Month: October 2015

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.

How to shave months off the time it takes to conclude an appeal – Part II

Posted on October 2, 2015 by - Appellate

In my last post, I discussed the opportunities that will allow the smart appellate litigator to shave months off the time necessary to conclude a basic appeal, from start to finish, in the Oregon Court of Appeals. In this post, I discuss a few more time-consuming events that are less common, but may still be anticipated as part of a larger, time-saving strategy, as follows:

Consolidation of two appeals

Occasionally, the litigants may be litigating two cases, having similar issues, that are going up on appeal separately. Or, there may be an appeal from a Limited Judgment entered before trial, and then a second appeal from the General Judgment entered after trial. In either case, it is often desirable for reasons of “judicial economy,” to consolidate the appeals, to save time.

Sometimes, when two appeals are consolidated, they are simply assigned the same briefing schedule and oral argument schedule. In other words, the two appeals “travel together.” Other times, the two appeals are in fact consolidated into one appeal, sharing common briefing, and creating an appellant and cross-appellant situation. Either way, the consolidation of two appeals requires the filing of a motion (which requires experienced legal judgment), and an order by the Court of Appeals.

One way to save more time is to file a joint motion to consolidate (i.e., a motion by both parties, without objection from any party). While it may take time to negotiate the terms of the joint motion, a joint motion eliminates any dispute between the parties that would requiring resolution by the Court of Appeals, thus saving time-to-ruling, although a joint motion may still be denied.

Another way to save still time, is to file the joint motion to consolidate early, while preparation of the transcript and/or opening brief is underway. This approach means that the time consumed by the Court of Appeals to decide the motion will run concurrently with other necessary work, so the motion does not require any additional time. Conversely, if you really want to slow things down, wait until all the work is done before filing the motion to consolidate. The motion may still be granted, but now everybody is waiting for the motion to be decided by the Court of Appeals, before the next step may be taken, for example, scheduling oral argument.

Correcting the trial court record

Throughout the course of litigation, each party maintains a copy of the trial court’s file and, on appeal, each party relies upon their file to get their work done, rarely knowing or suspecting that the trial court’s file – which is the all important record on appeal – is incomplete. If the trial court’s file is incomplete, the record on appeal is incomplete. If this problem is present, it is usually not discovered until very late in the process, and the time necessary to correct the trial court’s file may take a month or two, or even longer, if the parties dispute what is necessary or permissible to correct the trial court’s file. Although an incomplete trial court file is an uncommon occurrence, if you would rather be safe than sorry, this potential delay can be avoided by taking a trip to the courthouse early on, to inspect the trial court’s file. This way, any necessary corrections can be made early on, concurrent with other work, saving much time later on.

Conclusion

As you can see from the above discussion, it is possible to anticipate even the unusual events that may delay an appeal by several months, and to eliminate those occurrences before the delay is unavoidable. It is not always easy to do, however, and expediting an appeal may be counter intuitive. We have all become accustomed to waiting for deadlines, and following the prescribed or expected path. Your appeals lawyer will need to be both experienced and proactive, but in the right case, expediting an appeal can be highly desirable, and it will almost always save money under the theory that the longer litigation lasts, the more it will cost.