Ruby Hopkins v. HHS - Hib, bilateral sensorineural hearing loss (2007)
Case summary [AI summaries can sometimes make mistakes]
On December 11, 2000, petitioners Greg and Helen Hopkins filed a petition for compensation under the National Vaccine Injury Compensation Act on behalf of their daughter, Ruby Hopkins. They alleged that Ruby, who was four years old, suffered bilateral sensorineural hearing loss as a result of receiving Haemophilus influenzae type B (HIB), diphtheria-tetanus-pertussis (DTP), and oral polio (OPV) vaccinations on December 10, 1998.
Ruby's parents had previously delayed her immunizations due to concerns about vaccines. Ruby had received an earlier series of OPV and Tetramune (DTP/HIB) in July 1996 without apparent reaction.
Following the December 10, 1998 vaccinations, Ruby's parents noticed she was not responding consistently to their voices around January 1, 1999, approximately three weeks later. Ruby herself indicated her left ear "didn't work." She was seen at a pediatric clinic on January 4, 1999, where "perceived hearing loss" was documented.
She received another round of Tetramune and OPV on January 11, 1999. Audiological evaluations on January 12 and 18, 1999, revealed mild-to-moderate sensorineural hearing loss in the right ear and moderate-to-severe loss in the left ear, with normal middle ear function, indicating cochlear rather than infectious loss.
Subsequent evaluations by ENT specialists could not identify a syndromic cause. Dr.
Randall Ow noted a maternal family history of hearing loss, including a great-uncle who was deaf as a child, a maternal uncle with significant hearing loss, and a maternal aunt with cerebral palsy and mild hearing loss. Dr.
Ow concluded Ruby's hearing loss was "probably congenital" and likely "progressive hereditary." Genetic testing showed Ruby, her brother Finn, and her father all carried an M34T mutation in the Connexin 26 gene. A consulting geneticist, Dr.
Richard Smith, characterized this mutation as a benign polymorphism but stated the family history was consistent with autosomal recessive nonsyndromic hearing loss caused by a different gene. Dr.
Thad Woodward noted in August 1999 that it was "curious" that both children developed hearing loss shortly after receiving the DTP vaccine, though he did not personally believe it was the likely cause. The case was litigated as an off-Table claim.
The Chief Special Master initially issued a Factual Determination in 2005 finding the parents' testimony credible regarding the onset of hearing loss after the December 10, 1998 vaccinations, establishing the proximate temporal relationship. However, after hearing testimony from respondent's experts, particularly Dr.
Leila Mankarious, the Chief Special Master reversed this timing finding, concluding that the precise onset date was unknown due to the difficulty of detecting hearing loss in young children and the absence of a baseline pre-vaccination test. The Chief Special Master denied compensation.
The Court of Federal Claims agreed that the Chief Special Master erred in reversing himself on timing, noting the parents' credible testimony was the only contemporaneous evidence and was never expressly discredited. Even the government's expert, Dr.
Mankarious, conceded the hearing loss was "probably precipitously worse three weeks after the vaccine based on her history and what her father noticed." However, the court affirmed the denial on the second Althen prong (logical sequence of cause and effect). The Chief Special Master credited the government's experts, Drs.
Mankarious and Gerald Raymond, over petitioners' expert, Dr. Carlo Tornatore.
Dr. Tornatore proposed that the vaccine acted as an environmental "trigger" against a genetic predisposition.
The court accepted that Dr. Tornatore's reliance on mitochondrial-deafness literature was misapplied, as Ruby did not have a mitochondrial mutation.
The court also noted that Ruby's treating physicians (Drs. Donald Endres, Randall Ow, Phillip Massengill, and Mark J.
Stephan) attributed the hearing loss to heredity rather than the vaccine, and that the medical literature contained no documented association between the HIB, DTP, or OPV vaccines and sensorineural hearing loss. Compensation was denied.
Petitioners were represented by counsel, and respondent was represented by counsel. The Special Master was Gary Golkiewicz.
The court's opinion was written by Judge Horn.
Theory of causation
Petitioners alleged that Ruby Hopkins suffered bilateral sensorineural hearing loss as a result of HIB, DTP, and OPV vaccinations received on December 10, 1998. The case was litigated as an off-Table claim. Petitioners' expert, Dr. Carlo Tornatore, proposed a medical theory that the vaccine acted as an environmental "trigger" against a genetic predisposition for hearing loss, citing mitochondrial deafness literature and gene-environment interaction studies. Respondent's experts, Drs. Leila Mankarious and Gerald Raymond, countered that genetic hearing loss is typically spontaneous without a triggering event and that the cited literature was not applicable to Ruby's case or the vaccines administered. The Chief Special Master found Dr. Tornatore's testimony lacked credibility due to advocacy, imprecise interpretation of literature, and unsupported assumptions, while crediting the testimony of Drs. Mankarious and Raymond, who stated the vaccines involved do not cause hearing loss. Treating physicians also attributed the hearing loss to heredity. The court affirmed the denial, finding that the petitioners failed to establish a logical sequence of cause and effect by a preponderance of the evidence, as the proposed triggering mechanism was not sufficiently documented and the medical literature did not support a link between the vaccines and sensorineural hearing loss. The court also noted the lack of a clear temporal relationship, despite the parents' credible testimony, due to the difficulty in diagnosing hearing loss in young children and the absence of pre-vaccination baseline tests. Compensation was denied.
Source PDFs
USCOURTS-cofc-1_00-vv-00745