AAFP Joins AAP, Others in Urging Review of Vaccine Injury Decision
Georgia Supreme Court Ruling Challenges National Childhood Vaccine Injury Act
By David Mitchell
4/15/2009
The AAFP has endorsed an "amici curiae" (friends of the court) brief supporting review of a Georgia Supreme Court ruling that threatens to undermine the National Childhood Vaccine Injury Act of 1986. The American Academy of Pediatrics, or AAP, filed the brief with the U.S. Supreme Court in support of a petition for a writ of "certiorari" (judicial review) from vaccine manufacturers Wyeth and GlaxoSmithKline.
Last October, the Georgia high court ruled in American Home Products Corp. v. Ferrari (20-page PDF; About PDFs) that Marcelo and Carolyn Ferrari's civil lawsuit against Wyeth and GlaxoSmithKline on behalf of their son is not barred by the terms of the National Childhood Vaccine Injury Act.
This 1986 federal vaccine law sought to ensure a stable and adequate national vaccine supply and to provide fair and timely compensation to children injured by vaccines by establishing the National Vaccine Injury Compensation Program. In this standardized program, judicial special masters administer a no-fault compensation system through the U.S. Court of Federal Claims. Federal and state judges have consistently ruled that civil suits are pre-empted by the vaccine injury act and the associated compensation program.
In fact, according to the AAP brief, as recently as last month, the Third U.S. Circuit Court of Appeals ruled in Bruesewitz v. Wyeth Home Products Corp. that the National Childhood Vaccine Injury Act expressly pre-empts "all design defect claims, including those based on negligence."
The Ferrari lawsuit, which alleged both strict liability and negligence, claimed that the vaccine makers named as defendants in the suit could have and should have manufactured childhood vaccines without thimerosal.
A Georgia trial court ruled against the Ferraris in 2005, finding that the vaccine act preempted the plaintiffs' design defect and other claims. The Georgia Court of Appeals, however, overturned that ruling in 2007, and the Georgia Supreme Court upheld the reversal last year. In its ruling, the Georgia high court said plaintiffs are entitled to a determination as to whether a vaccine's side effects were unavoidable before the federal law's preemption is applied.
According to the AAP brief, if the Georgia ruling stands, vaccine manufacturers would have to defend their products on a case-by-case basis in state courts, which threatens to create a situation similar to what existed before the creation of the National Vaccine Injury Compensation Program.
Nearly 300 vaccine injury lawsuits against seven vaccine manufacturers were filed between January 1980 and March 1985, says the brief. This drove some manufacturers out of the U.S. market because of concerns about increasing litigation and insurance costs; other manufacturers halted development of new vaccines.
If other states follow the Georgia precedent, the AAP said, that could lead to reduced immunization rates and a resurgence of preventable diseases.
The AAFP agreed, saying in a statement that all children and adults should have access to all immunizations recommended by the Academy.
"A return to the chaotic environment that preceded the enactment of the National Childhood Vaccine Injury Act by Congress could dissuade pharmaceutical manufacturers from producing vaccines and researching new technologies, making it difficult to maintain vaccine supplies and compromising the nation’s public health efforts," the AAFP said.
Several other medical organizations and groups have signed on to the amici brief. They are
This 1986 federal vaccine law sought to ensure a stable and adequate national vaccine supply and to provide fair and timely compensation to children injured by vaccines by establishing the National Vaccine Injury Compensation Program. In this standardized program, judicial special masters administer a no-fault compensation system through the U.S. Court of Federal Claims. Federal and state judges have consistently ruled that civil suits are pre-empted by the vaccine injury act and the associated compensation program.
In fact, according to the AAP brief, as recently as last month, the Third U.S. Circuit Court of Appeals ruled in Bruesewitz v. Wyeth Home Products Corp. that the National Childhood Vaccine Injury Act expressly pre-empts "all design defect claims, including those based on negligence."
The Ferrari lawsuit, which alleged both strict liability and negligence, claimed that the vaccine makers named as defendants in the suit could have and should have manufactured childhood vaccines without thimerosal.
A Georgia trial court ruled against the Ferraris in 2005, finding that the vaccine act preempted the plaintiffs' design defect and other claims. The Georgia Court of Appeals, however, overturned that ruling in 2007, and the Georgia Supreme Court upheld the reversal last year. In its ruling, the Georgia high court said plaintiffs are entitled to a determination as to whether a vaccine's side effects were unavoidable before the federal law's preemption is applied.
According to the AAP brief, if the Georgia ruling stands, vaccine manufacturers would have to defend their products on a case-by-case basis in state courts, which threatens to create a situation similar to what existed before the creation of the National Vaccine Injury Compensation Program.
Nearly 300 vaccine injury lawsuits against seven vaccine manufacturers were filed between January 1980 and March 1985, says the brief. This drove some manufacturers out of the U.S. market because of concerns about increasing litigation and insurance costs; other manufacturers halted development of new vaccines.
If other states follow the Georgia precedent, the AAP said, that could lead to reduced immunization rates and a resurgence of preventable diseases.
The AAFP agreed, saying in a statement that all children and adults should have access to all immunizations recommended by the Academy.
"A return to the chaotic environment that preceded the enactment of the National Childhood Vaccine Injury Act by Congress could dissuade pharmaceutical manufacturers from producing vaccines and researching new technologies, making it difficult to maintain vaccine supplies and compromising the nation’s public health efforts," the AAFP said.
Several other medical organizations and groups have signed on to the amici brief. They are
- the American Medical Association,
- Association of State and Territorial Health Officials,
- the Vaccine Education Center at Children's Hospital of Philadelphia,
- the American College of Osteopathic Pediatricians,
- American Public Health Association,
- the Immunization Action Coalition,
- the Infectious Diseases Society of America,
- the Section of Infectious Disease of the American Academy of Pediatrics,
- the National Foundation for Infectious Diseases, and
- Every Child By Two.
According to various news outlets and legal blogs that have been following the Ferrari case, the fact that the federal circuit court ruling in the Bruesewitz case is directly at odds with the ruling handed down by the Georgia high court in the Ferrari case is likely to prompt consideration of the case by the U.S. Supreme Court.
Attorneys for GlaxoSmithKline and Wyeth confirmed that the manufacturers filed petitions for review with the Supreme Court on March 5 and expect to hear whether the court will hear an appeal by the second week in May.
Attorneys for GlaxoSmithKline and Wyeth confirmed that the manufacturers filed petitions for review with the Supreme Court on March 5 and expect to hear whether the court will hear an appeal by the second week in May.
