Federal judge slams secrecy of compounding pharmacies

April 10, 2014

As opposition to execution drugs grows, manufacturers are cutting off supplies and compounding pharmacies are under pressure.

Ned MilenkovichEighth Circuit Court of Appeals judge Kermit Bye attacked the secret use of compounding pharmacies to supply drugs deployed in lethal injections in a February 26, 2014 Missouri execution of Michael Taylor, 47, for the 1989 rape and murder of a 15-year-old girl. Taylor was put to death with a whopping dose of pentobarbital obtained from a pharmacist whose identity the state refused to disclose.

Both the Eighth Circuit and the United States Supreme Court refused to grant Taylor a stay of execution. Bye, however, dissented and drafted a passionate opinion about the secrecy shrouding execution practice in the United States.

Bye used an Eighth Amendment Constitutional argument, stating “[the Eighth Amendment] prohibits the unnecessary and wanton infliction of pain through torture, barbarous methods, or methods resulting in a lingering death.” He added that in light of “the absolute dearth of information Missouri has disclosed to this court, the ‘pharmacy’ on which Missouri relies could be nothing more than a high school chemistry class.”

Bye was joined in his dissent by two other appellate court judges. It is significant that three Supreme Court Justices  - Ruth Bader Ginsburg, Elena Kagan, and Sonia Sotomayor - backed Bye in his attack.

Justice Ginsburg wrote, “For reasons well stated by Judge Bye in his statement calling for Eighth Circuit rehearing en banc, I would grant the stay and consider the petition for certiorari in the ordinary course.”

 

Cruel and unusual?

Missouri first sourced its lethal formulation from an Oklahoma pharmacy that was not licensed in Missouri to supply dangerous drugs.

After the Oklahoma pharmacy decided, in the face of a legal challenge, to cease providing the drug, Missouri changed its protocol and asked another, unidentified, compounding pharmacy to make up the lethal drug.

Bye also questioned the proficiency with which the unnamed pharmacy formulated the execution drug.

“One should be suspicious of any pharmacy compounding a drug presumably for the first time, particularly when the pharmacy received Missouri’s request just a week before the scheduled execution,” he wrote, adding that “it is conceivable this lack of experience and knowledge would lead to Taylor’s death being excruciatingly painful.”

 

The Ohio example

Faced with shortage and discontinuation of pentobarbital supplies, states have turned to alternate, untested drug cocktails that might include midazolam and hydromorphone, and sometimes the addition of potassium chloride.

Midazolam is intended to sedate the inmate, while the massive dose of hydromorphone suppresses breathing centers, causing suffocation and death. The midazolam is also supposed to help suppress the excruciating burning sensation caused by the massive dose of potassium chloride while it works to arrest the heartbeat.

Recently, an Ohio inmate, Dennis McGuire, was put to death with a combination of midazolam and hydromorphone. Eyewitnesses to that execution stated that the never-before-used drug pair took almost 15 minutes to kill McGuire. The inmate was observed struggling continuously as he gasped for air, emitting what were characterized as gruesome snorting and snoring sounds.

Among executions on record, this was one of the longest in duration and was described by many observers as inhumane.

 

Pushback

Anti-death-penalty groups have called on pharmaceutical manufacturers that supply drugs for lethal injection to place distribution restrictions on such drugs, in order to block the possibility that they can be used by departments of correction for purposes of execution.

Several such drugs are no longer available in the United States, and European initiatives opposing execution have made it increasingly difficult for the 32 states that have the death penalty to obtain traditional drugs used for execution.

Ned Milenkovichis a partner and head of the drug and pharmacy legal practice at Roetzel and Andress LPA. He is also a member of the Illinois State Board of Pharmacy. Contact Ned at 312-582-1676 or atnmilenkovich@ralaw.com.