Decision - wyeth v. weeks (supreme court of alabama)

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  • 1. REL:01/11/2013Notice: 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 advances 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 et 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 WeeksC 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 1shows 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 nt 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 tas "Wyeth, L L C . "
  • 2. 1101397of Alabama, Southern Division ("the district court"), hascertified to t h i s Court the following question pursuant toR 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 courtp 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. Weekss 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
  • 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. Weekss 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 competitors 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 3
  • 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 competitors generic product). Since t h i s Courts 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 4
  • 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 questions 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 5
  • 6. 1101397 At the outset, we limit the question posed tomanufacturers of prescription drugs and not to anydistributors thereof. The Weekses complaint alleges thatthree brand-name manufacturers, Wyeth, Pfizer, I n c . , andS 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 deceptivelym 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 rmetoclopramide such that Danny Weekss physician, when heprescribed 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 dmisled about the l i k e l i h o o d that the drug would cause themovement disorder tardive dyskinesia and related movementdisorders. 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 da d u t y t o warn Dannys p h y s i c i a n about the r i s k s associatedw 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 hof 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 ofmetoclopramide, Teva Pharmaceuticals USA and ActavisE l i z a b e t h , LLC. 6
  • 7. 1101397deceive, 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 eo 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 don 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 offraudulent 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 ap 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 dutyt 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 claimsare, i n essence, "product-liability" claims. In Atkins v.American Motors Corp., 335 So. 2d 134 ( A l a . 1976), inc 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. 2d128 (Ala. 1976), this Court adopted t h e Alabama ExtendedManufacturers L i a b i l i t y Doctrine ("AEMLD"). The AEMLD i s "ajudicially created accommodation of Alabama law t o thedoctrine 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 yallegedly defective products." K e c k v. D r y v i t S y s . , I n c . , 830 7
  • 8. 1101397So. 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 eAEMLD d i d n o t subsume a common-law n e g l i g e n c e o r wantonnessclaim. 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 . , 901So. 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 thatfraudulent suppression is a claim separate from an AEMLDclaim. Keck, supra. Accordingly, f o r purposes of thisc 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 asAEMLD 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 pharmacistt 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 8
  • 9. 1101397product that is the pharmaceutical and therapeuticalequivalent o f t h e brand-name d r u g and that contains the samea 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 ms 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 eon the prescription. § 34-23-8, Ala. Code 1975. In thepresent case, i t appears that Dannys p r e s c r i p t i o n d i d notp 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 rt 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 fgeneric 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 gaveDanny 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 asserta fraudulent-misrepresentation claim against the brand-namemanufacturer. Additionally, many insurance plans arestructured 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 thef 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 extensivefederal regulation of that product by the Food and DrugAdministration ("FDA"). "Congress had established acomprehensive 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. 1101397control 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 FDAhas the ultimate authority to determine whether a newp 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 drugwithout 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 thed 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 beginsw 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 dto 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 . See21 U.S.C. § 3 5 5 ( b ) ; 21 C.F.R. § 312.21. The IND a l s o includespre-clinical data (animal pharmacology and t o x i c o l o g y ) , andprotocols 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 sd 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 100h 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 rs 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 twoi 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 ap 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 ft 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 lthousands 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 yand 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-fourstudies concurrent with market approval to conductpostmarketing 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 em 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 eFDA. 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 tthe 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 ohave 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 rsuggested 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 andt 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 edrug; (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 fthe manufacturing, p r o c e s s i n g , and p a c k a g i n g methods andcontrols; (5) s a m p l e s of the drug a n d i t s components ( i frequested); and (6) s a m p l e s of the proposed labeling. 21U.S.C. § 355(b)(1). The NDA also must disclose a l l theinvestigators who w o r k e d in clinical trials o f t h e d r u g asw 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 tnumber and e x p i r a t i o n dates o f any p a t e n t s related to orimpacted by t h e drug. 21 U.S.C. § 3 5 5 ( b ) ( 1 ) . The p a t e n t i sgenerally good f o r 20 y e a r s , g i v i n g the manufacturer (drugdeveloper) the exclusive right t o make and s e l l the drug312.95 11
  • 12. 1101397during that period. 35 U.S.C. § 1 5 4 ( a ) ( 2 ) . The m a n u f a c t u r e rmake 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, genericmanufacturers 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 eingredient 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 eapproval process f o r generic drugs in order to bringp 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 gp 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 theDrug P r i c e Competition and P a t e n t Term Restoration Act of1984. 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 ofbrand-name drugs. The ANDA r e l i e s on t h e FDAs previousd 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 datafor the extensive animal a n d human studies o f s a f e t y andeffectiveness that must accompany a full new drug 12
  • 13. 1101397application."). This allows an applicant for a genericversion of a drug to avoid the costly and time-consumingprocess 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 disseminationof 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 entitledto 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 becausesome 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 whosepatent 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 genericversions of their patented innovations. See AmericanBioscience, 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 ee 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 drugindustry 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 gt 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 bed 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 ft 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 dt 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 st 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 lp 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 si 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 rproducts 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 pharmaceuticalsales r e p r e s e n t a t i v e s provide information to physicians i nt 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 eproducts 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 eBeecham C o r p . , U.S. , , 132 S.Ct. 2156, 2163 (2012)(footnote omitted). 13
  • 14. 11013972 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 FDAwith "postmarketing reports," which include reports o f anyserious 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 rof a drug. 21 C.F.R. § 314.80. The brand-name manufacturermust also submit annual reports t o t h e FDA on significantinformation, including information that might affect thesafety, 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 tos 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 havedifferent 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 names. 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 es u b j e c t t o change. New r i s k s may become apparent only a f t e rt 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. 1101397M e n s i n g v. Wyeth, 588 F.3d 603, 606 ( 8 t h C i r . 2 0 0 9 ) , reversedon other grounds, PLIVA, supra. Under t h e "Changes BeingEffected" or "CBE" rule, a brand-name manufacturer, upondiscovering 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 slabel 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 . 21C.F.R. § 314.70(c)(6)(iii)(A). Ultimately, t h e FDA willreview 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 emanufacturer t o cease d i s t r i b u t i o n o f the drug with therevised 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 dother 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 eo 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 harticle." 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 sinterpretation 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 drugm 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 fcritical newly discovered risks or side effects of amedication. 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 cannotu 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 ors 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 doingso 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 thel 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 slabel. 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 othe FDA, and, i f the FDA agrees that such changes aren 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 rto c r e a t e a new label f o r both the brand-name and genericdrug. 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 tto which manufacturers may change their labels after FDAapproval. We note that, because of the extensive federalregulations, both the manufacturers o f brand-name d r u g s andgeneric drugs in those cases argued that the federal 17
  • 18. 1101397r 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 herforearm had to be amputated when a physicians assistantinjected her artery with the anti-nausea drug Phenergan byu 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 suedWyeth, 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 providean adequate warning about the different risks involved witht 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 oncommon-law n e g l i g e n c e and strict-liability theories. A juryfound that Wyeth had failed to provide an adequate warningabout the risks involved when P h e n e r g a n i s administered bythe IV push method. On appeal, Wyeth argued that thep 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 federalregulations regarding d r u g l a b e l i n g b e c a u s e i t was impossiblefor 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 ofstate-law s u i t s would undermine Congresss i n t e n t to entrustlabeling to the expertise of the FDA. The Supreme Courtrejected both contentions and held that there was nopreemption. 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 tod 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. 1101397federal 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 wc l a i m s a r e an i m p o r t a n t complement t o t h e FDAs r e g u l a t i o n o fp 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 regardinglabels, but the manufacturer there produced the genericversion 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 drugm 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 estate-law claims." U.S. at , 131 S.Ct. a t 2572. TheFDA had issued a labeling requirement r e g a r d i n g Reglan, the 19
  • 20. 1101397b 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 thepresent 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 nbut 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 esame 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 makers l a b e l i n g t o be t h e same as t h ebrand-name d r u g makers l a b e l i n g b e c a u s e t h e brand-name d r u gi 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 da "black box" warning f o r Reglan concerning the dangersassociated with i t s long-term use. The plaintiffs hads 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 cform 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 emanufacturers 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 owarn 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 claimswas that the warning labels f o r the generic drug wereinadequate and t h a t the g e n e r i c manufacturers had a duty t os 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 FDAs 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 foundthat t h e FDAs federal-labeling requirement preempted t h eplaintiffs state-law claims against the manufacturers of the 20
  • 21. 1101397generic d r u g b e c a u s e i t w o u l d have been impossible f o r thegeneric-drug manufacturers t o change their warning labelsw 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 ona generic drug match the warning on i t s brand-namecounterpart. " [ 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 names. 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 heldt 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 sf 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 cd 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 hboth their s t a t e - l a w duty t o change the l a b e l and theirfederal 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 seemingcontradiction in preempting claims against a genericmanufacturer i n PLIVA b u t a l l o w i n g state-law tort claims i n 21
  • 22. 1101397Wyeth: "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 Courts 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 acertified 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 lawhave held that Alabama law does not allow a person whoconsumed 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 thebrand-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), thep 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 equivalentm a n u f a c t u r e d by another company. They sued the brand-namemanufacturers of Reglan alleging, among other things,negligent and fraudulent misrepresentation regarding thewarnings contained i n the labels the plaintiffs argued the 23
  • 24. 1101397brand-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 cmanufacturers i n generating the warning l a b e l s f o r the genericversion of the drug. The federal court held that theplaintiffs could not rely on any allegedly negligentmisrepresentations made by t h e brand-name manufacturers tosupport 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 thebrand-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 statedthat their c l a i m of negligent misrepresentation should failbecause t h e brand-name manufacturers d i d n o t engage i n anybusiness transaction with the p l a i n t i f f s . With regard tofraudulent misrepresentation, the court held that theplaintiffs failed to present any b i n d i n g a u t h o r i t y f o r theassertion 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 econsumer o f a g e n e r i c version of i t s product and f a i l e d tocite 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 injuryr 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 obe 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 dmisrepresentation regarding t h e brand-name version of thegeneric 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 federallaw 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. 1101397p 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 byt 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 ebrand-name manufacturers a n d t h e consumer of the genericv 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 sbecome responsible for their own warning labels and anynecessary r e v i s i o n s t o those labels. Mosley i s distinguishable from the present case. TheWeekses 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 aduty. Instead, they are arguing that t h e Wyeth defendantsowed a duty t o Danny Weekss physician and t h a t , under t h elearned-intermediary doctrine, they are e n t i t l e d t o r e l y ont 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 notet 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 tin PLIVA, supra, expressly found that because i t wasi 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 hb 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 rl a b e l adequately warning o f t h e dangers i n h e r e n t i n long-termuse 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 asthe brand-name manufacturers label, any s t a t e - l a w c l a i m sa 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 uponthe reasoning i n Mosley that a generic manufacturer is 25
  • 26. 1101397r 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 thoselabels i s unsound. I n O v e r t o n v. Wyeth, I n c . , (No. CA 10-0491-KD-C, March15, 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 ebrand-name manufacturers filed a motion to dismiss theplaintiffs state-law claims of breach of warranty, fraudulentmisrepresentation, 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 eplaintiffs 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-named 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 sp 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 , whenthey knew the l a b e l s would be relied upon by the genericmanufacturers i n generating t h e i r own l a b e l s , and t h a t theirdoing 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 issueon the p l a i n t i f f s misrepresentation claims was w h e t h e r t h ebrand-name manufacturers owed any duty to p l a i n t i f f s whoingested the generic v e r s i o n o f t h e i r brand-name d r u g . Thefederal court held that the p l a i n t i f f s presented no e v i d e n c eindicating 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 oconsumers of the generic version of the drug so that theplaintiffs injuries could be considered to have been a 26
  • 27. 1101397p 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 allegedmisrepresentation regarding t h e brand-name drug. The courtnoted that FDA regulations could not provide the requisiteduty element because f e d e r a l law a l l o w s a g e n e r i c manufacturerto streamline the approval process by r e l y i n g on t h e i n i t i a lwarning labels provided b y t h e brand-name m a n u f a c t u r e r , b u tthe g e n e r i c manufacturer s t i l l had the burden of showing t h a tits warning label adequately described the r i s k associatedwith 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 responsiblefor 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 decidedPLIVA. A c c o r d i n g l y , the f e d e r a l courts c o n c l u s i o n i n Overtonthat a generic m a n u f a c t u r e r becomes responsible f o r i t s ownw 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 hadingested only the generic v e r s i o n of Reglan, could not recoverfor the alleged fraudulent misrepresentations to theplaintiffs 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. 1101397name manufacturers argued that, because they d i d notmanufacture 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 tallegedly had caused their injuries, the brand-namemanufacturers could n o t be h e l d liable. The plaintiffsa 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 swas 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 fthe brand-name manufacturers misinformation to thep 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 drecover from t h e brand-name m a n u f a c t u r e r s even though theywere third parties to the alleged deceit or concealmentbecause the deceit and concealment perpetrated against theplaintiffs prescribing doctors proximately caused theirdamage. 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 sr 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 aplaintiff may p r o p e r l y state a fraud claim even though t h edefendants 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, thef e d e r a l court noted that Delta Health went on t o h o l d t h a t aplaintiff must establish that he relied on themisrepresentation. 28
  • 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 witht 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 haver 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 shave attempted to hold a brand-name-drug manufacturerresponsible f o r damage caused by a g e n e r i c b r a n d of theirdrug, 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 ont 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-namemanufacturer 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 ni 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. 2d1351 (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 cdrug manufacturer to correctly advise a physician using i t sproduct of any associated risks, not the brand namemanufacturer." Simpson. The federal court i n Simpson went on t o address thelearned-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 PLIVAwas 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 correctlyadvise 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 drugr 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 bethe 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 allowedto 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 theywere 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 thosemanufacturers 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 , underthe learned-intermediary doctrine, could prove that theirphysicians had relied upon the brand-name manufacturerswarning, the plaintiffs still had to demonstrate that thebrand-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 thebrand-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 relyingon 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 (4thCir. 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. 1101397n 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 theprescription drug of the dangers associated with the drug. 5In 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 gthe g e n e r i c form o f Phenergan, a brand-name d r u g . They suedt 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 negligentmisrepresentation and s t r i c t l i a b i l i t y . The f e d e r a l districtcourt 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 versiontaken by the daughter. However, the court allowed thenegligent-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 gc 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 rg 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 y26, 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 pv. 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 tr 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. 1101397manufacturer 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 ti 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 ro 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 relationshipbetween defect and t h e p l a i n t i f f s injury. The federalappeals 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 oh 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 yanother 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 wouldr 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 tbe shown t o have m a n u f a c t u r e d the product that caused theinjury before the defendant could be h e l d liable f o r suchinjury. 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 dnot 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 eplaintiffs 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-namemanufacturer o f Phenergan that statements contained in itslabel f o r the drug could result i n injury t o a user of ageneric 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 manufacturers 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 manufacturers 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-namemanufacturers owed a duty because i t was f o r e s e e a b l e thatmisrepresentations regarding Phenergan could result inpersonal injury to the users of the generic equivalents ofPhenergan. 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 nthat 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 ytoo far. "The d u t y required f o r the t o r t of negligentmisrepresentation a r i s e s when t h e r e i s such a r e l a t i o n thatone party has t h e r i g h t to rely f o r information upon t h eo 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 tw 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 pexisted 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. 1101397t 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 . 29F.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), theCalifornia 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 abrand-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 aconsumer who purchased a generic form of the drug i f thec 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 for intentional misrepresentation by the brand-namedmanufacturer that developed the drug. Conte, the p l a i n t i f f i nt 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 cmanufacturers 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 overa 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 ofContes 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 edue to their dissemination of false, misleading and/ori n c o m p l e t e warnings about the drugs s i d e e f f e c t . " 168 C a l . 35
  • 36. 1101397App. 4 t h a t 95, 85 C a l . R p t r . 3d a t 305. The t r i a l courtentered a summary judgment f o r a l l the defendant drugmanufacturers, 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 appellatec 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-namemanufacturer after concluding that Conte had presented am 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 trelied on information disseminated by the brand-namemanufacturer of Reglan. Specifically, the a p p e l l a t e courtheld that t h e brand-name m a n u f a c t u r e r knew or should haveknown "that a significant number o f p a t i e n t s whose doctorsr 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 havegeneric metoclopramide p r e s c r i b e d or dispensed t o them" a n dthat the brand-name manufacturers "duty of care indisseminating product information extends t o those patientswho are i n j u r e d by generic metoclopramide as a result ofprescriptions written in reliance on [the brand-namemanufacturers] 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 ta 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 eg 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 onappeal 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. 1101397manufacturers had disseminated any information concerningtheir 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-namem 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 toa 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 eg 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 inthat case, sued the brand-name manufacturer and genericmanufacturers of metoclopramide, a l l e g i n g t h a t her long-termingestion of metoclopramide caused her to develop tardivedyskinesia; 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. Thecrux of Kelloggs argument was that a l l the defendantm a n u f a c t u r e r s were l i a b l e because they failed to adequatelywarn 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-termuse of metoclopramide. Both the brand-name manufacturerand each of the generic manufacturers filed a motion for asummary judgment on Kelloggs failure-to-warn claim; thefederal district court denied the motions. The court heldt h a t , because a l l the p a r t i e s agreed t h a t the defendant drugmanufacturers owed a duty to provide adequate warning toKelloggs prescribing physicians, a jury question e x i s t e d as 37
  • 38. 1101397to whether the defendant drug manufacturers had providedaccurate and adequate warnings. The f e d e r a l d i s t r i c t courtf 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 te 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 onproximate 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 andinaccurate information provided by the [defendant drugm 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 finallydenied t h e summary-judgment motion filed b y t h e brand-namem 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 tt 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 failingt 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 ophysicians, thereby causing the physicians to over-prescribemetoclopramide to her. The brand-name m a n u f a c t u r e r agreedt h a t i t had a duty t o p r o v i d e adequate warnings about Reglanto 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 oa doctor who prescribes Reglan i f t h e pharmacy fills thedoctors prescription with a generic brand. ApplyingVermonts negligence law, the f e d e r a l d i s t r i c t court noted 38
  • 39. 1101397t 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 reasonablecare to avoid causing injury to consumers of the genericb 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 upona 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 absenceof representations — about the risk of side effects of i t sdrug, when deciding to prescribe the drug for a patient,regardless of whether the pharmacist fills the prescriptionwith a generic form of the drug." 762 F. Supp. 2d at 709.The federal district court therefore held that Kellogg hadpresented triable issues of fact regarding whether "herdoctors 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 — orthe absence of accurate information -- from [the brand-namemanufacturer] concerning the risks and effects of long-termuse 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 notethat the Foster court relied on the finding that a genericmanufacturer of a prescription drug i s responsible for theaccuracy 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 issuedbefore 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 thata 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. 1101397name 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 ychange i t s label t o update a warning. The F o s t e r c o u r t sfinding 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 ef 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 gt 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" requirementd i s c u s s e d i n PLIVA. Moreover, the analysis in Foster confuses strictliability 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 manufacturerss 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 rinjuries 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 whoseproduction 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 . " 29F.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 claimand the issue was one o f a defect i n production of theproduct, 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 rmanufacturers production, design, or manufacturing defect.However, the Foster courts reasoning that a brand-namem 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 cv 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 dnot 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
  • 41. 1101397r e l a t e s t o the warnings contained i n the l a b e l i n g r e l a t i n g tothe d r u g and sound i n t o r t . In Foster, the p l a i n t i f f s allegedthat i t was the inadequate warning that caused theirdaughters death, n o t how the drug itself was produced.Because a warning label i s not a part of the manufacturingprocess, we do n o t a g r e e that the f a c t that a brand-namemanufacturer d i d not produce the v e r s i o n of the drug ingestedby the p l a i n t i f f bars the p l a i n t i f f s tort a c t i o n when t h eplaintiff i s arguing 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 et o warn. We recognize that the holding i n PLIVA d i d n o t a d d r e s sf 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 SupremeC 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 drugis required by federal regulations t o be t h e same as t h elabeling f o r t h e brand-name d r u g . Therefore, an o m i s s i o n ordefect in the labeling f o r the brand-name drug wouldn e c e s s a r i l y be r e p e a t e d i n the generic l a b e l i n g , foreseeablycausing 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 fi t s patent a n d w e l l aware t h a t a g e n e r i c v e r s i o n of the drugwill be made when t h e p a t e n t expires. I t i s recognized that 41
  • 42. 1101397g 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 . A brand-name m a n u f a c t u r e r could reasonably foresee that a physicianp 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 twould rely on the warning drafted by the brand-namemanufacturer even i f the patient ultimately consumed t h egeneric v e r s i o n of the drug. We now turn to the issuewhether t h e Wyeth d e f e n d a n t s owed a d u t y t o t h e Weekses ast h i r d p a r t i e s to the alleged fraud i n f a i l i n g to adequatelywarn 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 . The Weekses r e l yon 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 dan alleged misrepresentation made to a third party. TimS 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 dits 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 ya 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 yDelta Health building material f o r u s e on t h e S t a f f o r d s personal residence. After Delta Health filed a claim withLumbermens 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 i t s rights toLumbermens, 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 . This Courth 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 a p l a i n t i f f may p r o p e r l y 42
  • 43. 1101397s 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 dp 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 defendants 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 Healths 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 Staffords 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 hasa 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 tto a p l a i n t i f f but t o a t h i r d party. I n Thomas v. Halstead,605 So. 2d 1181 ( A l a . 1992), a patient sued h i s dentist 43
  • 44. 1101397alleging fraud, specifically alleging that the dentistobtained payment f r o m t h e p a t i e n t s insurer for services thatwere n e v e r r e n d e r e d . The p a t i e n t went t o s e e t h e d e n t i s t ,who t o o k s e v e r a l 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 da d d i t i o n a l d e n t a l work. 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 twas 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 einsurance coverage. Instead, the dentist submitted a claimfor t h e a d d i t i o n a l work on t h e p a t i e n t s teeth, which hadnever been done. The p a t i e n t argued that, even i fthemisrepresentation was not made directly to him, "amisrepresentation, made t o h i s i n s u r a n c e carrier, which i slegally obligated t o pay v a l i d claims submitted to i t ford e n t a l e x p e n s e s i n c u r r e d b y him, i s s u f f i c i e n t to s a t i s f y themisrepresentation element of fraud." 605 So. 2d a t 1184."While generally [a] s t r a n g e r to a transaction ... h a s noright of action [for fraud], there i s an e x c e p t i o n to thisgeneral rule: 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 , hemay r e c o v e r a g a i n s t t h e one who made p o s s i b l e t h e damages t ohim 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 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
  • 45. 1101397 Sims v. Tigrett, 229 A l a . 486, 158 So. 326 (1934),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. 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 argue that Delta Health isd i s t i n g u i s h a b l e because t h i s C o u r t has never e x t e n d e d third-party fraud beyond t h e economic realm to claims allegingp h y s i c a l harm. 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 dSims d i d n o t i n v o l v e a claim of p h y s i c a l injury. However,physical harm suffered by a consumer of prescriptionmedication would have been reasonably contemplated by amanufacturer who made fraudulent statements on t h e w a r n i n glabel 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 rextended third-party-fraud liability t o a defendant who d i dnot manufacture the product about which the p l a i n t i f f is 45
  • 46. 1101397complaining. We a g a i n note t h a t p r e s c r i p t i o n medication i sunlike other consumer products. Unlike "constructionmachinery," "lawnmowers," o r " p e r f u m e , " w h i c h a r e "used t omake 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 drug"may be necessary to alleviate pain and s u f f e r i n g or tosustain l i f e . " Brown v. S u p e r i o r C o u r t o f San F r a n c i s c o , 44Cal. 3d 1049, 1063, 245 C a l . R p t r . 412, 751 P.2d 740, 749(1988). P r e s c r i p t i o n medication i s h e a v i l y r e g u l a t e d by t h eFDA. I t c a n be o b t a i n e d only through a health-care providerwho c a n make a d e t e r m i n a t i o n as t o t h e b e n e f i t s a n d r i s k s o fa 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 enot based on t h e m a n u f a c t u r i n g of the product but insteadallege that the label — drafted by the brand-namem 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 elabel placed on t h e g e n e r i c version of the medication —failed t o warn. Moreover, t h e brand-name manufacturer i sunder a c o n t i n u i n g duty t o supply t h e FDA w i t h postmarketingr 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 i t s w a r n i n g s onits own accord. Wyeth v Levine, supra; 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 manufacturers l a b e l must be t h e same as t h e b r a n d - 46
  • 47. 1101397name 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 tunilaterally change i t s w a r n i n g label. We r e c o g n i z e that the p l a i n t i f f i n Delta Health d i d notsucceed i n h i s fraud claim because he failed to presente 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 on a n y o fthe alleged misrepresentations made b y h i s e m p l o y e r to theemployers i n s u r e r . 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 san e s s e n t i a l aspect o f showing t h a t the injury s u f f e r e d wascaused by t h e f r a u d . " [ 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 yl 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 r e s u l t e d , i . e . , oncethe 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 on t h e f r a u d . " Exparte Haynes Downard A n d r a & J o n e s , L L P , 924 So. 2d 687, 694(Ala. 2005). In the present c a s e , t h e Weekses have allegedthat Dannys physician reasonably relied on therepresentations made b y t h e Wyeth d e f e n d a n t s regarding thelong-term use o f Reglan i n p r e s c r i b i n g Reglan t o Danny. I nother words, t h e Weekses a r e a r g u i n g that i f a defendantsmisrepresentation to a third party causes t h e t h i r d p a r t y t otake 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 , then thefactual causation link i s satisfied and that, here, amisrepresentation t o Dannys p h y s i c i a n w o u l d d i r e c t l y impact 47
  • 48. 1101397t 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 & French Laboratories , 447 So.2d 1301 ( A l a . 1984), this Court adopted the learned-intermediary doctrine in a case addressing whether amanufacturers duty t o warn extends beyond the p r e s c r i b i n gp 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 ethe drugs. The principle behind the learned-intermediarydoctrine i s that prescribing physicians a c t as learnedi 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 tand 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 nto evaluate a patients needs and t o a s s e s s the r i s k s andb 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 through aphysician or other q u a l i f i e d health-care provider. 21 U.S.C.§ 353(b)(1). Physicians are t r a i n e d t o understand the h i g h l yt e c h n i c a l warnings 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 . 21C.F.R. § 201.56. The learned-intermediary doctrine wase 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 (N.Y. Sup. C t . 1 9 4 8 ) , as an a b s o l u t edefense f o r " f a i l u r e t o warn" c a s e s . As a M a t t e r o f F a c t o ra 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
  • 49. 110139753 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 F.2d 1264, 1276 (5th C i r . 1974). The learned-intermediary doctrine recognizes the r o l e ofthe physician as a learned intermediary between a drugmanufacturer and a patient. As the United States Court ofAppeals f o r the E l e v e n t h C i r c u i t has explained: " 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 Restatements 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
  • 50. 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 hCir. 2000)(citations omitted). A prescription-drug manufacturer fulfills i t s duty towarn the ultimate users of the risks of i t s product byp 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 whoprescribe the drug. Once that duty is fulfilled, them 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 directly.However, i f the warning to the learned intermediary isinadequate or misrepresents the r i s k , the manufacturer remainsl 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 . The p a t i e n tmust show t h a t t h e m a n u f a c t u r e r f a i l e d t o warn t h e p h y s i c i a nof a r i s k 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 and t h a t t h efailure t o warn was the a c t u a l and p r o x i m a t e cause of thepatients injury. In short, t h e p a t i e n t must show t h a t , b u tfor the false representation made in the warning, thep 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 nto 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 , abrand-name drug company may be held liable f o r fraud or 50
  • 51. 1101397misrepresentation (by misstatement or omission), based onstatements i t made i n c o n n e c t i o n with the manufacture of abrand-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 linjury c a u s e d by a generic d r u g m a n u f a c t u r e d by a differentcompany. Unlike other consumer p r o d u c t s , p r e s c r i p t i o n drugsa r e h i g h l y r e g u l a t e d by t h e FDA. Before a p r e s c r i p t i o n drugmay be s o l d to a consumer, a physician or other qualifiedhealth-care 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 . The UnitedStates Supreme Court in Wyeth v. Levine recognized thatC 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 sthat the FDA traditionally regarded state law as acomplementary form of drug r e g u l a t i o n : The FDA has limitedresources to monitor the 11,000 drugs on the market, andm 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 to i n f o r m a t i o n about t h e i rdrugs, especially in the postmarketing phase as new risksemerge; 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 andprovide 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 yr 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 tmay 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 , 555 U.S. at 578-79. FDA regulations provide that a generic-drug 51
  • 52. 1101397manufacturers labeling for a prescription drug must beexactly the same as the brand-name-drug manufacturerslabeling. 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 haveb 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 changet 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 requirementt 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 onthe brand-name version, preempting failure-to-warn claimsagainst 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-namem 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 ageneric-drug manufacturer, i t i s not fundamentally u n f a i r tohold t h e brand-name manufacturer liable f o r warnings on aproduct i t d i d not produce because the manufacturing processis irrelevant to misrepresentation theories based, n o t onmanufacturing defects in the product itself, but oninformation and w a r n i n g deficiencies, when those allegedm 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 rand 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, Main,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