Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 48

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

19 

SOTOMAYOR, J., dissenting 

The  majority  also  suggests  that  if  Congress  wished  to
preserve  design  defect  claims,  it  could  have  simply  pro-
vided  that  manufacturers  would  be  liable  for  “defective 
manufacture,  defective  directions  or  warning,  and  defec-
tive  design.”  Ante,  at  8  (internal  quotation  marks  omit-
ted).  Putting aside the fact that §22(a) already preserves 
design  defect  claims  (to  the  extent  §22(b)(1)  does  not  ap-
ply), the majority’s proposed solution would not have fully
effectuated  Congress’  intent.    As  the  legislative  history 
makes  clear,  Congress  used  the  term  “unavoidable”  to 
effectuate  its  intent  that  the  “principle  in  Comment  K 
regarding  ‘unavoidably  unsafe’  products  . . .  apply  to  the 
vaccines  covered  in  the  bill.”    1986  Report  26;  see  also 
1987  Report  691.  At  the  time  of  the  Vaccine  Act’s  enact-
ment  in  1986,  at  least  one  State  had  expressly  rejected 
comment  k,16  while  many  others  had  not  addressed  the
applicability  of  comment  k  specifically  to  vaccines  or  ap-
plied  comment  k  to  civil  actions  proceeding  on  a  theory 
other  than  strict  liability  (e.g.,  negligence17).  A  statute 

—————— 

an express saving clause in the same statutory section, see 42 U. S. C.
§300aa–22(a),  and  its  use  of  the  conditional  “if”  clause  in  defining  the
pre-emptive scope of the provision.  See Bates v. Dow Agrosciences LLC, 
544 U. S. 431, 449 (2005) (“In areas of traditional state  regulation, we 
assume  that  a  federal  statute  has  not  supplanted  state  law  unless
Congress  has  made  such  an  intention  clear  and  manifest”  (internal 
quotation marks omitted)). 

16 See Collins v. Eli Lilly Co., 116 Wis. 2d 166, 197, 342 N. W. 2d 37, 
52  (1984)  (“We  conclude  that  the  rule  embodied  in  comment  k  is  too 
restrictive  and,  therefore,  not  commensurate  with  strict  products 
liability  law  in  Wisconsin”).  Collins  did,  however,  “recognize  that  in
some exigent circumstances it may be necessary to place a drug on the
market before adequate testing can be done.”   Ibid.  It thus adopted  a 
narrower  defense  (based  on  “exigent  circumstances”)  than  that  recog-
nized in other jurisdictions that had expressly adopted comment k. 

17 See,  e.g.,  Kearl,  172  Cal.  App.  3d,  at  831,  n. 15,  218  Cal.  Rptr.,  at 
465,  n. 15  (“[T]he  unavoidably  dangerous  product  doctrine  merely
exempts  the  product  from  a  strict  liability  design  defect  analysis;  a 
plaintiff remains free to pursue his design defect theory on the basis of