Since their widespread development and use over a century ago, childhood vaccines have enjoyed remarkable success, saving countless lives and prolonging the life expectancy of millions of Americans.  As determined by Congress when it enacted the National Childhood Vaccine Injury Act of 1986 (the Vaccine Act), allowing state-court judgments against a vaccine manufacturer based on an alleged design defect would wholly undermine the preservation of a robust childhood vaccine market. Recently, however, the specter of costly state tort litigation against vaccine manufacturers threatened to undermine this important federal law intended to shield manufacturers from such suits.

Yesterday, the U. S. Supreme Court recognized that Congress meant what it said, holding that the Vaccine Act expressly preempts all state-law products liability suits challenging the design of widely administered childhood vaccines, which the Food and Drug Administration (FDA) has already determined to be safe and effective.

In its decision in Bruesewitz v. Wyeth, Inc., the Court sided with WLF, which filed a brief in the case urging affirmance of the decision below. The high court ultimately agreed with WLF that Congress mandated preemption of design defect claims when it adopted the Vaccine Act, which established a national, comprehensive, no-fault compensation program for vaccine-related injuries.

A contrary interpretation would ignore both the unique and vital role vaccines have historically played in safeguarding the public health, as well as the national health emergency that resulted in the 1980s from the very patchwork of state tort liability that the plaintiffs below sought to revive.

The case arose in connection with a lawsuit filed by Russell and Robalee Bruesewitz, who had unsuccessfully petitioned the federal Vaccine Court to compensate their daughter’s alleged injuries, which they claimed were caused by a routine Diphtheria, Tetanus, and Pertussis (DTP) vaccination administered in 1992.  The Vaccine Court dismissed with prejudice the Bruesewitzes’ claims for failure to establish any causal link between the administered DTP vaccine and their daughter’s alleged injuries.  Rather than appeal their dismissal to the Court of Federal Claims, the Bruesewitzes rejected the judgment of the Vaccine Court and filed a products liability suit against Wyeth, the vaccine’s manufacturer.

The district court granted judgment for Wyeth, holding that Section 22(b)(1) of the Vaccine Act expressly preempts all design defect claims arising from a vaccine-related injury.  Section 22(b)(1) provides that “[n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death . . . if the injury or death resulted from side effects that were unavoidable.”  The U.S. Court of Appeals for the Third Circuit affirmed that decision.  The U.S. Supreme Court agreed.

In its brief urging affirmance, WLF argued that the Vaccine Act was passed in the midst of a national crisis of out-of-control costs and vaccine shortages caused by an explosion in state tort litigation against vaccine manufacturers.  By providing a comprehensive, no-fault compensation regime to address vaccine-relate injuries, Congress sought to protect vaccine manufacturers from the same kind of burdensome litigation that previously drove so many vaccine manufacturers from the market.  Allowing a disappointed vaccine claimant who lost in Vaccine Court to then seek compensation for design defects via civil tort litigation would exacerbate, not ameliorate, the costly burden of litigation that initially prompted Congress to pass the Vaccine Act, WLF argued.

It is important to emphasize that the position advanced by WLF and adopted by the high court does not leave injured vaccine recipients without remedies.  For example, they are still free to pursue other, non-preempted claims against the manufacturer, such as a claim that the vaccine was manufactured negligently (i.e., not in conformance with the FDA-approved design), or that the manufacturer failed to accompany the vaccine with proper directions and warnings.  Alternatively, they can also pursue remedies against others who may be responsible for their injuries, such as the administering physician.