Hix v. Boston Scientific Corp.

          ORDER

          Honorable Diane J. Humetewa United States District Judge

         Before the Court is Defendant Boston Scientific Corporation's (“Boston Scientific”) Motion to Dismiss Plaintiffs' First Amended Complaint. (Doc. 19). Plaintiffs Ms. Jamie Hix (“Ms. Hix”) and Mr. Byron Hix (“Mr. Hix”) filed a Response (Doc. 22) and Boston Scientific filed a Reply. (Doc. 23).

         I. BACKGROUND

         Ms. Hix suffered from stress urinary incontinence. (Doc. 16 ¶37). To treat her condition, Ms. Hix choose to have Boston Scientific's Solyx Single Incision Sling System (“Solyx Sling”) surgically implanted on November 28, 2016. (Id. ¶¶ 5, 37-39). The Solyx Sling is a surgical mesh device that was manufactured, packaged, labeled, marketed, sold, and distributed by Boston Scientific as a treatment for stress urinary incontinence and pelvic organ prolapse. (Id. ¶¶ 12-13). The Solyx Sling contains non-absorbable synthetic, monofilament polypropylene mesh. (Id. ¶ 14).

         After the Solyx Sling was implanted, Ms. Hix alleges that she experienced serious adverse health effects, including chronic pelvic pain, impaired mobility, dyspareunia, and infections. (Id. ¶ 39). On December 19, 2017, Ms. Hix underwent surgery to have the Solyx Sling removed. (Id. ¶ 40). She also required Botulinum toxin A injections to her pelvic floor muscles and bilateral pudendal nerve blocks. (Id. ¶ 41). Ms. Hix was subsequently diagnosed with Complex Regional Pain Syndrome, Spastic Pelvic Floor Syndrome, and Pudendal Neuralgia, which she alleges were the result of complications from the Solyx Sling. (Id. ¶ 42). Ms. Hix continues to receive treatment for chronic pelvic pain and urinary issues. (Id.)

         Ms. Hix and her husband, Mr. Hix (collectively “Plaintiffs”), filed suit against Boston Scientific in Arizona Superior Court, pleading eleven causes of action. (Doc. 1-3 at 8-42). Boston Scientific removed the case to this Court. (Doc. 1). On March 5, 2019, Plaintiffs filed their First Amended Complaint, pleading eight causes of action: (1) Strict Products Liability for Defective Design; (2) Strict Liability for Manufacturing Defect; (3) Strict Liability for Failure to Warn/Inadequate Warning; (4) Negligence; (5) Negligent Misrepresentation; (6) Breach of Express Warranty; (7) Fraud; and (8) Loss of Consortium. (Doc. 16). Plaintiffs allege that the adverse effects occurred because, at least in part, the polypropylene in the Solyx Sling was biologically incompatible with human tissue. (Id. ¶ 14). Plaintiffs also allege that in addition to Ms. Hix, many other women^[1] that were implanted with the Solyx Sling experienced serious adverse effects, including chronic pain and functional disabilities. (Id. ¶¶ 17-21). Plaintiffs further allege that prior to Ms. Hix, and many other women being implanted with the Solyx Sling, Boston Scientific knew about, but ignored and downplayed the Solyx Sling's health risks and defects and continued to aggressively market and advertise it. (Id. ¶¶ 22-36).

         On March 19, 2019, Boston Scientific filed the pending Motion to Dismiss. Plaintiffs filed a Response, and Boston Scientific filed a Reply.

         II. LEGAL STANDARD

         Pursuant to Federal Rule of Civil Procedure (“Rule”) 12(b)(6), a cause of action 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 cause 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.” Sprewell v. Golden State Warriors, 266 F.3d 979, 988 (9th Cir. 2001), opinion amended on denial of reh'g, 275 F.3d 1187 (9th Cir. 2001). To avoid a dismissal under Rule 12(b)(6), “a complaint must contain sufficient factual matter, accepted as true, to state a claim to relief that is plausible on its face.” Twombly, 550 U.S. 544, 570 (2007). “A claim has facial plausibility when the plaintiff pleads factual content that allows the court to 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.” Iqbal, 556 U.S. at 678 (internal citations omitted) (quoting Twombly, 550 U.S. at 556). 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 the court grants a motion to dismiss, then the “district court should grant leave to amend even if no request to amend the pleading was made, unless it determines that the pleading could not possibly be cured by the allegation of other facts.” Henry A. v. Willden, 678 F.3d 991, 1005 (9th Cir. 2012).

         III. DISCUSSION

         Boston Scientific, pursuant to Rule 12(b)(6), moves to dismiss Plaintiffs' claims for: (1) Strict Liability for Manufacturing Defect (Second Cause of Action); (2) Strict Liability for Failure to Warn/Inadequate Warning (Third Cause of Action); (3) Negligence^[2] (Fourth Cause of Action); (4) Negligent Misrepresentation (Fifth Cause of Action); (5) Breach of Express Warranty (Sixth Cause of Action); and (6) Fraud (Seventh Cause of Action).^[3](Doc. 19). Additionally, Boston Scientific argues that Plaintiffs' request for punitive damages should be dismissed. (Id.)

         A. Manufacturing Defect Under Strict Liability and Negligence Theories

         Boston Scientific argues that Plaintiffs failed to state a claim for manufacturing defect under either strict liability or negligence theories because Plaintiffs failed to identify the specific manufacturing defect in the Solyx Sling that was implanted in Ms. Hix. (Doc. 19 at 3-4).

         In Arizona, the crux of a manufacturing defect claim is that the defective product differs from the manufacturer's intended result or from other ostensibly identical units of the same product line. See Spedale v. Constellation Pharm. Inc., 2019 WL 3858901, at *15 (D. Ariz. Aug. 16, 2019) (“A plaintiff should compare the injury-inducing product with other non-defective products in the same line”); Hearn v. R.J. Reynolds Tobacco Co., 279 F.Supp.2d 1096, 1115 (D. Ariz. 2003). Generally, a manufacturing defect claim posits that the product is flawed as a result of something that went wrong during the manufacturing process, whether or not a suitable design was in place. See Gomulka v. Yavapai Mach. and Auto Parts, Inc., 745 P.2d 986, 988-989 (Ariz.Ct.App. 1987). A plaintiff pursuing a manufacturing defect claim must identify/explain how the product either deviated from the manufacturer's intended result or how the product deviated from other seemingly identical models; thus, a bare allegation that the product had a manufacturing defect is an insufficient legal conclusion. See Enedina Coronado, et al., v. Costco Wholesale Corp., et al., 2019 WL 5448312, at *4 (D. Ariz. Oct. 24, 2019).

         According to Boston Scientific, Plaintiffs failed to allege factual allegations as to how Ms. Hix's particular Solyx Sling purportedly deviated from Boston Scientific's intended result or from other identical units of the same product line. (Doc. 19 at 4). In response, Plaintiffs argue that the following allegations in the complaint sufficiently alleged a manufacturing defect: (1) “that the use of polypropylene in the manufacturing process . . . result[ed] in an unwanted immune reaction” and (2) “that the welding of the mesh itself during production, which create[d] a toxic substance that contribute[d] to the degradation of the mesh and host tissue.” (Doc. 22 at 6-7). Plaintiffs further argue that they have plead a manufacturing defect claim, “[regardless of whether . . . the Solyx [Sling] differs from other products in the ...