Bales v. Astrazeneca Pharmaceuticals LP et al

MOTION to Dismiss for Failure to State a Claim

E.D. La.February 28, 2017

1 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA FREDDY BALES, * CIVIL ACTION NO. 2:16-CV-17744 * PLAINTIFF, * * vs. * JUDGE MILAZZO * ASTRAZENECA PHARMACEUTICALS * LP; and ASTRAZENECA LP, * MAGISTRATE KNOWLES * * DEFENDANTS. * **************************************** MOTION TO DISMISS 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 Complaint for failure to state a claim upon which relief can be granted. The Complaint fails to state a claim upon which relief can be granted for the following reasons:  First, Plaintiff’s claims do not satisfy Rule 9 of the Federal Rules of Civil Procedure because the Complaint fails to plead any alleged fraud allegations with particularity.  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;  Third, the Louisiana Products Liability Act (“LPLA”) provides the exclusive remedy for Plaintiff’s recovery, precluding Plaintiff’s claims for Strict Product Liability not based on the LPLA, Intentional Infliction of Emotional Distress, Negligent Infliction of Emotional Distress, Fraud, Negligence, Negligent Misrepresentation, Fraudulent Misrepresentation, Express Warranty, Implied Warranty, Warranty of Merchantability, and Warranty of Fitness.  Fourth, Plaintiff fails to plead his LPLA claims 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). Case 2:16-cv-17744-JTM-DEK Document 11 Filed 02/28/17 Page 1 of 3 2 For the reasons discussed more fully in the attached memorandum in support, AstraZeneca respectfully requests dismissal with prejudice of the Complaint in its entirety. WHEREFORE, for the reasons more fully explained in the attached Memorandum in Support of the Motion to Dismiss 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 2:16-cv-17744-JTM-DEK Document 11 Filed 02/28/17 Page 2 of 3 3 CERTIFICATE OF SERVICE I hereby certify that on the 28 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 SURPREANT Case 2:16-cv-17744-JTM-DEK Document 11 Filed 02/28/17 Page 3 of 3 1 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA FREDDY BALES, * CIVIL ACTION NO. 2:16-CV-17744 * PLAINTIFF, * * vs. * JUDGE MILAZZO * ASTRAZENECA PHARMACEUTICALS * LP; and ASTRAZENECA LP, * MAGISTRATE KNOWLES * * DEFENDANTS. * **************************************** MEMORANDUM IN SUPPORT OF MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM PURSUANT TO FED. R. CIV. P. 12(b)(6) Pursuant to Federal Rules of Civil Procedure 12(b)(6), 9(b), and 8(a)(2), Defendants, AstraZeneca Pharmaceuticals LP and AstraZeneca LP (collectively “AstraZeneca”), move to dismiss Plaintiff’s Complaint and respectfully show the Court the following: I. SUMMARY OF THE ARGUMENT Plaintiff, Freddy Bales (“Plaintiff”), alleges that “Nexium” caused him to suffer chronic kidney disease. The Complaint fails to state a claim upon which relief can be granted for the following reasons:  First, Plaintiff’s claims do not satisfy Rule 9 of the Federal Rules of Civil Procedure because the Complaint fails to plead any alleged fraud allegations with particularity.  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;  Third, the Louisiana Products Liability Act (“LPLA”) provides the exclusive remedy for Plaintiff’s recovery, precluding Plaintiff’s claims for Strict Product Liability not based on the LPLA, Intentional Infliction of Emotional Distress, Negligent Infliction of Emotional Distress, Fraud, Negligence, Negligent Misrepresentation, Fraudulent Misrepresentation, Case 2:16-cv-17744-JTM-DEK Document 11-1 Filed 02/28/17 Page 1 of 17 2 Express Warranty, Implied Warranty, Warranty of Merchantability, and Warranty of Fitness.  Fourth, Plaintiff fails to plead his LPLA claims 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 Complaint in its entirety. 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.” Twombly, 550 U.S. at 555, n.3. Accordingly, Case 2:16-cv-17744-JTM-DEK Document 11-1 Filed 02/28/17 Page 2 of 17 3 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 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 HAS FAILED TO PLEAD FRAUD ALLEGATIONS WITH PARTICULARITY. Plaintiff’s fraud allegations are not pled with the requisite particularity and should thus be stricken. Rule 9(b) 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). Case 2:16-cv-17744-JTM-DEK Document 11-1 Filed 02/28/17 Page 3 of 17 4 Plaintiff asserts his Fraud allegations argument in four conclusory paragraphs of the Complaint, generically alleging that Defendants “made material representations that were false and that were either known to be false when made or were asserted without knowledge of their truth.” (Rec. Doc. 1 ¶ 76.) Plaintiff’s allegations fail to 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 woefully short of the heightened requirements for pleading fraud established in Rule 9(b). Because Plaintiff’s fraud-based allegations fail to satisfy Rule 9(b), the fraud claims should be stricken. 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 the 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 defendant's liability, it “stops short of the line between possibility and plausibility of entitlement to relief.” Case 2:16-cv-17744-JTM-DEK Document 11-1 Filed 02/28/17 Page 4 of 17 5 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 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. The Complaint contains virtually no factual allegations regarding either the product at issue or Plaintiff’s alleged use of the product at issue. Indeed, only two paragraphs in the entire Complaint are specific as to Plaintiff’s alleged use of Nexium - one of which pertains to his citizenship only. (See Rec. Doc. 1 ¶¶ 48, 49.) More significantly, the Complaint does not plead any facts with respect to actions or inactions by AstraZeneca that could plausibly link it to Plaintiff’s purported injuries. Quite simply, the Complaint contains no factual allegations relating to any specific AstraZeneca conduct to support any claim for relief. At the outset, Plaintiff’s allegations are insufficient to identify whether he purchased and ingested prescription or over-the-counter “Nexium;” over-the-counter PPIs, including over-the- counter “Nexium,” are promoted and sold by different pharmaceutical companies. In addition, to the extent prescription “Nexium ” (Nexium ® ) is even at issue, which is unclear from the generic allegations, the Complaint is devoid of any indication as to: (i) how Plaintiff contends Nexium ® was defective or unsafe; (ii) what AstraZeneca supposedly knew or should have known about risks associated with use of Nexium ® , and when it supposedly knew or should have known; (iii) how Nexium ® 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 Case 2:16-cv-17744-JTM-DEK Document 11-1 Filed 02/28/17 Page 5 of 17 6 when and how such statements were supposedly made; or any other factual allegations to justify Plaintiff’s claims against AstraZeneca. At no point in the Complaint does Plaintiff allege any facts to support his meager allegations that Nexium ® (as opposed to over-the-counter “Nexium”) caused his injuries. Stated simply, Plaintiff’s Complaint fails to state a “plausible” claim because Plaintiff has failed 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. 1 For these reasons, Plaintiff’s Complaint neither provides proper notice to AstraZeneca of the claims against it nor allows the Court to draw the reasonable inference that AstraZeneca is liable for the misconduct alleged, and thus, AstraZeneca should be dismissed. Iqbal, 129 S. Ct. at 1954 (“Rule 8 does not empower [Plaintiffs] to plead the bare elements of [their] cause of action, affix the label ‘general allegation,’ and expect [their] 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). Also, Plaintiff’s claims for “punitive or exemplary 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 or exemplary damages under Louisiana law must be dismissed. 1 Indeed, the Complaint is so vague that AstraZeneca cannot determine whether it even has a viable affirmative defense of prescription. Plaintiff pleads no specific facts as to when he began to incur injuries allegedly resulting from the use of Nexium ® . Instead, Plaintiff conclusively asserts that he took Nexium from November 20, 2007 until April 27, 2016. (See Rec. Doc. 1. ¶ 49.) These threadbare allegations are insufficient to determine whether AstraZeneca may raise prescription as a defense. Case 2:16-cv-17744-JTM-DEK Document 11-1 Filed 02/28/17 Page 6 of 17 7 D. THE LOUISIANA PRODUCTS LIABILITY ACT PROVIDES THE EXCLUSIVE REMEDY FOR PLAINTIFF’S RECOVERY. Plaintiff’s claims for Strict Product Liability not based on the LPLA, Intentional Infliction of Emotional Distress, Negligent Infliction of Emotional Distress, Fraud, Negligence, Negligent Misrepresentation, Fraudulent Misrepresentation, Express Warranty, Implied Warranty, Warranty of Merchantability, and Warranty of Fitness 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); 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); Case 2:16-cv-17744-JTM-DEK Document 11-1 Filed 02/28/17 Page 7 of 17 8 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 Strict Product Liability not based on the LPLA, 2 Intentional Infliction of Emotional Distress, Negligent Infliction of Emotional Distress, Fraud, Negligence, Negligent Misrepresentation, Fraudulent Misrepresentation, Express Warranty, Implied Warranty, Warranty of Merchantability, and Warranty of Fitness are barred and should be dismissed accordingly. 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 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. In order for a plaintiff 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 2 Plaintiff’s Complaint does not specifically reference the LPLA with regard to Strict Product Liability. Additionally, Count 2 appears to state a claim for Strict Product Liability under the Restatement of Torts 402a (1965). To the extent that Plaintiff is asserting strict product liability claims that do not arise under the LPLA, these claims are precluded by the LPLA. Case 2:16-cv-17744-JTM-DEK Document 11-1 Filed 02/28/17 Page 8 of 17 9 dangerous” characteristic existed at the time the product left the manufacturer’s control, or resulted from a reasonably anticipated alteration to the product. Id. at § 2800.54(C). Plaintiff’s Complaint does not cite to the LPLA nor does it specify the categories of defect recognized by the LPLA on which he seeks relief. For purposes of this Motion only and without waiving any defenses, AstraZeneca will address Plaintiff’s Complaint in light of all categories of relief provided by the LPLA. As discussed more fully herein, Plaintiff’s claims fail to satisfy the LPLA requirements and Twombly such that the claims should be dismissed accordingly. i. Design Defect Any claim by Plaintiff for design defect under the LPLA is not sufficiently pled to state a claim. 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). Here, Plaintiff fails to plead the necessary facts to establish a design defect under the LPLA. In his Complaint, Plaintiff declares that “[t]he Nexium manufactured and/or distributed and/or supplied by Defendants was defective in design or formulation, in that, when it left the Case 2:16-cv-17744-JTM-DEK Document 11-1 Filed 02/28/17 Page 9 of 17 10 hands of manufacturers and/or suppliers and/or distributors, the foreseeable risks exceeded the benefits associated with the design and formulation of the drug” or “it was unreasonably dangerous, it was more dangerous than an ordinary consumer would expect and more dangerous than alternative drugs available for the treatment of Plaintiff’s condition.” (Rec. Doc. 1 ¶¶ 57- 58.) These are clearly legal conclusions, and as such are the sole province of the trier of fact. Stated simply, the Complaint is devoid of anything on the order of “factual” detail as to how the product is allegedly defective. 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.”). Notably, in House v. Bristol-Myers Squibb Co., 2017 WL 55876, at *2-3 (W.D. Ky. Jan. 4, 2017), the court rejected similar allegations as insufficient to state a design defect claim. Like here, “the only assertion . . . as to how the product design was defective is a description of how the class of products works.” Id. at *4. The House court concluded that it “cannot reasonably infer from the generic description of SGLT2 inhibitors’ mechanism of action that Farxiga was defective or unreasonably dangerous.” Id. (quotations and alterations omitted). Similarly, here, the Court cannot conclude from the generic description of PPIs that Nexium ® was defective or unreasonably dangerous. Plaintiff also fails to adequately plead the existence of an alternative design. Although Plaintiff attempts to identify alternative remedies in the form of H2 antagonists, Plaintiff fails to Case 2:16-cv-17744-JTM-DEK Document 11-1 Filed 02/28/17 Page 10 of 17 11 actually identify an alternative design for Nexium ® or how the design of H2 antagonists would have prevented his alleged injuries. Indeed, there is no factual information on the design of H2 antagonists. Additionally, Plaintiff fails to plead or identify any facts showing that the likelihood of Nexium ® ’s design would cause the harm complained of and that the gravity of that harm outweighed the burden of adopting an alternative design. See La. Rev. Stat. § 9: 2800.56. Indeed, there are no facts supplied regarding the gravity of the harm. Absent this factual support, Plaintiff’s design defect claim is inadequately pled and must 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. 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); Hargrove v. Bos. Sci. Corp., 2014 WL 4794763, at *11 (E.D. La. Sept. 24, 2014) (holding Case 2:16-cv-17744-JTM-DEK Document 11-1 Filed 02/28/17 Page 11 of 17 12 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 Complaint fails to satisfy either prong required for a failure to warn claim. Again, Plaintiff only recites conclusory statements regarding the alleged inadequate warning, but fails to allege any details as to the warning provided to the prescribing physician, even failing to identify who that physician is, and fails to explain why the warning was inadequate. 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); see also 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). While the Complaint contains numerous allegations that Defendants failed to warn (see Rec. Doc. 1 ¶¶ 28, 44, 47, 53, 54, 60-63), Plaintiff has failed to allege that his physician would not have prescribed him Nexium ® had a different warning been included in the 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 and 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 Case 2:16-cv-17744-JTM-DEK Document 11-1 Filed 02/28/17 Page 12 of 17 13 such allegations, an inadequate warning claim should be dismissed. See Kennedy, 2014 WL 4093065, at *5 (dismissing inadequate warning claim because the plaintiff failed to allege that an adequate warning would have caused her physician not to prescribe the medication at issue). Because the Complaint fails to allege that Plaintiff’s physician would not have prescribed Nexium ® had a different warning been included in the medication’s label, Plaintiff’s failure to warn claim should be dismissed. iii. Breach of Express Warranty It is unclear whether Plaintiff asserts a claim for breach of express warranty under the LPLA, but to the extent that he does, this claim also is not adequately pled. 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 a 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. 1 ¶ 89.) 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 a potential warranty are boilerplate assertions that “Defendants made representations to Plaintiff about the quality or Case 2:16-cv-17744-JTM-DEK Document 11-1 Filed 02/28/17 Page 13 of 17 14 characteristics of Nexium by affirmation of fact, promise and/or description.” (Rec. Doc. 1 ¶ 89.) But Plaintiff does not specify 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 states that Defendants made representations to Plaintiff. (See Rec. Doc. 1 ¶ 89.) Again, such 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 such warranty prompted the physician to prescribe Nexium ® or for Plaintiff to obtain Nexium ® 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. Case 2:16-cv-17744-JTM-DEK Document 11-1 Filed 02/28/17 Page 14 of 17 15 F. 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 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 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 filed a Complaint full of conclusory allegations and devoid of almost any specific allegations against AstraZeneca or Case 2:16-cv-17744-JTM-DEK Document 11-1 Filed 02/28/17 Page 15 of 17 16 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. Accordingly, AstraZeneca respectfully requests that the Court grant with prejudice its motion to dismiss for failure to state a claim upon which relief can be granted pursuant to Fed. R. Civ. P. 12(b)(6), 9(b), and 8. 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, Case 2:16-cv-17744-JTM-DEK Document 11-1 Filed 02/28/17 Page 16 of 17 17 AstraZeneca Pharmaceuticals LP and AstraZeneca LP CERTIFICATE OF SERVICE I hereby certify that on the 28 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 SURPREANT Case 2:16-cv-17744-JTM-DEK Document 11-1 Filed 02/28/17 Page 17 of 17 1 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA FREDDY BALES, * CIVIL ACTION NO. 2:16-CV-17744 * PLAINTIFF, * * vs. * JUDGE MILAZZO * ASTRAZENECA PHARMACEUTICALS * LP; and ASTRAZENECA LP, * MAGISTRATE KNOWLES * * DEFENDANTS. * **************************************** NOTICE OF SUBMISSION Please take notice that Defendants AstraZeneca Pharmaceuticals LP and AstraZeneca LP’s Motion to Dismiss for Failure to State a Claim Pursuant to Fed. R. Civ. P. 12(b)(6) will take place on March 22, 2017 at 9:30 a.m. in the United States District Court for the Eastern District of Louisiana, Section “H” before the Honorable Jane Triche Milazzo. 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 Case 2:16-cv-17744-JTM-DEK Document 11-2 Filed 02/28/17 Page 1 of 2 2 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 28 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 SURPREANT Case 2:16-cv-17744-JTM-DEK Document 11-2 Filed 02/28/17 Page 2 of 2