Sydney Rich v. HHS - Influenza, Acute Disseminated Encephalomyelitis (ADEM) (2016)

Filed 2012-11-01Decided 2016-12-16Vaccine Influenza
denied

Case summary [AI summaries can sometimes make mistakes]

Sydney Rich filed a petition on November 1, 2012, alleging that an influenza vaccine she received on September 26, 2010, caused her to develop Acute Disseminated Encephalomyelitis (ADEM). Petitioner was born on May 13, 1992, and was a freshman at the University of Oklahoma in the fall of 2010.

She had a history of asthma but was otherwise healthy. She had received influenza vaccinations annually for the five years prior to 2010 without reported adverse reactions.

Petitioner alleged that a few weeks after her September 26, 2010, flu vaccination, she began experiencing fatigue, lethargy, headaches, dizziness, and leg weakness. Her roommate, Caramia Enrich, and her co-worker, Aurora Tapia, corroborated these alleged symptoms, stating they began in October and November 2010 and worsened over time.

Petitioner's mother, Heather Rich, also stated that her daughter complained of fatigue and headaches a few weeks after the vaccination. However, Petitioner sought medical attention on three occasions during the fall of 2010.

On October 8, 2010, she saw her pediatrician, Dr. Colleen Dooley, complaining of difficulty breathing at night and increased use of her inhaler.

Dr. Dooley diagnosed an asthma exacerbation and prescribed medication.

Petitioner did not report leg heaviness or difficulty walking to Dr. Dooley at this visit.

On October 23, 2010, Petitioner returned to Dr. Dooley, again complaining of asthma symptoms.

Her mother accompanied her and attributed the symptoms to asthma. Medical records from this visit noted increased asthma symptoms and continued medication.

On November 10, 2010, Petitioner visited her college's medical center, reporting coughing, difficulty breathing, fever, night sweats, sore throat, headache, earache, wheezing, and muscle aches. The medical record from this visit, signed by Dr.

Stephanie Parker, noted no nausea, vomiting, or diarrhea, and no other complaints beyond those checked on the intake form. Petitioner testified that she had experienced dizziness, light-headedness, weakness, and nausea prior to this visit and felt like she was going to pass out, but she did not report these specific symptoms to the medical personnel.

The medical records from all three visits focused on respiratory and asthma-related issues. Petitioner was hospitalized on December 27, 2010, with wheezing, dyspnea, shortness of breath, and chest tightness.

Her neurological examination at that time was normal, and she denied weakness or fatigue. She was diagnosed with community-acquired pneumonia, pneumothorax, and asthma exacerbation.

Her condition worsened, leading to intubation. On January 6, 2011, an MRI revealed findings consistent with ADEM and hypoxic injury.

On January 7, 2011, she was diagnosed with suspected ADEM and began treatment. A sputum test later revealed H1N1 Influenza, and she was treated with Tamiflu.

She also received Intravenous Immunoglobulin (IVIG) treatment. By February 17, 2011, her condition stabilized, and she was transferred to a rehabilitation facility with diagnoses including acute demyelinating encephalomalacia with paralysis and quadriparesis, respiratory failure, and critical care myopathy.

She was discharged home on March 25, 2011, requiring ongoing care and a wheelchair. Two treating physicians, Dr.

Jenny Le and Dr. William Schueler, later attributed her condition to H1N1 Influenza.

Petitioner's expert, Dr. David Siegler, noted that a three-month latency period between vaccination and ADEM was long and that he had not found a case report with such a latency.

He stated that his theory of causation was dependent on the oral history of neurological symptoms developing a few weeks post-vaccine. Respondent's expert, Dr.

Michael Kohrman, concluded that the flu vaccine was "very unlikely" to be the cause of Petitioner's ADEM, citing the lack of documented neurological problems in medical records prior to hospitalization and the negative temporal relationship. He opined that H1N1 infection, bronchitis, or pneumonia were more likely causes.

An onset hearing was held on October 30, 2014, to determine the date of the first symptom or manifestation of ADEM. Special Master Lisa Hamilton-Fieldman issued a Finding of Fact on September 16, 2015, concluding that Petitioner's ADEM symptoms began on or after December 27, 2010, concurrently with or shortly after her hospitalization for pneumonia and pneumothorax.

The Special Master found that Petitioner's medical records did not support the testimony of Petitioner and her witnesses regarding earlier neurological symptoms, and that Petitioner had not reported such symptoms during her earlier medical visits. The Special Master found it implausible that Petitioner, who was familiar with seeking medical care for her asthma, would not have reported severe neurological symptoms if she had experienced them.

On June 30, 2016, Special Master Hamilton-Fieldman issued a decision dismissing the petition, finding that Petitioner failed to present a prima facie case for entitlement. She concluded that Petitioner had not demonstrated a logical sequence of cause and effect or a proximate temporal relationship between the vaccination and her ADEM, as both experts agreed that a three-month latency period was not consistent with causation, and treating physicians attributed her ADEM to H1N1.

Petitioner moved for review by the Court of Federal Claims. On December 16, 2016, Judge Elaine D.

Kaplan of the Court of Federal Claims sustained the Special Master's dismissal. The Court found that the Special Master's decision was supported by the evidence in the record and was not arbitrary, capricious, an abuse of discretion, or contrary to law.

The Court noted that medical records are generally considered trustworthy and contemporaneous evidence, and that the Special Master appropriately relied on the absence of reported neurological symptoms in the medical records. The Court found that the Special Master's rejection of Petitioner's explanations for not reporting symptoms was not arbitrary or capricious.

The Court affirmed that the Special Master's determination of the onset date was reasonable and that Petitioner failed to demonstrate causation. Interim attorneys' fees were awarded to Petitioner's counsel during the litigation.

The petition was ultimately denied.

Theory of causation

Sydney Rich, born May 13, 1992, received an influenza vaccine on September 26, 2010. She alleged this caused Acute Disseminated Encephalomyelitis (ADEM). Petitioner's witnesses and she herself claimed neurological symptoms began a few weeks after vaccination, in October/November 2010. However, contemporaneous medical records from three visits in Fall 2010 (Oct 8, Oct 23, Nov 10) documented only respiratory and asthma-related complaints, with no mention of neurological symptoms. Petitioner's ADEM diagnosis occurred after hospitalization on December 27, 2010, with onset determined by Special Master Lisa Hamilton-Fieldman to be on or after that date, establishing a latency period of at least three months. Both Petitioner's expert, Dr. David Siegler, and Respondent's expert, Dr. Michael Kohrman, agreed that a three-month latency period between vaccination and ADEM onset is not medically plausible for causation. Treating physicians attributed Petitioner's ADEM to H1N1 Influenza. Special Master Hamilton-Fieldman dismissed the petition on June 30, 2016, finding Petitioner failed to establish a prima facie case under the Althen test, specifically lacking a logical sequence of cause and effect and a proximate temporal relationship. Judge Elaine D. Kaplan of the Court of Federal Claims sustained the dismissal on December 16, 2016, finding the Special Master's decision was supported by the record and not arbitrary or capricious, particularly regarding the reliance on contemporaneous medical records and the determination of the onset date. Interim attorneys' fees were awarded. The petition was denied.

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