LOCAL
WEDNESDAY, NOVEMBER 13, 2019
THE OBSERVER — 5A
SCRUTINY
UNION
Continued from Page 1A
Continued from Page 1A
describing Arden’s fi rst
pacemaker implant there, in
February 2016.
She now works at Provi-
dence Medford, where, as of
press time, she was accept-
ing new patients.
Providence Health’s
communications director,
Gary Walker, declined to
comment on the allegations
in the dismissed lawsuit,
but said Arden has not done
any pacemaker surgeries in
Medford, and “a review of
our data at Providence St.
Vincent and at Providence
Medford does not refl ect any
questions about services
performed.”
Asked about her hiring
in Medford, he said, “We
don’t discuss an individual’s
hiring process, but I can tell
you that we make every
effort to review all available
information before hiring
any position.”
Asked whether the hospi-
tal system would do further
research now that it had
seen the lawsuit, Walker
declined to comment.
“We can’t comment
specifi cally on the case of one
caregiver,” he said. “We can
tell you that, as a learning
organization, Providence uses
all the information and data
available to make sure we
are providing the right care
in the right place at the right
time for everyone we serve.”
two garages detached from
the houses.
Wiggins said the city is
now doing renovation work
on one of the rentals and will
start work on a second after
the fi rst is completed. The
three home structures have
been rented on a monthly and
yearly basis for decades, but
once they are restored, the
city will begin renting them
on a nightly basis. Wiggins
said this will make it easier
for people visiting Union to
fi nd a place to stay overnight.
A long-term goal of the
city, Wiggins said after the
meeting, is to turn the ranger
station into an RV park with
a community center building.
The City of Union’s prepa-
rations for winter were not
discussed at Tuesday’s meet-
ing but they were addressed
in the written City Admin-
istrator/Public Works report
presented to the councilors
and available to everyone
attending the meeting.
Wiggins, who has been city
administrator since March
15, 2018, wrote that the city
is in better shape for winter
than at any time since he
was hired. He noted that the
city’s snow-removal equip-
ment for streets now consists
of one large plow, a medium-
sized plow, a small plow, a
road grader, two sanders and
a backhoe.
A written report submitted
to the city council by Union
Fire Chief Tod Hull indicated
that the department in Oc-
tober responded to fi ve calls
for medical assistance, two
motor vehicle accidents and
one tree fi re.
‘A great success’
Grande Ronde Hospital
is a small, 25-bed facility in
La Grande that has several
outlying clinics and em-
ploys more than 700 people,
according to its website. A
nonprofi t, it reported nearly
$106 million in revenue in
the fi scal year ending in
April 2018.
In February 2016, Arden’s
implantation of the fi rst pace-
maker ever at Grande Ronde
was dubbed by the hospital
newsletter “a great success.”
One year later, the long-
time cardiology nurse practi-
tioner, Onwezen, went to
work at Grande Ronde and
became Arden’s assistant.
Onwezen had particular
expertise in pacemakers.
She also had knowledge of
the law.
In 2007, Minnesota
federal court records show,
Onwezen and two other
people sued their former
employer, the medical device
giant Medtronic, accusing it
of offering “illegal kickbacks”
as “fraudulent inducements”
to doctors and hospitals to
promote sales of the fi rm’s
cardiac rhythm devices,
such as pacemakers and
defi brillators.
Under the federal False
Claims Act, employees of
businesses that defraud the
government can blow the
whistle and fi le a lawsuit on
behalf of the federal govern-
ment, collecting a percent-
age of any money recouped
— such as from Medicare.
Such whistleblower
lawsuits are fi led under
seal and kept secret while
federal offi cials conduct an
investigation, determine
whether the allegations are
true and decide whether
they want to prosecute the
case themselves to recoup
funds that had been de-
frauded.
After investigating
Medtronic in Minnesota,
federal lawyers validated
Onwezen’s allegations
and took over the case’s
prosecution, extracting a
court settlement from the
company of more than $27
million in 2011 — though
the fi rm continued to deny
wrongdoing. Court records
show that Onwezen and two
co-plaintiffs split about $3
million.
New misconduct claims
Six years later, having
moved to Oregon, Onwezen
found what she deemed
wrongdoing at Grande Ronde.
Biotronik Inc. photo
Courtesy photo
In addition to naming Grande Ronde Hospital, a
Aug. 15, 2018, suit also named Dr. Emilia Arden, two
pacemaker manufacturers — Abbott Laboratories and
Biotronik Inc. — as well as the companies’ sales repre-
sentatives, whom Kathy Onwezen, a cardiology nurse
practitioner who worked at Grande Ronde Hospital,
claimed had “induced” Arden’s surgeries through gifts
such as free travel.
According to her suit,
she began complaining of
misconduct to her superiors
after just a month on the
job, in March 2017. She
tendered her resignation in
June, only to withdraw it
after hospital management
promised to investigate, ac-
cording to the suit.
She eventually left for
good in April 2018, claiming
the hospital had decided to
“cover up Arden’s miscon-
duct and protect Grande
Ronde’s reputation.”
In all, Onwezen claimed,
“the lives of over 100 patients”
were placed “in jeopardy” over
the course of a year and a
half as a result of “implanting
unnecessary pacemakers and
failing to monitor them” at
Grande Ronde.
In addition to naming the
hospital, the Aug. 15, 2018,
suit also named Arden, two
pacemaker manufacturers
— Abbott Laboratories and
Biotronik Inc. — as well as
the companies’ sales repre-
sentatives, whom Onwezen
claimed had “induced”
Arden’s surgeries through
gifts such as free travel.
The sales representa-
tives could not be reached
for comment. Biotronik and
Abbott did not respond to
requests for comment.
In the suit, Onwezen
claimed the cardiologist em-
ployed improper methods to
justify pacemakers, including:
• Arden allegedly re-
placed a 90-year-old man’s
pacemaker with an MRI-
safe model, even though
the pacemaker leads that
already were in the man
meant he still couldn’t
undergo an MRI, meaning
“implantation would be
pointless and not worth the
extra cost.”
• That pacemaker, and
fi ve more of the same model,
were allegedly implanted by
Arden over the course of two
days after the pacemaker
sales representative in-
formed Arden of a promotion
that would reward the sales
rep — allegedly a personal
friend of Arden’s — for sell-
ing the most in a month.
• Arden allegedly told
Onwezen “that Arden had
to implant” some Biotronik
pacemakers “to get a speak-
ing engagement” and a free
trip to a resort in Coeur
d’Alene, Idaho.
• Arden allegedly justifi ed
“pacemaker implantation
whenever possible,” includ-
ing by citing a slow-heart-
beat condition that some-
times occurs during sleep.
Medicare prohibits implana-
tion of pacemakers for that
condition during sleep.
• Slow heartbeat, called
bradycardia, is a com-
mon side effect of taking
beta-blocker blood pressure
medication, the suit claimed,
and “Arden prescribed
beta-blockers to her patients
purposefully to induce brady-
cardia. Arden then used this
bradycardia to justify the
implantation of pacemakers.”
• Arden “falsely docu-
mented that patients exhib-
ited symptoms justifying
pacemaker implantation.
In reality, those patients did
not exhibit the documented
symptoms, and did not
require pacemakers.”
Cover-up alleged
Onwezen claimed in her
suit that she fi rst raised
concerns with a cardiology
An example of a pacemaker from Biotronik Inc.
According to a 2018 lawsuit, then-Grande Ronde Hosp-
ital cardiologist Dr. Emilia Arden allegedly told Kathy
Onwezen, a cardiology nurse practitioner who worked
at Grande Ronde Hospital, “that Arden had to implant”
some Biotronik pacemakers “to get a speaking en-
gagement” and a free trip to a resort in Coeur d’Alene,
Idaho.
manager at Grande Ronde
Hospital in March 2017. The
manager allegedly respond-
ed that “she was concerned
about Arden’s high rate of
pacemaker implantations,
and ... had heard patients
complaining that they did
not understand why they
had received pacemakers.”
Onwezen and the man-
ager allegedly reviewed the
pacemaker surgeries, and
the manager said “she did
not fi nd a single instance in
which the pacemaker was
necessary for the patient.”
The suit claims that
Grande Ronde management
revoked Arden’s authority to
implant pacemakers in July
2017, then suspended her
in August 2017 while her
patient fi les were sent for
further investigation.
The outside review alleg-
edly concluded that Arden
did not properly evaluate
patients for conditions that
would disqualify them for
pacemakers; did not have
adequate documentation to
justify implantations; and
that “patients experienced
the same or worsened heart
conditions after Arden’s
pacemaker implantation,”
according to the suit.
Onwezen claims she
urged the hospital man-
agement to refer Arden’s
patients to outside cardi-
ologists. But management
decided that “such referrals
could lead to the discovery
that the pacemakers were
unnecessary, and thereby
damage Grande Ronde’s
reputation and reduce rev-
enue,” the suit alleged.
According to the suit,
“Arden’s former patients
were informed that Arden’s
absence was due to a family
emergency. In reality, Grande
Ronde had suspended Arden
for misconduct that harmed
or could have harmed those
same patients.”
In her statement, Mardi
Ford, Grande Ronde Hos-
pital’s communications
director, noted that it made
“certain” reimbursements to
Medicare over the ques-
tioned pacemaker surger-
ies, and that the case was
voluntarily dismissed.
The federal government,
which takes over some
whistleblower cases in order
to recoup defrauded funds,
approved the dismissal of
the case on Oct. 23, as well
as the unsealing of the suit,
“based on its determina-
tion that such a dismissal
is commensurate with the
public interest and that the
matter does not warrant the
continued expenditure of
government resources.”
Onwezen’s former lawyer,
Brown, says the investiga-
tion shouldn’t end there.
“I would be pretty
outraged if one of my loved
ones was implanted with a
pacemaker that they didn’t
need.”
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A Centers for Disease Control and Prevention-funded campaign
