Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 38.0

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

9 

SOTOMAYOR, J., dissenting 

comment  k  had  long  required  manufacturers  invoking
the  defense  to  demonstrate  that  their  products  were  not 
only “unavoidably unsafe” but also properly manufactured 
and  labeled.7    By  requiring  “prope[r]  prepar[ation]”  and
“proper  directions  and  warnings”  in  §22(b)(1),  Congress
plainly  intended  to  incorporate  these  additional  comment 
k requirements.

The  1986  Report  thus  confirms  petitioners’  interpreta-
tion of §22(b)(1).  The Report makes clear that “side effects
that  were  unavoidable”  in  §22(b)(1)  refers  to  side  effects 
stemming from a vaccine’s design that were “unavoidable.” 
By  explaining  what  Congress  meant  by  the  term  “un-
avoidable,”  moreover,  the  Report  also  confirms  that
whether  a  side  effect  is  “unavoidable”  for  purposes  of 
§22(b)(1)  involves  a  specific  inquiry  in  each  case  as  to 
whether  the  vaccine  “in  the  present  state  of  human  skill 
and knowledge cannot be made safe,” 1986 Report 26—i.e., 
whether  a  feasible  alternative  design  existed  that  would
have  eliminated  the  adverse  side  effects  of  the  vaccine 
without  compromising  its  cost  and  utility.    See  Brief  for 
Kenneth W. Starr et al. as Amici Curiae 14–15 (“If a par-
ticular  plaintiff  could  show  that  her  injury  at  issue  was
avoidable  . . .  through  the  use  of  a  feasible  alternative
design  for  a  specific  vaccine,  then  she  would  satisfy  the 
plain  language  of  the  statute,  because  she  would  have
demonstrated that the side effects were not unavoidable”).
Finally, the Report confirms that the “even though” clause 
is properly read to establish two additional prerequisites—
proper  manufacturing  and  proper  labeling—to  qualify  for 

—————— 

sion that “unavoidable” is a term of art. 

7 See, e.g., Brochu v. Ortho Pharmaceutical Corp., 642 F. 2d 652, 657 
(CA1  1981);  Needham  v.  White  Labs.,  Inc.,  639  F. 2d  394,  402  (CA7 
1981);  Reyes  v.  Wyeth  Labs.,  498  F. 2d  1264,  1274–1275  (CA5  1974); 
Davis  v.  Wyeth  Labs.,  399  F. 2d  121,  127–129  (CA9  1968);  Feldman  v. 
Lederle  Labs.,  97  N. J.  429,  448,  479  A. 2d  374,  384  (1984);  see  also 
Toner v. Lederle Labs., 112 Idaho 328, 336, 732 P. 2d 297, 305 (1987).