First Federal Charges Issued Against a Drug Manufacturer

By: AffirmHealth

Reading Time: 3 minutes

Date: 05/07/2019

In an effort to reduce overprescribing of opioids nationwide, there has been serious crackdowns on physicians, pharmacists, and manufacturers in the industry to help control prescribing rates and their roles in contributing to the epidemic. Yet for the first time, federal charges were issued against a drug manufacturer last month.    

The Case Against Opioid Distributor, Rochester Drug Co-Operative 

Rochester Drug Co-Operative was charged with allegations of distributing controlled substances, oxycodone and fentanyl, as fraud and for non-medical reasons. They are one of the 10 largest wholesale pharmaceutical distributors in the United States. These are the first criminal charges issued against a pharmaceutical company and its executives in the ongoing epidemic [2]. 

Rochester's former CEO, Laurence Doud III, and Chief of Compliance, Willam Pietruszewski, were charged for knowingly contributing to the effects of the opioid crisis. Rochester Drug Co-Operative, or RDC, and Pietruszewski were both also charged with failing to file at least 2,000 suspicious order reports to the DEA (Drug Enforcement Administration). Their charges are based upon information collected from May 2012 to November 2016, during which RDC filled more than 1.5 million orders for controlled substances. [1]

"This prosecution is the first of its kind: executives of a pharmaceutical distributor and the distributor itself have been charged with drug trafficking, trafficking the same drugs that are fueling the opioid epidemic that is ravaging this country," U.S. Attorney for the Southern District of New York, Geoffrey Berman, said in a recent statement. "Our Office will do everything in its power to combat this epidemic, from street-level dealers to the executives who illegally distribute drugs from their boardrooms."

Both Doud and Pietruszewski face maximum sentences of life in prison, a minimum prison term of 10 years for the drug trafficking charges, and five year sentences on their charges of defrauding the U.S. federal government. 

U.S. Attorney Berman announced an agreement with RDC through which they accept responsibility for their actions and agree to pay a $20 million penalty, reform its Controlled Substances Act compliance program, and accept monitoring by legal supervision. After a duration of five years, if the company has been compliant with all agreed upon competencies, they will defer prosecution and seek to dismiss the charges. [3]

The Future of the Epidemic and Opioid Legislation

Although we have seen many instances nationwide of pharmacies closing and physicians losing their licenses to prescribe narcotics, this case has been the first against a drug manufacturer. This case could open the door for further investigation into similar instances of drug trafficking. Stricter and more intense monitoring will likely follow suit to ensure other drug manufacturers are following protocols and laws when selling/distributing opioids.

Our team is dedicated to keeping you up to date on the news and changes related to the drug industry and the opioid crisis. For more information regarding this case or the opioid epidemic, start a conversation with us. 




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