10th Circuit keeps war over Colorado’s $60 EpiPen program alive

DENVER (CN) — The 10th Circuit on Friday affirmed a denial of Colorado’s bid to dismiss a challenge to a 2023 law seeking to provide affordable access to EpiPens.

Anaphylaxis is a common and severe allergic reaction, typically treated by an epinephrine autoinjector, commonly known by the brand name EpiPen. To address the prohibitive costs an estimated 500,000 Coloradans face in accessing the life-saving devices, state legislators enacted HB23-100 in 2023, capping the cost to obtain a two-pack of EpiPens at $60.

While insurance companies are expected to make up the difference between their insuree’s $60 copay and the cost to obtain the device, manufacturers are left covering the difference for uninsured Coloradans who purchase the device at a pharmacy.

The law enables pharmacies to bill the manufacturer for the cost of the device, for which Teva Pharmaceuticals USA typically charges $300 per two-pack.

Although the company did not know how many of its products went to uninsured Coloradans, Teva sold 14,000 generic autoinjectors for children to Colorado wholesalers in 2022. It sued Colorado in federal court in October 2023, claiming the law violated its Fifth Amendment right against government takings.

Donald Trump-appointed U.S. District Judge Daniel Domenico denied Colorado’s 11th Amendment sovereign immunity claim for dismissal on Dec. 27, 2023. The state appealed, arguing just compensation is available in state court.

Whether relief is available in state court however, is not at issue, the panel found.

“Our straightforward Ex parte Young inquiry under Verizon does not extend to an analysis of whether injunctive relief is available in a particular case,” Senior U.S. Circuit Judge Bobby Baldock wrote in a 7-page opinion. “It is instead enough that plaintiff ‘seeks relief properly characterized as prospective.’”

The Ronald Reagan appointee focused on the ongoing impact of the law on companies like Teva.

“Plaintiff alleges an ongoing violation of federal law — that the affordability program’s reimburse or resupply requirement violates the Fifth Amendment’s Takings Clause,” Baldock wrote for the panel. “Plaintiff seeks relief properly characterized as prospective — injunctive relief enjoining enforcement of the reimburse or resupply requirement against plaintiff.”

U.S. Circuit Judge Robert Bacharach, appointed by Barack Obama, and Trump appointee U.S. Circuit Judge Joel Carson rounded out the panel. The case now returns to the Domenico’s court in Denver.

The Colorado Attorney General’s Office declined to comment citing the ongoing litigation.

Attorney Jay Lefkowitz, of the New York firm Kirkland and Ellis, represented Teva. Neither Lefkowitz nor Teva responded to requests for comment by press time.

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