A perfect storm is brewing for physicians prescribing narcotics

Defending physicians prescribing narcotics for chronic pain has never been easy and I have long criticized the the Drug enforcement Administration (DEA) for conflating the civil standard of care with the criminal conviction standard, thereby criminalizing the practice of medicine. Sixteen months ago I commented that the DEA unnecessarily extends its investigations to the detriment of physicians and patients (DEA investigations: How much is too much?), and 11 months ago I commented that a new standard of care has emerged for the treatment of chronic pain (The pendulum has swung: Treat chronic pain cautiously). Now Attorney General Jeff Sessions, who heads the DEA, has ordered his federal prosecutors to seek the maximum punishment for federal drug offenses. All tolled, a perfect storm is brewing for physicians prescribing narcotics to treat chronic pain.

Treating chronic painĀ > 90 days and 120 MED (morphine equivalent dose)

With a few exceptions (e.g., cancer pain or hospice care), if you treat chronic pain with narcotics in excess of 90 days and 120 MED (morphine equivalent dose) and your prescribing practices have not evolved over the past five to seven years consistent with the emerging standard of care, you have likely failed to “keep up” and you may be at risk of regulatory intervention. If you treat chronic pain with narcotics in excess of 90 days and 120 MED, and you are not a pain specialist, or you do not refer your patients to a pain specialist, and your patients are not on taper plans, your medical practice may be a ticking time bomb

Prescribing guidelines: The emerging standard of care

The following practice guidelines, offered by the Oregon Medical Board and Oregon Health & Science University (OHSU), reflect current standard of care expectations when prescribing narcotics to treat chronic pain:

If your practice is not in line with these recent guidelines, you may be risking sanctions by your state medical board or the DEA. If your practice comes to the attention of your state medical board, your medical license may be subject to quick restriction or threatened revocation. Similarly, if your practice comes to the attention of the DEA, your DEA Registration may be subject to restriction or revocation and, in a worst case scenario, you may be subject to a criminal investigation. This already serious problem has been exacerbated by a newly invigorated DEA that has been instructed United States Attorney General Jeff Sessions to pursue the maximum punishment available for federal drug law violations.

Physicians, marijuana, the new DEA, and the Oregon Medical Board

Physicians beware: marijuana may complicate your professional life

I earlier wrote about marijuana, the practice of medicine, and the Oregon Medical Board, cautioning physicians that regardless of state law, marijuana is still a Schedule I banned substance under federal law, meaning that without a research permit or exception, it cannot be used or prescribed for any purpose under federal law. Consequently, I cautioned physicians not to become complacent when recommending marijuana for medical use and not to confuse compliance with the Oregon Medical Marijuana Program (OMMP) with meeting the applicable standard of care.

Admittedly, under former Justice Department policy, federal law has been lightly enforced and in those states where marijuana is “legal,” a lax attitude prevails among the general public. For those of us that possess professional licenses, however, we are often held to higher standards and this seems to be particularly true for Oregon physicians, whether they are recommending marijuana for medical use, or consuming marijuana recreationally. This point was hammered home earlier this month when I represented two physicians during their Investigative Committee (IC) interviews at the Oregon Medical Board. One physician had recommended marijuana for medical use. Although he had strictly complied with the Oregon Medical Marijuana Program (OMMP), the Medical Board’s concern was the standard of care. The other physician had never recommended marijuana for medical use, but he had admitted to personal use, and not always in a state where it was legal under state law. Both physicians were honest, forthcoming and well-intentioned, but marijuana had complicated their professional lives, something we all want to avoid.

Physicians, the times they are a changing: the new DEA

The times are not getting any easier for physicians recommending or using marijuana. New Attorney General Jeff Sessions, who heads the Drug Enforcement Administration (DEA), has long opposed the legalization of recreational marijuana and yesterday, Sean Spicer, the President’s press secretary, explained during his daily press briefing that under the new administration we can expect “greater enforcement” of federal law banning the recreational use of marijuana even in those states where recreational use is “lawful” under state law. I suspect the Oregon Medical Board was not surprised. During a side conversation earlier this month, a Medical Board investigator commented this might happen under the new administration and, a few weeks later, it did. I think it is safe to assume that in this new era, the Oregon Medical Board will have still greater concerns about the recreational use of marijuana by physicians in any state, including Oregon, where it is “legal.”

Physician sentenced to a year and a day for seven drug felonies!

Is there a new leniency in federal sentencing for prescription drug crimes?

In an effort to follow Drug Enforcement Administration (DEA) prosecutions, convictions, and sentencings around the country, I read Google alerts weekly, sometimes daily. In recent months, I have been struck by relatively lenient sentences handed down by several different District Courts when sentencing physicians pleading to multiple counts of drug diversion (i.e., prescription drug crimes). I have defended physicians and pharmacists facing prescription drug charges long enough to recognize trends. Thus far, I haven’t commented, but today I am prompted to do so because I sense there may be a new trend, or new opportunities, for those that are paying attention. Here is one recent example:

On August 9, 2016, it was reported that a West Virginia physician was sentenced in federal District Court to a year and a day in jail after pleading guilty to seven felonies for illegal distribution of oxycodone. The sentence included an $18,200 penalty, and required the physician surrender her medical license, but for those who are unaware of typical sentences for federal drug charges, this sentence is lenient! According to news reports, this physician had both prior legal and disciplinary history, was charged with a 100-count indictment alleging that she and two coworkers wrote 157 illegal prescriptions for oxycodone, oxymorphone, methadone, and methylphenidate, and the physician authorized pre-signed, blank prescription forms, for use by her staff. I am aware of much harsher sentences on what would appear to be much “cleaner” records.

A new trend or opportunity?

I haven’t done the research, and do not presently have the case to justify the time and expense, but for those physicians (and their lawyers) currently preparing to plead and be sentenced,a six-month review of recent federal District Court sentences involving drug diversion pleas around the country may be a worthy endeavor. A little research will turn up other similar news reports of relatively lenient sentences, suggesting better results for physicians sentenced for prescription drug crimes than I have seen for a while. There is perhaps something to be learned.

Ten year anniversary of U.S. Supreme Court opinion against DEA in favor of physicians and pharmacists

This year marks ten years since the United States Supreme Court issued its opinion in the case of Gonzales v. Oregon (406 KB), decided January 17, 2006. In this case, the United States Supreme Court affirmed the Ninth Circuit Court of Appeals’ opinion (263 KB), which had earlier affirmed the federal District Court’s opinion (1.78 MB) enjoining former United States Attorney General John Ashcroft from prosecuting Oregon physicians and pharmacists.

Against the DEA, healthcare defense attorney seeks injunction

Normally, as a healthcare defense attorney, someone else, for example, a licensing Board or the Drug Enforcement Administration (DEA), initiates the litigation. In this case, however, in order to protect physicians and pharmacists throughout the State of Oregon, it was necessary that I become the plaintiffs’ attorney. I sued former Attorney General John Ashcroft and the DEA in federal District Court on behalf of a physician and a pharmacist who were threatened with federal criminal investigations, prosecutions, fines, and imprisonment. See Complaint (1.24 MB).

Important victory for physicians and pharmacists everywhere

The opinion by the United States Supreme Court is an important victory for physicians, pharmacists, and patients everywhere, because it establishes the precedent that the United States Attorney General may not define the scope of legitimate medical practice, and that the States, not the federal government, regulate the practice of medicine. Justice Kennedy, writing for the majority of the Court, concluded his 28 page opinion writing:

“The Government, in the end, maintains that the prescription requirement delegates to a single Executive officer the power to effect a radical shift of authority from the States to the Federal Government to define general standards of medical practice in every locality. The text and structure of the CSA show that Congress did not have this far-reaching intent to alter the federal-state balance and the congressional role in maintaining it. Gonzales v. Oregon (406 KB)(Kennedy, J.)”

This victory stands today – the injunction against the DEA is still in effect! This case is discussed in more detail on the appellate practice page of this website.

Pharmacist sentenced to 24 years in prison; convicted on “red flag” evidence

Pharmacist dispensed without a “legitimate medical purpose”

A Florida pharmacist was sentenced last week to 24 years in prison on multiple charges that include dispensing oxycodone without a “legitimate medical purpose.” The evidence against the pharmacist was summarized as follows: The pharmacist (1) accepted fake prescriptions from (2) customers who came in groups (3) from far distances to get (4) oxycodone. The prescriptions were written by (5) known suspect prescribers and (6) the patients paid a premium, in cash, for the oxycodone. In other words, the pharmacist failed to screen for the “red flags” of drug diversion. Here is a link to the story: http://www.pharmacytimes.com/news/pharmacist-to-serve-24-years-in-prison-for-illegal-oxycodone-dispensing.

The Oregon Board of Pharmacy expects pharmacists to screen for “red flags”

I can assure you from my work as a healthcare defense attorney defending physicians, pharmacists, and prescribing nurses against prescription drug charges by the Drug Enforcement Administration (DEA) that screening for red flags is expected of all prescribing and dispensing practitioners. Agreeable or not, screening for red flags is also important because whether a pharmacist screened for red flags will be considered by the Oregon Board of Pharmacy and DEA drug diversion investigators whenever there is suspected drug diversion. 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. If you are an Oregon pharmacist, I encourage you to view this video.

Defending physicians who prescribe opioids

Experiences of a healthcare defense attorney

I have defended physicians, pharmacists, and prescribing nurses from prescription drug charges by the Drug Enforcement Administration (DEA) long enough that I well remember the following events:

  • the short-lived FAQ’s briefly posted to the DEA’s website (the FAQs were removed from the DEA’s website because pain advocates and defense lawyers cited the favorable FAQ’s in the courtroom);
  • the “Quick Reference Card,” (the Quick Reference Card was a highly formatted legal crib sheet used by prosecuting attorneys in the courtroom, but it was discontinued due to its misstatements of the law of drug diversion);
  • the argument that opioid dosing is to be determined “titrating to full function” (finding the optimal dose to improve daily functioning – the best analgesia with the fewest side effects; but was this ever the standard?); and
  • the day in 2007 that Purdue Pharma pleaded guilty, and paid a $630 million settlement, against federal charges that it misled healthcare providers about the risks of OxyContin.

Overtime, I have accumulated the type of experience that causes me to offer cautious advice to prescribing physicians treating chronic pain with opioids. Cautious advice will sometimes disappoint a prescribing physician, and will certainly disappoint the physician’s patient seeking more aggressive treatment. I am, however, a healthcare defense attorney, and my experience includes keeping physicians out of prison, and winning their release from prison once they are there. In other words, my goal is to keep you out of trouble and cautious advice furthers that goal.

The pendulum has swung: Treat chronic pain cautiously

It is based on my experience that I can assure prescribing physicians and nurses that the treatment of chronic pain with opioids exposes you to scrutiny by the Oregon Medical Board, the Oregon State Board of Nursing, and the Drug Enforcement Administration. Based upon two recent experiences, I also detect that the pendulum has swung, and the emerging practice standards and protocols governing the treatment of chronic pain with opioids are more detailed than ever.

These Oregon Medical Board and OHSU publications may serve you well

I am a healthcare defense attorney, not a healthcare provider, so my opinion is informed by others, and at this point my opinion on this subject is not fully informed. Nonetheless, if you are a prescribing physician or nurse treating chronic pain with opioids, and you come under scrutiny by the Oregon Medical Board, the Oregon State Board of Nursing, and/or the Drug Enforcement Administration, you may be well served if you have followed these practice guidelines made available by the Oregon Medical Board and Oregon Health & Science University:

 

Purdue Pharma misleads physicians again?

I have been defending physicians, pharmacists, and prescribing nurses from prescription drug charges by the DEA long enough that I well remember the day in 2007 that Purdue Pharma pleaded guilty, and paid a $630 million settlement, against federal charges that it misled healthcare providers about the risks of OxyContin. Several of my physician clients during that period of time pointed to the misleading material they relied upon. Less than ten years later, here we go again. As reported by the Associated Press on June 10, 2016:

“The New Hampshire Attorney General’s office is targeting the maker of Oxycontin, a top selling prescription painkiller, with an investigation into whether it downplays the risks of addiction when marketing pain pills to doctors and other prescribers.”

And:

“. . . the company [Purdue Pharma] is no stranger to lawsuits: It pleaded guilty and paid a $630 million settlement in 2007 for federal charges that it misled doctors and patients about the risks of OxyContin. The OxyContin the company now produces uses a new formula that the company claims is less addictive.

“The new court filings allege Purdue is continuing to “engage in the type of deceptive marketing” that resulted in the 2007 settlement.”

Physicians, pharmacists, nurses caught in middle

Physicians, pharmacists, and prescribing nurses treating chronic pain are caught in the middle between the demands of patients and the scrutiny of the Drug Enforcement Administration (DEA), a difficult situation that is exacerbated by the ever-changing practice standards and, at times, misleading marketing by a prominent drug manufacture. The latest litigation is still its early stages, however, with the lawyers presently battling over discovery (the exchange of documents and other information), and alleged conflicts of interests. It will be interesting to see where this latest round of litigation against Purdue Pharma leads.

One way to evaluate an expert’s qualifications when defending against the DEA

Ask yourself: How many doctors has the expert’s testimony convicted?

I have the privilege of defending physicians, pharmacists and nurses before state licensing Boards and the Drug Enforcement Administration (DEA). In one such case defending against the DEA, there was much discussion about which expert physician had the better qualifications – our expert, or the the government’s expert? Each was capable of qualifying as an “expert witness,” but I feared my client, the defendant-physician, took too much comfort in the better qualifications of his expert. I feared this nuanced discussion of which expert witness had the better qualifications was creating a false sense well-being mere weeks before trial. For me, perhaps the more important question is how many doctors has the expert’s testimony convicted?

Do not dismiss the DEA’s expert witness

One thing is certain, if the DEA’s expert witness has led a jury to convict another physician, that’s a dangerous witness, despite any perceived lack of qualifications. In my experience, it is not the expert witness’ qualifications so much as it is what the expert is willing to say to a jury.

And do not become complacent

I can tell many stories where the physician believed the risk of conviction, or the risk of a lengthy prison sentence, was low. In my experience, physicians and their families often rationalize why they won’t be convicted, or, if they are convicted, why they will receive a lenient sentence, perhaps probation, or time served, or one year, only to be sentenced to 5 years or more, and in one case, to 15 years. While I have obtained good results, and have even obtained the release from prison of two physicians, most often, it doesn’t happen that way. If you want to see for yourself, search the internet using some of these search terms: “physician convicted,” “doctor convicted,” “physician sentenced,” “doctor sentenced,” “physician acquitted,” and “doctor acquitted.” You will soon discover that good results for defendant-physicians facing DEA prosecutions are few and far between. Prepare accordingly.

Criminalizing medicine

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?

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.