Danish company asks Florida to stop using its drug to kill inmates

Danish company asks Florida to stop using its drug to kill inmates

The head of Lundbeck, Inc., the Danish company that makes ones of the drugs Florida plans to use to execute its first death row inmate in 18 months, has twice written Gov. Rick Scott urging him not to use their product for capital punishment.
Staffan Schüberg, president of Lundbeck, wrote to Scott in May and again in June after he said his letters to the Florida Department of Corrections went unanswered. It's unclear if Scott's office has responded, either.
The drug — pentobarbital sodium, branded as Nembutal — is at the center of the Florida Supreme Court's decision this week to delay the execution of Manuel Valle, who shot and killed a South Florida police officer 33 years ago.
"The use of pentobarbital outside the approved labeling has not been established," Schüberg wrote. "As such, Lundbeck cannot assure the associated safety and efficacy profiles in such instances. For this reason, we are concerned about its use in prison executions."

Florida Lethal Injection Hearing to Proceed

Thursday, July 28, 2011

Florida Lethal Injection Hearing to Proceed

"Miami judge to hear testimony in lethal injection drug challenge," is the title of Patricia Mazzei's Miami Herald report.  The updated report is via the Sun-Sentinel.

A Miami judge will hear arguments Thursday morning for and against the new use of an anesthetic drug in Florida's lethal injections.

The hearing stems from the case of Manuel Valle, sentenced to death for shooting and killing a Coral Gables police officer in 1978. Valle's execution, initially scheduled for Aug. 2, was temporarily stayed on Monday until Sept. 1, pending a hearing on the safety and efficacy of the drug, pentobarbital.

The hearing will be held at 10 a.m. before Circuit Court Judge Jacqueline Hogan Scola. Valle's lawyers had tried to get a different judge, arguing that Hogan Scola has already found some of Valle's likely witnesses not to be credible, but the Florida Supreme Court rejected the attempt to disqualify the judge.

And:

A divided Supreme Court ruled 4-3 to grant him a hearing — and ordered the corrections department to provide documents from the drug's manufacturer, Lundbeck, on the safety and efficacy of pentobarbital.

The head of Lundbeck, a Danish company, has twice written Gov. Rick Scott urging him not to use the drug for capital punishment. Staffan Schüberg, president of Lundbeck, wrote to Scott in May and again in June after he said his letters to the corrections department went unanswered. It is unclear if Scott's office has responded, either.

"The use of pentobarbital outside the approved labeling has not been established," Schüberg wrote. "As such, Lundbeck cannot assure the associated safety and efficacy profiles in such instances. For this reason, we are concerned about its use in prison executions."

The News Service of Florida files, "Hearing on cop killer's execution can go forward."  It's via the Fort Myers News-Press.

The Florida Supreme Court rejected a request by lawyers for a death row inmate to change the judge in a hearing over the state's lethal injection drug.

And:

The drug was changed in June, and the Valle execution is set to be the first in Florida in which it is used.
The question is over the efficacy of the first of the three drugs used, pentobarbital, which is used to make the prisoner unconscious before the other two drugs paralyze and kill him.

At the Palm Beach Post, Dara Kam posts, "Danish manufacturer of lethal injection drug twice asked Scott not to use it to kill prisoners."

The Danish manufacturer of the controversial drug now being used to execute prisoners pleaded with Gov. Rick Scott twice to abandon its use, saying it “contradicts everything we are in business to do.”
Staffan Schüberg, president of Lundbeck Inc., wrote to Scott twice before the first-term governor signed his first death warrant ordering Manuel Valle to be executed on Aug. 2.
“We are adamantly opposed to the use of Nembutal to execute prisoners because it contradicts everything we are in business to do – provide therapies that improve people’s lives,” Schüberg wrote to Scott on May 16.

And:

DOC issued a new protocol with the replacement drug pentobarbital sodium, also known as Nembutal, on June 8.
That same day, Schüberg wrote another letter to Scott, again asking him not to use the drug.
“The use of pentobarbital outside of the approved labeling has not been established. As such, Lundbeck cannot assure the associated safety and efficacy profiles in such instances. For this reason, we are concerned about its use in prison executions,” he wrote.
In his first letter, Schüberg said he had written to DOC officials urging them not to use the drug but had not received a response.

Earlier coverage of the Florida lethal injection challenge begins at the link.  Related posts are in the lethal injection index.

Florida Issues: Expert report of David B. Waisel, MD

Florida Issues: Expert report of David B. Waisel, MD

http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1544623

The Role of State Medical Boards in Regulating Physician Participation in Executions

Ty Alper

University of California, Berkeley



Journal of Medical Licensure and Discipline, Vol. 95, No. 3, 2009

Dr. David Dershwitz, M.D. - the hearing in Miami

http://www.floridasupport.us/lethal/Valle/ED74Fd01.txt
From the testimony of :

Dr. David Dershwitz, M.D.
On Tuesday, August 2, 2011 the State presented the testimony of Martin Dershwitz, M.D., who testified that he is a physician who has also had a Ph.D. in Pharmacology since 1982. He has had his license and certification in anesthesiology since 1987. He has taught Medical Pharmacology since 2001 at the
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University of Massachusetts Medical School and also teaches Medical Biochemistry. He has written numerous articles, books and contributed chapters to books on pharmacology. He is presently an anesthesiologist at UMass Memorial Medical Center in Worcester, Massachusetts.
Dershwitz testified that pentobarbital, also known as Nembutal, is used primarily to induce a barbiturate coma or as a sedative or to treat intractable seizures. He explained that the dose usually administered was established in the 1970‘s. It is based on a person‘s body weight, age, and sometimes genetic factors though this last factor is not well-understood. The range of doses is quite large. However, the effect of 5000 mg. of Nembutal (pentobarbital), as provided for in the Florida lethal injection protocol, is ―far in excess of the dose that would be needed or used for a human‖. Two things would occur with the administering of this amount of drugs: first, the cardiovascular system and, second, the respiratory system would experience a shut-down. That is, the blood pressure would plummet and the circulatory system would cease to function. He distinguished the amount of the drug as well as the rate of administration of drugs given for hospital use versus that used in the execution protocol. The dose used in the lethal injection protocol at the rapid rate at which it is administered, would bring about a total flat line on the EEG in brain activity. Therefore, the person would have no perception of pain
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or sensation. However, he did point out that unconscious patients, while under sedation, can still have active EEG‘s while remaining unconscious and being in an anesthetized state. It is even possible for anesthetized patients to move and/ or react to stimuli as a reflex at the spinal cord level. This reaction does not necessarily indicate consciousness. He also stated that it is possible, though it does not occur frequently that people‘s eyes remain open while unconscious. It would then be necessary to close their eyes to prevent corneal damage or drying out.
According to Dr. Dershwitz, Nembutal is not used as an anesthetic because it lasts longer and causes a longer ―hangover‖ after medical procedures; doctors prefer their patients awake at the end of surgery. The FDA has not approved it for use in lethal injection. This is considered an ―off label use‖. There are a number of drugs which are commonly used by doctors for an ―off label use‖ . Interestingly, both Dr. Waisel and Dr. Dershwitz referred to Fentanyl as such a drug.
Dr. Dershwitz admitted that he had testified in the Dickens and Alderman cases about the efficacy of sodium thiopental. However, that drug is no longer available and has not been, to his knowledge, for some two (2) years or more.
Ultimately he testified that no one could survive 5000 mg of pentobarbital intravenously. The doses and rates of administering the drug for surgery are one tenth of what is used in the protocol.
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Dr. Dershwitz‘ testimony was credible and persuasive. Further, he refuted any suggestion that the dose of pentobarbital in the Florida lethal injection protocol would leave an inmate conscious and able to experience pain and suffering during the lethal injection process. The court credits the testimony of Dr. Dershwitz over that of Dr. Waisel.

Jacqueline M. Martin, M.D. - the hearing in Miami

http://www.floridasupport.us/lethal/Valle/ED74Fd01.txt
 From the teastinmony of :

Jacqueline M. Martin, M.D.
On Thursday July 28, 2011 the State called Jacqueline M. Martin, M.D., as a witness. Without objection she was sworn by both the clerk of Courts in Miami-Dade County, Florida, and a court reporter authorized to give an oath in New York, N.Y. from where the witness testified by telephone.
She stated that she was a witness to the June 23, 2011 execution of Roy Blankenship in Georgia. She is a physician licensed to practice in Georgia and also the Deputy Chief Medical Examiner for the Georgia Bureau of Investigation. She obtained her medical degree from Ponce School of Medicine in Puerto Rico in 1985. She has also acted as Deputy Medical Examiner in Rochester, N.Y. and from 1997-1999 she was the Medical Examiner in Palm Beach County, Florida. Though she is not a clinical physician she was trained in medical school to administer anesthesia. This was the third execution that she attended.
According to Dr. Martin she sat on the front row in the witness viewing area. She could see clearly from where she was and could see into the execution chamber. She was about 5 feet away from the inmate. Blankenship was strapped
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down with I.V. lines in each arm. There was a nurse on the right of the gurney and officers to the left and right. The warden read the execution order and left. Two (2) to three (3) minutes after the warden left, Blankenship looked to his left arm and moved his mouth-he had no teeth-and looked at his right arm, put his head down on the pillow and stayed put. She saw no obvious signs of distress or facial features indicating pain.
She did not consult with the Department of Corrections or the Georgia Bureau of Investigation afterward. It is part of her duties as M.E. to view the execution.
Dr. Martin‘s testimony is consistent with that of Mr. Harper. She is a medical professional who could see Blankenship‘s actions and facial features. Her interpretation of his reactions to the drugs substantiate that Blankenship in no way experienced pain or suffering.

John Harper - the hearing in Miami

http://www.floridasupport.us/lethal/Valle/ED74Fd01.txt
 From the testimony in Miami Court of :

John Harper
On July 28, 2011, the State presented witness John Harper, who being sworn by the Clerk of Court, stated the following:
He is a 23 year employee of the Georgia Department of Corrections ("GDC"). He has attended all 28 lethal injections in Georgia as part of his duties.
He witnessed the June 23, 2011 execution of Roy Blankenship at the Georgia Diagnostic and Classification Prison in Jackson, Georgia. He was in the
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mechanical room which is physically behind the execution chamber during the execution. That area is separated from the execution chamber by a one-way mirror and the gurney on which Blankenship lay restrained is 86 inches from where Harper was located in the mechanical room. His view was mostly unobstructed; however, people did walk in front of him. He could see Blankenship‘s left side profile. Blankenship had an intravenous line into each of his arms. He saw Blankenship look around and look at his left arm about five (5) seconds after the start of the first syringe. However, the pentobarbital was first administered to Blankenship‘s right arm. He heard Blankenship make a ―grunt‖ sound. Harper knew when the drugs were administered because he was given a signal and he was keeping a time log. About ten (10) seconds passed between the time the syringe was pushed and when Blankenship appeared to be unconscious. There was no flailing or thrashing. After the pentobarbital was administered a consciousness check was performed and Blankenship did not respond.
Of all the witnesses on the issue of the Blankenship execution, Harper is the most credible on this topic. He actually could hear and could see the pushing of the syringes and was keeping a time log. His testimony is in keeping, ironically, with the acceptable parameters testified to by Dr. Waisel. Waisel stated that if the pentobarbital were to work properly that it would take effect within fifteen (15)
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seconds. That it did, according to the only witness able to testify with any degree of certainty as to the timing of the administration of the drugs and rendering of unconsciousness.