Congress passed the 1986 National Childhood Vaccine Injury Act (NCVIA) in response to the increase in litigation against manufacturers that had led to shortages of certain vaccines.  In 2011, the Supreme Court held in Bruesewitz that the NCVIA is the sole remedy for claims related to vaccine injuries.  Writing for the majority, Justice Antonin Scalia said: “Provided that there was proper manufacture and warning, any remaining side effects, including those resulting from design defects, are deemed to have been unavoidable.”  This ruling protects manufacturers from design defects and other claims related to vaccines.  Pfizer, a defendant in the case characterized the decision as a win for public health.  But is it really?

The dissent written by Justice Sotomayor rightly pointed out that the ruling “leaves a regulatory vacuum in which no one ensures that vaccine manufacturers adequately take account of scientific and technological advancements when designing or distributing their products.”  If all a manufacturer has to do is properly manufacture and provide warnings to get immunity from lawsuits, what incentive is there to make them safer?  None.  

The NCVIA was passed due to the increase in litigation involving vaccines and to stabilize the vaccine supply.  The act may be well intended, but it overlooks obvious questions.  Was the increase in lawsuits a result of bad products?  What evidence is there that the NCVIA improves vaccine safety?  Finally, if the NCVIA is working and If vaccines are so safe, why is government immunity necessary? 

Manufacturers pay just $.75 a dose into the fund for vaccine injuries.  Spending billions in research and development to improve vaccine safety  is difficult to justify when this "$.75 insurance policy" exists.  In the majority's opinion, there is an admission that side effects are unavoidable.  But would they be unavoidable if there was a market incentive to make the vaccines safer or remove ones that cannot be made safe from the market?  

The vaccine injury fund has paid out over $2B in damages to those harmed by vaccines, but where is the evidence that the vaccines were made safer? Conversely, as a result of silicone breast implants being found responsible for health issues, Dow paid over $2B into an fund  for those injured and removed the product from the market.  Safer breast implants came to market because there was an incentive to make the product safer, which does not exist with vaccines.