Supreme Court Explores Doctor Intent in “Pill Mill” Criminal Prosecutions Under the Controlled Substances Act

Attorney & Author HeadshotBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Physicians and other healthcare professionals usually have broad scope to prescribe most drugs, including potentially dangerous ones. However, over the past decade, many limits, often imposed arbitrarily through criminal prosecutions or drastic administrative sanctions, have been used to impose limits.

The question was recently put before the U.S. Supreme Court as to how far a physician’s judgment can be allowed to go in the context of prescribing controlled substances before it becomes criminal. This was in the context of criminal prosecution of a physician for allegedly over-prescribing.

On March 1, 2022, the U.S. Supreme Court confronted the question of whether good faith is a defense for a doctor criminally prosecuted for unlawful distribution of controlled substances. For nearly 90 minutes, the Supreme Court heard oral arguments from both sides, struggling with the exact wording of the Controlled Substances Act (CSA), the clarity of the relevant federal regulation, and the proposition that a doctor who lacked subjective criminal intent could nevertheless go to jail for a substantial period of time, up to life imprisonment.

The two physicians whose cases are being considered are Xiulu Ruan, who was sentenced to 21 years in prison in 2017 for allegedly running a “pill mill,” and Shakeel Kahn, who was sentenced to 25 years in prison in 2019 for crimes including drug distribution of controlled drugs resulting in the death of a patient. The court consolidated their cases for the Supreme Court’s hearing.

Controversial Legal Standards Used to Convict.

The legal standard in question centers heavily on a disputed sentence in the Controlled Substances Act (CSA) that says, “Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally” to distribute controlled substances. The central question is how juries should assess the intentions of a doctor accused of prescribing narcotic painkillers outside “the usual course of his professional practice.”

The U.S. Department of Justice (DOJ) argued that the criminal intent standard is an objective one — or an “honest effort” to comply with professional norms. On the other hand, the attorneys for the doctors who were prosecuted argue that the standard must be subjective; that is did the doctor subjectively believe they were not prescribed for a legitimate medical purpose. This distinction gives rise to whether there is merely a violation of regulation as opposed to a crime having been committed.

Throughout the oral arguments, various justices seemed to cast doubt on whether deviating from mainstream standards on opioid prescribing is sufficient to throw physicians in jail, which could result in years or life in prison. In some states, this might even result in a death sentence, pretty drastic for what would otherwise be medical negligence.

How This Ruling Will Impact Future Prosecutions.

This case and the upcoming ruling raise alarms for healthcare providers and advocates for pain patients. Many fear that the ruling could enable even more aggressive prosecutions of opioid prescribers. They warn that such a decision could discourage doctors from providing opioids even when they’re fully warranted. In addition, the outcome could affect civil litigation accusing large pharmaceutical companies of recklessly selling prescription narcotics.

After hearing the oral arguments, the Supreme Court seemed likely to demand more substantial proof of intentional wrongdoing when the DOJ prosecutes opioid prescribers. A decision from the High Court is expected by late June 2022. The cases are Ruan v. U.S., case number 20-1410, and Kahn v. U.S., case number 21-5261, in the Supreme Court of the United States.

We will definitely keep you posted on the outcome of this case.

Click here to read one of my blogs about controlled substances and compliance.

Contact Health Law Attorneys Experienced in the Representation of Health Professionals and Providers.

The Health Law Firm and its attorneys have represented physicians, pharmacists, nurses, clinics, dentists, pharmacies, health facilities, and other health care providers in different cases involving allegations of over-prescribing narcotics and pain medications. These include criminal investigations by local police and law enforcement authorities, investigations by the U.S. Drug Enforcement Agency (DEA), U.S. Department of Justice (DOJ), complaints against professional licenses by the Florida Department of Health, investigations, and prosecutions by the Medicaid Fraud Control Units (MFCU), and other types of cases. Having attorneys familiar with the medical standards of care and guidelines for prescribing narcotics and having access to expert medical and pharmacy professionals who can testify as expert witnesses in such cases is also crucial. We have represented professionals in administrative investigations and administrative hearings at both the state and federal levels.

To contact The Health Law Firm, please call (407) 331-6620 or Toll-Free (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

Sources:

Overley, Jeff. “High Court Poised To Make DOJ’s Job Harder In Opioid Cases.” Law360. (March 1, 2022.) Web.

Gluck, Abby. “In opioids “pill mill” case, justices grapple with physician intent.” SCOTUS Blog. (March 2, 2022). Web.

Joseph, Andrew. “Fight over opioid prescribing — and when it turns criminal — heads to Supreme Court.” STAT News. (February 28, 2022). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 Toll-Free: (888) 331-6620

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2022 The Health Law Firm. All rights reserved.

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Two FL Pill Mill Owners Get Prison Time For Illegal Distribution Of Opioids

George IndestBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On October 7, 2020, two owners of a medical practice in Tampa, Florida, were sentenced to federal prison time for their roles in the illegal distribution of opioids. U.S. District Judge Mary S. Scriven sentenced Ernest Gonzalez to 46 months and Rosa Colon to 24 months in federal prison for conspiracy to distribute and dispense controlled substances for no legitimate medical purpose.

Plot to Illegally Distribute Controlled Substances.

According to court documents, Gonzalez served as the president and owner of Health and Pain Center (HPC), a Tampa pain management clinic. In June 2011, he transferred his executive title and ownership of HPC to Colon. The Drug Enforcement Administration (DEA) obtained a warrant in October 2016, while both were active participants of the administration and management of HPC.

The two owners allegedly hired physicians at HPC, who routinely prescribed controlled substances to patients eeking pain mediciations. Federal authorities always allege that such prescriptions are “outside the scope of professional (medical) practice.” Additionally, the owners are alleged to have participated and facilitated the physicians’ illegal prescribing practices by instructing employees to overlook failed urinalysis screens that help to detect drug abusers.

According to court papers, the owners also obtained MRI studies and other documents that the physicians used to justify the high volume of opioid prescriptions. According to court documents, the owners operated HPC as a cash-only business with little to no medical equipment on-site and staff with no medical training.

The owners pled guilty on September 11, 2018. It is unclear as to why they were not sentenced until October 7, 2020. As part of their sentences, the court entered money judgments of $47,780.96 against Gonzalez and $765,356.76 against Colon. This was in addition to the prison time stated above.

The facts above are typical of those in other state and federal prosecutions against physicians, pharmacists, and clinic owners. If you are a physician who is working for a clinic owned by non-physicians, you need to be very careful that you are working for a legitimate organization. If you are being pressured to write prescriptions for narcotics for patients, you need to be very careful about what you do and why you do it. Often physicians who work for pill mills just bury their heads in the sand and rationalize why they are writing and refilling the same prescriptions for opioids month after month.

For the past ten years, in Florida, the DEA, the Department of Health, the state Attorney General, and multi-jurisdictional task forces have been targeting physicians who write prescriptions for narcotics and pharmacies that fill such prescriptions. There are very few left. The cross-hairs of the regulators and law enforcement are now targeting those who are involved in only very small quantities. Watch out, it could be you next!

View the press release issued by the U.S. Attorney’s Office for the Middle District of Florida.

Read my prior blog and learn more about pill mills, here.

Contact Health Law Attorneys Experienced with DEA Cases.

The attorneys of The Health Law Firm are experienced in handling Drug Enforcement Administration (DEA) cases, board of medicine cases, and board of pharmacy case, Department of Health (DOH) investigations, and Department of Regulatory Agencies (DORA) investigations, regarding allegations of over-prescribing and illegal prescribing. If you are currently being investigated or facing other adverse actions by the DEA or a state licensing board, contact one of our attorneys by calling (407) 331-6620 or toll-free at (888) 331-6620. You can also visit our website for more information at www.TheHealthLawFirm.com.


Sources:

“Tampa Pill Mill Owners Sentenced To Prison For Illegal Distribution Of Opioids.” Tampa Free Press. (October 11, 2020). Web.

Otero, Sebastian. “Tampa pill mill owners sentenced to prison for illegal distribution of opioids.” ABC 7 WWSB. (October 8, 2020). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 Toll-Free: (888) 331-6620

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2020 The Health Law Firm. All rights reserved.

 

Non-physician Pill Mill Owners in Tampa Sentenced To Prison Time For Illegal Distribution Of Opioids

George IndestBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On October 7, 2020, two owners of a medical practice in Tampa, Florida, were sentenced to federal prison time for their roles in the illegal distribution of opioids. U.S. District Judge Mary S. Scriven sentenced Ernest Gonzalez to 46 months and Rosa Colon to 24 months in federal prison for conspiracy to distribute and dispense controlled substances for no legitimate medical purpose.

Plot to Illegally Distribute Controlled Substances.

According to court documents, Gonzalez served as the president and owner of Health and Pain Center (HPC), a Tampa pain management clinic. In June 2011, he transferred his executive title and ownership of HPC to Colon. The Drug Enforcement Administration (DEA) obtained a warrant in October 2016, while both were active participants of the administration and management of HPC.

The two owners allegedly hired physicians at HPC, who routinely prescribed controlled substances to patients eeking pain mediciations. Federal authorities always allege that such prescriptions are “outside the scope of professional (medical) practice.” Additionally, the owners are alleged to have participated and facilitated the physicians’ illegal prescribing practices by instructing employees to overlook failed urinalysis screens that help to detect drug abusers.

According to court papers, the owners also obtained MRI studies and other documents that the physicians used to justify the high volume of opioid prescriptions. According to court documents, the owners operated HPC as a cash-only business with little to no medical equipment on-site and staff with no medical training.

The owners pled guilty on September 11, 2018. It is unclear as to why they were not sentenced until October 7, 2020. As part of their sentences, the court entered money judgments of $47,780.96 against Gonzalez and $765,356.76 against Colon. This was in addition to the prison time stated above.

The facts above are typical of those in other state and federal prosecutions against physicians, pharmacists, and clinic owners. If you are a physician who is working for a clinic owned by non-physicians, you need to be very careful that you are working for a legitimate organization. If you are being pressured to write prescriptions for narcotics for patients, you need to be very careful about what you do and why you do it. Often physicians who work for pill mills just bury their heads in the sand and rationalize why they are writing and refilling the same prescriptions for opioids month after month.

For the past ten years, in Florida, the DEA, the Department of Health, the state Attorney General, and multi-jurisdictional task forces have been targeting physicians who write prescriptions for narcotics and pharmacies that fill such prescriptions. There are very few left. The cross-hairs of the regulators and law enforcement are now targeting those who are involved in only very small quantities. Watch out, it could be you next!

View the press release issued by the U.S. Attorney’s Office for the Middle District of Florida.

Read my prior blog and learn more about pill mills, here.

Contact Health Law Attorneys Experienced with DEA Cases.

The attorneys of The Health Law Firm are experienced in handling Drug Enforcement Administration (DEA) cases, board of medicine cases, and board of pharmacy case, Department of Health (DOH) investigations, and Department of Regulatory Agencies (DORA) investigations, regarding allegations of over-prescribing and illegal prescribing. If you are currently being investigated or facing other adverse actions by the DEA or a state licensing board, contact one of our attorneys by calling (407) 331-6620 or toll-free at (888) 331-6620. You can also visit our website for more information at www.TheHealthLawFirm.com.


Sources:

“Tampa Pill Mill Owners Sentenced To Prison For Illegal Distribution Of Opioids.” Tampa Free Press. (October 11, 2020). Web.

Otero, Sebastian. “Tampa pill mill owners sentenced to prison for illegal distribution of opioids.” ABC 7 WWSB. (October 8, 2020). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 Toll-Free: (888) 331-6620

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2020 The Health Law Firm. All rights reserved.

 

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