Sumrall v. Secretary of the Department of Health & Human Services

23 Cl. Ct. 1, 1991 U.S. Claims LEXIS 152, 1991 WL 68555
CourtUnited States Court of Claims
DecidedApril 17, 1991
DocketNo. 90-135 V
StatusPublished
Cited by5 cases

This text of 23 Cl. Ct. 1 (Sumrall v. Secretary of the Department of Health & Human Services) is published on Counsel Stack Legal Research, covering United States Court of Claims primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Sumrall v. Secretary of the Department of Health & Human Services, 23 Cl. Ct. 1, 1991 U.S. Claims LEXIS 152, 1991 WL 68555 (cc 1991).

Opinion

OPINION AND ORDER

TURNER, Judge.

Respondent seeks review of the special master’s January 10, 1991 decision recommending an award of compensation to petitioner for injuries suffered by his daughter Angeline (Angel) as a result of a diphtheria-pertussis-tetanus (DPT) vaccine. Stated broadly, the issue for review is whether the special master properly concluded that petitioner established by a preponderance of the evidence that Angel’s seizure disorder, which first manifested itself more than three days after vaccination, was caused by the vaccine. For the reasons given below, we conclude that the special master’s decision on the causation issue was not arbitrary or otherwise unlawful, and the decision will be sustained.

I

The facts relating to the onset of Angel’s seizure disorder and her current condition were stated succinctly by the special master and are not in dispute:

Angel Sumrall was bom February 28, 1985, the product of an uncomplicated pregnancy, labor, and delivery. She was healthy and developed normally through the age of two months.
On May 2, 1985, Angel received her first DPT vaccination. On May 7, 1985, five days after the shot, she suffered a focal motor seizure involving her right hand and two grand mal seizures. Evaluations during [the ensuing] hospitalization failed to reveal a specific underlying cause of the seizures. Within a few weeks, Angel developed myoclonic sei[2]*2zures and an abnormal EEG [electroencephalogram] consistent with hypsar-rhythmia, a pattern consistent with a syndrome described by her doctors as ‘infantile spasms.’ Treatment with ACTH [a drug to control seizures] was begun but subsequently discontinued because of hypertension side effects, and until January, 1989, medications failed to control her seizure activity.
Angel will be six years old in February, 1991. She began to respond positively to valporic acid, an anticonvulsant medication, and since January, 1989, her seizures have been described as ‘light and rare.’ Angel presently suffers profound developmental delay.

Sumrall v. Secretary of the Dep’t of Health and Human Serv., No. 90-135 V, 1991 WL 20074 (Cl.Ct. Sp. Mast. Jan. 10, 1991), slip op. at 2-3.1

II

Under 42 U.S.C. § 300aa-ll(c)(l)(C)(i), in conjunction with the table set forth in section 300aa-14(a), a residual seizure disorder first manifesting itself within three days of DPT vaccination is presumed to have been caused by the vaccine. See Vaccine Injury Table, section 300aa-14(a), line I.D. However, because Angel Sumrall’s seizure disorder first manifested itself five days after her DPT vaccination, petitioner did not enjoy a presumption of causation. Instead, petitioner proceeded under section 300aa-ll(c)(l)(C)(ii)(II), which allows for compensation for conditions or injuries listed in the Vaccine Injury Table first occurring after the time period set forth in the Table, if such injury or condition was caused by the vaccination. Petitioner was therefore required to demonstrate by a preponderance of the evidence that Angel’s seizure disorder was caused by the May 2, 1985 DPT vaccination, 42 U.S.C. § 300aa-13(a)(l)(A), and the government bore the burden of showing by a preponderance of the evidence that Angel’s seizure disorder was due to factors unrelated to the May 2, 1985 administration of DPT vaccine, 42 U.S.C. § 300aa-13(a)(l)(B). See Matthews v. Secretary of the Dep’t of Health and Human Serv., 18 Cl.Ct. 514, 518-19 (1989) (discussing allocation of burdens of proof in an action under National Vaccine Injury Compensation Program).

Ill

At the hearing before the special master, there was sharp disagreement between the parties’ expert witnesses on the issue of whether the May 2, 1985 DPT vaccination caused Angel’s seizure disorder. More precisely, the experts disagreed as to what kind of evidence was sufficient to establish causation.

Petitioner’s expert, Mark R. Geier, holds an M.D. and a Ph.D. in genetics. He served a one-year residency in obstetrics and gynecology, taught genetics and obstetrics at Johns Hopkins University for several years, and spent nine years at the National Institutes of Health (NIH) researching the effects of bacteria and other molecules on higher organisms. While at NIH, Dr. Geier and his colleagues accidentally discovered that commercial vaccines, including DPT, contained harmful endotox-ins. Dr. Geier went on to develop a theory as to how endotoxins in DPT could cause neurological injury, but this theory has not been published or subjected to peer review. For the past ten years Dr. Geier has run a private practice in the field of obstetrical genetics, offering genetic counseling services to parents and would-be parents. Dr. Geier has published numerous articles in medical journals, and estimated that he has spent thousands of hours reviewing medical literature on the subject of vaccine-related injuries.

Dr. Geier never examined or treated Angel, has never treated a seizure disorder, and cannot read an EEG, a CT scan, or a magnetic resonance image. Accordingly, the government asserted that Dr. Geier was not competent to offer an opinion on whether Angel’s seizure disorder was caused by the May 2, 1985 DPT vaccination. The special master allowed Dr. Geier to testify concerning causation of Angel’s seizure disorder based on his extensive re[3]*3view of studies on vaccine-related injuries and his review of Angel’s medical records.

Dr. Geier testified that if a neurologically intact child has seizures within seven days of a DPT vaccination, and if there is no known alternative cause, then it is more likely than not that the seizures were caused by the vaccine. For his opinion, Dr. Geier relied heavily on the National Childhood Encephalopathy Study (NCES) conducted in Great Britain in the late 1970s. The NCES studied 1000 children with seizure disorders and other neurological problems in an attempt to determine whether there was a link between the neurological problems and DPT vaccination. The authors of the NCES found that it was four times more likely that a child with given neurological disorders had had a DPT vaccination within the seven day period preceding the onset of the disorder than would have been expected if the association was random; such an association was statistically significant. The NCES concluded that if a previously normal child suffered a neurological disorder (of which seizure disorders are a subset) within seven days of receiving a DPT vaccine, then it was more likely than not, in the absence of an alternative explanation (such as a known trauma), that the DPT vaccine caused the disorder. The NCES did not discuss endotoxins in vaccines, nor did it propose a mechanism by which DPT causes neurological injury.

The government’s expert, Daniel L. Hurst, M.D., is a licensed, practicing child neurologist who has published many articles in medical journals. He testified that Angel’s seizure disorder was cryptogenic, 1. e., of unknown origin. Dr. Hurst criticized the NCES on several grounds, asserting that the statistics gathered by the NCES authors—relying on temporal relationships for an inference of causation— have been misinterpreted. Dr.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Cite This Page — Counsel Stack

Bluebook (online)
23 Cl. Ct. 1, 1991 U.S. Claims LEXIS 152, 1991 WL 68555, Counsel Stack Legal Research, https://law.counselstack.com/opinion/sumrall-v-secretary-of-the-department-of-health-human-services-cc-1991.