ACLU Sues FDA on State Lethal Injection Imports for Use in Executions

San Francisco – The American Civil Liberties Union of Northern California (ACLU-NC) and The San Francisco Bay Guardian (The Guardian) filed suit late Thursday against the U.S. Food and Drug Administration (FDA), seeking full disclosure of public documents regarding the federal government's role in overseeing a worldwide scramble by state prison officials to import controlled substances for use in executions.

The suit follows separate litigation filed in April against the Drug Enforcement Administration, which led to the disclosure of documents showing that state officials in Arizona, Arkansas, Georgia, Nebraska, South Carolina, South Dakota, and Tennessee violated federal law when they made hasty arrangements to buy lethal injection drugs from overseas suppliers in India and the United Kingdom. The April lawsuit was also filed by the ACLU of Northern California and The Guardian.

"The FDA has made contradictory statements about the role it plays under U.S. law in controlling the entry of controlled substances including lethal injection drugs," said Natasha Minsker, Death Penalty Policy Director for the ACLU of Northern California.

First, the federal agency tried to stop the import of one execution drug (sodium thiopental) citing concerns about its labeling and authenticity. Months later, the FDA cleared the drug for entry, claiming that it had a long-standing ';hands off' policy on lethal injection drugs. Even then, the agency issued a disclaimer saying it had not reviewed the drug to assure its "identity, safety, effectiveness, purity or any other characteristics."

Records obtained by the ACLU indicate that:

• The FDA was "concerned about the importations of non-FDA approved sodium thiopental used for executions" but then "signed off on the importation of this drug";
• The FDA prepared and circulated to other federal agencies a document about lethal injections titled "revised lethal injection memo 11 10 10.docx"; and
• The FDA was "looking for another agency to take on this issue to prevent [the] product from being brought into the country."

In response to a Freedom of Information Act (FOIA) request by the ACLU of Northern California and The Guardian, the FDA has produced a trickle of heavily redacted documents, but has failed to hand over its "revised lethal injection memo," or any documents explaining its "concern" about the importation of non-FDA approved sodium thiopental or its efforts to look for "another agency to take on this issue."

The ACLU of Northern California and The Guardian earlier filed suit and sought to enforce a request for records against the Drug Enforcement Administration, after which the DEA produced documents showing that all but one of the states that imported sodium thiopental from overseas violated at least one federal law in doing so.

Learn more:

Legal papers & documents.

Map with details on illegal imports.

Timeline on the lethal injection scramble.