Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 49.0

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BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

that  simply  stated  that  vaccine  manufacturers  would  be 
liable for “defective design” would be silent as to the avail-
ability  of  a  comment  k-type  defense  for  “unavoidably 
unsafe”  vaccines,  and  thus  would  not  have  fully  achieved 
Congress’  aim  of  extending  greater  liability  protection 
to  vaccine  manufacturers  by  providing  comment  k-type
protection in all civil actions as a matter of federal law. 

B 
The majority’s structural arguments fare no better than
its  textual  ones.  The  principal  thrust  of  the  majority’s
position  is  that,  since  nothing  in  the  Vaccine  Act  or  the
FDA’s  regulations  governing  vaccines  expressly  mentions 
design  defects,  Congress  must  have  intended  to  remove
issues  concerning  the  design  of  FDA-licensed  vaccines 
from  the  tort  system.    Ante,  at  13.    The  flaw  in  that  rea-
soning,  of  course,  is  that  the  FDA’s  silence  on  design  de-
fects  existed  long  before  the  Vaccine  Act  was  enacted.
Indeed,  the  majority  itself  concedes  that  the  “FDA  has 
never even spelled out in regulations the criteria it uses to
decide  whether  a  vaccine  is  safe  and  effective  for  its  in-
tended use.”18  Ibid.  And yet it is undisputed that prior to
the  Act,  vaccine  manufacturers  had  long  been  subject  to 
liability  under  state  tort  law  for  defective  vaccine  design. 
That the Vaccine Act did not itself set forth a comprehen-
sive  regulatory  scheme  with  respect  to  design  defects  is
thus best understood to mean not that Congress suddenly 
decided  to  change  course  sub  silentio  and  pre-empt  a 
—————— 

negligence”);  Toner,  112  Idaho,  at  340,  732  P. 2d,  at  309–310  (“The
authorities universally agree that where a product is deemed unavoid-
ably unsafe, the plaintiff is deprived of the advantage of a strict liabil-
ity  cause  of  action,  but  may  proceed  under  a  negligence  cause  of  ac-
tion”). 

18 See  42  U. S. C.  §262(a)(2)(C)(i)(I)  (“The  Secretary  shall  approve  a
biologics license application . . . on the basis of a demonstration that . . . 
the biological product that is the subject of the application is safe, pure, 
and potent”).