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The family of an infant who allegedly suffered a severe reaction to a vaccine may not sue the drugmaker for failing to update the vaccine with a newer, safer version, the US Supreme Court ruled on Tuesday. In a 6-to-2 decision, the high court said Russell and Robalee Bruesewitzs lawsuit was preempted under the National Childhood Vaccine Injury Act of 1986. The law grants drug companies immunity from certain lawsuits from injuries or deaths tied to vaccinations. We hold that the National Childhood Vaccine Injury Act preempts all design-defect claims against vaccine manufacturers brought by plaintiffs who seek compensation for injury or death caused by vaccine side effects, wrote Justice Antonin Scalia in the majority decision.
In a dissent, Justices Sonia Sotomayor and Ruth Bader Ginsburg said that, by preempting all design defect lawsuits by vaccine victims, the high court was imposing its own bare policy preference over the considered judgment of Congress. The decision leaves a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing and distributing their products, Justice Sotomayor wrote. Millions of infant vaccines are safely administered each year throughout the United States. But government officials acknowledge that a small percentage of infants experience a severe negative reaction from a vaccine. In some cases the reaction can be fatal.
Faced with open-ended damages from lawsuits filed on behalf of those who suffer severe reactions from vaccines, drug manufacturers considered avoiding the vaccine market altogether. In passing the National Childhood Vaccine Injury Act, Congress sought to strike a balance that would protect vaccine manufacturers from open-ended liability from private lawsuits while also creating a special fund to compensate those who suffer side effects from vaccines. Roughly 100 to 200 claims for compensation are submitted each year to a special vaccine court. To date, the compensation fund has paid out $1.8 billion to 2,500 petitioners. The average award is about $750,000. But compensation is only part of the Vaccine Injury Acts purpose. Congress also sought to preempt lawsuits seeking open-ended money damages against vaccine manufacturers.
The problem with the law is that Congress did not specifically spell out which lawsuits may move forward in the courts against vaccinemakers and which must be dismissed. The law says in part that no vaccine manufacturer shall be held liable for a vaccine-related injury or death 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. Products liability law establishes three grounds for potential liability if there is a defect in the manufacture, if there were inadequate warnings, or if there is a defective design.
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The research found that adult mice raised in a germ-free lab environment were more likely than normal lab mice to develop allergies, asthma and other serious autoimmune disorders, in which normally defensive immune system cells turn against the bodys tissues and organs. There are more than 80 autoimmune disorders, including common allergies such as hay fever; rheumatoid arthritis, which attacks the joints; Crohns disease, an inflammatory bowel condition; and juvenile diabetes.
Richard Blumberg, a professor at Harvard Medical School and chief of gastroenterology at Brigham and Womens Hospital in Massachusetts, says medical researchers in 1989 sought to explain these varied autoimmune disorders with what they called the hygiene hypothesis." The hypothesis has stated or suggested that early-life exposure to microbes is a very important determinant of later life sensitivity to allergic and so-called autoimmune diseases, such as hay fever, asthma, inflammatory bowel disease and others," said Blumberg.
The hygiene hypothesis proposed that all the washing and scrubbing people were doing with the increasingly popular anti-bacterial soaps and lotions could be making them sick by altering their immune systems. But this theory had not been tested, until now. Blumberg and colleagues have found the first biological evidence that childhood exposure to germs keeps the adult immune system in check, preventing the development of some autoimmune diseases. They compared a group of mice raised in a typical environment filled with bacteria, to a group of mice raised in a sterile environment.
The researchers discovered that inflammation in the lungs and colon of the adult germ-free mice was being caused by over-active killer T cells. These cells normally fight infection, but in these mice they were targeting healthy tissue - an autoimmune condition seen in asthma and ulcerative colitis. But Blumberg says the normal mice whose immune systems had been educated by exposure to a microbe-rich enviornment did not have the same inflammatory response. What was really most remarkable to us was the fact that once the education event provided by the microbes occurred in early life, it was durable and lasted throughout the life of the animal," he said. "And if that educational event provided by microbes was not given, it was impossible to educate the animal later in life.
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