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Death row prisoners sue FDA for allowing unapproved execution drug to be imported

BMJ 2011; 342 doi: (Published 07 February 2011) Cite this as: BMJ 2011;342:d818
  1. Clare Dyer
  1. 1BMJ

The US Food and Drug Administration is being sued by six prisoners on death row to try to stop it from allowing thiopental sodium, the anaesthetic widely used in lethal injections in the United States, to be imported into the country.

The lawsuit, filed by the international business law firm Sidley Austin, accuses the FDA of violating federal law by allowing state correction agencies to bring in unapproved supplies of the drug.

The complaint states: “The law requires FDA to ensure that only safe, effective drugs are brought into the United States. When the agency allowed states to import unapproved sodium thiopental, it abdicated its responsibilities and violated federal law.”

Thiopental sodium is part of the three drug protocol used by many of the states that carry out executions. After the sole supplier in the US decided to stop making it, state authorities were driven to import it from abroad.

Several states bought it from Dream Pharma, which operates from a driving school in Acton, west London (BMJ 2011;342:d95, 7 Jan, doi:10.1136/bmj.d95). Sidley Austin, which has 17 offices worldwide, including in London, says that records obtained through freedom of information requests show large amounts of thiopental sodium imported by at least five states “with the knowledge and acquiescence of FDA.”

The law firm adds: “The records suggest that the imported drug was manufactured in Austria and sold by a broker sharing space with a driving school in London to state officials in Arizona, Arkansas, California, Georgia, and Tennessee.”

Because the drug has not been approved and therefore not shown to work as intended, the firm alleges that its importation creates unacceptable risks that prisoners will not be properly anaesthetised before the other two drugs, to stop breathing and induce cardiac arrest, are administered.

“Whatever one’s views may be on the death penalty, no reasonable person is in favour of botched or inhumane executions,” said Bradley Berenson, a partner in Sidley Austin’s office in Washington, DC. “Ineffective anaesthesia that subjects condemned prisoners to needless, and indeed unconstitutional, suffering serves no one’s interests, least of all the states’.”

The lawsuit asks the federal district court in Washington, DC to declare that the FDA has violated the law, to ban it from allowing any further shipments, and to require it to recover any unapproved thiopental sodium previously allowed in.

Coleen Klasmeier, head of the firm’s food, drug and medical device regulatory practice, said, “Assuring drug safety and efficacy is the bedrock of FDA’s public health mission. We are asking FDA only to fulfil its duty to secure the border against the unlawful importation of potentially substandard and dangerous unapproved drugs.”


Cite this as: BMJ 2011;342:d818

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