Cassandra Burchett v. HHS - HPV, Guillain-Barré Syndrome (2014)
Case summary [AI summaries can sometimes make mistakes]
On February 22, 2012, Cassandra Burchett, a minor at the time, filed a petition seeking compensation under the National Vaccine Injury Compensation Program. She alleged that the human papillomavirus (HPV) vaccine, specifically Gardasil, administered on March 26, 2010, caused her to develop Guillain-Barré Syndrome (GBS).
Petitioner had a prior history of GBS diagnosed at age five in 1999, following an upper respiratory infection. In March 2010, she experienced symptoms of viral gastroenteritis and possible bacterial conjunctivitis.
Four days after receiving the HPV vaccine, on March 30, 2010, she began experiencing headache, numbness, body aches, and weakness. These symptoms progressed, leading to hospitalization on April 1, 2010, where she was diagnosed with GBS.
Her treating physicians noted a temporal association between the vaccine, antecedent viral infections, and her GBS. The respondent argued that the petitioner failed to prove the vaccine caused her GBS and that antecedent viral infections were the sole cause.
The Special Master, Nora Beth Dorsey, reviewed the case, including expert testimony from Dr. Allan E.
Rubenstein for the petitioner and Dr. Michael Kohrman for the respondent.
The Special Master found that the petitioner did not establish a medical theory or a logical sequence of cause and effect linking the HPV vaccine to her GBS, failing to meet the burden of proof for an "Off-Table" claim under the Althen standard. Specifically, Dr.
Rubenstein's theory of the vaccine enhancing a virally-induced GBS recurrence was found to be speculative and lacking scientific support. The Special Master also found that the respondent proved by a preponderance of the evidence that an antecedent viral infection (gastroenteritis and/or upper respiratory infection) was the sole cause of petitioner's GBS.
Despite the denial of entitlement on the merits, the parties later stipulated to an award of attorneys' fees and costs. On August 27, 2014, they filed a stipulation for a total award of $54,652.69, which Special Master Dorsey granted on September 18, 2014.
The decision denying entitlement was issued on May 13, 2014, and the attorneys' fees decision was issued on September 18, 2014. Petitioner was represented by Mark Theodore Sadaka, Esq., and respondent was represented by Darryl J.
Wishard, Esq.
Theory of causation
Petitioner Cassandra Burchett, age 16.1, received the HPV (Gardasil) vaccine on March 26, 2010, and subsequently developed Guillain-Barré Syndrome (GBS) on April 1, 2010. Petitioner had a prior history of GBS in 1999. Petitioner alleged the HPV vaccine caused her GBS. Respondent argued that antecedent viral infections were the sole cause. Petitioner's expert, Dr. Allan E. Rubenstein, proposed a theory that the HPV vaccine, in combination with antecedent viral infections (URI and gastroenteritis), caused a new autoimmune event leading to recurrent GBS, possibly through molecular mimicry or immune system enhancement, though he conceded the mechanism was unclear and lacked specific research support. Respondent's expert, Dr. Michael Kohrman, opined that viral infections alone, via molecular mimicry, caused the GBS, and that the HPV vaccine played no causal role, citing studies showing no increased risk of GBS with HPV vaccination. The Special Master, Nora Beth Dorsey, found petitioner failed to establish a medical theory (Althen Prong One) or a logical sequence of cause and effect (Althen Prong Two) linking the HPV vaccine to her GBS, noting Dr. Rubenstein's theory was speculative and unsupported. The Special Master also found respondent proved by a preponderance of the evidence that antecedent viral infections were the sole cause of petitioner's GBS, satisfying the Althen prongs for alternative causation. Entitlement was denied on September 18, 2014. However, parties stipulated to attorneys' fees and costs of $54,652.69, which was awarded. Petitioner was represented by Mark T. Sadaka, Esq., and respondent by Darryl J. Wishard, Esq.
Source PDFs
USCOURTS-cofc-1_12-vv-00119