Supreme Court upholds vaccine liability shield

The U.S. Supreme Court has upheld liability protections for vaccine makers, ruling that they can't be sued in state court for design-defect damages.

In its Feb. 22 opinion, the high court ruled 6-2 in favor of vaccine manufacturer Wyeth, now owned by Pfizer. The ruling said the National Childhood Vaccine Injury Act bars design-defect claims against the manufacturer. The 1986 federal law created a no-fault compensation program to shield vaccine manufacturers from excessive tort litigation and stabilize the vaccine market.

The act "reflects a sensible choice to leave complex epidemiological judgments about vaccine design to the [Food and Drug Administration] and the National Vaccine Program, rather than juries," the court said.

The parents of Hannah Bruesewitz sued Wyeth in 2005, after their claim filed through the federal compensation program was rejected. They said a dose of the diphtheria-tetanus-pertussis vaccine caused seizures and developmental delays in their daughter. Wyeth denied any wrongdoing.

"The Vaccine Act that Congress enacted nearly 25 years ago appropriately places the responsibility for determining the optimal design of life-saving childhood vaccines in the hands of expert federal agencies, not a patchwork of state tort systems," Amy Schulman, Pfizer executive vice president and general counsel, said in a statement. "We are pleased that the U.S. Supreme Court affirmed the ruling" of the appeals court, she added.

At this article's deadline, an attorney for the Bruesewitz family had not returned messages seeking comment. A spokesperson for the Pharmaceutical Research and Manufacturers of America said it was deferring comments on the case to Pfizer.

Between 1978 and the mid-1980s, product liability lawsuits against vaccine makers went from a few single cases to hundreds of actions. The massive litigation led to two of the largest domestic manufacturers going out of business. By 1984, serious vaccine shortages were overwhelming the country, court documents said.

Congress responded with the National Childhood Vaccine Injury Act. The law allows plaintiffs to file a petition for compensation in the U.S. Court of Federal Claims. Successful claimants can receive awards for medical, rehabilitation, counseling and other expenses. Vaccine-related death awards have a $250,000 cap. Compensation is paid through a fund created by a vaccine excise tax.

Many vaccine makers and health professionals feared a Supreme Court ruling for the plaintiff in the Bruesewitz case could have led to more lawsuits and vaccine shortages. In defense of the law, the American Academy of Pediatrics and 21 other health organizations, including the American Medical Association, filed a court brief in support of Wyeth/Pfizer in July 2010.

The 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," said AAP President O. Marion Burton, MD.