Editors note: This story has been updated throughout.
The latest battle over the efficacy of lethal injection drugs made by compounding pharmacies surfaced on Tuesday in an eleventh-hour appeal filed on behalf of a Texas inmate scheduled to be put to death on Wednesday.
Lawyers Maurie Levin of Philadelphia and Jonathan Ross of Houston filed the federal appeal for Willie Trottie, 45, claiming the Texas Department of Criminal Justice (TDCJ) intends to use expired pentobarbital that was produced by a compounding pharmacy and not by a drug manufacturer — and that has not been tested for sterility or potency in six months.
"There is a substantial risk that the use of expired drugs will subject Mr. Trottie to tortuous pain," the lawyers wrote in the appeal, filed before the U.S. 5th Circuit Court of Appeals in New Orleans. They argued that the drug stock TDCJ currently has on hand violates Trottie's 8th Amendment right to be free of "cruel and unusual punishment."
TDCJ spokesman Jason Clark insisted on Tuesday that the two 2.5-gram vials of pentobarbital expected to be used to execute Trottie on Wednesday evening have a "by use date" of Sept. 30. Two backup vials of pentobarbital have a "by use date" of Oct. 31.
"The drugs have been tested for potency and defect," he said. "The drugs have a potency of 108 percent and were found to have no defects."
For the past year, TDCJ and prisons nationwide that execute prisoners by lethal injection have had to mix up their drug cocktails and turn to compounding pharmacies to make the drugs they need for execution. That’s because drug manufacturers — many of them based in Europe — have stopped selling their wares for use in U.S. executions.
Clark said that according to the "industry standard” and the most recent round of testing, the compounded drug expected to be used in Trottie’s execution is good through the last day of September.
But Trottie's attorneys, noting that the testing on the drug occurred back in March, wrote in their appeal that there is no science to back up the agency's claim that the drugs are cleared for use.
"Defendants' bald assertion that the drugs will not expire until Sept. 30 is not supported by either documentary or expert evidence," they wrote.
In their appeal, Trottie's lawyers took aim at the testing lab used by TDCJ, Eagle Analytical Services of Houston, which was cited in 2013 by the Food and Drug Administration (FDA) for not using “scientifically sound and appropriate specifications, standards and test procedures to assure that components conform to appropriate standards of identity, strength, quality and purity.”
Since 2004, Eagle Analytical has operated as a "contract laboratory" for compounding pharmacies — pharmacies that mix drugs on demand through a prescription. In its response to the FDA report, Eagle's lawyers claimed they were being held to a standard used for drug manufacturers, not compounding pharmacies.
Trottie's lawyers claim problems in four recent executions can be traced to either untested combinations of lethal drugs or those compounded by pharmacies.
On Jan. 9, Michael Lee Wilson's final words in his Oklahoma execution were "I feel my whole body burning" after the three-drug cocktail there, which included compounded pentobarbital, was injected.
A week later, Ohio condemned inmate Dennis McGuire struggled and choked for about 10 minutes during his execution, the first to use manufactured midazolam.
On April 29, it took 43 minutes for Oklahoma death row inmate Clayton Lockett to die, reportedly from a heart attack, after midazolam was used.
On July 23 in Arizona, Joseph Wood's execution took nearly two hours to complete. Midazolam was also used in that execution.
If carried out on Wednesday, Trottie's execution will be the 516th in Texas since the state reinstated the death penalty in 1982, and the eighth for TDCJ so far this year. Texas switched to compounded pentobarbital a year ago after its supplies of manufactured pentobarbital ran out.