Purdue Pharma's Illegal Activities: Breaking The Law

Purdue Pharma, the company behind the powerful prescription painkiller OxyContin, pleaded guilty to federal criminal charges as part of an $8 billion settlement with the Justice Department. The deal does not release any of the company's executives or owners—members of the wealthy Sackler family—from criminal liability, and a criminal investigation is ongoing. The company will plead guilty to three counts, including conspiracy to defraud the United States and violating federal anti-kickback laws. Purdue has also agreed to a civil settlement of $2.8 billion to resolve its civil liability under the False Claims Act. The Sackler family has agreed to pay $225 million in damages to resolve its civil liability.

Purdue Pharma misled the public about the addictiveness of OxyContin

Purdue Pharma LP, formerly the Purdue Frederick Company, is a privately held pharmaceutical company that manufactures pain medicines such as hydromorphone, fentanyl, codeine, hydrocodone, and oxycodone, also known by its brand name, OxyContin.

Purdue Pharma has been accused of misleading the public about the addictiveness of OxyContin and has faced a series of lawsuits as a result. In 2007, the company paid out one of the largest fines ever levied against a pharmaceutical firm for misleading the public about how addictive OxyContin was compared to other pain medications.

In 2001, Purdue Pharma's former president, Richard Sackler, asked people gathered for the launch of OxyContin to envision natural disasters like an earthquake, a hurricane, or a blizzard. He said that the debut of OxyContin would be followed by "a blizzard of prescriptions that will bury the competition".

Five years later, as questions were raised about the risk of addiction and overdoses associated with OxyContin and other opioid medications, Sackler outlined a strategy to divert blame onto others, particularly those who became addicted to opioids. In an email from February 2001, he wrote, "We have to hammer on the abusers in every way possible. They are the culprits and the problem. They are reckless criminals."

Purdue Pharma trained its sales representatives to convey to doctors that the risk of addiction from OxyContin was "less than one percent." The company also cited studies that, although providing some insight on the risk of addiction for acute pain, did not establish the risk of iatrogenic addiction when opioids are used daily for a prolonged time to treat chronic pain.

In May 2007, Purdue Frederick Company Inc, an affiliate of Purdue Pharma, along with three company executives, pled guilty to criminal charges of misbranding OxyContin by claiming that it was less addictive and less subject to abuse and diversion than other opioids. The company agreed to pay $634 million in fines.

In October 2020, Purdue agreed to an $8 billion settlement that included a $2 billion criminal forfeiture, a $3.54 billion criminal fine, and $2.8 billion in damages for its civil liability. The company pleaded guilty to three criminal charges and will become a public benefit company under a trust that is required to consider American public health.

Purdue Pharma's misleading marketing of OxyContin as a drug with a low risk of addiction has had devastating consequences. From 1999 to 2020, nearly 841,000 people died from drug overdoses in the United States, with prescription and illicit opioids responsible for 500,000 of those deaths.

The company paid doctors to induce them to prescribe more OxyContin

Purdue Pharma LP, formerly the Purdue Frederick Company, was an American privately held pharmaceutical company founded by John Purdue Gray in 1892. The company manufactured pain medicines such as hydromorphone, fentanyl, codeine, hydrocodone, and oxycodone, also known by its brand name, OxyContin.

OxyContin was released in 1996 after Curtis Wright, an employee of the Food and Drug Administration (FDA), approved its use on a 12-hour dosage cycle. Purdue aggressively marketed OxyContin, persuading doctors to prescribe it in particular. The company enticed doctors with free trips to pain-management seminars (which were effectively all-expenses-paid vacations) and paid speaking engagements.

Purdue Pharma paid doctors through its speaker program to induce them to write more prescriptions for its opioid products. Between June 2009 and March 2017, Purdue made payments to two doctors through this program. The company also paid kickbacks to Practice Fusion Inc., an electronic health records company, in exchange for recommending and arranging for the ordering of its extended-release opioid products, including OxyContin.

Purdue's aggressive marketing and promotion of OxyContin contributed to a nearly tenfold increase in prescriptions for less serious pain. From about 670,000 in 1997, prescriptions rose to about 6.2 million in 2002. The company's internal data showed that these prescriptions led to a 60% increase in patients staying on OxyContin for longer than 90 days.

In 2019, Massachusetts Attorney General Maura Healey filed a lawsuit against Purdue Pharma, claiming that the company had a "deceptive sales campaign" and had "micromanaged" it. The lawsuit also alleged that Purdue Pharma was personally responsible for the deceptive sales practices of eight members of the Sackler family, who owned the company.

Purdue Pharma impeded the DEA by misrepresenting its anti-diversion program

Purdue Pharma LP, the company that manufactures OxyContin, pleaded guilty to impeding the Drug Enforcement Administration (DEA) by misrepresenting its anti-diversion program. This was part of a settlement of over $8 billion with the US Justice Department, which was announced on October 21, 2020.

From May 2007 through at least March 2017, Purdue Pharma misled the DEA by claiming to have an effective anti-diversion program in place. During this time, the company continued to market its opioid products to over 100 healthcare providers who they had reason to believe were diverting opioids. Purdue also reported misleading prescription data to the DEA to boost its manufacturing quotas. This included prescriptions written by doctors that Purdue believed were engaged in diversion.

Purdue Pharma admitted that it had:

> "conspired to defraud the United States by impeding the lawful function of the DEA by representing to the DEA that Purdue maintained an effective anti-diversion program when, in fact, Purdue continued to market its opioid products to more than 100 health care providers whom the company had good reason to believe were diverting opioids and by reporting misleading information to the DEA to boost Purdue’s manufacturing quotas."

The misleading information reported to the DEA included prescription data from doctors that Purdue believed were engaged in diversion. This enabled Purdue to facilitate the dispensing of its opioid products, including OxyContin, without a legitimate medical purpose and, therefore, without lawful prescriptions.

As a result of these actions, Purdue Pharma admitted to conspiring to defraud the United States and violating the Food, Drug, and Cosmetic Act. The company agreed to plead guilty to three criminal charges, including one count of dual-object conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetic Act, and two counts of conspiracy to violate the Federal Anti-Kickback Statute.

The company paid kickbacks to Practice Fusion Inc

Purdue Pharma LP, the manufacturer of OxyContin, has been at the center of several lawsuits and criminal investigations relating to its role in the opioid epidemic. In 2020, the company agreed to plead guilty to three criminal charges, including conspiracy to defraud the United States and violating federal anti-kickback laws.

As part of the resolution, Purdue admitted to conspiring to violate the Federal Anti-Kickback Statute by making payments to two doctors through its speaker program to induce them to write more prescriptions for its opioid products.

Between April 2016 and December 2016, Purdue made payments to Practice Fusion Inc., an electronic health records company, in exchange for referring, recommending, and arranging for the ordering of Purdue's extended-release opioid products, OxyContin, Butrans, and Hysingla. Purdue shelled out roughly $1 million in payments to Practice Fusion, which solicited and received kickbacks from the company.

Practice Fusion admitted to adding clinical decision support alerts in its software to increase opioid prescriptions. The company would receive "sponsorship payments" from pharmaceutical companies, which influenced the development and implementation of the CDS alerts. Healthcare providers that used the EHR software wrote prescriptions based on these alerts between 2014 and 2019. The alert on the Practice Fusion platform was triggered 230 million times from July 2016 until the spring of 2019.

The case against Practice Fusion represented the largest criminal fine in federal court history in Vermont, and it was the first-ever criminal action against a vendor of EHRs. Practice Fusion agreed to pay $145 million to resolve criminal and civil allegations, including $26 million in criminal fines and forfeiture, and $118.6 million in separate civil settlements.

Purdue Pharma aided and abetted violations of the Food, Drug, and Cosmetic Act

On October 21, 2020, the Department of Justice announced that Purdue Pharma had agreed to plead guilty to three federal criminal charges, including one count of dual-object conspiracy to defraud the United States and to violate the Food, Drug, and Cosmetic Act. This came as part of a settlement of over $8 billion, which included a criminal fine of $3.54 billion and $2 billion in criminal forfeiture.

From May 2007 through at least March 2017, Purdue conspired to impede the lawful function of the Drug Enforcement Administration (DEA). The company falsely represented to the DEA that it maintained an effective anti-diversion program, when in fact, it continued to market its opioid products to over 100 healthcare providers who were diverting opioids. Purdue also aided and abetted violations of the Food, Drug, and Cosmetic Act by facilitating the dispensing of its opioid products, including OxyContin, without a legitimate medical purpose and thus, without lawful prescriptions.

Purdue admitted that it had marketed and sold its opioid products to healthcare providers, even though it had reason to believe that these providers were diverting them to abusers. The company also lied to the DEA about its anti-diversion program, fraudulently increasing the amount of its products it was permitted to sell.

Purdue's actions had severe consequences, contributing to a national tragedy of addiction and deaths. The company's conduct was driven by greed, prioritising money over the health and well-being of patients.

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