Lawsuit filed against the FDA to recall execution drugs

The Washington DC firm Sidley Austin LLP filed suit in federal court this morning against the Food and Drug Administration. The subject of the suit: the FDA’s decision to let imports of British-made sodium thiopental go ahead to states that are planning on using the drug in executions. Six death row inmates are named as plaintiffs in the case, including Steve Livaditis and Brett Pensinger of California.

At issue is the drug, sodium thiopental, an anesthetic used in many states’ lethal injection procedures. Only one company, Hospira, has been approved to manufacture sodium thiopental for use in the United States. That company stopped making the drug in 2009 due to a raw materials shortage, meaning states that use the drug in executions were left to look for other sources. Hospira has since announced that they’re completely discontinuing the drug, due to controversy over its use in lethal injections.

Because of the national shortage, many states, including California, Arizona, and Tennessee, ordered supplies of the drug from the United Kingdom–and the FDA allowed the shipments to go ahead. Since then, many death penalty watchers have raised questions about the quality and legality of those drugs–saying that if the drug malfunctions, inmates could experience tremendous pain while dying, which they say violates the Eight Amendment’s ban on cruel and unusual punishment.

The complaint filed today says that it’s the FDA’s job to make sure that only safe, reliable drugs are brought into the country. The shipments, some of which have been traced to a pharmacy in West London that doubles as a driving school, were initially held by FDA agents who labeled it “misbranded.” ‘Misbranded” is a label commonly used for drugs that come from a non-FDA-approved source. Later, documents obtained by the ACLU show, after facing pressure from authorities in states that had ordered the drug, the FDA released all shipments with the following statement:

“In keeping with established practice, FDA does not review or approve products for the purpose of lethal injection. FDA has not reviewed the products in this shipment to determine their identity, safety, effectiveness, purity, or any other characteristics.”

Lawyers for the death row inmates say that was the wrong move–that the FDA’s decision to let shipments of an unapproved foreign drug go ahead is unprecedented. ”FDA’s recent actions with respect to thiopental are manifestly contrary to law and amount to an abdication of the obligations imposed by the (Food, Drug and Cosmetic Act of 1938),” the lawsuit states.

The suit asks the court to not only prevent future shipments of execution drugs from abroad, but to recall those that have already arrived in various states’ prisons. California’s has a stock of 521 grams of sodium thiopental from a company in the United Kingdom, for which the state paid $36,415 in November

KALW