Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 55

26 

BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

because  they  provide  injured  persons  with  significant
procedural  tools—including,  most  importantly,  civil  dis-
covery—that  are  not  available  in  administrative  proceed-
ings  under  the  compensation  program.    See  §§300aa– 
12(d)(2)(E),  (d)(3).    Congress  thus  clearly  believed  there
was  still  an  important  function  to  be  played  by  state  tort 
law. 

Instead  of  eliminating  design  defect  liability  entirely, 
Congress enacted numerous measures to reduce manufac-
turers’  liability  exposure,  including  a  limited  regulatory 
compliance  presumption  of  adequate  warnings,  see 
§300aa–22(b)(2),  elimination  of  claims  based  on  failure
to  provide  direct  warnings  to  patients,  §300aa–22(c),  a 
heightened  standard  for  punitive  damages,  §300aa–
23(d)(2),  and,  of  course,  immunity  from  damages  for  “un-
avoidable”  side  effects,  §300aa–22(b)(1).    Considered  in 
light  of  the  Vaccine  Act  as  a  whole,  §22(b)(1)’s  exemption
from  liability  for  unavoidably  unsafe  vaccines  is  just  one 
part of a broader statutory scheme that reflects Congress’ 
careful balance between providing adequate compensation
for  vaccine-injured  children  and  conferring  substantial
benefits  on  vaccine  manufacturers  to  ensure  a  stable  and 
predictable childhood vaccine supply.

The  majority’s  decision  today  disturbs  that  careful
balance based on a bare policy preference that it is better 
“to leave complex epidemiological judgments about vaccine
design  to  the  FDA  and  the  National  Vaccine  Program
rather than juries.”  Ante, at 15.24  To be sure, reasonable 
minds  can  disagree  about  the  wisdom  of  having  juries 
weigh  the  relative  costs  and  benefits  of  a  particular  vac-
cine  design.  But  whatever  the  merits  of  the  majority’s 

—————— 

24 JUSTICE  BREYER’s  separate  concurrence  is  even  more  explicitly
policy  driven,  reflecting  his  own  preference  for  the  “more  expert  judg-
ment”  of  federal  agencies  over  the  “less  expert”  judgment  of  juries. 
Ante, at 5.