Hamblen et al v. Davol, Inc. et al

Filing 25

ORDER: Defendants Davol, Inc. and C. Bard Inc.'s Motion to Dismiss, in Part, Plaintiffs' Amended Complaint (Doc. # 18 ) is DENIED. Defendants are directed to respond to the Amended Complaint by December 28, 2017. The parties are dire cted to file a joint status report by December 28, 2017, explaining why the present case has not be transferred to the consolidated multidistrict litigation In re: Kugel Mesh Hernia Repair Patch Litigation, No. 007-470-MDL. Signed by Judge Virginia M. Hernandez Covington on 12/15/2017. (KAK)

UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
TAMPA DIVISION
BARBARA
HAMBLEN,

HAMBLEN

and

HERBERT

Plaintiffs
v.

Case No. 8:17-cv-1613-T-33TGW

DAVOL, INC. and C.R. BARD, INC.,
Defendants.
______________________________/
ORDER
This cause is before the Court pursuant to Defendants
Davol, Inc. and C. Bard Inc.’s Motion to Dismiss, in Part,
Plaintiffs’ Amended Complaint (Doc. # 18), which was filed on
October 10, 2017.

Plaintiffs Barbara Hamblen and Herbert

Hamblen filed a Response in Opposition to the Motion (Doc. #
23) on October 23, 2017.

For the reasons that follow, the

Motion is denied.
I.

Background
On December 14, 2005, Ms. Hamblen had an incisional

hernia repaired by Dr. John Manubay at the Pine Brook Medical
Center in Brooksville, Florida. (Doc. # 15 at ¶ 42).

Dr.

Manubay used a Large Circle Bard® Composix® Kugel® Hernia
Patch. (Id. at ¶ 43). The Large Circle Bard® Composix® Kugel®
Hernia Patch “is designed for the repair of ventral and
inguinal hernias.” (Id. at ¶ 20).

Defendants’ Large Circle

Bard®

Composix®

polypropylene

Kugel®

Hernia

mesh,

a

Patch

“has

layer

two
of

layers

of

expanded

polytetrafluoroethylene (‘ePTFE’) and a single rigid plastic
polyethylene terephthalate ring.” (Id. at ¶ 23).
The Patch implanted in Ms. Hamblen was unreasonably
dangerous,

according

to

Plaintiffs,

because

“it

may

malfunction after being implanted; the rigid plastic ring may
break; in response to body forces the Bard CK Patch may
distort, buckle, or warp; it was not properly manufactured;
[it] was defectively designed; [and its] components could
cause a chronic inflammatory response.” (Id. at ¶ 10).
Defendants issued a product recall covering the Large
Circle Bard CK Patch in January of 2007. (Id. at ¶ 64).

Ms.

Hamblen indicates that she “suffered years of severe abdominal
pain and sought treatment from multiple doctors to identify
the cause of the pain and to find relief.

She was ultimately

seen by Dr. Marc Polecritti who diagnosed her abdominal wall
pain to be caused by her Bard CK Hernia Patch.” (Id. at ¶ 67).
Dr. Polecritti removed the mesh from Ms. Hamblen’s abdomen in
an operation that occurred on July 10, 2013. (Id. at ¶ 68).
Her doctor opines that “to a reasonable degree of medical
probability, that the memory recoil ring in Ms. Hamblen’s Bard
CK Patch was fractured and this break was a contributing cause
2

of the injuries suffered by Ms. Hamblen.” (Id. at ¶ 70).
Plaintiffs claim that Defendants omitted information
about the “risks, dangers, and disadvantages” of the product,
and “marketed, advertised, promoted, sold and distributed” the
product “as safe,” when in fact, Defendants “knew or should
have know” that the product “was not safe.” (Id. at ¶ 74).
On July 3, 2017, Plaintiffs Barbara Hamblen and Herbert
Hamblen filed a Complaint against Defendants Davol, Inc. and
C. Bard Inc. (Doc. # 1) and filed an Amended Complaint (Doc.
# 15) on September 26, 2017.
the

following

six

counts:

The Amended Complaint contains
negligence

(count

1),

strict

liability - design and/or manufacturing defect (count 2),
failure to warn (count 3), negligent misrepresentation (count
4),

fraud

-

fraudulent

misrepresentation

and

fraudulent

nondisclosure (count 5), and loss of consortium (count 6).
At this juncture, Defendants move for the dismissal of
counts

4

and

5

of

the

Amended

Complaint.

(Doc.

#

18).

Plaintiffs have filed a response in opposition to the Motion
to Dismiss and the Motion is ripe for review.
II.

Legal Standard
On a motion to dismiss, this Court accepts as true all of

the factual allegations in the complaint and construes them in
the

light

most

favorable

to
3

the

plaintiff.

Jackson

v.

Bellsouth Telecomms., 372 F.3d 1250, 1262 (11th Cir. 2004).
Further, this Court favors the plaintiff with all reasonable
inferences from the allegations in the complaint. Stephens v.
Dep’t of Health & Human Servs., 901 F.2d 1571, 1573 (11th Cir.
1990) (“On a motion to dismiss, the facts stated in [the]
complaint and all reasonable inferences therefrom are taken as
true.”).

However, the Supreme Court explains that:

While a complaint attacked by a Rule 12(b)(6)
motion to dismiss does not need detailed factual
allegations, a plaintiff’s obligation to provide
the grounds of his entitlement to relief requires
more than labels and conclusions, and a formulaic
recitation of the elements of a cause of action
will not do. Factual allegations must be enough to
raise a right to relief above the speculative
level.
Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007) (internal
citations omitted).

Further, courts are not “bound to accept

as true a legal conclusion couched as a factual allegation.”
Papasan v. Allain, 478 U.S. 265, 286 (1986).
In

accordance

with

Twombly,

Federal

Rule

of

Civil

Procedure 8(a) calls “for sufficient factual matter, accepted
as true, to ‘state a claim to relief that is plausible on its
face.’”

Ashcroft v. Iqbal, 556 U.S. 662, 663 (2009) (quoting

Twombly, 550 U.S. at 570).

A plausible claim for relief must

include “factual content [that] allows the court to draw the
reasonable inference that the defendant is liable for the
misconduct alleged.”

Id.
4

III. Analysis
With respect to fraud and misrepresentation claims, Rule
9(b), Fed. R. Civ. P., requires that “a party must state with
particularity the circumstances constituting fraud or mistake.
Malice, intent, knowledge, and other conditions of a person’s
mind may be alleged generally.”

The Court is mindful of the

directive that “a court considering a motion to dismiss for
failure to plead fraud with particularity should always be
careful to harmonize the directives of rule 9(b) with the
broader

policy

of

‘notice

pleading’

found

in

Rule

8.”

Friedlander v. Nims, 755 F.2d 810, 813 n.3 (11th Cir. 1985),
(abrogated on other grounds).
Fraud allegations must be stated with particularity to
alert defendants to the “precise misconduct with which they
are charged” and to protect defendants “against spurious
charges of immoral and fraudulent behavior.”

Durham v. Bus.

Mgmt. Assocs., 847 F.2d 1505, 1511 (11th Cir. 1988) (internal
quotation marks omitted). Rule 9(b) is satisfied if the claim
sets forth:
(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 omission, 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.
5

Ziemba v. Cascade Int'l, Inc., 256 F.3d 1194, 1202 (11th Cir.
2001) (citing Brooks v. BCBS Fla., Inc., 116 F.3d 1364, 1371
(11th Cir. 1997)).
A.

Negligent Misrepresentation (count 4)

Although Plaintiffs allege “negligent misrepresentation”
against

Defendants,

“by

definition

‘misrepresentation’

includes concealment of facts by fraud.” Cruz v. Mylan, Inc.,
No. 8:09-cv-1106-T-17EAJ, 2010 U.S. Dist. LEXIS 13563, at *7
(M.D. Fla. Feb. 17, 2010). Under Florida law, the elements of
such a claim are: “(1) the defendant made a misrepresentation
of material fact that he believed to be true but which was in
fact false; (2) the defendant was negligent in making the
statement because he should have known the representation was
false; (3) the defendant intended to induce the plaintiff to
rely . . . on the misrepresentation; and (4) injury resulted
to the plaintiff acting in justifiable reliance upon the
misrepresentation.” Lee Mem. Hosp. Sys. v. Blue Cross & Blue
Shield of Fla., Inc., No. 2:16-cv-901-FtM-38MRM, 2017 U.S.
Dist. LEXIS 47805, at *52 (M.D. Fla. Feb. 22, 2017). And,
“because negligent misrepresentation sounds in fraud, the
facts supporting the claim must be plead with particularity.”
Id.
Here, Plaintiffs have included factual allegations that
6

satisfy each required element for the misrepresentation claim,
and they have done so with sufficient particularity to meet
the strictures of Rule 9.

Plaintiffs allege that Defendants

misrepresented that the Bard CK Hernia Patch was safe and
effective for its intended use and omitted information showing
that the product was not safe. (Doc. # 15 at ¶¶ 11, 16, 17,
40, 45, 53, 56, 59, 74, 150, 159, 160, 165, 166, 170).
Plaintiff also allege that Defendants were negligent in making
those statements and with respect to key omissions and that
Defendants were well aware that the patch was dangerous to
patients and defectively designed. (Id. at ¶¶ 10, 12, 13, 14,
15, 35, 36, 37, 41, 46, 47, 50, 51, 52, 55, 60, 61, 64, 75,
77, 91, 97, 156, 157, 161, 162, 168).
allege

that

Defendants

made

the

Likewise, Plaintiffs

misrepresentations

and

omissions directly to the public, to the Plaintiffs, and to
healthcare providers in an effort to induce them to choose the
Bard Patch. (Id. at ¶¶ 151-155, 157-158, 167, 169, 171).
Finally, Plaintiffs allege that Mrs. Hamblen relied on the
misrepresentations and omissions and had the Patch implanted,
which caused her physical, emotional, and financial injury.
(Id. at ¶¶ 19, 67, 68, 69, 70, 71, 72, 96, 104, 172, 173).
In Cubbage v. Novartis Pharmaceuticals Corporation, No.
5:16-cv-129-Oc-30PRL, 2016 WL 3595747, (M.D. Fla. July 5,
2016), the court denied a motion to dismiss a negligent
7

misrepresentation
allegations.

claim

in

a

case

with

similar

factual

There, the plaintiff alleged that Novartis

“misrepresented to healthcare providers and the public that
[the drug] was proper for its intended use and more effective
and safe than other treatments . . . and Novartis knew that
[the drug] was less safe than other treatments and not fit for
its proper and intended use.” Id. at *11.

The plaintiff also

alleged that Novartis’s misrepresentations were located on the
drug’s labels and package inserts and “were also communicated
by

the

oral

representations

representatives.” Id.
allegations
alleged

met

Rule

sufficient

of

Novartis’s

sales

The Cubbage court found that these
9's

specifications:

factual

matter

“Plaintiff

has

satisfy

the

to

requirement[s]” of Rule 9. Id.
This

Court

reaches

the

same

result.

Plaintiffs’

negligent misrepresentation claim asserts that Defendants made
the misrepresentations and omissions through “promotional and
marketing campaigns as well as through direct representations
made by their sales representatives/territory managers to
healthcare providers, and by Defendants’ surgeon trainers to
healthcare providers and surgeons.” (Doc. # 15 at ¶ 150). The
Amended Complaint identifies Territory Manager Michael Baldwin
as one of the individuals who misrepresented the safety and
reliability of the Patch. (Id. at ¶¶ 150-151, 156).

The

Amended Complaint also explains that Defendants “ran a direct
8

to consumer campaign for National Hernia Awareness Month” in
which they offered hernia screenings but did not communicate
“the dangers and defects” of the Patch to consumers. (Id. at
¶ 158).

Likewise, Plaintiffs claim that the Instructions for

Use accompanying the Patch did not provide any information
about the dangers associated with the “risk of the plastic
ring breaking.” (Id. at ¶ 161).

These allegations satisfy

Rule 9. The Motion to Dismiss is therefore denied as to count
four.
B. Fraud (count 5)
To state a claim for fraud under Florida law, a Plaintiff
must allege: “(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.” Byrnes v. Small,
142 F. Supp. 3d 1262, 1266 (M.D. Fla. 2015).

Plaintiffs set

the tone for their fraud claim against Defendants by alleging:
“Defendants

fraudulently

presented

Ms.

Hamblen,

her

physicians, and the general public that the Bard CK Patch was
a safe and effective hernia repair product and concealed the
dangerous and defective elements identified herein of the Bard
CK Patch.” (Doc. # 15 at ¶ 176).

Count five is replete with

detailed allegations that support Plaintiffs’ fraud claims,

9

including: (1) that “Defendants did not timely or adequately
apprise the public and physicians of the defects or dangers
inherent in the Bard CK Patch, including the Bard CK Patch
implanted in Ms. Hamblen, despite Defendants’ knowledge that
the hernia repair products had failed due to the defects
described herein” (Id. at ¶ 16); and (2) “Following the market
introduction of the Bard CK Patches, including the Bard CK
Patch implanted in Ms. Hamblen, Defendants began to receive
actual notice of failures of the plastic ring; rings were
breaking. Defendants actively and intentionally concealed this
notice of the defective and dangerous condition from the
public, Ms. Hamblen, her physicians and the FDA.” (Id. at ¶
40).
The elements of fraudulent misrepresentation and fraud
are similar and the allegations contained in the Amended
Complaint that support the fraudulent misrepresentation claim,
discussed at length above, likewise support the fraud claim.
Plaintiffs

allege

that

Defendants

made

false

statements

regarding the Patch being safe and effective. (Id. at ¶¶ 11,
16, 17, 40, 45, 53, 59, 74, 176, 177, 179, 180, 181, 185, 186,
188,

190,

191,

192,

194).

Plaintiffs

also

claim

that

Defendants knew that the statements were false and were aware
that the Patch was unsafe and unfit for its intended purpose.
(Id. at ¶¶ 10, 12-15, 35-37, 41, 46-47, 50-52, 55, 60-61, 64,

10

75, 77, 91, 97, 175, 184, 189, 195, 197, 199, 203, 206).
Plaintiffs contend that the misrepresentations were made to
Mrs. Hamblen, doctors, and others to induce them to choose the
Patch for hernia repair. (Id. at ¶¶ 196, 198, 200, 204-205).
And, after Mrs. Hamblen chose the Patch, its implantation
caused her to suffer various injuries. (Id. at ¶¶ 19, 67, 68,
69, 70, 71, 72, 96, 104, 201, 207).

The lengthy Complaint

sets forth sufficiently detailed allegations to support the
fraud claim.

The Court finds that Rule 9 has been satisfied

and denies the Motion to Dismiss.
C. Learned Intermediary Doctrine
The

Court

recognizes

that

Defendants

advocate

for

dismissal of both counts four and five under the learned
intermediary doctrine. But, the Court determines that this
discussion should be had at the summary judgment stage,
because it entails a potentially fact intensive inquiry.

See

In re Trasylol Products Liability Litigation, MDL -1928, No.
08-cv-80386, 2011 U.S. Dist LEXIS 57057 (S.D. Fla. May 23,
2011)(granting summary judgment in favor of drug company on
negligence and fraud claims under the learned intermediary
doctrine after evaluating all of the evidence and finding a
lack of proximate cause); Levine v. Wyeth, Inc., No. 8:09-cv854-T-33AEP,

2010

WL

5137424

(M.D.

Fla.

Dec.

10,

2010)(analyzing the learned intermediary doctrine at the

11

summary judgment stage when plaintiff claimed that an acid
reflux medication caused an incurable neurological disorder);
Kaufman v. Pfizer Pharms., Inc., No. 1:02-cv-22692, 2010 U.S.
Dist. LEXIS 146552, at *15 (S.D. Fla. Nov. 23, 2010) (“The
undersigned tends to agree that application of the learned
intermediary doctrine at [the motion to dismiss] stage of the
proceedings would be premature.”).
D. FDUTPA and Law of Rhode Island
In the Motion to Dismiss, Defendants recognize that
Plaintiffs’ Amended Complaint does not state a claim for
violation of the Florida Deceptive and Unfair Trade Practices
Act, but that the Amended Complaint suggests that Plaintiffs
may be seeking relief under the consumer protection statutes
of one or more states. (Doc. # 18 at 8).

Defendants point out

that the FDUTPA expressly states that it does not apply to a
“claim for personal injury or death or a claim for damages to
property other than the property that is the subject of the
consumer transaction.” Fla. Stat. § 501.212(3).

In response

to the Motion to Dismiss, Plaintiffs make no response with
respect to the FDUTPA.

The Court accordingly determines that

Plaintiffs concede that they cannot seek relief under the
FDUTPA.
In addition, Plaintiffs mention in response to the Motion
to Dismiss that a choice of law determination has not yet been

12

made in this case, and that it is unclear whether the law of
Florida or Rhode Island applies. (Doc. # 23 at 12).

However,

both sides have provided case law only from the Eleventh
Circuit and from Florida state courts. Neither party included
a discussion of the law of Rhode Island on any disputed issue.
If either party contends that the law of Rhode Island applies,
it should provide the Court with operative law and choice of
law briefing.

In addition, the parties are directed to file

a joint status report by December 28, 2017, explaining why the
present case has not be transferred to the consolidated
multidistrict litigation In re: Kugel Mesh Hernia Repair Patch
Litigation, No. 007-470-MDL.
Accordingly, it is
ORDERED, ADJUDGED, and DECREED:
(1)

Defendants Davol, Inc. and C. Bard Inc.’s Motion to
Dismiss, in Part, Plaintiffs’ Amended Complaint (Doc. #
18) is DENIED.

(2)

Defendants

are

directed

to

respond

to

the

Amended

Complaint by December 28, 2017.
(3)

The parties are directed to file a joint status report by
December 28, 2017, explaining why the present case has
not be transferred to the consolidated multidistrict
litigation

In

re:

Kugel

Mesh

Litigation, No. 007-470-MDL.
13

Hernia

Repair

Patch

DONE and ORDERED in Chambers in Tampa, Florida, this 15th
day of December, 2017.

14