Shapiro v. Sec'y of Health & Human Servs.

• Decision Date: 15 November 2011
• Docket Number: No. 99-552V,99-552V
• Parties: ELIZABETH SHAPIRO, Petitioner, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent.
• Court: U.S. Claims Court

ELIZABETH SHAPIRO, Petitioner, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent.

No. 99-552V

United States Court of Federal Claims

Filed: October 31, 2011

Reissued: November 15, 2011¹

Vaccine case; Petition for review; Hepatitis-

B vaccination; Standard of review;

Hypothyroidism; Finding that

hypothyroidism predated vaccination was

arbitrary and capricious; Misapplication of

"contemporaneous record" rule; Failure to

explain or otherwise account for

contradiction in medical record as to critical

fact; Systemic Lupus Erythematosus; Failure

to show proximate temporal relationship

between the vaccination and the onset of

illness; Remand.

OPINION

Clifford John Shoemaker, Shoemaker and Associates, for petitioner.

Heather Lynn Pearlman, United States Department of Justice, Washington, D.C., with whom was Assistant Attorney General Tony West, for respondent.

ALLEGRA, Judge:

Petitioner, Elizabeth Shapiro, seeks review of a decision issued by Special Master Christian Moran denying her petition for vaccine injury compensation. Petitioner brought this action pursuant to the National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10 to 300aa-34 (2006), alleging that she suffers from hypothyroidism and Systemic LupusErythematosus (SLE) as a result of hepatitis-B vaccinations that she received. On review, Special Master Moran denied compensation, finding that Ms. Shapiro's illnesses were not caused by the hepatitis-B vaccinations. For the reasons that follow, this court affirms, in part, and reverses, in part, that decision.

I. BACKGROUND

A brief recitation of the facts provides necessary context.

Petitioner was born in 1950 and is a nurse-practitioner. She has three children and her husband is a pediatrician. The record contains no contemporaneous medical records suggesting that petitioner had either of the illnesses in question prior to receiving her first hepatitis-B vaccination in 1992. The record reflects that petitioner's only medical visits before the vaccinations were routine checkups with Dr. Sylvan Frieman, her gynecologist. Dr. Frieman submitted statements for the record indicating that petitioner was healthy prior to receiving the vaccinations in question. Petitioner's employer, Dr. Kenneth Klebanow, filed a similar statement.

On April 13, 1992, petitioner received the first of three hepatitis-B vaccinations. On April 29, 1992, she visited Dr. Frieman and reported abdominal bloating and weight gain. Dr. Frieman's records do not reflect when these symptoms began.

On September 21, 1992, petitioner received her second hepatitis-B vaccination. On October 19, 1992, she visited Dr. Richard Berg, an internist and infectious disease specialist, complaining of a five-day history of severe headache and neck ache; lightheadedness; a rapid, irregular heartbeat; and an extended menstrual period.² That same day, testing revealed that petitioner's thyroid stimulating hormone was ten times the normal level, a result indicative of hypothyroidism. On October 21, 1992, Dr. Berg prescribed Synthroid to treat petitioner's hypothyroidism. Notes from a follow-up visit with Dr. Berg that occurred approximately one month later indicate that petitioner's palpitations and lightheadedness had abated and that her menstrual period had improved.

On February 8, 1993, petitioner received her third and final hepatitis-B vaccination. Petitioner returned to Dr. Berg twice in March of 1993, complaining of worsening symptoms, and reporting palpitations, nausea and abdominal pain. Dr. Berg adjusted petitioner's dosage of Synthroid and referred her back to Dr. Frieman, as well as to a new doctor, Dr. Ronald L. Ginsburg, a gastroenterologist. Petitioner visited Dr. Ginsberg in April of 1993, complaining of constipation, weight gain, prolonged menstrual periods, palpitations and lightheadedness.Shortly after this visit, Dr. Ginsberg wrote Dr. Berg, summarizing his observations. In that letter, which was dated April 22, 1993, Dr. Ginsberg stated -

[Ms. Shapiro] dates the onset of her current illness to about October of 1991 with progressively worsening constipation for the next approximately year. She also suffered a certain amount of weight gain and finally, had rather prolonged menstrual periods. In addition, she developed palpitations and a lightheadedness and a very slow pulse rate for her, between 48-60. She began feeling chest pressure and at that point was seen [by Dr. Berg].

Although this passage of the letter suggested that petitioner's symptoms began before her first hepatitis-B vaccination, that notion is contradicted at a later point in the same letter. On the second page of his letter, Dr. Ginsberg wrote: "[i]nterestingly, [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." Because petitioner had her first hepatitis-B vaccination on April 13, 1992, this second statement suggests that petitioner's "initial symptoms" began in late April of 1992.

On July 23, 1993, petitioner filed an incident report with the Vaccine Adverse Event Reporting System in which she indicated that her symptoms first occurred after her first hepatitis-B immunization. From that point on, petitioner's medical records consistently reflect that, in providing her medical history on a half a dozen or more occasions, she told her doctors that her symptoms began after her first vaccination.³

At or about the time she filed her incident report, petitioner asserts that she began experiencing symptoms associated with SLE. On July 7, 1993, she saw Dr. Harvey Schonwald, a urologist, due to what she believed were symptoms of hematuria - the presence of red blood cells in her urine. Dr. Schonwald's records indicate that she had been experiencing this symptom for approximately two months. A cystoscopy (an endoscopy of the urinary bladder) taken at this time did not reveal the source of the hematuria. On a July 28, 1993, visit with Dr. Berg, petitioner also mentioned having joint pain. More than a year later, on August 2, 1994, petitioner had an antinuclear antibody test which was positive, another indication of SLE. Throughout this period, petitioner visited Dr. Joyce Burd, a rheumatologist, who catalogued petitioner's many symptoms. On September 2, 1994, Dr. Burd wrote that petitioner "probably" had SLE, the first mention of this disease in any medical record. From this point forward, petitioner's health deteriorated. Hundreds of pages of records demonstrate that she has continued to experience ill health up to and including the present time.

On August 2, 1999, petitioner filed her vaccine petition. In April of 2000, the special master originally assigned to this matter stayed the case, apparently hoping it would be settled under a global resolution of numerous hepatitis-B cases filed at or around that time. That settlement, however, never materialized.

Subsequently, petitioner filed several sets of medical records and a number of expert reports. Among those opinions was one from Dr. Joseph Bellanti, rendered in June 2006. Dr. Bellanti opined that Ms. Shapiro's symptoms worsened after each dose of the hepatitis-B vaccination, a causation pattern known as "challenge-rechallenge." He opined that this sequence of adverse reactions resulted in the development of SLE. On January 8, 2007, Ms. Shapiro filed a report by a second expert, Dr. Yehuda Shoenfield, who serves as the head of the Center for Autoimmune Diseases at Sheba Medical Center, Tel-Aviv University, Israel.⁴ Dr. Shoenfield opined that Ms. Shapiro likely had a genetic predisposition to develop autoimmune diseases and that the hepatitis-B vaccine triggered her autoimmune condition. Dr. Shoenfeld linked the three hepatitis-B vaccinations received by Ms. Shapiro to her development of thyroid disease and SLE. For its part, respondent provided expert reports from two doctors, Dr. Alan Brenner and Dr. Brian Ward. Both concluded that there was no association between Ms. Shapiro's medical conditions and her receipt of the hepatitis-B vaccine.

For reasons unexplained, there was no activity whatsoever in this case for more than three and a half years - from August 2, 2002, through February 8, 2006. On July 30, 2007, the case was reassigned to Special Master Moran. The Special Master thereafter conducted two hearings in the case - on November 24, 2008, and January 8, 2009, respectively. At the first of these hearings, Ms. Shapiro and Dr. Shoenfeld testified in person; at the second, Dr. Ward testified in person. Subsequent to these hearings, Ms. Shapiro was permitted to file additional evidence and medical literature in support of her case.

On April 27, 2011, the Special Master issued his decision denying petitioner's claim. Shapiro, 2011 WL 1897650. In that decision, the Special Master rejected the opinions of petitioner's experts, observing that they had relied on assertions made by Ms. Shapiro that she was healthy prior to 1992. Although Ms. Shapiro had reaffirmed these assertions in affidavits filed in the case, the Special Master concluded that "[a] record created much closer in time supports a different finding." Id. at *6. In this regard he found that -

A preponderance of evidence supports a finding that Ms. Shapiro was having health problems before 1992. In April 1993, Ms. Shapiro saw a gastroenterologist, Dr. Ginsberg, who obtained a history from her.

Dr. Ginsberg's record dates the onset of Ms. Shapiro's condition to "about October of 1991." He notes that Ms. Shapiro experienced progressively worsening constipation, weight gain, and prolonged menstrual periods during the following year. Dr. Ginsberg also recounts that Ms. Shapiro developed palpitations, lightheadedness, and a slow pulse rate (although he does not indicate when she develops these symptoms).

Thus, there is a conflict between Dr. Ginsberg's record and Ms. Shapiro's affidavit. Dr. Ginsberg's 1993 note

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