Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 1 of 23

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1 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 1 of 23 IN THE UNITED STATES DISTRICT COURT FOR THE SOUTHERN DISTRICT OF TEXAS CORPUS CHRISTI DIVISION MARIA LUISA GARZA, et al. VS. WYETH, LLC f/k/a WYETH d/b/a WYETH INC., et al. CIVIL ACTION NO. 2:12-CV DEFENDANTS TEVA PHARMACEUTICALS USA, INC.; PLIVA, INC.; BARR PHARMACEUTICALS, LLC; BARR LABORATORIES, INC.; WATSON LABORATORIES, INC.; AND WATSON PHARMA, INC. S MOTION TO DISMISS PLAINTIFFS FOURTH AMENDED COMPLAINT AND MEMORANDUM OF LAW IN SUPPORT I. STATEMENT OF THE ISSUES TO BE RULED UPON BY THE COURT Pursuant to Federal Rules of Civil Procedure 12(b)(6) and 12(c), Defendants Teva Pharmaceuticals USA, Inc. ( Teva ); PLIVA, Inc. ( PLIVA ); Barr Pharmaceuticals, LLC; Barr Laboratories, Inc.; Watson Laboratories, Inc. ( Watson ); and Watson Pharma, Inc. (collectively Generic Defendants ), by and through counsel, respectfully renew their motion to dismiss all claims of Plaintiffs Maria Luisa Garza and Oscar Garza, Sr. (collectively Plaintiffs ) 1 asserted against Generic Defendants in Plaintiffs Fourth Amended Original Petition (Doc. 72) ( Fourth Amended Complaint ) 2 because the claims are preempted by federal law pursuant to, inter alia, the decision of the Supreme Court of the United States in PLIVA, Inc. v. Mensing, 564 U.S. ---, 131 S. Ct. 2567, reh g denied 132 S. Ct. 55 (2011), and otherwise are barred pursuant to the presumption contained in Texas Civil Practice & Remedies Code In addition, Generic 1 Although the arguments for dismissal in this motion relate primarily to the claims of Mrs. Garza, who alleges ingestion of metoclopramide, they necessarily apply to Mr. Garza as well, insofar as his claims are solely derivative of his wife s alleged injuries. See Motor Express v. Rodriguez, 925 S.W.2d 638, 640 (Tex. 1996) 2 The document entitled Plaintiffs Fourth Amended Original Petition filed by Plaintiffs on January 10, 2013 (Doc. 72) actually is the second amended petition filed by Plaintiffs entitled Plaintiffs Fourth Amended Original Petition. The first such amended petition was filed in the state court proceedings in this case on or about July 8, Consequently, Generic Defendants shall refer to Plaintiffs latest amended petition (Doc. 72) as the Fourth Amended Complaint or Fourth Am. Compl.

2 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 2 of 23 Defendants move to dismiss Plaintiffs newly-asserted failure-to-update theory because (1) the theory is not viable under Texas law; (2) Plaintiffs lack standing to assert, and the Court lacks subject matter jurisdiction to consider, the theory because the Federal Food, Drug and Cosmetic Act ( FDCA ) does not provide for a private right of action; and (3) the theory otherwise is preempted by federal law pursuant to Mensing. 3 II. STATEMENT OF THE NATURE AND STAGE OF THE PROCEEDING Plaintiffs originally filed this lawsuit in state court (the 79th Judicial District Court, Jim Wells County, Texas) on December 6, 2010, against Generic Defendants, as well as various manufacturers of the brand-name drug Reglan. After Generic Defendants filed answers to the original petition, Plaintiffs filed three amended petitions. During that time, Generic Defendants were awaiting a decision by the Supreme Court of the United States in the appeals from Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010) and Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009), which would directly impact the viability of Plaintiffs claims against Generic Defendants. The Supreme Court issued the Mensing decision on June 23, 2011, holding that all state-law tort claims attacking labeling against generic pharmaceutical defendants are preempted by federal law. On June 5, 2012, Plaintiffs voluntarily nonsuited the non-diverse defendants and simultaneously moved to transfer the action to a state court in Pennsylvania. Defendant PLIVA, Inc., removed the case from state court to this Court on June 19, 2012, with the other defendants consent, invoking the equitable exception to the one-year removal deadline established by Tedford v. Warner Lambert Co., 327 F.3d 423 (5th Cir. 2003). (Doc. 1, Notice of Removal.) On October 12, 2012, Generic Defendants filed a motion to dismiss the claims asserted 3 Although all Generic Defendants are or have been involved in the manufacture or distribution of generic drug products, Plaintiffs incorrectly allege that all Generic Defendants manufactured or distributed generic metoclopramide products. Nevertheless, as set forth herein, all Generic Defendants should be dismissed. 2

3 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 3 of 23 against them in Plaintiffs then-pending Fourth Amended Original Petition. 4 In their motion, Generic Defendants demonstrated that all Plaintiffs claims against them are failure-to-warn claims under Texas law and are preempted by federal law pursuant to Mensing and otherwise are barred by Texas Civil Practice & Remedies Code Generic Defendants cited decisions from multiple judges sitting in the Southern District of Texas reaching that conclusion and dismissing virtually identical claims arising from the plaintiffs use of generic metoclopramide. (See Motion to Dismiss and Memorandum of Law in Support ( First MTD ) (Doc. 57), pp ) On November 1, 2012, Plaintiffs filed their response and memorandum in opposition to Generic Defendants motion (Doc. 63) asserting, inter alia, that they possessed some unspecified claim relating to allegations that PLIVA and/or other defendants failed to include in its/their metoclopramide labels certain language added to the brand drug s labeling in Their Fourth Amended Original Petition, however, contained no such allegations or claim. On November 9, 2012, Generic Defendants filed a reply memorandum in support of their motion to dismiss. Generic Defendants alerted the Court to the Fifth Circuit s October 25, 2012 decision in Demahy v. Schwarz Pharma, Inc., 702 F.3d 177 (2012) (which at that point had not been published), affirming the dismissal of claims against a manufacturer of generic metoclopramide. Generic Defendants also noted that Plaintiffs newly-asserted failure-toupdate theory is precluded by federal statute (21 U.S.C. 337(a)) and has been rejected by numerous courts. (See Reply in Support of the Motion to Dismiss ( Reply ) (Doc. 64), pp. 1-4, 6.) On December 21, 2012, the Court heard oral argument on Generic Defendants motion. 4 Defendant Barr Pharmaceuticals, LLC, originally was not a party to the motion to dismiss, but it joined in the motion on November 15, 2012 (Doc. 65). 3

4 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 4 of 23 During that argument, Plaintiffs argued their failure-to-update theory was not preempted by federal law and requested leave to again amend their petition to sufficiently plead the theory if the Court so desired. (See Transcript of Initial Conference, December 21, 2012 ( Tr. ), at 20:3-16 (Ex. A.) Plaintiffs conceded all their other claims are preempted by federal law: The as far as the rest of the points raised by Counsel, the other claims asserted by the plaintiff against the generic defendants, in other words, the claims against the generic manufacturers other than those for failing to update their labels, Judge, I m going to be totally candid with you and say that unless you want to take the novel approach of ruling in contravention of many of the decisions issued since Mensing, defense counsel is probably correct on the pre-emption in that sense. But that still leaves the issue of the failure of these generic manufacturers to update their labels, and I d urge you... to deny these defendants motions to dismiss on that point. (See id. at 20:17 21:5.) On December 31, 2012, the Court issued an Order Granting Leave to Amend Fourth Amended Original Petition. (Doc. 68.) The Court noted that in their response to Generic Defendants motion to dismiss, Plaintiffs alleged for the first time that Defendants failed to update their product labels to reflect the changes adopted by the FDA in 2004 and granted Plaintiffs leave to amend their petition. (Id.) On January 10, 2013, Plaintiffs filed their Fourth Amended Complaint. In that document, Plaintiffs went much farther than adding allegations relating to Generic Defendants alleged failure to update their product labels to reflect the changes adopted by the FDA in (See Order Granting Leave to Amend Fourth Amended Original Petition.) Plaintiffs also added a lengthy jurisdictional paragraph, asserted new allegations relating to changes made to the brand product labeling in 2003 and in 2009, and asserted new allegations that Teva and Watson failed to communicate certain information to physicians and failed to make changes in the packaging designs of the metoclopramide products. (See, e.g., Fourth Am. Compl., pp. 7, 9, 17-19, 23.) In 4

5 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 5 of 23 addition, Plaintiffs did not limit their claims to their failure-to-update theory despite their prior admission that their other claims are preempted. III. STANDARD OF REVIEW A motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) and a motion for judgment on the pleadings under Rule 12(c) are governed by the same standard. See Jebaco, Inc. v. Harrah s Operating Co., 587 F.3d 314, 318 (5th Cir. 2009). A defendant s 12(c) or 12(b)(6) motion should be granted when, viewing the facts in the light most favorable to the plaintiff, the complaint fails to state a claim upon which relief may be granted. See id. (citing Ashcroft v. Iqbal, 556 U.S. 662 (2009); Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007)). Although a court ruling on a Rule 12(b)(6) or (c) motion should accept as true all well-pleaded allegations and should view the complaint in a light most favorable to the plaintiff, the [f]actual allegations must be enough to raise a right to relief above the speculative level. Twombly, 550 U.S. at 555. In Iqbal, the United States Supreme Court articulated a two-step process for determining whether a complaint meets the standard to survive a motion to dismiss. First, the court must identify those allegations that, because they are no more than conclusions, are not entitled to the assumption of truth. See Iqbal, 556 U.S. at Threadbare recitals of the elements of a cause of action, supported by mere conclusory statements, do not suffice, id. at 678 (citing Twombly, 550 U.S. at 555), nor do [f]ormulaic recitation[s] of the elements of [the] cause[s] of action with no facts to support the claims. Twombly, 550 U.S. at 555; Iqbal, 556 U.S. at 678. Second, the court should assume the truth of well-pleaded factual allegations, if the complaint contains any, and determine whether they plausibly give rise to an entitlement to relief. See Iqbal, 556 U.S. at 681. [W]here the well-pleaded facts do not permit the court to infer more than the mere possibility of misconduct, the complaint has alleged but has not 5

6 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 6 of 23 show[n] that the pleader is entitled to relief, and, it, therefore, should be dismissed. Id. at 679 (quoting Fed. R. Civ. P. 8(a)(2)). IV. ARGUMENT A. Plaintiffs Non-Failure-to-Update Allegations Are Preempted and Barred In their prior motion to dismiss, Generic Defendants demonstrated that (1) Plaintiffs claims are indistinguishable from those found by the Supreme Court in Mensing to be preempted by federal law; (2) Mensing requires dismissal of all Plaintiffs claims; (3) Texas law treats all Plaintiffs claims against Generic Defendants as failure-to-warn claims, which are preempted pursuant to Mensing; and (4) all Plaintiffs claims otherwise are barred under Texas Civil Practice & Remedies Code In addition to the Mensing decision, Generic Defendants cited and discussed decisions from courts in the Southern District of Texas dismissing as preempted and/or barred virtually identical claims arising from the plaintiffs use of generic metoclopramide. Phares v. Actavis-Elizabeth LLC, No. B:11-63, 2012 U.S. Dist. LEXIS (S.D. Tex. Brownsville Div. Aug. 30, 2012); Del Valle v. Qualitest Pharm. Inc., No. 1:11-cv , 2012 WL (S.D. Tex. Brownsville Div. June 22, 2012), adopting 2011 WL (S.D. Tex. Brownsville Div. Dec. 21, 2011), appeal pending; and Eckhardt v. Qualitest Pharm. Inc., 858 F. Supp. 2d. 792 (S.D. Tex. McAllen Div. Apr. 30, 2012), motion to alter or amend denied No. 7:11-cv (S.D. Tex. McAllen Div. Jan. 8, 2013) (Ex. B), appeal pending. (See First MTD, pp ) Finally, in their reply memorandum in support of their prior motion to dismiss, Generic Defendants discussed the Fifth Circuit s recent Demahy decision (again affirming the dismissal of claims against generic manufacturers of metoclopramide) and demonstrated the lack of merit in Plaintiffs other arguments in opposition to the motion. (See generally Reply.) 6

7 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 7 of 23 Plaintiffs have conceded that their non-failure-to-update allegations are preempted under Mensing and that the Court would have to adopt a novel approach of ruling in contravention of many of the decisions issued since Mensing to find their non-failure-to-update claims not preempted. (See Tr. at 20:17 21:5 (Ex. A).) Given that admission and the fact that the Court s Order permitting amendment only concerned the issue of the 2004 labeling update, 5 Generic Defendants will not repeat the arguments set forth in their prior memoranda (Docs. 57 & 64) and in prior proceedings in this case, but instead incorporate those arguments by reference as if fully restated herein. However, Generic Defendants will address in greater detail the non-viability of Plaintiffs newly-asserted failure-to-update theory. B. Plaintiffs Failure-To-Update Theory Is Not Viable Under Texas Law Plaintiffs theory of liability based on Generic Defendants alleged failure to incorporate certain changes made to the brand-name drug Reglan s labeling in 2003, 2004, and/or 2009 fails for the simple reason that it does not state a claim under Texas law. 6 Indeed, there is no allegation in Plaintiffs latest amended complaint that a duty exists under Texas law requiring a generic drug manufacturer to conform its labeling to that of its brand-name equivalent drug. Other district courts have rejected the theory argued by Plaintiffs. See, e.g., Abicht v. PLIVA, 5 To the extent Plaintiffs Fourth Amended Complaint asserts new claims based on Generic Defendants purported failure to communicate a change made to the Reglan label to doctors, or other theories of liability, Generic Defendants incorporate by reference as if fully stated herein the relevant arguments in their prior memoranda (Docs. 57 & 64). 6 It is not clear from Plaintiffs Fourth Amended Complaint against whom they seek to assert their failure-toupdate theory. Plaintiffs make a number of allegations that Teva and Watson breached certain alleged federal obligations and failed to update their labels to match the Reglan label required by the FDA. (See Fourth Am. Compl. at 16, 18.) Other paragraphs make allegations against Defendants thereby presumably including the other Generic Defendants and even the brand-name drug manufacturer defendants (Wyeth and Schwarz). The latter allegations clearly make no sense because the brand drug defendants manufactured Reglan, the brand drug whose labeling Generic Defendants were required to match. (See, e.g., id. at 18, 23.) Further, pharmacy records produced by Plaintiffs conclusively document that Mrs. Garza was not dispensed any metoclopramide manufactured or distributed by PLIVA, Barr Pharmaceuticals, or Barr Laboratories, so it appears Plaintiffs may have deliberately excluded those Generic Defendants from their failure-to-update allegations. Finally, those same pharmacy records demonstrate that Mrs. Garza was not dispensed any Teva metoclopramide product until July 24, 2006, after Teva had changed its metoclopramide labeling to match the Reglan labeling. 7

8 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 8 of 23 Inc., No , 2013 WL , at *2 (D. Minn. Jan. 9, 2013) ( [f]ederal law is the gravamen of... failure-to-update claim[s], because the enforcement of such a duty is exclusively the province of the federal government, not of state tort law. ); Fulgenzi v. PLIVA, Inc., --- F. Supp. 2d ---, 2012 WL , at *7 (N.D. Ohio Mar. 31, 2012), appeal pending ( There is, however, no requirement under Ohio law that a generic manufacturer s label mirrors that of the name-brand label. ); Gross v. Pfizer, Inc., 825 F. Supp. 2d 654, 660 (D. Md. 2011), appeal pending ( Plaintiff does not claim that the alleged failure of PLIVA to update its label gives rise to any cause of action under Maryland law; nor is the Court aware of any such cause of action. ); Huck v. Trimark Physicians Grp., No. LACV (Iowa Dist. Ct. Feb. 23, 2012) (Ex. C) ( [T]o the extent Plaintiff s Petition is based on failure to implement the 2004 Reglan label change, that provision of the Petition should be dismissed on the additional ground that it fails to state a claim upon which relief can be granted. ). In fact, Plaintiffs continue to allege in their latest amended complaint that Teva and Watson had certain duties under the Code of Federal Regulations (CFR) to include updates to their labeling to reflect changes approved to the reference listed drug s ( RLD ) labeling. (See Fourth Am. Compl. at 16, 18.) In other words, as Plaintiffs acknowledge in their allegations, it is a federal duty that arises under federal law the FDCA (and its accompanying CFR provisions). Similarly, the Supreme Court recognized in Mensing it is federal law that require[s] that the warning labels of a brand-name drug and its generic copy must always be the same. Mensing, 131 S. Ct. at ; see 21 C.F.R (b)(10) (permitting FDA to withdraw approval for generic drug if labeling is no longer consistent with that for the listed drug referred to in the abbreviated new drug application, except for differences approved in the abbreviated new drug application ). 8

9 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 9 of 23 On that basis alone, Plaintiffs sole remaining theory fails. The theory also fails under Texas state law for another reason. What Plaintiffs, in essence, are alleging is that Generic Defendants should be held liable for failing to provide what they allege is an inadequate warning. Plaintiffs consistently have claimed that all warnings issued through at least 2009, including the 2003 and 2004 warnings, were inadequate. (See Fourth Am. Compl. at 8 ( Mrs. Garza s serious and permanent injuries... came about as a foreseeable and proximate result of defendants dissemination of inaccurate, misleading, materially incomplete, false and otherwise inadequate information concerning the potential effects of exposure to and long-term ingestion of Reglan/metoclopramide.... ) (emphasis added); id. at 9 ( Recognizing the inadequate nature of the Defendants labels and warnings, in February 2009 the FDA ordered a black box warning.... ) (emphases added).) In other words, while Plaintiffs want to premise their claims on Generic Defendants alleged failure to include certain changes that FDA approved for the brand-name product s labeling in 2003 and 2004, Plaintiffs allege that the labeling with those changes remained inadequate. As stated by Magistrate Judge Morgan in rejecting the same theory in his adopted Report and Recommendation in Del Valle: [Del Valle s failure-to-update] claim is at odds with Del Valle s complaint, which states that the label and warnings for Reglan/metoclopramide were inadequate until they were changed in February Dkt. No. 22, p. 13. In essence, Del Valle is asking the Court to hold PLIVA and Teva responsible for not updating their labeling in 2004 to a label that Del Valle believes, and has pled, would still be inadequate. Del Valle, 2011 WL , at *8, adopted by 2012 WL Similarly, as stated by another district court in rejecting the same theory: [Plaintiff] cannot state a plausible claim for relief based on the Generic Defendants [failure] in adopting the 2004 labeling changes [because her] complaint includes an allegation that the FDA-approved warning label for Reglan remained inadequate until the FDA issued a boxed warning in Essentially, therefore, [plaintiff] seeks... to assert a claim that Generic Defendants 9

10 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 10 of 23 are liable for failing to update their label to one that was still inadequate. Johnson v. Teva Pharm. USA, Inc., No. 2:10 CV 404, 2012 WL , at *3 (W.D. La. May 21, 2012), appeal pending; see also Bowman v. Wyeth, LLC, No (JNE/SER), 2012 WL , at *7 (D. Minn. Mar. 2, 2012) ( Bowman continues to contend that even the post-july 2004 Reglan warnings were inadequate and there is no duty for a manufacturer to provide an inadequate warning. ); Morris v. Wyeth, Inc., No. 3:09-cv-854, 2012 WL , at *4 (W.D. La. Feb. 23, 2012), appeal pending ( [A]ny claim based on the 2004 label would be inconsistent with Plaintiffs assertion that all pre-2009 labeling failed to adequately warn. ); Moretti v. Mutual Pharm. Co., 852 F. Supp. 2d 1114 (D. Minn. Feb. 13, 2012), appeal pending; Coney v. Mylan Pharm., Inc., No. 6:11-cv-35, 2012 WL , at *4 (S.D. Ga. Jan. 19, 2012); In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., MDL No. 2283, Civ. No (GEB- LHG), 2011 WL , at *8 (D.N.J. Nov. 21, 2011); Waguespack v. PLIVA USA, Inc., No , 2011 WL , at *2-3 (E.D. La. Nov. 3, 2011). Having repeatedly made the assertion that the labeling remained inadequate through at least 2009, Plaintiffs cannot contend that Generic Defendants can be held liable under Texas law for failing to provide those warnings in their post-2002 labeling. Texas simply does not recognize a claim for failure-to-inadequately-warn ; indeed, no American court, to Generic Defendants knowledge, has embraced a cause of action for failing to disseminate warnings that allegedly are inaccurate, misleading, materially incomplete, false and/or otherwise inadequate. In the end analysis, any alleged failure to update generic labeling does not give rise to any cause of action under Texas law. C. Plaintiffs Lack Standing to Assert, and the Court Lacks Subject Matter Jurisdiction to Consider, Plaintiffs Failure-to-Update Theory Because There Is No Private Right of Action Under the FDCA 10

11 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 11 of 23 Plaintiffs acknowledge that their failure-to-update theory arises from federal law. Further, the theory has been raised only as an afterthought in this litigation in an attempt to avoid the Supreme Court s holding in Mensing. Plaintiffs now allege Generic Defendants can be held liable for not adding language to their metoclopramide labeling that federal law required. As the sole issue left in this case is Generic Defendants alleged failure to comply with their federal duty of sameness, the case against them must be dismissed. Not only do Plaintiffs lack standing to pursue that claim, but also this Court lacks subject matter jurisdiction to entertain that claim. Congress specifically provided in 21 U.S.C. 337(a) that proceedings for enforcement, or to restrain violations, of the FDCA shall be by and in the name of the United States. See also Buckman Co. v. Plaintiffs Legal Comm., 531 U.S. 341, 349 n.4 (2001) ( The FDCA leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions. ) (citing 21 U.S.C. 337(a)). The Mensing Court cited Buckman, a unanimous decision based upon the FDCA s prohibition on private enforcement, as support for its rejection of the plaintiffs failure-to-ask theory. Mensing, 131 S. Ct. at 2578 ( [F]ederal drug and medical device laws pre-empted a state tort-law claim based on failure to properly communicate with the FDA. ). Because Congress vested sole authority to pursue violations of the FDCA and FDA s regulations in the United States government, courts have rejected the failure-to-update theory against generic drug manufacturers. See, e.g., Abicht, 2013 WL , at *2-3 (rejecting plaintiffs failure-to-update theory finding federal law is the premise of that theory and concluding that [w]here federal law supplies the duty, a state claim to enforce that duty is, in substance if not in form, a cause of action under federal law ; and such private actions are not allowed under the FDCA because federal law not only expressly preempts state law but also 11

12 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 12 of 23 precludes any private right of action for enforcement of the FDA s requirements ); Bell v. PLIVA, Inc., 845 F. Supp. 2d 967, 970 (E.D. Ark. 2012) (holding plaintiff does not have a federal private cause of action against PLIVA for its alleged failure to include the strengthened 2004 warning on the products dispensed to [plaintiff] in 2008 ), appeal pending; Morris, 2012 WL , at *5 (finding Plaintiffs have no standing to seek a remedy based on Defendants alleged violation of FDA regulations because the FDCA does not provide a private right of action ); Fulgenzi, 2012 WL at *2, *7 ( There is no private cause of action for violations of FDA regulations. ); Brinkley v. Pfizer, Inc., No CV W SOW, 2012 WL (W.D. Mo. April 12, 2012) (granting PLIVA s motion to dismiss complaint including failure-to-update allegations); Gross, 825 F. Supp. 2d at 660, 663 (denying plaintiff leave to amend claim to assert failure-to-update theory against PLIVA because the weight of authority suggests that such claims are unavailing after Mensing ; and stating Court is unaware of any state-law cause of action based on an alleged failure to update a generic drug s label as required by federal law); Huck v. Trimark Physicians Group, No. LAC018947, 2012 WL (Dist. Ct. of Sac Cty., Iowa Jan. 5, 2012), mot. for reconsid. denied, No. LAC (Dist. Ct. of Sac Cty., Iowa Feb. 23, 2012) (Ex. C) (granting PLIVA summary judgment following briefing focused on failure to update theory finding it fails to state a claim). The reason is aptly explained by the United States District Court for the District of Minnesota in Riley v. Cordis Corp., 625 F. Supp. 2d 769 (D. Minn. 2009): [A] private litigant cannot sue a defendant for violating the FDCA. Similarly, a private litigant cannot bring a state-law claim against a defendant when the statelaw claim is in substance (even if not in form) a claim for violating the FDCA that is, when the state claw claim would not exist if the FDCA did not exist. * * * * * 12

13 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 13 of 23 [T]he plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman). Riley, 625 F. Supp. 2d at ; see also, e.g., Cornett v. Johnson & Johnson, 48 A.3d 1041, 1054 (N.J. 2012) ( Thus, regardless of how a plaintiff styles a state claim, if the claim depends on the alleged violation of a federal requirement, it is functionally equivalent to a claim grounded solely on the federal violation, and is impliedly preempted. (citing Buckman, 531 U.S. at )). The courts dismissing such claims have recognized that attempts to apply state-law principles to alleged violations of the FDCA are merely attempted end-runs around Congress s prohibition of private rights of action. As stated by the Sixth Circuit in Kemp v. Medtronic, 231 F.3d 216 (6th Cir. 2000): The determination that a violation of a federal statute such as the FDCA will create state tort liability is not a matter solely of state law. A state s ability to use a federal statute violation as a basis for state tort liability depends on the intent of Congress, and not merely on the intent of the state. Thus, the congressional decision not to provide a private cause of action under the FDCA becomes quite important in considering the propriety of a [state-law] action for violation of the FDCA. Kemp, 231 F.3d at Numerous other courts also have rejected attempts to evade 337 s prohibition against private rights of action. See, e.g., Kinetic Co., Inc. v. Medtronic, Inc., 2011 WL (D. Minn. Apr. 19, 2011) (claim based on violation of FDA regulation precluded under Buckman); Reeves v. PharmaJet, Inc., 846 F. Supp. 2d 791, 796 (N.D. Ohio 2012) (noting it has been well settled by the Supreme Court and a host of federal Courts of Appeal and District Courts that 337(a) is clear that there is no private right of action for violations of the 7 Kemp was affirmed by the Supreme Court s decision in Buckman. In Buckman, the Court noted that [a] divided panel of the United States Court of Appeals for the Third Circuit reversed, concluding that plaintiffs fraud claims were neither expressly nor impliedly pre-empted. We granted certiorari, 530 U.S. (2000), to resolve a split among the Courts of Appeals on this question, see Kemp v. Medtronic, Inc., 231 F.3d 216, (6th Cir. 2000) (identifying split and holding such claims expressly pre-empted), and we now reverse. ). 13

14 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 14 of 23 FDCA and that a private litigant cannot bring a state-law claim against a defendant when the state-law claim is in substance (even if not in form) a claim for violating the FDCA ). 8 The fact that Plaintiffs theory is merely an improper attempt to enforce the FDCA and FDA s regulations also means this Court lacks jurisdiction to entertain the claim as the federal courts of appeals have recognized that a court does not have subject matter jurisdiction to entertain a claim filed by a private plaintiff that is premised on violations of the FDCA. See, e.g., Rodriguez v. SK & F Co., 833 F.2d 8 (1st Cir. 1987) (finding no basis for subject matter jurisdiction because FDCA does not afford a private cause of action); Fiedler v. Clark, 714 F.2d 77 (9th Cir. 1983) (affirming dismissal based on lack of subject matter jurisdiction finding no jurisdiction under FDCA where plaintiff is a private party). The lack of a valid state-law claim, standing, and subject matter jurisdiction mandate 8 See also Scott v. Pfizer, Inc., 182 Fed. App x 312, 315 (5th Cir. 2006) (upholding dismissal of claims alleging violations of FDCA on standing and subject matter jurisdiction grounds because plaintiff failed to show FDCA creates a private cause of action); Murungi v. Touro Infirmary, Civ. Action No , 2012 WL , at *2-3 (E.D. La. Mar. 21, 2012) (granting motion to dismiss claims alleging violations of FDCA because the statute does not expressly or impliedly grant private parties the right to sue for damages for an alleged violation of the statute ); Enzymotec Ltd. v. NBTY, Inc., No. 08-CV-2627, 2011 WL , at *6 (E.D.N.Y. June 29, 2011) (Plaintiff cannot gain... standing by attempting to privately enforce the FDCA. ); In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, Master File No. 2:06-cv-5774, 2009 WL , at *9-10 (D.N.J. July 10, 2009) (granting motion to dismiss because case was clearly an impermissible attempt by Plaintiffs to turn violations of the FDCA for off-label promotion into a private right of action under RICO and [state statutes]. ); Gaspard v. Our Lady of Lourdes Reg l Med. Center, Inc., 2009 WL , at *4 (W.D. La. Mar. 25, 2009) (granting motion to dismiss all claims, including claims alleging violations of FDCA on grounds that [i]t is well settled that the FDCA creates no private right of action and, therefore, plaintiff has alleged no federal cause of action under the FDCA ) (citations omitted); In re: Epogen & Aranesp Off-Label Mktg. & Sales Practices Litig., 590 F. Supp. 2d 1282, (C.D. Cal. 2008) (granting motion to dismiss because allegations of off-label promotion are, in essence, misbranding claims that should be reviewed by the FDA, and plaintiffs could not attempt to create indirectly a private right of action that the FDCA does not create directly ); In re Neurontin Mktg. and Sale Practices Litig., 244 F.R.D. 89, 92 n.6 (D. Mass. 2007) ( While off-labeling marketing is illegal [under the FDCA], there is no private right of action to enforce it. ); McCarthy v. Danek Med., Inc., 65 F. Supp. 2d 410, 414 (E.D. La. 1999) (granting defendant s motion for summary judgment on ground, inter alia, that [t]here is no private right of action under the FDCA ); Conger v. Danek Med., Inc., 27 F. Supp. 2d 717, 720 (N.D. Tex. 1998) ( [P]laintiffs would have no standing to assert that defendants engaged in a conspiracy to violate the FDCA because the statute does not provide for a private right of action. ); In re Orthopedic Bone Screw Prods. Liab. Litig., 1997 WL *10 (E.D. Pa. April 16, 1997) (same); Bailey v. Johnson, 48 F.3d 965, (6th Cir. 1995) (remanding for dismissal of action based on alleged violation of FDCA because no private right of action under the FDCA and court lacked jurisdiction); Martinez Caraballo v. Intermedics, Inc., 886 F. Supp. 974, 979 (D.P.R. 1995) (given the language of 337(a), plaintiff does not have standing to enforce FDA regulations ); Ginochio v. Surgikos, Inc., 864 F. Supp. 948, 957 (N.D. Cal. 1994) (Because no private FDCA right of action exists, summary judgment on the ground of no standing by plaintiff to bring a cause of action to enforce the [FDCA] is granted. ). 14

15 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 15 of 23 dismissal of Plaintiffs proposed theory against Generic Defendants. D. The Conclusion that Plaintiffs Failure-to-Update Theory Is an Improper Attempt to Enforce the FDCA Is Buttressed by the Lack of Exceptions in Mensing The Mensing decision is broad and without any exceptions. Indeed, the majority and the dissent in Mensing agreed on the breadth of the holding: [B]ecause pharmacists, acting in full accord with state law, substituted generic metoclopramide instead, federal law pre-empts these lawsuits.... We acknowledge the unfortunate hand that federal drug regulation has dealt Mensing, Demahy, and others similarly situated. Mensing, 131 S. Ct. at 2581 (Thomas, J., for the majority) (internal citations omitted). As the majority itself admits, a drug consumer s right to compensation for inadequate warnings now turns on the happenstance of whether her pharmacist filled her prescription with a brand-name drug or a generic. If a consumer takes a brand-name drug, she can sue the manufacturer for inadequate warnings under our opinion in Wyeth. If, however, she takes a generic drug, as occurs 75 percent of the time, she now has no right to sue. Id. at 2592 (Sotomayor, J., for the dissenters). That broad language is not limited or qualified in any way even though, at the time the majority and dissent wrote their opinions, the Supreme Court Justices were aware PLIVA may not have made a label change following the change to the Reglan labeling in 2004 (see Letter from Jay Lefkowitz to William Suter, Clerk of the Supreme Court of the United States (Mar. 11, 2011), Ex. D)), and even though the Court remanded the [cases] for further proceedings consistent with [the] opinion. Mensing, 131 S. Ct. at The majority did not include any except for... language in its opinion; and the dissent, which clearly was in search of paths to allow a drug consumer s right to compensation for inadequate warnings, also failed to mention an exception for consumers who received a generic drug distributed by a manufacturer that did not update its label. Any insinuation that there is an exception to Mensing s bar is unsupported by the plain 15

16 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 16 of 23 language of the opinion. Plaintiffs case is not distinguishable from Mensing or Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010) (the case consolidated in the Supreme Court with Mensing). In Mensing, there were three generic drug manufacturer defendants and, while PLIVA was not a defendant in Demahy, there was no information before the Supreme Court that supports an assumption that the metoclopramide Ms. Mensing took (other than PLIVA s) or that Ms. Demahy took carried all FDA-approved warnings. In fact, both Ms. Mensing and Ms. Demahy were prescribed Reglan and took the product after the 2004 label change (Ms. Mensing took it through March 2005 and Ms. Demahy took it through April 2007). If a failure to add language to the labeling that was approved for the RLD represented an exception to the Court s preemption decision in Mensing, it is reasonable to conclude, given its knowledge that at least one manufacturer had not made the change, that the Court would have so stated in its decision to permit the Fifth and Eighth Circuits to apply that exception on remand in further proceedings consistent with [the Court s] opinion as it instructed. Mensing, 131 S. Ct. at That is especially true given the Supreme Court does not lightly decide to preempt statelaw claims leaving plaintiffs without remedies. The Court s jurisprudence is replete with discussions that it, as well as other courts, must be cautious not to foreclose a plaintiff s ability to recover for injuries under state laws through the application of preemption principles. Yet, without noting any exception, the Court held Ms. Mensing s and Ms. Demahy s lawsuits were preempted. Numerous post-mensing decisions have recognized the lack of exceptions. For example, the Sixth Circuit Court of Appeals in Smith v. Wyeth, Inc., 657 F.3d 420 (6th Cir. 2011), recognized there were no exceptions in Mensing. As was true of the Supreme Court, the Sixth Circuit knew the Reglan label was updated in 2004 and PLIVA s labeling did not include the updated language when it issued its opinion in Smith. And like Ms. Mensing and 16

17 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 17 of 23 Ms. Demahy, the Smith plaintiffs prescriptions for Reglan spanned the 2004 change. After Mensing was released, the plaintiffs in Smith addressed that issue in supplemental briefing they requested and were granted leave to file before the Sixth Circuit rendered its decision. See Appellants Suppl. Letter Br., Smith v. Wyeth, Inc., Nos /5466/5509, 2011 WL , at *1 2 (6th Cir. Aug. 15, 2011). Notwithstanding those arguments, the Sixth Circuit dismissed their lawsuits. The Smith plaintiffs thought the Sixth Circuit did not consider the issue in writing its opinion and made the failure-to-update argument the centerpiece of a Petition for Rehearing and Rehearing En Banc. In that petition, they argued that the Sixth Circuit panel had overlooked a critical factual distinction between their cases and Mensing. Smith v. Wyeth, Inc., Case No , Petition for Rehearing and Rehearing En Banc (Oct. 6, 2011), pp. 1-7 (Ex. E). Specifically, they argued that Mensing did not address PLIVA s failure to implement the 2004 label change and that the Supreme Court did not say that state law may not impose a duty to change a generic drug label in order to incorporate a warning that had already been added to the RLD label. Id., p. 4, 7. According to the plaintiffs, the panel erroneously treated their cases as being on all fours with Mensing notwithstanding factual differences they claimed were critical and compelled a contrary conclusion. Id., p. 7. After the petition was circulated to all active judges of the court, none of whom requested a vote on the suggestion for rehearing en banc, the Sixth Circuit panel issued its order denying the petition. See Smith v. Wyeth, Inc., Order Denying Petition for Rehearing (6th Cir. Nov. 22, 2011) (Ex. F). In its Order, the panel succinctly concluded that the issues raised in the petition were fully considered upon the original submission and decision of the cases. Id. In other words, a generic drug manufacturer s alleged failure to update its label was considered and found 17

18 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 18 of 23 not to alter the preemptive effect of Mensing. The Smith plaintiffs then filed a petition for writ of certiorari in the Supreme Court, asserting, inter alia, that their failure-to-update theory was not preempted by Mensing, but the Supreme Court denied their petition. Smith v. Wyeth, 132 S. Ct (2012). The Eighth Circuit also recognized that Mensing does not include any exceptions. The same theory was presented to the Eighth Circuit after Mensing was remanded by the Supreme Court. See Appellant Gladys Mensing s Mot. for Leave to File a Suppl. Br., Mensing v.wyeth, Inc., No , at 3 (8th Cir. Sept. 8, 2011) at 4 3 ( [N]one of the Generic Drug Company Appellees here even modified their labels to add this new warning during the time that Ms. Mensing was still using their metoclopramide.... ) (Ex. G). However, the Eighth Circuit denied the request for supplemental briefing and entered judgment affirming the dismissal of the generic drug manufacturer defendants. Mensing v. Wyeth, Inc., 658 F.3d 867, 867 (8th Cir. 2011). It did not permit the supplemental briefing notwithstanding the Supreme Court s instructions to conduct further proceedings consistent with [the Court s] opinion. Mensing, 131 S. Ct. at Two related conclusions inescapably emerge. First, there is no exception to the Supreme Court s holding in Mensing that state-law failure-to-warn claims against generic drug companies are preempted because they conflict with federal law. Second, conflict with federal law includes both the situation where a plaintiff s proposed claim would require the addition of language not found in the brand labeling and the situation where a plaintiff s proposed claim, such as here, seeks to enforce the duty imposed by federal law upon a generic drug manufacturer to match its label to the brand-name drug s label. Federal law (21 U.S.C. 337(a)) bars private enforcement of that duty and, therefore, a state-law failure-to-warn claim seeking to enforce that duty 18

19 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 19 of 23 conflicts with federal law. Accordingly, Plaintiffs claims are preempted. E. Plaintiffs Claims Are Barred By Texas Civil Practice & Remedies Code Finally, as held in Phares, Del Valle, and Eckhardt and as discussed in Generic Defendants prior motion, Plaintiffs claims are subject to and barred by the presumption contained in Texas Civil Practice & Remedies Code , which establishes a rebuttable presumption in every products liability action involving a medicine, that the health care provider, manufacturer, distributor, and prescriber are not liable if the warnings or information that accompanied the product were approved by FDA. The statute also provides grounds to rebut that presumption, including fraud-on-the-fda i.e., that the defendant withheld from or misrepresented to FDA (i) required information that was (ii) material and relevant to the performance of the product and (iii) causally related to the claimant's injury. See Tex. Civ. Prac. & Rem. Code (b)(1). In their prior petitions, Plaintiffs attempted to plead an exception to the presumption by alleging the presumption is not available to defendants in this action because defendants allegedly withheld from and misrepresented to the United States FDA required information that was material and relevant to the performance of Reglan/metoclopramide and was casually related to Plaintiffs injuries. (See Fourth Am. Pet., Section XIII.) However, that attempt to allege the fraud-on-the-fda exception to found in (b)(1) is unavailing. As noted in Phares, Del Valle, and Eckhardt, and discussed in Generic Defendants prior motion, applying the Supreme Court s holding in Buckman, the Fifth Circuit held in Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372 (5th Cir. 2012), that a plaintiff cannot rebut the statutory presumption against liability for an alleged failure to warn found in if a defendant s label was approved by FDA, unless a plaintiff alleges that FDA itself 19

20 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 20 of 23 found fraud on the part of the defendant. See Lofton, 672 F.3d at 380; Phares, 2012 U.S. Dist. LEXIS , at *19-20; Del Valle, 2011 WL , at *3; Eckhardt, 858 F. Supp. 2d at 799. Because Plaintiffs have neither alleged nor shown that FDA has made such a finding regarding Generic Defendants, nor can they, Plaintiffs cannot rebut the Texas statutory presumption of non-liability. Plaintiffs responded to the issue by amending their Fourth Amended Complaint to continue to assert a purported misrepresentation exception under (b)(1) but to assert that the misrepresentation includes, but is not limited to, an allegation that Generic Defendants misrepresent[ed] to the FDA that their labels were updated to match the FDA-mandated label. (See Fourth Am. Compl., Section VI.) However, that amendment does not address Lofton s requirement that a plaintiff must allege that FDA made an actual finding of fraud by Generic Defendants based on that additional alleged misrepresentation. Accordingly, Plaintiffs claims against Generic Defendants are barred by as well. 20

21 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 21 of 23 V. CONCLUSION For all the foregoing reasons, Generic Defendants Motion to Dismiss all Plaintiffs claims against them in Plaintiffs Fourth Amended Complaint should be granted. Respectfully submitted, /s/ Michael A. Walsh Michael A. Walsh Texas State Bar No SD Texas Bar No STRASBURGER & PRICE, LLP 901 Main Street, Suite 4300 Dallas, TX Phone: Fax: Jonathan I. Price GOODWIN PROCTER LLP The New York Times Building 620 Eighth Avenue New York, New York Phone: Fax: Richard A. Oetheimer GOODWIN PROCTER LLP Exchange Place 53 State Street Boston, MA Phone: Fax: ATTORNEYS FOR DEFENDANT TEVA PHARMACEUTICALS USA, INC. 21

22 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 22 of 23 Rex A. Littrell ULMER BERNE LLP 88 East Broad Street, Suite 1600 Columbus, Ohio Phone: (614) Fax: (614) Linda E. Maichl Tiffany Reece Clark ULMER BERNE LLP 600 Vine Street, Suite 2800 Cincinnati, Ohio Phone: (513) Fax: (513) Michael G. Terry HARTLINE DACUS BARGER DREYER LLP State Bar No S.D. Texas Bar No N. Shoreline Blvd. Suite 2000, North Tower Corpus Christi, TX Phone: (361) Fax: ( ATTORNEYS FOR DEFENDANTS PLIVA, INC.; BARR LABORATORIES, INC.; BARR PHARMACEUTICALS, INC; WATSON PHARMA, INC.; AND WATSON LABORATORIES, INC. 22

23 Case 2:12-cv Document 78 Filed in TXSD on 02/11/13 Page 23 of 23 CERTIFICATE OF SERVICE I hereby certify that on February 11, 2013, a copy of the foregoing was filed electronically. Notice of this filing will be sent to all parties by operation of the Court s electronic system. Parties may access this filing through the Court s system. /s/ Michael A. Walsh 23