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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UNITED STATES DISTRICT COURT

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NORTHERN DISTRICT OF CALIFORNIA

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NICOLE BAKER,
Plaintiff,

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v.
BAYER HEALTHCARE
PHARMACEUTICALS, INC.,

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NO. C13-0490 TEH
ORDER GRANTING IN PART AND
DENYING IN PART DEFENDANT’S
MOTION TO DISMISS

Defendant.

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United States District Court
Northern District of California

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This matter came before the Court on December 9, 2013, on Defendant Bayer

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Healthcare Pharmaceuticals, Inc.’s (“Defendant”) motion to dismiss Plaintiff Nicole

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Baker’s (“Plaintiff”) Second Amended Complaint (“SAC”). After carefully considering

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the parties’ written and oral arguments, and relevant law, the Court now GRANTS in part

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and DENIES in part Defendant’s motion.

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BACKGROUND
This suit is a product liability case stemming from Plaintiff’s use of the intrauterine

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contraceptive device known as “Mirena.” Mirena is made by Defendant, a Delaware

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corporation, which is in the business of designing, manufacturing, marketing, testing, and

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distributing prescription drugs and women’s healthcare products, including Mirena. SAC

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¶¶ 4, 10, Docket No. 21. Mirena is a T-shaped polyethylene frame with a steroid reservoir

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that releases 20 μg/day of levonorgestrel, a prescription medication used as a

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contraceptive; it is inserted into the uterus by a healthcare provider during an office visit.

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The federal Food and Drug Administration approved Defendant’s New Drug Application

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for Mirena in December 2000. Id. ¶ 14-15.

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Plaintiff, a California resident, alleges that Mirena’s label does not accurately warn

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and understates the risks of certain medical conditions or injuries associated with use of

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Mirena, including spontaneous migration of Mirena, perforation of the uterus, embedment,

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infections, cysts, ectopic and intrauterine pregnancy, adhesions, fetal injury and fetal death

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caused by Mirena. Id. ¶¶ 18-19. Plaintiff alleges that Defendant did not effectively test or

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analyze results of pre-market tests before putting Mirena on the market, but nonetheless

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promoted Mirena through social media and online marketing campaigns while understating

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the associated risks. Id. ¶¶ 20-21. Plaintiff further alleges that in March 2009, the

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Department of Health and Human Services’ Division of Drug Marketing, Advertising, and

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Communications (“DDMAC”) issued a warning regarding Defendant’s advertising
materials for Mirena, stating that they did not communicate any risk information and

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United States District Court
Northern District of California

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inadequately communicated Mirena’s indications. Id. ¶¶ 22-23. Plaintiff also alleges that

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in December 2009, DDMAC contacted Defendant regarding its “Mirena Simple Styles

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Statements Program,” which Plaintiff alleges were consumer-directed live presentations

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directed toward “busy moms” that utilized scripts that omitted information regarding the

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serious risks associated with using Mirena. Id. ¶¶ 24-27. Plaintiff alleges that Defendant

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concealed its knowledge of the defects in their products from the Plaintiff, her physicians,

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hospitals, pharmacists, the FDA and the public in general. Id. ¶ 28.

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Plaintiff had her Mirena inserted on January 6, 2010 at Community Physicians

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Network for Women in Indianapolis, Indiana by her healthcare provider. Plaintiff alleges

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that she chose Mirena because it was promoted as a safe and effective method of birth

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control. Id. ¶ 29. On June 21, 2011, after suffering from extreme pelvic pain, Plaintiff was

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rushed to the emergency room (“ER”) at Parkview Community Hospital in Riverside,

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California. She received treatment for abdominal pain. Id. ¶ 30. Over the next four

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months, Plaintiff repeatedly went to the ER. On June 28, 2011, Plaintiff went to the ER at

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Riverside Community Hospital in Riverside, California for sharp pains on her left side. An

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ultrasound showed a left ovarian cyst. Plaintiff was treated for her pain. Id. ¶ 31. On

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September 3, 2011, Plaintiff went to the ER at Parkview Community Hospital for severe

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abdominal pain, nausea and pain associated with an ovarian cyst. Id. ¶ 32. On October 10,
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2011, Plaintiff was again rushed to the ER at Riverside Community Hospital for extreme

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pelvic pain, and noted that her pain level was a 7 out of 10. Plaintiff had a urinary tract

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infection, a fever and leukocytosis. Id. ¶ 33. Plaintiff’s Mirena “was expelled” on October

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20, 2011. After removal, Plaintiff continued to suffer from vaginal bleeding, pelvic pain,

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and pain when urinating. Id. ¶ 34. Prior to having Mirena, Plaintiff alleges that she did

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not suffer from these injuries. Id. In sum, Plaintiff maintains she has suffered severe

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injuries, including, but not limited to, abdominal pain, an ovarian cyst, infections,

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substantial mental and physical pain and suffering, and has incurred medical expenses for

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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

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United States District Court
Northern District of California

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pursuant to 28 U.S.C. § 1332. She asserts claims against Defendant for negligence, for

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strict liability for design defects, failure to warn, and manufacturing defects, as well as for

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breach of implied and express warranties. On March 12, 2013, the Court stayed the case

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pending a motion to transfer the case as potentially related to the Judicial Panel on

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Multidistrict Litigation (“JPML”) Docket No. 2434, In re: Mirena IUD Products Liability

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Litigation. Docket No. 13. On August 7, 2013, the JPML vacated the conditional transfer

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of the case because the Panel found that Plaintiff alleged injuries broader than injury

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related to the risk of perforation and migration associated with Mirena, which was the

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scope of the MDL. Docket Nos. 14, 16. After the Court lifted the stay, Plaintiff filed the

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SAC and this motion to dismiss followed.

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LEGAL STANDARD

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Dismissal is appropriate under Rule 12(b)(6) of the Federal Rules of Civil

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Procedure 1 when a plaintiff’s allegations fail “to state a claim upon which relief can be

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granted.” Fed. R. Civ. P. 12(b)(6). A dismissal under Rule 12(b)(6) “can be based on the

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lack of a cognizable legal theory or the absence of sufficient facts alleged under a

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All references to “Rules” hereinafter refer to the Federal Rules of Civil Procedure.
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cognizable legal theory.” Balistreri v. Pacifica Police Dep’t, 901 F.2d 696, 699 (9th Cir.

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1990).
Under Federal Rule of Civil Procedure 8(a), a plaintiff must plead “enough facts to

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state a claim to relief that is plausible on its face” with sufficient specificity to “give the

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defendant fair notice of what the . . . claim is and the grounds upon which it rests.” Bell

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Atlantic Corp. v. Twombly, 550 U.S. 544, 545, 570 (2007) (citation and quotation marks

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omitted). “Rule 8 . . . does not require ‘detailed factual allegations,’ but it demands more

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than an unadorned, the-defendant-unlawfully-harmed-me accusation.” Ashcroft v. Iqbal,

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556 U.S. 662, 678 (2009) (citation omitted). Plausibility does not equate to probability,

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but it requires “more than a sheer possibility that a defendant has acted unlawfully.” Id.

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United States District Court
Northern District of California

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“A claim has facial plausibility when the plaintiff pleads factual content that allows the

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court to draw the reasonable inference that the defendant is liable for the misconduct

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alleged.” Id. In ruling on a motion to dismiss, a court must “accept all material allegations

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of fact as true and construe the complaint in a light most favorable to the non-moving

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party.” Vasquez v. Los Angeles Cnty., 487 F.3d 1246, 1249 (9th Cir. 2007). The Court,

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however, is not “bound to accept as true a legal conclusion couched as a factual

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allegation.” Iqbal, 556 U.S. at 678 (internal quotation marks omitted). Dismissal of

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claims that fail to meet this standard should be with leave to amend unless it is clear that

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amendment could not possibly cure the deficiencies in the complaint. Steckman v. Hart

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Brewing, Inc., 143 F.3d 1293, 1296 (9th Cir. 1998).

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DISCUSSION
Defendant moves for dismissal on all claims under Rule 12(b)(6). For the reasons

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discussed below, Defendant’s motion is GRANTED in part and DENIED in part.

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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
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injury to the Plaintiff. Garcia v. W & W Cmty. Dev., Inc., 186 Cal. App. 4th 1038, 1044

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(2010). Defendant argues Plaintiff’s negligence claim is insufficiently pleaded under Rule

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8 because Plaintiff does not allege sufficient facts and relies on bare legal conclusions to

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assert her negligence claim.

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The Court holds that Plaintiff has sufficiently alleged facts supporting a negligence

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claim. The Court notes at the outset that the SAC is far from a model of clarity in

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pleading. Nonetheless, the Court must construe the SAC in a light most favorable to the

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non-moving party and assume the truth of non-conclusory, material allegations of fact

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contained therein. Plaintiff alleges that Defendant had a duty to exercise reasonable care
in the designing, researching, manufacturing, marketing, supplying, promoting, packaging,

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United States District Court
Northern District of California

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selling or distributing Mirena, which included a duty to assure that Mirena would not cause

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users to suffer unreasonable, dangerous side effects. SAC ¶ 37. Plaintiff alleges that

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Defendant breached that duty when it, among other things: failed to adequately warn the

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Plaintiff, other Mirena users, physicians and the FDA of serious side effects of Mirena,

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including but not limited to, migration, perforation, embedment, ectopic pregnancies,

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intrauterine pregnancies, infections, adhesions, cysts, fetal injury and death. Id. ¶ 37(g).

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Plaintiff alleges that Defendant concealed its knowledge of the defects of Mirena from

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Plaintiff and her physician, id. ¶ 28, and that Plaintiff chose Mirena because it was

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promoted as a safe and effective method of birth control. Id. ¶ 29. Plaintiff alleges that

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Defendant’s breach caused her injuries because after Mirena was inserted by her healthcare

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provider, she subsequently suffered from a series of injuries including extreme pelvic and

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abdominal pain, an ovarian cyst, nausea, urinary tract infection, fever, leukocytosis, all of

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which culminated when “Plaintiff’s Mirena was expelled,” after which she suffered from

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vaginal bleeding, pelvic pain, and pain when urinating. Id. ¶ 34. Plaintiff alleges that prior

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to having Mirena, Plaintiff did not suffer from these injuries. Id. Thus, read in a favorable

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light, Plaintiff has alleged sufficient factual matter to state a claim for negligence that is

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plausible on its face.

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Defendant states that the “only allegation that provides any specificity at all
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includes a number of injuries that Plaintiff does not contend to have suffered from.” Reply

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at 3-4, Docket No. 26 (citing SAC ¶ 38(g) and listing alleged injuries, but omitting

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“infections” and “cysts,” which are the injuries for which Defendant allegedly failed to

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provide adequate warnings and from which Plaintiff allegedly suffered). During oral

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argument, the Court questioned Plaintiff’s counsel regarding how a negligence action may

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be maintained based on a failure to warn about injuries Plaintiff did not allege she

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sustained. Plaintiff’s counsel argued that had Plaintiff been aware of the other alleged

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risks of Mirena, including migration of Mirena, that warning, had it been given, would

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have been relevant to her decision-making process. As the parties did not specifically brief

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this narrow issue, and because “adequacy of a warning is a question of fact for the jury” in

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United States District Court
Northern District of California

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most cases, the Court cannot say at the motion to dismiss stage that Plaintiff’s theory is

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implausible as a matter of law. Jackson v. Deft, Inc., 223 Cal. App. 3d 1305, 1320 (1990).

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Defendant also argues that it cannot be held liable for a failure to test Mirena

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because California law does not recognize an independent cause of action for failure to

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test. Defendant is correct. “Imposing liability for breach of a purported ‘independent duty

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to conduct long-term testing’ would be beyond the pale of any known California tort

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doctrine, because, inter alia, the causal link between Plaintiff’s known harm, and the

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unknown outcome of the hypothetical testing is entirely speculative.” Phillippi v. Stryker

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Corp., No. 2:08-CV-02445-JAM, 2010 WL 2650596, at *2 (E.D. Cal. July 1, 2010) aff’d,

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471 F. App’x 663 (9th Cir. 2012) (citing Valentine v. Baxter Healthcare Corporation, 68

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Cal. App. 4th 1467, 1485-86 (1999)). However, Plaintiff argues that she is not asserting

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that Defendant had an independent duty to conduct long-term testing, but that the duty to

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test was one of the duties owed to Plaintiff as part of the obligation to protect the end-user

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from long term risks. This concession brings Plaintiff’s duty to test allegation within the

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ambit of Valentine, which recognizes that testing and inspection duties may be tied to

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liability for manufacture, design, and failure to warn, even if they are not maintainable as

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an independent duty. 68 Cal. App. 4th at 1485.

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Accordingly, because Plaintiff has sufficiently pleaded a negligence claim,
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Defendant’s motion to dismiss the First Cause of Action for Negligence is DENIED.

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II.

Strict Liability – Product Liability

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California recognizes strict liability for three types of product defects –

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manufacturing defects, warning defects (inadequate warnings or failure to warn), and

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design defects. Lucas v. City of Visalia, 726 F. Supp. 2d 1149, 1154 (E.D. Cal. 2010)

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(citing Anderson v. Owens-Corning Fiberglas Co., 53 Cal. 3d 987, 995 (1991)). Plaintiff

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alleges that Defendant is strictly liable under all three product defect theories.

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A.

Strict Liability – Defective Manufacturing Claim

Under the “manufacturing defect” theory, generally a “manufacturing or production

United States District Court
Northern District of California

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defect is readily identifiable because a defective product is one that differs from the

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manufacturer’s intended result or from other ostensibly identical units of the same product

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line.” Lucas, 726 F. Supp. 2d at 1155 (citing Barker v. Lull Engineering Co., 20 Cal. 3d

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413, 429 (1978)). The “manufacturing defect” theory posits that “a suitable design is in

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place, but that the manufacturing process has in some way deviated from that design.” Id.

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(citation omitted). To survive a challenge to a manufacturing defect claim under Rule

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12(b)(6), a plaintiff must “identify/explain how the [product] either deviated from

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[defendant’s] intended result/design or how the [product] deviated from other seemingly

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identical [product] models.” Id. (emphasis in original) (citing Barker, 20 Cal. 3d at 429);

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see also Trabakoolas v. Watts Water Technologies, Inc., No. 12-CV-01172-YGR, 2012

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WL 2792441, at *4 (N.D. Cal. July 9, 2012) (dismissing manufacturing defect claim on

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motion to dismiss).

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Plaintiff’s claim for a strict product liability manufacturing defect fails because

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Plaintiff does not allege facts that identify or explain how Mirena either deviated from

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Defendant’s intended result or design or how Mirena deviated from other seemingly

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identical Mirena models. Lucas, 726 F. Supp. 2d at 1155. Plaintiff argues that because

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she suffered from certain injuries which she alleges were caused by Mirena, in hindsight,

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Mirena then clearly deviated from the Defendant’s intended result. However, the SAC
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contains no allegations of how the deviation occurred or whether her Mirena was

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manufactured defectively. Plaintiff has thus provided only insufficient legal conclusions

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that Mirena had a manufacturing defect, which are insufficient to state a legally cognizable

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manufacturing defect claim. Defendant’s motion to dismiss Plaintiff’s Second Cause of

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Action with respect to the strict liability manufacturing defect claim is GRANTED WITH

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LEAVE TO AMEND.

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B.

Strict Liability – Failure to Warn Claim

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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

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Cal. 3d 1049, 1069 (1988). In California, a defendant manufacturer can be held strictly

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United States District Court
Northern District of California

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liable for failure to warn if the plaintiff proves the following: “(1) the defendant

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manufactured, distributed, or sold the product; (2) the product had potential risks that were

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known or knowable at the time of manufacture or distribution, or sale; (3) that the potential

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risks presented a substantial danger to users of the product; (4) that ordinary consumers

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would not have recognized the potential risks; (5) that the defendant failed to adequately

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warn of the potential risks; (6) that the plaintiff was harmed while using the product in a

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reasonably foreseeable way; (7) and that the lack of sufficient warnings was a substantial

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factor in causing the plaintiff’s harm.” Tucker v. Wright Med. Tech., Inc., No. 11-CV-

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03086-YGR, 2013 WL 1149717, at *12 (N.D. Cal. Mar. 19, 2013) (citing Rosa v. City of

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Seaside, 675 F. Supp. 2d 1006, 1011 (N.D. Cal. 2009)), aff’d sub nom., Rosa v. Taser Int’l,

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Inc., 684 F.3d 941 (9th Cir. 2012) & (citing Jud. Council of Cal. Civ. Jury Instructions No.

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1205 [entitled “Strict Liability – Failure to Warn – Essential Factual Elements”] ). With

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respect to a known or knowable risk, the plaintiff must prove that “the defendant did not

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adequately warn of a particular risk that was known or knowable in light of the generally

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recognized and prevailing best scientific and medical knowledge available at the time of

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manufacture and distribution.” Rosa, 675 F. Supp. 2d at 1012 (citing Anderson, 53 Cal. 3d

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at 1002).

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A manufacturer of a prescription drug is obligated to warn physicians, not patients,
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of potential side effects associated with its pharmaceutical products. Motus v. Pfizer Inc.,

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358 F.3d 659, 661 (9th Cir. 2004) (“Motus II”); Carlin v. Superior Court, 13 Cal. 4th

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1104, 1116 (1996). Known as the “learned intermediary” doctrine, the duty to warn the

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physician – rather than the patient – is discharged if a manufacturer provides an adequate

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warning to the physician, regardless of whether the warning reaches the patient. Motus v.

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Pfizer Inc., 196 F. Supp. 2d 984, 991 (C.D. Cal. 2001) aff’d sub nom. Motus v. Pfizer Inc.

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(Roerig Div.), 358 F.3d 659 (9th Cir. 2004). “A plaintiff asserting causes of action for

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failure to warn must prove not only that no warning was provided or that the warning was

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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

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United States District Court
Northern District of California

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*7 (N.D. Cal. July 25, 2012) (emphasis added) (internal citations omitted)); Brown, 44 Cal.

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3d at 1062.

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Defendant contends that it “is left to guess about what aspects of the FDA-approved

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Mirena warnings are allegedly inadequate and how Plaintiff believes the warnings should

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be different.” Reply at 5. The Court disagrees.

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Plaintiff has alleged that (1) Defendant manufactured, distributed, and sold Mirena;

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(2) Mirena poses potential risks to users such as developing infection, cysts, and physical

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pain and these risks were known or knowable at the time of manufacture or distribution,

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see SAC ¶22, 70-74 (alleging that the Department of Health and Human Services issued a

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warning in March 2009 regarding Defendant’s advertising material noting that Defendant

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did not communicate any risk information); (3) the potential risks presented a substantial

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danger to users of Mirena; (4) ordinary consumers such as Plaintiff would not have

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recognized the potential risks; (5) the Defendant failed to adequately warn of the potential

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risks of developing infections and cysts, among other injuries; (6) Plaintiff was harmed

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while using the product in a reasonably foreseeable way; (7) and the lack of sufficient

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warnings was a substantial factor in causing Plaintiff’s harm because Plaintiff alleges she

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would not have used Mirena had she received adequate warnings disclosing these risks, see

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id. ¶ 79. Plaintiff has thus alleged in the SAC sufficient facts to state a plausible claim for
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strict liability failure to warn.
Neither party raised the learned intermediary defense in their papers with respect to

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strict liability failure to warn. Had Defendant invoked the learned intermediary defense at

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this procedural stage, the result would be no different. Defendant can discharge its duty to

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warn about Mirena if it provides an adequate warning to the physician. Motus I, 196 F.

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Supp. 2d at 991. Here, Plaintiff has also alleged that Defendant’s warning to her physician

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was non-existent or inadequate and that the inadequacy of the warning or its absence

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caused Plaintiff’s injury. See SAC ¶ 79 (“Plaintiff did not have the same knowledge as

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Defendant and no adequate warning was communicated to her or her physician(s). Had

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the Plaintiff received adequate warnings regarding Mirena, she would not have had the

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United States District Court
Northern District of California

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device implanted.”). At the motion to dismiss stage, even had Defendant raised the

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learned intermediary defense, Plaintiff has alleged sufficient facts to withstand the motion

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to dismiss. See Wendell v. Johnson & Johnson, No. C 09-04124 CW, 2010 WL 271423, at

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*3 (N.D. Cal. Jan. 20, 2010) (Wilkin, J.) (denying drug manufacturer’s motion to dismiss

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because at pleading stage manufacturer could not prove that the learned intermediary

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doctrine barred all plaintiff’s claims where plaintiff alleged manufacturer did not

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adequately convey to physicians the known or knowable risks of the drug).

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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.

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C.

Strict Liability – Design Defect Claim

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A design defects exist where a product is built in accordance with its intended

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specifications, but the design itself is inherently defective. Barker, 20 Cal. 3d at 429.

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Controlling California authority unequivocally prohibits strict liability claims for design

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defect against manufacturers of prescription drugs. See Brown, 44 Cal. 3d at 1069

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(holding that no manufacturer strict liability exists for design defect injuries caused by a

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prescription drug); Tucker, 2013 WL 1149717, at * 6 (collecting cases in accord and

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dismissing strict liability claim based on design defect as precluded by California law).

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Moreover, the California Court of Appeal has squarely held that a manufacturer of
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intrauterine devices cannot be held strictly liable for design defect. Plenger v. Alza Corp.,

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11 Cal. App. 4th 349, 360-61 (1992).
Here, Plaintiff alleges that her Mirena administers a prescribed drug, levonorgestrel,

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and was installed by a healthcare provider at Community Physicians Network for Women

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in Indianapolis, Indiana. SAC ¶¶ 14-16, 29. Accordingly, the Court holds that Plaintiff’s

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strict liability claim based on purported design defect in Mirena is precluded as a matter of

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California law. The Court therefore GRANTS WITHOUT LEAVE TO AMEND

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Defendant’s motion to dismiss Plaintiff’s strict liability – design defect claim.

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III.

Implied and Express Warranty Claims

United States District Court
Northern District of California

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A.

Breach of Implied Warranty

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Plaintiff alleges in her Third Cause of Action for breach of implied warranty that

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Defendant warranted Mirena to be of merchantable quality, safe and “fit for the ordinary

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purpose” of its use to Plaintiff, other Mirena users, physicians and healthcare providers.

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SAC ¶¶ 87-88. To maintain her claim, a plaintiff must allege (1) that she intended to use

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the product for a particular purpose; (2) that the defendant had reason to know of this

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purpose; (3) that the plaintiff relied on defendant’s skill or judgment to provide a product

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suitable for this purpose; (4) that the defendant had reason to know that buyers relied on its

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skill or judgment; and (5) that the product was unfit for the purpose for which it was

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purchased and that it subsequently damaged the plaintiff. Frisby-Cadillo v. Mylan, Inc.,

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No. C 09-05816 SI, 2010 WL 1838729, at *3 (N.D. Cal. May 5, 2010) (citing Keith v.

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Buchanan, 173 Cal. App. 3d 13, 25 (1985)).

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The Court finds that Plaintiff has adequately stated a claim for breach of an implied

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warranty. Plaintiff has alleged that she chose Mirena because it was promoted as a safe

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and effective method of birth control, SAC ¶ 91; Defendant had reason to know of this

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purpose because it promoted Mirena as a contraceptive, id. ¶¶ 87-88; Plaintiff relied on

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Defendant’s skill and judgment as Defendant is in the business of designing,

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manufacturing, advertising and distributing prescription drugs and women’s healthcare
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products, id. ¶ 90; that Defendant knew or had reason to know that consumers so relied, id.

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¶ 87; that Mirena was unfit for that purpose and Plaintiff subsequently suffered from

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infections, a cyst and abdominal pain as a result of Mirena, id. ¶¶ 93-95. These

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allegations, while brief, are sufficient to state a claim.

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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

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with Defendant. See Blanco v. Baxter Healthcare Corp., 158 Cal. App. 4th 1039, 1058-59

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(2008). However, California recognizes an exception to the privity requirement in breach

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of warranty claims pertaining to food or drug products. Wendell, 2010 WL 271423, at *5

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(citing Gottsdanker v. Cutter Labs., 182 Cal. App. 2d 602 (1960)); see also Arnold v. Dow

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United States District Court
Northern District of California

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Chem. Co., 91 Cal. App. 4th 698, 720 (2001) (citing Gottsdanker with approval). This

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exception allows an implied warranty to run from the manufacturer to the ultimate

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consumer. Aaronson v. Vital Pharm., Inc., No. 09-CV-1333 W (CAB), 2010 WL 625337,

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at *5 (S.D. Cal. Feb. 17, 2010) (citing Windham at Carmel Mtn. Ranch Assn. v. Superior

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Court, 109 Cal. App. 4th 1162, 1168-70 (2003)).

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Accordingly, that Plaintiff was not in privity with Defendant does not bar her

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implied breach of warranty claim as a matter of law given that claim is sufficiently

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pleaded. Defendant’s motion to dismiss Plaintiff’s Third Cause of Action is DENIED.

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2.

Breach of Express Warranty

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Under California law, “[i]n order to plead a cause of action for breach of express

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warranty, one must allege the exact terms of the warranty, plaintiff’s reasonable reliance

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thereon, and a breach of that warranty which proximately causes plaintiff injury.” Frisby-

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Cadillo, 2010 WL 1838729, at *4 (citing Williams v. Beechnut Nutrition Corp., 185 Cal.

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App. 3d 135, 142 (1986)). In Frisby-Cadillo, the court recognized that a plaintiff need not

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quote the exact terms of the warranty when the plaintiff alleged that defendant “utilized the

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advertising media to urge the use and application of [the subject product] and expressly

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warranted to the general public including plaintiff herein, that said product was effective,

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proper and safe for its intended use.” Id. (quotation marks omitted). Indeed, “[p]roduct
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advertisements, brochures, or packaging can serve to create part of an express warranty.”

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Rosales v. FitFlop USA, LLC, 882 F. Supp. 2d 1168, 1178 (S.D. Cal. 2012)) (citing Cal.

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Com. Code § 2313(1)(b) (2002)). While a plaintiff need not have relied on the individual

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advertisements, plaintiff must have actually been exposed to the advertising. See In re

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Toyota Motor Corp. Unintended Acceleration Mktg., Sales Practices, & Products Liab.

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Litig., 754 F. Supp. 2d 1145, 1183 (C.D. Cal. 2010).

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Contrary to Defendant’s argument, Plaintiff has pleaded a breach of express

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warranty claim. First, Plaintiff has sufficiently pleaded that Mirena’s advertising failed to

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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

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United States District Court
Northern District of California

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an inference to be drawn that Plaintiff knew about Defendant’s claims that Mirena was

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safe and effective for use by the public at large. Id. ¶ 97. Second, Plaintiff alleges that she

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reasonably relied on these warranties in choosing Mirena, thus obviating the requirement

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to show privity in a breach of express warranty claim. Id. ¶¶ 98-99. See Fieldstone Co. v.

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Briggs Plumbing Products, Inc., 54 Cal. App. 4th 357, 369 n. 10 (1997), superseded by

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statute on other grounds as stated in Greystone Homes, Inc. v. Midtec, Inc., 168 Cal. App.

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4th 1194, 1213 (2008) (an exception to the general rule that privity of contract is a required

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element of an express breach of warranty cause of action exists where a plaintiff’s decision

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to purchase the product was made in reliance on the manufacturers’ written representations

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in labels or advertising materials). Third, Plaintiff alleged that a breach of the express

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warranty proximately caused her injuries when she suffered from infections, an ovarian

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cyst, and abdominal pain caused by Mirena. SAC ¶¶ 101. Plaintiff has thus stated a claim

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for breach of express warranty. Identification of the specific statements used by Plaintiff

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in her purchasing decision are certainly an appropriate avenue for discovery, but at this

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procedural stage Plaintiff has adequately pleaded facts to establish an express warranty that

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was reasonably relied upon. Thus, Defendant’s motion to dismiss Plaintiff’s Fourth Cause

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of Action for breach of express warranty is DENIED.

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CONCLUSION

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For the foregoing reasons, the Court:

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1)

negligence;

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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

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Plaintiff’s Second Cause of Action with respect to the strict liability –

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manufacturing defect claim;

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3)

with respect to the strict liability – failure to warn claim;

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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

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Plaintiff’s Second Cause of Action with respect to strict liability – design

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defect claim;

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5)

breach of implied warranty; and

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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.

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Should Plaintiff amend the complaint, any amended pleading shall be filed no later
than January 9, 2014.

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IT IS SO ORDERED.

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Dated: 12/19/13

______________________________________
THELTON E. HENDERSON, JUDGE
UNITED STATES DISTRICT COURT

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