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Ninth Circuit Considers Limits to DEA Access to Oregon Prescription Drug Monitoring Program

Summary

On November 7, 2016, the US Court of Appeals for the Ninth Circuit heard arguments in Oregon Prescription Drug Monitoring Program v. United States DEA, No. 14-35402 (9th Cir. 2016). Here, the Drug Enforcement Administration (DEA) sought to overturn a ruling that the DEA’s use of administrative subpoenas to access records from the Prescription Drug Monitoring Program (PDMP) violates the Fourth Amendment, resulting in potentially wide-ranging implications.

In Depth

On November 7, 2016, the US Court of Appeals for the Ninth Circuit heard arguments in Oregon Prescription Drug Monitoring Program v. United States DEA, Case No. 14-35402 (9th Cir. 2016). The Drug Enforcement Administration (DEA) sought to overturn a US District Court for the District of Oregon ruling that the DEA’s use of administrative subpoenas to access records from the Prescription Drug Monitoring Program (PDMP) violates the Fourth Amendment (the District Court Case).

The case has potentially wide-ranging implications. Every state except Missouri currently maintains a PDMP. PDMPs maintain detailed records of controlled substances prescriptions filled by pharmacies, the physicians who prescribed the drugs and the patients who use them. Pharmacists and prescribers are expected to check the PDMP when filling and writing prescriptions, respectively. PDMPs are designed as a tool to improve health outcomes and to reduce prescription drug abuse. 

In creating the PDMP, the Oregon legislature classified information uploaded into the PDMP as “protected health information” subject to disclosure only upon issuance of a court order based on probable cause. O.R.S. §192.553. Under the federal Controlled Substances Act (CSA), however, the DEA may issue administrative subpoenas which may be executed without a court order.

The district court case originated with the State of Oregon’s request for a declaratory judgment on whether the DEA’s use of administrative subpoenas to access records in the Oregon PDMP was barred by the Oregon requirement for a court order finding probable cause be obtained for law enforcement access, or whether the CSA pre-empted the state’s requirement. The American Civil Liberties Union (ACLU) intervened on behalf of four patients and one physician, asserting that the use of administrative subpoenas to access the PDMP violated these individuals’ Fourth Amendment rights to privacy and against unreasonable search and seizure.  The DEA responded that there is no privacy interest in the prescription records and that the Supremacy Clause preempted the state requirement.

US District Judge Ancer L. Haggerty ruled that patients and physicians have a reasonable expectation of privacy for their prescription records, noting that, “It is difficult to conceive of information that is more private or more deserving of Fourth Amendment protection.” The district court consequently held that DEA’s use of administrative subpoenas to obtain prescription records from the PDMP violates the Fourth Amendment, and that a court order would be required for such access.

Before the Ninth Circuit, the DEA argued that the "administrative subpoenas" are valid and sufficient, and do not require a court order.  As a secondary position, the DEA stated that a finding of “reasonableness and relevance” should be the standard if a court order were required at all, as opposed to a finding of probable cause.

The Ninth Circuit panel questioned both the standing of the ACLU to intervene as well as the district court’s decision to grant the relief that the intervenor—as opposed to either party—had requested.  The ACLU emphasized that it had raised a distinctive argument, as opposed to a separate claim.

The ACLU argued that the PDMP database contains "extraordinarily sensitive information'' about people and their diagnoses, which was the reason that the Oregon legislature established specific privacy protections. The ACLU also noted that the DEA directs the state not to tell patients or prescribers if their information is the subject of a subpoena so they would have no way of knowing that their privacy rights may have been violated.

The lawyer for the DEA dismissed the ACLU's claim regarding heightened privacy expectations, noting that both state and federal law anticipate that the database prescription information "may be shared with others—from regulatory boards to law enforcement officials and health oversight authorities."  One member of the court stated that it struck him as odd that the federal government would instruct a state not to notify a doctor or patient who is the subject of a DEA subpoena, noting that it did “not strike [him] as a very good way to run a system.''  The DEA responded that administrative subpoenas are similar to grand jury subpoenas and are used in the course of a civil or criminal investigation when the investigators do not wish to tip off the subject of the inquiry.

In addition to these arguments, the American Medical Association filed a “friend of the court brief” in support of the state of Oregon, seeking to protect patient prescription data from becoming a "law enforcement tool" without "stringent legal requirements for disclosure.''

The Ninth Circuit’s decision could be significant both for privacy advocates and for law enforcement. If the court were to affirm the district court’s ruling, the DEA would presumably be required to meet the standard of probable cause in order to obtain records from PDMPs and from registrants (e.g., pharmacies). Logically, the ruling could have implications for other law enforcement agencies and for similar medical records.

© 2019 McDermott Will & Emery

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About this Author

Karen Owen Gibbs, Health, Life sciences, Attorney, McDermott Will, Law Firm
Partner

Karen Owen Gibbs is a partner in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Chicago office.  She has extensive background in regulatory, compliance and policy issues in the health care and life sciences industries, including pharmacies (retail, mail and specialty), pharmaceutical and biologics manufacturers, pharmacy benefit management (PBM) companies, device manufacturers, durable medical equipment (DME) suppliers, hospitals, retail clinics and senior living facilities.   Karen also has substantial experience advising investors and lenders focused on those...

312-984-3652
Patrick Callaghan, Health Care Attorney, McDermott Law Firm
Associate

Patrick Callaghan is an associate in the law firm of McDermott Will & Emery LLP and is based in the Firm’s Chicago office.  He focuses his practice on health law matters.

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