attorney for physicians unlawful dispensing drugs and narcotics

Defense Attorney For Drug Enforcement Agency Investigations

(855) 337-6836

 

DEA Investigations and Health Care Practitioners

The Drug Enforcement Agency (DEA) is the federal agency that oversees the distribution of controlled substances. These include  opiates and opioids (morphine, codeine, hydromorphone/Dilaudid, hydrocodone, Fentanyl); benzodiazepines (alprazolam/Xanax, lorazepam/Ativan, diazepam/Valium, midazolam/Versed); amphetamines (Ritalin and Adderall); and certain other drugs like carisoprodol/Soma and Ambien.  The DEA makes healthcare practitioners register to dispense these kind of narcotics. If you are the target of a DEA investigation, you should call the lawyers at James S. Bell, PC.

 

DEA Inspections

As a general rule, to inspect the doctor’s offices, the DEA needs an administrative warrant or inspection notice. But, this procedure is usually not followed.  Then, the DEA usually asks the doctor to surrender his or her license.  This is why you need experienced attorneys.

 


TO:                  FILE

RE:                  Memo of Law #1 and Jury Instructions for CLIENT

FROM:            JAMES S. BELL

 

Unlawful Distribution/Dispensation of Controlled Substance by a Physician

21 U.S.C. § 841(a)(1)

 

In 1975, the Supreme Court held in United States v. Moore that registered physicians can be prosecuted under section 841(a) when their activities fall outside the usual course of professional practice.

 

Elements of the Offense

 

Under the Drug Abuse Prevention and Control Act, someone who is a “practitioner” is authorized to prescribe drugs. A “practitioner” is defined as a physician, dentist … pharmacy … or other person licensed, registered, or otherwise permitted by the United States or the jurisdiction in which he practices … to distribute, dispense [or] administer [drugs] in the course of professional practice or research.

 

Thus, a doctor ( or dentist or pharmacist) who, in good faith, writes prescriptions for ( or dispenses) drugs in the regular course of a legitimate professional practice is protected from prosecution under the statute. But doctors who act outside the usual course of professional practice and prescribe or dispense drugs for no legitimate medical purpose may be guilty of violating the law.

 

Specifically, in order to prove this charge against the defendant, the government must establish beyond a reasonable doubt each of the following elements of the crime:

 

First, that the defendant dispensed or distributed narcotics;

 

Second, that the defendant did so knowingly and intentionally; and

 

Third, that the defendant dispensed the drug other than for a legitimate medical purpose and not in the usual course of medical practice.

 

Authority

 

Third Circuit: United States v. Polan, 970 F.2d 1280 (3d Cir. 1992).

 

Fourth Circuit: United States v. McIver, 470 F.3d 550 (4th Cir. 1996); United States v. Singh, 54 F.3d 1182 (4th Cir. 1995).

 

Fifth Circuit: United States v. Brown, 553 F.3d 768 (5th Cir. 2008), cert. denied, 558 U.S. 897, 130 S. Ct. 246 (2009); United States v. Armstrong, 550 F.3d 382 (5th Cir. 2008), cert. denied, 558 U.S. 829, 130 S. Ct. 54 (2009).

 

Sixth Circuit: United States v. Wells, 211 F.3d 988 (6th Cir. 2000); United States v. Voorhies, 663 F.2d 30 (6th Cir. 1981).

 

Seventh Circuit: United States v. Roya, 574 F.2d 386 (7th Cir. 1978).

 

Ninth Circuit: United States v. Feingold, 454 F.3d 1001 (9th Cir. 2006); United States v. King, 587 F.2d 956 (9th Cir. 1978).

 

Tenth Circuit: United States v. Varma, 691 F.2d 460 (10th Cir. 1982).

 

Eleventh Circuit: United States v. Steele, 147 F.3d 1316 (11th Cir. 1998) (en banc).

 

There is a split in the circuits as to whether the government must allege that the defendant dispensed the drugs other than for a legitimate medical purpose and not in the usual course of medical practice. Four courts of appeal have clearly held that this is an element of the offense that must be alleged in the indictment and proven beyond a reasonable doubt.[1]  On the other hand, four circuit courts have held that this fact falls within the language of section 885, which states that “[i]t shall not be necessary for the United States to negative any exemption or exception set forth in this subchapter … and the burden of going forward with the evidence with respect to any such exemption or exception shall be upon the person claiming its benefit.”[2]  Thus, those courts hold that the defendant has the burden of raising the issue and introducing evidence to support it.

 

Whether this is an element of the offense or a section 885 exemption, however, the burden of proof remains on the government to establish it beyond a reasonable doubt.[3]  Jurors must know that registered physicians are specifically exempted from prosecution by the statute for dispensing controlled substances for legitimate medical purposes and in the usual course of medical practice.  Reading the statutory definition of “practitioner” to the jurors helps establish the statute’s structure by emphasizing that a physician is permitted to distribute and dispense drugs “in the course of professional practice or research.”[4]

 

First Element–Distributing or Dispensing Drugs

 

The first thing you must determine is whether the defendant dispensed or distributed drugs.  The government may prove this element by showing beyond a reasonable doubt either that the defendant delivered the drug to the ultimate user or that the defendant wrote a prescription for the drugs.

Authority

 

Fifth Circuit: United States v. Dunbar, 614 F.2d 39 (5th Cir. 1980).

 

Sixth Circuit: United States v. Seelig, 622 F.2d 207 (6th Cir.1980).

 

Seventh Circuit: United States v. Roya, 574 F.2d 386 (7th Cir.1978).

 

Ninth Circuit: United States v. Boettjer, 569 F.2d 1078 (9th Cir. 1978).

 

Tenth Circuit: United States v. Genser, 710 F.2d 1426 (10th Cir. 1983).

 

Section 841(a) makes it unlawful to “distribute or dispense” a controlled substance other than in accordance with the provisions of the Drug Abuse Prevention and Control Act. According to section 802(10), “[t]he term ‘dispense’ means to deliver a controlled substance to an ultimate user … by, or pursuant to the lawful order of, a practitioner.”  A “practitioner,” according to section 802(20) “means a physician … licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices … to distribute, dispense [or] administer … a controlled substance in the course of professional practice or research.”

 

Second Element–Knowingly and Intentionally

 

The second element that the government must prove beyond a reasonable doubt is that when the defendant delivered or prescribed the drugs, he did so knowingly and intentionally. That is, the government must prove that the defendant knew what he was doing when he prescribed or delivered the drugs, and was not acting out of mistake or carelessness.

 

Authority

 

United States Supreme Court: United States v. Moore, 423 U.S. 122 (1975).

 

Fifth Circuit: United States v. Rogers, 609 F.2d 834 (5th Cir. 1980).

 

Tenth Circuit: United States v. Varma, 691 F.2d 460 (10th Cir. 1982).

 

When a pharmacist rather than a doctor is being prosecuted for violating section 841(a), there are essentially only two elements of the offense: (1) that the pharmacist dispensed or delivered the drugs, and (2) that the pharmacist knew that the prescription pursuant to which he was delivering the drugs was improperly issued by the prescribing physician.  The first element will rarely be disputed, and the court may charge on it simply by eliminating the word “either” and the phrase “or that the defendant wrote a prescription for the drugs.”

 

With respect to the second element in prosecutions of pharmacists, some expansion of the notion of acting intentionally and knowingly is required. Such an expanded instruction may take the following form:

 

The second element the government must prove is that the defendant knew that the prescription he filled was not properly issued by the prescribing doctor. That is, the government must prove, beyond a reasonable doubt, that the defendant knew that the prescribing doctor did not issue the prescription in the usual course of medical practice and that the prescription was not issued for a legitimate medical purpose.[5]

 

The phrases “in the usual course of medical practice” and “for a legitimate medical purpose” are essentially synonymous in the context of evaluating a physician’s behavior.

 

Third Element–No Legitimate Medical Purpose

 

The final element the government must prove beyond a reasonable doubt is that the defendant prescribed (or dispensed) the drug other than for a legitimate medical purpose and not in the usual course of medical practice.  In making a medical judgment concerning the right treatment for an individual patient, physicians have discretion to choose among a wide range of available options.  Therefore, in determining whether the defendant acted without a legitimate medical purpose, you should examine all of the defendant’s actions and the circumstances surrounding them.

 

For example, evidence that a doctor warns his patients to fill their prescriptions at different drug stores, or prescribes drugs without performing any physical examinations or only very superficial ones, or asks patients about the amount or type of drugs they want, may suggest that the doctor is not acting for a legitimate medical purpose and is outside the usual course of medical practice.  These examples are neither conclusive nor exhaustive.  They are simply meant to give you an idea of the kind of behavior from which you might conclude that a doctor was not prescribing drugs for a legitimate medical purpose and was not acting in the usual course of medical practice.

 

Authority

 

Second Circuit: United States v. Wexler, 522 F.3d 194 (2d Cir. 2008).

 

Fourth Circuit: United States v. McIver, 470 F.3d 550 (4th Cir. 1996); United States v. Singh, 54 F.3d 1182 (4th Cir. 1995).

 

Fifth Circuit: United States v. Chin, 795 F.2d 496 (5th Cir. 1986); United States v. Norris, 780 F.2d 1207 (5th Cir. 1986).

 

Sixth Circuit: United States v. Wells, 211 F.3d 988 (6th Cir. 2000); United States v. Voorhies, 663 F.2d 30 (6th Cir. 1981).

 

Seventh Circuit: United States v. Bek, 493 F.3d 790 (7th Cir. 2007).

 

Eighth Circuit: United States v. Katz, 445 F.3d 1023 (8th Cir. 2006).

 

Ninth Circuit: United States v. King, 587 F.2d 956 (9th Cir. 1978); United States v. Boettjer, 569 F.2d 1078 (9th Cir. 1978).

 

Tenth Circuit: United States v. Varma, 691 F.2d 460 (10th Cir. 1982).

 

As mentioned previously, there is a split in the circuits as to whether the government must allege that the defendant dispensed the drugs other than for a legitimate medical purpose and not in the usual course of medical practice, with at least five courts of appeal holding that this is an element of the offense that must be alleged in the indictment and proven beyond a reasonable doubt,  and three others holding that this fact falls within the language of section 885 placing the burden of going forward with the evidence on the defendant.

 

Section 885(a)(1) provides:

 

It shall not be necessary for the United States to negative any exemption or exception set forth in this subchapter in any complaint, information, indictment, or other pleading or in any trial, hearing, or other proceeding under this subchapter, and the burden of going forward with the evidence with respect to any such exemption or exception shall be upon the person claiming its benefit.

 

To the extent that this provision acts to shift the burden of proving that the prescriptions were issued for a legitimate medical purpose to the defendant, it raises constitutional questions because “[i]t is not ‘more likely than not’ that medical practitioners registered to dispense controlled substances do so illegitimately and are guilty of a criminal act; common experience … dictates precisely the opposite conclusion.”[6]

 

The most sensible and constitutionally acceptable way to read section 885 is simply as placing on a defendant physician an initial burden of production.  Once evidence is presented that the defendant was a medical practitioner duly registered to dispense controlled substances, as it will be in virtually every case in which a physician is prosecuted under section 841(a), the government must shoulder its normal burden of proving every element of the offense beyond a reasonable doubt. Thus, even in those circuits which have held that section 885 applies, the instruction is appropriate.

 

The first paragraph of the instruction is based in part on the regulation governing the issuance of prescriptions, which provides:

 

A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. § 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.[7]

 

The phrases “in the usual course of medical (professional) practice” and “for a legitimate medical purpose” have been found to “have essentially the same meaning,”[8] and the failure to include the first phrase in the instruction has been held not to constitute error.  One court has observed:

 

Even if “usual course” has any significance independent of medical legitimacy, we are satisfied that its negation is not an essential element of the government’s case. Proof beyond a reasonable doubt that the prescriptions were not issued pursuant to a legitimate medical purpose suffices to place them beyond the activities authorized by the Controlled Substances Act.[9]

 

Including both phrases in the instruction, however, is the better practice because it emphasizes the need for the jury to find that the prescriptions were wholly illegitimate.

 

The recommended instruction states these two concepts using the conjunctive “and” in keeping with the standard practice in the courts. This may not be required. Even assuming that the two concepts have different meanings, one court has recently pointed out that the regulation quoted above requires prescriptions to be issued both for a legitimate medical purpose and in the usual course of medical practice, so that if a prescription failed either part of that test, it would be ineffective. Accordingly, the court approved an instruction using the disjunctive “or” instead.[10]

 

In United States v. Rosen, the court identified a series of factual circumstances which indicate that a physician is acting outside of the accepted standards:

 

1.      Prescribing an inordinately large quantity of controlled substances.

2.      Issuing large numbers of prescriptions.

3.      Failing to give patients a physical examination before issuing prescriptions.

4.      Warning patients to fill prescriptions at different drug stores.

5.      Issuing prescriptions to a patient known to be delivering the drugs to others.

6.      Prescribing controlled drugs at intervals inconsistent with legitimate medical treatment.

7.      Using street slang rather than medical terminology for the drugs prescribed.

8.      The absence of a logical relationship between the drugs prescribed and the patient’s alleged condition.

9.      Writing more than one prescription at a time in order to allow patient to fill them at different times and places.[11]

 

Other types of evidence that have been deemed relevant include the fact that the narcotics had no medical use within the practitioner’s specialty,[12] that no medical history was taken[13], continuing to prescribe narcotics after defendant became aware that a patient was addicted[14], and repackaging narcotics in small distributable amounts.[15]  It is becoming increasingly well established that the government need not present expert testimony in order to establish that the defendant’s conduct was not in the usual course of professional practice.[16]

 

The Third Circuit has rejected the contention that a researcher charged with manufacturing controlled substances in violation of section 841(a)(1) is entitled to an instruction analogous to the instruction that medical professionals cannot be found guilty of distribution in violation of this section when acting within the “normal course of [their] professional activities.”[17]  The court reached this result because of its conclusion that “[s]ection 841(a)(1) may be the exclusive way to deal with unregistered manufacturers and Congress presumably meant to halt their activities whether within or without ‘normal distribution channels.'[18]

 

Doctor’s Good Faith

 

A doctor dispenses a drug in good faith in medically treating a patient when he or she dispenses the drug for a legitimate medical purpose in the usual course of medical practice; that is, the doctor has dispensed the drug lawfully.  Good faith in this context means good intentions and the honest exercise of best professional judgment as to a patient’s needs.  It means that the doctor acted in accordance with (what he reasonably believed to be)[19] the standard of medical practice generally recognized and accepted in the United States.

 

If you find that the defendant acted in good faith in dispensing the drugs, then you must find him not guilty.

 

Authority

 

Second Circuit: United States v. Wexler, 522 F.3d 194 (2d Cir. 2008); United States v. Vamos, 797 F.2d 1146 (2d Cir. 1986).

 

Fourth Circuit: United States v. McIver, 470 F.3d 550 (4th Cir. 2006) ; United States v. Hurwitz, 459 F.3d 463 (4th Cir. 2006).

 

Fifth Circuit: United States v. Armstrong, 550 F.3d 382 (5th Cir. 2008), cert. denied, 558 U.S. 829 (2009).

 

Sixth Circuit: United States v. Voorhies, 663 F.2d 30 (6th Cir. 1981).

 

Seventh Circuit: United States v. Chube, 538 F.3d 693 (7th Cir. 2008).

 

Ninth Circuit: United States v. Hayes, 794 F.2d 1348 (9th Cir. 1986) .

 

Eleventh Circuit: United States v. Merrill, 513 F.3d 1293 (11th Cir. 2008); United States v. Williams, 445 F.3d 1302 (11th Cir. 2006).

 

This instruction has recently become the subject of controversy, so it should be treated with caution.  In the context of prosecuting a physician for violating section 841(a), this good faith instruction is an elaboration of the latitude of behavior the physician may engage in lawfully rather than the formulation of a specific defense.  Accordingly, several courts have held that the failure to give a good faith instruction upon request is reversible error.[20]

 

In United States v. Moore, the Supreme Court stated that in enacting section 841, it was the intent of Congress “to confine authorized medical practice within accepted limits,”  and that “physicians who go beyond approved practice remain subject to serious criminal penalties.” Based on these statements, every court to examine the issue has held that a physician’s good faith should be measured by an objective standard.  Unfortunately, there is less agreement on how to charge this objective standard to a jury.

 

Following Moore, two slightly different instructions came into use. The Ninth Circuit approved an instruction taking language from the instruction given by the trial court in Moore:

 

[G]ood faith means an honest effort to prescribe for a patient’s condition in accordance with the standard of medical practice generally recognized and accepted in the country … . Good faith is not merely a doctor’s sincere intention towards the people who come to see him, but, rather, it involves his sincerity in attempting to conduct himself in accordance with a standard of medical practice generally recognized and accepted in the country.[21]

 

The other instruction addressed the need to provide an objective standard by speaking in terms of the physician’s reasonable belief:

 

A controlled substance is dispensed by a physician in the usual course of his professional practice, and therefore lawfully, if the substance is dispensed by him in good faith in medically treating a patient. Good faith in this context means good intentions and honest exercise of best professional judgment as to a patient’s medical needs. It connotes an observance of conduct in accordance with what the physician should reasonably believe to be proper medical practice.[22]

 

It is absolutely clear that the word “reasonably” is required in this formulation.  Indeed, in United States v. Hurwitz[23], the defendant requested an instruction omitting the term “reasonably” based on a prior decision of the Fourth Circuit approving a charge which had omitted it.  The court of appeals held that the requested instruction did not properly incorporate the necessary objective standard and so was properly denied.  Later, in United States v. McIver[24], the Fourth Circuit approved an instruction into an extended charge discussing good faith and the differences between civil medical malpractice and criminal dispensing of controlled substances.[25]

 

In contrast to McIver, which approves a “reasonably believed” instruction, is the Eleventh Circuit’s opinion in United States v. Williams.[26]  In that case, the defendant requested an instruction virtually identical to the recommended instruction including the “reasonably believed” language, which the trial court refused, and instead gave the following charge:

 

A controlled substance is prescribed by a physician in the usual course of a professional practice and, therefore, lawfully, if the substance is prescribed by him in good faith as part of his medical treatment of a patient in accordance with the standard of medical practice generally recognized and accepted in the United States.[27]

 

On appeal, instead of holding that the instruction given adequately covers the subject, which it clearly does, the court held that the requested instruction was contrary to Moore “because it fail[ed] to introduce any objective standard by which a physician’s prescribing behavior can be judged.”[28]

 

Williams is troubling because it holds that an instruction specifically approved by several courts as stating the proper objective standard does not do so without explaining why the phrase “reasonably believed” is not sufficient to achieve that goal.  That being said, the parenthetical language in the recommended instruction is clearly unacceptable in the Eleventh Circuit, and should be treated with caution elsewhere.

 

0