Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 43.0

14 

BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

render  §22(b)(1)  a  nullity.  Ibid.  A  tort  claimant,  accord-
ing to the majority, will always be able to point to a differ-
ently  designed  vaccine  not  containing  the  “harmful  ele-
ment,” and if that were sufficient to show that a vaccine’s 
side effects were not “unavoidable,” the statute would pre-
empt nothing.

The  starting  premise  of  the  majority’s  interpretation,
however,  is  fatally  flawed.  Although  in  the  most  literal
sense,  as  the  majority  notes,  a  side  effect  can  always  be 
avoided  “by  use  of  a  differently  designed  vaccine  not  con-
taining  the  harmful  element,”  ibid.,  this  interpretation  of
“unavoidable”  would  effectively  read  the  term  out  of  the
statute, and Congress could not have intended that result.
Indeed,  §22(b)(1)  specifically  uses  the  conditional  phrase
“if the injury or death resulted from side effects that were
unavoidable,”  which  plainly  indicates  that  Congress  con-
templated that there would be some instances in which a
vaccine’s  side  effects  are  “unavoidable”  and  other  in-
stances in which they are not.  See supra, at 3.  The major-
ity’s  premise  that  a  vaccine’s  side  effects  can  always  be
“avoid[ed]  by  use  of  a  differently  designed  vaccine  not 
containing  the  harmful  element,”  ante,  at  7,  entirely  ig-
nores  the  fact  that  removing  the  “harmful  element”  will 
often  result  in  a  less  effective  (or  entirely  ineffective) 
vaccine.  A  vaccine,  by  its  nature,  ordinarily  employs  a
killed or weakened form of a bacteria or virus to stimulate 
antibody  production;13  removing  that  bacteria  or  virus 
might  remove  the  “harmful  element,”  but  it  would  also
necessarily render the vaccine inert.  As explained above,
the  legislative  history  of  the  Vaccine  Act  and  the  cases
interpreting  comment  k  make  clear  that  a  side  effect  is 

—————— 

13 See American Academy of Pediatrics, Questions and Answers about 

Vaccine Ingredients (Oct. 2008), http://www.aap.org/immunization/ 
families/faq/Vaccineingredients.pdf (all Internet materials as visited 
Feb. 18, 2011, and available in Clerk of Court’s case file).