Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 27

Cite as:  562 U. S. ____ (2011) 

5 

BREYER, J., concurring 

ages,  and,  in  turn,  increasing  numbers  of  unimmunized 
children,  and,  perhaps,  a  resurgence  of  preventable  dis-
eases.”  H. R.  Rep.,  at  5.    At  the  same  time,  Congress 
sought  to  provide  generous  compensation  to  those  whom
vaccines  injured—as  determined  by  an  expert  compensa-
tion program.  Id., at 5, 24. 

Given  these  broad  general  purposes,  to  read  the  pre-
emption  clause  as  preserving  design-defect  suits  seems 
anomalous.
  The  Department  of  Health  and  Human 
Services  (HHS)  decides  when  a  vaccine  is  safe  enough  to
be  licensed  and  which  licensed  vaccines,  with  which 
associated  injuries,  should  be  placed  on  the  Vaccine  In- 
jury  Table. 
42  U. S. C.  §300aa–14;  ante,  at  3–4;  A 
Comprehensive  Review  of  Federal  Vaccine  Safety  Pro-
grams  and  Public  Health  Activities  13–15,  32–34 
(Dec.  2008),  http://www.hhs.gov/nvpo/nvac/documents/
vaccine-safety-review.pdf.  A  special  master  in  the  Act’s 
compensation  program  determines  whether  someone  has
suffered  an  injury  listed  on  the  Injury  Table  and,  if  not, 
whether the vaccine nonetheless caused the injury.  Ante, 
at  3–4;  §300aa–13.  To  allow  a  jury  in  effect  to  second-
guess those determinations is to substitute less expert for
more expert judgment, thereby threatening manufacturers 
with  liability  (indeed,  strict  liability)  in  instances  where 
any conflict between experts and nonexperts is likely to be
particularly  severe—instances  where  Congress  intended
the contrary.  That is because potential tort plaintiffs are 
unlikely to bring suit unless the specialized compensation 
program  has  determined  that  they  are  not  entitled  to
compensation  (say,  because  it  concludes  that  the  vaccine 
did  not  cause  the  injury).    Brief  for  United  States  as 
Amicus  Curiae  28  (“99.8%  of  successful  Compensation
Program  claimants  have  accepted  their  awards,  foregoing 
any  tort  remedies  against  vaccine  manufacturers”).    It  is 
difficult  to  reconcile  these  potential  conflicts  and  the  re-
sulting tort liabilities with a statute that seeks to diminish