United States District Court, M.D. Florida, Fort Myers Division
OPINION AND ORDER 
POLSTER CHAPPELL, UNITED STATES DISTRICT JUDGE
This matter comes before the Court on Boston Scientific's
Motion to Dismiss (Doc. 37), which was filed on June 1, 2018.
Plaintiff Felicia Davis responded on June 15, 2018. (Doc.
39). The matter is ripe for review.
facts of this products liability case have already been
outlined in the Court's previous Order dismissing
Davis' Amended Complaint. (Doc. 35). In the interests of
brevity, only the salient details will be repeated. This case
concerns Boston Scientific's permanent inferior vena cava
filter (the “Greenfield Filter), which was created to
prevent pulmonary embolisms. (Doc. 36 at ¶¶ 22,
27). A pulmonary embolism occurs when a blood clot travels
through blood vessels to block one of the pulmonary arteries
in the lungs. (Doc. 36 at ¶ 19). When clots form in deep
leg veins, this condition is called deep vein thrombosis.
(Doc. 36 at ¶ 19).
vena cava filters have been the subject of research over the
years. Davis cites two studies from as early as 2008 that
found permanent inferior vena cava filters like the
Greenfield Filter have comparable complication and protection
rates to retrievable filters. (Doc. 36 at ¶¶ 43,
45). And without specifying the dates, she alleges other
“cited studies have shown that long-term implantation
of [inferior vena cava filters] can cause subsequent
[pulmonary embolisms] and [deep vein thrombosis].”
(Doc. 36 at ¶ 27). She also alleges that in 2010 and
2014 the United States Food and Drug Administration cautioned
against implanting inferior vena cava filters for extended
periods of time due to potential adverse health
complications. (Doc. 36 at ¶¶ 36-40).
point prior to 2009, Davis suffered a pulmonary embolism.
(Doc. 36 at ¶ 23). She then had the Greenfield Filter
implanted in her right common femoral vein.(Doc. 36 at ¶
25). In 2015, she was hospitalized for chest pain and
diagnosed with bilateral segmental pulmonary emboli. (Doc. 36
at ¶ 27). Almost two years after that, she was
hospitalized again and diagnosed with deep vein thrombosis.
(Doc. 36 at ¶ 28).
then sued Boston Scientific in state court. (Doc. 2). After
the case was removed (Doc. 1), Boston Scientific moved to
dismiss. (Doc. 7). Upon review, the Court agreed with Boston
Scientific and dismissed the Complaint. (Doc. 19). Davis then
filed an Amended Complaint with claims including negligence,
strict liability manufacturing and design defect, breach of
warranty, fraudulent misrepresentation, negligent
misrepresentation, and fraudulent concealment. (Doc. 20).
Boston Scientific again moved to dismiss. (Doc. 21). The
Court then agreed with Boston Scientific in part and
dismissed the fraud and warranty-based claims. (Doc. 35 at
then filed a Second Amended Complaint. (Doc. 36). She alleges
the Greenfield Filter was defectively designed and
manufactured. (Doc. 36 at ¶ 55). She further alleges the
Greenfield Filter was inadequately tested and had inadequate
warnings, instructions, and labeling. (Doc. 36 at ¶ 55).
Based on these allegations, Davis claims Boston Scientific is
liable for: negligence (Count I), strict liability defective
design (Count II), strict liability manufacturing defect
(Count III), strict liability failure to warn (Count IV),
fraudulent misrepresentation (Count V), fraudulent
concealment (Count VI), and negligent misrepresentation
(Count VII). (Doc. 36 at ¶¶ 69-242). Now, for the
third time, Boston Scientific moves to dismiss. (Doc. 37).
to Federal Rule of Civil Procedure 8(a)(2), a pleading must
contain a short and plain statement of a claim showing the
pleader is entitled to relief. Fraud allegations are subject
to heightened pleading standards under Federal Rule of Civil
Procedure 9(b), which requires a party to “state with
particularity the circumstances constituting fraud.” To
meet this threshold, a pleading must allege
(1) precisely what statements were made in what documents or
oral representations or what omissions were made, and (2) the
time and place of each such statement and the person
responsible for making (or, in the case of omissions, not
making) same, and (3) the content of such statements and the
manner in which they misled the plaintiff, and (4) what the
defendants obtained as a consequence of the fraud.
Ziemba v. Cascade Int'l, Inc., 256 F.3d 1194,
1202 (11th Cir. 2001) (citing Brooks v. Blue
Cross and Blue Shield of Florida, Inc., 116 F.3d
1364, 1371 (11th Cir.1997)). But “[m]alice, intent,
knowledge, and other conditions of a person's mind may be
alleged generally.” Brooks, 116 F.3d at
1371.These standards are intended to “(1)
provide defendants with sufficient notice of what the
plaintiff complains to enable them to frame a response, (2)
prevent fishing expeditions to uncover unknown wrongs, and
(3) protect the defendant from unfounded accusations of
immoral or otherwise wrongful conduct.” U.S. ex
rel. Butler v. Magellan Health Servs., Inc., 101
F.Supp.2d 1365, 1368 (M.D. Fla. 2000).
Federal Rule of Civil Procedure 12(b)(6), a court may dismiss
a pleading for failure to state a claim upon which relief can
be granted. This decision hinges on the
Twombly-Iqbal plausibility standard, which requires
a plaintiff to “plead factual content that allows the
court to draw the reasonable inference that the defendant is
liable for the misconduct alleged.” Ashcroft v.
Iqbal, 556 U.S. 662, 678 (2009); see also
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 556
(2007). At this stage, the Court must accept all factual
allegations in a complaint as true and take them in the light
most favorable to the plaintiff. Pielage v.
McConnell, 516 F.3d 1282, 1284 (11th Cir. 2008). But
acceptance is limited to well-pleaded factual allegations.
La Grasta v. First Union Sec., Inc., 358 F.3d 840,
845 (11th Cir. 2004). A “the-defendant-unlawfully
harmed me accusation” is insufficient. Iqbal,
556 U.S. at 677. “Nor does a complaint suffice if it
tenders naked assertions devoid of further factual
enhancement.” Id. (internal quotations
Scientific argues Counts V, VI, and VII should be dismissed
with prejudice because Davis has failed to plausibly plead
her claims despite three chances to do so. Davis opposes. The
Court will address each count in turn.
alleges Boston Scientific fraudulently misrepresented the
Greenfield Filter's safety and efficacy through a number
of avenues including its website, product brochures, product
labeling and direct statements to Davis' doctor. The
elements of a fraudulent misrepresentation claim in Florida
are “(1) a false statement concerning a material fact;
(2) the representor's knowledge that the representation
is false; (3) an intention that the representation induce
another to act on it; and (4) consequent injury by the party
acting in reliance on the representation.” Butler
v. Yusem, 44 So.3d 102, 105 (Fla. 2010). Boston
Scientific argues Davis' allegations fail to meet the
heightened particularity threshold of Rule 9(b). The Court