Kathryn Jones v. Medtronic ( 2018 )

NOT FOR PUBLICATION FILED
UNITED STATES COURT OF APPEALS AUG 16 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.
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.
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. The parties agreed at oral argument that if Jones had plausibly alleged in
her complaint that (a) off-label use of the Medtronic devices had caused untoward
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results before the spinal procedures were 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
also 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
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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
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
and negligence per se claims 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.
AFFIRMED in part, VACATED in part and REMANDED for further
proceedings. Each party to bear its own costs.
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