De Bazan v. Secretary of the Department of Health & Human Services

70 Fed. Cl. 687, 2006 U.S. Claims LEXIS 121, 2006 WL 1388417
CourtUnited States Court of Federal Claims
DecidedMay 15, 2006
DocketNo. 03-620V
StatusPublished
Cited by5 cases

This text of 70 Fed. Cl. 687 (De Bazan v. Secretary of the Department of Health & Human Services) is published on Counsel Stack Legal Research, covering United States Court of Federal Claims primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
De Bazan v. Secretary of the Department of Health & Human Services, 70 Fed. Cl. 687, 2006 U.S. Claims LEXIS 121, 2006 WL 1388417 (uscfc 2006).

Opinion

OPINION AND ORDER

LETTOW, Judge.

Petitioner, Adela Quintana De Bazan, seeks review of a decision by a special master dated February 7, 2006, denying compensation under the National Childhood Vaccine Act of 1986, Pub.L. No. 99-660, § 311, 100 Stat. 3743, 3756 (Nov. 14, 1986) (codified, as amended, at 42 U.S.C. §§ 300aa-l to -34) (“Vaccine Act”). Ms. De Bazan alleged that her receipt of a tetanus-diphtheria (“Td”) vaccination caused her to develop acute disseminated encephalomyelitis (“ADEM”), a disorder characterized by damage to the central nervous system, which resulted in severe health problems and has left petitioner in a quadriplegic state.

The special master denied relief to Ms. De Bazan on the ground that she failed to satisfy her burden of proof that her ADEM developed within a temporally appropriate time. Specifically, he ruled that the vaccine could not have caused the onset of Ms. De Bazan’s symptoms because those symptoms appeared too soon, i.e., within twelve hours, after her vaccination. De Bazan v. United States, No. 03-620V, slip op. (Fed.Cl.Spec.Mstr. Feb. 7, 2006) (“Entitlement Decision”). For the reasons set out below, the court concludes that the special master misapplied the burdens of proof that appertain to a petitioner and respondent in a vaccine case. In particular, the special master failed first to determine whether petitioner had met her burden of making out a prima facie case of causation before proceeding to determine whether respondent had met its burden of proving that Ms. De Bazan’s ADEM was the result of some cause other than the Td vaccine. The special master in effect improperly collapsed the analysis and required Ms. De Bazan not only to prove her prima facie case by a preponderance of the evidence, but also to disprove respondent’s rebuttal case by a preponderance of the evidence. Upon review of the evidence adduced during the proceedings before the special master, the court determines that Ms. De Bazan established a pri-ma facie case by a preponderance of the evidence. Accordingly, this case will be remanded to the special master for determination whether respondent can meet its burden of showing by a preponderance of the evidence that petitioner’s illness was the result of some cause other than the Td vaccination Ms. De Bazan received.

BACKGROUND AND PROCEDURAL HISTORY2

ADEM is a disorder of the central nervous system (“CNS”) arising when one’s own immune system produces cells that destroy the myelin, the material that sheathes and protects the nerves. Entitlement Decision at 3. The exact cause of ADEM is unknown. Id. at 4. The expert witness who testified for the government, Dr. Subramaniam Sriram, opined that in 30 to 50 percent of ADEM cases the triggering event is unexplained. Id. at 3. The special master concluded that based on the evidence presented, the adverse immune response is typically triggered by a viral or bacterial infection or by a vaccina[689]*689tion, and that it can also occur spontaneously. Id. at 3-4.

Ms. De Bazan, an ostensibly healthy, active adult woman approximately 49 years of age, received a Td vaccination at some time before 11:00 a.m. on April 19, 2000. Entitlement Decision at 2. During the medical visit at which the vaccine was administered, Ms. De Bazan’s medical records noted that she had a sore throat, swelling on the left of her neck, and nasal discharge, but the special master found that there was insufficient evidence to show that petitioner was suffering from a viral or bacterial infection at the time. Id. at 3. By 9:00 p.m. on the same day the vaccine was administered, Ms. De Bazan began to experience symptoms of soreness in her arms, numbness, and a general decline in health that can be associated with ADEM. Id. at 2. By May 2, 2000, petitioner’s symptoms had become so severe that she was unable to walk without assistance, and she sought emergency medical attention. Id. On May 8, 2000, she was admitted to a hospital, and currently Ms. De Bazan remains hospitalized in a quadriplegic state as a result of her condition. Petitioner’s Motion for Review and Memorandum of Objections (“Pet.’s Mot.”) at 1.

The diagnosis of ADEM is not disputed. Both petitioner and respondent agree that respondent suffers from ADEM, and that petitioner began exhibiting symptoms of ADEM approximately 11 hours after the vaccination. Entitlement Decision at 2. In a preliminary ruling issued on March 18, 2005, the special master determined that “the only real questions left in this case are (1) can Td cause ADEM and (2) did this particular vaccination cause-in-fact [petitioner's ADEM.” Id. Stated another way, the key question for the special master was “whether Td can cause ADEM with onset 11 hours post-vaccination.” Id. at 6. To answer this question, the special master held an entitlement hearing for the purpose of taking expert testimony. Id. at 2. Petitioner’s expert witness was Dr. Susan Hansen, who is also petitioner’s treating neurologist. Id. Dr. Hansen is Board-certified in neurology, electrodiagnostic medicine, and clinical neurophysiology, and is an adjunct and associate professor at Stanford University’s School of Medicine and affiliated with its Medical Center. Id. at 2-3. Dr. Hansen has seen approximately five cases of ADEM during her career. Id. at 3. The government called Dr. Subramaniam Sriram, who is the director of the multiple sclerosis clinic at Vanderbilt Medical Center. Id. In that capacity, Dr. Sriram conducts clinical research concerning treatments for immunological diseases affecting the central nervous system and basic scientific research involving animal models. Id. Dr. Sriram is Board-certified in internal medicine and neurology; he sees approximately 5 to 6 cases of ADEM each year. Id.

Dr. Hansen provided testimony based primarily on her observations of Ms. De Bazan as one of her treating physicians as well as case reports of ADEM and related illnesses. Entitlement Decision at 7. Based upon these sources, it was Dr. Hansen’s opinion that.the Td vaccine can cause ADEM, and that the onset of ADEM can occur within hours of vaccination. Dr. Hansen presented two different lines of analysis to show that onset of ADEM can occur so rapidly. First, Dr. Hansen explained that some studies showed the onset of ADEM within hours of a triggering event (e.g., exposure to a vaccine). Id. Secondly, Dr. Hansen maintained that studies showed that neurological illnesses similar to ADEM have been observed to appear within hours of the triggering event; by analogy, Dr. Hansen testified that the onset of ADEM could occur within the same interval of time. Id. at 8.

The special master rejected both of Dr. Hansen’s rationales. First, the special master examined several of the studies cited by Dr. Hansen and found that he disagreed with Dr. Hansen’s interpretation that the studies showed that the onset of ADEM could occur within hours of a triggering event. Entitlement Decision at 7-8. The special master particularly discounted Dr. Hansen’s testimony in this respect because it conflicted with Dr. Sriram’s testimony. In rejecting Dr. Hansen’s testimony and alternate rationales, the special master appeared to adopt a set of circumscribing time limitations suggested by Dr. Sriram as being necessary for development of ADEM. Id. at 3-5, 10. Based upon [690]*690research with animal models, Dr.

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70 Fed. Cl. 687, 2006 U.S. Claims LEXIS 121, 2006 WL 1388417, Counsel Stack Legal Research, https://law.counselstack.com/opinion/de-bazan-v-secretary-of-the-department-of-health-human-services-uscfc-2006.