Tag: drug diversion

The Oregon pharmacist’s role in preventing prescription drug diversion

Posted on January 16, 2016 by - Licensure

The “corresponding responsibility” imposed on Oregon pharmacists

It is a crime is to “knowingly or intentionally” distribute or dispense a controlled substance unless “authorized” by the Controlled Substances Act (CSA). See, 21 U.S.C. § 841(a). Authorization is obtained by “registering” with the Attorney General. See, 21 U.S.C. § 822(a)(2). Persons registered with the Attorney General are authorized to possess, manufacture, distribute, or dispense controlled substances to the extent authorized by their registration. See, 21 U.S.C. § 822 (b). Physicians licensed by a state and registered with the Attorney General are “practitioners” and, as such, they are authorized to prescribe and dispense controlled substances (see, 21 U.S.C. § 829(a)&(b)) in “the course of [their] professional practice.” See, 21 U.S.C. § 802(21); see also, United States v. Moore, 423 U.S. 122, 140 (1975). Similarly, pharmacists licensed by a state and practicing in a pharmacy registered with the Attorney General, are authorized to dispense controlled substances. Giving effect to this federal statutory scheme, the Drug Enforcement Administration (DEA) promulgated a regulation that broadly requires all prescriptions to be issued for a “legitimate medical purpose” and imposes “a corresponding responsibility [on] the pharmacist who fills the prescription.” See 21 CFR § 1306.04(a). A pharmacist’s failure to observe whether a prescription is issued for a legitimate medical purpose can lead to administrative and criminal sanctions.

The difficult task faced by Oregon pharmacists

Compared to the prescribing physician or nurse, a pharmacist’s exposure to a patient is but a brief encounter. For most patients, a visit to a pharmacy is more akin to a sales transaction that a health care event and, should something seem amiss to the dispensing pharmacist, neither the patient nor the patient’s prescribing physician will have much tolerance for questions. Nonetheless, it is in this environment that the Oregon pharmacist is expected to ensure that all prescriptions are issued for a legitimate medical purpose.

The current practice standard: screening for “red flags”

I can assure you from my work defending physicians and pharmacists that screening for red flags is expected of all practitioners. For the pharmacist, however, screening for red flags may be one of the better tools available to detect prescription drug diversion, to ensure that all prescriptions are issued for a legitimate medical purpose. Agreeable or not, screening for red flags is also important because whether a pharmacist screened for red flags will be a consideration for the Oregon Board of Pharmacy and DEA drug diversion investigators whenever there is a suspicion of drug diversion and one or more red flags were present. The Oregon Board of Pharmacy addresses screening for red flags on its website at: http://www.oregon.gov/Pharmacy/pages/index.aspx), and further links to an YouTube educational video: https://www.youtube.com/watch?v=WY9BDgcdxaM&feature=youtu.be:

While screening for red flags to prevent drug diversion has its limits (and its critics, which include patients, prescribing and dispensing practitioners, and pain control advocates who may feel pitted against one another), it is nonetheless the current practice standard against which a pharmacist’s conduct will be measured, and it is therefore important to incorporate this type of scrutiny into the Oregon pharmacist’s day-to-day practice.

 

Drug diversion? Why “medical necessity” is not the standard

Posted on December 11, 2015 by - DEA Prosecutions

Last month two physicians, doctor John Couch and doctor Xiulu Ruan of Mobile, Alabama, pleaded not guilty to multiple charges of drug diversion. I have no personal knowledge of either Dr. John Couch or Dr. Xiulu Ruan, or of their case, having only read about the doctors in the media. What caught my attention was that the news report included a discussion of “medical necessity,” i.e., whether there was a “medical necessity for dispensing the controlled substance.” Medical necessity is not, however, the legal standard by which the crime is measured. Nor is malpractice. This is an issue I have devoted some time to while defending physicians charged with prescription drug crimes. Rather, “drug diversion” is a specific intent crime. To convict a doctor of drug diversion, the government must prove more than malpractice, and more than the absence of medical necessity.

The elements of the crime of drug diversion

Doctors Couch and Ruan had authority to prescribe controlled drugs by virtue of their DEA Registrations. Under 21 U.S.C. § 841(a)(1), it is generally agreed that the government must prove (1) that both doctors prescribed or dispensed a controlled substance, (2) that they acted knowingly and intentionally, and (3) that they did so other than for a legitimate medical purpose and in the usual course of his or her professional practice. See, e.g., United States v. Norris, 780 F2d 1207, 1209 (5th Cir. 1986); citing, U.S. v. Rosen, 582 F2d 1032, 1033 (5th Cir. 1978).

It is important to know, however, that the Controlled Substances Act (CSA), which is the statutory scheme passed by Congress, includes only the first two elements above. The third element,”legitimate medical purpose,” is rooted in an agency Rule promulgated by the Drug Enforcement Administration (DEA). See 21 C.F.R. 1306.04(a). That Rule provides that a controlled substance can be dispensed by a prescription “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. 1306.04(a); Norris, 780 F2d 1207,1209. Thus, lawyers defending doctors need to be careful that the agency’s Rule does not swallow the federal statute, watering down the criminal conviction standard.

Did the doctors “knowingly and intentionally” divert drugs?

Keeping the federal statute front and center, the question is whether Dr. John Couch or Dr. Xiulu Ruan intended to divert drugs, a specific intent crime. The DEA’s attorneys might very well prove that Dr. John Couch or Dr. Xiulu Ruan prescribed without medical necessity, or that they committed malpractice while prescribing, but more is required to prove the specific intent crime of drug diversion. The DEA’s attorneys must prove that doctors John Couch and Xiulu Ruan “knowingly and intentionally” diverted drugs to an illicit purpose. This is the burden of proof imposed upon the government, by the Congress, pursuant to 21 U.S.C. § 841(a)(1).

Against the DEA, lawyers mount vastly different defenses

Posted on December 1, 2015 by - Appellate, DEA Prosecutions

Part of my work requires that I review trial court records in order to prepare and file briefs on appeal. Consequently, I see the complete record, from beginning to end, prepared by different lawyers. One practice area that keeps me on my toes is defending physicians, pharmacists, and prescribing nurses from prescription drug charges by the DEA. Lawyers defending such cases can take vastly different approaches to their work. Some do a great deal of work to prepare, and do that work well in advance of trial. Others, not so much, saving preparations until close to trial, which can be unnerving to physicians, pharmacists and prescribing nurses, demanding professionals in their own right.

DEA lawyers present uniform prosecutions across the country

My experience includes directly defending or assisting physicians, pharmacists, and prescribing nurses in cases arising out of the Third, Fourth, Seventh, and Ninth Circuits and 13 states, including Indiana, South Carolina, Arizona, Oregon, Virginia, Georgia, Pennsylvania, Florida, Hawaii, Texas, Connecticut, California and Michigan. With this broad experience, I have seen first hand that the DEA lawyers take a similar if not uniform approach across the country when investigating and prosecuting physicians, pharmacists, and prescribing nurses, which should come as no surprise, since the DEA’s work is driven from the top down. I have also seen first hand that defense attorneys are far less uniform in their approach to their work, and the quality of each defense is dependent upon the individual firm and lawyer(s) responsible for preparing and delivering defense.

Working against the DEA, lawyer’s experience reveals common mistake

As a part of the work summarized above, I represented the physician and pharmacist before the United States Supreme Court in the case of Gonzales v. Oregon, 546 U.S. 243, 126 S. Ct. 904, 163 L. Ed. 2d 748 (2006). I am also the lawyer that obtained the release from prison of doctors David and Randall Chube, on appeal to Seventh Circuit Court of Appeals, in the case of US v. Chube II, 538 F3d 693 (7th Cir. 2008). Both these cases are discussed in detail elsewhere on this website, and that effort will not be repeated here, except one point bears repeating: If a case is not well-defended, the DEA will criminalize some aspects of the practice of medicine by confusing the civil standard of care with the criminal conviction standard. Don’t let this happen to you.

An adequate defense can be complicated and expensive

Drug diversion cases (i.e., prescribing or dispensing “without a legitimate medical purpose”) are complicated cases to defend, with each case presenting the intersection between law, medicine and, sometimes, politics, with the occasional involvement of the media. When mounting an adequate defense against the DEA, lawyers face divergent tasks, and it is difficult for one lawyer to do it all. This is not an uncommon problem in litigation generally. When I was a younger attorney, recruiting lawyers to help defend physicians in a small southern medical clinic, one senior attorney commented to me that “if we had four lawyers and $100,000 we could do something with this case,” and his comment is often spot on. The point I would stress to any physician, pharmacist, or prescribing nurse defending against prescription drug charges, is to ensure that your defense team is complete, and that your defense is prepared well in advance of trial.

Criminalizing medicine

Posted on November 14, 2015 by - Appellate, DEA Prosecutions

Are some physicians being convicted and sentenced for “legal” prescriptions?

I say “yes,” and I have first hand experience defending physicians on appeal from such convictions and sentences. Perhaps the best example I have to offer is the case involving Drs. David and Randall Chube, two Gary, Indiana, physicians that I represented on appeal to Seventh Circuit Court of Appeals. See US v. Chube II, 538 F3d 693 (7th Cir. 2008).

DEA attorneys confuse the legitimate medical purpose rule

The problem occurs when the criminal conviction standard and civil standard of care – two very distinct legal standards – are confused, substituted, and/or conflated by DEA investigators, DEA attorneys, federal prosecutors, the government’s expert witnesses, and the PSR writers. In my opinion, this legal error – i.e., criminalizing medicine – occurs too often, during key phases the criminal proceeding, which include the:

  • DEA investigation (leading to more counts in the indictment);
  • Federal prosecution (leading to more convictions at trial); and
  • Federal sentencing (leading to longer prison sentences).

In my experience, this legal error occurs when the civil and criminal standards are conflated through the misapplication of the rule against prescribing without a “legitimate medical purpose,” a subject that is discussed in more detail on the criminal violations page of this website, and numerous other pages as well.

Medical malpractice is neither criminal conduct nor relevant conduct

This point is key: A violation of the civil standard of care (usually called malpractice, or professional negligence) is, without more, not enough to prove a prescription drug crime, or the “relevant conduct” necessary to lengthen a prison sentence. The reason is simply. Malpractice alone, even when prescribing controlled substances, is not a crime, and malpractice alone is not enough to support a criminal conviction, or a finding of relevant conduct necessary to lengthen a prison sentence. Unfortunately for physicians, however, when the criminal conviction standard is conflated with the civil standard of care, the criminal conviction standard is lowered toward the malpractice standard, making multiple criminal convictions easier to win, and the relevant conduct necessary to lengthen a prison sentence, easier to find. Protect yourself – do not let this happen to you.

The legitimate medical purpose standard as applied in case of U.S. v. Chube II, 538 F3d 693 (7th Cir. 2008)

At the time of sentencing in the Chubes’ case, the federal prosecutor and the PSR writer seemingly counted every prescription written by the Chubes as “relevant conduct,” without first reviewing each prescription to determine whether “drug diversion” – which is the crime – had in fact occurred. Drug diversion includes unlawful prescribing, unlawful dispensing, or drug dealing, i.e,. it is criminal conduct. Under the federal sentencing guidelines, relevant conduct, which is essentially other criminal conduct, is applied at the time of sentencing to increase the length of a prison sentence. In the Chubes’ case, Dr. Randall Chube’s sentence was increased to five years and Dr. David Chube’s sentence was increased to fifteen years. In the Chubes’ case, however, it wasn’t relevant conduct because it wasn’t criminal conduct. Another way to look at it is that the DEA “criminalized” medical error. Criminalization occurs when there is an unchecked expansion of the law by over-aggressive law enforcement.

On appeal, the Seventh Circuit Court of Appeals vacated both doctors’ prison sentences and “remanded” the case back down to the District Court for re-sentencing. The Seventh Court of Appeals explained that the District Court relied upon insufficient evidence to prove that the relevant conduct was in fact criminal conduct. See US v. Chube II, 538 F3d 693 (7th Cir. 2008). Shortly thereafter, the trial court released both physicians from prison pending re-sentencing, and both physicians served substantially shorter sentences once relevant conduct was correctly understood and applied.

The DEA’s “legitimate medical purpose” standard – Part II

Posted on October 6, 2015 by - DEA Prosecutions, Licensure

Conflating the criminal and civil standards when prosecuting doctors for prescription drug crimes

In a prior post, I suggested that DEA lawyers and drug diversion investigators, while fulfilling their responsibilities to “police” both civil and criminal violations of the CSA, blur the line between civil violations (the standard of care) and criminal violations involving prescription drug crimes by doctors (e.g., unlawful prescribing, unlawful dispensing, drug diversion, or prescribing without a legitimate medical purpose), thereby “criminalizing” what would otherwise be a civil violation. Today I will share one example off how the DEA lawyers and drug diversion investigators accomplish this feat, conflating the civil standard of care with the criminal conviction standard when attempting to prove a doctor committed a prescription drug crime.

First, a basic understanding of the prescription drug crime

To convict a doctor of a prescription drug crime under 21 U.S.C. § 841(a)(1), it is generally agreed that the government must prove (1) that the doctor prescribed or dispensed a controlled substance, (2) that he or she acted knowingly and intentionally, and (3) that he or she did so other than for a legitimate medical purpose and in the usual course of his or her professional practice. See, e.g., United States v. Norris, 780 F2d 1207, 1209 (5th Cir. 1986); citing, U.S. v. Rosen, 582 F2d 1032, 1033 (5th Cir. 1978). A lawyer defending doctors accused of prescription drug crimes must be familiar with these concepts.

It is important to know, however, that the Controlled Substances Act (CSA) – the statutory scheme passed by Congress – includes only the first two elements above. The third element,”legitimate medical purpose,” is rooted in an agency rule promulgated by the Drug Enforcement Administration (DEA). See 21 C.F.R. 1306.04(a). That Rule provides that a controlled substance can be dispensed by a prescription “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. 1306.04(a); Norris, 780 F2d 1207,1209. Thus, lawyers defending doctors accused of prescription drug crimes will also need to be familiar with the interplay between the statute (21 U.S.C. § 841(a)(1)), and the rule (21 C.F.R. 1306.04(a)). Similarly lawyers defending pharmacists accused of unlawful dispensing will also need to be familiar with the interplay between the statute (21 U.S.C. § 841(a)(1)), and the rule (21 C.F.R. 1306.04(a)) because the rule further states that “a corresponding responsibility rests with the pharmacist who fills the prescription.”

So what does the CSA actually say?

Under the CSA, a doctor commits a prescription drug crime when he or she (1) knowingly or intentionally (2) distribute or dispense a controlled substance unless “authorized” by the Act. See, 21 U.S.C. § 841(a). Authorization is obtained by “registering” with the Attorney General. See, 21 U.S.C. § 822(a)(2). Persons registered with the Attorney General are authorized to possess, manufacture, distribute, or dispense controlled substances to the extent authorized by their registration. See, 21 U .S.C. § 822 (b). Physicians licensed by a state and registered with the Attorney General are “practitioners” and, as such, they are authorized to dispense controlled substances (see, 21 U.S.C. § 829(a)&(b)) in “the course of [their] professional practice.” In other words, a doctor commits a prescription drug crime when he or she (1) knowingly or intentionally, (2) distributes or dispenses a controlled substance, (3) outside the course of professional practice. There is no requirement in the statutory scheme of a “legitimate medical purpose.” Rather, that requirement is added by agency rule. See 21 C.F.R. 1306.04(a).

What’s the problem?

The problem arises when the DEA attorneys and drug diversion investigators focus on the language of the rule – “legitimate medical purpose” – to the exclusion of the three statutory elements of the crime discussed above (i.e., the knowing or intentional distribution of a controlled substance outside the course of professional practice). When this happens, the legal inquiry becomes too focused on the civil standard of care, not the elements of the prescription drug crime. Lawyers familiar with defending doctors charged with prescription drug crimes know this. I am aware of one recent case in which the physician was indicted for prescribing outside the course of professional practice and, remarkably, the indictment omitted any reference to the “knowing or intentional” element of the crime. This first crucial element of the crime, mandated by the CSA, was not included until a later, superseding indictment. Amazing.

Why does it matter?

The first element of a prescription drug crime – knowing or intentional – is hugely important because it makes clear that the crime of unlawful prescribing or dispensing is a “specific intent” crime. The crime includes a mens rea component, meaning that the prescribing physician or dispensing pharmacist intended to commit a prescription drug crime by writing or dispensing a prescription outside the course of professional practice. The specific intent requirement means that the presence of ordinary professional negligence (professional negligence or malpractice) is not enough to convict. More is needed. The problem occurs when DEA attorneys and drug diversion investigators focus on the civil standard of care, as if a violation of this civil standard is enough to prove a prescription drug crime, which can be very misleading to a jury.

Conclusion

This is but one example of the misapplication of the law when prosecuting doctors for prescription drug crimes. There are more examples, and constant vigilance is required. The legal challenge for lawyers defending against the DEA is to prevent this type of inquiry before conviction, or to reverse it on appeal after conviction, and it is challenging work with much at stake.

The DEA’s “legitimate medical purpose” standard – Part I

Posted on October 4, 2015 by - DEA Prosecutions, Licensure

Committing prescription drug crimes with your DEA “License”

Many physicians, all pharmacies, and some nurses, have DEA “Registrations.” Practitioners will often refer to their DEA Registration as a “license,” or simply, “my DEA.” The DEA Registration grants “authority” to the Registrant under the Controlled Substances Act (CSA) to possess, prescribe, and/or dispense controlled substances, to the extent authorized by the Registration.

If you possess a DEA Registration, you play an integral part in controlling the Nation’s drug supply, a “closed system” of inventory wherein every controlled drug is tracked from the point of manufacture to the end consumer, a patient. As such, DEA Registrants are subject to much scrutiny under the CSA, a complex legal scheme that keeps our federal trial and appellate courts quite busy.

A civil or criminal investigation – which is it?

When DEA lawyers and agents investigate physicians, pharmacists and nurses under the CSA, they may pursue the DEA Registrant civilly or criminally. The DEA has a choice. When the DEA pursues a Registrant civilly, the process can feel similar to a licensure proceeding before a state licensing board. When, however, the DEA pursues a Registrant criminally – for prescription drug crimes – it will feel like a criminal prosecution, with the full weight of the government bearing down.

Are the lines blurred between the civil and criminal standards?

I have successfully argued that DEA attorneys and agents, while fulfilling their responsibilities to “police” both civil and criminal violations of the CSA, have blurred the line between civil violations (the standard of care) and criminal violations involving prescription drug crimes (i.e., unlawful prescribing, unlawful dispensing, drug diversion, or prescribing without a legitimate medical purpose), thereby “criminalizing” what would otherwise be, at best, a civil violation, see US v. Chube II, 538 F3d 693 (7th Cir. 2008), or no violation at all. See Gonzales v. Oregon, 546 U.S. 243, 126 S. Ct. 904, 163 L. Ed. 2d 748 (2006).

Application of the legitimate medical purpose standard in civil and criminal proceedings

If, while pursuing civil violations, the DEA’s attorneys and agents investigate a doctor for prescribing without a legitimate medical purpose, and they equate a legitimate medical purpose with the civil standard of care, I am not sure what difference it makes. This is because on the “civil side” of the DEA, the DEA will enforce the standard of care, much like a state licensing board. If the DEA wants to call it by another name – i.e., legitimate medical purpose – I do not see how it matters, as the out come will likely be the same.

If, however, the DEA attorneys and agents are investigating a doctor for a prescription drug crime, and the DEA equates “prescribing without a legitimate medical purpose” with the civil standard of care, then we have a problem – the doctor’s “criminal” conduct will now be measured against the civil negligence standard, a lower legal standard, making it easier for the government to prove wrong doing. This is a trap for pharmacists too, because the so-called “legitimate medical purpose” rule states that “a corresponding responsibility rests with the pharmacist who fills the prescription.” See 21 CFR §1306.04(a) (legitimate medical purpose rule). Thus, whether you are a prescribing physician or a dispensing pharmacist, never forget that a violation of the civil standard of care when prescribing or dispensing controlled drugs is professional negligence, or malpractice; it should not be, without more, viewed as an intentional drug crime, which requires more proof, i.e., proof of intentional wrong doing.

Further discussion on this subject

In a subsequent post, I will shed light on one of the ways DEA attorneys and agents have accomplished this blurring of the lines, which, in my experience, “waters down” the burden of proof required to convict physicians and pharmacists of prescription drug crimes, and also makes it easier to find the “relevant conduct” necessary to lengthen a prison sentence under the federal sentencing guidelines.