NOT FOR PUBLICATION FILED
UNITED STATES COURT OF APPEALS JUN 12 2018
MOLLY C. DWYER, CLERK
U.S. COURT OF APPEALS
FOR THE NINTH CIRCUIT
KIMBERLY WEAVER and JAMES No. 17-55350
WEAVER,
D.C. No.
Plaintiffs-Appellants, 3:16-cv-00257-GPC-BGS
v.
MEMORANDUM*
ETHICON, INC. and DOES, 1-20,
inclusive,
Defendants-Appellees.
Appeal from the United States District Court
for the Southern District of California
Gonzalo P. Curiel, District Judge, Presiding
Submitted June 8, 2018**
Pasadena, California
Before: LIPEZ,*** TALLMAN, and OWENS, Circuit Judges.
Appellants Kimberly and James Weaver (“Appellants”) appeal the district
*
This disposition is not appropriate for publication and is not precedent
except as provided by Ninth Circuit Rule 36-3.
**
The panel unanimously concludes this case is suitable for decision
without oral argument. See Fed. R. App. P. 34(a)(2).
***
The Honorable Kermit V. Lipez, United States Circuit Judge for the
First Circuit, sitting by designation.
court’s dismissal with prejudice of their Third Amended Complaint (“TAC”). We
have jurisdiction under 28 U.S.C. § 1291, and we review “a district court’s
determination of whether a plaintiff’s complaint complied with the notice pleading
requirements” de novo. Lehman v. Nelson, 862 F.3d 1203, 1211 (9th Cir. 2017)
(quoting Pickern v. Pier 1 Imp. (U.S.), Inc., 457 F.3d 963, 968 (9th Cir. 2006)).
Appellees Ethicon, Inc., and other defendants (collectively, “Ethicon”),
produce the Surgiflo Hemostatic Matrix Kit (“Surgiflo”), a Class III medical
device subject to the Food and Drug Administration’s (“FDA”) rigorous premarket
approval regulations. Surgiflo acts as a self-absorbing wound packing to control
bleeding after surgery. In 2012, Ethicon voluntarily conducted two recalls of
Surgiflo packs based on issues with the sterility of the packaging. Both recalls
were completed by September 2014. The oldest recalled Surgiflo packs had
expiration dates of June 2013.
On November 24, 2014, Kimberly Weaver underwent sinus surgery and a
Surgiflo pack was used to control the bleeding. On December 4, however, Weaver
underwent a second surgery due to an infection resulting from the Surgiflo’s
alleged failure to reabsorb. Appellants sued Ethicon under a variety of theories,
and the district court ultimately dismissed with prejudice Appellants’ TAC alleging
manufacturing defects, a failure to warn, and loss of consortium.
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I
Through the Medical Device Amendments (“MDA”), 21 U.S.C. § 360 et
seq., Congress replaced a patchwork of state laws that had previously governed
medical devices with a uniform federal regulatory regime. Under § 360k(a), state
laws “which relate[] to the safety or effectiveness of the device” and are “different
from, or in addition to” federal requirements under the MDA, are expressly
preempted. To avoid preemption, state laws must be “equal to, or substantially
identical to, requirements imposed by or under the [MDA].” 21 C.F.R.
§ 808.1(d)(2). See Riegel v. Medtronic, Inc., 552 U.S. 312, 321–22 (2008).
Therefore, to survive dismissal, a plaintiff must plead sufficient factual allegations
to show that the state-law claims fall within the “narrow” parallel exception to
preemption. Perez v. Nidek Co., 711 F.3d 1109, 1120 (9th Cir. 2013). A plaintiff
must also plead the necessary elements of the state-law claims with “sufficient
factual content that allows the court to draw the reasonable inference that the
defendant is liable for the misconduct alleged.” Ashcroft v. Iqbal, 556 U.S. 662,
678 (2009). This requires Appellants to plead “more than an unadorned, the-
defendant-unlawfully-harmed-me accusation. Id.1
1
We observe that the district court’s order appears to conflate the MDA
preemption inquiry with the inquiry into whether the plaintiffs have stated a
claim under state law. Because “we may affirm based on any ground supported
by the record,” Johnson v. Riverside Healthcare Sys., LP, 534 F.3d 1116, 1121
(9th Cir. 2008), we resolve this case based on the Weavers’ failure to plead
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A
Appellants first contend that the district court erred by dismissing their
manufacturing defect claim at the pleadings stage because the information the
court required them to plead could only be obtained through discovery. Under
California law, a manufacturing defect occurs when the product “differs from the
manufacturer’s intended result or from other ostensibly identical units from the
same product line[,]” Barker v. Lull Eng’g Co., 573 P.2d 443, 454 (Cal. 1978), and
the alleged defect causes the plaintiff’s injury, Soule v. Gen. Motors Corp., 882
P.2d 298, 303 (Cal. 1994). Here, Appellants’ manufacturing defect claim fails
because even assuming they have pled a parallel state claim, they failed to
adequately allege (1) factual, non-conclusory support for the claim that Weaver’s
doctor used a recalled Surgiflo pack or (2) the nature of the manufacturing defect.
Accordingly, Appellants did not plead the necessary facts to support the causation
element, and we affirm the district court’s dismissal of Appellants’ manufacturing
defect claim.
necessary elements of their state law claims. We note, however, that the MDA
preemption inquiry examines a plaintiff’s possible expansion of the scope of the
defendant’s duty under existing federal law, see Stengel v. Medtronic Inc., 704
F.3d 1224, 1228 (9th Cir. 2013) (en banc) (“[T]he MDA does not preempt a
state-law claim for violating a state-law duty that parallels a federal-law duty
under the MDA.”) (emphases added), not whether the plaintiff adequately plead
the elements of a state law claim.
4
B
To prevail on their failure to warn claim, Appellants must plead facts to
support their claim that if Ethicon “had properly reported the adverse events to the
FDA as required under federal law, that information would have reached
[Weaver’s] doctors in time to prevent h[er] injuries.” See Stengel, 704 F.3d at
1234 (Watford, J., concurring). Here, Appellants proffer two events that allegedly
triggered Ethicon’s duty to report: first, a third-party’s 2010 report on a public
website that an element of the Surgiflo pack would not reconstitute,2 and second,
her own injury.
Again assuming (1) the Weavers have pled a parallel state claim and (2) the
2010 report was rationally related to the same defect allegedly at issue here, the
fact that Weaver’s doctor had access to that report on a public database maintained
by the FDA negates her claim. For even if Ethicon had a duty to report the 2010
issue to the FDA and failed to do so, Weaver’s physician could have viewed the
report independently, considered the alleged issue’s effect on his recommendation,
informed the Weavers, and elected not to use Surgiflo. Nor can Ethicon’s failure
to report Weaver’s injury logically be the cause of her injury as well.
2
The 2010 report was filed on the FDA’s Manufacturer and User Facility Device
Experience (“MAUDE”) website, which is publicly available at
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi
__id=1691379&pc=LMF.
5
Consequently, Appellants failed to plead a necessary element of the failure to warn
claim, and the district court’s dismissal was correct. We also agree that after three
tries, further amendment would have been futile.
C
Because Appellants’ loss of consortium claim is derivative of the
manufacturing defect and failure to warn claims, see Riegel, 552 U.S. at 321, we
affirm the district court’s dismissal of that claim as well.
Costs are awarded to Appellees.
AFFIRMED.
6