IN THE UNITED STATES DISTRICT COURT FOR THE
`WESTERN DISTRICT OF MISSOURI
`WESTERN DIVISION
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`
`UNITED STATES OF AMERICA,
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`
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`Plaintiff,
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`v.
`SPALITTO’S PHARMACY, L.C.,
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`
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`Defendant.
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`
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` Civil Action No. 4:21-cv-00600
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`COMPLAINT FOR PERMANENT INJUNCTION
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`The United States of America brings this complaint for permanent injunction against
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`defendant Spalitto’s Pharmacy, L.C. (the “Defendant”) and alleges as follows:
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`INTRODUCTION
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`1.
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`Starting no later than 2016, the Defendant, a pharmacy operating in Kansas City,
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`Missouri, has failed to implement or follow sufficient controls to guard against diversion of
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`controlled substances. The Defendant violated the Controlled Substances Act by filling two
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`different types of prescriptions.
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`2.
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`The first type of prescriptions consists of over one hundred forged narcotic
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`prescriptions presented by a single individual. The individual, fired by her treating physician in
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`early 2016, forged the prescriptions. See United States v. Gaston, Case No. 4:20-cr-149-HFS.
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`The Defendant filled the narcotic prescriptions for years despite the existence of significant red
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`flags, including, inter alia: (1) the paper prescriptions appeared to be photocopies; (2) the dosage
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`and quantity increased to result in an amount allegedly prescribed of more than triple the amount
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`recommended by the Centers for Disease Control and Prevention Guideline for Prescribing
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`Opioids for Chronic Pain; (3) the individual had insurance but chose to pay out-of-pocket; (4) the
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`individual’s physical condition was deteriorating; and (5) the prescription drug monitoring
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`Case 4:21-cv-00600-GAF Document 1 Filed 08/18/21 Page 1 of 9
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`program revealed that the Defendant was the only pharmacy who filled prescriptions for a
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`particular physician from August 22, 2018, through June 19, 2019. The Defendant did not verify
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`the prescriptions with the physician.
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`3.
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`The second type of prescriptions consists of a group of over one hundred
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`prescriptions presented, collectively, by approximately one dozen different individuals. All the
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`prescriptions purport to be prescribed by the same physician. Members of the group presented
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`prescriptions with substantially similar dosages and quantities for highly addictive and often-
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`abused narcotics. The Defendant filled the narcotic prescriptions for years despite the existence
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`of significant red flags, including, inter alia: (1) suspicious paper prescriptions, one or more with
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`alterations to the physician’s DEA registration number; (2) the physician’s alleged uniform
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`prescribing for a high quantity and dosage of immediate-release oxycodone; (3) the fact that the
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`group members did not generally fill nonnarcotic prescriptions with the Defendant; (4) with
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`limited exceptions, the group members all paid out-of-pocket; and (5) that the prescription drug
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`monitoring program revealed that the Defendant was the only pharmacy who filled prescriptions
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`for a particular prescriber from September 18, 2017, through March 26, 2020. The Defendant did
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`not verify the prescriptions with the physician until February 2020, at which time the physician
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`stated that he had been retired for about a year.
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`4.
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`In sum, on over two hundred occasions since the beginning of 2016, the
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`Defendant dispensed prescription drugs in violation of the Controlled Substances Act and its
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`implementing regulations.
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`5.
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`The United States seeks to prevent continuing and substantial injury to the public
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`caused by controlled substance diversion by bringing this action for a permanent injunction and
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`other equitable relief under 21 U.S.C. § 882(a) to enjoin the Defendant’s violation of:
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`(1) 21 U.S.C. § 841(a)(1), by dispensing controlled substances outside the usual course of
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`the professional practice of pharmacy; and
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`(2) 21 U.S.C. § 842(a)(1), by dispensing controlled substances in violation of 21 U.S.C.
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`§ 829 and the Controlled Substances Act’s implementing regulations.
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`JURISDICTION AND VENUE
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`6.
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`The Court has subject matter jurisdiction over this action under 21 U.S.C.
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`§ 882(a); 21 U.S.C. §§ 841(a)(1), 842(a)(1); and 28 U.S.C. §§ 2201–02.
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`7.
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`Venue is proper in this district under 28 U.S.C. § 1391(b)(1) and (2).
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`PARTIES
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`Plaintiff is the United States of America.
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`The Defendant is a Missouri Limited Liability Company operating a retail
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`8.
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`9.
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`pharmacy in Kansas City, Missouri, within Jackson County. The Defendant engaged in the
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`conduct described in this Complaint from within the Western District of Missouri.
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`FACTS
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`10.
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`Since at least 2016, the Defendant has been violating the Controlled Substances
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`Act by enabling the diversion of narcotics. The Defendant dispenses narcotic prescriptions that
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`present numerous red flags without taking steps to resolve the red flags or implementing or
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`following processes sufficient to guard against diversion of controlled substances.
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`The Amy Gaston prescriptions
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`11.
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`On or about January 14, 2016, Amy Gaston was terminated as a patient by her
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`physician, G.B. Gaston has not been treated by G.B. since that time, and G.B. did not write or
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`otherwise authorize prescriptions for Gaston after that date.
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`12.
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`At the time, G.B. practiced in Olathe, Kansas, and Gaston’s address was listed as
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`Shawnee, Kansas.
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`13.
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`From January 2016 through June 2019, Gaston presented the Defendant at least
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`122 forged prescriptions for narcotics purporting to be written by G.B.
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`14.
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`None of the 122 forged prescriptions bore G.B.’s authentic signature or seal.
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`15. Many of the forged prescriptions were multiple copies of the same prescription,
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`bearing the same alleged “Transaction ID” with only handwritten differences.
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`16.
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`Over time, Gaston increased the amount of oxycodone prescribed on the forged
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`prescriptions and began writing an additional prescription for a high strength (60mg) of
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`OxyContin.
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`17.
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`The Defendant’s Pharmacist-in-Charge Peter A. Spalitto (“Spalitto”) and the
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`Defendant’s other staff knew that the pharmacy had an obligation to verify with the physician
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`when there was a change in the prescription, such as a change in strength or the quantity of
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`dosage units.
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`18.
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`No one on behalf of the Defendant contacted G.B. to verify the authenticity or
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`instructions on any of the 122 forged prescriptions.
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`19.
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`On August 20, 2018, G.B.’s DEA registration was terminated and G.B. was no
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`longer authorized to issue prescriptions for controlled substances.
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`20.
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`The only other G.B. prescriptions filled at the Defendant’s pharmacy since 2015
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`were in 2015 and 2017. Gaston was the only individual filling G.B. prescriptions at the
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`Defendant’s pharmacy in 2018 and 2019.
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`21.
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`Gaston came into the Defendant’s pharmacy on or about June 11, 2019, with a
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`forged prescription for 120 oxycodone 30mg tablets.
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`22.
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`At that time, Spalitto observed that Gaston displayed noticeable signs of physical
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`deterioration.
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`23.
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`Spalitto told Gaston that he would not fill the prescription until he spoke with
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`G.B.
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`24.
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`25.
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`However, neither Spalitto nor any of the Defendant’s staff contacted G.B.
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`The next day, June 12, 2019, Spalitto nonetheless filled the forged prescription for
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`#120 oxycodone 30mg tablets.
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`26.
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`The Defendant also filled another forged prescription from Gaston a week later,
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`on June 19, 2019, for #70 oxycodone 15mg tablets.
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`27.
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` In whole, the Defendant dispensed narcotics to Gaston for 122 forged
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`prescriptions.
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`28.
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`Thirty-two of the 122 forged prescriptions were allegedly prescribed by G.B. at a
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`time when G.B. did not have authority to prescribe controlled substances.
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`29.
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`In September 2019, DEA asked Spalitto how the Defendant ensured that a
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`prescription is prescribed by an authorized DEA registrant. Spalitto asserted that he had no way
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`to verify when a prescriber’s DEA registration is invalid and that he generally relied on word of
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`mouth, including information obtained from customers and insurance providers.
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`30.
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`In response, DEA provided Spalitto information on how to obtain access to query
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`DEA’s registration database, a resource already freely available to him. See CSA Registration
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`Validation Tool, https://apps.deadiversion.usdoj.gov/webforms2/spring/validationLogin. DEA
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`has made this free tool available to DEA registrants, like the Defendant, since April 2007. DEA
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`also provided information on commercial software options, like DEALookup.com, which the
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`Defendant could decide to purchase. The software automates the process of validating the DEA
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`registration number on a prescription. If the DEA registration validation information is reviewed
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`and considered, the chances of diversion decrease.
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`31.
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`However, despite the availability of a free option to validate prescriptions, the
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`Defendant did not thereafter make changes to its practice of relying on word of mouth to learn
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`when prescriber DEA registration numbers became invalid.
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`The A.D. prescriptions
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`32.
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`In February 2020, Spalitto notified DEA that the Defendant filled oxycodone
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`prescriptions for several patients that he now had reason to believe were forged. All of the
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`prescriptions were allegedly written by a physician, A.D.
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`33.
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`A.D. has not had a valid DEA registration since June 2017. Accordingly, A.D. has
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`not had authority to prescribe controlled substances since that time.
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`34.
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`Between July 17, 2017, and January 31, 2020, the Defendant dispensed 125
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`invalid prescriptions purportedly from A.D.
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`Neither Spalitto nor any of the Defendant’s staff contacted A.D. during that time.
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`Of the 125 invalid prescriptions, 121 were for 120 tablets of oxycodone 20mg or
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`35.
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`36.
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`30mg tablets.
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`37.
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`Of the 121 oxycodone prescriptions, all but one contained a prescription for 175
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`daily MMEs or greater, approximately double the CDC’s 90 daily MME maximum under the
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`Guideline for Prescribing Opioids for Chronic Pain.
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`38.
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`39.
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`All but two of the A.D. prescriptions were paid for out-of-pocket.
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`At least one dozen different individuals obtained oxycodone from the Defendant
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`by presenting an invalid A.D. prescription.
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`40.
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`The individuals presenting the A.D. prescriptions generally sought to only fill the
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`narcotic prescriptions from A.D. and did not have other doctors’ prescriptions filled by the
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`Defendant.
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`Validating DEA numbers helps prevent diversion
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`41.
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`If the Defendant had implemented a practice of manually checking prescriptions
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`with the DEA’s free registration validation tool, see CSA Registration Validation Tool,
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`https://apps.deadiversion.usdoj.gov/webforms2/spring/validationLogin, or implemented
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`commercial software automating the validation of DEA registrations, the Defendant would have
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`been presented with direct information that 32 of the Gaston prescriptions and 125 of the A.D.
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`prescriptions were invalid and that the Defendant could not lawfully dispense the controlled
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`substances prescribed, regardless of them being forged.
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`42.
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`If the Defendant had refused to fill 32 of the Gaston prescriptions and 125 of the
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`A.D. prescriptions, the Defendant would not have violated, with respect to those prescriptions:
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`(1) 21 U.S.C. § 841(a)(1), by dispensing controlled substances outside the usual course of the
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`professional practice of pharmacy; and (2) 21 U.S.C. § 842(a)(1) by dispensing controlled
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`substances in violation of 21 U.S.C. § 829 and the Controlled Substances Act’s implementing
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`regulations.
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`COUNT I
`(21 U.S.C. § 882(a))
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`The United States re-alleges and incorporates Paragraphs 1 through 42 of this
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`43.
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`Complaint as though fully set forth herein.
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`44.
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`By reason of the conduct described herein, the Defendant violated, is violating,
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`and is about to violate (1) 21 U.S.C. § 841(a)(1), by dispensing controlled substances outside the
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`usual course of the professional practice of pharmacy; and (2) 21 U.S.C. § 842(a)(1) by
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`dispensing controlled substances in violation of 21 U.S.C. § 829 and the Controlled Substances
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`Act’s implementing regulations.
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`45.
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`Upon a showing that the Defendant is committing or about to commit a violation
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`of the Controlled Substances Act, the United States is entitled, under 21 U.S.C. § 882(a), to seek
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`a permanent injunction retraining or ameliorating such conduct.
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`WHEREFORE, Plaintiff, the United States of America, requests of the Court the
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`PRAYER FOR RELIEF
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`following relief:
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`(1) That the Court issue a permanent injunction, pursuant to 21 U.S.C. § 882(a),
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`prohibiting the Defendant, Defendant’s successors, agents, officers, and employees,
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`and all other persons and entities in active concert or participation with them from
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`dispensing any controlled substance without verifying, either manually or through the
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`implementation and review of a software or other automated program, that the
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`prescription for the controlled substance contains a valid DEA registration number for
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`the prescribing practitioner; and
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`(2) That the Court order such other and further relief as the Court shall deem just and
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`proper.
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`Date: August 18, 2021
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`Respectfully submitted,
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`Teresa A. Moore
`Acting United States Attorney
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`/s/ Alan T. Simpson
`Alan T. Simpson, MO Bar No. 65183
`Assistant United States Attorney
`Email: alan.simpson@usdoj.gov
`Charles Evans Whittaker Courthouse
`400 East Ninth Street, Room 5510
`Kansas City, Missouri 64106
`Telephone: (816) 426-3130
`Facsimile: (816) 426-3165
`ATTORNEY FOR THE
`UNITED STATES OF AMERICA
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`By:
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`Case 4:21-cv-00600-GAF Document 1 Filed 08/18/21 Page 9 of 9
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