Opinion ID: 6357225
Heading Depth: 3
Heading Rank: 2

Heading: UPMC's Reporting Obligation

Text: With this common-law background in mind, we turn now to the case at hand. While we employ a conventional Althaus analysis in assessing the prudence of imposing the duty that Plaintiffs seek, we begin by reviewing the legal obligation that Plaintiffs submit as supporting the imposition of that duty. Although Plaintiffs abandoned their negligence per se claims by declining to appeal the portion of the trial court's order sustaining Defendants' demurrers as to those claims, duty in ordinary negligence nonetheless may be informed by compliance with legal requirements, as it was in Witthoeft (even if in that case we ultimately declined to impose a duty). 18 Indeed, inasmuch as we often cite our preference for legislative judgments regarding social policy over judicial ones, considering the intentions reflected in statutes and regulations puts us on a firmer footing than we enjoyed in a number of the foregoing cases. In this case, the Superior Court and Plaintiffs have relied substantially upon the DEA regulations as an important, though by no means the exclusive, source of the duty they would have us impose. Pursuant to authority vested in the DEA by the Controlled Substances Act, individuals and entities that are registered to distribute or dispense controlled substances must notify the DEA of any significant theft or loss of such substances, as follows: The registrant shall notify the Field Division Office of the [DEA] in his area, in writing, of the theft or significant loss of any controlled substances within one business day of discovery of such loss or theft. The registrant shall also complete, and submit to the Field Division Office in his area, DEA Form 106 regarding the loss or theft.... 21 C.F.R. § 1301.76 (b). DEA Form 106, 19 of which we take judicial notice, delineates some of the information  that a reporting registrant is expected to provide. It provides fields for information that would identify when the loss resulted from a criminal act, including the Date of Theft or Loss. It further requests information regarding the type of theft, if any, including [n]ight break-in, [a]rmed robbery, and [e]mployee pilferage. If the loss is identified as an armed robbery, the reporting registrant should indicate whether anyone was killed or injured. Finally, the form asks whether the theft was reported to the police. UPMC notes that the form lacks any field or instruction regarding the identity of the perpetrator. However, the regulation, viewed in tandem with Form 106, makes clear that, while the form is a necessary component of discharging a registrant's reporting obligation, it is not necessarily sufficient . Subsection 1301.76(b) requires written notice within one business day of the theft or significant loss of any controlled substance, but makes clear that it considers such notice to be distinct from Form 106 in its requirement that, in tandem with provision of written notice, [t]he registrant shall also complete and submit Form 106. 21 C.F.R. § 1301.76 (b) (emphasis added). Notably, Subsection 1301.76(b) highlights several types of information not specifically anticipated by Form 106 as being relevant to the determination whether a loss is significant, which in turn dictates whether reporting is required in the first instance. For example, Subsection (b)(6) calls for consideration of [l]ocal trends and indicators of the diversion potential of the missing controlled substances; Subsection (b)(5) calls attention to [w]hether the specific controlled substances are likely candidates for diversion; and Subsection (b)(3) suggests that the reporting registrant assess [w]hether the loss of the controlled substances can be associated with access to those controlled substances by specific individuals  (emphasis added). Thus, that a given piece of information is not expressly mentioned by Form 106 is not conclusive as to whether the DEA sees value in, or entertains the prospect of taking action based upon, such information. In addition to the text of the regulation, we also have the benefit of DEA's rule-making commentary. In the ordinary course of modifying an earlier version of the rule to specify that a written report must be made within one business day of the discovery of the loss or theft, the DEA provided the following guidance: The purpose of immediate notification is to provide an opportunity for DEA, state, or local participation in the investigative process when warranted, and to create a record that the theft or significant loss was properly reported. It also alerts law enforcement to more broadly based circumstances and patterns of which the individual registrant may be unaware. This notification is considered part of a good-faith effort on the part of the regulated industries to maintain effective controls against the diversion of controlled substances, as required by 21 CFR 1301.71(a). Lack of prompt notification could prevent effective investigation and prosecution of individuals involved in the diversion of controlled substances .     The theft of controlled substances from a registrant is a criminal act .... Although not specifically required by DEA law or regulations, the registrant should also notify local law enforcement and  state regulatory agencies. Prompt notification of law enforcement agencies will allow them to investigate the incident and prosecute those responsible for the diversion . Proposed Rules, Reports by Registrants of Theft or Significant Loss of Controlled Substances, 68 F.R. 40576-01 (proposed July 8, 2003) (to be codified at 70 F.R. 47094-01 ) (emphasis added). 20 In light of these commentaries, it is reasonable to infer that the DEA recognizes two benefits to these reporting requirements. First, the rule enables the DEA to monitor patterns of diversion that might signal a systematic effort to traffic in controlled substances, and enables enforcement and controls to prevent such activities, which is in keeping with the intent of the Controlled Substances Act. See Gonzales v. Oregon , 546 U.S. 243 , 250, 126 S.Ct. 904 , 163 L.Ed.2d 748 (2006) (observing that the Act embodied the intent to combat[ ] drug abuse and control[ ] the legitimate and illegitimate traffic in controlled substances). Second, such reports may lead to and/or advance the identification, investigation, and prosecution of individual diverters like Kwiatkowski.