Wyeth, Inc., et al. v. Weeks

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The United States District Court for the Middle District of Alabama, Southern Division certified a question to the Alabama Supreme Court: "Under Alabama law, may a drug company be held liable for fraud or misrepresentation (by misstatement or omission), based on statements it made in connection with the manufacture or distribution of a brand-name drug, by a plaintiff claiming physical injury from a generic drug manufactured and distributed by a different company?" Plaintiffs Danny and Vicki Weeks filed this action against five current and former drug manufacturers for injuries that Mr. Weeks allegedly suffered as a result of his long-term use of the prescription drug product metoclopramide, the generic form of the brand-name drug "Reglan." The Weekses contended that the Wyeth defendants had a duty to warn Danny's physician about the risks associated with the long-term use of metoclopramide and that the Weekses, as third parties, have a right to enforce the alleged breach of that duty. The Supreme Court concluded: "[i]n the context of inadequate warnings by the brand-name manufacturer placed on a prescription drug manufactured by a generic-drug manufacturer, it is not fundamentally unfair to hold the brand-name manufacturer liable for warnings on a product it did not produce because the manufacturing process is irrelevant to misrepresentation theories based, not on manufacturing defects in the product itself, but on information and warning deficiencies, when those alleged misrepresentations were drafted by the brand-name manufacturer and merely repeated by the generic manufacturer."

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