue of
personal jurisdiction if later revelations indicate that the
facts alleged in support of jurisdiction remain in dispute.
See Metcalfe v. Renaissance Marine, Inc., 566 F.3d
324, 331 (3d Cir. 2009) (citing Carteret Sav. Bank, FA v.
Shushan, 954 F.2d 141, 142 n. 1 (3d Cir. 1992)).
a defendant has the initial burden of raising the defense of
lack of personal jurisdiction, once such a defense is raised,
the burden shifts to the plaintiff to demonstrate facts that
suffice to support an exercise of personal jurisdiction.
Provident Nat'l Bank v. Cal. Fed. Sav. & Loan
Ass'n, 819 F.2d 434, 437 (3d Cir. 1987);
Cumberland Truck Equip. Co. v. Detroit Diesel Corp.,
401 F.Supp.2d 415, 418 (E.D. Pa. 2005). Plaintiff may do so
through affidavits or competent evidence that show sufficient
contacts with the forum state. De Lage Landen Fin.
Servs., Inc. v. Rasa Floors, LP, No. 08-0533, 2008 WL
4822033, at *3 (E.D. Pa. Nov. 4, 2008). Such contacts must be
established with “reasonable particularity, ” to
present a prima facie case. Mellon Bank (East) PSFS,
Nat'l Ass'n v. Farino, 960 F.2d 1217, 1223 (3d
Cir. 1992) (quoting Provident Nat'l Bank, 819
F.2d at 437). If the plaintiff meets this burden, the
defendant must then establish the presence of other
considerations that would render personal jurisdiction
unreasonable. De Lage Landen, 2008 WL 4822033, at *3
(citing Carteret Sav. Bank, 954 F.2d at 150).
argues that Plaintiffs have failed to establish either
general or specific jurisdiction. I disagree and find that
the Amended Complaint and Plaintiffs' evidence of record
sufficiently set forth grounds for the exercise of specific
Federal Rule of Civil Procedure 4(k)(2), a court may look to
a foreign defendant's contacts with the United States in
the aggregate to determine whether the exercise of
jurisdiction is consistent with the due process clause of the
Fifth Amendment. In re Automotive Refinishing Paint
Antitrust Litig., 358 F.3d 288, 298-99 (3d Cir. 2004);
TruePosition, Inc. v. LM Ericsson Tel. Co., 844
F.Supp.2d 571, 586 (E.D. Pa. 2012). “Personal
jurisdiction therein is not limited to the defendant's
contacts with a particular federal judicial district or the
forum state.” Automotive Refinishing, 358 F.3d
at 299. Pursuant to such constitutional considerations,
physical presence within the forum is not required to
establish personal jurisdiction over a nonresident defendant.
IMO Indus., Inc. v. Kiekert AG, 155 F.3d 254, 259
(3d Cir. 1998). Instead, personal jurisdiction may be based
on either a defendant's general contacts or his specific
contacts with the forum. Gen. Elec. Co. v. Deutz AG,
270 F.3d 144, 150 (3d Cir. 2001).
do not assert that the Court has general jurisdiction over
Rather, they claim that RBH has minimum contacts with the
United States, from which the present dispute arises, such
that this Court's exercise of jurisdiction over it will
not violate traditional notions of fair play and substantial
plaintiff may rely on “specific jurisdiction”
where the cause of action is related to or arises out of the
defendant's contacts with the forum. IMO Indus.,
155 F.3d at 259 (citing Helicopteros Nacionales de
Colombia, S.A. v. Hall, 466 U.S. 408, 414 n.8 (1984)).
Proper establishment of specific jurisdiction under the Due
Process Clause requires satisfaction of a three-part test.
Louis A. Grant, Inc. v. Hurricane Equip., Inc., No.
07-438, 2008 WL 892152, at *3 (W.D. Pa. Apr. 2, 2008). First,
the plaintiff needs to show that the defendant has
“constitutionally sufficient ‘minimum
contacts' with the forum.” IMO Indus., 155
F.3d at 259 (citing Burger King Corp. v. Rudzewicz,
471 U.S. 462, 474 (1985)). Second, the plaintiff's claim
must “arise out of or relate to those
activities.” Helicopteros, 466 U.S. at 414.
Third, the reviewing court should consider additional factors
to ensure that the exercise of jurisdiction otherwise
“comport[s] with ‘fair play and substantial
justice.'” Burger King, 471 U.S. at 476
(quoting Int'l Shoe Co. v. Washington, 326 U.S.
310, 320 (1945)); see also O'Connor v. Sandy Lane
Hotel Co., Ltd., 496 F.3d 312, 317 (3d Cir. 2007)
(enumerating the three elements of specific jurisdiction).
satisfy the first two components of the specific jurisdiction
test, the acts identified by plaintiff must be “such
that [the defendant] should reasonably anticipate being haled
into court [in the forum state].” World-Wide
Volkswagen Corp. v. Woodson, 444 U.S. 286, 297 (1980).
The minimum contacts necessary to support specific
jurisdiction exist only where the defendant “has
purposefully directed its activities toward the residents of
the forum state . . . or otherwise ‘purposefully
avail[ed] itself of the privilege of conducting activities
within the forum State, thus invoking the benefits and
protections of its laws.'” IMO Indus, ,
155 F.3d at 259 (quoting Hanson v. Denckla, 357 U.S.
235, 253 (1958) (other internal quotations omitted)).
“This test is intended to protect a non-resident
defendant from jurisdiction based on contacts that are
‘random, fortuitous, ' or ‘attenuated, '
or that result from the unilateral activity of another party
or a third person.” Pullman Fin. Corp. v.
Hotaling, No. 07-1703, 2008 WL 2563372, at *4 (W.D. Pa.
June 24, 2008) (quoting Burger King, 471 U.S. at
475). “[I]n the course of this necessarily
fact-sensitive inquiry, the analysis should hew closely to
the reciprocity principle upon which specific jurisdiction
rests . . . . With each purposeful contact by an out-of-state
resident, the forum state's laws will extend certain
benefits and impose certain obligations . . . specific
jurisdiction is the cost of enjoying the benefits.”
O'Connor, 496 F.3d at 323 (internal citations
omitted). Contacts with a state's citizens that take
place outside the state are not purposeful contacts with the
state itself. Id. Nonetheless, a “substantial
connection” with a forum arising out of a “single
act can support jurisdiction.” Burger King,
471 U.S. at 475 n.18 (citing McGee v. Int'l
Life Ins. Co., 355 U.S. 220, 223 (1957)).
the Amended Complaint alleges that RBH is a British
Corporation incorporated under the laws of England and Wales,
with its registered office in Berkshire. (Id. ¶
12.) RBH signed an agreement with American company MonoSol to
develop the film version of Suboxone and bring it to market
in the United States. (Am. Compl. ¶ 46.) In addition,
“employees of [RBH] participated in discussion
regarding the plan to remove Tablets from the market.”
(Id. ¶ 71.) While these allegations alone are
insufficient to establish specific jurisdiction against RBH,
Plaintiffs set forth-both in the remainder of the Amended
Complaint and in exhibits attached to their response to the
Motion to Dismiss-multiple additional contacts by RBH with
the United States, as follows:
• RBH approved and paid for each stage of MonoSol's
development of the Suboxone film in the United States,
evaluated film samples for MonoSol, and provided MonoSol with
active ingredients, data, and information. (Decl. of Cheryl
Lee Johnson (“Johnson Decl.”), Ex. 1.)
• RBH worked on responses to the United States'
concerns about buprenorphine's environmental ...