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2 drugmakers file to halt use of wares in Arkansas executions

by Eric Besson | April 14, 2017 at 4:30 a.m.

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.

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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.

Information for this article was contributed by Linda Satter of the Arkansas Democrat-Gazette.

A Section on 04/14/2017

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