`
`IN THE UNITED STATES DISTRICT COURT
`
`FOR THE DISTRICT OF DELAWARE
`
`
`
`
`UNITED STATES OF AMERICA,
`
`
`Plaintiff,
`
`
`
`v.
`
`
`WALMART INC. AND WAL-MART STORES
`EAST, LP,
`
`
`Defendants.
`
`
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`)
`
`
`
`
`
`Jury Trial Demanded
`
`Case No. ______________
`
`
`
`
`
`
`
`
`
`
`
`COMPLAINT
`
`
`
`
`
`
`
`Case 1:20-cv-01744-UNA Document 1 Filed 12/22/20 Page 2 of 160 PageID #: 2
`
`TABLE OF CONTENTS
`
`INTRODUCTION .......................................................................................................................... 5
`A. As a pharmacy, Walmart violated the rules for dispensing controlled substances. ......... 8
`B. As a distributor, Walmart violated its duty to detect and report suspicious orders of
`controlled substances. ..................................................................................................... 12
`C. Walmart systematically violated the CSA even as it recognized the prescription
`drug abuse epidemic gripping the nation. ....................................................................... 14
`
`PARTIES ...................................................................................................................................... 16
`
`JURISDICTION AND VENUE ................................................................................................... 17
`
`I. WALMART’S CSA OBLIGATIONS AS A PHARMACY AND A DISTRIBUTOR. ..... 17
`A. Controlled substances generally. .................................................................................... 17
`B.
`The CSA creates a closed system for regulating controlled substances. ........................ 19
`C. A pharmacy must comply with certain rules before it fills a controlled-substance
`prescription. .................................................................................................................... 20
`1. The pharmacist must determine whether the prescription was issued in the usual
`course of professional practice and for a legitimate medical purpose. ........................ 22
`2. The pharmacist also must adhere to professional pharmacist practice standards,
`which require identifying and resolving any “red flags.” ............................................ 23
`3. Violations of these dispensing rules subject the pharmacy to civil penalties and
`other appropriate relief. ................................................................................................ 25
`D. Distributors must abide by certain legal obligations when they receive controlled-
`substance orders from pharmacies. ................................................................................. 27
`1. Distributors must detect and report suspicious orders. ................................................ 27
`2. Failure to report suspicious orders subjects the distributor to civil penalties. ............. 28
`
`II.
`
`WALMART, AS A PHARMACY, VIOLATED THE CSA. ........................................ 29
`A. Walmart impeded its pharmacists’ ability to comply with the legal requirements for
`dispensing controlled substances. ................................................................................... 31
`1. Walmart managers pressured pharmacists to fill prescriptions as quickly as
`possible. ........................................................................................................................ 31
`2. Walmart’s compliance unit chose not to give its pharmacists the information and
`authority it knew they needed to comply with the rules. ............................................. 36
`a. Consistent with the CSA, Walmart’s own policy required pharmacists to identify
`and resolve red flags, and to document any resolution of red flags. ......................... 36
`b. After Walmart was accused of dispensing violations, it committed to adopting a
`nationwide compliance program to identify red flags and prevent diversion. .......... 40
`c. While Walmart’s compliance unit did compile red-flag information, it chose not
`to disseminate that information to pharmacists. ........................................................ 41
`d. Walmart prohibited its pharmacists from refusing to fill, as a blanket matter, all
`prescriptions issued by pill-mill prescribers. ............................................................. 48
`
`2
`
`
`
`Case 1:20-cv-01744-UNA Document 1 Filed 12/22/20 Page 3 of 160 PageID #: 3
`
`B.
`
`Even after Walmart pharmacists identified pill-mill prescribers who were issuing
`invalid prescriptions, Walmart kept filling their prescriptions. ...................................... 50
`1. D.C.: “95% of the prescriptions from this prescriber are for controlled
`substances” ................................................................................................................... 52
`2. F.B.: “Always writes excessive quantities for all of his patients” .............................. 53
`3. F.T.: Prescribed “too many [drugs] for one person to take” ...................................... 56
`4. G.G.: “gives patients what they want and [does] not practice real medicine.” ........... 57
`5. G.H. and R.M.: “well known as a pill mill” ................................................................ 60
`6. H.D.: “filling for him is a risk that keeps me up at night”; “our concerns are
`falling upon deaf ears” ................................................................................................. 63
`J.F.: Prescriber of very heavy doses ............................................................................ 67
`7.
`J.I.: A “known pill-mill doctor” .................................................................................. 69
`8.
`9. M.L.: “continually writes for high quantities of narcotics” ........................................ 71
`10. M.M.: A “known pill mill” who sent his patients to Walmart .................................... 72
`11. M.N-A.: “many DEA red flags present” ..................................................................... 76
`12. P.T.: “too many questions regarding the ethics and integrity of this physician” ........ 77
`13. R.K.: Filling prescriptions from this “pill mill” was “putting pharmacists and
`Walmart in a bad situation legally” .............................................................................. 79
`14. R.M.: Prescriptions “are likely not prescribed for ethical purposes” .......................... 81
`15. R.P.: “horrendous prescribing practices”; “customers that were under the
`influence tell me that this doctor will write whatever they want” ............................... 83
`16. R.W.: Prescribed “cocktails” and recommended patients fill at Walmart .................. 85
`17. S.K.: “there is no way that many 25 year olds need 120 to 240 oxycodone per
`month” .......................................................................................................................... 86
`18. V.S.: A “shady doctor” who “writes only controlled medications for every
`patient” ......................................................................................................................... 89
`19. W.W.: A “pill mill prescriber” for “drug-seekers” ..................................................... 90
`20. Z.B.: A “questionable” prescriber sending patients to fill at Walmart ....................... 92
`C. Walmart filled many prescriptions showing, on their face, such glaring red flags
`that its pharmacists would have known that the prescriptions had a very high
`probability of being invalid. ........................................................................................... 94
`1. Red Flag No. 1: Dangerous combinations of opioids ................................................. 95
`2. Red Flag No. 2: Dangerous “cocktails” of opioids and non-opioids. ....................... 101
`3. Red Flag No. 3: Repeated fills of very high dosages of opioids ............................... 108
`4. Red Flag No. 4: Schedule IIs filled unusually early ................................................. 109
`D. Walmart filled many invalid prescriptions that were the same or similar to other
`prescriptions Walmart pharmacists had previously identified as invalid for the same
`customer ....................................................................................................................... 112
`
`IN ITS ROLE AS A DISTRIBUTOR, WALMART VIOLATED THE CSA. ............ 116
`III.
`A. Walmart had access to a wealth of information and data such that it could readily
`have designed a system to adequately detect suspicious orders ................................... 116
`
`3
`
`
`
`Case 1:20-cv-01744-UNA Document 1 Filed 12/22/20 Page 4 of 160 PageID #: 4
`
`B.
`
`1. Walmart’s self-distribution to its own pharmacies gave it extensive knowledge
`and data about dispensing patterns and orders. .......................................................... 116
`2. Walmart had information on the millions of orders for controlled substances its
`pharmacies placed with—and received from—independent distributors .................. 120
`For years, Walmart knew of significant defects with its policies and procedures for
`detecting and reporting suspicious orders, but failed to fix them ................................. 121
`1. Prior to August 2015, Walmart had a rudimentary suspicious-order monitoring
`system that failed to adequately detect and report suspicious orders......................... 121
`a. Walmart failed to detect and report orders of unusual frequency or pattern ........... 124
`b. Walmart failed to adequately detect and report unusually large orders. ................. 125
`c. Walmart ignored specific signs of diversion from its own pharmacies. .................. 136
`d. Walmart failed to adequately staff and train its compliance personnel, and
`shipped flagged orders before compliance personnel could examine them. ........... 138
`e. Walmart routinely failed to investigate flagged “orders of interest” and report
`any orders to DEA that Walmart was unable to clear. ............................................ 141
`f. Walmart often failed to document its evaluation of flagged orders, which
`deprived Walmart of crucial information needed to assess subsequent orders. ...... 144
`2. From August 2015 through November 2017, Walmart adopted a modified system
`for detecting and reporting suspicious orders, but this system remained defective ... 145
`a. Despite the modifications to Reddwerks, many of the same flaws remained ......... 146
`b. Walmart continued to fail to report unusually large orders. .................................... 147
`c. Walmart set hard limits for pharmacies that had already placed suspicious
`orders—then disregarded those hard limits ............................................................. 151
`C. Walmart’s flawed approach to monitoring pharmacy orders resulted in a failure to
`detect and report at least hundreds of thousands of suspicious orders ......................... 153
`D. Walmart’s failure to detect and report suspicious orders deprived Walmart of the
`opportunity, during the prescription drug abuse epidemic, to timely address
`potentially unlawful conduct ........................................................................................ 154
`
`CLAIMS FOR RELIEF .............................................................................................................. 157
`
`PRAYER FOR RELIEF ............................................................................................................. 159
`
`
`
`
`
`
`4
`
`
`
`Case 1:20-cv-01744-UNA Document 1 Filed 12/22/20 Page 5 of 160 PageID #: 5
`
`
`
`The United States of America files this Complaint against Walmart Inc. and Wal-Mart
`
`Stores East, LP (collectively “Walmart”), and alleges as follows:
`
`INTRODUCTION
`
`1.
`
`The United States of America brings this civil enforcement action against
`
`Walmart for violations of the Comprehensive Drug Abuse Prevention and Control Act of 1970
`
`(“Controlled Substances Act” or “CSA”), 21 U.S.C. §§ 801 et seq.
`
`2.
`
`The CSA comprehensively regulates every participant in the supply chain for
`
`controlled substances, from manufacturers to wholesale distributors to retail pharmacies.
`
`Because controlled substances by definition are drugs with the potential for abuse, this
`
`comprehensive scheme is designed to prevent the “diversion”—i.e., the illegal misuse—of
`
`controlled substances, including prescription opioids. Under the CSA, every participant in the
`
`supply chain bears responsibility for preventing the misuse of controlled substances.
`
`3.
`
`Walmart operates more than 5,000 pharmacies nationwide that dispense
`
`prescription opioids and other controlled substances. In addition, until 2018, Walmart acted as a
`
`wholesale distributor of controlled substances for its own pharmacies.
`
`4.
`
`As both a pharmacy and a distributor, Walmart assumed critical gatekeeping
`
`responsibilities under the CSA. At two stages—when deciding whether to fill its pharmacies’
`
`wholesale orders for controlled substances from its distribution warehouse, and when deciding
`
`whether to fill individuals’ prescriptions for controlled substances—Walmart was required by the
`
`CSA to take steps to prevent the diversion of the prescription drugs it sold.
`
`5.
`
`As a nationwide dispenser and distributor of opioids, and given the sheer number
`
`of pharmacies it operates, Walmart was uniquely well positioned to prevent the illegal diversion
`
`of opioids. Yet, for years, as the prescription drug abuse epidemic ravaged the country, Walmart
`
`5
`
`
`
`Case 1:20-cv-01744-UNA Document 1 Filed 12/22/20 Page 6 of 160 PageID #: 6
`
`abdicated those responsibilities.
`
`6.
`
`First, as a pharmacy, Walmart knowingly violated well established rules requiring
`
`it to scrutinize controlled-substance prescriptions to ensure that they were valid—that is, issued
`
`by prescribers in a legitimate manner for legitimate purposes, not for purposes of abuse or other
`
`diversion. These rules required Walmart to recognize, investigate, and resolve signs of a
`
`prescription’s invalidity—“red flags,” in pharmacy terminology—prior to filling a controlled-
`
`substance prescription. Walmart was well aware of these rules, but made little effort to ensure
`
`that it complied with them. In fact, Walmart made it difficult for its pharmacists to follow the
`
`rules. Walmart managers put enormous pressure on pharmacists to fill prescriptions—requiring
`
`pharmacists to process a high volume of prescriptions as fast as possible, while at the same time
`
`denying them the authority to categorically refuse to fill prescriptions issued by prescribers the
`
`pharmacists knew were continually issuing invalid prescriptions. And while Walmart’s
`
`compliance unit collected voluminous information indicating that Walmart was routinely being
`
`asked to fill invalid controlled-substance prescriptions, that unit for years withheld that
`
`information from pharmacists and allowed them to continue dispensing opioids based on invalid
`
`prescriptions.
`
`7.
`
`As a result of Walmart’s failures to take seriously its gatekeeping duties as a
`
`pharmacy, Walmart—during the prescription drug abuse epidemic—unlawfully filled thousands
`
`upon thousands of invalid controlled-substance prescriptions.
`
`a.
`
`Walmart filled prescriptions issued by prescribers who Walmart
`
`pharmacists had repeatedly reported were acting as egregious “pill mills”—even when
`
`Walmart was alerted that other pharmacies were not filling prescriptions for those
`
`prescribers. In fact, some of those pill-mill prescribers specifically told their patients to
`
`6
`
`
`
`Case 1:20-cv-01744-UNA Document 1 Filed 12/22/20 Page 7 of 160 PageID #: 7
`
`fill their prescriptions at Walmart.
`
`b.
`
`Walmart also filled prescriptions with glaringly obvious red flags,
`
`such as prescriptions for “trinities” and other well-known and highly dangerous drug
`
`“cocktails” that Walmart pharmacists knew were predominantly sought by individuals
`
`engaging in drug abuse.
`
`c.
`
`And Walmart filled prescriptions that were the same or similar to
`
`other prescriptions it had previously recognized as invalid for the same customer—which
`
`meant that when a Walmart pharmacist recognized that a customer’s prescription was
`
`invalid, the customer could simply shop around for another Walmart pharmacist or store
`
`to fill the same or a similar prescription.
`
`8.
`
`Second, as a wholesale distributor, Walmart had a basic obligation to detect
`
`suspicious orders placed by its own pharmacies for controlled substances, and to report those
`
`orders to the Drug Enforcement Administration (“DEA”). Walmart knew that this rule was
`
`designed to prevent diversion of controlled substances and that it would face civil penalties and
`
`other potential enforcement if it failed to comply. And compliance could have been readily
`
`accomplished, as Walmart had not only adequate resources but also a wealth of information
`
`about its pharmacies. But for years, Walmart kept in place a system that it knew was failing to
`
`adequately detect and report suspicious orders. Walmart periodically considered fixing its
`
`system, but time and time again it chose not to spend the time, money, and effort needed to bring
`
`its process into compliance.
`
`9.
`
`Because Walmart shirked this key legal obligation as a distributor, Walmart failed
`
`to detect and report at least hundreds of thousands of suspicious orders. This failure enabled
`
`Walmart’s pharmacies to place and receive controlled-substance orders that went essentially
`
`7
`
`
`
`Case 1:20-cv-01744-UNA Document 1 Filed 12/22/20 Page 8 of 160 PageID #: 8
`
`unmonitored, even when those orders were suspicious and could have revealed that diversion
`
`was ongoing.
`
`10.
`
`Predictably, Walmart’s violations of the CSA as both a pharmacy and a
`
`distributor had disastrous results, harming individuals who filled their controlled-substance
`
`prescriptions at Walmart and then abused the drugs. And given the nationwide scale of those
`
`violations, Walmart’s failures to follow basic legal rules helped fuel a national crisis.
`
`11.
`
`Accordingly, the United States seeks civil penalties under the CSA and
`
`appropriate injunctive relief.
`
`A.
`
`As a pharmacy, Walmart violated the rules for dispensing controlled
`substances.
`
`12. Walmart is one of the country’s largest pharmacy chains. It operates more than
`
`5,000 pharmacies at Walmart-branded and Sam’s Club-branded retail stores nationwide.
`
`Through its pharmacies, Walmart dispenses controlled substances to individuals.
`
`13.
`
`As the final step in the supply chain before individuals receive controlled
`
`substances, pharmacies are the last line of defense in preventing abuse and misuse of controlled
`
`substances. The CSA and its implementing regulations therefore require pharmacies to comply
`
`with certain legal requirements before filling controlled-substance prescriptions.
`
`14.
`
`Specifically, under the CSA, pharmacies may dispense controlled substances only
`
`pursuant to a valid prescription. A prescription must satisfy two requirements to be valid—or, in
`
`CSA terminology, “effective.” It must be issued (1) for a legitimate medical purpose and (2) by
`
`a medical practitioner acting in the usual course of his or her professional practice. See 21
`
`C.F.R. § 1306.04(a).
`
`15.
`
`Additionally, in filling prescriptions for controlled substances, pharmacists are
`
`required to adhere to the usual course of professional pharmacy practice. See id. § 1306.06.
`
`8
`
`
`
`Case 1:20-cv-01744-UNA Document 1 Filed 12/22/20 Page 9 of 160 PageID #: 9
`
`When presented with a controlled-substance prescription, the pharmacist, in order to act in the
`
`usual course of professional practice, must identify and resolve any “red flags”—signs indicating
`
`the invalidity of the prescription—before filling the prescription.
`
`16. Walmart knew from its own past experience that if its pharmacists failed to
`
`comply with their legal obligations when dispensing controlled substances, Walmart could face
`
`enforcement action. As discussed below in Part II.A.2.b, DEA initiated an administrative
`
`proceeding in 2009 seeking to revoke Walmart’s registration for a pharmacy that DEA alleged
`
`had failed to comply with its legal obligations when filling controlled-substance prescriptions.
`
`17.
`
`To resolve that proceeding, Walmart entered into an agreement with DEA in 2011
`
`in which Walmart agreed to adopt a national compliance program intended to ensure that it
`
`fulfilled its legal obligations when filling controlled-substance prescriptions. Walmart also
`
`agreed to collect reports from its pharmacists when those pharmacists determined that controlled-
`
`substance prescriptions were invalid and refused to fill them.
`
`18.
`
`The many refusal-to-fill reports that Walmart collected were shocking. They
`
`revealed, over and over again, that all across the country, Walmart pharmacies were regularly
`
`being presented with invalid prescriptions. For example, Walmart pharmacists alerted
`
`Walmart’s compliance unit to numerous prescribers who were “known pill mills,” did “not
`
`practice real medicine,” had “horrendous prescribing practices,” and continually issued high-
`
`dose controlled-substance prescriptions for many individuals. In addition, the reports showed
`
`that Walmart pharmacists were repeatedly being presented with other prescriptions showing such
`
`obvious red flags on their face that Walmart pharmacists recognized the prescriptions as invalid.
`
`19. While Walmart’s compliance unit collected and compiled all this information
`
`about invalid prescriptions, it chose, for years, not to alert Walmart pharmacists so that they
`
`9
`
`
`
`Case 1:20-cv-01744-UNA Document 1 Filed 12/22/20 Page 10 of 160 PageID #: 10
`
`could use that information to determine whether to fill similar prescriptions. As a director in the
`
`compliance unit, B.N., acknowledged in an email, rather than analyzing the refusal-to-fill
`
`reports, the compliance unit viewed “[d]riving sales and patient awareness” as “a far better use of
`
`our Market Directors and Market Manager’s time.”
`
`20.
`
`At the same time, Walmart’s managers made it exceedingly difficult for its
`
`pharmacists to comply with their legal obligations, by pressuring them to fill prescriptions as
`
`quickly as possible. Managers told pharmacists that prescriptions had to be filled quickly
`
`because “shorter wait times keep patients in store.” They urged pharmacists to speed up the time
`
`it took to fill each prescription because filling prescriptions “is a battle of seconds” and “[w]ait
`
`times are our Achilles heel!” Pharmacists, in turn, complained to Walmart’s compliance unit
`
`that the high volume of prescriptions, combined with Walmart’s low staffing, “doesn’t allow
`
`time for individual evaluation of prescriptions.”
`
`21. Walmart’s approach led it to fill thousands upon thousands of controlled-
`
`substance prescriptions that Walmart knew, in multiple ways, were highly likely to be invalid.
`
`22.
`
`First, as discussed below in Part II.B, Walmart filled prescriptions that it knew
`
`were issued by “pill-mill” prescribers. Walmart’s compliance unit had compiled extensive
`
`evidence that these particular prescribers were writing prescriptions that were invalid—outside
`
`the usual course of professional practice, without a legitimate medical purpose, or both.
`
`Pharmacists reported that some prescribers told their patients to fill prescriptions at Walmart.
`
`For example, one pharmacist reported learning that a prescriber “tells his patients that only Wal-
`
`Mart will fill his prescriptions.” Pharmacists made the urgency of their reports clear. For
`
`example, one pharmacist reported that he had “too much invested in [his] career and family to
`
`continue to risk” filling prescriptions for a pill-mill prescriber. But the compliance unit
`
`10
`
`
`
`Case 1:20-cv-01744-UNA Document 1 Filed 12/22/20 Page 11 of 160 PageID #: 11
`
`knowingly withheld this information from Walmart pharmacists, even though it was apparent
`
`that Walmart pharmacists would be presented with many more prescriptions from these same
`
`problem prescribers. And, sure enough, for years, despite these unresolved red flags, Walmart
`
`continued to fill many more prescriptions issued by these known pill-mill prescribers.
`
`23.
`
`Second, as discussed below in Part II.C, Walmart filled numerous prescriptions
`
`that, on their face, showed such obvious red flags—such as highly dangerous, commonly abused
`
`“cocktails” of drugs, sometimes in alarmingly high quantities—that Walmart pharmacists would
`
`have known that the prescriptions had a very high probability of being invalid.
`
`24.
`
`Third, as discussed below in Part II.D, Walmart filled many prescriptions that
`
`pharmacists knew were invalid because the prescriptions presented the same or similar red flags
`
`as the same or similar prescriptions other Walmart pharmacists had previously recognized as
`
`invalid for the same patient.
`
`25.
`
`In all, from June 26, 2013, to the present (hereinafter referred to as the
`
`“Dispensing Violations Period”), Walmart filled thousands upon thousands of invalid
`
`prescriptions and, in doing so, repeatedly violated the CSA dispensing requirements identified in
`
`21 C.F.R. § 1306.04(a) and § 1306.06. Walmart filled prescriptions that it knew were not issued
`
`for a legitimate medical purpose, or were not issued by a medical practitioner acting in the usual
`
`course of his or her professional practice, or both, in violation of section 1306.04(a). And by
`
`filling those prescriptions despite the red flags, Walmart pharmacists failed to adhere to the usual
`
`course of professional pharmacy practice, in violation of section 1306.06.
`
`26. Walmart violated the CSA each time it violated 21 C.F.R. § 1306.04(a) or
`
`§ 1306.06 in dispensing a controlled substance. See 21 U.S.C. § 842(a)(1). For each violation,
`
`11
`
`
`
`Case 1:20-cv-01744-UNA Document 1 Filed 12/22/20 Page 12 of 160 PageID #: 12
`
`Walmart is liable for a civil penalty. See 21 U.S.C. § 842(c)(1). The Court also may grant
`
`injunctive relief to address and restrain these violations. See 21 U.S.C. § 843(f).
`
`B.
`
`As a distributor, Walmart violated its duty to detect and report suspicious
`orders of controlled substances.
`
`27.
`
`As relevant to this Complaint, Walmart also operated as a distributor of controlled
`
`substances between June 26, 2013, and November 29, 2017 (hereinafter referred to as the
`
`“Distribution Violations Period”). In this role, Walmart shipped controlled substances to its own
`
`pharmacies around the country.
`
`28.
`
`Distributors of controlled substances are required by the CSA to “design and
`
`operate a system to disclose to the registrant suspicious orders of controlled substances,” and
`
`“shall inform” DEA of those suspicious orders “when discovered.” See 21 C.F.R. § 1301.74(b).
`
`Thus, a distributor must itself detect and identify suspicious orders and report them to DEA.
`
`This requirement protects against diversion and abuse by requiring distributors to monitor
`
`pharmacies for warning signs of such misconduct.
`
`29.
`
`The regulation provides that suspicious orders “include orders of unusual size,
`
`orders deviating substantially from a normal pattern, and orders of unusual frequency.” Id. In
`
`other words, orders that are unusual in one or more of those three ways—size, pattern, or
`
`frequency—are deemed “suspicious orders,” and a distributor must detect and report them. The
`
`regulation does not limit “suspicious orders” to those three categories, however. It states, non-
`
`exclusively, that suspicious orders “include” those categories.
`
`30.
`
`As discussed below in Part III.A, because Walmart acted as its own distributor for
`
`controlled substances, it had a special advantage: Walmart had access to extensive data and
`
`other information that gave it the ability—had it wanted to—to investigate the circumstances
`
`underlying orders for controlled substances.
`
`12
`
`
`
`Case 1:20-cv-01744-UNA Document 1 Filed 12/22/20 Page 13 of 160 PageID #: 13
`
`31.
`
`Nevertheless, as discussed below in Part III.B, for years Walmart maintained a
`
`wholly inadequate system for detecting and reporting suspicious controlled-substance orders
`
`placed by its pharmacies. Because Walmart’s suspicious-order monitoring system suffered from
`
`numerous flaws, Walmart routinely failed to detect and report orders that exhibited unusual
`
`frequency, deviated from the normal ordering pattern, or were of unusual size. Although
`
`Walmart knew its flawed system did not comply with the CSA, for years Walmart failed to use
`
`its ample resources to remedy these deficiencies.
`
`32. Walmart’s compliance unit knew that Walmart could face penalties for not
`
`complying with its obligation to detect and report suspicious orders. For example, in 2014,
`
`Walmart considered modifying Walmart’s system to “avoid DEA enforcement as a result of non-
`
`compliance with 21 CFR 1301.74(b).”
`
`33.
`
`But rather than bringing its system into compliance with its legal obligations to
`
`detect and report all suspicious orders, Walmart again prioritized speed. Members of Walmart’s
`
`compliance unit complained that its system for receiving and shipping orders was so fast that it
`
`allowed only “limited time for evaluation” of each order, that there were “too many orders to
`
`review each line [of alerts] in detail,” and that Walmart’s system “did not allow alerted orders to
`
`be ‘held’ pending evaluation.”
`
`34.
`
`Because Walmart prioritized speed, it failed to detect and report most of the
`
`suspicious orders that it received from its pharmacies. As discussed below in Part III.C, due to
`
`Walmart’s defective systems, Walmart failed to detect and report at least hundreds of thousands
`
`of suspicious orders of controlled substances during the Distribution Violations Period. Over an
`
`approximately four-year period, a time during which Walmart shipped an estimated 37.5 million
`
`controlled-substance orders to its pharmacies, it reported only 204 suspicious orders to DEA—in
`
`13
`
`
`
`Case 1:20-cv-01744-UNA Document 1 Filed 12/22/20 Page 14 of 160 PageID #: 14
`
`other words, almost none. By comparison, during the same time period, Walmart’s back-up
`
`distributor, McKesson Corporation, which filled orders only when Walmart could not and which
`
`therefore shipped far fewer than 37.5 million orders, reported to DEA more than 13,000
`
`suspicious orders from Walmart pharmacies.
`
`35. Walmart’s grossly inadequate suspicious-order monitoring program contributed to
`
`its failure to stop diversion of controlled substances at its pharmacies, as discussed below in Part
`
`III.D. Walmart’s systematic, years-long failure to detect and report each of its suspicious orders
`
`created a major obstacle to efforts to combat the prescription drug abuse epidemic. Had the
`
`company identified and investigated its hundreds of thousands of suspicious orders, it could have
`
`stopped the pharmacies that were placing those orders from unlawfully filling controlled-
`
`substance prescriptions or otherwise contributing to the diversion of controlled substances.
`
`36.
`
`Even when Walmart did detect a suspicious order, it often already had shipped the
`
`order and did not have it shipped back. As a Senior Manager for Logistics observed in an email,
`
`“if we see an issue that suggests the product shouldn’t have shipped, we just leave it at the store
`
`and let it enter the market,” even though having the order shipped back “feels like the more
`
`socially responsible approach….”
`
`37.
`
`Each time Walmart failed to comply with its legal obligation to detect and report a
`
`suspicious order, it violated the CSA. Pursuant to 21 U.S.C. § 842(a)(5), it is unlawful for a
`
`distributor to refuse or negligently fail to make or furnish reports, notifications, or information
`
`that are required under the CSA. For each violation of 21 U.S.C. § 842(a)(5), Walmart is liable
`
`for a civil penalty. See 21 U.S.C. § 842(c)(1)(A), (B).
`
`C. Walmart systematically violated the CSA even as it recognized the
`prescription drug abuse epidemic gripping the nation.
`
`38.
`
`During the very period when Walmart was systematically failing to comply with
`
`14
`
`
`
`Case 1:20-cv-01744-UNA Document 1 Filed 12/22/20 Page 15 of 160 PageID #: 15
`
`its legal responsibilities to protect against the diversion of prescription drugs, the prescription
`