Vaccine manufacturers immunized against certain kinds of claims - KOTA Territory News

Vaccine manufacturers immunized against certain kinds of claims


Gary Jensen
Beardsley, Jensen and Von Wald

Congress immunized vaccine manufacturers against certain kinds of claims, according to the United States Supreme Court.

Hannah  Bruesewitz was six months old when she was given a DTP vaccine manufactured by Lederle (later acquired by Wyeth).  Within 24 months, she developed a residual seizure disorder and was developmentally delayed.

Hannah's parents sued Wyeth in the Court of Federal Claims in accordance with a special procedure required by the National Childhood Vaccine Injury Act of 1986.  The special master rejected their claim.  Hannah's parents then filed suit in state court and Wyeth removed it to federal court.

The federal district court granted summary judgment in favor of Wyeth ("threw the case out of court"), holding that their state-law strict liability and negligent design claims were preempted by the NCVIA, which provides: 

… [n]o vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1998, 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.

The Third Circuit Court of Appeals affirmed the dismissal; Hannah's parents appealed to the United States Supreme Court.

The United State Supreme Court affirmed the lower courts' rulings in a 6-2 decision, holding that as long as the vaccine was ‘properly prepared and was accompanied by proper directions and warnings," any side effects are deemed to have been ‘unavoidable" and therefore not actionable because of NCVIA.

Is it "good" public policy to immunize vaccine manufacturers from certain claims?  Does it encourage the development of helpful and safe vaccines or does it remove the incentive from the manufacturer to develop "safe" vaccines?  Good questions upon which reasonable people can disagree. 

The court system in Hannah's case worked from the public policy and language of NCVIA passed by Congress.  While others may debate the wisdom of the public policy, the courts cannot.  The court is required to follow the public policy and language of the legislative body unless there's a fundamental flaw such as a constitutional violation. 

You can read more at Bruesewitz v. Wyeth LLC, No. 09-152.

E-mail Gary is intended as general information on legal issues affecting us all.  This information should not be relied upon in any particular case and should never be used in lieu of consulting with an attorney.


1.      You see yet another car accident at a spot where there have been many accidents in the past and will be more accidents in the future? 


2.      You learn another person is hurt using a machine that has injured others in the past and will injure others in the future? 


3.      You watch a dangerous practice – like where a school bus parks – you know is a disaster waiting to happen?  


What should you do? 


Try to prevent the next accident, injury, and catastrophe from happening. 


How can you do that? 


Send a letter or email to those responsible – the highway department, the owner and operator of the machine, the school district - putting them on notice of the danger.


Your letter or email will either prompt a "fix" or help the next innocent victim establish liability against those who failed to act.   


Taking a few minutes to write a letter or email can have a huge impact; you can be a difference maker. 

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