On November 24, 2020, Purdue Pharma LP pleaded guilty to allegations that it conspired to defraud the government and violate the anti-kickback statute. Purdue pleaded guilty to three felony charges: one count of dual-object conspiracy to defraud the United States and to violate the Food, Drug and Cosmetic Act (FDCA), and two counts of conspiracy to violate the Federal Anti-Kickback Statute.
Purdue admitted that it marketed and sold opioid products to healthcare providers when it knew that the products were being diverted to opioid abusers, and it further admitted that it lied to the Drug Enforcement Administration (DEA) about anti-diversion programs the company had implemented. Specifically, Purdue admitted that from May 2007 to at least March 2017, Purdue impeded the lawful function of the DEA by reporting misleading prescription data to boost Purdue’s manufacturing quotas. The conspiracy also involved facilitating the dispensing of Perdue’s opioid products, such as OxyContin, without a legitimate medical purpose, which constitutes aiding and abetting violations of the FDCA.
Purdue also admitted that it violated the Federal Anti-Kickback statute. From June 2009 to March 2017, Purdue paid doctors under the guise of a speaker program to induce those doctors to write more prescriptions for Purdue’s opioid products. Additionally, from April to December 2016, Purdue paid an electronic health records company to refer, recommend, and arrange for the ordering of Purdue opioid products.
According to the DOJ press release, the plea agreement imposes the largest penalty ever levied against a pharmaceutical manufacturer, including a criminal fine of $3.544 billion and an additional $2 billion in criminal forfeiture. Separately, Purdue agreed to pay $2.8 billion to resolve its civil liability under the False Claims Act. Notably, the criminal release extends only to Purdue; it does not release any individuals from potential criminal liability. None of the company’s executives or employees are receiving civil releases either. The guilty plea follows the resolution of DOJ’s criminal and civil investigations that was announced in October 2020 and about which Chilivis Grubman attorneys have written previously.
The attorneys at Chilivis Grubman represent both companies and individuals in connection with criminal and civil government investigations, particularly those related to allegations of healthcare fraud and abuse. If you have any questions related to such matters, please contact us today.