Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 56.0

Cite as:  562 U. S. ____ (2011) 

27 

SOTOMAYOR, J., dissenting 

policy  preference,  the  decision  to  bar  all  design  defect 
claims against vaccine manufacturers is one that Congress 
must  make,  not  this  Court.25    By  construing  §22(b)(1)  to 
—————— 

25 Respondent  notes  that  there  are  some  5,000  petitions  alleging  a
causal  link  between  certain  vaccines  and  autism  spectrum  disorders
that  are  currently  pending  in  an  omnibus  proceeding  in  the  Court  of 
Federal Claims (Vaccine Court).  Brief for Respondent 56–57.  Accord-
ing  to  respondent,  a  ruling  that  §22(b)(1)  does  not  pre-empt  design 
defect  claims  could  unleash  a  “crushing  wave”  of  tort  litigation  that 
would  bankrupt  vaccine  manufacturers  and  deplete  vaccine  supply. 
Id.,  at  28.  This  concern  underlies  many  of  the  policy  arguments  in
respondent’s brief and appears to underlie the majority and concurring 
opinions  in  this  case.    In  the  absence  of  any  empirical  data,  however,
the prospect of an onslaught of autism-related tort litigation by claim-
ants  denied  relief  by  the  Vaccine  Court  seems  wholly  speculative.    As 
an initial matter, the special masters in the autism cases have thus far
uniformly rejected the alleged causal link between vaccines and autism.
See  Brief  for  American  Academy  of  Pediatrics  et al.  as  Amici  Curiae 
20–21, n. 4 (collecting cases).  To be sure, those rulings do not necessar-
ily mean that  no such causal link exists, cf. Brief for United States as 
Amicus Curiae 29 (noting that injuries have been added to the Vaccine 
Injury Table for existing vaccines), or that claimants will not ultimately
be able to prove such a link in a state tort action, particularly with the 
added  tool  of  civil  discovery.    But  these  rulings  do  highlight  the  sub-
stantial hurdles to recovery a claimant faces.  See Schafer v. American 
Cyanamid  Co.,  20  F. 3d  1,  5  (CA1  1994)  (“[A]  petitioner  to  whom  the 
Vaccine Court gives nothing may see no point in trying to overcome tort
law’s  yet  more  serious  obstacles  to  recovery”).    Trial  courts,  moreover, 
have  considerable  experience  in  efficiently  handling  and  disposing  of
meritless  products  liability  claims,  and  decades  of  tort  litigation  (in-
cluding for design defect) in the prescription-drug context have not led 
to shortages in prescription drugs.  Despite the doomsday predictions of 
respondent and the various amici cited by the concurrence, ante, at 6–7, 
the possibility of a torrent of meritless lawsuits bankrupting manufac-
turers  and  causing  vaccine  shortages  seems  remote  at  best.    More 
fundamentally,  whatever  the  merits  of  these  policy  arguments,  the
issue in this case is what Congress has decided, and as to that question,
the  text,  structure,  and  legislative  history  compel  the  conclusion  that 
Congress intended to leave the courthouse doors open for children who
have  suffered  severe  injuries  from  defectively  designed  vaccines.    The 
majority’s  policy-driven  decision  to  the  contrary  usurps  Congress’  role 
and  deprives  such  vaccine-injured  children  of  a  key  remedy  that  Con-
gress intended them to have.