Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 34.0

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

5 

SOTOMAYOR, J., dissenting 

“the design” of the countermeasure, §247d–6d(a)(2)(B).

The  plain  text  and  structure  of  the  Vaccine  Act  thus
compel the conclusion that §22(b)(1) pre-empts some—but
not  all—design  defect  claims.  Contrary  to  the  majority’s
and respondent’s categorical reading, petitioners correctly 
contend  that,  where  a  plaintiff  has  proved  that  she  has 
suffered  an  injury  resulting  from  a  side  effect  caused  by
a  vaccine’s  design,  a  vaccine  manufacturer  may  invoke 
§22(b)(1)’s liability exemption only if it demonstrates that 
the  side  effect  stemming  from  the  particular  vaccine’s
design is “unavoidable,” and that the vaccine is otherwise
free from manufacturing and labeling defects.3 

B 
The  legislative  history  confirms  petitioners’  interpreta-
tion of §22(b)(1) and sheds further light on its pre-emptive 
scope.  The  House  Energy  and  Commerce  Committee 
Report accompanying the Vaccine Act, H. R. Rep. No. 99–
908,  pt.  1  (1986)  (hereinafter  1986  Report),  explains  in
relevant part: 

“Subsection  (b)—Unavoidable  Adverse  Side  Effects; 
Direct  Warnings.—This  provision  sets  forth  the  prin-
ciple  contained  in  Comment  K  of  Section  402A  of  the 
Restatement  of  Torts  (Second)  that  a  vaccine  manu-
facturer should not be liable for injuries or deaths re-
sulting from unavoidable side effects even though the 
vaccine  was  properly  prepared  and  accompanied  by
proper directions and warnings. 

“The  Committee  has  set  forth  Comment  K  in  this 
bill because it intends that the principle in Comment
K  regarding  ‘unavoidably  unsafe’  products,  i.e.,  those 
products  which  in  the  present  state  of  human  skill 
and knowledge cannot be made safe, apply to the vac-

—————— 

3 This  leaves  the  question  of  what  precisely  §22(b)(1)  means  by  “un-

avoidable” side effects, which I address in the next section.