Friday, October 15, 2010;
"THE THREAT to our vaccine supply in this country is a real one," read a congressional report from the mid-1980s.
At the time, manufacturers warned that they could be forced to suspend vaccine production because of costly lawsuits filed by families who believed their children had been injured by inoculations. Congress was also concerned that not every case involving an injured child was being heard, in part because lawyers would often take only the cases they believed would yield big judgments.
Lawmakers crafted the National Childhood Vaccine Injury Act with two goals in mind: to compensate the families of injured children and to guarantee a steady supply of the vital vaccines necessary to prevent millions of youngsters from contracting deadly or crippling diseases. In doing so, Congress created a special no-fault vaccine court and a government-managed account funded by an excise tax on vaccines. There are no limits on how much an individual or family may recover for medical expenses and ongoing care. The fund has paid $1.8 billion in claims since its inception.
Manufacturers, in turn, were promised immunity from most lawsuits "if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings."
Families must file their initial claims in the vaccine court, but they are allowed to take their case to a different federal court if they lose or reject the vaccine court's settlement offer. Even in federal court, they must comply with the terms of the vaccine act.
The Supreme Court heard arguments this week from a couple who believe that their then-6-month-old daughter began experiencing seizures after being given Wyeth's diphtheria, tetanus and pertussis (DTP) vaccine. The parents claim the vaccine suffered from a design defect that made it less safe than an alternative. The harm, in other words, was not "unavoidable," and the parents argue that their lawsuit should be allowed to proceed. The parents lost their case in the vaccine court and later in a Pennsylvania federal court, which embraced Wyeth's arguments that the act shielded it from such suits.
We believe Wyeth has the better of the arguments. In writing the law, Congress carved out only two exceptions to the manufacturers' immunity; had lawmakers intended to allow lawsuits for design defects, they should have been specific. The harm, moreover, may not have been unavoidable, as the parents believe, because the alternative vaccine was not approved by the Food and Drug Administration for use on children as young as 6 months until years later.
Vaccine-related injuries are heartbreaking, and the FDA has the power to pull unnecessarily dangerous vaccines off the market. Opening the door to more lawsuits is neither legally compelled nor wise public policy. As the American Academy of Pediatrics argues convincingly in a friend-of-the-court brief joined by 21 other physician and public health organizations, such a development could "drive vaccine manufacturers from the market and halt the future production and development of childhood vaccines in this country."