Vaccine Law: Friend or Adversary?

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Changing the Current Vaccine Law to Be Less Adversarial, More Administrative

By: Meredith Biggs

Introduction

Hannah Bruesewitz’s (Hannah) short and painful life has been the center of a larger controversy: she has been the subject of litigation for nine years, and the subject of scientific observation for nineteen.  On April 1, 1992, one-and-a-half year old Hannah received her third DTP¹ vaccination and began to show an unusual physical reaction.²  Her body began to stiffen periodically, her mood worsened, and she had periods of unresponsiveness.³  Doctors soon diagnosed her as suffering from seizures, which she began to experience more frequently and more severely as the days progressed.⁴  After being medicated, her seizures improved; however, Hannah developed slowly , showed signs of irritability, “smiled very little, and had a vacuous stare.”⁵  Hannah’s symptoms began the day she received her third DTP vaccine; and her condition will require medical care for the rest of her life.⁶

Many children have suffered neurological problems from a DTP vaccine. In fact, DTP vaccinations are responsible for the majority of proven vaccine-related injuries, and the injuries are primarily neurological.⁷ Hannah’s shot in particular came from a batch that had generated at least 65 known adverse reactions, including 39 visits to the emergency room, 6 hospitalizations, and even 2 deaths.⁸ “Hannah’s physician later indicated, as part of this litigation, that she would not have immunized Hannah had she known of the adverse event reports associated with this lot of the vaccine.”⁹  Only six years later, the vaccine manufacturer Wyeth completely abandoned that form of the DTP vaccine in favor of a new, safer vaccine.¹⁰

Hannah, whose claim was brought by her parents, is one of 13,755 people who have filed petitions under the National Vaccine Injury Compensation Program (VICP), believing that a vaccine caused her illness.¹¹  However, like many, her claim was denied. Hannah had the burden to prove causation—she had to prove that the shot caused her condition. It was difficult for Hannah to prove causation because her symptoms did not fit squarely into the “table,” which lists specific times and conditions of symptoms that are presumed to be caused by the vaccine.¹² Despite the fact that this particular vaccine had been causing so many problems, her temperature wasn’t high enough during the seizures to fit into the table and show conclusive causation.¹³ Even though there was no evidence available as to her actual temperature at the time of the seizures, the speculated temperature was only about 1.7 degrees Fahrenheit under what was necessary to prove causation-in-fact.¹⁴ Hannah’s inability to provide direct evidence that her temperature reached 101.1 degrees meant that she had not met her burden of proving causation, leaving Hannah out of luck.

Hannah’s parents hoped that, despite the lack of evidence as to temperature, a study tending to show that these types of symptoms, including seizures, were related to the DTP vaccination would help prove their case.  Nonetheless, the presiding judge in the Federal Claims Court, who under the VICP is called a “Special Master”, decided that the study was not relevant for two reasons: (1) because it was “unclear” whether the study applied to the exact type of symptoms Hannah was experiencing, and (2) the 20-year-old study did not give a conclusive answer as to whether the DTP “caused her seizure disorder.”¹⁵  Hannah, a girl who had no problems with seizures until the very day she had her third DTP shot, had failed to prove causation for a condition that now permeates her life and her future. Her parents took her claim all the way up to Supreme Court of the United States, only to hear the disappointing ruling that vaccine manufacturers could not be held responsible for designing an unsafe drug.¹⁶

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