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The McKinsey $650 Million Settlement: Compliance Lessons from the Opioid Crisis

Last week, McKinsey & Company resolved civil and criminal matters with the Department of Justice (DOJ). This settlement represents a seismic shift in corporate accountability. For the first time, a management consulting firm has been held criminally liable for advice that contributed to a client’s commission of a crime. This $650 million resolution with the DOJ offers profound lessons for industry compliance professionals. This should be coupled with the previous Foreign Corrupt Practices Act (FCPA) resolution for $122 million with the DOJ over the company’s bribery and corruption in South Africa. From failures in risk management to the imperative of ethical decision-making, McKinsey’s cases are a masterclass in how compliance missteps can lead to devastating consequences.

A Timeline of Ethical Erosion  

Between 2004 and 2019, McKinsey worked on 75 engagements with Purdue Pharma, a key player in the opioid epidemic. In 2013, McKinsey spearheaded a project to “turbocharge” OxyContin sales despite growing awareness of the drug’s role in the crisis. This “Evolve to Excellence” initiative targeted high-prescribing physicians, some already under scrutiny for unsafe practices. Despite Purdue’s 2007 guilty plea for misbranding OxyContin, McKinsey continued advising the company, prioritizing profits over public health.

The fallout included a criminal charge for obstruction of justice against a former senior partner, allegations of advising on fraudulent claims to federal healthcare programs, and revelations of conflicts of interest in dealings with the FDA. The penalties include a $231 million fine, $93 million in forfeitures, and $323 million under the False Claims Act. McKinsey also agreed to a Deferred Prosecution Agreement (DPA), mandating significant compliance reforms.

Key Compliance Takeaways  

1. Risk Assessment and Client Selection: The First Line of Defense

McKinsey’s failure to assess its work’s reputational and legal risks with Purdue underscores the importance of robust risk evaluation processes. Like any organization, consulting firms must consider client histories and engagement scopes. Purdue’s 2007 plea and ongoing controversies should have triggered heightened scrutiny, yet McKinsey continued its relationship unabated. One key lesson is to establish a formalized client diligence framework. Identify high-risk clients and engagements, factoring in legal histories, industry regulations, and reputational implications.

2. The Ethical Perils of Aggressive Strategy

The directive to “turbocharge” OxyContin sales illustrates the ethical blind spots that arise when profit-driven goals overshadow public welfare. McKinsey’s PowerPoint presentations and marketing strategies directly influenced Purdue’s ability to sustain OxyContin sales, exacerbating the opioid crisis. Every organization must build ethics into strategic decision-making. Compliance officers should collaborate with business units to ensure strategies align with ethical standards and regulatory requirements.

3. Document Retention and the Dangers of Obstruction

The case against former senior partner Martin Elling reveals how internal actions can escalate legal risks. Elling’s directive to “eliminate all our documents and emails” and his subsequent obstruction charge illustrates the severe consequences of tampering with evidence during investigations. Every company must develop and enforce strict document retention policies. Provide training to employees on legal holds and the dangers of obstructing investigations.

4. Conflict of Interest Management

McKinsey’s simultaneous work with Purdue and the FDA highlights a blatant disregard for conflict-of-interest policies. Misleading the FDA undermined trust and compounded McKinsey’s liability. Your organization must institute robust conflict-of-interest protocols. Regularly audit engagements to identify overlapping or competing interests and disclose conflicts proactively.

5. Deferred Prosecution Agreements: A Path to Reform

As part of the DPA, McKinsey committed to implementing significant compliance reforms, including a risk evaluation process, quality review programs, and new document retention procedures. These measures are designed to prevent a repeat of past mistakes. Indeed, no company wants to be under a DPA, but the conduct of McKinsey, both in this case and in its FCPA matter in South Africa, were both so egregious that the company should view its DPA as an opportunity for transformation. Compliance leaders should use such agreements to rebuild trust, enhance internal controls, and foster a culture of accountability.

Culture as a Compliance Imperative  

The most striking lesson from the McKinsey case is the absence of a culture of accountability. McKinsey’s actions were not the result of one rogue employee; they reflected systemic failings within the organization. From top executives to client teams, the firm consistently prioritized financial gain over ethical responsibility.

Building an ethical culture requires multiple steps. It all begins with Tone from the Top—a commitment from top leadership to demonstrate an unwavering commitment to compliance and ethics. A company must empower its corporate compliance functions with the authority and resources to challenge decisions that pose ethical risks. Through training, communication, and employee awareness, there must be awareness throughout the organization of this commitment to business ethically and in compliance. Organizations must regularly train employees on ethical decision-making, risk identification, and reporting mechanisms.

Looking Ahead: The Compliance Professional’s Role  

The McKinsey settlements are a wake-up call for compliance professionals. They challenge us to rethink our roles as rule enforcers and stewards of ethical integrity. This case underscores the importance of proactive measures to identify risks, implement controls, and foster a culture where doing the right thing is non-negotiable.

The DOJ’s message is clear: no entity is above the law. Consulting firms, financial advisors, and other service providers must now grapple with the reality that their advice carries legal and ethical implications. For compliance officers, this means doubling down on preventive measures, promoting transparency, and ensuring accountability at every level.

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Career Can D0

Self-Reflection for Success with Elle Ballard

What if the key to unlocking your career success is your skills or experiences, the way you think, and the relationships you build? In this special episode of Career Can Do, we’re re-sharing an inspiring conversation from Elle Ballard’s podcast, Empowered Global Women in Business, where Elle, the host, speaks with Careers Can Do’s one and only – Mary Ann Faremouth. Mary Ann brings a wealth of knowledge on how mindset and connection shape the trajectory of our careers.

In this episode, Mary Ann shares how your mindset can propel you toward success or hold you back. She explains that success isn’t just about the tactical aspects of your job—it’s about believing in yourself, adjusting your thinking, and overcoming the barriers that often exist in your mind. “Your mindset determines your success,” Mary Ann states. “When you shift your thinking, you shift your outcomes.”

A big focus of the conversation is the importance of building meaningful relationships in your professional life. Mary Ann emphasizes that success isn’t just about what you know but who you know. “The power of relationships cannot be overstated,” she says. “A strong network can help open doors and guide you through tough situations.”

Resilience also plays a central role in this conversation. Mary Ann talks about how setbacks are inevitable in any career, but how you respond to them truly matters. “Resilience isn’t about avoiding failure—it’s about how you pick yourself up and move forward,” she explains.

Whether you’re looking to pivot to a new career path, strengthen your confidence, or overcome obstacles, this episode is packed with practical advice to help you thrive in today’s dynamic professional world. Mary Ann’s actionable tips, paired with Elle’s insightful questions, will leave you inspired and ready to take charge of your career with renewed focus.

Resources

Elle Ballard on the Web | Empowered Global Women in Business Podcast (Apple Podcasts) | LinkedIn

Mary Ann Faremouth on the  Web | X (Twitter)

Buy Mary Ann’s book – Revolutionary Recruiting: How The Faremouth Method Helps Job Seekers, Recruiters and Businesses Learn To Match People With Their Passions

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Riskology

Riskology by Infortal™: Episode 38 – 2024 Risk Highlights

Join hosts Dr. Ian Oxnevad and Chris Mason as they highlight the 2024 season of Riskology by Infortal.

The Growing Importance of Geopolitical Risk

In 2024, geopolitical risk has increasingly taken center stage in boardroom discussions. Companies are recognizing the complex interplay between global events and their business operations. Firms increasingly acknowledge the need to integrate geopolitical risk management into their corporate strategies and compliance programs.

Board members have also shown a growing interest in geopolitical risk, understanding that global events can have substantial knock-on effects on their operations. This shift is particularly vital given the recent impact of geopolitical events and conflicts worldwide.

By establishing dedicated teams and intelligence networks, firms are now better positioned to consider geopolitics in strategic decision-making and everyday operations. This shift in focus demonstrates that geopolitical risk management is no longer a niche concern but a critical element of corporate governance.

The Reality of Geopolitical Risk

Companies must be vigilant and adaptable, as geopolitical events directly affect global supply chains, market stability, and business continuity.

Establishing robust risk management frameworks that include geopolitical considerations is beneficial and necessary for navigating the current global risk landscape. The lessons learned in 2024 remind businesses to continuously update their risk assessments to reflect the ever-changing geopolitical environment.

The Importance of Risk Intelligence and Due Diligence 

An increasingly complicated global risk environment requires understanding your risk exposure and spotting emerging risks before they threaten your business.

This requires tapping into the right intelligence to unpack hidden risks.

This also means conducting due diligence, including geopolitical risk analysis, when making significant investment or operational decisions.

The Election Impact and the Surge of Populism

The election cycle of 2024 was one of the most dramatic and consequential in recent memory.

Over half the world went to the polls, with significant political shifts across various regions. In the Western Hemisphere, there’s been a notable surge in populism, driven by the perception that mainstream institutions and political bodies have fallen out of touch with the average citizen.

Post-election change is on the horizon, and it will impact geopolitics as new regulations, tariffs, and sanctions emerge.

International Trade and Supply Chains

As we transition into 2025, one of the critical questions centers around the stability and functionality of international trade and supply chains. The disruptions witnessed in recent years due to geopolitical tensions and global conflicts have necessitated reevaluating supply chain strategies.

The reshaping of global trade routes and supply chains due to geopolitical tensions has underscored the need for both nearshoring and reshoring. Nearshoring—moving production closer to home markets—offers numerous benefits. This trend is being driven by:

  • Cost Reductions: Savings on shipping and logistics.
  • Supply Chain Resilience: Mitigating risks associated with international disruptions.
  • Speed to Market: Faster delivery times and reduced lead times for new product launches.

Reshoring, bringing manufacturing back to the company’s original country, is also gaining traction. This is particularly relevant in industries facing stringent regulatory requirements or where operational control is critical. The economic landscape is visibly shifting, with governments incentivizing domestic production through subsidies and tax breaks.

Preparing for 2025 and Beyond

As we prepare for the economic and regulatory realities 2025, businesses must prioritize adaptability and foresight. Navigating this evolving landscape requires a proactive approach. As new geopolitical developments emerge, staying informed and prepared will be key to sustained success.

We hope you join us for the latest episode of Riskology by Infortal.

Read full show notes at Infortal Worldwide

Resources:

Infortal Worldwide

Email

Dr. Ian Oxnevad on LinkedIn

Chris Mason on LinkedIn

Categories
Corruption, Crime and Compliance

BIT Mining Resolves FCPA Case for $10 Million and CEO Pan Indicted

What happens when a Chief Executive Officer becomes the architect of a global bribery scheme? In this episode of Corruption, Crime, and Compliance, Michael Volkov delivers an in-depth analysis of the BIT Mining FCPA case — a landmark matter that underscores the severe consequences of C-suite misconduct. With CEO Zhengmin Pan at the center of the conspiracy, BIT Mining’s efforts to infiltrate Japan’s emerging casino market were built on fraudulent payments, sham contracts, and falsified financial records.

Michael examines the tactics used to conceal illicit payments, the role of Japanese authorities in uncovering the misconduct, and the broader implications for corporate compliance and executive accountability.

You’ll hear him discuss:

  • How BIT Mining’s former CEO, Zhengming Pan, supervised a $2 million bribery scheme targeting Japanese government officials to secure entry into Japan’s integrated resort (IR) market.
  • The tactics used to launder bribe payments include sham consulting agreements, inflated lecture fees, and misclassifying bribes as “management advisory fees” and “travel expenses” in company records.
  • The DOJ’s charges against Pan included conspiracy to violate the FCPA’s anti-bribery and books-and-records provisions, multiple counts of books-and-records violations, and substantive anti-bribery offenses.
  • The terms of Bit Mining’s three-year Deferred Prosecution Agreement (DPA) with the DOJ, which included an agreed-upon $10 million criminal penalty, were reduced from an initial $54 million based on the company’s inability to pay.
  • The SEC’s parallel enforcement action, which resulted in a $4 million civil penalty, was later credited against the DOJ’s settlement amount.
  • How did Japanese enforcement authorities play a crucial role in uncovering the scheme, and what ultimately led to Bit Mining’s failure to win the integrated resort bid?
  • Practical compliance takeaways for corporate boards and executive teams, including the importance of strong third-party due diligence, financial control safeguards, and executive oversight to prevent and detect misconduct at the top.

Resources:

Michael Volkov on LinkedIn | Twitter

The Volkov Law Group

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Daily Compliance News

Daily Compliance News: December 16, 2024 – The Not Paying Musk Edition

Welcome to the Daily Compliance News. Each day, Tom Fox, the Voice of Compliance, brings you compliance-related stories to start your day. Sit back, enjoy a cup of morning coffee, and listen in to the Daily Compliance News—all from the Compliance Podcast Network. Each day, we consider four stories from the business world: compliance, ethics, risk management, leadership, or general interest for the compliance professional.

  • McKinsey hit with $650MM for opioid work, fraud. (Reuters)
  • Not Paying Musk could cost Tesla $100MM. (FT)
  • Return to the Office (or else). (WSJ)
  • Another whistleblower was found dead. (BBC)

For more information on the Ethico Toolkit for Middle Managers, available at no charge, click here.

Check out the entire 3-book series, The Compliance Kids, on Amazon.com.

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All Things Investigations

All Things Investigations – Mike Huneke on Navigating Uncharted Waters: Compliance Strategy in a Changing Administration

Welcome to the Hughes Hubbard Anti-Corruption & Internal Investigations Practice Group’s podcast, All Things Investigation. In this podcast, host Tom Fox joined Mike Huneke to explore the impact of the recent election on corporate compliance and enforcement.

Key topics include the continuity of corporate enforcement, the focus on national security in anti-corruption efforts, and the implications of U.S. policies on business operations in China. The dialogue also highlights the importance of a holistic and multidisciplinary approach to risk management and the need for corporations to engage in public policy discussions proactively. Mike provides a nuanced perspective on how businesses can navigate the evolving regulatory environment through detailed analysis and real-world examples.

Key highlights:

  • Corporate Enforcement Trends
  • FCPA Enforcement Policies
  • China Policy and Business Implications
  • Holistic Risk Management Framework
  • Proactive Public Engagement

Resources:

Hughes Hubbard & Reed website

Mike Huneke

Categories
FCPA Compliance Report

FCPA Compliance Report – The Art of Influence and Leadership: Insights from Jennifer B. Gardner

Welcome to the award-winning FCPA Compliance Report, the longest-running podcast in compliance. In this episode, Tom welcomes Jennifer B. Gardner, a seasoned trial lawyer and expert in leadership and influence. She shares her unique professional journey, from running her law practice to becoming a master storyteller in the courtroom.

Jennifer delves into the importance of emotional intelligence, right-brain communication in influencing and persuading, and the necessity of understanding human psychology to lead and connect with diverse audiences effectively. Jennifer also sheds light on how these skills translate into the corporate compliance world, emphasizing the power of crafting messages that resonate emotionally and using simple, compelling language.

She offers practical tips on combining data with storytelling, understanding one’s audience, and developing resilience in high-pressure situations. Whether you are a compliance officer, lawyer, or business leader, Jennifer’s insights provide valuable strategies for becoming more influential and effective in your professional role.

Highlights in this episode:

  • Jennifer’s Journey into Law and Leadership
  • The Power of Influence in Law
  • Applying Influence in the Corporate World
  • The Art of Storytelling in Legal Cases
  • Somatics and Leadership
  • The Importance of Self-Awareness and Mindfulness
  • Exploring the Art of Influence Program

Resources:

Jennifer B. Gardner on LinkedIn

Gardner and Associates Law Firm

The Art of Influence

Tom Fox

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