Byrnes et al v. Small et al

Filing 73

ORDER granting 32 Medtronic's motion to dismiss. Plaintiffs' Second and Third Causes of Action are DISMISSED with prejudice. Plaintiffs' First, Fourth, Fifth, Sixth, and Ninth Causes of Action are DISMISSED without prejudice. Plai ntiffs' request for punitive damages is DISMISSED without prejudice. Plaintiffs are granted leave to file an Amended Complaint within fourteen (14) days from the date of this Order which cures the deficiencies identified in this Order. Signed by Judge Charlene Edwards Honeywell on 3/18/2015. (AHH)

UNITED STATES DISTRICT COURT
MIDDLE DISTRICT OF FLORIDA
TAMPA DIVISION
LORI BYRNES and MATTHEW
BYRNES,
Plaintiffs,
v.

Case No: 8:14-cv-1726-T-36MAP

JOHN SMALL, MUSCULOSKELETAL
INSTITUTE CHARTERED,
MEDTRONIC, INC. and MEDTRONIC
SOFAMOR DANEK USA, INC.,
Defendants.
___________________________________/
ORDER
This cause comes before the Court upon the Motion to Dismiss filed by Defendants
Medtronic, Inc. and Medtronic Sofamor Danek USA, Inc. (collectively, “Medtronic”) (Doc. 32).
Plaintiffs Lori Byrnes and Matthew Byrnes (collectively, “Plaintiffs”) responded in opposition to
the Motion (Doc. 36). Medtronic replied in further support of its Motion (Doc. 39). On November
20, 2014, the Court held oral argument on the Motion. Doc. 57. Both sides submitted a number
of supplemental authorities (Docs. 43, 46-51, 53, 61-62, 64-65, 71). The Court, having considered
the parties’ submissions and the oral argument, and being fully advised in the premises, will now
GRANT the Motion to Dismiss.
I.

1

STATEMENT OF FACTS 1

The following statement of facts is derived from the Complaint (Doc. 2), the allegations of
which the Court must accept as true in ruling on a motion to dismiss. See Linder v. Portocarrero,
963 F.2d 332, 334 (11th Cir. 1992); Quality Foods de Centro Am., S.A. v. Latin Am.
Agribusiness Dev. Corp. S.A., 711 F. 2d 989, 994 (11th Cir. 1983).

This action arises over the injuries allegedly caused to Lori Byrnes by the bone graft device
Infuse, which was implanted in Ms. Byrnes in an off-label manner during a spinal fusion surgery.
The Complaint alleges as follows: Spinal fusion surgeries are performed to treat a number of
conditions, such as spinal deformities and back pain. Doc. 2 (“Compl.”) ¶ 50. The goal of a spinal
fusion surgery is to obtain a solid fusion of the vertebrae. Id. ¶ 51. Traditionally, in performing a
spinal fusion surgery, a surgeon places a graft consisting of the patient’s own bone or a cadaver
bone in a spacer cage within the disc space between the vertebrae. Id. However, newer options
using bio-engineered and bio-manufactured bone growth products have been developed, and are
more appealing to surgeons because they obviate the need to harvest bone. Id. ¶ 54.
Infuse is a bio-engineered bone graft device that was designed, manufactured, and
marketed by Medtronic for use in spinal fusion surgeries. Id. ¶ 2. It consists of three parts: (1) a
metallic spinal fusion cage (the “LT-Cage”); (2) the bone graft substitute; and (3) a sponge-like
carrier or scaffold for the bone graft substitute that is placed inside the fusion cage. Id. ¶ 56. The
fusion cage serves to maintain spacing and temporarily stabilize the diseased region of the spine.
Id. ¶ 57. The bone graft component serves to form the bone that will permanently stabilize the
treated portion of the spine. Id. The sponge serves to bind the bone graft substitute, and resorbs
over time. Id. ¶ 58. As the sponge dissolves, the bone graft substitute stimulates the production
of new bone. Id.
Infuse is a Class III medical device. Id. ¶ 65. Accordingly, before Medtronic could market
Infuse, it was required to submit a Premarket Approval Application (“PMA”) for approval by the
U.S. Food and Drug Administration (“FDA”). Id. ¶ 65. As presented in the PMA, Infuse consists
of both the LT-Cage and the bone graft component. Id. ¶ 71. In July 2002, the FDA approved
Infuse for a certain spinal fusion procedure, id. ¶ 63, specifically, the anterior lumbar interbody

2

fusion procedure, which involves a single-level fusion and is performed by approaching the spine
from the front through an incision in the abdomen, id. ¶ 72. The approved label indicates that
Infuse’s components must be used as a system, and that the bone graft component must not be
used without the LT-Cage. Id. ¶ 74.
Infuse has never been approved by the FDA for use in any other parts of the body or any
other type of procedure (other than two non-spinal uses), id. ¶ 76, due to the number of adverse
events resulting from the use of the bone graft substitute in off-label applications, id. ¶ 80. For
example, in a trial examining the application of the bone graft substitute to posterior lumbar
interbody fixation, a number of patients developed uncontrolled bone growth. Id. Further, the
FDA admonished Medtronic to guard against the off-label use of Infuse. Id. ¶¶ 84-86.
Despite being aware of the FDA’s concerns regarding the off-label use of Infuse,
Medtronic nevertheless sold the LT-Cage and the bone graft component separately. Id. ¶ 75.
Moreover, not only did Medtronic intentionally conceal from the general public the dangers of the
off-label use of Infuse, id. ¶¶ 114-15, it actively promoted the off-label use of Infuse through its
sales representatives and spine surgeon consultants, id. ¶ 132-38.
In October 2006, Dr. John Small performed a surgery on Ms. Byrnes using Infuse in an
off-label manner. Id. ¶ 248. Specifically, Dr. Small implanted Infuse by means of a posterior
approach lumbar fusion, and did not use the requisite LT-Cage. Id. Ms. Byrne subsequently
suffered and reported increasingly severe pain. Id. ¶ 250. Imaging studies ultimately revealed that
Ms. Byrnes had developed uncontrolled bone growth and nerve compression near where Infuse
had been implanted. Id. ¶¶ 251.
In the Complaint, Ms. Byrnes asserts, inter alia, that Medtronic is liable for: (1) fraudulent
misrepresentation and fraud in the inducement (First Cause of Action) (2) strict products liability

3

– failure to warn (Second Cause of Action); (3) strict products liability – design defect (Third
Cause of Action); (4) strict products liability – misrepresentation (Fourth Cause of Action); (5)
products liability – negligence (Fifth Cause of Action); and breach of express warranty (Sixth
Cause of Action). Id. ¶¶ 264-348. Ms. Byrnes’ husband, Matthew Byrnes, also asserts against
Medtronic a claim for loss of consortium (Ninth Cause of Action). Id. ¶¶ 378-79.
Medtronic now moves to dismiss the Causes of Action asserted against it, arguing that they
are preempted by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. (“FDCA”).
Specifically, Medtronic argues that all of Ms. Byrnes’ claims, with the possible exception of those
alleging affirmative fraud, are either expressly preempted by the Medical Device Amendments to
the FDCA (“MDA”), or impliedly preempted by 21 U.S.C. § 337(a). Medtronic also argues that,
to the extent Ms. Byrnes’ claims are premised on affirmative fraud, they must be dismissed because
they have not been pleaded with requisite particularity. Medtronic finally argues that Mr. Byrnes’
loss of consortium claim, as well as Plaintiffs’ request for punitive damages, must fail because all
of Ms. Byrnes’ claims fail.
II.

LEGAL STANDARD
To survive a motion to dismiss, a pleading must include a “short and plain statement of the

claim showing that the pleader is entitled to relief.” Ashcroft v. Iqbal, 556 U.S. 662, 677-78 (2009)
(quoting Fed. R. Civ. P. 8(a)(2)). Labels, conclusions and formulaic recitations of the elements of
a cause of action are not sufficient. Id. (citing Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 555
(2007)). Furthermore, mere naked assertions are not sufficient. Id. A complaint must contain
sufficient factual matter, which, if accepted as true, would “state a claim to relief that is plausible
on its face.” Id. (quoting Twombly, 550 U.S. at 570). “A claim has facial plausibility when the
plaintiff pleads factual content that allows the court to draw the reasonable inference that the

4

defendant is liable for the misconduct alleged.” Id. (citation omitted). The court, however, is not
bound to accept as true a legal conclusion stated as a “factual allegation” in the complaint. Id.
III.

DISCUSSION
A.

Statutory Framework of the Medical Device Amendments

The regulation of medical devices entering the market is governed by the FDCA, which
provides that the enforcement of violations “shall be by and in the name of the United States.” 21
U.S.C. § 337(a). In 1976, Congress passed the MDA, which amended the FDCA and imposed a
regime of detailed federal oversight. See 21 U.S.C. § 360c et seq. The new regulatory regime
separated medical devices into three classes based on the risks they pose to the public. Id.; Riegel
v. Medtronic, Inc., 552 U.S. 312, 316 (2008); United States v. Endotec, Inc., 563 F.3d 1187, 118990 (11th Cir. 2009). Class I devices are those that present no unreasonable risk of illness or injury
and are subject only to “general controls,” such as labeling requirements. Riegel, 552 U.S. at 316
(citing 21 U.S.C. § 360c(a)(1)(A)). Class II devices possess a greater potential for danger and thus
warrant “special controls” such as performance standards and postmarket surveillance measures.
Id. at 316-17 (citing 21 U.S.C. § 360c(a)(1)(B)). The strictest regulation, Class III, is reserved for
devices for which a less stringent classification could not provide reasonable assurance of safety
and effectiveness. Id. at 317 (citing 21 U.S.C. § 360c(a)(1)(C)).
1.

Premarket Approval

All Class III devices, such as the Infuse product, must undergo the “rigorous” PMA process
administered by the FDA. Medtronic, Inc. v. Lohr, 518 U.S. 470, 477 (1996). The PMA process
begins with the manufacturer submitting a multi-volume application, detailing a variety of
information including the safety and efficacy of the device. Riegel, 552 U.S. at 317-18 (citing 21
U.S.C. § 360e(c)(1)). After the FDA completes its review, PMA approval is granted only if there

5

is a “reasonable assurance” of the device’s “safety and effectiveness.” Id. at 318 (citing 21 U.S.C.
§ 360e(d)). The FDA may also condition approval on adherence to performance standards,
restrictions upon sale or distribution, or other compliance requirements. Id. at 319 (citing 21
C.F.R. §§ 861.1(b)(3), 814.82).
Even after PMA approval is granted, manufacturers are forbidden to make changes in
design specifications, manufacturing processes, labeling, or any other attribute that would affect
safety or effectiveness, without FDA permission. Id. (citing 21 U.S.C. § 360e(d)(6)(A)(i)). If a
manufacturer wishes to make such a change to a device, it must submit an application for
supplemental PMA, which is evaluated under identical criteria as the initial application. Id. (citing
21 U.S.C. § 360e(d)(6)).

Moreover, after PMA, manufacturers are subject to reporting

requirements. Id. (citing 21 U.S.C. § 360i). These include the obligation to inform the FDA of
new clinical investigations or scientific studies, 21 C.F.R. § 814.84(b)(2), and to report incidents
where the device may have caused or contributed to death or serious injury, 21 C.F.R. § 803.50(a).
Riegel, 552 U.S. at 319.
2.

Preemption under the FDCA Framework

Prior to the statutory enactment of the MDA, the introduction of new medical devices was
left largely for the states to supervise as they saw fit. Riegel, 552 U.S. at 315. However, the MDA
“swept back some state obligations and imposed a regime of detailed federal oversight.” Id. at 316.
The MDA’s express preemption provision provides that:
[N]o State or political subdivision of a State may establish or
continue in effect with respect to a device intended for human use
any requirement—
(1) which is different from, or in addition to, any requirement
applicable under this chapter to the device, and

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(2) which relates to the safety or effectiveness of the device or to
any other matter included in a requirement applicable to the device
under this chapter.
21 U.S.C. § 360k(a). In Riegel, the Supreme Court suggested that the MDA’s preemption of
certain state obligations in favor of more detailed federal oversight was justified because of the
harm that would be caused by stifling innovation in medical devices if “juries were allowed to
apply the tort law of 50 States to all innovations.” 552 U.S. at 326. The Supreme Court also noted
that “State tort law that requires a manufacturer’s [device] to be safer, but hence less effective,
than the model the FDA has approved disrupts the federal scheme.” Id. at 325.
Accordingly, “[t]he MDA expressly pre-empts [] state requirements different from, or in
addition to, any requirement applicable . . . to the device under federal law.” Wolicki-Gables v.
Arrow Int’l, Inc., 634 F.3d 1296, 1300 (11th Cir. 2011) (quoting Riegel, 552 U.S. at 321).
However, because § 360k(a) only preempts state requirements to the extent that they are “different
from, or in addition to the requirements imposed by federal law,” state law claims premised on
violations of FDA regulations that “parallel,” rather than add to federal requirements are not
preempted. Id. at 1300 (quoting Riegel, 552 U.S. at 330). In Wolicki-Gables, the Eleventh Circuit
explained the parallel claim principle as follows:
“In order for a state requirement to be parallel to a federal
requirement, and thus not expressly preempted under § 360k(a), the
plaintiff must show that the requirements are ‘genuinely equivalent.’
State and federal requirements are not genuinely equivalent if a
manufacturer could be held liable under the state law without having
violated the federal law.”
634 F.3d at 1300 (quoting McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005)).
In Riegel, the Supreme Court established a two-prong test for determining whether a state
claim is expressly preempted by the MDA: (1) determine whether the federal government has
established requirements applicable to the medical device; and (2) if so, determine whether the
7

state law claims are based upon requirements with respect to the device that are different from, or
in addition to, the federal ones, and that relate to safety and effectiveness. 552 U.S. at 321-22.
In addition to express preemption under the MDA, the FDCA also impliedly preempts suits
by private litigants “for noncompliance with the medical device provisions.” See Buckman, 531
U.S. at 349 n.4. That is because 21 U.S.C. § 337(a) states that all actions to enforce FDA
requirements “shall be by and in the name of the United States.” The Eighth Circuit has explained
the interaction between Riegel and Buckman as follows:
Riegel and Buckman create a narrow gap through which a plaintiff’s
state-law claim must fit if it is to escape express or implied
preemption. The plaintiff must be suing for conduct that violates
the FDCA (or else his claim is expressly preempted by § 360k(a)),
but the plaintiff must not be suing because the conduct violates the
FDCA (such a claim would be impliedly preempted under
Buckman).
In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010)
(internal citations and quotations omitted); see also In re Medtronic, Inc. Sprint Fidelis Leads
Prod. Liab. Litig., 592 F. Supp. 2d 1147, 1161 (D. Minn. 2009) (“[W]hen Sections 337(a) and
360k(a)—as construed in Buckman and Riegel, respectively—are read together, nearly all types of
claims concerning FDA-approved medical devices are preempted[.]”).
B.

Application of Preemption Analysis

Infuse was approved through the PMA process. Compl. ¶ 65. Therefore, for purposes of
evaluating express preemption, the first prong of the Riegel test is automatically satisfied. See
Riegel, 552 U.S. at 322-23 (“[p]remarket approval . . . imposes ‘requirements’ under the MDA’
that are ‘specific to individual devices’”); Wolicki-Gables, 634 F.3d at 1301. Citing Goodlin v.
Medtronic, Inc., 167 F.3d 1367 (11th Cir. 1999), Plaintiffs argue that the PMA process does not
result in device-specific federal requirements. See Doc. 36 at 27-28. That argument is without
merit—to the extent Goodlin is inconsistent with Riegel, it has been abrogated. See Yost v. Striker
8

Corp., Case No. 09-cv-28, 2010 WL 1141586, at *1 n.1 (M.D. Fla. Mar. 23, 2010). Accordingly,
the question remaining is whether any of the claims would impose state law requirements that are
different from, or in addition to, those under the federal regime. Further, for any of the claims that
the Court finds not expressly preempted, the Court must also evaluate whether they are impliedly
preempted by determining whether they are cognizable only by virtue of the provisions of the
FDCA, or whether they state a claim under state law even in the absence of the FDCA.
C.

Claim-by-Claim Analysis
1.

Fraudulent Misrepresentation and Fraud in the Inducement (First Cause of

Action)
Medtronic argues that the First Cause of Action is expressly and impliedly preempted to
the extent that it is premised on any failure-to-warn theory. The Court agrees. First, to the extent
that the claim is based on Medtronic’s failure to warn the medical community of the dangers
associated with the off-label use of Infuse, including any purported inadequacies in the warnings
and labels accompanying Infuse, it is expressly preempted. Critically, Plaintiffs have not identified
any federal requirement to inform the public or to update warning labels regarding the dangers of
off-label use.

Accord McClelland v. Medtronic, Inc., 944 F. Supp. 2d 1193, 1199 (M.D. Fla.

2013). Accordingly, regardless of whether Medtronic engaged in off-label promotion of Infuse,
such requirements would clearly be different from, or in addition to, the federal requirements. See
Schouest v. Medtronic, Inc., 13 F. Supp. 3d 692, 703 (S.D. Tex. 2014) (“[F]or a plaintiff to prevail
on a failure-to-warn claim, a jury would have to find either that Defendants were required to
include warnings beyond those in the FDA-approved label for the Infuse Device, or that
Defendants were obligated to issue post-sale warnings about potential adverse effects of using the

9

Infuse Device in an off-label manner. Either scenario would violate Riegel’s express preemption
framework.”) (quotation marks and citations omitted).
Second, to the extent that the claim is based on Medtronic’s failure to report adverse events
to the FDA, it is impliedly preempted.

Although federal law requires medical device

manufacturers to file adverse event reports whenever the device “may have caused or contributed
to a death or serious injury,” 21 U.S.C. § 360i(a)(1); 21 C.F.R. § 803.50(a), Plaintiffs have failed
to identify any Florida state law duty to report to the FDA. Accordingly, such a claim is impliedly
preempted, as it is merely “[an] attempt to recast a claim for violation of the FDCA as a state-law
negligence claim.” McClelland, 944 F. Supp. 2d at 1200; see also In re Medtronic, Inc., Sprint
Fidelis Leads Prod. Liability Litig., 623 F.3d 1200, 1205-06 (8th Cir. 2010).
It is unclear whether Medtronic believes that this claim is preempted even to the extent that
it is premised on the affirmative misrepresentations it allegedly made to promote the off-label use
of Infuse. See Doc. 32 at 11 (arguing that “[Plaintiffs’] claims are—with the possible exception of
claims predicated on certain alleged affirmative misrepresentations—the exact type of claim that
is expressly preempted under § 360k(a)”) (emphasis added). If that is Medtronic’s position, the
Court disagrees. Such a claim is not expressly preempted because, as many courts have explained,
“federal law bars off-label promotion when it is false or misleading.” Schouest, 13 F. Supp. 3d at
702 (referencing 21 U.S.C. §§ 331(a), 352(q)(1)). And such a claim is not impliedly preempted
because “it sounds in traditional state common law that exists independently from the FDCA and
not solely by virtue of the FDCA.” Brady v. Medtronic, Inc., Case No. 13-cv-62199, 2014 WL
1377830, at *7 (S.D. Fla. Apr. 8, 2014). 2

2

The Court emphasizes that its ruling applies only to untruthful off-label promotion, because
that is what has been alleged in this case, see Doc. 36 at 9 (“As Plaintiffs have alleged
throughout their Complaint, MEDTRONIC aggressively promoted untruthful off-label use of
10

The Court nevertheless agrees that this Cause of Action must be dismissed in its entirety,
because, to the extent it relies on affirmative falsehoods and is not preempted, Plaintiffs have failed
to plead fraud with the requisite particularity. See Fed. R. Civ. P. 9(b) (“a party must state with
particularity the circumstances constituting fraud or mistake”). Indeed, Plaintiffs only allege in a
vague and conclusory manner that Medtronic “fraudulently concealed and misrepresented” the
dangers of the off-label use of Infuse, Compl. ¶¶ 265-67, but fail to identify with particularity any
misrepresentations and/or concealments that were actually relied upon by Dr. Small, or how those
misrepresentations and/or concealments proximately caused Ms. Byrnes’ injuries. The Court,
however, will afford Plaintiffs an opportunity to amend the claim to conform to the heightened
pleading requirements of claims for fraud.
2.

Failure to Warn (Second Cause of Action)

For the reasons discussed in Section III.C.1, supra, Ms. Byrnes’ failure to warn claim is
preempted. Further, because this claim does not entail any affirmative falsehoods, it is preempted
in its entirety. The Court, therefore, will dismiss this claim with prejudice.
3.

Design Defect Claim (Third Cause of Action)

Medtronic argues that Ms. Byrnes’ design defect claim is expressly preempted. The Court
agrees. The Third Cause of Action alleges that Infuse was defectively designed because “the risks
of danger in the design outweigh the benefits of the design,” and that “[t]he foreseeable risks of
harm . . . could have been reduced or avoided by adopting a reasonably [sic] alternative design.”

Infuse”); 12 (“the case at hand revolves around fraudulent (and untruthful) off-label promotion
by MEDTRONIC”). To the extent that Plaintiffs are suggesting that a claim premised on truthful
off-label promotion is not preempted, see Doc. 36 at 10, the Court disagrees. Such a claim
would be impliedly preempted because, even if off-label promotion were prohibited under the
FDCA, Plaintiffs have failed to identify a state law duty to refrain from off-label promotion, see
Schouest, 13 F. Supp. 3d at 705 (“Mere ‘off-label’ promotion, divorced from any negligent or
fraudulent misrepresentations, would likely not run afoul of state tort law.”).
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Compl. ¶¶ 301, 303. Accordingly, to prevail on this claim, Ms. Byrnes necessarily would have to
prove that Medtronic should have employed a design different from the one approved by the
FDA—the consequence of which would be to impose requirements that are “different from, or in
addition to” the federal requirements.
Plaintiffs contend that the design defect claim is not preempted because they are not
arguing that the Infuse device should have been designed differently from that approved by the
FDA through the PMA process, but rather that Infuse was defectively designed for the off-label
use that Medtronic had been promoting. The Court is not persuaded. The first step of the Riegel
test requires a court simply to determine whether the federal government has established
requirements applicable to the medical device, not whether the federal government has established
requirements applicable to a specific use of the medical device. See Riegel, 552 U.S. at 321. And
the second step of the Riegel test requires a court simply to determine whether the state law claims
would impose requirements that are different from, or in addition to, the federal ones that relate to
safety and efficacy. See id. at 321-22. The design defect claim clearly meets both prongs.
To the extent Plaintiffs rely on Ramirez, 961 F. Supp. 2d 977, 999 (D. Ariz. 2013), which
held that such a claim was not preempted, the Court begins by noting that Ramirez is not binding
authority. More importantly, the Court disagrees with the reasoning in Ramirez, and therefore
declines to follow it. Ramirez’s holding draws a distinction not only between on-label and offlabel use, but also between off-label use that has been promoted and off-label use that has not been
promoted. See id. However, such a fine distinction appears nowhere in Riegel’s preemption test,
and, as noted by Medtronic, is patently illogical—adopting this standard would result in a design
defect claim being preempted if a doctor were to unilaterally decide to use a device in an off-label

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manner, but not being preempted if off-label promotion induced the doctor to use the device in the
exact same manner.
Accordingly, the Court finds that the Third Cause of Action is expressly preempted, and
will dismiss it with prejudice.
4.

Misrepresentation (Fourth Cause of Action)

Medtronic argues that Ms. Byrnes’ strict products liability claim for misrepresentation is
preempted, and that even if it is not, it must be dismissed pursuant to comment k to Section 402A
of the Restatements (Second) of Torts. 3 The Court agrees in part and disagrees in part. For the
reasons discussed in Section III.C.1, supra, this claim is preempted to the extent it relies on any
failure-to-warn theory.

Because this claim also contains allegations of affirmative

misrepresentations, however, it is not preempted in its entirety, also for the reasons discussed in
Section III.C.1, supra. Moreover, Medtronic has failed to establish that, for purposes of the motion
to dismiss, it is entitled to a defense based on comment k to Section 402A of the Restatements
(Second) of Torts. Comment k, which has been adopted by Florida courts as an affirmative defense
to a strict products liability claim for medical devices, see Adams v. G.D. Searle & Co., Inc., 576
So. 2d 728, 733 (Fla. 2d DCA 1991), essentially provides that a medical device manufacturer
escapes strict liability for “unavoidably unsafe products” if it can demonstrate that the device was
(1) incapable of being made safe; (2) properly prepared and marketed; and (3) accompanied by a
proper warning, see comment k, Restatement (Second) of Torts § 402A; see also Zanzuri v. G.D.
Searle & Co., 748 F. Supp. 1511, 1520 (S.D. Fla. 1990). Although Plaintiffs do not dispute that
the first element has been met, see Compl. ¶ 64 (“Class III devices pose the greatest risk of death

3

Because these are the only grounds for dismissal advanced by Medtronic and briefed by the
parties, the Court assumes, without deciding, that such a claim is otherwise cognizable under
Florida law.
13

or complications . . . . Infuse® is a Class III device”), and cannot challenge the third element
because such a claim would be expressly preempted, see Section III.C.1, supra, their allegations
that Medtronic made affirmative misrepresentations in promoting the off-label use of Infuse
undermine the second element, that the product was properly marketed.
Nevertheless, for the reasons discussed in Section III.C.1, supra, to the extent this claim is
not preempted, it has been inadequately pleaded. Accordingly, the Court will dismiss the Fourth
Cause of Action, but will also grant Plaintiffs leave to amend.
5.

Negligence (Fifth Cause of Action)

Ms. Byrnes’ negligence claim appears to be premised on several theories: (1) Medtronic’s
promotion and marketing of Infuse for off-label use; (2) Medtronic’s failure to warn physicians
and Ms. Byrnes of the dangers of the off-label use of Infuse; (3) Medtronic’s failure to comply
with federal law and regulations; and (4) Medtronic’s failure to exercise reasonable care to prevent
Infuse from creating an unreasonable risk of harm to Ms. Byrnes and other consumers. Compl. ¶
329. Each of these grounds, as alleged, is preempted. First, to the extent the negligence claim is
premised on a failure-to-warn theory (grounds 2 and 4), it is expressly preempted. See Section
III.C.1, supra. Second, to the extent that the claim is premised on the mere fact that Medtronic
engaged in off-label promotion (ground 1), it is impliedly preempted, because Plaintiffs have not
identified any state law duty to refrain from truthful off-label promotion and have not alleged any
affirmative misrepresentations. See supra note 2. Finally, to the extent that the claim is premised
on Medtronic’s failure to comply with federal law and regulations (ground 3), it is impliedly
preempted. See Section III.C.1, supra.
Although this claim, as pleaded, is preempted, the Court will give Plaintiffs an opportunity
to amend to assert a claim that falls in the narrow gap through which a plaintiff’s state-law claim

14

must fit if it is to escape express or implied preemption. Accordingly, the Court will dismiss this
claim, but without prejudice.
6.

Breach of Express Warranty Claim (Sixth Cause of Action)

Medtronic argues that Ms. Byrnes’ breach of express warranty claim is preempted because
to prevail on that claim, Plaintiffs must prove that Infuse was not safe and effective as labeled.
And, according to Medtronic, such a finding would impose requirements different from or in
addition to those imposed by the FDA.
The Court disagrees. As the Complaint makes clear, Ms. Byrnes’ breach of warranty claim
is premised on voluntary, affirmative (but false) warranty statements made by Medtronic, aside
from any FDA-approved label or warning, to promote the off-label use of Infuse. See, e.g., Compl.
¶ 339. And, as Plaintiffs note, “[f]ederal law already requires Medtronic to ensure that any
warranty statements it voluntarily makes are truthful, accurate, not misleading, and consistent with
applicable federal and state law.” Brady, 2014 WL 1377830, at *8 (quotation marks, alterations,
and citations omitted); see also 21 U.S.C. § 331(b). A state law requirement that holds medical
manufacturers to the voluntary express warranties it makes during off-label promotion therefore
would not impose requirements different from, or in addition to, the federal requirements. Accord
id. Moreover, such a claim is not impliedly preempted because it stands independently under
Florida state law, and does not seek simply to enforce the requirements of the FDCA. Accord id.
The Court declines to follow the cases cited by Medtronic, because they are not binding,
and because they fail to convincingly address why such a state law requirement would be different
from, or in addition to, the federal requirements. For example, the court in Gavin v. Medtronic,
Inc., Case No. 12-cv-851, 2013 WL 3791612, at *15-16 (E.D. La. July 19, 2013), cited Gomez v.
St. Jude Med. Daig Division Inc., 442 F.3d 919 (5th Cir. 2006), to hold that the plaintiff’s breach

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of express warranty claim was preempted. Gomez, however, did not deal with warranties made in
the off-label promotion of a medical device; rather, its preemption holding was based on the fact
that “[the] express warranty was part of the IFU, which is itself part of the PMA process.” Gomez,
442 F.3d at 932. See also Caplinger v. Medtronic, 921 F. Supp. 2d 1206, 1222 (W.D. Okla. 2013)
(holding that the plaintiff’s breach of express warranty claim was preempted because it would
require a plaintiff to “persuade a jury that the Infuse Device was not safe and effective . . . contrary
to the FDA’s approval,” but failing to address the fact that the FDA did not approve the off-label
use).
Although the Court finds that the breach of express warranty claim is not preempted, the
Court nevertheless agrees with Medtronic that this Cause of Action must be dismissed because
Plaintiffs’ allegations are insufficient. Indeed, Plaintiffs have failed to allege specifically what
affirmations of fact were made by Medtronic to Dr. Small, or how those express warranties
proximately caused Ms. Byrnes’ injury. See Compl. ¶¶ 339, 342 (with regard to the alleged express
warranties, asserting only that Medtronic made them to unspecified “physicians and other
members of the general public and medical community”; and, with regard to causation, alleging
only that “Defendants thus breached their express warranty which was a direct and proximate
cause of Plaintiff’s injuries and damages.”); Fla. Stat. § 672.313(1)(a) (“Express warranties by the
seller are created as follows: Any affirmation of fact or promise made by the seller to the buyer
which relates to the goods and becomes part of the basis of the bargain . . . .”) (emphasis added).
The Court will therefore dismiss this Cause of Action, but will also grant Plaintiffs leave
to amend to cure any defects in the pleadings. 4

4

To the extent Medtronic argues that this claim fails because Infuse’s FDA-approved label
expressly disclaims any warranties, see Doc. 32 at 34, the Court rejects this argument as a basis
for dismissal. In ruling on a motion to dismiss, a court must accept all the allegations of the
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7.

Loss of Consortium (Ninth Cause of Action)

Because all of Ms. Byrnes’ Causes of Action have now been dismissed, see also Doc. 55,
the Court must also dismiss Mr. Byrnes’ claim for loss of consortium. See Gates v. Foley, 247 So.
2d 40, 45 (Fla. 1971) (a claim for loss of consortium is derivative and may proceed “only if [the
spouse] has a cause of action against the same defendant”). However, because the dismissal of
some of Ms. Byrnes’ claims against Medtronic are without prejudice, the dismissal of Mr. Byrnes’
loss of consortium claim is also without prejudice.
8.

Punitive Damages

As is clear from the above discussion, all of Plaintiffs’ substantive causes of actions must
be dismissed. Accordingly, Plaintiffs’ claim for punitive damages must also be dismissed. See
Oliveira v. Ilion Taxi Aero LTDA, 830 So. 2d 241, 242 (Fla. 4th DCA 2002). The dismissal of
Plaintiffs’ claim for punitive damages is without prejudice. The allegations in the Amended
Complaint will control any determination by the Court as to whether Plaintiffs have adequately
alleged a basis for punitive damages.
IV.

CONCLUSION
Many courts have addressed issues that are nearly-identical, if not identical, to the ones

currently before this Court. Many have reached conclusions that differ in a multitude of ways, and
cannot be reconciled easily, if at all. Having conducted an exhaustive review of those opinions
and the reasoning behind them, the Court has applied the general principle that claims premised
on voluntary, affirmative falsehoods are not preempted. Accord Buccelli v. Mayer, Case No. 2014CA-1667, Order on Motion to Dismiss of Defendants Medtronic, Inc. and Medtronic Sofamore

complaint as true, and draw all reasonable inferences in favor of the non-moving party.
Accordingly, this argument is premature.
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Danek USA, Inc. (Fla. Cir. Ct. 12th Jud. Cir. Jan. 27, 2015) (Doc. 71-1). However, even though
some of Ms. Byrnes’ claims are not preempted under this principle, they still must be dismissed,
because they have not been pleaded with sufficient specificity.
Accordingly, it is hereby ORDERED:
1.

Medtronic’s Motion to Dismiss (Doc. 32) is GRANTED.

2.

Plaintiffs’ Second and Third Causes of Action are DISMISSED with prejudice.

3.

Plaintiffs’ First, Fourth, Fifth, Sixth, and Ninth Causes of Action are DISMISSED
without prejudice.

4.

Plaintiffs’ request for punitive damages is DISMISSED without prejudice.

5.

Plaintiffs are granted leave to file an Amended Complaint within fourteen (14) days
from the date of this Order which cures the deficiencies identified in this Order.

DONE AND ORDERED in Tampa, Florida on March 18, 2015.

Copies to:
Counsel of Record and Unrepresented Parties, if any

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