{"package_id":"USCOURTS-cofc-1_05-vv-00081","decision_granule_id":"USCOURTS-cofc-1_05-vv-00081-cl6656333","petitioner_identifier":"April Spates","is_minor":0,"age_at_vaccination":26.14,"age_unit_raw":"years","vaccine_type":"MMR","vaccination_date":"1994-01-07","condition_raw":"miscarriage","condition_category":"other","autism_spectrum_adjacent":0,"outcome":"denied","award_amount_usd":null,"decision_date":"2007-04-24","extraction_version":"gemini-v2","extracted_at":"2026-04-30T14:30:33.245151+00:00","number_of_concurrent_vaccines":1,"dose_number":null,"time_to_onset_days":21,"theory_of_causation":"MMR vaccine Jan 7, 1994 (petitioner immune to rubella; had received MMR as child) → miscarriage discovered Feb 1-4, 1994 (no fetal heartbeat). Petitioner's expert Dr. Sindoni: embryo 2 weeks old at vaccination; vulnerable stage; rubella destroyed embryonic cells. Respondent's expert Dr. Brent: immunity means vaccine couldn't harm embryo; CRL unreliable in dead embryo; MMWR showed no increased risk (CRS risk = zero). Pre-existing risk factors: cocaine, heavy smoking, prior miscarriages. SM dismissed Jan 31, 2007 (Dr. Brent credible; only temporal relationship). CFC Judge Bruggink Apr 24, 2007: SM AFFIRMED. DB petition_filed_date 2007-04-24 = wrong; corrected to 2005-01-10.","is_death":0,"date_of_death":null,"petition_filed_date":"2005-01-10","case_summary":"April Spates was born on November 22, 1967, in Brooklyn, New York. On January 7, 1994, she received the measles, mumps, and rubella (MMR) vaccine at the Fort Greene Health Clinic as a prerequisite for enrollment at the College of New Rochelle, even though medical records reflected that she had already received the MMR vaccine as a child and was immune to rubella. She believed she was not pregnant at the time.\n\nOn January 28, 1994 — twenty-one days after the vaccination — Ms. Spates was taken by ambulance to Brookdale Hospital Medical Center because she was feeling drowsy and weak. A pregnancy test administered that day confirmed she was pregnant. An ultrasound performed on February 1, 1994 showed a crown-rump length (CRL) of 0.54 centimeters, indicating approximately eight to ten weeks of gestation by one measure, with no fetal heartbeat detected. A repeat ultrasound on February 4 confirmed the results. On February 8, 1994, Ms. Spates underwent a dilation and curettage procedure to remove the fetal tissue.\n\nMs. Spates had a significant pre-vaccination medical history: acknowledged cocaine use in 1991, a diagnosis of depression in 1992, heavy smoking (approximately two and a half packs per day for five years), three live births, one prior miscarriage, one abortion, an ovarian cyst, and a history of anemia and excessive bleeding. Prior to and after the vaccination, she was repeatedly treated for vaginal bleeding and depression. She filed a medical malpractice lawsuit against the Fort Greene Health Clinic in November 1995; that case was dismissed in January 2004. She filed her Vaccine Act petition on January 10, 2005. Her petition originally included a count seeking compensation for the death of her unborn child, which the special master ordered her to address by way of a show-cause motion in January 2006; petitioner's counsel withdrew that count without briefing the legal issues.\n\nA hearing was held on November 20, 2006, limited to the issue of whether the MMR vaccine caused the miscarriage. Petitioner's expert, Dr. Frank Sindoni (an obstetrician-gynecologist in private practice for approximately twenty-five years), testified that the embryo had been only two weeks old at the time of the vaccination — the most vulnerable developmental stage — because the CRL measurement of 0.54 centimeters indicated the embryo was five weeks old at the time of the February ultrasound, suggesting a two-week gestational age at the time of vaccination in early January. Dr. Sindoni argued that the rubella component of the vaccine could destroy developing embryonic cells at this vulnerable stage, and he cited a Morbidity and Mortality Weekly Report (MMWR) showing that one out of thirty-two immune women who received the rubella vaccine while pregnant suffered a miscarriage. Respondent's expert, Dr. Robert Brent — a teratologist with a Ph.D. in both embryology and biophysics and fifty-five years of clinical research and editorial experience in reproductive and congenital defects — testified that Ms. Spates' pre-existing immunity to rubella meant the vaccine could not harm her embryo. Dr. Brent also pointed out that CRL is not a reliable measurement in a dying or dead embryo, making it impossible to determine the gestational age at the time of vaccination from the post-mortem CRL, and that the MMWR had not attributed the miscarriages to the vaccine — the report in fact concluded that the risk of congenital rubella syndrome following vaccination was \"zero.\"\n\nThe special master dismissed the petition on January 31, 2007, finding Dr. Brent credible and Dr. Sindoni not credible, and concluding that petitioner had established only a temporal relationship between the vaccination and the miscarriage, which is insufficient for causation.\n\nJudge Bruggink, writing for the Court of Federal Claims on April 24, 2007, sustained the special master's decision. The special master's credibility determination was not an abuse of discretion: Dr. Brent's qualifications — specialist credentials in teratology and embryology, fifty-five years of practice, and a record of peer-reviewed publications — were directly relevant to the specific question of the vaccine's impact on pregnancy, whereas Dr. Sindoni was a general obstetrician-gynecologist in private practice. On the merits, the first Althen causation element was not established: Dr. Sindoni's theory that the MMR vaccine can cause miscarriage in an immune woman was not supported by the MMWR, which did not identify the cause of the miscarriages it recorded and concluded there was no increased risk from vaccination. The second Althen element also failed: if the vaccine had killed the embryo at two weeks, the embryo would not have grown to the CRL of a five-week-old by early February, undermining Dr. Sindoni's own timeline. More fundamentally, the court observed that Ms. Spates' medical history before and after the vaccination was substantially the same — depression, vaginal bleeding, and miscarriages — and that her acknowledged cocaine use and heavy smoking increased her background risk. There was nothing in the record to suggest that the vaccination caused anything out of the ordinary. The government was not required to affirmatively identify an alternative cause; petitioner bore the burden of proving causation by a preponderance.","is_minor_inferred":0,"is_pediatric_broad":0,"special_master":null,"petitioner_identifier_original":null,"caption_petitioner_name":null,"petitioner_attorney_name":null,"petitioner_attorney_firm":null,"petitioner_attorney_location":null,"adjudicator_name":null,"caption_people_backfilled_at":null,"attorney_canonical_keys":null,"firm_canonical_key":null,"package_title":"Spates v. Secretary of the Department of Health & Human Services","canonical_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_05-vv-00081","plain_text_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_05-vv-00081.txt","json_url":"https://vicp-registry.org/case/USCOURTS-cofc-1_05-vv-00081.json","source_documents":[{"granule_id":"USCOURTS-cofc-1_05-vv-00081-cl6656333","title":"Spates v. Secretary of the Department of Health & Human Services","docket_text":"lead-opinion","date_issued":"2007-04-24","pdf_url":"https://www.courtlistener.com/opinion/6773253/spates-v-secretary-of-the-department-of-health-human-services/","pdf_bytes":null,"triage_decision":"keep","triage_reason":"recovered via CL opinion 6656333 (html_with_citations)","download_status":"ok","registry_pdf_url":"https://vicp-registry.org/pdf/USCOURTS-cofc-1_05-vv-00081/USCOURTS-cofc-1_05-vv-00081-cl6656333"}]}