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

86 Fed. Cl. 135, 2009 U.S. Claims LEXIS 65, 2009 WL 724926
CourtUnited States Court of Federal Claims
DecidedMarch 4, 2009
DocketNo. 02-469V
StatusPublished
Cited by209 cases

This text of 86 Fed. Cl. 135 (Loving 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
Loving v. Secretary of the Department of Health & Human Services, 86 Fed. Cl. 135, 2009 U.S. Claims LEXIS 65, 2009 WL 724926 (uscfc 2009).

Opinion

OPINION AND ORDER1

LETTOW, Judge.

Petitioners, Christopher and Carla Loving, seek review of a decision by a special master dated October 6, 2008, denying them compensation under the National Childhood Vaccine Injury Act of 1986, Pub.L. No. 99-660, § 311, 100 Stat. 3743, 3755 (1986) (codified, as amended, at 42 U.S.C. §§ 300aa-1 to -34) (“Vaccine Act”). The Lovings have brought this claim on behalf of their daughter Camille. They allege that Camille’s injection with a diphtheria, tetanus, and acellular pertussis (“DTaP”) vaccine resulted in a significant aggravation of her infantile spasms.2

[137]*137This is a so-called off-Table case in which the claimant must establish causation in fact.3 The special master denied relief to the Lovings on the ground that they had “failed to establish that the return of Camille’s infantile spasms happened at a time that was medically appropriate following the vaccine.” Loving v. Secretary of the Dep’t of Health & Human Servs., No. 02-469V, 2008 WL 4692376, at *10 (Fed.Cl.Spec.Mstr. Oct. 6, 2008) (“Entitlement Decision”). Specifically, the special master concluded that Camille began to suffer from infantile spasms too quickly after receiving the DTaP vaccine. Id. For the reasons set forth below, the court concludes that the special master erred in ruling that the petitioners had failed to establish the temporal-relationship prong needed to prove causation. In particular, the special master failed to account for the facts that the DTaP vaccine was contraindicated for Camille and that the significantly aggravating injury that she suffered after her vaccination was precisely what was apprehended by the contraindication. Moreover, Camille’s adverse reaction occurred promptly but not immediately after vaccination, and the medically accepted time for such occurrences indicates a 72-hour maximum but no minimum. Secondly, the special master also concluded that a prompt adverse reaction would have been accompanied by a systemic reaction to the vaccination and that Camille, in fact, did not have such a reaction. However, there was no evidence to support such a finding because, incredibly, Camille was neither examined nor treated by the attending physician or nurse after her adverse reaction began to occur, and thus no one evaluated whether or not she had or was having a systemic reaction.

BACKGROUND AND PROCEDURAL HISTORY

Infantile spasms, known also as West Syndrome, are a paroxysmal disorder that most commonly manifests itself in children less than a year old. See John H. Menkes, et al. Child Neurology 877 (7th ed.2006). The medical profession classifies infantile spasms as a form of generalized epilepsy. Id. Infantile spasms are divided into two categories: cryptogenic or symptomatic. Id. Cryptogenic infantile spasms reflect an inability of doctors to identify a triggering cause for the resulting seizures. Id. When the cause of the infantile spasms is known, they are identified as symptomatic. Id. at 877-78. The vast majority of infantile seizures are classified as symptomatic. Id. at 877. Approximately half the children who experience infantile spasms will stop having seizures by age three or will instead suffer from Lennox-Gastaut Syndrome or from “major motor” seizures. Id. at 878. Infants who suffer from infantile spasms often are developmentally challenged. Id.

Camille Loving was bom on August 2, 2000. Entitlement Decision at *1. Camille began to suffer from infantile spasms in January 2001. Id. Both parties agree that Camille suffered from infantile spasms prior to receiving her third DTaP vaccination in March 2001. Id. When Camille began to suffer infantile spasms, she was placed on medication that sought to limit the frequency and intensity of her seizures. Id. Camille proved to be responsive to Sabril, and with that medication her seizures markedly decreased to the point where Camille had not had clinical seizures for a period of 56 consecutive days. Tr. 36:21 to 38:13 (Test, of Dr. Robert M. Shuman, one of Camille’s treating physicians and petitioners’ expert), 457:24 to 462:15 (Shuman). As the special master noted, the degree of improvement and permanence of the improvement were disputed by the parties. Entitlement Decision at *1.4

[138]*138On March 27, 2001, Camille “received the third dose of the DTaP vaccine.” Entitlement Decision at *1. The DTaP Vaccine was contraindicated, see, e.g., Tr. 362:12-15 (Shuman); 658:3-4 (Test, of Dr. Michael Kohrman, respondent’s expert), because it risked aggravating Camille’s infantile spasms. Tr. 450:2-5. The manufacturer of the DTaP vaccine informed prospective users that “the presence of a personal history of convulsion or an evolving disorder affecting the central nervous system is considered warning against further immunization with this vaccine.” Tr. 361:17-21 (Shuman). The manufacturer of the vaccine also stated that infants who have “a recognized possible potential underlying neurologic condition” may begin to experience symptoms of “the underlying neurologic disorder within two or three days following whole-cell pertussis vaccination.” Tr. 657:12-17 (special master’s question to Kohrman, reading from PX 107 at 1501 (Physician Desk Reference: Tripedia (2003))). That warning is echoed by the Yellow Book issued by the Centers for Disease Control and Prevention (“CDC”) which states that

[C]ertain infrequent adverse events following pertussis vaccination are considered precautions (not contraindications) to additional doses of pertussis vaccine: a seizure, with or without fever, occurring within 3 days of immunization; temperature > 40.5°C (> 105°F) not resulting from another identifiable cause within 48 hours of immunization; collapse or a shock-like state (hypotonic-hyporesponsive episode) within 48 hours of immunization, or persistent, inconsolable crying lasting > 3 hours and occurring within 48 hours of immunization.

PX 45 at 547 (CDC Yellow Book).

Approximately five minutes after receiving the vaccination Camille “started having clusters of infantile spasms again.” Entitlement Decision at *3. Camille first experienced the renewed onset of seizures while she was still in the doctor’s office and being dressed by her mother after the vaccination. See id. Despite the fact that the seizure occurred at the doctor’s office, there is no indication that the attending physician or nurse performed a physical examination after Camille experienced her seizure. Tr. 664:17 to 665:6 (Kohr-man). The only contemporaneous account of the seizure is contained in Mrs. Loving’s journal which recites the onset of the seizure but no contemporaneous examination or treatment. See Entitlement Decision at *3.

After the vaccination on March 27, Camille began to experience one to two cluster seizures a day, each of which lasted several minutes. Petrs.’ Mot. for Review and Mem. of Objections (“Petrs.’ Mot.”) at 4. Prior to receiving the vaccination, Camille allegedly experienced less than one electrical, but not clinical, seizure per month and that seizure [139]*139typically would last only a few seconds. Id.

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

Related

Cite This Page — Counsel Stack

Bluebook (online)
86 Fed. Cl. 135, 2009 U.S. Claims LEXIS 65, 2009 WL 724926, Counsel Stack Legal Research, https://law.counselstack.com/opinion/loving-v-secretary-of-the-department-of-health-human-services-uscfc-2009.