Fresenius case puts spotlight on misuse of medicines in executions

A lawsuit filed by a German pharma company against the US state of Nebraska has once again drawn attention to US authorities finding it hard to obtain the drug cocktails they need to carry out the death penalty.

The United States remains an exception among Western democracies when it comes to the death penalty. As many as 31 US states have capital punishment on their books and almost 1,500 people have been executed in the country since 1976. Some 3,000 inmates in US prisons are currently on death row.   

To carry out executions, all US states resort to the use of lethal injections

There are three drugs typically used in the lethal-injection cocktail: Midazolam, which is used as an anesthetic; Vecuronium bromide, which causes paralysis; Potassium chloride, which is used to stop the heart.

But opposition to capital punishment has been on the rise worldwide, including in the US. While lethal injection was previously touted as a simple, humane way to put condemned prisoners to death, many now disagree.

The growing opposition has led most drug manufacturers worldwide to put in place measures to avoid any association with capital punishments. Many of them have barred the sale of their products to corrections agencies in the US. In recent years, European countries have also imposed export controls on an array of execution drugs in an attempt to stop American states from executing prisoners.

The mounting difficulty in obtaining lethal drugs has prompted authorities in a number of US states to scramble for supplies. Some states have even decided to switch to a one-drug lethal injection or covertly buy supplies from loosely regulated compounding pharmacies.

Despite their efforts, some states have had to delay executions for months or longer, due to either drug shortages or legal issues associated with the drugs and injection procedures.

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Illicit purchases?

The federal lawsuit filed this week by German pharmaceutical company Fresenius Kabi against the state of Nebraska is a case in point. Nebraska state officials are preparing for their first execution in two decades and first ever lethal injection with an untried combination of drugs.

The state plans to use four drugs — the sedative Diazepam, the powerful narcotic painkiller fentanyl citrate, the muscle relaxer cisatracurium and potassium chloride, which stops the heart.

Fresenius Kabi is suing to halt the planned execution, accusing the state authorities of illegally obtaining the potassium chloride and cisatracurium made by the company to use them in the lethal injection procedure.

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Potassium chloride is primarily used to prevent or treat low blood levels of potassium, a state called hypokalemia. And Cisatracurium was developed for anesthetic purposes and is currently one of the most commonly used neuromuscular blocking agent in intensive care units. 

Fresenius Kabi argues that Nebraska's use of its drugs in executions would damage its reputation and business relationships. To substantiate its allegations, the firm highlighted that the state's supply of the drug is stored in 30 milliliter vials. The drug maker said it's the only company that supplies potassium chloride in vials that size.

"These drugs, if manufactured by Fresenius Kabi, could only have been obtained by (the corrections department) in contradiction and contravention of the distribution contracts the company has in place and therefore through improper or illegal means," the company said in the lawsuit.

The company stressed it only sells those products to wholesalers and distributors who sign a contract agreeing not to supply the drugs to correctional departments.

Blocking sales

A spokeswoman for Nebraska Attorney General Doug Peterson, however, said the lethal injection drugs were purchased lawfully "and pursuant to the state of Nebraska's duty to carry out lawful capital sentences."

Nebraska state officials are preparing for their first execution in two decades and first ever lethal injection with an untried combination of drugs

But state officials have refused to identify their supplier and appealed a judge's order to release records that would reveal their source, prompting criticism from death penalty opponents and human rights activists.

"Every FDA-approved manufacturer of any drug sought by prisons for use in executions has blocked that drug's sale for this purpose. These companies have made it abundantly clear they don't want their life-saving medicines to be used to kill prisoners and have implemented controls to prevent this," Maya Foa, head of the Lethal Injection Information Center at Reprieve, a London-based human rights advocacy group, told DW.

"By not heeding their wishes and respecting these controls, Nebraska's actions undermine the interests of responsible healthcare companies and put public health at risk," she added.

A federal judge is expected to rule Friday on whether to temporarily prohibit the state from using the drugs in its possession for the execution of Carey Dean Moore, who was condemned to die for the 1979 murders of two Omaha cab drivers.

Fresenius' lawsuit is just the latest legal intervention by a healthcare company in opposition to the misuse of medicines in executions. It comes after the pharma firm Alvogen sued the state of Nevada last month to prevent the use of its medicines in a planned execution.

Alvogen sought the return of its product Midazolam, which it said Nevada had acquired "illicitly and through subterfuge." The suit was successful in blocking the state from using the company's medicines and postponing the scheduled execution.

Tracing the products

The cases raise the question of how much control companies like Fresenius have when it comes to monitoring and determining who ultimately uses their products and how they use them.

"Fresenius Kabi and most major US and international pharmaceutical manufacturers have established distribution controls in the United States to assure their products are not sold for use in lethal injection," the company said in a statement to DW. "Medical associations have put in place similar restrictions on the participation of their members in state executions," it added.

Experts say companies in the healthcare industry are required to be able to trace their products throughout the supply chain. This is how they are able to recall products when there are defects, prevent diversion and safeguard against counterfeit products entering the market.

"In the case of execution drugs, companies have designed distribution models that specifically enable them to guide the products they manufacture to hospitals and patients, and prevent them from being sold to prisons for use in executions," said Foa.

"The controls are working, which is why many states have had to change execution protocols. And some states are beginning to turn away from the lethal injection altogether," she underlined.

The expert pointed to the example from earlier this year when the state of Oklahoma abandoned lethal injection as its primary method of execution and moved to nitrogen hypoxia. "Officials there recognized that it was impossible for them to legally obtain the drugs they wanted."

The increasing unavailability of lethal drugs, however, has led some US states to even consider bringing back death by firing squad, electrocution or the gas chamber to carry out executions.

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Business | 10.08.2018

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