Beaty v. FDA Appealed

No surprise, the FDA has appealed US District Court Judge Richard Leon's ruling on Beaty et al. v. Food and Drug Administration et al., No. 11-cv-289. Nebraska refused to obey the order and urged the FDA to appeal. See Nebraska's Thiopental for Lethal Injection for some links and details.

Oklahoma's Attorney General was joined by the Nebraska AG and thirteen others in a letter to US AG Eric Holder, requesting an appeal of the case so that they can enforce capital punishment in their various states.

Nebraska's thiopental for lethal injection

Nebraska has refused to turn over its stock of thiopental for lethal injection to the FDA. The FDA was following a court order issued by US District Judge Richard Leon. The source of Nebraska's thiopental is dubious at best. (My bold added to my earlier post.)

Purchases from India: In 2010 and 2011 various US states inquired about and some purchased thiopental from India.  The Sunday Guardian reports that Navneet Verma, managing director of Kayem Pharmaceuticals, bought vials of thiopental with English labels from Mumbai company Neon Laboratories for sale to Nebraska and South Dakota because his existing stock was labeled in Portuguese for use in Angola. The Times of India reports that Kayem consists of a Mumbai office and storeroom, with a kitchen on a balcony. This seems very similar to the questionable situation with Dream Pharma. Later in 2011, Mr. Verma reversed his decision to sell more thiopental to various US states that had sent him inquiries.

Another Indian company, Naari, was duped by an Indian purchaser, Chris Harris, who stated that he was buying samples to ship to Zambia for approval and importation to that country. Instead, the drugs were sent to Nebraska, and Naari has protested to the Chief Justice of the Nebraska Supreme Court and started legal proceedings for their return. The Indian Express reported other details of this story.

Nebraska Attorney General Jon Bruning has urged the FDA to appeal Judge Leon's decision, and further litigation is assured in order to determine the administrative discretion of the FDA and to delineate the roles that the FDA and DEA will play in issuing import licenses.

Shortage of sodium thiopental for lethal injection

The shortage of sodium thiopental for lethal injection continues, and the US response to the shortage has progressed beyond that in my previous post below. First, a reminder that there is no FDA-approved source of injectable sodium thiopental. Any sodium thiopental imported for health care is an illegal substance. In contrast, the FDA has not acted on importation of thiopental for lethal injection. Beaty et al. v FDA has challenged this inaction in federal court and yesterday US District Judge Richard Leon banned the import of thiopental for lethal injection and ordered the states to return any supplies obtained abroad. Reuters quotes from Judge Leon's written opinion:

"The FDA appears to be simply wrapping itself in the flag of law enforcement discretion to justify its authority and masquerade an otherwise seemingly callous indifference to the health consequences of those imminently facing the executioner's needle. How utterly disappointing!"

Here is a PDF of the judge's order accompanying his opinion. The APA reference in the order is the Administrative Procedures Act. As I understand this law, one of its requirements is that federal agencies establish uniform standards governing their conduct. According to Judge Leon, the FDA has violated this requirement by refusing to act in the case of thiopental for lethal injection, as opposed to all the many actions the FDA does take to ensure that only safe and effective drugs are approved for import.


Shortages of Drugs for Lethal Injection