Criminalizing medicine

Posted on January 10, 2016 by - DEA Prosecutions

Conflating the civil and criminal standards

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. When this happens, the practice of medicine is “criminalized.” One way this occurs is by the misapplication of the DEA’s rule against prescribing without a legitimate medical purpose, which I discuss on the criminal violations page of this website. It was with this understanding of the law that I shaped the legal theory that won Drs. David and Randall Chube’s release from federal prison in US v. Chube II, 538 F3d 693 (7th Cir. 2008). The Chube case is also discussed on the appeals page of this website.

Criminalizing medical error

What I have learned defending or advising 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, is that the DEA relies heavily, and sometimes too heavily, on chart-reviewing standard of care experts. These chart-reviewing standard of care experts will first determine that the civil standard of care was not met based upon a chart review, and will then leap to a conclusion that the physician was engaged in criminal activity.

This appears to have occurred in Dr. Larry Eckstein’s case, where a chart-reviewing standard of care expert opined that several aspects of Dr. Eckstein’s treatment of an undercover detective fell “outside the ordinary course of the professional practice,” because Dr. Eckstein (1) never made a diagnosis, (2) never performed any of the appropriate physical examinations, (3) did not perform a risk assessment on the detective, (4) mixed opioids with other prescription drugs, and (5) increased the amount of drugs in the prescription “massively,” without a diagnosis or treatment plan. See, Boulder doctor indicted on charge of distributing oxycodone, Boulder News, August 19, 2015.

I earlier discussed Dr. Eckstein’s case in more detail. As I said then, I have no personal knowledge Dr. Eckstein, or his case, having only read about the doctor in the media. If the allegations and expert opinion against Dr. Eckstein are true, Dr. Eckstein may have fallen short of the standard of care, but this is a properly addressed by restricting, suspending, or revoking Dr. Eckstein’s DEA Registration, or his state medical license, or both, in administrative proceedings. It appears, however, that the opinion of a chart-reviewing standard of care expert was instead used to “criminalize” Dr. Eckstein’s practice of medicine, leading to his indictment and arrest.

Malpractice is not a crime

A violation of the civil standard of care (which may amount to professional negligence, or medical malpractice, same thing) is not, without more, a drug crime. Indeed, a physician may commit malpractice when prescribing controlled substances, but that does not mean the physician committed the crime of drug diversion. Drug diversion requires more. Drug diversion requires the knowing or intentional distribution of a controlled substance outside the course of professional practice, i.e., intentional drug dealing. Beware: Whenever the DEA uses a civil standard of care expert, applying the malpractice standard to reach a conclusion about criminality, the DEA is criminalizing medical error. While medical errors do occur in the practice of medicine, adequate remedies are already in place. Criminalization occurs when there is an unchecked expansion of the law by over-aggressive law enforcement. This is what happened in Drs. David and Randall Chube’s case (discussed above), and it appears to have happened in Dr. Eckstein’s case too. Defense attorneys and courts everywhere must guard against this insidious perversion of the law.

DEA investigations: How much is too much?

Posted on January 9, 2016 by - DEA Prosecutions

Why such lengthy criminal investigations?

In an earlier post I asked whether the number of deaths attributed to Dr. Sylvia Hofstetter’s clinic by the Drug Enforcement Administration (DEA) could have been reduced had the undercover investigation been terminated sooner, after two years instead of four. In other words, what did two more years of undercover work by the DEA add to Dr. Hofstetter’s case?

More likely than not, the additional two years added nothing of value. By the DEA’s own account, illicit drug use and deaths continued, unabated by the DEA, while the DEA continued its lengthy investigation, and for what purpose? The additional evidence accumulated against Dr. Hofstetter was of questionable value. If the allegations are true, Dr. Hofstetter’s case would have been overwhelming to defend after the first year. As I write this, I can think of two physicians convicted of only one count of drug diversion that were sentenced to 5 years each, and one physician convicted of only six counts of drug diversion that was sentenced to 15 years. And all it takes is one patient death to impose a mandatory 20-year sentence. So why spend four years investigating Dr. Hofstetter, when one year, or even six months, will suffice?

Some might argue that the DEA is preoccupied with large undercover investigations at the expense of preventing harm to others. Think about it. If there were an active shooter in a shopping mall, police would not secretly stand by, accumulating more evidence, allowing more deaths to occur, before intervening to save lives. If the DEA is right about the harm inflicted by drug diversion, and by Dr. Hofstetter, why then does the DEA stand by and allow the harm to continue? What interests are served?

Why wait for a crime or injury to occur in the first place?

And here’s the larger question – why not shut down questionable prescribing practices early-on, when the suspect prescribing practices are first brought to the DEA’s attention, before anyone is harmed? There is, after all, no need to wait for even one criminal act to occur. Criminality is not necessary before the DEA may take action. The DEA may restrict, suspend, or revoke the prescribing physician’s DEA Registration by exercising the DEA’s administrative powers over DEA Registrants, much like a state licensing Board will pursue a physician, pharmacist, or nurse for practicing below the standard of care under state law.

It doesn’t take much to stop illegal prescribing

As I write this, I can think of a doctor and a nurse that engaged is almost identical misconduct while prescribing controlled drugs. Each wrote prescriptions to another, knowing the other would fill the prescriptions and return the controlled drugs to the doctor or nurse, for the doctor or nurse’s personal use. In each case, the standard of care was violated, and a fraudulent medical record was created, a crime. If insurance paid for the controlled drugs, then insurance fraud occurred too, also a crime.

Both the doctor and the nurse were easily caught, and easily stopped. Both were reported by their co-workers. The doctor was reported to the Oregon Medical Board (OMB). He’s in treatment, on probation, and his license is restricted, but he’s still practicing medicine. The nurse, unfortunately, was reported to the police first, and then to the Oregon State Board of Nursing. She too obtained treatment, but the police report led to a criminal indictment and she eventually entered a plea agreement on two counts. The sentencing court, wishing to send a message, insisted on criminal convictions over misdemeanors. Because the nurse was convicted of two felonies, she surrendered her RN and NP licenses to the Oregon State Board of Nursing. And because the nurse was convicted of two drug felonies, she was further “excluded” by the Office of the Inspector General (OIG) from participation in any and all healthcare programs receiving federal dollars for five years!

As an aside, the doctor and the nurse were involved in similar misconduct, but were treated in a disparate fashion, because law enforcement became involved in the nurse’s case, but not the doctor’s case. The doctor is still practicing, albeit with a restricted license while on probation and receiving treatment. The nurse, however, is not practicing, because she had the misfortune of being reported to the police first, and then the Oregon State Board of Nursing. She lost her licensure and was excluded by the Office of the Inspector General (OIG) from working in any setting that received federal funding, which is most clinical settings. Such disparate treatment is worrisome, but the point I want to make is that in both cases, the prescribing misconduct was stopped early on, before it became a larger societal problem.

Early intervention may be best for all involved

Which brings me back to where I started. Imagine how much pain and suffering, not to mention loss of life, might have been spared had the DEA exercised is administrative powers, and stepped in four years earlier, at the first sign of trouble, to restrict, suspend, or revoke Dr. Sylvia Hofstetter’s DEA Registration, and then perhaps pursue criminal sanctions too.

Is Dr. Larry Eckstein a criminal?

Posted on December 15, 2015 by - DEA Prosecutions

Doctor Larry Eckstein, of Boulder, Colorado, was indicted this summer by a Boulder County grand jury on one felony count of distribution of a controlled substance. I have no personal knowledge of this case, or of doctor Larry Eckstein, having only read about the doctor in the media. As I understand it from the news reports, however, Dr. Eckstein’s case is a small case, as drug cases go, and the doctor has garnered much community support, evidenced by crowd fundraising, a Facebook page, and public letter writing and comments. Based upon what I read, I further question whether Dr. Eckstein’s case is properly treated as a criminal case.

The allegations against Dr. Eckstein

According to the lead news report, the factual allegations against doctor Larry Eckstein are that:

“an undercover police detective scheduled an appointment for July 22, 2014, at Eckstein’s Boulder office, 2760 29th St. The detective complained of “chronic soreness” and said that a friend’s “Roxies” ‚Äî the street name for the opiate Roxicodone ‚Äî had helped him before.

“Eckstein gave the detective a basic physical examination and then prescribed him hydrocodone, according to the indictment. Eckstein approved two more refills for the hydrocodone and made a second prescription for the drug at a second appointment with the undercover detective in October.

“But on a third appointment Oct. 30, Eckstein prescribed the undercover detective oxycodone, and he did so again at four other appointments between December and February, according to the indictment.

“Between Oct. 30 and Feb. 25, Eckstein dispensed 30 grams of oxycodone to the undercover officer, according to court documents.”

See, Boulder doctor indicted on charge of distributing oxycodone, Boulder News, August 19, 2015.

The government’s expert

According to the same news report, the expert opinion of a chart-reviewing physician offered in support of the indictment, is that several aspects of Dr. Eckstein’s treatment of the detective fell “outside the ordinary course of the professional practice,” because Dr. Eckstein (1) never made a diagnosis, (2) never performed any of the appropriate physical examinations, (3) did not perform a risk assessment on the detective, (4) mixed opioids with other prescription drugs, and (5) increased the amount of drugs in the prescription “massively,” without a diagnosis or treatment plan. See, Boulder doctor indicted on charge of distributing oxycodone, Boulder News, August 19, 2015.

Several observations worth consideration

Overall, it appears that Dr. Eckstein wrote two prescriptions for hydrocodone (allowing two refills) and five prescriptions for oxycodone, on seven different occasions, over the course of eight months, spanning July 2014 through March of 2015, in response to an undercover detective’s complaints of chronic pain.

Is the government’s expert opinion worth that much?

Please know that when a chart-reviewing “expert” physician concludes that another physician’s treatment of a patient falls “outside the ordinary course of the professional practice,” as happened here, the expert is most often rendering a standard of care opinion (i.e., a malpractice opinion), while using words taken from a criminal statute. This type of opinion can be very misleading, because malpractice (professional negligence), without more, is usually not criminal. In other words, the expert might very well render an opinion that the medical standard of care was not met, as appears to be the case here, but where is the rest of the evidence? – the evidence necessary to push Dr. Eckstein’s case into the realm of criminal drug dealing?

A crime, malpractice, or none of the above?

There can be little doubt that the undercover detective intended to do as much as possible to obtain prescriptions for controlled drugs from Dr. Eckstein, without helping the doctor. Under the circumstances, does Dr. Eckstein’s treatment of the detective sound like criminal activity, or malpractice, or none of the above? At least one clinician, having some expertise himself and writing in support of Dr. Eckstein, suggests it was no more than professional negligence. See, Charles Horowitz: Prescribing pain medication often a tough call, Boulder News (Opinion), August 29, 2015.

Why not leave this matter with the Colorado Medical Board?

As a matter of public policy, why isn’t the Colorado Medical Board’s emergency suspension of Dr. Eckstein’s medical license “on suspicion of a ‘deliberate and willful violation of the Medical Practice Act,’ ” an adequate response in this case? See, Colorado suspends license of Bolder doctor indicted on drug charges, Boulder News, September 15, 2015. It is, after all, the role of a State licensing board to regulate the practice of medicine, and here the Colorado Medical Board has stepped in and suspended Dr. Eckstein’s medical license, meaning Dr. Eckstein can no longer practice medicine, much less prescribe controlled drugs. In a case like this, I would expect the Colorado Medical Board to investigate, to determine whether the Medical Practice Act was violated and, if it was, to discipline Dr. Eckstein accordingly, by imposing restrictions on him and his license. Why isn’t that enough in a case like this?

Why not suspend, restrict, or revoke Dr. Eckstein’s DEA Registration?

As a matter of public policy, why did those with decision-making authority prefer to indict Dr. Eckstein when they could have more efficiently and cost effectively suspended, restricted, or revoked his DEA Registration? A DEA Registration is necessary to prescribe controlled drugs, and it was the DEA that issued Dr. Eckstein’s DEA Registration in the first place. The DEA is similarly empowered to suspend, restrict and/or revoke Dr. Eckstein’s Registration for failure to meet the medical standard of care and, without DEA authority obtained via his DEA Registration, Dr. Eckstein can no longer prescribe controlled drugs. Why isn’t that enough in a case like this?

Could some deaths been prevented in Dr. Sylvia Hofstetter’s case?

Posted on December 12, 2015 by - DEA Prosecutions

The lengthy DEA investigation of doctor Sylvia Hofstetter

I earlier commented on the case involving doctor Sylvia Hofstetter and, as I explained then, I have no personal knowledge of Dr. Hofstetter or her case, having only read about Dr. Hofstsetter in the media. Nonetheless, any lawyer having any experience defending doctors against drug diversion charges will know that the government’s investigations can be quite thorough, and this is certainly true of the investigation into Dr. Sylvia Hofstetter. By one account, it was described as a “lengthy multi-year investigation” into Dr. Hofstetter’s move from Florida to Knoxville, Tennessee. It was further reported that “there were at least seven overdose deaths” due to controlled drugs prescribed by Dr. Hofstetter’s clinics, and that number does not include “dozens” of other potential deaths, as follows:

“In four years, the FBI said prescriptions for more than 12 million pills were written by Hofstetter’s clinics * * * [and] there were at least seven overdose deaths due entirely to opioid drugs that were prescribed by Hofstetter’s clinics. [The investigator] said seven deaths was a solid estimate because that number does not include dozens of other overdose deaths where other drugs may have been in the victims’ systems.”

See http://www.wbir.com/story/news/crime/2015/03/13/overdose-deaths–organized-crime-linked-to-pill-mill-operation/70285100/

The unasked questions

How many deaths could have been prevented had the government concluded its investigation of doctor Sylvia Hofstetter in two years instead of four? It does not appear that the government’s case against Dr. Hofstetter would have been compromised in any way that would have affected the government’s ability to pursue Dr. Hofstetter on criminal grounds after a two-year investigation. Alternatively, how many deaths would have been prevented had the DEA acted quickly after Dr. Hofstetter’s practice standards became suspect, by administratively suspending and then revoking Dr. Hofstetter’s DEA Registration, which would have ended her ability to prescribe controlled drugs all together?

A matter of public policy

These questions are public policy questions only, exploring the tip of the iceberg of social values, priorities, and the allocation of public resources. These questions are not intended to suggest a legal defense.

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).

Dr. Lawrence Wean, of Media, Pennsylvania, sentenced to prison

Posted on December 10, 2015 by - Appellate, DEA Prosecutions

Yesterday it was reported that 61 year-old doctor Lawrence Wean, of Media, Pennsylvania, a suburb of Philadelphia, was sentenced to prison for 10 to 20 years, and that he had earlier rejected a plea agreement that would have required less prison time. Experienced lawyers will know that rejecting a plea agreement and proceeding to trial is something of a gamble, and if you lose that gamble, you can expect to serve more time than what might otherwise been ordered after a plea, so a longer sentence for doctor Lawrence Wean comes as no surprise.

I have no personal knowledge of Dr. Lawrence Wean, or of his case, having only read about Dr. Wean’s case in the media. As I understand it from news reports, Dr. Wean sold prescription drugs to undercover officers, was convicted in October of writing unlawful prescriptions and filing false insurance claims, has been ordered to pay over $40,000 in fines and $62,000 in restitution, and was just sentenced to 10 to 20 years.

Too much exposure for physicians?

One of the things I have learned as an appellate lawyer defending physicians on appeal is that the additional time imposed at sentencing, after losing at trial, is disproportionately more time than anyone expected when measured against earlier plea offers or negotiations. In other words, the gamble for physicians facing drug diversion charges for prescription drug crimes, may be a larger gamble than the typical defendant might face when rejecting a plea agreement. Physicians, family members, and lawyers defending physicians for the first time, are genuinely surprised, something I have witnessed first hand.

Is there a better approach for some physicians?

One of the opportunities I would like to explore when the right case presents itself, is the idea of negotiating a very early and favorable plea agreement, followed by an quick sentencing and an early self-report to serve time, before the typical two-or-more years have passed, and extensive financial resources have been depleted, which is common when taking drug diversion charges to trial. Some might recall that this type of efficient resolution was Martha Stewart’s solution to her legal woes a few years back. She quickly negotiated a plea agreement, was sentenced, surrendered, served her time, and then got on with her life.

A unique physician will be necessary

This approach will require the right type of individual, and I have no way of knowing whether doctor Lawrence Wean was such an individual. Most physicians, it seems, are willing to postpone the start of trial as often as will be permitted, and they appear further willing to spend all that they have to avoid serving time. These tendencies appear to be true even after conviction, if the case is on appeal (although “bond” is seldom allowed on appeal, I have helped physicians remain free pending appeal). Nonetheless, for the right physician, I find the idea of a quick resolution and sentence intriguing. In the right case, a physician could enter a plea and serve his or her time in three years, at little financial cost, relatively speaking. In sharp contrast, however, at the end of three years, all many physicians will have to show for their efforts is one of more convictions and financial ruin, with a sentencing hearing, a prison term, and an uncertain appeal, on the horizon.

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.

 

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.