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Vaccine Act

American Home Products Corp. v. Ferrari, 131 S.Ct. 1567 (2011)

668 S.E.2d 236 (Ga. 2008)

Issue

The issue in this case is whether the National Childhood Vaccine Injury Act preempts design defect claims asserted against a vaccine manufacturer.

AMA interest

The AMA believes that, in order to preserve the viability of vaccine manufacture, patients who claim injuries from vaccines should recover any damages through the National Vaccine Injury Compensation Program, rather than through common law tort claims.

Case summary

Marcelo and Carolyn Ferrari sued several vaccine manufacturers in a Georgia state court, alleging that their son had suffered neurological damage caused by vaccines made with the preservative thimerosal, which contained the toxic chemical mercury.  They claimed that the vaccine had been designed defectively, and they asserted claims under Georgia common law, based on strict liability and negligence.

The trial court granted partial summary judgment in favor of the drug manufacturers, ruling that the National Childhood Vaccine Injury Act, 42 USC §§ 300aa-1, et. seq., preempted the Ferraris’ claims.  However, the Georgia Court of Appeals reversed, and the Georgia Supreme Court affirmed the Court of Appeals, thus reinstating the Ferraris’ case.  They held that the Vaccine Act preempts certain types of claims based on defects in vaccine design, but the determination of whether the Ferraris’ claims were of this nature would require a trial.

The vaccine manufacturers then petitioned the United States Supreme Court for certiorari.  The Supreme Court granted certiorari, reversed the decision of the Georgia Supreme Court, and remanded for further proceedings consistent with its ruling in Bruesewitz v. Wyeth.

AMA involvement

The AMA, along with the American Academy of Pediatrics and several other medical societies, filed an amicus curiae brief to support the vaccine manufacturers’ certiorari petition.

United States Supreme Court brief.

Bruesewitz v. Wyeth, 131 S.Ct. 1068 (2011)

Issue

The issue in this case is whether the National Childhood Vaccine Injury Act preempts design defect claims asserted against a vaccine manufacturer.

AMA interest

The AMA believes that, in order to preserve the viability of vaccine manufacture,  patients who claim injuries from vaccines should recover any damages through the National Vaccine Injury Compensation Program, rather than through common law tort claims.

Case summary

Hannah Bruesewitz received a diphtheria-pertussis-tetanus vaccine as part of a five shot regimen.  After receiving her third shot, she suffered a seizure and was diagnosed with residual seizure disorder and developmental delay.  An investigation revealed that Hannah’s vaccine had come from a lot that had generated 65 reports to the Centers for Disease Control and the Food and Drug Administration of adverse reactions.  Her physician later indicated that she would not have immunized Hannah if she had known of the adverse reaction reports associated with this lot of vaccine.

Hannah’s parents, representing her, filed a petition in the Vaccine Court, a special tribunal designated to hear claims arising from injuries related to the administration of vaccines.  The petition was dismissed, based in part on a finding that Hannah had not proven that the vaccine had caused her injuries.

The Vaccine Act, 42 USC §§300aa-1, et seq., allows a petitioner to reject the judgment of the Vaccine Court in certain instances and pursue claims in state or federal court.  Hannah rejected the decision of the Vaccine Court and brought suit against Wyeth, the manufacturer of the vaccine, in federal court in Philadelphia, Pennsylvania.  The trial court granted summary judgment in favor of Wyeth.  Hannah then appealed to the United States Court of Appeals.

The Court of Appeals held that the Vaccine Act preempted Hannah’s design defect claims.  Thus, it held, these claims could not be pursued outside the Vaccine Court.  It affirmed the summary judgment of the trial court.  Hannah then appealed to the United States Supreme Court.  The Supreme Court affirmed the Court of Appeals, holding that the Vaccine Act preempted Hannah's lawsuit.

AMA involvement

The AMA, along with the American Academy of Pediatrics and several other medical societies, filed an amicus curiae brief to support Wyeth.

United States Supreme Court brief.