Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 51

22 

BRUESEWITZ v. WYETH LLC 

SOTOMAYOR, J., dissenting 

that  vaccines  are  optimally  designed  in  light  of  existing 
science  and  technology  has  traditionally  been  left  to  the
States  through  the  imposition  of  damages  for  design  de-
fects.  Cf. Bates, 544 U. S., at 451 (“ ‘[T]he specter of dam-
age  actions  may  provide  manufacturers  with  added  dy-
namic incentives to continue to keep abreast of all possible
injuries  stemming  from  use  of  their  product[s]  so  as  to 
forestall  such  actions  through  product  improvement’ ”); 
Wyeth v. Levine, 555 U. S. ___, ___ (2009) (slip op., at 22– 

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vaccine  designs  only  if  and  when  manufacturers  come  forward  with  a 
proposal”); Jones v. Lederle Labs., 695 F. Supp. 700, 711 (EDNY 1988)
(“[T]he  agency  takes  the  drugs  and  manufacturers  as  it  finds  them.
While its goal is to oversee inoculation with the best possible vaccine, it
is limited to reviewing only those drugs submitted by various manufac-
turers,  regardless  of  their  flaws”).    Although  the  FDA  has  authority 
under existing regulations to revoke a manufacturer’s biologics licenses,
that  authority  can  be  exercised  only  where  (as  relevant  here)  “[t]he
licensed product is not safe and effective for all of its intended uses.”  21 
CFR §601.5(b)(1)(vi) (2010); see §600.3(p) (defining “safety” as “relative
freedom  from  harmful  effect  to  persons  affected,  directly  or  indirectly,
by  a  product  when  prudently  administered,  taking  into  consideration 
the character of the product in relation to the condition of the recipient 
at  the  time”).    The  regulation  does  not  authorize  the  FDA  to  revoke  a
biologics  license  for  a  manufacturer’s  failure  to  adopt  an  optimal
vaccine design in light of existing science and technology.  See Conk, Is 
There  a  Design  Defect  in  the  Restatement  (Third)  of  Torts:  Products 
Liability? 109 Yale L. J. 1087, 1128–1129 (1999–2000) (“The FDA does
not claim to review products for optimal design . . . .  FDA review thus 
asks less of drug . . . manufacturers than the common law of products
liability  asks  of  other  kinds  of  manufacturers”).    At  oral  argument,
counsel  for  amicus  United  States  stated  that  the  Centers  for  Disease 
Control and Prevention (CDC) routinely performs comparative analyses 
of vaccines that are already on the market.  See Tr. of Oral Arg. 44–45; 
id.,  at  52–53  (describing  CDC’s  comparison  of  Sabin  and  Salk  polio 
vaccines).    Neither  the  United  States  nor  any  of  the  parties,  however, 
has  represented  that  CDC  examines  whether  a  safer  alternative 
vaccine  could  have  been  designed  given  practical  and  scientific  limits,
the  central  inquiry  in  a  state  tort  law  action  for  design  defect.    CDC 
does not issue biologics licenses, moreover, and thus has no authority to
require a manufacturer to adopt a different vaccine design.