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Garcia v. Boston Scientific Corp.

United States District Court, E.D. California

June 25, 2019

IDA GARCIA, Plaintiff


         I. Background

         Plaintiff Ida Garcia suffered from stress urinary incontinence. To address the condition, on August 22, 2011, Plaintiff was implanted with an Obtryx Transobturator Sling System (“Product”) made by Defendant Boston Scientific Corporation. After the Product was implanted, Plaintiff experienced severe pelvic pain and other side effects. On April 22, 2016, Plaintiff had the Product removed from her body.

         The Product is composed of surgical mesh. Devices made of surgical mesh have been used since the 1950s to treat hernias. Starting in the 1990s, they have been used to treat stress urinary incontinence and pelvic organ prolapse. There have been various warnings over the years that these devices were causing problems in patients. On July 13, 2011, the U.S. Food and Drug Administration issued a safety warning about surgical mesh devices used to treat pelvic organ prolapse. On April 16, 2019, the FDA ordered Defendant and other medical device manufacturers to stop selling the Product and similar devices used to treat stress urinary incontinence and pelvic organ prolapse. Plaintiff alleges that even before 2011, Defendant was aware that the Product was defective and caused injury to those in whom it was implanted.

         Plaintiff has filed suit alleging seven causes of action under California law: 1) strict liability manufacturing defect, 2) strict liability failure to warn, 3) strict liability failure to provide adequate warning, 4) breach of implied warranty, 4) breach of express warranty, 6) negligence, and, 7) fraudulent misrepresentation and concealment. Defendant has filed a motion to dismiss, arguing that several of Plaintiff's causes of action fail to state a legal claim. Doc. 7-1. Plaintiff opposes the motion. Doc. 10.

         II. Legal Standard

         Under Federal Rule of Civil Procedure 12(b)(6), a claim may be dismissed because of the plaintiff's “failure to state a claim upon which relief can be granted.” Fed. Rule Civ. Proc. 12(b)(6). A dismissal under Rule 12(b)(6) may be based on the lack of a cognizable legal theory or on the absence of sufficient facts alleged under a cognizable legal theory. Conservation Force v. Salazar, 646 F.3d 1240, 1242 (9th Cir. 2011); Johnson v. Riverside Healthcare Sys., 534 F.3d 1116, 1121 (9th Cir. 2008). In reviewing a complaint under Rule 12(b)(6), all allegations of material fact are taken as true and construed in the light most favorable to the non-moving party. Faulkner v. ADT Sec. Servs., 706 F.3d 1017, 1019 (9th Cir. 2013). However, complaints that offer no more than “labels and conclusions” or “a formulaic recitation of the elements of action will not do.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009). The Court is not required “to accept as true allegations that are merely conclusory, unwarranted deductions of fact, or unreasonable inferences.” Wilson v. Hewlett-Packard Co., 668 F.3d 1136, 1145 n. 4 (9th Cir. 2012); Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir. 2001). To avoid a Rule 12(b)(6) dismissal, “a complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face. A claim has facial plausibility when the plaintiff pleads factual content that allows the court draw the reasonable inference that the defendant is liable for the misconduct alleged. The plausibility standard is not akin to a ‘probability requirement,' but it asks for more than a sheer possibility that a defendant has acted unlawfully.” Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009); Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 570 (2007). The Ninth Circuit has distilled the following principles from Iqbal and Twombly: (1) to be entitled to the presumption of truth, allegations in a complaint or counterclaim may not simply recite the elements of a cause of action, but must contain sufficient allegations of underlying facts to give fair notice and to enable the opposing party to defend itself effectively; (2) the factual allegations that are taken as true must plausibly suggest an entitlement to relief, such that it is not unfair to require the opposing party to be subjected to the expense of discovery and continued litigation. Starr v. Baca, 652 F.3d 1202, 1216 (9th Cir. 2011). In assessing a motion to dismiss, courts may consider documents attached to the complaint, documents incorporated by reference in the complaint, or matters of judicial notice. Dichter-Mad Family Partners. LLP v. United States, 709 F.3d 749, 761 (9th Cir. 2013). If a motion to dismiss is granted, “[the] district court should grant leave to amend even if no request to amend the pleading was made.” Henry A. v. Willden, 678 F.3d 991, 1005 (9th Cir. 2012). However, leave to amend need not be granted if amendment would be futile or if the plaintiff has failed to cure deficiencies despite repeated opportunities. Mueller v. Aulker, 700 F.3d 1180, 1191 (9th Cir. 2012); Telesaurus VPC. LLC v. Power, 623 F.3d 998, 1003 (9th Cir. 2010).

         III. Discussion

         A. Manufacturing Defect - Strict Liability and Negligence

         Defendant argues that Plaintiff has not successfully stated a claim for manufacturing defect under the strict liability and negligence (first and sixth) causes of action. Generally, a “manufacturing or production defect is readily identifiable because a defective product is one that differs from the manufacturer's intended result or from other ostensibly identical units of the same product line.” Barker v. Lull Engineering Co., 20 Cal.3d 413, 429 (Cal. 1978). The “manufacturing defect” theory posits that “a suitable design is in place, but that the manufacturing process has in some way deviated from that design.” In re Coordinated Latex Glove Litigation, 99 Cal.App.4th 594, 613 (Cal.App. 4th Dist. 2002). That is, “the product does not conform to the manufacturer's design.” Garrett v. Howmedica Osteonics Corp., 214 Cal.App.4th 173, 190 (Cal.App. 2nd Dist. 2013). A plaintiff pursuing a manufacturing defect claim must inter alia identify/explain how the product either deviated from the manufacturer's intended result/design or how the product deviated from other seemingly identical models; a bare allegation that the product had “a manufacturing defect” is an insufficient legal conclusion. Lucas v. City of Visalia, 726 F.Supp.2d 1149, 1155 (E.D. Cal. 2010).

         Defendant asserts “There are no factual allegations as to how plaintiff's particular device purportedly deviated from Boston Scientific's intended result or from other identical unit of the same product line.” Doc. 7-1, 4:23-25. Plaintiff responds that the Products differed from Defendant's intended result in the following ways:

in written product descriptions, product labels, promotional and other materials directed at patients and their physicians, BSC represented that implanting the Product in patients was effective, reliable, safer than alternatives, and involved minimally invasive surgical techniques with few compli1cations. No reasonable manufacturer would intend for its product to deviate so drastically from the purposes for which it was advertised and sold….
The use of polypropylene and collagen in the Product, as compared with other materials, causes adverse immune reactions and injuries.
The mesh material reacts to human tissues and harbors infections.
The use of arms and anchors in the Product, when placed in patients, can injure major nerve ...

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