Wolicki-Gables v. Arrow International, Inc.

[PUBLISH]

IN THE UNITED STATES COURT OF APPEALS

FOR THE ELEVENTH CIRCUIT FILED
________________________ U.S. COURT OF APPEALS
ELEVENTH CIRCUIT
MARCH 8, 2011
No. 09-14342 JOHN LEY
________________________ CLERK

D. C. Docket No. 08-00151-CV-T-17-TBM

LINDA WOLICKI-GABLES,
ROBERT GABLES,
her husband,

Plaintiffs-Appellants,

ARROW INTERNATIONAL, INC.,
CODMAN & SHURTLEFF, INC.,
JOHNSON & JOHNSON,
GREG NELSON,

Defendants-Appellees.

________________________

Appeal from the United States District Court
for the Middle District of Florida
________________________

(March 8, 2011)
Before EDMONDSON, HILL and ALARCÓN,* Circuit Judges.

ALARCÓN, Circuit Judge:

Robert Gables and Linda Wolicki-Gables appeal from the District Court’s

grant of summary judgment in favor of Arrow International (“Arrow”), Codman &

Shurtleff (“Codman”), Johnson & Johnson, and Greg Nelson (collectively

“Appellees”). The Gableses contend that the state law claims they brought against

Appellees are not preempted by the Medical Device Amendments of 1976

(“MDA”). The Gableses also assert that the District Court erred in determining

that she was not entitled to a presumption that the catheter connector for the

Arrow pump implanted in Linda Wolicki-Gables was defective because it was

destroyed by the manufacturer. We affirm because we conclude that the Gableses’

claims are preempted, and the District Court did not err in determining that they

were not entitled to a presumption that the catheter connector was defective.

I

A

During much of the 1990s, Linda Wolicki-Gables (“Wolicki-Gables”)

endured pain and physical limitations from two back injuries. On Apri1 30, 2002,

Brian James, Wolicki-Gables's doctor, implanted an Arrow pump system in her

*
Honorable Arthur L. Alarcón, United States Circuit Judge for the Ninth Circuit, sitting
by designation

2
back to manage her pain. This pump system works by allowing the continuous

delivery of pain medication into the intraspinal space to eliminate the peaks and

valleys often experienced with traditional oral drug therapy. It also allows the

doctor to inject a separate bolus (a single, large quantity) of medication directly

into the intraspinal space. The system includes three components: a pump that

releases pain medication, an intrathecal catheter through which the medicine is

delivered into the spinal canal, and a metal connector that links the pump catheter

to the intrathecal catheter. As with all inherently risky “Class III” medical devices

on the market, the pump system had been approved by the Food and Drug

Administration (“FDA”) in a process called “premarket approval.” 21 U.S.C.

§ 360c(a)(1)(C)(ii)(II).1

Venture Medical Devices, founded by Greg Nelson, distributed the pump

for Arrow. In 2002, Codman, a subsidiary of Johnson & Johnson, acquired

Arrow's pump division and assumed the distribution contract between Arrow and

Venture. Nelson became a Codman employee in July 2003. In August 2002, at

1
Section 360c(a)(1)(C)(i-ii) of volume 21 of the United States Code reads as follows:
[A Class III device is a] device which because it cannot be
classified [under a less stringent classification], and is purported or
represented to be for a use in supporting or sustaining human life
or for a use which is of substantial importance in preventing
impairment of human health, or presents a potential unreasonable
risk of illness or injury, is to be subject . . . to premarket approval
to provide reasonable assurance of its safety and effectiveness.

3
Wolicki-Gables's request, Dr. James performed a dye injection test to assess

whether the Arrow pump was working properly. Dr. James observed the dye

spreading appropriately in the intraspinal space and saw no leaks in the system.

On July 10, 2003, Dr. James performed a second test and found that the dye was

not spreading appropriately. He hypothesized that the bolus feature of the pump

was malfunctioning.

On July 15, 2003, Dr. James removed the Arrow pump, cut the pump

catheter, and tested the bolus feature of the pump, which operated properly. Dr.

James then removed the connector and sent a bolus through the intrathecal

catheter, confirming that it too was functioning correctly. Having found nothing

wrong, Dr. James replaced the connector between the pump and intrathecal

catheters and reimplanted the pump into Wolicki-Gables. Nelson, who was

present during the procedure, provided Dr. James with the new connector. Dr.

James concluded in his postoperative report that the catheter “obviously had

crimped.”

Mr. Gables testified that Nelson approached him after the surgery and said

he would return the catheter connector removed from Wolicki-Gables's back to

the manufacturer. Mr. Gables also testified that Nelson later told him that the

manufacturer had destroyed the catheter connector.

4
 On July 29, 2003, Wolicki-Gables was taken to the hospital complaining of

paralysis in her legs. After undergoing extensive testing, she was discharged with

a diagnosis of transverse myelitis, the irritation or inflammation of the spinal cord.

The neurologist who treated Wolicki-Gables during her hospitalization noted that

there was no evidence of infection.

After she left the hospital, Wolicki-Gables entered HealthSouth, a

rehabilitation facility. A few days later, HealthSouth noticed a purulent discharge

around Walicki-Gables’s incision site and transferred her back to the hospital. Dr.

Raymon Priewe removed the entire pump system. Dr. Priewe’s postoperative note

stated that there was “no pus in pump pocket or dorsal spine, only superficial

skin.” Aside from a “superficial” infection at the incision site, the only other sign

of bacteria was found in a culture taken from the incision site. Wolicki-Gables was

discharged nine days after her readmission to the hospital with a diagnosis of

suspected transverse myelitis. She has since lost her ability to walk and has

become a partial paraplegic.

B

On July 24, 2007, the Gableses filed an action in the Florida State Circuit

Court in Sarasota County alleging state law claims for product liability,

negligence, vicarious liability, and loss of consortium against the Appellees. On

5
January 22, 2008, Codman and Johnson & Johnson filed a notice of removal to the

Middle District of Florida based on diversity jurisdiction pursuant to 28 U.S.C. §

1332. Arrow and Nelson consented to the removal. The Gableses filed an

amended complaint in the District Court on July 7, 2008. They alleged seventeen

counts against the Appellees.

On July 24, 2008, Appellees filed two separate motions to dismiss the action

pursuant to Rule 12(b)(6) of the Federal Rules of Civil Procedure. On December

10, 2008, the District Court granted in part and denied in part Appellees’ motions.

It dismissed three of the Gableses’ negligence claims for failure to state a claim

upon which relief can be granted. On March 12, 2009, the parties stipulated to the

dismissal of a claim for vicarious liability as to Arrow and Nelson, and a claim for

loss of consortium.

On March 12, 2009, Arrow filed a motion for summary judgment. It

asserted that the Gableses’ twelve remaining claims were preempted by the MDA.

On March 12, 2010, Codman, Johnson & Johnson and Nelson filed their own

motions for summary judgment and partial summary judgment and, on March 13,

2010, joined Arrow’s motion for summary judgment.

The Gableses opposed the motions, arguing that the District Court should

apply a presumption against preemption because Nelson participated in “off label”

6
use of the Arrow pump and its parts, which constitutes “performing a procedure

for which there was no provision within the Instructions for Use.” (Plaintiff’s

Response to Defendants’ Motion for Summary Judgment at 16-17.) They asserted

that Nelson should have advised Dr. James against replacement of only the

catheter connector and should have recommended replacement of the entire pump.

They also maintained that Nelson’s failure to do so constituted violation of the

PMA requirements for the pain pump. Further, the Gableses contended that the

District Court should grant them a presumption that the destroyed catheter

connector was defective.

The Gableses also moved for partial summary judgment based on their

assertion that Codman, Johnson & Johnson, and Nelson were distributors of the

Arrow pump.

In its July 22, 2009 order, Wolicki-Gables v. Arrow Int'l, Inc., 641 F. Supp.

2d 1270 (M.D. Fla. 2009), the District Court determined that each claim was

“expressly preempted”1 or was “derivative of”2 a preempted claim. The District

Court also articulated three alternative bases on which Appellees were entitled to

summary judgment on several of the claims. As to the strict liability and

negligence claims against Arrow, Codman and Johnson & Johnson, the District

1
Id. at 1285, 1286, 1288, 1290, 1295, 1296.
2
Id. at 1288, 1290, 1291, 1296.

7
Court stated that there was insufficient evidence to support the claims. Further,

the District Court determined that there was no evidence that Nelson acted

negligently or that he caused any injury to the Gableses. The District Court also

concluded that there was no evidence to support an agency relationship between

Nelson and Codman or Johnson & Johnson and that “undisputed record evidence

further establishes that Defendant Arrow International, Inc. designed,

manufactured, tested and sold the pump and catheter kit medical devices.” (Id. at

1290.)

The Gableses have timely appealed. This Court has jurisdiction pursuant to

28 U.S.C. § 1291.

II

The Gableses contend that the District Court erred in concluding that their

state law claims are preempted. They argue that their claims survive preemption

because they are parallel claims. The Gableses also assert that, because the

manufacturer destroyed the catheter connecter, they are entitled to a presumption

that the connector was not manufactured or designed in accordance with FDA

regulations. They rely on Cassisi v. Maytag, 396 So.2d 1140 (Fla. Dist. Ct. App.

1981) for the presumption that “evidence of the nature of the accident itself may,

under certain circumstances, give rise to a reasonable inference that the product

8
was defective . . . .” Id. at 1146. The Gableses rely on this alleged presumption,

maintaining that they have presented a parallel claim because “the device was not

designed or manufactured according to the pre-market approval or it would not

have failed.” (Appellants’ Opening Br. at 18.)

We review a District Court’s summary judgment ruling de novo. Brooks v.

Cnty. Comm'n of Jefferson Cnty., 446 F.3d 1160, 1161 (11th Cir. 2006). Summary

judgment is appropriate where “there is no genuine issue as to any material fact

and that the movant is entitled to judgment as a matter of law.” Fed. R. Civ. P.

56(c) (2).

A

“[T]he MDA expressly pre-empts only state requirements different from, or

in addition to, any requirement applicable . . . to the device under federal law, §

360k(a)(1) . . . .” Riegel v. Medtronic, Inc., 552 U.S. 312, 321 (2008) (internal

quotation marks omitted). Section 360k(a) reads as follows:

no 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

(2) which relates to the safety or effectiveness of the
device or to any other matter included in a requirement

9
 applicable to the device under this chapter.

21 U.S.C. § 360k(a).

In Riegel, the Supreme Court held that the MDA preemption clause does not

apply to a parallel claim. Id. at 330. The Court defined a parallel claim as

follows:

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.
§ 360k(a)(1). 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.

Id. (citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996)).

The Seventh 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.

McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005), citing Bates v.

Dow Agrosciences LLC, 544 U.S. 431, 454 (2005).

The Supreme Court established a two-pronged test in Riegel for deciding

whether state claims are preempted. First, a court must “determine whether the

10
Federal Government has established requirements applicable [to the device].” If

so, “[the court] must then determine whether the [plaintiff’s] common-law claims

are based upon [state law] requirements with respect to the device that are

‘different from, or in addition to’ the federal ones, and that relate to safety and

effectiveness.” Riegel, 552 U.S. at 321-22 (citing § 360K(a)).

The Court noted in Riegel that, in accordance with it’s holding in

Medtronic, Inc., v. Lohr, 518 U.S. 470 (1996), “[p]remarket approval . . . imposes

‘requirements’ under the MDA” which are “specific to individual devices.”

Riegel, 552 U.S. at 323. The Arrow pump’s pre-market approval imposes specific

requirements on it that are sufficient to preempt a state law claim.

In this matter, the District Court explained at length the Florida state laws

concerning (1) strict liability for manufacturing and design defect and failure to

warn, and (2) concerning liability for negligent design, manufacture and assembly.

Wolicki-Gables, 641 F. Supp. 2d at 1285-88. It determined that the Florida laws

corresponding to each of those claims imposed requirements that were “different

from, or in addition to” the federal requirements established for the Arrow pump.

Id. Accordingly, the District Court concluded that a fact-finder could find liability

even if the manufacturer had completely complied with the FDA regulations. Id.

In reviewing the District Court’s decision, we must first consider whether

11
the Gableses have demonstrated that they have alleged a parallel claim. Riegel,

552 U.S. at 330. “Plaintiffs cannot simply incant the magic words ‘[Appellees]

violated FDA regulations’ in order to avoid preemption.” In re Medtronic Inc.,

592 F. Supp. 2d 1147, 1158 (D. Minn. 2009). Parallel claims must be specifically

stated in the initial pleadings. A plaintiff must allege that “[the] defendant

violated a particular federal specification referring to the device at issue.”

Ilarraza v. Medtronic, Inc., 677 F.Supp. 2d 582, 589 (E.D.N.Y. 2009). “To

properly allege parallel claims, the complaint must set forth facts” pointing to

specific PMA requirements that have been violated. Parker v. Stryker Corp., 584

F.Supp. 2d 1298, 1301 (D. Colo. 2008). The trial court stated in Parker that an

allegation that “the manufacturing processes for the device and certain of their . . .

components did not satisfy the Food and Drug Administrations’s Pre-Market

Approval standards for the devices” is insufficient to satisfy the requisite elements

of a parallel claim as set forth in Riegel if the complaint fails to “provide any

factual detail to substantiate that crucial allegation.” Id. at 1302.

The Gableses alleged in their complaint that Arrow, Codman and Johnson &

Johnson:

(a) fail[ed] to reasonably design the implantable drug
delivery system in a manner which would have prevented
injury to those like LINDA WOLICKI-GABLES;
(b) fail[ed] to reasonably manufacture the implantable

12
 drug delivery systems in a reasonable manner; [and]
(c) fail[ed] to reasonably provide adequate warnings
regarding the defective and unreasonably dangerous
implantable drug delivery system, having actual or
constructive knowledge of the hazards associated with
the product.

(Complaint at 12-13, 16, 20.3) These allegations do not “set forth any specific

problem, or failure to comply with any FDA regulation that can be linked to the

injury alleged.” Ilarraza, 677 F.Supp. 2d at 589. Because the Gableses have

failed to allege facts in their complaint demonstrating the presence of the elements

of a parallel claim, we are persuaded that the District Court did not err in

concluding that their state common law claims were preempted.

B

The Gableses also contend that the District Court erred in concluding that

they are not “entitled to an inference that a defect existed within the pain pump.”

(Appellants’ Opening Br. at 19.) They argue that they are entitled to such an

inference because the malfunctioning connector was destroyed. In support of this

argument, they rely on Cassisi. In Cassisi, the Florida Court of Appeal held that

the evidence presented by the plaintiff was sufficient to create an inference “that

the malfunction itself . . . is evidence of the product’s defective condition at both

the time of the injury and at the time of the sale.” 396 So.2d at 1153.

3
The same claim is repeated against each of the three Appellees.

13
 In Worsham v. A.H. Robins Co., 734 F.2d 676 (11th Cir. 1984), this Court

stated that “the court in Cassisi held that absolute positive proof of product

malfunction is not necessary where the product is destroyed; provided plaintiff can

point to evidence that the cause of the accident most probably originated in the

product.” Id. at 683. “Evidence to so establish a defect can include facts that

negate other causes of the accident and at the same time point to the product as the

most logical cause.” Id. Much like the concept of res ipsa loquitur, the inference

of defect requires showing “more than a scintilla of evidence” that the device

malfunctioned and that the malfunction was likely caused by a defect in the

device’s design or manufacture. See Beauregard v. Cont’l Tire N. Am., Inc., 695

F. Supp. 2d 1344, 1354 (M.D. Fla. 2010) (declining to apply Cassisi where

plaintiff’s evidence of a tire belt separation could have happened due to normal

wear rather than defect).

Cassisi is inapplicable because the Gableses have failed to demonstrate that

a defect in the Arrow pump “most probably” caused her injuries and not some

other malfunction or obstruction. Their experts, Dr. Michael Meriweather and

Edward Reese, Ph.D.,4 testified that though the catheter connector could have

malfunctioned, they were unable to exclude alternate possible causes for a

4
Dr. Meriweather is the Gableses’ medical expert and Dr. Reese is their regulatory expert.

14
connecter to fail, such as an idiosyncratic complication with the patient, natural

bodily rejection, or clogging. (District Court Order at 13-14, 43-44.) The District

Court did not err in concluding that they were not entitled to a presumption that

the Arrow pump was defectively manufactured.

III

Because the Gableses’ claims are preempted, we do not address Arrow’s

assertion that private actions brought for violations of the FDA regulations are

barred pursuant to 21 U.S.C. §337(a). Under 21 U.S.C. § 337(a), “[e]xcept as

provided in subsection (b) [regarding actions brought by States], all such

proceedings for the enforcement, or to restrain violations, of [the MDA] shall be

by and in the name of the United States.”

Similarly, because the claims are preempted, we also need not address the

Gableses’ contention that the District Court erred in finding that they failed to

present sufficient evidence of an agency relationship between Nelson and Codman

or Johnson & Johnson.

Conclusion

The Gableses have failed to allege a parallel claim in their complaint.

Therefore their claims are preempted by the MDA. Further, they have not

demonstrated that they are entitled to a presumption that the destroyed catheter

15
connecter was defective. Accordingly, the District Court's grant of summary

judgment is AFFIRMED.

16