Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 31

2 

BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

I 

A 

Section  22  of  the  Vaccine  Act  provides  “[s]tandards  of
responsibility”  to  govern  civil  actions  against  vaccine
manufacturers.  42 U. S. C. §300aa–22.  Section 22(a) sets 
forth  the  “[g]eneral  rule”  that  “State  law  shall  apply  to  a
civil  action  brought  for  damages  for  a  vaccine-related
injury  or  death.”    §300aa–22(a).  This  baseline  rule  that 
state law applies is subject to three narrow exceptions, one 
of which, §22(b)(1), is at issue in this case.  Section 22(b)(1)
provides: 

“No vaccine manufacturer shall be liable in a civil ac-
tion for damages arising from a vaccine-related injury
or  death  associated  with  the  administration  of  a  vac-
cine  after  October  1,  1988,  if  the  injury  or  death  re-
sulted  from  side  effects  that  were  unavoidable  even 
though  the  vaccine  was  properly  prepared  and  was 
accompanied  by  proper  directions  and  warnings.” 
§300aa–22(b)(1). 

The  provision  contains  two  key  clauses:  “if  the  injury  or
death  resulted  from  side  effects  that  were  unavoidable” 
(the  “if ”  clause),  and  “even  though  the  vaccine  was  prop-
erly  prepared  and  was  accompanied  by  proper  directions
and warnings” (the “even though” clause). 

Blackletter  products  liability  law  generally  recognizes
three  different  types  of  product  defects:  design  defects, 
manufacturing defects, and labeling defects (e.g., failure to 
warn).1    The  reference  in  the  “even  though”  clause  to  a 
“properly prepared” vaccine “accompanied by proper direc-
tions  and  warnings”  is  an  obvious  reference  to  two  such 
defects—manufacturing  and  labeling  defects.    The  plain
terms  of  the  “even  though”  clause  thus  indicate  that 

—————— 

1 W. Keeton, D. Dobbs, R. Keeton, & D. Owen, Prosser and Keeton on 

Law of Torts 695 (5th ed. 1984).