Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 18

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

15 

Opinion of the Court 

cacy  testing.59    The  Act  requires  vaccine  manufacturers
and  health-care  providers  to  report  adverse  side  effects,60 
and  provides  for  monitoring  of  vaccine  safety  through  a
collaboration  with  eight  managed-care  organizations.61 
And of course whenever the FDA concludes that a vaccine 
is unsafe, it may revoke the license.62 

These  provisions  for  federal  agency  improvement  of 
vaccine design, and for federally prescribed compensation, 
once  again  suggest  that  §300aa–22(b)(1)’s  silence  regard-
ing design-defect liability was not inadvertent.  It instead 
reflects a sensible choice to leave complex epidemiological
judgments  about  vaccine  design  to  the  FDA  and  the  Na-
tional Vaccine Program rather than juries.63 

And  finally,  the  Act’s  structural  quid  pro  quo  leads  to 
the  same  conclusion:  The  vaccine  manufacturers  fund 
from  their  sales  an  informal,  efficient  compensation  pro-
gram  for  vaccine  injuries;64  in  exchange  they  avoid  costly 
tort  litigation  and  the  occasional  disproportionate  jury
verdict.65   But  design-defect  allegations  are  the  most
speculative and difficult type of products liability claim to 

—————— 

59 See §§300aa–2(a)(1)–(3), 300aa–3. 
60 See §300aa–25(b). 
61 See NVAC 18–19. 
62 See 21 CFR §601.5(b)(1)(vi) (2010). 
63 The dissent quotes just part of this sentence, to make it appear that
we  believe  complex  epidemiological  judgments  ought  to  be  assigned  in 
that  fashion.    See  post,  at  26.  We  do  not  state  our  preference,  but
merely note that it is Congress’s expressed preference—and in order to
preclude the argument that it is absurd to think Congress enacted such
a thing, we assert that the choice is reasonable and express some of the
reasons why.  Leaving it to the jury may (or may not) be reasonable as
well; we express no view. 

64 See  42  U. S. C.  §300aa–15(i)(2);  Pub.  L.  99–660,  §323(a),  100  Stat. 
3784.    The  dissent’s  unsupported  speculation  that  demand  in  the 
vaccine  market  is  inelastic,  see  post,  at  24,  n. 22,  sheds  no  light  on
whether Congress regarded the tax as a quid pro quo, most Members of 
Congress being neither professional economists nor law-and-economics 
scholars. 

65 See 42 U. S. C. §§300aa–11(a)(2), 300aa–22.