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 ยง1306.04(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.

Relevant conduct under the federal sentencing guidelines is criminal conduct

Posted on September 12, 2015 by - Appellate, DEA Prosecutions

U.S. v. Chube II, 538 F3d 693 (7th Cir. 2008)

I was the appellate lawyer lawyer for Drs. David and Randall Chube on appeal to the Seventh Circuit Court of Appeals in the case of US v. Chube II, 538 F3d 693 (7th Cir. 2008). At the time of sentencing in that case, both the DEA attorney (the federal prosecutor) and the “PSR writer” (the author of the Pre-sentence Investigation Report) seemingly counted every prescription for controlled substances, whether it was criminal or not, as relevant conduct when applying the federal sentencing guidelines, and the District Court (trial court) sentenced accordingly, which greatly increased the length of sentence for each physician – five years for Dr. Randall Chube, and fifteen years for Dr. David Chube.

On appeal, the Seventh Circuit Court of Appeals found that the District Court relied upon insufficient evidence to prove the relevant conduct was criminal conduct. Both physicians sentences were vacated and the case was remanded back down to the District Court for re-sentencing. A short while later, the trial court released both physicians from prison pending re-sentencing, and both physicians served substantially shorter sentences when relevant conduct was determined correctly. That was seven years ago.

Not much has changed

I was recently retained to assist defense counsel with the sentencing of a physician in a state located within the Fifth Circuit Court of Appeals, and it seems not much has changed. Like in the Chube case, both the DEA attorney and the PSR writer make the mistake of seemingly counting every prescription for a controlled substance as relevant conduct, without first establishing that the relevant conduct was criminal conduct, when applying the sentencing guidelines. If the District Court adopts these computations by the PSR writer and the DEA attorney at the time of sentencing, the District Court will commit reversible legal error just as the District Court did in US v. Chube II, 538 F3d 693 (7th Cir. 2008).

Prescribing without a legitimate medical purpose

The civil standard of care and the criminal conviction standard are two distinct legal standards, yet these two legal standards are often substituted, confused, and/or conflated, by the DEA’s drug diversion investigators, the DEA’s attorneys, the federal prosecutors, the prosecution’s medical experts, and the PSR writer, during the investigation, the trial and at sentencing. Most often, the civil and criminal standards are conflated through the misapplication of the rule against prescribing without a legitimate medical purpose, discussed on the criminal violations page and elsewhere on this website. Unfortunately for physicians, when the criminal conviction standard is conflated with the civil standard of care, the criminal conviction standard is lowered, making numerous criminal convictions easier to win, and the relevant conduct necessary to further lengthen a sentence, easier to find. The burden is upon defense counsel and the courts to keep these two distinct legal standards separate.

Never forget that relevant conduct is criminal conduct

A violation of the civil standard of care (which may amount to professional negligence or medical malpractice) is not, without more, a drug crime. In other words, a physician may commit malpractice when prescribing controlled substances, but that does not mean the physician committed a crime. Never forget that relevant conduct is criminal conduct. Because a violation of the civil standard of care when writing a prescription for a controlled substance is not, without more, criminal conduct, it is not properly considered relevant conduct for purposes of sentencing. More is required. See U.S. v. Chube II, 538 F3d 693 (7th Cir. 2008). By using an incorrect legal standard to determine which prescriptions are criminal, and therefore relevant conduct when applying the federal sentencing guidelines, a District Court will commit reversible legal error at the time of sentencing. It is incumbent upon defense counsel to preserve this legal error for appeal.

 

If a DEA Drug Diversion Agent asks you to sign a waiver or release, just say “no.”

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

If you possess a DEA Registration to prescribe, possess, or dispense controlled substances, you may one day be approached by a DEA Drug Diversion Investigator requesting an interview and asking you to sign a release or waiver of your right to remain silent. Just say “no.”

As my late friend Glen Crick has written,

“if you are told, ‘You have the right to remain silent,’ then remain silent. This warning is only given to someone who is the subject of a criminal investigation. If an investigator tells you that you have the right to remain silent, there is no guesswork involved. You are the subject of a criminal investigation, and there is nothing to be gained, and much to be lost, by talking to an investigator without legal counsel present.”

Two examples of what can go wrong

In one case, a senior physician was duped into writing prescriptions to young, drug seeking “patients.” His clinical assessments and charting were both good, and the drugs prescribed were appropriate and in therapeutic doses. The trouble arose, however, not from his charting, but from the statements he made during his voluntary interview with the Drug Diversion Investigator – he made the big mistake of signing a written release of his rights, and he then sat for an interview. Unfortunately, the mistakes he made during that interview hurt him, and he later pled to one “small count” (small by drug diversion standards) resulting in a sentence of probation, the surrender of his DEA Registration, and the closure of his practice. It was my opinion, however, that without the statements he made during his voluntary interview, his case was entirely defensible.

In another case, a physician made the same mistake of signing a written release of her rights, and she then sat for an interview with two Drug Diversion Investigators without legal counsel present. Before that interview was over, she was further persuaded to surrender her DEA Registration. This physician never faced allegations of criminal wrong doing, but she incurred much legal expense and trouble in an attempt to restore her Registration and medical practice. Although this case was never fully developed, it was my opinion based upon what was known, and what has been learned since, that this physician would not have lost her DEA Registration and there was no reason to surrender it to the DEA investigators in the first place.

What you need to know

In both the of the examples above, the physicians released their rights and agreed to be interviewed by Drug Diversion Investigators. It was my opinion that both cases were fully defensible. The lesson to be learned is that if a DEA Drug Diversion Investigator wants to interview you and asks you to sign a release or waiver of your right to remain silent, don’t do it. Just say “no.” If you are told, “You have the right to remain silent,” then remain silent. Decline all interviews until you have consulted with a lawyer familiar with prescribing issues under state and federal law. Whatever you do, don’t go it alone.