Friday, August 12, 2011
Dr. David Waisel, testified that he is an anesthesiologist at Boston Children‘s Hospital and medical ethicist
Dr. David Waisel, testified that he is an anesthesiologist at Boston Children‘s Hospital and medical ethicist (T. 8/2 49). Dr. Waisel performs "perioperative care," which includes anesthetizing patients for surgery. Dr. Waisel has been an anesthesiologist for 18 years, and has attended to approximately 15,000 to 20,000 patients (T. 8/2 40). In addition to his practice, Dr. Waisel is an associate professor at Harvard Medical School, lectures trainees and is in charge of the fellowship. As a medical ethicist, Dr. Waisel performs services for patients and families, as well as consulting with institutions on matters related to development of policy and quality of care (T. 8/2 43). In addition to being board certified in anesthesiology, Dr. Waisel has written approximately 30 peer-reviewed articles and numerous other contributions to publications regarding medical ethics and anesthesiology.
Dr. Waisel has consulted with capital defendants regarding lethal injection issues and testified in three states (T. 8/2 46). Dr. Waisel was contacted by Mr. Valle‘s counsel in early July, 2011. He reviewed the Florida lethal injection 9
protocols from 2007 and June 2011. In Dr. Waisel‘s opinion, the protocol‘s change from sodium thiopental to pentobarbital is significant (T. 8/2 49). As an anesthesiologist, Dr. Waisel is familiar with both pentobarbital and sodium thiopental (T. 8/2 49). The purpose of pentobarbital is to anesthetize the inmate prior to the injection of pancuronium, which paralyzes the inmate mostly for cosmetic reasons, and potassium chloride to stop the heart, which would be excruciatingly painful if the inmate were not anesthetized (T. 8/2 50). Dr. Waisel testified that the improper administration of pentobarbital could result in the inmate not being adequately anesthetized. This would result in paralysis, which would be a ―horrible‖ and ―terrifying‖ feeling and ―probably hellish‖ experience (T. 8/2 50-51). Both sodium thiopental and pentobarbital are classified as barbiturates, however, they are used in extremely different ways and are not interchangeable (T. 8/2 52). Both were developed in the late 1920's, early 1930's. By the early 1950‘s, sodium thiopental became the standard drug for intravenous injection of anesthesia in over 95% of patients. As a result, sodium thiopental was studied extensively. On the other hand, pentobarbital was not used for induction of anesthesia and is not widely studied. Dr. Waisel testified that there are only two studies, one from 1948 and one from 1951, examining pentobarbital for induction of anesthesia in relatively healthy patients. 10
Pentobarbital became a ―niche drug,‖ used in the intensive care unit for patients who had very bad seizures that could not be stopped any other way, to stop the electrical activity of the brain to prevent the brain from being injured (T. 8/2 54) Pentobarbital was also used for patients with swollen brains to decrease the electrical activity and the need of the brain for energy to help decrease damage to the brain. Pentobarbital might also be used for sedation in children receiving radiographic scans, but it has been replaced by better drugs for that use (T. 8/2 54). Besides these ―niche‖ uses, pentobarbital was used ―extraordinarily infrequently‖ in the operating room to provide brain protection when an interruption of blood flow to the brain was anticipated (T. 8/2 54). However, sodium thiopental was used ―nearly exclusively‖ for that purpose because it was a very common drug (T. 8/2 54). Moreover, when pentobarbital was used in those circumstances where patients required brain silence, an anesthetic was administered first (T. 8/2 56). Because of its extensive use, Dr. Waisel ―can't imagine there is a drug we know better in anesthesiology then sodium thiopental (T. 8/2 57). It has been tested in all sorts of patients, with all sorts of diseases, and all sorts of clinical situations, by novices and by experts. Because of this, we know its strengths and how to mitigate its weaknesses‖ (T. 8/2 59).
While ―nothing about [sodium thiopental] will surprise us,‖ (T. 8/2 59), the 11
same cannot be said for pentobarbital, which is only used in narrow circumstances (T. 8/2 60). Moreover, pentobarbital has been researched in the context of those narrow uses, but not in use for induction of anesthesia, because it was not used in that manner (T. 8/2 60). The information on pentobarbital is ―appropriately dismal‖ because it is not used for anesthesia (T. 8/2 60). Prior to June 8, 2011, the Florida lethal injection procedures called for five grams of sodium thiopental. The new lethal injection protocol calls for the use of five grams of pentobarbital. However, as Dr. Waisel explained, the dosages are not proportional. A 500 milligram dose of thiopental would anesthetize a 220 pound man, thus a dose of five grams is ten times the amount of the upper dose for induction of anesthesia (T. 8/2 61). However, with pentobarbital the upper dose for sedation, not for anesthesia, is 500 milligrams for an unspecified weight. That is also ten times the dose, but for sedation, which is significantly different than anesthesia (T. 8/2 61). In fact, the package insert for pentobarbital does not state that pentobarbital is to be used, or is approved for, the induction of anesthesia (T. 8/2 62).
Dr. Waisel explained that the package insert is ―the truth, the bible for what we know.‖ (T. 8/2 63). The Food and Drug Administration approves the package inserts for drugs, which lists the uses, effects and complications associated with its use (T. 8/2 64). According to the package insert, there is no average intravenous 12
dosage of pentobarbital that can be relied on to produce similar effects in different patients (T. 8/2 67). The commonly used initial dose for the 70 kilo adult is 100 milligrams (T. 8/2 67). "If necessary, additional small increments of the drug may be given up to a total of, from 200 to 500-milligrams for normal adults. However, there is a ―vast‖ difference between sedation and anesthesia (T. 8/2 68). It is probably best to think of sedation and anesthesia on a continuum from being wide awake to being completely anesthetized and being able to do an operation. In ―conscious sedation,‖ the patient can respond to voices, can make movements, and will respond to varying levels of pain (T. 8/2 68). As the patient gets closer to anesthesia, the amount of stimulus required to have the patient respond is increased. A greater stimulus will cause a response by the patient whereas lesser stimulus will not (T. 8/2 68). Dr. Waisel explained that trainees often will see a patient as quiet and still, assume that the patient is anesthetized, do something stimulating or painful. This results in the patient responding by grabbing whatever part of the body is being stimulated (T. 8/23 at 69). Dr. Waisel also explained that one cannot extrapolate an appropriate does of pentobarbital for anesthesia based on the upper limit dose because we do not have the data to know that (T. 8/2 70). This would only be done in the most extreme circumstances where there was no alternative (T. 8/2 70).
Pentobarbital is manufactured by a company called Lundbeck. Dr. Waisel 13
reviewed several letters from Lundbeck to officials in several states, including Florida, warning against the off-label use of pentobarbital (T. 8/2 71). As Dr. Waisel explained, such a manufacturer‘s warning is unusual. Nearly always, the FDA issues initial warnings and the drug manufacturers follow with their own statement (T. 8/2 72). Dr Waisel explained that ―I take any of these warnings very very serious, and so if the manufacturer chooses to do this in and of itself, I give it the highest regard.‖ (T. 8/2 72). If he, as an anesthesiologist, received such a warning about a drug, he would ―absolutely not use it‖ absent ―an absolute hail Mary situation‖ (T. 8/2 72). Dr. Waisel explained that the change in Florida‘s lethal injection protocol from sodium thiopental to pentobarbital was ―very significant‖ (T. 8/2 74) because: We're taking a drug that we know everything about, replacing it with a drug which we know nothing, almost nothing, about in terms of inducing anesthesia in otherwise healthy people. In addition, when we think about how errors happen, this increases the likelihood of errors and subsequent harm to the inmate -- substantial harm, dramatically. * * * The community knowledge of sodium thiopental provided a bulwark against substantial harm . . . When you have, as we've seen in other cases, a high risk procedure where there are many points where there could be errors, not having a bulwark, especially at the end exposes the inmate to extraordinary risk. (T. 8/2 74).
Dr. Waisel had the opportunity to speak to Greg Bluestein, a witness to the 14
execution of Roy Blankenship in Georgia3 (T. 8/2 75). Dr. Waisel also reviewed several affidavits of other witnesses to the Blankenship execution, including Eddie Ledbetter and Mitchell Peace, also journalists (T. 8/2 76). In addition, when consulting on the DeYoung case in Georgia, Dr. Waisel reviewed affidavits of approximately 13 employees of the Georgia Department of Corrections who witnessed the Blankenship‘s execution.
3 The State made a motion in limine ―to preclude Dr. Waisel from being used as a conduit for hearsay,‖ specifically regarding Dr. Waisel‘s conversations with Associated Press reporter Mr. Bluestein, who witnessed the execution of Roy Blankenship in Georgia on June 23, 2011, as well as the other affidavits Dr. Waisel reviewed with respect to the Blankenship execution (T. 8/2 6). Mr. Bluestein, a reporter for the Associated Press, was not available to testify due to journalist privilege and the policies of his employer. Attorneys for the Associated Press indicated that Mr. Bluestein would be available only if subpoenaed and would claim journalist‘s privilege (T. 8/2 9).
Blankenship was executed under Georgia‘s protocol, which calls for the use of pentobarbital (T. 8/2 80). Based on his review of the witnesses‘ affidavits, Dr. Waisel concluded that ―Mr. Blankenship suffered extremely during the execution.‖ (T. 8/2 78). By report, Blankenship looked to his one arm in pain and looked to the other arm in pain. He then grimaced, jerked his head up, continued breathing and mouthing words for up to three-minutes (T. 8/2 78-79). Dr. Waisel explained that this three minute span was significant in two ways. First, while some patients, while being induced under anesthesia, may make movements for the first 15 seconds or so, the movements are not focused or localized as Blankenship‘s were 15
(T. 8/2 79). Second, if pentobarbital worked as the state claimed, this would last for the first 3 seconds when the drug reaches the body, not for three minutes, which is not how the state claims pentobarbital works. On cross-examination, Dr. Waisel testified that ―phase induction‖ involves rendering a patient unconscious at the beginning of some surgical procedure, and induction of anesthesia is normally accomplished with intravenous drugs, but rarely just one (T. 8/2 82). For the duration or the of the surgical procedure, anesthesia is often maintained with a balanced anesthetic, which includes an inhaled anesthetic (T. 8/2 82). Sodium thiopental is no longer available (T. 8/2 70). Sodium thiopental is an ultra short acting barbiturate. Pentobarbital is classified as both a short acting and an intermediate acting barbiturate (T. 8/2 85). These classifications refer to the length that the drugs are effective, not to the rate at which they take effect (T. 8/2 85). Pentobarbital did not become the favored drug back before the 1950's because its effects last longer than sodium thiopental (T. 8/2 85).
Pentobarbital is used to control seizures. One of the primary objectives of seizure control using pentobarbital is to achieve burst suppression in the brain if the seizure is severe and intractable (T. 8/2 86). Burst suppression can be determined with the use of an EEG (T. 8/2 87). Dr. Waisel explained that the initial doses of pentobarbital to start are well established, because you want to start on the 16
lower end to build effect. The EEG is used as a monitor to help decide the appropriate amount of pentobarbital for this person who has a brain injury of some sort. Dr. Waisel opined that 5,000 milligrams of pentobarbital, if delivered intravenously, in the time frame of Florida‘s lethal injection protocol would most likely achieve burst suppression ―in the scenario of a patient who has brain damage, such as intractable seizures, such as a swollen brain.‖ (T. 8/2 89). However, there is no data of the affect of pentobarbital in a patient who does not have brain damage, intractable seizures, or brain swelling, so Dr. Waisel was not able to opine in that context (T. 8/2 90). While the dosages for burst suppression in people with injured brains is established, Dr. Waisel cautioned that in those situations, the patient is monitored and the dose is titrated to affect (T. 8/2 93). ―We don‘t just give a dose and walk away.‖ (T. 8/2 94). Anesthesiologists always monitor the patient closely. When they use a drug that we know less about, there is even greater vigilance (T. 8/2 97). We do not have the body of information about pentobarbital for induction of general anesthesia in healthy people (Id).