Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 39

10 

BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

§22(b)(1)’s liability exemption.8 

In  addition  to  the  1986  Report,  one  other  piece  of  the
Act’s  legislative  history  provides  further  confirmation  of 
the  petitioners’  textual  reading  of  §22(b)(1).    When  Con-
gress  enacted  the  Vaccine  Act  in  1986,  it  did  not  initially 
include a source of payment for the no-fault compensation
program  the  Act  established.  The  Act  thus  “made  the 
compensation  program  and  accompanying  tort  reforms
contingent  on  the  enactment  of  a  tax  to  provide  funding 
—————— 

8 Respondent  suggests  an  alternative  reading  of  the  1986  Report.
According to respondent, “the principle in Comment K” is simply that of 
nonliability  for  “unavoidably  unsafe”  products,  and  thus  Congress’ 
stated intent in the 1986 Report to apply the “principle in Comment K”
to  “the  vaccines  covered  in  the  bill”  means  that  Congress  viewed  the 
covered  vaccines  as  a  class  to  be  “ ‘unavoidably  unsafe.’ ”    1986  Report 
25–26;  Brief  for  Respondent  42.    The  concurrence  makes  a  similar 
argument.    Ante,  at  1–2  (opinion  of  BREYER,  J.).    This  interpretation 
finds  some  support  in  the  1986  Report,  which  states  that  “if  [injured
individuals]  cannot  demonstrate  under  applicable  law  either  that  a 
vaccine  was  improperly  prepared  or  that  it  was  accompanied  by  im-
proper  directions  or  inadequate  warnings  [they]  should  pursue  recom-
pense  in  the  compensation  system,  not  the  tort  system.”    1986  Report 
26.  It  also  finds  some  support  in  the  pre-Vaccine  Act  case  law,  which 
reflected  considerable  disagreement  in  the  courts  over  “whether  com-
ment k applies to pharmaceutical products across the board or only on
a  case-by-case  basis.”    Ausness,  Unavoidably  Unsafe  Products  and
Strict Products Liability: What Liability Rule Should be Applied to the 
Sellers  of  Pharmaceutical  Products?  78  Ky.  L. J.  705,  708,  and  n. 11 
(1989–1990) (collecting cases).  This interpretation, however, is under-
mined by the fact that Congress has never directed the Food and Drug
Administration  (FDA)  or  any  other  federal  agency  to  review  vaccines 
for  optimal  vaccine  design,  see  infra,  at  20–22,  and  n. 19,  and  thus  it 
seems  highly  unlikely  that  Congress  intended  to  eliminate  the  tradi-
tional mechanism for such review (i.e., design defect liability), particu-
larly given its express retention of state tort law in the Vaccine Act, see 
42 U. S. C. §300aa–22(a).  In any event, to the extent there is ambiguity 
as to how precisely Congress intended the “principle in Comment K” to 
apply  to  the  covered  vaccines,  that  ambiguity  is  explicitly  resolved  in
petitioners’ favor by the 1987 House Energy and Commerce Committee
Report,  H.  R.  Rep.  No.  100–391,  pt.  1,  pp.  690–691  (hereinafter  1987
Report).  See infra this page and 11–12.