Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 52

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

23 

SOTOMAYOR, J., dissenting 

23) (noting that the FDA has “traditionally regarded state
law  as  a  complementary  form  of  drug  regulation”  as
“[s]tate  tort  suits  uncover  unknown  drug  hazards  and 
provide  incentives  for  drug  manufacturers  to  disclose 
safety  risks  promptly”).20    The  importance  of  the  States’ 
traditional  regulatory  role  is  only  underscored  by  the 
unique features of the vaccine market, in which there are 
“only  one  or  two  manufacturers  for  a  majority  of  the  vac-
cines listed on the routine childhood immunization sched-
ule.”  Brief  for  Respondent  55.  The  normal  competitive
forces that  spur innovation and improvements to existing 
product lines in other markets thus operate with less force
in the vaccine market, particularly for vaccines that have 
already been released and marketed to the public.  Absent 
a  clear  statutory  mandate  to  the  contrary,  there  is  no 
reason  to  think  that  Congress  intended  in  the  vaccine 
context  to  eliminate  the  traditional  incentive  and  deter-
rence  functions  served  by  state  tort  liability  in  favor  of  a 
federal  regulatory  scheme  providing  only  carrots  and  no 
sticks.21  See Levine, 555 U. S., at ___ (slip op., at 18) (“The 

—————— 

20 Indeed,  we  observed  in  Levine  that  the  FDA  is  perpetually  under-
staffed  and  underfunded,  see  555  U. S.,  at  ___,  n. 11  (slip  op.,  at  22,
n. 11),  and  the  agency  has  been  criticized  in  the  past  for  its  slow  re-
sponse  in  failing  to  withdraw  or  warn  about  potentially  dangerous 
products, see, e.g., L. Leveton, H. Sox, & M. Soto, Institute of Medicine, 
HIV  and  the  Blood  Supply:  An  Analysis  of  Crisis  Decisionmaking 
(1995) (criticizing FDA response to transmission of AIDS through blood 
supply).  These  practical  shortcomings  reinforce  the  conclusion  that
“state  law  offers  an  additional,  and  important,  layer  of  consumer 
protection that complements FDA regulation.”  Levine, 555 U. S., at ___ 
(slip op., at 23). 

21 The majority mischaracterizes my position as expressing a general 
“skeptic[ism]  of  preemption  unless  the  congressional  substitute  oper-
ate[s]  like  the  tort  system.”    Ante,  at  16.    Congress  could,  of  course, 
adopt  a  regulatory  regime  that  operates  differently  from  state  tort 
systems,  and  such  a  difference  is  not  necessarily  a  reason  to  question
Congress’ pre-emptive intent.  In the specific context of the Vaccine Act,
however, the relevant point is that this Court should not lightly assume