R.P. v. HHS - Influenza, transverse myelitis (2019)
Case summary [AI summaries can sometimes make mistakes]
On August 20, 2013, Greg and Angela Palattao filed a petition on behalf of their minor son, R.P., seeking compensation under the National Vaccine Injury Compensation Program. They alleged that R.P. developed transverse myelitis (TM) as a result of receiving childhood vaccinations, including DTaP, Hib, IPV, PCV, and the influenza vaccine, on January 7, 2013.
R.P. was born on July 6, 2012. Following vaccination, R.P. developed a fever and decreased activity.
He was taken to the emergency room on January 8, 2013, and again on January 9, 2013, when his condition worsened, leading to admission to the pediatric intensive care unit and a diagnosis of TM. Petitioners' experts, Dr.
Marcel Kinsbourne and Dr. Ralph Shapiro, proposed a theory that the vaccinations caused an overproduction of proinflammatory cytokines, specifically IL-6, leading to inflammation and demyelination of the spinal cord.
They argued that this cytokine storm could breach the blood-brain barrier and attack the central nervous system. Respondent's experts, Dr.
Timothy Lotze and Dr. Christine McCusker, argued that the onset of R.P.'s symptoms on January 8, 2013, approximately 30-36 hours post-vaccination, was too soon to be medically reasonable for a vaccine-induced TM under the proposed cytokine-mediated causation theory.
They suggested R.P.'s TM was more likely idiopathic or related to a prior upper respiratory infection (URI) from December 2012. The Special Master found that R.P.'s TM symptoms likely began on January 8, 2013.
This timeframe was deemed too short to be medically reasonable for a vaccine-induced TM under the proposed cytokine-mediated causation theory, as supported by the medical literature cited by both parties. The Special Master also found Petitioners' causation theory to be unpersuasive and unreliable, lacking sufficient scientific evidence to support the link between peripheral cytokine upregulation from vaccines and TM.
The court noted that while TM can be vaccine-related, the specific mechanism proposed and the timing in this case were not sufficiently established. Ultimately, entitlement was denied because Petitioners failed to meet their burden of proof on the Althen prongs, particularly regarding the proximate temporal relationship and the reliability of the causation theory.
Petitioner's counsel was Kate Gerayne Westad. Respondent's counsel was Mollie D.
Gorney. The Special Master was Brian H.
Corcoran.
Theory of causation
Petitioners alleged that R.P.'s transverse myelitis (TM) was caused by childhood vaccinations received on January 7, 2013, including DTaP, Hib, IPV, PCV, and influenza. Petitioners' experts, Dr. Marcel Kinsbourne and Dr. Ralph Shapiro, proposed an off-Table theory that the vaccines triggered an overproduction of proinflammatory cytokines, particularly IL-6, leading to a cytokine storm that breached the blood-brain barrier and caused demyelination of the spinal cord. They suggested this innate immune system dysregulation could occur within 24-48 hours post-vaccination, potentially accelerated by prior vaccinations. Respondent's experts, Dr. Timothy Lotze and Dr. Christine McCusker, argued that the onset of R.P.'s symptoms on January 8, 2013 (30-36 hours post-vaccination), was too rapid for a vaccine-induced TM and suggested an idiopathic cause or a prior URI. The Special Master found the proposed cytokine-mediated mechanism lacked sufficient reliable scientific evidence to link peripheral cytokine upregulation from vaccines to TM. The Special Master also determined that the onset of symptoms within 30-36 hours was not medically reasonable, citing medical literature that suggested a longer timeframe for such a process. The petition was denied for failure to establish the Althen prongs, specifically the proximate temporal relationship and the reliability of the causation theory. Attorneys for Petitioners included Kate Gerayne Westad, and for Respondent, Mollie D. Gorney. Special Master Brian H. Corcoran issued the decision on March 1, 2019.
Source PDFs
USCOURTS-cofc-1_13-vv-00591