Part of America’s “War on Opioids”, the battle against opioid...

Part of America’s “War on Opioids”, the battle against opioid manufacturers, is escalating.

As of June 2018, there were more than 600 US state, county, and city governments that have filed opioid-related lawsuits. And although the federal government has yet to file a claim, it has formally declared that it has a financial interest in the case. Some filings have named multiple opioid manufacturers, others have included health networks, distributors, retail pharmacies and medical practices and some have targeted just Purdue. The hundreds of city and county suits have been drawn together to be heard by one federal judge in a Cleveland court. However, the states are not required to participate in this process. Forty-one states have been separately exploring their options for compensation and approximately twenty four of these have now chosen to file suit.

Three of these state law suits merit special mention.

Texas has opted to sue just Purdue, naming four Purdue companies. One of these is Purdue Transdermal Technologies LP, the manufacturer of Butrans. Texas is targeting Purdue for its FDA-approved abuse-deterrent opioid formulations as well as its earlier formulations. Alleged violations include that Purdue misrepresented that abuse-deterrent properties of some of their prescription opioids could curb addiction and abuse and that Purdue falsely represented that OxyContin’s abuse-deterrent formula reduces the risk of misuse, abuse, diversion, overdose, or addiction. Texas asserts that there is no scientific evidence to support Purdue’s claim that abuse-deterrent features make certain forms of abuse more difficult.  It cites CDC’s guidance that no reliable studies have established that abuse-deterrent features of opioids such as OxyContin are effective at risk mitigation for deterring or preventing abuse. It also cites CDC’s statement that abuse-deterrent features “do not prevent opiate abuse through oral intake, the most common route of opioid abuse, and can still be abused by non-oral routes” and “do not prevent overdose through oral intake”.

The second is the suit filed last month by the state of Massachusetts. This represents a new phase in the battle against opioid manufacturers because it is the first attempt to hold individual executive management and board members personally responsible for the US opioid crisis. Sixteen individuals are named, mostly members of the Sackler family who are currently or were formerly on the board of Purdue. As highlighted by the media this week, one of the defendants named is a current GSK executive who served on the Purdue board from 2011-2014. Massachusetts claims that these individuals “oversaw and engaged in a deadly, deceptive scheme to sell opioids in Massachusetts”. It is likely that the suing of individual pharma executives and directors will cause a fair degree of angst among the many past and present executives and board members of pharma which have marketed opioids.

The third lawsuit of interest comes from the state of Illinois. Illinois has filed suit against a number of opioid manufacturers, arguing that the companies have misled consumers and medical providers regarding the appropriate uses, risks, and safety of opioids. Illinois alleges, in part, that there have been no long-term studies demonstrating the safety and efficacy of opioids for long-term use, that opioid manufacturers provided a false perception of safety and efficacy that encouraged the use of opioids and that opioid manufacturers profited from their actions.

This suit could be seen as ironic when juxtaposed with the passing of a bill last month by Illinois lawmakers which allows any adult with a condition for which opioids might be prescribed to get near-immediate access to cannabis products from licensed dispensaries. The justification for the new law, provided by the Senator who sponsored the bill, was that “no one has died from overdose of cannabis”. This oversimplification ignores the fact that multiple studies have demonstrated the potential for serious health risks, addiction and public health problems associated with the use of cannabis. Additionally, there is no conclusive evidence that cannabis is effective in treating chronic pain. A recent large, long-term study by the UNSW found that chronic pain patients using cannabis had greater pain and anxiety and did not report reduced or discontinued use of opioids. Illinois stands to profit from the medical marijuana taxes it will raise from the passing of its bill (Colorado, for example, will receive an estimated $280 million from cannabis taxes this year). In addition, the lawmakers of Illinois have (legally) benefited from generous campaign donations made by the medical cannabis industry.

It may not happen soon, but I can see the day when a huge legal bunfight will erupt against “Big Cannabis”, following the example of the wars waged against “Big Tobacco” and “Big Pharma”. When it comes, I wonder whether individual US lawmakers will be sued.