Pharmaceutical companies make medicines to save and improve patients’ lives — not to end the lives of prisoners in executions. Five best practice steps to protect them from misuse.
Pharmaceutical manufacturers have long opposed the use of their medicines in lethal injection executions. Beyond running counter to the principles and ethos of the healthcare industry, the diversion of medicines to death rows carries serious fiscal, reputational and legal risks for the companies whose products are misused.
In the past fifteen years, over 100 companies have taken action to prevent it. Their action has had a profound impact, and states are now beginning to reconsider whether continuing to misuse medicines for capital punishment is viable at all. In the process, an industry standard has emerged — one recognized by corporate responsibility bodies including the Organisation for Economic Co-operation and Development and the United Nations Global Compact.
Investors in the healthcare sector have made clear that preventing the misuse of medicines in executions is an important corporate governance issue. One shareholder publicly divested a $70 million stake in a manufacturer after it emerged that the company had not effectively restricted sales of its products for use in executions. In another instance, a pension fund divested millions of euros in shares over the use of a company’s drugs in executions, citing its failure to “engage in a genuine dialogue” about their efforts to ensure their products are not used “in an undesirable way.”
When medicines are used in lethal injection executions, they risk being unfairly linked to a controversial non-medical practice that healthcare companies fundamentally oppose.
In one example, two companies were named in connection with a horrific botched execution in Oklahoma, which received international media coverage. Both companies were publicly criticized for having taken insufficient steps to protect their medicines from misuse in executions.
Court testimony from an anesthesiologist has described at length the reputational risks that arise for specific products when their name becomes associated with lethal injection executions. In Alvogen Inc. v. State of Nevada, Case No. A-18-777312-B (Sept. 12, 2018, Day 3, p. 34), an anesthesiologist testified that “when the public is exposed to information on drugs being related to adverse outcomes, intentional, unintentional, resulting in tragic loss, death, things like that, they become fearful. They become concerned and generally speaking they’ll want to avoid the drug.”
Companies whose medicines are used in executions face several forms of legal exposure. Any use of a company’s drugs in connection with lethal injection is an off-label use, contrary to the intended label use(s) for which the products were developed, approved and supplied. Companies have been sued by family members when executions go wrong, on the allegation that they should have known the drugs would cause unnecessary and extreme suffering.
Companies have also been forced to litigate to recover diverted medicines. One manufacturer sued a state for obtaining its drugs through false pretense, trickery and deceit. In another case, a district court granted a preliminary injunction after a manufacturer sued a state for acquiring its drugs illicitly and through subterfuge; the state was prohibited from using the supply in executions and subsequently agreed to return drugs to that company and two others that had intervened.
Such actions allow the company to defend the integrity of its contracts and the interests of its partners in the manufacturing sector; however, robust distribution systems, coupled with a clear public position statement and regular monitoring and evaluation of the controls will help ensure companies have no need to take legal recourse in the first place.
Companies seeking to protect their products from misuse — and to guard against the fiscal, reputational and legal risks set out above — should consult stakeholders and experts with knowledge of the capital punishment landscape in the United States.
The Dutch National Contact Point for the OECD Guidelines for Multinational Enterprises has urged pharmaceutical companies to work alongside distributors, specialist organizations and other partners to keep medicines out of lethal injections.
The UN Global Compact's good practice note on product misuse records how well this works in practice: a specialist organization worked with pharmaceutical companies to design a distribution model that protects medicines from being sold to prisons for use in executions — a model so effective it is now considered an industry standard.
Because the death penalty landscape shifts continuously, companies should keep an open line of communication with experts such as those at the Lethal Injection Information Center. The OECD further recommends engaging actively with investors — for whom, as the divestments above show, this is a live corporate governance issue — many of whom bring detailed knowledge from their work with other companies in the sector.
A public position statement shows to investors and other stakeholders that a company is mitigating the risk of its medicines being diverted to death rows. As the divestments above demonstrate, shareholders have pulled substantial stakes from companies precisely for failing to engage on this issue — making a published policy a matter of corporate governance as much as principle.
The statement may be apolitical in nature. It should confirm that the company opposes the misuse of its life-saving products in executions and that it has tailored distribution controls to protect its medicines through the supply chain. In the case of manufacturers, the statement should also make reference to all of the drugs the company manufactures that are controlled.
Beyond aligning the company with industry best practice — both the OECD Guidelines and the UN Guiding Principles expect businesses to set out their commitments in a published statement of policy — a clear public position provides reputational cover and serves an important deterrent function, discouraging entities from diverting products for use in executions.
Effective distribution controls are critical to protecting medicines from diversion and misuse — and, as the litigation described above shows, recovering product after the fact is far costlier than preventing its sale in the first place. Manufacturers with 'at-risk' medicines put strong distribution control systems in place to prevent Departments of Corrections from purchasing their products, whether directly or indirectly, for use in executions.
Sales of these medicines are restricted to legitimate medical users only — users who have agreed not to sell the medicine on to other users, vendors, or Departments of Corrections. The existence of these control systems is communicated to wholesalers, correctional facilities, state authorities, regulators and other interested stakeholders.
In order to ensure that supply chain controls are working effectively, and in line with federal regulations, pharmaceutical companies commit to regular auditing of their distribution systems, including monitoring, evaluation and reporting.
Companies work closely with their wholesalers to review sales patterns for 'at-risk' products, and request that regular audits be conducted to proactively identify risks.
Additional auditing and investigating takes place in cases where the company is informed or determines that 'at-risk' drugs manufactured, marketed or sold by the company may have been diverted to an executing state for use in executions. These safeguards minimize the possibility of diversions and/or misuse of restricted products, and the associated reputational, fiscal and legal risks documented above.
Companies report regularly to stakeholders on the results of their monitoring and evaluation of the controlled distribution systems.
Where a breach in a controlled distribution system has been identified, companies act quickly to remedy it. As the legal cases above show, manufacturers have pursued these remedies all the way to court — including litigation that ended with a state enjoined from using diverted drugs and agreeing to return them. Actions taken include:
Acting decisively defends the integrity of a company's contracts and the interests of its partners across the manufacturing sector.
Ultimately, it is far easier, and cheaper, to prevent these issues than to resolve them. A robust distribution system, coupled with a clear public position statement and regular monitoring and evaluation of the controls, will help ensure a company never needs to resort to the remedies above.
Guidance on this page draws on the OECD Guidelines for Multinational Enterprises, the UN Guiding Principles, and the UN Global Compact’s good practice note on product misuse. Quoted findings are summarized from the published documents linked alongside each. For tailored advice on distribution controls or position statements, please contact us at info@lethalinjectioninfo.org.
We support manufacturers and distributors pro bono on distribution controls and keep companies apprised as the landscape changes.