Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 57

28 

BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

pre-empt  all  design  defect  claims  against  vaccine  manu-
facturers  for  covered  vaccines,  the  majority’s  decision 
leaves  a  regulatory  vacuum  in  which  no  one—neither  the 
FDA  nor  any  other  federal  agency,  nor  state  and  federal
juries—ensures  that  vaccine  manufacturers  adequately 
take account of scientific and technological advancements. 
This  concern  is  especially  acute  with  respect  to  vaccines 
that  have  already  been  released  and  marketed  to  the 
public.  Manufacturers,  given  the  lack  of  robust  competi-
tion  in  the  vaccine  market,  will  often  have  little  or  no 
incentive  to  improve  the  designs  of  vaccines  that  are  al-
ready  generating  significant  profit  margins.    Nothing  in
the text, structure, or legislative history remotely suggests
that Congress intended that result. 

I respectfully dissent.