This week, officials from two California counties sued several of the makers of opioids, raising allegations that the companies violated California’s false advertising, unfair competition, and public nuisance laws.
The novelty of the case is not in its substantive allegations; those have been well-publicized for several years. Nonetheless, the complaint does a very nice job of explaining how the pharmaceutical industry created a new market for their product, by corrupting key opinion leaders, patient advocacy organizations, and the scientific literature, all playing down the risk of addiction to suggest that opioids could be safely and effectively used for long-term nonmalignant pain relief. For the institutional corruption themes in particular, see pages 35-51 of the complaint.
The novelty of this case is that state officials—rather than private plaintiffs or qui tam whistleblowers—have stepped forward to litigate the case. While uncommon in pharmaceuticals, this move echoes the strategy of states’ attorneys general in the tobacco wars. Mississippi State A.G. Michael Moore was one of the leaders of that battle, which transformed the litigation strategy from one of individual plaintiffs struggling to show causation in relatively small-dollar suits to a bet-the-company case involving billions of dollars and attracting top legal talent. This opioid case, likewise, appears to be a partnership between public officials and private litigators (a well-known class-action firm). And, like tobacco, this case avoids the difficult task of proving on an individual level that the pharmaceutical companies’ alleged misrepresentation caused any one particular prescription to be written or any one particular patient to become addicted and suffer the consequences. This case illustrates how state officials have a special power to reframe an issue as one of public health rather than personal damages.
Nonetheless, unlike tobacco, this case will be litigated in the shadow of the Food and Drug Administration, which directly and heavily regulates these very same products. I predict that a primary theme of the manufacturers’ defense will be that if there is a problem here, it is a problem for the FDA, not one for local county officials. This is not exactly a legal argument, since federal law does not preempt the sort of state laws that are implicated here. But it may be a compelling way to paint the case, in hopes that the state court judge will decide preliminary and procedural questions in ways that are favorable to the industry. If the industry succeeds in creating a general sense that this case is in the wrong place, the state officials will have to go for silver bullets that are clear violations of state law. They need singular instances of false and misleading statements, which are beyond the pale. Some of the current allegations, such as the claim that “addiction is rare,” leave a lot of room for interpretation.
As soon as this case looks like genuine dispute within the medical community, the industry wins. That is why the institutional corruption themes are so important. If the medical community has itself become corrupted by industry, and if the plaintiffs can demonstrate that fact, then the case may have legs.