The Federal Drug Schedules and Unlawful Distribution
In 1970, the United States Congress enacted the Controlled Substance Act (CSA – now codified in Title 21). The Act sought to provide regulatory framework for the sale, distribution, use and possession of specific narcotics. The CSA provides a drug scheduling table which guides the specific regulations. The table places specific drugs in Schedules I through V; with Schedule I receiving the strictest regulations and harshest penalties for non-compliance. This post will walk through each Schedule and then give an overview of the two common categories of federal prosecutions to a key piece of criminal regulation – unlawful distribution.
Congress has determined these drugs have a high potential for abuse and have no currently accepted medical use within the United States. The drugs that fit within this schedule are common street drugs that exist solely in the black market.
Examples of schedule I drugs include heroin, LSD, MDMA, and Peyote. Also included in this list is Marijuana; however, federal and state Congresses have passed marijuana specific rules to circumvent the absurdity of treating marijuana and heroin similarly under local penalty systems.
This schedule includes drugs that have a high potential for abuse, but still play a role in currently accepted medical practice. This schedule includes a combination of street drugs that retain medical value and addictive prescription drugs the federal government highly regulates. Many drugs in Schedule II may be prescribed by physicians across the United States. The drugs under this schedule form the basis for many unlawful distribution cases against physicians and pharmacies.
Examples of schedule II drugs include hydrocodone, oxycodone, cocaine, methamphetamine, and fentanyl.
This schedule includes drugs with a moderate to low potential for abuse and clear accepted medical uses within the United States. All the drugs within Schedule III may be prescribed by a physician and filled at your local pharmacies.
Examples of schedule III drugs include Ketamine, Testosterone, and anabolic steroids.
This schedule includes drugs with a lower risk for abuse or dependence (compared to Schedule III).
Examples of schedule IV drugs include Xanax, Soma, and Valium.
Schedule V consists of drugs Congress has determined have a low risk for abuse and accepted medical uses within the United States.
Examples include Lyrica, Motofen, and Robitussin AC.
Importance of the Schedules in Criminal Practice
The schedules create two subsets of clients in criminal practice. In federal court, we see two main types of unlawful distribution cases – street drugs involving extensive distribution schemes and prescription drugs involving smaller schemes localized in clinics and pharmacies.
Cocaine, heroin, and MDMA are not prescribed by physicians or filled at pharmacies. These drugs are sourced, distributed, and used by persons in violation of various sections of Title 21. Put differently, there is no legal way to sell, use, or possess these drugs in the United States. This reality leads to the infusion of the black market to fulfill demand.
Often, these cases are charged in multi-defendant indictments alleging a large conspiracy involved in the distribution of the illegal drug(s). These cases are investigated by task forces which incorporate the DEA and local state agencies. These task forces often use wire taps, undercover buys, informants, and surveillance to piece together the criminal case.
The second subset of clients involves the prescribing or filling of scheduled substances outside the regulations contained within Title 21. The most common drugs underlying these prosecutions include hydrocodone, oxycodone, fentanyl, and other drugs within the opioid family. The reason DOJ targets these select drugs is multifaceted: 1) these drugs are heavily involved in black market trade, 2) these drugs contribute to the ongoing opioid crisis, 3) according to the schedules, these drugs carry the highest risk for abuse, and 4) some clinics operate to serve as the source for the black market. All four of these factors have led DOJ to maintain a hyperfocus on opioid prescriptions and a heavy hand when going after physicians or pharmacies writing or filling these prescriptions.
The Two Subsects Require a Different Skill Set
Classic Street Drug Conspiracies
The initial subset of cases above involve the distribution of known street drugs with no link to a physician’s prescribing authority. These investigations normally involve months of wiretapping, surveillance, and undercover buys before authorities begin making arrests. Once arrests are made, the government relies on flipping defendants into witnesses to shore up any holes within their case. The government views co-defendant testimony as an integral part to exposing these schemes. This reality incentivizes the government to throw a large net when making charging decisions. After all, the more defendants that exist in the indictment, the more likely the government can produce multiple, credible witnesses at trial with inside knowledge of the scheme.
This large net will result in categories of defendants within the indictment: 1) the top tier in the indictment whom the government views as the leaders of the scheme, 2) mid-level actors where wiretaps and surveillance suggest they took part in some of the transactions, and 3) low-level actors where evidence may be weak as to their involvement. The defensive strategy employed largely depends on the client’s position within the hierarchy.
The mid to low-level actors may be able to challenge the government’s evidence to secure a not guilty at trial or a dismissal before trial. This can be done through motions to suppress evidence needed to prove a specific transaction or by noting weaknesses in the government’s theory.
For those mid to low level actors where the evidence is insurmountable (via wire taps, surveillance, and co-defendant admissions), a deal can often be worked out with the government. If the client is willing to cooperate, those deals can greatly reduce any prison sentence that would occur following trial. While cooperation is certainly the easiest way to lessen the sentence for a particular client, it is not always the best option. Cooperation can result in retribution from members of the conspiracy. This risk must be weighed against the benefits of the lower sentence.
The top tier defendants operate on a different playing field. The government is less likely to bargain with the leaders in a drug conspiracy. They may entertain cooperation, but the government will always want to send their message to the upper tiers of an indictment. And the government’s cooperation agreements with lower situated defendants will be based on their ability to shore up any holes in the government’s case at the top. This is not to say the leaders are indefensible. However, most federal drug cases are geared to stack the most evidence at the top of their food chain.
Prescription Related Distribution Schemes
The second subset of clients include physicians, NPs, pharmacies and other medical professionals charged under Title 21 with unlawfully prescribing or dispensing a controlled substance. These cases are vastly different from the drug conspiracies found under the last section.
These cases involve a dissection of a professional’s medical judgment and decision making. Under these distribution schemes, the government has alleged the physician prescribed certain scheduled substances without a legitimate medical purpose and outside the normal course of medical practice. This requires the government to go through specific patient files and analyze the medical decisions of a particular doctor.
Many of these cases can be defended if the physician is following standard medical practices (seeing the patient, diagnosing, and prescribing). If there are procedures in place, those procedures are followed, and the procedures impact the prescription being issued, there is a legitimate defense to the willfulness element of 18 U.S.C. § 841. (more on the good faith defense under Ruan can be found here).
The reality of our current landscape is physicians run a real risk of DOJ interference when they choose to prescribe substances with high risks for dependence, notably opioids. That risk increases with every prescription that is written. Clearly, physicians are within their powers to write a prescription for certain opioids when they decide the benefit to the patient outweighs any risk. However, the key to the good faith defense lies in the procedures and patient interactions that precede that decision. These procedures must place the doctor in a position to make such a medical determination. The facts in the patient room must support a theory for prescribing opioids. Put simply, the doctor needs to be practicing solid foundational medicine.
Most of our clients believe their practices will be saved by the Ruan case and the good faith standard. While certainly some of them benefit from this case, it is not a one size fits all proposition. We have seen cases that range from practicing good medicine to writing prescriptions for DEA agents without any knowledge of the person behind the identification. Most cases fall somewhere in the middle. Below is a list of common obstacles to raising the good faith defense we have seen in our practice.
Obstacles to Raising the Good Faith Defense
One major obstacle to the good faith defense occurs when the procedures in place do not affect the actual prescription written. For example, let’s say a physician operates a pain management clinic. Within that clinic, they drug test patients, require an MRI or other documentation of an injury, examine the patients, require them to fill out a pain assessment, and review the patient’s PMP for prior prescriptions from other doctors.
Every one of those steps serves a valuable diagnostic function. The overarching purpose behind the procedures is to ferret out persons with real, verifiable pain from those that are searching for access to pain medication. Let’s assume the physician follows his procedures for every patient that enters the clinic. However, 99% of the patients receive a prescription for hydrocodone or oxycodone. The likelihood of every patient having verifiable pain is nearly zero. The likelihood of every patient’s PMP being clean is nearly zero. The likelihood of no drug tests causing a concern is nearly zero. Under that scenario, the physician has set up procedures, but those procedures do not actually affect the treatment outcomes. The government can now persuasively argue the procedures were a ruse to justify the prescriptions; not a well-orchestrated plan designed to treat those patients with a justifiable need for pain management.
This is a subtle area of the good faith defense that is often misunderstood by physicians and other medical professionals. Adhering to government guidelines is not an absolute defense to unlawful distribution. Government agency suggestions are not just items to check off the chart to avoid government interference. They are not mandatory. They are simply suggestions aimed at resolving two major government concerns – diversion of opioids to the street and addiction.
Simply installing agency suggestions that do not serve those functions, because their results do not affect the decision to prescribe a certain drug, is counterproductive. Under Ruan, a doctor would be better off deploying his own procedures that serve the two aims above (diversion and addiction), following them closely, and allowing those procedures to dictate the treatment protocol. That scenario provides a valid route under Ruan even though the government suggestions have been entirely scrapped.
A second major obstacle we see to the good faith defense is the lack of alternative treatments for a patient’s pain. Most juries are not going to believe that opioids are the only treatment within a doctor’s tool belt. They will believe, inherently, that other steps such as physical therapy, non-narcotic medication, and potential surgeries, are worth consideration for at least some of the patients. When a physician’s only treatment plan involves the use of opioids, it allows the government to cut into the credibility of the physician’s good faith belief. Now, this issue can be handled with a well-developed expert, but nonetheless, it is an area of concern in many client cases.
The Tale of Two Prosecutions
The government’s treatment of certain drug classifications has created two diverging areas of unlawful distribution schemes. Each area involves a different set of legal principles to effectively represent clients. An attorney who handles large cocaine conspiracies may be ill-equipped to represent a physician charged with unlawfully prescribing schedule II drugs. The foundation of the schemes and the available defenses are vastly different. This means professionals charged with unlawful distribution need to retain qualified unlawful distribution attorneys that focus on this area of Title 21, understand the needs for expert assistance, and know the laws defining this criminal action.