Swiss pharmaceutical company Naari AG cried foul and asked Nebraska to return the sodium thiopental. State officials countered that they had legally obtained the lethal injection drug and would move forward to execute prisoner Michael Ryan. Ryan was scheduled to be put to death in March 2012 but received a stay of execution.
Naari AG said it gave samples of sodium thiopental, which was produced at its plant in India, to Chris Harris with Harris Pharma LLP, a Calcutta broker, who claimed he wanted to sell it as an anesthetic in Zambia, according to a November 18, 2011 letter from Naari AG CEO Prithi Kochhar to Nebraska Supreme Court Chief Justice Michael Heavican. Instead, Harris sold the samples to Nebraska officials for $5,411.
“I am shocked and appalled by this news,” wrote Kochhar. “I am writing to request that the thiopental which was wrongfully diverted ... to the Nebraska Department of Correctional Services be returned to its rightful owners, that is, that it be returned to us at Naari.”
A two-sentence statement from the Nebraska Attorney General’s office said the drug “was approved for legal export by the government of India and approved for legal import by the regulatory federal agencies of the United States (DEA and customs).”
The Nebraska Department of Correctional Services (NDCS) stated it had no plans to return the sodium thiopental. “From our perspective, we obtained that legally,” said NDCS spokeswoman Dawn-Renee Smith. “I’m not sure there really are any next steps at this point. We would, obviously, work with the Attorney General’s office as necessary.”
Sodium thiopental is no longer manufactured in the United States, and European countries have outlawed selling the drug to the U.S. because it is used in executions (the death penalty is banned in Europe). That restriction has led states to scramble to find alternative sources for the drug or other drugs to carry out death sentences. [See: PLN, June 2011, p.1].
On March 27, 2012, a U.S. District Court in the District of Columbia held that the Food and Drug Administration (FDA) should not have allowed unapproved foreign-manufactured sodium thiopental to be imported into the U.S., as it was a “misbranded drug and an unapproved new drug” under federal law. The FDA was ordered to instruct state agencies to surrender their supplies of foreign-made sodium thiopental, and the FDA was “permanently enjoined from permitting the entry of, or releasing any future shipments of, foreign manufactured thiopental into interstate commerce.” See: Beaty v. FDA, U.S.D.C. (D. DC), Case No. 1:11-cv-00289-RJL.
Nebraska refused to comply with the FDA’s request to give up the state’s sodium thiopental, however, arguing that it had obtained its supply of the drug from a different source than the one at issue in the case involving the FDA, which has since appealed the district court’s ruling.
“Other than the court’s erroneous order, we are unaware of any evidence or reasons why the Department of Correctional Services should be required to return any thiopental in its possession,” said Nebraska Assistant Attorney General James Smith.
The questionable method by which the state obtained its supply of sodium thiopental provided ammunition for opponents of the death penalty, including state Senator Brenda Council, who introduced legislation (LB 276) to replace capital punishment in Nebraska with life without parole.
“I don’t think the state should be involved in utilizing a product that the manufacturer has maintained was obtained under false pretenses,” Council said. “If you know the manufacturer had no intention that the drug be shipped to the United States – let alone to be used in lethal injection – that obliges you to step back.”
In September 2012, another European company, Germany-based Fresenius Kabi, announced that it would not sell propofol, a sedative, for use in executions in the U.S. Several states, including Missouri, had switched to propofol due to difficulties in obtaining other drugs used in lethal injections, such as thiopental.
“Fresenius Kabi objects to the use of its products in any manner that is not in full accordance with the medical indications for which they have been approved by health authorities,” the company stated. “Consequently, the company does not accept orders for propofol from any departments of correction in the United States. Nor will it do so.”
Sources: The Lincoln Star Journal, www.correctionsone.com, www.ketv.com, Associated Press
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Beaty v. FDA
|Cite||U.S.D.C. (D. DC), Case No. 1:11-cv-00289-RJL|