Knudsen by Knudsen v. Secretary of Dept. of Health and Human Services

• Decision Date: 09 September 1994
• Docket Number: No. 93-5107,93-5107
• Citation: 35 F.3d 543
• Parties: Debra Ann KNUDSEN, by her parents and legal guardians, Doris P. KNUDSEN and Dale Knudsen, Petitioners-Appellants, v. SECRETARY OF the DEPARTMENT OF HEALTH AND HUMAN SERVICES, Respondent-Appellee.
• Court: U.S. Court of Appeals — Federal Circuit

Page 543

35 F.3d 543

Debra Ann KNUDSEN, by her parents and legal guardians, Doris

P. KNUDSEN and Dale Knudsen, Petitioners-Appellants, v. SECRETARY OF the DEPARTMENT OF HEALTH AND HUMAN SERVICES,

Respondent-Appellee.

No. 93-5107.

United States Court of Appeals, Federal Circuit.

Sept. 9, 1994.

Debra Ziegler Ashley, Atty., Lambert & Boeder, of Wayzata, MN, submitted on the briefs for petitioners-appellants.

David L. Terzian, Atty., U.S. Dept. of Justice, of Washington, DC, submitted on the briefs for respondent-appellee.

Before ARCHER, Chief Judge, ¹ and NIES and CLEVENGER, Circuit Judges.

ARCHER, Chief Judge.

Doris P. Knudsen and Dale Knudsen, on behalf of their daughter Debra Ann Knudsen, appeal from a judgment of the United States Court of Federal Claims, No. 90-2067V (filed Feb. 2, 1993). The Court of Federal Claims upheld the decision of a special master dismissing the Knudsens' petition for compensation under the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. Secs. 300aa-10 to -34 (1988 & Supp. III 1991), for an encephalopathy and sequelae injuries allegedly caused by a diphtheria-tetanus-pertussis (DTP) vaccine. We vacate and remand.

I.

Debra Ann Knudsen was born a normal and healthy baby. She was apparently healthy and in good medical and physical condition when, on the morning of April 21, 1956, at the age of seven-months one-week, she received her third DTP vaccine.

The afternoon following her vaccination Debra was "fussy" and had a slight fever, and that evening she ate well and went to bed without problem. At two o'clock in the morning, April 22, Debra's parents were awakened by the sounds of Debra suffering a seizure. Mrs. Knudsen found Debra stiff, with her eyes rolled back in her head, having a high fever and darker than usual stools. Debra was making high-pitched sounds, her skin color was abnormal, and she was having trouble breathing. She may have vomited while in her crib. Soon after finding her, Debra's parents took her to the hospital. On the way, Debra vomited after consuming a few swallows of milk from her bottle, and had a convulsion lasting about one minute.

At the hospital, the family's physician, Dr. Frederick Lohr, examined Debra, noting that she was listless and pale with a temperature of 104 degrees. Although Debra vomited during Dr. Lohr's examination, she did not cry and did not offer any resistance. Dr. Lohr's notes show that Debra had a slight bulging anterior fontanel, sluggishly reactive pupils, an infected right ear drum, a slightly runny nose, and clotted mucus in her throat. A spinal fluid exam was performed; the spinal fluid was clear, and later tested negative. Dr. Lohr deferred making a diagnosis. He prescribed an antibiotic (penicillin) and an anticonvulsant. That afternoon, Debra's temperature was down and she seemed to be improving.

By 11:15 that night, however, and despite administration of a second antibiotic, Debra suffered three more convulsions and her temperature rose to 105.4 degrees. She was sponged off and her temperature dropped to 102.8 degrees.

The following morning, April 23, Debra was seen by Dr. James Boysen, a pediatrician. Debra's white blood cell count was elevated, her fontanel was still bulging slightly, and her fever had varied through the night from 102 to 105.4 degrees. Dr. Boysen prescribed gamma globulin, a drug used to fight viral and bacterial infections. Dr. Boysen also noted his impression at that time: "Convulsive seizure as result of DPT immunization." (Emphasis added.)

The following morning, April 24, Debra was still febrile with a moderately bulging fontanel, and was semi-conscious having been heavily sedated. Dr. Boysen's diagnosis entered in Debra's medical records was: "Encephalopathy most likely due to D.P.T. immunization (pertussis) received today [sic, April 21]." (Emphasis added.)

On April 25, Debra seemed more alert and fussy, and had a temperature of 101 degrees. On April 26, she developed a rash over her entire body. She was taking formula well and seemed improved to Dr. Lohr, despite a distended abdomen and frequent flatus. On April 27, Debra's temperature was down to 99.2 degrees, the rash was gone, and her color was good. The antibiotics and anticonvulsants were discontinued. On April 28, it was noted that Debra had not had a seizure for 24 hours and her white blood cell count was down. On April 29, however, her temperature increased to 100.2 degrees, she had clay-colored stools and was again expelling flatus.

On April 30, Debra was discharged from the hospital. Her temperature was 100 degrees and her fontanel was still bulging slightly. The discharge diagnosis was: "Encephalitis--etiology unknown; possibly due to D.P.T. immunization." (Emphasis added.)

Two months later, in June of 1956, Debra was again hospitalized with a convulsive seizure and high fever. She was diagnosed with bronchitis, bilateral otitis media, and atypical pneumonia. Debra did not have any more seizures until 1963, when Dr. Boysen diagnosed her with a convulsive disorder. Dr. Boysen's final diagnosis was that the convulsive disorder was idiopathic, meaning of unknown cause, but "possibly" due to an encephalopathy and DTP vaccination in infancy. Debra presently suffers from seizures on a continuing basis and has permanent mental deficiencies.

II.

On September 28, 1990, Mr. and Mrs. Knudsen filed, on behalf of their daughter, a petition pursuant to the Vaccine Act seeking compensation for Debra's injuries. The Knudsens alleged that the DTP vaccine administered April 21, 1956, caused Debra to suffer an encephalopathy on April 22, and a residual seizure disorder, which are injuries listed on the vaccine table for which vaccine causation is presumed. See 42 U.S.C. Sec. 300aa-14(a)(I).

In addition to Debra's medical records, the Knudsens' evidence in support of their petition included testimony by Dr. Lohr and Drs. Stephen A. Smith and James Curtis Beeler. Dr. Boysen did not testify. Dr. Lohr testified that, although the medical records reflect that he was not certain at the time, his opinion now is that the DTP vaccine caused Debra to suffer an encephalopathy on April 22 and caused the resultant seizure disorder. Dr. Lohr acknowledged that Debra's other symptoms at the time of her admission to the hospital were consistent with the presence of a viral infection. Dr. Beeler testified that nuclear magnetic resonance imaging (MRI) films taken of Debra's brain are consistent with her having suffered an encephalopathy caused either by a DTP vaccine or a viral infection.

Dr. Smith testified that Debra's seizures were caused by the DTP vaccine. He acknowledged that certain of Debra's other symptoms could be consistent with a viral infection, but felt that in Debra's case those symptoms either were in fact caused by the DTP vaccine or were not significant at all. Dr. Smith testified that in his opinion the DTP vaccine caused the encephalopathy and a viral infection did not cause the encephalopathy based on the temporal relationship between the vaccination and the onset of symptoms, the lack of white cells in Debra's spinal fluid, the clinical picture of Debra's neurological illness from onset to the present, and the MRI films.

Opposing this evidence, the government offered the testimony of Dr. Michael Nigro. Dr. Nigro agreed that Debra suffered an encephalopathy following vaccination. However, he testified that Debra's non-encephalopathic symptoms following vaccination could not be explained by the DTP vaccine but are consistent with a systemic viral infection. He further testified that in his opinion the encephalopathy was caused by the viral infection and not the DTP vaccine based on the MRI films and the clinical picture of Debra's neurological illness. Dr. Nigro also testified that the lack of white cells in the spinal fluid was not inconsistent with a viral encephalopathy. In addition, Dr. Nigro based his opinion on Osler's unity of diagnosis principle, which the special master stated to be as follows: "[A]n attempt should be made to try to put all the symptoms into one unified diagnosis to explain what a person's illness may be." [A19-A20] According to Dr. Nigro the single thing that could explain all of Debra's symptoms and injuries was a viral infection.

The special master weighed the evidence and found Dr. Nigro's testimony more persuasive than that of Drs. Smith, Beeler, and Lohr. The special master found that the unity of diagnosis principle was a valid basis for Dr. Nigro's opinion and that only viral infection could explain all of Debra's symptoms including encephalopathy. The special master found that Dr. Beeler's testimony did not favor DTP vaccine as the cause, and that Dr. Lohr's testimony was merely conclusory and not supported by his opinion at the time of Debra's encephalopathy. The special master found credible Dr. Nigro's opinion regarding the MRI films, the clinical picture, and the spinal fluid, and discounted Dr. Smith's opposing view for reasons expressed on the record. The special master noted that Dr. Boysen had not testified, and that his diagnoses in Debra's medical records showed a retreat from a belief that DTP "most likely" caused the encephalopathy to a belief that DTP "possibly" caused the encephalopathy. Finally, the special master found that encephalopathies caused by DTP vaccine occur less frequently than encephalopathies caused by viral infection, and that therefore Debra's encephalopathy was less likely to have been caused by the DTP vaccine than by the viral infection.

The special master found that Debra suffered an encephalopathy one day after receipt of the DTP vaccine, and therefore there was a presumption of causation. However, the special master concluded that, at the time Debra suffered the encephalopathy, she was also suffering from a systemic viral infection, and that the viral infection in fact caused the encephalopathy and the DTP vaccine did not. The special master therefore...