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Amended Brief of Appellants' to Include Table of Authorities

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TABLE OF CONTENTS INTRODUCTION .......................................................................................................... 1 JURISDICTION ............................................................................................................. 9 STATEMENT OF ISSUES .......................................................................................... 10 STATEMENT OF THE CASE ..................................................................................... 13 STANDARD OF REVIEW ........................................................................................... 38 I. Standard of review regarding constitutional claim ......................................... 38 II. Constitutional principles governing the distinction between and a facial versus an as-applied challenge ......................................................................... 39 STATEMENT OF FACTS ........................................................................................... 43 I. The Science: The testimony of four expert witnesses, representing four different scientific perspectives.. ...................................................................... 43 a. Dr. Stephens, PhD, neuropharmacologist. ................................................. 43 1. Dr. Stevens provided an abbreviated version of a year-long, graduate- level course on Central Nervous System Pharmacology; he explained the crucial concept “mechanism of action.” ........................................... 44 A. The central nervous system is made up of, approximately, 86 billion neurons, that each have, roughly, 10,000 connections to other neurons—it is these connections that produce the essential nature of neurons; at each connection neurons ‘speak’ with a very simple language of excitatory and inhibitory neurotransmitters........................................................................ 44 B. Three basic mechanisms of action: (1) independent effect on the brain; (2) enhancement of other chemicals in the brain; (3) blocking of other chemicals in the brain. .................................... 45 Document receivedbytheTNSupremeCourt. i C. The basic terminology of sedation: “the plane of general anesthesia” is crucial, only at this level is a human rendered insensate to pain. ......................................................................... 46 D. Diagramming basic neuropharmacological principles. .................... 47 2. The single, limited mechanism of action of Midazolam, compared with the multiple mechanisms of more potent pharmaceuticals .................. 49 A. The GABA receptor ...................................................................... 50 B. Midazolam has a single mechanism of action, while Pentobarbital has three mechanisms; due to this scientific reality Midazolam is not capable of causing the same effects as Pentobarbital. .............................................................................. 51 i. Different mechanisms of action, different uses. .................... 54 ii. Anesthetic gases have five-mechanisms of action; like barbiturates, they both increase inhibition and block excitation; this makes them yet more potent, and again illustrates the limitations of Midazolam. .............................. 55 C. Because of Midazolam’s single limited mechanism of action it has a ceiling effect, and it can never--regardless of dose--render a human insensate to pain, or unarousable by noxious stimuli; it can never bring a human to a plane of general anesthesia. ...... 57 i. The ceiling effect is not some magical property of Midazolam: other medications such as aspirin have ceiling effects. ......... 58 ii.There are two attributes to a ceiling effect: (1) maximum potency and (2) the dose at which maximum potency is reached. ...... 58 iii. The scientific proof of Midazolam’s ceiling: (1) mechanism of action, (2) real world experience and (3) peer reviewed scientific studies. ..................................................................... 59 Document receivedbytheTNSupremeCourt. ii iv.Larger doses do not change the mechanism of action; a 500 mg dose of Midazolam cannot break through the ceiling. ........... 60 3. The painful pharmacological effects of the three-drugs in Tennessee’s protocol: inmates will suffer severe pain and terror. ............................ 61 A. Midazolam is a strong acid, pH 3.0; 100 ml of acid is an immense quantity of acid to inject into a human being. ............................ 61 B. Vecuronium bromide is a paralytic, which will first paralyze the small muscles of the face, preventing obvious reaction, then the limbs, and finally the lungs, causing suffocation. ...................... 62 C. Potassium chloride is a depolarizing chemical that activates every pain-sensing neuron in the body; it will stop the human heart, causing death. ................................................................................. 63 4. Dr. Stevens’ final conclusions about the neuropharmacological impact of the three-drug protocol: it will cause severe pain and mental anguish; a two-drug protocol that did not include vecuronium would be less painful and cause less suffering; a one-drug protocol using Pentobarbital, if done properly, would not involve pain at all ............. 64 b. The Testimony of David J. Greenblatt, M.D., Louis Lasagna Endowed Professor of Pharmacology and Experimental Therapeutics at Tufts University School of Medicine and special and scientific research staff at Tufts Medical Center ................................................................................... 65 Document receivedbytheTNSupremeCourt. iii 1. Dr. Greenblatt has an excellent record as an academic and medical scientific researcher that spans more than 40 years, focusing on benzodiazepine drugs ............................................................................. 66 2. Dr. Greenblatt participated in the earliest research on Midazolam in the United States which became part of its review and approval for use by the F.D.A. ........................................................................................... 68 3. Dr. Greenblatt testified in agreement with Dr. Stevens on the pharmacology of Midazolam .................................................................. 68 4. Dr. Greenblatt was unequivocal in his opinion that Midazolam is incapable of inducing a level of anesthesia where a person would be insensate to the torturous effects of vecuronium bromide and potassium chloride as used in the Tennessee lethal injection protocol .................................................................................................... 69 A. Midazolam’s effects are based on a physical function in brain cells that is innately limited, which limits the effect of the drug .............................................................................................. 69 B. Midazolam is not used alone to induce general anesthesia; where it is used alone as a sedative it is because it allows a patient to be roused during a procedure ..................................... 71 C. There is a “ceiling effect” – a limit on the sedative effect – for Midazolam that has been demonstrated in scientific research . 72 D. Dr. Greenblatt studied patients who ingested massive overdoses of benzodiazepines and found that they were in a sedated state where they were still capable of being roused and responded to noxious stimuli ............................................................................. 76 E. Dr. Greenblatt testified that the injection of Midazolam in the Tennessee lethal injection protocol will not protect a person being executed from experiencing the torturous effects of the second and third chemical sin the protocol ................................ 79 5. Dr. Greenblatt testified that the pharmacokinetics of Midazolam create a time delay in the onset of its effects that make it certain that it will not have induced its peak sedative effect by the time vecuronium bromide and potassium chloride are injected into an inmate under the Protocol ................................................................................................... 81 Document receivedbytheTNSupremeCourt. iv 6. Because of the pH of Midazolam solution, the amount called for by the protocol would inflict severe damage to lung tissue and nearly certainly cause pulmonary edema ......................................................... 85 c. Testimony of Dr. Mark Edgar, M.D., diagnostic pathologist. .................... 86 1. Dr. Edgar reviewed the autopsies of twenty-seven inmates executed with Midazolam. ..................................................................................... 86 2. Dr. Edgar was surprised by the weights of the lungs recorded in the state autopsies; the lungs were not consistent with instantaneous death. ...................................................................................................... 86 3. Dr. Edgar explained that pulmonary edema is the result of an injury to the lining of the lungs ............................................................................ 87 4. 23 out of the 27 autopsies Dr. Edgar reviewed showed signs of pulmonary edema ................................................................................... 89 A. Fifteen inmates showed signs of fulminant pulmonary edema, the sudden, severe filling of the airspace with fluid .................. 95 B. Eight additional inmates showed signs of “acute” pulmonary edema ..........................................................................................
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