Pat District Council 82 v. Takeda Pharmaceuticals Company
Citation943 F.3d 1243
Date Filed2019-12-03
Docket18-55588
Cited36 times
StatusPublished
Full Opinion (html_with_citations)
FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
PAINTERS AND ALLIED TRADES No. 18-55588
DISTRICT COUNCIL 82 HEALTH CARE
FUND, third-party healthcare payor D.C. No.
fund; ANNIE M. SNYDER, a 2:17-cv-07223-
California consumer; RICKEY D. SVW-AS
ROSE, a Missouri consumer; JOHN
CARDARELLI, a New Jersey
consumer; MARLYON K. BUCKNER, a OPINION
Florida consumer; SYLVIE BIGORD, a
Massachusetts consumer, on behalf
of themselves and all others similarly
situated,
Plaintiffs-Appellants,
v.
TAKEDA PHARMACEUTICALS
COMPANY LIMITED, a Japanese
Corporation; TAKEDA
PHARMACEUTICALS U.S.A., FKA
Takeda Pharmaceuticals North
America, Inc., an Illinois
corporation; ELI LILLY AND
COMPANY, an Indiana corporation,
Defendants-Appellees.
Appeal from the United States District Court
for the Central District of California
Stephen V. Wilson, District Judge, Presiding
2 PAT DIST. COUNCIL 82 V. TAKEDA PHARM.
Argued and Submitted June 6, 2019
Seattle, Washington
Filed December 3, 2019
Before: Carlos T. Bea, Jacqueline H. Nguyen,
and Paul J. Watford *, Circuit Judges.
Opinion by Judge Bea
SUMMARY **
Racketeer Influenced and Corrupt Organizations Act
The panel reversed the district courtâs judgment
dismissing civil RICO claims under Fed. R. Civ. P. 12(b)(6)
for lack of RICO standing and remanded for further
proceedings.
Plaintiffs brought a putative class action against
pharmaceutical companies, alleging that the companies
refused to change the warning label of their drug Actos or
otherwise inform the public after they learned that the drug
increased a patientâs risk of developing bladder cancer.
Plaintiffs were five patients and a third-party payor (âTPPâ)
of health and welfare benefits to covered members and their
*
Judge Watford was drawn to replace Judge Rawlinson. Judge
Watford has read the briefs, reviewed the record, and watched the
recording of oral argument held on June 6, 2019.
**
This summary constitutes no part of the opinion of the court. It
has been prepared by court staff for the convenience of the reader.
PAT DIST. COUNCIL 82 V. TAKEDA PHARM. 3
families. Plaintiffs sought to represent a class of similarly
situated patients and TPPs who paid or incurred costs for
Actos. They alleged that defendants conspired to commit
mail and wire fraud by intentionally misleading physicians,
consumers, and TPPs to believe that Actos did not increase
a personâs risk of developing bladder cancer. Plaintiffs
sought to recover economic damages under RICO for the
payments they made to purchase Actos, which they allege
they would not have purchased had they known of the
bladder cancer risk. The district court held that plaintiffs
failed to allege that their harm was âby reason ofâ the alleged
RICO violation, as required for RICO standing, because they
failed to allege the claimed RICO violation was the
proximate cause of their claimed losses.
Agreeing with the First and Third Circuits, and
disagreeing with the Second and Seventh Circuits, the panel
held that plaintiffs sufficiently alleged proximate cause.
Supreme Court precedent requires a direct relationship
between the injury asserted and the defendantâs conduct.
The Supreme Court applies the Holmes factors, considering
(1) whether it would be too difficult to ascertain what
damages are attributable to defendantsâ alleged RICO
violation, (2) the risk of multiple recoveries by plaintiffs at
different levels of injury from defendantsâ acts, and
(3) whether holding defendants liable justifies the general
interest of deterring injurious conduct. The panel concluded
that plaintiffs sufficiently alleged a direct relationship, and
the Holmes factors weighed in favor of permitting their
RICO claims to proceed. The panel thus held that patients
and TPPs suing pharmaceutical companies for concealing an
allegedly unknown safety risk about a drug can satisfy
RICOâs proximate cause requirement. The panel concluded
that, although prescribing physicians served as
intermediaries between defendantsâ fraudulent omission of
4 PAT DIST. COUNCIL 82 V. TAKEDA PHARM.
Actosâs risk of causing bladder cancer and plaintiffsâ
payments for Actos, prescribing physicians did not
constitute an intervening cause to cut off the chain of
proximate causation. In addition, plaintiffs adequately
alleged reliance on defendantsâ alleged misrepresentations
and omissions.
The panel addressed additional claims in a concurrently
filed memorandum disposition.
COUNSEL
R. Brent Wisner (argued) and Michael L. Baum, Baum
Hedlund Aristei & Goldman PC, Los Angeles, California;
Christopher L. Coffin and Nicholas R. Rockforte, Pendley
Baudin & Coffin LLP, New Orleans, Louisiana; for
Plaintiffs-Appellants.
Jonathan S. Franklin (argued), Norton Rose Fulbright US
LLP, Washington, D.C.; Darryl W. Anderson and Geraldine
W. Young, Norton Rose Fulbright LLP, Houston, Texas; for
Defendants-Appellees Takeda Pharmaceuticals Company
Limited and Takeda Pharmaceuticals U.S.A.
Randall L. Christian (argued) and Susan E. Burnett,
Bowman and Brooke LLP, Austin, Texas, for Defendant-
Appellee Eli Lilly and Co.
PAT DIST. COUNCIL 82 V. TAKEDA PHARM. 5
OPINION
BEA, Circuit Judge:
Today we confront an issue of first impression in our
circuit, and one that has caused an apparent circuit split
among four of our sister circuits: In civil actions brought
under the Racketeer Influenced and Corrupt Organizations
Act (âRICOâ) against pharmaceutical companies, do
patients and health insurance companies who reimbursed
patients adequately allege the required element of proximate
cause where they allege that, but for the defendantâs omitted
mention of a drugâs known safety risk, they would not have
paid for the drug?
I. FACTUAL BACKGROUND
This appeal arises from a putative class action against
Takeda Pharmaceuticals USA, Inc., its parent company
Takeda Pharmaceutical Company Ltd., and Eli Lilly & Co.
(collectively, âDefendantsâ). Together, Defendants
developed and marketed a drug named Actos. Actos was
intended to lower blood sugar in type 2 diabetics.
Defendants obtained Food and Drug Administration
(âFDAâ) approval for Actos in 1999. The plaintiffs allege
that despite learning through multiple studies over the next
several years that Actos increased a patientâs risk of
developing bladder cancer, Defendants refused to change
Actosâs warning label or otherwise inform the public of such
risk. Further, the plaintiffs allege that Defendants convinced
the FDA that studies revealing that Actos increased the risk
of bladder cancer were wrong. Defendants are alleged to
have actively misled prescribing physicians, consumers, and
third-party payors into believing that Actos did not increase
a personâs risk of developing bladder cancer. Defendants did
6 PAT DIST. COUNCIL 82 V. TAKEDA PHARM.
all of this, the plaintiffs allege, simply to increase their
profits from the sale of Actos.
On September 17, 2010, after further studies of Actos
revealed an increased risk of bladder cancer, the FDA
announced that it was conducting a safety review of Actos.
On June 15, 2011, the FDA released an official warning to
the public that Actos may be linked to bladder cancer in
patients who use it over prolonged periods of time.
Following the FDAâs official warning, Defendants changed
Actosâs warning label to warn of a bladder cancer risk. The
sales of Actos are alleged to have dropped shortly after the
FDA issued its alert in 2010, and then again when the FDA
issued its official warning in 2011, by a total of
approximately 80%.
A group of patients who developed bladder cancer after
ingesting Actos and their family members then brought
personal injury and wrongful death claims against
Defendants in the Western District of Louisiana. After a
37-day trial in 2014, the jury returned a verdict in favor of
the plaintiffs, but the parties later agreed to a global
settlement program for all eligible personal injury claimants
who used Actos before December 1, 2011 and had been
diagnosed with bladder cancer. In re Actos (Pioglitazone)
Prods. Liab. Litig., MDL No. 6:11-MD-2299, 274 F. Supp.
3d 485, 503 (W.D. La. 2017). 1
The present action was also originally filed in the
Western District of Louisiana. But in late 2017, the parties
stipulated to transfer the case to the Central District of
California. The plaintiffs in this case comprise five
1
No argument has yet been made in this action that the settlement
encompassed the plaintiffsâ RICO claims or mooted them.
PAT DIST. COUNCIL 82 V. TAKEDA PHARM. 7
individual patients from different states (collectively,
âPatientsâ) and Painters and Allied Trades District Council
82 Health Care Fund (âPainters Fundâ) (together,
âPlaintiffsâ).
Painters Fund is a third-party payor (âTPPâ) of health
and welfare benefits to covered members and their families.
As a TPP, Painters Fund reimburses its membersâ claims for
drugs, including Actos, submitted by pharmacies and
healthcare providers covered by its plan. Painters Fund
ârelies on each member to submit claims for prescription
medications that are medically reasonable and necessary for
treatment,â with the expectation that patients and their
prescribing physicians will âmake informed decisions about
which drugs will be prescribed and, in turn, submitted to
[Painters Fund] for reimbursement.â Painters Fund âhas the
authority to determine which drugs are covered under its
plan, although, [it] entrusts the administration of claims and
formulary determinations to Prime Therapeutics, LLC,
based in Eagan, Minnesota.â 2
Patients are individuals with type 2 diabetes who were
prescribed Actos by their physicians and who took Actos to
help lower their blood sugar. Each patient paid an out-of-
pocket sum for Actos. Patients each allege that neither they
nor their physicians knew about Actosâs risk of bladder
cancer when they began taking the drug and that they
immediately stopped taking Actos once they learned that it
increased their risk of developing bladder cancer. Patients
also allege that they never would have purchased Actos had
they known that it increased their risk of developing bladder
cancer, and thus, that they never would have submitted
2
Prime Therapeutics, LLC is not a party to this litigation and is not
discussed elsewhere in the complaint.
8 PAT DIST. COUNCIL 82 V. TAKEDA PHARM.
claims for reimbursement for purchases of Actos to their
respective TPPs. Only one patient, Annie Snyder from
California, alleges that prior to starting her prescription, she
read and relied upon the Actos label. But Plaintiffs generally
allege that Patients relied on Defendantsâ misrepresentations
about Actos, by act or omission, in purchasing the drug, that
physicians relied on such misrepresentations in prescribing
Actos for their patients, and that TPPs relied on such
misrepresentations in agreeing to pay for Actos prescriptions
for their members.
Plaintiffs seek to represent a class of similarly situated
patients and TPPs âwho paid or incurred costs for the drug
Actos, for purposes other than resale, between 1999, i.e.,
when the drug was approved, and the present,â excluding
âthose consumers who are presently seeking a personal
injury claim arising out of their use of Actos.â Plaintiffs
argue that Defendants conspired to commit mail and wire
fraud under 18 U.S.C. §§ 1341, 1343 by intentionally
misleading physicians, consumers, and TPPs to believe that
Actos did not increase a personâs risk of developing bladder
cancer. Plaintiffs seek to recover economic damages under
RICO for the payments they made to purchase Actos under
the assumption that it was a safe drug, which they allege they
would not have purchased had they known that Actos
increases a personâs risk of developing bladder cancer (this
is called the âquantity effect theoryâ of damages). 3 Plaintiffs
3
Plaintiffs originally alleged a second damages theoryâthat they
overpaid for Actos prescriptions because Defendants inflated the price
of Actos under the guise that Actos did not increase a personâs risk of
developing bladder cancerâcalled the âexcess price theory.â But
Plaintiffs have abandoned their excess price theory for damages on
appeal.
PAT DIST. COUNCIL 82 V. TAKEDA PHARM. 9
do not, however, seek to recover economic or non-economic
damages caused by any personâs actual ingestion of Actos.
The district court dismissed with prejudice Plaintiffsâ
RICO claims under Federal Rule of Civil Procedure 12(b)(6)
in a single paragraph, holding that Plaintiffs failed
adequately to allege facts sufficient to establish that
Defendantsâ acts and omissions were the proximate cause of
their claimed damages. This appeal followed. 4
II. ANALYSIS
A. Standard of Review
We review de novo the district courtâs grant of a Rule
12(b)(6) motion to dismiss. Bain v. Cal. Teachers Assân,
891 F.3d 1206, 1211(9th Cir. 2018). We take all of Plaintiffsâ factual allegations as true, and we may affirm the dismissal âonly if it appears beyond doubt that [Plaintiffs] can prove no set of facts in support of [their] claim[s] which would entitle [them] to relief.âId.
(internal quotation marks
omitted).
B. Plaintiffsâ RICO Claims
The crux of Plaintiffsâ complaint rests on their civil
RICO claims. Although the RICO statute was originally
enacted to combat organized crime, âit has become a tool for
4
Plaintiffs also brought claims under state consumer protection laws
of California, Florida, Massachusetts, Minnesota, Missouri, and New
Jersey. In a separate order, the district court dismissed all of Plaintiffsâ
state law claims. With the exception of their Massachusetts claim,
Plaintiffs also appeal the dismissal of their state law claims. We address
those claims in a concurrently filed memorandum disposition.
10 PAT DIST. COUNCIL 82 V. TAKEDA PHARM.
everyday fraud cases brought against respected and
legitimate enterprises.â Sedima, S.P.R.L. v. Imrex Co.,
473 U.S. 479, 499(1985) (internal quotation marks omitted). Broadly speaking, there are two parts to a civil RICO claim. The civil RICO violation is defined under18 U.S.C. § 1962
, 5 while âRICO standingâ is defined under18 U.S.C. § 1964
(c). The district court dismissed Plaintiffsâ
RICO claims only for lack of standing, and thus we address
only that portion of Plaintiffsâ RICO claims.
To allege civil RICO standing under 18 U.S.C.
§ 1964(c), a âplaintiff must show: (1) that his alleged harm qualifies as injury to his business or property; and (2) that his harm was âby reason ofâ the RICO violation.â Canyon County v. Syngenta Seeds, Inc.,519 F.3d 969, 972
(9th Cir.
2008). Defendants do not dispute that Plaintiffs have alleged
an injury to their business or property. Rather, as the district
court held, Defendants argue that Plaintiffs have failed to
allege that their harm was âby reason ofâ the alleged RICO
violation because they have failed to allege the claimed
RICO violation was the proximate cause of their claimed
losses.
1. Supreme Court Precedent
The Supreme Court has interpreted the phrase âby reason
ofâ in 18 U.S.C. § 1964(c) to require, as elements for a civil
RICO recovery, both proximate and but-for causation. 6
5
To recover for a civil RICO violation, âa plaintiff must prove that
the defendant engaged in (1) conduct (2) of an enterprise (3) through a
pattern (4) of racketeering activity.â Chaset v. Fleer/Skybox Intâl, LP,
300 F.3d 1083, 1086 (9th Cir. 2002) (citing18 U.S.C. § 1962
).
6
Defendants do not argue in this appeal that Plaintiffsâ allegations
fail to allege but-for causation.
PAT DIST. COUNCIL 82 V. TAKEDA PHARM. 11
Holmes v. Sec. Invâr Prot. Corp., 503 U.S. 258, 268(1992). The requirement of proximate cause seeks to âlimit a personâs responsibility for the consequences of that personâs own acts.âId.
Put another way, âthe proximate-cause requirement generally bars suits for alleged harm that is âtoo remoteâ from the defendantâs unlawful conduct.â Lexmark Intâl, Inc. v. Static Control Components, Inc.,572 U.S. 118, 133
(2014). Thus, it âdemand[s] . . . some direct relation between the injury asserted and the injurious conduct alleged.â Holmes,503 U.S. at 268
.
This âdirect relationâ requirement is based upon three
practical factors, stated in Holmes:
First, the less direct an injury is, the more
difficult it becomes to ascertain the amount
of a plaintiffâs damages attributable to the
violation, as distinct from other, independent,
factors. Second, quite apart from problems
of proving factual causation, recognizing
claims of the indirectly injured 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, finally, 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, without any of
the problems attendant upon suits by
plaintiffs injured more remotely.
12 PAT DIST. COUNCIL 82 V. TAKEDA PHARM.
Id. at 269â70 (internal citations omitted). The Supreme
Court has applied the Holmes factors, along with its direct
relation requirement, in each of its decisions addressing
proximate cause for civil RICO claims.
In Anza v. Ideal Steel Supply Corp., the plaintiffâa steel
mill product retailer in New York Cityâalleged that one of
its retail competitors caused it economic harm by failing to
charge customers applicable New York state sales taxes,
thereby defrauding the New York state tax authority.
547 U.S. 451, 457â58 (2006). This conduct, the plaintiff alleged, allowed the defendant to offer lower prices and attract more customers, which in turn caused the plaintiff to lose customers and profit.Id.
The district court dismissed the plaintiffâs complaint under Rule 12(b)(6) for failure to plead proximate cause, but the Second Circuit vacated the district courtâs judgment, holding that the plaintiff had adequately pleaded that the defendant proximately caused its damages.Id. at 455
. The Supreme Court then reversed the Second Circuitâs judgment and held that the plaintiff failed to satisfy the requirement to allege proximate cause under RICO because the âdirect victim of this conduct was the State of New York, not [the plaintiff].âId. at 458
. Indeed, â[i]t was the State that was being defrauded and the State that lost tax revenue as a result.âId.
Although the plaintiff alleged that it suffered its own harms by losing customers and profits through the defendantâs failure to tax its customers, the plaintiffâs asserted harms were âentirely distinct from the alleged RICO violation (defrauding the state),â and thus the plaintiffâs allegations failed the Supreme Courtâs direct relation requirement for the element of proximate cause.Id.
Likewise, in Hemi Group, LLC v. City of New York, the
Supreme Court reversed the Second Circuitâs holding that
PAT DIST. COUNCIL 82 V. TAKEDA PHARM. 13
the plaintiffs had sufficiently alleged damages proximately
caused by the defendantsâ actions under RICO to survive
dismissal under Rule 12(b)(6). 559 U.S. 1, 4â5 (2010). There, the City of New York (the âCityâ), which imposed a $1.50-per-pack tax on each pack of cigarettes possessed within New York City for sale or use, sued a New Mexico retailer that sold cigarettes online to residents in New York City.Id.
at 4â6. The City alleged that the New Mexico retailer failed to comply with a federal law requiring out-of- state vendors to submit customer information to the states into which it ships cigarettes.Id. at 4
. That failure, the City argued, not only made it more difficult for the City to track down people who possessed cigarettes in New York City purchased elsewhere, but also constituted mail and wire fraud under RICO, which caused the City to lose millions of dollars in uncollected per-pack cigarette taxes.Id.
The Supreme Court disagreed. It held that the New
Mexico retailerâs failure to submit customer information to
the State of New York was too attenuated from the Cityâs
loss of cigarette possession tax proceeds to satisfy the
proximate cause allegation requirement. See id. at 11. The Supreme Court explained that the conduct constituting the alleged fraud was the New Mexico retailerâs failure to submit customer information to the State of New York, but âthe conduct directly responsible for the Cityâs harm was the customersâ failure to pay their taxes.âId.
Thus, âthe conduct directly causing the harm was distinct from the conduct giving rise to the fraud,â and therefore the City failed to satisfy the Supreme Courtâs direct relation requirement.Id.
In contrast, in Bridge v. Phoenix Bond & Indemnity Co.,
the Supreme Court affirmed the Seventh Circuitâs reversal
of the district courtâs order dismissing the plaintiffsâ
14 PAT DIST. COUNCIL 82 V. TAKEDA PHARM.
complaint for failure sufficiently to allege the proximate
cause element under RICO. 553 U.S. 639, 645, 661(2008). The plaintiffs were bidders at a county tax lien auction.Id. at 643
. To ensure fair distribution of tax liens during the auctions, the county enacted a âSingle, Simultaneous Bidder Rule,â requiring each âtax [lien] buying entityâ to bid in its own name and not to use agents or employees to submit simultaneous bids on its behalf.Id.
The plaintiffs alleged that the defendants violated that rule by using agents to submit simultaneous bids on the defendantsâ behalf and directing those agents to file false attestations that they had complied with the countyâs rules.Id.
at 643â44. The plaintiffs alleged that this deceptive practice resulted in the defendants receiving a disproportionately higher share of tax liens at the county auction.Id.
The plaintiffs further alleged that as a result of this deceptive practice, they were deprived of their ability to obtain their fair share of tax liens at the county auction.Id. at 644
.
The defendants countered that the plaintiffsâ alleged
harm was too speculative to satisfy RICOâs proximate cause
requirement because the defendants misrepresented
information to the county, not the plaintiffs. Id. at 648. But a unanimous Supreme Court rejected this argument, noting that proximate cause is âa flexible concept that does not lend itself to a black-letter rule that will dictate the result in every case.âId. at 654
(internal quotations omitted). Applying its direct relation requirement, the Supreme Court held that the plaintiffsâ âalleged injuryâthe loss of valuable liensâis the direct result of [the defendantsâ] fraud. It was a foreseeable and natural consequence of [the defendantsâ] scheme to obtain more liens for themselves that other bidders would obtain fewer liens.âId. at 658
. And unlike in Anza and Hemi
Group, where other parties suffered more direct injuries than
the plaintiffs, in Bridge, the countyâwhich sold the tax liens
PAT DIST. COUNCIL 82 V. TAKEDA PHARM. 15
at prices not dependent on who was the buyerâwas not
injured. Id.Rather, the plaintiffs were the immediate victims of the defendantsâ fraud and were best situated to sue the defendants.Id.
Thus, the Supreme Court held that the plaintiffs had sufficiently alleged proximate cause under RICO.Id. at 661
.
Under the Supreme Courtâs Bridge precedent alone, we
think Plaintiffsâ allegations satisfy the Supreme Courtâs
direct relation requirement. Here, the alleged violation is
that Defendants actively concealed Actosâs risk of causing
bladder cancer to sell more Actos to unsuspecting persons,
thereby increasing Actosâs revenue. And Plaintiffsâ alleged
injury is that they purchased Actos prescriptions for which
they would not have paid had they been warned about
Actosâs risk of bladder cancer. Because Plaintiffs were
immediate victims of Defendantsâ alleged fraudulent
scheme to conceal Actosâs risk of bladder cancer, the alleged
RICO violation (conspiracy to commit mail and wire fraud
violative of 18 U.S.C. §§ 1341, 1343) has a direct relation to
Plaintiffsâ alleged harm.
The Holmes factors also weigh in favor of permitting
Plaintiffsâ RICO claims to proceed. The first Holmes factor
tasks us with determining whether it would be too difficult
to ascertain what damages are attributable to Defendantsâ
alleged RICO violation, as opposed to factors other than, and
independent of, Defendantsâ alleged misrepresentations.
503 U.S. at 269. While âit is often easier to ascertain the damages that flow from actual, affirmative conduct, than to speculate what damages arose from a partyâs failure to act,â Oregon Laborers-Employers Health & Welfare Trust Fund v. Philip Morris Inc.,185 F.3d 957, 965
(9th Cir. 1999)
(internal quotation marks omitted), we are not persuaded that
it is so difficult here that Plaintiffs should be denied the
16 PAT DIST. COUNCIL 82 V. TAKEDA PHARM.
opportunity to prove their damages. 7 We leave it to the
district court on remand to assess Plaintiffsâ damages, if the
litigation proceeds to that phase.
Second, we consider the risk of multiple recoveries by
plaintiffs at different levels of injury from the defendantsâ
acts. Holmes, 503 U.S. at 269. Here, like in Bridge, and unlike in Anza and Hemi Group, there is no concern of âduplicative recoveries by plaintiffs removed at different levels of injury from the violation.â Bridge,553 U.S. at 658
.
It is each individual plaintiff who paid out money for Actos
prescriptions who now seeks recovery of those payments.
As we read Plaintiffsâ complaint, the damages suffered by
Patients and Painters Fund do not overlap, as it appears that
Patients seek to recover only the dollars they paid for Actos
out-of-pocket, for which they have not been reimbursed by
a TPP. 8 Further, Plaintiffsâ putative class expressly excludes
individuals who are pursuing personal injury claims, so there
7
We note that Defendantsâ argument that had Plaintiffs not taken
Actos, they would have paid for an alternative drug to treat their type 2
diabetes, has not fallen on deaf ears. It seems quite logical that Plaintiffs
would have paid for a different drug to treat patientsâ diabetes had they
known that Actos increases a personâs risk of developing bladder cancer.
But at this stage in the proceedings, we take Plaintiffsâ allegations that
they would not have bought or paid for Actos as true. Bain, 891 F.3d
at 1211. Plaintiffs do not allege that they would have paid for an
alternative diabetes drug had they known Actos carries an increased risk
of causing bladder cancer. Further, if what Defendants argue proves
true, Plaintiffs may still be entitled to damages if the alternative drugs
they would have paid for cost less than Actos. Plaintiffs have alleged
there are at least three less expensive alternatives to Actos, and discovery
may prove Plaintiffs were likely to have bought these alternatives. In
any event, this is a damages question for another day.
8
Of course, on remand, if discovery reveals that Patientsâ claimed
damages overlap with damages claimed by Painters Fund or another
TPP, Plaintiffs should not recover any overlapping damages.
PAT DIST. COUNCIL 82 V. TAKEDA PHARM. 17
is no risk that some plaintiffs will receive overlapping
economic and personal injury damages.
Finally, under the third Holmes factor, we consider
whether holding Defendants liable in this case justifies the
general interest of deterring injurious conduct or whether
there are more directly injured victims we can count on to
hold Defendants liable. 503 U.S. at 269â70. Here, patients
and TPPs who paid money for Actos are the most direct
victims of those who suffered economic injury. Although
people who ingested Actos and developed bladder cancer
suffered an additional and greater harm than others who paid
for Actos but did not develop bladder cancer, this does not
change the fact that all patients and TPPs who paid for Actos
on the premise that it did not cause an increased risk of
bladder cancer were allegedly defrauded by Defendants and
suffered the same direct economic injury: payments for a
drug which would not have been purchased if suitably
described. Additionally, others may have been affected by
Defendantsâ alleged fraud. For instance, prescribing
physicians who prescribed Actos for their patients may have
watched their patients develop bladder cancer. But as far as
we can tell from Plaintiffsâ complaint, prescribing
physicians did not suffer an economic injury. Thus, holding
Defendants liable for Plaintiffsâ alleged injuries advances
the interest in deterring injurious conduct, without including
others who did not suffer direct out-of-pocket losses.
2. Circuit Court Precedent
While our court has recognized the Supreme Courtâs
direct relation requirement and Holmes factors for RICO
proximate cause in several cases, see, e.g., Harmoni
International Spice, Inc. v. Hume, 914 F.3d 648(9th Cir. 2019); Canyon County,519 F.3d at 972
; Oregon Laborers,
18 PAT DIST. COUNCIL 82 V. TAKEDA PHARM.
185 F.3d at 963â66, 9 we have never applied it to the situation
at issue hereâwhether patients and TPPs suing
9
Oregon Laborers, the case most closely related to the present
action in this circuit to date, is distinguishable. There, six employee
health and welfare benefit plans sued tobacco companies and public
relations companies under federal RICO and other antitrust and state
laws. 185 F.3d at 961. The plaintiffs alleged that the defendants conspired to persuade the public that scientific studies linking smoking to health risks were not accurate and that the connection between smoking and disease was merely an âopen controversy.âId.
The plaintiffs alleged that this wrongful conduct âresulted in more smoking, less quitting, and smoking of more hazardous cigarettesâ among their plan participants, which then resulted in more disease among their plan participants who smoked.Id. at 962
. In turn, the plaintiffs alleged, they suffered higher expenditures to cover their plan participantsâ medical bills.Id.
The district court held that the plaintiffs failed to state a RICO claim
for relief under Rule 12(b)(6), and we affirmed. Id. at 961. We held that the plaintiffsâ alleged injury was âindirectâ and too remote to satisfy RICOâs proximate cause requirement.Id. at 963
. We explained that âall of [the] plaintiffsâ claims rely on alleged injury to smokersâwithout any injury to smokers, [the] plaintiffs would not have incurred the additional expenses in paying for the medical expenses of those smokers.âId.
(second emphasis added). Instead of the plaintiffs, we reasoned, the smokers were the direct victims of the defendantâs alleged wrongful conduct.Id. at 964
. Thus, under the Supreme Courtâs direct relation requirement, we held that the alleged RICO violation was distinct from the plaintiffsâ alleged injury. Seeid.
at 963â64. Therefore, the plaintiffs failed to allege that their damages were proximately caused by the defendantsâ actions. Seeid. at 966
.
Plaintiffsâ alleged injury in this case is distinct from the plaintiffsâ
alleged injury in Oregon Laborers. There, the chain of causation from
the defendantâs alleged misrepresentation to the plaintiffsâ alleged injury
depended upon an independent link that required the smokers to develop
illnesses that necessitated medical treatment, for which the plaintiffs then
paid. But here, Plaintiffsâ alleged injury is directly related to
Defendantsâ alleged misrepresentations, as they allege that they paid
PAT DIST. COUNCIL 82 V. TAKEDA PHARM. 19
pharmaceutical companies for concealing an allegedly
known safety risk about a drug can satisfy RICOâs proximate
cause requirement. 10 But several of our sister circuits have
money out-of-pocket for Actos, which they otherwise would not have
paid had Defendants not fraudulently omitted Actosâs risk of causing
bladder cancer. Whether Plaintiffs developed bladder cancer is
irrelevant to their claims. Thus, Oregon Laborers is distinguishable and
does not control here.
10
The Seventh Circuit once commented that the Ninth Circuit
âdeem[s] this [issue] so straightforward that [it] ha[s] issued
nonprecedential decisionsâ about it. Sidney Hillman Health Ctr. v.
Abbott Labs., 873 F.3d 574, 578(7th Cir. 2017). Not quite. Rather, in In re Actimmune Marketing Litigation, we summarily affirmed the district courtâs dismissal without prejudice of the plaintiffsâ RICO claims where the district court held in part that the plaintiffsâ complaint failed sufficiently to plead proximate cause for their civil RICO claim for lack of specificity under Federal Rule of Civil Procedure 8(a).464 F. Appâx 651
(9th Cir. 2011) (citing In re Actimmune Mktg. Litig.,614 F. Supp. 2d 1037
, 1050â51 (N.D. Cal. 2009)). When the plaintiffs filed their amended complaint, they abandoned their RICO claims. See In re Actimmune Mktg. Litig., No. C 08-02376 MHP,2009 WL 3740648
, at *1
(N.D. Cal. Nov. 6, 2009). Our summary affirmance of the district courtâs
decision to dismiss the plaintiffsâ RICO claims without prejudice can
hardly be considered a decision on the merits of the issue that we deemed
âso straightforwardâ as to issue a non-binding decision.
In United Food & Commercial Workers Central Pennsylvania &
Regional Health & Welfare Fund v. Amgen, Inc., the plaintiffs sued
Amgen, Inc. for concealing adverse test results about a drugâs off-label
uses. 400 F. Appâx 255, 257(9th Cir. 2010). We held that the plaintiffsâ complaint failed to identify false statements or material omissions that Amgen made about the drugâs safety.Id.
Further, we held that the
plaintiffs failed to plead a cognizable theory of proximate cause for their
civil RICO claim because the complaint âproffered an attenuated causal
chain that involved at least four independent linksââ(1) the United
States Pharmacopeia-Drug Information (âUSP-DIâ)âs listing of the drug
to be used for a certain off-label use; (2) Medicareâs decision to cover
the drug for that off-label use; (3) third-party payorsâ decision to cover
20 PAT DIST. COUNCIL 82 V. TAKEDA PHARM.
addressed this question in similar factual scenarios and have
reached different results, creating an apparent inter-circuit
split. We look to their reasoning for guidance.
a. Seventh Circuit
In Sidney Hillman Health Center v. Abbott Laboratories,
two TPPs who had paid to cover their patientsâ off-label 11
uses of a prescription drug named Depakote sued the drug
manufacturer under RICO for concealing its role in
promoting Depakoteâs off-label uses to intermediaries, such
as prescribing physicians. 873 F.3d 574, 575(7th Cir. 2017). In relevant part, the district court dismissed the TPPsâ complaint for failure to allege that their damages were proximately caused by the drug manufacturerâs concealed off-label promotion, and the Seventh Circuit affirmed.Id. at 575, 578
.
The Seventh Circuit first noted that, in some cases, an
injury to one person caused by wrongs against another can
satisfy RICOâs proximate cause requirement, as the Supreme
Court held in Bridge, 553 U.S. at 661.873 F.3d at 576
. However, the Seventh Circuit held that the TPPs in Sidney Hillman were too far removed from the alleged RICO the drug for the off-label use; and (4) doctorsâ decisions to prescribe the drug for the off-label use.Id.
But we never independently addressed
whether patients and TPPs can meet RICOâs proximate cause
requirement under the Supreme Courtâs direct relation requirement and
Holmes factors to hold pharmaceutical companies liable for mail and
wire fraud. Further, our present case does not require as many causal
links. And of course, because unpublished dispositions from our circuit
are not precedential, see Ninth Circuit Rule 36-3(a), we are free to decide
this issue in the first instance.
11
âOff-labelâ refers to using a drug to treat conditions other than
those it was originally developed to treat.
PAT DIST. COUNCIL 82 V. TAKEDA PHARM. 21
violation to satisfy the proximate cause requirement. Id.The Seventh Circuit opined that while TPPs âpart with money . . . it is not at all clear that they are the initially injured parties, let alone the sole injured parties.âId.
The Seventh Circuit explained that patients may be the most directly injured parties, as they incurred financial loss (if they paid a copayment to receive Depakote) and personal injury damages if they suffered harmful effects from using Depakote for an unsafe off-label use.Id.
Moreover, the Seventh Circuit noted, the âpatientsâ health and financial costs come first in line temporally; that pharmacies then send bills to [TPPs], which cover the remainder of the expense, does not make those [TPPs] the initial losersâ from the drug manufacturerâs unlawful promotion scheme.Id.
The Seventh Circuit opined that prescribing physicians may also suffer loss, though indirectly, because â[i]f a physician prescribes an ineffective medicine and so does not provide [patients] help, patients may turn elsewhere.âId.
The Seventh Circuit next explained that physicians make
independent decisions when prescribing patients medicine,
and it would be difficult to disentangle which physiciansâ
decisions, if any, were influenced by the drug
manufacturerâs unlawful promotions. Id.at 577â78. That, and other factors, such as the fact that some patients may have benefited from using Depakote for an off-label use, convinced the Seventh Circuit that it would be too difficult to calculate the plaintiffsâ alleged damages.Id.
Thus, the Seventh Circuit held that the TPPsââseveral levels removed in the causal sequenceâ from the drug manufacturerâs actionsâcould not satisfy RICOâs proximate cause requirement.Id.
at 576â78.
22 PAT DIST. COUNCIL 82 V. TAKEDA PHARM.
b. Second Circuit
Similarly, in UFCW Local 1776 v. Eli Lilly & Co., TPPs
and individual patients brought a putative class action for
civil RICO fraud against the manufacturer of the drug
Zyprexa, alleging that the manufacturer misrepresented
Zyprexaâs side effects and effectiveness to physicians and
promoted Zyprexa for off-label uses when there was no
evidence that Zyprexa was effective for off-label uses.
620 F.3d 121, 123, 129(2d Cir. 2010). The plaintiffs alleged two damages theories: (1) the âexcess price theoryââthat they overpaid for Zyprexa prescriptions because the manufacturer relied on its misrepresentations to charge higher prices; and (2) the âquantity effect theoryââthat they paid for Zyprexa prescriptions âthat would not have been issued but for the alleged misrepresentations.âId.
The district court certified a class of TPPs based upon their excess price theory for damages, but the Second Circuit reversed.Id. at 123, 137
.
As to the proximate cause requirement under RICO, the
Second Circuit held that the plaintiffsâ injuries under both of
their damages theories were too attenuated, as they ârest[] on
the independent actions of third and even fourth parties.â Id.at 134 (quoting Hemi Group,559 U.S. at 15
). The Second Circuit was not persuaded by the plaintiffsâ argument that âthe ultimate source for the information on which doctors based their prescribing decisions was [the manufacturer] and its consistent, pervasive marketing plan,â because the manufacturer was ânot . . . the only source of information on which doctors based prescribing decisions.âId. at 135
(emphasis in original). Rather, â[a]n individual patientâs
diagnosis, past and current medications being taken by the
patient, the physicianâs own experience with prescribing
Zyprexa, and the physicianâs knowledge regarding the side
PAT DIST. COUNCIL 82 V. TAKEDA PHARM. 23
effects of Zyprexa are all considerations that would have
been taken into account in addition to the alleged
misrepresentations distributed by [the manufacturer].â Id.Accordingly, the Second Circuit held that the plaintiffs failed to allege that their damages were proximately caused by the drug manufacturerâs wrongful conduct and reversed the district courtâs certification order. 12Id. at 134, 136
; see also Sergeants Benevolent Assân Health & Welfare Fund v. Sanofi-Aventis U.S. LLP,806 F.3d 71
, 90â91 (2d Cir. 2015) (holding that the plaintiffâs RICO claims were foreclosed by UFCW Local 1776,620 F.3d at 121
).
c. First Circuit
To the contrary, in In re Neurontin Marketing & Sales
Practices Litigation, a jury awarded Kaiser Foundation
Health Plan (âKaiserâ), a TPP, damages for the injury it
suffered in paying for off-label Neurontin prescriptions that
were induced by Pfizerâs (the drug manufacturer) fraudulent
scheme to misrepresent Neurontinâs effectiveness for off-
label conditions. 712 F.3d 21, 25â26 (1st Cir. 2013). The district court had found that Kaiser relied on Pfizerâs fraudulent marketing campaign in deciding to include Neurontin in its formularyâa list of medications its treating physicians were authorized to prescribe.Id.
at 28â29. The district court subsequently denied Pfizerâs motion for a new trial, and Pfizer appealed.Id. at 27
.
12
The Second Circuit remanded, however, for the district court to
consider individual claims based upon the plaintiffsâ quantity effect
damages theory. UFCW Local 1776, 620 F.3d at 136. The Second Circuit noted that âwhile that theory cannot support class certification, it is not clear that the theory is not viable with respect to individual claims by some TPPs or other [individual] purchasers.âId.
24 PAT DIST. COUNCIL 82 V. TAKEDA PHARM.
Pfizer argued that Kaiser could not satisfy RICOâs
proximate cause requirement as a matter of law. Id. at 34.
But the First Circuit disagreed, holding that âKaiser has met
both the direct relationship and functional tests articulated in
Holmes and its progeny.â Id. at 38. Unlike the Second and
Seventh Circuits, the First Circuit rejected the argument that
there were âtoo many steps in the causal chain between
[Pfizerâs] misrepresentations and Kaiserâs alleged injuryâ to
meet the âdirect relationâ requirement. Id. Rather, the First
Circuit held that âthe causal chain in this case is anything but
attenuated,â because Pfizer âhas always known that, because
of the structure of the American health care system,
physicians would not be the ones paying for the drugs they
prescribed.â Id. at 38â39. Pfizerâs fraudulent marketing
scheme, which was meant to increase its sales and profits,
âonly became successful once Pfizer received payments for
the additional Neurontin prescriptions it induced.â Id. at 39.
Those payments came from TPPs, including Kaiser. Id.
The First Circuit also rejected Pfizerâs argument that
âbecause doctors exercise independent medical judgment in
making decisions about prescriptions, the actions of these
doctors are independent intervening causesâ that cut off the
chain of causation. Id. The First Circuit explained that
âPfizerâs scheme relied on the expectation that physicians
would base their prescribing decisions in part on Pfizerâs
fraudulent marketing.â Id. âThe fact that some physicians
may have considered factors other than Pfizerâs detailing
materials in making their prescribing decisions does not add
such attenuation to the causal chain as to eliminate
proximate causeâ; rather, â[t]his is a damages questionâ
about the âtotal number of prescriptions that were
attributable to Pfizerâs actions.â Id. Finally, the First Circuit
noted that â[h]olding Pfizer liable will have an effect in
deterring wrongful conduct,â and thus it held that Kaiser had
PAT DIST. COUNCIL 82 V. TAKEDA PHARM. 25
satisfied the proximate cause requirement under RICO. Id.
at 39â40.
d. Third Circuit
Similarly, in In re Avandia Marketing, Sales Practices &
Product Liability Litigation, the Third Circuit held that the
TPP plaintiffs sufficiently alleged proximate cause for their
civil RICO claims. 804 F.3d 633, 634(3d Cir. 2015). There, TPPs filed a putative class action against the defendant alleging under RICO that the defendant misrepresented significant heart-related safety risks associated with the drug Avandia.Id.
at 634â36. The plaintiffs alleged that they included Avandia in their formularies and covered it at favorable rates for their members in reliance on the defendantâs misrepresentations about Avandiaâs safety.Id. at 636
. The plaintiffs also alleged that physicians relied on the defendantâs misrepresentations in deciding to prescribe Avandia and that they would have prescribed it to fewer patients if the defendant had not concealed its safety risks.Id.
The district court held that the plaintiffs adequately alleged that the defendant proximately caused their damages but certified its decision for interlocutory appeal.Id. at 637
.
The Third Circuit affirmed. Applying the Supreme
Courtâs direct relation requirement, the Third Circuit held
that â[t]he conduct that allegedly caused [the] plaintiffsâ
injuries is the same conduct forming the basis of the RICO
scheme alleged in the complaintâthe misrepresentation of
the heart-related risks of taking Avandia that caused TPPs
. . . to place Avandia in the formulary.â Id. at 644. Next, looking to the Holmes factors, the Third Circuit noted that it would not be too difficult to distinguish between the damages attributable to the defendantâs alleged violation from other independent factors, and that at the pleadings stage, the question of damages was âa question for another 26 PAT DIST. COUNCIL 82 V. TAKEDA PHARM. day.âId.
Further, the Third Circuit observed that the plaintiffs were best situated to sue, as the plaintiffsâ alleged injury âis an economic injury independent of any physical injury suffered by Avandia users,â and âprescribing physicians did not suffer RICO injury from [the defendantâs] marketing of Avandia.âId.
The Third Circuit, like the First Circuit, rejected the
defendantâs argument that âthe presence of intermediaries,
doctors and patients, destroys proximate cause because they
were the ones who ultimately decided whether to rely on [the
defendantâs] misrepresentations.â Id. at 645. The Third Circuit explained that âdrug manufacturers are well aware that TPPs cover the cost of their drugsâ and the defendantâs âfraudulent scheme could have been successful only if [the] plaintiffs paid for Avandia, [which] is the very injury that [the] plaintiffs seek recovery for.âId.
Thus, the plaintiffsâ alleged injury had a direct relation to the alleged RICO violation.Id.
Therefore, the Third Circuit affirmed the district courtâs holding that the plaintiffs adequately alleged RICO proximate cause at the pleadings stage.Id.
at 645â46.
e. Circuit Court Precedent Analysis
Although each of these four circuit court opinions arises
under similar factual scenarios, factual and procedural
distinctions exist between them. For example, the Third and
Seventh Circuitsâ opinions confronted the issue whether the
plaintiffs could satisfy the proximate cause requirement
under RICO at the pleadings stage, whereas the Second
Circuit considered the issue at the class certification stage,
and the Third Circuit reviewed the issue post-trial. Further,
while the Second, Third, and Seventh Circuit cases involved
putative class actions, the First Circuitâs opinion involved a
single TPP. But these minor factual and procedural
differences do not help us resolve the central dispute
PAT DIST. COUNCIL 82 V. TAKEDA PHARM. 27
between the Second and Seventh Circuitsâ reasoning and the
First and Third Circuitsâ reasoning.
Indeed, it seems the central dispute between the Second
and Seventh Circuits and the First and Third Circuits is
whether the decisions of prescribing physicians and
pharmacy benefit managers constitute intervening causes
that sever the chain of proximate cause between the drug
manufacturer and TPP. 13 We think the First and Third
Circuits have it right because their reasoning is more
consistent with the Supreme Courtâs direct relation
requirement.
In this case, although prescribing physicians serve as
intermediaries between Defendantsâ fraudulent omission of
Actosâs risk of causing bladder cancer and Plaintiffsâ
payments for Actos, prescribing physicians do not constitute
an intervening cause to cut off the chain of proximate cause.
An intervening cause is âa later cause of independent origin
that was not foreseeable.â Mendez v. County of Los Angeles,
897 F.3d 1067, 1081(9th Cir. 2018) (quoting Exxon Co. v. Sofec,517 U.S. 830
, 837 (1996)). Here, since Actos was a
13
We note that all four of our sister circuitsâ opinions may support
the claims by individual patients who are plaintiffs in this case, not just
the First and Third Circuitsâ opinions. In Sidney Hillman, in holding that
TPPs are too far removed from the drug manufacturerâs alleged wrongful
conduct to satisfy the RICO proximate cause requirement, the Seventh
Circuit implied that individual patients may be able to satisfy the
proximate cause requirement, as they are the most directly injured party
whose âhealth and financial costs come first in line temporally.â
873 F.3d at 576. And in UFCW Local 1776, although the Second Circuit reversed the district courtâs class certification order because the plaintiffs could not satisfy RICOâs proximate cause requirement as a class, it remanded to the district court to consider in the first instance individual plaintiffsâ claims based upon the quantity effect damages theory.620 F.3d at 136
. 28 PAT DIST. COUNCIL 82 V. TAKEDA PHARM. prescription drug, it was required to be prescribed by physicians. Hence, it was perfectly foreseeable that physicians who prescribed Actos would play a causative role in Defendantsâ alleged fraudulent scheme to increase Actosâs revenues. Further, âbecause of the structure of the American health care system,â Defendants have always known that âphysicians would not be the ones paying for the drugs they prescribed.â Neurontin, 712 F.3d at 38â39. Rather, they are well aware that TPPs and individual patients pay for the drugs. See Avandia,804 F.3d at 645
. Defendantsâ alleged fraudulent marketing scheme, which was intended to increase Actosâs sales, âonly became successful once [they] received payments for the additional [Actos] prescriptions [they] inducedââthe very injury for which Plaintiffs seek recovery. Neurontin,712 F.3d at 39
. This is consistent with the Supreme Courtâs requirement that the proximate cause inquiry focus on the direct relation between the alleged violation and alleged injury. Hemi Group,559 U.S. at 12
.
If we were to hold the oppositeâthat prescribing
physiciansâ and pharmacy benefit managersâ decisions
constitute an intervening cause to sever the chain of
proximate causeâas the Second and Seventh Circuits have
held, drug manufacturers would be insulated from liability
for their fraudulent marketing schemes, as they could
continuously hide behind prescribing physicians and
pharmacy benefit managers. That is not the purpose the
requirement of proximate cause is intended to serve.
Proximate cause exists to âlimit a personâs responsibility for
the consequences of that personâs own acts.â Holmes,
503 U.S. at 268. Here, Plaintiffs seek to hold Defendants
liable for the consequences of their own acts and omissions
toward Plaintiffs: the money spent by Plaintiffs to purchase
Actos.
PAT DIST. COUNCIL 82 V. TAKEDA PHARM. 29
There is also a difference between fraudulent promotion
of âoff-labelâ uses for a prescription drug as in Sidney
Hillman, 873 F.3d at 575and UFCW Local 1776,620 F.3d at 127
, and fraudulent failure to warn of a drugâs known risk
of causing bladder cancer, as in this case.
It was recognized in both Sidney Hillman and UFCW
Local 1776 that the drug manufacturerâs fraudulent
promotion of a prescription drug for off-label uses was not
the only basis upon which the prescribing physicians relied
in prescribing the drug. In Sidney Hillman, the Seventh
Circuit noted that it would be too difficult to disentangle
which physiciansâ prescribing decisions, if any, were
influenced by the defendantsâ unlawful promotion of the
prescription drug for off-label uses. 873 F.3d at 577â78.
Similarly, in UFCW Local 1776, the Second Circuit noted
that the drug manufacturerâs unlawful promotion of the
prescription drug for off-label uses was not the only source
of information upon which the prescribing physicians based
their decisions to prescribe the drug. 620 F.3d at 135.
Echoing the first factor of Holmes, the failure to warn of
the bladder cancer risk in this case makes Plaintiffsâ
damages more clearly âattributable to [Defendantsâ]
violation.â 503 U.S. at 269. The damages claimed from off-
label uses in Sidney Hillman and UFCW Local 1776 are less
directly attributable to the alleged false promotions. It is
much more likely that Actosâs risk of causing a disease as
serious as bladder cancer would materially influence
prescribing physiciansâ decisions whether to prescribe
Actos. Plaintiffsâ allegations confirm this theory, as they
allege that a survey conducted by Defendants in 2003
showed that 75% of surveyed physiciansâ interest in a
different oral anti-diabetic drug declined âgreatlyâ once they
learned that it carried a risk of causing bladder cancer.
30 PAT DIST. COUNCIL 82 V. TAKEDA PHARM.
Further, Plaintiffs allege that those survey results are
confirmed by their allegation that sales of Actos decreased
approximately 80% once the FDA issued its official warning
that Actos may be linked to bladder cancer in patients who
use it over a prolonged period of time. Taking those
allegations as true, as we must, the question whether
prescribing physicians would not have been influenced by
Defendantsâ alleged fraudulent omission is less concerning
in this case than it was to the Second and Seventh Circuits.
Moreover, the Seventh Circuitâs distinction that TPPsâ
injuries are too far removed from the drug manufacturerâs
fraudulent scheme to satisfy the RICO proximate cause
requirement because they are not âthe sole injured partiesâ
and because individual patientsâ âhealth and financial costs
come first in line temporallyâ misses the mark. Sidney
Hillman, 873 F.3d at 576. The Supreme Court has never made a distinction about temporal proximity of the plaintiffs to the damages caused to others when evaluating whether a plaintiff has adequately alleged that the defendant proximately caused the plaintiffâs damages under RICO. Additionally, the fact that individual patients and TPPs both suffered economic injuries from a drug manufacturerâs fraudulent scheme does not mean that one group of plaintiffs should be favored to recover over the other, so long as they both suffered the same economic injuries from the drug manufacturerâs same misconduct. Finally, the Seventh Circuitâs comment that prescribing physicians may suffer indirect loss does not attenuate the chain of causation so far as to break it. Seeid.
Even if prescribing physicians suffer
an indirect loss such as reputational harm for prescribing an
ineffective or unsafe drug, they are not out of pocket for the
price of the drug and thus do not suffer the same economic
loss as do individual patients and TPPs. For these reasons,
we agree with the First and Third Circuits that Plaintiffsâ
PAT DIST. COUNCIL 82 V. TAKEDA PHARM. 31
damages are not too far removed from Defendantsâ alleged
omissions and misrepresentations to satisfy RICOâs
proximate cause requirement.
3. Reliance
As a threshold matter, any argument that Patients have
not alleged that they relied on Defendantsâ
misrepresentations and omissions lacks merit. Each patient
alleged that had he âknown that Actos increased the risk of
causing bladder cancer, he would never have purchased and
ingested the drug.â Additionally, Patients alleged that they
ârelied on Defendantsâ . . . misrepresentations of Actosâ[s]
safety in purchasing the drug.â These statements are
sufficient to allege that Patients relied on Defendantsâ
misrepresentations.
Next, the Supreme Court has explained that if there is a
direct relationship between a defendantâs wrongful conduct
and a plaintiffâs alleged injury, a RICO plaintiff who did not
directly rely on the defendantâs omission or
misrepresentation can still satisfy the requirement of
proximate causation of damages. Recall that in Bridge the
defendantsâ misrepresentations that they complied with the
countyâs âSingle, Simultaneous Bidder Ruleâ were made to
the tax lien selling county, not to the plaintiff tax lien buyers.
553 U.S. at 648. But the Supreme Court held that it was sufficient to establish proximate cause between the defendantsâ alleged wrongful conduct and the plaintiffsâ alleged injury that the county had relied on the defendantsâ false attestations. Seeid.
at 658â59. What mattered most in the RICO proximate causation inquiry was whether there was a direct relationship between the alleged RICO violation and the plaintiffsâ alleged injury. Seeid.
And there was. The plaintiffsâ âalleged injuryâthe loss of valuable [tax] liensâ 32 PAT DIST. COUNCIL 82 V. TAKEDA PHARM. [was] the direct result of . . . [the defendantsâ] scheme to obtain more liens for themselves.âId. at 658
.
In so holding, the Supreme Court expressly rejected the
defendantsâ argument that â[direct] reliance is an element of
a civil RICO claim predicated on mail fraud.â 553 U.S.
at 646â49. The Supreme Court explained that the civil
RICO statute has no reliance requirement on its face, and a
person may be injured âby reason ofâ another personâs fraud
even if the injured party did not rely on any
misrepresentation. Id.at 648â49. Nonetheless, the Supreme Court noted that it âmay well be that a RICO plaintiff alleging injury by reason of a pattern of mail fraud must establish at least [indirect] reliance in order to prove causation.â 553 U.S. at 658â59. This is because, logically, a plaintiff cannot even establish but-for causation if no one relied on the defendantâs alleged misrepresentation.Id.
Despite this precedent, Defendants argue that Painters
Fund failed to allege reliance on Defendantsâ omissions of
Actosâs bladder cancer risk, since Painters Fund expressly
alleged that, as a TPP, it ârelies on [its] members and their
prescribers to make informed decisions about which drugs
will be prescribed and, in turn, submitted to Plaintiff Painters
Fund for reimbursement.â This argument is also meritless.
Like in Bridge, where it was sufficient to satisfy RICOâs
proximate cause requirement that the county (a third party)
had relied on the defendantsâ false attestations, here, it is
sufficient to satisfy RICOâs proximate cause requirement
that Painters Fund alleged that prescribing physicians (also
third parties, but not intervening causes) relied on
Defendantsâ misrepresentations and omissions.
Finally, Defendants argue that even if Painterâs Fund has
alleged indirect reliance, its general allegations of indirect
relianceâi.e., that prescribing physicians relied on
PAT DIST. COUNCIL 82 V. TAKEDA PHARM. 33
Defendantsâ misrepresentations and omissions in
prescribing Actos for their patients, which Painters Fund
then reimbursedâare insufficient, because Painters Fund
should have alleged with specificity exactly which
prescribing physicians were misled by Defendantsâ alleged
misrepresentations. Remembering that this case is before us
at the pleadings stage and without the benefit of discovery,
we recognize that it would be difficult for Painters Fund to
determine with specificity exactly which doctors relied on
Defendantsâ alleged misrepresentations. All that is required
of Painters Fund at this stage is to allege that someone in the
chain of causation relied on Defendantsâ alleged
misrepresentations and omissions, which it has done here.
Thus, we hold that Plaintiffs have adequately alleged the
reliance necessary to satisfy RICOâs proximate cause
requirement.
III. CONCLUSION
While we express no opinion on Plaintiffsâ chances of
success in this litigation as it proceeds, we hold that
Plaintiffs have satisfactorily alleged that Defendants
proximately caused their claimed damages at the pleadings
stage. We reverse the district courtâs judgment dismissing
Plaintiffsâ RICO claims under Rule 12(b)(6) for lack of
RICO standing, and we remand to the district court for
further proceedings consistent with this disposition.