Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca9-11-35109/USCOURTS-ca9-11-35109-0/pdf.json

Nature of Suit Code: 365
Nature of Suit: Personal Injury - Product Liability
Cause of Action: 

---

FOR PUBLICATION

UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

CHRISTINA MCCLELLAN,

Plaintiff-Appellant,

v.

I-FLOW CORPORATION, a Delaware

corporation; DJO, L.L.C., a

Delaware corporation; DJO

INCORPORATED, a Delaware

corporation; PACIFIC MEDICAL, INC.,

a California corporation,

Defendants-Appellees.

No. 11-35109

D.C. No. 

6:07-cv-01309-

AA

CHRISTINA MCCLELLAN,

Plaintiff-Appellee,

v.

I-FLOW CORPORATION, a Delaware

corporation,

Defendant-Appellant,

and

DJO, L.L.C., a Delaware

corporation; DJO INCORPORATED, a

Delaware corporation; PACIFIC

No. 11-35134

D.C. No. 

6:07-cv-01309-

AA

OPINION

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2 MCCLELLAN V. I-FLOW CORPORATION

MEDICAL, INC., a California

corporation,

Defendants.

Appeal from the United States District Court

for the District of Oregon

Ann L. Aiken, Chief District Judge, Presiding

Argued July 10, 2012

Submission Deferred July 12, 2012

Resubmitted January 13, 2015

Portland, Oregon

Filed January 23, 2015

Before: Alfred T. Goodwin, Harry Pregerson, and 

Morgan Christen, Circuit Judges.

Opinion by Judge Goodwin

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MCCLELLAN V. I-FLOW CORPORATION 3

SUMMARY*

Preemption 

The panel vacated the district court’s judgment, and

remanded for a new trial, in a diversity action alleging

common law claims for negligence and strict products

liability. The panel dismissed, as moot, the cross appeal

challenging the district court’s denial of costs.

Christina McClellan alleged she suffered injuries after she

was prescribed continuous infusion of a painkiller, delivered

through a PainBuster infusion pump device, I-Flow. The

PainBuster is regulated under the Medical Device

Amendments of 1976 (MDA) to the Food, Drug& Cosmetics

Act. The district court declined to give some of McClellan’s

requested jury instructions under Oregon law based on the

court’s conclusion that they were preempted by federal law.

The panel held that there was appellate jurisdiction

because judgment was entered as to all the defendants. The

panel held that the presumption against federal preemption

of state law applied to this case. The panel held that

McClellan’s case was not controlled by Buckman Co. v.

Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) (holding that

the state law claims were preempted because the state law

claims enjoyed no presumption against preemption and were

in conflict with the MDA). The panel further held that

McClellan’s requested jury instructions did not conflict with

the congressional intent behind the MDA, and would not

* This summary constitutes no part of the opinion of the court. It has

been prepared by court staff for the convenience of the reader.

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4 MCCLELLAN V. I-FLOW CORPORATION

usurp the exclusive federal enforcement power over the

MDA. The panel concluded that no federal preemption

applied, and the district court’s refusal to give the requested

jury instruction was not harmless error. The panel remanded

for a new trial due to the instructional error with leave to the

district court to determine in the first instance whether the

requested instructions were otherwise appropriate under

Oregon law. 

COUNSEL

R. Daniel Lindahl, (argued), Lindahl Law Firm PC, Portland,

Oregon, Leslie W. O’Leary, (substituted for R. Daniel

Lindahl), Portland, Oregon, Jeffrey B. Wihtol, Law Offices

of Jeffrey B. Wihtol, Portland, Oregon, for PlaintiffAppellant/Cross-Appellee.

Andrew G. Klevorn, (argued), James W. Joseph, Elmer Stahl

Klevorn & Solberg, LLP, Chicago, Illinois, Eric J. Neiman,

George S. Pitcher, Williams, Kastner & Gibbs, PLLC,

Portland, Oregon, for Defendants-Appellees/CrossAppellants I-Flow Corp.; Richard H. Nakamura, Jr., (argued) 

Morris Polich & Purdy LLP, Los Angeles, California, Patrick

Lysaught, Baker Sterchi Cowden & Rice, LLC, Kansas City,

Missouri, Roger G. Perkins, Morris Polich & Purdy LLP,

San Diego, California, for Defendants-Appellees/CrossAppellants DJO, LLC and DJO, Inc.

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MCCLELLAN V. I-FLOW CORPORATION 5

OPINION

GOODWIN, Circuit Judge:

Christina McClellan appeals the judgment entered in

favor of defendant-appellees after a jury trial. Defendant IFlow Corporation cross-appeals the district court’s denial of

costs. We vacate and remand for a new trial, and dismiss IFlow’s cross-appeal as moot.

I. BACKGROUND

McClellan underwent two surgeries to repair her anterior

labrum, located in the shoulder. After each surgery, she was

prescribed continuous infusion of a painkiller, delivered

through a PainBuster continuous infusion pump device. IFlow manufactured the PainBuster and defendants DJO, LLC

and DJO Incorporated (collectively, DJO) distributed and

sold the PainBuster.1 A continuous infusion pump contains

a portable medication reservoir attached to a catheter that

delivers the medication to the site—here, to the shoulder

joint.

During her recovery from the second surgery,

McClellan’s physician diagnosed her with chondrolysis of the

shoulder. This condition meant that McClellan suffered the

loss of articular cartilage in her main shoulder joint (the

glenohumeral joint). Articular cartilage provides a slick

surface allowing bones to move easily. In McClellan’s case,

it specifically allows the “ball-and-socket” of the

 

1

 DJO, Inc. is DJO, LLC’s parent company. The district court severed

the claims against DJO, Inc. The fourth defendant, Pacific Medical, Inc.,

was dismissed prior to trial.

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6 MCCLELLAN V. I-FLOW CORPORATION

glenohumeral joint to move properly. She suffered a

complete loss of articular cartilage, resulting in a spontaneous

fusion of her shoulder due to the ball and socket growing

together into a single bone. She has no motion in the joint

and can move her shoulder only a few degrees. McClellan’s

condition is not treatable.

McClellan filed suit, alleging state common law claims

for negligence and strict products liability. She advanced two

theories of liability: (1) I-Flow negligently failed to warn that

its pain pump should not be used in intra-articular spaces such

as the glenohumeral joint; and (2) I-Flow was strictly liable

for selling a product that was unreasonably dangerous due to

a lack of adequate warnings. Prior to submission of the case

to the jury and in denying McClellan’s motion for a new trial,

the district court declined to give certain requested

instructions, reasoning that they were preempted by federal

law.

II. REGULATORY REGIME

The PainBuster is regulated under the Medical Device

Amendments of 1976 (MDA) to the Food, Drug & Cosmetics

Act (FDCA).2 The MDA requires that manufacturers provide

the U.S. Food and Drug Administration with “reasonable

assurance of the safety and effectiveness” of a device prior to

marketing and sale. 21 U.S.C. § 360c(a)(1)(A)(i), (B), (C)(i). 

This reasonable assurance process is known as “premarket

approval.” Medtronic, Inc. v. Lohr, 518 U.S. 470, 477

(1996). However, devices already on the market prior to

2 For the sake of simplicity, we will refer to the FDCA as amended as

the MDA.

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MCCLELLAN V. I-FLOW CORPORATION 7

1976 are allowed to remain on the market without approval

until the FDA completes an evaluation. Id. at 478.

In addition to this “grandfathering provision,” Congress

also included a provision to increase competition and “to

prevent manufacturers of grandfathered devices from

monopolizing the market” while other manufacturers of

similar devices are undergoing the process of providing the

FDA with safety assurances. Id. This provision exempts a

device from the “reasonable assurance of safety” requirement

if the manufacturer shows that the device is “substantially

equivalent” to a grandfathered device. 21 U.S.C.

§ 360e(b)(1)(B); Lohr, 518 U.S. at 478.

This process is known as the 510(k) process (after the

original section number). Lohr, 518 U.S. at 478. The 510(k)

process requires the manufacturer to submit a “premarket

notification” to the FDA. 21 U.S.C. § 360(k); Lohr, 518 U.S.

at 478. The FDA then uses the “premarket notification” to

verify that the device is “substantially equivalent” to a

grandfathered device. Lohr, 518 U.S. at 478. Once a

manufacturer submits a 510(k) notification and the FDA finds

the device to be substantially equivalent to a pre-1976 device,

the device can be marketed without the manufacturer having

made any additional showing regarding the safety and

effectiveness of the device. Id.

III. DISCUSSION

In the discussion below, we first address and reject IFlow’s argument that we lack jurisdiction to hear this appeal. 

We then turn to McClellan’s contentions. McClellan assigns

four errors to the district court: (1) it wrongly refused to give

jury instructions regarding negligence and federal standards

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8 MCCLELLAN V. I-FLOW CORPORATION

because it incorrectly concluded they were preempted; (2) it

improperly barred expert testimony as to safety standards; (3)

it improperly barred expert testimony as to an association

between pain pump use and chondrolysis; and (4) it

improperly excluded certain documentary evidence as

hearsay. Because we hold that the requested instructions

were not preempted by the MDA and remand for a new trial,

we decline to reach the evidentiary issues.

A. Jurisdiction

We have appellate jurisdiction. This court has a duty to

ensure subject matter jurisdiction exists over an appeal. See,

e.g., D’Lil v. Best W. Encina Lodge & Suites, 538 F.3d 1031,

1035 (9th Cir. 2008). I-Flow argues that no final, appealable

judgment exists in this case, 28 U.S.C. § 1291, because a

judgment as to fewer than all parties may be appealed “only

if the [district] court expressly determines that there is no just

reason for delay,” Fed. R. Civ. P. 54(b). The judgment in this

case did not so state. There was no need to do so.

The district court severed the claims against DJO, Inc. as

its alleged liability would be wholly derivative of DJO,

LLC’s liability. I-Flow argues that this severance somehow

left the claims against DJO, Inc. unresolved, thereby

requiring the district court to expressly state that the judgment

was appealable. But as McClellan points out, the judgment

identifies I-Flow, DJO, LLC, and DJO, Inc. as defendants,

and states that judgment was entered in favor of the

defendants. That alone settles the issue, as judgment was

entered as to all defendants. And even if it was not, given the

alleged derivative liability of DJO, Inc., there can be no

serious argument that judgment in favor of DJO, LLC and

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MCCLELLAN V. I-FLOW CORPORATION 9

dismissal of the action could preserve DJO, Inc.’s alleged

liability. We therefore proceed to the merits of the appeal.

B. Preemption

McClellan challenges the district court’s refusal to give a

negligence per se instruction,3

an instruction as to considering

statutes and regulations in determining reasonable care,4and

nine special instructions related to federal law.

The SupremacyClause of the Constitution makes evident

that “state laws that conflict with federal law are ‘without

effect,’” Altria Grp., Inc. v. Good, 555 U.S. 70, 76 (2008)

(citation omitted). There are three types of preemption:

(1) express preemption, (2) field preemption, and (3) conflict

preemption. Id. at 76–77; Hillsborough Cnty., Fla. v.

Automated Med. Labs., Inc., 471 U.S. 707, 713 (1985). The

district court relied upon, and the parties discuss, only

conflict preemption.

Conflict preemption is implicit preemption of state law

that occurs where “there is an actual conflict between state

and federal law.” Altria Grp., 555 U.S. at 76–77. Conflict

preemption “arises when [1] ‘compliance with both federal

and state regulations is a physical impossibility,’ . . . or [2]

when state law ‘stands as an obstacle to the accomplishment

and execution of the full purposes and objectives of

Congress.’” Hillsborough Cnty., 471 U.S. at 713 (citations

omitted). Only the latter flavor of conflict, obstacle

preemption, is at issue here.

 

3

 Oregon Uniform Civil Jury Instruction 20.03.

 

4

 Oregon Uniform Civil Jury Instruction 20.04.

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10 MCCLELLAN V. I-FLOW CORPORATION

In evaluating whether federal law has preempted state

law, we must (1) look to “the purpose of Congress [as] the

ultimate touchstone,” while also (2) “start[ing] with the

assumption that the historic police powers of the States were

not to be superseded . . . unless that was the clear and

manifest purpose of Congress.” Wyeth v. Levine, 555 U.S.

555, 565 (2009). The presumption against preemption

“applies with particular force when Congress has legislated

in a field traditionally occupied by the States.” Altria Grp.,

555 U.S. at 77. With respect to express preemption, “when

the text of a pre-emption clause is susceptible of more than

one plausible reading, courts ordinarily ‘accept the reading

that disfavors pre-emption.’” Id. (citation omitted). This

presumption against preemption applies with equal force to

conflict preemption. Wyeth, 555 U.S. at 565 n.3.

In holding that McClellan’s requested instructions would

run afoul of MDA preemption, the district court relied upon

the Supreme Court’s decision in Buckman Co. v. Plaintiffs’

Legal Comm., 531 U.S. 341 (2001). That case involved statelaw claims that the defendant made fraudulent representations

to the FDA, resulting in improper market clearance for bone

screws, and harm to patients through their use. Id. at 346–47. 

The Court held that the claims enjoyed no presumption

against preemption, were in conflict with the MDA, and were

therefore preempted. Id. at 347–48.

In Buckman, the Supreme Court described the plaintiffs’

claims as “state-law fraud-on-the-FDA claims” and held that

“[p]olicing fraud against federal agencies is hardly ‘a field

which the States have traditionally occupied,’ such as to

warrant a presumption” against preemption. Id. at 347–48

(internal citation omitted). Despite I-Flow’s and DJO’s

urging for application of Buckman’s ultimate result, there is

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MCCLELLAN V. I-FLOW CORPORATION 11

no reason not to apply the presumption against preemption

here. Unlike the plaintiff in Buckman, McClellan has not

alleged any fraud on the FDA. Instead, McClellan has

alleged failure-to-warn theories that are clearly concerned

with the labeling and regulation of medical devices. The

regulation of medical devices prior to the MDA “was left

largely to the States to supervise as they saw fit.” Riegel v.

Medtronic, Inc., 552 U.S. 312, 315 (2008). Thus, we apply

the presumption against preemption in this case.

With that presumption in mind, we conclude this case is

not controlled by Buckman. There, the Court wrote that

“fraud-on-the-FDA claims inevitablyconflict with the FDA’s

responsibility to police fraud consistently with the

Administration’s judgment and objectives.” 531 U.S. at 350.

The claims in Buckman failed in part because there was “clear

evidence that Congress intended that the MDA be enforced

exclusively by the Federal Government.” Id. at 352. The

Court discussed its earlier decision in Medtronic, Inc. v. Lohr,

noting that the non-preempted claims in Lohr “arose from the

manufacturer’s alleged failure to use reasonable care in the

production of the product, not solely from the violation of

FDCA requirements.” Buckman, 531 U.S. at 352 (citing

Lohr, 518 U.S. at 481) (emphasis added). On the other hand,

the fraud claims in Buckman “exist[ed] solely by virtue of the

FDCA disclosure requirements.” 531 U.S. at 352–53

(emphasis added). The Court concluded that “were plaintiffs

to maintain their fraud-on-the-agencyclaims here, theywould

not be relying on traditional state tort law which had predated

the federal enactments in question. On the contrary, the

existence of these federal enactments is a critical element in

their case.” Id. at 353. Additionally, as this court recently

pointed out, Buckman occurred within the context of the

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12 MCCLELLAN V. I-FLOW CORPORATION

premarket approval process. Stengel v. Medtronic, Inc., 704

F.3d 1224, 1233 (9th Cir. 2013) (en banc).

Further, Buckman recognized that Lohr, while dealing

explicitly with only express preemption, left the door open to

state-law claims “parallel” to federal requirements. 531 U.S.

at 353; see also Stengel, 704 F.3d at 1228 (“The rule that

emerges from these [three Supreme Court MDA preemption

cases] is that the MDA does not preempt a state-law claim for

violating a state-law duty that parallels a federal-law duty

under the MDA.”). The Seventh Circuit recognized

Buckman’s limitations in holding that manufacturing defect

claims were not preempted even where they sought to borrow

the definition of “adulterated” from the MDA. Bausch v.

Stryker Corp., 630 F.3d 546, 556–58 (7th Cir. 2010). The

Fifth Circuit did likewise in holding that claims for failure to

warn, premised on violation of FDA regulations, were not

preempted under Buckman. Hughes v. Boston Scientific

Corp., 631 F.3d 762, 774–76 (5th Cir. 2011).

In this case, we perceive nothing about McClellan’s

requested instructions that conflicts with the congressional

intent behind the MDA. McClellan’s claims were not fraudon-the-FDA claims. The failure-to-warn claims McClellan

alleged did not arise solely by virtue of the MDA.5 Further,

there is no suggestion that Congress intended to displace

traditional tort law by making all policing of medical labels

and warnings the exclusive province of the FDA.

 

5

 In fact, if this were the case, McClellan’s claims could not have been

placed in front of a jury in the first instance, as there would have been no

traditional tort-law claims left to advance.

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MCCLELLAN V. I-FLOW CORPORATION 13

More generally, McClellan’s requested instructionswould

not usurp the exclusive federal enforcement power over the

MDA. The allegations at issue occur outside the context of

the regulatory process, unlike in Buckman. Where the

plaintiff in Buckman alleged that the defendant made

fraudulent representations during the market approval

process, to the FDA, 531 U.S. at 346–47, McClellan’s

requested instructions here have little to do with direct

regulatory interaction with the FDA. The appellees would

have us conclude that any use of federal law to establish a

standard of care is an attempt to enforce the underlying

federal provisions, but we do not accept that proposition.6

Appellees’ arguments fail to convince us that allowing a

jury to look to the MDA to establish certain standards of care

will create an obstacle to accomplishing the goals Congress

envisioned in passing the MDA. I-Flow’s and DJO’s

attempts to characterize McClellan’s claims as torts in form

only are poorly explained and unpersuasive.

Having concluded that no preemption applies, we

disagree with I-Flow and DJO that refusal to give the

requested instructions was harmless error. The instruction

actually given by the district court—allowing the jury to

consider federal law discussed during trial—is not equivalent

to instructions specifically including reference to federal law. 

6

It is also telling that I-Flow and DJO fail to offer any concrete

examples of FDA enforcement authority that McClellan would usurp if

she were to receive the requested instructions.

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14 MCCLELLAN V. I-FLOW CORPORATION

Moreover, the instruction given was far weaker than the

requested negligence per se instruction. We cannot say the

error was more probably than not harmless. See, e.g., Head

v. Glacier Nw., Inc., 413 F.3d 1053, 1063 (9th Cir. 2005). 

The appellees also argue that the error was harmless because

the jury implicitly made two findings that would make the

instructions irrelevant. Those arguments lack merit as they

speculate regarding how the jury reached its verdict.

In sum, we vacate the judgment and remand for a new

trial due to the instructional error. We leave it to the district

court to determine in the first instance whether the requested

instructions are otherwise appropriate under Oregon law.

C. Evidentiary Issues and I-Flow’s Costs

Because we conclude a new trial is warranted, we need

not reach the challenged evidentiary rulings, see Transue v.

Aesthetech Corp., 341 F.3d 911, 912–13 (9th Cir. 2003),

leaving any future reconsideration of those rulings to the

district court. The district court’s denial of I-Flow’s costs is

moot and we dismiss the cross-appeal. See, e.g., Cascade

Health Solutions v. PeaceHealth, 515 F.3d 883, 917 (9th Cir.

2008); Friedman & Friedman, Ltd. v. Tim McCandless, Inc.,

606 F.3d 494, 503 (8th Cir. 2010).

IV. CONCLUSION

Because the district court erred in not giving McClellan’s

requested jury instructions, incorrectly believing that the

MDA preempted such instructions, we vacate the judgment

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MCCLELLAN V. I-FLOW CORPORATION 15

and remand for a new trial. We dismiss I-Flow’s crossappeal as moot.

Each party shall bear its own costs on appeal. 

VACATEDANDREMANDED. Defendant-Appellant

I-Flow Corporation’s cross-appeal is DISMISSED as

moot.

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