United States District Court, D. Kansas
MEMORANDUM AND ORDER
KATHRYN H. VRATIL UNITED STATES DISTRICT JUDGE.
February 14, 2019, Amber Brooks and Jamie Gale filed suit
against Mentor Worldwide, LLC. Complaint (Doc. #1).
Plaintiffs allege that Mentor manufactured and sold defective
silicone breast implants which injured plaintiffs. Plaintiffs
sue Mentor under several theories: negligence and negligence
per se based on manufacturing defects and a failure to warn
(Count 1), strict products liability based on failure to warn
(Count 2) and strict products liability based on
manufacturing defects (Count 3). This matter is before the
Court on Mentor’s Rule 12(b)(6) Motion To Dismiss
Plaintiffs’ Complaint (Doc. #10) filed April 15,
2019. For reasons stated below, the Court
sustains Mentor’s motion.
summarized, plaintiffs’ complaint alleges the
1976, Congress passed the Medical Device Amendments
(“MDA”) to the federal Food Drug and Cosmetic Act
(“FDCA”). Under the MDA, certain medical devices
are subject to regulation depending on their classification.
The FDA eventually classified silicone gel-filled breast
implants as Class III devices. Among other requirements, the
FDCA required manufacturers of these implants to submit
pre-market approval applications (“PMAs”) with
data showing a reasonable assurance of safety and
effectiveness. Although it initially denied pre-market
approval, the FDA approved Mentor’s PMA on November 17,
2006. The FDA conditioned its approval on Mentor conducting
six post-approval studies to further assure the safety of the
devices. For a variety of reasons, Mentor did not properly
conduct these studies, or report negative test results to the
September 11, 2009, Jamie Gale received Mentor silicone gel
breast implants. After receiving them, she began to
experience health problems, including skin rashes,
inflammation, fatigue, brain fog, aching, weight gain, hair
loss, gastrointestinal issues, rising blood pressure, food
allergies, severe hearing loss and dry eyes. On May 24, 2017,
an MRI showed extracapsular silicone around both implants. On
July 25, 2017, Gale had the implants surgically removed.
After that, some of her symptoms and conditions improved or
disappeared, while others remained.
Brooks received Mentor silicone gel breast implants on March
4, 2016. After the surgery, Brooks also began to experience
health issues, including muscle and joint pain, fatigue,
vaginal infections, dry eyes and blurry vision, weight loss,
enlarged tonsils, rashes, fevers and chills, insomnia, chest
pain, constipation and dizziness. Approximately six months
later, she was hospitalized for sepsis and a life-threatening
staph infection. On February 17, 2017, Brooks had her
implants surgically removed. After that, some of her symptoms
and conditions improved or disappeared, while others
allege that Mentor’s breast implants caused their
injuries. Plaintiffs sue Mentor under several theories:
negligence and negligence per se based on manufacturing
defects and failure to warn (Count 1), strict products
liability based on failure to warn (Count 2) and strict
products liability based on manufacturing defects (Count 3).
ruling on a motion to dismiss under Rule 12(b)(6), Fed. R.
Civ. P., the Court assumes as true all well-pleaded factual
allegations and determines whether they plausibly give rise
to an entitlement of relief. Ashcroft v. Iqbal, 556
U.S. 662, 679 (2009). To survive a motion to dismiss, a
complaint must contain sufficient factual matter to state a
claim which is plausible – and not merely conceivable
– on its face. Id. at 679-80; Bell Atl.
Corp. v. Twombly, 550 U.S. 544, 555 (2007). To determine
whether a complaint states a plausible claim for relief, the
Court draws on its judicial experience and common sense.
Iqbal, 556 U.S. at 679. Plaintiffs make a facially
plausible claim when they plead factual content from which
the Court can reasonably infer that defendant is liable for
the misconduct alleged. Id. at 678. However,
plaintiffs must show more than a sheer possibility that
defendant has acted unlawfully – it is not enough to
plead facts that are “merely consistent with”
defendant’s liability. Id. (quoting
Twombly, 550 U.S. at 557). Where the well-pleaded
facts do not permit the Court to infer more than the mere
possibility of misconduct, the complaint has alleged –
but has not “shown” – that the pleader is
entitled to relief. Id. at 679. The degree of
specificity necessary to establish plausibility and fair
notice depends on context; what constitutes fair notice under
Fed. R. Civ. P. 8(a)(2) depends on the type of case.
Robbins v. Okla., 519 F.3d 1242, 1248 (10th Cir.
Court need not accept as true those allegations which state
only legal conclusions. See Iqbal, 556 U.S. at 678;
Hall v. Bellmon, 935 F.2d 1106, 1110 (10th Cir.
1991). Rather, plaintiffs bear the burden of framing their
complaint with enough factual matter to suggest that they are
entitled to relief; it is not enough to make threadbare
recitals of a cause of action accompanied by conclusory
statements. Twombly, 550 U.S. at 556. A pleading
that offers labels and conclusions, a formulaic recitation of
the elements of a cause of action or naked assertions devoid
of further factual enhancement will not stand.
Iqbal, 556 U.S. at 678.
this is a diversity case, the Court will apply federal
procedural law and the substantive law that the forum state
would apply. See Sylvia v. Wisler, No. 13-02534-EFM,
2019 WL 1384296, at *2 (D. Kan. Mar. 27, 2019) (citing
Evans v. Orion Ethanol, Inc., No. 09-1245-MLB, 2011
WL 2516929, at *1 (D. Kan. June 23, 2011)); see also
Burnham v. Humphrey Hosp. Reit Trust, Inc., 403 F.3d
709, 712 (10th Cir. 2005)). For the purposes of diversity
jurisdiction, choice-of-law rules are substantive.
Sylvia, 2019 WL 1384296, at *2. Accordingly, the
Court will apply Kansas choice-of-law rules for torts. Under
these rules, the lex loci delicti doctrine requires
the Court to apply the law of the state where the wrong
occurred. Id. (citing Ling v. Jan’s
Liquors, 237 Kan. 629, 634 (1985)). Where the wrong
occurred is where plaintiff suffered injury. Id.
(citing Ling, 237 Kan. at 634).
asserts that Kansas law should apply to Gale, and that
Missouri law should apply to Brooks. Mentor argues that
unlike Gale, who resided in Kansas before, during and after
the alleged injury, Brooks has been a Missouri resident at
all material times. Specifically, although Brooks allegedly
received her implants in Kansas, all of her alleged injuries
occurred in Missouri. Mentor points to plaintiffs’
complaint, which specifies that “soon after”
surgery – that is, after she returned home to Missouri
- Brooks began experiencing symptoms, and that six months
after the surgery - while still living in Missouri - she was
hospitalized with sepsis and a staph infection.
Complaint (Doc. #1) ¶ 12. According to Mentor,
Brooks “is not suing her plastic surgeon and makes no
allegation that any injury occurred in Kansas during her
implantation surgery.” Defendant Mentor Worldwide
LLC’s Memorandum In Support Of Rule 12(b)(6) Motion to
Dismiss Plaintiffs’ Complaint (Doc. #11) at 8.
Rather, she is suing the manufacturer of the allegedly
defective implants, which caused injuries when she returned
to Missouri. In response to Mentor’s motion to dismiss
for failure to state claim, plaintiffs do not argue where
Brooks’ alleged injury occurred, nor do they mention
what state law applies to her claims.
purposes of this analysis, and absent argument to the
contrary, the Court assumes that Brooks suffered her injuries
in Missouri. All of her injuries which the complaint lists,
including the physical ailments and infections, occurred
after Brooks had returned to Missouri. See Ling, 237
Kan. at 634 (applying Kansas law because injuries occurred in
car accident in Kansas even though liquor was sold in
Missouri). Accordingly, pursuant to ...