MF v. HHS - multiple, global developmental delay with static encephalopathy of unclear etiology, significant speech delay, autism spectrum disorder (2011)
Case summary [AI summaries can sometimes make mistakes]
On December 3, 2002, Petitioners Lisa and Mr. Fesanco, proceeding pro se, filed a Short Form Autism Petition for Vaccine Compensation on behalf of their son, MF, who was born in 1997.
MF received a series of childhood vaccinations between his birth and December 21, 2001, including DTaP, Polio, MMR, Haemophilus influenzae type b (HbPv), Hepatitis B (Hep B), Varicella, and Prevnar. The DTaP, HbPv, and Hep B vaccinations contained thimerosal.
MF's pediatric well-child exams from 3 weeks to 18 months all documented normal growth and development. Around December 5, 1999, when MF was approximately two years old, he developed severe constipation lasting over a year, and his parents noticed a regression in his speech and language.
A pediatrician noted a "lack of speech — dev delay — language" on December 9, 1999. A neurologist examined MF on February 8, 2000, describing him as a two-year-old boy with temper tantrums, global developmental delay, significant speech issues, fine and gross motor delays, occasional staring episodes, and sensory issues.
The neurologist diagnosed a "global developmental delay with static encephalopathy of unclear etiology" with "significant speech delay." Speech, language, occupational, and physical therapy began on February 16, 2000. By July 28, 2000, a pediatric neurologist diagnosed MF's condition as falling within the autism spectrum disorder (ASD) category, a diagnosis later confirmed by multiple specialists.
The case was part of the Omnibus Autism Proceeding (OAP) and was stayed until 2008. Petitioners' counsel entered an appearance on February 14, 2003, and later withdrew on August 15, 2007.
The Special Master issued orders regarding the establishment of filing deadlines and the completion of medical records. The Government did not oppose the case continuing within the OAP, believing the petition was timely filed and involved a diagnosed ASD.
On September 15, 2010, the Special Master ordered Petitioners to advise how they intended to proceed, offering an opportunity to present additional evidence. Petitioners requested the case be decided based on the record.
On November 9, 2010, Special Master George L. Hastings, Jr. denied the petition, finding that the medical records contained no evidence of a "Table Injury" and no medical expert's opinion or other evidence indicating a vaccine-caused condition.
The Special Master noted one physician was "suspicious" of a vaccine connection but did not express an affirmative opinion of causation, and no treating physicians did so. The Special Master also commented on whether autism was an accurate description of MF's condition, though he acknowledged MF suffered from severe speech deficits and social and mobility problems.
Petitioners moved for review, arguing the Special Master improperly commented on the diagnosis and that a report by Dr. S, Director of Clinical Immunology, stating that vaccine-related mercury damage "cannot be ruled out," supported causation.
The Government responded that the Special Master did not rule out autism and that the issue was whether vaccines caused the problems. The Government argued Dr.
S's statements were equivocal and that the OAP test cases had already rejected the theory that MMR or thimerosal-containing vaccines cause autism due to a lack of persuasive evidence. The Court of Federal Claims, Judge Susan G.
Braden, reviewed the Special Master's decision. Because ASDs are not on the Vaccine Table, Petitioners had the burden to prove causation in fact under the Althen standard, requiring a medical theory, a logical sequence of cause and effect, and a proximate temporal relationship.
The court noted that the OAP test cases had unanimously rejected the theory that MMR or thimerosal-containing vaccines cause autism, and Petitioners presented no new evidence or theories. The court found that Dr.
S's report only stated a link could not be ruled out and did not articulate an affirmative medical opinion of causation. Therefore, the court concluded Petitioners failed to establish a causal link and affirmed the Special Master's denial of the petition on May 16, 2011.
The court found the Special Master's decision was not arbitrary, capricious, or otherwise not in accordance with law.
Theory of causation
Petitioners alleged that multiple childhood vaccinations, including DTaP, Polio, MMR, HbPv, Hep B, Varicella, and Prevnar, some of which contained thimerosal, caused MF's autism spectrum disorder (ASD) and global developmental delay with static encephalopathy. The case involved a non-Table injury, requiring proof of causation in fact under the Althen standard. The medical records included a statement from Dr. S in 2002 suggesting that vaccine-related mercury damage "cannot be ruled out" and that "it does not rule out the possibility that [MF] had damage done by mercury when he was an infant and the mercury has since cleared by the damage to his central nervous system is still present," but also noted that "as to whether or not there was enough thimerosal in [MF’s] immunizations to cause mercury toxicity is still controversial and poorly supported by any data." No treating physician affirmatively opined that the vaccines caused MF's condition. Special Master Hastings denied the petition on November 9, 2010, finding no evidence of a Table Injury and no expert opinion supporting causation. The Court of Federal Claims, Judge Braden, affirmed on May 16, 2011, holding that Petitioners failed to establish a medical theory, a logical sequence of cause and effect, or a proximate temporal relationship, and that the OAP test cases had already rejected similar theories. Petitioners were represented by counsel, and the Respondent was the Government. The award amount was $0.
Source PDFs
USCOURTS-cofc-1_02-vv-01770