On The Docket

David B. Brushwood, BSPharm, JD

Thousands of ongoing lawsuits throughout the country have been consolidated as the “National Opiate Litigation.” States, counties, cities, and tribes are suing opioid manufacturers, wholesalers, and pharmacies. Noticeably missing from this list of defendants are the prescribers of opioids. The common narrative of these lawsuits is that the defendants caused an opioid crisis and therefore must pay the cost of resolving the opioid crisis. While many of these lawsuits have been settled out of court, others are proceeding to trial. A recent ruling in a wholesaler case from West Virginia serves as guidance on how these cases could be resolved at trial.

Background

A city and a county in West Virginia sued 3 large drug wholesalers. The plaintiffs’ contention was that the defendants had “created an opioid epidemic” for which the plaintiffs sought an “abatement of the public nuisance.”

The plaintiffs’ proposed abatement plan would result in a 15-year payment of just under $2.5 billion. The judge presiding over the case heard testimony from 70 witnesses.

Rationale

The judge first reviewed a DEA regulation requiring that wholesalers use suspicious order monitoring (SOM) systems to prevent the diversion of opioids by pharmacies.

The judge ruled that the plaintiffs “did not prove that defendants failed to maintain effective controls against diversion and design and operate sufficient SOM systems to do so.”

The judge explained that “the fact that defendants do not currently maintain copies of certain due diligence files (many years later) is not a very persuasive indicator that due diligence was not completed or that the files did not previously exist.”

The judge noted that one of the plaintiffs’ expert witnesses, a former DEA diversion investigator, “could not identify a single pharmacy customer of the defendants that was engaged in diversion.”
The court explained that controlled substances laws “do not hold distributors responsible for supplying opioids to pharmacies not reasonably suspected of being diverters or adjuncts thereof.”

The judge also noted that the plaintiffs “failed to show that the volume of prescription opioids distributed in [the city and county] was because of unreasonable conduct on the part of the defendants.” Rather, the court noted that “doctors prescribe medications based on the then-prevailing standard of care,” and that “beginning in the 1990s, the standard of care changed to recognize a broader range of appropriate uses for prescription opioids.” The court found “no evidence that defendants played any role in changing the standard of care for the treatment of pain or endorsed these changes.”

The court concluded that “at most, there is only a reasonable inference that someday, somehow, some of the opioids that defendants shipped fell into the wrong hands. That is not enough to sustain a reasonable finding that the defendants have caused diversion of opioids or an opioid epidemic.”

The court entered judgment in favor of the defendants, commenting, “The opioid crisis has taken a considerable toll on the citizens of [the city and county]. And while there is a natural tendency to assign blame in such cases, they must be decided not based on sympathy, but on the facts and the law.”

Takeaways

Although this case pertains to wholesalers, and not to pharmacies, the rationale of the court could be applied more broadly to pharmacy cases.

Important points to consider from this case are

• The failure to produce a documentary record of regulatory compliance from years earlier is not necessarily evidence of noncompliance.
• The unlawful distribution of opioids must be substantiated by actual diversion and not by suspicious conduct among those who received opioids.
• The prescribers were the source of high-volume opioid prescriptions, and they establish their standard of care.
• Association with the opioid crisis is not the same as causing the opioid crisis.
• Concern for those affected by opioid use disorder does not justify blaming those who provided opioids to relieve the suffering of chronic pain patients. ■