“Although factual allegations of a complaint are normally accepted as true on a motion to dismiss . . . that principle does not apply to general allegations that are contradicted ‘by more specific allegations in the Complaint.’”
How later courts described this case
- “Although factual allegations of a complaint are normally accepted as true on a motion to dismiss . . . that principle does not apply to general allegations that are contradicted ‘by more specific allegations in the Complaint.’”
- dismissing claims that showed “no more than [Defendant’s] off-label promotion . . . which does not by itself state a claim for fraud or misrepresentation”
- holding it was “unclear how either Mallinckrodt or Express Scripts communicated any, ‘misrepresentations,’ let alone communications made directly, to either [plaintiff].”
- “[H]igh prices do not in and of themselves constitute 13 Plaintiffs’ allegations that UBC employees were (1) trained by Mallinckrodt to relay the misleading messages about Acthar’s FDA approval for the five-day dose regimen to TPPs and (2
Written by the judges who cited it.
The opinion
IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF PENNSYLVANIA
THE COUNTY OF DAKOTA, CIVIL ACTION
NEBRASKA,
THE SHEET METAL WORKERS
LOCAL NO. 40 HEALTH FUND,
THE HARLEM SCHOOL DISTRICT 122,
4DUBS BBQ, INC., assignee of “DUSTIN’S NO. 24-4276
BAR-B-Q INC.,”
Plaintiffs,
v.
UNITED BIOSOURCE CORPORATION,
now known as “UNITED BIOSOURCE
LLC,” a wholly owned subsidiary of United
Biosource Holdings, Inc.,
EVERNORTH HEALTH, INC., formerly
known as “EXPRESS SCRIPTS
HOLDING COMPANY,”
EXPRESS SCRIPTS, INC.,
PRIORITY HEALTHCARE CORP. and
PRIORITY HEALTHCARE
DISTRIBTION, INC., respectively doing
business as “CURASCRIPT SD,” and
“CURASCRIPT SPECIALTY
DISTRIBUTION SD,”
CURASCRIPT SD and
ACCREDO HEALTH GROUP, INC.,
formerly known as “CURASCRIPT S.P.”
Defendants.
HODGE, J. March 5, 2026
MEMORANDUM
This case concerns an alleged scheme by non-party Mallinckrodt ARD LLC
(“Mallinckrodt”), the manufacturer of the prescription drug H.P. Acthar Gel (“Acthar”), and a
conglomerate of United Biosource Corporation; Evernorth Health, Inc.; Express Scripts, Inc.;
Priority Healthcare Corp. and Priority Healthcare Distribution, Inc.; Curascript SD; and Accredo
Health Group, Inc. (together, “Defendants” or the “Express Scripts Entities”) to remove Acthar
from retail distribution and raise its price by over 100,000%. Plaintiffs, the County of Dakota,
Nebraska (“Dakota County”), the Sheet Metal Workers Local No. 40 Health Fund (“SMW Local
40”), the Harlem School District 122 (“Harlem SD 122”), and Dustin’s Bar-B-Q Inc. (“Dustin’s”)
(together, “Plaintiffs”), are third party payors seeking to recover overpayments for Acthar caused
by Defendants’ alleged scheme to inflate the price of the drug.
Before the Court is Defendants’ Motion to Dismiss the Amended Complaint (ECF No. 23
(the “Motion”)), Plaintiffs’ Response in Opposition (ECF No. 28), and Defendants’ Reply to
Plaintiffs’ Opposition (ECF No. 29). Also before the Court are the Parties’ notices of supplemental
authority in support of their briefing on the Motion (ECF Nos. 30, 31, 32, 35, 37), as well as
Plaintiffs’ Motion to Strike Defendants’ Notice of Supplemental Authority (ECF No. 33),
Defendants’ Response thereto (ECF No. 34), and Plaintiffs’ Reply in further support of their
Motion to Strike (ECF No. 36).
Plaintiffs’ Amended Complaint (ECF No. 8 (“Am. Compl.”)) alleges violations of the
Racketeer Influenced and Corrupt Organizations Act (“RICO”) (Counts 1–2), violations of various
state consumer protection laws (Counts 3–6, 8), negligent misrepresentation (Count 7), aiding and
abetting (Count 8), unjust enrichment (Count 9), violations of state and federal antitrust statutes
(Counts 10–12), and conspiracy to defraud (Count 13), and requests declaratory and injunctive
relief (Count 14). For the reasons that follow, Defendants’ Motion to Dismiss is granted.
I. FACTUAL BACKGROUND1
The following allegations are taken from the Amended Complaint, and the Court accepts,
as it must, all non-conclusory allegations as true for the purposes of the Motion to Dismiss.
i. The Parties2
Mallinckrodt manufactures, markets, distributes, and sells Acthar. (Am. Compl. ¶ 17.)
Acthar is an adrenocorticotropic hormone (“ACTH”), which causes the body to produce cortisone
and other steroid hormones. (Id. ¶ 134.) In July 2001, Questcor Pharmaceuticals, Inc. (“Questcor”)
acquired Acthar from Aventis Pharmaceutical Products, Inc. for $100,000. (Id. ¶ 237.) The FDA
approved Acthar for two indications on its label: monotherapy for the treatment of infantile spasms
(“IS”) and treatment of acute exacerbations of Multiple Sclerosis (“MS”). (Id. ¶ 219.)3 In 2014,
Mallinckrodt acquired Questcor for approximately $5.9 billion.4 (Id. ¶ 114.) In October 2020,
Mallinckrodt filed for Chapter 11 bankruptcy in Delaware. In re Mallinckrodt PLC, Case No. 1:20-
1 The Court adopts the pagination supplied by the CM/ECF docketing system.
2 The Court notes that the Amended Complaint incorrectly defines “Defendants” as Mallinckrodt
and Express Scripts (Am. Compl. ¶ 130), but Mallinckrodt is not and has never been a defendant
in this action. The Court cannot evaluate allegations that do not state with particularity which
Defendant (or non-party) they relate to. (See, e.g., id. ¶ 293 (“Further, Plaintiffs have paid the
inflated AWPs directly set and charged by Defendants.”).) If Plaintiffs choose to replead, they
must clearly articulate which allegations in the second amended complaint refer to what parties
and non-parties to this action.
3 The Amended Complaint is unclear regarding what indications Acthar is currently approved for.
Plaintiffs allege that Acthar was approved by the FDA in 1952 for over 50 conditions, and this list
has been reduced to “19 indications” in the “present day.” (Am. Compl. ¶¶ 132, 206–11.) However,
the Amended Complaint also alleges that “the FDA has only ever approved Acthar for two narrow
indications: Infantile Spasms (IS) and acute exacerbations of multiple sclerosis (MS). It has never
been approved for the long-term treatment of any disease.” (Id. ¶ 133.) Plaintiffs do not provide
any further information regarding this discrepancy.
4 Throughout the Amended Complaint, Plaintiffs inconsistently refer to Questcor and Mallinckrodt
as interchangeable entities. The same is true of other legacy and present-day entities, such as
Accredo and CuraScript SP, which Plaintiffs sometimes also refer to as “Accredo/Curascript SP.”
For simplification purposes the Court refers to all entities by their current, non-legacy name,
including when they were in their legacy form.
bk-12522 (Bankr. D. Del.) (the “Bankruptcy Proceedings”); (Id. ¶ 117.). In April 2022, claims
against Mallinckrodt arising prior to October 2020, and similar to those asserted against
Defendants here, were discharged in the Bankruptcy Proceedings. (Am. Compl. ¶ 117.)
Mallinckrodt is not, nor has it ever been, a party to the current action.
Plaintiffs Dakota County, SMW Local 40, Harlem SD 122, and Dustin’s are third party
payors (“TPPs”) who provide healthcare benefits, including prescription drug benefits, to their
employees through contracts with other healthcare organizations. (Id. ¶¶ 93–111.)
Express Scripts, Inc. (“Express Scripts”) is a pharmacy benefits manager (“PBM”) that
contracted with TPPs like Plaintiffs to lower the costs of drugs. (Id. ¶ 82.) Express Scripts also
contracted with Mallinckrodt for price discounts. (Id.) Priority Healthcare Corp. and Priority
Healthcare Distribution, Inc., d/b/a Curascript, SD, f/k/a CuraScript Pharmacy, Inc. (“CuraScript”)
is a wholly owned subsidiary of Express Scripts. (Id. ¶ 119.) It was acquired by Express Scripts in
January 2004 and was expanded when Express Scripts acquired Priority Healthcare Corporation
in October 2005. (Id.) CuraScript is Mallinckrodt’s exclusive specialty pharmacy distributor for
Acthar. (Id. ¶ 120.)
Accredo Health Group, Inc., f/k/a CuraScript S.P. (“Accredo”) is Express Script’s legacy
specialty pharmacy operation. (Id. ¶¶ 68, 121.) Express Scripts merged with Medco in 2012, and
CuraScript S.P. was integrated into Medco’s specialty pharmacy business, Accredo. (Id. ¶ 68.) The
new, integrated operation was called Accredo. (Id.) Accredo received Acthar from CuraScript’s
warehouse, dispensed it directly to some of Plaintiffs’ beneficiaries, then billed the patients and
their TPPs. (Id.)
Beginning in 2007, Healthbridge was Express Script’s legacy “hub” operation. (Id. ¶¶ 70,
123, 128.) As a hub, Healthbridge was responsible for controlling prescription processing and
benefits coordination with patients and TPPs. (Id. ¶ 33.) Healthbridge was integrated into United
BioSource (“UBC”) when Express Scripts merged with Medco in 2012. (Id. ¶ 70.) The new
integrated operation was called UBC. (Id.) UBC acted as Mallinckrodt’s exclusive agent in the
processing of Acthar prescriptions through the Acthar Support and Access Program (“ASAP”).
(Id. ¶¶ 70, 127.) Doctors would call Acthar prescriptions into the hub, which would confirm and
authorize insurance coverage. (Id. ¶ 284.) Then, the hub would direct Accredo to fill the
prescription. (Id. ¶ 66.) Express Scripts sold UBC in November 2017 to Avista Capital Partners.
(Id. ¶ 126.) CuraScript, Accredo, and UBC were all wholly-owned subsidiaries of Express Scripts
from 2007 through 2017. (Id. ¶ 81.) Express Scripts is now a wholly-owned subsidiary of
Evernorth Health, Inc., f/k/a Express Scripts Holding Company (“Evernorth”). (Id. ¶ 82.)
ii. The “New Strategy”
In 2007, Mallinckrodt and Express Scripts created a so-called “new strategy” for selling,
distributing, and marketing Acthar. (Id.¶ 31.) This new strategy involved “re-launch[ing]” Acthar
with a limited distribution system at a higher price to make it appear as if the product were a new
drug “being launched as the only product indicated for IS,” which was an “off-label” indication
until the FDA approved it in 2010.5 (Id. ¶¶ 239, 273.) Mallinckrodt and the Express Scripts Entities
would then work to market the drug for additional off-label indications to increase demand for the
drug.
5 As defined by the Amended Complaint, “off-label” refers to the use of a drug for any purpose
other than what is described in the drug’s labeling. (Am. Compl. ¶ 152.) For Acthar, off-label use
included prescribing the drug for any condition other than its two FDA-approved uses—IS and
MS, although as noted in this opinion the Amended Complaint contains discrepancies as to how
many uses the FDA has actually approved the drug for. (Id. ¶ 133.)
1. The Distribution Scheme
In 2006, Express Scripts proposed that Mallinckrodt remove Acthar from wholesale
distribution and move it to exclusive “specialty” distribution through CuraScript. (Id. ¶ 22.) Acthar
would then be labelled a “specialty pharmaceutical,” although it had never been deemed as such
before. (Id. ¶ 20.) The distribution scheme limited the distribution of Achtar from multiple
wholesale and retail outlets to just one exclusive outlet, CuraScript—a subsidiary of Express
Scripts—after June 2007. (Id. ¶¶ 33, 67.) CuraScript engaged UBC to act as the “hub” that
processed Acthar prescriptions and coordinated benefits with patients and TPPs. (Id. ¶ 33.)
Accredo was engaged as the preferred specialty pharmacy. (Id.)
As part of the distribution scheme, Mallinckrodt and UBC created the ASAP. (Id. ¶¶ 34,
71.) Under the ASAP, a patient or physician seeking an Acthar prescription was directed to UBC
and then required to return the Acthar Start Form to UBC. (Id. ¶¶ 283, 500.) UBC then confirmed
the Acthar prescription with the provider, verified the patient’s insurance coverage, and arranged
for the Acthar to be delivered to the patient by CuraScript. (Id. ¶¶ 284, 286.) The Acthar Start
Form also authorized UBC or any other operator of the ASAP to provide Acthar and receive
payment for it from the patient and/or the TPP. (Id. ¶¶ 281–82, 287–88.) Possession and title to
Acthar passed from Mallinckrodt to the patient and TPP after UBC’s sign-off on the Acthar Start
Form. (Id. ¶ 290.) The Acthar Start Form also authorized Mallinckrodt and UBC to provide certain
services to the patient, including home injection training, which UBC arranged for. (Id. ¶¶ 288,
293)
In exchange for agreeing that the Express Scripts Entities would exclusively distribute
Acthar, Express Scripts allegedly agreed with Mallinckrodt to raise the price of Acthar 100,000%.
(Id. ¶¶ 20, 23.) Mallinckrodt signed contracts with CuraScript and UBC in June 2007
memorializing the exclusive distribution of Acthar and that UBC would be the exclusive hub for
the ASAP. (Id. ¶ 262.) The companies publicly announced the exclusive relationship in July 2007.
(Id. ¶¶ 496, 661.) This exclusive arrangement between the Express Scripts Entities and
Mallinckrodt lasted from 2007 through 2017. (Id. ¶ 758.)
2. The Pricing Scheme
At the time that Mallinckrodt (then Questcor) acquired Acthar in July 2001, the average
wholesale price (“AWP”) for a vial was approximately $40. (Id. ¶ 298.) In September 2001,
Mallinckrodt raised the AWP per vial to $935.20. (Id. ¶ 299.) From 2001 until 2007, the Acthar
AWP grew from $935.20 to $2,062.79. (Id. ¶ 301.) Once the exclusive distribution scheme was
implemented, from August 2007 through 2018 Mallinckrodt and Express Scripts agreed to raise
the AWPs of Acthar to over $40,000. (Id. ¶ 322.) This agreement to set the price of Acthar was
reflected in contracts, agreements, and understandings between Mallinckrodt and Defendants. (Id.
¶ 661.) Defendants “did not push back” on the price increases. (Id. ¶ 338.)
In 2007, when asked about the price increase, Express Scripts’ Chief Medical Officer,
Steve Miller, stated that “[t]he increase was a manufacturing decision,” meaning it was
Mallinckrodt’s decision, and he “[could not] comment on it.” (Id. ¶ 339.) In May 2017, Express
Scripts’ Senior Vice President, Supply Chain and Specialty Pharma, Everett Nevill, stated in
response to a question during a private investor conference, “I think everybody in our company
would agree, that the product is vastly overpriced for the value. We don’t set the price. We’ve told
[Mallinckrodt] that. I personally told [Mallinckrodt’s] management team that their drug is hugely
overpriced. I know Steve has as well.” (Id. ¶ 341.)
3. The Marketing Scheme
The marketing scheme promoted by Defendants and Mallinckrodt sought to broaden the
customer base of Acthar by promoting it for unapproved uses and doses, misrepresenting the
efficacy of Acthar, and issuing false statements about the reasons that the price of Acthar increased.
The Amended Complaint describes Mallinckrodt’s scheme as a “white coat marketing
scheme” that was used for off-label promotion of Acthar for new indications. (Id. ¶¶ 393–94.)
Through this scheme, Mallinckrodt and the Express Scripts Entities bribed Mallinckrodt’s “key
opinion leaders” or “KOLs” from around the country to serve as “spokes-doctors” to promote
prescriptions of Acthar for unapproved uses and doses. (Id. ¶ 38.) These bribes included
compensation from Mallinckrodt to certain KOLs for their “loyalty” to the company, including for
speaking at various engagements about Acthar’s off-label uses. (Id. ¶¶ 381–87.)
Additionally, the marketing scheme funneled tens of millions of dollars to UBC to run a
“patient assistance program” (“PAP”) to reduce co-pays for patients. (Id. ¶ 38.) The PAP allowed
Mallinckrodt to shift the costs of Acthar to private payors. (Id. ¶ 435.) Mallinckrodt paid copay
subsidies to a foundation called the Chronic Disease Fund (“CDF”) then UBC sent Medicare and
private payor patients to the CDF to receive the subsidies, which were used for Acthar to the
exclusion of other drugs. (Id. ¶¶ 437–38, 441.)
Mallinckrodt also used UBC’s reimbursement specialists as a mouthpiece to deliver
allegedly false messages about the value of Acthar relative to its price, why Acthar’s price
increased, Acthar’s unapproved uses and doses, and its benefits in relation to other treatments. (Id.
¶¶ 277, 432, 719.) The UBC reimbursement specialists were “directly trained by Mallinckrodt”
and followed the Standard Operating Procedure (“SOP”) created by Mallinckrodt. (Id. ¶ 184, 432.)
The SOP included a section on off-label usage of Acthar and the process by which UBC was to
approve off-label prescriptions. (Id. ¶¶ 184, 191.) The SOP also reflected that Mallinckrodt knew
that the “exact mechanisms of action of [Acthar] in the treatment of infantile spasms [were] not
fully understood,” but this lack of understanding did not impact their training of UBC’s
reimbursement specialists, who were responsible for passing on Mallinckrodt’s messages about
Acthar’s uses and benefits. (Id. ¶¶ 415, 421.)
The SOP also shows that UBC was “trained to misrepresent the reasons for the 2007 price
increase” and provided talking points for UBC personnel to use when discussing the price increase
with doctors, patients, and representatives of TPPs. (Id. ¶ 192.) The Mallinckrodt-supplied talking
points explained that Acthar’s price increase was necessary to ensure the drug’s “long term
viability and availability” and that it had “never been a profitable drug because it is not only a
difficult and expensive drug to manufacture, but is also a highly specialized, very low volume
product.” (Id. ¶¶ 192, 719.) Additionally, the talking points explain that the National Organization
for Rare Disorders (“NORD”) set up a rationing program for Acthar in the 1990s since it was often
not available during that time. (Id. ¶ 719.)
In another attempt to broaden Acthar’s customer base, UBC partnered with Mallinckrodt
to market a five-day, pulse therapy Acthar regimen created by Dr. Staley Brod for the widespread
treatment of MS. (Id. ¶ 73.) UBC employees were trained by Mallinckrodt to relay the allegedly
misleading messages about Acthar’s FDA approval for the five-day dose regimen to TPPs and
allegedly did convey those false messages. (Id. ¶¶ 75–76.)
The Amended Complaint also details non-party Dr. David Mandel’s role in promoting
Acthar for unapproved uses and doses. Dr. Mandel allegedly misrepresented and deceived patients
and payors about the Acthar mechanism of action and its limited FDA approval. (Id. ¶ 403) When
TPPs denied Acthar prescriptions, Dr. Mandel sent letters appealing those denials to UBC, which
then directed them to the payor. (Id. ¶ 404, 406.) These letters allegedly contained false and
misleading statements about the “limited FDA approval of Acthar and its purported [mechanism
of action].” (Id. ¶¶ 404, 427.)
iii. The Synacthen Acquisition
Through its price increases, Mallinckrodt increased its revenue from Acthar sales from less
than $1 million in 2001 to $798.9 million in 2013. (Id. ¶ 542.) Mallinckrodt was able to achieve
this increase in part because, at all times relevant to this case, there were no reasonably available
substitutes for Acthar and therefore Mallinckrodt possessed monopoly power in the relevant
product market. (Id. ¶¶ 551, 554.)
In 2009, Mallinckrodt identified a competitive threat to its monopoly power in the ACTH
market—Novartis AG’s Synacthen Depot (“Synacthen”), a synthetically derived ACTH
medication. (Id. ¶ 543.) Synacthen had not yet been approved by the FDA, but Mallinckrodt
recognized that potential entry of Synacthen in the U.S. market for ACTH drugs would threaten
its monopoly. (Id. ¶ 543.) In 2009, Mallinckrodt tried to buy the rights to the drug but failed. (Id.
¶ 543.) In 2013, Novartis agreed to sell Synacthen to Retrophin, Inc. (Id. ¶ 544.) However,
Mallinckrodt disrupted the bidding process for Synacthen and licensed Synacthen from Novartis
for more than eight times what Retrophin had agreed to buy the drug for. (Id. ¶¶ 545, 582.)
Mallinckrodt did not seek FDA approval to bring Synacthen to market after it bought the rights.
(Id. ¶ 582.) Instead, Mallinckrodt kept it off the market and raised Acthar prices. (Id. ¶¶ 545–46.)
iv. Related Lawsuits
The Express Scripts Entities are defendants in multiple lawsuits brought by various other
TPPs, including TPPs represented by Plaintiffs’ counsel in this action. (ECF No. 29 at 1.) Plaintiffs
describe at length in their Amended Complaint various actions that name Mallinckrodt as a
Defendant but that do not name the Express Scripts Entities, or, alternatively, actions that name
the Express Scripts Entities but do not relate to Acthar. For purposes of evaluating Defendants’
Motion, the Court has focused on the federal actions Plaintiffs and Defendants have identified in
their papers that directly pertain to the parties and issues in this case.6 (See, e.g., Am. Compl. ¶¶
335, 356; ECF No. 23-1 at 32–34.)
1. The Rockford Case
In April 2017, Plaintiffs’ counsel in this case filed a class action in the Northern District of
Illinois on behalf of the City of Rockford, Illinois (“Rockford”) and Acument Global Technologies
6 The parties have filed various notices of supplemental authority on the docket, which the Court
has taken into consideration as appropriate. (See ECF Nos. 30, 31, 32, 35, 37.) Plaintiffs filed a
Motion to Strike Defendants’ Notice of Supplemental Authority. (ECF No. 33.) The Supplemental
Authority Notice at issue in the Motion to Strike (ECF No. 31) notified the Court of an order
entered by the Honorable Paula Patrick, Philadelphia Court of Common Pleas on January 22, 2025,
sustaining the Express Scripts Entities’ preliminary objections in Law Enforcement Health
Benefits, Inc. v. Greenhouse, Case No. 240301976 (Pa. Com. Pl. Jan. 21, 2025) (“LEHB”).
Plaintiffs’ Motion to Strike notes that Judge Patrick recused herself from the case and the January
22, 2025 LEHB Order was vacated. (ECF No. 33 at 2–3.) Additionally, Plaintiffs note in their
Reply to the Motion to Strike that Judge Patrick’s August 20, 2024 order in LEHB was also vacated
for similar reasons. (ECF No. 36.) The Court notes that Defendants immediately notified the Court
on their own volition that the two LEHB orders were vacated and therefore Plaintiffs’ Motion to
Strike is Moot. (ECF Nos. 32, 35.) This Court urges the parties to avoid unnecessary motions
practice in the future and follow this Court’s order in this case requiring that “[s]even (7) days
prior to any motion being filed . . . counsel must notify opposing counsel to discuss the substance
of the potential motion, and the possible resolution of the same.” (ECF No. 4 at 1.)
Inc. (“Acument”) and a putative class of similarly situated TPPs, including Plaintiffs in this
litigation, against Mallinckrodt and the Express Scripts Entities. City of Rockford v. Mallinckrodt
ARD, Inc., et al., No. 3:17-cv-50107 (N.D. Ill.); (Am. Compl. ¶ 48.). The second amended
complaint alleged that Mallinckrodt and the Express Scripts Entities violated federal and state
antitrust and consumer protection laws, RICO, and various other state laws by illegally maintaining
and enhancing Mallinckrodt’s monopoly power in the ACTH market. See City of Rockford v.
Mallinckrodt ARD, Inc., 360 F. Supp. 3d 730, 743 (N.D. Ill. 2019). On January 25, 2019, the
Rockford court denied in part the Express Scripts Entities’ motions to dismiss, permitting
Rockford’s antitrust claims to proceed and allowing plaintiffs leave to replead. Id. at 778; (Am.
Compl. ¶ 49.). The Rockford court found that Acument did not have antitrust standing for the
federal claims because the plaintiffs did not plausibly allege that it was a direct purchaser from a
member of the alleged conspiracy. Rockford, 360 F. Supp. 3d at 752. The court did find that
Rockford had alleged antitrust standing, and that it had plausibly stated both Section 1 and Section
2 claims under the Sherman Act against Mallinckrodt and the Express Scripts Entities based on
(1) the exclusive dealing arrangement and (2) the Synacthen acquisition. Id. at 754–57.
The Rockford court dismissed the RICO claims for failure to adequately plead the predicate
acts of mail and wire fraud under the Rule 9(b) standard. Id. at 773–74. The court noted that
“plaintiffs allege little more than the existence of a price-fix scheme and defendants’ intent to
misrepresent prices, which is different than alleging the ‘who, what, when, where and how’ of an
actual misrepresentation.” Id. at 774 (citations omitted). Additionally, the court held that plaintiffs
had inadequately pled proximate cause for the alleged RICO violation because it was “unclear how
either Mallinckrodt or Express Scripts communicated any, ‘misrepresentations,’ let alone
communications made directly, to either [plaintiff].” Id. at 775. The court dismissed the fraud and
conspiracy to defraud claims upon similar reasoning. Id. at 776–77.
2. The Washington County Case
In June 2019, Plaintiffs’ counsel in this case filed a complaint in the District of Maryland
on behalf of the Washington County Board of Education against Mallinckrodt, the Express Scripts
Entities, and a former board member of Questcor. Wash. Cnty. Bd. Of Educ. v. Mallinckrodt ARD,
Inc., No. 1:19-cv-01854 (D. Md.). The amended complaint alleged that the defendants raised
Acthar’s price through similar schemes alleged here, raising claims of violation of the Maryland
Consumer Protection Act (“MCPA”), negligent misrepresentation, fraud, unjust enrichment, and
conspiracy to defraud. Wash. Cnty. Bd. of Educ., No. 1:19-cv-01854 (ECF No. 36); see Wash.
Cnty. Bd. of Educ. v. Mallinckrodt ARD, Inc., 431 F. Supp. 3d 698 (D. Md. 2020). The court
granted the defendants’ motions to dismiss on all counts.
With respect to the MCPA claim, the court found that the plaintiff failed to identify any
actionable misrepresentation on five bases—(1) Mallinckrodt and Express Scripts disclosed their
decision to enter into an exclusive distributorship in 2007, (2) the “artificial” and “inflated” AWPs
of Acthar did not constitute false representations, (3) plaintiff failed to allege that it relied on the
allegedly false statements to the market about Acthar’s price, (4) plaintiff failed to identify a
misrepresentation related to the PAP, and (5) plaintiff failed to allege it actually received any false
information from KOLs. Id. at 711–14. As for the negligent misrepresentation claim, the court
held the Acthar Start Form could not serve as the basis for that claim because (1) plaintiff did not
allege it ever saw the Acthar Start Form, and (2) the assertion that plaintiff relied on the alleged
misstatements in the form was conclusory. Id. at 716. The court also dismissed the fraud claim
because “there is nothing inherently fraudulent about charging a high price for a product.” Id. at
717.
3. The Steamfitters Case
In July 2019, Plaintiffs’ counsel in this case filed a class action complaint in this district
against Mallinckrodt and UBC on behalf of Steamfitters Local Union No. 420 (“Steamfitters”) and
similarly situated TPPs. Steamfitters Local Union 420 v. Mallinckrodt ARD, LLC, et al., No. 2:19-
cv-03047 (E.D. Pa.). The complaint alleges violations of the federal RICO statute and state
consumer fraud laws related to Mallinckrodt and UBC’s marketing and distribution of Acthar. (See
AC ¶ 62.) In a December 19, 2019 one-page order issued by Judge Schiller, the court denied
defendants’ motions to dismiss. Steamfitters, No. 2:19-cv-03047 (E.D. Pa.) (Dkt. No. 57).
In August 2023, the Steamfitters case was reassigned to this Court. Steamfitters, No. 2:19-
cv-03047 (E.D. Pa.) (Dkt. No. 131). Defendant UBC argued that the Steamfitters proceedings
should be bifurcated based on the potential collateral estoppel effects of the decision of In re
Mallinckrodt PLC, 638 B.R. 57 (Bankr. D. Del. 2021), which was issued as part of Mallinckrodt’s
Bankruptcy Proceedings. See, e.g., Steamfitters, No. 2:19-cv-03047 (E.D. Pa.) (Dkt. No. 113). In
an October 31, 2025 order and memorandum, this Court denied Defendant’s request to bifurcate
and found that the Bankruptcy court’s decision did not act as collateral estoppel to Plaintiff’s
claims. Steamfitters, No. 2:19-cv-03047 (E.D. Pa.) (ECF Nos. 152, 153).
4. The Plumbers Case
In November 2019, Plaintiffs’ counsel in this case filed a class action complaint in the
District of New Jersey on behalf of the United Association of Plumbers & Pipefitters Local 322 of
Southern New Jersey (“Plumbers”) and similarly situated TPPs against Mallinckrodt and the
Express Scripts Entities, as well as an individual sales specialist. Plumbers & Pipefitters Local 322
of S.N.J. v. Mallinckrodt ARD, LLC, et al., No. 1:20-cv-00188 (D.N.J.). Similar to the allegations
in the Rockford and Steamfitters matters, the amended complaint alleged that the Express Scripts
Entities and Mallinckrodt violated the New Jersey Antitrust Act and the New Jersey Consumer
Fraud Act by illegally “maintain[ing] and enhanc[ing] Mallinckrodt’s monopoly power in the
ACTH market” by “agree[ing] to maintain the supracompetitive prices of Acthar through the
ASAP Program, limiting distribution of the drug and stifling the ability of a competitor to enter
the ACTH market.” Plumbers, No. 1:20-cv-00188 (Dkt. No. 50 ¶¶ 611, 614). Additionally, the
amended complaint alleged that the Express Scripts Entities and Debtors violated New Jersey
RICO by “creat[ing] [an] exclusive distribution arrangement to limit and control distribution and
output of Acthar, and to raise the prices of Acthar to unconscionable levels,” “willfully
manipulat[ing] and inflat[ing] the prices paid by TPPs for Acthar.” Id. ¶ 10. The amended
complaint also brought negligent misrepresentation, civil conspiracy, and unjust enrichment
claims.
The Plumbers court granted the Express Scripts Entities’ motion to dismiss. United Ass’n
of Plumbers & Pipefitters Local 322 of S. N.J. v. Mallinckrodt ARD, LLC, 2020 WL 5627149
(D.N.J. Aug. 18, 2020). In doing so, the court looked to caselaw on the federal RICO statute when
interpreting New Jersey’s RICO statute. Id. at 17. Similar to the Rockford court, the Plumbers
court dismissed the RICO claims because plaintiff failed to meet Rule 9(b)’s pleading standard for
the predicate crimes of wire and mail fraud. Id. at 18. The court explained that plaintiff did not
identify any specific misrepresentations made in the course of the distribution scheme, and plaintiff
failed to supply any allegations that statements concerning Acthar’s price were false. Id. Finally,
with respect to the marketing scheme, the court held that plaintiff’s allegations of off-label
marketing were conclusory and/or failed to establish that the alleged misrepresentation actually
resulted in more Acthar prescriptions. Id. 18–19. The plaintiff also failed to explain why
Mallinckrodt’s non-disclosure of its payments to KOLs and role in the PAP amounted to actionable
omissions. Id. The Plumbers court rejected plaintiff’s negligent misrepresentation claim for similar
reasons.
II. LEGAL STANDARD
A motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) tests the legal
sufficiency of the complaint. Kost v. Kozakiewicz, 1 F.3d 176, 183 (3d Cir. 1993). In deciding a
motion to dismiss, the court is not opining on whether the plaintiff will likely prevail on the merits,
but simply accepts as true all well-pled factual allegations in the complaint and views them in a
light most favorable to the plaintiff. U.S. Express Lines Ltd. v. Higgins, 281 F.3d 383, 388 (3d Cir.
2002). While a complaint does not need detailed factual allegations to survive a Rule 12(b)(6)
motion to dismiss, a complaint must provide more than labels and conclusions. Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 555 (2007). “[C]onclusory or ‘bare-bones’ allegations will [not] survive
a motion to dismiss.” Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009). “To prevent
dismissal, all civil complaints must now set out ‘sufficient factual matter’ to show that the claim
is facially plausible.” Id. In evaluating a complaint on a motion to dismiss, the Third Circuit has
directed courts do the following: (1) identify the elements of the claim, (2) review the complaint
to strike conclusory allegations, and then (3) look at the well-pleaded components of the complaint
and evaluate whether all of the elements identified in part one of the inquiry are sufficiently
alleged. Malleus v. George, 641 F.3d 560, 563 (3d Cir. 2011).
Federal Rule of Civil Procedure 9(b) requires that “[i]n alleging fraud or mistake, a party
must state with particularity the circumstances constituting fraud or mistake. Malice, intent,
knowledge, and other conditions of a person’s mind may be alleged generally.” In order to satisfy
Rule 9(b)’s particularity requirement, a plaintiff must “state the circumstances of the alleged fraud
with sufficient particularity to place the defendant on notice of the precise misconduct with which
[it is] charged” and “plead or allege the date, time and place of the alleged fraud or otherwise inject
precision or some measure of substantiation into a fraud allegation.” Frederico v. Home Depot,
507 F.3d 188, 200 (3d Cir. 2007) (internal citations omitted). In short, a plaintiff must provide “the
who, what, when, where and how of the events at issue.” In re Rockefeller Ctr. Props., Inc. Sec.
Litig., 311 F.3d 198, 217 (3d Cir. 2002) (internal quotations omitted).
III. DISCUSSION
i. Rule 8
Federal Rule of Civil Procedure 8 requires that a complaint contain a “short and plain
statement of the claim” and be “simple, concise, and direct.” Defendants urge this Court to dismiss
the Amended Complaint for failure to comply with Rule 8’s requirements. (ECF No. 23-1 at 30–
34.) Defendants assert that the 204-page Amended Complaint is “replete with conclusory, vague,
and immaterial facts.” (ECF No. 23-1 at 31 (quoting Bartol v. Barrowclough, 251 F. Supp. 3d 855,
859 (E.D. Pa. 2017)).) For example, Defendants assert that Plaintiffs concede that their claims are
not based on off-label marketing or Acthar’s safety or efficacy, yet devote dozens of paragraphs
in the Amended Complaint to these issues; Plaintiffs do not allege that any Express Scripts Entities
paid doctors, yet spend pages of the Amended Complaint describing Mallinckrodt’s alleged doctor
bribery scheme; and Plaintiffs devote significant space in the Amended Complaint to discuss
Mallinckrodt’s acquisition of Synacthen, yet fail to allege that the Express Scripts Entities had any
role in this acquisition. (See ECF No. 23-1 at 31.) For the reasons further explained in this opinion,
this Court agrees with Defendants that the Amended Complaint is both imprecise and
overinclusive in parts, while completely contradictory in others. However, viewed in totality the
Court does not find that these deficiencies result in a violation of Rule 8.
With this in mind, the Court notes the Amended Complaint’s shortcomings throughout this
opinion. Any falsehoods apparent from the face of court documents incorporated by reference into
the Amended Complaint or contradictions within the Amended Complaint itself have not been
accepted by this Court as true.7 (See ECF No. 23-1 at 33–34); DPWN Holdings (USA), Inc. v.
United Air Lines, Inc., 747 F.3d 145, 151–52 (2d Cir. 2014) (“Although factual allegations of a
complaint are normally accepted as true on a motion to dismiss . . . that principle does not apply
to general allegations that are contradicted ‘by more specific allegations in the Complaint.’”)
(collecting cases). Moreover, Plaintiffs refer throughout the Amended Complaint to prior actions
and conduct that do not implicate the Express Scripts Entities at all. The Court has only considered
those allegations that directly relate to the Defendants to this action. If the Court struck from the
Amended Complaint all paragraphs that do not relate to Defendants in some way, the over 200-
page complaint would be whittled down significantly, illuminating just how sparse the allegations
pertaining directly to Defendants are.
ii. Collateral Estoppel
Defendants argue that the Bankruptcy Proceedings should act as collateral estoppel to
Plaintiff’s Amended Complaint. (See, e.g., ECF No. 23-1 at 26–30.) As discussed above, this Court
7 For example, Plaintiffs claim that “the FTC is now prosecuting Express Scripts for its ‘one-stop
shop’ proposed to Mallinckrodt back in 2007 for Acthar.” (Am. Compl. ¶ 6.) However, as Plaintiffs
note in the next sentence, the September 20, 2024 FTC complaint sued Express Scripts and two
other PBMs for engaging in anticompetitive and unfair rebating practices that artificially inflated
the price of insulin drugs, which do not include Acthar. Neither Acthar nor Mallinckrodt are
mentioned in the FTC complaint. Caremark Rx, et al., Docket No. 9437 (F.T.C. Sept. 20, 2024),
available at https://tinyurl.com/mrxr6my6.
has already considered and rejected this argument in the Steamfitters case and that rejection is
equally applicable here. Steamfitters, No. 2:19-cv-03047 (E.D. Pa.) (Dkt. Nos. 152, 153).
Plaintiffs also raise collateral estoppel arguments in their response in opposition. They
argue that “collateral estoppel should apply to prevent Express Scripts from relitigating issues
actually decided by the federal courts in Rockford and Steamfitters where Express Scripts is a party
and did litigate issues to finality [in] its Rule 12 motions to dismiss claims for federal antitrust and
RICO claims, and violations of state consumer fraud statutes and common law.” (ECF No. 28 at 6
n.6, 16, 19, 22 (emphasis in original).) As the Plumbers court stated in response to the same
assertion, “Plaintiff’s argument is absurd.” 2020 WL 5627149, at *10. Neither decision in
Steamfitters nor Rockford was a final judgment on the merits, meaning the doctrine of collateral
estoppel is inapplicable. See Gross-Quatrone v. Mizdol, 811 F. App’x 95, 97 (3d Cir. 2020).
Beyond that, Plaintiffs rely heavily in their brief on the similarities between the Steamfitters
case and this matter, coupled with Judge Schiller’s decision denying the Steamfitters defendants’
motions to dismiss. (ECF No. 28 at 7–8, 10, 16–17, 19–20, 22–25, 26.) With due respect to the
Steamfitters’ court’s decision, this Court does not consider the Steamfitters order controlling, as it
included only a singular sentence regarding the indirect purchaser rule in support of the denial of
the defendants’ motions to dismiss. Thus, this Court has considered the opinions and analysis of
each district court that has addressed similar issues to those presented in this action. Specifically,
this Court has considered the Rockford court’s detailed opinion in issuing its decision here. But
again, while the opinions of other jurists sitting in a similarly situated posture as this Court can
often offer helpful guidance, neither opinion is binding on this Court. See Am. Elec. Power Co. v.
Connecticut, 564 U.S. 410, 428 (2011) (“[F]ederal district judges, sitting as sole adjudicators, lack
authority to render precedential decisions binding other judges, even members of the same court.”).
iii. Antitrust Claims
Plaintiffs bring three antitrust claims: (1) a Sherman Act Section 1 restraint of trade claim
(Count 11), 15 U.S.C. § 1; (2) a Sherman Act Section 2 maintenance of monopolization claim
(Count 10), 15 U.S.C. § 2; and (3) antitrust claims under the Nebraska, Florida, and Illinois state
antitrust statutes (Count 12). Plaintiffs have not addressed Defendants’ arguments to dismiss the
antitrust claims in their brief in opposition.
“A response in opposition to a motion to dismiss that fails to respond to a substantive
argument is a waiver or abandonment of that claim.” Perez v. IMA Grp., No. CV 23-4367, 2024
WL 2925960, at *2 (E.D. Pa. June 10, 2024) (citing Dreibelbis v. Scholton, 274 F. App’x 183, 185
(3d Cir. 2008)); see Levy-Tatum v. Navient Sols., Inc., 183 F. Supp. 3d 701, 712 (E.D. Pa. 2016)
(collecting cases). Apart from their collateral estoppel arguments, which, as discussed, are legally
unsound, and arguments regarding the direct purchaser status of Plaintiffs for purposes of antitrust
standing (ECF No. 28 at 17–20), Plaintiffs surprisingly do not respond to any of the Express Scripts
Entities’ arguments concerning the merits of their antitrust claims in their 25-page opposition brief.
(See ECF No. 23-1 at 52–58.) Thus, the Court hereby dismisses the antitrust claims (Counts 10–
12) without prejudice.
iv. Federal RICO
Plaintiffs bring claims for violation of RICO and conspiracy to violate RICO under 18
U.S.C. § 1962(c) and (d), respectively, against UBC only. To state a RICO claim, a plaintiff must
plead: “(1) conduct (2) of an enterprise (3) through a pattern (4) of racketeering activity.” Lum v.
Bank of Am., 361 F.3d 217, 223 (3d Cir. 2004), abrogated on other grounds by Bell Atl. Corp. v.
Twombly, 550 U.S. 544, 557 (2007). A claim of a pattern of racketeering activities requires at least
two predicate acts of racketeering activity. Kolar v. Preferred Real Est. Invs., Inc., 361 F. App’x
354, 362 (3d Cir. 2010). Here, Plaintiffs allege the predicate acts of mail fraud and wire fraud. 18
U.S.C. §§ 1341, 1343; (Am. Compl. ¶¶ 606, 612, 628). The elements of a mail fraud claim are “(1)
a scheme or artifice to defraud for the purpose of obtaining money or property and (2) use of the
mails in furtherance of the scheme.” United States v. Rashid, 39 F. Supp. 3d 649, 653 (E.D. Pa.
2014), aff'd sub nom. Rashid v. Warden Phila. FDC, 617 F. App’x 221 (3d Cir. 2015). The
elements of wire fraud are “(1) knowing and willful participation in a scheme or artifice to defraud,
(2) with specific intent to defraud, and (3) use of interstate wire communications in furtherance of
the scheme.” Id. (internal quotations omitted).
In order to successfully plead wire and mail fraud, Plaintiffs must plead a fraudulent
misrepresentation or omission with particularity under Rule 9(b)’s standard. Humana, Inc. v.
Indivior, Inc., No. 21-2573, 2022 WL 17718342, at *3 n.30 (3d Cir. Dec. 15, 2022); Marangos v.
Swett, 341 F. App’x 752, 756 (3d Cir. 2009). Plaintiffs argue that the “mail and wire statutes do
not require a misrepresentation or omission; a scheme or artifice suffices.” (ECF No. 28 at 24.)
This argument not only perplexes the Court but misstates the law. The statute requires a “scheme
or artifice to defraud.” Lum v. Bank of Am., 361 F.3d at 223 (a mail or wire fraud scheme “must
involve some sort of fraudulent misrepresentation or omission”). One cannot defraud without
making some sort of fraudulent misrepresentation or omission. Rule 9(b) also requires Plaintiffs
to identify the “who, what, when and where details” of the alleged fraud. DiGiglio v. U.S. Xpress,
Inc., 293 F. Supp. 3d 522, 527 (E.D. Pa. 2018), aff’d, 2018 WL 11449580 (3d Cir. Apr. 24, 2018).
Plaintiffs fail to plead that UBC made a fraudulent misrepresentation or omission that
meets the particularity requirement of Rule 9(b) in relation to any of the alleged schemes in the
Amended Complaint. At the outset, the Court notes that Plaintiffs make various allegations about
misrepresentations made by parties other than UBC and non-parties. These allegations do not
support allegations of RICO violations as to UBC. (See, e.g., Am. Compl. ¶¶ 323, 328 (describing
allegedly misleading statements by Mallinckrodt’s CEO and Mallinckrodt’s press releases about
the price of Acthar).) Plaintiffs also dedicate many paragraphs to Mallincrkodt’s “white coat
marketing scheme” that used and bribed KOLs to promote prescriptions of Acthar for unapproved
uses and doses. (See, e.g., id. ¶¶ 4, 38, 60, 381–87, 393–94, 470.) However, when it comes time
to link the “white coat marketing scheme” to UBC, Plaintiffs cursorily state that these spokes-
doctors were “important spokes in the wheel of Mallinckrodt’s RICO conspiracy, as they are all
connected to Mallinckrodt’s self-described ‘HUB’ at UBC and all profit as integral ‘spokes’ in the
Mallinckrodt-UBC marketing and sales scheme.” (Id.¶ 387.) However, nothing more is offered to
support this claim and Plaintiffs do not explain UBC’s role in the alleged scheme. In short,
Plaintiffs fall far below Rule 9(b)’s standard, and any supposed misrepresentations related to the
KOLs cannot support that UBC committed the predicate acts for a RICO violation.8
The Amended Complaint’s allegations that do directly pertain to UBC in support of
Plaintiffs’ RICO claims fall into the following categories: (1) misrepresentations regarding
Acthar’s uses, efficacy, safety, and benefits (see, e.g., id. ¶¶ 72–76, 79, 180–84, 189–91, 199–200,
614) and (2) misrepresentations regarding the reasons for Acthar’s inflated price, its value relative
to that price, and how the PAP affected that price (see, e.g., id. ¶¶ 192–98, 441–45, 614).9
8 The same is true of Plaintiffs’ claims against non-party Dr. David Mandel. Plaintiffs state Dr.
Mandel misrepresented the Acthar mechanism of action and its limited FDA approval. (Am.
Compl. ¶ 403) When TPPs denied Acthar prescriptions, Dr. Mandel sent letters appealing those
denials to UBC, which then directed them to the payor. (Id. ¶ 404, 406.) These letters allegedly
contained false and misleading statements about the “limited FDA approval of Acthar and its
purported [mechanism of action].” (Id. ¶¶ 404, 427.) However, the only connection to UBC alleged
is that UBC directed these letters to the payors. This is insufficient to attribute those
misrepresentations to UBC.
9 To the extent that Plaintiffs claim that the Express Scripts Entities concealed their vertical
integration and agreement with Mallinckrodt (see ECF No. 28 at 25), these allegations and their
First, Plaintiffs allege that UBC promoted Acthar off-label and made misrepresentations
about its uses and safety. (See, e.g., id. ¶¶ 72–76, 79, 180–84, 189–91, 199–200, 614.) Plaintiffs
contradict themselves multiple times regarding this aspect of the scheme. The Amended Complaint
states that “[t]he civil claims at issue in this case do not arise out of or depend upon the Acthar
label, FDA approval (or lack thereof) or the safety or efficacy of Acthar.”10 (Id. ¶¶ 141, 147.) The
Amended Complaint then discusses how the Express Scripts Defendants falsely promoted Acthar
as “purportedly ‘approved for 19 indications.’”11 (Id. ¶¶ 173–80.) The Court is perplexed, yet
again, as to how Plaintiffs may assert that their claims do not depend “upon any FDA standard,”
“FDA approval (or lack thereof) or the safety or efficacy of Achtar” (id. ¶¶ 141, 147), yet premise
their RICO claims upon “mail or wire fraud in the form of deceptive advertising and
misrepresentations, as well as concealment of material facts about Acthar, in order to mislead
health care professionals and/or consumers and TPPs about the safety, efficacy and value of
Acthar which caused Plaintiffs to pay [more] for Acthar than it would have absent Defendants’
fraud.” (Id. ¶¶ 181–82 (emphasis added).) Plaintiffs’ allegations are in conflict and thus are
insufficient to serve as misrepresentations underlying the predicate acts of a RICO violation.
factual support are not detailed in the Amended Complaint. Moreover, Plaintiffs admit in their
Amended Complaint that the partnership between Mallinckrodt and the Express Scripts Entities
was publicly disclosed in 2007. (Am. Compl. ¶ 496 (describing Mallinckrodt’s public
announcement of the Specialty Pharmacy Distribution of Acthar).)
10 The Amended Complaint asserts that Mallinckrodt knew that the “exact mechanisms of action
of [Acthar] in the treatment of infantile spasms [were] not fully understood,” and this lack of
understanding did not impact their training of UBC’s reimbursement specialists, who were
responsible for passing on Mallinckrodt’s messages about Acthar’s uses and benefits. (Am. Compl.
¶¶ 415, 421.) This generalized allegation, without reference to any specific misstatement that UBC
made, much less when or to whom, fails to comply with Rule 9(b).
11 Plaintiffs contend in one paragraph of the Amended Complaint that Acthar actually was
approved for 19 indications. (Compare Am. Compl. ¶ 180 (alleging Acthar was falsely marketed
as being “approv[ed] for 19 indications”), with id. ¶ 132 (admitting Acthar has been approved to
treat 19 indications in the “present-day”).)
Even if these assertions were not in conflict, “off-label marketing is not per se fraudulent.”
Indiana/Kentucky/Ohio Reg’l Council of Carpenters Welfare Fund v. Cephalon, Inc., No. CIV.A.
13-7167, 2014 WL 2115498, at *5–6 (E.D. Pa. May 21, 2014) (collecting cases) (finding that
plaintiff failed to adequately allege a misrepresentation or omission based on off-label
prescriptions and promotion of a drug with sufficient specificity, even where the defendant’s
conduct may have constituted “improper off-label promotion” under the relevant regulations).
There is no allegation that UBC actively concealed information about what Acthar’s indications
were. In fact, Plaintiffs allege that the SOP Mallinckrodt created for UBC stated that indications
that were “not listed on the manufacturer’s package insert as an approved FDA diagnos[is]” were
“considered off label.” (Am. Compl. ¶¶ 88–91.) The fact that UBC would accept incoming
referrals that fall into the “off label” category does not in and of itself constitute a
misrepresentation, nor do Plaintiffs plead with specificity why it would be. (See id. ¶ 191.);12 see
Travelers Indem. Co. v. Cephalon, Inc., 32 F. Supp. 3d 538, 551 (E.D. Pa. 2014) (dismissing claims
that showed “no more than [Defendant’s] off-label promotion . . . which does not by itself state a
claim for fraud or misrepresentation”).
Second, Plaintiffs allege that UBC, at the direction of Mallinckrodt, made representations
regarding the reasons for Acthar’s inflated price, its value relative to that price, and that the price
itself was a misrepresentation. (See, e.g., id. ¶¶ 192–98, 441 614.) Plaintiffs allege that the talking
points Mallinckrodt gave UBC included misrepresentations about why the price of the drug had
increased. (Id. ¶ 192.) These talking points explained that the increase in price was necessary to
12 The fact that the 2007 SOP and other custodial files related to the ASAP program were destroyed
does not resuscitate Plaintiffs’ claims. Plaintiffs cannot skirt Rule 9(b)’s requirements by vaguely
alleging their claims are based on almost 20-year-old documents that it has discovered were
destroyed in a different litigation. See Fed. R. Civ. P. 11(b)(3).
ensure the drug’s “long term viability and availability” and that it had “never been a profitable
drug because it is not only a difficult and expensive drug to manufacture, but is also a highly
specialized, very low volume product.” (Id. ¶¶ 192, 719.) Additionally, the talking points explained
that the NORD set up a rationing program for Acthar in the 1990s since it was often not available
then. (Id. ¶ 719.)
Under Rule 9(b), Plaintiffs must identify the “who, what, when and where details” of the
alleged fraud. DiGiglio v. U.S. Xpress, Inc., 293 F. Supp. 3d 522, 527 (E.D. Pa. 2018), aff’d, 2018
WL 11449580 (3d Cir. Apr. 24, 2018). While the Plaintiffs do allege what the allegedly misleading
price statements were, they do not allege when or to whom they were made. Instead, they vaguely
state that “one or more of the above misrepresentations were repeated to representatives of the
Plaintiffs, their beneficiaries and/or their medical providers with the knowledge that these persons
would rely upon such misrepresentations to the detriment of Plaintiffs.” (Id. ¶ 193.) However,
these general allegations regarding who the misrepresentations were made to—including the
possibility that they were not even made to Plaintiffs, but to their beneficiaries or medical
providers—are broad and simply not enough to comply with Rule 9(b)’s particularity
requirement.13 See Rockford, 360 F. Supp. 3d at 775 (holding it was “unclear how either
Mallinckrodt or Express Scripts communicated any, ‘misrepresentations,’ let alone
communications made directly, to either [plaintiff].”).
Finally, charging high prices does not render the price “false” or constitute an actionable
misrepresentation or omission. Id. at 777 (“[H]igh prices do not in and of themselves constitute
13 Plaintiffs’ allegations that UBC employees were (1) trained by Mallinckrodt to relay the
misleading messages about Acthar’s FDA approval for the five-day dose regimen to TPPs and (2)
did convey those false messages also fail to specify the “who, what, when, and where” details of
the alleged misrepresentations. (Am. Compl. ¶¶ 75–76.)
false representations.”); Wash. Cnty., 431 F. Supp. 3d at 712–13 (same); Pipefitters, 2020 WL
5627149, at *20 (same). Nor do the “PAP services run by UBC” constitute actionable
misrepresentations or omissions. (Am. Compl. ¶¶ 441–45.) Plaintiffs detail how UBC worked with
IUOE Local 542’s patient to provide long term PAP assistance for a supposed MS exacerbation
after insurance coverage was denied, when the patient actually qualified for a short-term PAP. (Id.
¶¶ 441–46.) Plaintiffs allege that this constituted an omission by somehow “circumvent[ing]
patient complaints” and preventing “TPP advance awareness about Acthar’s high prices.” (Id. ¶
106.) This evades reason. These funds assisted the patients with their copays and Plaintiffs do not
allege with any particularity how they impacted TPPs’ “awareness” of prices.
In short, the Amended Complaint is framed with extensive allegations and conjecture that,
when opened, is hollow and devoid of the fundamental substance that is needed. Plaintiffs fail to
allege any misrepresentations or omissions with the particularity required by Rule 9(b) and
therefore their RICO claim must be dismissed. Because the Court finds Plaintiffs have failed to
state a claim for violation of the RICO statute under § 1962(c), their claim for conspiracy to violate
RICO under § 1962(d) must also fail. See Lum v. Bank of Am., 361 F.3d at 227 n.5 (“Any claim
under § 1962(d) based on an alleged conspiracy to violate the other subsections of § 1962
necessarily must fail if the substantive claims are themselves deficient.”).
Additionally, the parties bring arguments about the application of Illinois Brick and “direct
purchaser” standing of Plaintiffs as these issues pertain to their RICO claims. (ECF No. 23-1 at
38-40; ECF No. 28 at 17–20.) In light of the decision that the Plaintiffs have not otherwise
adequately pled their RICO claims, the Court need not reach these other issues.
v. Remaining State Law Claims
Defendants argue that Plaintiffs’ state law claims (Counts 3–9, 12–14) are barred by the
applicable statutes of limitations. (ECF No. 23-1 at 40–44.) “A complaint is subject to dismissal
for failure to state a claim on statute of limitations grounds only when the statute of limitations
defense is apparent on the face of the complaint.” Wisniewski v. Fisher, 857 F.3d 152, 157 (3d Cir.
2017). The Court finds that Counts 3–9 and 13–14 are subject to dismissal on statute of limitations
grounds because the defense is apparent on the face of the Amended Complaint.
When proceeding under diversity jurisdiction, as Plaintiffs do here (Am. Compl. ¶ 88), the
Court applies Pennsylvania’s tolling laws. Hurley v. BMW of N. Am., LLC, No. CV 18-5320, 2020
WL 1624861, at *9 (E.D. Pa. Apr. 2, 2020) (“When proceeding under diversity jurisdiction, this
Court applies the law of Pennsylvania with regard to tolling.”). In looking to Pennsylvania’s tolling
law, this Court finds that the two prior federal class actions against the Express Scripts Entities
related to Acthar—Rockford and Steamfitters—cannot toll limitations for Plaintiffs’ state law
claims due to Pennsylvania’s bar on cross-jurisdictional tolling. Hurley, 2020 WL 1624861, at *9.
Under this rule, a Pennsylvania court would not toll the statute of limitations on state law claims
based on the filing of a federal class action. See Conyers-Carson v. Albert Einstein Medical Center,
No. 140601960, 2015 WL 3512326, at *2 (Pa. Com. Pl. May 12, 2015) (“Pennsylvania courts have
repeatedly, and unambiguously, stated that the filing of an action in federal court does not toll the
running of the relevant, state law-based statutes of limitations.”) (collecting cases). American Pipe
tolling, which Plaintiffs argue applies, is a federal doctrine and therefore does not apply. The
Amended Complaint’s state law claims thus do not benefit from tolling.
Turning to the relevant statute of limitations period, as a federal district court adjudicating
state law claims, the Court must apply the choice of law rules of the forum state—Pennsylvania.
Klaxon Co. v. Stentor Elec. Mfg. Co., 313 U.S. 487, 496 (1941). In Pennsylvania, the limitations
period on foreign claims “shall be either that provided or prescribed by the law of the place where
the claim accrued or by the law of this Commonwealth, whichever first bars the claim.” 42 Pa.
C.S. § 5521(b) (emphasis added). Under Pennsylvania law, a cause of action accrues for statute of
limitations purposes when the plaintiff could have first maintained a viable cause of action.
William A. Graham Co. v. Haughey, 646 F.3d 138, 146 (3d Cir. 2011).
Here, Plaintiffs’ alleged injuries lie in their purchases of Acthar, and thus their claims
accrued at the time that they purchased the drug. The latest initial purchase of Acthar by Plaintiffs
was June 14, 2018. (Am. Compl. ¶ 94.) This was more than six years before the initial complaint
in this matter was filed on August 16, 2024. Moreover, the Rockford complaint was filed in April
2017. As Plaintiffs state in their response in opposition, the claims asserted in Rockford are the
“same exact claims Plaintiffs brought in their Amended Complaint here” and “the Amended
Complaint is modeled after both the Rockford and Steamfitters complaints.” (ECF No. 28 at 7.)
The Court sees no reason, and Plaintiffs have not provided such a reason, as to why Plaintiffs
would not have been able to bring the claims asserted herein at the time the Rockford action was
filed. Regardless of whether Plaintiffs’ state law claims accrued April 2017 or June 2018, they are
untimely.
Turning to the applicable statutes of limitations, the Court finds that each has been passed
by at least two months under Pennsylvania law. In analyzing the foreign state limitations periods
for the Connecticut, Illinois, Nebraska, and Florida consumer protection laws, this Court looks to
the Pennsylvania Unfair Trade Practices and Consumer Protection Law (“UTPCPL”) as the
analogous claim under Pennsylvania law. 73 P.S. § 201-1, et seq. This is the longest limitations
period, but would have required Plaintiffs to have filed their Complaint by June 14, 2024 based on
an accrual date of June 14, 2018, Plaintiffs’ latest initial purchase of Acthar. Because the
“limitations period for a foreign cause of action brought in Pennsylvania courts should never be
construed to be longer than would be the case if the same events had occurred in Pennsylvania to
a Pennsylvania plaintiff,” the Court concludes that the state claims are time barred and ends its
analysis here, rather than analyzing the statutes of limitations of the foreign jurisdictions. See Ross
v. Johns-Manville Corp., 766 F.2d 823, 827 (3d Cir. 1985). However, the Court has included those
foreign limitations periods below for reference.
Count Claim Limitations Period Analogous PA State
Limitations Period
3 Connecticut Unfair Three years. Conn. Gen. Stat. Six years. 42 Pa.
Trade Practices Act § 42-110g(f). C.S.A. § 5527(6);
(“CUPTA”) Morse v. Fisher Asset
Management, LLC, 206
A.3d 521, 526 (Pa.
Super. 2019).
4 Illinois Consumer Fraud Three years. 815 Ill. Comp. Six years. 42 Pa.
and Deceptive Practices Stat. 505/10a(e). C.S.A. § 5527(6);
Act (“CFA”) Morse v. Fisher Asset
Management, LLC, 206
A.3d 521, 526 (Pa.
Super. 2019).
5 Nebraska Consumer Four years. Neb. Rev. Stat. § Six years. 42 Pa.
Protection Act (“CPA”) 59-1612. C.S.A. § 5527(6);
Morse v. Fisher Asset
Management, LLC, 206
A.3d 521, 526 (Pa.
Super. 2019).
6 Florida Deceptive and Four years. Fla. Stat. § Six years. 42 Pa.
Unfair Trade Practices 95.11(3)(e). C.S.A. § 5527(6);
Act (“FDUTPA”) Morse v. Fisher Asset
Management, LLC, 206
A.3d 521, 526 (Pa.
Super. 2019).
7 Negligent Two years. 42 Pa. C.S. § N/A
Misrepresentation14 5524(7).
8 Aiding & Abetting/ Two years. Env’t Equip. & N/A
Conspiracy Serv. Co. v. Wachovia Bank,
N.A., 741 F. Supp. 2d 705, 727
(E.D. Pa. 2010) (aiding &
abetting); Hvizdak v. Citizens
Bank of Pa., 2015 WL
4878639, at *5 (W.D. Pa. Aug.
6, 2015) (conspiracy).
9 Unjust Enrichment Four years. Harry Miller N/A
Corp. v. Mancuso Chemicals
Ltd., 469 F. Supp. 2d 303, 319
(E.D. Pa. 2007).
13 Conspiracy to Two years. Hvizdak v. Citizens N/A
Defraud/Concerted Bank of Pennsylvania, 2015
Action WL 4878639, at *5 (W.D. Pa.
Aug. 6, 2015) (conspiracy).
14 Declaratory & Same as the underlying N/A
Injunctive Relief claims. Algrant v. Evergreen
Valley Nurseries Ltd. P’ship,
126 F.3d 178, 185 (3d Cir.
1997).
Plaintiffs argue that the doctrines of continuing violations and fraudulent concealment, as
well as the discovery rule save their claims from application of the statutes of limitations and that
those defenses are “well-pleaded in the Amended Complaint.” (ECF No. 28 at 22; Am. Compl. ¶¶
79, 312, 181, 185–93, 384, 453, 614, 648, 727f, 731, 803g.) However, the Court finds that none of
these doctrines save the lack of timeliness of Plaintiffs’ claims. Under the doctrine of fraudulent
14 Plaintiffs’ negligent misrepresentation claim appears to contemplate the application of
Pennsylvania law. (AC ¶ 713 (citing Bilt-Rite Contrs, Inc., v. Architectural Studio, 866 A.2d. 270,
273 n.1 (Pa. 2005)).
concealment, “the statute [of limitations] is tolled until plaintiffs knew or using reasonable
diligence should have known of the claim.” Hurley, 2020 WL 1624861, at *9 (citing Vernau v.
Vic’s Market, Inc., 896 F.2d 43, 46 (3d Cir. 1990)). Similarly, discovery rule tolls the statute of
limitations “whenever the plaintiff, despite the exercise of reasonable diligence, is unable to know
of the existence of the injury and its cause.” Bohus v. Beloff, 950 F.2d 919, 926 (3d Cir. 1991).
“The statute of limitations begins to run as soon as the plaintiff has discovered or, exercising
reasonable diligence, should have discovered the injury and its cause.” Id. at 925. As discussed
above, Plaintiffs were part of the Rockford class and therefore would have known of their claims
at least by the time that complaint was filed in 2017.
Finally, the continuing violations doctrine holds an action timely when “a defendant’s
conduct is part of a continuing practice . . . so long as the last act evidencing the continuing practice
falls within the limitations period; in such an instance, the court will grant relief for the earlier
related acts that would otherwise be time-barred.” Beltz v. Erie Indem. Co., 279 F. Supp. 3d 569,
582 (W.D. Pa. 2017), aff’d, 733 F. App’x 595 (3d Cir. 2018). However, the doctrine requires the
court to focus on “affirmative acts” rather than the effects of such acts. Id. The Amended
Complaint alleges that the exclusive arrangement between the Express Scripts Entities and
Mallinckrodt lasted from 2007 through 2017. (Am. Compl. ¶ 758.) It does not contain any
allegations of conduct within the limitations period—that is, after April 2017 if the Court is to use
the date that the Rockford complaint was filed—that could constitute a “continuing practice,” nor
do Plaintiffs explain what conduct would qualify as a “continuing practice” in their Response.
(ECF No. 28 at 22.)
Therefore, under relevant Pennsylvania law, the limitations periods have passed on
Plaintiffs’ aforementioned state law claims (Counts 3–9, 13–14) and they are dismissed with
prejudice.
IV. CONCLUSION
For the reasons discussed herein, the Court hereby grants Defendants’ Motion to Dismiss
with prejudice as to Counts 3–9 and 13–14, and without prejudice as to Counts 1–2 and 10–12.
The Court grants Plaintiffs leave to replead within 21 days of the date of this order to correct the
deficiencies as noted in this opinion. An appropriate order follows.
BY THE COURT:
/s/ Hon. Kelley B. Hodge
HODGE, KELLEY B., J.