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Seven Things To Know When You Receive A Notice Of Investigation From The Department Of Health

DOJ Drops Charges in Opioid Case After Supreme Court Ruling

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 had been charged with conspiring to distribute millions of addictive pain killers across rural Appalachia unlawfully.

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, click here to 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.”

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 is suffering from chronic pain is prescribed 20 mg of a narcotic medication three times per day.  Such prescriptions are normally written for a thirty (30) day supply.  The DEA (and sometime 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), then 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 within their power 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 here.

Click here to view Judge McFarland’s order granting 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 physicianspharmacists, nurses, clinics, dentists, pharmacieshealth 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


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. 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: [email protected] or fax to: (407) 331-3030.

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