Elizabeth Shapiro v. HHS - Hepatitis B, hypothyroidism and Systemic Lupus Erythematosus (SLE) (2011)

Elizabeth Shapiro, born in 1950 and a nurse-practitioner by profession, received three hepatitis B vaccinations on April 13, 1992, September 21, 1992, and February 8, 1993. She filed a petition on August 2, 1999, alleging that the vaccinations caused her to develop hypothyroidism and Systemic Lupus Erythematosus (SLE).

Following the first dose, Ms. Shapiro visited her gynecologist, Dr.

Frieman, on April 29, 1992 — sixteen days later — reporting abdominal bloating and weight gain. Following the second dose, she visited internist Dr.

Richard Berg on October 19, 1992, complaining of severe headache, neck ache, lightheadedness, a rapid irregular heartbeat, and an extended menstrual period. Testing that day revealed a thyroid stimulating hormone level ten times normal, consistent with hypothyroidism; Dr.

Berg prescribed Synthroid to treat it. In early 1993, following the third dose, Ms.

Shapiro's symptoms worsened. In April 1993, she visited gastroenterologist Dr.

Ronald Ginsberg, who sent a letter to Dr. Berg dated April 22, 1993.

On the first page of that letter, Dr. Ginsberg noted a history dating Ms.

Shapiro's condition to "about October of 1991" — before her first vaccination. On the second page of the same letter, however, Dr.

Ginsberg wrote that Ms. Shapiro "notes that she had hepatitis-B vaccine which was done about a few weeks before she began having her initial problem, and then a booster which was a few weeks before her recurrent problem" — supporting her claim that symptoms began after the vaccine.

Beginning in mid-1993, Ms. Shapiro experienced symptoms consistent with SLE, including hematuria and joint pain, and a formal SLE diagnosis was noted by her rheumatologist in September 1994.

Special Master Christian J. Moran denied petitioner's claim on April 27, 2011.

As to hypothyroidism, the Special Master relied almost entirely on the first page of Dr. Ginsberg's letter to find that Ms.

Shapiro's thyroid condition predated her first vaccination and was therefore not caused by the vaccine. He treated this letter as "contemporaneous" medical evidence, and used it to discount petitioner's affidavits, her employer's affidavit, and multiple subsequent medical histories from 1992 through 1994 — all of which supported the view that her symptoms began after the first vaccination.

As to SLE, the Special Master determined that the medically acceptable causation window was two to three weeks after vaccination — based on Dr. Shoenfeld's testimony and published study of five patients who developed SLE within three weeks of immunization.

The Special Master found that the symptoms Dr. Shoenfeld identified as heralding petitioner's SLE onset (joint pain and hematuria) did not manifest until July 1993, more than five months after the third vaccine dose, placing them outside the acceptable temporal window.

Judge Allegra, writing for the Court of Federal Claims on October 31, 2011, granted petitioner's motion for review in part and denied it in part. As to hypothyroidism, the court reversed and remanded, finding the Special Master's decision arbitrary and capricious on multiple grounds.

First, Dr. Ginsberg's April 1993 letter was not "contemporaneous" as that term is properly understood in vaccine law: the letter was written approximately one year after the events it described, not at the same time as those events.

The evidentiary principle favoring records created closer in time to the described events does not apply when, as here, the competing records were created within months of each other under similar circumstances. Second — and more fundamentally — the Special Master relied exclusively on the first page of Dr.

Ginsberg's letter while completely ignoring the second page, which contained a passage supporting petitioner's account. This selective reading was arbitrary: the Special Master was not at liberty to use one passage from the letter while ignoring the passage in the same letter that contradicted his findings.

Third, the truly contemporaneous evidence — Dr. Frieman's notes from April 29, 1992, sixteen days after the first dose — supported petitioner's account, as did her employer's affidavit and multiple medical histories from 1993 and 1994.

On remand, the Special Master must consider the record as a whole, including the second page of the Ginsberg letter. As to SLE, the court affirmed the denial.

The Special Master's factual finding that Ms. Shapiro's SLE symptoms did not arise within the accepted two-to-three week temporal causation window was supported by the record and was not arbitrary or capricious.

Petitioner's disagreement with that finding, without more, was insufficient to overturn it.