Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 35

6 

BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

cines covered in the bill and that such products not be
the subject of liability in the tort system.”  Id., at 25– 
26. 

The  Report  expressly  adopts  comment  k  of  §402A  of  the 
Restatement  of  Torts  (Second)  (1963–1964)  (hereinafter
Restatement),  which  provides  that  “unavoidably  unsafe” 
products—i.e.,  those  that  “in  the  present  state  of  human 
knowledge,  are  quite  incapable  of  being  made  safe  for 
their  intended  and  ordinary  use”—are  not  defective.4    As  
“[a]n  outstanding  example”  of  an  “[u]navoidably  unsafe” 
product,  comment  k  cites  “the  vaccine  for  the  Pasteur 
treatment  of  rabies,  which  not  uncommonly  leads  to  very 
serious  and  damaging  consequences  when  it  is  injected”; 

—————— 

4 Comment k provides as follows: 
“Unavoidably  unsafe  products.  There  are  some  products  which,  in 
the  present  state  of  human  knowledge,  are  quite  incapable  of  being
made  safe  for  their  intended  and  ordinary  use.    These  are  especially 
common  in  the  field  of  drugs.  An  outstanding  example  is  the  vaccine 
for  the  Pasteur  treatment  of  rabies,  which  not  uncommonly  leads  to
very serious and damaging consequences when it is injected.  Since the 
disease  itself  invariably  leads  to  a  dreadful  death,  both  the  marketing 
and  the  use  of  the  vaccine  are  fully  justified,  notwithstanding  the 
unavoidable  high  degree  of  risk  which  they  involve.    Such  a  product,
properly prepared, and accompanied by proper directions and warning,
is not defective, nor is it unreasonably dangerous.  The same is true of 
many  other  drugs,  vaccines,  and  the  like,  many  of  which  for  this  very
reason  cannot  legally  be  sold  except  to  physicians,  or  under  the  pre-
scription  of  a  physician.  It  is  also  true  in  particular  of  many  new  or
experimental drugs as to which, because of lack of time and opportunity 
for sufficient medical experience, there can be no assurance of safety, or 
perhaps  even  of  purity  of  ingredients,  but  such  experience  as  there  is 
justifies the marketing and use of the drug notwithstanding a medically 
recognizable risk.  The seller of such products, again with the qualifica-
tion that they are properly prepared and marketed, and proper warning 
is  given,  where  the  situation  calls  for  it,  is  not  to  be  held  to  strict
liability  for  unfortunate  consequences  attending  their  use,  merely 
because  he  has  undertaken  to  supply  the  public  with  an  apparently
useful  and  desirable  product,  attended  with  a  known  but  apparently 
reasonable risk.”  Restatement 353–354.