Doe v. AstraZeneca Pharmaceuticals LP et al

Filing 20

ORDER & REASONS: ORDERED that AstraZeneca's Motion to Dismiss and Amend Case Caption (Rec. Doc. 15) is GRANTED. FURTHER ORDERED that Plaintiff's claims are DISMISSED WITHOUT PREJUDICE. Plaintiff shall file an amended complaint within tw enty-one (21) days, lest Plaintiff's claims be dismissed with prejudice. FURTHER ORDERED that the caption of this case be amended to reflect Plaintiff's true identity. FURTHER ORDERED that Plaintiff's Motion for Oral Argument (Rec. Doc. 18) is DENIED. Signed by Judge Carl Barbier on 8/5/15. (sek)

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UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA JANE DOE CIVIL ACTION VERSUS NO: 15-438 ASTRAZENECA PHARMECEUTICALS, SECTION: J(2) LP, ET AL ORDER AND REASONS Before the Court is a Motion to Dismiss and Amend Case Caption (Rec. Doc. 15) filed by Defendant, AstraZeneca Pharmaceuticals, LP (“AstraZeneca”), and an Opposition thereto (Rec. Doc. 17) by Plaintiff, Jane Doe (“Plaintiff”). Plaintiff has requested that the Court conduct Oral Argument on the instant motion. (Rec. Doc. 18). Having considered the motion, the parties’ submissions, the record, and the applicable law, the Court finds, for the reasons expressed below, that the motion should be GRANTED. PROCEDURAL AND FACTUAL BACKGROUND In her complaint, Plaintiff, who has requested that her identity remain anonymous, alleges that she sustained adverse effects from her use of Seroquel and/or Seroquel XR, and their generics, Quetiapine and Quetiapine 1 Fumarate, respectively. AstraZeneca is the manufacturer of Seroquel and Seroquel XR, whereas Quetiapine and Quetiapine Fumarate are manufactured by Defendants Lupin Pharmaceuticals, Inc. (“Lupin”) and Teva Pharmaceuticals, Inc. (“Teva”). Seroquel, Seroquel XR, and their generics are approved by the U.S. Food and Drug Administration (“FDA”) for treatment of schizophrenia and bipolar disorder. (Rec. Doc. 1, p. 4). Plaintiff alleges that she was prescribed Seroquel, Seroquel XR, Quetiapine, and Quetiapine Fumarate “for sleep.” (Rec. Doc. 1, p. 4). Plaintiff further alleges that as a result of taking these prescription medications she sustained a litany of injuries including, “weight gain, inability to lose weight, medical suffering, severe complications, abdominal physical pain, damages, pain gastrointestinal and problems, hyperlipidia, mental anguish, [and] emotional distress,” as well as a number of more personal injuries which Plaintiff preferred to describe in a document filed under seal. (Rec. Doc. 1, p. 8; Rec. Doc. 4). In her complaint, Plaintiff alleges that Seroquel, Seroquel XR, and their generics are “unreasonably dangerous” both because AstraZeneca failed to provide an adequate warning regarding the drugs’ adverse effects to Plaintiff or her physician, and because the medications fail to conform to the express warranty that they are “safe, effective product[s].” (Rec. Doc. 1, pp. 11, 15). Upon Plaintiff’s motion, on June 10, 2 2015, this Court dismissed Plaintiff’s claims against Lupin and Teva, leaving AstraZeneca as the sole defendant in this matter. AstraZeneca has filed the instant motion seeking dismissal of all Plaintiff’s claims pursuant to Federal Rule of Civil Procedure 12(b)(6), and also requesting that the Court amend the case caption of this matter to disclose Plaintiff’s identity pursuant to Federal Rule of Civil Procedure 10(a). PARTIES’ ARGUMENTS AstraZeneca first argues that all claims asserted by Plaintiff in her complaint which fall outside the scope of the Louisiana Products Liability Act (“LPLA”) must be dismissed, as the LPLA provides the exclusive remedy for liability against a manufacturer for damage caused by its products. AstraZeneca further asserts that even those claims which the Court deems to fall within the scope of the LPLA should be dismissed because Plaintiff has failed to allege sufficient facts to state a claim under any of the four theories of liability enumerated by the LPLA. AstraZeneca also requests that the Court amend the caption of the case to reflect Plaintiff’s true identity, because the present circumstances do not require that Plaintiff litigate anonymously. In response, Plaintiff maintains that her complaint asserts plausible LPLA claims under theories 3 of failure to provide adequate warnings and failure to comply with an express warranty. Moreover, in her Opposition, Plaintiff requests leave to amend support her a complaint claim construction that or to include Seroquel composition is and/or additional information to dangerous in unreasonably in design, and to remove extra allegations pertaining to Defendants Teva and Lupin, who have been dismissed from this matter. Plaintiff also maintains that her complaint contains no claims beyond the scope of the LPLA. Finally, Plaintiff requests that the case caption be maintained to prevent disclosure of her true identity, because this lawsuit would reveal private information regarding her medical condition. LEGAL STANDARD Under the Federal Rules of Civil Procedure, a complaint must contain “a short and plain statement of the claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a)(2). The complaint must “give the defendant fair notice of what the claim is and the grounds upon which it rests.” Dura Pharm., Inc. v. Broudo, 544 U.S. 336, 346 (2005). The allegations “must be simple, concise, and direct.” Fed. R. Civ. P. 8(d)(1). “Under Rule 12(b)(6), a claim may be dismissed when a plaintiff fails to allege any set of facts in support of his 4 claim which would entitle him to relief.” Taylor v. Books A Million, Inc., 296 F.3d 376, 378 (5th Cir. 2002) (citing McConathy v. Dr. Pepper/Seven Up Corp., 131 F.3d 558, 561 (5th Cir. 1998)). To survive a Rule 12(b)(6) motion to dismiss, the plaintiff must plead enough facts to “state a claim to relief that is plausible on its face.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009) (quoting Bell Atl. Corp. v. Twombly, 550 U.S. 544, 547 (2007)). A claim is facially plausible when the plaintiff pleads facts inference that that the allow the court defendant is to “draw the reasonable for the misconduct liable alleged.” Id. A court must accept all well-pleaded facts as true and must draw all reasonable inferences in favor of the plaintiff. Lormand v. U.S. Unwired, Inc., 565 F.3d 228, 232-33 (5th Cir. 2009); Baker v. Putnal, 75 F.3d 190, 196 (5th Cir. 1996). The court is not, however, bound to accept as true legal conclusions couched as factual allegations. Iqbal, 556 U.S.at 678. DISCUSSION A. Non-LPLA Claims The LPLA “establishes the exclusive theories of liability for manufacturers for damage caused by their products,” and “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 5 set forth (2014). pleading in [the LPLA].” AstraZeneca which La. contends claims are Rev. that being Stat. “it is asserted Ann. § unclear under the 9:2800.52 from the LPLA or otherwise,” and submits that all non-LPLA claims asserted by Plaintiff must be dismissed pursuant to Rule 12(b)(6). (Rec. Doc. 15-1, p. 4). In response, Plaintiff maintains that “there are no non-Louisiana Products Liability Act claims in this case.” (Rec. Doc. 17, p. 10). The Court agrees with AstraZeneca that it is difficult to determine from Plaintiff’s complaint and Opposition the exact type and number of claims she is attempting to assert against AstraZeneca and whether these fall within or outside the scope of the LPLA. Therefore, to the extent that Plaintiff’s complaint contains non-LPLA claims, these are preempted by the LPLA. See Davis v. Teva Pharm. USA, Inc., No. 13-6365, 2014 WL 4450423, at *4 (E.D. La. Sept. 10, 2014) (citing Stahl v. Novartis Pharms. Corp., 283 F.3d 254, 261 (5th Cir. 2002)). B. LPLA Claims AstraZeneca next asserts that Plaintiff has failed to state a plausible claim under any of the four theories of liability provided for by the LPLA. AstraZeneca specifically contends that Plaintiff’s complaint contains only “irrelevant factual assertions and legal conclusions,” and is devoid of sufficient 6 relevant factual allegations to state a plausible claim. (Rec. Doc. 15-1, p. 2). In response, Plaintiff argues that she has set forth a sufficient factual basis to support her claims under the LPLA, and that AstraZeneca is the additional information factual which is information to be sought by appropriately disclosed through the discovery process. (Rec. Doc. 17, p. 3). Plaintiff maintains that her complaint asserts plausible claims under the LPLA for the unreasonable danger of Seroquel and Seroquel XR under theories of failure to provide an adequate warning and failure to conform to an express warranty. (Rec. Doc. 17, p. 3). Moreover, Plaintiff requests the Court’s leave to amend her complaint to assert additional claims under the LPLA for unreasonable danger in construction or composition and design, based on information which has come to light since the filing of her original complaint. (Rec. Doc. 17, p. 7). In order to prevail on a claim brought pursuant to the LPLA, a plaintiff must establish the following elements: (1) that the defendant is a manufacturer of the product; (2) that a characteristic of the product was the proximate cause of the claimant’s damage; (3) that the characteristic made the product “unreasonably dangerous”; and (4) that the claimant’s damage arose from a reasonably anticipated use of the product. La. Rev. Stat. Ann. § 9:2800.54(A) (2014). The LPLA defines a product as 7 “unreasonably dangerous” if it meets at least one of the following criteria: (1) (2) (3) The product is unreasonably dangerous in construction or composition The product is unreasonably dangerous in design The product is unreasonably dangerous because an adequate warning about the product has not been provided The product is unreasonably dangerous because it does not conform to an express warranty made by the manufacturer of the product. (4) La. Rev. Stat. Ann. § 9:2800.54(B); see also Stahl, 283 F.3d at 261; Jefferson v. Lead Indus. Ass’n, Inc., 930 F.Supp. 241, 245 (E.D. La. 1996 (Vance, J.). In her complaint, Plaintiff asserts that Seroquel and Seroquel XR were unreasonably dangerous as defined by the LPLA because they lacked adequate warnings and because they failed to conform to an express warranty provided by AstraZeneca. Despite labeling these Plaintiff has claims under claims failed either as to such, allege of AstraZeneca sufficient these asserts facts theories of to that support liability. Specifically, AstraZeneca notes that Plaintiff’s complaint lacks information regarding the dates on which Plaintiff was prescribed the drugs, the duration and number of times Plaintiff took the drugs, and the dates on which she began experiencing adverse symptoms. (Rec. Doc. 15-1, p. 2). In response, Plaintiff maintains that these facts were unnecessary to state a plausible 8 claim. Despite not providing any additional facts in her Opposition, Plaintiff does provide the Court with nearly four unnecessary pages of direct citations of various provisions of the LPLA. In order to maintain a failure-to-warn claim, “a plaintiff must demonstrate that that may damage cause reasonable care characteristic to and the product and the provide its possessed manufacturer an danger a adequate to users characteristic failed warning and to of handlers use such of the product.” Stahl, 283 F.3d at 261 (citing La. Rev. Stat. Ann. § 9:2800.57(A) (2014)). unnecessarily repetitive AstraZeneca Plaintiff extent of However, failed or the to Plaintiff’s legally provide Plaintiff’s adverse despite the conclusive adequate physician effects complaint of lengthiness assertions warnings regarding Seroquel of contains the and Plaintiff’s to that either nature and Seroquel XR. allegations, nowhere in her complaint does she make mention of any specific adverse effect of which AstraZeneca failed to warn, or assert a proper warning which she contends would have been appropriate. Due to the vagueness of Plaintiff’s complaint, an issue remains regarding whether warnings regarding AstraZeneca specific failed adverse to provide effects of the adequate drugs. Plaintiff must amend her complaint to specifically allege the 9 reasons why the warnings provided by AstraZeneca regarding the adverse effects of Seroquel and Seroquel XR were inadequate. In order to maintain a claim for failure to conform to an express warranty under the LPLA, a plaintiff must establish that: “(1) the manufacturer made an express warranty regarding the product, (2) the plaintiff was induced to use the product because of that warranty, (3) the product failed to conform to that express proximately warranty, caused and because (4) the the plaintiff’s express warranty damage was was untrue.” Caboni v. Gen. Motors Corp., 278 F.3d 448, 452 (5th Cir. 2002) (citing La. complaint, Rev. Stat. Plaintiff Ann. § 9:2800.58 repeatedly asserts (2014)). that In her AstraZeneca “expressly warranted in its materials presented to the FDA, its website and promotional, upon and information and informational belief[,] materials that safe, effective product.” (Rec. Doc. 1, p. 15). to reference specific promises or its marketing, Seroquel is a Plaintiff fails representations made by AstraZeneca or to explain how the drugs prescribed to her failed to conform to these representations. In order to proceed with this litigation, Plaintiff must amend her complaint to include sufficient factual allegations to support her claim for failure to conform with an express warranty. 10 In her Opposition, Plaintiff also requests leave to amend her complaint to include additional LPLA clams premised on Seroquel and Seroquel XR’s unreasonable danger in construction or composition and design. (Rec. Doc. 17, p. 10). Federal Rule of Civil Procedure 15(a) provides that leave should be granted to amend pleadings “when justice so requires.” Fed. R. Civ. P. 15(a). A decision to permit a party to amend pleadings lies within the sound discretion of the trial court. Tyson v. Tanner, No. 08-4445, 2010 WL 4808504, at *1 (citing Addington v. Farmer’s Elevator Mut. Ins. Co., 650 F.2d 663, 666 (5th Cir. 1981)). Plaintiff complaint, she asserts has that become since aware of the filing additional of her testimony regarding the nature and adverse effects of Seroquel, on which she could base claims for unreasonably dangerous construction and design. (Rec. Doc. 7-8). The Court finds that leave to amend the complaint on this basis is appropriate. The Court, however, cautions counsel for Plaintiff that it will not suffice to file an amended complaint in which she alleges purely legal conclusions without any factual basis. C. Amendment of the Case Caption Finally, AstraZeneca requests that the Court amend the case caption to specifically reveal Plaintiff’s asserts that true Plaintiff 11 has identity. no right AstraZeneca to proceed anonymously, as she will suffer no injury other than mere embarrassment as a result of the disclosure of her real name. Plaintiff maintains that she should be permitted to litigate anonymously, because “even one sentence, revealing [her] name and stating that she has taken Seroquel will reveal that she has a mental condition diagnosis [sic] and she should be afforded privacy and protection.” (Rec. Doc. 17, p. 10). Federal Rule of Civil Procedure 10(a) requires that the title of a complaint disclose the names of all parties involved. Fed. R. Civ. P. 10(a). This rule is not without exception, however, and in limited circumstances, a party may be permitted to proceed anonymously due to interests of privacy. Doe v. Griffon Mgmt., LLC, No. 14-2626, 2014 WL 7040390, at *1 (E.D. La. Dec. 11, 2014) (Africk, J.). Although the Fifth Circuit has refused to adopt a “hard whether a party should and be fast” formula permitted to for determining litigate under a pseudonym, it has recognized that such a determination “requires a balancing party’s of privacy considerations against the calling customary for and maintenance of a constitutionally- embedded presumption of openness in judicial proceedings.” Doe v. Stegall, 653 F.2d 180, 186 (5th Cir. 1981). “Examples of areas where involving courts abortion, have birth allowed pseudonyms control, 12 include transsexuality, cases mental illness, welfare rights of illegitimate children, AIDS, and homosexuality.” Griffon Mgmt., 2014 WL 7040390, at *2 (citing Doe v. Megless, 654 F.3d 404, 408 (3d Cir. 2011)). Plaintiff has failed to show that the present circumstances rise to those examples discussed in Doe v. Griffon Management. Plaintiff maintains that requiring her to litigate under her true identity would reveal that she suffers from mental illness. However, nowhere in her pleadings has Plaintiff ever asserted that she is afflicted with a mental condition. Instead, in her Complaint, she states that she was prescribed Seroquel and Seroquel XR “for sleep.” (Rec. Doc. 1, p. 4). Because Plaintiff has failed warrant show anonymity, interests practice to at of stake that the do of Court the circumstances concludes that not disclosure.” outweigh See the Stegall, her the “almost 653 F.2d complaint privacy universal at 186. Therefore, the caption of this case will be amended to reflect Plaintiff’s true identity. CONCLUSION Accordingly, IT IS HEREBY ORDERED that AstraZeneca’s Motion to Dismiss and Amend Case Caption (Rec. Doc. 15) is GRANTED. IT IS FURTHER ORDERED that Plaintiff’s claims are DISMISSED WITHOUT PREJUDICE. Plaintiff shall 13 file an amended complaint within twenty-one (21) days, lest Plaintiff’s claims be dismissed with prejudice. IT IS FURTHER ORDERED that the caption of this case be amended to reflect Plaintiff’s true identity. IT IS FURTHER ORDERED that Plaintiff’s Motion for Oral Argument (Rec. Doc. 18) is DENIED. New Orleans, Louisiana this 5th day of August, 2015. ________________________________ CARL J. BARBIER UNITED STATES DISTRICT JUDGE 14

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