Purdue Frederick: The Sales Pitch Its Own Evidence Contradicted

In the Purdue Frederick OxyContin misbranding case, the company and three top officers agreed to pay $634,515,475 over false claims that OxyContin was less addictive, less subject to abuse and less likely to cause withdrawal than other pain medicines. The May 10, 2007 resolution reached from the sales pitch to the people responsible for stopping it. Patients received prescriptions shaped by false safety claims, and Medicaid and other public health programs paid for them.

OxyContin Reached the Market in 1996

Purdue Frederick introduced OxyContin in 1996 as an extended-release form of oxycodone. The product offered long-acting pain relief. The promotion went further, presenting the drug as carrying less risk of addiction and abuse than other pain medications.

The commercial appeal was clear before the launch. In testimony to the Senate Judiciary Committee, the United States Attorney described Purdue’s 1995 focus groups with primary care physicians and surgeons. Doctors were reluctant to prescribe the drug for non-cancer pain because of addiction, side effects and abuse. They wanted a long-lasting pain reliever with fewer of those risks. Purdue marketed the reassurance they wanted.

The Justice Department’s October 2018 account of the case reports approximately $2.8 billion in OxyContin revenue from January 1996 through June 30, 2001. The sales claim that helped open that market was the claim the company later admitted was fraudulent.

What Purdue Told Doctors About Addiction

The charges described promotion from December 1995 through June 2001 that presented OxyContin as less addictive, less subject to abuse and diversion, and less likely to cause tolerance and withdrawal than other pain medicines. The company’s sales training carried the message into doctors’ offices.

According to the government’s account of the agreed facts, Purdue trained sales supervisors with graphs that exaggerated the differences between OxyContin’s blood levels and those of immediate-release opioids. Representatives used similar graphs in role-play training. The supposed difference in blood levels became a claim of less euphoria and less potential for abuse.

The package insert supplied another opening. Sales representatives treated its statement about delayed absorption reducing abuse liability as permission to say the drug produced no euphoria, had less addiction potential and was less likely to be diverted. The insert was later amended to qualify the statement: it applied when the tablets were used properly for pain management. Purdue continued the same marketing. The release’s account of the supervisors’ instructions is direct:

The company also trained representatives to say that extracting oxycodone from the tablets for intravenous abuse was more difficult. Its own study showed that approximately 68% of the oxycodone could be extracted from a single 10 mg tablet. The information inside Purdue and the reassurance reaching prescribers were moving in opposite directions.

Supervisors and employees also knew that many doctors incorrectly believed oxycodone was weaker than morphine. They did not want promotional materials, publications, meetings or communications with the sales force to disturb that belief.

Withdrawal Reports Met a Marketing Decision

Purdue used a medical-journal article to promote abrupt discontinuation at lower doses even after receiving information about possible withdrawal. The government’s account follows the information from the study to the sales force.

In 1999, Purdue received an analysis identifying eight osteoarthritis-study patients with symptoms possibly related to opioid withdrawal. That analysis said some patients became physically dependent and that abrupt withdrawal should be avoided.

The article appeared on March 27, 2000. By May, Purdue had received a patient’s report of withdrawal when trying to stop the drug, and executives learned that similar questions were coming into Medical Services. On June 26, each sales representative received the article and a marketing tip for using it to achieve sales success. Representatives distributed it to suggest that patients taking less than 60 milligrams a day could always stop abruptly without withdrawal symptoms.

A further review in February 2001 identified eleven study patients with adverse experiences possibly connected to withdrawal during breaks in treatment. On March 28, supervisors and employees decided against writing up the findings because they feared it might “add to the current negative press.”

The article had a route to every sales representative. The contrary findings met a decision not to write them up. That is a concrete distinction a clinical or regulatory affairs employee can recognize: what the company learned, what it passed to the field and what it chose to leave there.

The United States Attorney described warnings arriving from the field itself:

What the Company and Officers Agreed to Pay in 2007

Purdue Frederick pleaded guilty on May 10, 2007 to felony misbranding with intent to defraud and mislead. Its three officers pleaded guilty to misdemeanor misbranding. The pharmaceutical fraud resolution combined company payments, individual payments and a civil settlement over government healthcare claims.

The company’s share was approximately $600 million. That included $276.1 million forfeited to the United States and $160 million to federal and state agencies to resolve false claims made to Medicaid and other government healthcare programs.

The officers collectively gave up approximately $34.5 million in compensation, as the appeals court later described it. Each also faced a $5,000 criminal fine. These were payments by the executives themselves, separate from the company’s obligations.

The civil settlement also excluded Purdue Frederick from federal healthcare programs for 25 years. Corporate identity mattered: the prosecutor’s July 31, 2007 Senate testimony said Purdue Pharma would continue marketing OxyContin under a five-year corporate integrity agreement requiring compliance measures and independent reviews. The excluded company and the business continuing to market the drug were different entities.

The Officers Had Authority to Stop the Promotion

The president and chief executive, chief legal officer and former chief medical officer admitted responsibility for failing to prevent or promptly correct Purdue’s fraudulent marketing. Their misdemeanor pleas rested on their authority over the business, without requiring proof that each personally knew about or participated in the deception.

That distinction matters when discussing the responsibility of pharmaceutical executives. The company admitted intentional fraud. The officers admitted a failure to use their authority to prevent or correct it. Those are different admissions, and neither makes every employee who followed a sales instruction the person who designed the scheme.

Public Citizen’s 2018 study, Twenty-Seven Years of Pharmaceutical Industry Criminal and Civil Penalties: 1991 Through 2017, found that financial sanctions against executives were rare. It identified the Purdue settlement as an exception to the generally small individual fines.

The Officers’ Exclusion Appeal in 2012

On July 27, 2012, the appeals court upheld the government’s authority to exclude the three officers from federal health programs but required a new explanation of the exclusions’ length. The exclusions had begun at 20 years, then fallen to 15 and finally 12 during the administrative appeal.

What Evidence Is Needed to Prove Fraud?

In its opinion, the appeals court explained that Purdue’s misrepresentations led some doctors to prescribe OxyContin when they otherwise would have prescribed a different medicine or none at all. Federal and state health programs paid for some of those prescriptions.

Training graphs, instructions from supervisors, study reviews and messages to Medical Services show different parts of that chain. A sales representative or medical liaison may recognize the company’s pitch and know where a warning went. We examine who planned and directed the conduct and what an employee was instructed to do. If your own work included carrying out those instructions, speak with our experts about your role and the case you may be able to bring.

Public Citizen’s Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 to 2010, published in 2010, found that former pharmaceutical employees and other whistleblowers initiated the largest number of federal settlements during the preceding decade. The view from inside a sales operation can matter far beyond one prescription.

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

What Followed in the 2020 Purdue Pharma Case

On November 24, 2020, Purdue Pharma pleaded guilty to fraud and kickback conspiracies. The later case reached conduct after the Purdue Frederick resolution: payments to two doctors through the company’s speaker program between June 2009 and March 2017 to induce more opioid prescriptions, and payments to an electronic health-records company to encourage orders for Purdue’s opioids.

The later plea concerned different conduct and a different Purdue entity. The earlier payment and compliance agreement had not ended the opioid misconduct.

You Know What the Sales Force Was Told

If you saw a drug’s risks disappear between the study findings and the sales pitch, talk to our whistleblower experts. We build the case with you around who knew, who directed the promotion and where public money paid for it, and bring in pharmaceutical whistleblower lawyers who understand drug-marketing cases. We stay beside you through the pursuit of the recovery.