United States District Court, D. Arizona
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 ...