The U.S. Supreme Court is poised to issue what could be a monumental decision in the Court’s Controlled Substances Act (“CSA”) jurisprudence as applied to the nation’s opioid epidemic. At issue in Ruan v. United States is the requisite intent the government must prove to convict a physician under the CSA for the unlawful distribution of controlled substances. 

The outcome in Ruan could have significant implications for prescribers, including whether their risk of criminal liability is actually higher than a narcotics trafficker distributing heroin or cocaine. More specifically, to convict a drug trafficker, federal prosecutors must prove beyond a reasonable doubt that the trafficker knowingly and intentionally manufactured, transported, or distributed narcotics. If the government prevails in Ruan, the government would de facto have to show only that a prescribing physician was negligent in misprescribing opioids.

Concerns about ever-expanding prosecutorial discretion and the erosion of the criminal law’s traditional “guilty mind” requirement have focused significant attention on the case.

A Mini Survey of the CSA’s Statutory Scheme

Per the implementing regulations of 21 U.S.C. § 841(a)(1), a physician may lawfully prescribe controlled substances only if they are prescribed for “a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” Even a first-time offender could face decades in prison for misprescribing a Schedule II controlled substance, such as oxycodone, hydrocodone, hydromorphone, methadone, or fentanyl, in violation of the CSA.

The Government’s Case Against Dr. Ruan

In 2016, a federal grand jury returned an indictment charging Dr. Xiulu Ruan, a Drug Enforcement Administration (“DEA”)-registered pain management physician, with, among other things, “knowingly and unlawfully distribut[ing] and dispens[ing] . . . Schedule II Controlled Substances . . . outside the usual course of professional medical practice and not for a legitimate medical purpose, in violation of Title 21, United States Code, Section 841(a)(1).”

The government at trial presented evidence that Dr. Ruan and his business partner issued nearly 300,000 controlled substance prescriptions in a four-year period. Some of these prescriptions allegedly were signed without Dr. Ruan even seeing the patient. The government also presented evidence that Dr. Ruan increased prescriptions of a biopharma company’s fentanyl drug a hundredfold after he and his business partner invested in it.

Continue Reading Could It Be Easier to Convict a Doctor Than a Cartel Member? Why the Impending SCOTUS “Pill Mill” Ruling Makes Some Observers Nervous

On January 14, 2022, a federal district court in the Northern District of California declined to dismiss the first-ever enforcement action by the U.S. Securities and Exchange Commission (the “SEC”) based on allegations of “shadow trading” — the use of one company’s inside information to trade in securities of another, similarly situated, but unrelated company.  

Continue Reading Shadow Trading: Examining the SEC’s Insider Trading Theory in SEC v. Panuwat

On April 14, 2022, the Financial Crimes Enforcement Network (FinCEN) issued an advisory focusing on detecting kleptocrats (i.e., government officials who appropriate national resources for personal gain) and the proceeds of foreign public corruption and preventing them from entering the U.S. financial system. This guidance is the latest in a series of advisories FinCEN has issued focusing on Russian kleptocracy, and is part of a broader strategic initiative among key U.S. and global law enforcement and regulatory agencies focusing on corruption and money laundering as critical national security risks. In particular, the advisory highlights the enhanced focus of U.S. enforcement resources on the attempts of Russian oligarchs to evade sanctions imposed by the United States and its allies in response to Russia’s invasion of Ukraine.

U.S. law enforcement and regulatory agencies have high expectations as to the compliance efforts U.S. companies will adopt to meet this moment. Enforcement against companies and individuals involved in missteps is likely to be aggressive and robustly resourced. Indeed, the Department of Justice (DOJ) announced on April 6, 2022, in connection with the unsealing of an indictment of a Russian oligarch charged with U.S. sanctions violations, that it will “work relentlessly to counter Russian aggression, including by enforcing U.S. sanctions law.” Continue Reading As Russia Sanctions Mount, FinCEN Issues Advisory on Kleptocracy and Foreign Public Corruption

Following up on a recent Public Chatter blog in a series about internal investigations, note that Federal Rule of Evidence 502(g) states:

(1) “Attorney-client privilege” means the protection that applicable law provides for confidential attorney-client communications; and

(2) “Work-product protection” means the protection that applicable law provides for tangible material (or its intangible equivalent) prepared in anticipation of litigation or for trial.

The work-product privilege is more comprehensive than attorney-client privilege. Whereas the attorney-client privilege includes only communications between an attorney and the client, work product includes materials prepared or collected by persons other than the attorney or someone working for them with an eye towards the realistic possibility of impending litigation.

To read the full article on the Public Chatter blog, click here.

Background on the Guidelines and FOIA

On March 15, 2022, the United States Department of Justice (“DOJ”) released new guidelines favoring the disclosure of federal agency records under the Freedom of Information Act (“FOIA”). Signed into law by President Lyndon B. Johnson in 1967, FOIA established a statutory right of public access to executive branch records. At a high-level, FOIA provides that any person has a legally enforceable right to obtain federal agency records subject to the Act to the extent that such records are not protected from public disclosure by one of FOIA’s nine exemptions. The Supreme Court has explained that “the basic purpose of FOIA is to ensure an informed citizenry,” which is “needed to check against corruption and hold the governors accountable to the governed.”

The DOJ’s new guidelines direct federal departments and agencies to apply a presumption of openness in administering FOIA and explicitly state that the DOJ will not defend nondisclosure decisions that fail to do so. Under the new guidelines, the executive branch should not withhold requested information that might fall within one of FOIA’s exemptions unless the relevant agency can identify a foreseeable harm or legal bar to disclosure. The guidelines also remind federal agencies that FOIA requires the proactive disclosure of records and emphasize that such agencies should make records more readily accessible without requiring individuals to file FOIA requests. As an example, the guidelines note that the DOJ’s Executive Office for Immigration Review will no longer require individuals to file FOIA requests to obtain copies of their own records of immigration court proceedings.

Continue Reading New DOJ Guidelines Regarding FOIA Create Presumption of Openness

In remarks to the ABA Institute on White Collar Crime, U.S. Attorney General Merrick Garland and U.S. Assistant Attorney General Kenneth Polite Jr. delivered a wakeup call: enforcement activity by the U.S. Department of Justice (DOJ) “will only accelerate as we come out of the pandemic,” and federal prosecutors will focus more on white-collar criminal cases. The DOJ’s priority in these cases, AG Garland explained, is to hold accountable those individuals who commit and profit from corporate crime. And AAG Polite emphasized that the DOJ is committed to vindicating the rights of victims in white-collar cases who are too-often overlooked.

Continue Reading DOJ Foreshadows Increased Prosecutions of Corporate Crime

Recent briefing in SEC v. Team Resources, Inc., a long-running case challenging a U.S. Securities and Exchange Commission (“SEC”) disgorgement award, is a reminder of both the significance of the Supreme Court’s 2020 decision in Liu v. SEC and the open questions that remain regarding the SEC’s disgorgement remedy.

Continue Reading SEC v. Team Resources, Inc.: Exploring SEC Disgorgement Post-Liu

In its recent decision in United States ex. rel. Schutte v. SuperValu Inc., the Seventh Circuit joined four other circuits in holding that the Supreme Court’s objective scienter standard articulated in the Fair Credit Reporting Act (FCRA) case Safeco Insurance Company of America v. Burr applies to the False Claims Act (FCA). Under the objective scienter standard, a defendant who acts under an incorrect interpretation of a statute does not do so with reckless disregard—and therefore scienter, a required element of a FCA violation—if (i) the interpretation was objectively reasonable, and (ii) no authoritative guidance cautioned the defendant against it.

Notably for companies that contract with the federal government, this decision narrows the scope of their liability under the FCA. It also highlights the importance of such companies identifying and acting in accordance with authoritative guidance—a term of art whose precise contours remain undefined. Continue Reading Seventh Circuit Holds Objective Scienter Standard Applies to FCA

On January 20, 2022, the U.S. Supreme Court held in an 8-1 opinion in Hemphill v. New York that Darrell Hemphill did not “open the door” to the admission of out-of-court third-party testimony by making it “arguably relevant to his theory of defense.” The Court further held that the admission of such testimony violated Hemphill’s rights under the Sixth Amendment’s Confrontation Clause. The opinion will have practical significance for defense attorneys and prosecutors preparing for trial.  See Supreme Court to Weigh Protections Under Confrontation Clause.

Continue Reading U.S. Supreme Court Rejects Argument That Defendant “Opened the Door” to Evidence That Violated Confrontation Clause

Fiscal Year (FY) 2021 was a record-breaking year for the U.S. Securities and Exchange Commission’s (SEC’s) Office of the Whistleblower. Between October 1, 2020 and September 30, 2021, the SEC issued awards to more whistleblowers, and distributed more money in whistleblower funds, than in all prior years of the program combined. Now, just a few months into FY 2022 and two weeks into calendar year 2022, all signs point to a continued robust whistleblower program.

Continue Reading SEC Awards Over $17 Million to Whistleblowers in the First Two Weeks of 2022