Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 16

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

13 

Opinion of the Court 

III 

The structure of the NCVIA and of vaccine regulation in 
general  reinforces  what  the  text  of  §300aa–22(b)(1)  sug-
gests.  A  vaccine’s  license  spells  out  the  manufacturing
method  that  must  be  followed  and  the  directions  and 
warnings  that  must  accompany  the  product.50   Manufac-
turers ordinarily must obtain the Food and Drug Admini-
stration’s  (FDA)  approval  before  modifying  either.51    De-
viations from the license thus provide objective evidence of
manufacturing  defects  or  inadequate  warnings.    Further 
objective  evidence  comes  from  the  FDA’s  regulations—
more  than  90  of  them52—that  pervasively  regulate  the 
manufacturing  process,  down  to  the  requirements  for 
plumbing  and  ventilation  systems  at  each  manufacturing
facility.53    Material  noncompliance  with  any  one  of  them, 
or with any other FDA regulation, could cost the manufac-
turer its regulatory-compliance defense.54 

Design  defects,  in  contrast,  do  not  merit  a  single  men-
tion  in  the  NCVIA  or  the  FDA’s  regulations.    Indeed,  the 
FDA has never even spelled out in regulations the criteria 
it uses to decide whether a vaccine is safe and effective for 
its intended use.55  And the decision is surely not an easy 
one.  Drug  manufacturers  often  could  trade  a  little  less
efficacy for a little more safety, but the safest design is not 
always  the  best  one.  Striking  the  right  balance  between 
safety  and  efficacy  is  especially  difficult  with  respect  to 
vaccines, which affect  public as well as individual health.
Yet  the  Act,  which  in  every  other  respect  micromanages
manufacturers,  is  silent  on  how  to  evaluate  competing 
designs.  Are  manufacturers  liable  only  for  failing  to  em-
—————— 

50 See 42 U. S. C. §262(a), ( j); 21 CFR §§601.2(a), 314.105(b) (2010). 
51 See §601.12. 
52 See §§211.1 et seq., 600.10–600.15, 600.21–600.22, 820.1 et seq. 
53 See §§211.46, 211.48. 
54 See 42 U. S. C. §300aa–22(b)(2). 
55 Hutt, Merrill, & Grossman, Food and Drug Law, at 685, 891.