When one hears the terms “drug crime” and “drug case,” often the first thing that comes to mind is the prosecution of a drug cartel, or perhaps a local “drug ring.” While this is not wrong when it comes to federal drug cases, there is another side that is not often mentioned: the use of federal drug laws–in particular the federal Controlled Substances Act (“CSA”)–to prosecute healthcare providers: doctors, physicians, physician’s assistants, registered nurses, pharmacists, and others.

Sometimes, these prosecutions rightly target “pill mills,” or other healthcare providers whose only goal is to sell controlled substances to drug abusers for a profit. Sometimes, however, federal prosecutors can be overzealous and end up charging legitimate doctors who were merely trying to help their patient, or doctors who engage in unconventional treatment in good faith.

UPDATE: The Supreme Court has recently accepted two cases that could limit the government’s ability to charge doctors attempting to treat their patients in good faith. Burnham & Gorokhov will be monitoring these cases closely.

How can a healthcare provider be prosecuted under the Controlled Substances Act?

Many medications that provide pain relief, or that act as depressants or stimulants, are classified as “controlled substances” under the CSA. Common examples include oxycodone, oxymorphone, hydrocodone, and fentanyl. Like any other controlled substance, the manufacture, sale, and distribution of these medications is heavily regulated. Healthcare providers who prescribe controlled substances outside the bounds of the CSA are subject to prosecution, and federal law enforcement and prosecutors routinely investigate and bring drug distribution charges against healthcare providers who violate this law.

In general, the CSA, and the regulations issued pursuant to that Act, prohibit the manufacture, distribution, and sale of controlled substances. There are some exceptions to this prohibition. One such exception is for medical professionals. Under the CSA, medical professionals are allowed to prescribe and dispense controlled substances. However, under a guideline issued by the Department of Justice (“DOJ”), the prescription must be made for a “legitimate medical purpose” and the medical professional must be acting in his or her “usual course of professional practice.” If those two requirements are not met, the medical professional is subject to prosecution under the CSA.

What is a “legitimate medical purpose”? And what is acting “in the usual course of professional practice”?

A prescription for a controlled substance must be made for a legitimate medical purpose by a person authorized to issue prescriptions, while the person is acting in the usual course of his or her professional practice. “Legitimate medical purpose” and “usual course of professional practice” are not terms that are defined by the statute. The fact that these terms are not clearly defined creates confusion, and in some cases it can place even well-meaning doctors at risk for prosecution.

Generally speaking, a physician or other healthcare professional acts for a “legitimate medical purpose” when the primary purpose of the prescription is therapeutic. An action is “in the usual course of professional practice” when it is within the bounds of generally accepted medical practice. Real world cases are usually not clear cut. Whether specific instances of prescribing behavior are for legitimate medical purposes and made in the usual course of professional practice often depend on the specific facts and context of a case. Often, it may require expert testimony by medical professionals about what is and is not an accepted medical practice.

In one case, for example, a physician prescribed what prosecutors believed were unusually high quantities of Oxycontin to patients with chronic pain. However, it was also known to the physician that some of his patients had developed a high level of tolerance to opioid medication. Several medical experts agreed with his judgment as to the type and quantity of medications prescribed.

What are some common factors that can result in a prosecution under the Controlled Substances Act?

First, before bringing a charge, federal prosecutors will typically consult a medical expert paid by the government about a targeted physician’s prescribing behavior and other issues. If the opinion favors prosecution, it may also be presented at trial. In addition, prosecutors frequently rely on circumstantial evidence gathered during the investigation that suggests the physician is acting suspiciously. For example, federal prosecutors might rely on evidence of the following:

• Patients travel a long way to see the physician
• Patients come in groups and all receive the same controlled substance prescriptions
• Patients appear to show signs of substance abuse/addiction such as being sedated, intoxicated, etc.
• Patient fails drug screens
• Patient requests specific drugs, or specific combination of drugs

There may be entirely innocent explanations for these facts. For example, patients may travel a long distance to see a doctor because the doctors in a patient’s community are overly conservative and do not adequately treat the patient’s pain. Likewise, a patient who exhibits signs of drug abuse may in fact be exhibiting symptoms of a disease, or regular side effects of certain medication. Furthermore, a healthcare provider may legitimately treat known drug abusers, provided that the healthcare provider takes some steps to proceed with caution, and to counsel and monitor the patient more closely than he or she would otherwise. Nevertheless, it takes an experienced and skilled defense attorney to persuasively present these facts into a coherent argument–whether it is to obtain an acquittal at trial, or to convince the prosecutor to drop the charge before trial.

What are “red flags,” and why should healthcare providers be aware of them?

The DOJ and the Drug Enforcement Agency (DEA) take the controversial view that healthcare providers have a duty to detect suspicious activity, also called “red flags,” when making decisions about whether to prescribe controlled substances, or to dispense controlled substances pursuant to prescriptions presented by a patient. For example, the DEA has stated that it expects pharmacists to be able to recognize signs of when a prescription may have been issued for a non-medical purpose, or was otherwise fraudulently obtained. These “red flags” include:

• A pattern by one physician to prescribe the same drugs or same combination of drugs.
• A pattern of patients presenting prescriptions from a physician a long distance away.
• Patient pays for prescriptions in cash.
• Significant number of patients from the same physician with the same diagnosis code.
• Patients sharing addresses and presenting prescriptions on the same day.
• Patients presenting prescriptions for controlled substances.

The presence of one or more of these “red flags” does not necessarily mean there is actually anything criminal going on, at least not on the part of the doctor. Unfortunately, prosecutors and agents sometimes become overly fixated on these issues that they see as “red flags.” They sometimes fail to consider the situation from the perspective of a doctor, whose focus is not on being a policeman or lie detector, but rather on providing care (including pain relief) to their patients.

How can an attorney defend a healthcare professional who is charged with a Controlled Substances Act violation?

Controlled Substances Act prosecutions against medical professionals are among the most challenging cases to defend. The widespread negative publicity about prescription drug addiction and abuse, combined with often prejudicial evidence of patients who suffered bodily injury or death, often make a powerful impression on the jury. Effectively defending a Controlled Substance Act prosecution requires patience, experience, and skill. Here are some common elements to an effective defense:

Thorough review of medical records in consultation with a qualified expert.

Careful investigation is the foundation for any good defense, and CSA prosecutions against physicians are no different. An attorney should review the medical records with a qualified expert (someone other than the person who is charged), and determine answers to the following questions: what problems did the patient come in with? What did the patient tell the physician? What diagnosis did the physician give? Were there prior diagnoses from other doctors? What medications were prescribed? What, if any, treatment was given other than prescribing controlled substances? How did the patient’s condition and treatment progress over time?

A clear understanding of the history of a patient’s treatment is a fundamental and its importance cannot be overstated. An accounting of the course of medical treatment, however, is not enough. An effective representation will determine not only the “what” questions above, but also the “why.” A qualified expert reviewing the files can provide critical insight as to why a physician might take certain actions, and whether those actions were appropriate.

Focus and presentation on what was known to the medical professional, and what was not known.

It is important to ask what the doctor knew about the patient: did the doctor know that the patient had a history of drug abuse/addiction? that the patient was selling his or her prescription drugs? that the patient was getting similar prescriptions from other healthcare providers?

Prosecutors will often focus on what a doctor should have known and should have done, with reference to purportedly well-established practices. Yet, it is often the case that patients do not provide their doctor with all of the information, or actively mislead their doctor. It is the defense attorney’s job to direct the jury to what really matters in the case: what the doctor actually knew at the time he or she prescribed controlled medications.

Utilizing a reputable expert to dispel any inaccurate but prejudicial impressions created by the prosecution.

Some if not all of the jury members will have negative preconceptions about opioid medications. There has been significant negative publicity about prescription drug abuse and addiction, and the toll it has taken on people and communities. Prosecutors often present facts intended to shock the jury. Testimony by a highly qualified, credible, and articulate physician for the defense can go a long way to dispel these negative preconceptions.

In the highly-publicized prosecution of one doctor in the Eastern District of Virginia, the trial judge ultimately concluded, after the testimony of a number of highly qualified experts, that the doses prescribed by the defendant were reasonable and supported by the emerging medical literature and practice.

Effective arguments on the law, and jury instructions that state the law in a clear way.

One danger in CSA prosecutions against medical professionals is jury confusion over the applicable legal standard. In a medical malpractice case, the standard of liability is whether the doctor’s practice fell below a reasonable standard of care appropriate for the medical community. In a criminal case, however, the question is whether the doctor knowingly prescribed drugs for other than a medical purpose, not whether the doctor used good judgment or bad judgment in trying to actually treat a patient. Put another way, the question is whether the doctor abandoned the role of a medical professional to become a drug dealer. The doctor’s subjective intent is central. While prosecutors are generally allowed to present evidence about certain objective standards as circumstantial evidence of intent, it is essential to ensure that this type of evidence is placed in the appropriate context, and does not mislead the jury.

In order to ensure that the line between the criminal and civil standard is maintained, the trial attorney must assert the appropriate standard at every phase of litigation, including pretrial motions, voir dire (jury selection questions), direct and cross-examinations, motions for judgment of acquittal, closing arguments, and last but certainly not least, jury instructions.

How are penalties for Controlled Substances Act violations by medical professionals determined?

Criminal sentences for Controlled Substances Act violations are driven primarily by the quantity of drugs involved, although the sentencing judge will also consider things like the defendant’s history and characteristics. (Read our article on federal sentencing to learn more about how federal judges decide criminal sentences). Drug quantity affects both the Sentencing Guidelines range, as well as potential mandatory minimum sentences.

Beyond drug quantity, one of the most important factors governing the sentences imposed in Controlled Substance Act cases is whether the case involved serious bodily injury or death. In such cases, certain mandatory minimum sentences apply that make the stakes significantly higher. The Supreme Court requires the prosecutor to prove that the controlled substance involved is a “but for” cause of the patient’s death. Often, this will be a highly contentious and technical issue. A defense attorney needs to work with a qualified pathologist to review relevant medical reports (including any autopsy reports) to find independent causes of injury or death that are unrelated to the prescription drug use.

I am being investigated for, or charged with, a Controlled Substances Act offense. What should I do?

The first thing you should do is contact a qualified attorney, who has experience with federal cases and with criminal cases involving medical practitioners. If you have been interviewed or contacted by law enforcement agents, you should write down what you remember about any discussions you had, including what they said to you and what you said to them. You should also note any documents that you provided, that were seized, as well as documents and records that were shown to you during the course of the meeting.

If you have not been contacted or interviewed but have learned that you are under investigation, it is important to speak with an attorney as soon as possible so that you know what to do next.

Do not, under any circumstances, alter or delete your files and medical records without having spoken to an attorney. An attorney can advise you on what you may and may not in these circumstances. In addition, you should be very careful about speaking to coworkers, employees, patients, or even family members about the investigation. Often, even innocent conversations can lead to situations where the government can use your statements against you at trial.