There's A Standoff Between States And The Feds Over Illegal Execution Drugs

It's been nearly a year since the federal government seized thousands of vials of lethal injection drugs on their way to death penalty states. The states want their drugs, and neither side is showing signs of backing down.

Nearly a year after seizing thousands of vials of execution drugs destined for death penalty states, the federal government continues to hold onto the shipments — and shows no signs of releasing them anytime soon.

What’s more, much of the discussion between the states and the federal government has been hidden in secrecy, and requests for comment or documentation have been denied; ignored; or met with brief, vague responses.

Nonetheless, a Friday court filing by lawyers for Arizona made clear that the conflict continues — and appears to be headed for court.

Arizona, Texas, and Nebraska each ordered 1,000 vials of sodium thiopental from a man in India named Chris Harris. Harris has convinced several states to buy execution drugs from him over the past several years, even though his drugs have never been used after questions are raised about their legality.

Although Harris claimed to be a drug manufacturer, BuzzFeed News revealed the two facilities he lists with the United States are just an old apartment building he left owing rent on and a small office space he rents out. Neither can be used to manufacture drugs.

In total, the three states paid Harris nearly $80,000 for 3,000 vials of execution drugs that they have not, and likely will never, receive — let alone actually use in an execution.

The shipment for Nebraska never made it out of India after FedEx realized the drugs were illegal to import. The shipments to Arizona and Texas were intercepted at the airport by the Food and Drug Administration in July 2015, and the agency continues to hold the drugs.

Sodium thiopental, although used in countries like India as an anesthetic, is no longer used in the United States, and there are no FDA-approved manufacturers of the drug. In the past, it had been used widely by death penalty states to sedate the inmates.

Arizona and Texas have balked at the detention of their drugs, appealing to the FDA in October 2015 to release the vials. The FDA responded in April 2016 that they would continue detaining the drugs, although the states have so far kept the full response from the public.

After 11 months of holding onto the states’ drugs, the FDA has made no final ruling on destroying or sending the drugs back to India. The thousands of vials of execution drugs continue to be held, likely in a government warehouse.

“A lot of times these things are labelling issues, where something can be done to fix the problem,” Sonali Gunawardhana, an attorney at Wiley Rein LLP who specializes in importation law, told BuzzFeed News. When the issue is minor, she said, the importer can meet with the FDA and work out a way to make it compliant.

“But the reality is that this situation appears to be very different than those situations, and there’s not an easy way to make it compliant,” she said. “If I had to guess, the FDA is holding onto the drugs until they expire.”

Gunawardhana said the state’s next recourse would be to sue — something that Arizona has already indicated it plans to do if the FDA denies their request to release the drugs.

“At that point, we would proceed in court to challenge,” assistant attorney general Jeffrey Sparks told a federal judge in January.

Late Friday, the attorney general’s office wrote in a court filing that there is no estimated timeline for the FDA to make a final decision, and reiterated that “If the agency’s decision is unfavorable to the Department, its only recourse would be to file suit.”

The states all hired private attorneys for legal help. Arizona has hired Alston & Bird, an Atlanta-based law firm with more than 700 lawyers and offices across the country. The law firm’s argument to the FDA is that since the drugs aren’t used for any medical purpose, the FDA has no right to detain them.

“The detained drug is to be used only for law enforcement,” Alston & Bird partner Daniel Jarcho wrote in an October 2015 letter to the FDA. “The restrictive legend on the label (‘For law enforcement purpose only’) makes that clear.”

“The purpose of [the statutes] is to provide warnings to patients as they take their own drugs. Here there will be no lay patient ‘users’ taking the detained drugs. This is a circumstance in which the imported substance is a drug that will not be used for medicinal purposes at all,” Jarcho wrote.

The letter to the FDA was marked “confidential” and also included a command that the agency keep information on the supplier secret.

“We demand that FDA and CBP comply with [Arizona’s execution secrecy law] and maintain the confidentiality of such information, unless required by law to release it,” the attorney wrote. “Any such release of any such information should not occur without first notifying ADC.”

Alston & Bird would not answer questions about the feud with the FDA. “We don’t have anything to add here,” spokesperson Nick Clarke said.

The states have so far refused to turn over the FDA’s response to BuzzFeed News, which it received in April 2016. The Arizona Department of Corrections’ said it wasn’t a public record, and is “the work product of a private attorney in furtherance of ADC’s ongoing settlement discussions with FDA.”

Arizona Attorney General Mark Brnovich’s office insisted on Friday that they don’t even have a copy of the FDA’s response, which is remarkable considering his office discussed the status of the FDA situation the same day.

The Texas Department of Criminal Justice has also not turned over the FDA’s response, and is asking its attorney general to weigh in on if they are legally required to do so. Two months after BuzzFeed News requested the response, the attorney general hasn’t made a decision.

Both states also have attempted to redact the identity of the private law firms they’ve hired to represent them, although neither has pointed to a reason for the redaction or a law that allows them to do so.

The FDA also has been quiet on the conflict. A spokesperson would only say that “the drugs are still being held by the agency. This remains an ongoing proceeding, and the agency has no further comment.”

Although Arizona and Texas have tried to keep the details of the drug sale a secret, importation documents obtained by BuzzFeed News clearly state the supplier: Chris Harris.

In March 2015, Arizona wrote Harris a check for $23,700. The next day they cut him another check for $3,000, bringing the total to $26,700 — the same amount Nebraska paid for the drugs.

Later that month, Texas paid Harris $24,990. In total, Harris made at least $78,390 selling illegal drugs to the states in 2015.

Arizona declined to comment on purchasing the drugs from Harris. Texas did not respond to a request for comment.

While Arizona and Texas continue to fight with the FDA over the drugs, Nebraska has given up — at least for now.

After facing heavy criticism from state lawmakers, Nebraska Department of Correctional Services Director Scott Frakes attempted to get a refund from Harris in January 2016.

Frakes said not receiving the drugs the state paid for was “unacceptable” and “a breach of the representations and promised delivery date made by Harris Pharma.” He asked for “full reimbursement” and warned of “further proceedings” if Harris did not do so.

Harris wasn’t interested, writing that refund was “not possible as there has been no fault of my company.” He added: “Hope this issue does not spoil the relationship between our organisations and we are able to do business in the future.”

Although Frakes threatened to sue Harris if he didn’t give them a refund, that doesn’t seem like a likely possibility now. Frakes hasn’t reached out to Harris since then, and he has had extremely limited discussions with the attorney general’s office about the possibility.

Texas did not respond to a request for comment on if the state will sue the FDA for its drugs.

Unlike Texas, which currently has an inventory of execution drugs, Arizona is much more desperate. The state insists it has no other options than its detained supply of drugs from India.

“The Department has no pentobarbital, no sodium thiopental, and… no unexpired midazolam,” attorney David Weinzweig wrote on Friday.

“Other than prevailing in the FDA matter, the Department has no immediate or potential prospect of obtaining” execution drugs.

The judge may ask more about the FDA detention at a scheduled conference in ongoing litigation at the end of the month.

The state had hoped to use its supply of another execution drug before it expired, asking the judge to speed up litigation brought by death row inmates. But the judge denied that request, finding the inmates’ arguments to have merit.

If Arizona isn't able to find another legal supplier, the state will have to choose between holding off on executions further and going to battle with the federal government. But the longer the state waits to decide whether to sue, the more likely the state is to put itself at risk of running into the same issue: At the end of litigation, the drugs could very well be expired.

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