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Koehn v. Secretary of Health and Human Services

United States Court of Appeals, Federal Circuit

December 4, 2014

CHERYL KOEHN, as Mother and Next Friend of, VANESSIA KOEHN, Petitioners-Appellants,
v.
SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellee

Appeal from the United States Court of Federal Claims in No. 1:11-vv-00355-EGB, Senior Judge Eric G. Bruggink.

P. LEIGH O'DELL, Beasley, Allen, Crow, Methvin, Prortis, & Miles, P.C., of Montgomery, Alabama, argued for petitioners-appellants.

DARRYL R. WISHARD, Trial Attorney, Torts Branch, Civil Division, United States Department of Justice, of Washington, DC, argued for respondent-appellee. With him on the brief were STUART F. DELERY, Assistant Attorney General, RUPA BHATTACHARYYA, Director, VINCENT J. MATANOSKI, Deputy Director, and GABRIELLE M. FIELDING, Assistant Director.

Before MOORE, O'MALLEY, and REYNA, Circuit Judges. OPINION filed by Circuit Judge O'MALLEY. Concurring OPINION filed by Circuit Judge MOORE.

OPINION

Page 1240

O'Malley, Circuit Judge.

Cheryl Koehn appeals from a U.S. Court of Federal Claims judgment upholding a Special Master's denial of compensation for Koehn's daughter's systemic juvenile idiopathic arthritis (" SJIA" ) allegedly caused by a vaccine. Although the Special Master's assessment of Koehn's medical theory of causation contains several flaws,

Page 1241

the Special Master had a sufficient basis upon which to determine that Koehn did not meet her burden of demonstrating a proximate temporal relationship between her daughter receiving the vaccine and developing SJIA. We therefore affirm.

Background

Children with SJIA, an autoinflammatory disease, exhibit symptoms including arthritis, a fever, and a rash, and may experience flares involving similar symptoms as well as muscle and joint pain. Many of these symptoms result from dysfunctional production of proteins called cytokines, which certain cells release almost immediately after the body comes into contact with an antigen. Cytokines signal other cells to generate an immune response. Pro-inflammatory cytokines, like those associated with SJIA, can lead to fever or other inflammation. Examples of SJIA medication include prednisone, which reduces inflammation and suppresses the immune system, and etanercept, which inhibits a cytokine linked to SJIA.

Gardasil is a vaccine that immunizes against four strands of human papillomavirus (" HPV" ). The vaccine, administered in three doses, contains virus-like particles created from an HPV protein, as well as an adjuvant, which assists in generating a robust immune response to promote long-term immunity.

I.

Koehn's daughter, Vanessia, was born in February 1995, and was generally healthy for the first twelve years of her life. Dr. Elena Regala administered Vanessia's first dose of Gardasil in February 2008 and her second dose in April 2008. On June 21, 2008, Vanessia experienced a rash all over her body. Dr. Regala, believing it to be an allergic reaction, prescribed Benadryl and prednisone three days later. Vanessia's rash disappeared within three days. On June 28, 2008, Vanessia went to Marian Medical Center for severe joint pain and high fever. Vanessia had stopped taking prednisone by that time, which coincided with her developing pain in her knees, thighs, and calves. Vanessia saw a rheumatologist at the hospital and received ...


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