Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 12.0

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

9 

Opinion of the Court 

others  are  avoidable.”38   That  is  not  so.  The  “if ”  clause 
makes  total  sense  whether  the  design  to  which  “unavoid-
able” refers is (as the dissent believes) any feasible design
(making the side effects of the design used for the vaccine 
at issue avoidable), or (as we believe) the particular design 
used  for  the  vaccine  at  issue  (making  its  side  effects  un-
avoidable).  Under  the  latter  view,  the  condition  estab-
lished  by  the  “if”  clause  is  that  the  vaccine  have  been
properly labeled and manufactured; and under the former,
that it have been properly designed, labeled, and manufac-
tured.  Neither  view  renders  the  “if ”  clause  a  nullity. 
Which of the two variants must be preferred is addressed 
by  our  textual  analysis,  and  is  in  no  way  determined  by 
the “if ” clause. 

Petitioners’  and  the  dissent’s  textual  argument  also
rests upon the proposition that the word “unavoidable” in
§300aa–22(b)(1)  is  a  term  of  art  that  incorporates  com-
ment  k  to  Restatement  (Second)  of  Torts  §402A  (1963– 
1964).39  The Restatement generally holds a manufacturer 
strictly  liable  for  harm  to  person  or  property  caused  by
“any  product  in  a  defective  condition  unreasonably  dan-
gerous  to  the  user.”40  Comment  k  exempts  from  this
strict-liability  rule  “unavoidably  unsafe  products.”    An 
unavoidably unsafe product is defined by a hodge-podge of
criteria  and  a  few  examples,  such  as  the  Pasteur  rabies 
vaccine  and  experimental  pharmaceuticals.  Despite  this
lack  of  clarity,  petitioners  seize  upon  one  phrase  in  the 
comment k analysis, and assert that by 1986 a majority of 
courts  had  made  this  a  sine  qua  non  requirement  for  an
“unavoidably unsafe product”: a case-specific showing that
the  product  was  “quite  incapable  of  being  made  safer  for 

—————— 

38 Ibid. 
39 See Brief for Petitioners 29.

40 Restatement §402A, p. 347.