reglan generic decision weeks adv. wyeth mark@markzamora.com

1. 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
1
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 . "

2. 1101397
of Alabama, Southern Division ("the district court"), has
certified to t h i s Court the following question pursuant to
R u l e 18, A l a . R. App. 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 Court, the d i s t r i c t court
p r o v i d e d the f o l l o w i n g background 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
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3. 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-01771-
HGD, ... (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-cv-
602, (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
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4. 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
1
considered or resolved e i t h e r that question or the
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5. 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. CV-
1
2007-900065, 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 ) . "
Discussion
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At the outset, we limit the question posed to
manufacturers of prescription drugs and not to any
distributors thereof. The Weekses' complaint alleges that
three brand-name manufacturers, Wyeth, 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 such that Danny Weeks's physician, when he
prescribed 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
misled about the l i k e l i h o o d that the drug would cause the
movement disorder tardive dyskinesia and related movement
disorders. 2
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 about the r i s k s associated
w i t h t h e l o n g - t e r m use of metoclopramide a n d t h a t t h e Weekses,
as t h i r d p a r t i e s , 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
of t h a t duty.
A fraudulent-misrepresentation a c t i o n i s g o v e r n e d by § 6¬
5-101, Ala. Code 1975, which provides that
"[m]isrepresentations of a m a t e r i a l fact made w i l l f u l l y to
2
The Weekses also sued generic manufacturers of
metoclopramide, Teva Pharmaceuticals USA and Actavis
E l i z a b e t h , LLC.
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7. 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 . " A claim of
fraudulent misrepresentation comprises the f o l l o w i n g elements:
"(1) a f a l s e r e p r e s e n t a t i o n (2) c o n c e r n i n g a m a t e r i a l f a c t (3)
relied upon by the p l a i n t i f f (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 B a k e r v . B e n n e t t , 603 So. 2d 928, 935
(Ala. 1992)). "An essential element of fraudulent-
misrepresentation and f r a u d u l e n t - s u p p r e s s i o n 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 t h a t Wyeth a r g u e s t h a t t h e Weekses' claims
are, i n essence, "product-liability" claims. In Atkins v.
American Motors Corp., 335 So. 2d 134 ( 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 Court adopted t h e Alabama Extended
Manufacturer's L i a b i l i t y Doctrine ("AEMLD"). The AEMLD i s "a
judicially created accommodation of Alabama law t o the
doctrine of s t r i c t l i a b i l i t y 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 . , I n c . , 830
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8. 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 o r wantonness
claim. 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
(Ala. 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
So. 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. We h a v e a l s o r e c o g n i z e d that
fraudulent suppression is a claim separate from an AEMLD
claim. Keck, supra. Accordingly, f o r purposes of this
c e r t i f i e d q u e s t i o n , we w i l l 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 drug
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9. 1101397
product that is the pharmaceutical and therapeutical
equivalent o f t h e brand-name d r u g and that contains the same
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 i s the 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 prescription. § 34-23-8, Ala. Code 1975. In the
present case, i t appears that 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 drug f o r
t h e brand-name d r u g . " 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
generic s u b s t i t u t i o n law." PLIVA, I n c . v. M e n s i n g , U.S.
, , 131 S.Ct. 2567, 2583 (2011)(Sotomayor, J.,
dissenting). That a pharmacy a c t e d u n d e r § 34-23-8 and gave
Danny a g e n e r i c d r u g does n o t p r e c l u d e his a b i l i t y to assert
a fraudulent-misrepresentation claim against the brand-name
manufacturer. Additionally, many insurance plans are
structured t o promote the use of generic drugs. PLIVA,
U.S. at n.2, 131 S.Ct. at 2584 n.2. We now 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 drugs are unique because of the extensive
federal regulation of that product by the Food and Drug
Administration ("FDA"). "Congress had established a
comprehensive r e g u l a t o r y scheme, a d m i n i s t e r e d by the FDA, to
9

10. 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 ) . The FDA
has the ultimate authority to determine whether a new
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. 21 U.S.C. §§
355(a) 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 o f a new drug
without FDA a p p r o v a l o f a new-drug a p p l i c a t i o n showing the
d r u g t o be s a f e and e f f e c t i v e ) . 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. The IND a l s o includes
pre-clinical data (animal pharmacology and t o x i c o l o g y ) , and
protocols f o r human t e s t i n g must be d e t a i l e d . 3
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 life-
t 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 §
10

11. 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 ("NDA") t o t h e
FDA. 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
the 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 , recommended, o r
suggested i n the proposed labeling." 21 U.S.C. § 3 5 5 ( d ) ( 5 ) .
The NDA s h a l l i n c l u d e : (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 ; (4) a c o m p l e t e d e s c r i p t i o n o f
the manufacturing, p r o c e s s i n g , and p a c k a g i n g methods and
controls; (5) s a m p l e s of the drug a n d i t s components ( i f
requested); and (6) s a m p l e s of the proposed labeling. 21
U.S.C. § 355(b)(1). The NDA also must disclose a l l the
investigators who w o r k e d in clinical trials o f t h e d r u g as
w e l l as t h e i r reports. A l s o , an NDA must i n c l u d e t h e p a t e n t
number and e x p i r a t i o n dates o f any p a t e n t s related to or
impacted by t h e drug. 21 U.S.C. § 3 5 5 ( b ) ( 1 ) . The p a t e n t i s
generally good f o r 20 y e a r s , g i v i n g the manufacturer (drug
developer) the exclusive right t o make and s e l l the drug
312.95
11

12. 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 on a brand-name drug expires, generic
manufacturers may seek to replicate a generic version.
Generic 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 as t h e brand-name original. United States v.
Generix Drug Corp., 460 U.S. 453 (1983). To e x p e d i t e t h e
approval process f o r generic drugs 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 , Congress adopted the
Drug P r i c e Competition and P a t e n t Term Restoration Act of
1984. 21 U.S.C. § 355. T h i s A c t , a l s o known as t h e H a t c h -
Waxman A c t , p r o v i d e s f o r an a b b r e v i a t e d new-drug-application
("ANDA") p r o c e s s f o r the approval of generic versions of
brand-name drugs. The ANDA r e l i e s on t h e FDA's 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 data
for the extensive animal a n d human studies o f s a f e t y and
effectiveness that must accompany a full new drug
12

13. 1101397
application."). This allows an applicant for a generic
version of a drug to avoid the costly and time-consuming
process 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
4
dissemination
of low-cost generic drugs. See H.R. Rep. No. 98-857 ( P a r t I)
a t 14 (June 21, 1984) . A g e n e r i c manufacturer i s not entitled
to a l l data i n the master f i l e c o n t r o l l e d by t h e FDA because
some d a t a may 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 brand-
name m a n u f a c t u r e r . 21 C.F.R. § 314.430. At the same time,
Congress sought to protect brand-name manufacturers whose
patent 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
versions of their patented innovations. See American
Bioscience, Inc. v. Thompson, 243 F.3d 579, 580 (D.C. Cir.
4
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).
13

14. 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 manufacturers have a d u t y t o s u p p l y t h e FDA
with "postmarketing reports," which include reports o f any
serious and u n e x p e c t e d adverse r e a c t i o n s s u f f e r e d by a u s e r
of a drug. 21 C.F.R. § 314.80. The brand-name manufacturer
must also submit annual reports t o t h e FDA on significant
information, including information that might affect the
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. 21 C.F.R.
§ 314.81. A generic manufacturer i s likewise required to
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. However,
brand-name manufacturers and generic manufacturers have
different federal drug-labeling 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 , 131 S . C t . a t 2574. "Drug l a b e l s a r e
s u b j e c t t o change. New r i s k s may become 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

15. 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 ) , reversed
on other grounds, PLIVA, supra. Under t h e "Changes Being
Effected" or "CBE" rule, a brand-name manufacturer, upon
discovering a clinically 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
label t o "add o r s t r e n g t h e n a contraindication, warning,
precaution, or adverse reaction" without FDA a p p r o v a l . 21
C.F.R. § 314.70(c)(6)(iii)(A). Ultimately, t h e FDA will
review any CBE modification to a label. 21 C.F.R. §
314.70(c)(7). 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
manufacturer t o cease d i s t r i b u t i o n o f the drug with the
revised label. 21 C.F.R. § 314.70(c)(7).
A "label" i s defined as "a d i s p l a y o f w r i t t e n , printed,
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 o f any a r t i c l e
21 U.S.C. § 3 2 1 ( k ) . " ' [ 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 (1) upon any a r t i c l e
o r any o f i t s c o n t a i n e r s 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
article." 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

16. 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). The FDA includes ini t s
interpretation of l a b e l i n g "Dear D o c t o r " l e t t e r s , PLIVA,
U.S. at , 131 S . C t . a t 2576, which 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 or
s e n d a "Dear D o c t o r " l e t t e r u n d e r t h e CBE r u l e b e c a u s e doing
so w o u l d v i o l a t e the statutes and r e g u l a t i o n s 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

17. 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, I n c . , 857 F. Supp. 2d 1114, 1133 (D. Or.
2012)(emphasis added). A c c o r d i n g t o t h e FDA, i f a 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 i s r e q u i r e d t o propose such changes t o
the FDA, and, i f the FDA agrees that 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 label f o r both the brand-name and generic
drug. PLIVA, U.S. at , 131 S.Ct. 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 may change their labels after FDA
approval. We note that, because of the extensive federal
regulations, both the manufacturers o f brand-name d r u g s and
generic drugs in those cases argued that the federal
17

18. 1101397
r e g u l a t i o n s preempted s t a t e - l a w claims. I n Wyeth v. Levine,
555 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 her
forearm had to be amputated when a physician's assistant
injected her artery with the anti-nausea drug Phenergan by
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 injection. She sued
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 to provide
an adequate warning about the different risks involved with
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 the drug. She relied on
common-law n e g l i g e n c e and strict-liability theories. A jury
found that Wyeth had failed to provide an adequate warning
about the risks involved when P h e n e r g a n i s administered by
the IV push method. On appeal, Wyeth argued that the
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 federal
regulations regarding d r u g l a b e l i n g b e c a u s e i t was impossible
for 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 federal-
labeling obligations. 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 of
state-law s u i t s would undermine Congress's i n t e n t to entrust
labeling to the expertise of the FDA. The Supreme Court
rejected both contentions and held that there was no
preemption. The 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 to
d e m o n s t r a t e t h a t i t was impossible f o r i t t o comply w i t h both
18

19. 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 (footnote omitted).
PLIVA, supra, also i n v o l v e d a preemption claim regarding
labels, but the manufacturer there produced the generic
version o f a brand-name d r u g . "The question presented [was]
whether federal drug regulations applicable 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." U.S. at , 131 S.Ct. a t 2572. The
FDA had issued a labeling requirement r e g a r d i n g Reglan, the
19

20. 1101397
b r a n d name o f m e t o c l o p r a m i d e , the g e n e r i c drug a t i s s u e i n the
present case. 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 , 131 S . C t . a t 2575. By 2009, t h e FDA h a d o r d e r e d
a "black box" warning f o r Reglan concerning the dangers
associated with i t s long-term use. The 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 . The b a s i s o f t h e p l a i n t i f f s ' claims
was that the warning labels f o r the generic drug were
inadequate and t h a t 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 , 131 S . C t . a t 2575. The Supreme C o u r t found
that t h e FDA's federal-labeling requirement preempted t h e
plaintiffs' state-law claims against the manufacturers of the
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21. 1101397
generic d r u g b e c a u s e i t w o u l d have been impossible f o r the
generic-drug manufacturers t o change 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 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
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 s t a t e - l a w duty t o change the l a b e l and their
federal l a w d u t y t o keep t h e l a b e l t h e same." U.S. a t
, 131 S . C t . a t 2578.
The Supreme Court recognized i n PLIVA the seeming
contradiction in preempting claims against a generic
manufacturer i n PLIVA b u t a l l o w i n g state-law tort claims i n
21

22. 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 overstates what i t
22

23. 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. at , 131 S.Ct. at 2581-82.
As noted in the facts set out in the request for a
certified 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 law
have held that Alabama law does not allow a person who
consumed a g e n e r i c v e r s i o n of a brand-name d r u g to sue the
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 another company. They sued the brand-name
manufacturers of Reglan alleging, among other things,
negligent and fraudulent misrepresentation regarding the
warnings contained i n the labels the plaintiffs argued the
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24. 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 the drug. The federal court held that the
plaintiffs could not rely on any allegedly negligent
misrepresentations made by t h e brand-name 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 had i n g e s t e d a generic version. The c o u r t also stated
that their c l a i m of negligent misrepresentation should fail
because t h e brand-name manufacturers d i d n o t engage i n any
business transaction with the p l a i n t i f f s . With regard to
fraudulent misrepresentation, the court held that the
plaintiffs failed to present any b i n d i n g a u t h o r i t y f o r the
assertion 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 version of i t s product and f a i l e d to
cite 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 t h a t an 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 regarding t h e brand-name version of the
generic drug. 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

25. 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 own warning labels and any
necessary r e v i s i o n s t o those labels.
Mosley 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. Instead, they are arguing that t h e Wyeth defendants
owed a duty t o Danny Weeks's physician and t h a t , under t h e
learned-intermediary doctrine, they are e n t i t l e d t o r e l y on
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 . 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 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
the brand-name 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 . R e l i a n c e upon
the reasoning i n Mosley that a generic manufacturer is
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26. 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 and r e v i s i o n s of those
labels i s unsound.
I n O v e r t o n v. Wyeth, I n c . , (No. CA 10-0491-KD-C, March
15, 2011) (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 filed a motion to dismiss the
plaintiffs' state-law claims of breach of warranty, fraudulent
misrepresentation, 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
plaintiffs 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 be relied upon by the generic
manufacturers i n generating t h e i r own l a b e l s , and t h a t their
doing so was a d i r e c t 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 '
i n j u r i e s . The f e d e r a l court s t a t e d that the d i s p o s i t i v e issue
on the p l a i n t i f f s ' misrepresentation claims was w h e t h e r t h e
brand-name manufacturers owed any duty to p l a i n t i f f s who
ingested the generic v e r s i o n o f t h e i r brand-name d r u g . The
federal court held that the p l a i n t i f f s presented no e v i d e n c e
indicating 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
consumers of the generic version of the drug so that the
plaintiffs' injuries could be considered to have been a
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27. 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 ' alleged
misrepresentation regarding t h e brand-name drug. The court
noted that FDA regulations could not provide the 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 the approval process by r e l y i n g on t h e i n i t i a l
warning labels provided 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 warning label adequately described the r i s k associated
with the drug. "In other words, a f t e r 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 their own warning labels a n d any n e c e s s a r y revisions."
N o t e 9. 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 decided
PLIVA. 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
that a generic m a n u f a c t u r e r becomes responsible f o r i t s own
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 i s incorrect.
In Simpson v. Wyeth, Inc., (No. 7:10-cv-01771-HGD,
December 9, 2010)(N.D. A l a . 2 0 1 0 ) ( n o t reported i n F. Supp.
2d), the f e d e r a l court held that the p l a i n t i f f s , who had
ingested only the generic v e r s i o n of Reglan, could not recover
for the alleged fraudulent misrepresentations to the
plaintiffs' 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. The b r a n d -
27

28. 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 and t h a t
allegedly had caused their injuries, the brand-name
manufacturers could n o t be h e l d liable. The 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 from t h e brand-name m a n u f a c t u r e r s even though they
were third parties to the alleged deceit or concealment
because the deceit and concealment perpetrated against the
plaintiffs' prescribing doctors proximately caused their
damage. 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), which held that i n certain circumstances a
plaintiff may p r o p e r l y state a fraud claim even though t h e
defendant's false representation i s made t o a t h i r d party,
r a t h e r than t o the p l a i n t i f f . 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 must establish that he relied on the
misrepresentation.
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29. 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 to hold a brand-name-drug manufacturer
responsible f o r damage caused by a g e n e r i c b r a n d of their
drug, c i t i n g Mosley, supra. 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 advise a physician using i t s
product of any associated risks, not the brand name
manufacturer." Simpson.
The federal court i n Simpson went on t o address the
learned-intermediary 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

30. 1101397
t a k i n g t h i s product t o anyone o t h e r than t h e i r own
customers."
L i k e M o s l e y and O v e r t o n , Simpson was issued before PLIVA
was decided, 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 m a n u f a c t u r e r s have t h e i r own duty to correctly
advise 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 be
the same as t h e brand-name l a b e l -- i s questionable. Also,
the p l a i n t i f f s i n Simpson argued t h a t t h e y s h o u l d be allowed
to recover 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 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 those
manufacturers upon the plaintiffs' prescribing physicians.
The 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 , under
the learned-intermediary doctrine, could prove that their
physicians had relied upon the brand-name manufacturer's
warning, the plaintiffs still had to demonstrate that the
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 a duty before the
brand-name m a n u f a c t u r e r c o u l d be liable.
We recognize that other j u r i s d i c t i o n s , p r i m a r i l y relying
on F o s t e r v. A m e r i c a n Home P r o d u c t s C o r p . , 29 F.3d 165 (4th
Cir. 1 9 9 4 ) , have c o n c l u d e d t h a t a brand-name m a n u f a c t u r e r does
30

31. 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 version of the
prescription drug of the dangers associated with the drug. 5
In F o s t e r , the p l a i n t i f f s ' 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
the g e n e r i c form o f Phenergan, a brand-name d r u g . They sued
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 , alleging negligent
misrepresentation and s t r i c t l i a b i l i t y . The f e d e r a l district
court dismissed the s t r i c t - l i a b i l i t y c l a i m because the brand-
name m a n u f a c t u r e r had not manufactured the generic version
taken by the daughter. However, the court allowed the
negligent-misrepresentation claim to proceed. The brand-name
5
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. 3:11-
cv-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-CV-
1477, 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 ) .
31

32. 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 and t h e p l a i n t i f f ' s injury. The federal
appeals court stated that the p l a i n t i f f s 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 t o have m a n u f a c t u r e d the product that caused the
injury before the defendant could be h e l d liable f o r such
injury. 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
not owe a d u t y of care t o the p l a i n t i f f s , even though t h e
plaintiffs 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 t o t h e brand-name
manufacturer o f Phenergan that statements contained in its
label f o r the drug could result i n injury t o a user of a
generic v e r s i o n of the drug. The c o u r t 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

33. 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

34. 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 i n Foster argued that t h e brand-name
manufacturers owed a duty because i t was f o r e s e e a b l e that
misrepresentations regarding Phenergan could result in
personal injury to the users of the generic equivalents of
Phenergan. 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
that c a s e w o u l d be t o s t r e t c h the concept of f o r e s e e a b i l i t y
too far. "The d u t y required f o r the t o r t of negligent
misrepresentation a r i s e s when t h e r e i s 'such a r e l a t i o n that
one party has t h e r i g h t to rely f o r information 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 by a p r o d u c t
34

35. 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 . 29
F.3d a t 171 ( q u o t i n g Weisman v. C o n n o r s , 32 Md. 428, 443-44,
540 A.2d 783, 790 ( 1 9 8 8 ) ) .
A few c o u r t s have h e l d otherwise. I n C o n t e v. Wyeth,
Inc., 168 C a l . App. 4 t h 89, 85 C a l . R p t r . 3d 299 (2008), the
California Court of Appeals, applying state 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 by the brand-named
manufacturer that developed the drug. 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 and its generic version,
metoclopramide, alleging t h a t h e r use o f m e t o c l o p r a m i d e over
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 dyskinesia.
Conte had i n g e s t e d only the generic drug. "The crux of
Conte's claims against a l l of the drug company defendants
[was] 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
due to their dissemination of false, misleading and/or
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 . " 168 C a l .
35

36. 1101397
App. 4 t h a t 95, 85 C a l . R p t r . 3d a t 305. The t r i a l court
entered a summary judgment f o r a l l the defendant drug
manufacturers, 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 disseminated by the brand-name
manufacturer of Reglan. Specifically, the a p p e l l a t e court
held that t h e brand-name m a n u f a c t u r e r knew or should have
known "that a significant number o f p a t i e n t s whose doctors
r e l y on i t s p r o d u c t 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
generic metoclopramide p r e s c r i b e d or dispensed t o them" a n d
that the brand-name manufacturer's "duty of care in
disseminating product information extends t o those patients
who are i n j u r e d by generic metoclopramide as a result of
prescriptions written in reliance on [the brand-name
manufacturer's] product information f o r Reglan." 168 C a l .
App. 4 t h a t 107, 85 C a l . R p t r . 3d a t 315. 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

37. 1101397
manufacturers had disseminated any information concerning
their generic product.
I n K e l l o g g v. Wyeth, 762 F. Supp. 2d 694 (D. V t . 2010),
the Vermont federal district court held that a brand-name
m a n u f a c t u r e r o f a d r u g has a d u t y t o use reasonable care to
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 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. K e l l o g g , the p l a i n t i f f in
that case, sued the brand-name manufacturer and generic
manufacturers of metoclopramide, a l l e g i n g t h a t her long-term
ingestion of metoclopramide caused her to develop tardive
dyskinesia; K e l l o g g had i n g e s t e d o n l y the g e n e r i c drug. The
crux of Kellogg's argument was that a l l the defendant
m a n u f a c t u r e r s were l i a b l e because they failed to adequately
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 long-term
use of metoclopramide. Both the brand-name manufacturer
and each of the generic manufacturers filed a motion for a
summary judgment on Kellogg's failure-to-warn claim; the
federal district court denied the motions. The court 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 warning to
Kellogg's prescribing physicians, a jury question e x i s t e d as
37

38. 1101397
to whether the defendant drug manufacturers had provided
accurate and adequate warnings. The f e d e r a l d i s t r i c t court
f u r t h e r h e l d that the defendant 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 i s s u e on
proximate cause. Specifically, the court 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 drug
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 ] injury."
762 F. Supp. 2d a t 702. The f e d e r a l d i s t r i c t court finally
denied t h e summary-judgment motion filed 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 , fraud,
and f r a u d - b y - c o n c e a l m e n t 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 the physicians to over-prescribe
metoclopramide to her. The brand-name m a n u f a c t u r e r agreed
t h a t i t had a duty t o p r o v i d e adequate warnings about Reglan
to p h y s i c i a n s . 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
a doctor who prescribes Reglan i f t h e pharmacy fills the
doctor's prescription with a generic brand. Applying
Vermont's negligence law, the f e d e r a l d i s t r i c t court noted
38

39. 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 reasonable
care to avoid causing injury to consumers of the generic
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 F. Supp. 2d a t 706, because
"it i s reasonably foreseeable that a physician w i l l r e l y upon
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 — or the absence
of representations — about the risk of side effects of i t s
drug, when deciding to prescribe the drug for a patient,
regardless of whether the pharmacist fills the prescription
with a generic form of the drug." 762 F. Supp. 2d at 709.
The federal district court therefore held that Kellogg had
presented triable issues of fact regarding whether "her
doctors 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 information — or
the absence of accurate information -- from [the brand-name
manufacturer] concerning the risks and effects of long-term
use of [metoclopramide]." 762 F. Supp. 2d a t 710.
In l o o k i n g at the r e a s o n i n g i n F o s t e r and C o n t e , we note
that the Foster court relied on the finding that a generic
manufacturer of a prescription drug i s responsible for the
accuracy of l a b e l s p l a c e d on i t s product. F o s t e r was issued
before t h e Supreme C o u r t d e c i d e d 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

40. 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 t o update a warning. The F o s t e r c o u r t ' s
finding that 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, the analysis in Foster confuses strict
liability and t o r t law. 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
"[n]o legal precedent 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 . " 29
F.3d a t 170. 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 claim
and the issue was one o f a defect i n production of the
product, then 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 be sound.
C e r t a i n l y , a manufacturer w i l l n o t be h e l d l i a b l e f o r a n o t h e r
manufacturer's production, design, or manufacturing defect.
However, the Foster court's reasoning that a 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