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High court divided over vaccine safety appeal

By Bill Mears, CNN Supreme Court Producer
  • A couple claims that a DPT shot severely injured their daughter
  • A 1986 law set up a special court to handle vaccine-related claims
  • But its language "is certainly, to say the least, confusing," Justice Ginsburg says

Washington (CNN) -- The Supreme Court suggested Tuesday that congressional ambiguity in crafting a 24-year-old law is largely to blame for a bitter, ongoing legal and medical fight over the safety of childhood vaccines.

A Pennsylvania family engaged in what they call a "fight for justice" claims that a combined disease-prevention booster shot left their then-infant daughter with severe physical injuries.

The justices appeared deeply divided over whether drug makers can be sued outside a special judicial forum set up by Congress in 1986 to address specific claims over safety. The so-called "vaccine court," which has handled such disputes, was designed to ensure a reliable, steady supply of the drugs by reducing the threat of expensive lawsuits against pharmaceutical firms.

"The language that they [Congress] used is certainly, to say the least, confusing," Justice Ruth Bader Ginsburg said Tuesday.

The question in this latest case is whether such liability claims can proceed in separate state courts, if the vaccine-related injuries could have been "avoided" by better product design and if federal officials had approved another, allegedly safer drug.

Lawyers from both sides faced a torrent of questions in oral arguments, from often-frustrated justices, over precisely how the federal statute should be interpreted.

The lawsuit was brought by the parents of Hannah Bruesewitz, a young woman from the Philadelphia, Pennsylvania, area.

They claimed she was in fine health as an infant in 1992 when given a series of DPT shots-- a combination of vaccines to prevent diphtheria, pertussis (whooping cough), and tetanus. After the third series, according to court briefs, the child began having seizures and became disabled. Hannah, who turns 19 next week, continues to suffer what is described as "residual seizure disorder," and will require lifetime care.

The Bruesewitzes alleged Wyeth Laboratories failed to adequately warn them and other parents of the risks associated with the vaccine. Court records show the vaccine lot in question produced 65 reports of adverse reactions, including 39 emergency room visits.

The family alleges another vaccine owned by Wyeth -- known as Tri-Solgen -- had proven in earlier tests to result in fewer potential side effects. The Bruesewitzes claim the company and the federal Food and Drug Administration were lax in pushing use of the alternative, potentially safer vaccine. The original drug given Hannah was discontinued by Wyeth in 1998.

The vaccine court rejected the initial claim, so the family tried to revive the lawsuit in separate state and federal courts. Their lawyers claimed Congress did not intend to block all vaccine-related lawsuits, especially those filed when the harmful side effects were avoidable.

A federal appeals court eventually ruled for Wyeth, now owned by Pfizer Inc., concluding all design-defect claims were barred under the statute. Despite that victory, the company urged the high court to hear the case, saying it seeks final resolution on the broader legal questions. The Obama administration under then-Solicitor General Elena Kagan also urged review and is supporting the company and the federal law in question.

Kagan, now a Supreme Court justice, is sitting out the case to avoid a conflict of interest in the eventual ruling. That creates the possibility of a 4-4 tie that would not establish any guiding precedent for other other courts follow. Such a split would also mean the appeals court decision in favor of Wyeth would stand.

Wyeth and other drug manufacturers say their products are generally safe, but side effects can occur in very rare cases. They also say the vaccine industry is generally not profitable, but the health benefits for society in general have kept them in the business. For that, they say, legal protection provided by Congress is essential to ensure such drugs are widely available and affordable.

In the one-hour oral arguments, David Frederick, attorney for the family, asked for some flexibility, saying Congress allowed claims on a "case-by-case-basis" outside the vaccine court.

"There are no absolute provisions that preclude a state law claim," he said of the federal law. Russell and Robalee Bruesewitz watched the arguments, but did not comment afterward.

Chief Justice John Roberts was skeptical. "I would have thought the argument would go the other way," he said. "That because they [Congress] set up a compensation scheme, that was a good sign that they didn't want to allow state law claims."

"You assume that there is no burden to the manufacturers who defend these suits to assess settlement offers," added Justice Anthony Kennedy about the possibility of more lawsuits in state courts. "This is a tremendous expense."

On the other side of the debate, Ginsburg and Justice Sonia Sotomayor repeatedly pressed Wyeth attorney Kathleen Sullivan over the company's claims of "pre-emption" from design-defect claims.

"What is the motivation for the manufacturer to either continue the testing of their product and voluntarily stopping it if a better design has been found by someone else, or even an inducement for them to find a better design if a competitor comes around?" asked Sotomayor. "Because I don't see why they should stop until they have caused as many injuries as they need to before the FDA says stop."

Kennedy, who could prove the deciding vote in the case, followed up the point. "If the manufacturer is slow or remiss or negligent or willful in not giving the information to the government, there is nothing the injured person can do," he told Sullivan, under the company's reading of the statute.

"There are grave consequences if a manufacturer withholds knowledge of adverse effects from the FDA," she replied.

The high court has yet to act on a related pending appeal. The Georgia Supreme Court last year became the first appeals court in the United States to allow families to sue outside the special vaccine court. That case involved Atlanta-area parents who claimed their son, Stefan Ferrari, suffered severe neurological damage 12 years ago from booster shots by Wyeth and GlaxoSmithKiline that contained the mercury-based preservative thimerosal. Now 14, the boy is unable to speak, say his parents, Stefano and Carolyn Ferrari. The preservative has since been taken out of nearly all standard vaccines.

Despite winning at the state level, the family has since withdrawn its case, but the liability on drug companies resulting from that decision remains in force in Georgia.

The National Childhood Vaccine Injury Compensation Act was passed to establish a nationwide strategy to ensure a secure vaccine supply, promote safety and future research, and compensate innocent victims. Those goals were listed at the time as a "top public health priority."

Lawmakers at the time recognized the vaccine supply was suffering under rising company costs from potential liability claims. Despite Food and Drug Administration approval for the vaccines, pharmaceutical firms claimed they were being driven out of the market. The special federal court created under the legislation was a liability shield, designed to be a reliable, relatively quick, no-fault solution to various claims.

Unresolved over the years is whether and when certain exceptions to liability should be in play in specific cases.

The current high court case is Bruesewitz v. Wyeth (09-152). The pending case is American Home Products Corp. v. Ferrari (08-1120).