Lynch v. Olympus America, Inc. et al
Filing
86
MEMORANDUM OPINION AND ORDER by Magistrate Judge Nina Y. Wang on 6/5/2019. Defendant Olympus Medical Systems Corporation's Motion to Dismiss Plaintiff's Complaint for Lack of Personal Jurisdiction 54 is DENIED; Defendant Olympus Medical Systems Corporation's Motion to Dismiss Plaintiff's Complaint for Failure to State a Claim 57 is DENIED; Defendant Olympus America Inc.'s Motion to Dismiss Plaintiff's Complaint for Failure to State a Claim 56 is DENIED; Defendant Olympus Corporation of the Americas' Motion to Dismiss Plaintiff's Complaint for Failure to State a Claim 55 is DENIED. (bwilk, )
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLORADO
Civil Action No. 18-cv-00512-NYW
KATHLEEN LYNCH, an individual,
Plaintiff,
v.
OLYMPUS AMERICA, INC.,
OLYMPUS CORPORATION OF THE AMERICAS,
OLYMPUS MEDICAL SYSTEMS CORP., and
Does 1 through 20 inclusive,
Defendants.
MEMORANDUM OPINION AND ORDER
Magistrate Judge Nina Y. Wang
This case comes before the court on four renewed Motions to Dismiss filed by the three
named Defendants in this action, Olympus America, Inc. (“Olympus America”), Olympus
Corporation of the Americas (“OCA”), and Olympus Medical Systems Corporation (“Olymp us
Medical”; collectively, “Defendants”) following the court’s prior grant of the initial Motions to
Dismiss in the Order dated October 30, 2018 [#48] and Plaintiff’s subsequent filing of a First
Amended Complaint [#49]. The undersigned Magistrate Judge presides over this case pursuant to
28 U.S.C. § 636(c), the Parties’ consent, and the Order of Reference dated May 2, 2018. [#11;
#14]. In the renewed Motions to Dismiss, Defendants argue for dismissal pursuant to Fed. R. Civ.
P. 12(b)(6) (“the Renewed 12(b)(6) Motions”), alleging that Plaintiff Kathleen Lynch (“Plaintiff”
or “Ms. Lynch”) has failed to state a claim upon which relief can be granted [#55; #56; #57, filed
December 4, 2019]. On that same day, Olympus Medical filed a Rule 12(b)(2) motion (“the
Renewed 12(b)(2) Motion” and collectively with the Renewed 12(b)(6) Motions, the “Renewed
Defense Motions”), arguing that it should be dismissed as a defendant for want of personal
jurisdiction. [#54]. Plaintiff responded to the Renewed 12(b)(6) Motions on January 2, 2019 [#69;
#70; #71] and, after a period for jurisdictional discovery, the Renewed 12(b)(2) Motion on March
18, 2019 [#80]; the Defendants replied to the responses to the Renewed 12(b)(6) motions on
January 16 [#72; #73; #74] and to the Renewed 12(b)(2) argument on April 1 [#81]. Oral argument
was held before this court on April 16, 2019. [#85]. The Renewed Defense Motions are now ripe
for decision. For the reasons set forth in this Memorandum Opinion and Order, the Renewed Rule
12(b)(2) Motion is DENIED, and the Renewed 12(b)(6) Motions are DENIED.
BACKGROUND
The court has already provided a comprehensive background for this case in the Order
ruling on the original Defense Motions. [#48]. The court will therefore focus its attention for this
section to the developments following that Order. All substantive assertions of fact are taken from
the First Amended Complaint and assumed as true for purposes of this analysis. The discussion
on personal jurisdiction will contain a separate statement of facts adduced in briefing Olympus
Medical’s 12(b)(2) Motion as the court cannot properly consider those facts in ruling on a 12(b)(6)
motion.
This is a case about an allegedly defective medical device, the TJF-Q180V Duodenoscope
(“Q180V Scope” or “the Scope”), which is manufactured, sold, and supported by Defendants for
use by medical professionals in performing numerous medical procedures including, as relevant
here, an endoscopy, which is a medical procedure that involves the insertion of an endoscope into
a patient’s body for therapeutic and/or diagnostic purposes. See generally [#49]. In this case,
Plaintiff alleges that she underwent an endoscopy at UCH Hospital (“UCH” or “the Hospital”) in
January 2016 1 and subsequently contracted a drug-resistant bacterial infection because her Doctor
used a Q180V scope that retained biological contaminates from prior use that were not eliminated
due to the defective design and cleaning (or “reprocessing”) protocol provided with the Scope.
[Id. at ¶ 1]. The Scope was contaminated primarily due to the defective design of the Scope’s
distal-end cap which sealed the elevator wire channel from effective cleaning but did not protect
against the ingress of microscopic contaminates. [Id. at ¶¶ 1, 18, 31, 38, 59, 60]. The gravamen
of Plaintiff’s claim is that Olympus Medical designed the Scope with the defective end seal as
opposed to a more effective open-channel design, allowing contaminates but also easy cleaning,
or a fully removable end cap, permitting easier end-user verification of effective reprocessing,
which rendered the device unsafe. [Id. at ¶¶ 35, 60]. Plaintiff alleges that she fell ill due to the
contaminated Q180V Scope used in her January 2016 procedure, and she filed this action on March
1, 2018. [Id.].
In May 2018, the Defendants filed an initial set of Motions to Dismiss targeted at the
original Complaint, based on Rule 12(b)(2) and Rule 12(b)(6) just as the present Renewed Motions
are. [#17; #18; #19; #20]. In the Order dated October 30, 2018 [#48], the court found that the
Complaint suffered from numerous fatal deficiencies and dismissed it in its entirety. Specifica lly,
the court found the following issues: (1) the court lacked personal jurisdiction over Olympus
Medical, a Japanese corporation, without some evidence that Olympus Medical intentiona lly
targeted Colorado for the Scopes which harmed Plaintiff [#48 at 16]; (2) Plaintiff’s claim for a
1
The court takes judicial notice of filings on its own docket that indicates that Plaintiff underwent
the ERCP procedure at UCH Hospital using the Q180V scope on January 20, 2016. [#80 at 7;
#80-2].
design defect in the Scope failed as it did not address the relevant factors under Colorado law [id.
at 21]; (3) Plaintiff’s cursory assertion of an unspecified injury contracted an indeterminate time
after her procedure was insufficient to plausibly establish causation [id.]; (4) Plaintiff’s failure to
warn claim failed because it was premised on a failure to warn the patient and not the doctor per
the learned intermediary doctrine, which the court found applies [id. at 24]; (5) Plaintiff’s failure
to warn claim was conclusory and did not adequately set forth a plausible claim that an effective
warning would have prevented her harm [id. at 26]; (6) the claims for intentional and neglige nt
misrepresentation did not meet the heightened pleadings standards of Federal Rule of Civil
Procedure 9(b) as it did not distinguish between the Defendants or identify the misrepresentatio ns
at issue [id. at 28–32]. The court granted Plaintiff leave to file an amended complaint to address
these deficiencies, which she did on November 20, 2018. [#48].
The Defendants filed the Defense Motions shortly thereafter, arguing that Plaintiff has not
adequately remedied the deficiencies identified by the court in the October 30 Order. [#54; #55;
#56; #57]. Briefing on the renewed 12(b)(6) motions completed in the usual course, but the court
permitted jurisdictional discovery as to Olympus Medical, and therefore the briefing on that
motion only completed on April 1, 2019. [#81]. The court held Oral Argument on April 16, 2019
on the Defense Motions. For the reasons stated in this Order, the court finds that Plaintiff has
sufficiently remedied these deficiencies, and therefore all Renewed Defense Motions are
DENIED.
LEGAL STANDARDS
I.
Personal Jurisdiction under Rule 12(b)(2)
Rule 12(b)(2) of the Federal Rules of Civil Procedure allows a defendant to challenge the
court’s exercise of personal jurisdiction. Fed. R. Civ. P. 12(b)(2). Plaintiff bears the burden of
demonstrating that the court has personal jurisdiction over the Defendants. See Dudnikov v. Chalk
& Vermilion Fine Arts, 514 F.3d 1063, 1069 (10th Cir. 2008). When, as here, the court decides a
Rule 12(b)(2) motion to dismiss without holding an evidentiary hearing, “the plaintiff need only
make a prima facie showing of personal jurisdiction to defeat the motion.” AST Sports Sci., Inc.
v. CLF Distrib. Ltd., 514 F.3d 1054, 1057 (10th Cir. 2008). “The plaintiff[s] may make this prima
facie showing by demonstrating, via affidavit or other written materials, facts that if true would
support jurisdiction over the defendant.” OMI Holdings, Inc. v. Royal Ins. Co. of Canada, 149
F.3d 1086, 1091 (10th Cir. 1998). In considering this question, the court must accept all well
pleaded facts as true and must resolve any factual disputes in favor of the plaintiff.
Wenz v.
Memery Crystal, 55 F.3d 1503, 1505 (10th Cir. 1995).
To establish jurisdiction over a non-resident defendant, a plaintiff must show that the
exercise of jurisdiction is authorized under the relevant state long-arm statute, and does not offend
due process. Wenz, 55 F.3d at 1506. Because the Colorado Supreme Court has determined that
Colorado’s long-arm statute, Colo. Rev. Stat. § 13-1-124 (2018), is coextensive with due process
requirements, Keefe v. Kirschenbaum & Kirschenbaum, P.C., 40 P.3d 1267, 1270 (Colo. 2002),
the inquiry is thus simplified into one basic question: whether the exercise of personal jurisdic tio n
comports with the requirements of due process under the Fourteenth Amendment to the United
States Constitution. AST Sports, 514 F.3d at 1057.
However, even if this test is met, a court must still consider whether “the exercise of
personal jurisdiction over the defendant offends traditional notions of fair play and substantia l
justice.” OMI Holdings, 149 F.3d at 1091. In this inquiry the court considers: (1) the burden on
the defendant, (2) the forum state's interest in resolving the dispute, (3) the plaintiff’s interest in
receiving convenient and effective relief, (4) the interstate judicial system's interest in obtaining
the most efficient resolution of controversies, and (5) the shared interest of the several states in
furthering fundamental social policies. Id. at 1095.
Plaintiff does not assert general jurisdiction over Olympus Medical, nor does it appear she
could. This analysis, therefore, is confined to the assertion of specific jurisdiction over Olympus
Medical.
To determine whether this court may exercise specific jurisdiction over Olympus
Medical, this court looks to whether its contacts with this forum associated with the action at hand
is sufficient for it to be haled into court in this District: “(a) whether the plaintiff has shown that
the defendant has minimum contacts with the forum state; and, if so, (b) whether the defendant has
presented a compelling case that the presence of some other considerations would render
jurisdiction unreasonable.” Old Republic Ins. Co. v. Cont’l Motors, Inc., 877 F.3d 895, 904 (10th
Cir. 2017).
II.
Failure to State a Claim under Rule 12(b)(6)
Under Rule 12(b)(6) a court may dismiss a complaint for “failure to state a claim upon
which relief can be granted.” Fed. R. Civ. P. 12(b)(6). In deciding a motion under Rule 12(b)(6),
the court must “accept as true all well-pleaded factual allegations” and “view these allegations in
the light most favorable to the plaintiff.” Casanova v. Ulibarri, 595 F.3d 1120, 1124 (10th Cir.
2010) (quoting Smith v. United States, 561 F.3d 1090, 1098 (10th Cir. 2009)). A plaintiff may not
rely on mere labels or conclusions, “and a formulaic recitation of the elements of a cause of action
will not do.” Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555 (2007). Rather, “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, 677 (2009); see also Robbins v. Oklahoma, 519 F.3d 1242,
1247 (10th Cir. 2008) (explaining that plausibility refers “to the scope of the allegations in a
complaint,” and that the allegations must be sufficient to nudge a plaintiff’s claim(s) “across the
line from conceivable to plausible.”). To state a claim that is plausible on its face, a complaint
must “sufficiently allege[] facts supporting all the elements necessary to establish an entitle me nt
to relief under the legal theory proposed.” Forest Guardians v. Forsgren, 478 F.3d 1149, 1160
(10th Cir. 2007).
The court has subject matter jurisdiction over this case because the parties are completely
diverse and the amount in controversy exceeds $75,000. 28 U.S.C. § 1332(a). Therefore, the court
applies Colorado law when evaluating whether Plaintiff’s state law claims state a claim under Rule
12(b)(6). Rancho Lobo, Ltd. v. Devargas, 303 F.3d 1195, 1200 (10th Cir. 2002). Absent clear
guidance from the Colorado Supreme Court, a federal court exercising diversity jurisdiction must
make an Erie guess as to how that court would rule. Pehle v. Farm Bureau Life Ins. Co., 397 F.3d
897, 901 (10th Cir. 2005) (“Because Wyoming has not directly addressed this issue, this court
must make an Erie-guess as to how the Wyoming Supreme Court would rule.”). In making an
Erie guess, courts look to decisions of the state court of appeals as strongly persuasive, if not
governing, authority as to how the state supreme court would rule. Koch v. Koch Indus., Inc., 203
F.3d 1202, 1230 (10th Cir. 2000) (“Furthermore, this court must follow any intermediate state
court decision unless other authority convinces us that the state supreme court would decide
otherwise.” (formatting altered) (quoting Daitom, Inc. v. Pennwalt Corp., 741 F.2d 1569, 1574
(10th Cir. 1984)); see also, e.g., U.S. ex rel. Sun Constr. Co. v. Torix Gen. Contractors, LLC, No.
07-CV-01355-LTB-MJW, 2011 WL 841277, at *1 (D. Colo. Mar. 8, 2011).
III.
Pleading Special Matters Under Rule 9(b)
When a plaintiff alleges fraud or mistake, Federal Rule of Civil Procedure 9(b) requires
that the plaintiff “state with particularity the circumstances constituting fraud or mistake.” The
Rule’s purpose is to “to afford [a] defendant fair notice” of a plaintiff’s claims and the factual
grounds supporting those claims, George v. Urban Settlement Svcs., 833 F.3d 1242, 1255 (10th
Cir. 2016) (quoting Schwartz v. Celestial Seasonings, Inc., 124 F.3d 1246, 1252 (10th Cir. 1997)),
such that the defendant is provided the “minimum degree of detail necessary to begin a competent
defense.” Fulghum v. Embarq Corp., 785 F.3d 395, 416 (10th Cir. 2015). Rule 9(b) does not
require any particularity in connection with an averment of intent, knowledge or condition of mind,
rather it simply refers to only the requirement that a plaintiff identify the circumsta nces
constituting fraud with sufficient specificity. Schwartz, 124 F.3d at 1252.
Put simply, Rule 9(b) requires that a complaint “set forth the time, place and contents of
the false representation, the identity of the party making the false statements and the consequences
thereof.” Id. (quoting In re Edmonds, 924 F.2d 176, 180 (10th Cir. 1991)). When plaintiff brings
a claim against multiple defendants, Rule 9(b) obliges a plaintiff to specify the manner in which
each defendant participated. Brooks v. Bank of Boulder, 891 F. Supp. 1469, 1477 (D. Colo. 1995);
see also Lillard v. Stockton, 267 F. Supp. 2d 1081, 1094 (D. Kan. 2003) (“[W]here fraud is alleged
against multiple defendants, blanket allegations of fraud couched in language such as ‘by the
defendants’ are insufficient. Instead, the specifics of the alleged fraudulent activity of each
defendant must be set forth.”).
Rule 9(b) clearly applies to intentional misrepresentation and fraud, but the law is unsettled
on whether it applies to a claim of negligent misrepresentation. Compare Conrad v. The Educ.
Res. Inst., 652 F. Supp. 2d 1172, 1183 (D. Colo. 2009) (“Thus, a claim for neglige nt
misrepresentation should not be governed by the pleading standard set forth in Rule 9(b).”) and
Denver Health & Hosp. Auth. v. Beverage Distributors Co., LLC, 843 F. Supp. 2d 1171, 1177 (D.
Colo. 2012) (“Rule 9(b) does not apply to the negligent misrepresentation claim before me. The
crux of the claim . . . . rings not of fraud but negligence.”), with Gunningham v. Standard Fire Ins.
Co., No. 07-cv-02538-REB-KLM, 2008 WL 4377451, at *2 (D. Colo. 2008) (“I conclude that the
particularity requirement is applicable to the negligent misrepresentation claim. In this context,
negligence is a type of mistake and Rule 9(b) concerns allegations of fraud or mistake.”). In the
October 30 Order dismissing Plaintiff’s original Complaint, the court found that Rule 9(b) applied
to the negligent misrepresentation claim because it was “rife with allegations of willful
misconduct.”
[#48 at 13]. In the First Amended Complaint, Plaintiff’s claim of neglige nt
misrepresentation again contains allegations of willful misconduct, [#49 at ¶¶ 108–126], and now
Plaintiff concedes the applicability of Rule 9(b). [#70 at 4].
ANALYSIS
As noted above, the court identified six substantive deficiencies in the original Complaint.
Plaintiff’s First Amended Complaint brings the same claims and seeks to address these errors, and
the Renewed Defense Motions are premised on the Defendants’ arguments that the First Amended
Complaint has not adequately remedied the deficiencies. Given this overlap, the court will proceed
in an abbreviated fashion, analyzing by deficiency as opposed to by claim in determining whether
the First Amended Complaint has cured the deficiencies noted above before considering any
secondary issues raised in the pleadings or at oral argument. A federal court “generally may not
rule on the merits of a case without first determining that it has jurisdiction over the category of
claim in suit (subject-matter jurisdiction) and the parties (personal jurisdiction).” Sinochem Int’l
Co. v. Malaysia Int’l Shipping Corp., 549 U.S. 422, 430–31 (2007). Therefore, this court will
begin by analyzing the exercise of personal jurisdiction over Olympus Medical. 2
I.
Does the Court Have a Basis to Assert Personal Jurisdiction over Olympus Medical?
A.
Supplemental & Relevant Facts
Plaintiff, afforded jurisdictional discovery, has submitted additional facts in Response to
Olympus Medical’s Rule 12(b)(2) Motion. [#80]. Plaintiff presents the following facts to support
its argument of specific personal jurisdiction as to Olympus Medical, drawn from both the
operative Amended Complaint and additional facts adduced through discovery:
Olympus Medical maintains contact and business relations with UCH Hospital Doctor
Steven Edmundowicz, M.D., where is utilized as an evaluator of Olympus Medical’s prototype
devices. [#49 at ¶ 17]. Relevant here, Dr. Edmundowicz evaluated a prototype Q180V Scope for
Olympus Medical in 2009, before the introduction of the Scope to the U.S. market in 2010, and
again later in 2013 [id.], one year after UCH Hospital purchased the Scope in June 2012 [#80-12],
and approximately three years before Plaintiff’s procedure in January 2016. [#49 at ¶ 36]. Dr. Raj
Shah, Plaintiff’s treating physician who performed her ERCP on January 20, 2016, also has ties
with Olympus Medical. [#80 at 7]. Specifically, in 2009, Dr. Shah travelled to Tokyo, Japan on
2
There is no dispute that this court may exercise personal jurisdiction over Defendants Olympus
America and OCA.
Olympus Medical’s invitation several months prior to the release of the Q180V Scope to the United
States market to give feedback to Olympus Medical’s R&D team at the “Olympus Endoscopy New
Millennium Program.” [Id.; #80-4]. The Minutes from the 2009 trip indicate that Dr. Shah was
participating in his capacity as an Associate Professor of Medicine at the University of Colorado.
[Id.]. Dr. Shah toured the Olympus Medical manufacturing plants in Aomori and Aizu with
members of its marketing department, and heard a presentation from Mr. Kitano—presumably an
Olympus Medical employee—on the TJF-180V. 3 [#80-4 at 3–4, 5]. Dr. Shah provided comments
on the future scopes exhibited at the presentation and made comments praising Olympus Medical.
[Id. at 4, 6, 7, 10–11].
Olympus Medical’s employees also travelled to Colorado to build their relationships with
Dr. Shah and UCH Hospital. In 2010, Olympus Medical “Senior Supervisor” for the “Americas
Group,” Koya Tsubaki, travelled to Denver for a meeting with Dr. Shah and others at the
University of Colorado. [#80 at 7; #80-5]. The stated aim of the trip was to “enhance the doctors’
loyalty to Olympus [Medical]” and to boost sales of existing scope lines, which by that time
included the Q180V Scope. [Id. at 5]. Mr. Tsubaki visited again in February 2011 to attend the
“16th Rocky Mountain Interventional Endoscopy Course” where many Olympus Medical products
were displayed and demonstrated.
[#80 at 7; #80-6; #80-7]. After the trip, Mr. Tsubaki and
Olympus Medical Product Manager Charles Lavin were effusive in their mutual praise for the
success of the trip and the sales dividends it would provide. [#80-6 at 5–6]. In June 2012, UCH
Hospital purchased Q180V Scopes. [#80-12].
The Minutes omit the “Q” from the Scope name, but this appears to merely be a typo or an earlier
designation for the Scope at issue.
3
B.
Parties’ Arguments
Relevant here, Plaintiff’s original assertion of personal jurisdiction over Olympus Medical
was predicated on a nationwide marketing plan and the company’s shipment of Scopes to a
warehouse/distribution point in Pennsylvania, which the court found insufficient as these contacts
were not tethered to any Colorado-specific nexus. [Id. at 16]. Plaintiff now sets forth additiona l
factual allegations regarding Olympus Medical’s agents’ travel to Colorado and marketing to
Colorado doctors. Olympus Medical maintains Plaintiff’s showing remains insufficient because
(1) Dr. Edmundowicz’s 2009 and 2013 evaluation of Q180V prototypes is not alleged to be
connected to Plaintiff’s procedure which occurred years later [#54 at 9]; (2) Plaintiff has failed to
prove that Olympus Medical ever had more than a general awareness that its Scopes were sold in
Colorado [#81 at 2–3]; (3) Dr. Shah’s trip to Japan is unrelated to Olympus Medical’s targeting of
Colorado, citing Walden v. Fiore, 571 U.S. 277 (2014) [id. at 4]; (4) the two brief visits by
Olympus Medical Employee Koya Tsubaki are not related to the conduct forming the basis for this
litigation as “both visits appear to be unrelated to any particularized effort to sell the Q180V Scope
to UCH or anyone else in Colorado,” [id. at 5], and finally (6) notions of fair play and substantia l
justice weigh against the exercise of jurisdiction in this case [id. at 7]. 4 In doing so, Olympus
Medical relies heavily on another court’s decision on the same matter, Quashie v. Olympus Am.,
Inc., 315 F. Supp. 3d 1329 (N.D. Ga. 2018), which found no personal jurisdiction over Olympus
Medical.
Some of Olympus Medical’s original arguments have been effectively mooted by the subsequent
jurisdictional discovery and allegations made in Plaintiff’s Response. Those arguments which
have been substantively mooted and are not reasserted in the Reply are not addressed here.
4
C.
Legal Standard
Because Colorado’s long-arm statute is coextensive to that of the Due Process Clause of
the Fourteenth Amendment, this court’s analysis collapses into a single inquiry whether the
exercise of personal jurisdiction comports with due process. Nat'l Bus. Brokers, Ltd. v. Jim
Williamson Prods., Inc., 16 F. App’x 959, 962 (10th Cir. 2001). The Due Process Clause operates
to limit the power of a State to assert personal jurisdiction over a non-resident defendant.
Helicopteros Nacionales de Colombia, S.A. v. Hall, 466 U.S. 408, 413–14 (1984). Due Process
protects an individual’s liberty interest in not being subject to the binding judgments of a forum
with which he has established no meaningful contacts, ties, or relations. Burger King Corp. v.
Rudzewicz, 471 U.S. 462, 471–72 (1985). The standard for determining whether an exercise of
jurisdiction over the interests of persons is consistent with the Due Process Clause is the minimumcontacts standard set forth in International Shoe Co. v. Washington, 326 U.S. 310 (1945). Shaffer
v. Heitner, 433 U.S. 186, 207 (1977). International Shoe requires that a defendant “have certain
minimum contacts with it such that the maintenance of the suit does not offend traditional notions
of fair play and substantial justice.” Int’l Shoe, 326 U.S. at 316.
D.
Minimum Contacts
In the exercise of specific personal jurisdiction, the minimum contacts requireme nt
encompasses two distinct requirements: (1) the defendant must have purposefully directed its
activities at residents of the forum state, and (2) that the plaintiff’s injuries must arise out of the
defendant’s forum-related activities.
Old Republic, 877 F.3d at 895. The purposeful direction
requirement ensures that a defendant will not be haled into a jurisdiction solely as a result of
random, fortuitous, or attenuated contacts or of the unilateral activity of another party or a third
person. Burger King, 471 U.S. at 475 (quotation marks and citations omitted); Dudnikov v. Chalk
& Vermilion Fine Arts, Inc., 514 F.3d 1063, 1071 (10th Cir. 2008). While not necessarily
dispositive, forum-specific solicitation of business relationships and regular correspondence with
forum residents is strong evidence of purposeful direction.
See Pro Axess, Inc. v. Orlux
Distribution, Inc., 428 F.3d 1270, 1277–78 (10th Cir. 2005). In general, when considering a
foreign defendant’s contractual obligations, “parties who reach out beyond one state and create
continuing relationships and obligations with citizens of another state are subject to regulation and
sanctions in the other State for the consequences of their activities.” Id. at 1277 (citing Burger
King, 471 U.S. at 473).
In the October 30 Order, the court surveyed the unsettled landscape in the United States
Court of Appeals for the Tenth Circuit (“Tenth Circuit”) regarding the appropriate test to apply for
minimum contacts when jurisdiction arises by placing an item into the “stream of commerce.”
[#48 at 4–9]. In 2008, the Tenth Circuit decided Dudnikov, which addressed the “welter of
confusion” over the applicable framework for analyzing whether a plaintiff’s injuries arise out of
a defendant’s contact with the forum when considering the exercise of specific personal
jurisdiction.
The Dudnikov court rejected one test, the substantial connection test, but did not
affirmatively select between the remaining tests, the but-for test and the proximate cause test. See
id. at 1078 (“[W]e agree . . . that the ‘substantial connection’ test inappropriately blurs the
distinction between specific and general personal jurisdiction[.]”); see also id. at 1079 (“As
between the remaining but-for and proximate causation tests, we have no need to pick sides
today.”).
The proximate cause test “look[s] to whether the plaintiff has established cause in fact (i.e.,
the injury would not have occurred ‘but for’ the defendant’s forum-state activity) and legal cause
(i.e., the defendant's in-state conduct gave birth to the cause of action).” Mass. Sch. of Law at
Andover, Inc. v. Am. Bar Ass’n, 142 F.3d 26, 35 (1st Cir. 1998) (cited as the representative
proximate cause test in Dudnikov, 514 F.3d at 1078). By contrast, the but-for test inquires whether,
but for defendant’s contacts with the forum, plaintiff would have suffered the injury at issue.
Mattel, Inc. v. Greiner & Hausser GmbH, 354 F.3d 857, 864 (9th Cir. 2003) (cited as the
representative but-for test in Dudnikov, 514 F.3d at 1078). The Tenth Circuit has characterized
the proximate cause test as the more demanding of the two. Dudnikov, 514 F.3d at 1078 (“Under
the former approach, any event in the causal chain leading to the plaintiff's injury is sufficie ntly
related to the claim to support the exercise of specific jurisdiction. The latter approach, by contrast,
is considerably more restrictive and calls for courts to examines whether any of the defendant’s
contacts with the forum are relevant to the merits of the plaintiff's claim.” (formatting altered,
quotations omitted)); see also Newsome v. Gallacher, 722 F.3d 1257, 1270 (10th Cir. 2013)
(referring to “the more restrictive proximate cause test”); Bartile Roofs, 618 F.3d at 1161
(“Proximate cause is the most restrictive approach and requires courts to analyze whether any of
the defendant’s contacts with the forum are relevant to the merits of the plaintiff's claim.”
(quotation omitted)). The Tenth Circuit has repeatedly declined to definitively adopt one of the
two tests outside of the contract context. See Newsome, 722 F.3d at 1270 (“We have so far refused
to choose one test over the other, and we still need not pick between the two to resolve this case.”);
Employers Mut. Cas. Co. v. Bartile Roofs, Inc., 618 F.3d 1153, 1161 (10th Cir. 2010) (“We also
need not elect in this case between the proximate-cause and but-for-causation approaches.”); id. at
n.7 (“In contract actions, we have consistently applied the more-restrictive proximate-cause
approach.”).
District courts in the Tenth Circuit have repeatedly noted this ambiguity, but what is clear
is that, however formulated, the test as applied in the Tenth Circuit requires some purposeful
availment of the target forum, something greater than mere awareness that the device was sold in
the forum. [#48 at 8 n.5 (citing cases)]; see also Old Republic Insurance, 877 F.3d at 903 (Due
process requires . . . that the defendant “purposefully established minimum contacts within the
forum State.” (emphasis added) (citing Burger King Corp. v. Rudzewicz, 471 U.S. 462, 476
(1985)). The matter remains unresolved without binding precedent to guide the selection between
the two available tests. Cagle v. Rexon Indus. Corp., No. CIV-18-1209-R, 2019 WL 1960360, at
*5 (W.D. Okla. May 2, 2019); Salt Lake City Corp. v. Sekisui SPR Americas, LLC, No. 2017-cv01095-JNP-BCW, 2018 WL 4688356, at *6 (D. Utah Sept. 28, 2018). Typically, courts have
refrained from selecting between the tests because both tests come to the same conclusion. See,
e.g., Forte Supply, LLC v. Mojo Frozen Yogurt, LLC, No. 13-CV-00797-RM-BNB, 2013 WL
5477165, at *4 (D. Colo. Sept. 30, 2013).
In this case, the essential issue is not whether Defendant has contacts with the forum as
Plaintiff has shown several contacts with Colorado. Rather, the pertinent question is whether those
contacts are adequately related to the claims at issue, whether Plaintiff’s injuries arose from those
contacts. Contacts in the same industry are not relevant to the assertion of personal jurisdiction in
this case unless the contacts and Plaintiff’s harm share a causal nexus. RV Horizons, Inc. v. Smith,
No. 1:18-CV-02780-NYW, 2019 WL 1077366, at *9 (D. Colo. Mar. 7, 2019) (“The assertion of
specific personal jurisdiction must be based on a defendant’s particular contacts with the forum
that form the basis for the litigation; unrelated contacts that unavoidably happen to be in the same
industry are simply not relevant.”).
1.
Does the Selection of the Proximate Cause or But-For Test Affect the
Outcome?
Unlike other cases, the selection of the proximate cause or but-for test affects the court’s
determination with respect to personal jurisdiction.
Accordingly, this court analyzes the facts
separately to provide a clear record.
A.
Proximate Cause.
The proximate cause test is demanding and inquires whether “any of the defendant’s
contacts with the forum are relevant to the merits of the plaintiff’s claim.” Bartile Roofs, 618 F.3d
at 1161. For example, the Bartile Roofs court cited O’Connor v. Sandy Lane Hotel Co., 496 F.3d
312, 318 (3d Cir. 2007) in reciting this test.
In O’Connor, the Third Circuit held that a
Pennsylvania court had specific personal jurisdiction over a Barbados-based hotel when it mailed
flyers to plaintiffs after an initial stay, and “traded phone calls with them for the purpose of forming
an agreement to render spa services.” Id. at 317–18. Importantly, the court rejected several
contacts as irrelevant or insufficient under this test. Specifically, the court noted that “contacts
with a state’s citizens that take place outside the state are not purposeful contacts with the state
itself.” Id. at 317; see also id. (“A Philadelphia vendor may sell a lot of cheesesteaks to German
tourists, but that does not mean he has purposefully availed himself of the privilege of conducting
activities within Germany.”). In Harlow v. Children’s Hosp., 432 F.3d 50, 61 (1st Cir. 2005), the
court cautioned that “[t]he relatedness requirement is not an open door; it is closely read, and it
requires a showing of a material connection. . . . [T]he defendant’s in-state conduct must form an
important, or at least material, element of proof in the plaintiff's case.” (quotations omitted,
formatting altered). The proximate cause test is just what it sounds like—a requirement that
defendant’s contacts with the forum are the proximate cause of the resulting harm, in this case,
Plaintiff’s injury caused by the faulty end-cap design and reprocessing protocol attached to the
Q180V Scope.
In reviewing the record, this court concludes Plaintiff falls short of the mark to establish
specific personal jurisdiction over Olympus Medical when the proximate cause test is applied.
First, the court finds that Dr. Shah’s travels to Japan are insufficient under the O’Connor standard,
because out-of-state contacts cannot, in the usual course, constitute activity directed at the forum.
O’Connor, 496 F.3d at 318; see also Walden v. Fiore, 571 U.S. 277, 285 (2014) (“[The] ‘minimum
contacts’ analysis looks to the defendant’s contacts with the forum State itself, not the defendant’s
contacts with persons who reside there.”). Second, Mr. Tsubaki’s two visits to Colorado and Dr.
Edmundowicz’s 2009 and 2013 in-state evaluation of Q180V prototypes are also too attenuated
pursuant to Harlow. Plaintiff fails to provide enough evidence to tie the flawed design and
reprocessing protocol at issue in this case with Olympic Medical’s contacts with Colorado. There
is no indication that the 2009 prototype evaluation included the same design challenged herein, or
that any reprocessing protocols were even evaluated by Dr. Edmundowicz. The court is left to
conclude that Dr. Edmundowicz’s services do not relate to the design of the specific Scope at issue,
the Q180V, and are insufficient to establish proximate cause for Plaintiff’s harm. Accordingly,
the court finds that Ms. Lynch’s harms do not arise out of the specified contacts between Olympus
Medical and Colorado under the proximate cause test.
2.
But-For Causation
The but-for test is significantly less demanding. Under this test, “any event in the causal
chain leading to the plaintiff’s injury is sufficiently related to the claim to support the exercise of
specific jurisdiction.” Dudnikov, 514 F.3d at 1078; see also Newsome, 722 F.3d at 1269; Bartile
Roofs, 618 F.3d at 1161. All three of these cases cite, if at all, Ninth Circuit precedent in recounting
the but-for test. These cases hold that the but-for test is satisfied when defendant’s contacts with
the forum are a necessary event in the causal chain leading to the injury. Mattel, Inc. v. Greiner
& Hausser GmbH, 354 F.3d 857, 864 (9th Cir. 2003) (“The question can be formulated as this:
But for [defendant’s] contacts with California, would [plaintiff’s] claims against [defendant] have
arisen?”); Harris Rutsky & Co. Ins. Servs. v. Bell & Clements Ltd., 328 F.3d 1122, 1132 (9th Cir.
2003) (“But for [defendant’s] conduct, this injury would not have occurred.”). The less restrictive
but-for standard permits the court to focus not on the issue of whether Olympus Medical’s
Colorado contacts were proximately related to the challenged design of the scope, but rather on
the issue of whether Olympus Medical’s actions directed at Colorado were for the purposes of
developing and promoting the use Q180V by physicians and patients in Colorado. [#80-12].
Defendants point the court to Quashie, 315 F. Supp. 3d at 1337, where the court found that
plaintiff’s allegations were “insufficient to show a sufficient nexus between [Olympus America’s]
contacts and the litigation” to support their argument that personal jurisdiction is lacking. With
due respect to the comprehensive and well-reasoned opinion in Quashie, the court finds the present
case distinguishable.
The Quashie court first found Plaintiff had satisfied Georgia’s long- arm
statute by committing an injury that occurred in Georgia, by placing a product into the stream of
commerce with the expectation that consequences would occur in Georgia, and that the defendants
had derived substantial revenue from Georgia.
315 F. Supp. 3d at 1335. Unlike Colorado’s,
Georgia’s long-arm statute is not coextensive with due process requirements under the United
States Constitution.
Id. at 1334 (“Jurisdiction under the Georgia long-arm statute is not
coextensive with procedural due process.” (quotations omitted)).
Therefore, the Quashie court
went on to consider whether the exercise of personal jurisdiction would offend the Due Process
Clause and concluded that the plaintiff failed to allege facts to support the conclusion that Olympus
Medical “expected or should have expected their acts to have consequences within the [forum
state].” Id. at 1339.
Unlike Quashie, where there were only generalized allegations of contact with the forum
state leading that court to posit, “[w]hich acts?” and “[w]hat consequences,” id., jurisdictio na l
discovery adequately answered those questions in this case. Plaintiff has demonstrated that
Olympus America purposefully directed its activities related to the Q180V Scope at Colorado.
Which Acts? First, Plaintiff avers that Olympus Medical maintained a relationship with
Dr. Steven Edmundowicz of UCH, who evaluated prototype endoscopes including a prototype of
the TJF-Q180V in 2009 and again in late 2013. [#49 at ¶ 17]. Even without Dr. Edmundowic z’s
participation, 5 Olympus Medical physically sent its representative into the forum to solicit business
and sent scopes for prototype testing as well in 2010. Compare [#80-4] with id. at 1334–35 (only
alleging that the device was sold in Georgia). Mr. Tsubaki also traveled from Japan to Colorado
to work in conjunction with his American colleagues to build loyalty and increase sales of
Olympus Medical’s endoscopy scopes in Colorado. To that end, Mr. Tsubaki attended the Rocky
Mountain Interventional Endoscopy Course in 2011; asked to meet with Dr. Shah and other MDs
at the University of Colorado; and planned to observe a case and discuss it with Dr. Shah. [#80-5
5
Defendants contend Dr. Edmundowicz’s evaluation of the Olympus Medical scopes is irreleva nt,
because those prototype scopes are not at issue in this action, and Dr. Edmundowicz was not at
UCH at the time, but at Washington University School of Medicine in St. Louis, Missouri from at
least 2009 to 2014. [#54 at 9-10].
at 3].
What Consequences? Plaintiff alleges that the Q180V Scope was released in the United
States in 2010, and was based on an earlier Olympus scope, the TJF-160V. [#49 at ¶ 28]. Though
not explicit from the evidence proffered, this court reasonably infers that the purpose of Mr.
Tsubaki’s 2010 and 2011 trips to Colorado included promoting the Q180V Scope, given there is
nothing to suggest that Olympus Medical would have carved out the accused scope in its efforts
in promoting loyalty to Olympus and its endoscopy scopes. Indeed, particularly in light of Dr.
Shah’s visit to Olympus Medical in Japan in 2009, where the future GI scope line-up included the
“TJF-180V (New V-scope),” nothing in the jurisdictional discovery suggests that Olympus
Medical would have abandoned its efforts given Dr. Shah’s feedback as to that particular
prototype, and Dr. Shah’s affirmative statement that he “look[ed] forward to communicating with
your team to discuss my ideas further or to review prototype development for endoscopes or
endotherapy products.” [#80-4 at 4, 11]. Because all factual disputes are resolved in favor of the
plaintiff in determining whether plaintiff has made a prima facie showing, the court finds that
Plaintiff’s showing is sufficient to satisfy the but-for test for personal jurisdiction. Old Republic,
877 F.3d at 903.
In fact, the most closely analogous situation applied the proximate cause test—O’Connor
v. Sandy Lane Hotel Co., 496 F.3d 312 (3d Cir. 2007). In that case, much like the present, the only
contacts between the defendant and the forum was the defendant’s solicitation of business from
the plaintiffs. Id. at 318 (“After the O’Connors’ initial stay, Sandy Lane continued to cultivate the
relationship by mailing seasonal newsletters to their Pennsylvania home.”). So too here; Olympus
Medical continued to cultivate the relationship by sending its executive to meet with Dr. Shah and
others to promote their products, including the Q180V Scope. A district court in the Central
District of California came to a similar conclusion when considering whether advertising to a
plaintiff in the forum was a but-for cause of plaintiff availing itself of the advertised products.
Hope v. Otis Elevator Co., 389 F. Supp. 2d 1235, 1240 (E.D. Cal. 2005) (“The question, therefore,
is this: but for [hotel’s] advertising and associations with travel agents, would Plaintiff have stayed
at [its] hotel in Hawai[’]i? . . . It is reasonable to infer . . . that [hotel’s] advertising and association
with California travel agents were “but for” causes of Plaintiff’s stay . . . .”).
The court concludes that Plaintiff has met her burden of establishing minimum contacts
under the but-for test but has not met her burden under the proximate cause test.
E.
Traditional Notions of Fair Play and Substantial Justice
Having found that there are sufficient minimum contacts to support personal jurisdic tio n
under at least one of the available tests, the court next turns to examine whether the assertion of
personal jurisdiction would comport with traditional notions of fair play and substantial justice.
Old Republic, 877 F.3d at 903. Analyzing whether the exercise of personal jurisdiction would
offend traditional notions of fair play and substantial justice “requires a case-specific inquiry into
the reasonableness of the exercise of personal jurisdiction over a defendant who has minimum
contacts with the forum state.” TH Agric. & Nutrition, LLC v. Ace European Grp. Ltd., 488 F.3d
1282, 1292 (10th Cir. 2007). The court weighs five factors: (1) the burden on the defendant, (2)
the forum state’s interest in resolving the dispute, (3) the plaintiff’s interest in receiving convenie nt
and effective relief, (4) the interstate judicial system’s interest in obtaining the most effic ie nt
resolution of controversies, and (5) the shared interest of the several states in further ing
fundamental substantive social policies. Id. (quoting Intercon, Inc. v. Bell Atl. Internet Solutions,
Inc., 205 F.3d 1244, 1249 (10th Cir. 2000)). In applying this test, the court must be “cognizant of
the fact that, with minimum contacts established, it is incumbent on defendants to ‘present a
compelling case that the presence of some other considerations would render jurisdic tio n
unreasonable.’” Dudnikov, 514 F.3d at 1080 (quoting Pro Axess, 428 F.3d at 1280). The court
finds these factors weigh in favor of exercising jurisdiction.
Olympus Medical argues that the exercise of personal jurisdiction here offends traditio na l
notions of fair play and substantial justice. [#54 at 9–11; #81 at 7–8]. Defendant’s argument is
exclusively focused on the burden Olympus Medical would incur, and so the court’s analysis will
be similarly confined.
Defendant’s argument is centered on an analogy to Benton v. Cameco
Corp., 375 F.3d 1070, 1078 (10th Cir. 2004), where the court found the exercise of jurisdic tio n
inconsistent with fair play and substantial justice.
In Benton, the Tenth Circuit found the exercise of personal jurisdiction to be inconsis te nt
with traditional notions of fair play and substantial justice despite the existence of suffic ie nt
minimum contacts. 375 F.3d at 1078. The Benton court began by noting that,
The reasonableness prong of the due process inquiry evokes a sliding scale: the
weaker the plaintiff’s showing on minimum contacts, the less a defendant need
show in terms of unreasonableness to defeat jurisdiction. The reverse is equally
true: an especially strong showing of reasonableness may serve to fortify a
borderline showing of minimum contacts.
Id. at 1079 (formatting altered) (quoting OMI Holdings, 149 F.3d at 1095).
Applying this framework to plaintiff’s just-sufficient showing of minimum contacts, the
Tenth Circuit found that the burden on the Canadian defendant was “significant” as it “has no
office or property in Colorado, is not licensed to do business in Colorado, and has no employees
in Colorado.” Id. The Circuit further found that defendant’s “officers and employees will not only
have to travel outside their home country, they will also be forced to litigate the dispute in a foreign
forum unfamiliar with the Canadian law governing the dispute.” Id. Thus, the exercise of personal
jurisdiction was not consistent with fair play and substantial justice.
Given the specific
circumstances of this case, this court finds Benton distinguishable.
If Benton was “a very close case” that just barely rose to the level of minimum contacts,
this case—while by no means a clear call—is less arguable and so would require a greater showing
of prejudice on the “sliding scale” mentioned above. Id. Unlike Benton, Colorado law applies and
the court has no concern that Defendant, ably represented by counsel, would be forced to litigate
a dispute with unfamiliar law, or that the court would be forced to construe unfamiliar foreign law
as in Benton. Indeed, Olympus Medical shares counsel with its related entities Olympus America
and OCA, that are undisputedly subject to personal jurisdiction in this forum. Thus, a significa nt
element of prejudice found in Benton is lacking here. Further, the court notes that although
Olympus Medical is not physically located in Colorado, it has regularly travelled here to conduct
business and promote its products. Unlike in Benton where the Canadian defendant’s visits to
Colorado were limited to a discrete issue—due diligence—in performing one contract, Olympus
Medical’s visits were not so restricted in time or scope, and a senior executive visited instead of
lower-level functionaries charged with a single task. Id. at 1076. And courts have long noted that
modern telecommunication and travel infrastructure mitigate the burden in litigating in a distant,
even foreign, forum. Pro Axess, 428 F.3d 1270 (France); First Am. Mortg., Inc. v. First Home
Builders of Fla., No. 10-CV-0824-RBJ-MEH, 2011 WL 4963924, at *3 (D. Colo. Oct. 14, 2011)
(Florida); Media Res., Inc. v. Global Paper 3834875 Canada, Inc., No. CIV-05-1038-C, 2006 WL
8436512, at *4 (W.D. Okla. May 12, 2006) (Canada).
The primary burden apparent to the court is the substantial need for translation services.
Such difficulties have already forced Plaintiff to seek an extension of time to have written
discovery translated. [#78 (“Additionally, at least one-third of the 4,500 pages are in Japanese and
Plaintiff anticipates some delay in having any relevant pages reviewed and translated by a Japanese
linguist in preparation of its opposition.”)].
But this burden typically falls on Plaintiff, not
Defendant, and so is immaterial to the issue of Defendant’s burden. E&J Gallo Winery v. Cantine
Rallo, S.p.A., No. 1:04-cv-5153-OWW-DLB, 2006 WL 3251830, at *5 (E.D. Cal. Nov. 8, 2006)
(“Normally, in responding to a request for production of documents, the requesting party would
bear the cost of translating documents written in a foreign language”); In re Korean Air Lines
Disaster of Sept. 1, 1983, 103 F.R.D. 357, 357 (D.D.C. 1984) (“While the Court will not condone
an unnecessary escalation of such costs by the production of Korean language documents when
English translation are equally available, neither will Korean Air Lines or any defendants be
required to bear what is rightly Plaintiffs’ burden.”). To the extent that Olympus Medical puts
itself in the situation of bearing these costs through the unnecessary production of Japaneselanguage materials when an English version is available, or in responding to interrogatories by
production of Japanese-language business records under Federal Rule of Civil Procedure 33(d),
Nature’s Plus Nordic A/S v. Nat. Organics, Inc., 274 F.R.D. 437, 441 (E.D.N.Y. 2011) (“[W]hen
a party responds to an interrogatory by producing documents written in a foreign language, Rule
33(d) requires the responding party to provide a translation of those documents.”), that is a burden
it has voluntarily assumed and does not figure into this analysis.
In sum, the court finds that the Olympus America purposefully directed its activities
towards Colorado, that there is a prima facie case that its Colorado-specific activities were a but-
for cause Plaintiff’s injuries, and that the exercise of personal jurisdiction does not offend
traditional norms of fair play and substantial justice. The court thus concludes that Plaintiff has
satisfied its prima facie burden of establishing personal jurisdiction over Olympus Medical is
appropriate, and thus Olympus Medical’s Motion to Dismiss for Lack of Personal Jurisdiction is
DENIED.
II.
Does the First Amended Complaint Set Forth a Design Defect Claim Cognizable
under Colorado Law?
Having determined that this court may exercise personal jurisdiction over Olympus
Medical, this court now considers the issue of whether the First Amended Complaint sets forth a
cognizable claim, as challenged by all Defendants.
A. Elements of Design Defect Claims
The court analyzed Colorado law on the design defect claim in the October 30 Order and
will not repeat itself here. In brief, the court concluded that the absence of governing Colorado
law on the subject left the court to make an Erie guess as to how that court would rule, and this
court concluded that the Colorado Supreme Court would apply the Restatement (Second) of Torts
§ 402A. [#48 at 18 & n.7]. There has been no relevant contrary authority from the Colorado
Supreme Court since the October 30 Order. Under this test, there are five requirements to establish
a products liability claim based on a design defect theory: (1) the product is in a defective condition
unreasonably dangerous to the user or consumer; (2) the product is expected to and does reach the
consumer without substantial change in the condition in which it was sold; (3) the defect caused
the plaintiff's injury; (4) the defendant sold the product and is engaged in the business of selling
products; and (5) the plaintiff sustained damages. Barton v. Adams Rental, Inc., 938 P.2d 532,
536–37 (Colo. 1997) (citing Restatement (Second) of Torts § 402A (1965)); see also Camacho v.
Honda Motor Co., Ltd., 741 P.3d 1240, 1244 (Colo. 1987). To establish that an accused product
is in a “defective condition,” Colorado courts apply the seven-element test from Armentrout v.
FMC Corp., 842 P.2d 175, 184 (Colo. 1992):
(1) The usefulness and desirability of the product—its utility to the user and to the
public as a whole.
(2) The safety aspects of the product—the likelihood that it will cause injury and
the probable seriousness of the injury.
(3) The availability of the substitute product which would meet the same need and
not be as unsafe.
(4) The manufacturer’s ability to eliminate the unsafe character of the product
without impairing its usefulness or making it too expensive to maintain its utility.
(5) The user’s ability to avoid danger by the exercise of care in the use of the
product.
(6) The user’s anticipated awareness of the dangers inherent in the product and their
avoidability because of general public knowledge of the obvious condition of the
product, or of the existence of suitable warnings or instructions.
(7) The feasibility, on the part of the manufacturer, of spreading the loss by setting
the price of the product or carrying liability insurance.
This list is not exclusive, but merely illustrative of factors which may assist in determining whether
a design is unreasonably dangerous. Depending on the circumstances of each case, flexibility is
necessary to decide which factors are to be applied, and the list of factors may be expanded or
contracted as needed. Id.
In the October 30 Order, the court dismissed Plaintiff’s claim because Plaintiff did not
make a showing that the product was in a defective condition under the Armentrout test. [#48 at
21]. The court was not persuaded that Plaintiff had averred sufficient facts so that a factfinder
could conclude that the Q180V was per se defective because the device was more than “diffic ult”
to clean. [Id. at 21].
B.
Analysis
In the First Amended Complaint, Plaintiff asserts additional facts to support the conclusio n
that the Q180V Scope was defectively designed under the Armentrout test. The First Amended
Complaint establishes that that Q180V Scope, contrary to numerous other models manufactured
by Olympus Medical and contrary to their own internal guidelines, was designed with a fixed
distal-end cap that sealed the elevator wire channel from the outside, supposedly preventing the
ingress of fluids from a patient during use. [#49 at ¶¶ 30–35]. Plaintiff further contends that the
cap did not fully seal the elevator wire channel but did effectively prevent reprocessing under the
provided reprocessing protocols. [Id. at ¶¶ 38–40]. Until a subsequent May 2015 update, Olympus
Medical never subjected the Q180V Scope to a proper validation testing to ensure that the provided
reprocessing protocol was sufficient to ensure that the elevator wire channel was free of
contaminants and safe for further patient use; Olympus Medical also included the MAJ-1888 Brush
in this update, which had been necessary to effective reprocessing from the beginning.
[Id. at
¶¶ 36–37]. Plaintiff posits that two alternatives were feasible and would have prevented the
harm—either remove any end cap, permitting easy cleaning without the MAJ-1888 Brush or to
have a removable cap, which would both reduce the inflow of fluids and allow for easy
reprocessing. [Id. at ¶ 35]. In fact, these systems were used on other Olympus Scopes, includ ing
the Q180V’s predecessors, the TJF-160VF, and the 160VR. [Id.]. Not long after the May 2015
update, the United States Food and Drug Administration issued a recall of all Q180V scopes “to
fix the defective sealing mechanism at the distal end of the device.” [Id. at ¶ 46].
Nonetheless, Defendants argue that Plaintiff’s showing on this point remains deficie nt.
Defendants argue that Plaintiff fails to adequately allege causation as merely stating that she was
subject to a Scope contaminated with bacteria and then contracted a bacterial infection is
insufficient. [#55 at 9]. Further, Defendants argue that Plaintiff has not met the Armentrout factors
by failing to allege facts demonstrating that the risks outweighed the benefit. [Id. at 10–11]. The
Q180V Scope offered greater range of motion and Plaintiff “alleges no facts” to establish that the
alternatives referenced above “offered the same utility as the Q180V Scope without the same risk”
because the elevator channel itself could contain microscopic crevices that could harbor the same
contaminates. [Id. at 11].
First, as set forth in more detail below, the court finds that the First Amended Complaint
adequately sets forth a plausible causal chain of events. The essence of Plaintiff’s claim is that,
due to the particular design of the Q180V Scope, it was more likely to retain contaminates from
prior use and in fact did so during her procedure. As a result of this exposure, Plaintiff contracted
a multi-drug resistant bacterial infection, like the ones that had been previously identified as related
to the Q180V in the United States and Europe. [#49 at ¶ 43]. Plaintiff further contends that the
patient infections at Erasmus Medical Center in Rotterdam, the Netherlands, identified a defective
sealing mechanism for the elevator channel in 2012. [Id. at ¶ 44]. While clarifying the temporal
proximity between the January 2016 procedure and a subsequent diagnosis would be helpful, it is
not necessary at this stage in light of the additional allegations and the court did not intend to
suggest otherwise in its October 30 Order. Indeed, the purpose of Rule 12(b)(6) is not to require
a plaintiff to prove her case at this juncture, but merely to give Defendants adequate notice of a
cognizable claim.
Second, the court finds that Plaintiff meets the Armentrout test. Defendants miss the mark
in focusing on whether the elevator channel could retain contaminates in crevices regardless of the
end-cap design. The focus under one of the non-exclusive balancing factors in the Armentrout test
is the manufacturer’s “ability to eliminate the unsafe character of the product without impair ing
its usefulness or making it too expensive to maintain its utility.” 842 P.2d at 184. The unsafe
character of the Q180V Scope is alleged to be the fixed end cap which results in a contaminated
elevator channel—it is immaterial to Plaintiff’s claim that that the Q180V Scope was designed in
such a manner that it could still retain contaminates through an entirely different unsafe
characteristic.
See Fibreboard Corp. v. Fenton, 845 P.2d 1168, 1174 (Colo. 1993) (discussing
alternate design principles).
Identifying the unsafe characteristic and pointing to a feasible
alternative is sufficient; when a product’s design is based on technical and scientific knowledge,
it would be manifestly unreasonable and unfair to require a plaintiff to offer a complete redesign
as opposed to pointing to a discrete flaw and showing how it could be remedied.
III.
Does the First Amended Complaint Plausibly Allege Causation?
In the October 30 Order dismissing Plaintiff’s original Complaint, the court found that all
of Plaintiff’s claims suffered from a failure to adequately allege causation. [#48 at 21]. The court
found that Plaintiff’s bare allegations that sometime in January 2016 she had an ERCP and then
sometime thereafter fell ill with an unspecified condition was insufficient to plausibly link the two.
[Id. at 21–22 & n.8 (“Plaintiff’s only allegations regarding causation are that the procedure
happened and sometime thereafter Plaintiff fell ill.”); id. at n.8 (“[T]he Complaint fails to allege
when was Plaintiff was diagnosed and how long after the procedure, so that the court might
consider temporal proximity in causation. Similarly, the Complaint does not even identify the
particular infection. . . .”). Defendants seek dismissal on this point, alleging that the same basic
failures to establish causation identified in the October 30 Order persist in the First Amended
Complaint. The court respectfully disagrees.
Plaintiff’s theory of causation is now more detailed, and the court finds it sufficient to
allege causation. The First Amended Complaint now specifies that Ms. Lynch contracted “a multidrug resistant infection” from the “residual microbial contamination” left in the Q180V Scope
from a prior patient, presumably in the elevator channel incompletely sealed off from the device
by the distal end cap. [#49 at ¶ 53]. As discussed above, although specifying when Plaintiff fell
ill might assist the court in finding causation through temporal proximity, the court finds that the
First Amended Complaint adequately establishes a plausible case for causation by other averments,
i.e., identifying the specific mechanism in the Scope that retained bacteria; why it is difficult to
clean; generally identifying the type of infection Plaintiff contracted subsequent to her procedure;
and indicating that Defendants recalled the Q180V Scope after Ms. Lynch had her ERCP
procedure. See generally [#49].
IV.
Does Plaintiff’s Failure to Warn Claim State a Claim?
A.
Elements of Strict Products Liability: Failure to Warn
As before, the court will not repeat its analysis of Colorado law on the failure to warn
reflected in the October 30 Order but will briefly summarize its conclusion that the Colorado
Supreme Court would apply the Restatement (Third) of Torts § 6(d) to a failure to warn claim as
the Colorado Court of Appeals does. [#48 at 23]. The court further concluded that the applicable
elements of such a claim were: (1) The warning was defective or inadequate; (2) the alleged
inadequacy caused her doctor to prescribe the drug or use the medical device; and (3) had the
warning been adequate, the treating physician would not have prescribed that drug or used that
device. [Id. (quoting Ackermann v. Wyeth Pharms., 526 F.3d 203, 208 (5th Cir. 2008))]. Finally,
the court concluded that the “learned intermediary doctrine applied to such a claim; in other words,
the failure to warn must be presented as a failure to warn the patient’s doctor, the party cogniza nt
of the benefits and dangers of specific medical tools like the Q180V Scope and selecting the tool
from competing implements based on that judgment. [Id. at 24]. 6 Plaintiff’s original complaint
did not apply these elements or the learned intermediary doctrine and now attempts to do so in the
First Amended Complaint.
B.
Analysis
The First Amended Complaint asserts that Defendants are liable for failure to warn Ms.
Lynch or her treating physician that the redesign of the Q180V Scope rendered it unreasonably
dangerous for use in her January 2016 ERCP. [#49 at ¶¶ 67–81]. Specifically, Plaintiff alleges
that Defendants, in various joint statements issued prior to her procedure, failed to warn users that
the redesign of the scope made effective reprocessing extremely difficult, that the device was
associated with numerous infections across the globe due to cross-patient contamination, and that
the risk of infection due to cross-contamination from biological matter left in the elevator channel
from a previous patient was much higher than that in the Defendants’ prior scopes, specifically the
To further clarify the court’s analysis from the October 30 Order, the learned intermediar y
doctrine applies to the selection of a specialized medical device like the Q180V Scope because the
doctor is the individual selecting the tool from the array of available options based on her
professional judgment. The fact that a doctor decides the patient requires an ERCP and performs
it is related to this, but the essential fact is the doctor’s selection of a specialized tool for the job
that justifies application of the doctrine. Application of the doctrine would be less likely when,
for example, a doctor decides a patient needs stitches and uses an over-the-counter antiseptic in
the procedure. Caveny v. CIBA-GEIGY Corp., 818 F. Supp. 1404, 1406 (D. Colo. 1992);
O’Connell v. Biomet, Inc., 250 P.3d 1278, 1281–82 (Colo. App. 2010).
6
TJF-160F and TJF-160VF scopes. [Id. at ¶ 74]. Had Ms. Lynch and her doctor been warned, they
would not have used the Scope in her procedure. [Id. at ¶¶ 75–76]. The ineffective warnings
associated with the device rendered it unsafe for use and caused Plaintiff’s subsequent infectio n.
[Id. at ¶¶ 77–81].
Defendants argue that Plaintiff’s claim is deficient as to each of the three elements
described above. [#55 at 13]. Specifically, Plaintiff acknowledges that any prior deficiencies in
the instructions provided along with the Q180V Scope were remedied in the May 2015 update,
which included a specialized brush, the MAJ-1888, to effectively reprocess the Scope after use.
[Id. at 13–14; #49 at ¶ 40 (explaining that Defendants waited until May 2015 to provide additiona l
reprocessing instructions and the MAJ-1888 Brush to end-users)]. Further, Defendants claim that
Plaintiff fails to “articulate additional or different warnings from the warning disseminated in May
2015 or plead facts showing such warnings would have prevented her harm by causing her
physician to use a different device.” [#55 at 14]. Finally, Defendants argue that Plaintiff’s claim
fails on her own pleading because she specifically alleges that no warning could have cured the
design defect, an argument which this court already considered to effectively preclude a failure to
warn claim because it fatally undermines causation. [Id.; #49 at ¶ 99 (arguing that “no update to
the reprocessing protocol or accessory could mend” the “known design defects or increased risk
of infections with [the Q180V Scope]”); id. at ¶ 118 (same); #48 at 26 (“If the device cannot be
cleaned, then there cannot be an adequate warning regarding proper cleaning procedures, and
therefore the failure to include an adequate warning could not have resulted in an injury to the
Plaintiff.”)].
The court finds that the failure to warn claim does state a claim under Colorado law. The
court begins by clarifying the precise inquiry at issue for this cause of action as the parties appear
to disagree over whether the failure to warn claim focuses on the reprocessing protocols as the
putatively deficient warnings.
Plaintiff alleges that the reprocessing protocol and assorted
instructions for the Q180V Scope were inadequate to ensure effective reprocessing between uses.
[#49 at ¶ 74]. But Plaintiff’s Amended Complaint is contradictory on the adequacy of the May
2015 update. On one hand, Plaintiff argues that “additional steps were needed to adequately
reprocess the Q180V Scope” which were “not introduced until May 2015,” including the MAJ1888, which was “required” for adequate reprocessing of the Scope after use. [Id. at ¶ 40]. This
would seem to indicate that the Scope, as of May 2015 and certainly by her January 2016
procedure, did in fact have an adequate reprocessing protocol.
On the other hand, the First Amended Complaint emphatically states that no warning or
reprocessing protocol would have been sufficient. In the allegations specifically supporting the
failure to warn claim, Plaintiff states that “there was no reliable way to clean its Q180V Scopes
even after they were reprocessed by users, such as UCH Hospital, who correctly followed the
device manuals.” [Id. at ¶ 78]. Rather, to remedy the dangerous propensity of the Q180V Scope,
Defendants had to fundamentally change the design of the Scope, a process that was still
incomplete at time of Plaintiff’s procedure. [Id. at ¶ 73 (“[T]he Q180V Scope featured design
elements described herein that rendered it extremely difficult or impossible to adequately reprocess
absent a design change that had not been initiated until after Ms. Lynch had her ERCP
procedure[.]”)]. Defendants argue the First Amended Complaint’s inconsistent framing of the
adequacy of the reprocessing protocols is fatal to her failure to warn claim.
Plaintiff counters that Defendants have missed the mark—the “warning” at issue is not the
reprocessing protocol, but rather a supplemental warning, never given, regarding the increased risk
of infection inherent in the Scope’s design. [#70 at 11–12]. The First Amended Complaint sets
forth a detailed history of Scope infections that led Defendants to issue the May 2015 update, but
the update only reformulated the reprocessing protocols, it contained no mention of the greatly
enhanced risk of infection and cross-contamination due to the Scope’s design, a risk which may
have been mitigated but not fully eliminated by the update. [#49 at ¶¶ 43–46]. Whether the Scope
was difficult or impossible to reliably clean, the Scope did not contain any advisement that the
nature of the elevator channel cap design rendered it more likely to infect subsequent users.
Defendants counter that regardless of the framing of the inquiry, Plaintiff’s claim still fails because
she never sets forth what warning would have been adequate and would have lead her doctor to
refrain from using the Scope in her ERCP. [#73 at 3–4].
The court finds Plaintiff’s showing on this point to be adequate at this stage to plausibly
establish a design defect claim. The court is not persuaded by Defendants’ argument that Plaintiff
must “articulate” a specific warning that would have been sufficient except as inherent in plausibly
alleging causation. [#55 at 13, 14]. Plaintiff identifies the risk her doctor should have been warned
about—infection risk due to Scope design—and points to its obvious absence.
Nowell v.
Medtronic Inc., No. CIV 17-1010 JBSMV, 2019 WL 1434971, at *55 (D.N.M. Mar. 29, 2019)
(“[Plaintiff’s] failure-to-warn claim requires her to prove that the Defendants provided her with a
defective warning, or no warning at all, and that this warning, or lack of warning, caused her
injury.”).
Regardless of the difficulty or ease with which Defendants may have remedied the
underlying problem, the fact remains that Plaintiff alleges that the Q180V lacked any warning as
to its dangerous propensity, and so could not have “disclose[d] the nature and extent of the danger.”
Id. While this theory could be more clearly set forth in the First Amended Complaint as opposed
to the Response, the court is persuaded that the Complaint itself is sufficient in this regard, even
when disregarding the clarifying Response.
Plaintiff alleges facts supporting the element that the absence of an effective warning led
her doctor to use the device. According to Plaintiff, the Q180V was marketed as “easier to clean
than its predecessor” when in fact the redesign of the elevator channel with a distal end cap
rendered it far more difficult to clean without the MAJ-1888 or the updated reprocessing protocol,
and even that was not enough to do so reliably. [Id. at ¶¶ 35, 40]. She alleges her doctor would
not have used the Q180V had he known of the increased risks of infection associated with it. [Id.
at ¶ 76]. While this is a brief and somewhat conclusory allegation as to a critical element in a
failure to warn claim, the court is convinced that, in context, Plaintiff makes out a plausible case
that had her doctor been aware of the increased risks involved in using a Q180V Scope, he would
have selected a different device. 7 In the 30 October Order, the court found that Plaintiff’s claim
failed because the Complaint established that the device was per se dangerous after use, and that
there could be no warnings that would have prevented her harm. [#48 at 25]. Plaintiff’s theory of
the case as laid out in the First Amended Complaint, is that the device was hard to clean in general,
and impossible to reliably clean with the provided instructions which made the device more
7
Plaintiff does not make this argument, and so the court need not definitively resolve it, but
Colorado courts have recognized a so-called “heeding presumption” when applying Section 402A
to products liability cases. Uptain v. Huntington Lab, Inc., 723 P.2d 1322, 1326 (Colo. 1986).
The presumption states that “where warning is given, the seller may reasonably assume that it will
be read and heeded.” Id. Several courts have applied this doctrine to failure to warn claims for
prescription drugs, although application to medical devices appears to be comparatively less
common. Garside v. Osco Drug, Inc., 976 F.2d 77, 80 (1st Cir. 1992) (examining application and
rationale for presumption).
dangerous, more likely to carry contaminates, and Plaintiff’s doctor should have received a
warning as to this propensity. This is sufficient at this juncture. The court thus finds that the First
Amended Complaint states a plausible claim for relief for a failure to warn.
V.
Do the Intentional and Negligent Misrepresentation Claims Meet the Heighted
Pleading Standards of Rule 9(b)?
A.
Intentional Misrepresentation
The court’s October 30 Order found Plaintiff failed to specify the manner in which each
Defendant participated in making the statements at issue. [#48 at 29 (“Plaintiff fails to identify
which party is responsible for which misrepresentations, and instead Plaintiff simply asserts this
claim against all Defendants. . . . It seems unlikely that all three defendants made the same ‘false
representations to Plaintiff and/or Plaintiff’s physicians’, but even if that were the case, neither the
court nor the Defendants are given sufficient information to understand that representatives of
Olympus America and OCA made the same false representations to the respective Plaintiff and/or
her physicians.” (citation omitted)).
The court concluded that this form of undifferentiated
pleading, where neither the specific misrepresentations nor the speakers were identified with any
particularity, fell short of the applicable standards of Rule 9(b). [Id. at 28–30].
The First Amended Complaint individually identifies the misstatements at issue while
alleging that the misstatements were jointly made by all three Defendants. [#49 at ¶¶ 89–107].
Specifically, Plaintiff identifies four statements made between February 2 and May 6, 2015, by
OCA and Olympus America with input from Olympus Medical. [Id. at ¶¶ 96–99]. By specifica lly
alluding to the time and place of the misrepresentations, Plaintiff seems to have cured the defects.
But Defendants counter that this is still an inadequate showing because Plaintiff does not “specify
which defendant told which alleged lie and under what circumstances.” [#55 at 16]. Defendants
further counter that Plaintiff’s generalized allegations are insufficient and merely relabel the
originally objectionable “Defendants” with “Olympus Corp. and Olympus America, with input
from Olympus Medical.” [Id. at 17].
The court respectfully disagrees. The First Amended Complaint clearly sets forth four
specific statements and identifies the declarants, and so the court’s analysis will focus on whether
Plaintiff has adequately set forth the individual defendant’s participation in the misstateme nts.
Defendants are correct that Plaintiff’s claim is substantively the same as before, generally alleging
that all three defendants are responsible for the misstatements but using the specific names instead
of simply “Defendants.” But the Rule 9(b) analysis is holistic, and the court finds that, when read
as a whole, the First Amended Complaint’s claim of intentional misrepresentation meets the
heightened standards of Rule 9(b).
Rule 9(b) requires a plaintiff to identify the person or persons allegedly responsible for
making the misstatement, but it does not require the plaintiff to particularize the reasons why the
plaintiff believes the alleged speaker to be responsible for the statement. S.E.C. v. Nacchio, 438
F. Supp. 2d 1266, 1278 (D. Colo. 2006). For example, where misstatements are made in “grouppublished documents such as annual reports, which presumably involve collective actions of
corporate directors or officers, Rule 9(b) does not require a plaintiff to identify the individ ua l
source of a particular statement, so long as it adequately advises which defendants are alleged to
be responsible for the contents of the document.” Id. (internal quotation marks omitted) (quoting
Celestial Seasonings, 124 F.3d at 1254). Plaintiff’s theory of the case is that OCA and Olympus
America are “in effect indistinguishable.” [#49 at ¶ 7]. A plaintiff may plead collectively when
the Defendants participated in joint misstatements and the entities are indistinguishable from an
outsider’s perspective in making the identified statements. Swartz v. KPMG LLP, 476 F.3d 756,
764 (9th Cir. 2007) (“[T]here is no absolute requirement that where several defendants are sued in
connection with an alleged fraudulent scheme, the complaint must identify false statements made
by each and every defendant.”). Accordingly, this court finds that Plaintiff has adduced enough
detail such that her reliance on the characterizing the misstatements as mutual,
group
misstatements is adequate in context. The court is satisfied that Defendants have the “minimum
degree of detail necessary to begin a competent defense.” Fulghum v. Embarq Corp., 785 F.3d
395, 416 (10th Cir. 2015).
B.
Negligent Misrepresentation
Plaintiff concedes that this claim is also subject to Rule 9(b), but argues for a lessened
standard applicable to the negligent misrepresentation claim as it is premised on an omission as
opposed to affirmative representations.
[#70 at 18]. Defendants make the same argument for
dismissal of the negligent misrepresentation claim as for the intentional misrepresentation claim.
See, e.g., [#55 at 19]. But in the Reply briefs, Defendants make additional argument not found in
their original motions. [#72; #73; #74].
For largely the same reasons, the court finds the negligent misrepresentation claim is also
sufficient under Rule 9(b), but notes that this is a clearer decision because Rule 9(b)’s heighte ned
standards are lowered or “relaxed somewhat” when the misconduct is predicated on the omissio n
of certain information as opposed to affirmative misrepresentations as a simple logical necessity:
one cannot identify the time and place of a misrepresentation for non-disclosure of informatio n.
Martinez v. Nash Finch Co., 886 F. Supp. 2d 1212, 1216 (D. Colo. 2012). For claims premised
on omissions, a plaintiff must sufficiently identify “the particular information that should have
been disclosed, the reason the information should have been disclosed, the person who should have
disclosed it, and the approximate time or circumstances in which the information should have been
disclosed.” Id. (quoting S.E.C. v. Nacchio, 438 F. Supp. 2d 1266, 1277 (D.Colo. 2006)). The
court is satisfied that the First Amended Complaint meets this standard.
C.
Arguments Asserted for the First Time in Reply
For the first time in their Reply briefs, Defendants argue that the intentional and neglige nt
misrepresentation claims should also be subject to the learned intermediary doctrine just as the
failure to warn claim is. [#73 at 5]. This argument was not made in any of the Renewed Defense
Motions and so Plaintiff was not afforded an opportunity to respond to this argument. Argume nts
made for the first time in a reply brief are generally deemed waived. Kerber v. Qwest Grp. Life
Ins. Plan, 727 F. Supp. 2d 1076, 1079 (D. Colo. 2010). And, as Defendants note, no Colorado
case has adopted this standard in this context, and thus the application of this doctrine in this
context—even if logical—is not required of this court, and the court declines to wade into new
state law territory on a matter raised for the first time in reply. This argument is waived.
Also for the first time in Reply, Defendants argue that Plaintiff’s claims for neglige nt
misrepresentation must be dismissed because negligent misrepresentation, as recognized in
Colorado, only applies to affirmative statements. [#72 at 6]. Plaintiff’s claim is that the provided
information did not include a proper reprocessing protocol, and so Defendant argues her claims
must fail because her claim is premised on non-disclosure. [Id. at 6–8]. This argument was not
made in any of the Renewed Defense Motions and so Plaintiff was not afforded an opportunity to
respond to this argument.
As before, this is an unsettled area of law, and as before, the court
declines to make an Erie guess in this context – particularly given the fact that Plaintiff has not
had an opportunity to address it. Sheffield Servs. Co. v. Trowbridge, 211 P.3d 714, 725 (Colo.
App. 2009) (assuming but not deciding that Colorado recognizes a claim for neglige nt
nondisclosure), overruled on other grounds by Weinstein v. Colborne Foodbotics, LLC, 302 P.3d
26 (Colo. 2013). This argument is waived at this juncture.
In so ruling, this court makes no
substantive determinations, and Defendants may raise these arguments in conjunction with any
motion for summary judgment.
CONCLUSION
For the reasons set forth herein, it is ORDERED that:
(1)
Defendant Olympus Medical Systems Corporation’s Motion to Dismiss Plaintiff’s
Complaint for Lack of Personal Jurisdiction [#54] is DENIED;
(2)
Defendant Olympus Medical Systems Corporation’s Motion to Dismiss Plaintiff’s
Complaint for Failure to State a Claim [#57] is DENIED;
(3)
Defendant Olympus America Inc.’s Motion to Dismiss Plaintiff’s Complaint for
Failure to State a Claim [#56] is DENIED;
(4)
Defendant Olympus Corporation of the Americas’ Motion to Dismiss Plaintiff’s
Complaint for Failure to State a Claim [#55] is DENIED.
DATED: June 5, 2019
BY THE COURT:
_________
Nina Y. Wang
United States Magistrate Judge
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