Christina McClellan v. I-Flow Corporation , 776 F.3d 1035 ( 2015 )

FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
CHRISTINA MCCLELLAN, No. 11-35109
Plaintiff-Appellant,
D.C. No.
v. 6:07-cv-01309-
AA
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.
CHRISTINA MCCLELLAN, No. 11-35134
Plaintiff-Appellee,
D.C. No.
v. 6:07-cv-01309-
AA
I-FLOW CORPORATION, a Delaware
corporation,
Defendant-Appellant, OPINION
and
DJO, L.L.C., a Delaware
corporation; DJO INCORPORATED, a
Delaware corporation; PACIFIC
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
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.
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 Plaintiff-
Appellant/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/Cross-
Appellants 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/Cross-
Appellants DJO, LLC and DJO, Inc.
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 I-
Flow Corporation cross-appeals the district court’s denial of
costs. We vacate and remand for a new trial, and dismiss I-
Flow’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. I-
Flow 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.
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.
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 I-
Flow’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
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
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,4 and
nine special instructions related to federal law.
The Supremacy Clause 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.
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 state-
law 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
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 inevitably conflict 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-agency claims here, they would
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
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 fraud-
on-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.
MCCLELLAN V. I-FLOW CORPORATION 13
More generally, McClellan’s requested instructions would
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.
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
MCCLELLAN V. I-FLOW CORPORATION 15
and remand for a new trial. We dismiss I-Flow’s cross-
appeal as moot.
Each party shall bear its own costs on appeal.
VACATED AND REMANDED. Defendant-Appellant
I-Flow Corporation’s cross-appeal is DISMISSED as
moot.