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Page Number: 2.0

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BRUESEWITZ v. WYETH LLC 

Syllabus 

provides that “[n]o vaccine manufacturer shall be liable in a civil ac-
tion for damages arising from a vaccine-related injury or death asso-
ciated  with  the  administration  of  a  vaccine  after  October  1,  1988,  if 
the  injury  or  death  resulted  from  side-effects  that  were  unavoidable 
even though the vaccine was properly prepared and was accompanied
by proper directions and warnings.”  The Third Circuit affirmed. 

Held: The  NCVIA  preempts  all  design-defect  claims  against  vaccine 
manufacturers brought by plaintiffs seeking compensation for injury 
or death caused by a vaccine’s side effects.  Pp. 7–19.

(a) Section 300aa–22(b)(1)’s text suggests that a vaccine’s design is 
not open to question in a tort action.  If a manufacturer could be held 
liable  for  failure  to  use  a  different  design,  the  “even  though”  clause 
would  do  no  work.    A  vaccine  side  effect  could  always  have  been 
avoidable  by  use  of  a  different  vaccine  not  containing  the  harmful 
element.  The  language  of  the  provision  thus  suggests  the  design  is
not subject to question in a tort action.  What the statute establishes 
as  a  complete  defense  must  be  unavoidability  (given  safe  manufac-
ture and warning) with respect to the particular design.  This conclu-
sion is supported by the fact that, although products-liability law es-
tablishes 
liability—defective  manufacture, 
inadequate  directions  or  warnings,  and  defective  design—the  Act 
mentions  only  manufacture  and  warnings.    It  thus  seems  that  the 
Act’s failure to mention design-defect liability is “by deliberate choice, 
not inadvertence.”  Barnhart v. Peabody Coal Co., 537 U. S. 149, 168. 
Pp. 7–8.

three  grounds 

for 

(b) Contrary to petitioners’ argument, there is no reason to believe
that §300aa–22(b)(1)’s term “unavoidable” is a term of art incorporat-
ing Restatement (Second) of Torts §402A, Comment k, which exempts 
from  strict  liability  rules  “unavoidably  unsafe  products.”    “Unavoid-
able” is hardly a rarely used word, and cases interpreting comment k 
attach  special  significance  only  to  the  term  “unavoidably  unsafe
products,”  not  the  word  “unavoidable”  standing  alone.    Moreover, 
reading the phrase “side effects that were unavoidable” to exempt in-
juries caused by flawed design would require treating “even though”
as a coordinating conjunction linking independent ideas when it is a 
concessive,  subordinating  conjunction  conveying  that  one  clause 
weakens  or  qualifies  the  other.  The  canon  against  superfluity  does
not  undermine  this  Court’s  interpretation  because  petitioners’  com-
peting interpretation has superfluity problems of its own.  Pp. 8–12.

(c) The structure of the NCVIA and of vaccine regulation in general 
reinforces  what  §300aa–22(b)(1)’s  text  suggests.    Design  defects  do
not  merit  a  single  mention  in  the  Act  or  in  Food  and  Drug  Admini-
stration  regulations  that  pervasively  regulate  the  drug  manufactur-
ing process.  This lack of guidance for design defects, combined with