Document ID: ./input/supremecourt_opinions/opinions/10pdf/09-152.pdf
Page Number: 8.0

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

5 

Opinion of the Court 

ure  to  warn  if  they  have  complied  with  all  regulatory
requirements  (including  but  not  limited  to  warning  re-
quirements)  and  have  given  the  warning  either  to  the 
claimant  or  the  claimant’s  physician.25   They  are  immu-
nized from liability for punitive damages absent failure to 
comply with regulatory requirements, “fraud,” “intentional 
and wrongful withholding of information,” or other “crimi-
nal or illegal activity.”26  And most relevant to the present
case,  the  Act  expressly  eliminates  liability  for  a  vaccine’s 
unavoidable, adverse side effects: 

“No vaccine manufacturer shall be liable in a civil ac-
tion for damages arising from a vaccine-related injury
or  death  associated  with  the  administration  of  a  vac-
cine  after  October  1,  1988,  if  the  injury  or  death  re-
sulted  from  side  effects  that  were  unavoidable  even 
though the vaccine was properly prepared and was ac-
companied by proper directions and warnings.”27 

B 
The  vaccine  at  issue  here  is  a  DTP  vaccine  manufac-
tured  by  Lederle  Laboratories.  It  first  received  federal 
approval  in  1948  and  received  supplemental  approvals  in
1953  and  1970.  Respondent  Wyeth  purchased  Lederle  in
1994 and stopped manufacturing the vaccine in 1998. 

Hannah Bruesewitz was born on October 20, 1991.  Her 
pediatrician  administered  doses  of  the  DTP  vaccine  ac-
cording  to  the  Center  for  Disease  Control’s  recommended
childhood immunization schedule.  Within 24 hours of her 
April  1992  vaccination,  Hannah  started  to  experience 

—————— 

25 See §300aa–22(b)(2), (c).  The immunity does not apply if the plain-
tiff establishes by clear and convincing evidence that the manufacturer
was  negligent,  or  was  guilty  of  fraud,  intentional  and  wrongful  with-
holding  of  information,  or  other  unlawful  activity.    See  §§300aa– 
22(b)(2), 300aa–23(d)(2). 
26 §300aa–23(d)(2). 
27 §300aa–22(b)(1).