Supreme Court upholds ruling shielding vaccine makers

Lisa Schnirring

Feb 22, 2011 (CIDRAP News) – The US Supreme Court today upheld a federal shield law for vaccine makers in its ruling against a Pennsylvania family who claim that a Wyeth vaccine is responsible for their daughter's seizure disorder.

Many health groups applauded the court's 6-to-2 decision, while vaccine opponents condemned it. Justices Ruth Bader Ginsburg and Sonia Sotomayor were the dissenters. Justice Elena Kagan recused herself from the case because she participated in it while she was US solicitor general.

The parents' argument before the Supreme Court was that the Third Circuit Court of Appeals in Philadelphia erred when it ruled in 2009 that the federal shield law blocks all claims of vaccine-design defects, whether or not the side effects were avoidable. The family said the company could have sold a safer vaccine, but chose not to.

The girl at the center of the case is Hannah Bruesewitz, a teenager whose parents contend that her seizure disorder surfaced within hours of receiving the third dose of a diphtheria, tetanus, and pertussis (DPT) vaccine made by Wyeth, which is now a subsidiary of Pfizer, in 1992 when she was 6 months old. Her parents have testified that their daughter will need care for the rest of her life for a profound developmental impairment.

Her family had previously filed a compensation claim with the US Court of Federal Claims, which rejected it in 2002. The court was established in 1986 under the National Vaccine Injury Compensation Program to curb the number of lawsuits against physicians and vaccine makers. Congress passed the measure after a scare in the 1980s over the DPT vaccine threatened the national vaccine supply. Despite unfounded claims about the vaccine's side effects, juries gave some plaintiffs large awards, and most companies that made the vaccine ceased production.

As of Feb 8, 13,739 cases had been filed through the compensation program, 5,636 of them related to autism. The program has paid just over $2 billion to 2,580 claimants since 1988. The program is funded by an excise tax of 75 cents for each dose of covered vaccine.

When the Supreme Court agreed to take the case in March 2010, Pfizer welcomed the development as way to settle a persistent legal issue. The Obama Administration lent its support to the vaccine maker's side of the case when it filed an amicus brief stating that the law provides a "robust federal framework" that encourages the development of safer vaccines while providing compensation to families when appropriate.

In a statement today, Pfizer's executive vice president and general counsel, Amy Schulman, said that the National Childhood Vaccine Injury Act appropriately puts the responsibility for determining the optimal design of childhood vaccines "in the hands of expert federal agencies, not a patchwork of state tort systems. We are pleased that the US Supreme Court affirmed the ruling of the Third Circuit."

"We have great sympathy for the Bruesewitzes," she said. "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."

The American Public Health Association (APHA) in a statement today welcomed the Supreme Court's decision, saying that upholding the Vaccine Injury Compensation Program supports the role of vaccines in the nation's health.

Georges Benjamin, MD, the APHA's executive director, said vaccines are an important health measure that can save lives." We are pleased with today’s ruling in favor of a fair and just way to address the very rare but sometimes severe adverse events associated with vaccines, and that helps assure a strong national vaccination system," he said.

The APHA was one of 22 medical and public health groups that signed on to an amicus brief supporting the program's role in protecting vaccine companies and the nation's vaccine supplies.

The American Academy of Pediatrics (AAP), the main author of the brief, said today that it stands behind the Supreme Court ruling, which it says safeguards the nation's vaccine supply.

O. Marion Burton, MD, AAP president, said in a statement that the decision protects children by strengthening the nation's vaccine system and ensuring that vaccines will be available to protect against the spread of infectious diseases.

"Today, the U.S. Supreme Court affirmed what pediatricians have been advocating for decades,” Burton said. "Vaccines save lives."

Several anti-vaccine groups, however, condemned today's Supreme Court decision. The Coalition for Vaccine Safety said in a statement that the court majority's true intent appears to be preventing several thousand tort cases claiming a link between vaccines and autism from reaching civil court.

The group, which listed the support of 11 autism and anti-vaccine groups, called for Congressional hearings and actions to amend the National Childhood Vaccine Injury Act to allow parents to sue for vaccine design defects in civil court.