ENTRUSTING FOXES WITH THE HEN HOUSE: HOW A BAD LAW PITS BIG PHARMA AND THE FEDERAL GOVERNMENT AGAINST VACCINE-INJURED CHILDREN.

• Author: Cheffers, John

INTRODUCTION

In 1796, Edward Jenner, a natural scientist, was investigating tales of dairy-maids becoming immune to small pox after being infected with cowpox. (1) He purposefully infected the son of his gardener, a nine-year-old, with the cowpox, and after the boy recovered he was immune to the smallpox. (2) Vaccination (from the Latin vacca for cow) (3) was rapidly promoted; Thomas Jefferson was an early champion during his tenure in the White House. (4) Today, vaccination is considered one of the most effective weapons against infectious diseases. (5) When a certain threshold of people are immune to a particular illness, the disease stops circulating and the population at large achieves a 'herd immunity' that protects everyone from the disease, (6) especially people who are not immune; (7) governments worldwide strive to meet this public health goal of herd immunity through vaccination. (8) It is indisputable that vaccination has reduced the incidence of a number of diseases and improved general public health; (9) however, vaccinations are not without risk. (10)

On August 6, 1992, Scott Clements brought his healthy son, Andrew, for his third dose of the vaccine Diphtheria, Pertussis, Tetanus ("DPT"). (11) Later that night, Scott heard rasping coming from the room and found that his son was not breathing. (12) The fire department arrived shortly thereafter and determined that Andrew was having convulsions, so they brought him to the hospital for treatment. (13) Andrew went on to have another seizure when he arrived at the hospital and another eighty-four seizures over the course of the next three years. (14) The eighty-fifth seizure lasted over four hours and put Andrew in a coma for four months. (15)

When Andrew emerged from his coma, he was mentally retarded and had lost, amongst other things, the ability to swallow. (16) Andrew's family applied to the Vaccine Injury Compensation Program ("VICP"), (17) a special court located in Washington D.C. designed to give families with vaccine-injured children fast and generous payments through a no-fault alternative to civil litigation. (18) Even though Andrew was expected to live until he was forty, requiring extensive care, the government only offered the Clements $350 thousand. (19) After Andrew's parents refused to accept the settlement, their claim was denied in a hearing in 1998 because Andrew's symptoms no longer met the criteria set forth by the Department of Health and Human Services ("HHS") for encephalopathy, (20) which had been revised in 1995 to exclude residual seizure disorders such as Andrew's. (21)

Andrew's tragic story reveals an unexpected and ugly cost for the advances the United States has achieved against infectious diseases through vaccination. Although rare, side effects for vaccines can include long-term disability and death. (22) Since vaccines are essentially mandatory with a few narrow exceptions, (23) almost every child living in the United States is vaccinated. (24) To protect public health and ensure continued high rates of vaccination, Congress enacted the National Childhood Vaccine Injury Act ("NCVIA") in 1986 (25) when tort liability threatened to destabilize the vaccine market. (26) A portion of the NCVIA created the VICP, a special court designed program to provide a "swift, flexible, and less adversarial alternative to the often costly and lengthy civil arena of traditional tort litigation." (27) A close examination of Andrew's story will reveal that the NCVIA creates a series of deeply flawed incentives for the pharmaceutical companies and the federal government that probably led to Andrew's injury and certainly denied his family the money necessary to care for him.

Part I of this Note will examine the origins of the NCVIA, the VICP that it created, and the incentives that it put in place. Part II will look at how these incentives have led to bad results over the past thirty years, and how that dubious legacy has fueled a backlash that ironically threatens the health goals of the law. To conclude, the bad incentives inherent in the NCVIA made Andrew's story tragic and inevitable, and those incentives will continue to wreak havoc on families until Congress makes a substantial change to the NCVIA.

Vaccination is controversial for a number of reasons. The most widely-known controversy began in the 1990s when Dr. Andrew Wakefield published a now-retracted study in a medical journal linking the Mumps, Measles, and Rubella ("MMR") vaccine to autism. (28) There have been a number of other concerns raised over the safety of vaccines, (29) including concerns that the small amount of aluminum or mercury in vaccines accumulate to dangerously high levels after repeated injections. (30) In addition, there are religious objections to certain vaccines derived from aborted fetal tissue. (31) This Note takes no position on religious or medical objections to vaccination, and relies exclusively on generally accepted legal and medical knowledge concerning vaccination and its health risks when examining the NCVIA.

PART I: THE NCVIA

1. Born in Crisis

   Up until the 1980s, vaccination in the United States had broad public support. (32) The successful campaign against polio in the 1950s and the successful eradication of smallpox by 1980 were big wins for pharmaceutical companies, and public confidence in vaccines was high. (33) Between 1978 and 1981, there were only nine lawsuits filed against vaccine manufacturers for vaccine injuries. (34) Public confidence was shattered in 1982 when a documentary called "DPT Vaccine Roulette," produced by reporter Lea Thompson, aired locally in the Washington D.C. area on NBC affiliate WRC-TV and in excerpts on NBC's Today show. (35) The documentary won an Emmy nomination and drew national attention to the tendency of the Pertussis portion of the DPT vaccine to cause encephalopathy, a brain seizure disorder that can result in mental and physical retardation, (36) in a small number of patients. (37) Encephalopathy was, and remains today, a possible side effect of DPT. (38) By 1986, more than 250 suits were filed for DPT related injuries, (39) causing some manufacturers to stop producing childhood vaccines, which created severe instability in the market. (40) One remaining manufacturer estimated that its liability was two hundred times larger than its annual vaccine sales. (41) This crisis in the vaccine market could have led to a severe shortage of DPT and Polio vaccines. (42)

   At the peak of the crisis in 1986, Congress stepped in and passed the NCVIA. (43) It had two main goals: to adequately compensate children injured by vaccines, and to stabilize the vaccine market. (44) A substantial portion of the law was dedicated to creating the VICP, (45) which was intended to be a fast and generous alternative forum to the civil court system, (46) funded by a seventy-five cent excise tax on every vaccine dose administered. (47) The law effectively stabilized the market and brought a reduction to civil litigation, (48) but the incentives it put in place made it impossible for many of the families of injured children to quickly collect the compensation they needed. (49)

2. Stability Through Effective Tort Immunity

   To stabilize the market, the drafters of the law included a number of provisions to keep the cases out of civil court and effectively provide vaccine manufacturers with tort immunity. (50) The most important provision is that all vaccine injury claims must be adjudicated through the VICP, under the jurisdiction of the United States Court of Federal Claims, before they can be brought in civil court under state law. (51) In 1855, Congress created the Court of Federal Claims in Washington, D.C. (52) and eventually gave it the authority to make final determinations in cases against the federal government without a jury. (53) It has since been granted jurisdiction over a myriad of claims, ranging from disputes over military pay to disputes concerning oyster grower insurance. (54) In the NCVIA, Congress gave the Court of Federal Claims jurisdiction over vaccine injury claims by requiring that injured persons bring his or her claims against the federal government, naming the Secretary of HHS as the respondent. (55) Vaccine manufacturers are not parties to litigation in the Court of Federal Claims; (56) injured persons can only bring a state-law claim against a vaccine manufacturer if their claim against the Secretary of HHS is dismissed or they refuse to accept a settlement in the Court of Federal Claims. (57)

   The NCVIA contains certain provisions which severely limit the kinds of state-law claims that can be brought against vaccine manufacturers after an adjudication in the Court of Federal Claims. (58) The Supreme Court has held that the law effectively blocks actions based on products liability theory. (59) Products liability theory emerged as a way for plaintiffs to recover and hold manufacturers accountable for unsafe products. (60) The theory emerged as a response to the failures of traditional theories of warranty, privity of contract, and negligence to provide compensation in the face of complex modern manufacturing and distribution methods. (61) Products liability theory allows a plaintiff to sue if a product has a manufacturing defect, a design defect, or an insufficient warning. (62)

   The NCVIA specifically blocks any cause of action based on a products liability theory arising from a design defect or insufficient warning. (63) It does this by blocking a suit over the design of the vaccine "if the injury or death resulted from side effects that were unavoidable." (64) The Supreme Court held in Bruesewitz that this language leaves the design of vaccines to the experts and prevents second-guessing about the safety of vaccines. (65) The NCVIA also blocks any cases brought over an insufficient warning. (66) The law clarifies that if a warning label meets all the requirements set forth by the Food and...