Natalie Rowan v. HHS - HPV, headaches, including migraines, difficulty walking, abdominal pain, dizziness, weight loss, bronchial spasms, and an inability to leave her bed (2015)

Filed 2014-12-08Decided 2015-06-09Vaccine HPV
denied

Case summary [AI summaries can sometimes make mistakes]

On May 3, 2010, Michael Rowan, on behalf of his daughter Natalie Rowan, filed a petition for compensation under the National Vaccine Injury Compensation Program. Natalie Rowan, born October 11, 1995, received three doses of the Human Papillomavirus (HPV) vaccine, also known as Gardasil, on August 21, 2007, November 12, 2007, and July 14, 2008.

The petition alleged that these vaccinations caused her to develop headaches, including migraines, difficulty walking, abdominal pain, dizziness, weight loss, bronchial spasms, and an inability to leave her bed. Respondent, the Secretary of Health and Human Services, recommended against compensation, arguing that the petitioner had not presented adequate evidence demonstrating causation.

An entitlement hearing was held in January 2014, with testimony from Michael Rowan, Natalie Rowan, and the parties' respective experts. Petitioner was represented by Patricia Ann Finn, and respondent was represented by Darryl J.

Wishard. Special Master Nora Beth Dorsey presided over the hearing.

The parties agreed that the issues to be decided were whether petitioner had presented preponderant evidence of a "medically-recognized autoimmune condition" and, if so, whether the vaccine caused her injuries. Special Master Dorsey found that petitioner had provided preponderant evidence of illness or injury but failed to establish by a preponderance of the evidence that the Gardasil vaccinations caused her injuries.

Petitioner's primary care physician, Dr. Joanne Fogarty, treated her for headaches starting in 2007, and a neurologist, Dr.

Karen Powers, diagnosed her with chronic daily headaches in December 2008. Extensive diagnostic testing, including MRIs, CT scans, and EMGs, yielded normal results.

Petitioner's expert, Dr. Yehuda Shoenfeld, proposed a theory of "Autoimmune Syndrome Induced by Adjuvants" (ASIA), suggesting that the aluminum adjuvant in the vaccine caused chronic stimulation of the immune system.

However, Special Master Dorsey found Dr. Shoenfeld's theory unpersuasive, noting that ASIA is not a proven theory and that the studies cited were not relevant.

Respondent's experts, Dr. James Whitton and Dr.

Edward Cetaruk, testified that aluminum adjuvants are safe and do not cause injury. Dr.

Stephen McGeady opined that the HPV vaccine did not cause Ms. Rowan's injuries, citing her pre-existing headaches and normal diagnostic tests.

Special Master Dorsey denied entitlement, finding that Ms. Rowan failed to prove a medically recognized illness or injury caused by the vaccine, specifically failing to establish a persuasive medical theory, a logical sequence of cause and effect, or a proximate temporal relationship.

The decision was issued on December 8, 2014, and published on December 30, 2014. Petitioner sought review of this decision.

On June 9, 2015, Judge Francis M. Allegra of the United States Court of Federal Claims affirmed the Special Master's decision, finding that the Special Master's findings were supported by substantial evidence and were not arbitrary or capricious.

The court found that petitioner failed to establish any of the three Althen prongs by preponderant evidence. The petition was denied.

Theory of causation

Petitioner Natalie Rowan, age 11.31 at first vaccination, received three doses of the HPV (Gardasil) vaccine between August 21, 2007, and July 14, 2008. She alleged these vaccines caused headaches, migraines, difficulty walking, abdominal pain, dizziness, weight loss, bronchial spasms, and an inability to leave her bed. Petitioner's expert, Dr. Yehuda Shoenfeld, proposed the theory of "Autoimmune Syndrome Induced by Adjuvants" (ASIA), suggesting the aluminum adjuvant in the HPV vaccine caused chronic stimulation of the immune system, leading to autoimmune disease. He cited studies involving pristane and macrophagic myofasciitis (MMF) as support, and noted a low white blood count with elevated lymphocytes. Respondent's experts, Dr. James Whitton and Dr. Edward Cetaruk, testified that aluminum adjuvants are safe and do not cause injury, refuting the ASIA theory and its supporting studies. Dr. Stephen McGeady opined that the HPV vaccine did not cause Ms. Rowan's injuries, noting her pre-existing headaches, normal diagnostic tests, and lack of autoimmune disease evidence. Special Master Nora Beth Dorsey denied entitlement, finding Dr. Shoenfeld's ASIA theory unpersuasive, not proven, and unsupported by relevant studies. She found no persuasive evidence of a medically recognized illness or injury caused by the vaccine, nor a logical sequence of cause and effect or proximate temporal relationship. The court affirmed, agreeing that petitioner failed to establish the three Althen prongs (medical theory, logical sequence of cause and effect, proximate temporal relationship) by a preponderance of the evidence. The petition was denied.

Source PDFs 5 total · 2 downloaded