Case 2:22-cv-05209 Document 1 Filed 12/29/22 Page 1 of 87
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`UNITED STATES DISTRICT COURT
`FOR THE EASTERN DISTRICT OF PENNSYLVANIA
`
`
`
`UNITED STATES OF AMERICA,
`
`
`Plaintiff,
`
`
`
`v.
`
`AMERISOURCEBERGEN CORPORATION;
`AMERISOURCEBERGEN DRUG
`CORPORATION; and INTEGRATED
`COMMERCIALIZATION SOLUTIONS, LLC,
`
`
`Jury Trial Demanded
`
`Civ. A. No.
`
`
`
`
`
`
`Defendants.
`
`
`
`
`
`
`
`
`COMPLAINT
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`

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`Case 2:22-cv-05209 Document 1 Filed 12/29/22 Page 2 of 87
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`TABLE OF CONTENTS
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`2.
`
`2.
`
`3.
`
`INTRODUCTION .......................................................................................................................... 1
`PARTIES ........................................................................................................................................ 3
`JURISDICTION AND VENUE ..................................................................................................... 4
`BACKGROUND ............................................................................................................................ 5
`I.
`Defendants’ obligations under the CSA ............................................................................. 5
`A.
`Controlled substances generally ............................................................................. 5
`B.
`The CSA creates a closed system for regulating controlled substances ................. 7
`C.
`Distributors must abide by certain legal obligations when they receive
`controlled-substance orders from customers .......................................................... 8
`1.
`Distributors must report suspicious orders of controlled substances,
`including but not limited to orders of unusual size, orders deviating
`substantially from a normal pattern, and orders of unusual frequency ....... 9
`Failure to report a suspicious order is punishable by a civil penalty
`and injunctive relief .................................................................................. 11
`Defendants’ controlled-substance businesses ................................................................... 12
`A.
`ABC distributes drugs through a network of subsidiaries .................................... 12
`B.
`Defendants sell huge quantities of controlled substances, and controlled
`substances are a significant source of revenue for Defendants ............................. 13
`ABC has, at all relevant times, been responsible for certain aspects of the
`other Defendants’ CSA compliance...................................................................... 16
`Defendants’ CSA compliance programs suffered from serious systemic defects that
`enabled significant CSA violations ................................................................................... 17
`A.
`Defendants grossly underfunded their CSA compliance programs ...................... 18
`B.
`Defendants adopted, but did not adequately implement, Know Your Customer
`policies, which facilitated Defendants’ servicing of problematic customers ....... 20
`1.
`ABC allowed sales personnel—who were incentivized to recruit and retain
`customers—to conduct due diligence rather than compliance personnel . 22
`In violation of their own policies, Defendants did not obtain the
`diligence information necessary to assess the possible risks associated
`with prospective customers ....................................................................... 23
`Defendants ignored, or failed to address, red flags of diversion and
`other problems, including when alleged diligence information
`conflicted with a customer’s actual practices ........................................... 23
`ABC designed ABDC’s Order Monitoring Program to flag for review only
`orders that exceeded certain statistical thresholds ................................................ 25
`
`II.
`
`III.
`
`C.
`
`C.
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`

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`D.
`
`ABDC’s original Order Monitoring Program applied high thresholds
`for identifying suspicious orders, and CSRA sometimes raised
`thresholds upon request............................................................................. 25
`ABDC’s original Order Monitoring Program relied exclusively on
`numerical order thresholds and did not monitor for other suspicious
`practices .................................................................................................... 27
`Beginning in 2014, ABC created a revised order monitoring program that
`sharply cut the number of suspicious-order reports to DEA ................................. 28
`1.
`ROMP flagged only orders that were both unusual in size and pattern
`or of extraordinarily unusual pattern......................................................... 29
`ABC designed ROMP recognizing it would flag fewer orders for
`review and report fewer orders to DEA .................................................... 31
`The human review element of the ABDC order monitoring program was
`grossly insufficient ................................................................................................ 33
`1.
`For a portion of the relevant period, ABC tasked insufficiently trained
`distribution center personnel—not compliance personnel—with
`reviewing many suspicious orders, including opioid orders ..................... 34
`Even when flagged orders were reviewed by alleged compliance
`personnel, ABC devoted inadequate resources towards that task,
`resulting in cursory, if not non-existent, reviews ...................................... 35
`ABC’s order reviewers did not have access to information and did
`not receive adequate training needed to conduct investigations ............... 37
`The compliance program for ICS suffered similar defects ................................... 39
`F.
`Defendants violated the CSA by refusing or negligently failing to report suspicious
`orders of controlled substances ......................................................................................... 41
`A.
`Defendants violated the CSA by failing to report suspicious orders placed by
`customers Defendants had notice were likely facilitating diversion .................... 42
`1.
`Pharmacy 1 (Fort Lee, NJ) ........................................................................ 43
`2.
`Pharmacy 2 (Trenton, NJ) ......................................................................... 51
`3.
`Pharmacy 3 (Beckley, WV) ...................................................................... 54
`4.
`Pharmacy 4 (Gainesville, FL) ................................................................... 58
`5.
`Pharmacy 5 (Lakewood, CO) ................................................................... 61
`Defendants violated the CSA by failing to report flagged suspicious orders
`that Defendants’ reviewers confirmed were suspicious and therefore rejected .... 66
`Defendants violated the CSA by failing to report flagged suspicious orders
`for which they did not dispel suspicion ................................................................ 67
`1.
`Suspicious flagged ABDC orders falsely cleared as not subject to
`diversion or abuse ..................................................................................... 68
`Suspicious flagged ABDC orders cleared as typical ................................ 70
`
`IV.
`
`E.
`
`B.
`
`C.
`
`1.
`
`2.
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`2.
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`2.
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`3.
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`2.
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`

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`D.
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`Suspicious flagged ABDC orders cleared without justification ............... 72
`3.
`Suspicious flagged ICS orders .................................................................. 73
`4.
`Defendants violated the CSA by failing to report suspicious orders that they
`designed their thresholds not to flag ..................................................................... 74
`CLAIM FOR RELIEF .................................................................................................................. 77
`PRAYER FOR RELIEF ............................................................................................................... 78
`JURY DEMAND .......................................................................................................................... 78
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`

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`Case 2:22-cv-05209 Document 1 Filed 12/29/22 Page 5 of 87
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`The United States of America brings this civil enforcement action against
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`AmerisourceBergen Corporation, AmerisourceBergen Drug Corporation, and Integrated
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`Commercialization Solutions, LLC (collectively, “Defendants”) for their violations of the
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`Comprehensive Drug Abuse Prevention and Control Act of 1970, 21 U.S.C. §§ 801 et seq.
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`(“Controlled Substances Act” or “CSA”). In support of this complaint, the United States alleges
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`as follows:
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`INTRODUCTION
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`1.
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`The opioid epidemic has had profound and devastating effects on this country and
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`its citizens. This action seeks to hold Defendants civilly liable for their role in this epidemic.
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`2.
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`Because of their significant potential for diversion and abuse, opioids and other
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`controlled substances are regulated by the CSA and the implementing regulations issued by the
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`Drug Enforcement Administration (“DEA”).
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`3.
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`In order to prevent controlled substances from being diverted for illegal uses, the
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`CSA requires wholesalers that distribute controlled substances to pharmacies and other
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`customers to monitor their customers’ controlled-substance orders.
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`4.
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`A controlled-substance order that has an unusual size, deviates substantially from
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`a normal pattern, has an unusual frequency, or carries other indicia of suspicion must be reported
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`to DEA unless the distributor conducts an investigation that dispels all suspicion. If suspicion
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`remains after an investigation, or if no investigation is undertaken, the distributor must report the
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`order to DEA, regardless of whether the distributor fills the order.
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`5.
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`This legal obligation requires distributors either to look into their customers’
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`orders if there is suspicious activity and resolve the suspicion or to alert DEA to their customers’
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`suspicious behavior.
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`1
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`6.
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`AmerisourceBergen Corporation, one of the largest and highest-earning
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`companies in the country, has for years violated this critical responsibility in distributing
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`controlled substances to customers across the country.
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`7.
`
`8.
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`Defendants violated their obligation to report suspicious orders in multiple ways.
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`Defendants repeatedly refused or negligently failed to report suspicious orders
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`placed by pharmacy customers that Defendants had reason to know were allowing opioids and
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`other controlled substances to be diverted into illegal channels. This includes instances in which
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`Defendants knew that opioids they distributed were likely being sold in pharmacies’ parking lots
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`for cash but they continued to supply those pharmacies with huge amounts of opioids anyway. It
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`also includes an instance in which an AmerisourceBergen Corporation employee identified
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`specific problematic customers of a pharmacy and raised the question of whether they were
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`“drug addict[s]” who were feeding their opioid addictions with drugs obtained from the
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`pharmacy, but Defendants continued to flood the pharmacy with massive quantities of opioids
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`for years after. Two of the customers whom the employee identified later died of drug overdoses
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`shortly after buying opioids from that pharmacy.
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`9.
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`On numerous occasions, Defendants failed to report to DEA opioid and other
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`controlled-substance orders that Defendants themselves confirmed were so suspicious that they
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`could not be shipped.
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`10.
`
`In even more instances, Defendants failed to report opioid and other controlled-
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`substance orders that were flagged for review by their own order monitoring systems as bearing
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`signs of suspicion, but for which Defendants failed to dispel suspicions through investigations.
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`11.
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`Finally, on many occasions, Defendants failed to report suspicious orders that
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`their faulty electronic order monitoring algorithms did not flag for review. Defendants’ order
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`2
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`

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`monitoring systems were deeply deficient in both design and implementation—flagging only a
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`tiny fraction of customers’ highly unusual controlled-substance orders and ultimately enabling
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`diversion of controlled substances, which fueled the country’s opioid epidemic. Indeed, in the
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`midst of the opioid epidemic, AmerisourceBergen Corporation intentionally altered the order
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`monitoring system for its largest subsidiary, Defendant AmerisourceBergen Drug Corporation, in
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`a way that dramatically reduced the number of controlled-substance orders reviewed by
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`employees.
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`12.
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`Defendants have for years flouted their legal obligations and prioritized profits
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`over the well-being of Americans. The United States brings this suit to hold Defendants
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`accountable for their egregious failure to report suspicious orders and their role in contributing to
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`the opioid epidemic.
`
`PARTIES
`
`Plaintiff is the United States of America.
`
`Defendant AmerisourceBergen Corporation (“ABC”) is a corporation
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`13.
`
`14.
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`incorporated in the State of Delaware, with its principal place of business in the Eastern District
`
`of Pennsylvania.
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`15.
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`Defendant AmerisourceBergen Drug Corporation (“ABDC”) is a corporation
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`incorporated in the State of Delaware, with its principal place of business in the Eastern District
`
`of Pennsylvania.
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`16.
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`Defendant Integrated Commercialization Solutions, LLC (“ICS”) is a California
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`limited liability company. It is the successor to Integrated Commercialization Solutions, Inc.,
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`which converted to a limited liability company on March 31, 2017. The pre-conversion and
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`post-conversion corporate entities are both referred to herein as “ICS.”
`
`3
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`

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`17.
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`Defendants ABDC and ICS are subsidiaries of ABC, and they are subject to
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`ABC’s ultimate control in certain relevant respects, as described below.
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`18.
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`ABC, as the parent company based in Pennsylvania, provides various shared
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`personnel and services utilized by all Defendants, including ABC’s Corporate Security and
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`Regulatory Affairs Department (“CSRA”), which has responsibility for certain aspects of
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`Defendants ABDC and ICS’s CSA compliance.
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`19.
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`According to CSRA’s charter, CSRA is administered under the authority of
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`ABC’s legal department, and it takes direction from ABC’s Board of Directors and ABC’s
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`Ethics Committee.
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`20.
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`Defendants have repeatedly represented that ABDC and ICS rely on ABC’s
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`officers or executives to serve as their officers or executives.
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`JURISDICTION AND VENUE
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`21.
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`This Court has subject matter jurisdiction over this action under 28 U.S.C.
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`§§ 1331, 1345, and 1355(a), and 21 U.S.C. §§ 842(c)(1) and 843(f)(2).
`
`22.
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`This Court has personal jurisdiction over ABC because ABC’s principal place of
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`business is in Pennsylvania, ABC is doing business in Pennsylvania, and the United States’
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`claims against ABC arise out of and relate to ABC’s activities in Pennsylvania.
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`23.
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`This Court has personal jurisdiction over ABDC because ABDC’s principal place
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`of business is in Pennsylvania, ABDC is doing business in Pennsylvania, and the United States’
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`claims against ABDC arise out of and relate to ABDC’s activities in Pennsylvania.
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`24.
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`This Court has personal jurisdiction over ICS because ICS is doing business in
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`Pennsylvania, and because ICS purposefully directed its activities at Pennsylvania, the home of
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`ABC, whose CSRA handled and exercised control over certain aspects of ICS’s CSA compliance
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`functions. CSRA also implemented enterprise-wide policies that governed ICS’s CSA
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`4
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`

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`compliance and its reporting of suspicious orders of controlled substances. And under policies
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`implemented by both ABC and ICS, CSRA was responsible for reporting suspicious orders
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`received by ICS. This litigation relates to activities that Pennsylvania-based ABC performed for
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`ICS and/or activities that ICS directed at Pennsylvania by relying on CSRA to report suspicious
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`orders and perform certain other CSA compliance functions. Moreover, there was a
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`manifestation that ABC would act for ICS with respect to certain aspects of CSA compliance and
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`with respect to suspicious-order reporting, and ICS and ABC each accepted the understanding
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`that Pennsylvania-based ABC, acting through CSRA personnel, was responsible for and in
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`control of those undertakings. Alternatively, the Court has pendent jurisdiction over ICS
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`because the United States’ claims arise from a common nucleus of operative facts, and the
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`exercise of pendent jurisdiction serves the interests of judicial economy, convenience, and
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`fairness.
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`25.
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`Venue is proper in this District under 28 U.S.C. §§ 1391 and 1395(a) and 21
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`U.S.C. § 843(f) because each Defendant resides in, can be found in, and does business in this
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`District, because a substantial part of the events or omissions giving rise to the claims occurred
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`in this District, and because claims accrued in this District.
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`I.
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`DEFENDANTS’ OBLIGATIONS UNDER THE CSA
`
`BACKGROUND
`
`A.
`
`26.
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`Controlled substances generally
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`The CSA creates a category of drugs, known as “controlled substances,” that are
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`subject to strict federal monitoring and regulation based on their potential for abuse. Controlled
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`substances are categorized into five schedules based on several factors, including whether they
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`have a currently accepted medical use to treat patients, their abuse potential, and the likelihood
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`5
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`

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`they will cause dependence if abused. A drug becomes a “controlled substance” when it is added
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`to one of these five schedules.
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`27.
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`Schedule I controlled substances have a high potential for abuse and have no
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`currently accepted use in medical treatment in the United States. There is also a lack of accepted
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`safety for use of these substances under medical supervision. 21 U.S.C. § 812(b)(1). Heroin, for
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`instance, is a Schedule I controlled substance.
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`28.
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`The remaining schedules—Schedules II through V—are relevant to this case. The
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`drugs in these schedules have legitimate medical purposes when used properly and require a
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`prescription, with certain exceptions. See 21 U.S.C. § 829; 21 C.F.R. §§ 1306.11, 1306.21,
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`1306.26. By definition, all scheduled drugs are susceptible to abuse, either alone or in
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`combination with other substances.
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`29.
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`Schedule II includes controlled substances that have “a high potential for abuse”;
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`that, if abused, “may lead to severe psychological or physical dependence”; but that nonetheless
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`have “a currently accepted medical use in treatment in the United States or a currently accepted
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`medical use with severe restrictions.” 21 U.S.C. § 812(b)(2). Schedule II includes, among other
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`substances, opioids such as oxycodone, hydrocodone, and methadone, and stimulants such as
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`amphetamine. See 21 C.F.R. § 1308.12.
`
`30.
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`Schedule III includes controlled substances that have “a potential for abuse less
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`than the drugs or other substances in schedules I and II”; that, if abused, “may lead to moderate
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`or low physical dependence or high psychological dependence”; but that nonetheless have “a
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`currently accepted medical use in treatment in the United States.” 21 U.S.C. § 812(b)(3).
`
`31.
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`Schedule IV includes controlled substances that have “a low potential for abuse
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`relative to the drugs or other substances in schedule III”; that, if abused, “may lead to limited
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`6
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`
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`physical dependence or psychological dependence relative to the drugs or other substances in
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`schedule III”; but that nonetheless have “a currently accepted medical use in treatment in the
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`United States.” 21 U.S.C. § 812(b)(4). Schedule IV includes, among other substances,
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`alprazolam (commonly sold under the brand name Xanax), diazepam (commonly sold under the
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`brand name Valium), and lorazepam (commonly sold under the brand name Ativan). See 21
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`C.F.R. § 1308.14.
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`32.
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`Schedule V includes controlled substances that have “a low potential for abuse
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`relative to the drugs or other substances in schedule IV”; that, if abused, “may lead to limited
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`physical dependence or psychological dependence relative to the drugs or other substances in
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`schedule IV”; but that nonetheless have “a currently accepted medical use in treatment in the
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`United States.” 21 U.S.C. § 812(b)(5).
`
`B.
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`33.
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`The CSA creates a closed system for regulating controlled substances
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`The CSA seeks to prevent diversion and abuse of controlled substances. To
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`accomplish this goal, the CSA establishes a closed system for regulating and monitoring
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`controlled substances, under which it is unlawful to distribute or dispense any controlled
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`substance, except in a manner authorized by law.
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`34.
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`The CSA and its implementing regulations govern every step in the handling of
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`controlled substances, from their production in a manufacturing facility to their distribution to a
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`pharmacy or other purchaser, and from their prescription by a medical practitioner to their
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`dispensing by a pharmacy filling a prescription for a patient.
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`35.
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`The system is “closed” in that each part of the supply chain—including
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`manufacturers, distributors, prescribers, and pharmacies—must register with DEA and comply
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`with the CSA and its implementing regulations. See 21 U.S.C. §§ 822(a) and 823(f).
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`7
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`36.
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`Entities that register with DEA (known as “registrants”) agree to comply with the
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`CSA and its implementing regulations, and may manufacture, distribute, prescribe, or dispense
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`controlled substances only to the extent authorized by their registration and the law. See 21
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`U.S.C. §§ 822(a)–(b), 823(f).
`
`C.
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`Distributors must abide by certain legal obligations when they receive
`controlled-substance orders from customers
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`37.
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`The CSA defines a “distributor” as a person or an entity that delivers (other than
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`by administering or dispensing) a controlled substance. 21 U.S.C. § 802(11).
`
`38.
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`The CSA defines “delivery” as the “actual, constructive, or attempted transfer of a
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`controlled substance.” See 21 U.S.C. §§ 802(8), (11).
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`39.
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`Defendants ABDC and ICS are distributors of controlled substances within the
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`meaning of the CSA.
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`40.
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`Distributors of controlled substances are required by the CSA to register with
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`DEA and to maintain effective controls against the diversion of controlled substances for
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`illegitimate uses. See, e.g., 21 U.S.C. § 823(b)(1); see also 21 C.F.R. § 1301.71(a).
`
`41.
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`A distributor that fails to maintain effective controls against diversion may have
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`its DEA registration(s) revoked and thus lose its ability to distribute controlled substances. See
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`21 U.S.C. §§ 823(b)(1), (e)(1), 824(a)(4).
`
`42.
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`Distributors are a critical part of the “closed” system of regulating and delivering
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`controlled substances because they are the connective link between the manufacturers of
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`pharmaceutical products and the retail pharmacies, hospitals, and other entities at which
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`individuals fill prescriptions for pharmaceutical products.
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`43.
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`Distributors have a unique understanding of controlled-substance usage and
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`trends because they monitor and maintain the supply chain.
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`8
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`
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`1.
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`Distributors must report suspicious orders of controlled substances,
`including but not limited to orders of unusual size, orders deviating
`substantially from a normal pattern, and orders of unusual frequency
`
`44.
`
`It is unlawful for a distributor to distribute a controlled substance “[e]xcept as
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`authorized” by the CSA. 21 U.S.C. § 841(a).
`
`45.
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`The CSA provides the Attorney General with broad authority to “promulgate and
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`enforce any rules, regulations, and procedures which he may deem necessary and appropriate for
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`the efficient execution of his functions under this subchapter.” 21 U.S.C. § 871(b); see also 21
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`U.S.C. § 821. The Attorney General has issued numerous regulations establishing an extensive
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`regulatory regime governing controlled substances. See 21 C.F.R. §§ 1300.01–1321.01.
`
`46.
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`Regulations promulgated by the Attorney General to implement the CSA have
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`long required each distributor to design and operate a system to identify suspicious orders of
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`controlled substances, and to report suspicious orders to DEA.
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`47.
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`21 C.F.R. § 1301.74(b) provides: “The registrant shall design and operate a
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`system to disclose to the registrant suspicious orders of controlled substances. The registrant
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`shall inform [DEA] of suspicious orders when discovered by the registrant. Suspicious orders
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`include orders of unusual size, orders deviating substantially from a normal pattern, and orders of
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`unusual frequency.” Id.
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`48.
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`“Suspicious orders,” however, are not limited to those three non-exclusive
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`categories. A controlled-substance order is also suspicious if it has one or more indicia of
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`suspicion other than unusual size, unusual pattern, or unusual frequency.
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`49.
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`“A pharmacy’s business model, dispensing patterns, or other characteristics might
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`make an order suspicious, despite the particular order not being of unusual size, pattern, or
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`frequency[,]” so “orders placed by a pharmacy which engages in suspicious activity, but places
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`orders of regular size, pattern, and frequency, could still be deemed suspicious.” In re Masters
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`9
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`
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`Pharm., Inc., 80 Fed. Reg. 55418, 55477 (Drug Enf’t Admin. 2015), pet. for review denied sub
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`nom. Masters Pharm., Inc. v. DEA, 861 F.3d 206 (D.C. Cir. 2017).
`
`50.
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`Thus, “a registrant cannot ignore information it obtains that raises a suspicion not
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`only with respect to a specific order, but also as to the legitimacy of a customer’s business
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`practices.” Id. at 55478.
`
`51.
`
`On October 24, 2018, the President signed into law the Substance Use-Disorder
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`Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of
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`2018 (the “SUPPORT Act”), which codified these existing regulatory requirements into the
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`CSA’s statutory text. Since the effective date of the SUPPORT Act, the CSA statutory language
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`has obligated each distributor to design and operate a system to identify suspicious orders of
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`controlled substances, and to report suspicious orders to DEA. See 21 U.S.C. § 832(a). The
`
`relevant provision mandates that “[e]ach registrant shall (1) design and operate a system to
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`identify suspicious orders for the registrant; (2) ensure that the system designed and operated
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`under paragraph (1) by the registrant complies with applicable Federal and State privacy laws;
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`and (3) upon discovering a suspicious order or series of orders, notify [DEA].” Id.
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`52.
`
`The SUPPORT Act also incorporates the regulatory language defining a
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`“suspicious order.” The CSA states that a “suspicious order” includes but is “not limited to
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`(A) an order of a controlled substance of unusual size; (B) an order of a controlled substance
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`deviating substantially from a normal pattern; and (C) orders of controlled substances of unusual
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`frequency.” 21 U.S.C. § 802(57).
`
`53.
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`Both prior to, and after, the enactment of the SUPPORT Act, upon discovering an
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`order with one or more indicia of suspicion, a distributor was and always has been required to
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`10
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`report the order to DEA, unless the distributor investigates the order and dispels all suspicion
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`relating to the order.
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`54.
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`If, and only if, the distributor dispels all suspicion through an adequate
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`investigation may the distributor determine that the order is not suspicious and need not be
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`reported to DEA.
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`55.
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`If a distributor does not dispel all suspicion through an investigation, then the
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`distributor must report the order to DEA.
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`56.
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`These obligations apply to each suspicious order a distributor receives, whether or
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`not the distributor fills the order.
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`57.
`
`One purpose of the suspicious order reporting requirement is to provide DEA
`
`investigators in the field with information regarding potential illegal activity in an expeditious
`
`manner.
`
`2.
`
`Failure to report a suspicious order is punishable by a civil penalty
`and injunctive relief
`
`58.
`
`It is unlawful for any person “to refuse or negligently fail to make, keep, or
`
`furnish any record, report, notification, . . . or information required under this subchapter.” 21
`
`U.S.C. § 842(a)(5). A person who refuses or negligently fails to make a required suspicious
`
`order report to DEA is thus liable for a civil penalty and injunctive relief. 21 U.S.C. §§ 842(c),
`
`843(f).
`
`59.
`
`These statutory provisions apply to both registrants and to persons responsible for
`
`a registrant’s compliance with the CSA. See United States v. Ahmad, Civ. A. No. 15-181, 2016
`
`WL 11645908, at *3-4 (E.D. Ark. May 2, 2016), aff’d sub nom., United States v. United Pain
`
`Care, Ltd., 747 Fed. Appx. 439 (8th Cir. 2019); United States v. Clinical Leasing Serv., Inc., 759
`
`F. Supp. 310, 313-14 (E.D. La. 1990), aff’d, 925 F.2d 120 (5th Cir. 1991).
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`Case 2:22-cv-05209 Document 1 Filed 12/29/22 Page 16 of 87
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`
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`60.
`
`Between January 1, 2014 and November 2, 2015, the CSA provided a maximum
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`civil penalty of $10,000 for each refusal or negligent failure to file a required report. See 21
`
`U.S.C. § 842(c)(1)(A), (B).
`
`61.
`
`The maximum civil penalty increased to $16,864 per-violation, due to regulatory
`
`adjustments reflecting increases in cost of living, effective November 3, 2015. 28 C.F.R. § 85.5.
`
`62.
`
`Effective October 24, 2018, the SUPPORT Act distinguishes between penalties
`
`for non-opioid-related reporting violations and opioid-related reporting violations. The
`
`maximum penalty for non-opioid violations occurring on or after October 24, 2018 remains
`
`$16,864 per violation. See 21 U.S.C. § 842(c)(1)(B)(i); 28 C.F.R. § 85.5. But the maximum
`
`penalty for refusing or negligently failing to report a suspicious order of opioids (as defined in 21
`
`U.S.C. § 802(18)) is $109,374 for each violation occurring on or after October 24, 2018. See 21
`
`U.S.C. § 842(c)(1)(B)(ii); 28 C.F.R. § 85.5.
`
`II.
`
`DEFENDANTS’ CONTROLLED-SUBSTANCE BUSINESSES
`
`ABC distributes drugs through a network of subsidiaries
`
`ABC is one of the largest pharmaceutical distribution companies in the United
`
`A.
`
`63.
`
`States.
`
`64.
`
`ABC is also one of the ten largest companies in the country by revenue. For the
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`fiscal year that ended on September 30, 2022, ABC reported revenues of more than $238 billion,
`
`with gross profits of just under $8.3 billion.
`
`65.
`
`ABC distributes pharmaceuticals, including controlled substances, to thousands of
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`customers throughout the United States.
`
`66.
`
`ABC operates through a network of subsidiaries, including Defendants ABDC
`
`and ICS. It is these subsidiaries, not ABC itself, that serve as the DEA registrants for
`
`Defendants’ various drug distribution centers.
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`Case 2:22-cv-05209 Document 1 Filed 12/29/22 Page 17 of 87
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`
`
`67.
`
`68.
`
`Defendant ABDC is the DEA registrant for at least 25 distribution centers.
`
`ABDC’s distribution centers are in the following localities: Bethlehem,
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`Pennsylvania; Romeoville, Illinois; Lockbourne, Ohio; Kansas City, Missouri; Shakopee,
`
`Minnesota; Williamston, Michigan; Buford, Georgia; Roanoke, Texas; Sugar Land, Texas;
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`Orlando, Florida; Mansfield, Massachusetts; Morrisville, North Carolina; Glen Allen, Virginia;
`
`North Amityville, New York; Newburgh, New York; Corona, California; Denver, Colorado;
`
`Honolulu, Hawaii; Phoenix, Arizona; Sacramento, California; Salt Lake City, Utah; Des Moines,
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`Washington; Olive Branch, Mississippi; Whitestown, Indiana; and Louisville, Kentucky.
`
`69.
`
`Defendant ABDC has also been the registrant for at least nine other distribution
`
`centers since January 1, 2014, but those registrations are now retired.
`
`70.
`
`71.
`
`Defendant ICS is the DEA registrant for at least three distribution centers.
`
`ICS’s distributi