Issue: March 2011
March 01, 2011
2 min read
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Supreme Court upholds Vaccine Court

Issue: March 2011
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The Supreme Court has upheld a recent ruling that backed the National Childhood Vaccine Injury Compensation Act’s role in preempting design-defect claims against vaccine manufacturers.

The ruling involved a case brought by the guardians of Hannah Brusewitz, who, according to court documents, sustained long-term damage after receiving a vaccine that was manufactured by Wyeth.

The lawsuit argued that the vaccine Hannah received was flawed, and therefore outside the jurisdiction of the Vaccine Injury Compensation Court, which was established by the National Childhood Vaccine Injury Compensation Act of 1986. As noted in the Supreme Court decision, several pharmaceutical companies were pulling out of the vaccine market prior to the Act because of threats of lawsuits. Congress responded by passing the Vaccine Act, which established the no-fault alternative VICP to compensate the families of children who suffer from rare adverse reactions caused by vaccines, and to protect the nation’s vaccine supply.

The opinion of the Court, written by Justice Antonin Scalia, stated that “[The Vaccine Act] reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the FDA and the National Vaccine Program rather than juries.”

“We have great sympathy for the Bruesewitzes,” Pfizer Executive Vice President and General Counsel, Amy Schulman, said in a press release following the ruling. “We recognize, however, that the Vaccine Act provides for full consideration of the liability issues through the National Vaccine Injury Compensation Program. Here, the Vaccine Court concluded that the petitioners failed to prove their child’s condition was caused by vaccination.”

In amicus briefs supporting Wyeth’s position, many expert medical and scientific groups, including the AAP, as well as HHS, expressed their view that upholding the preeminence of expert federal agencies would benefit public health by protecting the supply of childhood vaccines.

In a concurring opinion, Justice Stephen Breyer articulated that HHS's view on this matter holds significant weight because of the importance of this case to childhood health. Justice Breyer stated that “HHS's position is particularly persuasive here because expert public health organizations support its views and the matter concerns a medical and scientific question of great importance: how best to save the lives of children.”

In a press release issued after the ruling, AAP officials backed the decision.

“Today’s Supreme Court decision protects children by strengthening our national immunization system and ensuring that vaccines will continue to prevent the spread of infectious diseases in this country,” AAP President Marion Burton, MD, said in a press release following the decision. “The U.S. Supreme Court affirmed what pediatricians have been advocating for decades. Vaccines save lives.” – by Colleen Zacharyczuk

PERSPECTIVE

The decision by the US Supreme Court this week has established the National Vaccine Injury Compensation mechanism as the scientifically sound review for possible vaccine-related complications in the United States. It is also a vindication for all the hard work of many pediatricians and national organizations to take care of children in a fair and equitable manner. The ruling to uphold a lower court decision to prohibit litigation of vaccine manufacturers by allowing the national program to evaluate claims of potential vaccine-related complications provides relief to a beleaguered industry. We need to continue research and development of vaccines in an era where historic numbers of infectious diseases are prevented or reduced. All pediatricians will celebrate this victory as a milestone in our quest for children's health.

– Richard F. Jacobs, MD

Infectious Diseases in Children Chief Medical Editor

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