Fordham Law


New lethal-injection drugs raise new health, oversight questions

Deborah W. Denno in Al Jazeera America, October 14, 2013

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New lethal-injection drugs raise new health, oversight questions
by Timothy Bella

Inmates Michael Yowell and William Happ were on death row for more than 40 years combined. In Texas, Yowell shot his father, strangled his mother with a cord and burned their house to the ground in May 1998. In Florida, Happ kidnapped a 21-year-old girl, beating, raping and strangling her on Memorial Day weekend in 1986.

Before this month, Yowell and Happ were only connected by their lives as death-row inmates. Now, they will be connected in their deaths, both executed with controversial new drugs.

Texas and Florida are two states that can no longer use pentobarbital, the drug that 16 states have relied on in the last four years. Last week, Yowell was the first inmate in Texas to be executed with the compounded version of pentobarbital, a version of the drug that is not subject to federal oversight. On Tuesday in Florida, Happ will be the first inmate in the U.S. to be put to death using midazolam hydrochloride, a sedative that hasn’t been tested in executions.

Since 2010, pentobarbital has been the drug used for almost all of the lethal injections in the U.S. But medical organizations that produce pentobarbital in the past couple of years have agreed to prohibit the sale of these drugs to state prisons for the purpose of executions. Now, the supply for the state prisons has almost run dry. 

The scarcity of the most commonly used lethal-injection drug of the past four years in the U.S. has left state prisons questioning where to look to next. Among those states are Texas and Florida, which are using untested workarounds that have come into question by human-rights groups and death-penalty experts.

“It’s a desperate act on the part of states,” says Deborah Denno, a Fordham University law professor. “It’s a dangerous act because it’s extremely risky. These states just can’t go jumping from drug to drug to drug.”

In February 2009, Danish drugmaker Lundbeck purchased Illinois-based Ovation Pharmaceuticals for about $900 million. Lundbeck lauded the transaction as a “very important milestone” for the company, calling Ovation an “excellent match.”

“One of the reasons for buying [Ovation] was that they had a number of mature products, and pentobarbital was one of them,” says Anders Schroll, director of corporate communications for Lundbeck. “We looked at them and said, ‘We wanted that mature product.’”

Nembutal, the Lundbeck product containing pentobarbital, was first used in executions in Oklahoma and Ohio, and 13 states made the switch to the drug in 2011. But the Danish drugmaker was uncomfortable with the drug's usage, and doctors and human rights organizations pressured the company to end its supply to the U.S. In July 2011, Lundbeck restricted prisons from buying the drug. In December 2011, the company went one step further, selling its pentobarbital rights to Illinois-based AKORN in a the deal that prohibited AKORN from selling pentobarbital to prisons for executions.

“It was our responsibility to give access to people who needed pentobarbital and restrict it to prisons,” Schroll says.
'It's getting worse'

As the pentobarbital supply in U.S. prisons is set to expire, states have already begun to adopt new versions or replacements for the drug.

In Texas, the state’s department of criminal justice has partnered with a compounding pharmacy in suburban Houston to help produce a version of the drug specifically for executions. Earlier this month, the Texas Department of Criminal Justice responded to a Freedom of Information request from the Associated Press, showing that eight vials of pentobarbital were purchased from the Woodlands Compounding Pharmacy, which is not subject to any oversight from the Food and Drug Administration.

“The agency has purchased a new supply of the drug from a Texas pharmacy that has the ability to compound,” TDCJ said in a statement. “The purchase will allow the agency to carry out all currently scheduled executions.”

TDCJ Spokesman Jason Clark told America Tonight that there are five executions scheduled between November and February 2014.

“We’ve made it clear that we’re going to continue to use pentobarbital,” Clark says.

The drug has already caused a stir. This month, three Texas death-row inmates filed a federal lawsuit challenging the state’s use of the untested drug, saying it would violate the constitutional right against cruel and unusual punishment. After a federal judge rejected the argument, Yowell was executed last week with the compounded version of pentobarbital.

The lack of federal scrutiny on the drug for the purpose of executions will continue to be an issue of concern for the foreseeable future, says Megan McCracken, the Eighth Amendment resource counsel at the University of California-Berkeley School of Law.

“When a compounding pharmacy provides a drug, it’s appropriately filling a very important need in the medical community,” says McCracken, “but in this context, because of the lack of oversight and the lack of FDA regulation, it is not possible to have the assurances like we’d have with FDA-approved products.”

In Florida, the state is shifting away from pentobarbital altogether. On Tuesday, the state will use midazolam hydrochloride, a sedative that’s intended to serve as the unconsciousness-inducing first injection in the three-drug intravenous process.

The switch to midazolam hydrochloride has opponents of the drug pointing to Versed, its branded product form, which they say is one of the shortest-acting benzodiazepines on the market. If the drug is ineffective, there is concern that midazolam hydrochloride could potentially make the next two steps in Florida’s three-step lethal injection process, paralysis and cardiac arrest, to be inhumanely painful for an inmate.

“There’s no one who can say with 100-percent certainty how this new concoction is going to work,” says Mark Elliott, executive director of Floridians for Alternatives to the Death Penalty. “No one really knows what’s going to happen.”

The developments in Texas and Florida serve as a stern reminder of the evolution of lethal injection, as well as the future of a procedure used regularly for executions.

“The compounded drugs [in Texas] and the drugs that Florida is using, this was never what this lethal-injection procedure was supposed to be about,” Denno says. “States started going to lethal injection because they wanted to mimic medical procedures, but this process has been turned on its head. It’s getting worse and riskier than it ever has been.”