Tag: legitimate medical purpose

What happened to the doctor “let go” by Dr. Sylvia Hofstetter?

Posted on December 5, 2015 by - DEA Prosecutions

The story of doctor Sylvia Hofstetter, in what has been characterized as “the largest drug network unearthed so far in East Tennessee,” is unfolding publicly this year, although the investigation certainly traces back several years. I have no personal knowledge of this case, or of Dr. Sylvia Hofstetter, having only read about Dr. Hofstsetter’s case in the media. As I understand it from news reports, Dr. Hofstetter was indicted earlier this year and is facing trial next year for prescription drug charges arising out of a large “pill mill operation” in Knowxville and Lenoir City. The facts as alleged certainly look bad for doctor Sylvia Hofstetter and her colleagues, but they always do, even in the cases that turn out better in the end.

At least one doctor was viewed favorably

What caught my eye was the testimony of an FBI Special Agent, who reportedly testified that Dr. Sylvia Hofstetter let one doctor “go” because that doctor spent more time with patients and wouldn’t always write a prescription for a narcotic. One implication from the Special Agent’s testimony is that this doctor was exercising clinical judgment, which suggests he was practicing medicine, and not intentionally dealing (i.e., diverting) drugs. Even if you assume the factual allegations are true with respect to Dr. Hofstetter and the others, this doctor is situated differently, even in the eyes of the FBI Special Agent. The doctor is not identified by name and I wonder what happened to him. Most often, every physician in the clinic is indicted, but was this doctor spared from indictment?

A “legitimate medical purpose,” or intentionally dealing drugs?

If this doctor was indicted, the issue for him will likely be whether he was practicing medicine or intentionally dealing drugs, and it is further likely his case will become entangled in the quarrel between what constitutes “prescribing without a legitimate medical purpose” (in my opinion, this agency rule is often misused by the DEA), and what constitutes the “knowing or intentional distribution of a controlled substance outside the course of professional practice,” which is the statutory crime legislated by Congress in the Controlled Substances Act, a quarrel I have discussed elsewhere on this website, and will not repeat again here today.

 

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.