The opioid crisis is currently a national epidemic. According to the United States Health Resources and Services Administration, 116 people die of an overdose every day. This number has only been rising in recent years.
Unlike traditional street drugs, opioid access often begins in doctors offices. Indeed, many of the most commonly abused opioids are legally manufactured by pharmaceutical companies, administered by licensed medical professionals, and accessed through the neighborhood pharmacy.
However, the great demand for opioid medications has led to increasing cases of abuse in the medical community. Accordingly, the term “pill mill” has been defined by the Department of Justice (DOJ) as “a medical clinic that is dispensing controlled substances inappropriately, unlawfully, and for non-medical reasons.”
A large number of medications fall under the category of a “controlled substance”, as we will discuss below. Thus pill mills are not limited to opioid dispensaries. However, the relevance of the opioid epidemic in discussing pill mills is that its crisis level has placed a great deal of federal scrutiny on physicians who prescribe controlled substances.
This article address the criminalization of “pill mill” operations under federal law. If you are concerned about your own conduct, please understand that the information provided here is no substitute for legal counsel. However, you should come away with a better understanding of how illegal activity is detected and prosecuted, as well as how you can best defend yourself against criminal accusations.
Pill Mills Under Federal Law:
In understanding how the federal government criminalizes the operation of pill mills, we first need to look to The Controlled Substances Act (CSA). This federal statute regulates the manufacture, importation, possession, use, and distribution of certain substances.
Drugs are classified into five different schedules under the CSA, depending on their potential for abuse, their accepted medical purpose, and their likelihood to cause addiction.
Here’s a brief breakdown of the CSA classification schedules:
|Severe Physical and Mental
|Severe Physical and Mental
|Severe Mental, Moderate Physical
|Mild Mental or Physical
|Mild Mental of Physical
As doctors widely prescribe many controlled substances for the treatment of legitimate medical conditions, the CSA provides a strict registration process under which pharmaceutical companies, healthcare providers, and pharmacies can legally create and administer these substances.
21 U.S. Code § 841 makes it a crime to manufacture, distribute, or dispense controlled substances in violation of CSA protocol. Proving a CSA violation requires evidence of the following three elements:
(1) knowingly or intentionally
(2) manufactured, distributed, or dispensed
(3) a controlled substance.
Should your case reach the trial stage, the prosecution will have the burden of proving each of those three elements beyond a reasonable doubt. Scroll down to the “Criminal Proceedings” section of this article for a more detailed breakdown of how a CSA violation is established in federal court.
Efforts to put a stop to the growing opioid epidemic prompted the DOJ to establish the Opioid Fraud and Abuse Detection Unit in August of 2017. In announcement of the new effort, U.S. Attorney General Jeff Sessions issued the following warning: “If you are a doctor illegally prescribing opioids for profit or a pharmacist letting these pills walk out the door…we are coming after you, we will reverse these devastating trends with every tool we have.”
With such aggressive focus on solving the opioid crisis, it is important to understand that even if you are not illegally prescribing opioids for profit, your activity could trigger an investigation. Monitoring programs set up by The Drug Enforcement Agency (DEA) are designed to spot potential pill mill activity, and alarm bells could go off for such innocent conduct as a billing dispute, a higher than average prescription rate, or a patient death within 60 days of receiving a prescription.
If potential illegality is suspected, the DEA will generally look to your practice’s prescription record. Anything out of the ordinary can prompt a formal investigation, which may involve setting up surveillance around your practice and sending in wired undercover agents into your office in search of an opioid prescription.
Undercover officers will likely not announce themselves as addicts in need of a fix, and you may be reasonably fooled into believing them to be patients seeking treatment for legitimate pain symptoms. That is why it is so important to be fully informed of your legal responsibilities as a healthcare provider. Indeed, we discuss the kinds of behavior that could give rise to criminal liability in more detail later in this article.
Once enough evidence is gathered, law enforcement may obtain an arrest warrant. It is important to note that you may not have any awareness that you are being investigated prior to being placed in handcuffs and taken into custody.
If you are arrested, you will be read your Miranda Rights. While many are familiar with the “right to remain silent” speech, few give consideration to what it means. Essentially, law enforcement will attempt to question you as part of their investigation, but under the Fifth Amendment of the Constitution you have a right against self incrimination. This means that you have the option to either answer questions, remain silent, or ask to speak with a criminal attorney.
Know that if you remain silent, the government is free to continue to try to question you. However, if you invoke your right to counsel, the government cannot legally resume attempts to question you until after you have had a chance to speak with a criminal attorney.
Once the prosecution’s office files formal charges, you will be presented with the decision to plead guilty or not guilty.
Your criminal attorney will be able to review the evidence to rule out any possible fatal weaknesses in the prosecution’s case. These could include procedural violations, such as where evidence is gathered in violation of your Fourth Amendment right to privacy.
Remember the government’s compelling public health interest in stopping the opioid epidemic. This zealousness increases the odds of a search and seizure violation barring the admission of critical evidence in a pill mill context. Evidence gathered in violation of your Fifth and Sixth Amendment rights against self incrimination can also be barred, leading to a collapse of the prosecution’s case.
Among many other reasons described below, it is imperative to consult with a criminal attorney prior to making any major decisions in order to determine whether your case comes with such a built in loophole.
At the start, you may be offered an opportunity to plead guilty to a lesser charge, and accordingly receive reduced penalties. This is commonly referred to as a plea deal.
Understand that while the prosecution may claim the deal is their best offer, their claim is not binding. Indeed, patience and good lawyering often pave the way for a better plea deal down the road.
However, making the best possible decision requires an in-depth risk-benefit analysis. One of the primary functions of your criminal attorney is to help you understand how the relevant laws interact with your specific circumstances, to uncover potential weaknesses in the prosecution’s case, and to assess the likelihood of success in either getting your case dismissed, negotiating a better plea deal, or succeeding at trial.
Plea deals often come with a time limit, and failing to accept before they expire means running the risk that the deal will permanently leave the table. An experienced criminal defense attorney is skilled in knowing how to assess this probability and advise you accordingly.
Should you choose to continue to plead not guilty, your best case scenario will involve getting your case dismissed. Whether this occurs will largely depend on who you retain to represent you.
Your criminal lawyer should prepare your case as if it’s going to trial in order to communicate a strong defense to the prosecution. This will increase your chances of dismissal or at least an improved plea deal before trial, and will also put your criminal attorney in the best position to advise you of your chances of success in the courtroom.
Should your case proceed to trial, your criminal attorney will likely hire experts and call witnesses to contest the credibility of the prosecution’s evidence.
Remember that successfully proving a violation of the controlled substances act requires evidence of three separate elements: (1) you knowingly or intentionally, (2) manufactured, distributed, or dispensed, (3) a controlled substance.
Because this exact behavior is legal when conducted by lawfully registered healthcare providers and drug manufacturers, it is not enough for the prosecution to simply establish these elements, as it would be in a case against a common drug dealer on the street.
Rather, the prosecution generally has the additional burden of establishing either (1) the prescription was not written for a “legitimate medical purpose”, or (2) the medical professional was not acting in his or her “usual course of professional practice”.
If you are wondering what those terms mean, the answer is that they are not clearly defined by statute. As a result, exploiting this ambiguity is often the basis of a strong defense strategy in a pill mill case.
For example, the term “legitimate medical purpose” generally refers to therapeutic use. Yet doctors are entitled to a great deal of discretion in assigning medication to symptoms. Depending on the circumstances, it may be difficult for the prosecution’s argument that you prescribed opioids to serve the patient’s addiction, rather than to treat pain, to hold up to scrutiny.
Indeed, pain is a subjective condition, and many opioid addicts in search of prescriptions do have a history of painful conditions to legitimize the prescriptions they receive. At the very least, most patients in search of opioid prescriptions are smart enough to claim that they are suffering from pain.
So even if a patient of yours testifies that he was lying about his condition in order to feed his addiction, the prosecution is still left with the difficult task of proving that you were aware of his lie and prescribed opioids to him anyway.
As for whether your conformed to the “usual course of medical practice”, this too is a subjective standard. The prosecution will likely call medical experts to claim that your behavior was out of line with customary procedure in the industry.
But depending on the circumstances your criminal attorney may be able to attack the authority of that expert or the firmness of his claims on cross examination. He may also be able to present an independent medical expert to testify that your conduct did conform to customary medical practice.
Of course, there are cases where these defense strategies would likely fail. If you were running an operation where patients simply walked up to a counter and paid cash in exchange for a bottle of pills, your attorney has very little leeway in arguing that you were prescribing for a legitimate medical purpose in the usual course of medical practice.
However, a good criminal defense attorney would likely advise you to accept the plea deal in such a case, unless another weakness, such as a lack of evidence, was likely to lead to acquittal.
Ultimately, the important thing to remember about trial is that the prosecution has the burden of establishing each component of your offense beyond a reasonable doubt. The good news for you is that you have the power to retain a skilled criminal attorney who will illuminate those areas of doubt in the minds of the jury.
Consequences of Conviction:
Due to the devastating effect of the opioid epidemic and the enormous abuse of power involved where healthcare providers administer controlled substances to addicts, the federal government affords very little leniency in prosecuting pill mill cases, even for first time offenders.
Generally speaking, the following factors are considered in determining drug trafficking sentences:
- The specific substances dispensed,
- The quantity of substances dispensed,
- Whether death or serious bodily injury resulted,
- Your criminal history,
Penalties regarding Schedule 1 substances include a minimum of 10 years in prison for a first time offense, and 20 years if death or serious bodily injury resulted. For a second time offense, 20 years or life in prison if death or serious bodily injury resulted.
However, as mentioned above, sentencing tends to be harsher in pill mill cases, again due to the abuse of power and corresponding threat to the public that these cases demonstrate.
Typically a federal prison sentence of 10 to 20 years will be imposed. However, life in prison is possible for doctors who write unnecessary opioid prescriptions that result in death.
Regardless of whether death has resulted, additional consequences of conviction often include forfeiture of property, millions in fines, and loss of one’s medical license.
Pill Mills in the News:
The news is full of examples of defendants being found guilty for running pill mills. Just last month, an 80 year old doctor and his 82 year old wife were sentenced to 1-3 years in prison for running an $80 million oxycodone sales operation in Manhattan. Their cash only practice sold to junkies and runners from major drug rings on a daily basis for nearly ten years.
What is important to note about this story is that the couple rejected several jail-only plea deals before losing at trial. This example underscores the importance of strategic lawyering and knowledgeable counsel in helping you rationally assess your options.
There are success stories, including the case of Dr. Joseph E. Oesterling, who was charged with criminally overprescribing drugs after undercover DEA agents faked pain to receive prescriptions. Oesterling’s criminal attorney presented testimony from many of his former patients and employees in order to successfully argue that his prescribing practices were in the best interests of his patients, and intended to treat their legitimate complaints of pain.
These two examples illustrate the wide disparity that pill mill cases can present, from cash only transactions to what the DEA considers a over-eagerness to prescribe. How your case is handled and the consequences you will face will largely depend on where your fact pattern falls in that spectrum, and your criminal defense attorney can best advise you on the approach best suited to your situation.
What to Do if You Prescribe Controlled Substances:
Whether you have concerns about your past activity, are under investigation, or are facing formal charges, your first course of action should be to consult with a criminal defense attorney.
Prior to Arrest:
Recall that you may not be aware that you are being investigated until you are placed under arrest. Indeed, it is common practice for the DEA to send undercover officers disguised as patients in their investigation of whether you are illegally prescribing controlled substances.
Even if you are complying with the law, understanding the nuances of what the DEA is looking for can save you thousands of dollars in legal fees and years of your life defending yourself against ultimately baseless allegations.
For example, undercover officers will likely present behavior designed to test your awareness of what the government considers to be red flags in addition to their complaints of pain. Offers to pay for a prescription in cash, requests for specific prescriptions according to their street names, and other behavior indicative of addiction may be employed.
Consulting with a criminal attorney is an invaluable precautionary measure all physicians prescribing controlled substances should take.
As previously mentioned, invoking your right to counsel once you are taken into custody halts law enforcement’s legal efforts to question you. Past that point, any evidence gathered will be inadmissible as a violation of your Fifth Amendment rights.
In addition, it is crucial that you understand your legal rights and responsibilities before answering questions. You may inadvertently provide incriminating statements and thus provide the prosecution with the basis of your conviction. They might otherwise have been forced to drop your case due to insufficient evidence had you stayed quiet.
Perhaps most importantly, lying to law enforcement can lead to additional charges for obstruction of a criminal investigation. This would not only impede all possibility of acquittal, but add years to your sentence.
Fighting Criminal Charges:
Finally, while legal representation can be expensive, proceeding without an attorney can cost you your medical license, millions in fines, and years of your life behind bars.
Federal drug distribution charges are serious and life altering. But how your case resolves will largely depend on the decisions you make regarding how to respond. Understand that until you either formally accepted a plea deal, or are found guilty at trial, it is not too late to find the criminal attorney best situated to advise you of your most prudent and beneficial course of action.