UNITED STATES DISTRICT COURT

MIDDLE DISTRICT OF FLORIDA

TAMPA DIVISION

BARBARA HAMBLEN and HERBERT

HAMBLEN,

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

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Bard® Composix® Kugel® Hernia Patch “has two layers of

polypropylene mesh, a layer 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

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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 Amended Complaint contains

the following six counts: 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 the plaintiff. Jackson v.

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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.

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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.

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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

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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). Likewise, Plaintiffs

allege that Defendants made the 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

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misrepresentation claim in a case with similar factual

allegations. 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 of Novartis’s sales

representatives.” Id. The Cubbage court found that these

allegations met Rule 9's specifications: “Plaintiff has

alleged sufficient factual matter to satisfy the

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

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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,

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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,

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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

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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

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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 Hernia Repair Patch

Litigation, No. 007-470-MDL.

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DONE and ORDERED in Chambers in Tampa, Florida, this 15th

day of December, 2017. 

 

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