Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 50

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

21 

SOTOMAYOR, J., dissenting 

longstanding,  traditional  category  of  state  tort  law,  but 
rather,  that  Congress  intended  to  leave  the  status  quo
alone  (except,  of  course,  with  respect  to  those  aspects  of
state  tort  law  that  the  Act  expressly  altered).    See  1987 
Report  691  (“It  is  not  the  Committee’s  intention  to  pre-
clude  court  actions  under  applicable  law.    The  Commit-
tee’s intent at the time of considering the Act . . . was . . .
to  leave  otherwise  applicable  law  unaffected,  except  as
expressly altered by the Act”). 

The  majority  also  suggests  that  Congress  necessarily
intended to pre-empt design defect claims since the aim of 
such tort suits is to promote the development of improved
designs and provide compensation for injured individuals, 
and  the  Vaccine  Act  “provides  other  means  for  achieving 
both  effects”—most  notably  through  the  no-fault  compen-
sation program and the National Vaccine Program.  Ante, 
at 14, and nn. 57–60 (citing 42 U. S. C. §§300aa–1, 300aa–
2(a)(1)–(3),  300aa–3,  300aa–25(b),  300aa–27(a)(1)).    But 
the  majority’s  position  elides  a  significant  difference  be-
tween  state  tort  law  and  the  federal  regulatory  scheme.
Although the Vaccine Act charges the Secretary of Health 
and  Human  Services  with  the  obligation  to  “promote  the 
development  of  childhood  vaccines”  and  “make  or  assure
improvements in . . .  vaccines, and research on vaccines,” 
§300aa–27(a),  neither  the  Act  nor  any  other  provision  of 
federal  law  places  a  legal  duty  on  vaccine  manufacturers 
to  improve  the  design  of  their  vaccines  to  account  for 
scientific  and  technological  advances.    Indeed,  the  FDA 
does  not  condition  approval  of  a  vaccine  on  it  being  the
most  optimally  designed  among  reasonably  available
alternatives,  nor  does  it  (or  any  other  federal  entity)  en-
sure  that  licensed  vaccines  keep  pace  with  technological 
and scientific advances.19  Rather, the function of ensuring 

—————— 

19 See, e.g., Hurley v. Lederle Labs., 863 F. 2d 1173, 1177 (CA5 1988) 
(“[T]he  FDA  is  a  passive  agency:  it  considers  whether  to  approve