With the filing of two class action lawsuits, one against Walgreens and Costco, and one against CVS, in two federal district courts on August 6, pharmacies find themselves in a perplexing situation (yet again). For these suits were filed not by those who suffered from the over-dispensing of opioids, but by chronic pain patients who were denied opioid medication by pharmacies.
These complaints (found here and here) are not, of course, ultimately about the named plaintiffs. They are class actions. And their arguments, if successful, could further complicate compliance risk assessments conducted by pharmacies, especially independent retail pharmacies – some of which recently received letters threatening similar litigation. Law professors often say that lawsuits are a misnomer…. they are really “fact suits.” These class actions are lawsuits. In addition to alleging various state law violations, they allege federal violations implicating the Americans with Disabilities Act, Section 504 of the Rehabilitation Act of 1973, and the Anti-Discrimination Provisions of the Affordable Care Act. The basic theory of the case is that chronic pain is a disability, these statutes prohibit discrimination against people with disabilities, and adopting opioid dispensing policies which “flag” or “blacklist” patients with such a disability is unlawful discrimination.
Now without detailing all the specific guidelines employed by the pharmacies sued in this case, they appear to have been focused on fulfilling a pharmacy’s corresponding responsibility aimed at ensuring that the dispensing of opioids is for a legitimate medical purpose. A facially valid prescription from a prescriber is just the start of the process, not the ending point.
That said, the complaint quotes a letter sent by the Alaska Board of Pharmacy in January of 2019 to all pharmacists, noting concern about “an influx of communication concerning patients not able to get controlled substance prescriptions filled for various reasons, even when signs of forgery or fraudulence were not presented.” Forgery or fraudulence? This does not sound like corresponding responsibility. The Alaska BOP goes on to state that, “if a pharmacist has any concern regarding a prescription, they should attempt to have a professional conversation with the practitioner to resolve those concerns and not simply refuse the prescription.” That sounds more like corresponding responsibility. But all these discussions do not end in agreement. A practitioner may say that his or her high-dose, high-quantity prescription is the only way to go. The pharmacist may disagree. What then? The letter does not say, but four of the five numbered paragraphs in the Alaska BOP letter end with language about the potential for refusals to “call into question the knowledge, skill or judgment of the pharmacist and may be deemed unprofessional conduct.” Sounds like a warning.
As quoted in the complaints, the American Medical Association has weighed in on this issue as well, arguing that pharmacies, health insurance companies, and pharmacy benefit management companies have rigidly interpreted the CDC opioid guidelines, such that it has continued “to receive concerns from physicians and patients as to the disruptive nature of health plan, pharmacy chain, or PBM interference in the patient/physician relationship.” It is not particularly surprising that the AMA would reject anything they perceive as an intrusion in that relationship, as they have long fought the notion that pharmacists have a legal obligation to independently scrutinize controlled substance prescriptions. I think the AMA is playing with fire by continuing to take this position. Prescribers currently enjoy some level of “immunity” from being dragged into the Opioid MDL. Continuing to try and undermine the corresponding responsibility obligation imposed on pharmacists may ultimately attract attention from plaintiffs’ counsel looking for the next deep pocket to pick once the Opioid MDL is concluded. It will certainly attract the attention of DEA (at least that is what I hope for).
These cases may also be foreboding shots across the bow of health insurance companies and PBMs. Are similar class actions awaiting these market actors? I think so, as these cases tend to replicate quickly (especially if you give them water or get them wet).
So what’s a pharmacist to do? Neglect his or her corresponding responsibility and defer to practitioners unless there is evidence of forgery or fraudulence? Well, that’s a ticket to DEA and state regulatory enforcement (except maybe Alaska and a few other states). Pursue a compliance policy based on corresponding responsibility? Well, that may be a ticket to Class Action Town. It is astonishing, that after nearly five decades, “corresponding responsibility” continues to be one of the most misunderstood obligations for DEA registrants. Lawsuits such as these present opportunities to obtain greater clarity, but rarely achieve such lofty goals.