DOJ Drops Charges in Appalachia Opioid Case After Supreme Court Ruling

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

On August 12, 2022, the U.S. Department of Justice (DOJ) announced that it dropped charges against the remaining defendants in a case against a former Ohio drug distributor. In 2019, Miami-Luken, two of its executives, and two pharmacists were charged with unlawfully conspiring to distribute millions of addictive painkillers across rural Appalachia.

The Original Indictment.

The DOJ issued an indictment against the five defendants in 2019 and charged all with conspiracy to distribute a controlled substance. It alleged Miami-Luken had sent millions of Class II and III narcotic painkillers to pharmacies that served rural towns in Appalachia. The indictment said that this occurred from about 2008 to 2015 when the opioid crisis was at its height.

During that time, the government alleged that Miami-Luken sent over “six million doses” of drugs to a West Virginia pharmacy and “regularly exceeded the internal threshold limit” set for that area. The charges were tied to alleged violations of the Controlled Substances Act. For more information about the charges, read the DOJ’s press release.

In a lengthy motion to dismiss, the former drug distributor said the claims were not clearly prohibited by the Controlled Substances Act and said the case was “the first time that the DOJ has relied on Drug Enforcement Administration (DEA) guidance letters interpreting a federal statute — the Controlled Substances Act — as the basis for a criminal prosecution.”

Pharmacy Fraud Cases using gavel and stethoscope with spilled opioid pills

As an aside, I note that the DEA (and when DOJ is representing it, DOJ adopts the same tactic) routinely engages in what I call “bean counting” to exaggerate the perception of the seriousness of the matter. They do this by counting the number of individual pills prescribed or dispensed when, overall, it really is not that significant. Let’s say a hypothetical patient suffering from chronic pain

is prescribed 20 mg of a narcotic medication thrice daily. Such prescriptions are normally written for a thirty (30) day supply. The DEA (and sometimes the DOJ) will multiply these out and allege the doctor prescribed 90 pills X 12 months or 1,080 pills. If the pharmacists did not have 20 mg size pills and filled it with 10 mg pills (doubling

the number of pills, but not the dosage), this doubles the number of pills to 2,160. It sounds like a tremendous number, but it is actually the average that would be prescribed for such a patient.

And then, when one considers that a pharmacy probably has thousands of patients each month who get their prescriptions filled, this greatly magnifies the number of individual pills. Then take it a step further, and consider a medical distributor that may be distributing medications to a hundred different individual drug stores. This multiplies out the number to a much greater one. Using a figure such as “six million pills distributed” sounds much more terrible than “three thousand patients received an average dosage of pills that were distributed through the drug distribution company.” Defense attorneys must do everything possible to eliminate or reduce the impact of such “bean counting” or “pill counting” in such cases.

In March 2021, U.S. District Judge Matthew W. McFarland of the Southern District of Ohio refused to toss the case, saying the motion was “premised on the mischaracterization of the crime.”

Unopposed Motion to Dismiss the Charges.

This time, Surprisingly, there was a motion by the DOJ to dismiss the case. Judge McFarland granted the government’s unopposed motion to dismiss the charges against the remaining defendants, including former Miami-Luken President Anthony Rattini, who died last year. Another former Miami-Luken executive had accepted a plea deal in December 2021.

View the government’s motion to dismiss the indictment without prejudice and stipulation.

View Judge McFarland’s order granting the motion to dismiss the indictment.

It’s important to note that the government did not specify why the charges were dropped; however, the move came shortly after a U.S. Supreme Court ruling that made such cases harder to prove. The decision in Ruan v. U.S. said that prosecutions under the Controlled Substances Act for excessive prescribing of opioids and other addictive drugs must show that doctors knew they lacked a legitimate medical purpose.

Click here to read my previous blog to learn more about this topic.

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 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 hearings at 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:

Weld, Elliot. “Appalachia Opioid Charges Dropped After High Court Ruling.” Law360. (August 12, 2022). Web.

Raymond Nate. “Opioid distributor Miami-Luken, execs seek dismissal of indictment.” Reuters. (May 1, 2020). Web.

Overley, Jeff. “DOJ Indicts Opioid Distributor, Execs Over Painkiller Sales.” Law360. (July 18, 2019). 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

Attorney Positions with The Health Law Firm. The Health Law Firm is always looking for qualified attorneys interested in the practice of health law. Its main office is in the Orlando, Florida, area. If you are a member of The Florida Bar and are interested, forward a cover letter and your resume to: PAlexander@TheHealthLawFirm.com or fax to: (407) 331-3030.

“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.

2022-09-07T23:39:52-04:00September 7th, 2022|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

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.

2022-06-24T16:22:15-04:00June 24th, 2022|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments
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