Purdue Pharma's 2007 criminal misbranding case
DopesickPurdue Pharma's 2007 criminal misbranding case brought the company and three top executives to sentencing over OxyContin's promotion, but the resolution was narrower than the federal case prosecutors had initially considered. The episode joined evidence about what regulators had been told before approval to a contest over how far the government would pursue corporate and executive accountability.
Evidence Before the Case
The record described in the book reaches back to the U.S. Food and Drug Administration's 1995 review of OxyContin. Although Purdue Pharma later claimed it had not known of the drug's abuse problems until February 2000, the New Drug Application review, signed by examiner Curtis Wright, noted that crushing a tablet could release the drug immediately rather than gradually. It also recorded withdrawal symptoms during clinical trials and found that 68 percent of the oxycodone in one crushed tablet could be recovered when liquefied for injection. These details formed a stark contrast with the company's later account of when it learned of the risks; they are presented as evidence in the history of the controversy, not as findings of the eventual plea agreement.
Wright's approval summary urged caution in promotional materials, but the book says that caution was not reflected in Purdue Pharma's marketing. Two years after the approval, Wright went on to work as a consultant for the company. The sequence added questions about oversight and the movement of personnel between regulator and industry to the case's larger context, without itself establishing the terms or outcome of the criminal prosecution.
The Investigation and Its Narrowing
By the fall of 2006, prosecutors' case had raised the prospect of felony charges against Purdue Pharma and its senior executives, not only for misbranding but also for mail fraud, wire fraud, and money laundering. A memo to U.S. Attorney John Brownlee reflected the seriousness of that possibility. The case's scope and potential penalties, however, diminished as it moved through the United States Department of Justice. An observer connected to the case attributed that narrowing in part to lobbying by Purdue Pharma's representatives, including Rudy Giuliani. During negotiations, Purdue Pharma initially offered $10 million, while the government's initial proposal was $1 billion.
Pressure on Brownlee had surfaced earlier. In 2005, Purdue Pharma's lawyers contacted then–Deputy Attorney General James Comey to challenge Brownlee's investigative tactics. Comey raised concerns with Brownlee, who drove to Washington to explain his strategy; Comey then told him to return to Virginia and continue the case. The episode showed that the investigation was being contested within the federal apparatus as well as between prosecutors and the company's lawyers.
The Deadline and the Plea
The decisive pressure came in October 2006, on the night before the plea agreement was due to expire. At a Purdue Pharma lawyer's request, a senior Justice Department officer telephoned Brownlee at home and urged him to extend the deadline, which would have given the company more time before it faced charges. Brownlee refused further delay. Later that night, Purdue Pharma accepted the agreement rather than risk more serious charges or a jury trial in western Virginia, where the drug's problems had become widely known.
The acceptance did not end scrutiny of the negotiations. Eight days later, Brownlee saw his name on a list of U.S. attorneys slated for dismissal, alongside four others. He was not ultimately fired, but the episode intensified criticism of then–Attorney General Alberto Gonzales and concerns that the work of U.S. attorneys' offices might be subject to political influence. The book identifies Mary Jo White, a former Manhattan U.S. attorney and lawyer for Howard Udell, as the person who had pressed a Justice Department official for more time on Purdue Pharma's behalf. Brownlee later described the attempted influence in a Senate hearing about the case.
In 2007, Purdue Pharma and three of its top executives were sentenced for criminal misbranding. That outcome established a criminal resolution, but it did not include the full range of charges prosecutors had contemplated during the investigation. The difference between the initial exposure of the case and its final scope is central to the episode: the plea concluded the prosecution while leaving open arguments about whether the government's response had matched the scale of the controversy.
Aftermath and Wider Accountability
The book places the case within a wider struggle over responsibility for the opioid crisis. Eight years after the 2007 sentencing, lawsuits against Purdue Pharma and other opioid manufacturers and distributors were accumulating. Plaintiffs included Everett, Washington; the state of Ohio; Cabell County, West Virginia; and Dickenson County, Virginia. West Virginia and Kentucky had already obtained settlements of $10 million and $24 million, respectively. The comparison with tobacco litigation was tempting, but the book stresses a material difference: opioids have legitimate medical uses when prescribed and used correctly, a distinction that complicated efforts to hold manufacturers accountable for widespread harm.
Separate investigations also widened scrutiny of the institutions surrounding opioid prescribing. Reporting by John Fauber exposed private annual meetings between FDA regulators and pharmaceutical executives, held through an industry-funded nonprofit, and the development of enriched enrollment, a method that could exclude trial participants who did not respond well to a drug. Fauber's reporting also examined pain advocacy groups' support for expanded long-term opioid use while receiving millions from drug companies. A 2012 Senate investigation targeted the American Pain Foundation and Purdue Pharma, among others, but its findings remained sealed in the Senate Finance Committee's office. These developments were not adjudicated as part of the 2007 plea; they show how questions about corporate conduct and regulatory safeguards continued after the criminal case closed.
That continuing debate unfolded amid a crisis experienced by families across Roanoke and beyond, where the book follows loved ones through addiction, rehabilitation, prison, recovery, and relapse. It also exposes an uneven boundary between public-health language and criminal enforcement: calls that society could not arrest its way out of the epidemic were more readily applied to mostly white opioid users than to Black and brown people arrested for selling drugs. The case therefore sits at the intersection of corporate accountability and a broader response that treated the makers of a widely prescribed drug, its users, and its sellers through sharply different systems of judgment.