Barnes v. Astrazeneca Pharmaceuticals LP et al

MOTION TO DISMISS FOR FAILURE TO STATE A CLAIM [Amended Complaint] with Brief In Support

N.D. Ga.April 19, 2017

111356534.1 IN THE UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF GEORGIA ATLANTA DIVISION CELESTINE BARNES, ) ) Plaintiff, ) ) CASE NO. 1:17-cv-00142-ODE v. ) ) JURY TRIAL DEMANDED ASTRAZENECA ) PHARMACEUTICALS LP, ) and ASTRAZENECA LP, ) ) Defendants. ) DEFENDANTS ASTRAZENECA PHARMACEUTICALS LP’S AND ASTRAZENECA LP’S MOTION TO DISMISS Defendants AstraZeneca Pharmaceuticals LP and AstraZeneca LP (collectively, “AstraZeneca”), move to dismiss Plaintiff’s Amended Complaint (“Amended Complaint”) (D.E. 12) pursuant to Federal Rules of Civil Procedure 8(a) and 12(b)(6). Plaintiff’s Amended Complaint suffers from pleading deficiencies and fails to state a claim upon which relief can be granted. The Amended Complaint facially fails to state a claim against AstraZeneca because it is devoid of any factual support for Plaintiff’s sweeping accusations and, at bottom, is founded on nothing more than conclusory allegations in contravention of Rule 8(a) and the pleading requirements clarified and explained in Ashcroft v. Iqbal, 556 Case 1:17-cv-00142-ODE Document 25 Filed 04/19/17 Page 1 of 3 - 2 - 110878854.1 U.S. 662 (2009), and Bell Atlantic Corporation v. Twombly, 550 U.S. 544 (2007). AstraZeneca requests that this Court dismiss the Amended Complaint in its entirety and grant any and all further relief as this Court deems just and proper. AstraZeneca has submitted its Memorandum of Law in support of this Motion to Dismiss contemporaneously with this motion. Respectfully submitted this 19 th day of April, 2017. CARLTON FIELDS JORDEN BURT, P.A. /s/ Christopher B. Freeman Christopher B. Freeman Georgia Bar No. 140867 Justan C. Bounds Georgia Bar No. 339789 1201 West Peachtree Street Suite 3000 Atlanta, Georgia 30309 (404) 815-3400 (404) 815-3415 (fax) cfreeman@carltonfields.com Attorneys for Defendants Case 1:17-cv-00142-ODE Document 25 Filed 04/19/17 Page 2 of 3 - 3 - 110878854.1 CERTIFICATE OF SERVICE I hereby certify that a true and correct copy of the foregoing was electronically filed with the Clerk of Court using CM/ECF, which will send notification to the registered attorney(s) of record that the document has been filed and are available for viewing and downloading. This 19 th day of April, 2017. /s/ Christopher B. Freeman Christopher B. Freeman Case 1:17-cv-00142-ODE Document 25 Filed 04/19/17 Page 3 of 3 111346506.1 IN THE UNITED STATES DISTRICT COURT NORTHERN DISTRICT OF GEORGIA ATLANTA DIVISION CELESTINE BARNES, ) ) Plaintiff, ) ) CASE NO. 1:17-cv-00142-ODE v. ) ) JURY TRIAL DEMANDED ASTRAZENECA ) PHARMACEUTICALS LP, ) and ASTRAZENECA LP, ) ) Defendants. ) __________________________________ ) MEMORANDUM OF LAW IN SUPPORT OF DEFENDANTS ASTRAZENECA PHARMACEUTICALS LP’S AND ASTRAZENECA LP’S MOTION TO DISMISS Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 1 of 26 - 2 - 111346506.1 I. Introduction In this boilerplate, shotgun Amended Complaint, Plaintiff seeks damages from Defendants AstraZeneca Pharmaceuticals LP and AstraZeneca LP (together, “AstraZeneca” or the “Defendants”) for an alleged diagnosis of Acute Kidney Injury (“AKI”) purportedly suffered sometime in 2015. Plaintiff’s second effort fares no better than her first and falls woefully short of the pleading requirements imposed on her by Rule 8. Plaintiff fails to offer anything more than a bare possibility that Defendants were even involved with - let alone the proximate cause of - her alleged injuries. In filing her Amended Complaint (D.E. 12), Plaintiff substantially amended the allegations in the original Complaint (D.E. 1), but those alterations only exacerbated Plaintiff’s pleading deficiencies. In this products liability dispute, Plaintiff fails to identify the allegedly defective product, fails to identify any defects with that unidentified product, fails to identify a causal link between the unidentified product, and the purported injury, and fails to define when the injury occurred. Without such basic allegations, Plaintiff is left with nothing more than a mere possibility that AstraZeneca may have been involved with a product Plaintiff might have ingested that might have had some relationship to Plaintiff’s development of AKI. But “[t]he mere possibility that the defendant might have Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 2 of 26 - 3 - 111346506.1 acted unlawfully is not sufficient to allow a claim to survive a motion to dismiss.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (emphasis added). Rule 8 requires more than pleading a “possibility”; it requires “plausibility.” Id. Plaintiff fails to meet that threshold, and dismissal is warranted. II. Factual Allegations A. Plaintiff fails to identify the allegedly defective product, how it was obtained, or from whom it was obtained. Plaintiff begins by defining “Nexium” as every proton pump inhibitor (“PPI”) that is or ever has been on the market. (D.E. 12 ¶¶ 1-2, 50.) Plaintiff does not define or further identify the “Nexium” or “PPI” that she used. (See, generally, id.) Plaintiff alleges that both AstraZeneca Defendants are the holders of approved new drug applications for four “forms of Nexium.” (Id. ¶¶ 31-34.) But Plaintiff does not allege that she even ingested one of these four forms; rather, she alleges only that she “ingested Nexium,” which she defines broadly as all “proton pump inhibitors.” (Id. ¶¶ 1-2, 6.) Thus, it is unclear whether Plaintiff ingested prescription Nexium, Nexium®, over-the-counter Nexium, or some other proton pump inhibitors altogether; over-the-counter PPIs, including over-the-counter Nexium, are Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 3 of 26 - 4 - 111346506.1 promoted and marketed by different pharmaceutical companies, as are a host of non-Nexium® PPIs. 1 B. Plaintiff fails to identify the purportedly improper actions taken by AstraZeneca. Plaintiff’s allegations are not limited to a specific act, but instead target AstraZeneca’s general participation in the PPI market, accusing them of having “designed, developed, researched, tested, licensed, manufactured, packaged, labeled, promoted, marketed, sold, and distributed Nexium [defined as any PPI] in a defective and unreasonable dangerous condition.” (Id. ¶ 108.) Plaintiff also broadens the definition of Defendants exponentially to include a myriad of third-party entities and individuals: At all times alleged herein, Defendants shall include any and all named or unnamed parent companies, parent corporations, subsidiaries, affiliates, divisions, franchises, partners, joint-venturers, and any organizational units of any kind, their predecessors, successors, successors in interest, assignees, and their officers, directors, employees, agents, representatives and any and all other persons acting on their behalf. 1 See, e.g., Food and Drug Administration’s Drug Approval Package, www.accessdata.fda.gov/drgsatfda_docs/nda/2006/021849TOC.cfm (last referenced March 26, 2017) (approving PPI Zegerid that is manufactured by Santarus, Inc.); see also Thomas v. Alcon Laboratories, 116 F. Supp. 3d 1361, 1365 (N.D. Ga. 2013) (“courts have taken judicial notice of documents from the FDA, a government entity, when ruling on a motion to dismiss”). Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 4 of 26 - 5 - 111346506.1 (Id. ¶ 16.) Thus Plaintiff not only ascribes the manufacturing and selling of all PPIs on the market to AstraZeneca, but also incorporates into her definition of AstraZeneca third parties that have neither been named nor served with summons or the Amended Complaint. (See, generally, id.) C. Plaintiff provides no detail about the origin of her injury. Plaintiff factually details her alleged injury in only a single paragraph of the 154-paragraph Amended Complaint. (Id. ¶ 8.) In that sole paragraph, she is unable to affirmatively state her injury, speculating only that, “[u]pon information and belief, Plaintiff Celestine Barnes was diagnosed with Acute Kidney Injury in 2015 as a result of her use of the aforementioned Nexium.” (Id.) Thus the extent of Plaintiff’s allegations regarding her injury is that she believes that she was diagnosed with Acute Kidney Injury (“AKI”) as a result of her use of Nexium (broadly defined as any PPI on the market) in 2015. III. Argument A. A well-pled Amended Complaint requires more than labels, conclusions, and a mere possibility that Defendants’ actions were wrongful. Federal Rule of Civil Procedure 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.” To survive a motion to dismiss, “a complaint must contain sufficient factual matter, Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 5 of 26 - 6 - 111346506.1 accepted as true, to ‘state a claim to relief that is plausible on its face.’” Ashcroft v. Iqbal, 556 U.S. 662 (2009) (quoting Twombly, 550 U.S. at 570). The factual allegations in the Amended Complaint “must be enough to raise a right to relief above the speculative level,” or else dismissal is warranted. Twombly, 550 U.S. at 555. A claim is plausible if it “allows the court to draw the reasonable inference that the defendant is liable for the misconduct alleged.” Iqbal, 556 U.S. at 663. Importantly, however, “conclusory allegations, unwarranted deductions of facts or legal conclusions masquerading as facts will not prevent dismissal.” Oxford Asset Mgmt., Ltd. v. Jaharis, 297 F.3d 1182, 1188 (11th Cir. 2002). See also Fin. Sec. Assur., Inc. v. Stephens, Inc., 500 F.3d 1276, 1282 (11th Cir. 2007) (“more than ‘labels and conclusions’ are required and “a complaint must ‘possess enough heft’ to set forth ‘a plausible entitlement to relief’”) (quoting Twombly, 550 U.S. at 555- 556). Further, pleadings that are factually or legally conclusory are not entitled to a presumption of truth and must be supported by well-pleaded factual allegations. See Iqbal, 556 U.S. at 679. Thus, where a complaint fails to state sufficient facts that allege a claim for relief that is plausible on the face of the complaint, dismissal under Rule 12(b)(6) is warranted. Iqbal, 556 U.S. at 679; Twombly, 550 U.S. at 570. Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 6 of 26 - 7 - 111346506.1 “Although a court is required to accept well-pleaded facts as true when evaluating a motion to dismiss, it is not required to accept the plaintiff’s legal conclusions.” Brazil v. Janssen Research & Dev. LLC, No. 4:15-CV-02040HLM, 2016 WL 4844442, at *8 (N.D. Ga. Mar. 24, 2016) (citing Chandler v. Sec’y of Fla. Dep’t of Transp., 695 F.3d 1194, 1199 (11th Cir. 2012)). Thus “unwarranted deductions of fact or legal conclusions masquerading as facts” are insufficient to overcome a Rule 12(b)(6) motion to dismiss. Snow v. DirecTV, Inc., 450 F.3d 1314, 1320 (11th Cir. 2006) (internal citation omitted). Nor will speculation suffice; the complaint must contain more than “a statement of facts that merely creates a suspicion [of] a legally cognizable right of action.” Id. There “must be enough to raise a right to relief above the speculative level on the assumption that all the allegations in the complaint are true (even if doubtful in fact).” Id. “ The mere possibility that the defendant might have acted unlawfully is not sufficient to allow a claim to survive a motion to dismiss.” Brazil, 2016 WL 4844442, at *8. Rather, factual allegations must move the claim “across the line from conceivable to plausible.” Twombly, 550 U.S. at 570. B. Plaintiff’s Amended Complaint is a shotgun pleading that fails to provide Defendants with adequate notice of Plaintiff’s claims. The boilerplate, shotgun style of the Amended Complaint is fatal to Plaintiff’s claims. “A complaint is a shotgun complaint where it is virtually Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 7 of 26 - 8 - 111346506.1 impossible to know which allegations of fact are intended to support which claim(s) for relief.” Brazil, 2016 WL 4844442, at *8 (quoting Anderson v. District Bd. Of Trustees of Cent. Fla. Comm. College, 77 F.3d 364, 366 (11th Cir. 1996)). “The unifying characteristic of all types of shotgun pleadings is that they fail to one degree or another, and in one way or another, to give the defendants adequate notice of the claims against them and the grounds upon which each claim rests.” Id. (quoting Weiland v. Palm Beach Cty. Sheriff’s Office, 792 F.3d 1313, 1323 (11th Cir. 2015)). The Amended Complaint includes all of the hallmarks of a shotgun pleading. Each of the five counts in the Amended Complaint begins by incorporating each and every paragraph above it “by reference hereto as if set forth at length.” (D.E. 12 ¶¶ 101, 107, 124, 136, and 144.) Moreover, Plaintiff includes in her definition of Defendants “any and all named or unnamed parent companies, parent corporations, subsidiaries, affiliates, divisions, franchises, partners, joint- venturers, and any organizational units of any kind, their predecessors, successors, successors in interest, assignees, and their officers, directors, employees, agents, representatives and any and all other persons acting on their behalf.” (Id. ¶ 16.) Plaintiff also refuses to identify what actions AstraZeneca took as opposed to the litany of third-parties Plaintiff includes in her definition of Defendants that caused Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 8 of 26 - 9 - 111346506.1 her alleged injury, broadly alleging that “Defendants designed, developed, researched, tested, licensed, manufactured, packaged, labeled, promoted, marketed, sold, and distributed Nexium.” (Id. ¶ 108.) Consequently, Plaintiff fails “to give the defendants adequate notice of the claims against them and the grounds upon which each claim rests.” Brazil, 2016 WL 4844442, at *8. The Amended Complaint is not a personalized account of Plaintiff’s allegations, but rather an attempt at a one-size-fits-all-form complaint that Plaintiff’s counsel uses against AstraZeneca in other lawsuits. Indeed, the amended complaint in Thornton v. AstraZeneca LP, et al., Case No. 1:17-cv- 00653-SCJ, filed in this Court by Plaintiff’s counsel on the same day as the Amended Complaint in this dispute, 2 is virtually identical to that at issue here. Aside from changing the plaintiffs’ names, there are a total of six changed words in the bodies of the two complaints. The result is an impersonal account of purported issues with PPIs generally and only sparse references to any injury allegedly sustained by Plaintiff here. In fact, in her 154-paragraph Amended Complaint, only 5 paragraphs are dedicated to the specific circumstances of this 2 A “district court may take judicial notice of public records, such as filings in other judicial proceedings, without converting a 12(b)(6) motion into a motion for summary judgment.” Wells Fargo Bank, NA v. Dabney, No. 1:15-cv-3714-WSD, 2016 WL 1601206, at *1 n.3 (citing Lowman v. City of Riviera Beach, 713 F.3d 1066, 1075 n.9 (11th Cir. 2013)). Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 9 of 26 - 10 - 111346506.1 Plaintiff, including the lone paragraph describing her alleged injury. In this second bite at the apple, Plaintiff should not be permitted to proceed on general allegations of wrongdoing in the PPI market that are not even alleged to bear any causal or factual relationship to the Plaintiff’s personal circumstance. C. By failing to identify products, conduct, or causality, Plaintiff raises no more than a mere possibility that Defendants’ conduct caused her injury. Plaintiff’s Amended Complaint fails to plead the most basic facts necessary to support a claim against AstraZeneca. The Amended Complaint contains no factual allegations regarding the specific product at issue and no factual allegations linking any alleged conduct by Defendants to Plaintiff’s purported injury. With no identified product, no identified conduct, and no identified causation, Plaintiff is left relying on inference, conjecture, and a rote recitation of the various elements of her claim. But “labels and conclusions, and a formulaic recitation of the elements of a cause of action will not do.” Twombly, 550 U.S. at 555. The Eleventh Circuit has “consistently held that conclusory allegations without specific supporting facts have no probative value.” Evers v. Gen. Motors Corp., 770 F.2d 984, 986 (11th Cir. 1985) (citing Gordon v. Terry, 684 F.2d 736, 744 (11th Cir. 1982), cert. denied, 459 U.S. 1203 (1983)); see also Hansel v. All Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 10 of 26 - 11 - 111346506.1 Gone Towing Co., 132 F. Appx. 308, 310 (11th Cir. 2005) (“Simply put, such conclusory allegations, with no factual support, are insufficient to state a claim.”); Bailey v. Janssen Pharmaceutical, Inc., 288 F. Appx. 597, 609 (11th Cir. 2008) (affirming dismissal of claims because the plaintiff failed to plead duty, breach, and causation as to each defendant and failed to explain the source of each individual defendant’s duty and breach dismissing). Other courts in this circuit are in accord. See Henderson v. Sun Pharm. Indus., Ltd., 809 F. Supp. 2d 1373, 1378- 1379 (N.D. Ga. 2011) (allegations were insufficient to state a manufacturing or design defect claim against defendant because none of the allegations provided a causal link between any manufacturing or design defect and any injury plaintiff suffered); Goodson v. Boston Scientific Corp., No. 1:11-CV-3023-TWT, 2011 WL 6840593 (N.D. Ga. Dec. 29, 2011) (dismissing plaintiff’s strict liability, manufacturing defect, and failure to warn claims because the allegations were conclusory). 1. Plaintiff does not identify the alleged defective product. Bluntly, in this products-liability dispute, Plaintiff fails to identify the product that allegedly injured her. This remains the case despite Defendants raising the issue in their initial motion to dismiss. Every count asserted against Defendants, however, is dependent in some way on the failure or defectiveness of Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 11 of 26 - 12 - 111346506.1 the product actually ingested by Plaintiff. (See D.E. 12 at 21-31 (outlining claims for Negligence, Strict Products Liability, Breach of Express Warranty, Breach of Implied Warranty, and Fraudulent Misrepresentation and Omission based on the alleged defects of an unnamed PPI).) Where a plaintiff fails to identify the actual product in a products-liability dispute, her claims must fail. Henderson, 2011 WL 4024656, at *5 (dismissing complaint because, among other reasons, the “[p]laintiff [did] not allege that any specific Defendant’s Phenytoin [the drug- product at issue] caused his injuries or that any specific Defendant’s Phenytoin product included manufacturing or design defects”). Here, Plaintiff wholly fails to identify the product that allegedly provides the very basis of her Amended Complaint. Instead, when attempting to identify the product, Plaintiff hedges, defining “Nexium” to include, without limitation, all “proton pump inhibitors” or “PPIs.” (D.E. 12 ¶¶ 1-2.) Plaintiff does not clarify this generalization, nor does she specify the particular product in a later paragraph. Even where she identifies four types of PPIs for which AstraZeneca allegedly hold the new drug application, she does not (in her second attempt to plead a claim) state that she ingested any particular one of the four. (D.E. ¶¶ 31-34.) In order to proceed with her claims, Plaintiff must be able to identify the product that allegedly injured her. She has not. Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 12 of 26 - 13 - 111346506.1 2. The Amended Complaint lacks any causal link between Defendants’ conduct and Plaintiff’s injury. To the extent Nexium® is even at issue, which is speculative at best, the Amended Complaint is devoid of any indication as to a host of facts necessary to establish a causal connection between Defendants’ purported conduct and Plaintiff’s injury, including: (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, where it made them, and to whom; (v) what statements were made by AstraZeneca to physicians or Plaintiff, and when and how such statements were supposedly made; or (vi) how Plaintiff’s AKI originated. (See generally Compl.) These omissions are fatal to Plaintiff’s obligation to plead factual allegations establishing a causal link between the alleged wrongful conduct and the purported injury. See, e.g., Henderson, 809 F. Supp. 2d at 1379 (conclusory causal allegation that “[as] a direct and proximate result of the design and manufacturing defects . . . [plaintiff] suffered harm as alleged herein” was “devoid of any specific, factual content to support the legal conclusions are plainly insufficient under Iqbal . . . to state a plausible claim that [the drug’s] defective Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 13 of 26 - 14 - 111346506.1 condition proximately caused Plaintiff’s injuries”); Brazil, 2016 WL 4844442, at *9 (holding that, because complaint failed to allege a specific design defect, “the Court cannot draw the reasonable inference that a design or manufacturing defect caused the decedent’s injuries”). Plaintiff’s sole factual allegation linking Nexium (defined by Plaintiff as all “proton pump inhibitors”) to her specific injury is her assertion that “[u]pon information and belief, Plaintiff Celestine Barnes was diagnosed with Acute Kidney Injury in 2015 as a result of her use of the aforementioned Nexium.” (D.E. 12 ¶ 8.) As an initial matter, “since the seminal decisions in Twombly and Iqbal, for purposes of a Rule 12(b)(6) motion to dismiss, courts do not have to take as true allegations based merely upon information and belief.” Tamanji v. Nationstar Mortg. LLC, No. 4:14-CV-222-HLM, 2014 WL 12513893, at *2 (N.D. Ga. Dec. 12, 2014) (quoting Smith v. City of Sumiton, 578 Fed. Appx. 933, 936 n.4 (11th Cir. 2014)); see also Mann v. Palmer, 713 F.3d 1306, 1315 (11th Cir. 2013). These “upon information and belief” allegations as to the existence, extent, and alleged cause of Plaintiff’s injuries constitute allegations regarding information that should be within Plaintiff’s knowledge. Plaintiff’s inability to allege - even generally - a causal link between Nexium® and her injury is fatal to the Amended Complaint. Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 14 of 26 - 15 - 111346506.1 The Amended Complaint fails to allege any causal relationship (which AstraZeneca denies) between Plaintiff’s alleged injury, AKI, and Nexium®. Rather, Plaintiff asks the Court to infer such a relationship based solely on generalized statements regarding PPIs and various diseases other than AKI. Under binding precedent, this does not suffice. Without either factual allegations specific to a defendant or factual allegations establishing a causal link between the alleged wrongful conduct and her injury, 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, 556 U.S. at 664. D. Plaintiff’s claim of Strict Products Liability must fail as she has not pled (and cannot plead) a plausible manufacturing defect, design defect, or failure-to-warn claim. To establish strict liability, a plaintiff must show that “the property when sold by the manufacturer was not merchantable and reasonably suited to the use intended, and its condition when sold is the proximate cause of the injury sustained.” O.C.G.A. § 51-1-11(b)(1); see also Goodson v. Boston Scientific, No. 1:11-CV-3023, 2011 WL 6840593, at *4 (N.D. Ga. Dec. 29, 2011) (noting “existence of a defect is crucial”). While Plaintiff alleges that the unidentified PPIs she ingested were defective in their manufacture, design, and warnings, she fails to plead sufficient facts supporting a claim under these theories. Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 15 of 26 - 16 - 111346506.1 1. Plaintiff has not pled a plausible manufacturing defect claim. To prevail on a manufacturing defect claim, a plaintiff must show that the product deviated from the manufacturer’s specifications and the defect proximately caused her injury. See Jones v. Amazing Prods., Inc., 231 F. Supp. 2d 1228, 1236 (N.D. Ga. 2002). Here, Plaintiff alleges only that an unidentified PPI was defectively manufactured, but she does not allege how that unidentified drug deviated from its intended design or how any defect caused her injuries. Thus, her claim is reduced to an unsupported conclusory statement insufficient to survive a motion to dismiss. See Henderson, 2011 WL 4024656, at *5 (dismissing claim where plaintiff did not allege specific manufacturing defect proximately caused injury); Moore v. Mylan Inc., 840 F. Supp. 2d 1337, 1344-45 (N.D. Ga. 2011) (similar). 2. Plaintiff has not pled a plausible design defect claim. A design defect claim is deficient “if it fails to allege a specific design . . . defect.” Coney v. Mylan Pharms., Inc., No. 6:11-cv-35, 2012 WL 170143, at *6 (S.D. Ga. Jan 19, 2012). Plaintiff alleges that an unidentified PPI was “in a defective and unreasonably dangerous condition,” and the “design defect made Nexium more dangerous than an ordinary consumer would expect and more dangerous than other drugs used to treat GERD.” (D.E. 12 ¶ 108). But she fails to Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 16 of 26 - 17 - 111346506.1 allege any facts identifying the specific defect (or product) at issue or how it supposedly caused her injuries. And though Plaintiff alleges that there were “several alternative safer methods for treating GERD,” (id. ¶ 41), she does not explain how they would have prevented her injuries. The failure to provide any supporting factual allegations reduces Plaintiff’s design defect claim to a mere legal conclusion. See Henderson, 2011 WL 4024656, at *5 (dismissing claim because while plaintiff alleged that drug risks exceeded benefits, he failed to allege “any specific design . . . defect that proximately caused” injuries); Coney, 2012 WL 170143, at *6 (similar); Moore, 840 F. Supp. 2d at 1344-45 (similar); Goodson, 2011 WL 6840593, at *4 (similar). 3. Plaintiff has not pled a plausible failure-to-warn claim. To succeed on a failure-to-warn claim, a plaintiff must prove that (1) the manufacturer failed to provide her prescribing physician with adequate warnings about risks of which it knew or should have known, and (2) the inadequate warning proximately caused her injuries. See, e.g., Dietz v. Smithkline Beecham Corp., 598 F.3d 812, 815 (11th Cir. 2010); McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 595 (Ga. 2003). Plaintiff fails to state a plausible claim. Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 17 of 26 - 18 - 111346506.1 Plaintiff alleges throughout the Amended Complaint that Defendants failed to warn her and other consumers about an unidentified PPI’s alleged risks. 3 (See, e.g., D.E. 12 ¶¶ 22, (“failed to adequately warn consumers”), 39 (“did not warn patients”), 42 (concealed “from Plaintiff”), 85 (“failed to adequately warn consumers”) 118 (“failure to warn Plaintiff”).) ”), 85 (“failed to adequately warn consumers”) 118 (“failure to warn Plaintiff”).) She does not provide the warning given to her physician. She does not assert that, had her physician known of the purported link between the drug Plaintiff was prescribed and an increased risk in AKI, the physician would have made a different choice. This pleading deficiency is highlighted by Plaintiff’s inability to even identify the allegedly damaging product. Further, Plaintiff’s claim is premised solely on Defendants’ alleged failure to warn about a risk of kidney injuries. But Plaintiff does not sufficiently allege that Defendants knew or should have known prior to her alleged diagnosis of AKI about a risk of AKI, her alleged injury. Rather, she simply enumerates a myriad of studies/case reports with respect to PPIs in general and other diseases. Thus, Plaintiff has not sufficiently alleged that Defendants knew or should have known about an increased risk of AKI before her alleged injury. 3 This analysis does not change even if Plaintiff had actually identified Nexium® as the drug at issue. Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 18 of 26 - 19 - 111346506.1 E. Plaintiff’s claim for Negligence fails for the same reasons as her Strict Liability Claim. Like her strict liability claim, Plaintiff’s cause of action for negligence is premised on an alleged failure to properly manufacture, design, and label an unidentified PPI, which may or may not include Nexium®. (D.E. 12 ¶¶ 101-106.) Her negligence claim therefore fails for the same reasons as her strict liability claim. “Under Georgia law, a plaintiff asserting a negligence claim must prove the following elements: (1) a legal duty to conform to a standard of conduct raised by the law for the protection of others against unreasonable risk of harm; (2) breach of this standard; (3) a legally attributable causal connection between the conduct and resulting injury; and (4) some loss or damage flowing to the Plaintiff’s legally protected interest as a result of the alleged breach of the legal duty.” Brazil, 2016 WL 4844442, at *10 (quoting Estate of Thornton v. Unum Life Ins. Co. of Am., 445 F. Supp. 2d 1379, 1382 (N.D. Ga. 2006)). Merely reciting the elements of a claim are insufficient to survive a motion to dismiss, as “conclusory allegations without specific supporting facts have no probative value.” Evers v. Gen. Motors Corp., 770 F.2d 984, 986 (11th Cir. 1985) (citing Gordon v. Terry, 684 F.2d 736, 744 (11th Cir. 1982), cert. denied, 459 U.S. 1203 (1983)); see also Hansel v. All Gone Towing Co., 132 F. Appx. 308, 310 (11th Cir. 2005) (“Simply put, such Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 19 of 26 - 20 - 111346506.1 conclusory allegations, with no factual support, are insufficient to state a claim.”). Further, as noted above, in her second attempt at stating a plausible claim for relief, Plaintiff actually broadens her definition of Defendants to include unserved and unnamed third parties. Assuming Plaintiff’s factual allegations are true, then, requires an assumption that it is just as plausible that unnamed and unserved parties manufactured and distributed the unnamed product that purportedly injured Plaintiff. Such a claim must fail under the Supreme Court’s guidance in Iqbal. In addition, because of the broad definition of Defendants, the Amended Complaint “fails to provide proper notice of [plaintiff’s] claims to any one Defendant.” Id. Bailey v. Janssen Pharmaceutical, Inc., 288 F. Appx. 597, 609 (11th Cir. 2008) (affirming dismissal of claims because the plaintiff failed to plead duty, breach, and causation as to each defendant and failed to explain the source of each individual defendant’s duty and breach). F. Plaintiff fails to assert any specific misrepresentations and thus fails to meet the heightened standard of pleading fraud with particularity under Federal Rule of Civil Procedure 9(b). Count Five of Plaintiff’s Amended Complaint asserts that Defendants defrauded Plaintiff by making fraudulent misrepresentations. 4 “A plaintiff 4 Plaintiff’s Amended Complaint appears to suffer from other pleading deficiencies, but given the complete lack of factual assertions regarding the type of product used, the specific uses, the type of defect in the product, the specific times Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 20 of 26 - 21 - 111346506.1 asserting a fraud claim under Georgia law must establish five elements: (1) a false representation by the defendant; (2) scienter; (3) intention to induce the plaintiff to act or refrain from acting; (4) justifiable reliance by the plaintiff, and (5) damage to the plaintiff.” Brazil, 2016 WL 4844442, at *10. “To plead a fraud claim with particularity, “a plaintiff must plead facts as to time, place, substance of the defendants alleged fraud, specifically the details of the defendant’s allegedly fraudulent acts, when they occurred, and who engaged in them.” Id. “This means that to state an actionable claim for fraud, the plaintiff must state the who, what, when[,] where, and how.” Id. “A blanket allegation that ‘defendants made representations’ without any further specificity is fatal to [a fraud] claim.” Id. Here, Plaintiff does not identify any statements that were allegedly misrepresentations. (D.E. ¶¶ 144-150.) Plaintiff does not identify the person who made any particular statement. (Id.) And Plaintiff does not identify to whom or when the alleged statements were made. (Id.) Thus “Plaintiff does not state the who, what, when, where, and how of the facts supporting the fraud claims; nor do Plaintiff’s allegations give Defendants notice of what actions they are accused of and circumstance when the product was used, and a causal link between the alleged conduct and the purported injury, Defendants cannot fully address those deficiencies in this brief and reserve the right to do so. Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 21 of 26 - 22 - 111346506.1 taking that amount to fraud.” Brazil, 2016 WL 4844442, at *11. Plaintiff’s fraud claims, then, should be dismissed. G. Plaintiff’s Breach of Warranty claims fail to allege any warranty asserted by any Defendant. An express warranty is created by an “affirmation of fact or promise” that relates to the product and becomes part of the “basis of the bargain.” O.C.G.A. § 11-2-313. Plaintiff generically alleges that Nexium’s prescribing information “purports to expressly describe the relevant and material side-effects that Defendants knew or should have known about.” (D.E. 12 ¶ 127.) But nowhere does Plaintiff identify those side effects; nowhere does she disclose what warranties were made, relying instead on general and conclusory allegations that regurgitate the elements of this claim and state that the unidentified “warranties and representations were false.” (Id. ¶ 131.) Such conclusory and recital allegations fail to state a plausible claim for relief. See Twombly, 550 U.S. at 555. Plaintiff’s Breach of Implied Warranty claim, which incorporates both an implied warranty of merchantability and an implied warranty of fitness for a particular purpose (O.C.G.A. §§ 11-2-315, 11-2-316), fares no better. Plaintiff merely raises conclusory allegations that match the purported claims - i.e., that Nexium is neither fit for a particular purpose nor merchantable. Such conclusory allegations, given the instruction from the Supreme Court in Iqbal, must fail. Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 22 of 26 - 23 - 111346506.1 IV. Conclusion Plaintiff’s claims are barred by Georgia’s two year statute of limitations for personal injury claims. Moreover, Plaintiff’s Amended Complaint consists of a handful of factual assertions surrounded by speculation and conclusions. After excising - as must be done in Rule 12(b)(6) analyses - both the speculation and self-serving conclusions, Plaintiff is left with the factual allegations that she ingested some unknown PPI that may or may not have been Nexium®, that at some point in time, she may or may not have suffered an injury that may or may not have been caused by some action or inaction by AstraZeneca. These allegations, taken as true, fail to lift Plaintiff’s claim from “possible” to “plausible.” And where a claim is not “plausible,” but merely “possible,” it should “be exposed at the point of minimum expenditure of time and money by the parties and the court.” Twombly, 550 U.S. at 558. A party may not reach the gates of discovery through mere speculation, but that is precisely what Plaintiff attempts to do here. Discovery does not exist, however, to permit one asserting a claim in the first place to determine whether she was in fact injured in any manner and, then, by any product manufactured by a defendant. This is Plaintiff’s second attempt to state a claim sufficient to survive a motion to dismiss. Again, she has failed to do so. Defendants move the Court to Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 23 of 26 - 24 - 111346506.1 expose Plaintiff’s deficiencies at this point of minimum expenditure and dismiss Plaintiff’s Amended Complaint with prejudice. Respectfully submitted this 19 th day of April, 2017. CARLTON FIELDS JORDEN BURT, P.A. /s/ Christopher B. Freeman Christopher B. Freeman Georgia Bar No. 140867 Justan C. Bounds Georgia Bar No. 339789 1201 West Peachtree Street Suite 3000 Atlanta, Georgia 30309 (404) 815-3400 (404) 815-3415 (fax) cfreeman@carltonfields.com Attorneys for Defendants Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 24 of 26 - 25 - 111346506.1 The undersigned counsel hereby certifies, pursuant to Local Rule 7.1(D), that this brief has been prepared using Times New Roman 14 point font. /s/ Christopher B. Freeman Christopher B. Freeman Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 25 of 26 - 26 - 111346506.1 CERTIFICATE OF SERVICE I hereby certify that a true and correct copy of the foregoing was electronically filed with the Clerk of Court using CM/ECF, which will send notification to the registered attorney(s) of record that the document has been filed and are available for viewing and downloading. This 19 th day of April, 2017. /s/ Christopher B. Freeman Christopher B. Freeman Case 1:17-cv-00142-ODE Document 25-1 Filed 04/19/17 Page 26 of 26