

SPAKOVSKY: Risky side effects of vaccine act challenge

Trial lawyer win could be another blow to pharmaceutical industry

- The Washington Times - Tuesday, October 26, 2010

Today, the vast majority of America's children reach adulthood. We take that fact almost for granted.

But what if diseases such as whooping cough, diphtheria and polio, which crippled and killed so many children in prior generations, were still widespread? What if we lacked the vaccines that have wiped out these scourges, or if they were prohibitively expensive? What if the research efforts to develop new vaccines stopped?

These questions are at stake in the case of Bruesewitz v. Wyeth, which is now before the U.S. Supreme Court.

At issue is the National Childhood Vaccine Injury Act (NCVI) of 1986. The NCVI was passed when a liability crisis was driving vaccine makers out of business. Why? Because vaccines are inherently dangerous. Yes, immunization prevents large numbers of individuals from contracting a dehabilitating and potentially fatal disease. But we also know that a few individuals will react adversely to immunization, no matter how safely and carefully a vaccine is designed and manufactured.

This is unfortunate, to say the least, but the benefit provided to the vast majority of individuals clearly outweighs the detriment to the small number harmed by the vaccine - except, of course, in the eyes of the plaintiffs' bar. A series of lawsuits against vaccine manufacturers in the 1970s not only caused several critical vaccines - including for diphtheria, tetanus toxinoids, pertussis (DPT), polio and measles - to increase dramatically in price, but threatened to make them unavailable.

The manufacturers of the DPT vaccine dropped from seven to two, of the polio vaccine from three to one, and of the measles vaccine from six to one. One company official testified that the "potential liability from lawsuits [over the DPT vaccine] was more than 200 times greater than its annual sales." Almost 90 percent of the cost of vaccines covered potential liability awards. In essence, state tort lawsuits were threatening to eliminate the vital vaccines that are essential to the health of America's children, as well as those abroad who benefited from the export of American vaccines.

The federal vaccine law was intended to presumptively pre-empt almost all state tort claims against vaccine makers. Instead, Congress set up a trust fund administered by the Department of Justice through a special "vaccine court" to provide compensation in the "rare instances where an injury results from vaccination."

According to Justice, more than 1,500 people have been paid more than $1.18 billion since 1988 for their injuries. Awards are often in excess of $1 million, so this program does not skimp in its payments. It's a no-fault system: Claimants don't have to show that a vaccine was in any way defective. But they do have to show actual, scientific proof that a vaccine caused the injury, something that does not sit well with trial lawyers.

That is because trial lawyers know that state court juries can usually be convinced to award huge verdicts even without real evidence of wrongdoing. Juries are not medical experts. Unlike the Centers for Disease Control and Prevention, and the other federal agencies that oversee "the safety and efficacy testing of vaccines," juries do not usually balance the benefit a vaccine may hold for a large group of individuals against the potential harm or side effects in a very small number of individuals.

They see only a disabled or injured child in a courtroom, and hear conflicting scientific opinions by "experts" (hired guns) in an atmosphere of highly charged emotions.

They don't see the millions of healthy children saved from potential epidemics because of a vaccine. And juries often make awards based on sympathy for an injured individual, not on actual proof of causation of injury.

In Bruesewitz, that proof was lacking. Hannah Bruesewitz received the DPT vaccine. Her family claimed that as a result, she became developmentally impaired. But the family could produce no evidence that the vaccine caused Hannah's medical problems, so the vaccine court dismissed her claims.

Her family then filed a tort lawsuit in Pennsylvania, asserting that the vaccine was defectively designed. The lower courts correctly held that the state tort claims were pre-empted by the federal vaccine law.

It's wrong to say the Bruesewitz case is simply giving injured children their day in court. Injured children can receive ample compensation through the federal vaccine program. What this case is really about is tort lawyers trying to bypass the scientific evidence requirements of the federal system to reap huge, unjustified damage awards by playing on the sympathies of state court juries. The potential for a windfall of billions of dollars is staggering.

But the costs of allowing claims in courts are all too real. Five children died in California earlier this year from pertussis (whooping cough), the same disease against which Hannah Bruesewitz was immunized, and the very vaccine whose availability was in jeopardy during the earlier vaccine crisis. American companies export inexpensive vaccines to many Third World countries.

Maintaining the federal pre-emption over state tort claims against vaccine makers is absolutely crucial. It is no exaggeration to say that if the Supreme Court decides this the wrong way, it is virtually certain that the development and manufacture of life-saving vaccines will largely shut down in the United States. The effect of that on our children and so many others will be almost incalculable.

Hans A. von Spakovsky is a senior legal fellow at the Heritage Foundation.
