Baker v. Bayer HealthCare Pharmaceuticals Inc.

Filing 29

Order Granting in Part and Denying in Part Defendant's 22 Motion to Dismiss. Signed by Judge Thelton E. Henderson on 12/19/13. (tehlc2, COURT STAFF) (Filed on 12/19/2013)

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1 UNITED STATES DISTRICT COURT 2 NORTHERN DISTRICT OF CALIFORNIA 3 4 NICOLE BAKER, Plaintiff, 5 6 7 8 v. BAYER HEALTHCARE PHARMACEUTICALS, INC., 9 NO. C13-0490 TEH ORDER GRANTING IN PART AND DENYING IN PART DEFENDANT’S MOTION TO DISMISS Defendant. 10 United States District Court Northern District of California 11 12 This matter came before the Court on December 9, 2013, on Defendant Bayer 13 Healthcare Pharmaceuticals, Inc.’s (“Defendant”) motion to dismiss Plaintiff Nicole 14 Baker’s (“Plaintiff”) Second Amended Complaint (“SAC”). After carefully considering 15 the parties’ written and oral arguments, and relevant law, the Court now GRANTS in part 16 and DENIES in part Defendant’s motion. 17 18 19 BACKGROUND This suit is a product liability case stemming from Plaintiff’s use of the intrauterine 20 contraceptive device known as “Mirena.” Mirena is made by Defendant, a Delaware 21 corporation, which is in the business of designing, manufacturing, marketing, testing, and 22 distributing prescription drugs and women’s healthcare products, including Mirena. SAC 23 ¶¶ 4, 10, Docket No. 21. Mirena is a T-shaped polyethylene frame with a steroid reservoir 24 that releases 20 μg/day of levonorgestrel, a prescription medication used as a 25 contraceptive; it is inserted into the uterus by a healthcare provider during an office visit. 26 The federal Food and Drug Administration approved Defendant’s New Drug Application 27 for Mirena in December 2000. Id. ¶ 14-15. 28 Plaintiff, a California resident, alleges that Mirena’s label does not accurately warn 1 and understates the risks of certain medical conditions or injuries associated with use of 2 Mirena, including spontaneous migration of Mirena, perforation of the uterus, embedment, 3 infections, cysts, ectopic and intrauterine pregnancy, adhesions, fetal injury and fetal death 4 caused by Mirena. Id. ¶¶ 18-19. Plaintiff alleges that Defendant did not effectively test or 5 analyze results of pre-market tests before putting Mirena on the market, but nonetheless 6 promoted Mirena through social media and online marketing campaigns while understating 7 the associated risks. Id. ¶¶ 20-21. Plaintiff further alleges that in March 2009, the 8 Department of Health and Human Services’ Division of Drug Marketing, Advertising, and 9 Communications (“DDMAC”) issued a warning regarding Defendant’s advertising materials for Mirena, stating that they did not communicate any risk information and 11 United States District Court Northern District of California 10 inadequately communicated Mirena’s indications. Id. ¶¶ 22-23. Plaintiff also alleges that 12 in December 2009, DDMAC contacted Defendant regarding its “Mirena Simple Styles 13 Statements Program,” which Plaintiff alleges were consumer-directed live presentations 14 directed toward “busy moms” that utilized scripts that omitted information regarding the 15 serious risks associated with using Mirena. Id. ¶¶ 24-27. Plaintiff alleges that Defendant 16 concealed its knowledge of the defects in their products from the Plaintiff, her physicians, 17 hospitals, pharmacists, the FDA and the public in general. Id. ¶ 28. 18 Plaintiff had her Mirena inserted on January 6, 2010 at Community Physicians 19 Network for Women in Indianapolis, Indiana by her healthcare provider. Plaintiff alleges 20 that she chose Mirena because it was promoted as a safe and effective method of birth 21 control. Id. ¶ 29. On June 21, 2011, after suffering from extreme pelvic pain, Plaintiff was 22 rushed to the emergency room (“ER”) at Parkview Community Hospital in Riverside, 23 California. She received treatment for abdominal pain. Id. ¶ 30. Over the next four 24 months, Plaintiff repeatedly went to the ER. On June 28, 2011, Plaintiff went to the ER at 25 Riverside Community Hospital in Riverside, California for sharp pains on her left side. An 26 ultrasound showed a left ovarian cyst. Plaintiff was treated for her pain. Id. ¶ 31. On 27 September 3, 2011, Plaintiff went to the ER at Parkview Community Hospital for severe 28 abdominal pain, nausea and pain associated with an ovarian cyst. Id. ¶ 32. On October 10, 2 1 2011, Plaintiff was again rushed to the ER at Riverside Community Hospital for extreme 2 pelvic pain, and noted that her pain level was a 7 out of 10. Plaintiff had a urinary tract 3 infection, a fever and leukocytosis. Id. ¶ 33. Plaintiff’s Mirena “was expelled” on October 4 20, 2011. After removal, Plaintiff continued to suffer from vaginal bleeding, pelvic pain, 5 and pain when urinating. Id. ¶ 34. Prior to having Mirena, Plaintiff alleges that she did 6 not suffer from these injuries. Id. In sum, Plaintiff maintains she has suffered severe 7 injuries, including, but not limited to, abdominal pain, an ovarian cyst, infections, 8 substantial mental and physical pain and suffering, and has incurred medical expenses for 9 treatment and care, and will continue to incur expenses in the future. Id. ¶ 35. Plaintiff filed suit on February 4, 2012, invoking this Court’s diversity jurisdiction 10 United States District Court Northern District of California 11 pursuant to 28 U.S.C. § 1332. She asserts claims against Defendant for negligence, for 12 strict liability for design defects, failure to warn, and manufacturing defects, as well as for 13 breach of implied and express warranties. On March 12, 2013, the Court stayed the case 14 pending a motion to transfer the case as potentially related to the Judicial Panel on 15 Multidistrict Litigation (“JPML”) Docket No. 2434, In re: Mirena IUD Products Liability 16 Litigation. Docket No. 13. On August 7, 2013, the JPML vacated the conditional transfer 17 of the case because the Panel found that Plaintiff alleged injuries broader than injury 18 related to the risk of perforation and migration associated with Mirena, which was the 19 scope of the MDL. Docket Nos. 14, 16. After the Court lifted the stay, Plaintiff filed the 20 SAC and this motion to dismiss followed. 21 22 LEGAL STANDARD 23 Dismissal is appropriate under Rule 12(b)(6) of the Federal Rules of Civil 24 Procedure 1 when a plaintiff’s allegations fail “to state a claim upon which relief can be 25 granted.” Fed. R. Civ. P. 12(b)(6). A dismissal under Rule 12(b)(6) “can be based on the 26 lack of a cognizable legal theory or the absence of sufficient facts alleged under a 27 28 1 All references to “Rules” hereinafter refer to the Federal Rules of Civil Procedure. 3 1 cognizable legal theory.” Balistreri v. Pacifica Police Dep’t, 901 F.2d 696, 699 (9th Cir. 2 1990). Under Federal Rule of Civil Procedure 8(a), a plaintiff must plead “enough facts to 3 state a claim to relief that is plausible on its face” with sufficient specificity to “give the 5 defendant fair notice of what the . . . claim is and the grounds upon which it rests.” Bell 6 Atlantic Corp. v. Twombly, 550 U.S. 544, 545, 570 (2007) (citation and quotation marks 7 omitted). “Rule 8 . . . does not require ‘detailed factual allegations,’ but it demands more 8 than an unadorned, the-defendant-unlawfully-harmed-me accusation.” Ashcroft v. Iqbal, 9 556 U.S. 662, 678 (2009) (citation omitted). Plausibility does not equate to probability, 10 but it requires “more than a sheer possibility that a defendant has acted unlawfully.” Id. 11 United States District Court Northern District of California 4 “A claim has facial plausibility when the plaintiff pleads factual content that allows the 12 court to draw the reasonable inference that the defendant is liable for the misconduct 13 alleged.” Id. In ruling on a motion to dismiss, a court must “accept all material allegations 14 of fact as true and construe the complaint in a light most favorable to the non-moving 15 party.” Vasquez v. Los Angeles Cnty., 487 F.3d 1246, 1249 (9th Cir. 2007). The Court, 16 however, is not “bound to accept as true a legal conclusion couched as a factual 17 allegation.” Iqbal, 556 U.S. at 678 (internal quotation marks omitted). Dismissal of 18 claims that fail to meet this standard should be with leave to amend unless it is clear that 19 amendment could not possibly cure the deficiencies in the complaint. Steckman v. Hart 20 Brewing, Inc., 143 F.3d 1293, 1296 (9th Cir. 1998). 21 22 DISCUSSION Defendant moves for dismissal on all claims under Rule 12(b)(6). For the reasons 23 24 discussed below, Defendant’s motion is GRANTED in part and DENIED in part. 25 26 27 28 I. Negligence Claim Under California law, to maintain a negligence action, Plaintiff must allege that Defendant owed a legal duty, breached that duty, and that the breach proximately caused 4 1 injury to the Plaintiff. Garcia v. W & W Cmty. Dev., Inc., 186 Cal. App. 4th 1038, 1044 2 (2010). Defendant argues Plaintiff’s negligence claim is insufficiently pleaded under Rule 3 8 because Plaintiff does not allege sufficient facts and relies on bare legal conclusions to 4 assert her negligence claim. 5 The Court holds that Plaintiff has sufficiently alleged facts supporting a negligence 6 claim. The Court notes at the outset that the SAC is far from a model of clarity in 7 pleading. Nonetheless, the Court must construe the SAC in a light most favorable to the 8 non-moving party and assume the truth of non-conclusory, material allegations of fact 9 contained therein. Plaintiff alleges that Defendant had a duty to exercise reasonable care in the designing, researching, manufacturing, marketing, supplying, promoting, packaging, 11 United States District Court Northern District of California 10 selling or distributing Mirena, which included a duty to assure that Mirena would not cause 12 users to suffer unreasonable, dangerous side effects. SAC ¶ 37. Plaintiff alleges that 13 Defendant breached that duty when it, among other things: failed to adequately warn the 14 Plaintiff, other Mirena users, physicians and the FDA of serious side effects of Mirena, 15 including but not limited to, migration, perforation, embedment, ectopic pregnancies, 16 intrauterine pregnancies, infections, adhesions, cysts, fetal injury and death. Id. ¶ 37(g). 17 Plaintiff alleges that Defendant concealed its knowledge of the defects of Mirena from 18 Plaintiff and her physician, id. ¶ 28, and that Plaintiff chose Mirena because it was 19 promoted as a safe and effective method of birth control. Id. ¶ 29. Plaintiff alleges that 20 Defendant’s breach caused her injuries because after Mirena was inserted by her healthcare 21 provider, she subsequently suffered from a series of injuries including extreme pelvic and 22 abdominal pain, an ovarian cyst, nausea, urinary tract infection, fever, leukocytosis, all of 23 which culminated when “Plaintiff’s Mirena was expelled,” after which she suffered from 24 vaginal bleeding, pelvic pain, and pain when urinating. Id. ¶ 34. Plaintiff alleges that prior 25 to having Mirena, Plaintiff did not suffer from these injuries. Id. Thus, read in a favorable 26 light, Plaintiff has alleged sufficient factual matter to state a claim for negligence that is 27 plausible on its face. 28 Defendant states that the “only allegation that provides any specificity at all 5 includes a number of injuries that Plaintiff does not contend to have suffered from.” Reply 2 at 3-4, Docket No. 26 (citing SAC ¶ 38(g) and listing alleged injuries, but omitting 3 “infections” and “cysts,” which are the injuries for which Defendant allegedly failed to 4 provide adequate warnings and from which Plaintiff allegedly suffered). During oral 5 argument, the Court questioned Plaintiff’s counsel regarding how a negligence action may 6 be maintained based on a failure to warn about injuries Plaintiff did not allege she 7 sustained. Plaintiff’s counsel argued that had Plaintiff been aware of the other alleged 8 risks of Mirena, including migration of Mirena, that warning, had it been given, would 9 have been relevant to her decision-making process. As the parties did not specifically brief 10 this narrow issue, and because “adequacy of a warning is a question of fact for the jury” in 11 United States District Court Northern District of California 1 most cases, the Court cannot say at the motion to dismiss stage that Plaintiff’s theory is 12 implausible as a matter of law. Jackson v. Deft, Inc., 223 Cal. App. 3d 1305, 1320 (1990). 13 Defendant also argues that it cannot be held liable for a failure to test Mirena 14 because California law does not recognize an independent cause of action for failure to 15 test. Defendant is correct. “Imposing liability for breach of a purported ‘independent duty 16 to conduct long-term testing’ would be beyond the pale of any known California tort 17 doctrine, because, inter alia, the causal link between Plaintiff’s known harm, and the 18 unknown outcome of the hypothetical testing is entirely speculative.” Phillippi v. Stryker 19 Corp., No. 2:08-CV-02445-JAM, 2010 WL 2650596, at *2 (E.D. Cal. July 1, 2010) aff’d, 20 471 F. App’x 663 (9th Cir. 2012) (citing Valentine v. Baxter Healthcare Corporation, 68 21 Cal. App. 4th 1467, 1485-86 (1999)). However, Plaintiff argues that she is not asserting 22 that Defendant had an independent duty to conduct long-term testing, but that the duty to 23 test was one of the duties owed to Plaintiff as part of the obligation to protect the end-user 24 from long term risks. This concession brings Plaintiff’s duty to test allegation within the 25 ambit of Valentine, which recognizes that testing and inspection duties may be tied to 26 liability for manufacture, design, and failure to warn, even if they are not maintainable as 27 an independent duty. 68 Cal. App. 4th at 1485. 28 Accordingly, because Plaintiff has sufficiently pleaded a negligence claim, 6 1 Defendant’s motion to dismiss the First Cause of Action for Negligence is DENIED. 2 3 II. Strict Liability – Product Liability 4 California recognizes strict liability for three types of product defects – 5 manufacturing defects, warning defects (inadequate warnings or failure to warn), and 6 design defects. Lucas v. City of Visalia, 726 F. Supp. 2d 1149, 1154 (E.D. Cal. 2010) 7 (citing Anderson v. Owens-Corning Fiberglas Co., 53 Cal. 3d 987, 995 (1991)). Plaintiff 8 alleges that Defendant is strictly liable under all three product defect theories. 9 10 A. Strict Liability – Defective Manufacturing Claim Under the “manufacturing defect” theory, generally a “manufacturing or production United States District Court Northern District of California 11 defect is readily identifiable because a defective product is one that differs from the 12 manufacturer’s intended result or from other ostensibly identical units of the same product 13 line.” Lucas, 726 F. Supp. 2d at 1155 (citing Barker v. Lull Engineering Co., 20 Cal. 3d 14 413, 429 (1978)). The “manufacturing defect” theory posits that “a suitable design is in 15 place, but that the manufacturing process has in some way deviated from that design.” Id. 16 (citation omitted). To survive a challenge to a manufacturing defect claim under Rule 17 12(b)(6), a plaintiff must “identify/explain how the [product] either deviated from 18 [defendant’s] intended result/design or how the [product] deviated from other seemingly 19 identical [product] models.” Id. (emphasis in original) (citing Barker, 20 Cal. 3d at 429); 20 see also Trabakoolas v. Watts Water Technologies, Inc., No. 12-CV-01172-YGR, 2012 21 WL 2792441, at *4 (N.D. Cal. July 9, 2012) (dismissing manufacturing defect claim on 22 motion to dismiss). 23 Plaintiff’s claim for a strict product liability manufacturing defect fails because 24 Plaintiff does not allege facts that identify or explain how Mirena either deviated from 25 Defendant’s intended result or design or how Mirena deviated from other seemingly 26 identical Mirena models. Lucas, 726 F. Supp. 2d at 1155. Plaintiff argues that because 27 she suffered from certain injuries which she alleges were caused by Mirena, in hindsight, 28 Mirena then clearly deviated from the Defendant’s intended result. However, the SAC 7 1 contains no allegations of how the deviation occurred or whether her Mirena was 2 manufactured defectively. Plaintiff has thus provided only insufficient legal conclusions 3 that Mirena had a manufacturing defect, which are insufficient to state a legally cognizable 4 manufacturing defect claim. Defendant’s motion to dismiss Plaintiff’s Second Cause of 5 Action with respect to the strict liability manufacturing defect claim is GRANTED WITH 6 LEAVE TO AMEND. 7 B. Strict Liability – Failure to Warn Claim 8 The California Supreme Court has held that manufacturers of prescription drugs can be held strictly liable for failure to warn of knowable risks. Brown v. Superior Court, 44 10 Cal. 3d 1049, 1069 (1988). In California, a defendant manufacturer can be held strictly 11 United States District Court Northern District of California 9 liable for failure to warn if the plaintiff proves the following: “(1) the defendant 12 manufactured, distributed, or sold the product; (2) the product had potential risks that were 13 known or knowable at the time of manufacture or distribution, or sale; (3) that the potential 14 risks presented a substantial danger to users of the product; (4) that ordinary consumers 15 would not have recognized the potential risks; (5) that the defendant failed to adequately 16 warn of the potential risks; (6) that the plaintiff was harmed while using the product in a 17 reasonably foreseeable way; (7) and that the lack of sufficient warnings was a substantial 18 factor in causing the plaintiff’s harm.” Tucker v. Wright Med. Tech., Inc., No. 11-CV- 19 03086-YGR, 2013 WL 1149717, at *12 (N.D. Cal. Mar. 19, 2013) (citing Rosa v. City of 20 Seaside, 675 F. Supp. 2d 1006, 1011 (N.D. Cal. 2009)), aff’d sub nom., Rosa v. Taser Int’l, 21 Inc., 684 F.3d 941 (9th Cir. 2012) & (citing Jud. Council of Cal. Civ. Jury Instructions No. 22 1205 [entitled “Strict Liability – Failure to Warn – Essential Factual Elements”] ). With 23 respect to a known or knowable risk, the plaintiff must prove that “the defendant did not 24 adequately warn of a particular risk that was known or knowable in light of the generally 25 recognized and prevailing best scientific and medical knowledge available at the time of 26 manufacture and distribution.” Rosa, 675 F. Supp. 2d at 1012 (citing Anderson, 53 Cal. 3d 27 at 1002). 28 A manufacturer of a prescription drug is obligated to warn physicians, not patients, 8 1 of potential side effects associated with its pharmaceutical products. Motus v. Pfizer Inc., 2 358 F.3d 659, 661 (9th Cir. 2004) (“Motus II”); Carlin v. Superior Court, 13 Cal. 4th 3 1104, 1116 (1996). Known as the “learned intermediary” doctrine, the duty to warn the 4 physician – rather than the patient – is discharged if a manufacturer provides an adequate 5 warning to the physician, regardless of whether the warning reaches the patient. Motus v. 6 Pfizer Inc., 196 F. Supp. 2d 984, 991 (C.D. Cal. 2001) aff’d sub nom. Motus v. Pfizer Inc. 7 (Roerig Div.), 358 F.3d 659 (9th Cir. 2004). “A plaintiff asserting causes of action for 8 failure to warn must prove not only that no warning was provided or that the warning was 9 inadequate, but also that the inadequacy or absence of a warning caused the plaintiff’s injury.” See Wendell v. Johnson & Johnson, No. C 09–04124 CW, 2012 WL 3042302, at 11 United States District Court Northern District of California 10 *7 (N.D. Cal. July 25, 2012) (emphasis added) (internal citations omitted)); Brown, 44 Cal. 12 3d at 1062. 13 Defendant contends that it “is left to guess about what aspects of the FDA-approved 14 Mirena warnings are allegedly inadequate and how Plaintiff believes the warnings should 15 be different.” Reply at 5. The Court disagrees. 16 Plaintiff has alleged that (1) Defendant manufactured, distributed, and sold Mirena; 17 (2) Mirena poses potential risks to users such as developing infection, cysts, and physical 18 pain and these risks were known or knowable at the time of manufacture or distribution, 19 see SAC ¶22, 70-74 (alleging that the Department of Health and Human Services issued a 20 warning in March 2009 regarding Defendant’s advertising material noting that Defendant 21 did not communicate any risk information); (3) the potential risks presented a substantial 22 danger to users of Mirena; (4) ordinary consumers such as Plaintiff would not have 23 recognized the potential risks; (5) the Defendant failed to adequately warn of the potential 24 risks of developing infections and cysts, among other injuries; (6) Plaintiff was harmed 25 while using the product in a reasonably foreseeable way; (7) and the lack of sufficient 26 warnings was a substantial factor in causing Plaintiff’s harm because Plaintiff alleges she 27 would not have used Mirena had she received adequate warnings disclosing these risks, see 28 id. ¶ 79. Plaintiff has thus alleged in the SAC sufficient facts to state a plausible claim for 9 1 strict liability failure to warn. Neither party raised the learned intermediary defense in their papers with respect to 3 strict liability failure to warn. Had Defendant invoked the learned intermediary defense at 4 this procedural stage, the result would be no different. Defendant can discharge its duty to 5 warn about Mirena if it provides an adequate warning to the physician. Motus I, 196 F. 6 Supp. 2d at 991. Here, Plaintiff has also alleged that Defendant’s warning to her physician 7 was non-existent or inadequate and that the inadequacy of the warning or its absence 8 caused Plaintiff’s injury. See SAC ¶ 79 (“Plaintiff did not have the same knowledge as 9 Defendant and no adequate warning was communicated to her or her physician(s). Had 10 the Plaintiff received adequate warnings regarding Mirena, she would not have had the 11 United States District Court Northern District of California 2 device implanted.”). At the motion to dismiss stage, even had Defendant raised the 12 learned intermediary defense, Plaintiff has alleged sufficient facts to withstand the motion 13 to dismiss. See Wendell v. Johnson & Johnson, No. C 09-04124 CW, 2010 WL 271423, at 14 *3 (N.D. Cal. Jan. 20, 2010) (Wilkin, J.) (denying drug manufacturer’s motion to dismiss 15 because at pleading stage manufacturer could not prove that the learned intermediary 16 doctrine barred all plaintiff’s claims where plaintiff alleged manufacturer did not 17 adequately convey to physicians the known or knowable risks of the drug). 18 19 For the foregoing reasons, Defendant’s motion to dismiss Plaintiff’s Second Cause of Action with respect to the strict liability – failure to warn claim is DENIED. 20 C. Strict Liability – Design Defect Claim 21 A design defects exist where a product is built in accordance with its intended 22 specifications, but the design itself is inherently defective. Barker, 20 Cal. 3d at 429. 23 Controlling California authority unequivocally prohibits strict liability claims for design 24 defect against manufacturers of prescription drugs. See Brown, 44 Cal. 3d at 1069 25 (holding that no manufacturer strict liability exists for design defect injuries caused by a 26 prescription drug); Tucker, 2013 WL 1149717, at * 6 (collecting cases in accord and 27 dismissing strict liability claim based on design defect as precluded by California law). 28 Moreover, the California Court of Appeal has squarely held that a manufacturer of 10 1 intrauterine devices cannot be held strictly liable for design defect. Plenger v. Alza Corp., 2 11 Cal. App. 4th 349, 360-61 (1992). Here, Plaintiff alleges that her Mirena administers a prescribed drug, levonorgestrel, 3 4 and was installed by a healthcare provider at Community Physicians Network for Women 5 in Indianapolis, Indiana. SAC ¶¶ 14-16, 29. Accordingly, the Court holds that Plaintiff’s 6 strict liability claim based on purported design defect in Mirena is precluded as a matter of 7 California law. The Court therefore GRANTS WITHOUT LEAVE TO AMEND 8 Defendant’s motion to dismiss Plaintiff’s strict liability – design defect claim. 9 10 III. Implied and Express Warranty Claims United States District Court Northern District of California 11 A. Breach of Implied Warranty 12 Plaintiff alleges in her Third Cause of Action for breach of implied warranty that 13 Defendant warranted Mirena to be of merchantable quality, safe and “fit for the ordinary 14 purpose” of its use to Plaintiff, other Mirena users, physicians and healthcare providers. 15 SAC ¶¶ 87-88. To maintain her claim, a plaintiff must allege (1) that she intended to use 16 the product for a particular purpose; (2) that the defendant had reason to know of this 17 purpose; (3) that the plaintiff relied on defendant’s skill or judgment to provide a product 18 suitable for this purpose; (4) that the defendant had reason to know that buyers relied on its 19 skill or judgment; and (5) that the product was unfit for the purpose for which it was 20 purchased and that it subsequently damaged the plaintiff. Frisby-Cadillo v. Mylan, Inc., 21 No. C 09-05816 SI, 2010 WL 1838729, at *3 (N.D. Cal. May 5, 2010) (citing Keith v. 22 Buchanan, 173 Cal. App. 3d 13, 25 (1985)). 23 The Court finds that Plaintiff has adequately stated a claim for breach of an implied 24 warranty. Plaintiff has alleged that she chose Mirena because it was promoted as a safe 25 and effective method of birth control, SAC ¶ 91; Defendant had reason to know of this 26 purpose because it promoted Mirena as a contraceptive, id. ¶¶ 87-88; Plaintiff relied on 27 Defendant’s skill and judgment as Defendant is in the business of designing, 28 manufacturing, advertising and distributing prescription drugs and women’s healthcare 11 1 products, id. ¶ 90; that Defendant knew or had reason to know that consumers so relied, id. 2 ¶ 87; that Mirena was unfit for that purpose and Plaintiff subsequently suffered from 3 infections, a cyst and abdominal pain as a result of Mirena, id. ¶¶ 93-95. These 4 allegations, while brief, are sufficient to state a claim. 5 In addition to challenging the sufficiency of the pleadings, Defendant also argues that her breach of implied warranty claim fails because she was not in contractual privity 7 with Defendant. See Blanco v. Baxter Healthcare Corp., 158 Cal. App. 4th 1039, 1058-59 8 (2008). However, California recognizes an exception to the privity requirement in breach 9 of warranty claims pertaining to food or drug products. Wendell, 2010 WL 271423, at *5 10 (citing Gottsdanker v. Cutter Labs., 182 Cal. App. 2d 602 (1960)); see also Arnold v. Dow 11 United States District Court Northern District of California 6 Chem. Co., 91 Cal. App. 4th 698, 720 (2001) (citing Gottsdanker with approval). This 12 exception allows an implied warranty to run from the manufacturer to the ultimate 13 consumer. Aaronson v. Vital Pharm., Inc., No. 09-CV-1333 W (CAB), 2010 WL 625337, 14 at *5 (S.D. Cal. Feb. 17, 2010) (citing Windham at Carmel Mtn. Ranch Assn. v. Superior 15 Court, 109 Cal. App. 4th 1162, 1168-70 (2003)). 16 Accordingly, that Plaintiff was not in privity with Defendant does not bar her 17 implied breach of warranty claim as a matter of law given that claim is sufficiently 18 pleaded. Defendant’s motion to dismiss Plaintiff’s Third Cause of Action is DENIED. 19 2. Breach of Express Warranty 20 Under California law, “[i]n order to plead a cause of action for breach of express 21 warranty, one must allege the exact terms of the warranty, plaintiff’s reasonable reliance 22 thereon, and a breach of that warranty which proximately causes plaintiff injury.” Frisby- 23 Cadillo, 2010 WL 1838729, at *4 (citing Williams v. Beechnut Nutrition Corp., 185 Cal. 24 App. 3d 135, 142 (1986)). In Frisby-Cadillo, the court recognized that a plaintiff need not 25 quote the exact terms of the warranty when the plaintiff alleged that defendant “utilized the 26 advertising media to urge the use and application of [the subject product] and expressly 27 warranted to the general public including plaintiff herein, that said product was effective, 28 proper and safe for its intended use.” Id. (quotation marks omitted). Indeed, “[p]roduct 12 1 advertisements, brochures, or packaging can serve to create part of an express warranty.” 2 Rosales v. FitFlop USA, LLC, 882 F. Supp. 2d 1168, 1178 (S.D. Cal. 2012)) (citing Cal. 3 Com. Code § 2313(1)(b) (2002)). While a plaintiff need not have relied on the individual 4 advertisements, plaintiff must have actually been exposed to the advertising. See In re 5 Toyota Motor Corp. Unintended Acceleration Mktg., Sales Practices, & Products Liab. 6 Litig., 754 F. Supp. 2d 1145, 1183 (C.D. Cal. 2010). 7 Contrary to Defendant’s argument, Plaintiff has pleaded a breach of express 8 warranty claim. First, Plaintiff has sufficiently pleaded that Mirena’s advertising failed to 9 adequately warn about the potential health risks of Mirena and that Defendant promoted Mirena as safe for use. SAC ¶¶ 18-19, 21, 97. Plaintiff’s allegations in the SAC allow for 11 United States District Court Northern District of California 10 an inference to be drawn that Plaintiff knew about Defendant’s claims that Mirena was 12 safe and effective for use by the public at large. Id. ¶ 97. Second, Plaintiff alleges that she 13 reasonably relied on these warranties in choosing Mirena, thus obviating the requirement 14 to show privity in a breach of express warranty claim. Id. ¶¶ 98-99. See Fieldstone Co. v. 15 Briggs Plumbing Products, Inc., 54 Cal. App. 4th 357, 369 n. 10 (1997), superseded by 16 statute on other grounds as stated in Greystone Homes, Inc. v. Midtec, Inc., 168 Cal. App. 17 4th 1194, 1213 (2008) (an exception to the general rule that privity of contract is a required 18 element of an express breach of warranty cause of action exists where a plaintiff’s decision 19 to purchase the product was made in reliance on the manufacturers’ written representations 20 in labels or advertising materials). Third, Plaintiff alleged that a breach of the express 21 warranty proximately caused her injuries when she suffered from infections, an ovarian 22 cyst, and abdominal pain caused by Mirena. SAC ¶¶ 101. Plaintiff has thus stated a claim 23 for breach of express warranty. Identification of the specific statements used by Plaintiff 24 in her purchasing decision are certainly an appropriate avenue for discovery, but at this 25 procedural stage Plaintiff has adequately pleaded facts to establish an express warranty that 26 was reasonably relied upon. Thus, Defendant’s motion to dismiss Plaintiff’s Fourth Cause 27 of Action for breach of express warranty is DENIED. 28 13 1 CONCLUSION 2 For the foregoing reasons, the Court: 3 1) negligence; 4 5 DENIES Defendant’s motion to dismiss Plaintiff’s First Cause of Action for 2) GRANTS WITH LEAVE TO AMEND Defendant’s motion to dismiss 6 Plaintiff’s Second Cause of Action with respect to the strict liability – 7 manufacturing defect claim; 8 3) with respect to the strict liability – failure to warn claim; 9 10 DENIES Defendant’s motion to dismiss Plaintiff’s Second Cause of Action 4) GRANTS WITHOUT LEAVE TO AMEND Defendant’s motion to dismiss United States District Court Northern District of California 11 Plaintiff’s Second Cause of Action with respect to strict liability – design 12 defect claim; 13 5) breach of implied warranty; and 14 15 16 DENIES Defendant’s motion to dismiss Plaintiff’s Third Cause of Action for 3) DENIES Defendant’s motion to dismiss Plaintiff’s Fourth Cause of Action for breach of express warranty. 17 18 19 Should Plaintiff amend the complaint, any amended pleading shall be filed no later than January 9, 2014. 20 21 IT IS SO ORDERED. 22 23 24 Dated: 12/19/13 ______________________________________ THELTON E. HENDERSON, JUDGE UNITED STATES DISTRICT COURT 25 26 27 28 14

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