Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 33.0

4 

BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

state  tort  liability.  In  §22(b)(2),  Congress  created  a  pre-
sumption  that,  for  purposes  of  §22(b)(1),  “a  vaccine  shall
be  presumed  to  be  accompanied  by  proper  directions  and 
warnings  if  the  vaccine  manufacturer  shows  that  it  com-
plied  in  all  material  respects  with”  federal  labeling  re-
quirements.    42  U. S. C.  §300aa–22(b)(2).    Similarly,  in
§23(d)(2),  Congress  created  an  exemption  from  punitive
damages “[i]f . . . the manufacturer shows that it complied,
in  all  material  respects,”  with  applicable  federal  laws,
unless  it  engages  in  “fraud,”  “intentional  and  wrongful
withholding  of  information”  from  federal  regulators,  or 
“other  criminal  or  illegal  activity.”    §300aa–23(d)(2).  It 
would  be  highly  anomalous  for  Congress  to  use  a  condi-
tional  “if ”  clause  in  §§22(b)(2)  and  23(d)(2)  to  require  a
specific  inquiry  in  each  case  while  using  the  same  condi-
tional  “if ”  clause  in  §22(b)(1)  to  denote  a  categorical  ex-
emption  from  liability.  Cf.  Erlenbaugh  v.  United  States, 
409  U. S.  239,  243  (1972)  (“[A]  legislative  body  generally 
uses  a  particular  word  with  a  consistent  meaning  in  a
given context”).

Indeed,  when  Congress  intends  to  pre-empt  design
defect  claims  categorically,  it  does  so  using  categorical
(e.g.,  “all”)  and/or  declarative  language  (e.g.,  “shall”),
rather  than  a  conditional  term  (“if ”).    For  example,  in
a  related  context,  Congress  has  authorized  the  Secretary
of  Health  and  Human  Services  to  designate  a  vaccine 
designed to prevent a pandemic or epidemic as a “covered 
countermeasure.” 
(i)(1),
(i)(7)(A)(i).  With  respect  to  such  “covered  countermea-
sure[s],”  Congress  provided  that  subject  to  certain  excep-
tions,  “a  covered  person  shall  be  immune  from  suit  and 
liability  under  Federal  and  State  law  with  respect  to  all 
claims  for  loss  caused  by,  arising  out  of,  relating  to,  or 
resulting  from  the  administration  to  or  the  use  by  an
individual  of  a  covered  countermeasure,”  §247d–6d(a)(1) 
(emphasis added), including specifically claims relating to 

42  U. S. C.  §§247d–6d(b),