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Jennifer Locane v. Secretary of Health and Human Services

July 12, 2012


Appeal from the United States Court of Federal Claims in Case No.99-VV-589, Judge Christine O.C. Miller.

The opinion of the court was delivered by: Wallach, Circuit Judge.

Before NEWMAN, PLAGER, and WALLACH, Circuit Judges.

Ms. Jennifer Locane ("Ms. Locane") filed a petition for compensation under the National Childhood Vaccine Injury Act ("Vaccine Act"), 42 U.S.C. §§ 300aa-1 to -34 (2006), alleging that she suffered Crohn's disease as a direct result of hepatitis B vaccination. Special Master Christian J. Moran denied the claim, finding Ms. Locane's disease began before her vaccination and finding that Ms. Locane failed to prove by a preponderance of the evidence that the vaccine caused or significantly aggravated her disease. See Locane v. Sec'y of Health & Human Servs., 99 Fed. Cl. 715 (2011). Because the Court of Federal Claims ("Claims Court") correctly concluded that the Special Master's decision was not arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law, we affirm.



Ms. Locane was born on July 14, 1983. She was adopted and does not know the medical history of her biological family. Through age ten, Ms. Locane had typical childhood illnesses and injuries and maintained an average growth rate, with height and weight in the fiftieth percentile for children her age. However, in early adolescence Ms. Locane's growth rate began to diminish. At thirteen she was in the twenty-fifth percentile for height and fifteenth percentile for weight, and one year later she fell to the tenth percentile for weight although she remained in the twenty-fifth percentile for height.

On August 29, 1997, her pediatrician, Dr. Tanis, did a routine examination necessary for her participation in high school athletics and administered the first of three doses of hepatitis B vaccine. Within two weeks, Ms. Locane suffered stomach cramps, loose stools, nausea, and decreased appetite. Her discomfort persisted, and on November 18, 1997, when Ms. Locane returned to see her pediatrician she weighed four pounds less than she had in August and was diagnosed with a virus. Ten days later, Ms. Locane returned to her pediatrician because there was blood in her stool and she had lost more weight. Dr. Tanis concluded Ms. Locane had either Crohn's disease or ulcerative colitis and referred her to Dr. Tano, a pediatric gastroenterologist.

Dr. Tano noted Ms. Locane's weight placed her below the fifth percentile for children her age. Dr. Tano opined that Ms. Locane was suffering from inflammatory bowel disease and recommended she go to the hospital. After a series of tests that showed results "consistent with Crohn's disease," she was prescribed Prednisone (a steroid) and discharged from the hospital on December 9, 1997.

On December 11, 1997, Ms. Locane was given her second dose of the hepatitis B vaccine, as well as other vaccinations, without any adverse effects. Her Prednisone prescription was adjusted over the next few weeks as her condition seemingly improved. Ms. Locane received her third dose of the hepatitis B vaccine on February 6, 1998. Shortly thereafter her condition deteriorated. In response, Dr. Tano increased her Prednisone prescription on March 16, 1998.


Ms. Locane filed her petition in the Claims Court on August 4, 1999, but development of the case was put on hold as the parties attempted to establish a mechanism for cases involving the hepatitis B vaccine. A Special Master was assigned to the case on February 8, 2006, and expert testimony was heard on April 17, 2008.

Ms. Locane argued that the hepatitis B vaccine caused her Crohn's disease and/or caused significant aggravation to her condition. Ms. Locane testified that she had no intestinal problems before her August 1997 hepatitis B vaccination. She attributed the fact that she had no reaction to the second vaccination in December 1997 to her high dosage of Prednisone at the time. Ms. Locane described the consequences of her Crohn's disease, which included multiple protracted hospital visits throughout college.

As a preliminary step, the Special Master held that it was necessary to resolve when Ms. Locane's Crohn's disease began. Ultimately, the Special Master concluded that the preponderance of the evidence proved Ms. Locane had Crohn's disease before her August 1997 vaccination and therefore the vaccination could not have caused her Crohn's disease.

Dr. Bellanti, Ms. Locane's expert, is a professor of immunology. Dr. Bellanti testified that there is a clear temporal relationship between the hepatitis vaccination and Ms. Locane's development of Crohn's disease, and ...

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