### I N THE UNI TED STATES COURT OF APPEALS FOR THE FI F TH CI RCUI T

N o. 12-60861 c/w No. 12-41148

WALTER LASHLEY, Plaintiff-Appellant,
v. PFIZER, INC.; WYETH, INC.; SCHWARZ PHARMA, INC.; WATSON PHARMA, INC.; WATSON LABORATORIES, INC.;, Defendants-Appellees.

MARIA DEL VALLE, Plaintiff-Appellant,
v. TEVA PHARMACEUTICALS USA, INC.; PLIVA, INC.; WYETH, INC.; SCHWARZ PHARMA, INC.; VINTAGE PHARMACEUTICALS, LLC., Defendants-Appellees. U n i t e d S t a te s C o u r t o f A p p e al s

F i f t h C i rc u i t 

### F I L E D February 21, 2014 Ly l e W . Cay ce ClerkNo. 12-60861 c/w No. 12-41148

Appeals from the United States District Courts for the Southern District of Mississippi and the Southern District of Texas

USDC Nos. 1:09-cv-00749 and 1:11-cv-000113

Before STEWART, Chief Judge, and HIGGINBOTHAM, Circuit Judge. * PER CURIAM: These appeals aris e out of claims against both generic and b rand-name manufacturers for injuries related t o u s e of the drug metoclopramide (brandnam e R eglan). Because the p ertinent f acts and l egal i ssues of these cases are nearly identical, we consolidate them for disposition. In case No. 12-60861, Lashley v. P fizer , e t a l., Appellant Walter L a s h l ey ( “Lashley”) appeals the S outhern District of M ississippi’s g rant of W a t s o n Pharmaceuticals, Inc. a n d Watson L aboratories, Inc.’s ( “Watson generic defendants”) motion to dismiss, as well as its grant of summary judgment in favor of defendants Pfizer, Inc.; W yeth, Inc.; and S chwarz P harma, Inc. (“Pfizer brand d efendants”). Lashley’s claims against t h e W a t son generic defendants

were based upon their s ale a nd distribution of metoclopramide to Lashley. His claims against the P fizer b rand defendants were based o n allegedly f alse and misleading representations they made to the medical community. In case N o. 12-41148, Del Valle v. Teva Pharm. , et al., Appellant M aria Del V a l l e ( “ Del Valle”) similarly appeals the Southern District of Texas’s grant of Qualitest P harmaceuticals, Inc.; Teva Pharmaceuticals USA, Inc.; PLIVA, Inc.; and Vintage Pharmaceuticals, LLC’s (“Teva g eneric def e n d a n ts”) 1 motion to dismiss a nd i ts grant o f Sc h w a r z P harma, I nc. and W yeth, Inc.’s (“Schwarz

* This m atter is being d ecid ed by a quorum
. 28 U. S. C. § 46( d)

.

1 Collectively, w e will ref er to the generic def

end ants f

rom both cas es as the “generic
m anuf acturers

. ” 2No. 12-60861 c/w No. 12-41148

brand defendants”) 2 motion for summary judgment. D el Valle alleged that the Teva generic defendants were liable for d amages she experienced as a r esult of her i n gestion of metoclopramide manufactured by these defendants. Her claims

a g a i n s t t h e S c h w a r z brand defendants w ere based on a lleged m i s r e p r e s e n t a t i o n s they made to the medical community. For the reasons stated herein, w e AFFIRM the district courts’ rulings in both cases. I. Facts Lashley took g eneric m etoclopramide from 2002 until late 2006. In 2004, brand defendan t S c hwarz submitted a label update f or Reglan adding that “[t]herapy with Reglan tablets should not exceed 1 2 weeks in duration,” which the FDA approved. Not a l l g e n eric m anufacturers m odified their labels to conform with the newly approved warnings at that time. L ashley developed the movement disorders tardive dyskinesia and akathisia as a result of taking the drug and b rought suit in October 2009. A s noted above, he sued the Watson generic defendants based on their sale and d istribution of the d rug and sued the Pfizer brand defendants for misre p r e s e n t a t i o n s m a de to the medical community. He brought claims against all defendants under theories including negligence,
gross negligence, strict liability, breach of warranty as to merchantability, breach of warranty as to fitness for a particular purpose, misrepresentation, fraud, and suppression of evidence. Del V alle took generic metoclopramide from 2004 to February 2011. Like Lashley, she developed tardive dyskinesia and akathisia as a result of taking the drug. S he brought suit in June of 2011. She sued the Teva generic defendants based on their manufacture and distribution of metoclopramide, under theories of negligence, g ross negligence, m isrepresentation, fraud, s uppression of

2 C ollectively, w e w ill ref er to the brand d ef

end ants f

rom both cas es as the “brand
m anuf acturers

. ” 3No. 12-60861 c/w No. 12-41148

evidence, strict liability, b reach of warranty as to merchantability, breach of warranty as to fit n e s s f o r a p articular purpose, and deceptive trade practices. She b rought the same claims against the Schwarz brand defendants for their role in the promotion and manufact u r e o f the drug, w ith the exception of deceptive trade practices. The courts below i n b o t h c a s es dismissed the claims against the generic

man u f a cturers, finding them to be e ither p reempted under PLIVA, Inc. v. Mensing , 131 S. Ct. 2567 (2011) ( holding failure-to-warn claims against generic manufacturers of Reglan preempted) or deficient for failure to state a c laim on which relief could be granted. See Fed. R. Civ. P. 12. All the claims against the generic manufacturers were treated as v ariations o f a f ailure-to-warn claim. See Morris v. P

L I V A , Inc. , 7 13 F.3d 774, 778 & n.6 (5th Cir. 2013) (per curiam) (“Appellants next argue that the generic defendants failed t o test and inspect the product a ccording to federal law . . . [A]ny ‘useful’ reporting—at least from the standpoint of t hose injured—would ostensibly c onsist of some sort of warn i n g
. ” )

. 3 The district courts granted summary judgment i n favor o f b rand manufacturers in b o t h c a s e s b elow, on the grounds that neither Lashley nor Del Valle e ver ingested their product, Reglan. These appeals timely followed.

II. Claims Against Generic Manufacturers Appellants a rgue tha t the lower courts erred in d ismissing their claims against generic manufacturers as preempted under Mensing

. 4 We review grants

3 Citing H

a ckett v
. G

. D

. Sea rl e & Co. , Cas e N o. A- 01- CA- 399- SS, 2002 U

. S. D is t. LEX IS 16246, at *7 ( W. D

. T ex. Jun. 25, 2002) , the m agis tr a t e jud ge in D el Va l l e s p ecif ically noted that f ailure to w arn is the “only valid claim ” in a s uit f or p e r s o n a l i n juries caus ed by p res crip tion d rugs in Texas

.

4 In M ensi ng , the Sup rem e Court cons id ered cons olid ated law s uits involving s tate tort claim s b a s e d o n a d rug manuf acturer’s f

ailure to provid e ad equate w arning labels f or m etoclop ram id e. The s pecif ic ques tion the C o u rt cons id ered w as “w hether f ed eral d rug regulations ap p licable to ge neric d rug m anuf acturers d irectly conf lict[ ed ] w ith, and thus
4No. 12-60861 c/w No. 12-41148

of Rule 12(b)(6) motions to dismiss de novo. H ighland C

apital Mgmt. LP v. Bank of A m , Nat’l Ass’n , 698 F.3d 20 2, 205 (5th Cir. 2012). Judgments on the pleadings are also r eviewed de novo; Rule 12(c) motions are govern e d by the

same standard as Rule 12(b)(6) motions. 5 Jebaco, Inc. v
. Harrah’s Operating Co. , 587 F

. 3 d 314, 318 (5th Cir. 2008). The fundamental question i s whether the plaintiff states a claim on which relief may be granted. In order to place their claims outside the ambit of Mensing , both Lashley and Del Valle argue for a very n arrow i nterpretation of th a t c a s e. Their arguments are unavailing. The Court in M ensing held that federal law demands “generic drug labels be the same at all times as t he corresponding b rand-name labels.” 131 S. Ct. at 2 578. This duty o f s ameness is overlaid with the agency’s
pronouncemen t t hat “Dear Doctor” letters (or o ther forms of w arning) from a generic manufacturer c o n stitute labeling. Because of this, potential s tate law duties requiring generic manufacturers t o act unilate r a l l y concerning any

consumer warnings are p reempted. I d. a t 2 5 8 0

– 8 1

. At their core, all Lashley and Del Valle’s claims against the generic manufacturers turn on the adequacy of labeling and r elated information, a n d can thus be c ons t r u e d a s f ailure-to-warn claims. As such, we find them to be preempted under Mensing

.

p re- em p t[ ed ] , thes e s tate- law claim s
. ” 131 S. Ct. at 2572. The Court held that f ed eral law p reem p ted s t a t e law s im p os ing a d uty to change a d rug’s label up on generic d rug m anuf acturers

.
5 Wats on generic d ef

end ants and d ef

end ant V intage s ought d is m is s al und er Rule 12( b) ( 6)

. H ow ever, as the d is trict cou r t i n L a shl ey noted , w hile Wats on generic d ef end ants invok ed the s tand ard ap p licable to Rule 12( b) ( 6) in their m o t ion to d is m is s , their rebuttal
m em orand um ref

erenced a motion f

or jud gm ent on the p lead ings p urs uant to Fed

. R. Civ. P. 12( c)

. M eanw hile, generic d ef end ants PLIVA, Q ualites t, and T eva s ought d is m is s al p urs uant to Fed

. R. C iv. P. 12( c) in the Del Va l l e cas e. T he low er courts in both cas es exp lained that the
s tand ard w as the s am e f or b o t h m o t ions ( see Gui dry v
. A mer. Publ ic Li f e Ins. Co. , 512 F

. 3d 177, 180 ( 5th Cir. 2007) ) ; t h e D e l V a l l e court noted that the motions to d is m is s both, in
es s ence, as s erted that D el Valle had f ailed to “p rovid e s uf

f icient f acts ‘to s tate a claim to relief that is p laus ible on its f ace, ’” and s o they w ould be ad dres s ed together. See P orter v
. V

a l dez , 424 F. Ap p ’x 382, 385 ( 5th Cir. 2011) ( p er curiam ) ( unp ublis hed ) (quoting A shcrof t v
. I qba l , 556 U

. S. 662, 129 S. Ct. 1937, 1949 ( 2009) )

. 5No. 12-60861 c/w No. 12-41148

Appellants argue that not all failure-to-warn c l aims run afoul of Mensing, such as those alleging that generic manufacturers could have taken steps that would not require them to differ their labeling from that of the reference listed drug (“RLD”) for metoclopramide, Reglan. 6 The duty of s ameness, they contend, would not be v i o lated by generic manufacturers communicating information consistent with t he b rand-name l abeling. Under thi s t h e ory, generic manufacturers would be liable for failing t o convey FDA-approved warnings; for

e xample, they could have circu l a t e d “ p r o m o t i o n a l l a b e l i n g ”

- t y p e c o m m u n i c a t i o n s warning of the dangers of m etoclopramide use after twelve w eeks. According to the complaints, the generic m anufacturers should have made consumers aware of the risks associated with metoclopramide and, b y not doing so, negligently or fraudulently caused i njuries. This C ourt addressed an almost i dentical argument in Morris v. PLIVA, Inc. , a nd rejected s uch f ailure-to-warn claims in light of Mensing

. 7 In Morris , we wrote: Mensing forecloses such claims because failure to “ communicate” extends beyond j ust a label change. To avoid liability, t h e manufacturer must take affirmative ste p s to alert consumers, doctors, or pharmacists of changes in the d r u g l a b e l. Because t h e duty of sameness p rohibits the generic manufacturers from taking such action unilaterally, they are d e p e ndent on brand-names taking the lead. [ Mensing , 131 S. Ct.] at 2576 ( “ [ I ] f g eneric drug manufacturers, but not the brand-name manufacturer, sent [additional warnin g s s u ch as ‘Dear Doctor’ letters], that would inaccurately imply a therapeutic difference between the brand and generic drugs and thus could be impermissibly ‘ misl e a d ing.’”). Under federal law, the inquiry i s whether the br a n d

- n ame manufacturers s ent out a warning, not whether t he proposed

6 U nd er the current law , generic d r u gs g a i n FD A ap p roval s im p ly by s how ing equivalence to an RLD that has alread y obtained FD A ap p roval. G eneric d rugs ap plying f or ap p roval und er this p roces s m us t s how that the s af ety and ef

f icacy labeling they pr o p o s e is the s am e as the labeling ap p roved f or the RLD

. See 21 U

. S. C. § 355( j) ( 2) ( A) ( v)

.
7 Regard les s of the sp ecif ic f orm in w hich the argum ent is s tyled ( negligence, f raud , d ecep tive trad e practices ) , each charge is , at bas e, a f ailure- to- w arn claim

. 6No. 12-60861 c/w No. 12-41148

warning to be disseminated con t ains substantially similar information as the label. Because no brand-nam e manufacturer sent a warning based on the 2 0 0 4 label change, the generic manufacturers were n ot at liberty to do so. As Mensing concluded, preemption is thus triggered since it w ould be impossible for PLIVA to comply w ith both the state law duty to warn and the federal law duty of sameness. 713 F.3d at 777 (second alteration in original). Thus, follo w i n g c l e a r p r e c e d e n t, we affirm the dismissal of these failure-towarn claims here as well. 8 Like in Morr i s , Appellants a lso maintain t hat certain generic manufacturers should be liable for n ot conforming to the 20 0 4 l abel change. Assuming arguendo that Lashley or Del Valle adequately pleaded t his theory, 9

we disagree that defendants should be held liable. W e addressed, and rejected, this a rgument in M

o r ris

. There, t his court observed that “ it i s logically incoherent to contend that PLIVA had a duty to apply the 2004 warning label when Appellants also assert repeatedly that no labels predating 2009 were adequate. Tort liability does not arise for failure to attach a n i n a dequate label.” Morris , 7 13 F.3d at 777. Furthermore, we concluded that “a claim that PLIVA breached a federal labeling obligation sounds e x c l u s ively in federal (not state) law, and is preempted.” Id. (internal citations omitted). Appellants f

urther argue that the i r n o n-failure-to-warn c laims, such as those based on strict liability and breach of w arranty theories, are not

8 Even if generic m anuf acturers could have, hyp o t h e t i cally, p rovid ed ad d itional inf orm ation cons is tent w ith the R LD labeling w ithout violating the duty of s am enes s , s uch a s t ep is unlik ely to have rem ed ied the s ituation; Ap p ellants ’ com p laints ind icate tha t a l l allow able p re- 2009 w arnings w ere ins uf f icient. Thus , the claim w ould be dis m is s ed , even if not p reem p ted

. See M orri s , 713 F. 3d at 777.

9 G eneric m anuf

acturers in both cas es m aintain that neither Las hley nor D el Valle p rop erly includ ed this claim in their original p lead ings

.

7No. 12-60861 c/w No. 12-41148

preempted under Mensing

. They contend that g eneric manufacturers should be liable for any d amages caused by the production and/or distribution of an unsafe product; recognizing that generic manufacturers could not have made changes in labeling to add information, Appellants nevertheless ar g u e that generic manufacturers should be held l i a b l e for damages c a used b y the insufficient information they w e r e a llowed to disseminate. However, w e find these non-failure-to-warn claims to be preempted i n light of Morris and the S upreme Court’s recent d ecision in Mutual Pharm., Co., Inc. v. B artlett , 133 S. C t. 2466 (2013). 1 0 This is because, assuming d i stribution of the drug was acceptable in the first place, any useful a ction (or l a ck thereof) for which the companies could be held responsible would necessarily involve some form of warning. See Morris , 713 F.3d at 778. These theories all r e ly on the same g r o u n d s : t he generic manufacturers failure to provide ade q u a t e information. In Morris , this court recognized that “[a]ny state law-based holding that the generic manufacturers should h ave a c t e d d i f

f erently with respect t o warnings or should have ceased manufacturing these products because of insufficient warnings not only violates the duty of sameness b ut conflicts with FDA’s exclusive authority to approve drugs and drug labels.” Id. State law claims for damages are not available as

an e nd-run around preemption; t he non-failure-to-warn claims against generic manufacturers are “attempt[s] to circumvent disfavored failure-to-warn claims” and are thus preempted as well. Id. Lastly, we do n o t agree with L ashley or D el Valle that some of their state law claims against generic manufacturers are p arallel to federal l aw claims, and

1 0 B a rtl ett f

oreclos es f

ailure- to- w arn claim s p led as s trict liability or breach of w ar r a n t y . In that cas e, the Firs t Circuit allow ed a claim that a d rug w as s o unreas onably d angerous , as d es igned , that the m anuf acturer s hould have never s old it in the f irs t p lace; there w ere s af er alternatives that w ere jus t as ef f ective. The Sup rem e Court revers ed the Firs t Circuit’s ruling, hold ing that s tate- law d es ign d ef ects claim s that turn on the ad equacy of a d rug’s w arnings
are preem p ted by fed eral law und er M ensi ng
. 133 S. C t

. a t 2 4 70; see D em a hy v
. Schw a rz Pha rm
. , Inc. , 702 F. 3d 177, 186–87 ( 5th Cir. 2012)

. 8No. 12-60861 c/w No. 12-41148

thus not preempted

. S ee M edtronic, Inc. v
. L ohr , 518 U.S. 470 (1996); Hughes

v. Boston Scientific , 631 F.3d 7 62 (5th Cir. 2011). Medtronic and Hughes concern express preem ption; in those cases, “parallel” state l aw claims against manufacturers of medical e quipment w e re allowed to proceed because there was

no express preemption found in the applicable statute. In M e n sing , a s here, the Supremacy C lause—not a statute—made it impossible for t h e generic defendant to do what state l a w required of it and, therefore, the state law claim was preempted. 1 1 In t hese t ypes of cases, the inquiry is not whether there is a “parallel” claim w here one l ooks for absence of conflict w ith the statute; the inquiry is whether the state law claim is impliedly preempted. In sum, the district c ourts correctly dismissed Appellants’ claims against generic manufacturers, a s these claims are preempted in light of Mensing and Bartlett

. III. Claims Against Brand Manufacturers Lashley and Del Valle next argue that the lower courts erred in granting
summary j udgment to b rand manufacturers. We review motions for summary judgment de novo. EEOC v. WC& M E n t e r s
. , 496 F .3d 393, 397–98 (5th Cir. 2007). The moving p arty is entitled to summary judgement if there are no

m a t erial facts in dispute and that party is entitled to judgment as a matter of law. Fed. R. Civ. P. 56. We disagree with Appellants’ contentions that s ummary j udg m e n t was i m proper here. Their claims against brand manufacturers are foreclosed b y Lash l ey and Del Valle’s respective states’ product l i ability laws (Mississippi’s, in Lashley’s case, a nd Texas’s, in Del Valle’s case), which s hield the companies from liability for products they did not create. Miss Code Ann. § 11-1-63; T ex.

11 Becaus e only the brand

- nam es can m ak e changes to the warning s ys tem , thos e m anuf acturers are the ones agains t w hom “p arallel” claim s are norm ally rais ed

. See Wyeth
v
. Lev i ne , 555 U

. S. 555 ( 2009)

. 9No. 12-60861 c/w No. 12-41148

C i v . Prac. & Rem. Code Ann. § 82.001(2) (West 2012). Furthermore, b e c a u s e Appellants did not i ngest the brand manufacturers’ products, these defendants have no common-law duty to them. The Mississippi Products Liability Act (“MPLA”) applies “in any a ction for damages caused by a product” and r equires a plaintiff to prove that it w a s the defendant’s p roduct that caused the injury

. Miss. C ode Ann. § 11-1-63; see also Monsanto Co. v. Hall , 912 So.2d 134, 136–37 (Miss. 2005). Lashley argues that the Pfizer brand defendants are n o t “manufacturers or sellers” of the product, relying on a Mississippi case holding that “the MPLA does n ot preclude claims against defendants who a re n ei t her manufacturers nor s ellers” of a defective product. Lawson v. Honeywell Int’l, Inc. , 75 So.3d 1024, 1030 ( Miss. 2011). This argument f

a i l s b e c a u s e b r a n d d efendants are, indeed, manufacturers—and were they not, there w ould b e n o relationship on which t o presume liability (since they d i d not design the d rug). 1 2 I n any event, b ecause Lashley did not i ngest t h e Pfizer brand defendants’ products, he has not established a duty. Moore ex rel. Moore v
. Miss. Valley Gas Co. , 863 S o. 2d 43, 46 (Miss. 2003) (“[I]t is incumbent
upon the plaintiff in any pro d u c t s l iability action t o show that the defendant’s product was the cause of the p laintiff's injuries.”); s e e also Demahy , 702 F.3d at 183 n.4 (“[E]ven if the [Louisiana Products Liability A ct] did not apply, [plaintiff’s] tort claims would fail since [defendants] did not manufacture the generic product givin g r i s e t o [plaintiff’s] c laims, and thus o wed [ plaintiff] no duty of care.”); Smith v. Wyeth, Inc. , 657 F.3d 420, 424 (6th Cir. 2011) (“As have the majority of courts to address this question, we rej e c t t he argument that a name-brand drug manufacturer owes a duty of care to i n dividuals w ho have never taken the drug actually manufactured by that company.”).

1 2 D el Valle’s argum ent that Schw ar z b r a n d d ef end ants are not “m anuf acturers ”
s im ilarly f

ails f or thes e reas ons
. 10No. 12-60861 c/w No. 12-41148

Under Texas law, m eanwhile, a p roducts l iability action is broadly defined

as “any action against a manufacturer or seller for recovery of damages arising out of personal injury

. . . alle g e d l y c a u s e d by a defective product w hether the action is based in strict tort liability, strict products liabilit y , negligence, misrepresentation, breach of express or i mplied warranty, or any other theory

or combination of theories.” Tex. Civ. Prac. & Rem. Code Ann. § 8 2.001(2). The Texas Supreme Court has determined that under this statute, entities are “‘manufacturers’

. . . only with respect to their own p roducts.” Owens & Minor, Inc. v. A nsell Healthcare Prods., Inc. , 251 S.W.3d 481, 485 (Tex. 2008) (internal quotation marks omitted). It has also found that “[a] f undamental p rinciple of t r a d i tional products liability law i s that the plaintiff must prove that t h e defendants s upplied the product which caused the i n jury.” Gaulding v. Celotex Corp. , 772 S.W.2d 6 6, 6 8 (Tex. 1989); see also Firestone Steel Pr o d u c t s C o
. v. Barajas , 927 S.W.2d 608, 614 (Tex. 1996) (“A manufacturer generally does not h a ve a duty to warn or instruct about another manufacturer’s produc t s , e v e n though a third p arty might use those products in c onnection with the manuf acturer’s own product.

. . . U nder traditional p roducts liability law, the plaintiff must prove the defendant s upplied t he p r oduct that caused the injury. It is not enough that the seller merely introduced products of s imilar design and manufacture into the stream of commerce.” (citations o m i t ted)). D el Valle admits that she did n o t i ngest the Schwarz b rand defendants’ product; thus, we find t hat Schwarz brand defendants are not liable under Texas products liability law. Furthermore, “[u]nder Te x a s l a w , a d r u g m a n u f a c t u r e r e n

j o y s a r e buttable presumption t hat it is not l iable for failure to w arn if the F DA has approved ‘the warnings or information’ accompanying t he product alleged to have h armed the plaintiff.” Lofton v. McNeil Consumer & Specialty Pharm. , 6 72 F.3 d 372, 374 (5th Cir. 2 012)(quoting Tex. Civ. P rac. & R em. Code § 8 2.007(a)(1)). It is

11No. 12-60861 c/w No. 12-41148

undisp u t e d t hat the “warnings or information” on the Schwarz brand defendants’ label were a pproved by the F DA. T hough Del Valle argues that the Schwarz brand defendants lost their presumption of n on-liabilit y b e c ause of fraud p erpetrated on the F DA, the FDA has not made such a f inding and, t h e r e f ore, that avenue f

or overturning the brand defendants’ presumption of non-liability is foreclosed to Del Valle. See id. at 380. In sum, since Appellants did not t ake the brand manufacturers’ p roducts, the brand m a n u f

a c t u r e r s a r e n o t l i able for Appellants’ injuries under Mississippi and T exas law. T herefore, w e a ffirm the district courts’ j udgments regarding those defendants. IV. For th e f o r e g o i n g r e a s o n s, we AFFIRM the district courts’ dismissals of the claims a g a i n s t both the Watson generic defendants and the Teva generic defendants. W e f

urther AFFIRM the grants of s ummary judgment to both the Pfizer brand defendants and the Schwarz brand defendants.

12