The Supreme Court Takes Bruesewitz v. Wyeth: Is There Justice for Vaccine Injury Victims?

By Mary Holland, Esq. and Jim Moody, Esq.

On March 8, the Supreme Court voted to hear Bruesewitz v. Wyeth, an appeal from the Third Circuit Court of Appeals.  The Supreme Court will decide whether a vaccine-injured child has the right to pursue a traditional "design defect" claim under state tort law when "Vaccine Court" refuses compensation.  The Supreme Court must interpret the 1986 National Childhood Vaccine Injury Act and decide whether Congress intended to "preempt" all industry tort liability when it wrote, “No vaccine manufacturer shall be liable…if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”

Did Congress intend to extinguish the right to sue for all defective vaccine designs in civil court?  While the statutory language is awkward and thus somewhat opaque, Congress’s legislative intent was not – the statute as a whole shows clearly that Congress intended to leave civil courthouse doors open for petitioners who elect to leave Vaccine Court to sue for design defects.  Lower courts, nonetheless, have decided the question both ways.  So the Supreme Court must step in and resolve the conflict.  The stakes are high: whether a person injured by a vaccine can challenge the safety of the design in any court in the United States.

A three judge panel of the Third Circuit unanimously decided in March 2009 that petitioner Hannah Bruesewitz did not have the right to sue vaccine manufacturer Wyeth, Inc. to assert that its vaccine design was unsafe.  [See Bruesewitz-Decision]  Hannah was born in October, 1991, and received her third DPT shot on schedule on April 1, 1992.  Shortly thereafter she developed "residual seizure disorder," recognized as a Table Injury at the time, meaning that causation was presumed.  "Residual seizure disorder" was deleted from the Table just one month before she filed her case.  Finally, on December 20, 2002, more than ten years later, Vaccine Court categorically rejected her claim.  This hardly complies with Congress’ promise in the 1986 NCVIA that awards be “made to vaccine-injured persons quickly, easily, and with certainty and generosity.”  The Bruesewitz family argues that the safer acellular DTaP vaccine was long available by the time Hannah received the DPT and suffered seizures, and that her vaccine injury was avoidable had the manufacturer used this demonstrably safer vaccine design.

Before Bruesewitz, in October 2008, the Supreme Court of Georgia came out in the exact opposite way in Ferrari v. American Home Products, Inc.  That nine member court decided unanimously that petitioners could pursue their claim for a vaccine design defect in state civil court.  [See Ferrari decision]  The Ferrari family alleged that the mercury-containing preservative in his childhood vaccines, thimerosal, contributed to his autism.  AoA discussed the Ferrari decision HERE. 

In a recent development, the Ferrari family decided to voluntarily withdraw their claim at the trial court level without prejudice – in other words, the family decided that now is not the most auspicious time to continue the lawsuit, for whatever reason.  Most commentators, although not all, believe that the Ferraris could reopen their lawsuit later, if they chose to, while the child is still a minor.  So, while Bruesewitz and Ferrari interpret the 1986 statute in diametrically opposite ways, the Supreme Court has decided to hear the Bruesewitz case as the vehicle to resolve the conflict.

The significance of the Bruesewitz case relates to all vaccine injury – it goes to the heart of whether Vaccine Court is fulfilling the role Congress set for it, and whether it is possible to challenge the design safety of a vaccine in any court in the United States.  For the autism community, the case could not be more central – it will determine whether the 5,000 petitioners in the Omnibus Autism Proceeding can continue their claims in state and federal courts if Vaccine Court ultimately dismisses their claims.

This will be the first major vaccine case that the Supreme Court in over fifteen years.  It follows in a line of cases about federal preemption – or which law prevails when state and federal law conflict.  In the most recent case in this line, Wyeth v. Levine, the Supreme Court decided 6-3 in favor of a drug-injured plaintiff from Vermont and against Wyeth’s claim that federal Food and Drug Administration approval of the drug trumped state tort law.

Many “friends” of the Supreme Court submitted briefs to urge the Supreme Court to resolve this conflict on interpretation of the 1986 law.  The American Medical Association and the American Academy of Pediatrics, with other medical organizations, took a position firmly in favor of Wyeth and the pharmaceutical industry.  [See Amicus Brief] We submitted a brief on behalf of many civil society organizations, [NVIC et al Bruesewitz amicus ] including the National Vaccine Information Center, Autism One, the National Autism Association, the Coalition for Safe Minds, among others, firmly supporting vaccine-injured petitioners’ rights to bring design defect claims to civil court.  In addition to these organizations, parent advocates who helped to draft the 1986 law signed the petition individually, arguing that recourse to civil court is what Congress intended and what is essential for vaccine safety.

In light of these differing decisions, the Supreme Court requested the Department of Justice to weigh in on this matter.  After many months, in February, the Obama Administration Department of Justice submitted a brief – strongly in favor of the pharmaceutical industry’s position [DOJ Ferrari amicus].   To those who thought that President Obama might offer a new perspective on vaccine injury and autism, as the President suggested on the campaign trail, this brief was a crushing disappointment.  It is, however, quite consistent with the Department of Justice’s positions on behalf of Health and Human Services in the Court of Federal Claims.

If the Supreme Court upholds Bruesewitz, it will basically achieve what the pharmaceutical industry and the American Medical Association wanted in 1986 and since – that so-called vaccine court is the “exclusive remedy” for cases of vaccine injury.  They seek this “exclusive remedy” although it is anything but – vaccine court fails those whom vaccines injure.  [See article on vaccine court by Mary Holland] While compulsory vaccine mandates without corporate accountability may be an appealing business model to industry, the risks to the public are unacceptable.  As the Georgia Supreme Court wrote in Ferrari,

We hesitate to hold that a manufacturer is excused from making changes it knows will improve its product merely because an older, more dangerous version received FDA approval….[To do so] “would ‘have the perverse effect of granting complete [tort] immunity from design defect liability to an entire industry.’”  284 Ga. 384, 394 (citations omitted).

The Supreme Court will hear oral arguments in Bruesewitz in the fall.  It will be critically important that not only the communities for informed consent to vaccination and autism advocacy weigh in, but other well-respected parts of civil society on the front lines of the vaccine safety issue.  Retired military leaders, healthcare workers, teachers’ unions and other first responders will need to take a stand that vaccine safety requires recourse to civil court, as Congress intended.  Only by ensuring that vaccine designs are as safe as reasonably possible and by ensuring access to justice in the event of injury will parents and individuals comply with vaccine mandates.

Mary Holland, Esq. and Jim Moody, Esq. are counsel for the amici curiae National Vaccine Information Center, its co-founders and 11 other organizations in support of petitioners in Bruesewitz v. Wyeth.  They are co-founders of the Elizabeth Birt Center for Autism Law and Advocacy.  Mary can be contacted at; Jim can be contacted at