The opinion
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF OREGON
KATHY MAE HAWKINS personal No. 3:24-cv-00502-HZ
Representative for the ESTATE OF LEAFY
ANN LUNDIN, OPINION & ORDER
Plaintiff(s),
v.
KAISER FOUNDATION HEALTH PLAN OF
THE NORTHWEST dba KAISER
PERMANENTE, an Oregon nonprofit corporation;
SUNGEYUN DAVID CHO, M.D. an individual;
COVIDIEN SALES LLC; COVIDIEN LP;
COVIDIEN HOLDING, Inc.; and MEDTRONIC,
Inc.,
Defendant(s).
George McCoy
Warren Allen LLP
10535 N.E. Glisan Street
Suite 200
Portland, OR 97220
Attorneys for Plaintiff
Michael J. Estok
Lindsay Hart LLP
1300 S.W. Fifth Avenue
Suite 3400
Portland, OR 97201
Attorneys for Defendants Covidien Sales, LLC; Covidien LP; Covidien Holdings, Inc.;
and Medtronic, Inc.
HERNÁNDEZ, District Judge:
This matter is before the Court on the Motion to Dismiss the Second Claim of Plaintiff’s
Complaint Pursuant to Rule 12(b)(6), ECF 5, filed by Defendants Covidien Sales, LLC;
Covidien LP; Covidien Holdings, Inc.; and Medtronic, Inc. (“Medtronic Defendants”). For the
reasons that follow the Court grants Medtronic Defendants’ Motion to Dismiss.
BACKGROUND
The following facts are taken from the Complaint and Medtronic Defendants’ Motion to
Dismiss and are viewed in the light most favorable to Plaintiff.
On October 14, 2021, Leafy Ann Lundin was admitted to Kaiser Sunnyside Medical
Center for “laparoscopic splenic flexure resection surgery as a result of her colon cancer.”
Compl. at 3, ECF 1, Ex. 1. Defendant Sungeyun David Cho, M.D., performed the surgery,
“during which he used the LigaSure medical device.” Id. At some point “during the dissection an
unusual alarm sounded on the LigaSure. It appeared there was an electronic shortage in the
LigaSure, which created a bowel injury.” Id. Dr. Moran1 was called in to assist with the injury.
“Dr. Moran patched the injury line and inserted a PIC line to ensure that Lundin would be able to
eat.” Id.
1 Dr. Moran is not a party to this action and is not identified by their full name in the Complaint.
On November 5, 2021, Lundin was discharged from the medical center, however she was
“unable to eat any food via her mouth for over a month . . . due to the injury from the LigaSure
device and the required PIC2 line.” Compl. ¶ 10.
On January 1, 2022, Lundin returned to “the hospital” for an additional surgery scheduled
for January 5, 2022. The surgery was postponed “due to an emergency surgery needed
on a different patient. Ms. Lundin passed on January 5, 2022, at 4:26 p.m. Her cause of death
[was] attributed to ‘prior colectomy with intraoperative duodenal jejunal injury and being on
total parenteral nutrition.’” Compl. ¶ 11.
On March 21, 2024, Plaintiff Kathy Mae Hawkins, personal representative for the Estate
of Lundin, filed a complaint in Clackamas County Circuit Court against Medtronic Defendants,
Kaiser Foundation Health Plan of the Northwest (“Kaiser”), and Dr. Cho asserting claims for
negligence and wrongful death.
On March 22, 2024, Medtronic Defendants removed the matter to this Court on the basis
of diversity jurisdiction.
On April 18, 2024, Medtronic Defendants filed a Motion to Dismiss Plaintiff’s second
claim. Plaintiff did not file a response and the Court took the matter under advisement on
May 23, 2024.
STANDARDS
A motion to dismiss under Federal Rule of Civil Procedure 12(b)(6) tests the sufficiency
of the claims. Navarro v. Block, 250 F.3d 729, 732 (9th Cir. 2001). When evaluating the
2 A PIC line is “[a] peripherally inserted central catheter . . . inserted through a vein in [the] arm
and passed through to the larger veins near [the] heart. . . . A PIC[] line gives [the] doctor access
to the large central veins near the heart. It's generally used to give medications or liquid
nutrition.” https://www.mayoclinic.org/tests-procedures/picc-line/about/pac-20468748 (last
visited May 15, 2024)
sufficiency of a complaint’s factual allegations, the court must accept all material facts alleged in
the complaint as true and construe them in the light most favorable to the non-moving party.
Wilson v. Hewlett-Packard Co., 668 F.3d 1136, 1140 (9th Cir. 2012). A motion to dismiss under
Rule 12(b)(6) will be granted if a plaintiff alleges the “grounds” of his “entitlement to relief”
with nothing “more than labels and conclusions, and a formulaic recitation of the elements of a
cause of action[.]” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). “Factual allegations
must be enough to raise a right to relief above the speculative level on the assumption that all the
allegations in the complaint are true (even if doubtful in fact)[.]” Id. (citations and footnote
omitted).
To survive a motion to dismiss, a complaint “must contain sufficient factual matter,
accepted as true, to state a claim to relief that is plausible on its face.” Ashcroft v. Iqbal, 556 U.S.
662, 678 (2009) (internal quotation marks omitted). A plaintiff must “plead[] factual content that
allows the court to draw the reasonable inference that the defendant is liable for the misconduct
alleged.” Id. In other words, a complaint must state a plausible claim for relief and contain “well-
pleaded facts” that “permit the court to infer more than the mere possibility of misconduct[.]” Id.
at 679.
DISCUSSION
Medtronic Defendants move to dismiss Plaintiff’s second claim for negligence and
wrongful death3 as untimely and for failure to state a claim.
Plaintiff alleges the following facts in her second claim against Medtronic Defendants:
3 The Complaint combines claims for negligence and wrongful death against Medtronic
Defendants in one claim, supported by the same allegations.
Medtronic Defendants “either individually or through affiliates designed, manufactured,
marketed, packaged, labeled, and sold a defective medical device known as ‘LigaSure.’” Compl.
¶ 15. LigaSure was used by Defendant Kaiser in Lundin’s laparoscopic splenic flexure resection.
LigaSure “was defective because it had an electronic shortage during use, caused an injury of an
improper dissection of . . . Lundin’s bowel, and failed to contain adequate warnings.” Id. ¶ 17.
“[T]his defective condition rendered the product unreasonably dangerous to” Lundin and
proximately caused damages. “At the time the LigaSure left the control of [Medtronic
Defendants] they knew or in the light of reasonably available knowledge, should have known
about the danger that caused the damage to [Lundin] for which recovery is sought and that the
ordinary user or consumer would not realize the dangerous condition presented by” LigaSure. Id.
¶ 19. Medtronic Defendants, however, failed to warn that the device could “negligently and
unexpectedly have an electronic shortage during use” and failed to “communicate sufficient
information on the dangers and safe use of” LigaSure. Id. ¶¶ 18, 20.
Plaintiff also alleges LigaSure was “designed in a defective manner” and “there existed a
feasible design alternative that would have to [sic] reasonable probability prevent the harm to
[Lundin] . . . without impairing the utility, usefulness, practicality, or desirability of the product
to user or consumers.” Compl. ¶¶ 21, 23. Plaintiff contends that Medtronic Defendants’ “conduct
in releasing the LigaSure for sale to the unsuspecting public when [they] knew or in the exercise
of reasonable care should have known that [it] was defective and unreasonably dangerous and
likely to cause serious health complicated showed actual malice, gross negligence which
evidences a willful, wanton, or reckless disregard for the safety of others.” Id. ¶ 27. Finally
Plaintiff alleges “[t]here are other similar incidents throughout the United States of personal
injuries caused by the failure to LigaSure.” Id. ¶ 27.
I. Wrongful Death Claim
Although Plaintiff labels the second claim as one for wrongful death, the allegations
indicate that Plaintiff’s claim is in part one for products liability under Oregon law. Oregon
Revised Statute § 30.900 defines a “product liability civil action” as:
a civil action brought against a manufacturer, distributor, seller or lessor of
a product for damages for personal injury [or] death . . . arising out of:
(1) Any design, inspection, testing, manufacturing or other defect
in a product;
(2) Any failure to warn regarding a product; or
(3) Any failure to properly instruct in the use of a product.
Oregon courts have made clear that “[a] ‘product liability civil action’ . . . embraces all theories a
plaintiff can claim in an action based on a product defect, including negligence and strict liability
claims.” Brown v. GlaxoSmithKline, LLC, 323 Or. App. 214, 219 (2022)(quotation omitted).
Oregon Revised Statute § 30.920 imposes strict liability on a manufacturer for injuries
caused by its product if the product is “both defective and unreasonably dangerous.” Purdy v.
Deere & Co., 311 Or. App. 244, 247 (2021). “Unreasonably dangerous defects in products come
from two principal sources: (1) mismanufacture and (2) faulty design, including failure to warn
as a design defect.” Harris v. Nw. Nat. Gas Co., 284 Or. 571, 576 (1978).
To state a claim for strict liability under Oregon Revised Statute § 30.920, a plaintiff
must allege facts showing: “(1) the sale or leasing of a product by one engaged in the business of
selling or leasing such products; (2) a product that was expected to, and did, reach the user or
consumer without substantial change in condition; (3) a product that, when sold, was in a
defective condition unreasonably dangerous to the user or consumer; (4) injury to the user or
consumer, . . .; (5) that was caused by the product's defective condition.” Chong v. STL Int'l, Inc.,
152 F. Supp. 3d 1305, 1316–17 (D. Or. 2016)(quoting McCathern v. Toyota Motor Corp., 332
Or. 59, 77 n.15 (2001)). “[T]o recover on a product liability theory, a plaintiff must establish not
only that the product was defective but also that the defect was of a type that rendered the
product unreasonably dangerous to persons or property. Not every defect that causes a product to
be in a condition not reasonably contemplated by a user is an unreasonably dangerous one.”
Russell v. Deere & Co., 186 Or. App. 78, 82 (2003)(quotation omitted). “A defective product
presents an unreasonable danger when it is dangerous to an extent beyond that which would be
contemplated by the ordinary consumer who purchases it, with the ordinary knowledge common
to the community as to its characteristics.” Id. (quotation omitted).
Plaintiff broadly alleges LigaSure was defective because “it had an electronic shortage
during use” and failed to contain adequate warnings and that Medtronic Defendants failed to
communicate sufficient information on the dangers and safe use of the device and designed the
product in a defective manner. Plaintiff, however, does not identify which of the component
parts of the device at issue are “defective” or describe the nature of the purported defect. Rather,
the Complaint states only that “[t]he LigaSure device was defective because it had an electronic
shortage” during use. Compl. at 3. Under similar circumstances courts have found plaintiffs
failed to adequately plead claims for products liability. See, e.g., Lawrence v. Medtronic, 791 F.
App'x 679, 680 (9th Cir. 2020)(finding district court did not err in dismissing the plaintiff’s
claims because the complaint “contains only conclusory allegations, which fail to identify any
specific . . . requirement that was violated or the specific nature of the Pump’s purported defects”
nor did the plaintiff “plausibly allege either the violation of a specific requirement or the specific
nature of the defect”); Yarbrough v. Stryker Corp., No. 3:20-CV-00506-IM, 2021 WL 27291, at
*3 (D. Or. Jan. 4, 2021)(“Simply alleging that a device is ‘defective’ is not sufficient to satisfy
pleading requirements, and the fact that Plaintiff required a replacement surgery does not alone
equate to a defect, particularly in a case involving a complex medical device.”)
As to Plaintiff’s assertion of inadequate warnings or information, “Oregon has long
recognized that product sellers have a duty to provide adequate warnings about nonobvious risks
of injury associated with the use of their products when they know, or reasonably should know,
of those risks of injury.” Gonzalez v. Gibbs Int'l, Inc., No. 3:21-CV-01844-AN, 2023 WL
6319051, at *5 (D. Or. Sept. 28, 2023)(citing Benjamin v. Wal-Mart Stores, Inc., 185 Or. App.
444, 454-55 (2002)). Plaintiff, however, fails to allege any facts that support its conclusory
statement that Medtronic Defendants knew or reasonably should have known of a defect in
LigaSure that could cause an electronic shortage during use. Plaintiff’s allegation that “[t]here
are other similar incidents throughout the United States of personal injuries caused by the failure
of” LigaSure is not sufficiently specific to infer that other injuries were caused by an electronic
shortage of the device at issue or that Medtronic Defendants should have known of the risk of
injury of the kind Lundin suffered.
To the extent that Plaintiff alleges any warnings or information provided by Medtronic
Defendants was inadequate, under Oregon law a warning is inadequate when “it is misleading,
ambiguous, contains important omissions, fails to reveal the full extent of the dangers, or fails to
provide notice that use of the product should be permanently discontinued prior to the patient
suffering irreversible injury.” Hobus v. Howmedica Osteonics Corp., No. 3:21-CV-00080-AN,
2023 WL 6850144, at *14 (D. Or. Oct. 17, 2023)(citing McEwen v. Ortho Pharm. Corp., 270 Or.
375, 402-04 (1974)). The Complaint, however, does not allege what warnings were provided for
the device or how the warnings were misleading, ambiguous, contained important omissions or
similar. In addition, to recover damages under Oregon law the inadequate warning “‘must be a
substantial cause of the person’s injuries.’” Crosswhite v. Jumpking, Inc., 411 F. Supp. 2d 1228,
1235 (D. Or. 2006)(quoting Benjamin v. Wal–Mart Stores, Inc., 185 Or.App. 444, 453 (2002)).
Plaintiff does not allege Lundin’s surgeon would have performed the procedure differently if
Medtronic Defendants had provided an adequate warning of the danger associated with the
device.
In summary, Plaintiff fails to allege facts sufficient to state a claim under § 30.900.
Accordingly, the Court grants Medtronic Defendants’ Motion to Dismiss this portion of
Plaintiff’s second claim.
II. Negligence Claim
Medtronic Defendants assert Plaintiff’s claim for ordinary negligence against them must
be dismissed as time barred.
“A federal court sitting in diversity applies the substantive law of the state, including the
state's statute of limitations.” Albano v. Shea Homes Ltd. P'ship, 634 F.3d 524, 530 (9th Cir.
2011). Oregon Revised Statute § 30.905(1) provides: “a product liability civil action for personal
injury . . . must be commenced not later than two years after the plaintiff discovers, or reasonably
should have discovered, the personal injury . . . and the causal relationship between the injury . . .
and the product, or the causal relationship between the injury . . . and the conduct of the
defendant.”
Plaintiff alleges that Lundin died January 5, 2022, and her cause of death was “attributed
to prior colectomy with intraoperative duodenal jejunal injury and being on total parenteral
nutrition.” Compl. ¶ 11. Oregon Revised Statute § 432.133(a) provides that “[a] report of death
for each death that occurs in [Oregon] must be submitted to the county registrar of the county in
which the death occurred or to the Center for Health Statistics . . . within five calendar days after
death. . . .” The report of Lundin’s death, therefore, was required to be completed and available
to be obtained by her estate no later than January 10, 2022. Accordingly, Plaintiff reasonably
could have discovered the cause of Plaintiff’s death was “intraoperative duodenal jejunal injury”
by January 10, 2022.
Under Oregon law “[w]hen a plaintiff serves a defendant within 60 days of filing the
complaint, the action is considered commenced on the date the complaint was filed.” Bulek v.
Kaiser Found. Hosps., No. 3:23-CV-01585-MO, 2024 WL 1436134, at *2 (D. Or. Apr. 3, 2024)
(citing ORS 12.020(2)). In their Notice of Removal Medtronic Defendants note the Complaint
was not served on any defendant at the time this matter was removed on March 22, 2024. Even
assuming, however, that Plaintiff serves Defendants within 60 days of filing the Complaint, this
matter was commenced no earlier than March 21, 2024. Accordingly, Plaintiff filed the
Complaint against Medtronic Defendants more than two years after she reasonably should have
discovered the cause of Plaintiff’s injury. Plaintiff’s ordinary negligence claim is, therefore, time
barred.
CONCLUSION
The Court GRANTS Medtronic Defendants’ Motion to Dismiss the Second Claim of
Plaintiff’s Complaint Pursuant to Rule 12(b)(6), ECF 5. The Court grants Plaintiff leave to file
an Amended Complaint no later than 14 days after the entry of this Opinion and Order, limited to
Plaintiff’s second claim and to the extent Plaintiff can cure the defects in that claim as set out in
this Opinion and Order
IT IS SO ORDERED.
DATED:_____J_u_n_e_ _1_0_,_ 2_0__2_4______.
______________________________
MARCO A. HERNÁNDEZ
United States District Judge