Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 24

2 

BRUESEWITZ v. WYETH LLC 

BREYER, J., concurring 

compensation system, not the tort system.”  H. R. Rep.
No.  99–908,  pt. 1,  p.  24  (1986)  (hereinafter  H. R.
Rep.). 

The  Report  lists  two  specific  kinds  of  tort  suits  that  the 
clause does not pre-empt (suits based on improper manu-
facturing  and  improper  labeling),  while  going  on  to  state 
that compensation for other tort claims, e.g., design-defect
claims,  lies  in  “the  [NCVIA’s  no-fault]  compensation  sys-
tem, not the tort system.”  Ibid. 

The  strongest  contrary  argument  rests  upon  the  Re-
port’s  earlier  description  of  the  statute  as  “set[ting]  forth
the  principle  contained  in  Comment  k”  (of  the  Restate-
ment Second of Torts’ strict liability section, 402A) that “a
vaccine  manufacturer  should  not  be  liable  for  injuries  or 
deaths resulting from unavoidable side effects.”  Id., at 23 
(emphasis  added).    But  the  appearance  of  the  word  “un-
avoidable” in this last-mentioned sentence cannot provide 
petitioners  with  much  help.    That  is  because  nothing  in
the  Report  suggests  that  the  statute  means  the  word 
“unavoidable”  to  summon  up  an  otherwise  unmentioned 
third  exception  encompassing  suits  based  on  design  de-
fects.  Nor can the Report’s reference to comment k fill the 
gap.  The  Report  itself  refers,  not  to  comment  k’s  details, 
but  only  to  its  “principle,”  namely,  that  vaccine  manufac-
turers  should  not  be  held  liable  for  unavoidable  injuries.
It  says  nothing  at  all  about  who—judge,  jury,  or  federal
safety  agency—should  decide  whether  a  safer  vaccine 
could  have  been  designed.    Indeed,  at  the  time  Congress
wrote this Report, different state courts had come to very
different  conclusions  about  that  matter.  See  Cupp,  Re-
thinking  Conscious  Design  Liability  for  Prescription 
Drugs: The Restatement (Third) Standard Versus a Negli-
gence Approach, 63 Geo. Wash. L. Rev. 76, 79 (1994–1995) 
(“[C]ourts [had] adopted a broad range of conflicting inter-
pretations”  of  comment  k).    Neither  the  word  “unavoid-