Criminal Defense Lawyers

The Ruan Defense – What the Supreme Court Changed

The Ruan Defense – What the Supreme Court Changed

If you are a prescriber facing federal charges for distributing controlled substances, you need to understand Ruan v. United States. This 2022 Supreme Court decision fundamentally changed what prosecutors must prove to convict you. It may be the most important legal development in healthcare provider defense in decades.

Before Ruan, prosecutors could convict you by showing that no reasonable doctor would have prescribed the way you did. The standard was objective. If your prescribing was “objectively unreasonable,” you could be convicted – even if you genuinly believed you were helping your patients.

Ruan changed that. The Supreme Court unanimously held – 9-0 – that prosecutors must prove you knew your prescriptions lacked a legitimate medical purpose. Not that you should have known. That you actualy knew. The government must prove your subjective mental state, not how a hypothetical reasonable doctor would have acted.

This is a sea change. This is the defense you need to understand.

The Standard That Changed Everything

Heres the system revelation at the heart of Ruan. Federal law makes it a crime to distribute controlled substances “except as authorized.” Doctors are authorized to prescribe controlled substances if the prescription is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” The question in Ruan was simple but profound – what mental state must prosecutors prove?

The statute says “knowingly or intentionally.” For years, lower courts had applied that language to the act of prescribing itself. Did you knowingly prescribe the drugs? Yes, obviously. That was easy to prove. But the courts didnt require prosecutors to prove you knew the prescriptions were unauthorized.

The Supreme Court said that was wrong. The words “knowingly or intentionally” apply to the “except as authorized” clause. That means prosecutors must prove you knew – or intended – that your prescriptions lacked legitimate medical purpose. Not that they objectively lacked medical purpose. That you knew they did.

This is the inversion that protects prescribers. Before Ruan, the question was “would a reasonable doctor have prescribed this way?” After Ruan, the question is “did this doctor know the prescriptions were illegitimate?” Those are completly different questions – and the second one is much harder for prosecutors to prove.

What Prosecutors Had to Prove Before Ruan

Before the Supreme Court decided Ruan, federal prosecutors in different circuits used different standards. But the most common approach was essentially an objective one. Prosecutors would show that the prescribing was outside the usual course of professional practice. Expert witnesses would testify that no reasonable doctor would have prescribed the way you did. The jury would conclude you must have known.

The government argued for something called an “objectively reasonable good-faith effort” standard. Under this approach, if you made an objectively reasonable effort to practice medicine legitimately, you were protected. But if your prescribing was objectively unreasonable – if no reasonable doctor would have prescribed that way – you could be convicted.

This standard was devastating for prescribers. It effectivley turned aggressive prescribing into criminal conduct. Pain doctors who treated chronic pain with high-dose opioids faced prosecution. Doctors who saw many patients with controlled substance prescriptions faced prosecution. The standard didnt require prosecutors to prove you intended to do wrong. It only required them to prove that what you did was objectively unreasonable.

Heres the irony that should outrage every healthcare provider. For years, doctors went to prison under a standard the Supreme Court unanimously rejected. Dr. Xiulu Ruan was sentenced to 21 years. Dr. Shakeel Kahn faced similar consequences. They were convicted under a standard that the statute dosent actualy require.

What Prosecutors Must Prove Now

After Ruan, the prosecution’s burden is fundamentaly different. The government must prove beyond a reasonable doubt that you knew – or intended – that your prescriptions were unauthorized. This is a subjective standard, not an objective one. It focuses on your mental state, not on how a hypothetical reasonable doctor would have acted.

What does this mean in practice? Prosecutors cant just bring expert witnesses to say “no reasonable doctor would prescribe this way.” They must present evidence that YOU knew the prescriptions lacked legitimate medical purpose. They must show that you prescribed drugs knowing they werent for real medical treatment.

This is much harder to prove. You cannot get inside someone’s head. You cannot directly observe what someone believed. Prosecutors must rely on circumstantial evidence – statements you made, patterns in your practice, the characteristics of the patients you saw. They must build a case that demonstrates subjective knowledge, not just objective unreasonableness.

And heres the system revelation about burden allocation. You have the burden of production – you must present evidence that you were authorized to prescribe (that you had a license, that you examined patients, that you made clinical judgments). But the government has the burden of persuasion – they must prove beyond a reasonable doubt that you knew your prescriptions were unauthorized. You dont have to prove you acted in good faith. They have to prove you didnt.

The Good Faith Defense That Actualy Works

Heres the hidden connection that Ruan creates for prescriber defense. If you genuinly believed your prescriptions were for legitimate medical purposes – even if that belief was wrong – you are not guilty under Ruan. Good faith belief is a defense. Not “objective good faith” judged against what reasonable doctors would do. Your actual, subjective belief.

This is enormous. Consider a pain doctor who prescribes aggressively. Before Ruan, prosecutors would say “no reasonable doctor prescribes this way” and the doctor would face conviction. After Ruan, the question is whether the doctor genuinly believed the prescriptions served legitimate medical purposes. If the doctor believed – truly believed – that the patients needed the medications for pain management, the doctor is not guilty. Even if other doctors would have prescribed differently. Even if experts say the prescribing was unreasonable.

The Supreme Court explained why this matters. A strong scienter requirement “helps to diminish the risk of ‘overdeterrence,’ i.e., punishing acceptable and beneficial conduct that lies close to, but on the permissible side of, the criminal line.” Medicine involves judgment. Doctors make decisions based on patient needs. Those decisions shouldnt become criminal just becuase other doctors would have decided differently.

The good faith defense under Ruan protects you if you genuinly believed you were practicing legitimate medicine – even if prosecutors can find experts who disagree with your clinical judgment.

What Ruan Means for Your Case

If your facing federal charges for prescribing controlled substances, Ruan may be the most important case in your defense. Here is what it means practicaly.

The prosecution cannot convict you just by showing your prescribing was unusual, aggressive, or outside normal parameters. They must show you knew – actualy knew – that your prescriptions lacked medical legitimacy. If you can establish that you genuinly believed you were helping patients, the prosecution’s case becomes much harder.

Your defense should focus on demonstrating your good faith. What did you believe about each patient? What clinical decisions did you make? What examinations did you conduct? What medical records did you review? Every piece of evidence showing you engaged in actual medical decision-making supports a good faith defense.

But heres the uncomfortable truth. Ruan dosent create immunity for egregious conduct. If the evidence shows you knew prescriptions were illegitimate – if you prescribed to patients you knew were diverting, if you ignored obvious red flags, if you operated what was clearly a pill mill – the jury will still convict. Ruan raises the bar for prosecution. It dosent eliminate prosecution entirely.

Ruan helps “close call” cases. Doctors who prescribed aggressively but genuinly believed in what they were doing. Doctors whose practices looked suspicious but were actualy treating real patients with real conditions. Doctors caught in the middle of the opioid enforcement wave who were trying to help suffering patients. These doctors have a defense under Ruan that didnt exist before.

The Doctors Who Made This Happen

The irony of Ruan is that the doctors who secured this protection were already in prison. Dr. Xiulu Ruan operated a pain clinic in Alabama. He was convicted and sentenced to 21 years in federal prison. Dr. Shakeel Kahn practiced in Wyoming. He was sentenced to over 20 years. Both men lost their freedom before the Supreme Court said prosecutors had been proving the wrong thing.

Their cases were consolidated. Their appeals reached the Supreme Court. And on June 27, 2022, the Court unanimously reversed their convictions. Nine justices agreed that the lower courts had applied the wrong standard. Nine justices agreed that “knowingly or intentionally” applies to the authorization exception. Nine justices agreed that subjective knowledge must be proven.

Justice Breyer wrote the majority opinion. He explained that the “strong scienter requirement” protects against overdeterrence – against punishing conduct that is close to the criminal line but actualy on the permissible side. Medicine involves judgment. Criminalizing aggressive judgment destroys medical practice. The subjective standard protects the exercise of medical discretion.

The cases were remanded for further proceedings. The doctors didnt automaticaly go free. But they got new trials under the correct standard. And every doctor charged since then benefits from the rule they established.

Dr. Ruan and Dr. Kahn spent years in prison under convictions that shouldnt have happened the way they did. They fought for a principle that now protects every prescriber facing federal charges. Whatever you think of their conduct, their case changed the law for everyone.

What Ruan Does Not Protect

Heres the uncomfortable truth about Ruan’s limits. The case changes what prosecutors must prove. It dosent make prescribers immune from prosecution. And for the most egregious conduct, convictions will still happen.

“Pill mill” doctors – prescribers who operated cash-based practices dispensing controlled substances with no legitimate medical purpose – will still face conviction under Ruan. The evidence in these cases typicaly shows the doctors knew they werent practicing real medicine. Patients seen for minutes. No examinations. Cash only. Cookie-cutter prescriptions. The circumstantial evidence of subjective knowledge is overwhelming.

Doctors who prescribed to patients they knew were diverting will still face conviction. If you knew – actualy knew – that your patients were selling the drugs, the Ruan standard is satisfied. Your subjective knowledge is the very thing prosecutors must prove.

And Ruan only applies to criminal prosecution. Administrative actions by the DEA operate under different standards. The DEA can still revoke your registration for prescribing outside the usual course of professional practice. The DEA dosent have to prove you knew anything. Ruan protects you from prison. It dosent protect your license.

State medical boards also operate under different standards. They can discipline you for medical practice that falls below acceptable standards. They dont have to prove criminal intent. Ruan is a shield against federal criminal prosecution. It is not a shield against all consequences.

The Evidence Prosecutors Use to Prove Knowledge

Even under Ruan’s subjective standard, prosecutors still convict doctors. They do it by building circumstantial cases that demonstrate you knew – actualy knew – that prescriptions lacked medical legitimacy. Understanding what evidence they use helps you understand your exposure.

First, they look at your statements. Anything you said to patients, staff, or investigators that suggests you knew prescriptions werent legitimate. Comments like “I know this is alot of pills” or “just give them what they want” become devastating evidence. Jokes about being a “candy man” or running a “pill mill” – even if you didnt mean them – get presented to juries as admissions.

Second, they examine patient encounters. How long did you spend with each patient? Did you conduct physical examinations? Did you review medical histories? Prosecutors argue that doctors who spent two minutes per patient couldnt have been making genuine medical decisions. The brevity of encounters becomes evidence that you knew prescriptions werent medically justified.

Third, they analyze red flags. Did patients travel long distances to see you? Did they pay cash? Did they request specific drugs by name and dosage? Did you ignore drug screens showing patients werent taking prescribed medications? Each ignored red flag is evidence that you knew – or deliberately avoided knowing – that prescriptions lacked legitimacy.

Fourth, they look at your business model. Cash-only practices. No insurance billing. High volume of controlled substance prescriptions. These patterns suggest a practice oriented around dispensing drugs rather then practicing medicine. The business structure becomes evidence of subjective knowledge.

Heres the uncomfortable reality. Ruan requires subjective knowledge – but circumstantial evidence can prove subjective knowledge. If prosecutors can show you ignored obvious warning signs, juries infer that you knew. Deliberate ignorance is treated as knowledge under federal law.

How to Use Ruan in Your Defense

If your facing federal charges for controlled substance distribution, Ruan should be central to your defense strategy. Here is how to use it.

First, ensure your attorney understands Ruan and its implications. Not every criminal defense attorney is current on the latest Supreme Court developments. You need representation that knows how to argue subjective knowledge and build a good faith defense.

Second, gather evidence of your good faith:

• Patient records showing actual examinations
• Documentation of clinical decision-making
• Evidence of continuing medical education
• Testimony from patients you helped
• Professional affiliations and certifications
• Everything that shows you believed you were practicing legitimate medicine

Third, challenge the prosecution’s evidence of subjective knowledge. What evidence do they have that you knew prescriptions were unauthorized? Statements you made? Context them. Patterns in your practice? Explain them. Red flags you should have seen? Argue you didnt actualy see them. The prosecution must prove subjective knowledge – make them do it.

Fourth, argue the jury instructions must reflect Ruan. The jury must be told that the government must prove you knew your prescriptions lacked legitimate medical purpose. The jury must be told that good faith belief is a defense. The jury must understand that objective unreasonableness alone is not enough for conviction.

Fifth, consider whether convictions under the old standard should be challenged. If you were convicted before Ruan under an “objectively reasonable” standard, you may have grounds for appeal or post-conviction relief. Consult with appellate counsel about your options.

The Protection That Always Existed

Heres the paradox at the heart of Ruan. The protection the Supreme Court recognized always existed. The statute always said “knowingly or intentionally.” The Constitution always required mens rea for serious criminal offenses. The rule the Court announced in 2022 was not new – it was a correction of how courts had been reading the law.

For years, prosecutors convicted doctors under a standard that didnt actualy apply. For years, courts allowed objective reasonableness to substitute for subjective knowledge. For years, prescribers went to prison for conduct that – properly analyzed – might not have been criminal.

Ruan corrected that error. But it cannot undo the years of wrongful prosecutions that preceded it. It cannot restore the careers destroyed. It cannot give back the time served. It can only protect prescribers going forward – and provide a basis for those already convicted to seek relief.

If your facing charges now, Ruan is your shield. If you were convicted before Ruan, it may be your path to relief. Either way, understanding what the Supreme Court held – and why – is essential to protecting yourself.

The government must prove you knew your prescriptions were unauthorized. That is the Ruan standard. That is what makes conviction harder. That is the defense you need to understand.

The Stakes of Getting This Wrong

Heres the final uncomfortable truth. Understanding Ruan is not optional if your facing federal prescribing charges. The difference between a conviction and an acquittal may depend on wheather your jury understands that objective unreasonableness is not enough – that prosecutors must prove you actualy knew your prescriptions were unauthorized.

The doctors who went to prison before Ruan didnt have this protection. They were convicted under standards that the Supreme Court unanimously rejected. Some of them may have genuinly believed they were helping patients. Some of them may have been aggressive prescribers who made clinical judgments that other doctors wouldnt have made. But under the correct legal standard, genuine belief in medical legitimacy should have protected them.

You have the benefit of Ruan. Use it. Make sure your attorney understands it. Make sure your jury hears about it. Make sure the evidence of your good faith belief gets presented. Becuase in federal prescribing cases, the difference between decades in prison and walking free may come down to wheather the jury applies the right legal standard.

The Ruan defense exists. It protects doctors who genuinly believed they were practicing medicine. Whether it protects you depends on the evidence – and on having representation that knows how to present it.