United States District Court, M.D. Florida, Fort Myers Division
OPINION AND ORDER 
matter comes before the Court on Boston Scientific's
Motion to Dismiss (Doc. 41), which was filed on June 4, 2018.
Plaintiff Valerie Douse responded on June 18, 2018. (Doc.
43). The matter is ripe for review.
facts of this products liability case have already been
outlined in the Court's previous Order dismissing
Douse's Amended Complaint. (Doc. 39). In the interest of
brevity, the Court will only recite the salient details. This
case concerns Boston Scientific's permanent inferior vena
cava filter (the “Greenfield Filter”), which was
created to prevent pulmonary embolisms. (Doc. 40 at
¶¶ 22-23). A pulmonary embolism occurs when a blood
clot travels through blood vessels to block one of the
pulmonary arteries in the lungs. (Doc. 40 at ¶ 19). When
clots form in deep leg veins, this condition is called deep
vein thrombosis. (Doc. 40 at ¶ 19).
September 2003, Douse suffered a pulmonary embolism. (Doc. 40
at ¶ 23). Based on the advice of an unnamed entity, she
agreed to have the Greenfield Filter implanted to prevent
further blood clot-related issues. (Doc. 40 at ¶¶
23-24) In 2017, Douse was treated for complications
associated with the Greenfield Filter, and was informed that
it had perforated the walls of the vein in which it had been
implanted. (Doc. 40 at ¶ 27). Apparently, such injuries
are commonplace among patients who have undergone the
implantation of permanent inferior vena cava filters. (Doc.
40 at ¶ 28).
then sued Boston Scientific in state court. (Doc. 2). After
the case was removed (Doc. 1), Boston Scientific moved to
dismiss. (Doc. 3). Upon review, the Court agreed with Boston
Scientific and dismissed the Complaint. (Doc. 25). Douse then
filed an Amended Complaint with claims including negligence,
strict liability manufacturing defect, strict liability
design defect, strict liability failure to warn, breach of
warranty, negligent misrepresentation, implied warranty of
merchantability, implied warranty of fitness, fraudulent
misrepresentation, fraudulent concealment, and consumer
fraud. (Doc. 27). Boston Scientific again moved to dismiss.
(Doc. 29). The Court then agreed with Boston Scientific in
part and dismissed the fraud and warranty-based claims. (Doc.
then filed a Second Amended Complaint. (Doc. 40). She alleges
the Greenfield Filter was defectively designed and
manufactured. (Doc. 40 at 16-21). She further alleges the
Greenfield Filter was inadequately tested and had inadequate
warnings, instructions, and labeling. (Doc. 40 at 21-26).
Based on these allegations, Douse 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. 40 at 12-41). Now, for the third time,
Boston Scientific moves to dismiss. (Doc. 41).
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 a 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 Douse has failed to plausibly plead
her claims despite three chances to do so. (Doc. 41). Douse
opposes. (Doc. 43). The Court will address each claim in
alleges Boston Scientific fraudulently misrepresented the
Greenfield Filter's safety and efficacy through several
avenues including its website, product brochures, product
labeling and statements to Douse's healthcare providers.
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 Douse's
allegations fail to meet the heightened particularity
threshold of Rule 9(b). The Court agrees.