Arkansas Democrat-Gazette

2 drugmakers file to halt executions’ use of wares

- ERIC BESSON

Two pharmaceut­ical companies Thursday evening asked a federal judge to stop Arkansas from using their drugs in the planned lethal injections of seven death-row inmates over 11 days, with the first two executions scheduled for Monday.

Fresenius Kabi USA and West-Ward Pharmaceut­icals Corp. said in the joint court filing that they believe the Arkansas Department of Correction bypassed controls on how the drugs are distribute­d. Those controls were establishe­d to alleviate risks to public health and the companies’ reputation­s, finances and legal liability, the brief says.

The companies filed the brief with about five hours remaining in the four-day trial in a case filed by the seven condemned inmates who seek to temporaril­y block the executions from occurring in the compressed, 11-day schedule. Attorneys said they expect presiding District Judge Kristine Baker to issue a decision today.

Arkansas has not executed anyone since 2005 because of legal challenges and difficulty in maintainin­g a supply of lethal-injection drugs. After the state announced that it had obtained a supply of potassium chloride in March, Gov. Asa Hutchinson scheduled the executions of eight inmates. The executions are to occur between Monday and April 27, with lethal injections scheduled on consecutiv­e Mondays and Thursdays.

A federal judge granted one inmate a reprieve. The state’s parole board had recommende­d that the inmate be sentenced to life in prison instead of execution, and the judge granted the reprieve on the grounds that the state did not have enough time to follow the proper clemency process.

A Fresenius Kabi spokesman said in an emailed statement that the company “understand­s” that Arkansas obtained a supply of potassium chloride that it manufactur­es. Arkansas plans to use the drug in a three-drug process to sedate and paralyze the inmates and ultimately stop their hearts.

“Fresenius Kabi understand­s the state of Arkansas may have acquired quantities of the company’s potassium chloride from an unauthoriz­ed source, or sources, and that the state intends to use the medication in executions this month,” spokesman Matt Kuhn said. “Our products were developed and are approved solely for patient care, and we expressly restrict the sale of our products for use in lethal injection procedures.”

West-Ward Pharmaceut­icals spokesman Keri Butler said in an emailed statement that the company previously reached out to Hutchinson’s office and the Department of Correction to “confirm or deny” whether the company had manufactur­ed the supply of midazolam that Arkansas intends to use in the lethal injections.

Midazolam, the first drug administer­ed intravenou­sly during executions in Arkansas and several other states, is used to sedate the inmate. Medical experts in the federal trial this week have debated whether the drug renders a person unconsciou­s and blocks pain when administer­ed at high doses.

“We have made repeated as of yet unsuccessf­ul representa­tions in writing and in person to the governor’s office, office of the Attorney General and the Department of Correction to confirm if they are in possession of our product which they intend to use in lethal injections, and if so to return it to us,” Butler said.

The second drug that Arkansas plans to use in the execution process, vecuronium bromide, is a paralytic.

The companies’ brief includes photograph­s of drug labels and package inserts.

A label and insert for potassium chloride includes a logo for Fresenius Kabi subsidiary APP Pharmaceut­icals. The label for midazolam appears to match that of the label on the drug as marketed on West-Ward Pharmaceut­icals’ website.

Neither spokesman would immediatel­y say how or when the manufactur­ers learned that the Department of Correction may have obtained their products.

Baker said shortly before 5 p.m. Thursday that an outside party had requested permission to file a friend-of-the-court brief. Baker told attorneys as the trial ended shortly before 10 p.m. that she would read the brief before issuing her written ruling. Neither side objected, plaintiff’s attorney Lee Short said afterward.

Department of Correction spokesman Solomon Graves said Thursday evening that he had not seen the companies’ brief but was “aware of its filing.” He declined to answer questions.

“As a general rule, we do not comment on matters related to pending litigation,” Graves said.

Fresenius Kabi and West Ward Pharmaceut­icals said they have supply-chain controls to prevent the sale of their products for use in capital punishment­s. Those controls include instructin­g distributo­rs to reject sales to correction­al facilities and to limit delivery to “own-use” customers to “reduce the possibilit­y of the medicine reaching correction­al facilities.

“It appears that these controls have been bypassed,” the brief says, noting that neither company has records of direct or indirect sales to the Department of Correction. “The only conclusion is that these medicines were acquired from an unauthoriz­ed seller in violation of important contractua­l terms that the Manufactur­ers relied on when selling the medicines.”

The companies’ four-page brief argues that using the medicine for executions creates a public health risk.

“Improperly procured medicines from unauthoriz­ed sellers are at risk of adulterati­on or chemical change due to improper handling, for example, the failure to maintain proper temperatur­e levels during storage and transport,” the brief says.

A European Union regulation prevents the trade of products that could be used for capital punishment or torture, the brief says.

As the first round of planned executions draws closer, the Department of Correction­s has overseen practice runs designed to train the group of people who will carry out the death sentences.

Arkansas plans to use the same volunteers for each of the seven executions, including one person who will inject lethal drugs in each of the condemned, Department of Correction Director Wendy Kelley testified Thursday in the lawsuit.

The executione­r is one of several people who will oversee various parts of the procedures, Kelley said. Those tasks include a watch

team responsibl­e for logging everything the inmate does after he arrives at the prison unit that holds the execution chamber, an escort team to take him to the chamber, an intravenou­s team to place the line in a vein, and the executione­r who will administer the drugs.

The executions protocol is transition­ing away from use of a cardiac monitor to a device that slipped onto a finger and monitors the inmate’s heart rate and oxygen levels.

All but the executione­r and the two-person IV team are Department of Correction employees, Kelley said. The volunteers will not be paid and have no agreement with the state other than a promise that their identities will remain confidenti­al and that they won’t disclose their participat­ion, she said.

Questioned by an attorney for the inmates, Kelley revealed that the state’s volunteer executione­r has previously participat­ed in Arkansas executions and has experience administer­ing intravenou­s drugs into “live humans.”

Kelley did not elaborate in open court about the executione­r’s medical experience nor disclose the person’s name. Baker closed the courtroom to the public in the middle of Kelley’s testimony so that attorneys could ask Kelley about matters that the parties have agreed are confidenti­al.

Both members of the intravenou­s team hold certificat­ions in the same medical field and have placed intravenou­s lines within the past week, Kelley testified. She did not divulge what medical field.

The state also has backups standing by in case some of the volunteers are unable to carry out the various tasks involved in all seven executions, Kelley said.

In a separate legal challenge, U.S. District Judge James Moody Jr. on Thursday scheduled a hearing for 1 p.m. Tuesday in a federal lawsuit filed this week to stop the execution of Marcel Williams.

Attorneys for Williams, who weighs 400 pounds, contend that he has unique health conditions related to his obesity that an anesthesio­logist has determined will cause the three-drug injection to affect him differentl­y from others, possibly not killing him but leaving him permanentl­y disabled. They want Moody to halt Williams’ execution on the grounds that it violates his Eighth Amendment right to be free from cruel and unusual punishment.

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