62. The effects of such misrepresentations and nondisclosure were that Jesse and Paul Gelsinger believed the risks of injection of the adenovirus vector were minimal and the potential benefits of Jesse’s participation to the future treatment of OTC patients in the study were enormous.
63. On September 9, 1999, Jesse returned to Philadelphia to begin the gene transfer trial.
64. Jesse was scheduled to be the last of three patients in the sixth cohort in the trial.
65. On September 13, 1999, Jesse was taken to the interventional-radiology suite where he was sedated and strapped to a table while a team of radiologists threaded two catheters into his groin.
66. At approximately 10:30 a.m., Dr. Raper drew 30 milliliters of the vector and injected it into Jesse.
67. The procedure was completed at approximately 12:30 p.m.
68. On the evening of September 13, 1999, Jesse was sick to his stomach and had a fever of 104.5 degrees.
69. The following morning Jesse seemed disoriented.
70. When Dr. Raper examined Jesse the morning of September 14, 1999, he noticed that Jesse’s eyes were yellow.
71. Blood tests performed on September 14, 1999, indicated that Jesse’s bilirubin was four times the normal level.
72. The symptoms that Jesse was experiencing were similar to those defendants had seen in the monkeys that had been given a similar vector.
73. By the afternoon of September 14, 1999, Jesse had slipped into a coma.
74. At 11:30 p.m. on September 14, 1999, Jesse’s ammonia level was 393 micro moles per deciliter of blood. The normal level is 35 micro moles.
75. Thereafter, the doctors placed Jesse on dialysis.
76. Initially, Jesse’s condition improved but soon began to deteriorate.
77. After consultation between Drs. Wilson, Raper and Batshaw, the doctors decided to perform extra corporeal membrane oxygenation.
78. On September 16, 1999, Jesse’s kidneys stopped making urine and he began to suffer from multiple organ system failure.
79. On the evening of September 16, 1999, Jesse was bloated beyond recognition; his ears and eyes had swollen shut.
80. On the morning of September 17, 1999, tests indicated that Jesse was brain dead.
81. On September 17, 1999, the ECMO machine was shut off and Jesse was pronounced dead at 2:30 p.m.
82. The cause of Jesse’s death was attributed to acute respiratory distress and multiple-organ failure, both of which were the direct result of injection of the adenovirus vector.
83. After Jesse’s death, the FDA determined there were numerous violations of FDA guidelines by the defendants. Some of these violations were:
a. failing to tell the National Institute of Health Recombinant DNA Advisory Committee (“the RAC”) of a change in the way the virus was to be delivered to patients;
b. changing the informed consent form from what had been approved by the FDA by removing information concerning the death or illness of several monkeys during a similar study;
c. failing to report to the FDA that patients prior to Jesse suffered significant liver toxicity which required that the study be put on hold;
d. failing to follow the study protocol which mandated that in each cohort at least two women be subject to injection before any male;
e. admitting Jesse in the trial when his blood ammonia level on the day before he received the gene transfer exceeded the limit set out in the FDA protocol; and
f. allowing the vectors to sit and/or be stored on lab shelves for 25 months before being tested in animals, making them less potent then they could have been. The vectors administered to the plaintiff’s decedent were only stored for two months. The 25 month storage in turn, may have resulted in an underestimation of the vectors potency in humans. Additionally, the animals who received the vector stored for 25 months would have been given a dose of vector from 52.2% to 65.3% below the vector dose specified in the FDA protocol.
COUNT I – WRONGFUL DEATH
JOHN GELSINGER, AS ADMINISTRATOR AND PERSONAL REPRESENTATIVE OF THE ESTATE OF JESSE GELSINGER v. THE TRUSTEES OF THEUNIVERSITY OF PENNSYLVANIA, CHILDREN’S HOSPITAL OF PHILADELPHIA, CHILDREN’S NATIONAL MEDICAL CENTER, JAMES WILSON, M.D., GENOVO, INC., STEVEN RAPER, M.D. MARK BATSHAW, M.D., WILLIAM N. KELLEY, M.D., AND ARTHUR CAPLAN, Ph.D.
84. Plaintiffs incorporate by reference paragraphs 1 through 83 as if fully set forth at length herein.
85. At all times mentioned herein and material hereto, the defendants, and each of them respectively, jointly and severally, were charged with the professional responsibility of rendering proper care and treatment to Jesse Gelsinger, of properly and carefully examining him in order to determine his condition and eligibility for the gene transfer trial, of properly and carefully administering the gene transfer protocol in a careful and prudent fashion, and of assuring that proper medical care and attention were provided during all periods of time during which he remained under said defendants’ care and treatment.
86. As a result of the careless, negligent and reckless conduct of the defendants herein, Jesse Gelsinger was caused to suffer excruciating and agonizing pain and discomfort and ultimately died as a result of defendants’ conduct.
87. Defendants together, and each of them respectively, jointly and severally, by and through their separate and respective agents, servants, workmen, representatives, physicians, nurses, staff, contractors, medical personnel, medical assistants and employees were careless, negligent and reckless in:
a. failing to properly and adequately evaluate Jesse Gelsinger’s condition and eligibility for the gene transfer trial;
b. failing to properly diagnose Jessie Gelsinger’s condition subsequent to the administration of the gene transfer;
c. failing to perform proper and adequate testing for his condition;
d. failing to properly and adequately treat his condition;
e. failing to properly and adequately care for his condition;
f. failing to monitor his ammonia levels both during and after the administration of the gene transfer;
g. failing to provide and afford proper and careful medical care and treatment;
h. failing to perform proper and careful medical practices and procedures in accordance with the standards prevailing in the community in which defendants practiced at the time;
i. failing to properly care for his condition under all of the circumstances;
j. caring for Jesse Gelsinger in a negligent and improper manner;
k. failing to properly monitor his condition both prior to and subsequent to the performance of the gene transfer procedure;
l. failing to use a proper, adequate and safe vector for gene transfer;
m. failing to inform Jesse Gelsinger of all the risks of performing the gene transfer procedure so as to afford him with the opportunity to make an informed decision as to the performance of said procedure;
n. failing to properly and timely observe, discover, diagnose, treat and care for his condition;
o. failing to conform to the standard of care and treatment prevailing in the medical community in which defendants practiced at the time in conducting gene transfer;
p. failing to exercise reasonable care under all of the circumstances, in accordance with the accepted practices and procedures in the medical community in which defendants practiced;
q. failing to follow and abide by guidelines set forth by various governmental agencies; and
r. acting negligently per se.
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