Robles Bush v. Thoratec Corporation

Filing 202

FINDINGS OF FACT AND CONCLUSIONS OF LAW - IT IS ORDERED that the United States pay Mrs. Bush $200,000.00 for sorrow, mental anguish, and solace and pay $23,535.00 in compensation for reasonably expected loss of income of the decedent and services, protection, care and assistance provided by the decedent, with a credit for the amount of consideration paid for the prior settlement. Signed by Judge Eldon E. Fallon on 4/1/14.(dno)

UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF LOUISIANA

DINA M. ROBLES BUSH

CIVIL ACTION

VERSUS

NO. 11-1654

THORATEC CORPORATION, ET AL.

SECTION "L" (3)

FINDINGS OF FACT & CONCLUSIONS OF LAW
I.

PROCEDURAL HISTORY
Plaintiff Diana Robles Bush ("Mrs. Bush") brings this case on behalf of her deceased

husband, Pete Bush ("Mr. Bush"). Mr. Bush was a recipient of the Thoratec HeartMate II left
ventricular assist system ("LVAS"), a surgically implanted heart pump manufactured by nowdismissed Defendant Thoratec Corporation ("Thoratec"). It was implanted by the Hunter Holmes
McGuire VA Medical Center ("McGuire"), a facility operated by Defendant United States, and
Mr. Bush received follow-up care at both McGuire and at Tulane University Medical Center and
Clinic ("Tulane"), a facility operated by Defendant University Healthcare System, L.L.C., which
has also been dismissed.
Mrs. Bush originally filed suit in Civil District Court for the Parish of Orleans against
Thoratec and Tulane. On July 14, 2011, Thoratec removed to this Court, and on October 24,
2011, the Court denied Mrs. Bush's motion to remand and granted Tulane's motion to dismiss on
the basis that Mrs. Bush had not proceeded through a medical review panel with respect to her
claims against Tulane. (Rec. Doc. 40).
On November 29, 2011, the Court granted Thoratec's motion to dismiss Mrs. Bush's
claims on the grounds of preemption pursuant to 21 U.S.C. § 360k(a) and Riegel v. Medtronic,
Inc., 552 U.S. 312 (2007). (Rec. Doc. 41). However, the Court granted Mrs. Bush's motion for

leave to amend her complaint so that she could attempt to state a nonpreempted claim. Mrs. Bush
filed an amended complaint (Rec. Doc. 44) and then sought and received leave to file a second
amended complaint (Rec. Doc. 68).
In her second amended complaint, Mrs. Bush articulated three potentially parallel state
law claims. She argued that because the Food and Drug Administration ("FDA") had no
requirements for recall communications, warning requirements under state law were therefore
consistent with federal law; or alternatively that Thoratec failed to comply with 21 C.F.R. § 7.49,
which provides guidelines for recall notices; or alternatively that Thoratec violated federal
regulations either by failing to include adequate notice and instructions in its correction letter, or
by failing to identify the design defect in the percutaneous lead and by failing to take appropriate
corrective action. However, Mrs. Bush later abandoned all but one theory: that Thoratec violated
21 C.F.R. § 7.49 by failing to include suggested content in its urgent medical device correction
letter (the "correction letter"), and that a violation of federal law also violated Thoratec's duty to
warn under Louisiana law.
Thoratec then moved to dismiss the second amended complaint because it was precluded
by the express preemption clause of the Medical Device Amendments to the Food, Drug, and
Cosmetics Act. 21 U.S.C. § 360k(a). (Rec. Doc. 74). In denying its motion, the Court reasoned
that Thoratec's arguments were enshrouded in fact. (Rec. Doc. 89).
On July 27, 2012, Mrs. Bush requested leave to further amend her complaint, this time
adding claims against the United States. (Rec. Doc. 90). The Court granted Mrs. Bush's request
(Rec. Doc. 91), and her third amended complaint was entered into the record. (Rec. Doc. 92).
The third amended complaint was dismissed without prejudice shortly thereafter and
immediately re-entered, following the presumed final denial of Mrs. Bush's administrative appeal

2

in Virginia. (Rec. Docs. 98, 99, 100). All claims against Thoratec were then settled and
dismissed on June 28, 2013. Currently, the only remaining claims are those against McGuire
under the Federal Tort Claims Act ("FTCA"). Specifically, Mrs. Bush alleges:
Dr. Gundars Katlaps, Lisa Martin and other employees of
McGuire failed to properly monitor [the] LVAS, failed to properly
instruct the Bushes on how to monitor the percutaneous lead of
[the] LVAS for damage, failed to provide proper notice to the
Bushes regarding the defects of the . . . LVAS, failed to render
proper medical care to him at the time of his medical emergency
on May 4, 2010, and committed other acts of negligence and
medical malpractice . . . .
(Rec. Doc. 100 at 14).
On August 14, 2013, McGuire filed a motion for summary judgment (Rec. Doc. 120) and
then on August 16, 2013, it filed motion in liminie to strike Mrs. Bush's expert witness (Rec.
Doc. 121). Both were denied on September 30, 2013. (Rec. Doc. 170).
This matter came on for trial before the Court without a jury. After considering the
testimony of the witnesses, the exhibits admitted into evidence, and the memoranda submitted by
the parties, the Court now makes the following findings of fact and conclusions of law, pursuant
to Federal Rule of Civil Procedure 52. To the extent that a finding of fact constitutes a
conclusion of law, the Court adopts it as such; to the extent that a conclusion of law constitutes a
finding of fact, the Court also adopts that as such.
II.

FINDINGS OF FACT
Mr. Bush was born on May 5, 1949. After enlisting in the United States Air Force, Mr.

Bush served in Vietnam, where he sustained a service-related hearing loss, and appears to have
had a difficult transition from military to civilian life. On July 26, 2001, he married Mrs. Bush.
The couple resided in Slidell, Louisiana.

3

Mr. Bush began to experience cardiovascular difficulties and at some point, he began
relying on a pacemaker. In mid-2008, his condition deteriorated and he was admitted for
inpatient care. On July 29, 2008, he was transferred from a U.S. Department of Veterans Affairs
("VA") facility in Louisiana to the VA's McGuire facility in Virginia. At the time he was
admitted, his primary diagnosis was congestive heart failure and other diagnoses included
hypertrophic cardiomyopathy, aortic valve stenosis, and chronic obstructive pulmonary disease.
He reported shortness of breath even without physical exertion, which was associated with sharp,
stabbing chest pain, which also prevented him from sleeping. According to his medical record,
he felt as though "the air [was being] sucked out of him." (J. Ex. 15 at 2). Mr. Bush was initially
placed in the intensive care unit, but was later transferred to the cardiology unit.
In late-September, the healthcare providers at McGuire determined that, without further
action, Mr. Bush would die within several months. They spoke with Mr. and Mrs. Bush about his
options, and recommended that he receive a left ventricular assist system ("LVAS"), until he
could undergo a heart transplant. The LVAS is equipment that consists of external and implanted
components. The implanted portion, referred to as the left ventricular assist device ("LVAD"),
includes both the heart pump itself and a percutaneous lead, which carries power and information
to and from the pump. The external portion consists of a system controller and display.
Ordinarily, the system receives power from an electrical outlet or a set of rechargeable batteries,
but in emergencies, another battery could be used to provide power for up to 12 hours.
Thoratec describes the LVAS as follows:
The LVAD helps your heart pump blood through your body. A
small electric motor inside the LVAD drives the pump. The LVAD
is placed (implanted) below your heart. It is attached to your heart
and the aorta (the large blood vessel that carries blood from your
heart to the rest of your body) . . . . Blood from your heart flows

4

into the LVAD. Blood is then pumped into the aorta; and, from
there, to the rest of your body.
Your heart pump helps your heart by taking over the
function of the diseased left ventricle (your heart's primary
pumping chamber). The electric motor drives a small rotor (similar
to a propeller), which pushes blood into the aorta and out to the
body. Your heart pump is designed to restore blood circulation to
the body and its primary organs. You may feel the pump working.
This is normal.
(J. Ex. 1 at 8).
On September 25, 2008, Dr. Katlaps implanted the LVAD in Mr. Bush. Prior to surgery,
Mr. Bush signed a consent form acknowledging that the "[m]echanical failure of the [LVAD]
device due to mechanical, electrical, or other intricate parts of the [LVAD] may lead to death."
(J. Ex. 15 at 170). Mr. Bush was the first patient at McGuire to begin using this particular LVAS
model, and by all accounts, the surgery was a success.
Following the surgery, Dr. Katlaps and Ms. Martin, the LVAD coordinator, met with Mr.
and Mrs. Bush almost every day they were in the hospital. Ms. Martin educated Mr. and Mrs.
Bush on how to care for the LVAS components and how to recognize and respond to the various
alarm lights and sounds.
In her October 1, 2008,1 note, Ms. Martin stated that she "[b]riefly reviewed" the LVAS
with Mr. and Mrs. Bush" and that "[a]s patient progresses, will continue w[ith] daily education
. . . ." (Id. at 128). In her next note, dated October 9, 2008,2 she wrote:
Met w/patient and wife to provide education on
[LVAS]. . . .
Began initial education on [LVAS] equipment. Reviewed
all components of system including pump, percutaneous lead,
system controller, [power base unit], batteries, and battery
clips. . . .

1
2

Ms. Martin created this note 165 days later on March 15, 2009.
Ms. Martin created this note 158 days later on March 15, 2009.

5

Reviewed system controller and discussed buttons and
lights and their meanings. . . .
Patient and wife eager to learn and ask appropriate
questions. They have "Patient Education" handbook for further
review and plan to watch the DVD again soon.
(Id. at 119).
Although Ms. Martin also provided Mr. and Mrs. Bush with a copy of the 2008 Patient
Handbook and an instructional video, she told them that they did not need to review those
independently because she had covered the same material with them in person. Mrs. Bush
testified that, as a result, she never read the 2008 Patient Handbook all the way through nor
watched the video.
Ms. Martin's next note, dated October 16, 2008,3 stated:
Met w[ith] patient and wife for continuing education on
[LVAS]. Patient and wife have reviewed the DVD several times
and have become very knowledgeable about the pump and it's [sic]
components. . . .
....
I am very impressed with the way both patient and wife
have learned so much about the equipment and how their comfort
level and confidence has increased from last week. They are eager
to learn as much as possible and we have started to discuss plans
for discharge!
(Id. at 111).
In her next note, dated October 21, 2008,4 Ms. Martin relates the following:
Today, I reviewed all alarms and advisories with patient
and wife and what their meanings were. Reviewed what to do in
each case and who to notify. . . . Also reviewed how to change
system controller in event of problem and instructed that they were
to notify [Ms. Martin] immediately if this occurred. Patient and
wife are learning this information and answer correctly when
"quizzed" on different scenarios most of the time.

3
4

Ms. Martin created this note 150 days later on March 15, 2009.
Ms. Martin created this note 145 days later on March 15, 2009.

6

(Id. at 109).
With regard to the alarms, Ms. Martin testified that she instructed Mr. and Mrs. Bush that
the system controller would indicate any problem with the pump or the power supply. Ms.
Martin further emphasized that they should contact the local emergency medical services
("EMS") if the system controller emitted a continuous alarm and should contact Ms. Martin if the
system controller emitted an intermittent alarm. Ms. Martin explained that continuous alarms are
emergent or life threatening and that intermittent alarms are not. As Barbara Elias, an LVAD
coordinator who testified as a qualified expert witness, explained, "[t]he patient . . . needs to
know what's emergent and what is non-emergent." (Tr. at 320).
On October 24, 2008, nearly a month after the implantation, Thoratec sent a correction
letter to providers, including Dr. Katlaps. It noted:
Description of problem: Thoratec has become aware that,
over time, wear and fatigue of the percutaneous lead connecting
the [LVAS] blood pump with the external [c]ontroller may result in
damage that has the potential to interrupt pump function and may
require a reoperation to replace the pump. . . . The need for pump
replacement due to percutaneous lead damage has occurred after
implant durations ranging from 6 to 38 months . . . . The estimated
probability of the need for pump replacement due to percutaneous
lead damage is 1.3% at 12 months, 8.5% at 24 months and 11.4%
at 36 months.
Symptoms of problem: Damage due to wear and fatigue
of the percutaneous lead has occurred in both the externalized and
implanted portions of the lead. Damage to the electrical conductors
within the lead may or may not be preceded by visible damage to
the outer layer of the lead. The damage may be evidenced by the
following:
Transient alarms due to short or open circuits, often
associated with movement of the patient or the lead. . . .
....
Immediate action to be taken: You should request any
ongoing [LVAS] patients to return to the hospital for inspection of
the percutaneous lead. If you suspect that a [LVAS] patient may
have a damaged percutaneous lead, please contact [technical
services] for assistance. . . . NOTE: if damage to the electrical

7

conductors in the lead is confirmed, the [LVAS] should be
replaced as soon as possible.
Preventative action: Please review the instructions for
[u]se with all [LVAS] surgeons and ongoing [LVAS] patients. The
attached excerpts . . . are intended to prolong the useful life.
Thoratec will revise the labeling . . . and the informed
consent documents . . . to incorporate the updated risk information
contained in this letter. . . .
Acknowledgment: Please complete and sign the attached
[a]cknowledgment [f]orm and fax it to Thoratec . . . .
(J. Ex. 2-B at 1-2 (emphasis added)).
On October 28, 2008, Dr. Katlaps signed and returned the acknowledgment form that was
attached to the correction letter. The acknowledgment form provided:
Please check all boxes below before returning this form [to
Thoratec].
[Box 1] I have reviewed the symptoms that may be
associated with damage to the percutaneous lead, and reemphasized the instructions for care with all of my ongoing
patients.
[Box 2] I understand the risk information that Thoratec has
provided in this notice, and that the labeling for commercially
distributed devices and informed consent documents for clinical
studies will be revised to reflect this new information from clinical
experience. I also agree to carefully review this risk vs. benefit
information with prospective patients.
[Box 3] I acknowledge that I have received [the letter]
concerning the percutaneous lead for the [LVAS] and that I
understand the contents and have communicated the contents to the
appropriate personnel. . . .
(J. Ex. 2-C at 1). The letter also contained an enclosure intended for patients.5
5

In part, this noted:
[I]t is extremely important that you protect your percutaneous
lead, especially if you are active. Always keep your percutaneous lead
protected and damage-free. Damage to the percutaneous lead, depending
on the degree, may cause the pump to stop.
Remember to follow these recommendations:
....
Check your percutaneous lead daily for signs of damage (cuts,
holes, tears). If you discover damage to your lead, report it immediately
to your hospital contact person.

8

Between October 24, 2008, and October 28, 2008, none of Dr. Katlaps' notes reference
the letter, nor do they indicate that he provided any new information to Mr. and Mrs. Bush. Ms.
Martin's only note during this period, dated October 28, 2008,6 stated:
Met with patient and wife to review education re[garding LVAS].
Again discussed all aspects of [the power base unit], batteries, and
system controller. Reviewed all alarms [sic] conditions again, their
meaning, and what to do in each situation.
(J. Ex. 15 at 103). Likewise, it did not indicate that she or Dr. Katlaps relayed the new
information regarding the potential of a new alarm, namely a transient alarm..
Dr. Katlaps and Ms. Martin have both testified that they made Mr. and Mrs. Bush aware
of the contents of the correction letter, but did not provide them with a physical copy. They also
testified that they had concluded that the letter added nothing new and that they had already
advised Mr. and Mrs. Bush on the nature of each alarm and response required of the patient. As
discussed above, there is no mention of the correction letter or the information contained therein
within Mr. Bush's medical record.7 Ms. Martin explained this absence as intentional; she had

(J. Ex. 2-B at 5).
6

Ms. Martin created this note 138 days later on March 15, 2009.
Whatever credibility Ms. Martin's notes carry is further compromised by the method by which
those notes were recorded. Ms. Martin routinely used a notebook, rather than the available electronic
records system, to document her interactions with Mr. and Mrs. Bush. In many instances it was nearly six
months or a year before she transferred those notes to McGuire's electronic records system, at which point
she destroyed the originals. She testified:
7

I think that obviously the closer to the time of the event [a note is
entered], the better it is.
....
I just think [entering a note contemporaneously is] probably the
appropriate thing to do. Looking back, I wish I'd never used those
[note]books. I wish I had put the notes in the record at the time, but I
can't change what I did now.
(Tr. at 303). As one text notes:

9

been trained to exclude references to incident reports and assumed that the letter was analogous.
However, she noted that, in retrospect, she should have included a reference to the letter in the
notes. Ms. Martin indicated that she never discussed the possibility that Mr. Bush would
experience transient alarms, which were symptomatic of percutaneous lead damage.
In contrast, Mrs. Bush asserts that she and Mr. Bush were never made aware of the
correction letter or the information it contained. This appears to be the credible account. First,
Dr. Katlaps Ms. Martin have made it abundantly clear that Mrs. Bush was incredibly attentive to
her husband's treatment and receptive to the information they had provided. Second, Mr. Bush's
medical records, which are often incredibly detailed, do not reference the letter or indicate that
its contents were communicated to Mr. and Mrs. Bush. Last, even if the records had referenced
it, all of Ms. Martin's notes regarding the instruction she provided to Mr. and Mrs. Bush were
entered months after the fact, raising questions as to their accuracy. Nor is it believable that Dr.
Katlaps or Ms. Martin provided the information at a later date. It is the Court's impression, from
the testimony, that both Dr. Katlaps and Ms. Martin concluded that the correction letter added
nothing new to the information they had already provided to Mr. and Mrs. Bush and that their
only obligation was to re-emphasize the information they had previously imparted, including
advising of them of the significance of the continuous and intermittent alarms and what to do
when each type of alarm occurred. The credible testimony and evidence supports the conclusion
that Mr. and Mrs. Bush were never made aware that the LVAS was capable of emitting an
additional alarm, namely a transient alarm, which required immediate action. This is significant
By the time a malpractice action comes to trial memories may have
dimmed as to what actually occurred at the time negligence is alleged to
have taken place, leaving the medical record as the most telling evidence
....
BARRY R. FURROW, ET AL., HEALTH LAW 295 (6th ed. 2008).

10

because a transient alarm is a non-continuous alarm but nevertheless emergent, life threatening,
and requires immediate action—characteristics Mr. and Mrs. Bush were told only attached to
continuous alarms.
Ms. Martin's next note, dated October 31, 2008,8 indicated that Mr. Bush was discharged
to a residential facility. He remained there, often visiting McGuire daily, until he returned to
Slidell, Louisiana, on December 12, 2008. His post-discharge care was handled jointly by
McGuire, Tulane, and the Slidell facilities. His primary care physician was in Louisiana,
however Ms. Martin remained Mr. Bush's primary contact with regard to the LVAS.
On the night of May 3, 2010, Mr. and Mrs. Bush were asleep when they heard the LVAS
emit a sound, which Mrs. Bush described as "a little beep, light beep." (Tr. at 176). Mr. and Mrs.
Bush then checked "everything," but were unable to find any malfunction. Mr. Bush, who felt
fine, returned to sleep. The following morning they heard the same sound and, again, they
checked everything and, once again, found nothing. Mr. Bush continued to feel fine. Mr. and
Mrs. Bush then changed the controller, and heard another noise. However, the LVAS was not
displaying any visual or auditory alarms. Mr. Bush then switched to battery power. Although
everything appeared to be normal, the alarms concerned Mrs. Bush enough that at approximately
8:00 a.m. on May 4, 2010, she called Ms. Martin in Virginia from her home in Louisiana . She
was unable to reach Ms. Martin, who was assisting with a surgery, and instead spoke with Mary
Compton, Ms. Martin's administrative assistant. According to Ms. Compton, Mrs. Bush
expressly stated that she had heard a noise coming from the LVAS which she had never heard
before and that Mr. Bush was experiencing intermittent alarms or beeps." (Rec. Doc. 173). Mrs.
Bush explained that she wanted to speak with Ms. Martin about the noise and alarms, but noted

8

Ms. Martin created this note contemporaneously.

11

that Mr. Bush was doing well and it was not an emergency. Ms. Compton informed Mrs. Bush
that Ms. Martin was in surgery and was not available.
At 4:00 p.m., Ms. Martin was out of surgery and Ms. Compton relayed the message.
Several minutes later, Ms. Martin called Mrs. Bush back from her car. Their conversation lasted
about 30 minutes. Mrs. Bush explained what had happened over the past day. Mrs. Bush wanted
Ms. Martin to hear the noise, so she transfered Mr. Bush off of battery power and changed the
controller to see if she could replicate it. When she changed the controller, the noise returned and
Mr. Bush indicated that he was dizzy. Mrs. Bush told Ms. Martin that it was indicating a "low
flow" alarm. Ms. Martin instructed Mrs. Bush to put Mr. Bush back onto battery power and, after
doing so, Mr. Bush indicated that he began to feel fine once more. Ms. Martin told Mrs. Bush to
keep him on battery power until she could determine the cause of the problem. Mrs. Bush
testified that Mrs. Martin told her that they should only be concerned if the LVAS emitted an
auditory and visual alarm, and if so, Mr. Bush should be taken to the hospital immediately.
Ms. Martin testified the alarms Mrs. Bush described "didn't make any sense":
Well, because the way she described the alarms didn't fit with what
I knew to be the alarms. Because each alarm has a very specific
light and sound associated with it, and they also have changes in
the numbers. Because when they're attached to their power
module, there are numbers that come up there. So whenever
anybody calls and says they've heard an alarm, there's a very
specific checklist I go through in my head to ask them, you know,
what lights did you see, what did it sound like, what do you feel
like, and what the numbers are. And [Mrs. Bush] told me the
numbers were all good. And so what they told me didn't add up at
all, and I—it didn't seem—it didn't make sense.
(Tr. at 86). Even though the alarms were unusual and inconsistent with the designed alarms, she
did not instruct Mrs. Bush to call EMS. Instead, Ms. Martin decided to contact Thoratec and get
back to Mrs. Bush.

12

Less than 30 minutes after Ms. Martin and Mrs. Bush had spoken, and while Ms. Martin
was on the telephone with a representative of Thoratec, Mr. Bush collapsed. Mrs. Bush testified
that after he collapsed, she was unable to hear the sound of the LVAS functioning. She
immediately called EMS, who transported Mr. Bush to a hospital, where he was pronounced
dead at 6:58 p.m. According to his autopsy, he experienced "sudden cardiac death." (J. Ex. 4 at
1).
The LVAS components were analyzed by Thoratec after Mr. Bush's death. It was
discovered that the implanted portion of the percutaneous lead had frayed interior wires, which
likely made contact with one another. The system controller that Mr. Bush was using at the time
of his death had shorted completely, and Ms. Martin was unable to retrieve any data from it. The
other system controller, which Mr. Bush had recently used, did have salvageable data, although it
has not been properly authenticated. Following Mr. Bush's death, Ms. Martin stated that Mrs.
Bush had done everything exactly as she should have. However, Ms. Martin later testified that
her opinion had changed when she learned that a Thoratec log indicated that there were multiple
alarms, including a continuous "red heart" alarms, that "somebody should have told me about."
(Tr. at 93). The testimony and evidence reveal that the log files, and other materials prepared as
part of Thoratec's investigation, are not entirely reliable because there appears to have been
confusion about which controller Mr. Bush was using at which times and also because the
malfunction of the LVAS may have unpredictably altered its behavior. (See id.).
III.

CONCLUSIONS OF LAW
A.

FTCA Choice of Law

Mrs. Bush's complaint alleges tortious conduct by McGuire, which is owned, operated,
and controlled by the United States, and is brought pursuant to the FTCA. As a general matter,

13

the United States is immune to suits brought by individuals except where it has explicitly waived
its immunity by statute. In re FEMA Trailer Formaldehyde Prods. Liab. Litig., 668 F.3d 281,
287 (5th Cir. 2012). The FTCA creates such a waiver, and "provides the sole basis of recovery
for tort claims against the United States." Id. (citing 28 U.S.C. § 2671, § 1346). Specifically, the
statute provides:
[T]he district courts . . . shall have exclusive jurisdiction of
civil actions on claims against the United States, for money
damages [for] personal injury or death caused by the negligent or
wrongful act or omission of any employee of the [United States]
while acting within the scope of his office or employment, under
circumstances where the United States, if a private person, would
be liable to the claimant in accordance with the law of the place
where the act or omission occurred.
28 U.S.C. § 1346(b)(1) (emphasis added). As is the case with all waivers of sovereign immunity,
the language of the FTCA is to be "narrowly construed in favor of the United States." In re
FEMA Trailer Formaldehyde Prods. Liab. Litig., 668 F.3d at 287.
The FTCA "requires application of the whole law of the [s]tate where the act or omission
occurred," including that state's choice of law rules. See Richards v. United States, 369 U.S. 1, 11
(1962); Guillory v. United States, 699 F.2d 781, 784 (5th Cir.1983). It is therefore possible that a
state's choice of law rules may require application of yet another state's substantive law.
Accordingly, it is necessary to determine where the alleged torts occurred in order to
apply the appropriate choice of law provisions. In the context of claims brought under the FTCA,
a tort occurs in the place of the act or omission, not the place of the resulting injury. Richards,
369 U.S. at 9-10.As the United States Supreme Court has noted:
In the [FTCA] Congress has expressly stated that the
[United States]'s liability is to be determined by the application of
a particular law, the law of the place where the act or omission
occurred, and we must, of course, start with the assumption that the

14

legislative purpose is expressed by the ordinary meaning of the
words used. We believe that it would be difficult to conceive of
any more precise language Congress could have used to command
application of the law of the place where the negligence occurred
than the words it did employ in the [FTCA]. Thus we first reject
the alternative . . . . The legislative materials cited to us . . . not
only lack probative force in a judicial sense, but they are
completely unpersuasive to support the argument that Congress
intended the words "act or omission" to refer to the place where the
negligence had its operative effect. The ease of application
inherent in the rule urged . . . lends a certain attractiveness, but we
are bound to operate within the framework of the words chosen by
Congress and not to question the wisdom of the latter in the
process of construction. We conclude that Congress has, in the
[FTCA], enacted a rule which requires federal courts, in multistate
tort actions, to look in the first instance to the law of the place
where the acts of negligence took place.
Id.; see, e.g., Ins. Co. of Pa. v. United States, 590 F. Supp. 435, 442 (S.D. Miss. 1984) (holding
that where acts or omissions of an out-of-state tortfeasor caused an in-state injury, the law of
tortfeasor's state must be applied).
Here, it is apparent that the allegedly negligent acts or omissions occurred in Virginia.
Mr. Bush's LVAS device was implanted in Virginia and much of his recovery occurred in
Virginia. Dr. Katlaps received the correction letter and signed the acknowledgment in Virginia,
and he and Ms. Martin allegedly failed to inform Mr. Bush of the new information contained in
the correction letter during his recovery in Virginia. Although providers in Louisiana and
Virginia shared the responsibility for Mr. Bush's care after he returned to Louisiana, Mrs. Bush
has previously asserted that the Louisiana providers were never made aware of the correction
letter. Further, Mrs. Bush indicates that Ms. Martin "continued to provide close and continuing
care to [Mr.] Bush in Louisiana up to and including the day he died." (Rec. Doc. 127-11 at 2).
The fact that Mrs. Bush only called Ms. Martin, and not the providers in Louisiana, on the day of
Mr. Bush's death implies that she considered Ms. Martin primarily responsible for Mr. Bush's

15

care. In sum, Mrs. Bush's understanding of the facts does not controvert McGuire's assertion that
the alleged acts and omissions all occurred in Virginia, even though the resulting injury to Mr.
Bush was in Louisiana.
B.

Virginia Choice of Law

Having concluded that the incident occurred in Virginia, it is necessary to apply that
state's choice of law provisions to determine which substantive and procedural laws apply. The
place-of-the-wrong standard is the "settled rule in Virginia" when resolving conflicts arising in
multistate tort actions. Jones v. R.S. Jones & Assocs., Inc., 431 S.E.2d 33, 34 (Va. 1993) (internal
quotation marks omitted). Pursuant to this rule, the claims are governed by the substantive law of
the forum where the torts occurred and the procedural law of the forum where the action was
brought. Id. As discussed above, the acts or omissions here took place in Virginia, and
accordingly, the substantive law of Virginia is applicable. Because this action was brought in
federal court in Louisiana, federal procedural law governs.
C.

Virginia Medical Malpractice Act

The Virginia Medical Malpractice Act ("VMMA") provides relief for "any tort action or
breach of contract action for personal injuries or wrongful death, based on health care or
professional services rendered, or which should have been rendered, by a health care provider, to
a patient." VA. CODE ANN. § 8.01-581.1. By its plain language, the statute broadly includes any
claims sounding in tort or contract. Thus, all of Mrs. Bush's claims are within the substantive
scope of the VMMA.
It is also necessary to determine whether the parties meet the VMMA's criteria. The
statute states that any "person . . . licensed by [Virginia] to provide health care or professional
services as a physician [or] registered nurse" is considered a health care provider, as is "any

16

corporation . . . or other entity" if it "employs or engages" such a person and if the corporation or
other entity also "engages in health care services." VA. CODE ANN. § 8.01-581.1. Here, evidence
in the record indicates that Dr. Katlaps and Ms. Martin were licensed by Virginia to provide
health care or professional services as a physician and as a registered nurse, respectively. (Rec.
Docs. 165-1, 165-2). With regard to McGuire itself, Mrs. Bush specifically asserts that "as a
federal facility, [it] is not licensed by the Commonwealth of Virginia" and it thus falls outside the
VMMA's reach. (Rec. Doc. 160-2 at 1). However, the plain language of the VMMA states that "a
corporation . . . or any other entity, except a state-operated facility, which employs or engages a
licensed health care provider and which primarily renders health care services" is itself a health
care provider. VA. CODE ANN. § 8.01-581.1. Thus, McGuire, while not licensed by Virginia
itself, is considered a health care provider under the VMMA both because it employs or engages
health care providers licensed by Virginia, including Dr. Katlaps and Ms. Martin, and also
because it primarily renders health care services.9 For these reasons, the VMMA also covers the
relationships that existed between Mr. Bush and Dr. Katlaps, Ms. Martin, and McGuire, and
applies to the extent it is substantive.
D.

Malpractice

The VMMA defines "malpractice" as "any tort action . . . for personal injuries or
wrongful death, based on health care or professional services rendered, or which should have
been rendered, by a health care provider, to a patient." VA. CODE ANN. § 8.01-581.1. "In medical
malpractice cases, as in other negligence actions, the plaintiff must establish not only that the
defendant violated the applicable standard of care, and was therefore negligent, he must also
9

The fact that a state-operated facility would be excluded is of no moment, because the
FTCA provides "that the federal government shall be liable for tort claims 'in the same manner
and to the same extent as a private individual under like circumstances.'" Lucas v. United States,
807 F.2d 414, 417 (5th Cir. 1986) (citing 28 U.S.C. § 2674).

17

sustain the burden of showing that the negligent acts constituted a proximate cause of the injury
or death." Brown v. Koulizakis, 331 S.E.2d 440, 446 (Va. 1985).
Under the VMMA, "expert testimony is ordinarily necessary to establish the appropriate
standard of care, to establish a deviation from the standard, and to establish that such a deviation
was the proximate cause of the claimed damages."10 Raines v. Lutz, 341 S.E.2d 194, 196 (Va.
1986). The reason for this requirement is that "[i]ssues involving medical malpractice often fall
beyond the realm of common knowledge and experience of a lay jury." Beverly EnterprisesVirginia, Inc. v. Nichols, 441 S.E.2d 1, 3 (Va. 1994). "Therefore, in most instances, expert
testimony is required to assist [that] jury." Id.
As a general matter, "whether a witness is qualified to testify as an expert is largely
within the sound discretion of the trial court." Lloyd v. Kime, 654 S.E.2d 563, 569 (Va. 2008)
(internal quotation marks omitted). However, for claims brought under the VMMA, "this
determination must be made with reference to [the expert qualification requirement]," which
establishes standards for experts testifying on the standard of care.11 Id. It states:
[I]n any action against a physician, . . . nurse, hospital or other
health care provider to recover damages alleged to have been
caused by medical malpractice where the acts or omissions so
complained of are alleged to have occurred in [Virginia], the
standard of care by which the acts or omissions are to be judged
shall be that degree of skill and diligence practiced by a reasonably
prudent practitioner in the field of practice or specialty in
[Virginia] and the testimony of an expert witness, otherwise
qualified, as to such standard of care, shall be admitted . . . .
VA. CODE ANN. § 8.01-581.20.
10

The Court has previously held that Virgina's expert qualification requirement is substantive
law that governs this dispute.
11
It is necessary to note that the expert qualification requirement "addresses only the
qualifications of experts to testify on the standard of care and whether the standard of care is
breached," it "do[es] not address whether an expert witness is qualified to testify on proximate
causation." Lloyd, 654 S.E.2d at 571.

18

While physicians are presumed to know the statewide standard of care in their particular
specialties or fields of medicine if they are licensed in Virginia or are licensed in another state
and also meet the educational and examination requirements in Virginia, "[i]f neither situation
applies, a witness nonetheless may be qualified to testify as to the standard of care if the witness
demonstrates sufficient knowledge, skill, or experience to make him competent to testify as an
expert on the subject matter at issue." Lloyd, 654 S.E.2d at 569 (internal quotation marks
omitted). However, "[i]n all cases, to qualify as an expert witness on the standard of care, the
witness must have expert knowledge on the standard of care in the defendant's specialty and an
active clinical practice in either the defendant's specialty or a related field of medicine within one
year of the date of the alleged act or omission forming the basis of the action." Id. (internal
quotation marks omitted); see VA. CODE ANN. § 8.01-581.20. Thus, in most instances, to be
eligible to testify as an expert witness, the person must be a medical practitioner with an active
clinical practice.
However, there are exceptions to this requirement "in those rare cases in which a health
care provider's act or omission is clearly negligent within the common knowledge of laymen."
Raines, 341 S.E.2d at 196 n.2 (citing Easterling v. Walton, 156 S.E.2d 787, 790-91 (Va. 1967)).
The Virginia Supreme Court has been careful to note that "[t]he medical malpractice statutes did
not supersede the jury system." Id. at 197 ("The determination of negligence, proximate cause,
and damages remains within the jury's province.").
There are a number of instances where, pursuant to this exception, qualified expert
testimony in medical malpractice cases has not been required. For example, in Jefferson
Hospital, Inc. v. Van Lear, a patient fell and broke his hip while trying to locate a bathroom after
the floor nurse failed to respond to a call light that had been plainly visible to her for 20 to 30

19

minutes. 41 S.E.2d 441, 442-43 (Va. 1947). There, the Virginia Supreme Court recognized that
expert testimony was not necessary because the hospital employees "were, of course, aware of
the physical condition of [the patient, t]hey knew the nature of his operation and
disabilities[, t]hey knew, or should have known, that a delay in answering his call for a nurse or
an orderly . . . might induce him to get out of bed and attempt to wait on himself." Id at 443.
In Beverly Enterprises-Virginia, Inc. v. Nichols, a patient choked after she attempted to
eat food that a provider left without offering assistance. 441 S.E.2d at 3. There, the Virginia
Supreme Court again concluded that it was possible to find "negligence without the necessity of
expert testimony on the appropriate standard of care," because the provider "was aware of [the
patient's] mental and physical condition [and] that she was unable to feed herself and had two
prior serious choking incidents." Id. "Certainly, a jury does not need expert testimony to
ascertain whether the defendant was negligent because its employees failed to assist [the patient]
under these circumstances." Id.
Likewise, in Nichols v. Kaiser Found. Health Plan of Mid-Atlantic States, Inc., a patient
became seriously ill after she was given the wrong medicine. The Virginia Supreme Court
upheld the trial court's conclusion that "expert testimony was unnecessary because a jury could
understand, without the aid of such testimony, that dispensing wrong medication is a breach of a
pharmacist's standard of care." 514 S.E.2d 608, 609 (Va. 1999). It reasoned:
Here, plaintiff did not present expert testimony in the strict
sense of that term, that is, a witness was not formally qualified who
responded to hypothetical questions. Nevertheless, there was
abundant opinion testimony from plaintiff's treating physicians,
particularly [the patient's doctor].
Consequently, the case reduces to whether there was
sufficient evidence, comprised of medical opinion and lay
testimony, to present a jury question on causation. We answer that
query in the affirmative; testimony from a 'pure' expert witness
was unnecessary.
20

Id. at 612.
In yet another case, Coston v. Bio-Medical Applications of Va., Inc., a patient was injured
after she was placed in a defective chair by an employee who knew the chair was broken. 654
S.E.2d 560, 563 (Va. 2008). The Virginia Supreme Court reasoned that "[c]ertainly, the issue
whether the [employees] acts or omissions in this case constitute medical negligence is within a
jury's common knowledge and experience and, therefore, expert testimony is not necessary. Id.
Because Mrs. Bush did not present the testimony of a qualified doctor or nurse with
regard to the elements of medical malpractice—the applicable standard of care, whether that
standard of care had been breached, and whether the alleged breach was the proximate cause of
the alleged injury12—each of these elements must be within the common knowledge and
experience of a layperson. Mrs. Bush has alleged that Dr. Katlaps and Ms. Martin are negligent
both for their decision to withhold the new information contained in the correction letter and that
Ms. Martin is negligent for not instructing Mr. Bush to seek immediate medical attention on the
day of his death.

12

At trial, McGuire moved for judgment as a matter of law, pursuant to Federal Rule of Civil
Procedure 52(c). In doing so, it noted that the Virginia Supreme Court has held that "[t]o recover against a
physician for failure to provide . . . information [about a proposed medical treatment or procedure], the
patient generally is required to establish by expert testimony whether and to what extent any information
should have been disclosed." Tashman v. Gibbs, 556 S.E.2d 772, 777 (2002). For instance, in Tashman v.
Gibbs, a physician failed to disclose the risks of a particular procedure, the physician's inexperience in
performing that procedure, and the available alternatives to that procedure. Id. at 778. There, the Virginia
Supreme Court held that the patient was required to establish the standard of care through expert
testimony. Id. Here, the circumstances are distinguished. The correction letter's information on the
transient alarms was not intended to inform Mr. Bush's decision to give or withhold consent for his doctor
to proceed, instead it was intended to inform Mr. and Mrs. Bush's decision as to how they should proceed.
After hearing argument at trial, the Court denied the motion, in part noting that the common knowledge
exception to the expert testimony requirement may apply or, if the exception did not apply, that the expert
testimony could be provided by McGuire. The Court further concludes that, because summary disclosures
were not provided for Dr. Katlaps and Ms. Martin, they are only capable of providing fact testimony, not
expert testimony, under the provisions of Federal Rule of Civil Procedure 26.

21

1.

Standard of Care

It is necessary to determine whether the standard of care required that Dr. Katlaps and
Ms. Martin relay the correction letter or its contents to Mr. and Mrs. Bush or required Ms. Martin
to instruct Mr. and Mrs. Bush to seek immediate medical attention on May 4, 2010. As
mentioned previously, the Virginia Supreme Court has held that "the standard of care in a
medical malpractice action [is] that degree of skill and diligence exercised by a reasonably
prudent practitioner in the same field of practice or specialty in Virginia." Tashman v. Gibbs, 556
S.E.2d 772, 777 (Va. 2002). Likewise, the VMMA requires:
[I]n any action against a physician, . . . nurse, hospital or other
health care provider to recover damages alleged to have been
caused by medical malpractice . . . , the standard of care by which
the acts or omissions are to be judged shall be that degree of skill
and diligence practiced by a reasonably prudent practitioner in the
field of practice or specialty in [Virginia] . . . .
VA. CODE. ANN. § 8.01-581.20(a). A provider is not the "insurer of [a] diagnosis and treatment
. . . ." Brown, 331 S.E.2d at 445.
In determining the applicable standard of care, the testimony of a qualified expert witness
may assist in the determination, but it is not itself dispositive. Despite the necessity of qualified
expert testimony on the standard of care in most instances, "[t]he determination of negligence,
proximate cause, and damages remains within the [fact finder]'s province." Raines, 341 S.E.2d at
197. "[A]ny issue as to the standard of care to be applied shall be determined by the [fact
finder]." VA. CODE. ANN. § 8.01-581.20(b). Although an expert must ordinarily testify as to the
"degree of skill and diligence practiced by a reasonably prudent practitioner," VA. CODE. ANN.
§ 8.01-581.20(a) (emphasis added), it is the fact finder—not the expert—who establishes the
standard of care, provided their determination is "based upon evidence and not upon
speculation." Raines, 341 S.E.2d at 197. As Justice Oliver Wendell Holmes noted: "What usually

22

is done may be evidence of what ought to be done, but what ought to be done is fixed by a
standard of reasonable prudence, whether it usually is complied with or not." Tex. & P. Ry. Co.
v. Behymer, 189 U.S. 468, 470 (1903) (emphasis added). Judge Learned Hand elaborated:
[I]n most cases reasonable prudence is in fact common prudence;
but strictly it is never its measure; a whole calling may have
unduly lagged in the adoption of new and available devices. It
never may set its own tests, however persuasive be its usages.
Courts must in the end say what is required; there are precautions
so imperative that even their universal disregard will not excuse
their omission.
T.J. Hooper, 60 F.2d 737, 740 (2d Cir. 1932).
With regard to the correction letter, it is necessary to determine whether the standard of
care required that Dr. Katlaps and Ms. Bush relay its contents to Mr. and Mrs. Bush. Mrs. Bush
has not offered the testimony of a qualified expert witness. Thus, as a threshold matter, it is
necessary to decide whether the contents of the letter can be understood by a layperson.
In making this determination, it is useful to consider the letter itself. The letter, which
was intended for healthcare providers, contains language that is not incomprehensible to a
layperson (that is, someone other than a licensed doctor or nurse).13 In fact, it was authored by an

13

Presumably, a layperson includes anyone who is a "practitioner in the field of practice or
specialty" of the alleged tortfeasor. VA. CODE. ANN. § 8.01-581.2(a). Provided, of course, that such a
person is also among those listed as healthcare providers by the VMMA:
[A] person, corporation, facility or institution licensed by this
Commonwealth to provide health care or professional services as a
physician or hospital, dentist, pharmacist, registered nurse or licensed
practical nurse or a person who holds a multistate privilege to practice
such nursing under the Nurse Licensure Compact, optometrist, podiatrist,
chiropractor, physical therapist, physical therapy assistant, clinical
psychologist, clinical social worker, professional counselor, licensed
marriage and family therapist, licensed dental hygienist, health
maintenance organization, or emergency medical care attendant or
technician who provides services on a fee basis . . . .
VA. CODE. ANN. § 8.01-581.1. Further, Black's Law Dictionary defines "layman" as "[a]
person who is not a member of a profession or an expert on a particular subject. "

23

engineering-technician-turned-director-of regulatory-affairs at Thoratec with a bachelor's degree
in biological science, who himself was a layperson (it had also been approved by a vice
president, who also appears to be a layperson). The letter's author confirmed that its intended
audience was healthcare providers (including, doctors, nurses, and laypersons), and explained
that Thoratec also intended for those providers to communicate its contents to patients. In sum, it
was written by a layperson and its contents were intended to be transmitted to laypersons. This
means that, even if its content were too complex to be understood by a layperson without
specialized knowledge, it could be explained by a layperson with such specialized knowledge.
Thus, to the extent the new information contained in the correction letter is relevant to whether a
doctor or a nurse had a duty to relay that information, such a determination is plainly within the
common knowledge and experience of a layperson.
Dr. Matthias Loebe, McGuire's qualified expert witness, testified that "[t]he standard of
care would require to alert the patient and his caregivers to seek support when they have
recurrent alarms; and, in particular, seek—and if these alarms do not go away, to seek support in
an institution that is close by." (Tr. at 360). He also indicated that it was incredibly important that
patients had been properly educated on how to react to various alarms, but it was not necessary
that they understand the underlying causes of those alarms. Of the alarms, Ms. Elias explained
that it was necessary for both patients and healthcare providers to "know what's emergent and
what is non-emergent." (Tr. at 320).
Prior to receiving the correction letter, doctors and nurses were only provided
information about continuous and intermittent alarms. Within this context, the question is

Layman, BLACK'S LAW DICT. (9th ed. 2009). Accordingly, under the specific
circumstances here, a layperson is anyone who is not a doctor or a nurse.

24

whether the so-called transient alarm, discussed by the correction letter, constituted a new type of
alarm, separate and distinct from the continuous and intermittent alarms. As a preliminary
matter, it is useful to consider the plain meaning of each of these terms. The term "continuous"
means something that is uninterrupted.14 In contrast, the term "intermittent" means something
that is not continuous, but comes and goes.15 Patients were trained that continuous alarms were
emergent—requiring them to immediately contact EMS—and that intermittent alarms were nonemergent—requiring them to call their healthcare provider. It is within this context that Mr. and
Mrs. Bush responded to the alarms they recognized prior to Mr. Bush's death. The correction
letter referenced neither continuous nor intermittent alarms, instead describing "[t]ransient
alarms due to short or open circuits, often associated with movement of the patient or the lead"
symptomatic of a problem "that has the potential to interrupt pump function and may require a[n]
operation to replace the pump." (J. Ex. 2-B at 1-2). Like the term "intermittent," the term
"transient" means something that also comes and goes.16 Ruhi Arslanoglu, a biomechanical
engineer, noted that continuous and intermittent alarms were "designed to be present when the
device is functioning properly" whereas a transient alarm is "caused by the unexpected,
unforeseen damage [and] it is not necessarily predictable . . . how [it] would present itself." (Tr.

14

These terms appear to have consistent meanings both in their common and medical usage. For
instance, Merriam-Webster defines “continuous“ as “marked by uninterrupted extension in space, time, or
sequence.“ Continuous, MERRIAM-WEBSTER, http://www.merriam-webster.com/dictionary/constant.
Likewise, Stedman‘s Medical Dictionary defines “continued“ as “continuous; without intermission . . . “
Continuous, STEDMAN‘S MED. DICT. (27th ed. 2000).
15
As for the term “intermittent,“ Merriam-Webster defines it as “coming and going at intervals “
and “not continuous.“ Intermittent, MERRIAM-WEBSTER, http://www.merriamwebster.com/dictionary/intermittent. Similarly, Stedman‘s Medical Dictionary defines it as “[m]arked by
intervals of complete quietude between two periods of activity.“ Intermittent, STEDMAN‘S MED. DICT.
(27th ed. 2000).
16
Merriam-Webster defines “transient“ as “passing especially quickly into and out of existence.“
Transient, MERRIAM-WEBSTER, http://www.merriam-webster.com/dictionary/transient. Steadman‘s
Medical Dictionary defines it as “[s]hort-lived; passing; not permanent; said of a disease or an attack.“
Transient, STEDMAN‘S MED. DICT. (27th ed. 2000).

25

at 155). Although a transient alarm is like an intermittent alarm because it is one that comes and
goes, it is unlike an intermittent alarm because it requires immediate action.
As noted above, Dr. Loebe and Ms. Elias testified that the standard of care required a
healthcare provider to supply information about the nature of each type of alarm. Despite this,
they concluded that Dr. Katlaps and Ms. Martin did not breach the standard of care by not
providing information about a new type of alarm. This is inconsistent with the requirement that
the healthcare provider provide information about each alarm. Such an inconsistency defies logic
and Dr. Loebe's and Ms. Mratin's detailed testimony regarding the standard of care itself, and it
hampers the credibility of their determination that the standard of care had not been breached by
Dr. Katlaps and Ms. Martin. The credible testimony and evidence supports the conclusion that
the standard of care in this case required that a doctor or nurse provide information about all
alarms to their patients.
Had Dr. Katlaps and Ms. Martin provided the information contained within the correction
letter, Mr. and Mrs. Bush would have been able to determine the meaning of the transient alarms
they experienced and react themselves. However, this information was not communicated to
them and they were not able to respond appropriately on their own. Instead, they were only able
to describe the LVAS' behavior to Ms. Martin, forcing her to do what they might have done
themselves had they been properly informed.
2.

Breach

Having established that the standard of care required a doctor or nurse to educate the
patient about all alarms and also that a nurse recognize and respond appropriately to those
alarms, it is necessary to determine whether that standard was breached by either Dr. Katlaps or
Ms. Martin. With regard to the correction letter, Mrs. Bush alleges that Dr. Katlaps and Ms.

26

Martin did not provide the information it contained and thus breached the standard of care. Dr.
Katlaps noted that he reviewed the symptoms of the percutaneous lead problem. He also
conceded that the correction letter "did not tell us anything new [and] there was no new concept
described in that notice and no new additional action necessary beyond what it describe[d]."
(Katlaps Tr. at 59-60). He stated that he did speak with Mr. Bush about the correction letter, but
he was vague regarding what he said, and there is nothing to indicate that he mentioned anything
about a transient alarm:
I do not have a vivid detailed recollection of exactly
specifically what we discussed. I do remember that we had a
conversation that there is a notice . . . . [I said] the most important
thing, if there are any alarms on the device, he needs to notify a
proper provider. Again, that's depending on what the alarm.
....
There are alarms on the device that he needs to act appropriately
according to his previous training. That has been—we have tried
to drive this message home again and again and again. Different
things can happen to the device. Different things can happen to
you. Different things can happen, you know, in the interface
between you and the device. One of the reasons why the alarms are
there is so that you can let us know if there is something
wrong. . . .
(Katlaps Tr. at 62-63 (emphasis added)). It is apparent that Dr. Katlaps did not believe the
correction letter contained information that would change the way Mr. and Mrs. Bush responded
to certain alarms, nor is there any indication in the medical record that he discussed the existence
or nature of transient alarms.
Ms. Martin had a similar mindset. Although she understood the difference between a
transient alarm, which irregularly stops and starts, and an intermittent alarm, which has regular
"short little inter-beeps every second or every four seconds," (Tr. at 56), she did not appear to
have drawn this distinction for Mr. and Mrs. Bush after she received the correction letter:

27

We told [Mr. and Mrs. Bush] that we would be monitoring
for the alarms that we were aware of, yes, but not any mention
of—I never ever have used the word "transient" in any discussion
with anybody related to the [LVAS].
....
[I do not think it is not important to use that term], I just
think it makes it confusing for everybody when you say another
word. I mean, we knew alarms were bad. So—but, no, intermittent
alarms are not life-threatening; continuous alarms are lifethreatening. Intermittent alarms can progress to continuous alarms.
So to add "transient," I don't think that—I mean, that confuses me,
honestly.
(Tr. at 59-60).
As discussed in detail above, McGuire's qualified expert witnesses, Dr. Loebe and Ms.
Elias, both testified that the standard of care would require a doctor or nurse to educate a patient
on how to react to all alarms. The evidence and testimony demonstrates that Dr. Katlaps and Ms.
Martin did not discuss with Mr. and Mrs. Bush potential of a transient alarm or that this new type
of alarm required immediate action. Thus, they breached the standard of care.
Mrs. Bush has also alleged that Ms. Martin breached the standard of care by not
recognizing and appropriately responding to the transient alarms described on the day of Mr.
Bush's death. Ms. Martin's own testimony indicates that she did not recognize the existence of
the transient alarms described by the correction letter, nor did she instruct Mr. and Mrs. Bush to
seek immediate medical attention. Accordingly, she breached the standard of care in this
instance, as well.
Before turning to the question of causation, it is necessary to address McGuire's assertion
that Mr. and Mrs. Bush were contributory negligent because they did not timely and accurately
describe the alarms Mr. Bush had experienced. "Contributory negligence is an affirmative
defense that is based on the objective standard of whether a plaintiff failed to act as a reasonable
person would have acted for his own safety under the circumstances." Sawyer v. Comerci, 563

28

S.E.2d 748, 752 (Va. 2002). "[I]n order for contributory negligence to bar a plaintiff's recovery
in a medical negligence action, the plaintiff's negligence must be concurrent with the defendant's
negligence." Id. "A defendant who relies upon the defense of contributory negligence must prove
that the plaintiff deviated from a standard of care and that the deviation was a proximate cause of
damages." Id. at 753.The defendant has the burden of proving its existence by a preponderance
of the evidence. Id. at 752. It is generally a question of fact, not law. Id. In this case, there are
two areas where it is suggested that contributory negligence is present: first, in Mrs. Bush's
failure to report the alarms recorded on the log and, second, in her failure to accurately describe
the alarms which she communicated to Ms. Martin. Each is discussed in turn.
As noted previously, Mrs. Bush's account of the alarms Mr. Bush experienced appears to
be credible. Ms. Martin's account differs, but she bases that mainly on statements she received
from Thoratec, not her own experience. Further, the results of Thoratec's investigation are not
conclusive with regard to what alarms occurred and when they occured, especially given the
mechanical and electrical damage to the device. As Dr. Arslanoglu's testimony demonstrated, the
transient alarms occurred as a result of a malfunction in the alarm mechanism itself; they were
unplanned, unexpected, and unpredictable symptoms of underlying damage. Mr. and Mrs. Bush
were observed by Dr. Katlaps and Ms. Martin to be incredibly vigilant with regard to Mr. Bush's
care, and it defies logic to think that they would have purposefully neglected to inform Dr.
Katlaps or Ms. Martin of any emergent alarm the device had issued. Even if McGuire had
demonstrated that they were negligent by concealing these alarms, that negligence does not meet
the concurrency requirement of Virginia law. Accordingly, the Court concludes that Mr. and
Mrs. Bush were not negligent.

29

3.

Causation

Next, it is necessary to determine whether Dr. Katlaps' or Ms. Martin's breach of the
standard of care was the proximate cause of Mr. Bush's death. In Virginia, it is "simply
[necessary] to prove that the particular time and manner of the patient's death resulted from the
defendant's negligence," not "that the patient would have recovered perfect health, or survived
indefinitely in the absence of the negligence." Blondel v. Hays, 403 S.E.2d 340, 344 (Va. 1991).
Here, had Mr. and Mrs. Bush been armed with the information contained in the
correction letter, it is unlikely that Mr. Bush would have spent May 4, 2010, running errands or
moving around his yard after experiencing irregular alarms the previous night and that morning.
Instead, he and Mrs. Bush would have recognized the possibility that the alarms were caused by
underlying damage to the percutaneous lead and understood that, if that was what was causing
the alarms, the damage could be exacerbated by additional movement. As Dr. Katlaps and Ms.
Martin testified, Mr. and Mrs. Bush were incredibly receptive to the information they had
provided and attentive to Mr. Bush's care. Therefore, it is more likely than not that they would
have recognized the alarms as a symptom of percutaneous lead damage and been proactive in
their response. Ms. Martin testified that she had provided Mr. and Mrs. Bush with several
methods of contacting her or, if she was unavailable, someone else at McGuire. She also
instructed that they page—rather than call—her in an emergency. Had they been aware of the
significance of the transient alarms, it is more likely than not that they would have followed her
instructions and paged her. If she had not responded, they would have sought immediate medical
attention. They also would have been able to limit Mr. Bush's movement and prevent any further
damage. Likewise, had Ms. Martin recognized the alarms as a possible consequence of

30

percutaneous lead damage, she could have instructed Mr. Bush to limit his movement and seek
immediate medical attention.
Although it is impossible to predict exactly what would have occurred, Mr. Bush would
more likely than not have been in a hospital—perhaps even one with a VAD center—at the time
he collapsed on May 4, 2010. This is so whether or not the transient alarms were symptomatic of
the percutaneous lead damage or some other problem with the LVAS. It is not clear that being in
a hospital would have resulted in Mr. Bush's long-term survival, but it is likely, if not certain,
that his life would have been prolonged. (If the transient alarms were symptomatic of
percutaneous lead damage, which it appears that they were, Mr. Bush may have lived minutes,
hours, days, or weeks longer simply by limiting his movement, even without immediate medical
attention.)
However, the conclusion that Mr. Bush would have lived longer depends on a finding
that his death was the result of the LVAS' failure. This is a question of medical causation. As the
Virginia Supreme Court has noted, "the question of causation of a human injury is a component
part of a diagnosis, which in turn is part of the practice of medicine." Combs v. Norfolk & W. Ry.
Co., 507 S.E.2d 355, 358 (Va. 1998). There are instances where laypersons may be treated as
qualified expert witnesses regarding causation, however in this instance causation is closely tied
to a diagnosis. Here, both Dr. Loebe and Dr. Katlaps have addressed this issue.
Dr. Loebe testified that Mr. Bush's death was not a result of the LVAS' failure. Instead,
he stated that the LVAS had not replaced the function of Mr. Bush's heart, that the malfunction
of the LVAS "is usually not [a] fatal event for the patient," and that "patients do not die when the
[LVAS] suddenly stops." (Tr. at 359, 367). Instead, he indicated that the proximate cause of Mr.
Bush's death was his underlying heart disease, not any failure of the LVAS. Put differently, the

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progression of Mr. Bush's heart disease was an intervening event severing the causal relationship
between the device's failure and Mr. Bush's death. However, his is not the only testimony on this
point.
Despite its intended purpose of assisting his heart—not replacing it—Dr. Katlaps, Mr.
Bush's treating physician, testified that the LVAS had been keeping Mr. Bush alive. He
estimated that without it, he would only have remained alive for days or weeks, but that with it
he would live at least a year. Unlike Dr. Loebe, he concluded that Mr. Bush's heart disease had
progressed to the point where his heart was unable to function without the LVAS. Thus, any
failure of the device would result in Mr. Bush's death. He discussed Mr. Bush's life expectancy
with the device:
That would be quite—you know, that would be really an
estimate. As you understand, there is no way to know . . . . But
there are some criteria that can help us make that estimate more
accurate, like [the] patient's age . . . . Mr. Bush was already in his
early sixties and comorbidities. [Mr.] Bush had had two entries
into his chest. You know, his surgery was more invasive than, than
some others. [Mr.] Bush had, they called it history of terminal
vascular disease, chronic obstruction pulmonary disease, COPD.
He had recorded a history of a set of vascular accidents.
Taking all that into account, his life expectancy was limited
for many reasons, which were not—which had nothing to do with
[the] LVAD. . . . And we knew based on the experience of, of ours
and other centers at that time . . . the statistical analysis, you know,
one year, two year, three year survival on those devices.
....
[His life expectancy at the time of his death was m]aybe,
maybe, maybe one, two or three years.
(Katlaps Tr. at 67-69).
Having weighed the testimony of Dr. Loebe and that of Dr. Katlaps, it appears that Dr.
Katlaps' conclusions are a better and more credible fit with the other testimony and evidence.
Although it is not impossible that Mr. Bush's natural heart would have stopped at the moment it

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did—even if the LVAS had continued to function properly—the timing seems too great a
coincidence. Further, Dr. Katlaps was intimately familiar with Mr. Bush's condition, having
implanted the device and served as his doctor—albeit remotely—for a number of years. In
contrast, Dr. Loebe reached his determination on the basis of what he had read, relying in part on
the medical record that had been prepared by Dr. Katlaps and Ms. Martin. Accordingly, the
testimony and evidence establishes that Mr. Bush died as a direct and proximate consequence of
the device's failure. Therefore, but for Dr. Katlaps' and Ms. Martin's breach of the standard of
care, Mr. Bush's life would have been extended by some measure.
E.

Damages
1.

Amount

Having concluded that Mr. Bush's death would not have occurred but for Dr. Katlaps' and
Ms. Martin's breach of the applicable standard of care, it is necessary to consider damages.
Under Virginia law, a court "may award such damages as to it may seem fair and just." VA.
CODE ANN. § 8.01-52. The following types of damages are permitted:
1. Sorrow, mental anguish, and solace which may include
society, companionship, comfort, guidance, kindly offices and
advice of the decedent;
2. Compensation for reasonably expected loss of (i) income
of the decedent and (ii) services, protection, care and assistance
provided by the decedent;
3. Expenses for the care, treatment and hospitalization of
the decedent incident to the injury resulting in death;
4. Reasonable funeral expenses; and
5. Punitive damages may be recovered for willful or
wanton conduct, or such recklessness as evinces a conscious
disregard for the safety of others.
Id. Prior to reaching a determination as to damages, it is relevant to consider the awards made in
other instances where medical malpractice has resulted in death. Of course, prior awards are not
dispositive since each case is dependent on its own unique facts, but prior awards for similar

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damages are instructive. A survey of these awards demonstrates that general damages—that is,
those for sorrow, mental anguish, and solace—are usually between $150,000.00 and $950,000.00
for each survivor and specific damages vary. See, e.g., Estate of Robertson v. Perry, 2013 WL
7139777 (Va. Cir. Ct. 2013) (awarding $50.466.80 in medical expenses, $10,316.85 in funeral
expenses, and $216,822.27 to each survivor of an 89-year-old patient); Estate of Willever v.
Williams, 2012 WL 4503122 (Va. Cir. Ct. 2012) (awarding $438,000.00 in medical expenses and
$390,500.00 to each survivor of a 73-year-old patient); Estate of Madison v. Chesapeake
Anesthesiologists, 2011 WL 7163456 (Va. Cir. Ct. 2011) (awarding $425,000.00 to the spouse
and $125,000.00 to each child of a patient); Estate of Lopez v. Galumbeck, 2010 WL 5517655
(Va. Cir. Ct. 2010) (awarding $975,000.00 to the spouse and $243,750.00 to each child of a 36year-old patient); Estate of Budnick v. Barry v. Walter, 2009 WL 5171892 (Va. Cir. Ct. 2009)
(awarding $46,997.56 for medical expenses, $2,675.00 for funeral expenses, and $2,200,000.00
to the survivor of a patient); Estate of Browder v. Gamache, 2009 WL 1912388 (Vir. Cir. Ct.
2009) (awarding $211,953.29 for medical expenses, $785,000.00 for economic loss, and
$6,500,000.00 to the survivor of a patient); Cumbee v. Nicholson, 2007 WL 4755239 (Va. Cir.
Ct. 2007) (awarding $56,163.29 in medical expenses, $10,512.38 in funeral expenses, and
$140,000.00 to each of survivor of a patient); Estate of Butler v. Mid-Atlantic Permanente Med.
Grp., P.C., 2003 WL 22111034 (Va. Cir. Ct. 2003) (awarding $950,000.00, approximately
$161,615.00 to $368,614.00 of which was for loss of income, to the survivor of a 53-year-old
patient with a life expectancy of 15 to 20 years); Estate of Fadle v. Mueller, 1998 WL 1757227
(Va. Cir. Ct. 1998) (awarding $724,000.00 to the survivor of a 63-year-old patient). Additionally,

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there does not appear to have been any award for punitive damages in such a case in the past
decade.18
Here, Mrs. Bush seeks $665,000.00 plus interest in general damages, $195,000.00 in
punitive damages, and $184,307 in special damages. In support of her claim for sorrow, mental
anguish, and solace, Mrs. Bush testified that, after Mr. Bush's death, she was hospitalized for
depression and experienced weight loss, isolationism, and insomnia. She was treated for
approximately four days. Her medical records indicate that she was billed $11,967.74 for that
hospitalization. (J. Ex. 5 at 1-4). Mrs. Bush appears to have suffered significantly as a result of
Mr. Bush's untimely death and the Court concludes that damages for sorrow, mental anguish, and
solace of $200,000.00 are fair and just.
With regard to damages for reasonably expected loss of income or services, the credible
evidence indicates that Mr. Bush would have been able to live an additional two years had the
LVAS continued to function properly. Accordingly, the Court adopts the conclusions of Mrs.
Bush's expert witness, who calculates Mrs. Bush's damages for reasonably expected loss of
income or services for that period as $23,535.00.
With regard to the expenses for care, treatment, and hospitalization as well as funeral
expenses, the Court notes that the parties stipulated that Mrs. Bush is not entitled to any
reimbursement because these expenses have been or will be paid by the United States.

18

Mrs. Bush additionally seeks damages "for [Mr. Bush's] physical and mental pain and suffering that he
endured in suffering a fatal heart attack and dying, and his loss of enjoyment of life." (Rec. Doc. 100 at 17). Under
Virginia law, which is controlling in this matter, a plaintiff may not seek damages for a decedent's pain and
suffering. See Jappell v. Arlington Health Found., No. 97–9631, 1998 WL 34174587, at *4 (Va. Cir. Ct. Dec. 2,
1998) ("[T]he fact that the [legislature] included the decedent's hospital and funeral expenses among the damages
permitted under the Wrongful Death Act and made no mention of the decedent's pain and suffering during such
hospitalization implies that such omission was intentional." (citing VA. CODE ANN. § 8.01-52)). Further, even if such
damages were available, there is no testimony or evidence to support an award here.

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With regard to punitive damages, the testimony and evidence do not justify or support an
award. Under Virginia law, "negligence which is so willful or wanton as to evince a conscious
disregard of the rights of others, as well as malicious conduct, will support an award of punitive
damages in a personal injury case." Booth v. Robertson, 374 S.E.2d 1, 3 (Va. 1988); see Doe v.
Isaacs, 579 S.E.2d 174, 176 (Va. 2003). Here, Dr. Katlaps and Ms. Martin were negligent in
failing to provide information about the new type of alarm and Ms. Martin was negligent in
failing to recognize the immediate nature of the situation on the day of Mr. Bush's death. The
testimony and evidence clearly demonstrates that Dr. Katlaps and Ms. Martin did what they
thought was best for Mr. Bush—that it did not coincide with what the standard of care required is
unfortunate but does not suggest malice or a wilful or wanton disregard of Mr. Bush's rights. At
all points, they acted carefully, thoughtfully, and diligently. For instance, Dr. Katlaps and Ms.
Martin did not merely neglect to tell Mr. and Mrs. Bush about the transient alarms; instead they
made a decision not to tell them after having read and discussed the correction letter. Similarly,
Ms. Martin did not merely dismiss Mrs. Bush on the day of Mr. Bush's death; rather she
immediately called Thoratec and attempted to determine the problem. It is abundantly clear that
Dr. Katlaps and Ms. Martin genuinely cared for Mr. and Mrs. Bush.
2.

Distribution

Having determined the aggregate amount of damages, it is necessary to decide whether
they must be reduced because of a prior settlement. With regard to FTCA claims, state law
dictates how a settlement before trial will impact the distribution of damages after trial. See Gill
v. United States, 429 F.2d 1072, 1078 (5th Cir. 1970). Under Virginia law, "[w]hen a
release . . . is given in good faith to one of two or more persons liable for . . . wrongful death,"
that release does not "discharge any other person from liability[,] but any amount recovered

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against the other person or any one of them shall be reduced . . . in the amount of the
consideration paid for [the release]." VA. CODE ANN. § 8.01-35.1(a); see Fairfax Hosp. Sys., Inc.
v. Nevitt, 457 S.E.2d 10, 14 (Va. 1995). Here, Mr. Bush suffered but one wrongful death, which
Mrs. Bush alleges was caused by the United States and other now-dismissed parties, thus any
damages will be reduced by the amount of consideration paid for the prior settlement. (See Rec.
Doc. 188).
IV.

SUMMARY
On the basis of the above findings of fact and conclusions of law, the Court finds that

Mrs. Bush has not sustained any injury due to the negligence of the United States or its
employees, Dr. Katlaps and Ms. Martin. Accordingly, IT IS ORDERED that the United States
pay Mrs. Bush $200,000.00 for sorrow, mental anguish, and solace and pay $23,535.00 in
compensation for reasonably expected loss of income of the decedent and services, protection,
care and assistance provided by the decedent, with a credit for the amount of consideration paid
for the prior settlement. (See Rec. Doc. 188).
New Orleans, Louisiana, this 1st day of April, 2014.

UNITED STATES DISTRICT JUDGE

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