FILED
UNITED STATES COURT OF APPEALS
SEP 07 2018
FOR THE NINTH CIRCUIT MOLLY C. DWYER, CLERK
U.S. COURT OF APPEALS
KATHRYN MARIE JONES, No. 15-15653
Plaintiff-Appellant, D.C. No. 2:14-cv-00383
v.
ORDER
MEDTRONIC, INC., et al.,
Defendants-Appellees.
Before: GRABER and HURWITZ, Circuit Judges, and LEMELLE,* District
Judge.
The memorandum disposition filed August 16, 2018, is amended by the
memorandum disposition filed concurrently with this order, as follows:
On page 2, line 2 from the bottom, delete "The parties agreed at oral
argument that".
On page 3, line 5, delete "also".
On page 5, line 2, add at the beginning of that line "regarding the Class III
devices"; at line 2, after the phrase per se claims add "regarding the Class II and
III devices"; at line 6 add as the last two sentences of that paragraph "Jones did
not assert a design defect claim below with respect to any Medtronic Class II
*
The Honorable Ivan L.R. Lemelle, United States District Judge for the
Eastern District of Louisiana, sitting by designation.
device, and we therefore express no opinion as to the viability of such a claim.
Whether she should be given leave to make such claim on remand is an issue not
before us, but one we leave to the sound discretion of the district judge."
With these amendments, Appellant's petition for limited panel rehearing is
DENIED. No further petitions for panel rehearing or rehearing en banc may be
filed.
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NOT FOR PUBLICATION FILED
UNITED STATES COURT OF APPEALS SEP 7 2018
MOLLY C. DWYER, CLERK
U.S. COURT OF APPEALS
FOR THE NINTH CIRCUIT
KATHRYN MARIE JONES, No. 15-15653
Plaintiff-Appellant, D.C. No. 2:14-cv-00383
v.
AMENDED MEMORANDUM*
MEDTRONIC, INC., et al.,
Defendants-Appellees.
Appeal from the United States District Court
for the District of Arizona
Steve P. Logan, District Judge, Presiding
Argued and Submitted July 12, 2018
San Francisco, California
Before: GRABER and HURWITZ, Circuit Judges, and LEMELLE,** Senior
District Judge.
In October 2010, Plaintiff Kathryn Marie Jones underwent three spinal fusion
surgeries (the “spinal procedures”), during which her surgeons implanted several
devices manufactured and sold by Medtronic, Inc. Jones’ pro se complaint alleged
*
This disposition is not appropriate for publication and is not precedent
except as provided by Ninth Circuit Rule 36-3.
**
The Honorable Ivan L.R. Lemelle, Senior United States District Judge
for the Eastern District of Louisiana, sitting by designation.
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that she was permanently disabled as a result of the spinal procedures, and she
asserted various state law claims against Medtronic.
The district court dismissed most of Jones’ claims as preempted by the
Medical Device Amendments (“MDA”) to the Food, Drug, and Cosmetic Act
(“FDCA”), 21 U.S.C. § 301 et seq. The court dismissed the remainder of Jones’
claims, without leave to amend, as inadequately pleaded. We review de novo the
district court’s preemption rulings and its denial of leave to amend based upon those
rulings. Stengel v. Medtronic Inc., 704 F.3d 1224, 1227 (9th Cir. 2013) (en banc).
We affirm in part, vacate in part, and remand for further proceedings.
1. The express preemption clause in the MDA prevents certain state-law
claims concerning medical devices approved by the Food and Drug Administration.
21 U.S.C. § 360k(a). The FDCA also impliedly preempts private attempts to enforce
the MDA. See 21 U.S.C. § 337(a); Buckman Co. v. Plaintiffs’ Legal Comm., 531
U.S. 341 (2001). But there is a narrow gap through which a state-law claim can fit
to escape preemption. Perez v. Nidek Co., 711 F.3d 1109, 1120 (9th Cir. 2013). If a
state-law claim imposes requirements that are “parallel” to, rather than in addition
to or different from, federal requirements, the state-law claim is not preempted.
Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008); Perez, 711 F.3d at 1120.
2. If Jones had plausibly alleged in her complaint that (a) off-label use of the
Medtronic devices had caused untoward results before the spinal procedures were
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performed; (b) Medtronic failed to report such results to the FDA as required; (c)
this failure to report caused the FDA not to issue further warnings; and (d) in turn,
this failure to warn caused Jones’ injuries, any such claim would not be preempted.
See Stengel, 704 F.3d at 1233. The parties agreed that a properly alleged claim of
manufacturing defect would not be preempted. Leave to amend should be granted
freely when justice so requires. Fed. R. Civ. P. 15(a). Because Jones, now
represented by counsel, seeks to amend her complaint to assert such claims, we
vacate the judgment below and remand to allow her to attempt to do so.
3. Federal law requires manufacturers of medical devices to update labeling
in accordance with new intended uses of approved devices. 21 C.F.R. § 801.4. A
claim alleging a parallel Arizona state-law “misbranding” claim would therefore not
be preempted. See Medtronic, Inc., v. Lohr, 518 U.S. 470 (1996); Riegel, 552 U.S.
312; Buckman, 531 U.S. at 352–53. Because it does not appear from the record that
Jones could not assert such a claim, she may attempt to do so on remand.
4. We affirm the district court’s dismissal of Jones’ fraud claims. Jones
contends that Medtronic fraudulently promoted the Infuse Bone Graft and Infuse
Device for off-label use, “thus inducing patients and doctors to use the device in
manners that had not been approved by the FDA.”
A claim for fraud requires proof of nine elements by clear and
convincing evidence: (1) a representation; (2) its falsity; (3) its
materiality; (4) the speaker’s knowledge of its falsity or ignorance of
its truth; (5) the speaker’s intent that it be acted upon by the recipient
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in the manner reasonably contemplated; (6) the hearer’s ignorance of
its falsity; (7) the hearer’s reliance on its truth; (8) the hearer’s right to
rely on it; (9) the hearer’s consequent and proximate injury.
Comerica Bank v. Mahmoodi, 229 P.3d 1031, 1033–34 (Ariz. Ct. App. 2010); see
also Correa v. Pecos Valley Dev. Corp., 617 P.2d 767, 771 (Ariz. Ct. App. 1980)
(holding that “[t]he requisites of a private cause of action for a statutory fraud are a
false promise or a misrepresentation made in connection with the sale or
advertisement of merchandise and the consumer’s consequent and proximate injury”
which “occurs when the consumer relies on the misrepresentation”). We agree that
Jones failed to plausibly allege reliance on any alleged Medtronic misrepresentation
with the particularity or specificity required by Federal Rule of Civil Procedure 9(b).
Indeed, any such allegation is foreclosed by Jones’ express allegations that “at no
point were any of the Medtronic products mentioned or discussed with her prior to
their being implanted in her body during the Spinal Procedure.” Consequently,
amendment would be futile. See Krainski v. Nevada ex rel. Bd. of Regents of Nev.
Sys. of Higher Educ., 616 F.3d 963, 972 (9th Cir. 2010) (“Dismissal without leave
to amend is improper unless it is clear, upon de novo review, that the complaint could
not be saved by any amendment.”) (citation omitted). Jones also asserted
constructive fraud. The district court liberally construed this as a fraud-by-omission
claim, and correctly rejected it as expressly preempted. See Perez, 711 F.3d at 1118.
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5. We affirm also the district court’s rulings that Jones’ design defect claims
regarding the Class III devices and negligence per se claims regarding the Class II
and Class III devices are preempted. See Riegel, 552 U.S. at 325 (“State tort law that
requires a manufacturer’s [Class III device] to be safer, but hence less effective, than
the model the FDA has approved disrupts the federal scheme . . . .”); Buckman, 531
U.S. at 352–53. Jones did not assert a design defect claim below with respect to any
Medtronic Class II device, and we therefore express no opinion as to the viability of
such a claim. Whether she should be given leave to make such claim on remand is
an issue not before us, but one we leave to the sound discretion of the district judge.
AFFIRMED in part, VACATED in part and REMANDED for further
proceedings. Each party to bear its own costs.
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