United States District Court, E.D. California
ORDER RE: MOTION TO DISMISS
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
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.
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.
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).
Manufacturing Defect - Strict Liability and
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).
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
The use of arms and anchors in the Product, when placed in
patients, can injure major nerve ...