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

Legal update 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 [email protected]; Jim can be contacted at [email protected].



Meredith DiLiberto

This needs to be challenged head-on for what it is: an unconstitutional restriction. Make it a constitutional issue and you change the "mood" on the Court.

Kathy Blanco

My son was a definate DPT injury type of kid, today at twenty eight, he has seizures, mito problems, and a multitude of health problems, including autism. Eleven days after his DPT shot he suffered high pitch screaming, convulsions, and was essentially paralyzed by DPT for a week. He was never the same. Big pharma reduced teh windo of injury, but on medline, you can react to DPT up to thirty days. These people know exactly what they are doing. I wouldn't want to be them at judegment day...I may not get what is coming to me in this life, but they will in the next...


the Ferrari family decided to voluntarily withdraw their claim at the trial court level without prejudice

As with many lawsuits, is there not a possibility, that this was quietly settled out of court for an undisclosed sum, therefor, silencing the Ferrari's?

Harry H.

When we have a majority on the supreme court that believes corporations have the same or even more rights than people, we can predict the outcome. The other major consideration is that governemnts all over the world will protect the "vaccine program" at ALL costs. I will be surprised only if the outcome is less than unanimous in favor of the manufacturers.

Theresa Cedillo

Thank you Mary and Jim for the update.


As I may or may not have stated on this very blogg do not look for Obama to be of any assistance AT ALL. Even if Barack felt we were right, and we are, he simply does not have the courage to stand up and do the right thing. The only thing that we may have in our favor is that Obama was pubilicy critical of the supreme court and they are now pissed at him so they may be more prepared to be critical of the pharmaceutical blanket prodouct liability indemnity conjured up by congress.

Should the supreme court rule in their favor we should not even blink but continue, undaunted as it were, and without qualm or trepidation on our path of to truth and justice. We have to make that clear to people even before they rule that we wil not be cowed or deterred by any ruling by any court. Papers like that by Thorenson that are clearly unreliable must be foist upon the court as a clear example of the kind of fraudulent garbage being used to sell and force these unsafe biological prodoucts on an unwitting and trusting public that has been decieved at all levels by the vaccine makers and their minions, included of course is the vaccine court that has been not only unfair to the public but acts as a legal arm of the very people they are to be judging.

Kevin Barry

Thank you Mary and Jim!

michael framson

To omnibusted: I think another industry which has this type of blanket immunity is nuclear power plants.

Yes, Pharma, AMA, AAP there is a Santa Claus and its called the Supreme Court. "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."

I never heard one word from the Obama campaign that would have lead me to believe, "a new perspective," might emerge. And even if McCain would have been elected, who did utter a few words which offered some a sense of encouragement, McCain would be no match for the PHARMA, AMA, AAP MEDIA FULL COURT PRESS we are witnessing.

Pharma, AMA, AAP will be dancing on the graves of injured children after the Supreme Court renders its all but certain decision. Simultaneously, all pharma stocks will experience one hell of gain.

Cliff Shoemaker mentions how the table of vaccine injuries has been eviscerated. The only thing left was for the Supreme Court to slam the door and weld it shut.


The vaccine court. I hate to even see the articles written about them. Such injustice, no justice, miscarriage of justice. It is like living in an imperalist country.

What is worse: people who knowingly harm an increasing amount of (still a small percent) of children but do not care, and makes no effort to figure out why and who they are; or people who allows victims to suffer continously as their disabiltiy will lead to proverty and the guilty to go scott free.

Autism Grandma

As long as the Vaccine Kangaroo Court is the only option for pursuing compensation for vaccine injuries, there will never be any motivation for the vaccine industry to make any efforts at improving vaccine safety. As long as they have no financial responsibility for their actions, they are carrying a legally approved hunting license so it's open season on our deer children. They will just continue to crank out more vaccines with more heavy metals and toxins and they will keep poisoning innocent children into oblivion.


So far we are being abandoned by the majority of media, government, and mainstream medicine. It seems that (with rare exceptions) the only people who see a problem (or at least who admit to seeing a problem) are those whose families are directly affected. If the Supreme Court abandons us as well it will be a great tragedy. But if the vaccine program continues as is, more and more families will be affected, so this controversy will continue to grow, not end, in spite of all the powerful efforts to put a lid on it.


Anyone else boycot pharma and peds today? One day at a time...



Randy, I think the Toyota analogy cannot be overstated. The drama plays out daily as new wrinkles are revealed, forcing consumers to question whose interests are being served by automakers and regulators.

We can manufacture a little doubt of our own.


I think (call me crazy) that once a person's right to pursue claim is effectively removed once and for all, and ALL the risk is laid on our kids, maybe we won't wanna run so fast to get that next flu shot.

If the courts wouldn't let me touch Toyota, I ain't buyin' another Toyota. Doesn't mean all Toyota's are unsafe. I actually like some of the Toyotas. But make the industry untouchable and I walk. I don't really like the prospect of being left to rot on the side of the road when the ride hits the rocks. Even if it's not "likely". I demand accountability. And I might find the walk is a better way to get where I'm going anyway.

Apologies for another beat-to-death Toyota analogy...

Theodore M. Van Oosbree

What's easier - hitting a home run off Nolan Ryan or getting a favorable judgment in vaccine court? You guessed it.


Gee I wonder if this has anything to do with the O.A.P.theory two test case decisions taking so long- Somebody waiting to see what the supreme court says first?? us crazy parents can only quess-


Great article! Vaccine Court is such a farce! You would think it was modeled on the courts of Iran or North Korea!

Change needs to come! And perhaps this fall will bring change. Unfortunately, I'm not going to hold my breath.


Can`t print what i would like to print concerning pharma but the first word starts with f ends with k and the 2nd word is Em!

L.O.L. GOOD LUCK fingers crossed



The problem is, this is a very pro-business stacked Supreme Court.


please post a copy of this link to
Big Noise Films
[email protected]


Wow, sounds like a bad dream come true for big pharma. To face vaccine injured children in court possibly with a jury. No longer able to hide behind the sham that is the vicp. What other consumer product enjoys this LIEabilty protection? If vaccines are so safe and effective, why do they need this much protection?

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