Matthew Herder considers possible regulatory responses to the opioid epidemic that aim to recover health care costs, compensate survivors, or prosecute pharmaceutical companies.
Canada, like the United States, is in the midst of an opioid epidemic. While the harm reduction measures used to curb the Canadian epidemic compare favourably with the public health response south of the border, little legal action against the companies involved in marketing prescription opioids has occurred in Canada apart from one national class action lawsuit.
Last month, a Saskatchewan judge refused to approve a proposed settlement agreement in that class action lawsuit against Purdue Pharma and its affiliates. Although it had already been sanctioned by courts in Ontario, Nova Scotia, and Québec, Justice Barrington-Foote was not persuaded that the agreement was “fair, reasonable and in the best interests” of the members of the class.
While the settlement is on hold, it’s important to re-open the question of what should be done for the victims and survivors of the ongoing opioid epidemic, and for the provincial and territorial governments bearing the brunt of the health care costs associated with this public health disaster. At least four options should be on the table.
First, follow the strategy used against Big Tobacco. In the late 1990s Canadian provinces began enacting laws with the express purpose of recovering health care costs related to tobacco use and addiction. The laws are designed to facilitate provincial governments’ ability to sue cigarette makers. Critically, the laws apply retroactively, permitting health care payers to recover costs incurred prior to their passage.
Despite being in force for over two decades, provincial governments have yet to recover damages under these tobacco laws. Big Tobacco’s lawyers have tied up these lawsuits in a slew of procedural battles.
Though they have the potential to recover damages in the billions, it remains to be seen how effective these laws are in recovering health care costs related to a public health crisis. In contrast, only $ 2 million has been earmarked for provinces and territories in the class action settlement.
Second, establish a national compensation package for survivors of the opioid epidemic. The federal government has provided this sort of compensation for the individuals who suffered the severely ill-effects of the drug thalidomide, while they developed in utero. Thalidomide was prescribed in the late 1950s and early 1960s for the treatment of nausea during pregnancy, after receiving approval from Canada’s drug regulator.
The number of people presently affected by the opioid epidemic is significantly greater than the number of thalidomide survivors. However, the compensation provided for thalidomide survivors in 2015, comprised of a one-time payment of $ 125,000 plus an annual pension in the range of $25,000-$100,000, far exceeds the $11,000 – $13,500 proposed for each member of the opioid class action lawsuit.
Third, formally charge Purdue Pharma, its affiliates, and other prescription opioid makers with violating the Food and Drugs Act. Section 9 of that statute prohibits a person from labeling, packaging, treating, processing, selling or advertising a drug “in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.”
Proving deception in court is no easy matter. Further, even if Canadian prosecutors succeeded in establishing a violation of the prohibition on false, misleading or deceptive sales, the applicable penalties are limited for conduct that occurred prior to 2014. Until that year, a violation of the Food and Drugs Act could result in no more than a $5,000 fine and 3 months imprisonment. Post-2014, though, more significant penalties are in play: if Purdue were shown to have misled the federal Minister of Health about the safety of the drugs in question, a court has the discretion to set the fine at an amount it deems reasonable and impose a 5-year term of imprisonment.
Fourth, create an independent Commission of Inquiry. Doing so holds the potential to examine a series of questions such as Purdue’s marketing practices, the role of Health Canada, and necessary amendments to the Food and Drugs Act. A Commission of Inquiry could identify key areas for regulatory reform and, most importantly, provide a forum for those who have suffered through the opioid epidemic. The “Krever Commission,” which examined Canada’s tainted blood crisis, served a similar function.
None of the above four options is without its limitations. However, each has the potential to serve an important purpose, from recovering health care costs and compensating survivors, to signalling a will to prosecute past wrongdoing and examining how Canada’s regulatory system might be improved in the future. None of the above four options is mutually exclusive. If, in contrast, the proposed class action settlement is finalized, at least one of the above options—provincial legislation to recover health care costs—will be foreclosed. The Saskatchewan court judgment provides a timely opportunity to rethink that choice and explore other options at the provincial, territorial, and federal levels.
Matthew Herder is the Director of the Health Law Institute at Dalhousie University. @cmrherder