U.S. v. Nazir

Decision Date16 July 2002
Docket NumberNo. 01-1029-CR.,01-1029-CR.
CourtU.S. District Court — Southern District of Florida
PartiesUNITED STATES of America v. Carlos NAZIR, David Gaudio, Francisco Munoz, Alberto Llona, Prescription Specialties, Inc., & U.S. One Telemarketing, Inc.

Christopher J. Clark, Assistant U.S. Attorney, Miami, FL, for United States.

Ricahrd Sharpstein, Miami, FL, for Carlos Nazir.

Alan Sobol, O'Connell Flatherty & Attmore, LLC, Hartford, CT, David Rothman, Thronton & Rothman, P.A., Miami, FL, for David Gaudio.

Jose Quinon, Miami, FL, for Francisco Munoz.

Faith Gay, White & Case LLP, Mimai, FL, for Alberto Llona.

Harvey Rogers, Miami, FL, for U.S. One Telemarketing, Inc.

JORDAN, District Judge.

ORDER DENYING MOTION TO DISMISS COUNTS 15-24

The defendants move to dismiss counts 15-24 of the indictment on the ground that they fail to allege criminal offenses. For the reasons which follow, the motion to dismiss [D.E. 81] is DENIED.

I

The indictment alleges that defendant Carlos Nazir, a physician licensed to practice in the state of Florida, wrote "false prescriptions" for prescription drugs ("Power Gel" and "Vigor") which had not been approved by the FDA, referring to them respectively as "tri-mix" and "bimix." See Indictment at ¶¶ 8, 12-13, 17. Dr. Nazir, according to the indictment, "used the names of patients in his medical practice ... without their knowledge or permission for the prescriptions that were sent" to co-defendants David Gaudio and Prescription Specialties, Inc. "These patients never received the drugs as reflected on the false prescriptions." See id. at ¶ 18. Instead, Mr. Gaudio and Prescription Specialties filled the false prescriptions, caused bulk shipments of the drugs to be mailed to Dr. Nazir, and simultaneously sent invoices for the false shipments to co-defendants Francisco Munoz, Alberto Llona, and U.S. One Telemarketing, Inc. See id. at ¶ 19. Dr. Nazir then forwarded the drugs to Mr. Munoz, Mr. Llona, and U.S. One Telemarketing for repackaging and further shipment to "unsuspecting customers throughout the United States." See id. at ¶ 20. Mr. Munoz, Mr. Llona, and U.S. One Telemarketing caused monies to be paid to Dr. Nazir "in exchange for his role in writing prescriptions." These monies were "commissions [Dr. Nazir] was to receive from sales of `Power Gel' and `Vigor.'" See id. at ¶ 25. Mr. Munoz, Mr. Llona, and U.S. One Telemarketing also caused payments to be made to Dr. Nazir, through International Urological Consultants, "for his role in writing phony prescriptions." See id. at ¶ 26.

Counts 15-20 charge all of the defendants with the dispensing of prescription drugs without a prescription, and with the intent to defraud or mislead, in violation of 21 U.S.C. §§ 331(a) and 333(a)(2). Each of these counts alleges that on a particular date, "Power Gel" or "Vigor" were dispensed contrary to 21 U.S.C. § 353(b)(1), "in that the drugs were dispensed without the prescription of a practitioner licensed by law to administer them, which resulted in the drugs being misbranded while held for sale."

Counts 21-24 are similar. These counts charge all of the defendants with the dispensing of prescription drugs (i.e., "Power Gel" or "Vigor") on certain dates without a valid prescription, and with the intent to defraud or mislead, in violation of 21 U.S.C. §§ 331(k) and 333(a)(2). The counts allege that the drugs were dispensed contrary to 21 U.S.C. § 353(b)(1), "in that the drugs were dispensed without the prescription of a practitioner licensed by law to administer them," which "resulted in the drugs being misbranded."

II

Under 21 U.S.C. § 331(a), it is unlawful to "introduc[e] or deliver[] for introduction into interstate commerce ... any ... drug ... that is adulterated or misbranded." And under § 331(k), it is unlawful to commit any act "while [an] article is held for sale ... after shipment in interstate commerce and [which] results in the article being adulterated or misbranded." If committed with the "intent to defraud or mislead," a violation of § 331(a) is punishable by up to three years in prison and a fine of up to $10,000. See 21 U.S.C. § 333(a)(2).

In turn, 21 U.S.C. § 353(b)(1), which was added to the Food, Drug, and Cosmetic Act in 1951, provides in pertinent part as follows:

(b) Prescription by physician....

(1) A drug intended for use by man which—

(A) because of its toxicity or other potentiality for harmful effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner licensed by law to administer such drug;

(B) is limited by an approved application under section 355 of this title to use under the professional supervision of a practitioner licensed by law to administer such drug,

....

shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced promptly to writing and filled by the pharmacist, or (iii) by refilling any such written or oral prescription.... The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.

(emphasis added). As explained in United States v. Carlisle, 234 F.2d 196, 199 (5th Cir.1956), a violation of § 353(b)(1) constitutes misbranding and is punishable under § 331.

III

The indictment alleges that Dr. Nazir — with the intent to defraud or mislead — wrote false "Power Gel" and "Vigor" prescriptions for patients of his whom he never evaluated with respect to these drugs, and that the customers who ultimately received the drugs were never examined by, or consulted, a doctor about the drugs. In short, the indictment charges that the defendants used Dr. Nazir's so-called phony prescriptions as a means for unlawfully delivering the drugs to individuals without the benefit of medical consultations or examinations.

The defendants, invoking the rule of lenity, nevertheless argue that counts 15-24 fail to state criminal offenses because the indictment alleges that Dr. Nazir in fact issued prescriptions for "Power Gel" and "Vigor." In the defendants' view, § 353(b)(1) says only that a prescription by a licensed doctor is required, and it makes no difference whether the prescription is phony. If a doctor signs a paper prescribing a drug for someone—no matter what the circumstances—there can be no misbranding under the statute. The government, on the other hand, asserts that a phony prescription is no prescription at all under § 353(b)(1), and that the so-called prescriptions issued by Dr. Nazir caused the "Power Gel" and "Vigor" to be misbranded. The critical question, then, is the meaning of the word "prescription" as it is used in the statute. See generally United States v. Plummer, 221 F.3d 1298 1302 (11th Cir.2000) (in reviewing a motion to dismiss an indictment, a court looks only at whether the government has alleged each of the elements of the relevant statute).

As in other contexts, the starting point in the interpretation of a criminal statute is the text employed by Congress. See, e.g., Staples v. United States, 511 U.S. 600, 605, 114 S.Ct. 1793, 128 L.Ed.2d 608 (1994); United States v. Rojas-Contreras, 474 U.S. 231, 234, 106 S.Ct. 555, 88 L.Ed.2d 537 (1985); United States v. Diaz-Clark, 292 F.3d 1310, 1315 (11th Cir. 2002). Because § 353(b) does not define the word "prescription," it should be given its ordinary meaning and usage. See, e.g., United States v. Chamberlain, 159 F.3d 656, 661 (1st Cir.1998) (consulting dictionary to interpret the word "commitment" in 18 U.S.C. § 922(g)(4)). The dictionary definition of the word, in this medical context, is "a written direction for the preparation, compounding, and administration of a medicine." WEBSTER'S THIRD NEW INTERNATIONAL DICTIONARY 1792 (1976). The medical literature contains similar, but more expansive, definitions. One dictionary, for example, defines a "prescription" as "a written direction for the preparation and administration of a remedy. A prescription consists of the heading or superscription —that is, the symbol Rx or the word Recipe, meaning `take'; the inscription, which contains the names and quantities of the ingredients; the subscription, or the sign S. for sig'na, `mark,' which gives the directions for the patient which are to be marked on the receptacle." DORLAND'S ILLUSTRATED MEDICAL DICTIONARY 1349 (28th ed.1994). And, as quoted in a Fifth Circuit case, a pharmacology textbook from around the time when § 353(b)(1) was enacted provided the following definition:

A prescription, by strict definition, is a physician's written order to a pharmacist for medicinal substances for a patient. It includes directions to the pharmacist regarding the preparation and to the patient regarding the use of the medicine.

In reality, however, a prescription is infinitively more than can be simply defined. It is a summary of the physician's diagnosis, prognosis, and treatment of the patient's illness. It brings to a focus on one slip of paper the diagnostic acumen and therapeutic proficiency of the physician. The prescription is an important practical phase in the application of pharmacology to clinical medicine, and combines the knowledge of the absorption, fate, excretion, action, toxicology, and dosage of drugs with the requirements for restoration of the patient's health.

De Freese v. United States, 270 F.2d 730, 733 n. 4 (5th Cir.1959) (quoting GOODMAN & GILMAN, THE PHARMACOLOGICAL BASIS OF THERAPEUTICS 1759 (2d ed.1955)). Given these definitions, it seems to me that the word prescription in § 353(b)(1), in common parlance, means only a bona fide order —i.e., directions for the preparation and administration of a medicine, remedy, or drug for a real patient who actually needs it after some sort of examination or consultation by a licensed doctor—and does not include...

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3 cases
  • United States v. Williams
    • United States
    • U.S. District Court — Western District of Oklahoma
    • September 14, 2011
    ...were written by ... physicians who did not see or examine the customer." Superseding Indictment, p. 3. See United States v. Nazir, 211 F.Supp.2d 1372, 1375 (S.D.Fla. 2002) (the term prescription, as used in 21 U.S.C. § 353(b)(1) "means only a bona fide order-i.e., directions for the prepara......
  • United States v. Stelmachowski
    • United States
    • U.S. District Court — Northern District of Illinois
    • February 12, 2018
    ...43 F. Supp. 3d 301, 308 (S.D.N.Y. 2014) ("the statute provides no definition for the term 'prescription'"); United States v. Nazir, 211 F. Supp. 2d 1372, 1375 (S.D. Fla. 2002) ("§ 353(b) does not define the word 'prescription'"). Stelmachowski's attempt to define "prescription" as a physici......
  • United States v. Williams
    • United States
    • U.S. District Court — Western District of Oklahoma
    • September 14, 2011
    ...were written by ... physicians who did not see or examine the customer." Superseding Indictment, p. 3. See United States v. Nazir, 211 F.Supp.2d 1372, 1375 (S.D.Fla. 2002) (the term prescription, as used in 21 U.S.C. § 353(b)(1) "means only a bona fide order-i.e., directions for the prepara......

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