A one shot deal: the National Childhood Vaccine Injury Act.

• Author: Breen, Elizabeth A.

Andrew Clements is six years old.(1) Like most other children his age, Andrew enjoys stuffed animals and the characters from Walt Disney's 101 Dalmatians.(2) Plastic decals of black and white spotted dogs adorn his bedroom walls, and furry, stuffed creatures cover his furniture.(3) Any six-year-old would approve.

Yet Andrew's parents realize that their son has little more in common with other children his age. Andrew is not enrolled in elementary school.(4) He cannot walk.(5) He cannot talk.(6) He cannot sit up without assistance.(7) He cannot feed himself, but must be fed through a feeding tube.(8) Although he recognizes their voices, Andrew cannot tell his parents what he thinks or how he feels.(9)

Andrew was not born with disabilities.(10) His difficulties began August 6, 1992, the day his mother took him for his six-month well-baby visit and Andrew received his third DPT vaccination.(11) Later that evening, Andrew suffered his first seizure and was rushed to the hospital.(12) By the age of three and a half, he had returned to the emergency room more than seventy times and experienced equally as many additional seizures.(13) Between each seizure, Andrew appeared a happy and healthy child.(14)

In the fall of 1995, the Clements's family life changed permanently. Andrew suffered another seizure, which lasted more than four hours, and developed an infection that caused his body temperature to peak at 108 degrees.(15) Although he recovered, Andrew never returned to being the relatively normal three-year-old he had been between each previous seizure episode.(16)

In July of 1995, Andrew Clements's parents filed a petition for compensation under the National Childhood Vaccine Injury Act (the Act).(17) Enacted in 1986, the Act created a no-fault compensation system through which parents could seek monetary relief for vaccine-related injuries suffered by their children.(18) Because the Clements family blamed the DPT shot for their son's injuries, they alleged that the vaccination was the cause-in-fact of Andrew's encephalopathy and seizure disorder.(19) Despite the Clements's presentation of favorable evidence including testimony from a medical expert, the special master assigned to their petition denied the family's claim.(20)

This Note addresses both the motivation that prompted Congress's passage of the National Childhood Vaccine Injury Act and its implementation since the Act's passage in 1986. Ultimately, this Note suggests that the Act, as enforced, has not met Congress's good intentions.

Part I discusses the purpose of the National Childhood Vaccine Injury Act, with particular regard to the history of immunizations in the United States and the potential shortage in availability of specific vaccines in the mid-1980s. Part II addresses the Act as a no-fault alternative to compensation, including the Act's pleading requirements and the role of the special master in determining whether recovery is appropriate. Part III focuses on the standard of proof required of petitioners in order to recover, with further emphasis on the special masters' role in adjudication of claims. Part IV concludes that Congress's initial goals in passing the National Childhood Vaccine Injury Act have not been met with respect to many petitioners. Although Congress has achieved its goal of ensuring a sufficient supply of vaccines, Part IV emphasizes that this victory has been realized only at the expense of efficiency and fairness. Although the no-fault compensation scheme has insulated the pharmaceutical industry from liability, it has not been an equal cure for individuals injured by vaccinations covered by the Act.

HISTORY OF VACCINES

The authority of states to require their citizens to be immunized against certain diseases and illnesses is well-settled.(21) All fifty states and the District of Columbia have immunization requirements for children that must be met before they may attend public school.(22) Due to the overwhelming success of vaccines in reducing the overall incidence of preventable illness, doctors and public health experts have referred to immunization programs as one of "the single most effective [means of] health intervention."(23) At the turn of the century, infectious disease proved to be among the greatest health risks threatening the world population.(24) One hundred and sixty children per every one thousand births in the United States died as a direct result of an infectious disease.(25)

The advent of comprehensive vaccination programs has all but eradicated specific illnesses or significantly reduced their incidence.(26) Most recently, in 1993, Congress enacted a law providing free immunization for all eligible children.(27) Known as the Childhood Immunization Initiative (CII), this law also increased state and local standards for vaccination rates among preschool age children. It set a three-year goal to have 90% of all children in the United States fully immunized by age two.(28) By the 1996 target date, the CII had been modestly successful; thirty states and fourteen of the twenty-eight targeted urban areas had met the original requirements.(29)

Societal Response

Despite comprehensive health programs and the undeniable health benefits achieved through immunizations, many children remain unvaccinated against the most preventable infectious diseases.(30) Although a noble congressional effort, the CII has not served as a permanent motivational force. In 1998, fewer than one half of all two-year-olds were fully vaccinated.(31) The lack of childhood immunizations has led to an average of 70,000 deaths per year due to vaccine-preventable illnesses.(32)

Inadequate immunization rates among children may be due to parents' general misunderstanding about vaccination. Some parents may be unaware of the importance of immunizations, believing them to be unnecessary or a thing of the past.(33) Conversely, other parents may be aware of the benefits of vaccinating their children against preventable illnesses, but may fear the potential adverse side effects associated with some vaccines.(34) Although not unfounded, their fears may be exaggerated.(35)

Beneficial to the vast number of recipients, vaccinations cause a small number of children to surfer significant adverse reactions.(36) Complicating matters is the unforeseeable nature of such reactions. Certain physical conditions provide physicians with an indication that a child may have a greater propensity to react to a vaccine, but the potentially harmful side effects cannot be predicted with any certainty.(37)

Ideally, a recipient will experience no reaction to a vaccine. The side effects displayed by those who do react vary greatly depending on the individual. More frequently, the recipient of a vaccine will experience local side effects, including redness and swelling around the injection sight, or mild systemic responses, including drowsiness and occasional vomiting.(38) Some vaccines cause significantly more harmful and severe reactions.(39) Though infrequent, recipients may experience significantly elevated body temperatures, enter a shock-like state, or in some cases surfer convulsions and encephalopathy.(40) In the most rare situation, a child may die from a vaccine.(41)

The risks that vaccines present may be accorded greater weight by parents than appropriate. More than 100 million doses of vaccines are issued every year to American children.(42) Yet in 1997, fewer than 100 children died as the direct result of receiving an immunization.(43) Nonfatal reactions are similarly scarce; DPT injections carry the greatest risk among childhood vaccinations, with recipients standing a one in one hundred thousand chance of suffering permanent brain damage.(44) The recent advent of safer vaccines has reduced further the risks involved.(45)

The individual risks and potential societal consequences of an unimmunized population are far greater than those posed by the vaccinations themselves.(46) Parents unwilling to face the potential adverse consequences of immunizing their children may assume their children are not at risk for exposure to vaccine-preventable illnesses because other children are immunized.(47) To the contrary, outbreaks of measles and pertussis in unvaccinated persons have been documented in the last decade.(48)

Pharmaceutical Industry

For several decades, the risk inherent to immunization remained relatively static until the recent development of safer vaccines.(49) Ironically, as the safety of vaccines has increased, so has public awareness of the potential adverse side effects. For example, the pharmaceutical industry came under sharp public criticism due, in part, to the 1982 television documentary, "DPT Vaccine Roulette." This documentary garnered significant media attention and earned an Emmy nomination for its depiction of children who suffered from irreparable neurological disabilities after receiving DPT vaccinations.(50)

As a result of the increased media attention and public awareness, individuals who suffered adverse reactions from vaccines began suing the pharmaceutical companies that produced the drugs.(51) In turn, the pharmaceutical companies increased the prices of the vaccines they produced.(52) Some companies no longer could justify financially the manufacture of specific drugs that had become the target of increasing numbers of civil suits.(53) By 1986, few pharmaceutical companies remained willing to produce childhood vaccines.(54) Only two companies continued to produce DPT vaccines and only one company manufactured the polio vaccine.(55) Facing a potentially severe shortage in available vaccines, a decline in the number of immunized children, and the pleas of the uncompensated victims of vaccination injuries, Congress enacted the National Childhood Vaccine Injury Act.(56)

NATIONAL CHILDHOOD VACCINE INJURY ACT

Two overriding concerns led to Congress's implementation of the Act. Both the inadequate and inconsistent nature of...