AAFP Joins AAP, Others in Urging Supreme Court to Protect Vaccine Injury Compensation Program

Wyeth Says Ruling Against Manufacturer Would Lead to 'Flood of Civil Actions'

August 18, 2010 05:25 pm News Staff

The AAFP has signed on to an amicus curiae (friend-of-the-court) brief(www.abanet.org) in a case pending before the U.S. Supreme Court that could affect the future of vaccine injury compensation.

The Academy is one of more than 20 medical organizations that signed on to the brief filed July 30 by the American Academy of Pediatrics in Bruesewitz v. Wyeth Inc. The brief urges the Supreme Court to confirm that the National Childhood Vaccine Injury Compensation Act of 1986 preempts all design defect claims against vaccine manufacturers.

The brief points out that before the 1986 law created the Vaccine Injury Compensation Program, manufacturers were overwhelmed with lawsuits, and rising litigation and insurance costs were becoming threats to vaccine development and production.

The act also created the Office of Special Masters within the U.S. Court of Federal Claims, commonly referred to as "Vaccine Court." The brief said the no-fault court has prevented manufacturers from leaving the vaccine market while providing an alternative litigation process that has resulted in more than 2,400 awards to plaintiffs totaling nearly $2 billion since 1989.

The case in question has been in the legal system for 15 years. Hannah Bruesewitz was diagnosed with residual seizure disorder and developmental delay after receiving the third dose of Wyeth's diphtheria, pertussis and tetanus vaccine, which was marketed as Tri-Immunol, as a 6-month-old in 1992.

According to court documents(www.ca3.uscourts.gov), the vaccine Bruesewitz received came from a lot linked to 65 adverse events reported to the FDA and the CDC, including 39 emergency room visits, six hospitalizations and two deaths.

Wyeth pulled Tri-Immunol from the market in 1998.

The Bruesewitz family filed a petition in the Vaccine Court in 1995, alleging that Hannah suffered vaccine-related residual seizure disorder and encephalopathy, but the court dismissed the claim with prejudice in 2002.

The family then filed a complaint in the Court of Common Pleas of Philadelphia County in 2005, which, in August 2007, led to a summary judgment in Wyeth's favor in the U.S. District Court for the Eastern District of Pennsylvania.

In September 2008, the U.S. Court Of Appeals for the Third Circuit affirmed the district court ruling, saying that the plaintiffs' claims were preempted by the vaccine act and the plaintiffs had failed to establish a manufacturing defect or a warning defect claim.

The U.S. Supreme Court has agreed to hear the case and is expected to hear arguments this fall.

Wyeth wrote in its Supreme Court brief(www.abanet.org) that if the court holds that the vaccine act does not preempt design defect claims, "claimants in the omnibus (autism) proceeding could be emboldened to pursue a flood of civil actions."