Paul Doering, a frequent DEA expert in criminal and administrative diversion actions, has retreated from many of the "red flag" opinions the DEA has relied upon in order to show cause proceedings against pharmacists and other practitioners [See Holiday CVS, LLC d/b/a CVS Pharmacy Nos. 219 and 5195, FR 62,316, 62,321-22 (2012)].
In order to establish a violation of corresponding responsibility, the DEA must prove by a preponderance of the evidence that “(1) The Respondent dispensed a controlled substance; (2) a red flag was or should have been recognized at or before the time the controlled substance was dispensed; and (3) the question created by the red flag was not resolved conclusively prior to the dispensing of the controlled substance.” Holiday CVS, 77 FR at 62341; 21 C.F.R. § 1301.44(d). With respect to identifying red flags, the DEA evaluates pharmacists in light of what would be considered suspicious by a "reasonable pharmacist." Id. (citing East Main Street Pharmacy, 75 FR 66149, 66165(2010)). Therefore, in order to prove its case, the DEA must establish by a preponderance of the evidence that the pharmacist recognized or should have recognized a red flag at or before the time the controlled substance was dispensed through expert testimony on the objective “reasonable pharmacist standard” for the state in which the pharmacist practices.
During the voir dire and cross examination of the DEA’s putative expert, Doering, it was revealed that he does not hold a valid license to practice pharmacy in the state of Florida. DEA Ex. 32, TR, 836:19-22, 1770:11-16. Based on this, the Respondents objected to him being offered as an expert. Respondents continue to maintain that Doering’s lapsed license, in and of itself, makes his testimony inappropriate for consideration of meeting the DEA’s burden of proof as someone without an active Florida license cannot opine on the reasonable pharmacist standard in that state. This is especially true in light of the fact that Doering had not practiced in a retail setting in over 40 years. TR, 831:6-832:2. However, even assuming for the sake of argument that Doering’s lapsed license is not a per se basis to exclude his testimony, it is certainly another factor which calls into question his competence to serve as an expert under the Daubert standard.
In addition to not having a valid license to practice in Florida, Doering’s testimony should be excluded as his testimony regarding the standard of care for a pharmacist when addressing red flags is inconsistent with his testimony on the same subject in Holiday CVS. This dichotomy illustrates that Doering’s testimony in the present case is unreliable and does not meet the Daubert standard. Id.
In Holiday CVS, Doering served as the DEA’s expert witness and, as in the present case, testified regarding red flags that pharmacists should look out for and the standard of care that a reasonable pharmacist should use when analyzing such red flags. Doering testified that he was presenting the standard of care for pharmacy registrants in Florida. Holiday CVS, 77 FR at 62332. In elaborating on the standard of care, he alluded to the red flags pharmacists may encounter in practice which create an obligation to decline to fill a prescription or to take other action, such as the address of the patient versus the address of the prescriber, and the method of payment. Id. During his testimony, Doering reached very specific conclusions regarding a variety of dispensing events and red flags, finding largely that a reasonable pharmacist exercising his or her responsibility should not have dispensed the medications at issue. Id. In reaching his conclusions, he made sweeping statements regarding the standard of care for pharmacists in Florida, including that the standards he was applying are what pharmacists are “taught in school” and that the feedback he receives is “universally consistent with [his] point of view.” Holiday CVS, 77 FR at 62318. In one instance, Doering stated that prescriptions were not issued in the usual course of medical practice and that there was “no explanation that’s going to resolve that in [his] mind.” Holiday CVS, 77 FR at 62319. Finally, he concluded that standards of care are not necessarily derived from laws, but rather stem from what pharmacists would do in similar circumstances. Holiday CVS, 77 FR at 62332.
By contrast, in the instant case, Doering failed to establish a specific standard that a reasonable pharmacist would use, conceding that reasonable pharmacists may “disagree as to what’s reasonable and what’s not reasonable.” TR, 1828:7-10. Although Doering concluded with respect to specific instances that certain red flags were not resolvable when analyzed under the standard of care exhibited by a reasonable pharmacist in Florida, he later contradicted himself by admitting that reasonable pharmacists may disagree as to what red flags are resolvable and not resolvable, whether an early refill is reasonable, whether it is appropriate to fill a prescription that may demonstrate a potential drug/drug interaction, whether it is appropriate to dispense drugs that represent duplicative drug therapy, and whether a particular cocktail or combination of prescriptions is appropriate. TR, 1828:15-25; 1829:1-7. Furthermore, Doering stated “the guidance offers general guidance but the ultimate decision is left up to the practitioner and that’s the rub. Practitioners want others to make those decisions for them and the DEA cannot do that because they are not pharmacists.” TR, 1842:22-25. “Evaluation of what a pharmacist did is always retrospective because you cannot postulate each and every circumstance.” TR, 1844:18-21.Doering went so far as to concede that the best practices that he taught pharmacy students were above the standard of reasonable pharmacists in Florida and that a pharmacist may violate best practice standards without violating the standard of care. TR, 1998:12-19. Lastly, he admitted that two reasonable pharmacists in Florida may not only differ as to resolving red flags, but may differ as to whether something is a red flag in the first place. TR, 1999:2-15. This may be because Doering’s true position on the matter is as he expressed to the media, that there is insufficient clarity as to “red flags” in the state of Florida such that there is no uniform standard. Rather, it is so muddled that, for pharmacists, it is like playing a football game without a rule book. TR, 1843:4-1845:18.
Pursuant to DEA precedent in Holiday CVS, a pharmacy has a “corresponding responsibility under Federal Law to dispense only lawful prescriptions." 77 FR 62315, 62341 (2012)(citing Liddy's Pharmacy, L.L.C., 76 FR 48887, 48895 (2011)). The DEA has construed "legitimate medical purpose" as a responsibility that prohibits a pharmacist from “filling a prescription for a controlled substance when he either knows or has reason to know that the prescription was not written for a legitimate medical purpose," and "[w]hen prescriptions are clearly not issued for legitimate medical purposes, a pharmacist may not intentionally close his eyes and thereby avoid [actual] knowledge of the real purpose of the prescription." Id. Pharmacists may not dispense prescriptions where red flags are present, and violations of this responsibility occur where: “(1) the Respondent dispensed a controlled substance; (2) a red flag was or shouldhave been recognized at or before the time the controlled substance was dispensed; and (3) the question created by the red flag was not resolved conclusively prior to the dispensing of the controlled substance.” Id. As outlined, above, in Holiday CVS the Court relied primarily upon Doering’s testimony as to the standard a reasonable pharmacist would use as well as his opinion regarding specific dispensing events and whether a reasonable pharmacist would have acted differently. Id. at 62342. During his testimony in that case, Doering reached very specific conclusions regarding a variety of dispensing events and red flags, finding largely that a reasonable pharmacist exercising his or her responsibility should not have dispensed the medications at issue. Id. at 62332. In reaching his conclusions, he made sweeping statements regarding the standard of care for pharmacists in Florida, including that the standards he was applying are what pharmacists are “taught in school” and that the feedback he receives is “universally consistent with [his] point of view.” Id. at 62318. In one instance, Doering stated that prescriptions were not issued in the usual course of medical practice and that there was “no explanation that’s going to resolve that in [his] mind.” Id. at 62319. Finally, he concluded that standards of care are not necessarily derived from laws, but rather stem from what pharmacists would do in similar circumstances. Id. at 62332. The Holiday CVS case has consistently been cited in DEA decisions as the seminal case discussing “red flags” which must be resolved conclusively prior to filling prescriptions. See Top RX Pharmacy, 78 FR 26069 (2013); JM Pharmacy Group, Inc., 80 FR 28667, 28671 (2015); The Medicine Shoppe, 79 FR 59504, 59510 (2014); Jana Marjenhoff, D.O., 80 FR 29067, 29094 (2015). In JM Pharmacy Group, Inc., the Court cited to Holiday CVS several times in its analysis of whether a pharmacy’s registration should be approved. The Court reiterated the three (3) factors stated in Holiday CVS in determining whether a pharmacist violated the reasonable pharmacist standard of care. Id. at 28685. The Court further cited to Holiday CVS for the proposition that “in the context of a pharmacy, a red flag is simply a circumstance arising during the presentation of a prescription, which creates a reasonable suspicion that the prescription is not valid and which imposes on a pharmacist the obligation to conduct further inquiry into whether the prescription is valid or to not fill it at all.” Id. at 28672. In Jana Marjenhoff, D.O., the Court found that once the pharmacist “had identified a red flag that indicates that a controlled substance scrip was potentially illegal, he was prohibited under the law from dispensing until the red flag had been conclusively resolved.” Jana Marjenhoff, D.O., 80 FR at 29094. Holiday CVS and its progeny all find their basis in the testimony of Doering. As such, their validity is called into question by the testimony of Doering in the instant case.[1] For instance, as discussed previously, Doering’s testimony conceded that there is no established standard that all “reasonable pharmacists” would use in the state of Florida with respect to what constitutes a “red flag” and how it may be resolved with respect to each category of supposed “red flags.” TR, 1828:7-10, TR, 1828:15-25; 1829:1-7. Rather, he has publicly taken the position that there is so much uncertainty that it is akin to playing a football game without a rulebook.