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525 F.Supp.3d 946
D. Minnesota
2021
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Background

  • Minnesota enacted the Alec Smith Insulin Affordability Act requiring insulin manufacturers to provide free insulin through two programs: a continuing Safety Net Program (up to one year via 90‑day supplies) and an Urgent Need Program (one 30‑day emergency supply).
  • Under the Act manufacturers must review eligibility, issue statements of eligibility or direct applicants to copay assistance, and either reimburse pharmacies or supply replacement insulin; pharmacies may collect capped copayments and manufacturers receive none of the copay.
  • PhRMA (representing major insulin manufacturers) sued state pharmacy board members challenging the Act as an uncompensated taking under the Fifth Amendment and, alternatively, as a dormant Commerce Clause violation if one statutory exemption is construed as a price‑condition.
  • PhRMA sought declaratory and injunctive relief (not damages); defendants moved to dismiss and PhRMA moved for summary judgment and for leave to file a supplemental complaint.
  • The court dismissed the takings claim for lack of standing/redressability under Knick because Minnesota provides inverse condemnation remedies; it dismissed the dormant Commerce Clause claim as derivative, denied leave to supplement as futile, denied PhRMA’s summary judgment as moot, and dismissed the case without prejudice (Mar. 15, 2021).

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Takings claim — availability of equitable relief PhRMA: equitable relief (injunction/declaration) is available because state remedies are inadequate to compensate ongoing/future takings Defs: Knick forecloses injunctive/declaratory takings relief where state just‑compensation remedies exist Held: Dismissed for lack of standing/redressability; Knick bars equitable relief because Minnesota inverse‑condemnation remedies are adequate
Adequacy of Minnesota inverse‑condemnation remedies PhRMA: state procedure cannot adequately compensate for continuous or future takings Defs: Minnesota law permits inverse condemnation/mandamus and can provide just compensation Held: Court finds Minnesota remedies adequate and rejects the ‘‘future taking’’/inadequacy arguments
Dormant Commerce Clause (statutory exemption) PhRMA: exemption could operate to condition avoidance of a taking on lowering national list prices (WAC), thus regulating out‑of‑state commerce Defs: Dormant Commerce claim depends on takings claim proceeding and statutory construction; otherwise derivative Held: Dismissed as derivative of the dismissed takings claim
Motion to supplement complaint (Rule 15(d)) PhRMA: seeks to add post‑pleading events if court finds ripeness/injury issues Defs: Proposed supplementation would not cure pleading defects Held: Denied as futile; supplemental allegations would not overcome jurisdictional defects

Key Cases Cited

  • Knick v. Township of Scott, 139 S. Ct. 2162 (2019) (holding that a property owner may sue in federal court but that injunctive/declaratory relief for takings is unavailable where adequate state just‑compensation remedies exist)
  • Williamson County Regional Planning Commission v. Hamilton Bank, 473 U.S. 172 (1985) (Takings Clause framework; just compensation requirement)
  • Lujan v. Defenders of Wildlife, 504 U.S. 555 (1992) (standing requirements: injury, causation, redressability)
  • Allen v. Wright, 468 U.S. 737 (1984) (standing principles and redressability)
  • American Family Insurance Co. v. City of Minneapolis, 836 F.3d 918 (8th Cir. 2016) (Minnesota inverse‑condemnation procedures allow mandamus to obtain compensation)
  • Cormack v. Settle‑Beshears, 474 F.3d 528 (8th Cir. 2007) (noting courts have not found state inverse‑condemnation procedures inadequate)
  • Boumediene v. Bush, 553 U.S. 723 (2008) (courts should avoid deciding hypothetical constitutional questions)
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Case Details

Case Name: Pharmaceutical Research and Manufacturers of America v. Williams
Court Name: District Court, D. Minnesota
Date Published: Mar 15, 2021
Citations: 525 F.Supp.3d 946; 0:20-cv-01497
Docket Number: 0:20-cv-01497
Court Abbreviation: D. Minnesota
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    Pharmaceutical Research and Manufacturers of America v. Williams, 525 F.Supp.3d 946