H.L. on behalf of A.I. v. HHS - Influenza, Leigh Disease (also known as Leigh Syndrome), metabolic decompensation, respiratory failure, sepsis, possible hypoxic seizures, neurodegeneration (2016)
Case summary [AI summaries can sometimes make mistakes]
On April 1, 2010, H.L., on behalf of her deceased daughter A.I., filed a petition for vaccine compensation. A.I., who was six years old, received a FluMist vaccine on January 11, 2008.
The petition alleged that the vaccine significantly aggravated A.I.'s pre-existing Leigh Disease, leading to her death on April 5, 2008, due to metabolic decompensation, respiratory failure, and sepsis. The respondent argued that the petitioner failed to prove causation or significant aggravation, asserting that A.I.'s death was attributable to her underlying Leigh Disease and not caused or aggravated by the vaccine.
The case involved expert testimony from Dr. Frances D.
Kendall for the petitioner and Dr. Shawn E.
McCandless for the respondent. Dr.
Kendall contended that the vaccine, combined with a concurrent upper respiratory infection, acted as a stressor that triggered A.I.'s metabolic decompensation. Dr.
McCandless disagreed, stating that the metabolic community has not identified a clear association between immunization and metabolic decompensation and that A.I.'s condition was characteristic of her Leigh Disease, with the infection being a more likely trigger. The Special Master, George L.
Hastings, Jr., found Dr. McCandless's opinion more persuasive.
The Special Master concluded that the petitioner failed to meet the burden of proof for causation-in-fact under the Althen test. Specifically, the Special Master found the timing of A.I.'s symptoms inconsistent with vaccine causation, that A.I.'s prior tolerance of illnesses did not support the vaccine as a stressor, and that the cited medical literature did not establish a causal link.
The Special Master denied the claim on March 17, 2016. Petitioner filed a motion for review with the U.S.
Court of Federal Claims. On September 29, 2016, Judge Susan G.
Braden denied the motion for review, upholding the Special Master's decision. The court found that the Special Master's decision was not arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.
Petitioner counsel was Robert J. Krakow, and respondent counsel was Justine Walters.
No award was granted.
Theory of causation
Petitioner H.L., on behalf of A.I. (6 years old), alleged that the FluMist vaccine administered on January 11, 2008, significantly aggravated A.I.'s pre-existing Leigh Disease, leading to her death on April 5, 2008. Petitioner's expert, Dr. Frances D. Kendall, argued that the vaccine, combined with a concurrent upper respiratory infection, acted as a stressor, triggering metabolic decompensation. Respondent's expert, Dr. Shawn E. McCandless, contended that there is no clear association between immunization and metabolic decompensation and that A.I.'s condition was characteristic of her Leigh Disease, with the infection being the more likely trigger. The Special Master, George L. Hastings, Jr., found Dr. McCandless's opinion more persuasive, concluding that Petitioner failed to meet the burden of proof under the Althen test for causation-in-fact. Key findings included that the timing of A.I.'s symptoms was inconsistent with vaccine causation, A.I.'s prior tolerance of illnesses did not support the vaccine as a stressor, and the cited medical literature did not establish a causal link. The Special Master denied the claim on March 17, 2016. Judge Susan G. Braden denied Petitioner's motion for review on September 29, 2016, upholding the Special Master's decision. The claim was denied, and no award was granted. Petitioner counsel: Robert J. Krakow. Respondent counsel: Justine Walters. Special Master: George L. Hastings, Jr. Judge: Susan G. Braden.