REL:01/11/2013
Notice: T h i s o p i n i o n i s s u b j e c t t o f o r m a l r e v i s i o n b e f o r e p u b l i c a t i o n i n t h e advance
s h e e t s o f Southern R e p o r t e r . R e a d e r s a r e r e q u e s t e d t o n o t i f y t h e R e p o r t e r o f D e c i s i o n s ,
A l a b a m a A p p e l l a t e C o u r t s , 300 D e x t e r A v e n u e , M o n t g o m e r y , A l a b a m a 3 6 1 0 4 - 3 7 4 1 ( ( 3 3 4 ) 2 2 9 ¬
0 6 4 9 ) , o f a n y t y p o g r a p h i c a l o r o t h e r e r r o r s , i n o r d e r t h a t c o r r e c t i o n s may b e made b e f o r e
t h e o p i n i o n i s p r i n t e d i n Southern R e p o r t e r .
SUPREME COURT OF ALABAMA
OCTOBER TERM, 2012-2013
1101397
Wyeth, I n c . ,
1
et a l .
v.
Danny Weeks and V i c k i Weeks
C e r t i f i e d Question from the U n i t e d S t a t e s D i s t r i c t Court f o r
the Middle D i s t r i c t o f Alabama, Southern D i v i s i o n
(Case No. 1:10-cv-602)
BOLIN,
Justice.
The U n i t e d S t a t e s D i s t r i c t C o u r t
f o r the Middle
District
Although the s t y l e of the order c e r t i f y i n g the question
shows t h i s e n t i t y as "Wyeth, I n c . , " i t i s a l s o r e f e r r e d t o i n
t h e o r d e r , b r i e f s , a n d o t h e r documents s u b m i t t e d t o t h i s C o u r t
as "Wyeth, L L C . "
1
1101397
of
Alabama,
certified
Southern
to t h i s
Division
Court the
R u l e 18, A l a . R. App.
("the
following
district
court"),
has
question pursuant
to
P.:
" U n d e r A l a b a m a l a w , may a d r u g company be h e l d
liable
for
fraud
or
misrepresentation
(by
m i s s t a t e m e n t o r o m i s s i o n ) , b a s e d on s t a t e m e n t s i t
made
in
connection
with
the
manufacture
or
d i s t r i b u t i o n o f a brand-name d r u g , by a p l a i n t i f f
claiming
physical
injury
from
a
generic
drug
manufactured
and
distributed
by
a
different
company?"
F a c t s and P r o c e d u r a l H i s t o r y
In
i t s certification
to t h i s
p r o v i d e d the f o l l o w i n g background
Court, the d i s t r i c t
court
information:
" P l a i n t i f f s Danny and V i c k i Weeks f i l e d t h i s
action
against
five
current
and
former
drug
m a n u f a c t u r e r s f o r i n j u r i e s t h a t Mr. Weeks a l l e g e d l y
s u f f e r e d as a r e s u l t o f h i s l o n g - t e r m u s e o f t h e
p r e s c r i p t i o n drug product metoclopramide, which i s
t h e g e n e r i c f o r m o f t h e brand-name d r u g Reglan.®
The
Weekses c l a i m
that
two
c o m p a n i e s -Teva
P h a r m a c e u t i c a l s USA and A c t a v i s E l i z a b e t h , LLC -¬
m a n u f a c t u r e d and s o l d t h e g e n e r i c
metoclopramide
t h a t Mr. Weeks i n g e s t e d .
"The Weekses c o n c e d e t h a t Mr. Weeks d i d n o t
i n g e s t any Reglan® m a n u f a c t u r e d by t h e t h r e e b r a n d name d e f e n d a n t s , Wyeth LLC, P f i z e r I n c . , and S c h w a r z
Pharma, I n c . The Weekses n o n e t h e l e s s a s s e r t t h a t t h e
brand-name d e f e n d a n t s a r e l i a b l e f o r Mr. Weeks's
harm on f r a u d , m i s r e p r e s e n t a t i o n , a n d / o r s u p p r e s s i o n
theories
because
they
at
different
times
manufactured
or
sold
brand-name
Reglan®
and
purportedly
either
misrepresented
or
failed
a d e q u a t e l y t o warn Mr. Weeks o r h i s p h y s i c i a n a b o u t
2
1101397
t h e r i s k s o f u s i n g Reglan® l o n g - t e r m .
The b r a n d name d e f e n d a n t s moved t o d i s m i s s t h e c l a i m s a g a i n s t
them, a r g u i n g , among o t h e r t h i n g s , ( 1 ) t h a t t h e
W e e k s e s ' c l a i m s , however p l e d , a r e i n f a c t
product
l i a b i l i t y claims that are barred f o r f a i l u r e of
' p r o d u c t i d e n t i f i c a t i o n ' a n d ( 2 ) t h a t t h e y h a d no
duty
t o warn a b o u t t h e r i s k s
associated
with
ingestion of their competitors' generic
products.
The Weekses r e s p o n d e d t o t h e brand-name
defendants'
m o t i o n , and t h e d e f e n d a n t s r e p l i e d .
On M a r c h 3 1 ,
2011, t h i s C o u r t g r a n t e d i n p a r t a n d d e n i e d i n p a r t
t h e brand-name d e f e n d a n t s ' m o t i o n , h o l d i n g t h a t t h e
Weekses m i g h t be a b l e t o s t a t e a c l a i m f o r r e l i e f
under Alabama l a w i f they c o u l d prove t h a t t h e
brand-name m a n u f a c t u r e r s h a d a d u t y t o w a r n Mr.
Weeks's p h y s i c i a n a b o u t t h e r i s k s a s s o c i a t e d w i t h
l o n g - t e r m u s e o f brand-name Reglan® a n d , f u r t h e r ,
t h a t t h e Weekses, as t h i r d p a r t i e s , h a d a r i g h t t o
e n f o r c e an a l l e g e d b r e a c h o f t h a t d u t y .
"Within the l a s t year alone, f e d e r a l d i s t r i c t
c o u r t s i n t h i s S t a t e have i s s u e d f o u r d e c i s i o n s
a d d r e s s i n g t h e q u e s t i o n w h e t h e r brand-name Reglan®
manufacturers
c a n be
held
liable
on
fraud,
m i s r e p r e s e n t a t i o n , and/or s u p p r e s s i o n t h e o r i e s f o r
p h y s i c a l i n j u r i e s a l l e g e d l y caused by p l a i n t i f f s '
i n g e s t i o n of generic metoclopramide.
The f i r s t two
courts
answered n o ; however,
this
Court
held
otherwise,
thereby
c r e a t i n g an i n t r a s t a t e
split.
Compare S i m p s o n v . Wyeth, I n c . , No. 7:10-CV-01771HGD, ... (N.D. A l a . Dec. 9, 2010) [ n o t r e p o r t e d i n F.
Supp. 2 d ] , r e p o r t a n d r e c o m m e n d a t i o n a d o p t e d (N.D.
Ala.
J a n . 4, 2011) [ n o t r e p o r t e d i n F. Supp. 2d]
( h o l d i n g t h a t a brand-name m a n u f a c t u r e r h a s no d u t y
u n d e r A l a b a m a l a w t o warn o f t h e r i s k s a s s o c i a t e d
with a competitor's
g e n e r i c p r o d u c t ) ; M o s l e y v.
Wyeth, I n c . , 719 F. Supp. 2d 1340 (S.D. A l a .
2 0 1 0 ) ( s a m e ) , w i t h Weeks v. Wyeth, I n c . , No. 1:10-cv602,
(M.D. A l a . Mar. 3 1 , 2 0 1 1 ) [ n o t r e p o r t e d i n F.
Supp. 2 d ] ( d e n y i n g brand-name m a n u f a c t u r e r s '
motion
t o d i s m i s s on t h e g r o u n d t h a t t h e p l a i n t i f f s t h e r e
had p l e a d e d a c l a i m ' t h a t d e f e n d a n t s p e r p e t r a t e d a
3
1101397
f r a u d on t h e p h y s i c i a n ' ) ; s e e a l s o B a r n h i l l v. Teva
Pharm. USA. I n c . , No. C i v . 06-0282-CB-M (S.D. A l a .
A p r . 24, 2007) [ n o t r e p o r t e d i n F. Supp. 2 d ] ( h o l d i n g
t h a t a brand-name m a n u f a c t u r e r o f t h e d r u g Keflex®
has no d u t y u n d e r A l a b a m a l a w t o warn o f t h e r i s k s
associated with a competitor's generic product).
Since t h i s Court's d e c i s i o n , another d i s t r i c t court
i n A l a b a m a has f o l l o w e d t h e e a r l i e r d e c i s i o n s . See
O v e r t o n v. Wyeth, I n c . , No. CA 10-0491-KD-C (S.D.
A l a . Mar. 15, 2 0 1 1 ) [ n o t r e p o r t e d i n F. Supp. 2 d ] ,
r e p o r t and r e c o m m e n d a t i o n a d o p t e d (S.D. A l a . A p r . 7,
2011) [ n o t r e p o r t e d i n F. Supp. 2 d ] .
" C e r t i f i c a t i o n i s a p p r o p r i a t e here t o r e s o l v e
t h e d i s a g r e e m e n t among t h e f e d e r a l d i s t r i c t c o u r t s
w i t h i n Alabama and t o p r e v e n t b o t h f e d e r a l c o u r t s
w i t h i n t h e S t a t e and s t a t e c o u r t s a r o u n d t h e c o u n t r y
f r o m h a v i n g t o 'mak[e] u n n e c e s s a r y E r i e g u e s s e s '
a b o u t u n s e t t l e d q u e s t i o n s o f A l a b a m a l a w . T o b i n v.
M i c h i g a n Mut. I n s . Co., 398 F.3d 1267, 1274 ( 1 1 t h
C i r . 2 0 0 5 ) ; s e e a l s o , e.g., Lehman B r o s . v. S c h e i n ,
416 U.S. 386, 391 ( 1 9 7 4 ) ( n o t i n g t h a t c e r t i f i c a t i o n
o f t e n ' s a v e [ s ] t i m e , e n e r g y , and r e s o u r c e s and h e l p s
b u i l d a c o o p e r a t i v e j u d i c i a l f e d e r a l i s m ' ) . 'Because
t h e o n l y a u t h o r i t a t i v e v o i c e on A l a b a m a l a w i s t h e
A l a b a m a Supreme C o u r t , i t i s a x i o m a t i c t h a t t h a t
c o u r t i s t h e b e s t one t o d e c i d e i s s u e s o f A l a b a m a
law.'
B l u e C r o s s & B l u e S h i e l d o f A l a . , I n c . v.
N i e l s e n , 116 F.3d 1406, 1413 ( 1 1 t h C i r . 1 9 9 7 ) .
"The
question
framed
...
satisfies
the
requirements
o f A l a . R. App. P. 1 8 ( a ) : f i r s t , i t
p r e s e n t s a pure q u e s t i o n o f Alabama law; second, i t
i s ' d e t e r m i n a t i v e ' of t h i s case i n the sense t h a t a
negative
answer w o u l d r e q u i r e d i s m i s s a l o f t h e
Weekses' c l a i m s a g a i n s t t h e brand-named d e f e n d a n t s ;
and t h i r d , a l t h o u g h two A l a b a m a t r i a l c o u r t s have
addressed
the
question
whether
a
brand-name
m a n u f a c t u r e r can e v e r be h e l d l i a b l e f o r p h y s i c a l
harm c a u s e d by a g e n e r i c p r o d u c t and a n s w e r e d i t i n
t h e n e g a t i v e , t h e A l a b a m a Supreme C o u r t has n e v e r
considered or resolved e i t h e r that question or the
1
4
1101397
s u b s i d i a r y q u e s t i o n whether a p l a i n t i f f
claiming
physical
injury
can
prevail
on
fraud,
m i s r e p r e s e n t a t i o n , and/or s u p p r e s s i o n t h e o r i e s under
these f a c t s .
"Considerations of j u d i c i a l e f f i c i e n c y l i k e w i s e
counsel c e r t i f i c a t i o n . During the l a s t year, the
number o f Reglan®/metoclopramide c a s e s
nationwide
b a l l o o n e d f r o m 250 t o a p p r o x i m a t e l y 3500.
Current
e s t i m a t e s s u g g e s t t h a t among t h e 3500 c a s e s t h e r e
a r e a t l e a s t 250 A l a b a m a - r e s i d e n t p l a i n t i f f s a n d
t h a t most ( i f n o t a l l ) o f t h e s e p l a i n t i f f s a s s e r t
the f r a u d , m i s r e p r e s e n t a t i o n ,
and/or
suppression
t h e o r i e s a s s e r t e d here.
The A l a b a m a Supreme C o u r t ' s
d e f i n i t i v e r e s o l u t i o n of the question presented w i l l
t h e r e f o r e a f f e c t not only cases pending (or t h a t
might l a t e r a r i s e ) i n t h i s S t a t e , but a l s o the
scores of Alabama-resident cases pending i n courts
around
the country
-particularly
i n large
consolidated actions pending i n C a l i f o r n i a ,
New
J e r s e y , and P e n n s y l v a n i a .
Moreover, the question's
significance
extends
well
beyond
t h e Reglan®
litigation
—
and f o r t h a t m a t t e r ,
even beyond
p h a r m a c e u t i c a l l i t i g a t i o n . I t i s l i k e l y t o r e c u r any
t i m e a brand-name m a n u f a c t u r e r ( o f any p r o d u c t ) i s
s u e d on f r a u d , m i s r e p r e s e n t a t i o n , a n d / o r s u p p r e s s i o n
t h e o r i e s b y a p l a i n t i f f who c l a i m s t o have b e e n
i n j u r e d while using a generic-equivalent product.
"
" See B u c h a n a n v . Wyeth Pharm,, I n c . , No. CV2007-900065, O r d e r a t 1 ( A l a . C i r . C t . O c t . 20,
2 0 0 8 ) ; G r e e n v. Wyeth Pharm., I n c . , No. CV-06-3917
ER ( A l a . C i r . C t . May 14, 2 0 0 7 ) . "
1
Discussion
5
1101397
At
the
outset,
manufacturers
distributors
three
of
we
the
prescription
thereof.
brand-name
limit
question
drugs
The Weekses'
manufacturers,
and
posed
to
any
complaint alleges
that
Wyeth,
not
to
Pfizer,
I n c . , and
S c h w a r z Pharma, I n c . ( h e r e i n a f t e r c o l l e c t i v e l y r e f e r r e d t o as
"the
Wyeth
defendants"),
falsely
and
deceptively
m i s r e p r e s e n t e d o r k n o w i n g l y s u p p r e s s e d f a c t s about Reglan o r
metoclopramide
prescribed
misled
that
Danny
Weeks's
the l i k e l i h o o d
disorder
disorders.
2
tardive
that
the drug
dyskinesia
and
about
w i t h t h e l o n g - t e r m use of metoclopramide
as t h i r d p a r t i e s ,
he
would
cause
related
the
movement
the r i s k s
associated
a n d t h a t t h e Weekses,
have a r i g h t t o e n f o r c e t h e a l l e g e d b r e a c h
duty.
A fraudulent-misrepresentation
5-101,
when
The Weekses c o n t e n d t h a t t h e Wyeth d e f e n d a n t s h a d
a d u t y t o warn Danny's p h y s i c i a n
of t h a t
physician,
t h e d r u g t o Danny, was m a t e r i a l l y m i s i n f o r m e d a n d
about
movement
such
Ala.
Code
"[m]isrepresentations
1975,
a c t i o n i s g o v e r n e d by § 6¬
which
of a m a t e r i a l
fact
The
Weekses
also
sued
generic
metoclopramide,
Teva
Pharmaceuticals
E l i z a b e t h , LLC.
2
6
provides
made w i l l f u l l y
that
to
manufacturers
of
USA
and
Actavis
1101397
deceive,
or r e c k l e s s l y without
k n o w l e d g e , a n d a c t e d on b y t h e
o p p o s i t e p a r t y , o r i f made b y m i s t a k e a n d i n n o c e n t l y a n d a c t e d
on b y t h e o p p o s i t e p a r t y , c o n s t i t u t e l e g a l f r a u d . "
fraudulent misrepresentation
"(1) a f a l s e r e p r e s e n t a t i o n
relied
upon
by
A claim of
comprises the f o l l o w i n g elements:
(2) c o n c e r n i n g
the p l a i n t i f f
a m a t e r i a l f a c t (3)
(4) who
was
damaged
as
a
p r o x i m a t e r e s u l t . " F i s h e r v. Comer P l a n t a t i o n , 772 So. 2d 455,
463
(Ala. 2000)(quoting
(Ala.
1992)).
misrepresentation
"An
B a k e r v . B e n n e t t , 603 So. 2d 928, 935
essential
element
of
and f r a u d u l e n t - s u p p r e s s i o n
fraudulent-
claims i s a duty
t o d i s c l o s e . " N e s b i t t v. F r e d e r i c k , 941 So. 2d 950, 955 ( A l a .
2006).
We r e c o g n i z e
are,
i n essence,
American
Motors
t h a t Wyeth a r g u e s t h a t t h e Weekses'
"product-liability"
Corp.,
335
So.
2d
claims.
134
claims
In Atkins
v.
( A l a . 1976),
in
c o n j u n c t i o n w i t h C a s r e l l v . A l t e c I n d u s t r i e s , I n c . , 335 So. 2d
128
(Ala.
1976),
this
Manufacturer's L i a b i l i t y
judicially
created
Court
adopted
Doctrine
accommodation
doctrine of s t r i c t l i a b i l i t y
t h e Alabama
("AEMLD").
of
Extended
The AEMLD i s "a
Alabama
law t o the
f o r damage o r i n j u r i e s c a u s e d b y
allegedly defective products."
K e c k v. D r y v i t S y s . ,
7
I n c . , 830
1101397
So.
2d 1, 5 ( A l a . 2 0 0 2 ) .
This Court
has e x p l a i n e d t h a t t h e
AEMLD d i d n o t subsume a common-law n e g l i g e n c e
claim.
(Ala.
So.
o r wantonness
T i l l m a n v. R . J . R e y n o l d s T o b a c c o Co., 871 So. 2d 28
2 0 0 3 ) ; V e s t a F i r e I n s . C o r p . v . M i l a m & Co. C o n s t r . , 901
2d 84 ( A l a . 2 0 0 4 ) .
" I t must be remembered, ... t h a t t h e AEMLD, as
e s t a b l i s h e d i n C a s r e l l a n d A t k i n s , s u p r a , i s 'an
example o f j u d i c i a l l e g i s l a t i o n , ' n o t o f l e g i s l a t i v e
e n a c t m e n t . K e c k v. D r y v i t S y s . , I n c . , 830 So. 2d 1,
8 ( A l a . 2002).
T h i s Court warned l a s t year i n Keck
t h a t ' [ j ] u d i c i a l d e c i s i o n - m a k i n g s h o u l d n o t be s e e n
as t h e o p p o r t u n i t y t o l e g i s l a t e . '
830 So. 2d a t 8.
A l a b a m a r e m a i n s a common-law s t a t e , a n d t h e r e f o r e
common-law t o r t a c t i o n s 'so f a r as [ t h e y a r e ] n o t
inconsistent
with
t h e C o n s t i t u t i o n , laws
and
institutions
o f t h i s s t a t e ... s h a l l c o n t i n u e i n
force, except
as f r o m t i m e t o t i m e
... may be
a l t e r e d o r r e p e a l e d b y t h e L e g i s l a t u r e . ' § 1-3-1,
A l a . Code 1 9 7 5 . We w i l l n o t presume t o so d e f i n e
t h e b o u n d a r i e s o f t h e j u d i c i a l l y c r e a t e d AEMLD s o
t h a t i t subsumes t h e common-law t o r t a c t i o n s o f
negligence
and wantonness a g a i n s t
the r e t a i l e r
defendants."
Tillman,
871 So. 2d a t 34-35.
fraudulent
claim.
suppression
Keck,
supra.
is a
We h a v e a l s o r e c o g n i z e d
claim
Accordingly,
c e r t i f i e d q u e s t i o n , we w i l l
separate
from
f o r purposes
that
an AEMLD
of
this
n o t t r e a t t h e Weekses' c l a i m s as
AEMLD c l a i m s g o v e r n e d b y t h e p r i n c i p l e s o f t h e AEMLD.
We n o t e t h a t A l a b a m a ' s Pharmacy A c t p e r m i t s
a
pharmacist
t o s e l e c t i n p l a c e o f a brand-name d r u g a l e s s e x p e n s i v e
8
drug
1101397
product
that
equivalent
is
the
pharmaceutical
o f t h e brand-name d r u g and
a c t i v e i n g r e d i e n t or i n g r e d i e n t s
and
and
therapeutical
that contains
i s the
the
same
same d o s a g e - f o r m
s t r e n g t h , u n l e s s the p r e s c r i b i n g p h y s i c i a n i n d i c a t e s o t h e r w i s e
on
the
present
prescription. §
case,
34-23-8,
i t appears
that
Ala.
Code
1975.
In
the
Danny's p r e s c r i p t i o n d i d
not
p r o h i b i t the p h a r m a c i s t from s u b s t i t u t i n g a g e n e r i c
t h e brand-name d r u g .
generic
,
131
dissenting).
S.Ct.
PLIVA, I n c . v. M e n s i n g ,
2567,
manufacturer.
U.S.
at
u n d e r § 34-23-8 and
t o promote the
n.2,
claim
Additionally,
131
use
S.Ct.
of
at
U.S.
(2011)(Sotomayor,
d r u g does n o t p r e c l u d e
fraudulent-misrepresentation
structured
2583
That a pharmacy a c t e d
Danny a g e n e r i c
a
" C u r r e n t l y a l l s t a t e s have some f o r m o f
s u b s t i t u t i o n law."
,
drug f o r
his a b i l i t y
against
many
the
2584 n.2.
now
assert
plans
drugs.
We
gave
brand-name
insurance
generic
to
J.,
are
PLIVA,
turn to
the
f e d e r a l laws g o v e r n i n g p r e s c r i p t i o n drugs.
Prescription
federal
drugs
regulation
Administration
of
are
that
("FDA").
comprehensive r e g u l a t o r y
unique because of
product
"Congress
by
the
had
scheme, a d m i n i s t e r e d
9
the
Food
extensive
and
Drug
established
by
the
FDA,
a
to
1101397
control
the design
and d i s t r i b u t i o n
of p r e s c r i p t i o n drugs."
B l a c k m o n v . A m e r i c a n Home P r o d s . C o r p . , 328 F. Supp. 2d 659,
665
(S.D. Tex. 2 0 0 4 ) ( c i t i n g 21 U.S.C. §§ 3 0 1 - 3 9 3 ) .
has
the ultimate
authority
to
determine
whether
p r e s c r i p t i o n drug i s s a f e and e f f e c t i v e f o r use.
355(a)
without
and
( d ) ( p r o h i b i t i n g the d i s t r i b u t i o n
FDA a p p r o v a l
d r u g t o be s a f e
o f a new-drug
and e f f e c t i v e ) .
The FDA
a
new
21 U.S.C. §§
o f a new
drug
a p p l i c a t i o n showing the
The a p p r o v a l
process
begins
w i t h an i n v e s t i g a t i o n a l new-drug a p p l i c a t i o n ("IND") s u b m i t t e d
to
t h e FDA, w h i c h i n c l u d e s
information
about t h e
chemistry,
m a n u f a c t u r i n g , p h a r m a c o l o g y , a n d t o x i c o l o g y o f t h e d r u g . See
21 U.S.C. § 3 5 5 ( b ) ; 21 C.F.R. § 312.21.
pre-clinical
protocols
data
(animal
The IND a l s o
includes
pharmacology and t o x i c o l o g y ) , and
f o r human t e s t i n g must be d e t a i l e d .
3
T h e c l i n i c a l p h a s e o f t e s t i n g on human s u b j e c t s i s
d i v i d e d i n t o t h r e e p h a s e s : Phase one i n v o l v e s a b o u t 20 t o 100
h e a l t h y , n o m i n a l l y p a i d v o l u n t e e r s and i s d e s i g n e d t o t e s t f o r
s a f e t y a n d t o l e r a b i l i t y (21 C.F.R. § 3 1 2 . 2 1 ( a ) ) ; p h a s e two
i n v o l v e s s e v e r a l hundred unpaid v o l u n t e e r s diagnosed w i t h a
p a r t i c u l a r c o n d i t i o n and a s s e s s e s t h e p r e l i m i n a r y e f f i c a c y o f
t h e d r u g as w e l l as s a f e t y a n d t o l e r a b i l i t y
(21 C.F.R. §
3 1 2 . 2 1 ( b ) ) ; and phase t h r e e i n v o l v e s hundreds t o s e v e r a l
thousands o f p a t i e n t s and i s d e s i g n e d t o e v a l u a t e t h e s a f e t y
and e f f i c a c y o f t h e d r u g on a l a r g e r segment o f t h e p o p u l a t i o n
(21 C.F.R. § 3 1 2 . 2 1 ( c ) ) .
The FDA may r e q u i r e
phase-four
studies
concurrent
with
market
approval
to
conduct
postmarketing reports
i n drugs intended
to treat
lifet h r e a t e n i n g and s e v e r e l y d e b i l i t a t i n g i l l n e s s e s .
21 C.F.R §
3
10
1101397
After clinical
trials
on humans have b e e n c o m p l e t e d , t h e
m a n u f a c t u r e r may s u b m i t a new-drug a p p l i c a t i o n
FDA.
the
("NDA") t o t h e
The m a n u f a c t u r e r must p r e s e n t " s u b s t a n t i a l e v i d e n c e t h a t
d r u g w i l l have t h e e f f e c t i t p u r p o r t s o r i s r e p r e s e n t e d t o
have u n d e r t h e c o n d i t i o n s o f u s e p r e s c r i b e d ,
suggested i n the proposed
The NDA s h a l l i n c l u d e :
labeling."
recommended, o r
21 U.S.C. § 3 5 5 ( d ) ( 5 ) .
(1) r e p o r t s o f t h e c l i n i c a l
t r i a l s and
t e s t i n g done t o d e t e r m i n e t h e s a f e t y a n d e f f e c t i v e n e s s o f t h e
drug;
(2) t h e c o m p l e t e i n g r e d i e n t s o r components o f t h e d r u g ;
(3) t h e c o m p o s i t i o n o f t h e d r u g ;
the
manufacturing,
controls;
U.S.C.
§
p r o c e s s i n g , and p a c k a g i n g
(5) s a m p l e s
requested);
and
of the drug
(6) s a m p l e s
355(b)(1).
who w o r k e d
w e l l as t h e i r
reports.
and e x p i r a t i o n
impacted by t h e drug.
generally
developer)
good
also
in clinical
methods
and
a n d i t s components ( i f
of the proposed
The NDA
investigators
number
(4) a c o m p l e t e d e s c r i p t i o n o f
must
labeling.
disclose
trials
21
a l l the
o f t h e d r u g as
A l s o , an NDA must i n c l u d e t h e p a t e n t
dates
o f any p a t e n t s
21 U.S.C. § 3 5 5 ( b ) ( 1 ) .
f o r 20 y e a r s , g i v i n g
the exclusive
right
312.95
11
related
The p a t e n t i s
the manufacturer
t o make
to or
and s e l l
(drug
the drug
1101397
during that period.
35 U.S.C. § 1 5 4 ( a ) ( 2 ) .
The m a n u f a c t u r e r
make s e e k a f i v e - y e a r e x t e n s i o n o f t h e p a t e n t u n d e r 35 U.S.C.
§
156(g)(6)(A).
When
the patent
manufacturers
Generic
seek
to
drug
replicate
a
expires,
generic
generic
version.
v e r s i o n s o f brand-name d r u g s c o n t a i n t h e same a c t i v e
ingredient
Generix
may
on a brand-name
as t h e brand-name
Drug
approval
Corp.,
process
460 U.S.
original.
453
f o r generic
United
(1983).
drugs
States
v.
To e x p e d i t e t h e
in
order
to
bring
p r e s c r i p t i o n - d r u g c o s t s down w h i l e a t t h e same t i m e p r e s e r v i n g
p a t e n t p r o t e c t i o n s f o r brand-name d r u g s ,
Drug
1984.
P r i c e Competition
and P a t e n t
21 U.S.C. § 355.
Waxman A c t , p r o v i d e s
("ANDA") p r o c e s s
brand-name
Term
Restoration Act of
T h i s A c t , a l s o known
f o r an a b b r e v i a t e d
f o r the approval
drugs.
Congress adopted the
as t h e H a t c h -
new-drug-application
of generic
The ANDA r e l i e s
versions
on t h e FDA's
of
previous
d e t e r m i n a t i o n t h a t t h e brand-name d r u g i s s a f e a n d e f f e c t i v e .
See E l i L i l l y
& Co. v. M e d t r o n i c ,
I n c . , 496 U.S.
661, 675
( 1 9 9 0 ) ( " T h e ANDA a p p l i c a n t c a n s u b s t i t u t e b i o e q u i v a l e n c e
for
the extensive
effectiveness
that
animal
must
a n d human
accompany
12
studies
a
data
o f s a f e t y and
full
new
drug
1101397
application.").
version
of
process
drug
to
allows
avoid
the
applicant
costly
for
and
4
generic drugs.
(June 21, 1984) .
to a l l data
some d a t a may
See
H.R.
Rep.
No.
i n the master f i l e
c o n t r o l l e d by
Congress
protect
sought
time-consuming
dissemination
98-857 ( P a r t I)
Bioscience,
entitled
t h e FDA
to
C.F.R. § 314.430.
brand-name
At
the
because
their
Inc.
v.
patented
innovations.
Thompson,
243
F.3d
same
manufacturers
r i g h t s c o u l d be t h r e a t e n e d by t h e m a r k e t i n g
of
generic
c o n s t i t u t e t r a d e s e c r e t s b e l o n g i n g t o the brand21
versions
a
A g e n e r i c manufacturer i s not
name m a n u f a c t u r e r .
patent
an
a s s o c i a t e d w i t h a NDA, w h i c h a l l o w s t h e
of low-cost
a t 14
a
This
579,
See
580
of
time,
whose
generic
American
(D.C.
Cir.
The m a r k e t i n g
o f brand-name d r u g s a l s o adds t o t h e
e x p e n s e o f t h e brand-name d r u g s .
"The
p r e s c r i p t i o n drug
industry i s subject to extensive f e d e r a l r e g u l a t i o n , i n c l u d i n g
t h e now
f a m i l i a r requirement t h a t p r e s c r i p t i o n drugs
be
d i s p e n s e d o n l y upon a p h y s i c i a n ' s p r e s c r i p t i o n . I n l i g h t o f
t h i s r e q u i r e m e n t , p h a r m a c e u t i c a l c o m p a n i e s have l o n g f o c u s e d
t h e i r d i r e c t m a r k e t i n g e f f o r t s n o t on t h e r e t a i l p h a r m a c i e s
t h a t d i s p e n s e p r e s c r i p t i o n d r u g s , b u t r a t h e r on t h e m e d i c a l
p r a c t i t i o n e r s who p o s s e s s t h e a u t h o r i t y t o p r e s c r i b e t h e d r u g s
i n the f i r s t p l a c e .
P h a r m a c e u t i c a l companies promote t h e i r
products to physicians through a process c a l l e d ' d e t a i l i n g '
w h e r e b y e m p l o y e e s known as ' d e t a i l e r s ' o r
'pharmaceutical
sales r e p r e s e n t a t i v e s ' provide information to physicians i n
t h e hopes o f p e r s u a d i n g them t o w r i t e p r e s c r i p t i o n s f o r t h e
products i n appropriate cases."
C h r i s t o p h e r v. S m i t h K l i n e
Beecham C o r p . ,
U.S.
,
, 132 S.Ct.
2156,
2163
(2012)(footnote omitted).
4
13
1101397
2 0 0 1 ) ; P u r e p a c Pharm. Co. v. Thompson, 238 F. Supp. 2d 191 (D.
D.C.
2002).
Brand-name
with
have a d u t y t o s u p p l y t h e FDA
"postmarketing reports,"
serious
and u n e x p e c t e d
of a drug.
must
manufacturers
also
which
information,
annual
including
reports
reports
The brand-name
t o t h e FDA
information
that
manufacturer
on
significant
might
affect
safety, e f f e c t i v e n e s s , or l a b e l i n g of the product.
§
314.81.
A
generic manufacturer
i s likewise
different
manufacturers
and
federal drug-labeling
generic
the
21 C.F.R.
required
s u b m i t t h e s e r e p o r t s t o t h e FDA. 21 C.F.R. § 314.98.
brand-name
o f any
adverse r e a c t i o n s s u f f e r e d by a u s e r
21 C.F.R. § 314.80.
submit
include
to
However,
manufacturers
have
responsibilities.
"A brand-name m a n u f a c t u r e r s e e k i n g new d r u g a p p r o v a l
i s r e s p o n s i b l e f o r t h e a c c u r a c y and adequacy o f i t s
l a b e l . See, e.g., 21 U.S.C. §§ 3 5 5 ( b ) ( 1 ) , ( d ) ; Wyeth
[v. L e v i n e , 555 U.S.
5 5 5 ] , 550-571
(2009)]. A
m a n u f a c t u r e r s e e k i n g g e n e r i c d r u g a p p r o v a l , on t h e
o t h e r hand, i s r e s p o n s i b l e f o r e n s u r i n g t h a t i t s
w a r n i n g l a b e l i s t h e same as t h e b r a n d name's. See,
e.g., § 3 5 5 ( j ) ( 2 ) ( A ) ( v ) ; § 3 5 5 ( j ) ( 4 ) ( G ) ; 21 CFR §§
314.94(a)(8), 314.127(a)(7)."
PLIVA,
U.S.
at
s u b j e c t t o change.
, 131 S . C t . a t 2574.
New
r i s k s may become
"Drug l a b e l s a r e
apparent only a f t e r
t h e d r u g h a s b e e n u s e d more w i d e l y a n d f o r l o n g e r p e r i o d s . "
14
1101397
M e n s i n g v. Wyeth, 588 F.3d 603, 606 ( 8 t h C i r . 2 0 0 9 ) ,
on
other
grounds,
Effected"
or
discovering
label
PLIVA,
"CBE"
supra.
rule,
a clinically
a
brand-name
or adverse
C.F.R.
§
review
any
314.70(c)(7).
manufacturer
revised
A
a
reaction"
314.70(c)(6)(iii)(A).
CBE
t h e "Changes
manufacturer,
upon
modification
contraindication,
without
FDA a p p r o v a l .
Ultimately,
to a
warning,
label.
t h e FDA
21
21
will
C.F.R.
§
I f t h e FDA r e j e c t s t h e change, i t may o r d e r t h e
t o cease
label.
"label"
d i s t r i b u t i o n o f the drug
21 C.F.R. §
i s defined
21 U.S.C. § 3 2 1 ( k ) .
as "a d i s p l a y o f w r i t t e n ,
the
printed,
o f any a r t i c l e
" ' [ L ] a b e l i n g ' means a l l l a b e l s a n d
other w r i t t e n , p r i n t e d , or graphic matter
o r any o f i t s c o n t a i n e r s
with
314.70(c)(7).
o r g r a p h i c m a t t e r upon t h e i m m e d i a t e c o n t a i n e r
article."
Being
s i g n i f i c a n t h a z a r d , may m o d i f y i t s
t o "add o r s t r e n g t h e n
precaution,
Under
reversed
(1) upon any a r t i c l e
o r w r a p p e r s , o r (2) a c c o m p a n y i n g s u c h
21 U.S.C. § 321(m).
The FDA i n t e r p r e t s " l a b e l i n g "
broadly, to include:
"[b]rochures, booklets, mailing pieces, f i l e cards,
b u l l e t i n s , c a l e n d a r s , p r i c e l i s t s , c a t a l o g s , house
organs, l e t t e r s , motion p i c t u r e f i l m s , f i l m s t r i p s ,
lantern
slides,
sound
recordings,
exhibits,
literature,
and r e p r i n t s and s i m i l a r p i e c e s o f
p r i n t e d , audio, or v i s u a l matter d e s c r i p t i v e of a
15
1101397
drug and r e f e r e n c e s p u b l i s h e d ( f o r example, t h e
' P h y s i c i a n s Desk R e f e r e n c e ' ) f o r u s e b y m e d i c a l
p r a c t i t i o n e r s , pharmacists, or nurses, containing
drug
information
s u p p l i e d by t h e m a n u f a c t u r e r ,
packer, or d i s t r i b u t o r o f the drug
"
21
C.F.R.
§
202.1(l)(2).
interpretation
U.S.
at
of l a b e l i n g
The
FDA
includes
"Dear D o c t o r " l e t t e r s ,
, 131 S . C t . a t 2576,
which
ini t s
PLIVA,
are l e t t e r s
drug
m a n u f a c t u r e r s s e n d t o h e a l t h - c a r e p r o v i d e r s i n f o r m i n g them o f
critical
newly
discovered
risks
or
side
effects
of
a
medication.
The FDA h a s d e t e r m i n e d t h a t a g e n e r i c m a n u f a c t u r e r
cannot
u n i l a t e r a l l y s t r e n g t h e n a warning l a b e l f o r a g e n e r i c drug
s e n d a "Dear D o c t o r " l e t t e r u n d e r
so w o u l d v i o l a t e
the statutes
t h e CBE r u l e b e c a u s e
and r e g u l a t i o n s
or
doing
requiring the
l a b e l o f a g e n e r i c d r u g t o m a t c h t h e brand-name m a n u f a c t u r e r ' s
label.
PLIVA,
U.S. a t
, 131 S . C t . a t 2575.
"Federal r e g u l a t i o n s a p p l i c a b l e t o g e n e r i c drug
manufacturers
directly
conflict
with,
and thus
preempt,
state
laws
that
hold
generic
drug
manufacturers l i a b l e f o r inadequate warning l a b e l s
on t h e i r p r o d u c t s . M e n s i n g ,
131 S . C t . a t 2578.
Under t h e F e d e r a l Food, Drug, a n d C o s m e t i c A c t , 21
U.S.C. § 301 e t s e q . , a m a n u f a c t u r e r s e e k i n g f e d e r a l
a p p r o v a l t o m a r k e t a new d r u g must p r o v e t h a t i t i s
s a f e and e f f e c t i v e and t h a t t h e p r o p o s e d l a b e l i s
a c c u r a t e a n d a d e q u a t e . 21 U.S.C. § 3 5 5 ( b ) ( 1 ) . By
c o n t r a s t , under
t h e Drug P r i c e C o m p e t i t i o n a n d
Patent
Term
Restoration
A c t , known
as t h e
16
1101397
Hatch-Waxman Amendments, g e n e r i c d r u g f o r m u l a t i o n s
can g a i n FDA a p p r o v a l by s h o w i n g b i o e q u i v a l e n c e t o
a
reference-listed
drug
t h a t has
a l r e a d y been
a p p r o v e d by t h e FDA. 21 U.S.C. § 3 5 5 ( j ) ( 2 ) ( A ) . A
g e n e r i c d r u g a p p l i c a t i o n must a l s o show t h a t 'the
l a b e l i n g p r o p o s e d f o r t h e new d r u g i s t h e same as
the l a b e l i n g approved f o r the l i s t e d drug.'
21
U.S.C. § 3 5 5 ( j ) ( 2 ) ( A ) ( v ) . T h e r e f o r e , r a t h e r t h a n a
d u t y t o w a r n , ' g e n e r i c m a n u f a c t u r e r s have an o n g o i n g
f e d e r a l d u t y o f sameness' r e g a r d i n g t h e i r w a r n i n g
labels.
M e n s i n g , 131 S.Ct. a t 2574. Under t h e same
r u l e s , g e n e r i c d r u g m a n u f a c t u r e r s may
not i s s u e
a d d i t i o n a l w a r n i n g s t h r o u g h Dear D o c t o r l e t t e r s , n o r
may
they
imply
i n any
way
that
there i s a
t h e r a p e u t i c d i f f e r e n c e b e t w e e n t h e i r p r o d u c t and t h e
name-brand d r u g .
I d . a t 257 6."
Phelps
v.
Wyeth,
2012)(emphasis
I n c . , 857
added).
F.
Supp.
2d
1114,
A c c o r d i n g t o t h e FDA,
1133
i f a
(D.
Or.
generic-
drug m a n u f a c t u r e r b e l i e v e s t h a t s t r o n g e r warnings are needed,
then the manufacturer
the
FDA,
and,
i s r e q u i r e d t o propose
i f the
FDA
agrees
that
such changes t o
such
changes
are
n e c e s s a r y , t h e FDA w i l l work w i t h t h e brand-name m a n u f a c t u r e r
to
c r e a t e a new
drug.
PLIVA,
label
U.S.
f o r both
at
the
, 131
brand-name
S.Ct.
and
generic
a t 2576.
The Supreme C o u r t , i n two c a s e s , has a d d r e s s e d t h e e x t e n t
to
which
manufacturers
approval.
We
regulations,
generic
note
may
that,
change
because
their
of
both the manufacturers
drugs
in
those
cases
17
the
labels
after
extensive
federal
o f brand-name d r u g s
argued
that
the
FDA
and
federal
1101397
r e g u l a t i o n s preempted s t a t e - l a w
555
claims.
I n Wyeth v.
Levine,
U.S.
555
( 2 0 0 9 ) , t h e p l a i n t i f f d e v e l o p e d g a n g r e n e and
forearm
had
to
injected
her
be
amputated
artery with
when
the
a
physician's
anti-nausea
u s i n g t h e " I V p u s h " method o f i n t r a v e n o u s
drug
adequate warning about the
injection.
different risks
t h e v a r i o u s methods o f a d m i n i s t e r i n g
common-law n e g l i g e n c e
and
found that
failed
about
the
the
IV
Wyeth had
risks
push
strict-liability
involved
method.
the drug.
to provide
when P h e n e r g a n
On
appeal,
assistant
Phenergan
Wyeth, t h e m a n u f a c t u r e r o f P h e n e r g a n , f o r f a i l i n g
an
She
to
for
adequate
Wyeth
argued
labeling
rejected
warning
the
both
preemption.
The
by
the
federal
impossible
federal-
Wyeth a l s o a r g u e d t h a t r e c o g n i t i o n
s u i t s would undermine Congress's i n t e n t to
to
expertise
contentions
of
the
and
FDA.
held
The
that
Court
was
no
Supreme C o u r t c o n c l u d e d t h a t Wyeth f a i l e d
d e m o n s t r a t e t h a t i t was
impossible
18
of
entrust
Supreme
there
on
jury
that
a m a n u f a c t u r e r t o c o m p l y w i t h b o t h s t a t e l a w s and
state-law
A
i s administered
d r u g l a b e l i n g b e c a u s e i t was
labeling obligations.
with
relied
p l a i n t i f f ' s f a i l u r e - t o - w a r n c l a i m s were p r e e m p t e d by
regulations regarding
sued
involved
She
by
provide
theories.
an
her
f o r i t t o comply w i t h
to
both
1101397
federal
and
state
r e q u i r e m e n t s , and
i t noted that s t a t e - l a w
c l a i m s a r e an i m p o r t a n t complement t o t h e FDA's r e g u l a t i o n o f
p r e s c r i p t i o n drugs.
The
Supreme C o u r t
stated:
"In keeping w i t h Congress' d e c i s i o n not t o p r e ¬
empt common-law t o r t s u i t s , i t a p p e a r s t h a t t h e FDA
t r a d i t i o n a l l y r e g a r d e d s t a t e l a w as a c o m p l e m e n t a r y
form
of drug
regulation.
The
FDA
has
limited
r e s o u r c e s t o m o n i t o r t h e 11,000 d r u g s on t h e m a r k e t ,
and
manufacturers
have
superior
access
to
i n f o r m a t i o n about t h e i r drugs, e s p e c i a l l y i n the
p o s t m a r k e t i n g p h a s e as new r i s k s emerge. S t a t e t o r t
s u i t s u n c o v e r unknown d r u g h a z a r d s and p r o v i d e
i n c e n t i v e s f o r drug manufacturers to d i s c l o s e s a f e t y
risks
promptly.
They
also
serve
a
distinct
compensatory
f u n c t i o n t h a t may
motivate
injured
p e r s o n s t o come f o r w a r d w i t h i n f o r m a t i o n . F a i l u r e to-warn a c t i o n s , i n p a r t i c u l a r , l e n d f o r c e to the
[ F e d e r a l Food, Drug, and C o s m e t i c A c t ] ' s p r e m i s e
that manufacturers,
not
t h e FDA,
bear
primary
r e s p o n s i b i l i t y f o r t h e i r drug l a b e l i n g at a l l times.
Thus, t h e FDA l o n g m a i n t a i n e d t h a t s t a t e l a w o f f e r s
an a d d i t i o n a l , and i m p o r t a n t , l a y e r o f consumer
p r o t e c t i o n t h a t c o m p l e m e n t s FDA r e g u l a t i o n . "
555 U.S.
a t 578-79
PLIVA,
labels,
but
(footnote omitted).
supra, also i n v o l v e d a preemption claim regarding
the
manufacturer
version
o f a brand-name d r u g .
whether
federal
drug
there
"The
regulations
produced
the
generic
question presented
applicable
[was]
t o g e n e r i c drug
m a n u f a c t u r e r s d i r e c t l y c o n f l i c t w i t h , and t h u s p r e - e m p t , t h e s e
state-law claims."
FDA
had
U.S.
issued a labeling
at
, 131
S.Ct.
a t 2572.
requirement r e g a r d i n g Reglan,
19
The
the
1101397
b r a n d name o f m e t o c l o p r a m i d e ,
present case.
the g e n e r i c drug a t i s s u e i n the
The p l a i n t i f f s
i n P L I V A were p r e s c r i b e d R e g l a n
but r e c e i v e d t h e g e n e r i c form o f t h e drug, which c o n t a i n e d t h e
same l a b e l i n g i n f o r m a t i o n t h e FDA h a d a p p r o v e d f o r t h e b r a n d name d r u g .
A c c o r d i n g t o t h e FDA, 57 F e d . Reg. 17961 (1992)
r e q u i r e s a g e n e r i c - d r u g maker's l a b e l i n g t o be t h e same as t h e
brand-name d r u g maker's l a b e l i n g b e c a u s e t h e brand-name d r u g
i s t h e b a s i s f o r a p p r o v a l o f t h e g e n e r i c d r u g b y t h e FDA.
U.S. a t
a
"black
, 131 S . C t . a t 2575.
box" warning
associated
with
By 2009, t h e FDA h a d o r d e r e d
f o r Reglan
i t s long-term
concerning
use.
The
the
dangers
plaintiffs
had
s u f f e r e d severe n e u r o l o g i c a l r e a c t i o n s from t a k i n g t h e g e n e r i c
form o f t h e drug and b r o u g h t s t a t e - l a w t o r t c l a i m s a g a i n s t t h e
manufacturers o f t h e g e n e r i c form o f t h e drug, f o r f a i l i n g t o
warn them o f s u c h d a n g e r .
was
that
the warning
inadequate and t h a t
The b a s i s o f t h e p l a i n t i f f s '
labels
f o r the generic
drug
claims
were
the g e n e r i c manufacturers had a duty t o
s t r e n g t h e n t h e i r w a r n i n g l a b e l s u n d e r t h e FDA's CBE p r o c e s s .
U.S. a t
that
, 131 S . C t . a t 2575.
t h e FDA's
plaintiffs'
federal-labeling
The Supreme C o u r t
requirement
found
preempted t h e
state-law claims against the manufacturers of the
20
1101397
generic
d r u g b e c a u s e i t w o u l d have been
generic-drug
manufacturers
t o change
impossible f o r the
their
warning
labels
w i t h o u t v i o l a t i n g t h e f e d e r a l r e q u i r e m e n t t h a t t h e w a r n i n g on
a
generic
drug
match
the
warning
on
i t s
brand-name
counterpart.
" [ B ] r a n d - n a m e a n d g e n e r i c d r u g m a n u f a c t u r e r s have
d i f f e r e n t f e d e r a l drug l a b e l i n g d u t i e s .
A brandname m a n u f a c t u r e r
s e e k i n g new d r u g a p p r o v a l i s
r e s p o n s i b l e f o r t h e a c c u r a c y and adequacy o f i t s
label.
See, e . g . , 21 U.S.C. §§ 3 5 5 ( b ) ( 1 ) , ( d ) ;
Wyeth [ v . L e v i n e ] , [555 U.S. 555] a t 570-571, 129
S.Ct. 1187 [ ( 2 0 0 9 ) ] . A m a n u f a c t u r e r s e e k i n g g e n e r i c
d r u g a p p r o v a l , on t h e o t h e r hand, i s r e s p o n s i b l e f o r
e n s u r i n g t h a t i t s w a r n i n g l a b e l i s t h e same as t h e
b r a n d name's.
See, e . g . , § 3 5 5 ( j ) ( 2 ) ( A ) ( v ) ; §
355(j)(4)(G);
21
C.F.R.
§§
314.94(a)(8),
314.127(a) ( 7 ) . "
U.S. a t
, 131 S . C t . a t 2574. The Supreme C o u r t
held
t h a t b e c a u s e t h e FDA p r e v e n t e d t h e g e n e r i c - d r u g m a n u f a c t u r e r s
f r o m i n d e p e n d e n t l y c h a n g i n g t h e s a f e t y l a b e l on t h e i r g e n e r i c
d r u g s , " i t was i m p o s s i b l e f o r t h e M a n u f a c t u r e r s t o c o m p l y w i t h
both
their
federal
s t a t e - l a w duty
t o change
l a w d u t y t o keep t h e l a b e l
the l a b e l
and
t h e same."
their
U.S. a t
, 131 S . C t . a t 2578.
The
Supreme
contradiction
manufacturer
in
Court
recognized
preempting
claims
i n PLIVA b u t a l l o w i n g
21
i n PLIVA
the
seeming
a
generic
against
state-law tort
claims i n
1101397
Wyeth:
"We r e c o g n i z e t h a t f r o m t h e p e r s p e c t i v e o f [ t h e
p l a i n t i f f s ] , f i n d i n g pre-emption here but not i n
Wyeth makes l i t t l e s e n s e .
Had [ t h e p l a i n t i f f s ]
t a k e n R e g l a n , t h e brand-name d r u g p r e s c r i b e d b y
their
doctors,
Wyeth w o u l d
control
and t h e i r
lawsuits
w o u l d n o t be p r e - e m p t e d . B u t b e c a u s e
pharmacists, a c t i n g i n f u l l accord with state law,
s u b s t i t u t e d generic metoclopramide i n s t e a d , f e d e r a l
law p r e - e m p t s t h e s e l a w s u i t s . See, e . g . , M i n n . S t a t .
§ 151.21 (2010) ( d e s c r i b i n g when p h a r m a c i s t s may
s u b s t i t u t e g e n e r i c d r u g s ) ; L a . Rev. S t a t . Ann. §
3 7 : 1 2 4 1 ( A ) ( 1 7 ) (West 2007) (same). We a c k n o w l e d g e
the u n f o r t u n a t e hand t h a t f e d e r a l drug r e g u l a t i o n
has
dealt
[the p l a i n t i f f s ]
and o t h e r s
similarly
situated.
9
"But
' i t i s not t h i s Court's task t o decide
w h e t h e r t h e s t a t u t o r y scheme e s t a b l i s h e d b y C o n g r e s s
i s u n u s u a l o r e v e n b i z a r r e . ' Cuomo v. C l e a r i n g House
A s s n . , L.L.C., 557 U.S. 519, 556 (2009) (Thomas, J . ,
c o n c u r r i n g i n p a r t and d i s s e n t i n g i n p a r t ) ( i n t e r n a l
q u o t a t i o n marks a n d b r a c k e t s o m i t t e d ) . I t i s b e y o n d
d i s p u t e t h a t t h e f e d e r a l s t a t u t e s and r e g u l a t i o n s
that
apply
t o brand
name
manufacturers
are
meaningfully
d i f f e r e n t than those that apply t o
generic
drug manufacturers.
Indeed, i t i s t h e
s p e c i a l , and d i f f e r e n t , r e g u l a t i o n o f g e n e r i c drugs
that allowed
t h e g e n e r i c drug market t o expand,
b r i n g i n g more d r u g s more q u i c k l y a n d c h e a p l y t o t h e
public.
But d i f f e r e n t
federal
s t a t u t e s and
r e g u l a t i o n s may, as h e r e , l e a d t o d i f f e r e n t p r e ¬
e m p t i o n r e s u l t s . We w i l l n o t d i s t o r t t h e Supremacy
Clause i n order t o create s i m i l a r pre-emption across
a d i s s i m i l a r s t a t u t o r y scheme. As a l w a y s , C o n g r e s s
and t h e FDA r e t a i n t h e a u t h o r i t y t o change t h e l a w
and r e g u l a t i o n s i f t h e y s o d e s i r e .
" That
9
said,
the dissent
22
overstates
what i t
1101397
c h a r a c t e r i z e s as t h e 'many a b s u r d c o n s e q u e n c e s ' o f
o u r h o l d i n g . P o s t , [131 S.Ct.] a t 2592. F i r s t , t h e
FDA
informs
us
that
'[a]s a p r a c t i c a l
matter,
g e n u i n e l y new i n f o r m a t i o n a b o u t d r u g s i n l o n g use
(as
generic
drugs
typically
are)
appears
i n f r e q u e n t l y . ' U.S.
B r i e f 34-35. T h a t i s b e c a u s e
patent p r o t e c t i o n s o r d i n a r i l y prevent g e n e r i c drugs
f r o m a r r i v i n g on t h e m a r k e t f o r a number o f y e a r s
after
the
brand-name
drug
appears.
Indeed,
s i t u a t i o n s l i k e t h e one a l l e g e d h e r e a r e a p p a r e n t l y
so r a r e t h a t t h e FDA has no ' f o r m a l r e g u l a t i o n '
e s t a b l i s h i n g generic drug manufacturers'
duty to
initiate
a l a b e l c h a n g e , n o r does i t have
any
r e g u l a t i o n s e t t i n g out t h a t l a b e l - c h a n g e
process.
I d . , a t 20-21. S e c o n d , t h e d i s s e n t a d m i t s t h a t , e v e n
under i t s approach, g e n e r i c drug m a n u f a c t u r e r s c o u l d
e s t a b l i s h p r e - e m p t i o n i n a number o f s c e n a r i o s .
P o s t , [131 S.Ct.] a t 2588-2589."
U.S.
As
at
noted
certified
have
, 131
held
in
S.Ct.
the
at
facts
2581-82.
set
out
in
the
request
for
q u e s t i o n , o t h e r f e d e r a l c o u r t s a p p l y i n g Alabama
that
Alabama
consumed a g e n e r i c
law
does
v e r s i o n of
not
allow
a
a brand-name d r u g
a
law
person
who
to
the
sue
brand-name m a n u f a c t u r e r b a s e d on f r a u d u l e n t m i s r e p r e s e n t a t i o n .
I n M o s l e y v. Wyeth, 719 F. Supp. 2d 1340
(S.D.
A l a . 2010),
the
p l a i n t i f f s d i d not i n g e s t Reglan but took a g e n e r i c
equivalent
m a n u f a c t u r e d by
brand-name
manufacturers
negligent
warnings
and
another
of
company.
Reglan
fraudulent
contained
i n the
They
alleging,
sued
among
misrepresentation
labels
23
the
the
other
things,
regarding
plaintiffs
argued
the
the
1101397
brand-name m a n u f a c t u r e r s knew w o u l d be r e l i e d upon by g e n e r i c
manufacturers i n generating the warning l a b e l s f o r the generic
version
of
plaintiffs
the drug.
could
misrepresentations
not
The
rely
made by
federal
court
on
allegedly
any
t h e brand-name
held
that
the
negligent
manufacturers
to
support t h e i r c l a i m of n e g l i g e n t m i s r e p r e s e n t a t i o n because the
brand-name m a n u f a c t u r e r s d i d n o t owe a d u t y t o t h e p l a i n t i f f s ,
who
that
had i n g e s t e d
their
because
a generic
plaintiffs
assertion
failed
to present
the
also
stated
should
fail
d i d n o t engage i n any
the p l a i n t i f f s .
misrepresentation,
With
court
any b i n d i n g
held
regard
that
to
the
a u t h o r i t y f o r the
t h a t a brand-name m a n u f a c t u r e r owed a d u t y t o t h e
consumer o f a g e n e r i c
cite
manufacturers
transaction with
fraudulent
The c o u r t
c l a i m of negligent misrepresentation
t h e brand-name
business
version.
version
of i t s product
any b i n d i n g a u t h o r i t y f o r t h e c o n t e n t i o n
and f a i l e d
t h a t an
to
injury
r e s u l t i n g f r o m c o n s u m i n g a g e n e r i c d r u g c o u l d be c o n s i d e r e d t o
be p r o x i m a t e l y
c a u s e d by a brand-name m a n u f a c t u r e r ' s a l l e g e d
misrepresentation
generic drug.
regarding
t h e brand-name
version
of the
The c o u r t a l s o n o t e d t h a t t h e f a c t t h a t
federal
law a l l o w e d a g e n e r i c m a n u f a c t u r e r t o s t r e a m l i n e t h e a p p r o v a l
24
1101397
p r o c e s s b y r e l y i n g on t h e i n i t i a l
warning l a b e l s p r o v i d e d by
t h e brand-name m a n u f a c t u r e r s d i d n o t c r e a t e a d u t y b e t w e e n t h e
brand-name
manufacturers
a n d t h e consumer
of the generic
v e r s i o n b e c a u s e , a f t e r t h e ANDA p r o c e s s , g e n e r i c m a n u f a c t u r e r s
become
responsible
for their
necessary r e v i s i o n s t o those
Mosley
own
warning
labels
and any
labels.
i s distinguishable
from
the present
case.
The
Weekses a r e n o t a r g u i n g t h a t t h e Wyeth d e f e n d a n t s owed them a
duty.
owed
Instead, they are arguing that
a duty
t o Danny Weeks's
t h e Wyeth
physician
learned-intermediary doctrine,
defendants
and t h a t ,
they are e n t i t l e d
t h e r e p r e s e n t a t i o n s made t o t h e i r p h y s i c i a n .
under t h e
t o r e l y on
Also,
we
note
t h a t M o s l e y was i s s u e d b e f o r e t h e U n i t e d S t a t e s Supreme C o u r t
in
PLIVA,
supra,
expressly
found
that
because
i t was
i m p o s s i b l e f o r t h e g e n e r i c - d r u g m a n u f a c t u r e r s t o comply w i t h
b o t h t h e i r s t a t e - l a w d u t y t o change t h e d r u g l a b e l t o a s a f e r
l a b e l adequately warning o f t h e dangers i n h e r e n t i n long-term
use a n d t h e i r
the
brand-name
f e d e r a l - l a w d u t y t o keep t h e l a b e l t h e same as
manufacturer's
label,
any s t a t e - l a w c l a i m s
a g a i n s t a g e n e r i c m a n u f a c t u r e r were p r e e m p t e d .
the
reasoning
i n Mosley
that
25
a
generic
R e l i a n c e upon
manufacturer
is
1101397
r e s p o n s i b l e f o r i t s own w a r n i n g l a b e l s
labels
and r e v i s i o n s
of those
i s unsound.
I n O v e r t o n v. Wyeth, I n c . , (No. CA 10-0491-KD-C,
15,
2011)
March
(S.D. A l a . 2 0 1 1 ) ( n o t r e p o r t e d i n F. Supp. 2 d ) , t h e
brand-name
manufacturers
plaintiffs'
state-law claims of breach of warranty,
misrepresentation,
plaintiffs
filed
a
motion
to
dismiss
the
fraudulent
and n e g l i g e n t m i s r e p r e s e n t a t i o n
where t h e
h a d i n g e s t e d t h e g e n e r i c v e r s i o n s o f t h e brand-name
d r u g . The p l a i n t i f f s
a r g u e d t h a t t h e brand-name m a n u f a c t u r e r s
p l a c e d f a l s e a n d m i s l e a d i n g i n f o r m a t i o n i n t h e i r l a b e l s , when
they
knew
the l a b e l s
would
manufacturers i n generating
doing
so was a d i r e c t
i n j u r i e s . The f e d e r a l
on
the p l a i n t i f f s '
brand-name
ingested
federal
be
relied
consumers
plaintiffs'
the
generic
and t h a t
their
and p r o x i m a t e cause o f t h e p l a i n t i f f s '
court s t a t e d that the d i s p o s i t i v e
manufacturers
owed
any
claims
duty
issue
was w h e t h e r t h e
to p l a i n t i f f s
who
v e r s i o n o f t h e i r brand-name d r u g .
The
court held that the p l a i n t i f f s
indicating
by
t h e i r own l a b e l s ,
misrepresentation
the generic
upon
presented
no e v i d e n c e
t h a t t h e brand-name m a n u f a c t u r e r s owed a d u t y t o
of the generic
injuries
version
could
be
26
of the drug
considered
to
so
have
that
the
been
a
1101397
p r o x i m a t e c o n s e q u e n c e o f a brand-name m a n u f a c t u r e r s '
misrepresentation
noted
that
FDA
regarding
t h e brand-name
regulations could
drug.
not provide
alleged
The
the
court
requisite
duty element because f e d e r a l law a l l o w s a g e n e r i c manufacturer
to
streamline
warning
the approval
labels provided
process
by r e l y i n g on t h e i n i t i a l
b y t h e brand-name m a n u f a c t u r e r , b u t
the g e n e r i c manufacturer s t i l l
had the burden of showing t h a t
its
described
with
warning
label
the drug.
adequately
"In other
words, a f t e r
the r i s k
associated
the i n i t i a l
approval
(ANDA a p p r o v a l ) , t h e g e n e r i c m a n u f a c t u r e r s become
responsible
for
revisions."
their
N o t e 9.
PLIVA.
that
own
warning
labels
a n d any n e c e s s a r y
O v e r t o n was i s s u e d b e f o r e
t h e Supreme C o u r t
A c c o r d i n g l y , the f e d e r a l court's c o n c l u s i o n i n Overton
a generic
m a n u f a c t u r e r becomes
w a r n i n g l a b e l a f t e r t h e ANDA p r o c e s s
In
December
2d),
decided
Simpson
9,
v.
Wyeth,
Inc.,
responsible
i s incorrect.
(No.
2010)(N.D. A l a . 2 0 1 0 ) ( n o t
the f e d e r a l
court
held
that
f o r i t s own
7:10-cv-01771-HGD,
reported
i n F.
the p l a i n t i f f s ,
Supp.
who
had
ingested only the generic v e r s i o n of Reglan, could not recover
for
the
plaintiffs'
alleged
fraudulent
misrepresentations
d o c t o r by t h e m a n u f a c t u r e r s o f Reglan.
27
to
the
The b r a n d -
1101397
name
manufacturers
argued
that,
because
they
d i d not
manufacture the product the p l a i n t i f f s had i n g e s t e d
allegedly
had
manufacturers
caused
could
their
injuries,
n o t be h e l d
the
liable.
The
and t h a t
brand-name
plaintiffs
a l l e g e d t h a t t h e i r c l a i m a g a i n s t t h e brand-name m a n u f a c t u r e r s
was b a s e d on t h e damage c a u s e d b y t h e p r o d u c t as a r e s u l t o f
the
brand-name
manufacturers'
misinformation
to
the
p r e s c r i b i n g d o c t o r s , and t h e p l a i n t i f f s argued t h a t t h e y c o u l d
recover
were
from
third
because
t h e brand-name
parties
the deceit
plaintiffs'
damage.
m a n u f a c t u r e r s even
to the alleged
and concealment
prescribing
doctors
deceit
though
or
perpetrated
proximately
they
concealment
against the
caused
their
I n s u p p o r t o f t h e i r argument, t h e Simpson p l a i n t i f f s
r e l i e d on D e l t a H e a l t h Group, I n c . v. S t a f f o r d , 887 So. 2d 887
(Ala.
2004),
plaintiff
which
held
may p r o p e r l y
defendant's
false
that
state
i n certain
a fraud
representation
r a t h e r than t o the p l a i n t i f f .
claim
circumstances a
even
though t h e
i s made t o a t h i r d
party,
In discussing Delta Health, the
f e d e r a l court noted that Delta Health
went on t o h o l d t h a t a
plaintiff
he
must
establish
that
misrepresentation.
28
relied
on
the
1101397
The f e d e r a l c o u r t i n S i m p s o n s t a t e d t h a t t h e p r o b l e m
with
t h e p l a i n t i f f s ' r e l i a n c e argument was t h a t A l a b a m a c o u r t s have
r e p e a t e d l y r e j e c t e d a t h e o r y o f l i a b i l i t y when t h e p l a i n t i f f s
have
attempted
responsible
to
hold
f o r damage
a
brand-name-drug
caused
drug, c i t i n g Mosley, supra.
manufacturer
by a g e n e r i c b r a n d
of
their
The f e d e r a l c o u r t a l s o r e l i e d on
t h e f a c t t h a t t h e FDA r e g u l a t i o n d i d n o t r e q u i r e a brand-name
manufacturer t o ensure t h a t the l a b e l of the g e n e r i c v e r s i o n
i s a c c u r a t e , c i t i n g S w i c e g o o d v. PLIVA, I n c . , 543 F. Supp. 2d
1351
(N.D. Ga. 2008) .
"Thus, i t i s t h e d u t y o f t h e g e n e r i c
drug manufacturer
to correctly
product
associated
of
any
manufacturer."
The
federal
advise a physician
risks,
not
the
using i t s
brand
name
Simpson.
court
learned-intermediary
i n Simpson
went
on
t o address the
doctrine:
"Likewise,
'[u]nder the l e a r n e d i n t e r m e d i a r y
d o c t r i n e , a m a n u f a c t u r e r ' s d u t y t o warn i s l i m i t e d
t o an o b l i g a t i o n t o a d v i s e a p r e s c r i b i n g p h y s i c i a n
o f any p o t e n t i a l d a n g e r s t h a t may r e s u l t f r o m t h e
use o f i t s p r o d u c t . '
W a l l s v. [Alpharma] USPD,
[ I n c . ] , 887 So. 2d [881,] 883 [ ( A l a . 2 0 0 4 ) ] .
Thus,
t h e d u t y t o warn o f r i s k s r e l a t e d t o t h e u s e o f a
d r u g i s owed t o t h e p r e s c r i b i n g p h y s i c i a n b y t h e
d r u g m a n u f a c t u r e r , n o t some o t h e r m a n u f a c t u r e r o f
t h e same o r a s i m i l a r p r o d u c t . As a m a t t e r o f l a w ,
the
manufacturers
of Reglan
have
no d u t y t o
c o m m u n i c a t e any i n f o r m a t i o n r e g a r d i n g t h e r i s k s o f
29
1101397
t a k i n g t h i s product
customers."
L i k e M o s l e y and
was
decided,
O v e r t o n , Simpson was
than t h e i r
own
issued before
PLIVA
and t h e f e d e r a l c o u r t ' s c o n c l u s i o n i n S i m p s o n
that generic
advise
t o anyone o t h e r
m a n u f a c t u r e r s have t h e i r
own
duty to
correctly
a p h y s i c i a n of r i s k s a s s o c i a t e d w i t h the g e n e r i c
drug
r e g a r d l e s s of the f a c t t h a t a g e n e r i c l a b e l i s r e q u i r e d to
the
same as
t h e brand-name l a b e l
the p l a i n t i f f s
to
recover
--
i s questionable.
i n Simpson argued t h a t t h e y
s h o u l d be
allowed
they
were t h i r d p a r t i e s t o t h e a l l e g e d f r a u d p e r p e t r a t e d by
The
upon
the
plaintiffs'
learned-intermediary
physicians
warning,
had
the
relied
doctrine,
upon
plaintiffs
the
still
could
to
We
on
recognize
F o s t e r v.
Cir.
their
manufacturer's
that
the
a duty before
the
liable.
that other j u r i s d i c t i o n s , p r i m a r i l y
A m e r i c a n Home P r o d u c t s
1 9 9 4 ) , have c o n c l u d e d
under
that
demonstrate
brand-name m a n u f a c t u r e r owed t h e p l a i n t i f f s
brand-name m a n u f a c t u r e r c o u l d be
prove
brand-name
had
those
prescribing physicians.
Simpson c o u r t s t a t e d t h a t , even i f the p l a i n t i f f s ,
the
be
Also,
f r o m t h e brand-name m a n u f a c t u r e r s e v e n t h o u g h
manufacturers
—
C o r p . , 29
F.3d
relying
165
(4th
t h a t a brand-name m a n u f a c t u r e r does
30
1101397
n o t owe
a d u t y t o warn u s e r s o f t h e g e n e r i c
prescription
drug of the dangers
In F o s t e r , the p l a i n t i f f s '
the g e n e r i c
associated with
a brand-name d r u g .
t h e brand-name m a n u f a c t u r e r o f P h e n e r g a n ,
and s t r i c t l i a b i l i t y .
court dismissed the s t r i c t - l i a b i l i t y
name m a n u f a c t u r e r
taken
by
the
5
However,
They
alleging
The f e d e r a l
sued
negligent
district
c l a i m because the brand-
had not manufactured
daughter.
the drug.
d a u g h t e r d i e d as a r e s u l t o f t a k i n g
form o f Phenergan,
misrepresentation
version of the
the
the generic
court
negligent-misrepresentation claim to proceed.
version
allowed
the
The brand-name
S e e , e.g., B a y m i l l e r v. R a n b a x y Pharm., I n c . , [No. 3:11cv-858-RCJ-VPC, S e p t e m b e r 6, 2012]
F. Supp. 2d
(D.
Nev. 2 0 1 2 ) ; P h e l p s v. Wyeth, I n c . , 857 F.Supp.2d 1114 (D. Or.
2 0 1 2 ) ; F i s h e r v. P e l s t r i n g , (No. 4:09-cv-00252-TLW, J u l y 28,
2010) (D. S.C. 2010) ( n o t r e p o r t e d i n F. Supp. 2 d ) ( c o l l e c t i n g
c a s e s ) ; S w i c e g o o d v. PLIVA, I n c . , 543 F. Supp. 2d 1351, 1358
(N.D. Ga. 2 0 0 8 ) ; G o l d y c h v. E l i L i l l y & Co., (No. 5:04-CV1477, J u l y 19, 2006) (N.D. N.Y. 2006) ( n o t r e p o r t e d i n F. Supp.
2 d ) ; C o l a c i c c o v. A p o t e x , I n c . , 432 F. Supp. 2d 514, 538-43
(E.D. Pa. 2 0 0 6 ) , a f f ' d i n p a r t and r e v ' d i n p a r t on o t h e r
g r o u n d s , 521 F.3d 253 (3d C i r . 2 0 0 8 ) , v a c a t e d , 129 S . C t . 1578
( 2 0 0 9 ) ; T a r v e r v. Wyeth, I n c . , (No. C i v . A.3-04-2036, J a n u a r y
26, 2006)(W.D. L a . 2 0 0 6 ) ( n o t r e p o r t e d i n F. Supp. 2 d ) ; S h a r p
v. L e i c h u s , (2004-CA-0643, F e b r u a r y 17, 2006) ( F l a . C i r . C t .
2006) ; K e l l y v. Wyeth, (CIV. A. MICV 2003-03324B, May 6,
2005) ( S u p e r . C t . Mass. 2 0 0 5 ) ; S h e e k s v. A m e r i c a n Home P r o d s .
C o r p . , (No. 02CV337, O c t o b e r 15, 2 0 0 4 ) ( C o l o . D i s t . C t . 2 0 0 4 ) ;
Doe v. O r t h o - C l i n i c a l D i a g n o s t i c s , I n c . , 335 F. Supp. 2d 614,
626-30
(M.D.
N.C.
2004);
Block
v. Wyeth,
I n c . , (No.
C i v . A . 3 : 0 2 - C V - 1 0 7 7 , J a n u a r y 28, 2 0 0 3 ) ( N . D . Tex. 2003) ( n o t
r e p o r t e d i n F. Supp. 2 d ) ; B e u t e l l a v. A.H. R o b i n s Co., (No.
980502372, December 10, 2001) (Utah D i s t . C t . 2 0 0 1 ) .
5
31
1101397
manufacturer appealed.
The f e d e r a l a p p e a l s c o u r t n o t e d t h a t ,
under M a r y l a n d law, a p l a i n t i f f had t o prove t h a t t h e p r o d u c t
i n q u e s t i o n was d e f e c t i v e , a t t r i b u t e t h a t d e f e c t t o t h e s e l l e r
o f t h e p r o d u c t , a n d p r o v e t h a t t h e r e was a c a u s a l
relationship
between
defect
The
appeals
court
and t h e p l a i n t i f f ' s
stated that
injury.
the p l a i n t i f f s
federal
were a t t e m p t i n g t o
h o l d t h e brand-name m a n u f a c t u r e r l i a b l e f o r i n j u r i e s c a u s e d b y
another m a n u f a c t u r e r ' s p r o d u c t and t h a t M a r y l a n d c o u r t s would
r e j e c t an e f f o r t t o c i r c u m v e n t t h e n e c e s s i t y t h a t a d e f e n d a n t
be
shown
injury
injury.
not
t o have m a n u f a c t u r e d
before
the defendant
plaintiffs
be h e l d
of care t o the p l a i n t i f f s ,
a l l e g e d t h a t i t was f o r e s e e a b l e
manufacturer
generic
could
that
caused the
liable
f o r such
The c o u r t h e l d t h a t t h e brand-name m a n u f a c t u r e r d i d
owe a d u t y
label
the product
o f Phenergan
f o r the drug
could
that
statements
result
v e r s i o n of the drug.
i n injury
The c o u r t
even
though t h e
t o t h e brand-name
contained
in
t o a user
its
of a
stated:
"We do n o t a c c e p t t h e a s s e r t i o n t h a t a g e n e r i c
manufacturer
i s not responsible
f o r negligent
m i s r e p r e s e n t a t i o n s on i t s p r o d u c t l a b e l s i f i t d i d
not
initially
formulate
the
warnings
and
r e p r e s e n t a t i o n s i t s e l f . When a g e n e r i c m a n u f a c t u r e r
a d o p t s a name b r a n d m a n u f a c t u r e r ' s w a r n i n g s a n d
r e p r e s e n t a t i o n s without independent i n v e s t i g a t i o n ,
i t does so a t t h e r i s k t h a t s u c h w a r n i n g s a n d
32
1101397
r e p r e s e n t a t i o n s may be f l a w e d . I n c a s e s i n v o l v i n g
p r o d u c t s a l l e g e d t o be d e f e c t i v e due t o i n a d e q u a t e
w a r n i n g s , 'the m a n u f a c t u r e r i s h e l d t o t h e k n o w l e d g e
and s k i l l o f an e x p e r t
The m a n u f a c t u r e r ' s s t a t u s
as e x p e r t means t h a t a t a minimum he must keep
a b r e a s t o f s c i e n t i f i c knowledge, d i s c o v e r i e s , and
a d v a n c e s a n d i s p r e s u m e d t o know what i s i m p a r t e d
thereby.'
O w e n s - I l l i n o i s v . Z e n o b i a , 325 Md. 420,
601 A . 2 d 633, 639 (Md. 1 9 9 2 ) ( q u o t i n g B o r e l v .
F i b r e b o a r d P a p e r P r o d s . C o r p . , 493 F.2d 1076, 1098
(5th
C i r . 1 9 7 3 ) , c e r t . d e n i e d , 419 U.S. 869, 95
S.Ct.
127, 42 L.Ed.2d
107
(1974)).
The same
p r i n c i p l e a p p l i e s i n t h e i n s t a n t c a s e ; a s an e x p e r t ,
a manufacturer of generic products i s r e s p o n s i b l e
f o r t h e a c c u r a c y o f l a b e l s p l a c e d on i t s p r o d u c t s .
A l t h o u g h g e n e r i c m a n u f a c t u r e r s must i n c l u d e t h e same
l a b e l i n g i n f o r m a t i o n as t h e e q u i v a l e n t name b r a n d
drug, they a r e a l s o p e r m i t t e d t o add o r s t r e n g t h e n
w a r n i n g s a n d d e l e t e m i s l e a d i n g s t a t e m e n t s on l a b e l s ,
e v e n w i t h o u t p r i o r FDA a p p r o v a l . 21 C.F.R. § 314.70
( 1 9 9 3 ) . The s t a t u t o r y scheme g o v e r n i n g p r e m a r k e t i n g
approval
f o r drugs
simply
does
not evidence
Congressional
intent
to insulate
generic
drug
m a n u f a c t u r e r s from l i a b i l i t y f o r m i s r e p r e s e n t a t i o n s
made r e g a r d i n g t h e i r p r o d u c t s , o r t o o t h e r w i s e a l t e r
state products l i a b i l i t y
law.
Manufacturers of
generic drugs, l i k e a l l other manufacturers, are
responsible
f o r the r e p r e s e n t a t i o n s they
make
regarding t h e i r products.
"We a l s o r e j e c t t h e c o n t e n t i o n t h a t a name b r a n d
manufacturer's
statements r e g a r d i n g i t s drug can
s e r v e as t h e b a s i s f o r l i a b i l i t y f o r i n j u r i e s c a u s e d
by
another
manufacturer's
drug.
Name
brand
manufacturers undertake t h e expense o f d e v e l o p i n g
pioneer drugs, performing the s t u d i e s necessary t o
obtain
premarketing
approval,
and f o r m u l a t i n g
l a b e l i n g i n f o r m a t i o n . Generic manufacturers avoid
these expenses by d u p l i c a t i n g s u c c e s s f u l p i o n e e r
drugs and t h e i r l a b e l s .
Name b r a n d
advertising
b e n e f i t s g e n e r i c c o m p e t i t o r s because g e n e r i c s a r e
g e n e r a l l y s o l d as s u b s t i t u t e s f o r name b r a n d d r u g s ,
33
1101397
so t h e more a name b r a n d d r u g i s p r e s c r i b e d , t h e
more
potential
sales
exist
f o r i t s generic
equivalents.
T h e r e i s no l e g a l p r e c e d e n t f o r u s i n g
a name b r a n d m a n u f a c t u r e r ' s s t a t e m e n t s a b o u t i t s own
p r o d u c t as a b a s i s f o r l i a b i l i t y f o r i n j u r i e s c a u s e d
by
other
manufacturers'
products,
over
whose
production
t h e name b r a n d m a n u f a c t u r e r
h a d no
control.
T h i s w o u l d be e s p e c i a l l y u n f a i r when, as
here, t h e g e n e r i c manufacturer reaps t h e b e n e f i t s o f
t h e name b r a n d m a n u f a c t u r e r ' s s t a t e m e n t s b y c o p y i n g
its
l a b e l s a n d r i d i n g on t h e c o a t t a i l s o f i t s
advertising.
The p r e m a r k e t i n g a p p r o v a l
scheme
Congress
established f o r generic equivalents of
p r e v i o u s l y a p p r o v e d d r u g s c a n n o t be c o n s t r u e d t o
c r e a t e l i a b i l i t y o f a name b r a n d m a n u f a c t u r e r when
a n o t h e r m a n u f a c t u r e r ' s d r u g h a s b e e n consumed."
F o s t e r , 29 F.3d a t 169-70.
The
plaintiffs
manufacturers
owed
misrepresentations
personal
injury
Phenergan.
i n Foster
a duty
because
regarding
t h e brand-name
i t was f o r e s e e a b l e
Phenergan
could
result
that
in
equivalents of
The F o s t e r c o u r t c o n c l u d e d t h a t t o i m p o s e d u t y i n
c a s e w o u l d be t o s t r e t c h
too
far.
"The d u t y
misrepresentation
party
that
to the users of the generic
that
one
argued
the concept
required
f o r the t o r t
a r i s e s when t h e r e
has t h e r i g h t
of f o r e s e e a b i l i t y
to rely
of
negligent
i s 'such a r e l a t i o n
f o r information
that
upon t h e
o t h e r , a n d t h e o t h e r g i v i n g i n f o r m a t i o n owes a d u t y t o g i v e i t
w i t h c a r e , ' " a n d t h e c o u r t c o n c l u d e d t h a t no s u c h r e l a t i o n s h i p
existed
between t h e p l a i n t i f f
who was i n j u r e d
34
by a p r o d u c t
1101397
t h a t was n o t m a n u f a c t u r e d by t h e brand-name m a n u f a c t u r e r .
F.3d
a t 171
( q u o t i n g Weisman v. C o n n o r s ,
32 Md.
29
428, 443-44,
540 A.2d 783, 790 ( 1 9 8 8 ) ) .
A
Inc.,
few c o u r t s
have h e l d
otherwise.
I n C o n t e v. Wyeth,
168 C a l . App. 4 t h 89, 85 C a l . R p t r . 3d 299
California
Court of Appeals, applying
state
(2008), the
n e g l i g e n c e law,
h e l d as a m a t t e r o f f i r s t i m p r e s s i o n t h a t a m a n u f a c t u r e r o f a
brand-name d r u g may be h e l d l i a b l e f o r i n j u r i e s s u f f e r e d by a
consumer
who
purchased
a generic
form
of the drug
i f the
c o n s u m e r ' s i n j u r i e s were f o r e s e e a b l y c a u s e d b y n e g l i g e n c e o f
or
intentional
misrepresentation
manufacturer that developed the drug.
by
the
brand-named
Conte, the p l a i n t i f f i n
t h a t c a s e , s u e d t h e brand-name m a n u f a c t u r e r a n d t h r e e g e n e r i c
manufacturers
of
Reglan
metoclopramide,
alleging
and
its
generic
t h a t h e r use o f m e t o c l o p r a m i d e
a f o u r - y e a r p e r i o d caused her t o develop t a r d i v e
Conte had i n g e s t e d
Conte's
[was]
due
claims
only
against
version,
the generic
drug.
a l l of the drug
over
dyskinesia.
"The
company
crux of
defendants
t h a t she was i n j u r i o u s l y o v e r e x p o s e d t o m e t o c l o p r a m i d e
to
their
dissemination
of
false,
misleading
i n c o m p l e t e warnings about the drug's s i d e e f f e c t . "
35
and/or
168 C a l .
1101397
App.
4 t h a t 95, 85 C a l . R p t r .
entered
a
summary
manufacturers,
judgment
3d a t 305.
The t r i a l
court
f o r a l l the
defendant
drug
and C o n t e a p p e a l e d .
The C a l i f o r n i a
appellate
c o u r t r e v e r s e d t h e summary j u d g m e n t i n f a v o r o f t h e brand-name
manufacturer
after
concluding
that
Conte
had
presented
a
m a t e r i a l f a c t u a l d i s p u t e as t o w h e t h e r h e r d o c t o r h a d i n f a c t
relied
on
information
manufacturer
held
that
known
of Reglan.
the
the a p p e l l a t e
knew
product
are i n j u r e d
manufacturer's]
by
brand-name
court
or should
number o f p a t i e n t s whose
have
doctors
i n f o r m a t i o n f o r R e g l a n a r e l i k e l y t o have
brand-name
prescriptions
App.
the
metoclopramide p r e s c r i b e d or dispensed
disseminating
who
Specifically,
a significant
r e l y on i t s p r o d u c t
that
by
t h e brand-name m a n u f a c t u r e r
"that
generic
disseminated
manufacturer's
information
generic
written
product
in
"duty
t o them" a n d
of
care
extends t o those
metoclopramide
reliance
information
on
as a
[the
f o r Reglan."
4 t h a t 107, 85 C a l . R p t r . 3d a t 315.
in
patients
result
of
brand-name
168 C a l .
The a p p e l l a t e c o u r t
a f f i r m e d t h e summary j u d g m e n t i n f a v o r o f e a c h o f t h e t h r e e
g e n e r i c m a n u f a c t u r e r s on t h e g r o u n d t h a t C o n t e h a d c o n c e d e d on
appeal
t h a t t h e r e was no e v i d e n c e i n d i c a t i n g t h a t t h e g e n e r i c
36
1101397
manufacturers
had
disseminated
their generic
product.
I n K e l l o g g v. Wyeth, 762
the
Vermont
any
F.
federal district
m a n u f a c t u r e r o f a d r u g has
Supp. 2d
court
sued
the
of
metoclopramide
dyskinesia;
crux
of
K e l l o g g had
Kellogg's
(D. V t .
that
a
brand-name
reasonable
manufacturer
and
her
to
each
summary
federal
of
the
was
that
because they
judgment
district
Both the
generic
on
a l l the
failed
long-term
tardive
denied
filed
adequately
motions.
long-term
manufacturer
a motion
failure-to-warn
the
The
defendant
to
brand-name
manufacturers
Kellogg's
court
in
generic
develop
warn h e r d o c t o r s a b o u t t h e r i s k s a s s o c i a t e d w i t h t h e
and
to
i n g e s t e d o n l y the g e n e r i c drug.
m a n u f a c t u r e r s were l i a b l e
of metoclopramide.
care
a l l e g i n g t h a t her
caused
argument
use
2010),
K e l l o g g , the p l a i n t i f f
brand-name
manufacturers of metoclopramide,
ingestion
694
concerning
have b e e n p r e s c r i b e d t h e
g e n e r i c b i o e q u i v a l e n t of i t s drug.
case,
held
a d u t y t o use
a v o i d c a u s i n g i n j u r y t o c o n s u m e r s who
that
information
The
for
claim;
court
a
the
held
t h a t , because a l l the p a r t i e s agreed t h a t the defendant drug
manufacturers
owed
a
duty
to
provide
adequate
Kellogg's prescribing physicians, a jury question
37
warning
to
e x i s t e d as
1101397
to
whether
accurate
the
defendant
and adequate
drug
warnings.
f u r t h e r h e l d that the defendant
manufacturers
had
provided
The f e d e r a l d i s t r i c t
d r u g m a n u f a c t u r e r s were n o t
e n t i t l e d t o summary j u d g m e n t s f o r l a c k o f a t r i a b l e
proximate
cause.
Specifically,
court
the court
i s s u e on
stated that
"[a]
r e a s o n a b l e j u r y c o u l d c o n c l u d e t h a t i n a d e q u a t e , m i s l e a d i n g and
inaccurate
information
provided
by
the
[defendant
m a n u f a c t u r e r s ] was a p r o x i m a t e c a u s e o f [ K e l l o g g ' s ]
762 F. Supp. 2d a t 702.
denied
The f e d e r a l d i s t r i c t
t h e summary-judgment
motion
filed
injury."
court
finally
b y t h e brand-name
m a n u f a c t u r e r on K e l l o g g ' s n e g l i g e n t - m i s r e p r e s e n t a t i o n ,
and f r a u d - b y - c o n c e a l m e n t
drug
fraud,
claims i n which K e l l o g g a l l e g e d t h a t
t h e brand-name m a n u f a c t u r e r o f R e g l a n was l i a b l e
for failing
t o u s e due c a r e i n d i s s e m i n a t i n g i n f o r m a t i o n a b o u t t h e d r u g t o
physicians,
thereby causing
metoclopramide
to her.
the physicians to over-prescribe
The brand-name m a n u f a c t u r e r
t h a t i t had a duty t o p r o v i d e
to p h y s i c i a n s .
a
doctor
who
adequate
warnings
about
agreed
Reglan
However, i t c o n t e n d e d t h a t i t owed no d u t y t o
prescribes
doctor's
prescription
Vermont's
negligence
Reglan
with
a
i f t h e pharmacy
generic
brand.
law, the f e d e r a l d i s t r i c t
38
fills
the
Applying
court
noted
1101397
t h a t "a brand-name m a n u f a c t u r e r owes a d u t y t o use
care
to
avoid
causing
injury
to
consumers
b i o e q u i v a l e n t s o f i t s d r u g s , " 762
"it
i s reasonably
foreseeable
the
generic
F. Supp. 2d a t 706,
because
that a physician w i l l
a b r a n d name m a n u f a c t u r e r ' s r e p r e s e n t a t i o n s
of
representations
drug,
when
deciding
regardless
with
The
federal
doctors
the
form of
triable
risk
prescribe
drug."
court
of
accurate
concerning
[metoclopramide]."
the
risks
762
F.
the
Foster
manufacturer
of
court
relied
a prescription
accuracy of l a b e l s p l a c e d
before
on
on
for
fills
the
F.
-and
of i t s
patient,
prescription
at
Kellogg
whether
from
[the
effects
finding
709.
had
"her
information —
i n F o s t e r and
drug
a
that
Supp. 2d a t
the
absence
Supp. 2d
held
or
brand-name
of
long-term
710.
C o n t e , we
that
a
i s responsible
i t s product.
t h e Supreme C o u r t d e c i d e d
or the
regarding
information
r e l y upon
side effects
762
fact
—
drug
therefore
In l o o k i n g at the r e a s o n i n g
that
the
pharmacist
the
issues
of
r e l i e d on i n a c c u r a t e and m i s l e a d i n g
absence of
of
to
district
manufacturer]
use
about the
of whether the
a generic
presented
—
of
reasonable
F o s t e r was
note
generic
for
the
issued
PLIVA, i n w h i c h i t h e l d
that
a g e n e r i c m a n u f a c t u r e r ' s l a b e l must be i d e n t i c a l t o t h e b r a n d -
39
1101397
name l a b e l a n d t h a t a g e n e r i c m a n u f a c t u r e r c a n n o t u n i l a t e r a l l y
change
i t s label
finding
that
t o update
a warning.
The F o s t e r c o u r t ' s
manufacturers o f g e n e r i c drugs a r e r e s p o n s i b l e
f o r t h e r e p r e s e n t a t i o n s t h e y make i n t h e i r l a b e l i n g r e g a r d i n g
t h e i r p r o d u c t s i s f l a w e d b a s e d on t h e "sameness"
requirement
d i s c u s s e d i n PLIVA.
Moreover,
liability
"[n]o
the
analysis
and t o r t law.
legal
precedent
in
Foster
confuses
strict
The F o s t e r c o u r t s t a t e d t h a t t h e r e i s
f o r u s i n g a name b r a n d
manufacturer's
s t a t e m e n t s a b o u t i t s own p r o d u c t as a b a s i s f o r l i a b i l i t y o r
injuries
c a u s e d b y o t h e r m a n u f a c t u r e r s ' p r o d u c t s , o v e r whose
production
t h e name b r a n d m a n u f a c t u r e r h a d no c o n t r o l . "
F.3d a t 170.
and
I f a p l a i n t i f f brought a s t r i c t - l i a b i l i t y
the issue
product,
then
was
one o f a
However,
be
sound.
n o t be h e l d l i a b l e f o r a n o t h e r
production, design, or manufacturing
the Foster
claim
i n production of the
t h e F o s t e r c o u r t ' s r e a s o n i n g would
C e r t a i n l y , a manufacturer w i l l
manufacturer's
defect
29
court's
reasoning
that
a
defect.
brand-name
m a n u f a c t u r e r does n o t owe a d u t y t o p e r s o n s t a k i n g t h e g e n e r i c
v e r s i o n o f t h e i r d r u g b e c a u s e t h e brand-name m a n u f a c t u r e r d i d
not manufacture
t h a t d r u g i s f l a w e d when t h e c a u s e o f a c t i o n
40
1101397
r e l a t e s t o the warnings contained
the d r u g and sound i n t o r t .
that
i t was
daughter's
Because
the
death,
a warning
process,
we
In Foster, the p l a i n t i f f s
inadequate
n o t how
label
i n the l a b e l i n g r e l a t i n g to
warning
the drug
that
itself
i s not a part
do n o t a g r e e
that
caused
was
the p l a i n t i f f
plaintiff
bars
of the manufacturing
the f a c t
i s arguing
the p l a i n t i f f ' s
their
produced.
that
a
brand-name
manufacturer d i d not produce the v e r s i o n of the drug
by
alleged
tort
ingested
a c t i o n when t h e
t h a t he o r she was i n j u r e d b y a f a i l u r e
t o warn.
We
recognize
that
the holding
i n PLIVA d i d n o t a d d r e s s
f o r e s e e a b i l i t y as t h e F o s t e r c o u r t d i d .
However, t h e Supreme
C o u r t c o n c l u d e d i n PLIVA t h a t t h e l a b e l i n g f o r a g e n e r i c
is
required
labeling
defect
by
federal
f o r t h e brand-name d r u g .
in
the
labeling
n e c e s s a r i l y be r e p e a t e d
causing
regulations
t o be
t h e same
Therefore,
f o r the
as t h e
an o m i s s i o n
brand-name
i n the generic
drug
drug
or
would
l a b e l i n g , foreseeably
harm t o a p a t i e n t who i n g e s t e d
the generic
product.
A brand-name m a n u f a c t u r e r i s w e l l aware o f t h e e x p i r a t i o n o f
i t s patent
will
a n d w e l l aware t h a t a g e n e r i c
be made when t h e p a t e n t
expires.
41
v e r s i o n of the drug
I t i s recognized
that
1101397
g e n e r i c s u b s t i t u t i o n s a r e a l l o w e d i n a l l 50 s t a t e s .
name m a n u f a c t u r e r
could
reasonably
foresee
A brand-
that a physician
p r e s c r i b i n g a brand-name d r u g ( o r a g e n e r i c d r u g ) t o a p a t i e n t
would
rely
on
manufacturer
the
even
warning
drafted
i f the patient
generic v e r s i o n of the drug.
whether
t h e Wyeth d e f e n d a n t s
by
the
ultimately
We
now
turn
owed a d u t y
brand-name
consumed t h e
to the issue
t o t h e Weekses as
t h i r d p a r t i e s to the alleged fraud i n f a i l i n g
warn o f t h e r i s k s o f R e g l a n i n i t s l a b e l i n g .
to
adequately
The Weekses r e l y
on D e l t a H e a l t h Group, I n c . v. S t a f f o r d , s u p r a , w h i c h i n v o l v e d
an
alleged
misrepresentation
made
to a third
party.
Tim
S t a f f o r d a n d L a n a S t a f f o r d a l l e g e d t h a t D e l t a H e a l t h Group a n d
its
i n s u r e r , Lumbermens M u t u a l C a s u a l t y
Company, h a d f a l s e l y
a c c u s e d T i m S t a f f o r d o f p i l f e r i n g f r o m a n u r s i n g home owned b y
Delta
Health
personal
building material
residence.
Lumbermens
After Delta
f o r u s e on t h e S t a f f o r d s '
Health
filed
f o r i t s a l l e g e d l o s s and a s s i g n e d
a claim
with
i t s rights to
Lumbermens, Lumbermens s u e d T i m S t a f f o r d , a l l e g i n g
conversion.
The S t a f f o r d s t h e n s u e d D e l t a H e a l t h a n d Lumbermens, a l l e g i n g ,
among o t h e r t h i n g s , f r a u d u l e n t m i s r e p r e s e n t a t i o n .
h e l d t h a t under l i m i t e d c i r c u m s t a n c e s
42
This
Court
a p l a i n t i f f may p r o p e r l y
1101397
s t a t e a f r a u d c l a i m b a s e d on a f a l s e r e p r e s e n t a t i o n t o a t h i r d
p a r t y rather than t o the p l a i n t i f f .
This Court
stated:
"We a g r e e w i t h S t a f f o r d t h a t i n c e r t a i n l i m i t e d
circumstances
n o t r e l e v a n t h e r e a p l a i n t i f f may
properly
state
a fraud
c l a i m even though t h e
d e f e n d a n t makes a f a l s e r e p r e s e n t a t i o n t o a t h i r d
p a r t y r a t h e r t h a n t o t h e p l a i n t i f f . However, we do
n o t r e a d Thomas [ v . H a l s t e a d , 605 So. 2d 1181 ( A l a .
1992] as e x c u s i n g a p l a i n t i f f f r o m t h e r e q u i r e m e n t
of
establishing
his
reliance
upon
that
misrepresentation.
Thomas a p p e a r s t o c o n t e m p l a t e
t h a t t h e p l a i n t i f f , i n f a c t , h a s r e l i e d on t h e
defendant's
misrepresentation,
even
though the
m i s r e p r e s e n t a t i o n was made t o a n o t h e r p a r t y . N e i t h e r
have we l o c a t e d a n y o t h e r a u t h o r i t y t h a t p u r p o r t s t o
excuse
a
plaintiff
in a
fraud
action
from
e s t a b l i s h i n g t h e element of r e l i a n c e .
" I n t h i s c a s e , t h e r e c o r d i s d e v o i d o f any
evidence tending t o e s t a b l i s h that S t a f f o r d r e l i e d
to
h i s detriment
on
any
of
the
alleged
misrepresentations
made
by
Delta
Health
to
Lumbermens. F o r t h i s
reason,
we c o n c l u d e
that
S t a f f o r d f a i l e d t o produce s u f f i c i e n t evidence t o
c r e a t e a j u r y q u e s t i o n on e a c h o f t h e e l e m e n t s
necessary f o r h i s fraud claim. Therefore, the t r i a l
court erred i n denying Delta Health's motion f o ra
j u d g m e n t as a m a t t e r o f l a w r e g a r d i n g
Stafford's
fraud
claim;
that
claim
should
n o t have
been
submitted t o the j u r y . "
887
So. 2d a t 899.
Delta
Health
i s not the f i r s t
time
this
Court
has
a d d r e s s e d a f r a u d c l a i m b a s e d on m i s r e p r e s e n t a t i o n s
made n o t
to a p l a i n t i f f
Halstead,
605
but t o a t h i r d party.
So. 2d 1181
( A l a . 1992),
43
I n Thomas v.
a patient
sued
h i s dentist
1101397
alleging
fraud,
obtained
specifically
payment f r o m t h e p a t i e n t ' s
were n e v e r r e n d e r e d .
who t o o k s e v e r a l
The p a t i e n t
dentist
insurer for services
that
went t o s e e t h e d e n t i s t ,
The p a t i e n t c l a i m e d t h a t t h e d e n t i s t
coverage.
Instead,
t h e a d d i t i o n a l work
never
been
done.
the dentist
on t h e p a t i e n t ' s
The p a t i e n t
made
misrepresentation,
made t o h i s i n s u r a n c e
legally
t o pay v a l i d
d e n t a l e x p e n s e s i n c u r r e d b y him,
misrepresentation
"While
right
generally
of action
general
rule:
element
[for fraud],'
teeth,
directly
claims
which had
even
to
i fthe
him,
carrier,
submitted
claim
"a
which i s
to i t
for
i s s u f f i c i e n t to s a t i s f y the
of fraud."
'[a] s t r a n g e r
submitted a
that,
was
obligated
not
argued
misrepresentation
605 So. 2d a t 1184.
to a transaction
there
... h a s no
i s an e x c e p t i o n
to this
' I f a t h i r d p e r s o n i s i n j u r e d b y t h e d e c e i t , he
may r e c o v e r a g a i n s t
him
the
t o submit a form t o t h e p a t i e n t ' s i n s u r e r t o determine t h e
insurance
for
that
X - r a y s o f h i s mouth a n d t o l d h i m he n e e d e d
a d d i t i o n a l d e n t a l work.
was
alleging
t h e one who made p o s s i b l e
by p r a c t i c i n g t h e d e c e i t
i n the f i r s t
t h e damages t o
place.'
37 C.J.S.
F r a u d § 60, p. 344 ( 1 9 4 3 ) , s e e Sims v. T i g r e t t , 229 A l a . 486,
158
So. 326 ( 1 9 3 4 ) . " 605 So. 2d a t 1184.
44
1101397
Sims
v.
Tigrett,
229 A l a . 486, 158
i n v o l v e d d e c e i t i n t h e s e l l i n g o f bonds.
So.
326
(1934),
This Court
stated:
" B u t we may o b s e r v e t h a t i f d e f e n d a n t c a u s e d t h e
r e p r e s e n t a t i o n s t o be made, a n d t h e p u b l i c were
i n t e n d e d t o be t h e r e b y i n d u c e d t o a c t upon them, a n d
plaintiff
was
within
the class
of those
so
contemplated,
the action
f o r deceit
against
d e f e n d a n t may be m a i n t a i n e d b y p l a i n t i f f ,
though
d e f e n d a n t d i d n o t s e l l t h e bonds t o p l a i n t i f f , b u t
s o l d them t o a n o t h e r , a n d he t o p l a i n t i f f , b o t h i n
r e l i a n c e on t h e t r u t h o f t h e r e p r e s e n t a t i o n s .
King
v. L i v i n g s t o n M f g . Co., 180 A l a . 118, 126, 60 So.
143 [ ( 1 9 1 2 ) ] ; 26 C . J . 1 1 2 1 , §§ 47, 48."
229 A l a . a t 4 9 1 , 158 So. a t 330.
The
Wyeth
defendants
d i s t i n g u i s h a b l e because
party
fraud
beyond
p h y s i c a l harm.
harm
medication
manufacturer
would
that
Delta
Health
t h i s C o u r t has never e x t e n d e d
t h e economic
realm
to claims
is
third-
alleging
We r e c o g n i z e t h a t D e l t a H e a l t h , Thomas, a n d
Sims d i d n o t i n v o l v e
physical
argue
a claim
suffered
have
who made
of p h y s i c a l
by
been
a
consumer
reasonably
fraudulent
injury.
of
However,
prescription
contemplated
statements
by
a
on t h e w a r n i n g
label related to that medication.
The Wyeth d e f e n d a n t s a l s o a r g u e t h a t t h i s C o u r t h a s n e v e r
extended
not
third-party-fraud
manufacture
liability
the product
about
45
t o a defendant
which
who d i d
the p l a i n t i f f
is
1101397
complaining.
unlike
We a g a i n
other
machinery,"
note t h a t p r e s c r i p t i o n medication i s
consumer
products.
Unlike
"construction
"lawnmowers," o r " p e r f u m e , " w h i c h
a r e "used t o
make l i f e e a s i e r o r t o p r o v i d e p l e a s u r e , " a p r e s c r i p t i o n
"may
be
necessary
sustain l i f e . "
Cal.
to alleviate
pain
Brown v. S u p e r i o r C o u r t
3d 1049, 1063, 245 C a l . R p t r .
(1988).
FDA.
and s u f f e r i n g
P r e s c r i p t i o n medication
I t c a n be o b t a i n e d
or to
o f San F r a n c i s c o , 44
412, 751 P.2d 740, 749
i s h e a v i l y r e g u l a t e d by t h e
only through
who c a n make a d e t e r m i n a t i o n
drug
a health-care
provider
as t o t h e b e n e f i t s a n d r i s k s o f
a d r u g f o r a p a r t i c u l a r p a t i e n t . A l s o , t h e Weekses' c l a i m s a r e
not
based
allege
on t h e m a n u f a c t u r i n g
that
the
label
—
of the product
drafted
by
but instead
the
brand-name
m a n u f a c t u r e r a n d r e q u i r e d b y f e d e r a l l a w t o be t h e same as t h e
label
placed
failed
on t h e g e n e r i c
t o warn.
Moreover,
under a c o n t i n u i n g duty
version
of the medication
t h e brand-name
t o supply
its
own
accord.
Wyeth
v
manufacturer i s
t h e FDA w i t h
r e p o r t s o f s e r i o u s i n j u r y and can s t r e n g t h e n
Levine,
supra;
—
postmarketing
i t s w a r n i n g s on
21
C.F.R.
§
2 0 1 . 5 7 ( c ) ( 6 ) ( I ) ; 21 C.F.R. § 2 0 1 . 5 6 ( a ) ( 2 ) - ( b ) ( 1 ) . I n c o n t r a s t ,
a generic manufacturer's
l a b e l must be t h e same as t h e b r a n d -
46
1101397
name m a n u f a c t u r e r ' s l a b e l , a n d t h e g e n e r i c m a n u f a c t u r e r c a n n o t
unilaterally
change i t s w a r n i n g
We r e c o g n i z e
succeed
label.
that the p l a i n t i f f i n Delta Health
i n h i s fraud
claim
because
he
failed
to
e v i d e n c e i n d i c a t i n g t h a t he r e l i e d t o h i s d e t r i m e n t
the
alleged misrepresentations
employer's i n s u r e r .
an
on a n y o f
to the
In a f r a u d case, d e t r i m e n t a l r e l i a n c e i s
the injury
s u f f e r e d was
" [ A ] f r a u d c l a i m f u l l y a c c r u e s once a n y
l e g a l l y c o g n i z a b l e damage h a s p r o x i m a t e l y
the
present
made b y h i s e m p l o y e r
e s s e n t i a l aspect o f showing t h a t
caused by t h e f r a u d .
d i d not
p l a i n t i f f has ' d e t r i m e n t a l l y ' r e l i e d
r e s u l t e d , i . e . , once
on t h e f r a u d . "
Ex
parte
Haynes Downard A n d r a & J o n e s , L L P , 924 So. 2d 687, 694
(Ala.
2005).
that
In the present
Danny's
representations
long-term
other
physician
relied
to a third party
that
causation
misrepresentation
link
on
i f a defendant's
causes t h e t h i r d p a r t y t o
i s satisfied
and
that,
then the
here,
t o Danny's p h y s i c i a n w o u l d d i r e c t l y
47
the
t o Danny. I n
actions r e s u l t i n g i n the p l a i n t i f f ' s i n j u r i e s ,
factual
alleged
regarding the
i n p r e s c r i b i n g Reglan
t h e Weekses a r e a r g u i n g
misrepresentation
take
reasonably
made b y t h e Wyeth d e f e n d a n t s
use o f Reglan
words,
c a s e , t h e Weekses have
a
impact
1101397
t h e m e d i c a l c a r e r e c e i v e d b y Danny.
I n S t o n e v. S m i t h , K l i n e
2d
1301
( A l a . 1984),
intermediary
this
doctrine
manufacturer's
duty
& French Laboratories ,
in
t o warn
Court
a
case
adopted
the
addressing
extends
beyond
447 So.
learned-
whether
a
the p r e s c r i b i n g
p h y s i c i a n t o t h e p h y s i c i a n ' s p a t i e n t who w o u l d u l t i m a t e l y u s e
the
drugs.
doctrine
The
principle
i s that
behind
prescribing
the learned-intermediary
physicians
a c t as
learned
i n t e r m e d i a r i e s between a m a n u f a c t u r e r and t h e c o n s u m e r / p a t i e n t
and t h a t , t h e r e f o r e , t h e p h y s i c i a n s t a n d s i n t h e b e s t p o s i t i o n
to
evaluate a patient's
needs
and t o a s s e s s
the r i s k s
and
b e n e f i t s of a p a r t i c u l a r course of treatment f o rthe p a t i e n t .
A
consumer
can o b t a i n
a prescription
drug
only
physician or other q u a l i f i e d health-care provider.
§ 353(b)(1).
§
a
21 U.S.C.
Physicians are t r a i n e d t o understand the h i g h l y
t e c h n i c a l warnings
C.F.R.
through
r e q u i r e d b y t h e FDA i n d r u g l a b e l i n g .
201.56.
The
learned-intermediary doctrine
21
was
e s t a b l i s h e d i n M a r c u s v. S p e c i f i c P h a r m a c e u t i c a l s , 191 M i s c .
285,
77 N.Y.S.2d
508
defense f o r " f a i l u r e
(N.Y. Sup. C t . 1 9 4 8 ) ,
t o warn" c a s e s .
as an a b s o l u t e
As a M a t t e r o f F a c t o r
a M a t t e r o f Law: The L e a r n e d I n t e r m e d i a r y D o c t r i n e i n A l a b a m a ,
48
1101397
53 A l a . L. Rev.
1299,
1301
(2002).
"Prescription
drugs
are
likely
to
be
complex
m e d i c i n e s , e s o t e r i c i n f o r m u l a and v a r i e d i n e f f e c t .
As a m e d i c a l e x p e r t , t h e p r e s c r i b i n g p h y s i c i a n can
t a k e i n t o a c c o u n t t h e p r o p e n s i t i e s o f t h e d r u g , as
w e l l as t h e s u s c e p t i b i l i t i e s o f h i s p a t i e n t . H i s i s
a t a s k o f w e i g h i n g t h e b e n e f i t s o f any
medication
a g a i n s t i t s p o t e n t i a l d a n g e r s . The c h o i c e he makes
is
an
informed
one,
an
individualized
medical
j u d g m e n t b o t t o m e d on a k n o w l e d g e o f b o t h p a t i e n t and
palliative."
R e y e s v. Wyeth L a b s . , 498
The
the
F.2d
learned-intermediary
physician
manufacturer
as
and
a
1264,
Appeals f o r the E l e v e n t h
(5th C i r . 1974).
doctrine recognizes
learned
a patient.
1276
intermediary
As
the
C i r c u i t has
United
the r o l e
between
States
a
" I n c a s e s i n v o l v i n g c o m p l e x p r o d u c t s , s u c h as
those i n which p h a r m a c e u t i c a l companies are s e l l i n g
prescription
drugs,
the
learned
intermediary
d o c t r i n e a p p l i e s . Under t h e l e a r n e d
intermediary
d o c t r i n e , a m a n u f a c t u r e r ' s d u t y t o warn i s l i m i t e d
t o an o b l i g a t i o n t o a d v i s e t h e p r e s c r i b i n g p h y s i c i a n
o f any p o t e n t i a l d a n g e r s t h a t may r e s u l t f r o m t h e
use
of
i t s product.
This
standard
is
'an
understandable
exception
to
the
Restatement's
g e n e r a l r u l e t h a t one who m a r k e t s goods must warn
f o r e s e e a b l e u l t i m a t e users of dangers i n h e r e n t i n
his products.'
As s u c h , we r e l y on t h e e x p e r t i s e o f
t h e p h y s i c i a n i n t e r m e d i a r y t o b r i d g e t h e gap
in
s p e c i a l c a s e s where t h e p r o d u c t and r e l a t e d w a r n i n g
a r e s u f f i c i e n t l y c o m p l e x so as n o t t o be
fully
appreciated
by
the
consumer.
...
'[U]nder
the
" l e a r n e d i n t e r m e d i a r y d o c t r i n e " the adequacy of [the
d e f e n d a n t ' s ] w a r n i n g i s m e a s u r e d by i t s e f f e c t on
t h e p h y s i c i a n , ... t o whom i t owed a d u t y t o w a r n ,
49
drug
Court
explained:
of
of
1101397
and n o t by i t s e f f e c t on
[the consumer].'"
T o o l e v. B a x t e r H e a l t h c a r e C o r p . , 235 F.3d 1307, 1313-14 ( 1 1 t h
Cir.
2000)(citations
A
warn
omitted).
prescription-drug
the
ultimate
manufacturer
users
of
the
fulfills
risks
of
i t s duty
to
i t s product
by
p r o v i d i n g adequate warnings t o the l e a r n e d i n t e r m e d i a r i e s
who
prescribe
the
the
drug.
Once
that
duty
is
fulfilled,
m a n u f a c t u r e r has no f u r t h e r d u t y t o warn t h e p a t i e n t
However,
i f the
warning
to
the
learned
directly.
intermediary
inadequate or misrepresents the r i s k , the manufacturer
l i a b l e f o r t h e i n j u r i e s s u s t a i n e d by the p a t i e n t .
must show t h a t t h e m a n u f a c t u r e r
of a r i s k
failure
patient's injury.
for
the
false
the a c t u a l
In short,
remains
The p a t i e n t
f a i l e d t o warn t h e p h y s i c i a n
n o t o t h e r w i s e known t o t h e p h y s i c i a n
t o warn was
is
and p r o x i m a t e
and t h a t t h e
cause
of the
t h e p a t i e n t must show t h a t , b u t
representation
made
in
the
warning,
the
p r e s c r i b i n g p h y s i c i a n w o u l d n o t have p r e s c r i b e d t h e m e d i c a t i o n
to h i s p a t i e n t .
Conclusion
We
a n s w e r t h e q u e s t i o n as f o l l o w s : Under A l a b a m a l a w , a
brand-name
drug
company
may
be
50
held
liable
f o r fraud
or
1101397
misrepresentation
statements
(by
misstatement
i t made i n c o n n e c t i o n
or
with
omission),
the
based
manufacture
on
of
a
brand-name p r e s c r i p t i o n d r u g , by a p l a i n t i f f c l a i m i n g p h y s i c a l
injury
c a u s e d by
company.
a generic
Unlike other
consumer p r o d u c t s ,
a r e h i g h l y r e g u l a t e d by
may
be
s o l d to
health-care
States
a
d r u g m a n u f a c t u r e d by
t h e FDA.
consumer,
Before
a physician
a
p r e s c r i p t i o n drugs
a p r e s c r i p t i o n drug
or
other
p r o v i d e r must w r i t e a p r e s c r i p t i o n .
Supreme
Court
in
Wyeth
v.
different
Levine
qualified
The
United
recognized
that
C o n g r e s s d i d n o t p r e e m p t common-law t o r t s u i t s , and i t a p p e a r s
that
the
FDA
complementary
resources
to
traditionally
form
of
monitor
drug
the
regarded
r e g u l a t i o n : The
11,000
m a n u f a c t u r e r s have s u p e r i o r a c c e s s
drugs,
especially in
the
state
drugs
on
law
as
FDA
has
the
market,
limited
and
to i n f o r m a t i o n about t h e i r
postmarketing
phase
as
new
risks
emerge; s t a t e - l a w t o r t s u i t s u n c o v e r unknown d r u g h a z a r d s
provide
a
and
i n c e n t i v e s f o r drug manufacturers to d i s c l o s e s a f e t y
r i s k s p r o m p t l y and s e r v e a d i s t i n c t c o m p e n s a t o r y f u n c t i o n t h a t
may
motivate
i n j u r e d p e r s o n s t o come f o r w a r d w i t h i n f o r m a t i o n .
Wyeth v. L e v i n e ,
FDA
555
U.S.
regulations
at
578-79.
provide
51
that
a
generic-drug
1101397
manufacturer's
exactly
the
labeling.
labeling
same
as
for a
the
prescription
brand-name-drug
drug
must
be
manufacturer's
The Supreme C o u r t i n PLIVA h e l d t h a t i t w o u l d have
b e e n i m p o s s i b l e f o r t h e g e n e r i c - d r u g m a n u f a c t u r e r s t o change
t h e i r warning l a b e l s without v i o l a t i n g the f e d e r a l requirement
t h a t t h e w a r n i n g on a g e n e r i c d r u g must m a t c h t h e w a r n i n g on
the
brand-name
version,
preempting
failure-to-warn
claims
against generic manufacturers.
I n t h e c o n t e x t o f i n a d e q u a t e w a r n i n g s b y t h e brand-name
m a n u f a c t u r e r p l a c e d on a p r e s c r i p t i o n d r u g m a n u f a c t u r e d
by a
generic-drug manufacturer, i t i s not fundamentally u n f a i r to
hold
t h e brand-name
manufacturer
liable
f o r warnings
on a
product i t d i d not produce because the manufacturing process
is
irrelevant
manufacturing
information
to misrepresentation theories
defects
in
and w a r n i n g
the
product
deficiencies,
based,
itself,
when
those
n o t on
but
on
alleged
m i s r e p r e s e n t a t i o n s were d r a f t e d b y t h e brand-name m a n u f a c t u r e r
and m e r e l y r e p e a t e d b y t h e g e n e r i c m a n u f a c t u r e r .
QUESTION ANSWERED.
Malone,
C . J . , and W o o d a l l ,
Stuart,
P a r k e r , Shaw,
and W i s e , J J . , c o n c u r .
Murdock, J . , d i s s e n t s
(writing to follow).
52
Main,