BOSTON (Legal Newsline) - Purdue Pharma is asking a Massachusetts court to dismiss the state’s lawsuit against it, calling sensational allegations of wrongdoing by company executives and members of the founding Sackler family “oversimplified scapegoating based on a distorted account of the facts.”
The motion to dismiss, Purdue’s second, was filed Friday in response to an expanded complaint Massachusetts Attorney General Maura Healey filed against the OxyContin manufacturer in December. That 277-complaint generated headlines nationwide for claims that the Sackler family pulled billions of dollars from the company and “made choices that caused much of the opioid epidemic.”
Purdue said Massachusetts assembled its complaint by selectively quoting from millions of pages of documents the state obtained in discovery, while ignoring fundamental legal flaws with its case. The state is suing Purdue for violating its consumer laws by making allegedly false statements about the risk of addiction from OxyContin and for creating a public nuisance with its products.
But both claims are legally doomed by the fact Purdue sold 4% or less of the legal opioids in Massachusetts and illegal heroin and fentanyl account for most of the overdose deaths in the state, the company says.
Massachusetts Attorney General Maura Healey
The abuse crisis in Massachusetts can’t “be tied to one company that manufactures a tiny fraction of the prescription opioids” sold in the state, Purdue says in the 46-page motion.
Purdue, which is reportedly investigating bankruptcy protection from the claims against it, faces long odds against having the Massachusetts case dismissed in state court. U.S. District Judge Dan Aaron Polster in Ohio, who is overseeing federal multidistrict litigation against the opioid industry, has rejected similar arguments, as have judges in other states.
A Connecticut judge threw out lawsuits by four cities against opioid makers in January, calling them an attempt at “junk justice,” and a Delaware court last year dismissed public nuisance claims against the industry. But that court, while dismissing claims against pharmacies, recently allowed Delaware to continue suing drug distributors and manufacturers over allegedly improper marketing practices.
Massachusetts accuses Purdue of misleading prescribing physicians by distributing marketing materials that suggest OxyContin is less susceptible to abuse and addiction. The long-acting pills were designed to be more difficult to crush and heat into an injectable liquid, but Massachusetts cites internal documents showing Purdue executives and board members were long aware that the anti-abuse properties were being circumvented.
Purdue says one report cited by Massachusetts actually says a new formulation, with a polymer making the pills difficult to crush, averted thousands of cases of abuse. The drug is currently on Massachusetts’ Medicaid formulary, Purdue says.
“If the Commonwealth truly believed its own allegations, it certainly would not continue to cover Purdue’s opioid medications as a `brand preferred’ medication in its state-funded healthcare programs,” the company says.
Purdue argues Massachusetts is barred from suing it over marketing materials because its labeling is regulated by the Food and Drug Administration. The state consumer protection law contains an exemption for “actions otherwise permitted under laws as administered by any regulatory board” of the state or federal government.
OxyContin is still approved for long-term use, after 23 years and more than 30 labeling changes, the company says, and the current “black box” label warns physicians OxyContin poses “risks of addiction, abuse and misuse” and doctors should “monitor regularly for these behaviors and conditions.”
The complaint primarily accuses Purdue of improperly marketing its drugs for long-term therapy at high doses, an indication the FDA repeatedly has approved. In 2013, the agency rejected a citizen petition to limit the duration and daily dose of prescription opioids and also declined to require warnings about the risks of longer-term therapy and higher doses.
Purdue settled similar claims of marketing abuses with 27 states including Massachusetts in 2007, the company says, and Massachusetts never accused it of violating the terms of its consent agreement during a three-year monitoring period after the settlement. Purdue also operated under a five-year monitoring agreement with the federal government, which ended in 2013 without any further accusations of wrongdoing.
The company also attacks what it calls a broken chain of causation between the factory floor and the opioid addiction crisis. The Massachusetts Public Health Department found that 89% of opioid overdose victims tested positive for fentanyl and 34% had heroin in their system, meaning prescription opioids can’t be blamed for the bulk of opioid deaths, the company says. The Public Health Department also has said no single substance or practice is solely responsible for the opioid crisis, calling it “a complex issue with a number of contributing factors.”
“Under this theory of causation the Commonwealth seeks to hold Purdue liable for a whole host of alleged injuries far removed from a physician prescribing a Purdue medication,” the company says.
While Purdue has little likelihood of convincing a state court judge to dismiss claims based on broadly worded consumer protection statutes, it might have better luck with the public nuisance claims, which traditionally were restricted to cases in which the public was deprived of a general right - such as the right to travel freely on a public road. Judges in Delaware and Connecticut have dismissed similar public nuisance claims, with the Delaware judge noting last year “a clear national trend to limit public nuisance to land use.”