Source: United States Department of Justice Criminal Division
McKinsey & Company Inc. (McKinsey), a global management consulting firm based in New York, has agreed to pay $650 million to resolve a criminal and civil investigation into the firm’s consulting work with opioids manufacturer Purdue Pharma L.P. (Purdue). The resolution pertains to McKinsey’s advice to Purdue concerning the sales and marketing of Purdue’s extended-release opioid drug, OxyContin, including a 2013 engagement in which McKinsey advised on steps to “turbocharge” sales of OxyContin.
Today’s resolution marks the first time a management consulting firm has been held criminally responsible for advice resulting in the commission of a crime by a client and reflects the Justice Department’s ongoing efforts to hold actors accountable for their roles in the opioid crisis. The resolution is also the largest civil recovery for such conduct.
Additionally, a former McKinsey senior partner who worked on Purdue matters has been charged with obstruction of justice in federal court in Abingdon, Virginia. Martin E. Elling, 60, a U.S. citizen currently residing in Bangkok, Thailand, has been charged with one count of knowingly destroying records, documents and tangible objects with the intent to impede, obstruct and influence the investigation and proper administration of a matter within the jurisdiction of the Justice Department. Elling has agreed to plead guilty and is expected to appear in federal court in Abingdon to enter his plea and for sentencing at later dates.
As part of the government’s resolution with McKinsey, the company has entered into a five-year deferred prosecution agreement (DPA) in connection with a criminal Information filed in U.S. District Court for the Western District of Virginia against McKinsey’s U.S. subsidiary (McKinsey & Company Inc. United States, “McKinsey U.S.”). The information charges McKinsey U.S. with one felony count of knowingly destroying records, documents and tangible objects with the intent to impede, obstruct, and influence the investigation and proper administration of a matter within the jurisdiction of the Justice Department; and one misdemeanor count of knowingly and intentionally conspiring with Purdue and others to aid and abet the misbranding of prescription drugs, held for sale after shipment in interstate commerce, without valid prescriptions.
McKinsey has agreed to pay a penalty of over $231 million, a forfeiture amount of over $93 million (reflecting all money it was paid by Purdue from 2004 to 2019) and a payment of $2 million to the Virginia Medicaid Fraud Control Unit to resolve the criminal allegations. McKinsey also has entered into a civil settlement agreement in which it will pay over $323 million to resolve its liability under the False Claims Act for allegedly providing advice to Purdue Pharma L.P. that caused the submission of false and fraudulent claims to federal healthcare programs for medically unnecessary prescriptions of OxyContin, as well as allegedly failing to disclose to the U.S. Food and Drug Administration (FDA) conflicts of interest arising from McKinsey US’s concurrent work for Purdue and the FDA. This brings the total payments under the global resolution to $650 million.
Today’s filing includes a 71-page Agreed Statement of Facts, which provides a detailed account of McKinsey’s work with Purdue relating to OxyContin. As part of the resolution, McKinsey has agreed to implement a significant compliance program, including a system of policies and procedures designed to identify and assess high-risk client engagements. As part of this compliance program, McKinsey will implement new document retention procedures and training for all partners, officers and employees who provide or implement advice to clients. This compliance program is in addition to the provisions negotiated between McKinsey and the Department in a concurrent resolution with McKinsey & Company Africa that was announced on Thursday, Dec. 5.
McKinsey has also agreed that it will not do any work related to the marketing, sale, promotion or distribution of controlled substances during the five-year term of the DPA. The resolution requires McKinsey’s Managing Partner to certify, on an annual basis, the firm’s compliance with its obligations under the DPA and federal law.
“This global resolution shows the department’s commitment to holding accountable those who played key roles in fueling the opioid crisis,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “Consulting companies cannot advise their clients to break the law, and then skirt responsibility when their clients do so.”
“For the first time in history, the Justice Department is holding a management consulting firm and one of its senior executives criminally responsible for the sales and marketing advice it gave resulting in the commission of crime by a client,” said U.S. Attorney Christopher R. Kavanaugh for the Western District of Virginia. “This ground-breaking resolution demonstrates the Justice Department’s ongoing commitment to hold accountable those companies and individuals who profited from our Nation’s opioid crisis.”
“McKinsey schemed with Purdue Pharma to ‘turbocharge’ OxyContin sales during a raging opioid epidemic — an epidemic that continues to decimate families and communities across the nation. Today’s groundbreaking resolution makes clear our office’s commitment to holding powerful companies accountable for their part in the opioid epidemic, even if they did not make, sell, or dispense the drugs,” said U.S. Attorney Joshua Levy for the District of Massachusetts. “Consulting firms like McKinsey should get the message: if the advice you give to companies in boardrooms and PowerPoint presentations aids and abets criminal activity, we will come after you and we will expose the truth.”
“No amount of money can make-up for the devastating impact and heartbreaking loss of life the opioid crisis has inflicted on the people of Massachusetts, and our country. But today’s settlement is a sobering reminder that if you try to capitalize on a crisis by putting profits over patient safety — and then try to obstruct a federal investigation — you will pay a hefty price,” said Special Agent in Charge Jodi Cohen of the FBI Boston Field Office. “McKinsey is now being held criminally and financially accountable for devising an aggressive marketing strategy that was in reality a roadmap to boost sales of highly addictive opioids. Their actions resulted in powerful prescription painkillers being used in an unsafe, ineffective, and medically unnecessary manner. As both health care consumers, and taxpayers, this type of fraud negatively impacts all of us.”
“McKinsey’s management consulting work with Purdue Pharmaceuticals significantly contributed to a devastating public health crisis affecting American families and communities nationwide,” said Inspector General Christi A. Grimm of the Department of Health and Human Services Office of Inspector General (HHS-OIG). “HHS-OIG is committed to holding accountable those who violate the law and put the public at risk, including health care consultants who are complicit in fraudulent schemes.”
“Aiding and abetting in the potential misbranding and illegal distribution of controlled substances poses a danger to U.S. consumers,” said Special Agent in Charge George A. Scavdis of the FDA Office of Criminal Investigations Metro Washington Field Office. We will continue to investigate and bring to justice companies whose actions put profits over patient safety.”
“Today’s resolution holds this defendant accountable for its role in the aggressive marketing and promotion of opioids. Their actions led to medically unnecessary opioid prescriptions, which compromised the integrity of VA’s healthcare system that cares for our nation’s veterans,” said Department of Veterans Affairs (VA) Inspector General Michael J. Missal. “We thank our law enforcement partners for their diligent work in bringing this case to closure.”
“It shocks the conscience that a major consulting corporation would actively seek to increase the submission of fraudulent claims for medically unnecessarily opioid prescriptions in the midst of the opioid crisis,” said Inspector General Krista A. Boyd of the U.S. Office of Personnel Management Office of the Inspector General. “The outstanding efforts of our law enforcement partners and colleagues at the Department of Justice led to this ground-breaking result. We must hold accountable those who prey upon the most vulnerable Americans in the name of increased profits.”
As described in the DPA, McKinsey received credit for its cooperation with the United States in connection with the criminal investigation, including providing updates regarding information obtained through is internal investigation; highlighting documents of interest in voluminous productions; and facilitating interviews. McKinsey also engaged in extensive remedial measures, including voluntarily stopping all work in 2019 on any opioid-specific business issues; terminating two senior partners, including Elling, who communicated about deleting opioid-related documents concerning Purdue; hiring a new chief legal officer and chief ethics and compliance officer; significantly enhancing its new client selection framework; and deploying a formalized diligence review and intake process for all clients. McKinsey has agreed to continue to cooperate with the United States.
McKinsey’s Criminal Liability for Misbranding
The criminal misbranding charge was based on McKinsey’s advice to Purdue Pharma L.P. as set forth in the Agreed Statement of Facts filed today. Between 2004 and 2019, McKinsey contracted with Purdue on 75 different engagements in the United States. In 2007, a Purdue affiliate pleaded guilty to misbranding OxyContin, from 1996 through 2001, by falsely marketing it as less addictive, less subject to abuse and diversion, and less likely to cause dependence and withdrawal than other pain medications, and Purdue entered into a five-year corporate integrity agreement (CIA) with HHS-OIG. After the 2007 guilty plea, McKinsey partners maintained close contact with Purdue, and in 2009, worked with Purdue to enhance “brand loyalty” for OxyContin and protect market share. In 2010 McKinsey worked with Purdue to obtain FDA approval for a version of OxyContin that was reformulated with abuse-deterrent properties. Following the introduction of reformulated OxyContin in August 2010, OxyContin sales immediately began to decline. Purdue studied the drivers for this decline and attributed it, in large part, to a drop in prescriptions for individuals abusing OxyContin and increases in regulatory safeguards intended to hinder medically unnecessary prescribing of OxyContin.
In May 2013, Purdue retained McKinsey to conduct a rapid assessment of the underlying drivers of OxyContin performance, identify key opportunities to increase near-term OxyContin revenue and develop plans to capture priority opportunities. This 2013 effort was called Evolve to Excellence, or “E2E,” and included McKinsey advising Purdue on how to “turbocharge” the sales pipeline for OxyContin by, among other strategies, intensifying marketing to High Value Prescribers, included prescribers who were writing opioid prescriptions for uses that were unsafe, ineffective, and medically unnecessary. McKinsey consultants spoke with Purdue about the concerns and increasing reluctance of pharmacists and pharmacy chains to fill prescriptions for OxyContin as abuse of the drug rose. McKinsey consultants also went on several “ride-alongs” with Purdue sales representatives in the field, as these sales representatives called on prescribers and pharmacists. In notes about one of these ride-alongs, a McKinsey consultant wrote, in part, “Pharmacist; [had] a gun and was shaking; abuse is definitely a huge issue[.]”
In August 2013, McKinsey partners met with certain members of the Purdue Board of Directors (members of the family that controlled Purdue) to present McKinsey’s findings and proposal; as one McKinsey partner reported afterwards, “[b]y the end of the meeting the findings were crystal clear to everyone and they gave a ringing endorsement of ‘moving forward fast.’” McKinsey also described for Purdue the financial value at stake: “hundreds of millions, not tens of millions.”
For Purdue and McKinsey, E2E was a financial success. Their targeting of High Value Prescribers slowed OxyContin’s declining sales and kept Purdue’s profits flowing at the expense of public health. After the conclusion of McKinsey’s work for Purdue on E2E, McKinsey performed additional work with Purdue that also sought to maximize OxyContin sales by further targeting sales efforts to High Value Prescribers.
Obstruction of Justice by Former McKinsey Senior Partner
According to the charging documents filed today, Elling served as the Director of the client services team for approximately 30 of McKinsey’s engagements with Purdue. He had a senior, relationship-focused role with respect to the E2E engagement and was involved in securing the engagement for McKinsey. On July 4, 2018, Elling allegedly emailed another senior partner: “Just saw in the FT that [Purdue board member] is being sued by states attorneys general for her role on the [Purdue] Board. It probably makes sense to have a quick conversation with the risk committee to see if we should be doing anything other [than] eliminating all our documents and emails. Suspect not but as things get tougher there someone might turn to us.” According to court documents, forensic analysis of Elling’s McKinsey-issued laptop found that Elling in fact removed materials related to McKinsey’s work for Purdue from the laptop, as well as a Purdue-related folder from his Outlook email account.
Elling faces a maximum penalty of 20 years in prison, three years of supervised release and a fine up to $250,000 for the obstruction of justice charge. A federal district court judge will determine any sentence after considering the U.S. Sentencing Guidelines and other statutory factors.
False Claims to Federal Healthcare Programs
The department’s civil False Claims Act settlement resolves allegations that, from 2013 to 2014, McKinsey US, by advising Purdue to turbocharge OxyContin marketing to High Value Prescribers, some of whom were already prescribing very large quantities of OxyContin, as a means to increase OxyContin sales, and despite its awareness of the opioid crises, thereby knowingly caused false and fraudulent claims for OxyContin to be submitted to Medicare, Medicaid, TRICARE, the Federal Employees Health Benefit Program and the Veterans Health Administration.
Along with the civil settlement, McKinsey US entered into a five-year Corporate Integrity Agreement with HHS-OIG. The CIA, HHS-OIG’s first with a management consulting firm, contains novel obligations regarding risk assessment and quality control. First, the CIA requires McKinsey’s Compliance Committee to establish a robust risk evaluation process, evaluating engagement risks and providing quality oversight for certain client deliverables. Second, it requires McKinsey to establish a Quality Review Program to assess the quality of McKinsey’s advice to certain life sciences and health care clients with the dual goals of ensuring that McKinsey complies with applicable laws and does not provide or assist clients with plans, advice, or strategies that violate the law. HHS-OIG will select an independent Compliance Expert to review McKinsey’s systems and processes under the Quality Review Program and to review a sample of McKinsey client engagements, including the advice provided to those clients.
False Claims to FDA
The department’s civil False Claims Act settlement also resolves allegations that, from 2014 to 2017, McKinsey US knowingly misled the FDA by assigning consultants to concurrently work on both FDA projects and competitively sensitive Purdue projects, contrary to McKinsey US’ conflict of interest policy. While soliciting a contract from the FDA, McKinsey US represented to the FDA that it had a conflict-of-interest policy in which its consultants serving the FDA would not be assigned to a competitively sensitive project for a significant period of time following an assignment for FDA. The FDA then awarded McKinsey US the first in a series of contracts on a project relating to the monitoring of the safety of FDA-regulated products. McKinsey US admitted that it did not inform the FDA that its consultants worked on the Purdue projects around the same time those consultants also worked on the FDA project.
Assistant U.S. Attorney Randy Ramseyer for the Western District of Virginia; Assistant U.S. Attorneys Amanda P. Masselam Strachan and William B. Brady for the District of Massachusetts; Senior Trial Counsel Kristen M. Echemendia of the Civil Division’s Commercial Litigation Branch, Fraud Section; Trial Attorneys Jessica Harvey and Steven R. Scott of the Civil Division’s Consumer Protection Branch; and Special Assistant U.S. Attorneys and Assistant Attorneys General Kristin Gray and Kimberly Bolton of the Virginia Office of the Attorney General’s Medicaid Fraud Control Unit are prosecuting the criminal case against Elling and McKinsey.
The civil resolution was handled by Senior Trial Counsel Christopher Terranova of the Civil Division’s Commercial Litigation Branch, Fraud Section. The FDA Office of Criminal Investigations, FBI and Offices of the Inspector General of the Department of Health and Human Services, Department of Veterans Affairs and Office of Personnel Management investigated the case, with assistance from the Department of Justice’s Computer Crimes and Intellectual Property Section Cybercrime Lab.
The details contained in the charging documents and civil resolution are merely allegations. All defendants are presumed innocent until proven guilty beyond a reasonable doubt in a court of law.