News & Analysis as of

Opioid Pharmaceutical Industry Controlled Substances Act

American Conference Institute (ACI)

[Event] 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement - March 14th - 15th, Washington, DC

Join American Conference Institute at the 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement on March 14-15, 2023, in Washington. Hear from leading stakeholders, discuss your most pressing...more

Oberheiden P.C.

U.S. Supreme Court Overturns Doctors’ Opioid Convictions in Ruan v. United States, Paving the Way for Additional Appeals

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On June 27, 2022, the U.S. Supreme Court issued an important decision for doctors who have been convicted of violating the federal Controlled Substances Act in connection with the nation’s opioid crisis. In Ruan v. United...more

Quarles & Brady LLP

High Court Rules “State of Mind” Relevant in Prosecuting Prescribers under the Controlled Substance Act

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Last week the Supreme Court ("the Court") released a decision holding that the Federal Controlled Substance Act (the "Act") provision that criminalizes the dispensing of a controlled substance “except as authorized” includes...more

Fox Rothschild LLP

Enhanced Scrutiny of Opioid Prescriptions Poses Legal Risks for Medical Professionals

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The U.S. Department of Justice recently charged multiple physicians and health care professionals for opioid-related crimes in a crackdown with a clear message to individuals in the industry: If you are involved with...more

McGuireWoods LLP

Pain Management or Pill Mill? Supreme Court to Weigh in on Standards for Prosecutions of Practitioners Prescribing Narcotics

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Introduction - Next week, the Supreme Court will hear oral argument in a pair of cases that may reshape the landscape of legitimate prescribing under the Controlled Substances Act (“CSA” or “the Act”). In companion cases...more

Oberheiden P.C.

DOJ Opioid Enforcement Defense

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The Controlled Substances Act (“CSA”) - The CSA (21 U.S.C. 801 et seq.) imposes a framework that regulates different categories of certain drugs that pose dependency and abuse risks to the public. The CSA applies only to...more

Oberheiden P.C.

While COVID-19 Takes Center Stage, DOJ Continues to Target Providers for Opioid Epidemic

Oberheiden P.C. on

The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more

The Volkov Law Group

DOJ Files Civil Complaint Against Walmart for Illegal Opioid Distribution

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The Justice Department handed Walmart a huge slap in the face last year with the filing of a comprehensive civil case alleging that Walmart knowingly distributed large quantities of opioids in disregard of the law that fueled...more

Mintz - Health Care Viewpoints

DEA Releases Long-Awaited Suspicious Orders Proposed Rule

It has been a long time coming. On November 2, 2020, the Drug Enforcement Administration (DEA) released its long-awaited proposed rule to revise the regulations related to suspicious orders of controlled substances. The...more

Oberheiden P.C.

DEA Compliance for 2021 - How the DEA’s 2021 Proposed Aggregate Production Quotas Affect Pharmaceutical Companies and Society

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The DEA struggles to balance the pressing need to provide pain relief for those suffering from the novel coronavirus with the ongoing effort to reduce the opioid epidemic in the United States. I. Overview on the DEA and the...more

Carlton Fields

Sixth Circuit Rejects a Novel Concept: Certification of “Negotiation Class” in Opioid Multidistrict Litigation

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The Sixth Circuit recently addressed whether a novel negotiation class could be certified to facilitate possible future settlement negotiations in multidistrict litigation (MDL)....more

Harris Beach PLLC

Partial Summary Judgment Win for Major Pharmacy Chains in New York Litigation Deemed "Essential"

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The pharmacy defendants – major national corporations CVS Pharmacy, Inc., Rite Aid of Maryland, Inc., Walgreen Co., and Walmart Inc., sued by Long Island counties Nassau and Suffolk (County Plaintiffs) in their capacities as...more

Kramer Levin Naftalis & Frankel LLP

Delaware Chancery Court Holds That Stockholders Had a “Proper Purpose” to Seek Board Materials From Opioid Distributor, and Orders...

In a 63-page decision issued on Jan. 13, 2020, in Lebanon County Employees’ Retirement Fund v. AmerisourceBergen Corporation, Vice Chancellor J. Travis Laster of the Delaware Court of Chancery found that stockholders of...more

WilmerHale

Insys Ruling Casts Doubt on DOJ Opioid Investigations

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On May 2, 2019, a jury sitting in the District of Massachusetts convicted five senior executives of Insys Therapeutics, Inc. (Insys) with racketeering conspiracy in violation of Title 18, United States Code, Section 1962(d)....more

Harris Beach PLLC

Two Executives and Distributor Charged for Unlawfully Distributing Controlled Substances

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Rochester Drug Co-Operative, Inc. (“RDC”), one of the 10 largest pharmaceutical distributors in the United States, was recently charged along with its former Chief Executive Officer and former Chief Compliance Officer, for...more

Troutman Pepper

DOJ Files Unprecedented Criminal Charges Against Opioid Distributor and Two Executives

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On April 23, federal prosecutors announced the first-ever felony charges against a drug distributor — Rochester Drug Co-Operative, Inc. (RDC) — and two of its executives for illegally distributing opioid painkillers....more

McDermott Will & Emery

DOJ Expands New Enforcement Tactic – Obtains TRO to Prevent Pharmacy From Dispensing Opioids

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On February 8, 2019, the Department of Justice (DOJ) announced that it obtained a temporary restraining order (TRO) in the Middle District of Tennessee against two pharmacies, their owner and three pharmacists from dispensing...more

Foley & Lardner LLP

President Signs New Law Allowing Telemedicine Prescribing of Controlled Substances: DEA Special Registration to Go Live

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President Trump just signed into law the “Special Registration for Telemedicine Act of 2018” (the Act), requiring the Drug Enforcement Administration (DEA) to activate a special registration allowing physicians and nurse...more

Steptoe & Johnson PLLC

Opioid Reduction Act Imposes New Restrictions and Responsibilities on Prescribers

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Prescribers in West Virginia are bound by new restrictions set forth in the Opioid Reduction Act, aimed at combating the opioid crisis in West Virginia. The Act was enacted by the state legislature to limit patient access in...more

Burr & Forman

What’s at Stake for Medical Professionals in “Pill Mill” Investigations

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In an earlier article, I detailed how the DOJ has focused its attention on the aggressive investigation and prosecution of “pill mill” cases. In this article, I discuss the consequences physicians and other medical...more

Foley & Lardner LLP

New Connecticut Law Allows Telemedicine Prescribing of Controlled Substances

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Connecticut has taken another step towards expanding the meaningful use of telemedicine in connection with treatment of mental health and substance use disorders. SB 302, signed by Governor Dannel Malloy and effective July 1,...more

Ruder Ware

Recent Fraud Settlements Illustrate Current Compliance Risk Areas

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One of the reasons compliance officers and health care attorneys read fraud settlements is to identify issues the government is focused on. The cases the government decides to pursue are very indicative of the areas of fraud...more

Mintz - Health Care Viewpoints

Congress Holds Hearings and Proposes Legislation to Combat Vexing Opioid Crisis

On Tuesday, May 8th, the House held three hearings related to combating the opioid epidemic. The first hearing came out of the Energy and Commerce (E&C) Subcommittee on Oversight and Investigations, which examined opioid...more

Fox Rothschild LLP

Judge Andrews Grants State Of Delaware’s Motion To Remand To State Court Suit It Filed Against Opioid Manufactures, Distributors...

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By Memorandum Opinion entered by The Honorable Richard G. Andrews in State of Delaware v. Purdue Pharma L.P. et al., Civil Action No. 18-383-RGA (D.Del. April 25, 2018), the Court granted Plaintiff State of Delaware’s Motion...more

Mintz - Health Care Viewpoints

Federal Enforcement Actions Continue to Focus on Opioid-Related Misconduct

As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices. Earlier this month, the...more

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