Introduction
When does a trusted physician become a criminal defendant? In the United States, the answer increasingly depends on how prosecutors interpret prescription patterns, patient deception, and the gray zone between poor medical judgment and felony drug trafficking.
Consider the cautionary example of Dr. Noel L. Smith, an 82-year-old general surgeon and family practitioner in Manhattan. After 57 years treating New Yorkers, Dr. Smith was indicted for allegedly distributing controlled substances — medications like oxycodone, Adderall, Klonopin, and Suboxone — in a manner that prosecutors said defied public health and safety. Some of his patients, authorities allege, sold their prescriptions on the street, resulting in asset seizures that stripped Dr. Smith of decades of earnings.
Is this an isolated scandal or a warning for every doctor who writes scripts for legitimate conditions but lacks clairvoyance to detect patient deception? To find answers, I gathered seasoned healthcare defense lawyers, former prosecutors, judges, compliance officers, and policy researchers for a roundtable on how America’s drug enforcement approach risks criminalizing medical practice, what needs to change, and what every prescriber should do to protect their practice — and their freedom.
1. The Legal Framework: When Does Treatment Become Trafficking?
At the heart of these prosecutions lies the Controlled Substances Act (CSA), the 1970 federal statute that gives the DEA broad powers to regulate and enforce prescribing. Under the CSA, it is a felony to “distribute or dispense a controlled substance except as authorized.” For licensed physicians, authorization hinges on the phrase “in the usual course of professional practice.”
But what does “usual course” really mean? The Supreme Court’s 1975 decision in United States v. Moore confirmed that physicians could be prosecuted under the CSA if they abandon their role as medical caregivers and act as “pushers.” Yet the statute gives no concrete test for crossing that line.
In Ruan v. United States (2022), the Court unanimously clarified that prosecutors must prove the prescriber “knowingly or intentionally” acted outside the scope of professional practice. As Reason Magazine’s analysis emphasized, this decision raised the bar for conviction, but it did not eliminate the ambiguous red flag factors that still drive investigations.
2. The Prosecutor’s Playbook: Red Flags and Data Mining
Former Assistant U.S. Attorney Cynthia Torres, who led dozens of prescription drug diversion cases, breaks down the modern strategy. “It starts with big data,” she says. Prescription Drug Monitoring Programs (PDMPs) allow states and the DEA to flag outlier prescribers based on metrics like dosage, drug combinations, and cash payments.
The CDC’s Public Health Law Program details the common “red flag” criteria, including:
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High daily doses (often 90+ morphine milligram equivalents).
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Concurrent prescriptions for benzodiazepines and opioids.
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Cash-only payments with no insurance documentation.
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Absence of physical exams or patient contracts.
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Frequent early refill requests.
Next comes undercover work. Tactical Diversion Squads often deploy undercover patients, posing as individuals with vague pain complaints to test if the physician will prescribe controlled substances without proper examination or documentation.
But data and stings can misrepresent reality. As defense attorney Alan Feldstein explains, “Red flags are risk indicators, not proof of a crime. Many chronic pain patients fit these patterns legitimately, and the burden should be on the government to prove intent, not just unusual numbers.”
3. The Ruinous Role of Civil Asset Forfeiture
One aspect that sets these cases apart is asset forfeiture. Once an investigation begins, prosecutors can move quickly to seize a physician’s bank accounts, homes, and retirement funds on the claim they are proceeds of illegal drug activity — even before trial.
According to the Institute for Justice, federal and state agencies seized more than $68.8 billion in cash and property between 2000 and 2019. In the healthcare space, these seizures can exceed the fines imposed after conviction. In Dr. Smith’s situation, authorities seized decades of savings while the case is still pending.
The United States v. 92 Buena Vista Ave. precedent highlights the harsh reality: property can be forfeited even if the owner is an “innocent owner” who did not know it was allegedly connected to criminal activity. Critics argue this “innocent owner loophole” flips the presumption of innocence, incentivizing prosecutors to go after high-value targets.
4. Judicial View: How Ruan Changed — and Didn’t Change — the Rules
Retired Federal Judge Harriet Lynn, who presided over several diversion cases in the Southern District of New York, notes that while Ruan v. United States strengthened the requirement to prove intent, it didn’t eliminate the practical problem.
“The problem is jurors confuse negligence with criminality,” she says. “If a doctor fails to document something or overlooks a forged ID, the government still frames that as intentional disregard. Ruan is helpful, but only if defense counsel drives the point home.”
A Reason deep dive into Ruan shows that federal prosecutors continue to argue that egregious deviations from “objective” medical norms imply knowing misconduct — a slippery slope that sustains prosecutions.
5. Racial and Civil Rights Concerns: Who Pays the Price?
Beyond individual physicians, the system’s bias is systemic. The NCBI Bookshelf’s workshop on racial disparities in drug enforcement reveals how communities of color often bear the brunt of harsh sentencing and forfeiture.
A landmark finding: 96% of “school-zone” drug arrests in New York City target Black or Latino individuals, despite comparable rates of drug use across racial groups. Critics argue that the same bias infects prosecutorial discretion in doctor cases: urban doctors serving marginalized patients face higher risk when their prescribing data flags “red flags” linked to complex patient needs.
6. The Human Impact: When Doctors Stop Prescribing
The American Medical Association reported in 2021 that 11% of physicians have stopped prescribing controlled substances entirely, citing fear of prosecution. The CDC’s rural health studies show that so-called “prescriber deserts” now leave cancer patients, palliative care patients, and those with severe chronic pain traveling hours to find a willing doctor.
A composite patient voice captures the crisis: “I live with metastatic breast cancer. My doctor retired early after a DEA audit. Now I drive four hours each way for pain care. I’m terrified I’ll be left without meds.”
7. Best Practices: Strengthening Compliance and Defense
Laura Simmons, a healthcare compliance expert, says doctors must assume they are under constant audit. Borrowing insights from Chapman Law Group’s guide on pill mill defense, she highlights key tactics:
✅ Proactive Audits: Conduct internal chart reviews to detect documentation gaps or prescribing patterns that might look suspicious.
✅ Undercover Patient Protocols: Train staff to document unusual patient behavior and consult legal counsel before prescribing under suspicious circumstances.
✅ Patient Contracts: Use detailed opioid agreements, informed consent forms, and urine drug testing to show good faith monitoring.
✅ Specialist Referrals: Maintain a referral network to demonstrate that complex cases are co-managed.
✅ Legal Counsel: Engage experienced healthcare defense lawyers before problems arise. Build a response plan for surprise inspections or subpoenas.
8. Defense Strategies When Prosecuted
Defense attorney Carla Thompson, who has successfully defended multiple physicians, outlines the essentials:
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Challenge Causation: Argue there is no clear link between prescriptions and alleged diversion. Patients who sell pills should bear the burden.
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Use Ruan Aggressively: Demand the government prove intentional or knowing misconduct.
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Expert Witnesses: Bring in pain management or addiction specialists to contextualize high-dose regimens.
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Expose Bias: Highlight how prosecutors rely on “red flags” that don’t account for individualized care.
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Negotiate Early: Sometimes, structured settlements or compliance agreements can avoid ruinous jury trials.
9. International Comparisons: A More Balanced Approach
Other countries balance enforcement with support:
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In Canada, medical boards like the College of Physicians and Surgeons focus on professional remediation and continuing education before involving law enforcement.
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The UK’s Care Quality Commission (CQC) works closely with the General Medical Council (GMC) to monitor prescribing trends, retrain doctors, or suspend licenses. Criminal charges arise only when deliberate misconduct is clear.
10. Policy Proposals for Reform
Many experts believe the U.S. must recalibrate its approach. Suggested reforms include:
✅ Clarify “Usual Course”: Amend the Controlled Substances Act to set clear, objective medical criteria.
✅ Reform Asset Forfeiture: Support bipartisan bills like the FAIR Act, requiring conviction before property seizure.
✅ Address Racial Disparities: Fund research and policies that reduce bias in prescribing investigations and prosecutions.
✅ Safe Harbor Protections: Develop guidelines that shield doctors following evidence-based practices.
✅ Transparency: Require agencies to publicly account for how forfeiture funds are used.
✅ AMA and CDC Partnerships: Encourage state legislatures to align with the AMA’s push to stop criminalizing medical judgment for unintended outcomes.
Key Sidebar: Major Cases to Know
📌 Hurwitz: Pain doctor sentenced to 25 years for opioids — later partly overturned, showing risks of overreach.
📌 Volkman: Multiple life sentences based on data and patient deaths; remains controversial.
📌 Ruan: Supreme Court ruling that prosecutors must prove intent; reshaped, but didn’t end, aggressive tactics.
Additional Recommended Sources
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CDC Prescription Drug Monitoring — An overview of state policies, data, and red flag criteria. Explore resource
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Reason’s Analysis of Ruan — Clear breakdown of how Ruan reshaped prosecutorial burdens. Read more
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NCBI Bookshelf Workshop — Deep dive into racial disparities in drug enforcement. View report
FAQs
Q1: How likely is it that my practice will face an investigation?
A1: While rare, any physician prescribing controlled substances can face an audit. The risk rises with outlier prescribing data and poor documentation.
Q2: Is asset forfeiture always linked to a conviction?
A2: No. Many forfeitures happen pretrial, exploiting the “innocent owner loophole.”
Q3: How does Ruan help physicians?
A3: It demands proof of knowing or intentional misconduct, but doctors must ensure records show good faith.
Q4: What should I do if undercover patients come to my office?
A4: Train staff to spot suspicious signs, document carefully, and consult counsel if something feels off.
Disclaimer
This LinkedIn article is meant to inform, not advise. While it explores current trends and perspectives in healthcare enforcement, it is not a substitute for legal counsel. Every case has unique facts, and laws vary by jurisdiction. For advice tailored to your situation, consult a qualified legal professional. The author and publisher accept no responsibility for decisions made solely on the basis of this content — consider it a starting point, not the final word.
About the Author
Dr. Daniel Cham is a physician and medical-legal consultant with extensive experience in healthcare compliance and regulatory strategy. He focuses on delivering practical, actionable insights that help professionals navigate complex challenges at the intersection of medicine and law. Connect with Dr. Cham on LinkedIn: Daniel Cham, MD
Relevant Hashtags
#HealthcareLaw #PhysicianDefense #OpioidProsecution #RuanDecision #AssetForfeiture #CivilRights #MedicalCompliance #PainManagement #DOJ #DEA #MedicalJustice #HealthcareForfeiture
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