US v. Poulin, Civil A. No. 93-12265-REK.

CourtUnited States District Courts. 1st Circuit. United States District Courts. 1st Circuit. District of Massachusetts
Writing for the CourtKEETON
Citation926 F. Supp. 246
PartiesUNITED STATES of America, Plaintiff, v. David P. POULIN and Mattapoisett Pharmacy, Inc. d/b/a Marion Pharmacy and Mattapoisett Pharmacy, Defendants.
Decision Date19 April 1996
Docket NumberCivil A. No. 93-12265-REK.

926 F. Supp. 246

UNITED STATES of America, Plaintiff,
v.
David P. POULIN and Mattapoisett Pharmacy, Inc. d/b/a Marion Pharmacy and Mattapoisett Pharmacy, Defendants.

Civil A. No. 93-12265-REK.

United States District Court, D. Massachusetts.

April 19, 1996.


926 F. Supp. 247
COPYRIGHT MATERIAL OMITTED
926 F. Supp. 248
COPYRIGHT MATERIAL OMITTED
926 F. Supp. 249
John J. Falvey, Jr., David Abelman, Sara M. Bloom, United States Attorney's Office, Boston, MA, Julie S. Schrager, Assistant U.S. Attorney, Boston, MA, for U.S

William H. Kettlewell, Boston, MA, for David P. Poulin, Mattapoisett Pharmacy, Inc.; dba Marion Pharmacy, dba Mattapoisett Pharmacy.

Memorandum and Order

KEETON, District Judge.

I.

This is a civil action brought by the United States against David P. Poulin and Mattapoisett Pharmacy, Inc., for violations of the Comprehensive Drug Abuse Prevention and Control Act of 1970 ("Controlled Substances Act"), 21 U.S.C. § 801 et seq. The court held a nonjury trial on January 12, 1996. This document records the court's findings of fact, conclusions of law, and explanation of the court's decision.

II. Findings of Basic Facts

1. David Poulin is the sole owner and proprietor of the Mattapoisett Pharmacy, located at 76 County Road, Mattapoisett, Massachusetts, and the Marion Pharmacy, located at 148 Front Street, Marion, Massachusetts. Mattapoisett Pharmacy and Marion Pharmacy are both owned by Mattapoisett Pharmacy, Inc., of which David Poulin is the sole stockholder.

2. In the summer of 1993, a total of four thousand six hundred two (4602) dosage units of Schedule II drugs with high abuse potential disappeared from the two pharmacies.1 Three thousand three hundred (3,300) dosage units of eighteen different Schedule II drugs, including Codeine, Morphine, Methadone, Roxicet, Percodan, Percocet, Dilaudid, Demoral, Dexedrine, Dolphine, MS Contin, Nembutal, Oxycodone, Opium, Seconal, Tuinal, Tylox, and Secobarbital, disappeared from the Mattapoisett Pharmacy sometime before July 30, 1993. Nine hundred fifty-one (951) dosage units of Roxicet, a Schedule II drug, disappeared from the Marion Pharmacy before July 30, 1993. An additional three hundred fifty-one (351) dosage units of Roxicet disappeared from the Marion Pharmacy between July 30, 1993 and September 5, 1993.

3. In August and September of 1993, DEA Investigator Harold B. Mosher, Massachusetts State Trooper Thomas Summers, and Inspector Charles Young from the Massachusetts Board of Registration of Pharmacy conducted an investigation at the two pharmacies.

4. DEA Investigator Mosher found that most of the drugs reported stolen were Schedule II controlled substances that had been kept in an unmarked paper bag in an unlocked wooden cabinet in the dispensing area. Mr. Poulin told DEA Investigator Mosher and testified at trial that he used the paper bag to store out of date drugs, and most of the drugs in the bag may have been there since they were acquired from the Sassaquin Pharmacy in 1989.

5. During the inspections, DEA Investigator Mosher reviewed the pharmacies' DEA 222 Order Forms, which are required to be used for all orders of Schedule II controlled substances and to record the amount of drugs actually received by the purchaser and the date of their receipt. DEA Investigator Mosher found a total of nine defective order forms. At the Marion Pharmacy, he found seven forms that were defective because they

926 F. Supp. 250
did not contain the number of controlled substances received or the date received. At the Mattapoisett Pharmacy, he found two defective DEA Form 222s, one of which was unsigned and one of which was signed by a pharmacist for whom no power of attorney was available on that date

6. At each pharmacy, DEA Investigator Mosher asked to see the pharmacy's "power of attorney" forms on file. These were not produced at either pharmacy at the time of the inspections.

7. At each pharmacy, DEA Investigator Mosher then asked to see a copy of the pharmacy's biennial inventory. The mandated inventory could not be produced at either pharmacy at the time of the inspections.

8. DEA Investigator Mosher reviewed the pharmacies' Schedule II prescription files and found that, in violation of the Controlled Substances Act, five prescriptions had been filled even though the physician had not placed the patient's address on the prescription and one was undated and not signed or initialed by a pharmacist.

9. The investigators located, on the shelf of the Mattapoisett Pharmacy, Cocaine HCL powder, a Schedule II drug, that had not been documented as having been received or as being within the pharmacy's inventory.

10. David Poulin ran both the Marion and Mattapoisett pharmacies. He made hiring and firing decisions for the pharmacies. He assigned tasks to employees at both pharmacies. He is a licensed pharmacist and worked as a pharmacist in both pharmacies and was involved in the day to day operations of both pharmacies. He had ultimate responsibility for proper recordkeeping for both pharmacies.

11. Defendant Mattapoisett Pharmacy, Inc. is a corporation created by Mr. Poulin on the advice of his accountant for tax purposes. Mr. Poulin is the President, Treasurer and sole owner of Mattapoisett Pharmacy, Inc. His wife, Judith Poulin is the clerk. Mr. and Mrs. Poulin are and have always been the sole officers and directors of Mattapoisett Pharmacy, Inc.

12. The only corporate records of Mattapoisett Pharmacy, Inc., other than its tax returns, are its filings with the Secretary of State for the years 1989 through 1994. There are no minutes of any meeting. Mattapoisett Pharmacy, Inc. has been in existence since 1973.

13. Mr. Poulin has stated that he personally lent money to the Mattapoisett Pharmacy, Inc., but no note or other loan documents were ever created.

14. The buildings in which Mattapoisett Pharmacy Inc. operates are leased from Mr. and Mrs. Poulin individually. No formal leases exist. Mattapoisett Pharmacy has always operated in buildings owned by Mr. and Mrs. Poulin and has paid rent to the Poulins for those buildings.

III. Legal Issues and Conclusions

A. Strict Liability for Recordkeeping Violations

The Controlled Substances Act, 21 U.S.C. § 801 et seq., focuses on recordkeeping, in "an attempt to regulate closely the distribution of certain substances determined by Congress to pose dangers, if freely available, to the public at large." United States v. Averi, 715 F.Supp. 1508, 1510 (M.D.Ala. 1989). The Act imposes strict liability for recordkeeping violations. United States v. Green Drugs, 905 F.2d 694, 696 (3rd Cir.), cert. denied, 498 U.S. 985, 111 S.Ct. 518, 112 L.Ed.2d 530 (1990). The recordkeeping provisions of the Act apply to all persons who dispense drugs, even if they have not registered as required under the Act. United States v. Clinical Leasing Service, Inc., 759 F.Supp. 310 (E.D.La.1990), aff'd, 925 F.2d 120 (5th Cir.1991), cert. denied, 502 U.S. 864, 112 S.Ct. 188, 116 L.Ed.2d 149 (1991). Persons who dispense drugs are strictly liable and cannot absolve themselves by arguing that the violations were "due to human error" or that there was "no intent to violate the statute." Green Drugs, 905 F.2d at 695. Compliance with reasonable commercial recordkeeping practices is no defense to liability. United States v. Williams, 416 F.Supp. 611, 614 (D.D.C.1976). Knowing or intentional violations of the statute are subject to criminal penalties. 21 U.S.C. § 842(a)(5). A civil fine of up to a maximum of $25,000.00 may be assessed for each violation

926 F. Supp. 251
of the statute, without evidence of intent. 21 U.S.C. § 842(c)(1)

B. Biennial Inventories

Section 827(a) of the Controlled Substances Act provides that each DEA registrant who dispenses controlled substances must "make a complete and accurate record of all stocks thereof on hand" when the registrant begins to dispense controlled substances and every two years thereafter, either on the anniversary of the initial record or on the registrant's regular inventory date if it is within six months of the anniversary. 21 U.S.C. § 827(a). The regulation provides that if the registrant elects to take the biennial inventory on the registrant's regular general physical inventory date or another fixed date, the registrant "shall notify the Administration of this election and of the date on which the biennial inventory will be taken." 21 C.F.R. 1304.13.

A pharmacist's biennial inventory must record, among other things, the name of the substance and the quantity of the substance. 21 C.F.R. §§ 1304.15. If the substance is a Schedule II drug, the pharmacist must make an exact count of the contents of each container. 21 C.F.R. § 1304.17. The registrant must indicate "on the inventory records whether the inventory is taken as of the opening or as of the close of business and the date the inventory is taken." 21 C.F.R. § 1304.12.

Pharmacists are required to keep biennial inventories separately from all other records and to make them available for at least two years for inspection and copying for government inspection. 21 U.S.C. § 827(b). Under § 842(a)(5), "to refuse or fail to make, keep, or furnish any record, report, notification, declaration, order or order form, statement, invoice, or information required" under the Controlled Substances Act is unlawful.

The mandated biennial inventories were not produced, and could not be produced at either pharmacy at the time of the inspections in August and September of 1993.

David Poulin testified at trial that he did not and does not take a biennial inventory of Schedule II drugs, and that instead of counting the contents of each container, he uses a "rolling inventory" system of deduction of the amount most recently dispensed from the previous number listed. The rolling inventories of Schedule II drugs do not meet the regulatory requirements for biennial inventories. They are not a listing of all Schedule II drugs present on one...

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12 practice notes
  • Advance Pharmaceutical, Inc. v. U.S., No. 02-6233.
    • United States
    • U.S. Court of Appeals — Second Circuit
    • December 3, 2004
    ...ability to pay a penalty. See, e.g., United States v. Salcedo, 2003 WL 21196843, at *2 (E.D.N.Y. Feb.19, 2003); United States v. Poulin, 926 F.Supp. 246, 253-54 (D.Mass.1996); United States v. Queen Vill. Pharmacy, 1990 WL 165907, at *2 (E.D.Pa. Oct.25, 1990); United States v. Barbacoff, 41......
  • Applications, hearings, determinations, etc.: Alexander Drug Co., Inc.,
    • United States
    • Federal Register April 06, 2001
    • April 6, 2001
    ...substances determined by Congress to pose dangers, if freely available, to the public at large.' '' United States v. David P. Poulin, 926 F. Supp. 246, 250 (D. Mass. 1996) quoting United States v. Averi, 715 F. Supp. 1508, 1510 (M.D. Ala. 1989). The statutory text and legislative history of......
  • U.S. v. Little, Civil Action No. 97-30067-MAP.
    • United States
    • U.S. District Court — District of Massachusetts
    • July 23, 1999
    ...may not exculpate themselves by claiming "human error," inadvertence or lack of intent. Id. See also United States v. Poulin, 926 F.Supp. 246, 250 (D.Mass. 1996). What Defendants knew or should have known is The Government argues that Defendants' strict liability — and therefore s......
  • United States v. Heim, CASE NO. 5:13CV210
    • United States
    • United States District Courts. 6th Circuit. United States District Court of Northern District of Ohio
    • January 22, 2014
    ...694, 695 (3d Cir. 1990) (three controlled substances, assessed at $2,000 each, for a total penalty of $6,000); United States v. Poulin, 926 F. Supp. 246 (D. Mass. 1996) (eighteen controlled substances, assessed at $1,000 each, for a total penalty of $18,000 for failing to keep accurate reco......
  • Request a trial to view additional results
11 cases
  • Advance Pharmaceutical, Inc. v. U.S., No. 02-6233.
    • United States
    • U.S. Court of Appeals — Second Circuit
    • December 3, 2004
    ...ability to pay a penalty. See, e.g., United States v. Salcedo, 2003 WL 21196843, at *2 (E.D.N.Y. Feb.19, 2003); United States v. Poulin, 926 F.Supp. 246, 253-54 (D.Mass.1996); United States v. Queen Vill. Pharmacy, 1990 WL 165907, at *2 (E.D.Pa. Oct.25, 1990); United States v. Barbacoff, 41......
  • U.S. v. Little, Civil Action No. 97-30067-MAP.
    • United States
    • U.S. District Court — District of Massachusetts
    • July 23, 1999
    ...of the Act may not exculpate themselves by claiming "human error," inadvertence or lack of intent. Id. See also United States v. Poulin, 926 F.Supp. 246, 250 (D.Mass. 1996). What Defendants knew or should have known is The Government argues that Defendants' strict liability — and therefore ......
  • United States v. Heim, CASE NO. 5:13CV210
    • United States
    • United States District Courts. 6th Circuit. United States District Court of Northern District of Ohio
    • January 22, 2014
    ...694, 695 (3d Cir. 1990) (three controlled substances, assessed at $2,000 each, for a total penalty of $6,000); United States v. Poulin, 926 F. Supp. 246 (D. Mass. 1996) (eighteen controlled substances, assessed at $1,000 each, for a total penalty of $18,000 for failing to keep accurate reco......
  • Jones v. State, No. 57850-2-I.
    • United States
    • Court of Appeals of Washington
    • June 4, 2007
    ...the Controlled Substances Act for the type of insufficient Schedule II records Jones acknowledged, see, e.g., United States v. Poulin, 926 F.Supp. 246 (D.Mass.1996), and cases demonstrating real harm to individual patients when a pharmacist failed to keep proper records. See, e.g., Wahba v.......
  • Request a trial to view additional results

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