Opinion

Opinion

Court
District Court, E.D. Pennsylvania
Filed
Mar 5, 2026
Cited by
0 cases
Authority
More cited than 41.0%

“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.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.

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