Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 17.0

14 

BRUESEWITZ v. WYETH LLC 

Opinion of the Court 

ploy an alternative design that the FDA has approved for
distribution  (an  approval  it  takes  years  to  obtain56)?  Or 
does it suffice that a vaccine design has been approved in
other  countries?    Or  could  there  be  liability  for  failure  to
use a design that exists only in a lab?  Neither the Act nor 
the  FDA  regulations  provide  an  answer,  leaving  the  uni-
verse  of  alternative  designs  to  be  limited  only  by  an  ex-
pert’s imagination. 

Jurors,  of  course,  often  decide  similar  questions  with
little  guidance,  and  we  do  not  suggest  that  the  absence
of  guidance  alone  suggests  preemption.  But  the  lack  of 
guidance  for  design  defects  combined  with  the  exten- 
sive  guidance  for  the  two  grounds  of  liability  specifically
mentioned in the Act strongly suggests that design defects 
were  not  mentioned  because  they  are  not  a  basis  for 
liability.

The  mandates  contained  in  the  Act  lead  to  the  same 
conclusion.  Design-defect  torts,  broadly  speaking,  have
two  beneficial  effects:  (1)  prompting  the  development  of
improved  designs,  and  (2)  providing  compensation  for 
inflicted  injuries.  The  NCVIA  provides  other  means  for
achieving  both  effects.   We  have  already  discussed  the
Act’s  generous  compensation  scheme.  And  the  Act  pro-
vides many means of improving vaccine design.  It directs 
the  Secretary  of  Health  and  Human  Services  to  promote 
“the  development  of  childhood  vaccines  that  result  in
fewer and less serious adverse reactions.”57  It establishes 
a National Vaccine Program, whose Director is “to achieve 
optimal prevention of human infectious diseases . . . and to 
achieve  optimal  prevention  against  adverse  reactions.”58 
The  Program  is  to  set  priorities  for  federal  vaccine  re-
search,  and  to  coordinate  federal  vaccine  safety  and  effi-

—————— 

56 See Sing & William, Supplying Vaccines, at 66–67. 
57 42 U. S. C. §300aa–27(a)(1). 
58 §300aa–1.