Modicue v. Astrazeneca Pharmaceuticals L P et al

MOTION to Dismiss Amended Complaint For Failure to State a Claim

W.D. La.February 27, 2017

1 UNITED STATES DISTRICT COURT WESTERN DISTRICT OF LOUISIANA LAFAYETTE DIVISION Tagi Modicue Plaintiff, v. AstraZeneca Pharmaceuticals LP; AstraZeneca LP; Procter & Gamble Manufacturing Company, and the Procter & Gamble Company Defendants. ) ) ) ) ) ) ) ) ) ) ) ) Case No. 6:16-cv-01444 Judge Rebecca F. Doherty Magistrate Judge Patrick J. Hanna MOTION TO DISMISS AMENDED COMPLAINT FOR FAILURE TO STATE A CLAIM PURSUANT TO FED. R. CIV. P. 12(B)(6) Defendants, AstraZeneca Pharmaceuticals LP and AstraZeneca LP (collectively “AstraZeneca”), through undersigned counsel move this Court pursuant to Rules 12(b)(6), 9(b), and 8(a)(2) of the Federal Rules of Civil Procedure for an order dismissing Plaintiff’s Amended Complaint for failure to state a claim upon which relief can be granted. The Amended Complaint fails to state a claim upon which relief can be granted for the following reasons:  First, Plaintiff’s claims are barred by prescription. Plaintiff pleads on the face of the Amended Complaint that he was diagnosed with chronic kidney disease in approximately 2012 as well as suffering acute kidney injuries in approximately 2013 and 2015, but failed to file this suit until October 14, 2016. Louisiana applies a one-year prescriptive period for products liability claims, making Plaintiff’s claims time barred.  Second, Plaintiff’s claims do not satisfy Rule 8 of the Federal Rules of Civil Procedure, nor do they state a claim upon which relief can be granted. Plaintiff fails to differentiate between defendants and the products at issue, instead generically claiming that he “ingested Nexium, Prilosec and Prilosec OTC, which resulted in injuries to his kidneys.” (Rec. Doc. 35 ¶ 3.) The Amended Complaint continues to collectively group AstraZeneca with the other defendants and its products with the other PPIs respectively.  Third the Louisiana Products Liability Act (LPLA) provides the exclusive remedy for Plaintiff’s recovery, precluding Plaintiff’s claims for violations of the Louisiana Unfair Trade Practices and Consumer Protection Law (LUTPA) (Count 1), Redhibition based on Case 6:16-cv-01444-RFD-PJH Document 39 Filed 02/27/17 Page 1 of 3 PageID #: 795 2 non-economic losses and personal injuries (Count 3), Breach of Implied Warranties under La. Civil Code art. 2524 (Count 4), and violations of federal regulations (Rec. Doc. 35 ¶¶ 94-97 “Federal Requirements”).  Fourth, Plaintiff fails to plead his LPLA claims and redhibition claim with sufficient specificity to state a claim for relief as required by Bell Atl. Corp. v. Twombly, 550 U.S. 544, 556, 127 S. Ct. 1955, 1965, 167 L. Ed. 2d 929 (2007). For the reasons discussed more fully in the attached memorandum in support, AstraZeneca respectfully requests dismissal with prejudice of the Amended Complaint in its entirety. WHEREFORE, for the reasons more fully explained in the attached Memorandum in Support of the Motion to Dismiss Amended Complaint for failure to state a claim pursuant to Fed. R. Civ. P. 12(b)(6), AstraZeneca respectfully prays that this Motion to Dismiss be granted and that Plaintiff’s claims be dismissed with prejudice. Respectfully submitted, Adams and Reese LLP s/ Diana Cole Surprenant E. PAIGE SENSENBRENNER (#18429) - T.A. DIANA SURPRENANT (#33399) One Shell Square 701 Poydras, Suite 4500 New Orleans, Louisiana 70139 paige.sensenbrenner@arlaw.com diana.surprenant@arlaw.com (504) 581-3234 (telephone) (504) 553-9489 (facsimile) Kellen J. Mathews (#31860) 450 Laurel Street, Suite 1900 Baton Rouge, Louisiana 70801 Telephone: (225) 336-5200 Facsimile: (225) 336-5220 kellen.mathews@arlaw.com Attorneys for Defendants, AstraZeneca Pharmaceuticals LP and AstraZeneca LP Case 6:16-cv-01444-RFD-PJH Document 39 Filed 02/27/17 Page 2 of 3 PageID #: 796 3 CERTIFICATE OF SERVICE I hereby certify that on the 27 th day of February 2017, I electronically filed the foregoing with the Clerk of Court using the CM/ECF system, which will send a notice of electronic filing to all CM/ECF participants. s/ Diana Cole Surprenant DIANA COLE SURPRENANT Case 6:16-cv-01444-RFD-PJH Document 39 Filed 02/27/17 Page 3 of 3 PageID #: 797 i UNITED STATES DISTRICT COURT WESTERN DISTRICT OF LOUISIANA LAFAYETTE DIVISION Tagi Modicue Plaintiff, v. AstraZeneca Pharmaceuticals LP; AstraZeneca LP; Procter & Gamble Manufacturing Company, and the Procter & Gamble Company Defendants. ) ) ) ) ) ) ) ) ) ) ) ) Case No. 6:16-cv-01444 Judge Rebecca F. Doherty Magistrate Judge Patrick J. Hanna MEMORANDUM IN SUPPORT OF MOTION TO DISMISS AMENDED COMPLAINT FOR FAILURE TO STATE A CLAIM PURSUANT TO FED. R. CIV. P. 12(B)(6) TABLE OF CONTENTS I. SUMMARY OF THE ARGUMENT…………………………………………………………...1 II. ARGUMENT ………………………………………………………………………………….2 A. LEGAL STANDARD…………………………………………………………………2 B. PLAINTIFF’S CLAIMS ARE BARRED BY PRESCRIPTION……………………..3 C. PLAINTIFF’S CLAIMS DO NOT SATISFY RULE 8 NOR DO THEY STATE A CLAIM UPON WHICH RELIEF CAN BE GRANTED…………….…….5 D. THE LOUISIANA PRODUCTS LIABILITY ACT PROVIDES THE EXCLUSIVE REMEDY FOR PLAINTIFF’S RECOVERY…………………………9 E. PLAINTIFF FAILS TO PLEAD HIS LPLA CLAIMS WITH SUFFICIENT SPECIFICITY UNDER TWOMBLY…………………………………..……………..11 1. Design Defect………………………………………………………………….12 2. Manufacturing Defect in Construction or Composition………………….…...14 3. Failure to Warn………………………………………………………………..16 4. Breach of Express Warranty…………………………………………………..18 Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 1 of 31 PageID #: 798 ii F. PLAINTIFF FAILS TO PLEAD HIS REDHIBITION CLAIM WITH SUFFICIENT SPECIFICITY UNDER TWOMBLY………………………………….19 G. PLAINTIFF IS NOT ENTITLED TO CONDUCT DISCOVERY OR LEAVE TO AMEND………………………………………………………………...21 III. CONCLUSION………………………………………………………………………………22 Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 2 of 31 PageID #: 799 iii TABLE OF CASES CASES PAGE(S) Abene v. Jaybar, LLC, 802 F. Supp. 2d 716, 722 (E.D. La. 2011) ………………………………………..3 Adams v. I-Flow Corp. et al. 2010 WL 1339948 (C.D. Cal. March 30, 2010)…………………………………..7 Addington v. Farmer's Elevator Mut. Ins. Co., 650 F.2d 663 (5th Cir. 1981) …………………………………………………………………...21 Ashcroft v. Iqbal, 556 U.S. 662, (2009)…………………………………………....2, 5, 6, 8, 9, 21, 22 Aucoin v. Amneal Pharm., LLC, No. 11-1275, 2012 WL 2990697 (E.D. La. July 20, 2012) ……………………………………………………..15, 16 Aucoin v. Southern Quality Homes, LLC, 2007-1014, (La.2/26/08), 984 So. 2d 685……………………………………………………………….19, 20 Averette v. Bayer Healthcare Pharm. Inc., 2014 WL 1246851, at *4 (E.D. La. Mar. 25, 2014) ………………………………3 Bass v. Stryker, 669 F.3d 501 (5th Cir. 2012)……………………………………………………...2 Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007)…………………………………1, 2, 5, 6, 9, 11, 12, 19, 21, 22 Bladen v. C.B. Fleet Holding Company, et al, 487 F. Supp. 2d 759 (W.D. La. April 25, 2007)…………………………………10 Brennon v. Pfizer, Inc., 2009 WL 2525180 (W.D. La. Aug. 17, 2009)……………………………….......10 Broussard v. Procter & Gamble Co., 463 F. Supp. 2d 596, (W.D. La. 2006) aff'd, 517 F.3d 767 (5th Cir. 2008) ……………………………………………………………………12 Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001) ………………………………………..………………11 Butler v. Louisiana State Univ. Health Scis. Ctr., 2012 WL 3263888 (W.D. La. Aug. 9, 2012)………………………………...……9 Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 3 of 31 PageID #: 800 iv Campo v. Correa, 828 So. 2d 502, 508 (La. 6/21/02) ………………………………………………..3 Carroll v. Fort James Corp., 470 F.3d 1171 (5th Cir. 2006)…………………………………………………...21 Carter v. Haygood, 892 So. 2d 1261, 1267 (La. 1/19/05) ……………………………………………..3 Cole v. Celotex Corp., 620 So. 2d 1154, 1157 (La. 1993) ………………………………………………..4 Combs v Stryker Corp., 2009 WL 4929110 (E.D. Cal. Dec. 14, 2009)………………………………….....7 Cooper v. Wyeth, Inc., 2010 WL 2653321 (M.D. La. June 25, 2010)……………………………………10 Corley v. Stryker Corp., 2014 WL 3375596 (W.D. La. May 27, 2014)……………………………...........19 Cuvillier v. Taylor, 503 F.3d 397 (5th Cir. 2007)……………………………………………………...2 Daughtery v. I-Flow, Inc. et al., 2010 WL 2034835 (N.D. Tex. April 29, 2010)…………………………………...7 Dittman v. DJO, LLC, 2009 WL 3246128 (D. Colo. Oct. 5, 2009)…………………………………….....7 Ervin v. Guidant Corp., 2010 WL 3081306 (E.D. La. Aug. 5, 2010)………………………………………9 Ferrer v. Chevron Corp., 484 F.3d 776 (5th Cir. 2007)………………………………………………….....22 Flagg v. Stryker Corp., 647 F. App’x 314 (5th Cir. 2016)………………………………17 Gilmore v. DJO, Inc., 663 F. Supp. 2d 856 (D. Ariz. 2009)……………………………………………...7 Hargrove v. Bos. Sci. Corp., 2014 WL 4794763 (E.D. La. Sept. 24, 2014) ………...16, 17 Harris v. Merck & Co. No. 12-1446, 2012 WL 538470 (W.D. La. Nov. 1, 2012)………………………………….15, 16 Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 4 of 31 PageID #: 801 v Haskins v. Zimmer Holdings Inc., et al., 2010 WL 342552 (D. VT, Jan. 29, 2010)…………………………………………7 Hilton v. Atlas Roofing Corp. of Miss., 2006 WL 1581239 (E.D. La. May 18, 2006)……………………………………………………..…..10 Hollybrook Cottonseed Processing, LLC v. Carver, Inc., No. 09-0750, 2010 WL 2195685 (W.D. La. May 28, 2010)…………………………………...20 Huffman v. Squibb, No. 2016 WL 6024532 (E.D. La. Oct. 14, 2016) …………………..17 Hunt v. McNeil Consumer Healthcare, 6 F. Supp. 3d 694 (E.D. La. 2014)…………………………..……………………………………….11 Jason v. Amer. Arbitration Ass'n, Inc., 2002 WL 1059005 (E.D. La. May 23, 2002)……………………………………...2 Jenkins v. Bristol-Myers Squibb, 2015 WL 5012130 (E.D. La. Aug. 21, 2015) ………..17 Jefferson v. Lead Indus. Ass'n, 106 F.3d 1245 (5th Cir. 1997)...…………………………………………………..9 Johnson v. CHL Enterprises, 115 F. Supp. 2d 723 (W.D. La. 2000).…………………...20 Kennedy v. Pfizer, 2014 WL 4093065 (W.D. La. Aug. 15, 2014)……………………….13, 15, 16, 17 Lewis v. Pfizer Pharm. Co., 2010 WL 2545195 (W.D. La. June 18, 2010)…………………………………...10 McLaughlin v. GlaxoSmithKline, LLC, 2014 WL 669349 (W.D. La. Jan. 6 2014)…………………………………...10, 14 McNeely v. Danek Medical, Inc., 1999 WL 1117108, at *2 (W.D. La. July 8, 1999) ……………………………….3 McQuiston v. Bos. Sci. Corp., 2009 WL 4016120 (W.D. La. Nov. 19, 2009)………………………………………………………..11 Ortego v. Merial, LLC, 2011 WL 400383, at *7 (W.D. La. Feb. 2, 2011) ………………………………...4 Peterson v. Breg, Inc., et al., 2010 WL 2044248 (D. Ariz. April 29, 2010)…………………………………......7 Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 5 of 31 PageID #: 802 vi Pitre v. Yamaha Motor Co., 51 F. Supp. 3d 644 (E.D. La. 2014)…………………………………………...9, 10 Purvis v. Teva Pharmaceuticals, USA, Inc. 901 F. Supp. 2d 716 (M.D. La. Oct. 30, 2012)………………………………12, 13 Robertson v. AstraZeneca Pharms., 2015 WL 5823326 (E.D. La. Oct. 6, 2015)………………………………….18, 19 Scianneaux v. St. Jude Med. S.C., Inc., 961 F. Supp. 2d 808 (E.D. La. Aug. 9, 2013)……………………………………………………...…..10 Scott v. Am. Tobacco Co., 2004-2095 (La. App. 4 Cir. 2/7/07), 949 So. 2d 1266, writ denied, 2007-0662 (La. 1/7/08), 973 So. 2d 740, writ denied, 2007-0654 (La. 1/7/08), 973 So. 2d 740………..…11 Sherman v. Stryker Corp., 2009 WL 2241664 (C.D. Cal. March 30, 2009)……………………………......5, 7 Shushany v. Allwaste, Inc., 992 F.2d 517 (5th Cir. 1993)……………………………………………………...4 Stahl v. Novartis Pharm., 283 F.3d 254(5th Cir. 2002) ………………………………………….9, 12, 15, 16 Tel-Phonic Serv., Inc. v. TBS Int’l, Inc., 975 F.2d 1134 (5th Cir.1992)……………………………………………………..4 Thompson v. Bayer Healthcare Pharm., Inc., 2013 WL 5375441 (E.D. La. Sept. 24, 2013) …………………………………….3 Timmons v. Linvatec Corp., 263 F.R.D. 582 (C.D. Cal. Feb. 9, 2010)……………………………………….....7 Watson v. Bayer Healthcare Pharm., Inc., No. 13-212, 2013 WL 1558328 (E.D. La. Apr. 11, 2013)……………………………………………………..15, 16 Willett v. Baxter, 929 F.2d 1094 (5th Cir. 1991)……………………………………………….16, 17 Williams v. Janssen Pharmaceuticals, 2016 WL 6127526 (W.D. La. October 20, 2016)…………………………………………………….11 Wimm v. Jack Eckerd Corp., 3 F.3d 137 (5th Cir. 1993)……………………………………………………….21 Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 6 of 31 PageID #: 803 vii CODE ARTICLES La. Civ. Code art. 2315.3………… . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ……..12 La. Civ. Code art. 2315.4………… . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ……..12 La. Civ. Code art. 2315.7………… . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ……..12 La. Civ. Code art. 2315.8………… . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ……..12 La. Civ. Code art. 2520………… . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ……….20 La. Civ. Code art. 2524………… . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ….1, 9, 10 La. Civ. Code 3492………… . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . …………….3 STATUTES La. Rev. Stat. § 9:2800.52. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . …………9 La. Rev. Stat. § 9:2800.53. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ………..19 La. Rev. Stat. § 9:2800.54. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ………..12 La. Rev. Stat. § 9:2800.55. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ………..14 La. Rev. Stat. § 9:2800.56. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ………..12 La. Rev. Stat. § 9:2800.57(A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . …………..16 La. Rev. Stat. § 9:2800.58. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ……18, 19 La. Rev. Stat. § 51:1409. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ……………...3 21 U.S.C. § 321. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . …….……………...10 21 U.S.C. § 352. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ……………………10 FEDERAL RULES OF CIVIL PROCEDURE Fed. R. Civ. P. 8(a)(2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1, 2, 4, 5, 6, 7, 8, 15, 21, 22 Fed. R. Civ. P. 9(b).... . . . . . . . . . . . . . . . . . . …………………………………...1, 4, 5, 23 Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 7 of 31 PageID #: 804 viii Fed. R. Civ. P. 12(b)(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1, 2, 3, 14, 15, 19, 22, 23 Fed. R. Civ. P. 15(a) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . …..21 Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 8 of 31 PageID #: 805 1 MEMORANDUM Pursuant to Federal Rules of Civil Procedure 12(b)(6), 8(a)(2), 9(b), Defendants AstraZeneca Pharmaceuticals LP and AstraZeneca LP (collectively “AstraZeneca”), move to dismiss Plaintiff’s Amended Complaint and respectfully show the Court the following: I. SUMMARY OF THE ARGUMENT Plaintiff, Tagi Modicue, (“Plaintiff”), alleges that he “ingested Nexium, Prilosec and Prilosec OTC, which resulted in injuries to his kidneys, including chronic kidney disease.” (See Rec. Doc. 35 ¶ 4.) The Amended Complaint fails to state a claim upon which relief can be granted for the following reasons:  First, Plaintiff’s claims are barred by prescription. Plaintiff pleads on the face of the Amended Complaint that he was diagnosed with chronic kidney disease in approximately 2012 as well as suffering acute kidney injuries in approximately 2013 and 2015, but failed to file this suit until October 14, 2016. Louisiana applies a one-year prescriptive period for products liability claims, making Plaintiff’s claims time barred.  Second, Plaintiff’s claims do not satisfy Rule 8 of the Federal Rules of Civil Procedure, nor do they state a claim upon which relief can be granted. Plaintiff fails to differentiate between defendants and the products at issue, instead generically claiming that he “ingested Nexium, Prilosec and Prilosec OTC, which resulted in injuries to his kidneys.” (Rec. Doc. 35 ¶ 3.) The Amended Complaint continues to collectively group AstraZeneca with the other defendants and all products together.  Third the Louisiana Products Liability Act (LPLA) provides the exclusive remedy for Plaintiff’s recovery, precluding Plaintiff’s claims for violations of the Louisiana Unfair Trade Practices and Consumer Protection Law (LUTPA) (Count 1), Redhibition based on non-economic losses and personal injuries (Count 3), Breach of Implied Warranties under La. Civil Code art. 2524 (Count 4), and violations of federal regulations (Rec. Doc. 35 ¶¶ 94-97 “Federal Requirements”).  Fourth, Plaintiff fails to plead his LPLA claims and redhibition claim with sufficient specificity to state a claim for relief as required by Bell Atl. Corp. v. Twombly, 550 U.S. 544, 556, 127 S. Ct. 1955, 1965, 167 L. Ed. 2d 929 (2007). For the reasons discussed more fully herein, AstraZeneca respectfully requests dismissal with prejudice of the Amended Complaint in its entirety. Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 9 of 31 PageID #: 806 2 II. ARGUMENT A. LEGAL STANDARD Fed. R. Civ. P. 12(b)(6) permits a court to dismiss a claim when the plaintiff “fail[s] to state a claim upon which relief can be granted.” Motions to dismiss test the legal sufficiency of a complaint. Jason v. Amer. Arbitration Ass'n, Inc., 2002 WL 1059005, at *1 (E.D. La. May 23, 2002). Dismissal under Rule 12(b)(6) “is appropriate when the plaintiff has not alleged enough facts to state a claim to relief that is plausible on its face or has failed to raise his right to relief above the speculative level.” Bass v. Stryker, 669 F.3d 501, 506 (5th Cir. 2012). Rule 8(a) requires that the complaint set forth “a short and plain statement of the claim showing that the pleader is entitled to relief” or be subject to dismissal. Fed. R. Civ. P. 8(a)(2). Accordingly, to comply with Rule 8, the complaint must provide “more than labels and conclusions” or “a formulaic recitation of the elements of a cause of action.” Twombly, 550 U.S. at 555. Moreover, “[t]he pleading must contain something more . . . than . . . a statement of facts that merely creates a suspicion [of] a legally cognizable right of action.” Id. This is because, as the Supreme Court has explained, “[w]ithout some factual allegation in the complaint, it is hard to see how a claimant could satisfy the requirement of providing not only ‘fair notice’ of the nature of the claim, but also ‘grounds’ on which the claim rests.” Id. at 555, n.3. Accordingly, courts “are not bound to accept as true a legal conclusion couched as a factual allegation” and pleadings that lack a “statement of circumstances, occurrences, and events in support of the claim presented” should be dismissed. Id.; see also Ashcroft v. Iqbal, 556 U.S. 662, 679, 129 S. Ct. 1937, 1950, 173 L. Ed. 2d 868 (2009) (applying Twombly and noting that Rule 8 “does not unlock the doors of discovery for a plaintiff armed with nothing more than conclusions.”); Cuvillier v. Taylor, 503 F.3d 397, 401 (5th Cir. 2007), citing Twombly, 550 U.S. at 558 (“[w]hen the allegations in a Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 10 of 31 PageID #: 807 3 complaint, however true, could not raise a claim of entitlement to relief, this basic deficiency should . . . be exposed at the point of minimum expenditure of time and money by the parties and the court”) (internal quotation marks omitted). As set forth more fully herein, Plaintiff has offered nothing more than legal conclusions masquerading as factual allegations and as such AstraZeneca’s motion should be granted, and Plaintiff’s claims should be dismissed. B. PLAINTIFF’S CLAIMS ARE BARRED BY PRESCRIPTION. Louisiana applies a one-year prescriptive period for products liability claims. 1 See La. Civ. Code art. 3492; Thompson v. Bayer Healthcare Pharm., Inc., 2013 WL 5375441, at *2 (E.D. La. Sept. 24, 2013); McNeely v. Danek Medical, Inc., 1999 WL 1117108, at *2 (W.D. La. July 8, 1999). Prescription runs from the day that the injury or damage is sustained. La. Civ. Code art. 3492. “[I]f prescription is evident on the face of the pleadings, the burden shifts to the plaintiffs to show that the action has not prescribed.” Carter v. Haygood, 892 So. 2d 1261, 1267 (La. 1/19/05); Campo v. Correa, 828 So. 2d 502, 508 (La. 6/21/02). If the plaintiff cannot discharge his burden of establishing an exception to prescription, dismissal of the action under Rule 12(b)(6) is appropriate. Averette v. Bayer Healthcare Pharm. Inc., 2014 WL 1246851, at *4 (E.D. La. Mar. 25, 2014). Here, Plaintiff pleads on the face of his Amended Complaint that he suffered chronic kidney disease in 2012 and acute kidney injury in 2013 and 2015. (Rec. Doc. 35 ¶ 4.) 2 Thus, 1 The one year prescriptive period also applies to Plaintiff’s LUTPA and breach of implied warranty claims, which have likewise expired. The breach of implied warranty claim is prescribed due to the expiration of the one-year prescriptive period for delictual actions. La. Civ. Code 3492. The LUTPA claim is perempted due to expiration of the one-year prescriptive period, and is not subject to suspension or interruption. La. Rev. Stat. § 51:1409; Abene v. Jaybar, LLC, 802 F. Supp. 2d 716, 722 (E.D. La. 2011). Accordingly, said claims must be dismissed as well. Furthermore, as discussed in Section D, those claims are also precluded by the LPLA and should be dismissed on those grounds. 2 Again, Plaintiff does not differentiate between the products at issue. Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 11 of 31 PageID #: 808 4 Plaintiff’s claim began to run as early as 2012 when he was diagnosed with chronic kidney disease, and expired in 2013. See e.g., Cole v. Celotex Corp., 620 So. 2d 1154, 1157 (La. 1993) (prescription begins to run from date of diagnosis); Ortego v. Merial, LLC, 2011 WL 400383, at *7 (W.D. La. Feb. 2, 2011) (prescription begins to run from date of diagnoses under LPLA). However, Plaintiff did not file suit against AstraZeneca until October 14, 2016, approximately four years after the alleged diagnosis and three years after the prescriptive period expired. Prescription is therefore evident on the face of Plaintiff’s pleading. As such, the Court should dismiss Plaintiff’s Amended Complaint as time barred. Notwithstanding that the Amended Complaint is prescribed on its face, Plaintiff alleges that the “running of any statute of limitations has been tolled by reason of Defendants’ fraudulent concealment.” (Rec. Doc. 35 ¶ 98) (emphasis added). Plaintiff’s fraud allegations are not pled with the requisite particularity and should thus be stricken. Rule 9(b) of the Federal Rules of Civil Procedure provides that “[i]n all averments of fraud or mistake, the circumstances constituting fraud or mistake shall be stated with particularity.” Fed. R. Civ. P. 9. Thus, allegations of fraud must meet a higher standard than the basic notice pleading required by Rule 8. Shushany v. Allwaste, Inc., 992 F.2d 517, 521 (5th Cir. 1993). “At a minimum, Rule 9(b) requires allegations of the particulars of ‘time, place, and contents of the false representations, as well as the identity of the person making the misrepresentation and what he obtained thereby.’” Tel-Phonic Serv., Inc. v. TBS Int’l, Inc., 975 F.2d 1134, 1139 (5th Cir. 1992). Plaintiff asserts his Fraudulent Concealment argument in only two conclusory paragraphs of the Amended Complaint. (Rec. Doc. 35 ¶¶ 98-99.) Significantly, Plaintiff’s allegations do not specify the times, dates, places, and details of the alleged fraudulent activity, or the person(s) making the alleged misrepresentations. In short, Plaintiff’s attempted fraud allegations fall Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 12 of 31 PageID #: 809 5 woefully short of the heightened requirements for pleading fraud established in Rule 9(b). Also fatal to these allegations is Plaintiff’s failure to differentiate these claims between AstraZeneca and the other named defendants. “Rule 9(b) does not allow a complaint to merely lump multiple defendants together but requires plaintiffs to differentiate their allegations when suing more than one defendant . . . and inform each defendant separately of the allegations surrounding his alleged participation in the fraud.” Sherman v. Stryker Corp., 2009 WL 2241664, *2 (C.D. Cal. March 30, 2009) (internal citations omitted) (noting “because [plaintiff] does not differentiate these claims as to [defendant] and the other defendants, the dismissal of these claims is proper on this basis alone. [Plaintiff] must specifically allege the role of each defendant in each scheme.”). Because Plaintiff’s fraud-based allegations fail to satisfy Rule 9(b), the fraud claims should be stricken and not allowed to resuscitate Plaintiff’s expired Amended Complaint, which should be dismissed for Plaintiff’s failure to file timely. C. PLAINTIFF’S CLAIMS DO NOT SATISFY RULE 8 NOR DO THEY STATE A CLAIM UPON WHICH RELIEF CAN BE GRANTED. Rule 8 of the Federal Rules of Procedure requires that the “[f]actual allegations must be enough to raise a right to relief above the speculative level.” Twombly, 550 U.S. at 555. Thus, in addressing a motion to dismiss, courts should consider whether the complaint contains sufficient factual allegations to “state a claim for relief that is plausible on its face.” Twombly, 550 U.S. at 556. As the Supreme Court elaborated in Iqbal, facial plausibility requires plaintiff to plead specific facts implicating each named defendant: A claim has facial plausibility when the plaintiff pleads factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged. The plausibility standard is not akin to a “probability requirement,” but it asks for more than a sheer possibility that a defendant has acted unlawfully. Where a complaint pleads facts that are “merely consistent with” a Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 13 of 31 PageID #: 810 6 defendant’s liability, it “stops short of the line between possibility and plausibility of entitlement to relief.” Iqbal, 129 S. Ct at 1949 (emphasis added; citations omitted). Therefore, “a court considering a motion to dismiss can choose to begin by identifying pleadings that, because they are no more than conclusions, are not entitled to the assumption of truth.” Id. at 1950. Here, Plaintiff’s Amended Complaint fails to plead the most basic facts necessary to support a claim against AstraZeneca. It does not set forth the “circumstances, occurrences and events” that Twombly confirms that Rule 8 mandates. Plaintiff generically asserts this to be “a personal injury action against AstraZeneca, Procter & Gamble and their affiliates, subsidiaries, alter-egos, and/or joint venturers who were responsible for designing, researching developing, testing, manufacturing, packaging, labeling, marketing, promoting, distributing, and/or selling proton pump inhibitors (“PPIs”), specifically Nexium, Prilosec and Prilosec OTC, respectively.” (Rec. Doc. 35 ¶ 1.) Throughout the entirety of the Amended Complaint, Plaintiff mainly refers to the product(s) at issue as “PPIs” or “Proton Pump Inhibitors.” See, e.g., (Rec. Doc. 35 ¶ 88) (“Defendants concealed and continue to conceal their knowledge that PPIs can cause kidney injuries to Plaintiff . . . “); (Rec. Doc. 35 ¶ 135) (“ . . . Proton Pump Inhibitors are unreasonably dangerous . . .”). When Plaintiff does mention specific products, Plaintiff typically groups them all together. (See Rec. Doc. 35 ¶¶ 1, 2, 4, 8, 9, 19, 21, 22, 50, 57, 88, 89, 115.) Likewise, Plaintiff generally groups all Defendants together. Other than listing the Defendants, Plaintiff makes allegations specific to AstraZeneca only eleven times in the 150 Paragraph Amended Complaint. (See Rec. Doc. 35 ¶¶ 25, 26, 28, 29, 30, 36, 37, 39, 40, 51, 119.) Additionally, the Amended Complaint does not plead any facts with respect to actions or inactions by AstraZeneca that could plausibly link it to Plaintiff’s purported injuries, but collectively groups AstraZeneca with the other named Defendants. It is well-established that this Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 14 of 31 PageID #: 811 7 type of pleading - e.g. asserting generic claims regarding “PPIs” globally against “the Defendants” - is not permitted under Rule 8 in the context of pharmaceutical product liability litigation. 3 In addition, the Amended Complaint still contains virtually no factual allegations regarding either the specific individual product(s) at issue or Plaintiff’s alleged use of the specific individual product(s) at issue. Plaintiff does not identify whether he purchased or ingested prescription PPIs or over-the-counter PPIs with respect to “Nexium.” Over-the-counter PPIs, including over-the-counter Nexium are promoted and marketed by different 3 The body of case-law that developed from the anesthetic medication/pain pump litigation illustrates that courts will not tolerate such ill-defined and generic pleading, such as here, where, Plaintiff directs his allegations regarding “PPIs” against all “Defendants.” When faced with similarly deficient pleadings that failed to differentiate between the products and defendants at issue (using terms such “local anesthetic” and lumping together allegations against multiple defendants), courts across the country did not hesitate to dismiss claims against AstraZeneca and other defendants. See Adams v. I-Flow Corp. et al., 2010 WL 1339948, *1-3 (C.D. Cal. March 30, 2010) (dismissing plaintiffs’ complaint for use of generic product descriptions and failure to differentiate between the defendants, and stating "the Complaint uses generalized terms to identify these products, such as ‘pain pump’ and ‘local anesthetic' . . . As such, plaintiffs plead nothing more than the sheer possibility that any particular defendant might have manufactured the [product at issue]. This sort of speculative pleading is not permitted . . .”); Daughtery v. I-Flow, Inc. et al., 2010 WL 2034835, *3 (N.D. Tex. April 29, 2010) (granting defendants’ motions to dismiss because “[plaintiff] has not set forth allegations sufficient or specific enough to plead the existence of a causal connection between his injury and the conduct of any particular defendant(s).”); Peterson v. Breg, Inc., et al., 2010 WL 2044248, *2 (D. Ariz. April 29, 2010) (granting defendants’ motions to dismiss where “plaintiffs merely posit that it is possible that one or more of the named defendants manufactured the pain pumps or anesthetics that caused their injuries. Such speculative pleading is not permissible . . .”); Haskins v. Zimmer Holdings Inc., et al., 2010 WL 342552, *5 (D. VT, Jan. 29, 2010) (granting AstraZeneca’s motion to dismiss and stating that “[t]his threshold allegation [of product identification] is necessary to show a plausible entitlement to relief”); Timmons v. Linvatec Corp.,, 263 F.R.D. 582, 584-5 (C.D. Cal. Feb. 9, 2010) (granting with prejudice AstraZeneca’s motion to dismiss complaint that “names eight anesthetic manufacturers as defendants” because “[p]laintiffs’ claims against AstraZeneca [did] not rise above the speculative level” and “the Complaint does not allege any facts that would permit a reasonable inference of liability against AstraZeneca”); Combs v Stryker Corp., 2009 WL 4929110, *3 (E.D. Cal. Dec. 14, 2009) (granting AstraZeneca’s motion to dismiss with prejudice because “[p]laintiffs are merely speculating that [AstraZeneca] could be liable. Thus [p]laintiffs’ allegations do not plead adequate facts for even an inference of [d]efendants’ liability, and their claims against [d]efendants cannot stand”); Dittman v. DJO, LLC, 2009 WL 3246128, *3 (D. Colo. Oct. 5, 2009) (granting with prejudice motions to dismiss of AstraZeneca and others, holding that the “Plaintiff has no facts, only speculation, on which to base his claim that defendants’ products caused or contributed to his injury”); Sherman, 2009 WL 2241664, at *4-5 (complaint containing “generalized descriptions”-i.e., “anesthetics,” “anesthetic drugs,” and “pain relief drugs”-of the anesthetic administered was dismissed with prejudice as to anesthetic defendants because plaintiff “conspicuously fail[ed]” to allege which defendant, if any, was responsible for the pain medication at issue); Gilmore v. DJO, Inc., 663 F. Supp. 2d 856, 862 (D. Ariz. 2009) (granting AstraZeneca’s motion to dismiss because the plaintiffs had “done little more than allege that the AstraZeneca defendants caused them harm” and “that is not sufficient to withstand a motion to dismiss.” “As the AstraZeneca defendants point out, there are only two paragraphs in the [complaint] that even mention them specifically.”). Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 15 of 31 PageID #: 812 8 pharmaceutical companies. To the extent that any prescription Nexium® or prescription Prilosec® product is at issue, which is entirely unclear from the generic allegations, the Amended Complaint is devoid of any indication as to: (i) how Plaintiff contends any prescription Nexium® or prescription Prilosec® was defective or unsafe; (ii) what AstraZeneca supposedly knew or should have known about risks associated with use of prescription Nexium® or prescription Prilosec®, and when it supposedly knew or should have known; (iii) how any prescription Nexium® or prescription Prilosec® could have been designed, tested or marketed differently or more safely; (iv) what warranties AstraZeneca supposedly made, and where, when and to whom it supposedly made those warranties; (v) what statements were made by AstraZeneca to physicians or Plaintiff, and when and how such statements were supposedly made; or any other factual allegations to justify Plaintiff’s claims against AstraZeneca. Furthermore, at no point in the Amended Complaint does Plaintiff allege any facts to support his meager allegations that any prescription Nexium® or prescription Prilosec® (as opposed to other proton pump inhibitor) caused his injuries. Quite simply, the Amended Complaint still contains no factual allegations relating specifically to AstraZeneca or prescription Nexium® or prescription Prilosec® to support any claim for relief. Accordingly, Plaintiff’s Amended Complaint fails to state a “plausible” claim because Plaintiff fails to plead “factual content that allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 129 S. Ct. at 1949. For these reasons, Plaintiff’s Amended Complaint neither provides proper notice to AstraZeneca of the claims against it (as opposed to some other Defendant) nor allows the Court to draw the reasonable inference that AstraZeneca is liable for the misconduct alleged, and thus, Plaintiff’s claims against AstraZeneca should be dismissed. Iqbal, 129 S. Ct. at 1954 (“Rule 8 Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 16 of 31 PageID #: 813 9 does not empower [Plaintiff] to plead the bare elements of [their] cause of action, affix the label “general allegation,’ and expect [her] claim to survive a motion to dismiss.”); Butler v. Louisiana State Univ. Health Scis. Ctr., 2012 WL 3263888, at *3 (W.D. La. Aug. 9, 2012) (dismissing plaintiff’s LPLA claims because the petition was void of the required specific factual allegations as required by the Supreme Court in Iqbal, and Twombly) (internal citations omitted). D. THE LOUISIANA PRODUCTS LIABILITY ACT PROVIDES THE EXCLUSIVE REMEDY FOR PLAINTIFF’S RECOVERY. Plaintiff’s claims for violations of LUTPA (Count 1), Redhibition based on non- economic losses and personal injuries (Count 3), Breach of Implied Warranty under La Civ. Code art. 2524 (Count 4), and violations of federal regulations (Rec. Doc. 35 ¶¶ 94-97 “Federal Requirements”) are precluded by the LPLA. It is axiomatic that the LPLA is the “exclusive remedy for products liability actions against manufacturers under Louisiana law.” Stahl v. Novartis Pharm., 283 F.3d 254, 260 (5th Cir. 2002). The LPLA expressly states that a “claimant may not recover from a manufacturer for damage caused by a product on the basis of any theory of liability that is not set forth in this Chapter.” La. Rev. Stat. § 9:2800.52. Louisiana courts have made clear that the LPLA preempts alternate causes of action: [A] court applying Louisiana law may dismiss claims against manufacturers that are inconsistent with these exclusive theories of liability set forth in the LPLA. Furthermore, courts applying Louisiana law have frequently dismissed cases that assert theories of fraud, negligence, and misrepresentation because such claims are outside the scope of the LPLA. Ervin v. Guidant Corp., 2010 WL 3081306, at *2 (E.D. La. Aug. 5, 2010); see also Jefferson v. Lead Indus. Ass'n, 106 F.3d 1245, 1248 (5th Cir. 1997) (holding that Louisiana law only recognizes the four theories of recovery for product liability actions which are set forth by the LPLA); Pitre v. Yamaha Motor Co., 51 F. Supp. 3d 644, 662 (E.D. La. 2014) (“courts applying Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 17 of 31 PageID #: 814 10 Louisiana law have concluded that the LPLA bars plaintiffs from maintaining an action under the LUTPA”); Scianneaux v. St. Jude Med. S.C., Inc., 961 F. Supp. 2d 808, 809 (E.D. La. Aug. 9, 2013) (finding that plaintiff could not assert claims outside the scope of the LPLA); Cooper v. Wyeth, Inc., 2010 WL 2653321 (M.D. La. June 25, 2010) (dismissing fraud, negligence, negligent misrepresentation, breach of implied warranty, and punitive damages claims under the LPLA); Brennon v. Pfizer, Inc., 2009 WL 2525180, at *3 (W.D. La. Aug. 17, 2009) (“LPLA’s exclusivity provision further precludes plaintiff's claims for…breach of implied warranty); Bladen v. C.B. Fleet Holding Company, et al, 487 F. Supp. 2d 759, 769 (W.D. La. April 25, 2007) (“LUTPA complaints [] are precluded by the clear statutory declaration found within the LPLA”); Hilton v. Atlas Roofing Corp. of Miss., 2006 WL 1581239, at *3 (E.D. La. May 18, 2006) (dismissing plaintiff’s claims for breach of express and implied warranties, negligence, fraud, and unjust enrichment under the LPLA). Thus, because the LPLA is the exclusive remedy for products liability actions against manufacturers under Louisiana law, Plaintiff’s claims for violations of LUTPA, Redhibition based on non-economic losses and personal injuries, Breach of Implied Warranty under La. Civil Code art. 2524, and violations of “Federal Requirements” are precluded by statute and should be dismissed accordingly. 4 In addition, to the extent Plaintiff asserts violations of federal regulations, these claims also fail. Plaintiff asserts that Defendants violated certain federal regulations, 21 U.S.C. § 352. (See Rec. Doc. 35 ¶ 96.) But, “these provisions [21 U.S.C. §§ 321, 352] do not create a cause of 4 To the extent that Plaintiff pleads claims of fraudulent misrepresentations, these claims are also precluded under the exclusivity of the LPLA. See McLaughlin v. GlaxoSmithKline, LLC, 2014 WL 669349, at *3(W.D. La. Jan. 6, 2014) (holding that because “the LPLA establishes [p]laintiff’s sole theories of recovery . . . any claims pled beyond the scope of her exclusive remedy under the LPLA” - including plaintiff’s fraud claim - “must be dismissed”); Cooper v. Wyeth, Inc., 2010 WL 2653321 (dismissing fraud claim under the LPLA); Lewis v. Pfizer Pharm. Co., 2010 WL 2545195 (W.D. La. June 18, 2010) (dismissing fraudulent misrepresentation claim under the LPLA). Accordingly, Plaintiff cannot maintain a claim for fraud under the LPLA. Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 18 of 31 PageID #: 815 11 action for private parties based upon a violation of their requirements.” Williams v. Janssen Pharmaceuticals, 2016 WL 6127526 (W.D. La. October 20, 2016). Furthermore, because Plaintiff’s alleged violations of federal regulations are based on the allegedly defective PPI products, the LPLA likewise bars such claims due to its exclusivity provision. Id. Further, to the extent that Plaintiff is alleging “fraud-on-the-FDA” claims through the federal violations, these claims are also preempted by federal law. 5 See Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 353, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001) (finding that plaintiffs’ state-law-based fraud-on-the-FDA claims are preempted); see also Hunt v. McNeil Consumer Healthcare, 6 F. Supp. 3d 694, 698 n.4 (E.D. La. 2014) (because “the LPLA provides the exclusive remedy against manufacturers for damage caused by their products” it “therefore precludes any cause of action for fraud-on-the-FDA”); McQuiston v. Bos. Sci. Corp., 2009 WL 4016120, at *6 n.5 (W.D. La. Nov. 19, 2009). Accordingly, to the extent that Plaintiff’s claims rely on misrepresentations or omissions made to the FDA, the claims are preempted by federal law. Notwithstanding that such claims are preempted, as a general principle, Louisiana courts have held that “[f]raud claims cannot be used to circumvent the LPLA.” 6 As such, Plaintiff’s claims in this regard would fail even if they were not preempted by federal law. E. PLAINTIFF FAILS TO PLEAD HIS LPLA CLAIMS WITH SUFFICIENT SPECIFICITY UNDER TWOMBLY. Under the LPLA, the plaintiff bears the burden of proof. To establish liability under the LPLA, a plaintiff must show that (1) the defendant is a manufacturer of the product, (2) the 5 Plaintiff’s allegations are unclear in this section, as no specific cause of action is identified, such that it is hard to identify what cause of action is alleged. (See Rec. Doc. 35 ¶¶ 94-97.) 6 Scott v. Am. Tobacco Co., 2004-2095 (La. App. 4 Cir. 2/7/07), 949 So. 2d 1266, 1274, writ denied, 2007-0662 (La. 1/7/08), 973 So. 2d 740, writ denied, 2007-0654 (La. 1/7/08), 973 So. 2d 740. Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 19 of 31 PageID #: 816 12 plaintiff’s damage was proximately caused by a characteristic of the product, (3) that this characteristic made the product “unreasonably dangerous,” and (4) that plaintiff’s damage arose from a reasonably anticipated use of the product. See La. Rev. Stat. § 9:2800.54; Stahl, 283 F. 3d. at 261. To establish that a product is unreasonably dangerous, the plaintiff must show that the defect relates to: (i) construction or composition of the product, (ii) design, (iii) the adequacy of warning, (iv) or the manufacturer’s failure to conform to an express warranty. La. Rev. Stat. § 9:2800.54(B). Lastly, the plaintiff must show that the “unreasonably dangerous” characteristic existed at the time the product left the manufacturer’s control, or resulted from a reasonably anticipated alteration to the product. Id. § 2800.54(C). As discussed more fully herein, Plaintiff’s claims fail to satisfy the LPLA requirements and Twombly such that the claims should be dismissed accordingly. 7 i. Design Defect Under the LPLA, a product is considered “unreasonably dangerous in design” if at the time it left the manufacturer’s control, (1) there existed an alternative design that was capable of preventing claimant’s damage, and (2) the likelihood that the product’s design would cause the harm complained of, and the gravity of that harm, together outweighed the burden of adopting the alternative design. La. Rev. Stat. § 9:2800.56; Broussard v. Procter & Gamble Co., 463 F. Supp. 2d 596, 610 (W.D. La. 2006), aff'd, 517 F.3d 767 (5th Cir. 2008). While a plaintiff need not plead each of these elements with specificity, a “formulaic recitation of the statutory provisions” and “conclusory allegations” are not sufficient. See Purvis v. Teva Pharms., USA, 901 F. Supp. 2d 716, 721 (M.D. La. 2012). 7 To the extent that Plaintiff seeks punitive damages (Rec. Doc. 35 ¶ 117, “Defendants’ reckless conduct warrants an award of punitive damages.”), Plaintiff’s claims for punitive damages under Louisiana law are barred. The recovery of punitive damages in Louisiana is limited to discreet circumstances, none of which apply here. See La. Civil Code arts. 2315.3, 2315.4, 2315.7, 2315.8. Accordingly, Plaintiff’s claims for punitive damages under Louisiana law also must be dismissed. Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 20 of 31 PageID #: 817 13 Here, Plaintiff fails to plead the necessary facts to establish a design defect under the LPLA. In his Amended Complaint, Plaintiff alleges that Proton Pump Inhibitors are “unreasonably dangerous in design.” (Rec. Doc. 35 ¶ 135(b)). These are clearly legal conclusions, and as such are the sole province of the trier of fact. These allegations fail to explain how any particular Defendant’s specific product was allegedly defective or what attributes of each Defendant’s product made it unreasonably dangerous. Stated simply, the Amended Complaint is devoid of anything on the order of “factual” detail as to how the product is allegedly defective. Although the Amended Complaint attempts to identify alternative methods of treatment for GERD through home remedies and other medications, including H2 antagonists (see Rec. Doc. 35 ¶ 48), it fails to identify any actual alternative design for any of the products identified. This is because Plaintiff cannot even specify what makes any of the products identified defective. In sum, Plaintiff’s conclusory allegations are void of sufficient factual content. But it is well-settled that a mere “formulaic recitation of the statutory provisions” and “conclusory allegations” are not sufficient to satisfy a design defect claim. See Kennedy v. Pfizer, 2014 WL 4093065, at *4 (W.D. La. Aug. 15, 2014) (holding that mere “labels and conclusions” and “a formulaic recitation of the elements of a cause of action” are not sufficient to support a design defect claim); see also Purvis, 901 F. Supp. 2d at 721 (“[Plaintiff] has not alleged that there existed an alternative design for the drug which is an essential element of a LPLA design defect claim.”). Additionally, the Amended Complaint does not even allege that Plaintiff has GERD or specify what home remedies were even available. Further, Plaintiff fails to assert factual support showing the likelihood that the product’s design would cause the harm complained of or that the gravity of that harm outweighed the burden of adopting the alternative design. See Purvis, 901 F. Supp. 2d at 721. Instead, Plaintiff Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 21 of 31 PageID #: 818 14 makes conclusory allegations that the gravity of the harm outweighed the burden of adopting an alternative design. (See Rec. Doc. 35 ¶ 137(b)) (“The likelihood that the product’s design would cause the Plaintiff’s damages and the gravity of those damages outweigh the burden on the manufacturer of adapting such alternative design and the adverse effect, if any, of such alternative design on the utility of the product.”). Absent factual support that the gravity of the harm outweighed the burden of adopting the alternative design, Plaintiff’s design defect claim is inadequately pled and should be dismissed. In short, Plaintiff’s conclusory allegations are insufficient to state a claim for relief, and the design defect claim should be dismissed accordingly pursuant to Rule 12(b)(6). ii. Manufacturing Defect in Construction or Composition Under the LPLA, a product is “unreasonably dangerous in construction or composition,” if the product deviated in a material way from identical products made by the same manufacturer, or from the manufacturer’s specifications or performance standards of the product. La. Rev. Stat. § 9:2800.55. To establish a claim based on a construction defect, the plaintiff must establish the following: “(1) the defendant is a manufacturer of the product; (2) the product proximately caused the plaintiff’s damage; (3) the damaging characteristic of the product rendered it ‘unreasonably dangerous in construction or composition’; and (4) the plaintiff’s damages arose from a reasonably anticipated use of the product.” McLaughlin v. GlaxoSmithKline, LLC, No. 12-2946, 2014 WL 669349, at *4 (W.D. La. Jan. 6, 2014). Here, Plaintiff’s Amended Complaint is devoid of necessary allegations under the LPLA’s “construction or composition defect section.” Instead, Plaintiff pleads that Proton Pump Inhibitors are “unreasonably dangerous in construction or composition as per LSA R.S. 9:2800.55.” (See Rec. Doc. 35 ¶ 135(a).) These statements are clearly legal conclusions and a Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 22 of 31 PageID #: 819 15 mere recitation of Plaintiff’s cause of action. Stated simply, the Amended Complaint is devoid of anything on the order of “factual” detail as to how prescription Nexium® or prescription Prilosec® caused damage to Plaintiff, what characteristics of prescription Nexium® or prescription Prilosec® made it unreasonably dangerous, how the prescription Nexium® or prescription Prilosec® allegedly used by Plaintiff, if any, was supposedly different from AstraZeneca’s specifications and/or performance standards, or what AstraZeneca’s specifications and/or performance standards even were. Indeed, numerous courts have found allegations similar to Plaintiff’s allegations insufficient to state a claim. See, e.g., Stahl, 283 F.3d at 263 (finding no manufacturing defect because “[plaintiff] has not provided any evidence suggesting that the particular pills he received deviated in any way from the manufacturer’s production standards or from the manufacturer’s otherwise identical products.”); Kennedy, No. 13-3132, 2014 WL 4092918, at *3 (“The allegations in Plaintiff Kennedy’s complaint regarding the construction and composition of Seroquel are a clear example of mere ‘labels and conclusions’ and ‘a formulaic recitation of the elements of a cause of action.’ . . . Thus, such allegations do not state a claim for relief under Rule 8(a)(2) and/or Rule 12(b)(6).”) (citing Harris v. Merck & Co. No. 12-1446, 2012 WL 538470, *2 (W.D. La. Nov. 1, 2012)); Watson v. Bayer Healthcare Pharm., Inc., No. 13-212, 2013 WL 1558328, at *4 (E.D. La. Apr. 11, 2013) (J. Feldman) (“But she fails to allege facts about the ‘condition’, or suggest how Mirena® deviated from its intended design. She also fails to allege facts explaining how the unknown manufacturing defect caused her alleged injuries. Absent factual allegations addressing how the Mirena® deviated from Bayer’s normal production standards, the plaintiff fails to meet the plausibility standard.”); Aucoin v. Amneal Pharm., LLC, No. 11-1275, 2012 WL 2990697, at *10 (E.D. La. July 20, 2012) (J. Brown) Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 23 of 31 PageID #: 820 16 (“Likewise, regarding Plaintiff's construction or composition defect claim, Plaintiff has not alleged that the medicine he received deviated in any way from the manufacturer’s production standards or from the manufacturer’s otherwise identical products-he merely recites the elements of this cause of action.”). As in Stahl, Kennedy, Harris, Watson, and Aucoin, Plaintiff has failed to state a claim for construction defect because he has not alleged any facts to support the conclusory statements set forth in his Amended Complaint. Therefore, his manufacturing defect claim must be dismissed. iii. Failure to Warn To successfully maintain a failure to warn claim under the LPLA, the plaintiff must prove that the product has a potentially damage-causing characteristic and that the manufacturer failed to use reasonable care to provide an adequate warning about the characteristic. La. Rev. Stat. § 9:2800.57(A); Stahl, 283 F.3d at 264. For product liability claims involving prescription drugs, Louisiana applies the “learned intermediary doctrine.” Under this doctrine, “a drug manufacturer discharges its duty to consumers by reasonably informing prescribing physicians of the dangers of harm from a drug.” Stahl, 283 F.3d 254 at 265. Accordingly, to prevail on a failure to warn case under the LPLA, a plaintiff must prove (1) that the manufacturer failed to warn the treating physician of the dangers associated with the drug and (2) that this failure was both a cause in fact and proximate cause of the plaintiff’s injury. Willett v. Baxter, 929 F.2d 1094, 1098-99 (5th Cir. 1991) (emphasis added); Hargrove v. Bos. Sci. Corp., 2014 WL 4794763, at *11 (E.D. La. Sept. 24, 2014) (holding that under the learned intermediary doctrine “the manufacturer has no duty to warn the patient, but need only warn the patient’s physician”). Plaintiff’s Amended Complaint fails to satisfy either prong required for a failure to warn claim. Again, Plaintiff only recites conclusory statements regarding the alleged inadequate Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 24 of 31 PageID #: 821 17 warning (see Rec. Doc. 35 ¶ 116) (“PPIs’ inadequate warnings rendered it unreasonably dangerous and defective.”), but fails to allege any details as to the warning provided to the prescribing physician, even failing to identify who that physician is. In addition, Plaintiff’s warning claim fails because he has not alleged causation, a requisite under the statute. To establish the element of causation, “the plaintiff must show that a proper warning would have changed the decision of the treating physician, i.e. that but for the inadequate warning, the treating physician would not have used or prescribed the product.” Jenkins v. Bristol-Myers Squibb, 2015 WL 5012130, at *4 (E.D. La. Aug. 21, 2015) (emphasis added); Willett, 929 F.2d at 1098-99 (“the plaintiff must show that a proper warning would have changed the decision of the treating physician…) (emphasis added). Here, Plaintiff has failed to allege that his physician would not have prescribed him prescription Nexium® or prescription Prilosec® had a different warning been included in each medication’s label. See e.g., Flagg v. Stryker Corp., 647 F. App’x 314, 316 n.3 (5th Cir. 2016); Hargrove, 2014 WL 4794763, at *11 (E.D. La. Sept. 24, 2014) (dismissing an inadequate warning claim under the LPLA after finding that plaintiff’s “conclusory allegations [did] not address whether ‘a proper warning would have changed the decision of the treating physician.”). Indeed, alleging “[causation] is necessary so that [the] Court can draw the ‘reasonable inference that the defendant is liable for the misconduct alleged.’” Huffman v. Squibb, No. 2016 WL 6024532, at *2 (E.D. La. Oct. 14, 2016). Absent such allegations, an inadequate warning claim should be dismissed. See Kennedy, 2014 WL 4093065, at *5 (dismissing inadequate warning claim because plaintiff failed to allege that an adequate warning would have caused her physician not to prescribe the medication at issue). Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 25 of 31 PageID #: 822 18 Because the Amended Complaint fails to allege that Plaintiff’s physician would not have prescribed any particular Defendant’s product had a different warning been included in the medication’s label, Plaintiff’s failure to warn claim should be dismissed. iv. Breach of Express Warranty To support an LPLA claim for failure to conform to an express warranty, an express warranty must have existed to which the product did not conform. La. Rev. Stat. § 9:2800.58. To state a claim for breach of express warranty under the LPLA, the plaintiff must “(1) allege the content of the warranty and (2) explain how the warranty was untrue.” Robertson v. AstraZeneca Pharms., 2015 WL 5823326, at *5 (E.D. La. Oct. 6, 2015). In addition, the plaintiff must prove that he was induced to use the product by the representations made on the warranty and prove that he sustained damages proximately caused as result of the warranty being untrue. La. Rev. Stat. § 9:2800.58. Plaintiff fails to satisfy this standard for a number of reasons. First, Plaintiff does not identify the specific warranty allegedly breached or the contents thereof. (See Rec. Doc. 35 ¶¶ 126, 128, 129, 130, 131, 132, 133, 135(d), 140, 141). Although “[t]he complaint need not ‘identify specific language offered by a manufacturer,’” it must nevertheless “‘specify the warranty in question’[.]” Robertson, 2015 WL 5823326, at *5. Plaintiff’s only statements regarding the warranty are boilerplate assertions that Defendants expressly warranted that “Proton Pump Inhibitors were safe, effective, fit and proper for its intended use.” (See Rec. Doc. 35 ¶ 140.) But, Plaintiff does not specify the particular product at issue or the alleged warranty in question or its contents as required by the statute. As such, it is impossible to assess whether the warranty is even applicable or whether it was in fact breached. Second, Plaintiff fails to identify the specific materials where the warranties appear, and simply makes general assertions that “Defendants expressly warranted to the market . . . orally Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 26 of 31 PageID #: 823 19 and in publications, package inserts, advertisements and other materials to the health care and general community. . . .” (See Rec. Doc. 35 ¶ 140.) Again, such general allegations do not withstand a 12(b)(6) motion. See Robertson, 2015 WL 5823326, at *5 (finding that plaintiff’s allegations as to warranties in materials was only a “general reference” and therefore “not specific enough to survive a Rule 12(b)(6) motion”); see also Corley v. Stryker Corp., 2014 WL 3375596, at *5 (W.D. La. May 27, 2014) (breach of express warranty claim failed because plaintiff “vaguely pointed to an alleged variety of statements, press releases, verbal assurances, and written information but did not identify, quote, or disclose the content of any of them”). Again, absent any indication as to warranties, the content thereof, or the placement of the warranties, Plaintiff has failed to state a claim for which relief can be granted. Plaintiff further fails to allege that any specific warranty prompted any particular physician to prescribe any particular product of Defendants or for Plaintiff to obtain any particular product of Defendants as required by the statute. See La. Rev. Stat. § 9:2800.58. Accordingly, Plaintiff’s general allegations are insufficient to establish a breach of warranty claim. See Corley, 2014 WL 3375596, at *5 (“Stating that a product is safe or effective for its intended use is nothing more than a general opinion about or praise for a product and therefore does not satisfy the statutory definition of an express warranty.”). For these reasons, Plaintiff fails to state a claim for breach of express warranty. F. PLAINTIFF FAILS TO PLEAD HIS REDHIBITION CLAIM WITH SUFFICIENT SPECIFICITY UNDER TWOMBLY. “Redhibition claims for damage to a product itself or economic loss are the only exceptions to the LPLA’s exclusivity provision.” Hollybrook Cottonseed Processing, LLC v. Carver, Inc., No. 09-0750, 2010 WL 2195685, at *4 (W.D. La. May 28, 2010) (citing La. Rev. Stat. § 9:2800.53(5); Aucoin v. Southern Quality Homes, LLC, 2007-1014, p. 7, n. 8 Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 27 of 31 PageID #: 824 20 (La.2/26/08); 984 So. 2d 685, 691). Here, Plaintiff has failed to adequately plead any redhibition claim based on damage to a product or economic loss. Indeed, Plaintiff does not identify any damage to a product. Further, Plaintiff fails to adequately plead a claim based on economic loss. Article 2520 of the Louisiana Civil Code provides a cause of action for redhibition and states in pertinent part as follows: The seller warrants the buyer against redhibitory defects, or vices, in the thing sold. A defect is redhibitory when it renders the thing useless, or its use so inconvenient that it must be presumed that a buyer would not have bought the thing had he known of the defect. A defect is redhibitory also when, without rendering the thing totally useless, it diminishes its usefulness or its value so that it must be presumed that a buyer would still have bought it but for a lesser price. La. Civ. Code art. 2520. To establish a claim for redhibition under Louisiana law, the plaintiff must prove that: “(1) the seller sold the thing to him and it is either absolutely useless for its intended purpose or its use is so inconvenient or imperfect that, judged by the reasonable person standard, had he known of the defect, he would never have purchased it; (2) the thing contained a non-apparent defect at the time of sale; and (3) the seller was given an opportunity to repair the defect.” Johnson v. CHL Enterprises, 115 F. Supp. 2d 723, 728 (W.D. La. 2000). Here, Plaintiff has failed to adequately plead a claim for redhibition because he has failed to identify any factual allegations to support his claim. Instead, Plaintiff alleges in a conclusory fashion that “[t]he subject product sold and promoted by Defendants, possesses a redhibitory defect because it was not manufactured and marketed in accordance with industry standards and/or is unreasonably dangerous, as described above, which renders the product useless or so inconvenient that it must be presumed that a buyer would not have bought the subject product Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 28 of 31 PageID #: 825 21 had he known of the defect” and that “the subject product alternatively possesses a redhibitory defect because the subject product was not manufactured and marketed in accordance with industry standards and/or is unreasonably dangerous. . . .” (Rec. Doc. 35 ¶¶ 144-145.) These statements are clearly legal conclusions. The Amended Complaint fails to provide any factual information about the seller or how any particular product is absolutely useless for its intended purpose or so inconvenient as judged by the reasonable person standard. Likewise, the Amended Complaint fails to detail how each particular product of each Defendant is allegedly defective. It also fails to plead that the seller was given an opportunity to repair the defect. In sum, there are simply no facts supporting a redhibition claim based on damage to a product or economic loss. Thus, Plaintiff has failed to state a claim for redhibition because he has not alleged any facts to support the conclusory statements set forth in his Amended Complaint. Thus, his redhibition claim must be dismissed. G. PLAINTIFF IS NOT ENTITLED TO CONDUCT DISCOVERY OR LEAVE TO AMEND. This Court should dismiss the claims against AstraZeneca without discovery and without leave to amend. Leave to amend “is by no means automatic.” Wimm v. Jack Eckerd Corp., 3 F.3d 137, 139 (5th Cir. 1993) (citing Addington v. Farmer's Elevator Mut. Ins. Co., 650 F.2d 663, 666 (5th Cir. 1981). Permission should only be granted “when justice so requires.” Fed. R. Civ. P. 15(a). An amendment should be denied when there is a valid justification for the denial. Carroll v. Fort James Corp., 470 F.3d 1171, 1175 (5th Cir. 2006). Any request for discovery to alter the allegations contained in Plaintiff’s Amended Complaint would run directly afoul of controlling United States Supreme Court precedent. In Twombly and Iqbal, the Supreme Court made clear that a plaintiff who fails to meet the pleadings requirements of Rule 8(a)(2) at the outset should not be allowed to conduct discovery in hope of unearthing evidence to support a Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 29 of 31 PageID #: 826 22 claim against the defendant. See Iqbal, 129 S. Ct. at 1954 (“Because [plaintiff’s] complaint is deficient under Rule 8, he is not entitled to discovery, cabined or otherwise.”); Twombly, 550 U.S. at 559 ("It is no answer to say that a claim just shy of a plausible entitlement to relief can, if groundless, be weeded out early in the discovery process through ‘careful case management’ . . .”). Plaintiff has presented no plausible claim against AstraZeneca and, as such, AstraZeneca should not be subjected to costly discovery obligations. See Ferrer v. Chevron Corp., 484 F.3d 776, 782 (5th Cir. 2007) (stating that a “12(b)(6) inquiry focuses on the allegations in the pleadings, not whether a plaintiff actually has sufficient evidence to succeed on the merits”). In this case, the Court should exercise its broad discretion to dismiss the claims against AstraZeneca with prejudice and without leave to amend. Plaintiff has already had one opportunity to amend and has failed to meet his pleading burden. Plaintiff filed a Complaint and Amended Complaint full of conclusory allegations and devoid of almost any specific allegations against AstraZeneca or factual support therefor. It would be patently unfair to force AstraZeneca to defend this matter and to allow Plaintiff to use this insufficiently pleaded cause of action as a ticket to conduct a fishing expedition in hopes that he may later be able to set forth a claim that passes muster under Rule 12(b)(6). III. CONCLUSION For the reasons set forth above, Plaintiff’s claims against AstraZeneca do not meet the pleading requirements under the plain language of the Federal Rules of Civil Procedure, fail to state a claim, and are preempted by the LPLA. Specifically, Plaintiff’s failure to differentiate the defendants or products at issue fails to meet federal pleading requirements. Accordingly, AstraZeneca respectfully requests that the Court grant with prejudice its motion to dismiss for Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 30 of 31 PageID #: 827 23 failure to state a claim upon which relief can be granted pursuant to Fed. R. Civ. P. 12(b)(6), 8, and 9(b). Respectfully submitted, Adams and Reese LLP s/ Diana Cole Surprenant E. PAIGE SENSENBRENNER (#18429) - T.A. DIANA SURPRENANT (#33399) One Shell Square 701 Poydras, Suite 4500 New Orleans, Louisiana 70139 paige.sensenbrenner@arlaw.com diana.surprenant@arlaw.com (504) 581-3234 (telephone) (504) 553-9489 (facsimile) Kellen J. Mathews (#31860) 450 Laurel Street, Suite 1900 Baton Rouge, Louisiana 70801 Telephone: (225) 336-5200 Facsimile: (225) 336-5220 kellen.mathews@arlaw.com Attorneys for Defendants, AstraZeneca Pharmaceuticals LP and AstraZeneca LP CERTIFICATE OF SERVICE I hereby certify that on the 27 th of February 2017, I electronically filed the foregoing with the Clerk of Court using the CM/ECF system, which will send a notice of electronic filing to all CM/ECF participants. s/ Diana Cole Surprenant DIANA COLE SURPRENANT Case 6:16-cv-01444-RFD-PJH Document 39-1 Filed 02/27/17 Page 31 of 31 PageID #: 828