‘Good-Faith’ Defense in CSA Prosecutions: An Invitation To Rethink Strategy Banner Image

White Collar Criminal Defense and Investigations

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‘Good-Faith’ Defense in CSA Prosecutions: An Invitation To Rethink Strategy

September 12, 2022

Reprinted with permission from the September 12, 2022, issue of the New Jersey Law Journal. © 2022 ALM Media Properties, LLC. Further duplication without permission is prohibited. All rights reserved.

Under the Controlled Substances Act, the defendant-physician now has the burden to produce some evidence that he or she was prescribing in good faith, to trigger the government’s burden of proving criminal intent beyond a reasonable doubt.

In pursuit of accountability for the ongoing opioid crisis, the Department of Justice has enhanced its scrutiny of individual physicians who prescribe highly addictive and potentially lethal drugs.

To that end, federal prosecutors are using the Controlled Substances Act (CSA), the so-called drug dealer statute, to prosecute physicians alleged to have prescribed narcotics outside the professional standards of care—often referred to as “dirty doctors” running “pill mills.” Born from these prosecutions was a uniquely criminal question: can a physician be convicted of a crime in the absence of criminal intent?

The question was (mostly) answered in June by the U.S. Supreme Court in Ruan v. United States. The Court held that in certain prosecutions under the CSA, the government will have the burden of proving beyond a reasonable doubt that the doctor “knowingly or intentionally” acted in an “unauthorized” manner. The decision specifically bears on the availability of what amounts to a good-faith defense, but it has wider practical implications on diversion prosecutions and defenses.

So, What’s Changed?

First, when it comes to defense experts: not much. Experts will continue to rule the day in physician-diversion cases, so find a good one.

Specifically, locate one who can speak to your client’s exact field of medicine (e.g., internal medicine, oncology, pain management); the type of patients your client treats (e.g., hospice, indigent, workers’ comp, veterans); and the location of your client’s practice (rural, urban, limited access). In addition, select an expert well-versed in clinical trends and academic support for your client’s approach to treatment, whether highly recognized or not.

This is true whether you are defending a physician, pharmacist or mid-level practitioner with prescribing authority. Cookie-cutter experts simply won’t cut it.

Second, the defendant-physician now has the burden to produce some evidence that he or she was prescribing in good faith (“the burden of production”) to trigger the government’s burden of proving criminal intent beyond a reasonable doubt (the “burden of persuasion”). It’s not immediately clear how much is enough.

The defendant-physician could testify, which is not a game-changer. Physicians have often opted to take the stand in diversion cases because they can best explain the “why” from their unique clinical perspective. Otherwise, expert testimony to the objective reasonableness of the physician’s prescribing decisions may (and I’d argue, should) trigger the government’s burden. Again, the defense strategy remains unchanged—the same defense expert would be put up anyway to speak to objective reasonableness.

New Wrinkle

Third, diversion cases mixed with health care fraud, kickbacks or other seedy conduct may foreclose a good-faith defense, placing the defendant right back to pre-Ruan. However, in some cases, it may not. This is a new wrinkle, for sure. For instance, receiving a kickback for an otherwise clinically appropriate prescription, without more, is not diversion. The client may be greedy on the one hand, but an excellent physician on the other. If the defense manages to cleanly divorce the medicine from the money, the good-faith defense could still be in play.

Finally, the last and perhaps most notable consequence of Ruan is that it very likely expanded the government’s Brady obligation because evidence of a physician’s subjective intent is now a potential affirmative defense.

Prescribing decisions are complex, and the “why” is often informed by a litany of sources of evidence, say, in his or her emails (“this is a difficult case, but I believe the benefits outweigh the risks”), treatment notes (“in my judgment, the best course is to slowly wean this patient off opioids or otherwise risk …”), discussions with colleagues (“I spoke with [respected physician] and he agrees …”) or lectures and publications (e.g., if your client lectured on the clinical benefits of the course of treatment for which he or she was charged, that’s proof he or she believed in it).

In other words, any evidence that shows this specific physician, for better or worse, reasonably and sincerely believed his or her prescriptions were legitimate and medically necessary is now, in my view, potentially exculpatory.

Ryan O’Neill is a partner in the White-Collar Criminal Defense and Investigations Practice at Riker Danzig in Morristown, and a former assistant U.S. Attorney in the District of New Jersey. Dominique Marino, a 2022 summer associate at the firm, contributed to this article.

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