)IN RE PHARMACEUTICAL INDUSTRY ) M.D.L. No. 1456AVERAGE WHOLESALE PRICE ) Civil Action No. 01-12257-PBSLITIGATION ) )
MEMORANDUM AND ORDER I. INTRODUCTION
In this massive proposed class action, Plaintiffs allege
that forty-two pharmaceutical companies fraudulently overstate
the published “average wholesale prices” (“AWP”) of many of their
prescription drugs, which results in inflated payments for such
drugs by consumers and beneficiaries of the federal Medicare Part
B program (through co-payments), private health and welfare
plans, health insurers, self-insured employers and other end-
payors for prescription drugs.1 They have identified 321 drugs
1 The Amended Complaint names eleven plaintiffs, including
five ERISA-qualified employee benefit plans, a voluntary employeebenefit plan and five associations. It names the followingcompanies as defendants (corporate groupings are separated bysemicolon): Abbott Laboratories; Amgen Inc.; “AstraZeneca,”which includes Zeneca, Inc., AstraZeneca US, and AstraZenecaPharmaceuticals L.P.; “The Aventis Group,” which includes AventisPharmaceuticals, Inc., Hoechst Marion Roussel, Inc., and AventisBehring LLC; “Baxter,” which includes Baxter International Inc. and Baxter Healthcare Corporation; Bayer Corp.; “The Boehringer
On May 13, 2003, the Court allowed in part a motion to
dismiss the original master consolidated complaint. See In re
Pharm. Indust. Average Wholesale Price Litig., 263 F. Supp. 2d
172, 178-80 (D. Mass. 2003) (Saris, J.) (Pharm. I). The Court
assumes close familiarity with that opinion, which sets forth the
factual background of the allegations as well as the appropriate
legal standards. In response to that opinion, Plaintiffs have
filed a 297-page amended master consolidated complaint (“AMCC”),
which asserts violations of the federal racketeering statute,
eleven consumer fraud statutes and the antitrust laws.2 Again,
Group,” which includes Boehringer Ingelheim Corp., Ben VenueLaboratories Inc. and Bedford Laboratories; B. Braun of America,Inc.; “The BMS Group,” which includes Bristol-Myers Squibb Co.,Oncology Therapeutics Network Corp., and Apothecon, Inc.; Dey,Inc.; “The Fujisawa Group,” which includes Fujisawa Healthcare,Inc. and Fujisawa U.S.A., Inc.; “The GSK Group,” which includesGlaxoSmithKline, P.L.C., SmithKline Beecham Corp., and GlaxoWellcome, Inc.; Hoffman-LaRoche, Inc.; Immunex Corp.; “TheJohnson and Johnson Group,” which includes Johnson & Johnson,Centocor, Inc., Janssen Phamarceutical Products, L.P., McNeil-PPC, Inc., and Ortho Biotech; Novartis Pharmaceuticals Corp.;Pfizer, Inc.; “The Pharmacia Group,” which includes PharmaciaCorp. and Pharmacia & Upjohn, Inc.; “The Schering-Plough Group,”which includes Schering-Plough Corp. and Warrick PharmaceuticalsCorp.; “The Sicor Group,” which includes Sicor, Inc., Gensia,Inc., and Gensia Sicor Pharmaceuticals, Inc.; TAP PharmaceuticalProducts, Inc.; and Watson Pharamaceuticals, Inc.
The Amended Master Consolidated Complaint (the “AMCC”)
pleads causes of action under the Racketeer Influenced andCorrupt Organizations Act (“RICO”), 18 U.S.C. §§ 1962(c),(d);Section 16 of the Clayton Act, 15 U.S.C. § 26; the Sherman Act,15 U.S.C. § 1; the antitrust statutes of 22 states; stateconsumer protection statutes of 11 states; and civil conspiracy
the Defendant pharmaceutical manufacturer companies move to
After hearing, the Court ALLOWS IN PART and DENIES IN PART
the motion to dismiss the claims that the pharmaceutical
companies violated the Racketeer Influenced and Corrupt
Organizations Act (“RICO”) and antitrust law. Among other
things, the Court holds that Plaintiffs have set forth sufficient
facts to state claims concerning: (1) the alleged RICO
enterprises between the pharmaceutical manufacturers and four
pharmacy benefit managers (“PBM’s”) with the common objective of
promoting fraudulent AWP’s; (2) the alleged price-fixing
conspiracy of the Together Card Program Defendants in violation
law. The AMCC also seeks declaratory relief pursuant to theDeclaratory Judgment Act, 28 U.S.C. §§ 2201, 2202. Plaintiffsbring this action on behalf of themselves and two classes:
All persons or entities who, for purposes other thanresale and during the Class Period, paid any portion ofthe purchase for a prescription drug manufactured by aDefendant Drug Manufacturer (as identified in AppendixA) at a price calculated by reference to the publishedAWP during the Class Period.
[2] Sub-Class: The PBM Third-Party Payor Class:
All Third-Party Payors that, during the Class Period,contracted with a PBM to provide to its participants aprescription drug manufactured by a Defendant DrugManufacturer and identified in Appendix A.
of the antitrust laws; and (3) RICO claims involving multi-source
II. DISCUSSION
Plaintiffs allege three primary paradigms that accomplish
this fraud. First, Plaintiffs allege that each Defendant
artificially raises its published AWP’s to benefit medical
providers (like doctors). The “spread” between the actual cost
of the drug and the AWP encourages providers to use that
Defendant’s drugs at the expense of the beneficiaries of Medicare
Part B who make co-payments.3 Second, Plaintiffs allege that
each Defendant increases AWP’s and provides other fraudulent
kickbacks, discounts and rebates to encourage pharmacy benefit
managers to put its drugs on their formularies. Third,
Plaintiffs allege that certain Defendant manufacturers
participate in an antitrust and RICO conspiracy through a
discount drug program, the Together Rx Program. The Defendants
use this program to “raise, fix, maintain and/or stabilize the
AWP of the Together Card Drugs,” thereby raising the prices paid
by the elderly, uninsured participants as well as by non-
participants who also pay for those drugs based on AWP.
The Defendants do not address separately this paradigm,
but they make arguments under Rule 9(b) in the context of thesecond paradigm that are applicable to both the first and secondparadigms.
Plaintiffs allege that Defendants engaged in a pattern of
racketeering activity in violation of 18 U.S.C. § 1962(c) by
establishing the fraudulent AWP pricing scheme through the use of
interstate mails and wire communications. To state a RICO claim
under § 1962(c), a plaintiff must allege four elements: "(1)
conduct; (2) of an enterprise; (3) through a pattern; (4) of
racketeering activity.”4 See Libertad v. Welch, 53 F.3d 428, 441
(1st Cir. 1995). While pleadings are to be construed liberally,
“a greater degree of specificity is required in RICO cases.”
Bessette v. Avco Fin. Servs., Inc., 130 F.3d 439, 443 (1st Cir.
Defendants argue that the RICO claims must be dismissed for
five reasons: (1) Plaintiffs do not plead a viable enterprise;
(2) Defendants did not conduct or participate in the conduct of
any enterprise; (3) Defendants’ actions were not the proximate
cause of the Plaintiffs’ injuries; (4) Plaintiffs failed to
allege facts sufficient to satisfy Federal Rule of Civil
Procedure 9(b); and (5) Plaintiffs’ multi-source drug allegations
It shall be unlawful for any person employedby or associated with any enterprise engagedin, or the activities of which affect,interstate or foreign commerce, to conduct orparticipate, directly or indirectly, in theconduct of such enterprise's affairs througha pattern of racketeering activity . . . . 1. Enterprises
Plaintiffs allege two types of enterprises. The first type
is the Manufacturer-Publisher enterprise between each drug
manufacturer and each of the publishers printing the AWP data.
The second type is the Manufacturer-Pharmacy Benefit Manager
enterprise between each drug manufacturer and each PBM. Each
type of enterprise will be discussed separately. The Manufacturer - Publisher Enterprises (Count I ¶¶ 624 - 628)
In Count I, Plaintiffs claim that the Defendant drug
manufacturers engaged in an illegal pattern of racketeering
activity wherein each manufacturer formed a separate association-
in-fact enterprise with each of the companies that published the
AWP’s, and that each manufacturer conducted the affairs of its
enterprises. The complaint identifies Thomson Medical
Enterprise, First DataBank, Inc. and Facts & Comparisons, Inc. as
the publishers. (¶ 622.) For example, Plaintiffs allege an
enterprise between Abbott and Thomson Medical, which “is an
ongoing and continuing business organization consisting of both
corporations and individuals that are and have been associated
for the common or shared purposes of (a) publishing or otherwise
disseminating false and misleading AWP’s”, (b) “selling,
purchasing, and administering” [drugs with AWP’s to plaintiffs]
and (c) “deriving profits from these activities.” (¶ 628(a).)
Defendants argue that these allegations do not suffice to
plead an association-in-fact enterprise under the tests
established by the First Circuit. See Pharm. I, 263 F. Supp. 2d
at 182. The First Circuit has considered several factors in
determining whether a RICO association-in-fact enterprise has
been properly asserted: (1) whether the associates have a common
purpose; (2) whether there is systematic linkage, such as
overlapping leadership, structured or financial ties or
continuing coordination; (3) whether there is a common
communication network for sharing information on a regular basis;
(4) whether the associates hold meetings and sessions where
important discussions take place; (5) whether the associates wear
common colors, signs or insignia to make the group identifiable;
and (6) whether the group conducted common training and
According to the AMCC, each manufacturer-publisher
enterprise “has a systematic linkage because there are
contractual relationships, financial ties, and continuing
coordination of activities” between the participants and a
“common communication network” through which the participants
“share information on a regular basis.” (See, e.g., ¶ 628.) The
primary communication between the participants in each alleged
enterprise is the sending of the allegedly fraudulent AWP’s by
the manufacturer to the publisher for publication. (¶ 625.) The
AMCC alleges that the publishers know of the fraudulent nature of
the reported AWP’s (¶ 626), but they publish the information
anyway. The AMCC alleges that “each one of the Publishers was
aware of the Defendant Drug Manufacturers’ AWP scheme, was a
knowing and willing participant in that scheme, and reaped
profits from that scheme.” (¶ 212.) Finally, according to the
AMCC, “[e]ach of the enterprises has the common purpose of
perpetuating use of the AWP’s”: the manufacturers wish to push
the spread to increase their market share, and the publishers
have an economic incentive to publish without question the prices
reported “because if they did not, the manufacturers could easily
revert to the other methods of publishing prices or the
publishers would have to independently investigate the AWP at
These allegations of an association-in-fact enterprise fall
short in two ways. An enterprise must be “a group of persons
associated together for a common purpose of engaging in a course
of conduct.” United States v. Tourette, 452 U.S. 576, 580
(1981). The participants, as described, do not share a common
purpose more specific than that common to many human endeavors,
the reaping of a profit. The publishers are indifferent as to
whether the AWP spread exists or not; their financial interest
lies in earning money through selling books listing numbers. The
spread is irrelevant to their financial well being.
Further, Plaintiffs do not cite sufficient facts to support
the allegation that the publishers know of the fraudulent nature
of the AWP’s they publish. Plaintiffs rely on surveys by unnamed
publishers undertaken prior to 1992 regarding unnamed drugs, but
the allegations in the complaint relate to behavior beginning in
1991. They also point to reports on AWP inflation by
Congressional bodies and government agencies, and a recent
lawsuit brought by Defendant Dey seeking to force publishers to
publish the AWP it reports rather than the true price of its
drugs, after publishers lowered its AWP’s following a Texas
prosecution of Dey for AWP fraud. While some of these factors
may support an inference that some publishers may have been aware
of concerns by governmental entities about inflated AWP’s, they
are insufficient to draw a reasonable inference that each of the
publishers knew of the fraudulent nature of the AWP’s for the
Plaintiffs further insist that “each of the manufacturer-
publisher enterprises has a common purpose of perpetuating the
use of AWP’s as a benchmark for reimbursement in the
pharmaceutical industry” (¶ 624), thus skirting the issue of
whether the publishers knew of the fraud. It is true that the
use of AWP as a pricing benchmark may be a common objective, and
the members of an enterprise do not have to share all objectives
so long as they have one in common. See, e.g., United States v.
London, 66 F.3d 1227, 1244 (1st Cir. 1995) (holding that there
was a common or shared purpose animating the enterprise, a bar,
check-cashing business and an individual engaged in gambling:
profiting from the bookmakers who were engaged in illegal
gambling). However, without a shared illegal purpose to defraud,
the shared innocent objective of using AWP as a published
benchmark would not support a claim of a RICO enterprise. See
Blue Cross v. Smithkline Beecham Clinical Labs., Inc., 62 F.
Supp. 2d 544, 549 (D. Conn. 1998) (dismissing RICO complaint for
insufficient allegations of a common purpose to defraud).
Second, even if the common “reaping-a-profit” objective were
to suffice, the AMCC contains only conclusory allegations
concerning systematic linkages and ascertainable structures.
Essentially, Plaintiffs have merely parroted language from Pharm.
I dismissing a similar claim in the initial master complaint.
The only systematic linkage or structured or financial ties
described with some detail in the AMCC are the contracts for the
publishing of the AWP’s; there are no allegations of a common
command structure or any considered response to evolving
conditions. Allegations of a common communication network beyond
the sending of AWP information to be published are barebones:
there are no common communications alleged beyond those that
would be exchanged by parties to an arms-length contract. The
Plaintiffs do not attempt to allege the remaining factors
(meetings, joint training, etc.) relevant to a determination of
whether an association-in-fact existed. The publishers’ printing
of fraudulent AWP’s under a contract with the manufacturers does
(b) The Manufacturer - PBM Enterprises (Count II ¶¶ 651 - 661)
In Count II, Plaintiffs allege multiple associations-in-
fact, each consisting of: (1) a PBM that, acting as a middleman
between drug manufacturers and end-payors, administered purchases
of a defendant manufacturer’s drugs and billed end-payors based
on the reported AWP and (2) a defendant drug manufacturer. (¶
651.) The four named PBM’s are: Advance PCS, serving 75 million
health plan members; Caremark Rx, Inc., with $5.6 billion in
revenues in 2001; Express Scripts, Inc., the third-largest PBM in
America; and Medco Health Solutions, Inc., a wholly-owned
subsidiary of Merck. (¶ 650.) For example, the AMCC alleges an
Abbott-Caremark Rx Enterprise. (¶ 661(a).)
According to Plaintiffs, PBM’s, with the knowing assistance
of the manufacturers, have engaged in hidden profit-making
schemes falling into three general categories: (1) garnering
rebates and other “soft dollars from drug manufacturers that the
PBM’s, to a large extent, keep without disclosing to the health
plans the true amounts of the rebates”; (2) pocketing “secret
spreads” between actual drug costs and the prices charged to
health plans and their members; and (3) keeping “secret
discounts” provided by the drug manufacturers in association with
the PBM’s mail-order operations. (¶ 654.)
The paradigms here are somewhat different from the paradigm
in the Medicare Part B context, discussed in Pharm. I. First,
the AMCC alleges that the PBM benefits because it pockets the
spreads between the published AWP’s for brand-name drugs, which
it uses to calculate the rates it charges to end-payors (e.g.,
AWP minus 13 percent), and the actual prices which it pays the
retail pharmacies (e.g., AWP minus 15 percent). (See ¶ 171.)
Second, there is a “spread” in PBM mail-order operations in which
the PBM acts as a pharmacy between the published AWP price and
the actual acquisition cost. (Id.) Finally, the PBM pockets
spreads in the mail-order context in which a third-party
“repackager” is used between the rates charged to end-payors and
The “spreads” motivate the PBM’s to put the brand-name drug
on a formulary: the greater the AWP inflation, the greater the
profit to the PBM from the spread. (Id.) Each manufacturer
benefits from a spread because it encourages PBM’s to sell that
manufacturer’s drug, rather than a competitor’s.
Alleged communications between PBM’s and the manufacturers
include, inter alia: (1) marketing materials about the AWP’s for
brand-name drugs sent from manufacturers to PBM’s; (2) written
representations of the AWP’s sent by the manufacturers; (3)
“thousands of written and oral communications discussing,
negotiating and confirming the placement of a Defendant drug
manufacturer’s drug on a particular PBM’s formulary”; and (4)
written communications, including checks, relating to rebates,
kickbacks and other financial inducements. (¶ 666(a)-(i).)
Additionally, salespersons from manufacturers regularly meet with
PBM’s in order to promote their products and the fraudulent AWP
scheme. (¶¶ 664, 667(e).) Plaintiffs allege that Defendants
controlled, inter alia, the setting of the AWP’s, the
distribution of marketing material used to inform the PBM’s of
the benefits of using AWP’s, and the affairs of the PBM’s by
providing rebates and administrative fees in exchange for the
PBM’s use of a particular manufacturer’s AWP’s. (¶ 667.)
These allegations provide a plausible common fraudulent
purpose (a falsely-inflated AWP) and describe systematic
linkages, common communication networks, and regular meetings
among associates. It is true that Plaintiffs have not alleged
specific communications for each enterprise, but courts have
recognized that relaxation of pleading requirements is permitted
where information is in a defendant’s sole possession. See,
e.g., Efron v. Embassy Suites (P.R.) Inc., 223 F.3d 12, 16 (1st
Cir. 2000). Such relaxation is particularly appropriate here
where most of the Defendants have conceded that AWP’s represent
only an “undiscounted sticker price” that has no direct relation
to the actual average price they charge for their drugs and that
this is a widespread pricing and reporting practice. Pharm. I,
Conduct or Participate in the Conduct (Manufacturer - PBM Enterprises)
Defendants argue that the AMCC makes insufficient
allegations that each manufacturer conducted or participated in
the conduct of the manufacturer - PBM enterprises. The “conduct
or participate in the conduct” portion of § 1962(c) “requires
some participation in the operation or management of the
enterprise itself.” Reves v. Ernst & Young, 507 U.S. 170, 176
(1993). “An enterprise is ‘operated’ not just by upper
management but also by lower-rung participants in the enterprise
who are under the direction of upper management. An enterprise
also might be ‘operated’ or ‘managed’ by others ‘associated with’
the enterprise who exert control over it as, for example, by
bribery.” Id. at 184 (footnote omitted). See United States v.
Shifman, 124 F.3d 31, 36 (1st Cir. 1997) (holding that debtor who
referred persons to loan shark in exchange for debt relief or
fees conducted or participated in the conduct of loan sharking
enterprise); Aetna Cas. Sur. Co. v. P & B Autobody, 43 F.3d 1546,
1559 (1st Cir. 1994) (holding that operation or management test
required a “degree of direction” which can be direct or
Defendants argue that, at best, the AMCC alleges that they
were simply conducting their own affairs, not participating in
the enterprises. As noted above, the AMCC alleges that the
Defendants were not simply acting legally to promote their
products, but rather promoted the fraudulent AWP scheme. By
directing the affairs of each enterprise through kickbacks and
other financial incentives to PBM’s, the Defendants sought to
take advantage of an honor system established for price reporting
3. Causation
“When a plaintiff attempts to base a civil RICO claim on §
1962(c), that claim cannot succeed unless the injuries of which
the plaintiff complains were caused by one or more of the
specified acts of racketeering.” Camelio v. Am. Fed’n, 137 F.3d
666, 669 (1st Cir. 1998) (citing Miranda v. Ponce Fed. Bank, 948
F.2d 41, 46-47 (1st Cir. 1991)). “[M]erely proving that the
alleged predicate acts were a ‘cause in fact’ of plaintiff’s
injuries will not be sufficient. Instead, § 1964(c) requires
proof that at least one of the defendant’s predicate acts was the
proximate cause of the plaintiff’s injuries.” Id. (citing Holmes
v. Sec. Investor Prot. Corp., 503 U.S. 258, 268 (1992)).
In Holmes, the Supreme Court applied three policy tests to
support its finding that the defendant’s actions were not the
proximate cause of the plaintiff’s injuries: first, how
difficult it is “to ascertain the amount of a plaintiff’s damages
attributable to the violation, as distinct from other,
independent factors”; second, whether holding the defendant
liable “would force courts to adopt complicated rules
apportioning damages among plaintiffs removed at different levels
of injury from the violative acts, to obviate the risk of
multiple recoveries”; and third, whether “the need to grapple
with these problems is simply unjustified by the general interest
in deterring injurious conduct, since directly injured victims
can generally be counted on to vindicate the law as private
attorneys general.” Holmes, 503 U.S. at 269-70.
Here, Defendants argue that the alleged predicate acts are
not the proximate cause of Plaintiffs’ alleged injuries, for
there are intervening acts between Plaintiffs’ alleged injuries
and the alleged acts of the Defendants. Specifically, Defendants
note that the alleged misrepresentations were made to third-party
publishers, not Plaintiffs; that the prescribing doctors set
their own charges under Medicare; that numerous government
actors, including Congress and carriers, chose to base their
reimbursements on AWP; and finally, that any injury arising from
a Manufacturer-PBM enterprise was not proximately caused by the
Defendants, but rather by the PBM’s or the Plaintiffs themselves.
The Defendants’ arguments are not persuasive. In the
private, end-payor context, the harm alleged by Defendants’
alleged actions is visited directly upon the end-payor
Plaintiffs, as they have paid directly for the named drugs based
on the AWP’s. Similar arguments about intervening causes between
the setting of an AWP by a defendant and injuries to plans and
individual co-payors were recently rejected as “border[ing] on
the frivolous,” In re Lupron Marketing and Sales Practices
Litig., 295 F. Supp. 2d 148, 175 (D. Mass. 2003) (Stearns, J.),
for “the argument ignores . . . the corollary requirement that
the intervening act be unforeseeable and completely independent
of any act undertaken by the original actor,” id., a requirement
The conclusion that proximate cause exists is supported by
the reasoning set forth in Holmes: the Defendants do not argue
that there would be any particular difficulty in allocating
damages; there are no other victims that will be sharing in the
amounts claimed by Plaintiffs; and as the Plaintiffs are the ones
directly injured, no other party is better placed to vindicate
4. Rule 9(b)
Defendants challenge the sufficiency of Plaintiffs’
allegations under Rule 9(b) on numerous bases: (1) Plaintiffs
have not identified the time, date and place of specific
statements between PBM’s and manufacturers; (2) Plaintiffs have
not linked particular drugs to particular PBM’s; (3) Plaintiffs
have not identified the prices they paid for each drug (thus
allowing for a calculation of the “spread” in some cases) or the
mechanisms within their contracts for calculating prices; (4) the
allegations of volume discounts, rebates, credit memos, and the
like are devoid of particulars; (5) Plaintiffs fail to specify
the states in which drugs were purchased; (6) certain Plaintiffs,
including the associations, did not allege the purchase of any
drugs from certain Defendants; (7) Plaintiffs have failed to
allege competitors for each drug; and (8) Plaintiffs do not
allege that certain drugs were purchased under Medicare Part B.
In Pharm. I, the Court held that in light of the detailed
fraudulent scheme alleged, the plaintiffs’ allegations were
sufficient with respect to “any drug identified in the complaint
together with the allegedly fraudulent AWP published by a named
defendant for that drug.” 263 F. Supp. 2d at 194. The Court
instructed that if plaintiffs were to file an amended complaint,
“plaintiffs shall clearly and concisely allege with respect to
each defendant: (1) the specific drug or drugs that were
purchased from defendant, (2) the allegedly fraudulent AWP for
each drug, and (3) the name of the specific plaintiff(s) that
With respect to most Defendants, the Court finds that
Plaintiffs in the AMCC have pled allegations concerning the
fraudulent scheme with enough specificity to comply with the
requirements of Rules 9(b) and 8(a). See Franklin ex rel. v.
Parke-Davis, 147 F. Supp. 2d 39, 46 (D. Mass. 2001) (Saris, J.)
(“[W]here the alleged scheme of fraud is complex and far-
reaching, pleading every instance of fraud would be extremely
ungainly, if not impossible. Courts facing similar claims under
the False Claims Act have not placed the bar so high as to
require pleading with total insight.”). In the AMCC, Plaintiffs
describe extensively the factual investigations undertaken that
formed the bases of Plaintiffs’ allegations, and in so doing
identify particular allegedly-fraudulent conduct on the part of
each Defendant, except one. (See ¶¶ 155 - 157 (describing
government investigations); 187 (chart displaying spreads
calculated by Department of Justice for eleven defendants); 200 -
540 (descriptions of varying specificity by particular defendant
of pricing mechanisms, government investigations, internal
documents identifying spread, and related items).) The
amendments to the original complaint allege the particular drugs
involved, and the AWP’s for those drugs. Compare Pharm. I, 263
The Court has examined each motion to dismiss filed by
individual Defendants. After a review of Defendant-specific
1. The claims by a Plaintiff association against a
Defendant manufacturer are dismissed unless a member of that
association is alleged to have purchased a drug from that
2. The Court continues to defer ruling on the juridical
linkage doctrine as that issue is more properly resolved in the
context of class certification. See Payton v. Kane, 308 F.3d
673, 679-80 (7th Cir. 2002) (holding that a court should consider
“issues of class certification prior to issues of standing” and
pointing out that once a class is properly certified “standing
requirements must be assessed with reference to the class as a
whole, not simply with reference to the individual named
plaintiffs”). Accordingly, so long as there is one named
Plaintiff who purchased a drug from a Defendant, the Court will
not dismiss the claims of fraud involving other drugs
manufactured by that Defendant even if none of the named
Plaintiffs purchased that particular drug. The Court declines
the invitation at this early stage of the litigation to evaluate
intricate arguments involving standing (for example, whether a
plaintiff who has standing with respect to a Medicare Part B drug
has standing to represent a purchaser of a drug under a private
plan), although these issues may be appropriate in a typicality
analysis under Fed. R. Civ. P. 23(a)(3).
3. In light of the allegations and concessions concerning
an industry-wide practice of inflating AWP’s, the Court rejects
arguments that Plaintiffs must allege a specific spread for each
drug, so long as sufficient facts were alleged to infer a
fraudulent scheme by each particular Defendant manufacturer
(i.e., government investigations concerning that company,
internal company documents, specific alleged fraudulent spreads
on other drugs manufactured by that company and the like). The
allegations not meeting this standard are discussed below.
4. The Court dismisses the claims regarding Viramune as it
was apparently not manufactured by the Boehringer Group.
5. The Court dismisses Hoffman-LaRoche on the ground that
there are insufficient allegations to support a claim of a
fraudulent scheme. While industry-wide practices are relevant,
this is essentially a guilt-by-association claim as there are no
allegations concerning government investigations, internal
documents or specific fraudulent spreads relating to this
particular company. Defendant Hoffman-La Roche is the only
Defendant for which no examples of allegedly-incriminating
communications, fraudulent pricing, or government investigations
were given. Plaintiffs explain that statements pertaining to
Hoffman-La Roche’s drug Kytril are detailed in the AMCC section
pertaining to a competitor, the GSK Group. GSK allegedly sold
Kytril to Hoffman-La Roche, and the AWP of Kytril has not
decreased since the sale. (See ¶¶ 386 - 404 (citing documents
discussing benefits of spread).) I agree with Hoffman-La Roche
that this pleading implicating another defendant is not
particular enough to infer that Hoffman-La Roche engaged in
Plaintiffs further argue that under First Circuit precedent,
the proper course is to permit discovery, noting that unlike the
other Defendants, Hoffman-LaRoche has never been subject to
discovery. See New England Data Serv., Inc., v. Becher, 829 F.2d
286, 290-91 (1st Cir. 1987) (“[W]here, for example the specific
allegations of the plaintiff make it likely that the defendant
used interstate mail . . ., and the specific information as to
use is likely in the exclusive control of the defendant, the
court should make a second determination as to whether the claim
as presented warrants the allowance of discovery and if so,
thereafter provide an opportunity to amend the defective
complaint.”); but see Feinstein v. Resolution Trust Corp., 942
F.2d 34, 44 (1st Cir. 1991) (noting that “[a]lthough Becher may
in certain circumstances give a plaintiff a second bite at the
apple, its generous formulation is not automatically bestowed on
Here, the Court makes the second determination that
discovery is not warranted. Unlike in Becher, where the
complaint contained other allegations of particular facts with
regard to the defendants, 829 F.2d at 287, no specifics have been
alleged as to the conduct of Hoffman-LaRoche. Therefore,
Hoffman-La Roche’s motion to dismiss is ALLOWED.
6. The Court shall allow discovery to proceed with respect
to B. Braun of America. Plaintiffs must respond to the issues of
personal jurisdiction and whether the service of B. Braun of
America relates back to the service of B. Braun Medical, Inc. by
5. Multi-source Drugs
In Pharm. I, the Court dismissed without prejudice
plaintiffs’ claims relating to multiple-source (including
generic) drugs because the allegations were not specific with
respect to such drugs and they “do not fit the paradigm described
in the complaint.” 263 F. Supp. 2d at 194 n.11.
In the AMCC, Plaintiffs allege that AWP fraud is “most
exacerbated for generic drugs or for brand name drugs for which
there are biological or therapeutic equivalents.” (¶¶ 179-190.)
They further allege that the AWP fraud affects private end-payors
as well as the Medicare Part B program. According to the
Plaintiffs, in the private payor arena, generic drug
reimbursement is determined either in the same manner as for
brand-name drugs (i.e., a certain percentage “discount” off of
the AWP) or is based on the amount specified as the maximum
allowable cost or “MAC.” MAC prices or reimbursement rates are a
schedule of pricing for generically equivalent drugs based upon
the AWP’s of competing generic drug manufacturers. The federal
government issues a MAC price for generic products that have
three or more manufacturers or distributors on the market. PBM’s
sometimes utilize this MAC reimbursement publication, and
sometimes calculate a maximum allowable cost based on their own
formulae, which utilize the list average wholesale prices of
competing generic drug manufacturers. The use of a maximum
allowable cost based on the list average wholesale price is
termed in the industry as the “average average wholesale price.”
In the public payor arena under Medicare Part B, multi-
source drugs or biologicals are reimbursed on the basis of the
lessor of the median AWP of all of the generic forms of the drug
or biological, or the lowest brand-name product AWP, with the
resulting price confusingly being also termed “AWP”. (¶ 149
(citing Program Memorandum AB-99-63 (Sept. 1999)).)
The raising of an individual Defendant’s reported AWP for a
multi-source drug can (but does not necessarily) raise the median
AWP at which the generic drug is reimbursed. Moreover, while any
one generic manufacturer can only affect the median generic
reimbursement for AWP for a product, rather than directly
affecting its own drug’s reimbursement. Defendants still benefit
from the spread between the median AWP and the actual prices
paid. (¶ 186.) According to the AMCC, “[t]he natural and
expected result of this ‘leap frogging’ of increasing AWPs is
that multi-source drugs have some of the highest spreads of any
drugs, sometimes resulting in an AWP over 50,000% over actual
costs.” (¶ 187.) For example, Baxter publishes the AWP for
Sodium Chloride at $928.51, while the DOJ determined that the
actual AWP was $1.71, a percentage spread of 54,199%. (¶ 187,
Defendants argue that the allegations regarding the
underlying fraudulent scheme for multi-source drugs are
insufficient under Rule 9(b). Defendants reason that they have
no motive to compete by increasing the “spread” between the
average wholesale price of multi-source drugs and the actual
price of such drugs to providers, because Medicare Part B pays
for multi-source drugs at “the lesser of the median average
wholesale price for all sources of the generic forms of the drug
or biological or the lowest average wholesale price of the brand
name forms of the drug or biological.” 42 C.F.R. § 405.517
(2003). No one drug maker could gain an advantage by
leapfrogging the AWP over a competitor’s, Defendants argue, as
reimbursement is based on the median. For similar reasons, there
is no reason to compete with regard to non-Medicare Part B,
multi-source drugs, which are reimbursed based on MAC’s.
Plaintiffs respond that prices of multi-source drugs are
often based on AWP in the private payor context, giving drug
makers the same incentive to increase AWP. In any event, at this
stage of the proceeding, Plaintiffs are not required to prove
motive, see Fed. R. Civ. P. 9(b), and the allegations are
specific enough to accord with Fed. R. Civ. P. 9(b). State Civil Conspiracy Claims, State Consumer Protection Statutes
The Court declines to reach the merits of the motions to
dismiss the multiple state law claims, which were briefed
inadequately. The Court will address these state law claims at
Together Rx Claims
Plaintiffs claim that Defendants illegally manipulate AWP’s
through the creation of a discount card program – the Together Rx
Program – to share price data, fix prices and stave off public
In response, Together Rx LLC (“Together Rx”) and its member
companies5 (collectively, the “Together Rx Defendants”) move to
dismiss Counts V (Section 16 of the Clayton Act, 15 U.S.C. § 26),
VI (Section 1 of the Sherman Act, 15 U.S.C. § 1), VII (various
state antitrust statutes), VIII (RICO, 18 U.S.C. § 1962(c), (d))
and X (Civil Conspiracy) of the AMCC, all counts directed against
5 The eight member companies of Together Rx are: Abbott
Laboratories; AstraZeneca Pharmaceuticals, L.P.; AventisPharmaceuticals, Inc.; Bristol-Myers Squibb Company; SmithKlineBeecham Corporation d/b/a GlaxoSmithKline; Janssen PharmaceuticalProducts, L.P. and McNeil-OPC, Inc. (both affiliates of Johnson &Johnson); and Novartis Pharmaceuticals Corporation.
The AMCC makes the following allegations regarding the
Together Rx Program. In 2001 or 2002, the Together Rx Defendants
agreed to establish a program to offer drug discounts to older,
uninsured and poor consumers. (¶¶ 542-544.) To implement the
program, they fixed the AWP “spread” (the difference between
published AWP and the wholesale acquisition cost or “WAC”) on
over 170 widely-prescribed brand-name drugs purchased through the
program (“Together Card drugs”). (¶ 544.) The Together Card
Program has caused Plaintiffs and the nationwide end-payor
Together Card class to pay more for Together Card drugs. (¶
545.) Plaintiffs therefore allege a conspiracy “to raise, fix,
maintain and/or stabilize” the AWP spread. (¶ 545.) Another
purpose of the program, according to the AMCC, was to allow the
Together Rx Defendants to respond to public pressure over
escalating drug costs. (¶ 550.) The Together Rx Program was
As proof of this scheme, Plaintiffs allege that the Together
Rx Defendants simultaneously and uniformly increased the spreads
between posted AWP’s and WAC’s on over 80% of their Together Card
drugs in order to provide an incentive to others in the
distribution chain to participate in the program, an incentive
6 Defendants address the non-antitrust claims only summarily
that operated to the detriment of end-payors (like insurance
companies and health plans). (¶¶ 588-591.) The effectively-
simultaneous timing of the Together Rx Defendants’ increases in
AWP spreads is unprecedented in terms of the number of products
per manufacturer and number of manufacturers within the
pharmaceutical industry. (¶ 592.) Notably, each of the seven
Together Rx Defendants achieved precisely a 25% spread following
the formation of the program as shown below. (¶ 591.)
Together Together Card Drug Defendant Alliance Alliance Alliance Alliance Alliance Alliance
The total percentage of all Together Card drugs manufactured by
the Together Rx Defendants with an AWP spread greater than 24%
increased from 25.5% in 2000, to 92% by 2002. (¶ 590.)
Plaintiffs contend that “the Together Card Defendants’ immediate
increase of the AWP spread on Together Card drugs diluted any
meaningful discount for the relatively small number of eligible
consumers and raised the price for other consumers significantly
beyond what was charged prior to the Together Card Defendants’
formation of the alliance.” (¶¶ 10, 593.)
Defendants contend that all conspiracy counts should be
dismissed because the factual allegations “make no economic
sense” and because Plaintiffs lack standing. The standard
governing motions to dismiss pursuant to Fed. R. Civ. P. 12(b)(6)
applies to an antitrust claim. See Caribe BMW, Inc. v.
Bayerische Motoren Werke Aktiengesellschaft, 19 F.3d 745, 748
(1st Cir. 1994). In antitrust cases “where the proof is largely
in the hands of the [defendant], dismissals prior to giving the
plaintiff ample opportunity for discovery should be granted
sparingly.” Hosp. Bldg. Co. v. Trs. of the Rex Hosp., 425 U.S.
738, 746 (1976). However, sparingly does not mean never. A
plaintiff must allege sufficient facts in order to state each
element of the antitrust violation. See C.R. Bard, Inc. v. Med.
Elecs. Corp., 529 F. Supp. 1382, 1389 (D. Mass. 1982).
1. Sufficiency of Antitrust Allegations
Section One of the Sherman Act prohibits “[e]very contract,
combination . . . or conspiracy, in restraint of trade.” 15
U.S.C. § 1 (1997). That language establishes two prerequisites
for a Section 1 claim. Podiatrist Ass’n v. La Cruz Azul de
Puerto Rico, Inc., 332 F.3d 6, 12 (1st Cir. 2003). First, the
plaintiff must show concerted action between two or more separate
parties. Monsanto Co. v. Spray-Rite Serv. Corp., 465 U.S. 752,
761 (1984). Second, the plaintiff must show that such action
unreasonably restrains trade. NYNEX Corp. v. Discon, Inc., 525
U.S. 128, 133 (1998). A small set of acts constitute per se
violations of Section 1 because the acts are regarded by the
Court “as sufficiently dangerous and so clearly without redeeming
value that they are condemned out of hand, that is, without a
showing of wrongful purpose, power or effect.” Eastern Food
Servs., Inc. v. Pontifical Catholic Univ. Servs., Inc., 2004 WL
110844, at *2 (1st Cir. Jan. 20, 2004). Thus, “proof of the
defendant’s power, of illicit purpose and, of anticompetitive
effect” are irrelevant. U.S. Healthcare, Inc. v. Healthsource,
Inc., 986 F.2d 589, 593 (1st Cir. 1993).
Price fixing agreements qualify for the per se label.
“Stabilizing prices as well as raising them is within the ban of
§ 1 of the Sherman Act.” United States v. Container Corp. of
Am., 393 U.S. 333, 337 (1969). “Under the Sherman Act a
combination formed for the purpose and with the effect of
raising, depressing, fixing, pegging, or stabilizing the price of
a commodity in interstate or foreign commerce is illegal per se.”
United States v. Socony-Vacuum Oil Co., 310 U.S. 150, 223 (1940).
Defendants’ core argument is that Plaintiffs have not
alleged an economically plausible theory because Defendants have
no economic incentive to collude to increase AWP’s or the “AWP
spread” on Together Rx drugs. The Supreme Court has held that
“if the factual context renders [plaintiff’s] claim implausible –
if the claim is simply one that makes no economic sense –
[plaintiff] must come forward with more persuasive evidence to
support their claim than would otherwise be necessary.”
Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S.
574, 587 (1986). Following this precedent, courts have dismissed
antitrust conspiracy claims where a plaintiff has presented
nothing more than “unlikely speculations.” DM Research, Inc. v.
College of Am. Pathologists, 170 F.3d 53, 56 (1st Cir. 1999)
(holding that allegations of a “conspiracy” or “agreement” “might
well be sufficient in conjunction with a more specific allegation
– for example identifying . . . a basis for inferring a tacit
agreement,” but reasoning that “the discovery process is not
available where, at the complaint stage, a plaintiff has nothing
more than unlikely speculations”). See also Car Carriers, Inc.
v. Ford Motor Co., Inc., 745 F.2d 1101 (7th Cir. 1984) (holding
that “a complaint must contain either direct or inferential
allegations respecting all the material elements necessary to
sustain a recovery under some viable legal theory”).
Defendants argue that the Together Rx transactions alleged
by Plaintiffs make no economic sense. In one type of transaction
specifically alleged in the AMCC, Novartis offered its drugs to
Together Rx Card holders with incomes less than $24,000 for a
flat fee of $12 per prescription. The difference between $12 and
the price the pharmacy charges for the drug is the amount of the
subsidy provided by Novartis. (¶ 558.) Defendants argue that an
increase in AWP spread would actually hurt each drug company,
which would have to pay more in subsidies to each retail pharmacy
with no offsetting increase in revenues. In another type of
Together Rx transaction alleged by Plaintiffs, the manufacturer
pays a specific dollar subsidy and the cardholder pays the
difference between that subsidy and the pharmacy’s selling price.
With respect to this type of transaction, Defendants point out,
increasing the spread between WAC and AWP does not increase the
revenue the Defendant manufacturer receives. Therefore,
Defendants argue, the theory behind the entire alleged conspiracy
Plaintiffs argue that a conspiracy which stabilizes a
volatile market and fixes both prices and discounts is a classic
example of a horizontal, per se violation of the Sherman Act.
The AMCC alleges that the Together Card Program was created, at
least in part, to stave off congressional and public scrutiny.
(¶ 550.) Moreover, from an economic viewpoint, Plaintiffs argue,
increasing the AWP spread on the 170 drugs would shift the
financial burden of the Together Card Program onto non-Together
Rx third party end-payors and create “spread dollars” for others
in the distribution chain (like pharmacies and wholesalers). In
other words, it functions as a cross-subsidy placed on end-payors
to incentivize these other entities to participate in the
In light of the extremely complex nature of drug pricing,
the record is inadequate for fully evaluating either argument.
It is worth pointing out, however, that Defendants have not given
a plausible reason why they all simultaneously created the same
spread for market based reasons. At this stage, with all
reasonable inferences drawn in their favor, Plaintiffs have not
alleged an implausible economic or political theory.
Defendants also argue that parallel price movements alone
are insufficient to establish a conspiracy. Clamp-All Corp. v.
Cast Iron Soil Pipe Inst., 851 F.2d 478, 484 (1st Cir. 1988)
(finding that evidence “consisting of little more than” “follow-
the-leader” price lists for virtually identical products “would
not permit a finding of more than such individual,
interdependent, price setting”). “Since mere parallel behavior
can be consistent with independent conduct, courts have held that
a plaintiff must show the existence of additional circumstances,
often referred to as ‘plus’ factors, which, when viewed in
connection with the parallel acts, can serve to allow a fact-
finder to infer a conspiracy.” Apex Oil Co. v. DiMauro, 822 F.2d
246, 253 (2d Cir. 1987). Such circumstances might include a
common motive to conspire or a high level of inter-firm
communications. Id. at 254 (citations omitted). See also
Illinois Corp. Travel v. American Airlines, 806 F.2d 722, 726
(7th Cir. 1985) (explaining that “to show conspiracy indirectly
the plaintiff must demonstrate that the firm is behaving in a way
that is inconsistent with unilateral decisionmaking,” i.e., that
“the defendant acted in a way that, but for a hypothesis of joint
action, would not be in its own interest”).
The Plaintiffs’ Together Rx allegations include more than
mere parallel pricing. The AMCC alleges, for example, that the
Together Rx Defendants joined the Together Rx program with the
common motive of staving off Congressional and public scrutiny (¶
550) and that the Together Rx program facilitated the sharing of
price information. (¶ 546.) Moreover, the Together Rx
Defendants simultaneously created identical AWP spreads on
several widely-prescribed drugs, raising a reasonable inference
of conspiracy. (¶ 592.) Cf. Cayman Exploration Corp. v. United
Gas Pipe Line Co., 873 F.2d 1357, 1361 (10th Cir. 1989)
(affirming dismissal of horizontal price-fixing conspiracy claim
where plaintiff “did not identify the alleged conspirators, when
or how they functioned, or the nature and extent of [defendant’s]
participation in the alleged conspiracy”); Yellow Page Solutions,
Inc. v. Bell Atlantic Yellow Pages, 2001 WL 1468168, at * 14
(S.D.N.Y. Nov. 19, 2001) (dismissing complaint where “plaintiffs
do not allege, as they must” when or where any unlawful agreement
was made, or by whom, or why the parties would enter into this
agreement, or that uniform pricing policies are “anything other
than independent, parallel conduct meant to maximize each party’s
own revenues”). The Together Rx Plaintiffs, by contrast, have
alleged parallel movements, as well as sufficient “plus” factors
2. Standing
Plaintiffs bring their Together Card claims on behalf of the
All persons or entities in the UnitedStates and its territories who paid anyportion of the purchase price for, or whoreimbursed any portion of the purchaseprice of, a drug covered by the TogetherRx Program on the basis, in whole or inpart, on the published average wholesaleprice during the time period January 1,2002 up to and including the present.
(¶ 604.) Defendants argue that Plaintiffs lack standing to
assert their claims because no Plaintiff is enrolled in the
Together Rx Program. The Plaintiffs assert they either paid for
or were reimbursed for Together Card drugs, the prices of which
were based on AWP. Therefore, Plaintiffs have standing to assert
their claims.7 See RSA Media, Inc. v. AK Media Group, Inc., 260
7 The Court does not decide at this point whether Plaintiffs
have standing to assert claims on behalf of elderly program
F.3d 10, 14 (1st Cir. 2001) (“Although we technically balance the
six factors [articulated in Associated Gen. Contractors of Cal.,
Inc. v. Cal. State Council of Carpenters, 459 U.S. 519 (1983)] to
determine if standing is appropriate, this Court has emphasized
the causation requirements of that test.”); Morales-Villalobos v.
Garcia-Llorens, 316 F.3d 51, 55 (1st Cir. 2003) (overturning
grant of motion to dismiss for lack of antitrust standing where
plaintiff alleged but-for causation and direct injury and court
found “no reason why . . . the injury to her would not be of the
kind that antitrust laws are intended to address”).
Defendants’ motions to dismiss the Amended Master
Consolidated Complaint are ALLOWED IN PART, DENIED IN PART. The
motion to dismiss Count I is ALLOWED. The motion to dismiss the
other counts is DENIED. The Court dismisses Hoffman-LaRoche, the
claims involving Viramune, and the claims by an association
against a defendant from which none of its members purchased
drugs. The stay of discovery as to multi-source drugs is lifted.
Plaintiffs must respond to the jurisdictional and service issues
with respect to B. Braun of America by August 24, 2004.
S/PATTI B. SARIS
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