L.A.M. v. HHS - HPV, alleged migraines, POTS, chronic fatigue syndrome, conversion disorder, undifferentiated connective tissue disease, and small fiber polyneuropathy (2017)
Case summary [AI summaries can sometimes make mistakes]
On December 6, 2011, L.A.M.'s father filed a petition under the National Childhood Vaccine Injury Act, alleging that the Gardasil vaccine administered on December 3, 2008, caused his daughter severe headaches, photophobia, phonophobia, fatigue, dizziness, and gait disturbances. L.A.M. was later substituted as the petitioner after reaching the age of majority.
The petition focused on the second Gardasil dose and subsequent symptoms in 2009. Petitioner was born on February 2, 1994.
Pre-vaccination medical records indicated that some of the symptoms later attributed to Gardasil had appeared earlier. In June 2007, at age thirteen, she experienced severe headaches, light sensitivity, and dizziness, leading to a diagnosis of migrainous headache.
Her pre-vaccination orthopedic history also included repeated ankle injuries and a thumb injury with suspected complex regional pain syndrome. Petitioner received her first Gardasil dose on August 26, 2008, with no recorded systemic complaints.
She received her second Gardasil dose on December 3, 2008. In February 2009, she developed flu-like symptoms, followed by a severe headache, nausea, photophobia, and phonophobia.
Numerous medications were prescribed for her symptoms. Petitioner's course was complicated by gait complaints, weakness, reading problems, syncopal episodes, and tachycardia, leading to a POTS diagnosis.
Several specialists found no structural neurologic or ophthalmologic explanation for her symptoms, with some suggesting psychiatric or psychological evaluation. A rheumatologist diagnosed undifferentiated connective tissue disease (UCTD) but did not connect it to Gardasil.
Petitioner's expert, immunologist Dr. Yehuda Shoenfeld, theorized that the aluminum adjuvant in Gardasil triggered Autoimmune/Auto-inflammatory Syndrome Induced by Adjuvants (ASIA), causing her POTS, chronic fatigue syndrome (CFS), UCTD, and possible small fiber polyneuropathy.
Respondent presented several experts, including Dr. J.
Lindsay Whitton and Dr. Edward Cetaruk, who disputed the ASIA theory, and pediatric neurologist Dr.
Max Wiznitzer, pediatric rheumatologist Dr. Carlos Rose, and pediatrician/immunologist Dr.
Stephen McGeady, who attributed her symptoms to pre-existing conditions, deconditioning, or conversion disorder. Special Master Laura D.
Millman dismissed the petition on January 31, 2017. She found that petitioner had migraine symptoms before vaccination and that Dr.
Shoenfeld did not link Gardasil to migraines. Regarding POTS, she found the onset was much later than claimed and that the evidence pointed to non-autoimmune POTS.
She credited explanations that fatigue followed immobility and deconditioning, not vaccination. She found that autoantibodies likely predated vaccination and that the rheumatologist did not link UCTD to Gardasil.
She also found no proof of small fiber polyneuropathy. The Special Master concluded that petitioner failed to prove Gardasil caused any of her alleged illnesses.
Petitioner was represented by attorney Patricia A. Finn.
Respondent's counsel included Debra A. Filteau Begley, Gordon Shemin, and Lara A.
Englund. An interim award of attorneys' fees and costs totaling $62,350.00 was made on December 19, 2014, based on a stipulation.
Theory of causation
Petitioner L.A.M. received Gardasil on December 3, 2008, at age 14.83. The petition alleged that Gardasil caused migraines, POTS, CFS, UCTD, and small fiber polyneuropathy. The Special Master dismissed the case on January 31, 2017, finding no proof of causation. Petitioner's expert, Dr. Yehuda Shoenfeld, proposed the ASIA syndrome theory, positing that the aluminum adjuvant in Gardasil triggered autoimmune responses leading to the alleged conditions. Respondent's experts, including Drs. J. Lindsay Whitton, Edward Cetaruk, Max Wiznitzer, Carlos Rose, and Stephen McGeady, disputed the ASIA theory and attributed the symptoms to pre-existing conditions, deconditioning, or conversion disorder. Key evidence considered included petitioner's pre-vaccination history of migraines and orthopedic issues, the timing of symptom onset (which the Special Master found to be significantly later than alleged for POTS), the lack of proof for autoimmune POTS (petitioner's ganglionic neuronal antibody tests were negative), and the absence of a confirmed diagnosis of small fiber polyneuropathy. The Special Master found that petitioner failed to meet the Althen criteria for causation for any of the alleged conditions. Petitioner was represented by Patricia A. Finn; respondent's counsel included Debra A. Filteau Begley, Gordon Shemin, and Lara A. Englund. No award for injury was made.
Source PDFs
USCOURTS-cofc-1_11-vv-00852