Compiled and edited from reports in Cryonics magazine by Mike Darwin, September through November, 1988. See also A Stunning Legal Victory for Alcor.
On August 30th, 1988, a long-time Alcor Suspension Member who wished to remain anonymous filed suit against the California Public Health Service. [This member was later identified as Richard Clair Jones, creator of the Emmy-winning television series Facts of Life.]
The purpose of the suit was to seek declaratory relief from a Magistrate to allow for the member's suspension. The member used the pseudonym of John Roe in order to protect his professional reputation and livelihood. Alcor joined with Mr. Roe in the suit on behalf of all 107 of its other Suspension Members. The suit was necessitated by the PHS' refusal to issue VS-9 permits of disposition of human remains and their written and verbal threats to prosecute both Alcor and Trans Time for holding human remains in cryonic suspension which they have publicly stated is "illegal." In June, David Mitchell of the PHS reportedly wrote a letter to the Riverside and Alameda County PHS departments and District Attorney's Offices recommending enforcement. Enforcement would presumably mean turning over Alcor patients to a mortuary, crematory, or other licensed facility for "conventional" and "legal" disposal. This left Alcor little choice but to go to the court for declaratory relief.
On September 25th, Alcor member "John Roe" (a legal pseudonym being used to comply with "Mr. Roe's" desire for privacy) entered a Los Angeles-area hospital for treatment of a very serious and imminently life-threatening AIDS-related infection. Mr. Roe was alert on admission, and he is an intelligent, articulate, pleasant, and impressive man. In short, he is not a kook or a fool, and he is someone who is reasonable and who can be expected to be taken seriously. Mr. Roe, his physician, and Alcor informed the hospital of his long-standing arrangements for cryonic suspension and asked for noninterference in execution of these arrangements; principally that Mr. Roe be promptly pronounced legally dead (after cessation of heartbeat and breathing) and that Alcor be given immediate access to him in order to stabilize and transport him to the Alcor facility.
The hospital not only refused to cooperate in prompt pronouncement of legal death but also stated that they would refuse to release Mr. Roe to us even after clinical and legal death had been pronounced! While Mr. Roe remained very seriously ill and imminently terminal, his condition had improved somewhat. It was anticipated that he would survive this particular episode and be discharged from the hospital. However, the refusal of the medical facility treating Mr. Roe to give Alcor (or any other cryonics organization) access to Mr. Roe after legal death was a problem of enormous concern. The reason the hospital cited in their refusal to release Mr. Roe to Alcor was that in their opinion "Alcor does not have the legal right to have or hold human remains." This statement apparently came courtesy of the State of California Department of Health Services in Sacramento. We understood that this position would also be taken by Coroner's offices throughout California as well.
As anticipated, John Roe did make it through his hospital admission and managed to go home. Unfortunately, his stay at home was short-lived. Mr. Roe was home only a little over 24 hours when he experienced a serious central nervous system infection and had to be rushed back to the hospital — the same hospital which had previously refused to cooperate with Alcor regarding Mr. Roe's desire for suspension. Plans to pursue a preliminary restraining order against the hospital and the California Department of Health Services, which were moving ahead at a reasonable pace, had to be put into high gear. Alcor was faced with a three-alarm legal emergency.
Late on Monday, October 10, Mr. Roe was rushed to the hospital suffering multiple seizures and was in a semiconscious state. His physician suspected a primary brain infection and was not optimistic about Mr. Roe surviving for more than a few days at most — unless the infection could be rapidly identified and then responded to treatment. A decision was made to go into court for a temporary restraining order (TRO) against the hospital and the Department of Health Services. The next three days were spent in frantic preparations to go into court. On Friday, October 14th, Superior Court Judge Aurelio Munoz granted Alcor a temporary restraining order preventing the hospital from:
. . . preventing, restricting or in any manner whatsoever interfering with the application of a portable resuscitator, after the pronouncement of his "legal death" by a licensed physician, to the body of John Roe at the hospital facility located at 4929 Van Nuys Boulevard, Van Nuys, California for such period of time, not to exceed two hours, as shall be necessary thereafter to accomplish the release of the body of John Roe to a licensed funeral director and the transport of his body, after the application of the portable resuscitator, from the hospital.
The hospital fought Alcor every step of the way. In a six page brief filed by the hospital in opposition to Alcor's request for a TRO, the hospital and its legal staff trotted out just about every argument against cryonics imaginable. We summarize some of the more interesting ones below:
Allowing Alcor into the hospital to resuscitate, medicate and transport Mr. Roe was alleged to "violate the hospital's established practices, Health and Safety Code Title 22 Regulations, and the standards of the Joint Commission on Accreditation of Health Care Organizations."
In other words, allowing Alcor to carry out transport procedures on a patient in their hospital would, in effect, be the same as condoning cryonics and tantamount to its approval. Anything not in the rule book is de facto prohibited.
Only medical staff which have been properly licensed and credentialed are allowed to perform medical procedures in a hospital and only physicians who are "on-staff" at the hospital are able to determine what procedures will or will not be allowed in the hospital.
In other words, only doctors are allowed to practice medicine and to determine what constitutes medicine. This cryonics business smells like medicine to them, and furthermore it smells like quack medicine, therefore they aren't about to allow it to occur. Never mind the fact that they have already pronounced the patient dead. They are the doctors and they get to say whether medicine is medicine or not, even if it is being practiced on people whom they consider dead.
"Mr. Roe's and Alcor's requests would violate hospital procedure for the handling of the remains of AIDS patients, whose body fluids are infectious. The customary procedure for handling such remains is to seal them in a nonpermeable shroud marked 'communicable disease' and have a mortician remove the body from the hospital in a sealed shroud, without performing any procedures on the body at the hospital."
This objection was the only one of any of them held even the remotest credibility. It was addressed by retaining a licensed mortician and by the fact that Alcor has, and has had on staff two licensed physicians and surgeons as Medical Directors.
Finally, "Alcor is requesting that after a pronouncement of death, that Alcor personnel be permitted to inject Mr. Roe's remains with a barbiturate. The purpose of the injection is to prevent Mr. Roe from 'coming back to life' once he is placed on the heart-lung resuscitator machine. . . . This proposed action raises the issue of euthanasia which is currently illegal."
This last objection caused the judge considerable amusement. As he was at pains to point out, if the hospital pronounced the patient legally dead by current criteria and Alcor was able to revive the patient, then that would be a major medical advance and a marvel for the world! In other words, you can't kill a dead person. This is something the Riverside County Coroner has yet to figure out. As an aside, it is worth noting that the statements about preventing the patient from "coming back to life" did not originate from Alcor, but rather from the medical staff. Early on in our negotiations with the hospital, one of the staff physicians raised the issue of barbiturates being used to protect the brain against ischemic injury because he had previously been associated with a pilot clinical program at another institution involving the use of barbiturates to the same end. This physician also raised the issue of the potential return of consciousness during vigorous post-mortem resuscitation efforts. Having raised these issues themselves, the hospital then proceeded to use them against us!
Despite the hospital's arguments, or perhaps because of them, Judge Munoz granted Alcor the TRO and ordered the hospital to cooperate in releasing Mr. Roe to Alcor and in allowing Alcor personnel to begin cardiopulmonary resuscitation and external cooling of Mr. Roe in the hospital. Judge Munoz cited Mr. Roe's right to determine the course of his medical care and post-mortem disposition as being paramount and as overriding the rights of the hospital to determine what kinds of procedures are carried out on patients in their facility providing that such procedures did not jeopardize other patients or staff.
Even in the face of a court order, the hospital did not admit defeat easily. On Monday, the 17th of October, Alcor Suspension Team Leader Jerry Leaf showed up at the hospital in order to allow the hospital's biomedical engineering staff to inspect the Alcor equipment that would be brought onto the premises to make sure it posed no hazard to staff and to insure that it was FDA approved (yes, FDA approved for use on a dead man!). Every single item of equipment including the oxygen bottles were subjected to an inspection. A problem immediately developed. Neither of the two heart-lung resuscitators on the market (both types of which Alcor owned) are Underwriters Laboratories (UL) or FDA approved! The hospital thus refused to allow Alcor to bring either of these devices onto their premises.
Neither device is electrical (they operate on compressed oxygen gas delivered from an oxygen cylinder) and both units are in common use in hospitals and ambulances throughout the United States. Neither device is FDA approved since both were made and marketed before the recent expansion of the FDA's authority over medical devices (as opposed to drugs) occurred. In such situations the FDA simply "grandfathers" the device: One shudders to think of the enormous logistic problems that would ensue if every device already on the market from the scalpel to the heart-lung machine had to go through retroactive FDA approval demonstrating safety and efficacy! Stethoscopes aren't FDA approved either! Medicine would grind to a halt for decades or centuries while the research studies and required paperwork were processed.
Another impasse had been reached: it seemed likely that Alcor would have to go into court again armed with statements from the manufacturers and ambulance companies and hospitals that heart-lung resuscitators are not some exotic, unapproved, or hazardous device, and a threat to the hospital staff's life and limb.
When it became apparent that we were not going to tolerate being dealt with in such an arbitrary manner and that we were willing and ready to go back into court, the hospital decided to behave reasonably and allow Alcor to use the heart-lung resuscitator.
After the TRO was issued, Mr. Roe went home briefly, but had to be hospitalized again due to sharp deterioration in his condition. On Friday, October 28th, Alcor was granted a Preliminary Injunction against the hospital and the Department of Health Services. The hospital did not contest this injunction and went on record stating that they would not interfere with Mr. Roe's suspension. Credit for success with the TRO and Preliminary Injunction rests primarily with Saul Kent, Jerry Leaf and Alcor's attorneys, David Epstein, Chris Ashworth, and Scott Tepper. In particular Saul worked tirelessly to prepare materials needed for the TRO and David Epstein delivered a magnificent performance both in court and out.
by Mike Darwin
From Cryonics, January 1989
On the 12th of December, Alcor placed into suspension long-time cryonicist Richard Clair Jones. Dick was the "John Roe" of Roe vs. California Department of Health Services and was also known professionally as Dick Clair. Dick was a highly creative talent who was responsible for many of the funniest episodes of the Carol Burnett Show. He also created several popular television situation comedies, including Flo, Mama's Family, and the Emmy-Award-winning Facts of Life. All told, Dick had won three Emmies for his writing efforts.
Dick was present at the meetings leading to the founding of the Cryonics Society of California in late 1966, and had been a Suspension Member of one cryonics organization or another continuously ever since. He has been an Alcor Suspension Member since 1979.
Placing any member into cryonic suspension is never an easy task — emotionally or practically. In Dick's case, the effort required was monumental. Most of us knew Dick very well. He was a regular at Alcor social gatherings and he was a close personal friend to a fair number of the Alcor directors, officers, and members. He was a stalwart backer of Alcor and gave generously of his money, his time, and his reputation. He opened his home to our holiday gatherings and he opened his heart to suspension patients in need. Watching Dick's slow, painful decline and having to place him into suspension was almost unbearable for everyone involved.
Two years before his ischemic coma, Dick had been diagnosed with AIDS. He was fortunate to have had a relatively stable, complication-free illness up until the last four months of his life. Unfortunately, what he was spared in terms of minor crises was more than made up for in major ones during the last 12 weeks of his illness.
As is typical of patients with AIDS, he was hospitalized frequently near the end of his illness; initially with pneumocystis carinii pneumonia (PCP), mycoplasm avians intracellularae (MAI) (a liver infection), and cytomegalovirus (CMV) (a systemic viral infection). Shortly after he was discharged from the hospital with these problems, he was readmitted with a protozoan infection of his brain (toxoplasmosis gondii) which robbed him of his rational faculties and left him in a confused, twilight state for the last 12 weeks of his life.
Dick's multiple health and legal crises were a serious drain on everyone concerned. Alcor staff were called in for Remote Standby a number of times before Dick's ischemic coma on December 12th. On several occasions, Alcor Suspension Team Members Mike Darwin and Jerry Leaf were at the hospital around the clock for 2 - 3 days at a time.
As reported above, it was necessary for Dick and Alcor to go to court to obtain a restraining order forcing Sherman Oaks Community Hospital, where Dick was a patient, to give Alcor prompt access to him and to release him to Alcor's care after pronouncement of legal death. The hospital had refused to cooperate with Alcor, in part due to the position taken by the California Department of Health Services (DHS) that cryonics is illegal.
Despite the legal complications and problems, Dick did get suspended. At about 9:00 PM on the evening of December 11th the Alcor phone rang: the nursing personnel attending Dick notified us that he was deteriorating sharply and that cardiac arrest was only a few hours or at most a day or so away. Jerry Leaf, Scott Greene, Mike Darwin, Arthur McCombs, and Carlos Mondragon were dispatched to the hospital, and the mortician Alcor had retained to handle his transport was notified and also came to stand by.
The Alcor Transport Team waited down the hall from Dick's room until we were notified, at about 3:45 AM PST on December 12, that Dick was experiencing final, agonal respirations. At 3:59 AM PST Dick was pronounced legally dead and cardiopulmonary support using a heart-lung resuscitator (HLR) began a few minutes later. Since we were prohibited (by the court order) from intubating Dick by the hospital, we used an Esophageal Gastric Tube Airway (EGTA) to secure his airway against stomach secretions and ventilate him. We also used a new (to us) model of HLR, the Michigan Instruments MICPR unit. Both the EGTA and the MICPR unit performed very well. Dick promptly regained color and the EGTA was very effective at both protecting his airway and giving good chest expansion during ventilation. At the same time cardiopulmonary support was started, Dick was packed in ice. He was then moved out of the hospital to the mortuary we had contracted with, which was conveniently located only a mile or two from hospital.
We arrived at the mortuary at approximately 4:30 AM and began administration of transport medications at 4:40 AM. We were unable to give transport medications in the hospital at the start of cardiopulmonary support as we normally do because of restrictions placed on us by the hospital. By 5:25 AM Dick had been positioned on the Mobile Advanced Life Support System (MALSS) and surgery was underway to raise his femoral artery and vein. In addition to his continuing good skin color, Dick's arterial blood was noted to be bright red (indicating good oxygenation) and he had bright red capillary bleeding into the wound during surgery — all good signs. At 6:00 AM Dick was on bypass — connected to the blood pump and membrane oxygenator of the MALSS. He had already cooled to 29.3°C by the time bypass was started, and was rapidly cooled to a rectal temperature of 9°C over the next 45 minutes.
|1) After arrival at Alcor, Dick was placed on the operating table and repacked in ice. A bed scale was used as the operating table platform so that pre- and post-procedure weights could be taken to determine the degree of any dehydration or edema as a result of cryoprotective perfusion.|
Around 7: 30 AM Dick was transported from the mortuary in Sherman Oaks to Alcor's facilities in Riverside. He was further cooled to a pharyngeal temperature of 6.0°C, taken off MALSS support and positioned on the operating table. A median sternotomy with cannulation of the aortic root and right heart was used to access his circulation. Complete blood washout was started at 5:27 PM using Alcor's standard Sucrose-Hepes Perfusate (SHP-1), containing 5%w/v glycerol. The cryoprotective "ramp," wherein glycerol concentration is slowly increased in the circulating perfusate, was begun at 5:45 PM at a rate of 30 mM/minute.
2) Suspension Team Leader Jerry Leaf and Alcor physician Thomas Munson begin surgery to connect Dick to the heart-lung machine for cryoprotective perfusion.
3) The heart-lung machine used to deliver cryoprotective drugs to Dick's tissues.
Blood washout and cryoprotective perfusion went very well. Dick had experienced a fairly long period of severe hypotension (low blood pressure) and hypoxia prior to cardiac arrest. His immediate cause of death was probably a toxoplasmosis lesion in his brain stem, and he no doubt suffered some hypoxic and ischemic injury prior to legal death. As a consequence he developed moderate facial and mild cerebral edema during MALSS support (as evidenced by slight bulging of his cerebral cortex surface against the edges of the burr hole that had been made to observe the brain) and we were concerned that this would limit subsequent cryoprotective perfusion. However, both his peripheral and cerebral edema disappeared during glycerolization and, as usual, brain volume decreased due to osmotic removal of water by the glycerol.
As perfusion progressed, very modest cerebral edema was again noted and it was decided to switch from continuous to pulsatile perfusion. Because of the possibility of ischemic injury we had set up the perfusion circuit with a Shiley Inc. Tamari-Kaplitt pulsatile perfusion system. This device converts the smooth, continuous flow generated by the heart-lung machine roller pump into a pulsatile flow which mimics that normally delivered by the heart. Numerous studies have documented the benefits of pulsatile flow during human cardiopulmonary bypass in reducing cerebral edema and increasing the degree of perfusion to ischemically injured tissues.
|4) The Shiley Tamari-Kaplitt pulsatile perfusion unit. This device converts the relatively constant flow produced by the heart-lung machine roller pump into a pulsatile flow which mimics that of the heart.|
Within 15 minutes of beginning pulsatile flow there was a noticeable reduction in the degree of cerebral edema, and within 30 minutes brain volume had returned to normal — where it remained until the conclusion of perfusion. Perfusion was discontinued at 8:43 PM when a venous glycerol concentration of 4.2M was reached. Following closure of the scalp and chest incisions, Dick was placed inside two heavy plastic bags and submerged in a silicone oil (Silcool) bath which had been precooled to -17°C. His temperature was then lowered at a rate of approximately 1°C per hour to -77°C by gradual addition of dry ice to the Silcool bath. This was the first time the new cooling chest had been used (other than in static tests) and it performed very well. A high capacity circulating pump was used to circulate the oil and pump it through a spray-bar assembly positioned over the patient. This technique completely eliminated the "hot spots" and "cold spots" which have plagued other whole body cooling efforts. The superior insulation of the cooling chest reduced dry ice consumption from the 15 pounds per hour experienced during the last whole body suspension to an average of 5 pounds per hour during Dick's.
5) Mike Darwin adds dry ice to the Silcool bath.
6) Dick was cooled to -79°C by submersion in a silicone oil (Silcool) bath. This photo shows the spray bar used to distribute Silcool evenly over the patient, preventing 'hot spots' or 'cold spots.' The 1-gallon plastic jugs to either side of Dick were filled with sand and used as to consume volume in the cooling tank (i.e., to raise the Silcool level), minimizing the amount of costly Silcool required.
7) Following cooling to -77°C, the Silcool was pumped out of the cooling tank and Dick was covered with dry ice for temporary storage at -79°C.
Cooling to -196°C
Dick reached dry ice temperature at 12:30 PM on December 15. At 2:25 PM on December 18, Dick was transferred from the dry ice chest to an Alcor dual patient dewar for controlled cooling to liquid nitrogen temperature (-196°C). This set another record for speed, in beginning cooldown to liquid nitrogen temperature.
8) Dick was lifted out of the cooling chest and placed momentarily on an insulated table top for for removal of the outer, oil soaked, protective plastic bag.
9) Precooled cryogenic dewar with the patient insertion guide in place.
10) Hugh Hixon, Mike Darwin, and Jerry Leaf position the controlled rate cooling lid atop Dick's dewar for the descent to -196°C.
|11) The dewar, rocked upright and set up for controlled cooling of the patient to -196°C.|
Once the dewar had been precooled and rocked upright with Dick inside, a custom-fabricated lid with a fill line and fan was sealed into place with Dux-Seal putty. The fan was then turned on and boluses of liquid nitrogen were added at 15 to 30 minute intervals over the next nine days. The nitrogen was sprayed into a 6 foot long aluminum pipe, closed at the bottom, placed inside the dewar to prevent pooling of liquid at the bottom of the dewar and excessive cooling of the patient's head. Temperature readings were taken at 30 minute intervals during most of the cooldown. Careful monitoring and control using this system resulted in a 1°C differential between the top and bottom of the dewar, and a 1°C to 2°C differential between external head and pharyngeal (core) temperatures.
At 19:42 on December 27, the dewar was completely filled with liquid nitrogen and Dick entered long term storage.