Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 36

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

7 

SOTOMAYOR, J., dissenting 

“[s]ince  the  disease  itself  invariably  leads  to  a  dreadful
death,  both  the  marketing  and  the  use  of  the  vaccine  are 
fully  justified,  notwithstanding  the  unavoidable  high
degree of risk which they involve.”  Id., at 353.  Comment 
k  thus  provides  that  “seller[s]”  of  “[u]navoidably  unsafe” 
products  are  “not  to  be  held  to  strict  liability”  provided 
that  such  products  “are  properly  prepared  and  marketed, 
and proper warning is given.”  Ibid. 

As the 1986 Report explains, Congress intended that the
“principle  in  Comment  K  regarding  ‘unavoidably  unsafe’ 
products”  apply  to  the  vaccines  covered  in  the  bill.    1986 
Report 26.  That intent, in turn, is manifested in the plain
text of §22(b)(1)—in particular, Congress’ use  of the word
“unavoidable,” as well  as the phrases “properly prepared”
and  “accompanied  by  proper  directions  and  warnings,” 
which  were  taken  nearly  verbatim  from  comment  k.  42 
U. S. C. §300aa–22(b)(1); see Restatement 353–354 (“Such
a[n  unavoidably  unsafe]  product,  properly  prepared,  and 
accompanied  by  proper  directions  and  warning,  is  not 
defective”).  By the time of the Vaccine Act’s enactment in 
1986,  numerous  state  and  federal  courts  had  interpreted 
comment k to mean that a product is “unavoidably unsafe”
when, given proper manufacture and labeling, no feasible 
alternative  design  would  reduce  the  safety  risks  without
compromising  the  product’s  cost  and  utility.5   Given  Con-

—————— 

5 See,  e.g.,  Smith  ex  rel.  Smith  v.  Wyeth  Labs.,  Inc.,  No.  Civ.  A  84– 
2002, 1986 WL 720792, *5 (SD W. Va., Aug. 21, 1986) (“[A] prescription
drug  is  not  ‘unavoidably  unsafe’  when  its  dangers  can  be  eliminated
through  design  changes  that  do  not  unduly  affect  its  cost  or  utility”); 
Kearl  v.  Lederle  Labs.,  172  Cal.  App.  3d  812,  830,  218  Cal.  Rptr.  453,
464  (1985)  (“unavoidability”  turns  on  “(i)  whether  the  product  was
designed to minimize—to the extent scientifically knowable at the time
it was distributed—the risk inherent in the product, and (ii) the avail-
ability  . . .  of  any  alternative  product  that  would  have  as  effectively 
accomplished  the  full  intended  purpose  of  the  subject  product”),  disap-
proved in part by Brown v. Superior Ct., 44 Cal. 3d 1049, 751 P. 2d 470 
(1988);  Belle  Bonfils  Memorial  Blood  Bank  v.  Hansen,  665  P. 2d  118,