Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 37.0

8 

BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

gress’ expressed intent to codify the “principle in Comment 
K,” 1986 Report 26, the term “unavoidable” in §22(b)(1) is
best  understood  as  a  term  of  art,  which  incorporates  the
commonly  understood  meaning  of  “unavoidably  unsafe” 
products under comment  k at  the time of the Act’s enact-
ment in 1986.  See McDermott Int’l, Inc. v. Wilander, 498 
U. S.  337,  342  (1991)  (“[W]e  assume  that  when  a  statute
uses  . . .  a  term  [of  art],  Congress  intended  it  to  have  its
established  meaning”);  Morissette  v.  United  States,  342 
U. S.  246,  263  (1952)  (same).6    Similarly,  courts  applying 

—————— 

122 (Colo. 1983) (“[A]pplicability of comment k . . . depends upon the co-
existence of several factors,” including that “the product’s benefits must
not be achievable in another manner; and the risk must be unavoidable 
under  the  present  state  of  knowledge”);  see  also  1  L.  Frumer  &  M. 
Friedman,  Products  Liability  §§8.07[1]–[2],  pp.  8–277  to  8–278  (2010)
(comment  k  applies  “only  to  defects  in  design,”  and  there  “must  be  no 
feasible  alternative  design  which  on  balance  accomplishes  the  subject
product’s  purpose  with  a  lesser  risk”  (internal  quotation  marks  omit-
ted)).  To  be  sure,  a  number  of  courts  at  the  time  of  the  Vaccine  Act’s 
enactment had interpreted comment k to preclude design defect claims 
categorically for certain kinds of products, see Hill v. Searle Labs., 884 
F. 2d 1064, 1068 (CA8  1989) (collecting cases), but  as  indicated by  the 
sources cited above, the courts that had construed comment k to apply
on a case-specific basis generally agreed on the basic elements of what 
constituted an “unavoidably unsafe” product.  See also n. 8, infra.  The 
majority’s suggestion that “judges who must rule on motions to dismiss,
motions for summary judgment, and motions for judgment as a matter
of law” are incapable of adjudicating claims alleging “unavoidable” side
effects, ante, at 7–8, n. 35, is thus belied by the experience of the many
courts  that  had  adjudicated  such  claims  for  years  by  the  time  of  the 
Vaccine Act’s enactment. 

6 The majority refuses to recognize that “unavoidable” is a term of art
derived  from  comment  k,  suggesting  that  “ ‘[u]navoidable’  is  hardly  a 
rarely  used  word.”  Ante,  at  10.  In  fact,  however,  “unavoidable”  is  an 
extremely  rare  word  in  the  relevant  context.    It  appears  exactly  once 
(i.e.,  in  §300aa–22(b)(1))  in  the  entirety  of  Title  42  of  the  U. S.  Code
(“Public  Health  and  Welfare”),  which  governs,  inter  alia,  Social  Secu-
rity, see 42 U. S. C. §301 et seq., Medicare, see §1395 et seq., and several 
other  of  the  Federal  Government’s largest  entitlement  programs.    The 
singular  rarity  in  which  Congress  used  the  term  supports  the  conclu-