University of Washington Medical Center v. Becerra
Becerra
Court
District Court, District of Columbia
Decided
June 17, 2025
Jurisdiction
FD
Importance
42%
Case Summary
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA OREGON HEALTH & SCIENCE : UNIVERSITY, : : Plaintiff, : Civil Action No.: 24-2184 (RC) : v. : Re Document Nos.: 18, 20 : THOMAS J. ENGELS, et al., : : Defendants; : : MAINEGENERAL MEDICAL CENTER, : : Plaintiff, : Civil Action No.: 24-2187 (RC) : v. : Re Document Nos.: 19, 21 : THOMAS J. ENGELS, et al., : : Defendants; : : UNIVERSITY OF ROCHESTER, : : Plaintiff, : Civil Action No.: 24-2268 (RC) : v. : Re Document Nos.: 18, 20 : THOMAS J. ENGELS, et al., : : Defendants; : : CHILDREN’S NATIONAL : MEDICAL CENTER, : : Plaintiff, : Civil Action No.: 24-2563 (RC) : v. : Re Document Nos.: 15, 18 : THOMAS J. ENGELS, et al., : : Defendants; : : UNIVERSITY OF WASHINGTON : MEDICAL CENTER, : : Plaintiff, : Civil Action No.: 24-2998 (RC) : v. : Re Document Nos.: 26, 28 : ROBERT F. KENNEDY, JR., et al., : : Defendants. : : MEMORANDUM OPINION 1 GRANTING DEFENDANTS’ MOTIONS TO DISMISS; AND GRANTING JOHNSON & JOHNSON’S MOTIONS FOR LEAVE TO FILE AMICUS BRIEFS I. INTRODUCTION In April 2024, Johnson & Johnson Health Care Systems Inc. (“J&J”), a pharmaceutical drug manufacturer, contacted Plaintiffs, healthcare providers, regarding their utilization of drugs in the 340B Drug Pricing Program, 42 U.S.C. § 256b. The 340B Program requires that pharmaceutical drug manufacturers that participate in Medicaid and Medicare Part B, like J&J, sell drugs to statutorily covered entities, like the hospitals and medical centers operated by Plaintiffs, 2 at lower prices. The statute also authorizes manufacturers to conduct audits of 1 This Memorandum Opinion addresses pending motions in the five cases listed above. For convenience, the Court will cite to docket numbers from the earliest filed case, Oregon Health & Science University v. Engels, No. 24-cv-2184, unless otherwise specified. 2 Plaintiffs are Oregon Health & Science University (“OHSU”), MaineGeneral Medical Center (“MaineGeneral”), University of Rochester, Children’s National Medical Center (“Children’s National”), and University of Washington Medical Center (“UWMC”). 2 covered entities, at the manufacturers’ expense, to ensure compliance with statutory provisions related to those lower prices. J&J submitted audit plans for Plaintiffs to the Health Resources and Services Administration (“HRSA” or “Agency”), an agency within the Department of Health and Human Services (“HHS”), and HRSA approved the audit plans. But Plaintiffs objected, and brought this suit against the heads of HRSA and HHS, arguing that HRSA’s allowance of J&J’s audit without following certain procedures was arbitrary, capricious, and contrary to law under the Administrative Procedure Act (“APA”), 5 U.S.C. § 706. 3 Defendants filed motions to dismiss each of the cases under Federal Rule of Civil Procedure 12(b)(1) and 12(b)(6), arguing that this Court lacks subject matter jurisdiction because the cases are not ripe and that Plaintiffs failed to state a claim because HRSA’s approvals of J&J’s audit plans were not “final agency action” subject to judicial review
Case Details
Case Details
Legal case information
Status
Decided
Date Decided
June 17, 2025
Jurisdiction
FD
Court Type
district
Legal Significance
Case importance metrics
Metadata
Additional information
Quick Actions
Case management tools
Case Summary
Summary of the key points and legal principles
UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA
OREGON HEALTH & SCIENCE : UNIVERSITY, : : Plaintiff, : Civil Action No.: 24-2184 (RC) : v. : Re Document Nos.: 18, 20 : THOMAS J. ENGELS, et al., : : Defendants; : : MAINEGENERAL MEDICAL CENTER, : : Plaintiff, : Civil Action No.: 24-2187 (RC) : v. : Re Document Nos.: 19, 21 : THOMAS J. ENGELS, et al., : : Defendants; : : UNIVERSITY OF ROCHESTER, : : Plaintiff, : Civil Action No.: 24-2268 (RC) : v. : Re Document Nos.: 18, 20 : THOMAS J. ENGELS, et al., : : Defendants; : : CHILDREN’S NATIONAL : MEDICAL CENTER, : : Plaintiff, : Civil Action No.: 24-2563 (RC) : v. : Re Document Nos.: 15, 18 : THOMAS J. ENGELS, et al., : : Defendants; : : UNIVERSITY OF WASHINGTON : MEDICAL CENTER, : : Plaintiff, : Civil Action No.: 24-2998 (RC) : v. : Re Document Nos.: 26, 28 : ROBERT F. KENNEDY, JR., et al., : : Defendants. : :
MEMORANDUM OPINION 1
GRANTING DEFENDANTS’ MOTIONS TO DISMISS; AND GRANTING JOHNSON & JOHNSON’S MOTIONS FOR LEAVE TO FILE AMICUS BRIEFS
I. INTRODUCTION
In April 2024, Johnson & Johnson Health Care Systems Inc. (“J&J”), a pharmaceutical
drug manufacturer, contacted Plaintiffs, healthcare providers, regarding their utilization of drugs
in the 340B Drug Pricing Program, 42 U.S.C. § 256b. The 340B Program requires that
pharmaceutical drug manufacturers that participate in Medicaid and Medicare Part B, like J&J,
sell drugs to statutorily covered entities, like the hospitals and medical centers operated by
Plaintiffs, 2 at lower prices. The statute also authorizes manufacturers to conduct audits of
1
This Memorandum Opinion addresses pending motions in the five cases listed above.
For convenience, the Court will cite to docket numbers from the earliest filed case, Oregon Health & Science University v. Engels, No. 24-cv-2184, unless otherwise specified. 2 Plaintiffs are Oregon Health & Science University (“OHSU”), MaineGeneral Medical Center (“MaineGeneral”), University of Rochester, Children’s National Medical Center (“Children’s National”), and University of Washington Medical Center (“UWMC”).
2
covered entities, at the manufacturers’ expense, to ensure compliance with statutory provisions
related to those lower prices. J&J submitted audit plans for Plaintiffs to the Health Resources
and Services Administration (“HRSA” or “Agency”), an agency within the Department of Health
and Human Services (“HHS”), and HRSA approved the audit plans. But Plaintiffs objected, and
brought this suit against the heads of HRSA and HHS, arguing that HRSA’s allowance of J&J’s
audit without following certain procedures was arbitrary, capricious, and contrary to law under
the Administrative Procedure Act (“APA”), 5 U.S.C. § 706. 3 Defendants filed motions to
dismiss each of the cases under Federal Rule of Civil Procedure 12(b)(1) and 12(b)(6), arguing
that this Court lacks subject matter jurisdiction because the cases are not ripe and that Plaintiffs
failed to state a claim because HRSA’s approvals of J&J’s audit plans were not “final agency
action” subject to judicial review
Case Information
Detailed case metadata and classifications
Court Proceedings
Document Details
Legal Classification
Judicial Panel
Similar Cases
Cases with similar legal principles and precedents
Case Details
Legal case information
Status
Decided
Date Decided
June 17, 2025
Jurisdiction
FD
Court Type
district
Legal Significance
Case importance metrics
Metadata
Additional information
Quick Actions
Case management tools