When the Law Catches Up to the Science on Opioid Litigation

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Kudos to Dr. Josh Bloom for persistently and valiantly beating the drum against blaming prescription opiates for the “opioid epidemic.” Sometimes battling windmills isn’t for naught.

Three weeks ago, a California judge saw the light, and last week the Oklahoma high court followed suit. We haven’t seen the last of this though, and more cases are pending.

To date, over 3000 lawsuits have been filed by states and local governments against multiple pharmaceutical companies. These cases seek to hold Big pharma responsible for the nearly 500,000 opioid deaths the government has reported over the last two decades. No one doubts the excess deaths – the question facing the courts was whether state and local governments could extract billions of dollars from pharmaceutical manufacturers for their allegedly “wicked” marketing practices, which the plaintiffs claim fueled the opioid epidemic under the theory that the manufacturers created a public nuisance.

The California decision exonerating several pharmaceutical companies was billed as “tentative,” but this is merely an idiosyncratic procedural “nicety” California judges use to inform the parties they are leaning a certain way and offer them a chance to negotiate. No one expects any mind-changing or negotiation here.

Defendants do not dispute that there is an opioid crisis.”

Judge Wilson

In his 42-page decision, Judge Peter Wilson called the plaintiff-governments to task for conflating correlation with causation.

  • Yes, he said, there are more opioid-related deaths now than there were a decade ago.
  • Yes, he said, more opioid prescriptions were written in the last two decades.
  • But, no, he said, that’s not enough.  The mere increase in the number, dose, or duration of prescriptions without distinguishing between medically appropriate and medically inappropriate prescriptions would not suffice to sustain the plaintiffs’ claim.
  • Without proof that the prescriptions were wrongfully prescribed -- the plaintiff’s suit, seeking 50 billion dollars, was doomed.

The decision ruled that the claim of public nuisance required proof of causation – or more pointedly that the defendants’ conduct was a substantial factor in bringing about the result (excess opiate-related deaths). The mere number of prescriptions issued – or their increase over time - without distinguishing between medically appropriate and inappropriate -- doesn’t establish this causal element.

But the decision goes further. The judge also denied claims for false (or misleading) advertising and unlawful (fraudulent or unfair) business practices, along with the claim that the campaigns constituted a public nuisance.

            “There is no dispute that the ‘interference with collective social interests’ cause by the abuse of opioids is substantial.”

Judge Wilson.

Acknowledging that the drugs carry a high potential for abuse and could lead to severe psychological or physical dependence, the judge also noted the high social utility of the products. There are patients for whom prescription opioids are medically appropriate and for whom they are necessary to alleviate pain and suffering, or sustain life (shades of our Dr. Bloom) and for whom the benefits outweigh the risks.  Indeed, the judge echoes the Health & Safety Code, noting:

“For some patients, pain management is the single most important treatment a physician can provide….A patient suffering from severe chronic intractable pain should have access to proper treatment of his or her pain.”

Even if the advertising was false or that the marketing did cause an increase in the number of prescriptions issued, the judge ruled that:

any adverse downstream consequences flowing from medically appropriate prescriptions cannot constitute an actionable public nuisance.” [emphasis in the original].

Judge Wilson explained that this was because the Federal government (via the FDA) and the California Legislature have already determined that the social utility of medically appropriate prescriptions outweighs the gravity of the harm inflicted by them, and so it is neither “unreasonable” nor actionable. Going further, he noted that the California Legislature expanded its approval of opiate drug usage for conditions causing pain, including intractable pain. In short, the judge found the defendants' actions were not unreasonable, even if “highly regrettable but foreseeable adverse downstream consequences” occur.

A lack of proof

The missing element of the plaintiffs’ case was proof that physicians prescribed the drugs when it was not sound practice to do so. There was no evidence that the prescriptions were not being administered solely for their intended purpose- to relieve pain in appropriate circumstances or that their actions were in any way unreasonable.

The court also ruled the plaintiffs must prove that the marketing materials were likely to deceive the intended recipients. When the marketing is targeted to a sophisticated user or class, the determination is whether this class will be misled, not others to whom the materials are not primarily directed. And only specific claims can be actionable, not general assertions which would be regarded as mere “puffery.”

In reviewing scores of documents (containing many hundreds of pages of information) produced by the five defendants, the court found none had false or misleading information during the period in question.

Not two weeks later, a similar ruling was issued by the Supreme Court of Oklahoma, striking down the $465 million verdict awarded against Johnson and Johnson, finding that the landmark award rested on an improper expansion of state law, and also rejecting the claim of public nuisance.

"… the Oklahoma State Supreme Court ... rejected the misguided and unprecedented expansion of the public nuisance law as a means to regulate the manufacture, marketing, and sale of products, including the Company's prescription opioid medications.” Johnson and Johnson.

The comment is an understatement. The decision makes it quite clear that public nuisance law is inappropriate in this context – and didn’t even address the question of the propriety of the drugs’ prescription. 

Johnson and Johnson no longer promotes or aggressively markets opioid drugs and hasn’t done so for years and they furnished 3% of prescription opioids to the State of Oklahoma, leaving one to wonder if the Oklahoma suit, at least, was motivated by a search for a deep-pocket rather than the true culprits.

Is this the end of the line for these lawsuits?

Carl Tobias of the University of Richmond said it's too early to conclude that all these cases are likely to fail. "You don't have a trend when you only have two fairly disparate cases."It may well turn out to be a valid theory." And the California plaintiffs plan to appeal, so we don’t have the final word on the subject - at least in California. But the Oklahoma case was quite definitive that the public nuisance vehicle is an improper theory to pursue this type of litigation. One judge even filed a separate opinion to signal his disdain.

Of more concern to me, though, is why Johnson & Johnson (and other manufacturers, including Teva) are still pursuing global settlement negotiations -- to the tune of $26 billion(J&J already reached a $263 million settlement in New York). The business excuse doesn’t cut it. It would be far cheaper for J&J to try several cases and set a track record to discourage future cases. One wonders if they themselves aren’t persuaded that these decisions will stand.

Alternatively, perhaps there lurks within company files smoking gun memos regarding improper marketing strategies- that they would prefer to keep hidden. But given that both the Oklahoma and California cases refuse to implicate the drug manufacturer for what happens after sale, even “dark” memos might not legally sustain causation. Still, their strategy remains a mystery in light of these latest decisions.

Hopefully, the settlement posture will not deter future prescriptions of opiates when medically indicated nor curtail their manufacture.