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

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

7 

Opinion of the Court 

II 

A 

We set forth again the statutory text at issue: 

“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 ac-
companied by proper directions and warnings.”34 

The “even though” clause clarifies the word that precedes
it.  It delineates the preventative measures that a vaccine 
manufacturer must have taken for a side-effect to be con-
sidered  “unavoidable”  under  the  statute.    Provided  that 
there  was  proper  manufacture  and  warning,  any  remain-
ing  side  effects,  including  those  resulting  from  design
defects,  are  deemed  to  have  been  unavoidable.    State-law 
design-defect claims are therefore preempted. 

If a manufacturer could be held liable for failure to use a 
different  design,  the  word  “unavoidable”  would  do  no 
work.  A  side  effect  of  a  vaccine  could  always  have  been 
avoidable  by  use  of  a  differently  designed  vaccine  not 
containing  the  harmful  element.  The  language  of  the
provision thus suggests that the design of the vaccine is a 
given, not subject to question in the tort action.  What the 
statute  establishes  as  a  complete  defense  must  be  un-
avoidability  (given  safe  manufacture  and  warning)  with 
respect  to  the  particular  design.  Which  plainly  implies
that the design itself is not open to question.35 

—————— 

34 42 U. S. C. §300aa–22(b)(1). 
35 The  dissent  advocates  for  another  possibility:    “[A]  side  effect  is 
‘unavoidable’  . . .  where  there  is  no  feasible  alternative  design  that 
would eliminate the side effect of the vaccine without compromising its 
cost  and  utility.”    Post,  at  15  (opinion  of  SOTOMAYOR, J.).    The  dissent 
makes no effort to ground that position  in the text of §300aa–22(b)(1).