Acting New York State Attorney General Barbara Underwood. Photo: David Handschuh/NYLJ

New York state is suing Purdue Pharma for allegedly misleading prescribers and patients about the risks associated with opioids, including their addictive nature.

The lawsuit, filed in Suffolk County Supreme Court on Tuesday, claims Purdue's actions have contributed to the ever-growing opioid epidemic in New York.

Underwood is seeking to have Purdue disgorge any profits it's made through its allegedly deceptive marketing strategies, and pay restitution and damages to the state. The company would also pay at least $15,000 in civil penalties and change the way it markets opioids.

“Through its actions, Purdue and its owners obtained billions of dollars in profits, at the cost of lost lives and tens of billions of dollars in devastation inflicted on communities that are now awash in opioids and their ill effects,” the lawsuit said. “Purdue now must pay penalties and damages to the state of New York for its unlawful conduct, disgorge its ill-gotten gains, and abate the resulting harm inflicted throughout New York.”

The legal action stems from an ongoing investigation by the state and other governmental entities, according to the complaint. The lawsuit claims Purdue downplayed the risk of addiction associated with the opioids it marketed, including how addictive they are and the dangers associated with that addiction.

A top official at Purdue coined the term “pseudoaddiction” for a person's drug-seeking behavior after being prescribed opioids, for example, according to the complaint. The company called that “pseudoaddiction” because it claimed the patient was seeking more opioids for lasting pain, not because of an actual addiction, the lawsuit said.

“Purdue persisted in promoting its drugs to treat patients with these drug-seeking behaviors, arguing that most of them were experiencing pseudoaddiction related to undertreatment of pain—which could only be remedied by more of Purdue's opioids,” the lawsuit said. “Purdue effectively encouraged medical providers to ignore the hallmarks of actual addiction.”

The allegedly deceptive marketing practices continued after Purdue faced enforcement actions from state and federal officials, the complaint said. The company entered into a global criminal, civil and administrative settlement with the federal government in 2007 for $635 million over misleading marketing activities, according to the complaint. Purdue also entered into an agreement with New York in 2015 in which it pledged stronger oversight of its sales representatives, signs of abuse, and inappropriate prescribing methods, Underwood's office said.

The lawsuit claims the company continued to aggressively market its opioids through in-person visits to health care providers and facilities despite those agreements. Purdue made more than 114,000 visits in New York between August 2015 and December 2017 alone, according to the complaint.

Purdue said in a statement Tuesday that it acted appropriately by communicating with prescribers about the opioids it sells.

“We vigorously deny the state's allegations. The state claims Purdue acted improperly by communicating with prescribers about scientific and medical information that FDA has expressly considered and continues to approve,” Purdue said. “We believe it is inappropriate for the state to substitute its judgment for the judgment of the regulatory, scientific and medical experts at FDA.”

The broad claim the state made in the complaint is that Purdue has behaved negligently through its marketing practices, which have resulted in significant harm to New York's residents, sometimes resulting in death. Underwood said in a statement that Purdue has unjustly profited from a product that has endangered the public.

“Our investigation found a pattern of deception and reckless disregard for New Yorkers' health and wellbeing—as Purdue lined its own pockets by deliberately exploiting our communities and fueling an opioid epidemic that's destroyed families across the state,” Underwood said. “We're now holding Purdue to account for this reprehensible and illegal conduct. Our work won't stop with this lawsuit: our office will continue to lead the multistate investigation of opioid manufacturers and distributors across the country.”

Purdue also said in its statement that it recognizes the opioid crisis and offered to work with the state on solutions to address it. 

“We share the state's concern about the opioid crisis. While our opioid medicines account for less than 2 percent of total prescriptions, we will continue to work collaboratively with the state toward bringing meaningful solutions to address this public health challenge,” Purdue said.