Wolicki-Gables v. Doctors Same Day Surgery Center, Ltd.

NOT FINAL UNTIL TIME EXPIRES TO FILE REHEARING
MOTION AND, IF FILED, DETERMINED

IN THE DISTRICT COURT OF APPEAL
OF FLORIDA
SECOND DISTRICT

LINDA WOLICKI-GABLES and ROBERT )
GABLES, her husband, )
)
Appellants, )
)
v. ) Case No. 2D15-2495
)
DOCTORS SAME DAY SURGERY )
CENTER, LTD., d/b/a DOCTORS SAME )
DAY SURGERY CENTER, )
)
Appellee. )
)

Opinion filed February 15, 2017.

Appeal from the Circuit Court for Sarasota
County; Peter A. Dubensky, Judge.

T. Patton Youngblood, Jr. of the
Youngblood Law Firm, St. Petersburg, for
Appellants.

Joshua P. Welsh of Bush Ross, P.A.,
Tampa, for Appellee.

LaROSE, Judge.

Linda Wolicki-Gables and her husband, Robert Gables, appeal the trial

court's final summary judgment in favor of Doctors Same Day Surgery Center, Ltd. (the

Surgery Center). The Gableses brought a third-party spoliation lawsuit against the

Surgery Center. They asserted that if the Surgery Center had kept an allegedly

defective pain-pump connector removed from Mrs. Wolicki-Gables, the Gableses could
have maintained a civil action against Arrow International, Inc., on one of two grounds:

(1) a first-party spoliation suit; or (2) a "parallel claim" for negligent design and/or

manufacture under Florida law. We have jurisdiction. See Fla. R. App. P.

9.030(b)(1)(A). Because any potential state law claim for negligent design or

manufacture against Arrow is preempted by federal law, and because the Gableses

cannot assert a "parallel claim" against Arrow under Florida law, we are compelled to

affirm.

Background

Mrs. Wolicki-Gables suffered from back and neck pain. To alleviate the

condition, Dr. James of the Surgery Center implanted a "pain pump system" into Mrs.

Wolicki-Gables in the spring of 2002. The system consisted of: (1) an infusion pump to

hold and release pain medication; (2) an intrathecal catheter that delivered the

medication into Mrs. Wolicki-Gables's spinal canal; and (3) a connector that linked these

two components. Arrow manufactured all three components, which are Class III

medical devices approved through the Premarket Approval Process (PMA) of the Food

and Drug Administration (FDA). See Medical Device Amendments of 1976 (MDA)

5121 U.S.C. § 360e (2012); 21 C.F.R. §§ 814.1-.126.

Unfortunately, Mrs. Wolicki-Gables's pain persisted. In response, Dr.

James increased the dosage of the medication being dispensed from the pump in the

summer of 2002. Mrs. Wolicki-Gables experienced no relief. About a year later, Dr.

James performed a dye injection test to assess whether the pain pump system was

operating properly. He concluded that the pain medication was not being directed

through the intrathecal catheter into Mrs. Wolicki-Gables's spine; rather, it leaked from

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the injection site and dripped down Mrs. Wolicki-Gables's sides. Dr. James scheduled

Mrs. Wolicki-Gables for surgery and contacted an Arrow representative, Greg Nelson.

On July 15, 2003, Mrs. Wolicki-Gables arrived at the Surgery Center for

the operation. She signed an Informed Consent to Treat and Disclose Information form.

She handwrote on the form, "we want old pump." She also noted on the form that she

did not want technical support personnel, which would include Mr. Nelson, present

during the surgery.

Dr. James proceeded with the surgery, during which Mr. Nelson was

present. Dr. James removed the pain pump system and determined that the most likely

cause of the malfunction was the connector between the pump and the intrathecal

catheter. Dr. James replaced the connector and reinserted the pain pump system into

Mrs. Wolicki-Gables's body. Dr. James confirmed that the pain pump system was

operating properly.

Following the surgery, Mr. Nelson approached Mr. Gables in the waiting

room to explain that the connector had been replaced. Mr. Gables asked for the old

connector. Mr. Nelson refused, stating that he had to take it to Arrow for testing. Mrs.

Wolicki-Gables claims that she also made a similar request to Dr. James later that same

day. He, too, stated that the connector had to go to Arrow.

When released from the Surgery Center, Mrs. Wolicki-Gables had no

apparent complications. At a postoperative follow-up on July 17, 2003, she presented

no signs of infection and the pain pump system was working properly. Sadly, twelve

days later, Mrs. Wolicki-Gables was rushed to the hospital where she was diagnosed

with transverse myelitis—inflammation of the spinal cord. Several days later, the

hospital released her. She returned three days later when her incision site became
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infected. The hospital again diagnosed Mrs. Wolicki-Gables with transverse myelitis,

and added an infected pain pump to her diagnosis. Mrs. Wolick-Gables underwent

another surgery where the pain pump system was permanently removed. During her

convalescence from this third procedure, Mr. Gables contacted Mr. Nelson to obtain the

old connector removed in the second surgery. Mr. Gables learned that Arrow tested the

connector, found no defect, and destroyed it in accordance with company policy. The

Gableses then sued Arrow in state court.

The Gableses asserted numerous claims against Arrow, including strict

liability and negligence claims. Arrow removed the case to federal district court based

on diversity jurisdiction. See 28 U.S.C. § 1332 (2011). Ultimately, the federal district

court granted summary judgment to Arrow, concluding that their claims were expressly

preempted by the Medical Devices Amendment (MDA) to the Federal Food, Drug, and

Cosmetic Act (FDCA). Wolicki-Gables v. Arrow Int'l, Inc., 641 F. Supp. 2d 1270, 1296

(M.D. Fla. 2009), aff'd, 634 F.3d 1296, 1303 (11th Cir. 2011). The federal district court

also granted summary judgment in favor of Mr. Nelson on the Gableses' claims of

negligence and loss of consortium. Wolicki-Gables, 641 F. Supp. 2d at 1292-96. The

federal district court also concluded that they failed to demonstrate any causal relation

between her injuries and the loss of the connector. Id. at 1295. Importantly, experts in

the federal case were not impeded from offering meaningful testimony because the

connector was unavailable. Id. at 1281.

Undeterred, and convinced that they would have prevailed against Arrow if

they had the old connector, the Gableses sued the Surgery Center in state court,

asserting a third-party spoliation claim. A third-party spoliation claim arises when "a

person or an entity, though not a party to the underlying action causing the plaintiff's
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injuries or damages, lost, misplaced, or destroyed evidence critical to that action."

Martino v. Wal-Mart Stores, Inc., 908 So. 2d 342, 345 n.2 (Fla. 2005). In such a case,

the plaintiff attempts to recover from the third party "the loss of a probable expectancy of

recovery against the first-party torfeasor." Id. (citing Humana Worker's Comp. Servs. v.

Home Emergency Servs., Inc., 842 So. 2d 778, 781 (Fla. 2003)). The Gableses alleged

that but for the Surgery Center allowing Mr. Nelson to take the old connector, they could

have proceeded successfully against Arrow on (1) a first-party spoliation claim, or (2) a

negligent design/manufacture theory. The trial court granted summary judgment to the

Surgery Center. The trial court found that neither a first-party spoliation claim nor a

permissible "parallel claim" against Arrow for negligent design/manufacture existed

under Florida law. This appeal followed.

Discussion

The Gableses argue that the trial court erred in concluding that they could

not assert a "parallel claim" against Arrow under Florida law for negligent manufacture

based on a violation of MDA regulations related to Class III medical devices. We write

to explain why the trial court committed no error on this point. As to the first-party

spoliation claim, we affirm without further discussion. See Martino, 908 So. 2d at 347.

a. Express and Implied Preemption Statutes

We begin our "parallel claim" analysis by noting that the MDA bars

virtually all state-based claims for allegedly defective Class III medical devices. Two

statutes are relevant. 21 U.S.C. § 360k(a) 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.
This section expressly preempts any state requirement or other obligation that is

"different from, or in addition to, any requirement applicable [under the MDA] to the

device," related to the "safety or effectiveness of the device." Id.

The second statute, 21 U.S.C. § 337(a), provides that "all such

proceedings for the enforcement, or to restrain violations, of this chapter shall be by and

in the name of the United States." Section 337(a) impliedly preempts any action "for the

enforcement, or to restrain violations," of the MDA in any name other than that of the

United States. Thus, enforcement of MDA requirements, in the first instance, is left to

the federal government.

In tandem, §§ 360k(a) and 337(a) make it exceedingly difficult for a

plaintiff to maintain negligence claims for allegedly defective medical devices that

entered commerce through the PMA approval process. Often, state law claims, such as

claims for negligent manufacture, are broad in scope and are expressly preempted by

§ 360k(a). This was the conclusion reached by the federal district court in the Gableses'

initial lawsuit against Arrow. Wolicki-Gables, 641 F. Supp. 2d at 1288. But, when a

plaintiff attempts to assert a claim specifically based on a violation of the MDA, the claim

is impliedly preempted by § 337(a), which leaves enforcement of the MDA to the United

States.

The PMA approval process does not swallow the entire universe of

potential state law claims. Under our federal system, states may enact laws which

create a private cause of action for "failure to comply with the federal standards which

were established [for a medical device] through the PMA process." Wolicki-Gables, 641

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F. Supp. 2d at 1284 (citing Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008)).

Unfortunately for the Gableses, Florida has no such law.

b. Framework for Preemption Analysis

Three Supreme Court cases provide the primary framework for

preemption analysis in the MDA context. The first is Medtronic, Inc. v. Lohr, 518 U.S.

470 (1996). There, the Court determined that the MDA did not preempt the Lohrs'

negligent manufacture claims against Medtronic for a faulty pacemaker. Id. at 503. The

Court noted, however, that Medtronic's pacemaker device did not undergo the PMA

process, as had Mrs. Wolicki-Gables' pain pump system. Id. at 480. The Court

described the PMA process as a "rigorous" process during which the manufacturer

"submit[s] detailed information regarding the safety and efficacy of their devices, which

the FDA then reviews, spending an average of 1,200 hours on each submission." Id. at

477. Without FDA approval, a device which receives premarket approval cannot be

modified by the manufacturer in a way which would affect the device's safety or efficacy.

21 U.S.C. § 360e(d)(6).

In contrast, Mr. Lohr's pacemaker had entered the market through the

§ 510(k) process (as amended, 21 U.S.C. § 360(k) (2012)), which compares a device

created after the implementation of the MDA to one that was created before enactment

of the MDA. The § 510(k) process determines whether a new device is "substantially

equivalent" to one that entered the market before the MDA. Lohr, 518 U.S. at 492-93.

As the Court observed, the § 510(k) process involves a truncated, limited review–twenty

hours on average. Id. at 478-79. "Section 510(k) notification requires little information,

rarely elicits a negative response from the FDA, and gets processed very quickly." Id. at

479 (citations omitted). The Court emphasized that the § 510(k) process was based on
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equivalency to a pre-MDA device, not on the actual safety of the device that is carried

out under the PMA process. Id. at 493. As a result, the Court found that a "substantial

equivalence" finding under the § 510(k) process did not preempt the Lohrs' negligent

manufacture claims against Medtronic; the § 510(k) process only was meant to

"maintain the status quo with respect to the marketing of existing medical devices and

their substantial equivalents. . . . [I]nclud[ing] the possibility that the manufacturer of the

device [might] have to defend itself against state-law claims of negligent design." Id. at

494. Because of the approval process involved, Lohr lends little support to Mrs.

Wolicki-Gables' claim.

Subsequently, in Buckman Co. v. Plaintiff's Legal Committee, 531 U.S.

341, 346-47 (2001), the plaintiffs asserted that Buckman defrauded the FDA when it

separated its bone screw device, intended for spinal surgery, into component parts—the

bone screws themselves and the nested bone plates—in order to obtain a § 510(k)

exemption. Apparently, Buckman had been unsuccessful in obtaining such an

exemption for the device as a whole. Id. at 346. Allegedly, Buckman knew that the

FDA would not approve of Buckman's intended use for the bone screw device

components in their totality. As a result of the alleged fraud, plaintiff suffered injuries

from Buckman's bone screws. See id. at 346-47 (discussing plaintiffs' claims).

Ultimately, the Court determined that the plaintiffs' claims were impliedly preempted,

finding that:

[T]he federal statutory scheme amply empowers the FDA to
punish and deter fraud against the [FDA]. . . . [T]his
authority is used by the [FDA] to achieve a somewhat
delicate balance of statutory objectives. The balance sought
by the [FDA] can be skewed by allowing fraud-on-the-FDA
claims under state tort law.

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Id. at 348.

Although Buckman, like Lohr, involved this § 510(k) process, the Court

was unwilling to allow a private state law fraud claim to proceed. In reconciling

Buckman with Lohr, the Court observed as follows:

[A]lthough [Lohr] can be read to allow certain state-law
causes of actions that parallel federal safety requirements, it
does not and cannot stand for the proposition that any
violation of the FDCA will support a state-law claim. . . .
[W]ere plaintiffs to maintain their fraud-on-the-agency claims
here, they would not be relying on traditional state tort law
which had predated the federal enactments in questions. On
the contrary, the existence of these federal enactments is a
critical element in their case.

Buckman, 531 U.S. at 353. Thus, the Court seemed willing to permit state law causes

of action based on violations of state law requirements that mirrored federal

requirements, but it was unwilling to permit a state law cause of action based upon a

violation of federal law. Id.

The third and final case to refine the MDA preemption analysis applicable

here is Riegel. In Riegel, a balloon catheter used to dilate the plaintiff's coronary artery

ruptured. 552 U.S. at 320. The plaintiff had to undergo emergency coronary bypass

surgery. Id. The plaintiff sued Medtronic, alleging various common law claims,

including "strict liability; breach of implied warranty; and negligence in the design,

testing, inspection, distribution, labeling, marketing, and sale of the catheter." Id. He

theorized that Medtronic's catheter was "designed, labeled, and manufactured in a

manner that violated New York common law." Id.

In Riegel, the Court observed that unlike Lohr, where the device had been

approved through the § 510(k) exemption process, the catheter went through the more

exacting PMA process. Id. at 322-23. As noted earlier, PMA approval imposes rigorous
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requirements under the MDA. Id. The Court observed that PMA approval "is in no

sense an exemption from federal safety review—it is federal safety review." Id. at 323.

With this in mind, the Court determined that the plaintiff's state common law claims for

negligence and strict liability imposed requirements preempted by federal requirements

specific to the medical device. Id. at 323-24. The Court explained that "[a]bsent other

indication, reference to a State's 'requirements' includes its common-law duties,"

reasoning that "[s]tate tort law that requires a manufacturer's catheters to be safer, but

hence less effective, than the model the FDA has approved [through the PMA process]

disrupts the federal scheme no less than state regulatory law to the same effect." Id. at

324. Thus, the Court stood by its holding in Lohr that "§ 360k does not prevent a State

from providing a damages remedy for claims premised on a violation of FDA

regulations; the state duties in such a case 'parallel,' rather than add to, federal

requirements." Id. at 330 (citing Lohr, 518 U.S. at 495). But the Court concluded that

Riegel's claims were preempted because they asserted that "Medtronic's device

violated state tort law notwithstanding compliance with the relevant federal

requirements." Id. at 330. Seemingly, the Court would not tolerate the pursuit of state

law claims that posed the risk of liability, even if the manufacturer complied with all

requirements imposed by the PMA.

Taken together, Lohr, Buckman, and Riegel "create a narrow gap through

which a plaintiff's state-law claim must fit if it is to escape express or implied

preemption" under the MDA. Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn.

2009). The Court maintained in Riegel that it was, in fact, still possible to bring a

parallel claim under state law. Defining a parallel claim, however, remains frustratingly

difficult.
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 c. Parallel Claims

The Gableses' spoliation claim against the Surgery Center rises or falls on

whether they could have asserted a parallel claim against Arrow. As the Eleventh

Circuit noted in the Gableses' federal lawsuit against Arrow:

State requirements are pre-empted under the MDA only to
the extent that they are "different from, or in addition to the
requirements imposed by federal law." Thus, § 360k does
not prevent a State from providing a damages remedy for
claims premised on a violation of FDA regulations; the state
duties in such a case "parallel," rather than add to, federal
requirements.

Wolicki-Gables, 634 F.3d at 1300 (citing Lohr, 518 U.S. at 495) (citations omitted).

Thus, the Eleventh Circuit anticipated the existence of a state law that allows a private

cause of action for a violation of the MDA and related regulations. Common law

damage claims are inadequate to escape federal preemption.

An MDA parallel claim is much like a unicorn—existing in legend, but

elusive in reality. "[C]laims alleging a failure to comply with the federal standards which

were established through the PMA process are not preempted. Such claims are

'parallel' claims, which do not add to or differ from federal requirements." Wolicki-

Gables, 641 F. Supp. 2d at 1284 (citing Riegel, 552 U.S. at 330); accord Lohr, 518 U.S.

at 495 ("[section] 360k does not prevent a State from providing a damages remedy for

claims premised on a violation of FDA regulations; the state duties in such a case

'parallel,' rather than add to, federal requirements."). Since Riegel, the "narrow gap"

available to allow a parallel claim remains open where the state legislature provides a

law that makes available the parallel private remedy for a violation of FDA regulations.

Analogous to Goldilocks' porridge, such a statute cannot be overly broad—and thus

expressly preempted by § 360k—nor sound like an action to enforce or restrain
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violations of the MDA—and thus impliedly preempted by § 337(a). See generally 21

U.S.C. §§ 360k(a), 337(a). The state law must be just right to allow passage through

Riegel's narrow gap.

A handful of post-Riegel cases involve a plaintiff who adequately alleged a

parallel claim sufficient to survive a motion to dismiss. See, e.g., Waltenburg v. St. Jude

Med., Inc., 33 F. Supp. 3d 818 (W.D. Ky. 2014) (granting defendant's motion to dismiss

plaintiff's negligence per se claims premised on violations of federal law, but denying

defendant's motion to dismiss plaintiff's claims for negligent manufacture, negligent

failure to warn, and strict liability manufacturing defects, finding that they were not

expressly or impliedly preempted by the MDA); James v. Diva Int'l, 803 F. Supp. 2d 945

(S.D. Ind. 2011) (denying defendant's motion to dismiss plaintiff's state law claims,

finding that the claims were not preempted by the MDA). Many others conclude that

plaintiffs' claims are expressly preempted by § 360k(a) for imposing requirements

"different from, or in addition to," the MDA, or impliedly preempted by § 337(a) because

they attempt to enforce, or restrain violations of, the MDA. See, e.g., Mink v. Smith &

Nephew, Inc., 169 F. Supp. 3d 1321 (S.D. Fla. 2016) (granting defendant's motion to

dismiss based on preemption under the MDA); Marmol v. St. Jude Med. Ctr., 132 F.

Supp. 3d 1359 (M.D. Fla. 2015) (granting defendant's motion to dismiss, and holding

that Florida does not recognize private causes of action—such as plaintiff's product

liability claim—for violations of FDA regulations); Pearsall v. Medtronics, Inc., 147 F.

Supp. 3d 188 (E.D.N.Y. 2015) (dismissing plaintiff's state law claims, including claims

for manufacturing defects, as preempted by the MDA); Gross v. Stryker Corp., 858 F.

Supp. 2d 466 (W.D. Pa. 2012) (holding that plaintiff's breach of implied warranty claim

was expressly preempted because it imposed requirements different than, or in addition
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to, applicable federal requirements); In re Medtronic, Inc. Sprint Fidelis Leads Prod.

Liab. Litig., 592 F. Supp. 2d 1147 (D. Minn. 2009) (dismissing a consolidated complaint

with prejudice due to preemption under the MDA).

As Judge Kyle noted in In re Medtronic, "nearly all types of claims

concerning FDA-approved medical devices are preempted." 592 F. Supp. 2d at 1161.

Despite the potential to assert a parallel claim, there appears to be little solid ground

remaining on which to construct such a claim for a plaintiff who alleges injury from a

PMA-approved medical device.

At the core, the Gableses hoped that with the old connector in hand, they

could demonstrate that Arrow did not manufacture the connector in compliance with

PMA requirements. Their only basis to proceed is by a parallel claim. Their proposed

theory, however, lacks a firm footing under Florida law. "Florida law does not permit a

private action to enforce violations of FDA requirements." Marmol, 132 F. Supp. 3d at

1367-68; accord Kaiser v. DePuy Spine, Inc., 944 F. Supp. 2d 1187, 1192 (M.D. Fla.

2013) ("The Court also finds Plaintiff's claims should be dismissed since Florida law

does not allow Plaintiff to bring a private cause of action to enforce FDA regulations.");

Wheeler v. DePuy Spine, Inc., 706 F. Supp. 2d 1264, 1270 (S.D. Fla. 2010) ("Whether

these claims are characterized as negligent design, manufacture, or sale of the product,

Florida law does not authorize the only type of 'negligence' claims that might survive the

MDA, i.e., a claim based on violation of federal requirements."). Although frequently

recited, the holdings in these cases are rarely explained.

Under Florida law, a statutory violation does not give rise to a private

cause of action absent a clear legislative intent to do so. Wheeler, 706 F. Supp. 2d at

1268 (citing Murthy v. N. Sinha Corp., 644 So. 2d 983 (Fla. 1994)). Certainly, the MDA
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does not reflect a congressional intent to create such a private cause of action. See 21

U.S.C. § 360 (including no specific language to indicate an intent to create a civil cause

of action for violation). And the weight of authority in Florida, too, reflects no state

legislative effort to create the statutory parallel claim.

The spoliation theory the Gableses assert, if allowed, would permit what

the Florida Supreme Court prohibited in Murthy–creation of a private civil cause of

action in Florida for violation of a federal statute absent clear legislative intent to do so.

See 644 So. 2d at 985–87 (declining to judicially create a civil cause of action based on

a statute where the legislature had expressed no clear intent to create such a cause of

action).

Conclusion

Congress has expressed a clear intent to limit liability for manufacturers of

medical devices. Presumably, Congress intended to promote innovation in the medical

device field. Florida law provides no parallel claim that would allow the Gableses to

pursue Arrow. The Florida Legislature may choose to do so, but it is not within our ken

to create a cause of action by judicial fiat. As a result, the spoliation claim must fail.

Even if they had the old connector, the Gableses would not have been able to proceed

further against Arrow.

Accordingly, we affirm the trial court's entry of summary judgment in favor

of the Surgery Center.

Affirmed.

SILBERMAN and BADALAMENTI, JJ., Concur.

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