Saying that her lawsuit “breaks new ground by setting forth an extensive set of facts alleging that prescription drug distributors failed to exercise their duties to detect and report diversion of opioids through poorly designed, poorly resourced, and poorly executed suspicious order monitoring programs,” the New York Attorney General, Letitia James, has filed charges against AmerisourceBergen, Cardinal Health, McKesson and Rochester Drug Cooperative, alleging violations of the state Controlled Substances Act and related claims. The suit also targets most manufacturers of opioid-based drugs, as well as the Sackler family members individually (owners of Purdue Pharma).
The suit, filed in state court, doesn’t specify a dollar amount, but notes that each of 17 charges provide penalties of upwards of $15,000 per violation (and there are potentially thousands of violations), Most of the listed companies, as well as some of the distributors, face similar suits in some 36 states (the list continues to grow), and these state suits are distinct from 1,600 suits that have been gathered in a federal court in Ohio. On March 25, Purdue Pharma settled with the state of Oklahoma for $270 million over similar charges.
The 269-page suit makes for some interesting reading, notwithstanding redactions in various places. Specific to the wholesalers, the suit contends that:
- The distributor defendants routinely failed to staff their compliance functions with qualified personnel
- None of them had a consistent practice of conducting appropriate due diligence of either prospective new customers or their existing customers
- They routinely failed to detect, block and report their customers’ suspicious orders; and failed to act to suspend customers from ordering controlled substances, let alone terminate their accounts, even after compliance staff had blocked and reported dozens, or even hundreds, of suspicious orders
- None of them systematically stored, organized, and made accessible for reference information about their customers or their owners, pharmacists, and top prescribers.
These charges sound as if the distributors did nothing at all about suspicious order monitoring or enforcement, which flies in the face of the Controlled Substances Act (as well as a New York state version of that law). But the details in the suit paint a different picture—a sort of Zeno’s Paradox of continually upgrading their monitoring activities, but never seeming to achieve an effective level of compliance. In one case, a distributor went from reporting no suspicious orders, to reporting an overwhelming number (and filing the reports with government authorities), but then continuing to supply product. In another instance, a designated permissible client order volume (after which, nominally, a suspicious-order report would be issued) was determined—and then tripled “to allow for client growth” and subsequently reduced to 2X, and then 1.5X.
It has long been a contention of wholesalers, individually and as represented by the Healthcare Distribution Alliance, their trade association, that DEA has been insufficiently specific about what needs to be reported, and that DEA, as the locus of all suspicious order reports, was in the best position to determine which pharmacies were stocking up from multiple wholesalers. DEA made a policy change in February to allow pooled communications between it and wholesalers; but this won’t be effective unless wholesalers themselves provide some consistency in their reporting.
It’s worth noting that even as these corporations gear up for lengthy and complicated litigation, there are still an estimated 130 individuals dying daily from opioid abuse, which has now moved mostly to the illegal distribution of (non-prescription) heroin and fentanyl. And while prescription opioid consumption peaked in 2012, it is still elevated in some regions of the country, and prescription products are often the gateway to abuse of non-prescription opioids.