Diversion in court:
the legal record

On 31 January 2025, twelve public health and drug safety experts — including a former FDA Commissioner and a former Principal Deputy Commissioner — filed a brief warning that Arizona’s procurement of pentobarbital for executions poses a risk to public safety.

The experts write that because there is no safe or legal way to obtain pentobarbital, the State has procured illicit raw ingredients, mixed by an unregulated compounding pharmacy, in breach of the laws that govern the drug supply. Secretive procurement of this kind, they argue, sustains illicit supply chains and risks lethal substances reaching the public.

The brief follows the collapse of the independent review of Arizona’s execution procedures ordered by Governor Katie Hobbs in January 2023. The retired federal judge appointed to lead it was dismissed in November 2024, and afterwards set out serious problems with the chain of custody for the drugs and with the lack of transparency in the state’s protocol.

On 31 January 2024, five pharmaceutical manufacturers — Exela Pharma Sciences, Fresenius Kabi USA, Hikma Pharmaceuticals USA, Sagent Pharmaceuticals and Sandoz — filed a joint brief in litigation challenging the constitutionality of South Carolina’s execution methods and of the secrecy law the state enacted in May 2023.

The companies rejected the suggestion that secrecy is something they want. They wish to emphasize that a secrecy regime is more harmful than transparency, the brief states, and note that they have repeatedly and emphatically requested that they not be granted cover of secrecy.

Concealing how execution drugs are acquired and handled, they argue, undermines drug safety and quality control, weakens the closed distribution systems built to prevent diversion, and exposes manufacturers to legal, fiscal, and other harms. A companion brief from public health professionals made a parallel point: the law prevents federal enforcement officials, and the public, from knowing how the drugs were sourced and transported.

In January 2024, public health professionals filed a brief in the same litigation, complementing the manufacturers’ brief. It set out the significant public health risks, including risks to prisoner health, that South Carolina created by enacting its secrecy law in May 2023.

The experts focused on how the law prevents federal drug enforcement officials, and the public, from understanding where execution drugs come from and how they are acquired, safeguarded and used.

The result, the brief argues, is a dangerous lack of transparency and oversight over how the state acquires and transports the dangerous drugs used in lethal injection.

On 26 July 2018, Hikma Pharmaceuticals moved to intervene in a lawsuit in Nevada, challenging the state’s illegal and unauthorized acquisition and possession of Hikma Fentanyl.

In doing so, Hikma joined Alvogen, which had sued Nevada earlier that month to prevent the use of its medicines in an upcoming execution. Sandoz, which produces the paralytic Cisatracurium Besylate named in Nevada’s protocol, also formally objected to its medicines being used in the execution.

A coalition of drug regulators and experts filed a brief in the US Supreme Court warning that death rows’ efforts to obtain lethal injection drugs could end up causing a public health crisis. The brief was signed by 18 public health and drug safety experts, including a former FDA Commissioner and Deputy Commissioner.

The experts warn that restrictions on the sale of medicines for capital punishment mean a small minority of states now obtain drugs through overseas sellers, unlicensed middlemen, and secret compounding pharmacies, undermining federal laws that protect the public health. Those risks, they write, are not merely theoretical: drugs obtained ostensibly for lethal injection have been diverted and have reached the patient population.

The experts take no formal position on capital punishment, but urge the Court to hold that pursuing execution by lethal injection does not permit a state to violate federal laws and regulations that protect the public health.

The Association for Accessible Medicines, the trade association for American generic drugmakers, filed an amicus brief before the US Supreme Court in a case concerning the constitutionality of the lethal injection.

The brief notes that the AAM and its members strongly oppose the use of their medicines in executions, and have enacted restricted distribution controls to prevent it. It warns that continued misuse of drugs by corrections officials could ultimately harm patients by contributing to drug shortages, and create market distortions affecting access to certain medicines.

The AAM’s membership consists of 25 global pharmaceutical companies.

On 10 July 2018, Alvogen sued the state of Nevada to prevent the use of its medicines in upcoming executions. Lawyers for the company alleged that officials had acquired its medicines illicitly and through subterfuge, violating state laws intended to tackle the opioid epidemic and prevent the misuse of dangerous drugs.

The complaint alleges the medicines were obtained without disclosing to the supplier that they were intended for a non-therapeutic use, and were purchased using the medical license of the department’s director. Alvogen sought an emergency injunction and the immediate return of its medicines.

The following day a Nevada judge issued a temporary restraining order blocking the scheduled execution of Scott Dozier, ruling the state may not use the company’s medicine in its lethal injection protocol. The judge found the order necessary to protect Alvogen from irreparable harm to its reputation as a company that produces life-enhancing and life-saving drugs.

In July 2017, Fresenius Kabi USA and Sandoz Inc. submitted a brief to the Ohio Supreme Court, challenging the use of state legislation to conceal the identities of the manufacturers whose drugs Ohio had obtained for use in upcoming lethal injections.

The companies describe themselves as among the many US and international pharmaceutical companies that have instituted supply chain controls to prevent the sale of their medicines for use in capital punishment, and so help ensure those drugs remain available for patient care. They note a significant interest in the proper implementation of those controls, warning that the use of their medicines in lethal injections carries serious reputational, fiscal and legal risks.

In April 2017, Fresenius Kabi and West-Ward intervened in the case of five death row prisoners in Arkansas who were scheduled to be executed by lethal injection using medicines manufactured by the two companies.

The companies write that the use of their medicines for lethal injections violates the contractual supply-chain controls they have implemented. They explain that improperly procured medicines from unauthorized sellers are at risk of adulteration or chemical change through improper handling — for example, a failure to maintain proper temperatures during storage and transport — and warn that the practice creates a public-health risk, because it could result in the denial of medicines to the patients who need them most.

In 2016 the Arkansas Department of Corrections sought to circumvent McKesson’s policies, procuring vecuronium bromide under the false pretense that it would be used for medical purposes in the department’s health facility.

On learning the product might be held for lethal injection, McKesson requested its return and was assured it would be returned. The company issued a full refund and made several further requests, but the product never came back. In April 2017 McKesson took legal action, alleging the products had been obtained through false pretense, trickery, and bad faith. The suit resulted in the temporary stay of eight executions by an Arkansas state court.

The complaint warns that McKesson would suffer grave reputational harm from association with the planned executions, using products that had been banned for that purpose — harm that would also affect its relationships with contractual partners.

In April 2017, West-Ward Pharmaceuticals and Fresenius Kabi USA submitted a brief in an Arkansas court in support of the suit brought by McKesson Corporation.

The companies write that the use of their medicines for lethal injections violates the contractual supply-chain controls the manufacturers have implemented, and that improperly procured medicines from unauthorized sellers are at risk of adulteration or chemical change. They further warn that the practice creates a public-health risk, because it could result in the denial of medicines to the patients who need them most.