Madison Astle v. HHS - Varicella, intracranial hypertension; chronic headaches; pseudotumor cerebri-like condition; cerebral venous thromboembolic event (2018)
Case summary [AI summaries can sometimes make mistakes]
On April 30, 2014, Stephanie Astle filed a petition for compensation under the National Vaccine Injury Compensation Program on behalf of her minor daughter, Madison Astle. The petition alleged that the human papillomavirus (HPV) and varicella vaccinations Madison received on January 16, 2012, caused her to develop severe headaches and increased spinal fluid pressure.
Madison, who was 13 years old at the time of vaccination, subsequently experienced persistent and worsening headaches, leading to multiple medical evaluations, emergency room visits, and hospitalizations. Her condition was diagnosed as possible pseudotumor cerebri without papilledema and chronic persistent headaches associated with increased intracranial pressure.
An amended petition specified that one or both vaccines caused a cerebral venous thromboembolic event, resulting in increased cerebrospinal fluid pressures and a pseudotumor cerebri-like condition. The respondent recommended against compensation, arguing that the petitioner failed to present adequate evidence of a vaccine-related cause.
Petitioner's expert, neurologist Dr. Carlo Tornatore, opined that the varicella vaccine caused Madison's intracranial hypertension and subsequent chronic headaches through inflammation of blood vessels in the brain, leading to impaired cerebrospinal fluid drainage and increased intracranial pressure.
Respondent's expert, neurologist Dr. Peter M.
Bingham, argued that Madison suffered from migraines and that the evidence did not support a vaccine-related cause for intracranial hypertension. The Special Master, Chief Special Master Nora Beth Dorsey, considered the medical records, expert testimony, and applicable legal standards.
The public decision does not describe the specific symptoms Madison experienced beyond headaches, nor does it detail the specific treatments she received beyond medication management and diagnostic procedures. The Special Master found that Madison's medical records, the opinions of her treating physicians (including Dr.
Gratz and Dr. Lipton), and medical literature provided preponderant evidence that the varicella vaccine caused her intracranial hypertension and subsequent chronic headaches, satisfying the Althen prongs for causation.
The Special Master also found evidence of a cerebral venous thromboembolic event. As entitlement was granted, a separate damages order was to be issued.
Petitioner was represented by Clifford J. Shoemaker of Shoemaker, Gentry & Knickelbein, and respondent was represented by Glenn Alexander MacLeod of the U.S.
Department of Justice.
Theory of causation
Madison Astle, age 13, received a varicella vaccine on January 16, 2012. Approximately one week later, she developed severe headaches, which evolved into chronic intracranial hypertension and a possible cerebral venous thromboembolic event. Petitioner's expert, Dr. Carlo Tornatore, proposed that the live attenuated varicella virus in the vaccine infected nerves and/or blood vessels in the brain, causing inflammation, stenosis, or clotting in the cerebral venous sinuses. This obstruction impaired cerebrospinal fluid (CSF) drainage, leading to increased intracranial pressure (ICP) and subsequent chronic headaches. Dr. Tornatore cited case reports linking varicella infection to increased ICP via venous outflow abnormalities, inflammation, or clotting, and noted that the vaccine package insert warns of possible transmission of the virus. He also pointed to Madison's abnormal MRV studies showing potential occlusion and irregularities in the left internal jugular vein and left sigmoid sinus, and the opinions of treating physicians like Dr. Gratz who diagnosed presumptive pseudotumor cerebri without papilledema due to increased intracranial pressure. Respondent's expert, Dr. Peter M. Bingham, argued Madison suffered from migraines, citing the presence of spontaneous venous pulsations (SVP) and a borderline opening lumbar puncture pressure of 30 cmH2O as evidence against increased ICP, and questioned the significance of unilateral MRV abnormalities. The Special Master, Chief Special Master Nora Beth Dorsey, found Dr. Tornatore's theory persuasive, supported by medical literature and Madison's clinical course, including the opinions of her treating physicians, and concluded that the varicella vaccine more likely than not caused Madison's intracranial hypertension and cerebral venous thromboembolic event. Entitlement was granted, with a separate damages order to follow. Petitioner was represented by Clifford J. Shoemaker, and respondent by Glenn Alexander MacLeod.
Source PDFs
USCOURTS-cofc-1_14-vv-00369