Posted on Friday, 12th September 2008 by dcooley
This is the first in a series of posts outlining the major legal issues associated with internet pharmacy prosecutions. Today, I will be outlining the typical federal distribution of a controlled substance case against online pharmacies, pharmacists, doctors, and prescription website owners (online consultation and direct prescription services, as well as no record pharmacies). Note that while many states have similar laws and are prosecuting internet pharmacies and disciplining licensed professionals, the DEA and DOJ have been much more active and the potential punishments are much more significant. Thus, I am outlining their case here.
Most federal cases against doctors prescribing, pharmacists filling, and website owners facilitating internet prescriptions are brought under The Controlled Substances Act(CSA). 21 U.S.C. 801-971. The CSA governs the manufacture, distribution, and dispensing of controlled substances. This is the statute in which cocaine, meth, etc. distributors are traditionally prosecuted as well. The statute attempts to classify controlled substances into five “schedules,” depending upon their degree of potential addiction and abuse, with Schedule I drugs being the most addictive. Schedule III includes, for example, hydrocodone (Vicodin). Schedule IV includes, for example, Alprazolam (Xanax) and Zolpidem (Ambien). The CSA generally makes it illegal to distribute any of the scheduled drugs; however, it exempts from prosecution those individuals that have licenses to distribute controlled Schedule III and IV substances with a valid prescription (i.e. physicians). 21 USC 829(b).
Therefore, the entire basis for CSA prosecutions of the individuals associated with an internet pharmacy (the owner, pharmacist, and doctor) rests completely on whether the prescription was illegitimate (and, thus, not even a prescription at all). If it was legitimate, then the players did nothing wrong, pursuant to the CSA. If it was invalid, however, the DEA believes that all members can be prosecuted.
Whether a prescription is valid under federal law is anything but clear, unfortunately, despite what the Government might believe. The Government looks to 21 C.F.R. 1306.04(a) to determine the standard for valid prescriptions:
“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 the 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 21 USC 829 and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to penalties provided for violations of the provisions of law relating to controlled substances.”
One would think that the CFR would help rather than just add to the confusion of what constitutes a valid prescription. The phrase “practitioner acting in the usual course of his professional practice” has received some judicial scrutiny (unfortunately most on instructional issues). The scrutiny it has received, however, was not enough to determine its true meaning. The DEA has drafted guidelines in attempt to provide greater clarity. DEA Guidance 66 F.R. 211810-01, April 27, 2008 states:
“Under federal and state law, for a doctor to be acting in the usual course of professional practice, there must be a bonafide doctor-patient relationship.”
“Completing a questionnaire that is then reviewed by a doctor hired by the Internet Pharmacy could not be considered the basis for a doctor - patient relationship.”
Thus, the Government’s argument can be summarized as follows: To distribute controlled substances legally under the CSA, one must write a valid prescription. A valid prescription is one issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice. The DEA implicitly states, via its Guidelines, that the usual course of professional practice requires a doctor-patient relationship. Because online consultations do not constitute a doctor-patient relationship, the website owners, pharmacists, pharmacies, and doctors can all be prosecuted under the CSA.
The traditional way that the DOJ then drafts its indictment is to include conspiracy counts to distribute controlled substances for all the players, individual counts against each player for the distribution of controlled substances, and, finally, counts for money laundering and criminal forfeiture.
An astute reader (if you have made it this far) might recognize the tremendous number of holes and fallacies entrenched within the Government’s analysis, most of which occur when the DEA starts discussing a doctor-patient relationship.
The remaining several parts of this series will cover all of the perceived holes and criminal defense strategies associated with the DOJ and DEA’s analysis individually and in more depth; however, I will outline them here so that you know in advance what is in store over the next week or two:
- Where did the DEA get the idea that a doctor-patient relationship was required? The CFR does not include that term whatsoever. It only requires that the prescription be issued for a legitimate medical purpose and in the usual course of professional practice. Does the doctor-patient relationship issue serve to add an additional requirement onto the CFR or does the DEA believe that a doctor-patient relationship subsumes the two requirements in the CFR? Either way, the DEA Guidelines can not trump the CFR.
- Even if a doctor-patient relationship was required, why is an online consultation not one? A doctor, after thoroughly reviewing medical records, probably has done more than one’s average GP doctor. Additionally, the Federation of State Medical Boards has expressly indicated that online consultations do constitute doctor-patient relationships.
- How can a website owner be punished under the CSA? Certainly no one can argue that prescriptions without face-to-face consultations are so obviously outside the usual course of professional practice that everyone, even non-medical professionals, should recognize its illegality. No one can tell me that a online consultation website owner, if they are not professional doctors or pharmacists themselves, should be able to determine that OCS is so far outside the usual course of professional practice to satisfy the mens rea requirement under the statute.
- How can a pharmacist KNOW that the prescription was issued outside the course of professional practice? Obviously there are certain cases where it might be obvious (e.g. where the pharmacy all of the sudden was filling 700% more Vicodin pills than normal or where the doctor and patient’s addresses do not corroborate each other); however, in many cases, I believe that this might be questionable at best.
- There is a possible constitutional vagueness argument concerning a lay website owner (as long as this person is not a doctor or pharmacist) truly understanding what the “usual course of professional practice” means. Certainly, Congress believes the statute lacks clarity themselves. Otherwise, they would not find the need to try and pass The Ryan Haight Act, which would explicitly invalidate prescriptions without face to face consultations.
- There is another possible constitutional argument that lay website owners might not have adequate notice that they are covered under the CSA. As you will note that statute and corresponding CFR say nothing about website owners. They speak solely to pharmacists and physicians. However, there is a section of the CSA which states:
“It shall be unlawful for any person knowingly or intentionally to use any communication facility in committing or in causing or facilitating the commission of any act or acts constituting a felony . . . the term “communication facility” means any and all public and private instrumentalities used or useful in transmission of writing, signs, signals, pictures, or sounds of all kinds and includes mail, telephone, wire, radio, and all other means of communication.”
Clearly this section covers doctors and pharmacists who use websites, but what is entirely unclear is whether it also covers the “communication facility” owners. Obviously in terms of the mail, it can not logically be meant to cover the post office who facilitates your packages getting to you. Consequently, how could it cover the website owner who also merely facilitates the drugs arriving at your door?
As you can see, there is a lot to talk about. I hope over the next few weeks you can stay with me as I go into each of these issues in significant depth.
The content on this post does not constitute legal advice and is for informational purposes only. You should not act upon the information presented on this website without seeking the advice of legal counsel. Should you wish to speak to an experienced criminal defense attorney knowledgeable in internet pharmacy, prescription, and drug law, please feel free to contact me directly.
Tags: Controlled Substances, Criminal Appeals, Criminal Defense, Internet Pharmacy Law, Non-Controlled Substances, Ryan Haight Act
Posted in Court Cases, DEA, Direct "Script", Doctors, Online Consultations, Pharmacies, Website Owners | Comments (25)
September 13th, 2008 at 12:05 pm
This is a very helpful analysis, and I’m looking forward to the next two blog posts on this topic. In response to your question about where the DEA gets the idea about a doctor-patient relationship being required, I think it’s helpful to look to United States v. Moore, 423 U.S. 122 (1975) (at least, the DEA looks to this case). On the one hand, Moore is, as far as I know, still good law, and in that case — old as the case is — Dr. Moore was prosecuted for, among other things, not having a proper physician-patient relationship with those he wrote prescriptions to and for. On the other hand, it’s not a recent case (which may or may not matter in court) and one can argue the extent to which the facts are on point today. It’s difficult to argue that they aren’t on point at all, however.
Additionally, I respectfully disagree with the characterization of the Federation of State Medical Board’s position on this topic. I think that their Rx Beat newsletter (http://www.fsmb.org/pdf/NCIP_Newsletter_RX-Beat_Vol2_Issue3.pdf, for one example) and other statements fairly well establish that organization’s discomfort with online consultations — something that we’ll blog about on our end at http://legitscript.com.
That said, this is a very helpful and timely set of blogs. There’s no question that there’s a lack of clarity on some issues related to online pharmacies, and regardless of what side you fall on on this issue, the lack of clarity doesn’t do anybody any good. Well done.
September 13th, 2008 at 3:59 pm
Hi John,
I completely agree that the FSMB is very concerned with online consultations. In fact, I think the FSMB would go so far as to argue that a doctor is negligent for performing them. However, I think one would be hard pressed to argue that, despite the negligence, a doctor-patient relationship isn’t created when their very guidelines expressly say that online consultations do in fact create such relationships:
“[a]lthough the Board recognizes that it may be difficult in some circumstances, particularly in an online setting, to define precisely the beginning of the physician-patient relationship, it tends to begin when an individual seeks assistance from a physician with a health-related matter for which the physician may provide assistance. However, the relationship is clearly established when the physician agrees to undertake diagnosis and treatment of the patient and the patient agrees, whether or not there has been a personal encounter between the physician (or other supervised health care practitioner) and patient.”
FSMB, Model Guidelines for the Appropriate Use of the Internet in Medicine Practice, p. 4. (http://www.fsmb.org/pdf/2002_grpol_Use_of_Internet.pdf)
Thanks for the comment, and I look forward to your blog post on the subject.
September 15th, 2008 at 1:28 pm
I wholeheartedly applaud your efforts to begin picking through the DEA spin. The organization’s name defines it as an enforcement body, not a legal interpretive body. They must look to law to inform their actions, rather than attempt to re-spin the law to suit their objectives.
I’m not a lawyer. But am intensely interested in the way law plays out.
I have noted that many legal cases from the largest to the smallest, turn on the definition of a single word or phrase. One particular one phrase leaps out in this case.
Over years of treatment in a New York State University Psychiatric Clinic, where I could testify to numerous Dr.’s in the course of a 15 min. consult window, (with my 3 inch stack of records sitting on the table unread), that those Dr.s were operating outside federal law, if we assume a “reasonable” interpretation of current Federal law, which states that prescriptions be issued ‘for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.’” The DR’s there, on a number of occasions, prescribed medications that would be dangerous to me, because they had not read my history, as filled out when I was admitted for treatment. So much for using “face to face” as a basis for a Dr Patient relationship.
In that sense, my “face to face” examinations would appear to be partially or wholly voided by a court. Upon admission to the clinic, no complete or standard physical exam was done, (often relied on as reasonably required to protect the patient’s safety) was done… not even blood pressure. They simply relied on a written referral by a psychiatrist who also did not do a physical examination. In fact, in the course of my treatment by the all the physicians mentioned (8 or more), I cannot recall being physically touched by any of them.
in the:
“Trustees Report on Internet Prescribing: AMA Position on Using the Internet for Prescribing and Dispensing Drugs, 1999
• “The Board of Trustees recommends: That our AMA vigorously oppose the use of the Internet . . . to prescribe medications in the absence of safeguards that ensure: an adequate medical history is taken; full disclosure of risks, side-effects and limitations is provided; and where appropriate, additional interventions and follow-up care are provided.”
Their own criteria (and basis for that criteria) are violated routinely by face to face consults nationwide, and have not been proved to be any more effective in attaining the goals of patient care the AMA board is suggesting. Many Online Consulting Services do provide the “safeguards” mentioned above, often more so than a face to face Dr visit.
You quote, the 21 C.F.R. 1306.04(a) definition for a legitimate prescription:
“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.”
My point and question is:
Where does it clearly state in the CFR that the “usual course” of the practice does not include any and all means by which diagnosis can be made?
Psychiatrists particularly, often conduct telephonic consultations.
The AMA Guidance for Physicians on Internet Prescribing, H-120.949
2003 provides an exception to preforming a physical examination “in the following specific instances: treatment provided
in consultation with another physician who has an
ongoing professional relationship with the patient”
Even “The American Heritage® Medical Dictionary” defines consultation as “a meeting of two or more health professionals to discuss the diagnosis, prognosis, and treatment of a particular case.”
The form of the meeting is not specified.
So the lack of clear legal precedence or even clear language in existing law puts the DEA on extremely shaky ground as you point out.
The current test for language in place on the Federal level uses “normative standards”:
• Norm:
• “A pattern or trait taken to be typical in the behavior of a social group”
• “A widespread or usual practice, procedure, or custom”
But as the CFR states, the term “usual practice” is further defined as “his professional practice”, as opposed to another DR’s practice.
DEA Guidance 66 FR 211810-01, April 27, 2001 says:
• “It is illegal to receive a prescription for a controlled substance without the establishment of a legitimate doctor/patient relationship, and it is unlikely for such a relationship to be formed through Internet correspondence alone.”
“unlikely” is the term around which the entire section depends.
If I were in a courtroom I assume there would be laughter at the recitation of this alleged “guidance” to prosecutors.
also refer to these cases (from NABP.net ):
Irvin v. Smith
• Adams v. Via Christi Regional Med. Center, 270 Kan. 824, 835 (2001). McKinney, 118 Ohio App.3d at 336 (lack of direct contact between physician and patient does not preclude the finding of a physician-patient relationship);
• Cogswell, 672 N.Y.S.2d 460 (physician-patient relationship can be established by a telephone call to physician);
• Millard, 14 S.W.3d at 49 (Mo.) (physician-patient relationship may be found even in the absence of contact between the physician and patient); St. John, 901 S.W.2d at 424 (Tex.) (physician-patient relationship does not require a formal contract and may be implied by the circumstances).
The more law I read, the more DEA Guidance I read, the more I am convinced this is an “agenda driven issue”, as far as DEA is concerned… they have no clear uncontested basis to rely on.
Keep up the excellent work.
September 16th, 2008 at 1:17 am
Tom,
Thanks for you thorough analysis on the subject. The cases you cite further detail the lack of clarity in the law. Given the fact that many states find that doctor-patient relationships exist without any physical examination, it would be hard to argue that the law is so clear that a website owner knowingly and beyond a reasonable doubt violated The Controlled Substances Act. I had not seen a few of these cases and appreciate your research.
Additionally, your point regarding actual “physical examinations” is extremely valid. When the average appointment today with your GP lasts 5-10 minutes and includes the most cursory of examinations, it is hard to argue that a doctor could do much less over a phone or an internet pharmacy chat room.
Thanks again, and I appreciate your interest in http://www.internetdruglaw.com.
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