Over the last couple of months, DEA has issued four decisions revoking the registrations of pharmacies (recall that DEA issued only one decision in 2017 involving a pharmacy). In February 2018, the Acting Administrator revoked the registrations of Trinity Pharmacy I, 83 Fed. Reg. 7220 (Feb. 20, 2018), and Trinity Pharmacy II, 83 Fed. Reg. 7304 (Feb. 20, 2018). Then in March, the Acting Administrator revoked the registration of Pharmacy Doctors Enterprises d/b/a/ Zion Clinic Pharmacy, 83 Fed. Reg. 10,876 (Mar. 13, 2018). Most recently, the Acting Administrator revoked Health Fit Pharmacy’s registration, albeit solely on lack of state authority grounds, 83 Fed. Reg. 24,348 (May 25, 2018).
The Trinity II and Zion Clinic decisions are a must-read for any pharmacy registrant (or counsel) facing a DEA administrative hearing. Likewise, they contain important discussions concerning DEA procedural rules and expert testimony. A few highlights:
“Willful Blindness” Scienter Standard for Violation of Corresponding Responsibility
Around the time when it was first introduced, we discussed the unique “scienter” (i.e., knowledge) requirement that is necessary for a finding that a pharmacy violated its corresponding responsibility. That requirement is now an adjudicated standard in DEA pharmacy cases, and it is important to know for purposes of (1) training pharmacy staff on addressing red flags of diversion and (2) defending against a DEA administrative action based on allegations of corresponding responsibility violations.
Specifically, for DEA to prove that a pharmacist or pharmacy violated its corresponding responsibility, it must show “either that: (1) The pharmacist filled a prescription notwithstanding her “actual knowledge” that the prescription lacked a legitimate medical purpose; or (2) the pharmacist was “willfully blind” or “deliberately ignorant” to the fact that the prescription lacked a legitimate medical purpose.” Zion Clinic, 83 Fed. Reg. at 10,896; accord Trinity II, 83 Fed. Reg. at 7,329. In order to demonstrate “willful blindness,” DEA must “prove that the pharmacist had a subjective belief that there was a high probability that a fact existed and she took deliberate actions to avoid learning of that fact.” Zion Clinic, 83 Fed. Reg. at 10,896; accord Trinity II, 83 Fed. Reg. at 7,329.
Red Flags of Diversion
At this point, given the widespread opioid crisis, any entity that holds a DEA registration is aware of so-called “red flags” of diversion, which flags are not spelled out in DEA’s regulations. Instead, DEA has indicated certain red flags exist in a litany of different sources, including administrative decisions, presentations to industry, letters to industry, or other informal communications. In Zion Clinic, the Acting Administrator provided a non-exhaustive list of red flags for pharmacies that would support a finding of the requisite scienter or knowledge to support a corresponding responsibility violation:
- Multiple customers filling prescriptions written by the same prescriber for the same drugs in the same quantities
- Customers with the same last name and street address presenting similar prescriptions on the same day or within a short time span
- Two short-acting opiates prescribed together
- Patients traveling long distances to fill opioid prescriptions
- Drug cocktails
- Payment by cash
- Unusually large quantity of a controlled substance
- Pattern prescribing
- Irregular dosing instructions
- Lack of individualized therapy or dosing
- Early fills/refills
- Other pharmacies’ refusals to fill the prescriptions
83 Fed. Reg. at 10896-97.
Expert Testimony and Reliance on DEA-6s
In Trinity II, the respondent pharmacy discovered that DEA’s expert had received a copy of the DEA-6 (DEA’s internal investigation report addressing DEAs findings and in recent years typically unavailable to respondents during the show cause process and any appeal), and that the expert had reviewed the document prior to rendering testimony in the case. Though it is difficult to understanding the underlying details solely from the Final Order, the pharmacy raised issue during the administrative hearing that the DEA-6 had not been produced. According to the Final Order, the Chief Administrative Law Judge found in his Recommended Decision that: (1) DEA’s provision of the DEA-6 to the expert demonstrated the Agency’s intent that the expert rely on the document in formulating his opinion; and (2) the record supported that the expert relied on the DEA-6 as “a framework to examine other potential evidence.” Trinity II, 83 Fed. Reg. at 7323-24.
The Acting Administrator disagreed, contending that DEA’s “intent” was not at issue, but rather whether the expert “actually relied” on the document in rendering his opinion in the case. Additionally, the Acting Administrator disagreed that using the DEA-6 as a “framework” or “beacon or flashlight” to review other documents was not sufficient to require disclosure. Instead, the appropriate question is whether the expert, “in fact, relied upon the DEA-6s as a substantive basis for his expert opinion.” Id. at 7324 (emphasis added). Note that the Acting Administrator cited the past decisions of T.J. McNichol, M.D., 77 Fed. Reg. 57133, 57146 n.18 (Sept. 17, 2012), and CBS Wholesale Distributors, 74 Fed. Reg. 36746, 36749 (July 24, 2009), in support of this standard, but neither of these decisions use the “substantive basis” or similar language when discussing whether documents reviewed by an expert should be disclosed.
The Acting Administrator’s standard is far afield of any standard set forth in the Federal Rules of Civil Procedure (Rule 26) for the use of expert testimony, and the ability to access information that an expert reviews in forming his or her opinions. It is, in fact, simply difficult to imagine why, or in what circumstance, an expert would review a DEA-6 without using it as a substantive basis—let alone just relying on it—for the expert’s opinion. And, it seems fundamentally unfair that a respondent would not have access to materials that an expert relies on in forming his or her opinions so that the respondent can test the accuracy, legitimacy, and validity of those opinions. While DEA’s existing precedent recognizes the necessity of allowing a respondent to review the documents relied on by DEA’s expert, this new standard makes it all the more difficult for respondents.
Other Issues
While there is not enough room in this blog post, the Trinity II decision is also worth reading for its discussion of the notice standards for anticipated summaries of witness testimony and the reliability of expert testimony, among other issues.