By Jay K. Joshi, MD & Ron Chapman II, JD

Roughly a month ago, a prestigious consulting firm found itself, once again, in hot water for its involvement in allegedly contributing to the opioid crisis. We saw many of the same headlines competing for the top spot in our inbox.

“Justice Department is investing in an elite consulting firm.”

“Top management firm under criminal investigation.”

Beneath that, we saw a second layer of headlines, with a more scandalous tinge of corporate gossip.

“Former partner claims he was made opioids scapegoat.”

“The consulting firm advised drug companies how to turbocharge opioid sales.”

The headlines would have piqued more attention if we hadn’t heard them before. At the end of last year, the firm agreed to another settlement, this time with health insurers, for 78 million dollars. That’s on top of the 600 million dollars the consulting firm paid to American states in 2021 and the 280 million dollars paid to local municipalities in September 2023.

But this one is different. Now the consulting firm is being investigated criminally: Something that has been a long time in the making.

From the early 2000s until 2019, the firm worked with opioid manufacturers, as well as federal agencies like the FDA, on opioid-related projects. The extent of its involvement in the opioid crisis came to light in January 2019 through documents disclosed by the Massachusetts Attorney General in its litigation against Purdue Pharma.

These documents originated from the firm’s archives and are released based on the stipulations outlined in the settlement agreement.

In November 2021, just months after the settlement, the House Committee on Oversight and Reform reviewed the newly available documents and initiated an investigation. In April 2022, the Committee released a report revealing significant, years-long conflicts of interest, where the consulting firm would consult both federal regulators and opioid manufacturers, often at the same time, for similar opioid-related issues.

The report, though not intended to be part of any criminal prosecution, provides the mold for how the federal government will make its criminal case:

1.Detail elements of the business strategy that the firm used to advise its clients.

2. Emphasize the marketing elements, including discussions on sales.

3. Correlate the sales discussions with the rise in opioid prescriptions.

We have seen this formula used by different state attorneys general offices when they filed complaints against the consulting firm. In California, the state focused on the firm’s targeting and rewarding high-volume opioid prescribers. In Washington state, the complaint focused on deceptive marketing tactics, branding the firm as a corporate stooge for Purdue Pharma.

The complaints are based on multiple questionable stipulations:

1. Opioid manufacturers promoted a product that was more harmful than good because, in their estimates, the risk of addiction outweighed the benefits of pain management.

2. Opioids are not effective for long-term chronic pain.

3. A rise in prescription opioids portends a rise in opioid-related overdose deaths.

The three points, when taken together, imply the following: Had the consulting firm adhered to ethical business practices, which include regulatory compliance with the law, it wouldn’t have advised its clients the way it did.

But these points aren’t entirely true in the clinical sense. Prescription opioids hold tremendous value for select patients with long-term pain. True, they shouldn’t be first-line treatment for either acute or chronic pain, but they have clear clinical benefits. The CDC acknowledges this and developed practical guidelines after conducting systematic reviews of the best available evidence on the benefits and risks of prescription opioid treatments.

This is the crux of the matter. Federal prosecutors have little clinical evidence to substantiate any criminal investigation. So, they make the case for criminal misconduct using the documentation as evidence—effectively stating that a failure to maintain regulatory compliance is a crime.

They cannot prove the direct correlation between prescription opioids and overdose deaths. In fact, none of the complaints include any clinical evidence that prescription opioids cause unilateral harm. Nor do they detail whether the firm advised its clients to violate state or federal prescribing laws.

That’s the point. It’s the insinuation that prescription opioids are a uniquely harmful product that creates the pretense of criminality in the documents. Criminal cases are immensely complex. But most come down to two key concepts:

1. Mens rea

2. Actus reus

Mens rea refers to criminal intent. It’s the literal translation from Latin for guilty mind. Actus reus refers to the specific criminal act or an omission that would then comprise the elements of a crime: Intent and act.

Therefore, despite all the sensationalization, the case will be decided in a much more mundane way: Through the firm’s compliance system.

The prosecution will identify certain actions, such as the deletion of emails or the years-long history of undisclosed conflicts of interest, as actions that substantiate a particular intent or a criminal state of mind.

It’s the most straightforward argument, and there’s legal precedent – namely, the litany of previous opioid settlements and prior guilty pleas from other corporate entities.

The precedent that most accurately predicts the government’s strategy comes from a 2020 civil case filed by the Department of Justice against Wal-Mart. The case claims Wal-Mart didn’t do enough to stop the fulfillment of suspicious prescription opioid orders. Like most of the litigation at that time, it eventually led to a settlement, but the legal arguments presented by the federal government were telling.

The government characterized prescribing opioids as a closed system. This means all entities involved in the manufacturing, distributing, prescribing, and dispensing of prescription opioids must register with the Drug Enforcement Agency (DEA). As part of that registration process, certain stipulations must be met.

Distributors must detect and report suspicious orders.

Failure to report suspicious orders subjects the distributor to civil penalties.

In a closed system, liability spreads to consulting firms. Prosecutors will use this framework to argue that the firm deliberately engaged in criminal behavior by failing to warn its clients and the public about the dangers of its consulting work.

The consulting firm’s defense rests on the argument that the firm acted in good faith and provided honest consulting advice using the available clinical evidence and similar consulting procedures across all clients, regardless of whether the project involved opioids. It’ll argue that a conviction requires specific criminal actions, not simply the speculation that arises from not acting in a way that can be retroactively construed as criminal.

In other words, the legal argument will be based on its compliance system—the mundane, esoteric bookkeeping and data recording that everyone from physicians to administrators abhors.

Sure, there’ll be plenty of scandal and intrigue. But set that aside; that’s just noise. The core legal arguments boil down to compliance requirements and who fell short and why.

1. How do you define criminal actions that would fit the legally accepted definition of criminal intent as it applies to opioid litigation?

2. Do these actions have to be actual acts that occurred, or can they also be acts that did not occur but should have?

3. How much of a deviation is permissible while remaining within the bounds and the intent of the compliance system?

How prosecutors and legal representatives for the firm wrestle with these three questions will determine how the legal case proceeds. How the courts ultimately answer these questions will determine the fate of this once prestigious consulting firm.