Mettias v. United States of America
Filing
235
FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION - Signed by JUDGE ALAN C KAY on 4/21/2015. "And now, following the conclusion of a bench trial in this matter, and in accordance with the foregoing findings of facts a nd conclusions of law, it is hereby ordered that judgment shall enter in favor of Plaintiffs and against the United States in the above matter in the amount of $4,150,307 to Plaintiff Christina Mettias, and $100,000 to Plaintiff Christina Mettias as next friend of her minor son, N.M." (emt, )CERTIFICATE OF SERVICEParticipants registered to receive electronic notifications received this document electronically at the e-mail address listed on the Notice of Electronic Filing (NEF). Participants not registered to receive electronic notifications were served by first class mail on the date of this docket entry
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF HAWAII
CHRISTINA METTIAS, Individually
and as Next Friend of Her Minor
Son N.M.,
Plaintiffs,
v.
UNITED STATES OF AMERICA,
Defendant.
) Civ. No. 12-00527 ACK-KSC
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FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION
SYNOPSIS
On April 1, 2014, Plaintiff Christina Mettias
(“Christina”) filed an Amended Complaint on behalf of herself and
her minor son N.M. (together, “Plaintiffs”) against Defendant,
the United States of America (“the Government”), pursuant to the
Federal Tort Claims Act (“FTCA”), 28 U.S.C. §§ 1346, 2671 et seq.
(Doc. No. 68.) Plaintiffs assert claims of medical negligence,
failure to obtain informed consent, negligent infliction of
emotional distress, and loss of consortium in connection with a
Roux en Y gastric bypass surgery that Christina underwent on
September 27, 2010 at Tripler Army Medical Center (“Tripler”),
which is owned, operated, and controlled by the United States.
For the reasons set forth herein, the Court finds and
concludes that the Tripler providers breached the applicable
standard of care by offering Christina the gastric bypass surgery
notwithstanding the fact that she did not meet the eligibility
criteria that represented the prevailing standard of conduct in
the applicable medical community. The Court further finds and
concludes that the Tripler providers failed to give Christina
sufficient and adequate information such that she was able to
give her informed consent to the procedure. Thus, for the reasons
discussed herein, and as set forth below, the Court finds and
concludes that judgment in favor of Plaintiffs and against the
United States is appropriate in the amount of $4,150,307 to
Plaintiff Christina Mettias, and $100,000 to Plaintiff Christina
Mettias as next friend of her minor son, N.M.
A 13-day bench trial was commenced on February 24,
2015, and completed on March 16, 2015. Having heard and weighed
all the evidence and testimony adduced at the trial, having
observed the demeanor of the witnesses and evaluated their
credibility and candor, having heard the arguments of counsel and
considered the memoranda submitted, and pursuant to Fed. R. Civ.
P. 52(a)(1), this Court makes the following findings of fact and
conclusions of law. Where appropriate, findings of fact shall
operate as conclusions of law, and conclusions of law shall
operate as findings of fact.
2
TABLE OF CONTENTS
FINDINGS OF FACT
4
I.
Jurisdiction and Venue
4
II.
Background: Roux En Y Gastric Bypass Surgery
5
III. The Applicable Standard of Care Regarding Patient
Eligibility for Bariatric Surgery
7
A.
The First Prong: BMI Criterion
14
B.
The Second Prong: Prior Weight Loss Attempts
21
IV.
The Tripler Bariatric Surgery Program
28
V.
Christina’s Course of Care at Tripler
31
A.
Christina’s Personal and Medical History
31
B.
Christina’s Referral to the Bariatric
Surgery Program
C.
35
Christina’s Enrollment and Participation
in Tripler’s Bariatric Surgery Program
D.
The Preoperative Meeting with Dr. Payne
47
E.
VI.
37
The Day of Surgery
50
Christina’s Post-Surgery Complications
56
CONCLUSIONS OF LAW
69
I.
The FTCA and Vicarious Liability
69
II.
Medical Negligence
70
III. Informed Consent
IV.
76
Negligent Infliction of Emotional
Distress as to N.M.
81
V.
Loss of Parental Consortium
82
VI.
Damages
83
DECISION
86
3
FINDINGS OF FACT
I.
Jurisdiction and Venue
1. This Court has jurisdiction under the FTCA, and
venue is proper, as the events that gave rise to this action
occurred within this district. See 28 U.S.C. §§ 1346(b),
1391(e)(2).
2. Pursuant to the provisions of the FTCA, Plaintiffs
filed administrative claims on November 3, 2011, for personal
injury against the United States of America within the statutory
period as required by law. The Government acknowledged receipt of
the FTCA claims forms on November 22, 2011, and Plaintiffs filed
their original Complaint on September 24, 2012. As of September
24, 2012, Defendant United States had not taken final
administrative action on the Plaintiffs’ claims. Therefore,
Plaintiffs duly exhausted all administrative procedures and the
Complaint was timely filed.
3. Plaintiffs’ Amended Complaint was filed on April 1,
2014. On October 14, 2014, the Court entered its Order Denying
Defendant’s Motion to Dismiss as to Plaintiffs’ Informed Consent
Claim, holding that Plaintiffs had exhausted their administrative
remedies as to their informed consent claim and that the Court
thus has subject-matter jurisdiction over Plaintiffs’ informed
consent claim. (Doc. No. 106.) Plaintiffs have therefore duly
exhausted all administrative procedures and the Amended Complaint
4
was timely filed.
II.
Background: Roux En Y Gastric Bypass Surgery
4. Bariatric surgery is a type of weight loss surgery.
The procedure at issue in the instant case that was performed on
Christina on September 27, 2010, was a laparoscopic Roux en Y
gastric bypass surgery. Roux en Y gastric bypass is the most
invasive of the various weight loss surgeries, and has the
highest degree of risk. (Ex. J4 at 4.) It also tends to produce
the greatest reduction in weight. (Id.) In the normal digestive
tract, food passes down the esophagus, through the stomach and
into the small intestine, where most of the nutrients and
calories are absorbed. The food then passes into the large
intestine, and is finally excreted as waste. In a Roux-en-Y
gastric bypass, a small part of the stomach is separated
surgically, often by use of staples, to create a new stomach
pouch, approximately the size of a plumb. The small intestine is
then cut in its middle portion in an area called the jejunum, and
the lower end of the small intestine is then brought up through
the abdomen and connected to the newly created stomach pouch,
thereby bypassing the majority of the stomach and the upper
portion of the small intestine. (Ex. J5; Leitman: 4-65–68;
Ernsberger: 7-34; Ex. 245.)
5. According to Dr. Robert Lim, the head of Tripler’s
Bariatric Surgery Program at the time of Christina’s surgery,
5
there is an overall complication rate for bariatric surgery of
twenty percent. (Lim 9/4/13 (Ex. 355) at 64-65.) The medical
literature appears to echo this complication rate. (Ex. 1031
(2008 SAGES Guidelines) at 13/31; Ex. 273 (2013 Jones Article) at
008443.)
6. Even when successful, Roux En Y gastric bypass
surgery leaves the patient with a compromised digestive system
that by design causes malnutrition and malabsorption, and
therefore requires lifelong dietary restrictions, nutritional
supplements, and medical follow up. (Leitman: 4-66-67;
Ernsberger: 7-34-36; Ex. 119 at 13; Ex. 1163.) The language of
the patient eligibility standards, along with the testimony of
experts in the field, therefore make clear that weight loss
surgery is not a “first-line” treatment. (Leitman: 4-68-69,
4-160; Ernsberger: 7-33; Jones: 8-97; Verschell: 12-120.)
7. Although randomized, high quality data on the longterm outcomes of weight loss surgery are lacking, (Jones: 9-21,)
some data suggests that, while initial weight loss after surgery
can be impressive, many patients experience weight regain after
the first few years following surgery. For example, the Swedish
Obesity Study found that the mean sustained weight loss for
gastric bypass patients at ten years after surgery was 25% to 26%
of initial weight, that about one-quarter of patients sustained
less than 20% weight loss, and that 9% of patients sustained less
6
than 5% weight loss. (Ex. 273 at 008443-8444; Leitman: 4-135;
Jones 9-21.) On the other hand, there is also evidence that
“[w]eight-loss surgery is the most effective treatment for morbid
obesity, producing durable weight loss, improvement or remission
of comorbid conditions, and longer life.” (Ex. 1031 (SAGES
Guidelines) at 3; Jones: 8-109.)
III. The Applicable Standard of Care Regarding Patient
Eligibility for Bariatric Surgery
8. Patient eligibility standards for bariatric surgery
were developed as part of a multidisciplinary effort that
included nutritionists, psychologists, public health officials,
and bariatric surgeons. These patient eligibility criteria
represent an attempt by the medical community to establish the
threshold at which the risks of bariatric surgery likely outweigh
the benefits. (Ex. J4 (1991 NIH Consensus Statement) at 1; Ex.
119 (Leitman Report) at 14.)
9. The liability experts on both sides of the instant
case, as well as Dr. Lim, the witness designated as most
knowledgeable regarding the Tripler Bariatric Surgery Program
under Rule 30(b)(6) of the Federal Rules of Civil Procedure, all
agree, and the Court so finds, that there is a patient
eligibility standard that must be met before bariatric surgery
may be performed on a patient. (Leitman: 4-24, 4-160; Jones: 837; Ernsberger: 7-57-58; Lim 9/4/13 (Ex. 355) at 29-32.)
10. The liability experts on both sides of the instant
7
case, as well as Dr. Lim, all also agree that the applicable
national standard for patient eligibility for bariatric surgery
was first set forth in 1991 in the National Institutes of Health
(“NIH”) Consensus Statement. (Ex. 1042 (Jones Report) at 5; Ex.
119 (Leitman Report) at 14-15; Lim 9/4/13 (Ex. 355) at 28-29; see
also Ex. J4 (NIH Consensus Statement).) The NIH Consensus
Statement includes the following recommendations:
A decision to use surgery requires assessing the
risk-benefit ratio in each case. Those patients
judged by experienced clinicians to have a low
probability of success with nonsurgical measures,
as demonstrated for example by failures in
established weight control programs or reluctance
by the patient to enter such a program, may be
considered for surgery.
A gastric restrictive or bypass procedure should
be considered only for well-informed and motivated
patients with acceptable operative risks. The
patient should be able to participate in treatment
and long-term follow-up.
Patients whose BMI1/ exceeds 40 are potential
candidates for surgery if they strongly desire
substantial weight loss, because obesity severely
impairs the quality of their lives. They must
1/
The acronym “BMI” was used extensively at trial. “BMI”
refers to “body mass index,” which is a calculation that reflects
an individual’s relative size based on the individual’s mass (or
body weight) and height. The BMI for an individual is defined as
their body mass divided by the square of their height, with the
value universally being given in units of kg/m2. There are BMI
calculators readily available on-line. See, e.g., National
Institutes of Health, Calculate Your Body Mass Index, available
at http://www.nhlbi.nih.gov/health/educational/lose_wt/BMI. At
all relevant times, the Tripler electronic medical record system
automatically computed and entered a patient’s BMI when the
patient’s height and weight were recorded as designated chart
entries. (Williams: 1-62-63; Lim 09/04/13 (Ex. 355) at 36.)
8
clearly and realistically understand how their
lives may change after the operation.
In certain instances less severely obese patients
(with BMIs between 35 and 40) may also be
considered for surgery. Included in this category
are patients with high-risk comorbid conditions
such as life-threatening cardiopulmonary problems
(e.g., severe sleep apnea, Pickwickian syndrome,
and obesity related cardiomyopathy) or severe
diabetes mellitus. Other possible indications for
patients with BMIs between 35 and 40 include
obesity-induced physical problems interfering with
lifestyle (e.g., joint disease treatable but for
obesity, or body size problems precluding or
severely interfering with employment, family
function, and ambulation).
(Ex. J4 at 5.)
11. The Abstract to the NIH Consensus Statement states
that the panel recommended that “patients seeking therapy for
severe obesity for the first time should be considered for
treatment in a nonsurgical program with integrated components of
a dietary regimen, appropriate exercise, and behavioral
modification and support [and that bariatric surgery] could be
considered for well-informed and motivated patients with
acceptable operative risks . . ..” (Id. at 2.). The NIH
Consensus Statement also noted: “The possibility should not be
excluded that the highly motivated patient can achieve sustained
weight reduction by a combination of supervised low-calorie diets
and prolonged, intensive behavior modification therapy.” (Id. at
4.)
12. Since publication in 1991, the patient eligibility
9
criteria in the NIH Consensus Statement have been interpreted and
applied by numerous health care providers involved in the
management of obesity. The Court has reviewed a number of
documents that incorporate and apply the NIH Consensus Statement,
including position statements and clinical guidelines
promulgated by professional medical associations (specifically,
those promulgated by the American Society of Metabolic and
Bariatric Surgeons (“ASMBS”), the Society of American
Gastointestinal and Endoscopic Surgeons (“SAGES”), the American
College of Physicians, the American Dietetic Association, the
National Heart, Lung and Blood Institute, and the Society for
Surgery on the Alimentary Tract (“SSAT”)); documents setting
forth the coverage criteria for weight loss surgery promulgated
by public and private third party payers; and hospital websites
listing patient eligibility qualifications for weight loss
surgery. (See Exs. 1029 (ASMBS Guidelines), 1031 (SAGES
Guidelines), 247 (Lenox Hill Hospital Website), 254 (Final Rule:
Tricare Reimbursement for Bariatric Surgery), 341 (Kaiser
Reimbursement for Bariatric Surgery); Jones: 8-79-83, 8-90-91, 8124-127, 8-128-136.) The Court finds that all of these documents
are helpful in understanding and determining the standard of care
that existed in 2010 for patient eligibility for weight loss
surgery. No one document, however, is determinative of the
standard of care.
10
13. The ASMBS articulates the qualifications for
bariatric surgery as a BMI of greater than or equal to 40 with no
comorbidities (or between 35 and 40 and at least two obesityrelated comorbidities), and an “[i]nability to achieve a healthy
weight loss sustained for a period of time with prior weight loss
efforts.” (Ex. 1029.) The Court notes that the ASMBS appears to
be the sole professional association devoted exclusively to
weight loss surgery and comprised primarily of bariatric surgeons
and other health care professionals. Nevertheless, the ASMBS
guidelines are merely one of a number of sources the Court must
consider in determining the standard of care. (Leitman 4-156.)
14. The Court notes that the 2008 SAGES “Guidelines for
Clinical Application of Laproscopic Bariatric Surgery,” endorsed
by the ASMBS, contains a disclaimer stating that the guidelines
are not intended to establish a legal standard of care, and that
they are “intended to be flexible, as the surgeon must always
choose the approach best suited to the patient and to the
variables at the moment of decision.” (Ex. 1031 at 2.)
Importantly, however, the SAGES Guidelines make clear that
deviation from the general eligibility criteria set forth in the
guidelines should be based upon some clinical rationale, for
example, “the condition of the patient, limitations on available
resources or advances in knowledge or technology.” (Id.) Indeed,
Dr. Jones testified that a departure from the articulated
11
criteria would require “some kind of reason . . . [i]t’s not just
arbitrarily decided to depart,” and that doctors must “justify
the [departure] in some way.” (Jones: 8-130-131.)
15. In addition to the guidelines of professional
organizations, the Court also finds relevant, albeit not
determinative, the Tricare coverage criteria developed by the
Department of Defense (“DOD”). The Tricare coverage criteria for
bariatric surgery were developed between October of 2009 and
March of 2011, and state that Tricare coverage is limited to
those procedures “for which the safety and efficacy has been
proven comparable or superior to conventional therapies and is
consistent with the generally accepted norms for medical practice
in the United States medical community.” (Ex. 254 at 008115.) As
is relevant here, the Tricare conditions of coverage for
bariatric surgery require that a patient without comorbidities
must have a BMI of greater than or equal to 40 and must have
“previously been unsuccessful with medical treatment for
obesity.” (Id.)
16. In determining the standard of care for patient
eligibility for bariatric surgery, the Court has also weighed the
testimony of the two primary liability experts retained by the
parties, Dr. Leitman and Dr. Jones. The Court finds both experts
to be highly qualified to provide expert opinions under Rule 702
of the Federal Rules of Evidence.
12
17. The Court found Dr. Leitman’s testimony to be
direct, responsive, and credible.
18. The Court generally found Dr. Jones’s testimony to
be informed and usually, although not always, responsive. The
Court has some concern, however regarding Dr. Jones’s
credibility. The Court notes the apparent conflict of interest in
Dr. Jones offering opinions in a case involving the bariatric
surgery program over which Dr. Lim has direct responsibility. Dr.
Lim completed a fellowship with Dr. Jones immediately prior to
his employment as the head of the Tripler Bariatric Surgery
Program, Dr. Jones and Dr. Lim have co-authored numerous articles
and books together, and it was Dr. Lim who suggested Dr. Jones be
retained as an expert in this case. (Jones: 8-10-12.) While this
conflict was clearly disclosed to the Court, it does bear on Dr.
Jones’s credibility and, thus, the weight afforded to his
testimony.
19. After having reviewed the NIH Consensus Statement
and all of the relevant guidelines and documents interpreting and
applying that Consensus Statement, and hearing testimony from
both parties’ experts, the Court concludes that, for purposes of
the instant case, the standard of care for patient eligibility
for gastric bypass surgery at the time of Christina’s surgery
involved two essential inquiries, or “prongs.” Although these two
prongs are not the only considerations relevant to the
13
appropriateness of surgery, they are the two that are directly
implicated in the instant suit. (Ex. 119 (Leitman Report); Jones:
8-170.) The Court addresses each below.
A.
The First Prong: BMI Criterion
20. The liability experts of both parties, as well as
Dr. Lim, all agree, and the Court therefore finds, that the first
prong of the patient eligibility standard of care required that
Christina have a BMI of 40 or above (given the undisputed fact
that she had no obesity-related comorbidities at any relevant
time) in order to be an appropriate candidate for bariatric
surgery. (Lim 9/4/13 (Ex. 355) at 28-30, 38; Leitman: 4-21-22;
Jones: 8-39.)
21. The BMI eligibility requirement represents “an
attempt to balance the risk of a surgical procedure against the
potential to either correct or prevent the consequences of
prolonged obesity.” (Payne: 2-118.) Thus, it reflects a judgment
by the medical community that the risks of weight loss surgery
outweigh its benefits when it is performed on a patient who has a
BMI of less than 40 and no obesity-related comorbidities. (Payne:
2-120-121; Leitman: 4-24.) The experts and other witnesses
dispute, however, when the relevant BMI measurement should occur.
(See, e.g., Payne: 2-120-121.)
22. Dr. Jones, the Government’s expert in bariatric
surgery, opined that the BMI criterion was required to be applied
14
only when Christina entered Tripler’s Bariatric Surgery Program
in March of 2010, and it need not have been revisited - at least
for purposes of surgery eligibility - again. (Jones: 7-136, 7138; Ex. 1042 (Jones Report).)
23. Dr. Leitman, Plaintiffs’ expert in bariatric
surgery, opined that the BMI criterion was required to be applied
continuously until the time of surgery, including on the date
Christina was determined to be an appropriate candidate for
surgery, as well as on the actual day of surgery. (Leitman: 4-2123, 4-49, 4-171-172; Ex. 119 (Leitman Report).)
24. Dr. Ernsberger, Plaintiffs’ expert in obesity
management, agreed with Dr. Leitman that Christina should have
been told she was no longer eligible for surgery when she did not
meet the BMI criterion on September 14, 2010, the date of her
pre-surgical meeting with Dr. Payne, her surgeon. (Ernsberger: 767; Ex. 121.)
25. Dr. Jones’s opinion is apparently based upon his
own experience. When asked during cross-examination whether there
exists any medical authority that explicitly addresses the issue
of when the BMI criterion should be applied, Dr. Jones initially
cited an article published in 2008 or 2009 in the journal Surgery
for Obesity and Related Diseases; however, Dr. Jones later
admitted that the article did not, in fact, include any language
supporting his opinion that the BMI criterion could be applied
15
upon entry into a bariatric surgery program. (Jones: 8-154-155.)
26. Dr. Jones also pointed to a position statement from
the International Federation for the Surgery of Obesity and
Metabolic Disorders (“IFSO”) to support his contention that
surgery is not inappropriate where a patient’s BMI falls below 40
after entry into a bariatric surgery program. Specifically, the
IFSO position statement states that a lower BMI “as a result of
intensified treatment before surgery . . . is not a
contraindication for the planned bariatric surgery.” (Jones: 956-57.) The weight of the position statement is undermined,
however, as it has never been adopted by the ASMBS or any other
professional organization in the United States. (Id. 9-64-65.)
27. The Department of Defense’s final rule regarding
Tricare reimbursement for bariatric surgery stated in response to
a public comment regarding the laproscopic adjustable gastric
banding surgical procedure that coverage “is contingent upon the
patient meeting Tricare morbid obesity policy criteria at the
time of his or her surgery.” (Ex. 254 at 008113.) As noted above,
the “morbid obesity policy criteria” include the requirement that
the patient’s BMI be equal to or exceed 40. (Id. at 008115.)
28. The Court finds no medical literature (other than
the IFSO position statement) has been presented which establishes
that the BMI criterion need only be applied as of the date the
patient enters the bariatric surgery program.
16
29. The Court finds significant the fact that all of
the hospital webpages reviewed during the course of trial
(including those for Beth Israel Deaconess Hospital (where Dr.
Jones works), Lenox Hill Hospital (where Dr. Shah and Dr. Leitman
have worked), and Kaiser Permanente (where Dr. Payne has worked))
express the BMI criterion as a qualification for surgery, and not
as a qualification for acceptance into a bariatric surgery
program. (Jones: 8-128-137; Ex. 351 (Lenox Hill Website); Ex. 341
(Kaiser Website).) The Court notes, however, that Dr. Jones
testified that the websites set forth the criterion as such to
inform patients as to what most insurance companies require for
coverage. (Jones: 8-130, 8-132.)
30. The Court finds problematic the fact that, under
Dr. Jones’s asserted interpretation of the BMI criterion, an
interval of several years may pass between the BMI assessment at
entry into the bariatric surgery program and the actual date of
surgery. (Jones: 8-159-160.)
31. The Court is likewise troubled by the Government
witnesses’ statements that, so long as a patient meets the BMI
criterion at the time of entry into the bariatric program, any
subsequent fall in her BMI would not typically disqualify her for
surgery. For example, Dr. Jones testified that a patient would
not be disqualified from surgery unless her BMI fell below 30
prior to surgery. (Jones: 8-160-161.) Dr. Jones explained that
17
patients should not be penalized if they have success losing some
weight through diet and exercise undertaken in preparation for
surgery. (Jones: 8-162-163, 8-165-167.) Further, Dr. Jones
asserted that 95% of obese people will typically regain any
weight they may lose without surgical intervention. (Id. at
8-89-90.) Dr. Jones also testified that preoperative weight loss
may actually improve surgical outcomes by decreasing the size of
the liver and teaching the patient how to comply with
postsurgical dietary restrictions. (Jones: 7-154-155.) Similarly,
Dr. Payne asserted that a patient whose BMI fell to 29 during the
course of the preoperative program would not be disqualified from
surgery. (Payne: 2-125.) He testified that this would be the
equivalent of making patients comply with preoperative
requirements and then “pull[ing] the rug out from under them just
because they’ve been successful . . ..” (Id. at 2-123.)
Nevertheless, the Court finds that an approach wherein
preoperative lowering of the BMI will not disqualify a patient
from eligibility undermines the risk-benefit analysis on which
the patient eligibility BMI criterion is based.
32. The Court heard testimony during trial regarding
the Code Sheet used to document Christina’s gastric bypass
surgery performed on September 27, 2010. (Ex. J1 at 001138.) The
Code Sheet was not used to obtain payment for Christina’s surgery
because she was a military dependent; however, it was Tripler’s
18
practice to generate such a form for every inpatient admission at
the hospital. (Thompson 12/23/14 (Ex. 359) at 25-26.) Plaintiff’s
“principal diagnosis” “present on admission” was coded as “morbid
obesity” on September 27, 2010. (Ex. J1 at 001138.) Morbid
obesity is generally defined as a BMI of 40 or greater, or 35 or
greater with comorbidities. (Leitman: 4-27; Ernsberger: 7-67.)
The Court finds that Plaintiff did not meet the definition of
“morbidly obese” on the day of surgery, as her BMI was 35.8 on
that date and it is undisputed that she did not have any obesityrelated comorbidities. (Ex. J1 at 001152; Payne: 2-173-174;
Leitman: 4-38, 4-132-134; Ernsberger: 7-66.)
33. There was some testimony at trial that, because
Christina’s ethnic background was Hispanic and Samoan, surgery
may have been appropriate at a slightly lower BMI. (See Jones: 7156, 8-88, 8-146; Ex. 1008 at 000599.) There was no testimony or
other evidence, however, indicating that the Tripler doctors
relied upon Christina’s ethnicity as a rationale for departing
from the BMI eligibility criterion.
34. In the context of third party payors, weight loss
surgery would only be reimbursable if the relevant code sheet
reflected a diagnosis of morbid obesity on the date of surgery,
making the date of surgery the relevant date for purposes of the
BMI eligibility assessment. (Leitman: 4-165-166.) The testimony
regarding the practices of third party payors therefore
19
undermines Dr. Jones’s testimony that it is the standard practice
of physicians to perform bariatric surgery on patients who do not
meet the definition of morbid obesity, and thus do not meet the
BMI criterion at the time of surgery.
35. Moreover, the Court finds that Dr. Jones’s
credibility is undermined somewhat by his testimony that he had
never considered the issue of the timing of the BMI eligibility
assessment prior to being retained as an expert in this case,
notwithstanding his testimony that he was aware that insurance
companies sometimes deny coverage for patients who fall below the
BMI criterion because of presurgical weight loss. (Jones: 9-7273.)
36. Considering all the evidence before it, the Court
finds and concludes that, for purposes of the standard of care
for bariatric surgery as established by the prevailing standards
of conduct in the applicable medical community, the first prong
of the patient eligibility standard requires that the BMI
criterion be applied at the time the patient is determined to be
an appropriate candidate for bariatric surgery, and continually
thereafter until the time of surgery. In making this finding, the
Court relies upon Dr. Leitman and Dr. Ernsberger’s expert
testimony and the language of the NIH Consensus Statement and the
various guidelines interpreting that document, as well as the
other submitted evidence. The NIH Consensus Statement and the
20
subsequent guidelines promulgated by professional organizations
all evinced an intent to establish a BMI level below which the
risks of surgery outweigh its potential benefits. The Court
concludes that the expert testimony and the aforementioned
authorities establish the standard of care that the assessment of
whether a patient is below or above this BMI level (as is
relevant here, a BMI of 40 or above) must be done at the time the
determination is made that a patient is an appropriate candidate
for surgery and continually thereafter until the time of surgery,
rather than at some prior point months or even years beforehand.
The Court notes that Dr. Jones testified that applying the BMI
criterion on the day of surgery could lead to chaotic results;
however, this concern should be alleviated if at the preoperative
meeting shortly before a scheduled surgery it appears that a
patient may not meet the BMI requirement, as the hospital would
at that point be on notice that it may need to reassess the
appropriateness of surgery.
B.
The Second Prong: Prior Weight Loss Attempts
37. The second prong of the patient eligibility
standard for bariatric surgery involves an assessment of whether
a patient has made any prior nonsurgical weight loss attempts.
38. Dr. Leitman testified that the applicable standard
of care requires that a patient have tried and failed a
“medically supervised” weight loss program prior to being deemed
21
an appropriate candidate for bariatric surgery. (Leitman: 4-4041; Ex. 119 (Leitman Report).) Similarly, Dr. Ernsberger
testified that bariatric surgery should only be offered after
“the failure of multiple serious and medically [] supervised
attempts at losing weight.” (Ernsberger: 7-34.)
39. Dr. Lim appeared to agree with Dr. Leitman and Dr.
Ernsberger. Specifically, Dr. Lim testified that, before a
patient could be considered for weight loss surgery at Tripler,
the patient must have attempted some medical weight loss program.
(Lim 9/4/13 (Ex. 355) at 31-32.) Further, Dr. Lim acknowledged
that a document titled “Weight Loss Surgery: Is It Right for
You?” that was given to Tripler Bariatric Surgery Program
patients included the statement that surgery “should only be
considered if [the patient had] failed all medical weight loss
options and [felt] that any further non-surgical attempts would
be futile.” (Id. at 71; Ex. J5.) Dr. Lim confirmed that this
statement was consistent with the standards for entry into the
Tripler Bariatric Surgery Program. (Lim 9/4/13 (Ex. 355) at 71.)
40. Dr. Verschell, the head of Tripler’s LEAN Healthy
Lifestyles Program, also testified that one of the criteria for
entry into Tripler’s Bariatric Surgery Program was that the
patient “had made a reasonable effort at a weight loss attempt
and not been successful.” (Verschell: 10-196-97.) Dr. Verschell
stated that “it doesn’t have to be a formal program[,]” but that
22
patients must have tried some form of supervised nonsurgical
weight loss program: “It could be that they were working with,
for instance, closely with their primary care doctor or a
dietician, but some type of health care professional, with regard
to making sure that they’re getting appropriate advice with
regard to how to achieve weight loss.” (Id. at 10-199-200.) Dr.
Verschell summarized by stating that it “is the standard
protocol” that “patients should be getting professional
counseling with regard to how to go about achieving weight loss
in an effective way.” (Id. at 10-200.)
41. During the course of the trial, the Court also
reviewed statements regarding the second eligibility prong made
in clinical guidelines and position statements issued by
professional organizations, in the coverage criteria of third
party payors, and on hospital websites. These included clinical
guidelines and position statements from the NIH, ASMBS, SAGES,
SSAT, the American College of Physicians, the American Diatetic
Association, and the National Heart, Lung and Blood Institute.
They also included the Depart of Defense’s Tricare coverage
criteria and the DoD/Veterans Administration Clinical Practice
Guideline, as well as the websites of the hospitals where Dr.
Jones, Dr. Shah, Dr. Payne, and Dr. Leitman performed bariatric
surgery. (See Exs. 1029 (ASMBS Guidelines), 1031 (SAGES
Guidelines), 247 (Lenox Hill Hospital Website), 254 (Final Rule:
23
Tricare Reimbursement for Bariatric Surgery), 341 (Kaiser
Reimbursement for Bariatric Surgery); Ex. 121 (Ernsberger
Report); Jones: 8-79-83, 8-90-94, 8-124-127, 8-128-136;
Ernsberger: 7-44.) All of these sources articulated the second
eligibility prong as requiring that the patient have failed in
prior, nonsurgical weight loss attempts. For example, as noted
above, the ASMBS guidelines state the second eligibility prong as
follows: “Inability to achieve a healthy weight loss sustained
for a period of time with prior weight loss efforts.” (Ex. 1029.)
42. Similarly, the Court reviewed a statement published
on the Kaiser Permanente website addressing the second prong, and
stating that, in order to be eligible for surgery, a patient must
have “completed a medically supervised weight loss program within
the last two years[,]” and “have been morbidly obese for at least
3 of the last 5 years . . . documented by a physician . . ..”
(Ex. 341 at 009128.)
43. Moreover, a chapter in a 2009 book edited by Dr.
Jones (Obesity Surgery: Patient Safety and Best Practices)
contains a similar formulation of the second prong. Specifically,
the chapter states that “therapy combining low calorie diet,
increased physical activity, and behavioral treatment is the most
successful strategy for weight loss and weight maintenance . . ..
This kind of lifestyle intervention should be attempted with the
patient for at least six months before considering any type of
24
drug treatment or surgical treatment.” (Jones: 8-87.) The Court
notes that Dr. Jones testified that he had not read this chapter
before publishing it in his book (that he merely moderated the
conference from which the book materials were gleaned), and that
he was not familiar with it, nor did he agree with it. (Id. at 885-87, 8-90-91.)
44. Dr. Jones is the only witness to testify at trial
who disagreed that the standard of care required that a patient
must have tried nonsurgical weight loss attempts prior to being
offered bariatric surgery. Dr. Jones opined that patients must
have tried “behavior modifications, diet and exercise prior to
surgery,” but that these nonsurgical options may be initiated
after a patient joins a bariatric program if they have not been
tried before. (Jones: 8-118.) Dr. Jones also disagreed that a
patient needs to have “failed” prior weight loss attempts to be
eligible for surgery; rather, Dr. Jones asserted that the patient
needs to be successful in preoperative weight loss through the
bariatric surgery program in order to be a good candidate for
surgery. (Id. at 8-110-111.) Dr. Jones asserted that 95% of obese
people typically regain any weight they may lose without surgical
intervention. (Id. at 8-89-90.) Dr. Lim also testified that most
patients who lose weight typically regain that weight and are
unable to keep it off. (Lim 9/4/13 (Ex. 355) at 39-40.)
45. The Court notes that Dr. Jones’s testimony
25
regarding the second eligibility prong is at odds with the
language on the website for his own hospital, the Beth Israel
Deaconess Medical Center. Specifically, the website states that,
to be a candidate for weight loss surgery, a patient must “have
failed to lose weight through medical diets and exercise,” and
that weight loss surgery may be appropriate if a patient’s
“serious attempts to lose weight have had only short-term
success.” (Jones: 8-135.) The website also states that weight
loss surgery may be a good option for “seriously obese patients
who have been unsuccessful in nonsurgical weight loss methods
such as diets, medications, behavior modification or exercise
programs . . ..” (Jones: 8-136.)
46. The Court finds that Dr. Jones’s opinions regarding
the second prong of the patient eligibility criteria are
inconsistent with the weight of evidence before the Court,
including the clinical guidelines and position statements of
numerous professional associations, and the testimony of the
other medical professionals.
47. Based on the weight of the evidence before the
Court, including the clinical guidelines and position statements
of numerous professional associations, and the testimony of Dr.
Lim, Dr. Verschell, Dr. Leitman, and Dr. Ernsberger, the Court
finds that the applicable standard of care for bariatric surgery,
as established by the relevant medical community, requires that a
26
patient must have failed in prior attempts at nonsurgical weight
loss in order to be eligible as an appropriate candidate for
bariatric surgery.
48. As to what types of prior weight loss efforts would
satisfy the second eligibility prong, Dr. Leitman opined that the
prior weight loss effort must be “medically supervised.”
(Leitman: 4-43.) The Court notes, however, that many of the
clinical guidelines and position statements the Court reviewed
during the course of the trial have no such requirement. (See,
e.g., Ex. 1029 (ASBMS Guidelines); Ex. 1031 (SAGES Guidelines);
Jones: 8-83 (American College of Physicians Guideline); Jones: 8126 (SSAT Guideline); Jones: 9-56-57 (IFSO article).) In
addition, Dr. Verschell and Dr. Smiley both disagreed that prior
weight loss attempts must be “medically supervised.” (Verschell:
10-201; Smiley: 2-52.)
49. The Court concludes that it need not reach the
question of whether the second eligibility prong specifically
requires prior weight loss attempts to be “medically supervised.”
Rather, the Court finds that the second eligibility prong
requires, at a minimum, that a patient must have failed a formal
weight loss program of some kind, whether characterized as
medically supervised or as an adequate trial of nonsurgical
weight loss.
50. With respect to the assessment and verification of
27
prior weight loss efforts, Dr. Leitman and Dr. Jones both
testified that this would involve taking a medical history from
the patient and subsequently reviewing the patient’s medical
records. (Leitman: 4-39; Jones: 9-10-12.) Dr. Shah echoed this
testimony, stating that he takes a thorough medical history and
reviews the patient’s medical records to the extent they are
available. (Shah: 4-207-208.) The Court therefore finds that the
applicable standard of care requires that a full and complete
medical history be taken that includes specific questions about a
patient’s past weight loss attempts, and that past medical
records be reviewed, if possible, to verify the patient’s
responses.
IV.
The Tripler Bariatric Surgery Program
51. Active duty military members are prohibited from
receiving bariatric surgery; however, military dependants such as
Christina may have the surgery at no charge provided it is
performed at a Military Treatment Facility such as Tripler.
(Wodartz 5/8/14 (Ex. 361) at 30.)
52. Nurse Yvette Williams was hired as the Bariatric
Nurse Coordinator for the Tripler Bariatric Surgery Program in
November of 2008, and continued in that position until August of
2012. (Williams: 1-34.)
53. Dr. Robert Lim was hired to run the Tripler
Bariatric Surgery Program in July of 2009, and sought to make
28
Tripler a Center of Excellence, which required, inter alia,
implementation of a multidisciplinary approach and an increase in
the number of bariatric surgeries performed at Tripler. (Lim
9/4/13 (Ex. 355) at 13-14, 19.)
54. As part of his effort to achieve Center of
Excellence status for Tripler, Dr. Lim (along with Nurse
Williams) made presentations about the program at a number of
primary care clinics, telling primary care providers that, even
if they were uncertain whether patients qualified for surgery,
the patients were welcome to attend an Information Session. (Id.
at 25.)
55. Dr. Lim testified that Tripler followed “accepted
practice in the community” in making eligibility determinations
for bariatric surgery, including by following the NIH Consensus
Statement and the guidelines subsequently promulgated by the
ASMBS and SAGES. (Id. at 22, 28-30.) Dr. Lim stated that,
accordingly, prior to acceptance into the Tripler Bariatric
Surgery Program, patients had to have a BMI of over 40 (or over
35 with comorbidities), and had to have attempted some
nonsurgical weight loss program. (Id. at 25, 30-32, 71.) Nurse
Williams echoed Dr. Lim’s testimony regarding the eligibility
requirements of the Tripler Bariatric Surgery Program. (Williams:
1-48-49, 1-72.) Likewise, Dr. Mark Verschell and Dr. Nancy Smiley
both also confirmed these requirements for entry into the
29
program. (Verschell: 10-199-201; Smiley: 2-46, 1-166.)
56. Based on the testimony of the Tripler providers,
the Court finds that there were two primary criteria used at
Tripler in 2010 to screen patients for eligibility for entry into
the Tripler Bariatric Surgery Program: (1) the patient must have
a BMI of 40 or above with no comorbidities, or 35 or above with
comorbidities; and (2) the patient must have failed “all medical
weight loss options and [must feel] that any further non-surgical
attempts would be futile.” (Ex. J5.)
57. Nurse Williams was responsible for screening all
potential candidates for weight loss surgery to determine whether
they met the Tripler Bariatric Surgery Program eligibility
criteria. (Williams: 1-44; Verschell: 10-194; Ex. 222 (Tripler
Weight Loss Surgery Guidelines).) Nurse Williams testified that,
generally the consult from the primary care physician would
contain information addressing the two patient eligibility
criteria, but that if she received a consult that did not have
that information, she would obtain it herself. (Williams: 1-46,
1-49-51.)
58. Patients are first enrolled in the Tripler
Bariatric Surgery Program during the Information Session. (Ex.
166 (Tripler Pre-Op Pathway).)
59. Tripler’s “Multidisciplinary Pre-Op Weight Loss
Pathway” indicates that, typically patients would meet one-on-one
30
with a bariatric surgeon within approximately one month of the
Information Session. (Ex. 166.) Here, the only evidence that a
surgeon was involved in screening Christina for acceptance into
the Tripler Bariatric Surgery Program is a medical note entered
by Dr. Schriver on March 30, 2010, the same date that Christina
attended the Information Session. (Ex. 1008 at USA 000601-02.)
Dr. Schriver did not testify at trial. Dr. Schriver’s note did
not document any previous diagnoses of obesity, or any prior
weight loss efforts by Christina. (Id.) There is no other
evidence that Christina met one-one-one with a surgeon prior to
her presurgical meeting on September 14, 2010.
V.
Christina’s Course of Care at Tripler
A. Christina’s Personal and Medical History
60. Christina was born in Omaha, Nebraska on January
21, 1978. She was adopted at two weeks of age and raised
primarily in Florida after her father retired from the military.
(Christina: 5-8-9.)
61. Christina married Aaron Moseley in 1997, and the
two had a son, N.M., who was born on February 10, 1998. Christina
and Aaron divorced, and shared custody of N.M. thereafter. (Id.
at 5-11-13, 5-21-22.)
62. Christina testified at trial that she considered
herself to be relatively petite during her youth, and that she
weighed 98 pounds when she got pregnant with her son at age 20.
31
(Id. at 5-108.) She further testified that she was able to lose
most of her pregnancy weight and return to a normal body weight
of approximately 110 to 115 pounds about a six months to a year
after giving birth. (Id. at 5-109.)
63. A few years after giving birth, Christina trained
as a truck driver and began driving semi trucks for a national
trucking company. For approximately four years she worked this
job, during which time her weight rose to 150 to 160 pounds. (Id.
at 5-14-17.)
64. During the four years that Christina worked as a
truck driver, N.M. lived with his father in Kentucky, and
Christina tried whenever possible to get routed through Kentucky
to see them. (Id. at 5-16-17.) In early 2007, Christina decided
to end her career as a truck driver to spend more time with her
son. She moved to Kentucky and obtained a job at the front desk
of a Holiday Inn Express. Her son moved in with her. (Id. at 520-21.)
65. Christina arranged a transfer to the Holiday Inn
near Dothan, Alabama, where her parents lived, and she and her
son moved there sometime in 2007. (Id. at 5-22-24.)
66. Christina married Angelo Rivera in January of 2008.
(Id. at 5-24-26; Rivera: 3-98.) At the time of her marriage,
Christina recalls that she “had gotten bigger,” or gained more
weight. (Christina: 5-26.) Angelo joined the Army in January
32
2008, and after boot camp his first duty assignment was to
Wheeler Air Base in Honolulu, Hawaii. (Rivera: 3-97, 3-101-103.)
Christina and Angelo therefore moved to Honolulu in 2008. N.M.
remained in Kentucky with his father. (Christina: 5-27-30.) At
the time of the move to Hawaii in 2008, Christina states she
weighed approximately 170 or 180 pounds. (Id. at 5-111-112.)
67. Prior to moving, Christina was required to undergo
a screening to make sure she could travel to her husband’s new
duty station without limit. On June 12, 2008, therefore,
Christina was examined by Dr. Xiaolu Wu at the Lyster Army Health
Clinic at Fort Rucker, Alabama. (Ex. 350 at 000560.) At the time
of this visit, Christina’s documented weight was 190 pounds and
her BMI was calculated to be 35.9. Dr. Wu’s report stated that
she was “currently very health” and that she could travel to
Angelo’s duty station without limit. (Id. at 000561.) The record
of Christina’s visit with Dr. Wu does not mention obesity as a
diagnosis. (Id.)
68. Christina testified that her medical history prior
to moving to Hawaii consisted of a hernia operation at age 4, a
tonsillectomy during childhood, and a cesarean section for the
birth of her son. (Christina: 5-29; Ex. 349.) She stated that her
general health throughout her life had been good, and that she
had never thought of herself as having a weight problem.
(Christina: 5-29, 5-37-38.) Christina also testified that she had
33
never tried any sort of formal or informal diet before her entry
into the Tripler Bariatric Surgery Program. (Id. at 5-38, 5-44.)
69. Angelo Rivera likewise testified that Christina’s
weight was never a concern for him. (Rivera: 3-103.) He stated
that, to his knowledge, prior to entering Tripler’s Bariatric
Surgery Program, Christina had never tried any kind of weight
loss “program” that you “had to pay for,” nor had any of her
medical providers tried to assist her with weight loss. (Id. at
3-109.) Angelo testified that he remembered that there were diet
pills in their home at some point, and that they had tried
Hydroxycut, but he could not recall whether that was before or
after Christina joined the Tripler Bariatric Surgery Program.
(Id. 3-126.) Angelo also testified that Christina had spoken to
him about going to the gym a couple of times. (Id. at 3-148.)
Angelo stated that he and Christina knew about weight loss
surgery (although they had not heard the term “bariatric”) before
she learned about the Bariatric Surgery Program, and that they
had researched weight loss surgery online when they lived in
Alabama. (Id. at 3-107, 3-148-149, 3-154.) He also testified
that, after he returned from deployment (in September 2009),
Christina first mentioned weight loss surgery to him as
“something that I think she -- she kind of knew about.” (Id. at
3-103, 3-106-107.) Nevertheless, he stated that she only
expressed concern about her weight to him after she had been
34
referred to the Bariatric Surgery Program. (Id. at 3-149.)
70. Beginning in June of 2008, Christina received her
health care through the military health care system; thus, all of
her outpatient medical records from June 2008 to the date of her
surgery on September 27, 2010 were maintained within the
military’s electronic medical record system called “AHLTA.” (Ex.
1008; Smiley: 1-143-145, 1-148, 2-11.) Christina’s AHLTA records
do contain some entries addressing Christina’s weight history. In
a May 20, 2010 note, Andrew Ching wrote that “Christina states
her weight problems began at age 25,” and that “Christina states
that in the past she has attempted to use diet pills as a way to
lose weight.” (Ex. 1008 at 000620.) In a September 8, 2010
medical note, Xavier Pena wrote that Christina “reported a
personal history of weight problems for the past 8 years,” and
that “[d]espite previous attempts at weight loss in the past 8
years, including exercise and Alli she began to consider having
gastric bypass surgery.” (Ex. 1008 at 000706.)
71. During the period from June 2008, when she moved to
Hawaii, until March 19, 2010, Christina sought medical treatment
approximately fourteen times for minor, routine health issues.
Each of these visits generated an electronic medical record, none
of which document any serious medical problems, and none of which
mention a weight problem or obesity. (Ex. 350.)
B.
Christina’s Referral to the Bariatric Surgery Program
35
72. On March 19, 2010, Christina went to see Dr. Nancy
Smiley at the Schofield Barracks Family Practice Service Clinic
for a routine “well woman visit.” (Ex. 1008 at USA 000598;
Smiley: 1-146.) Dr. Smiley recorded Christina’s weight on that
date as 220 pounds, and her BMI was automatically calculated to
be 41.57. (Ex. 1008 at 000598, Smiley: 1-151.) Dr. Smiley
testified that Christina “had a normal exam except for morbid
obesity.” (Smiley: 1-151.)
73. Dr. Smiley testified that she discussed Christina’s
weight problem with her, and asked her what she had done in the
past to try to lose weight. Dr. Smiley testified at trial that
Christina told her that she had just started exercising, and that
she “had tried many times in the past to lose weight with diet
and exercise and wasn’t successful.” (Id. at 1-150-152.) During
prior deposition testimony, however, Dr. Smiley did not mention
this exchange about Christina’s prior weight loss efforts. (Id.
at 2-9.) The AHLTA record reflects Dr. Smiley’s diagnosis of
“obesity” and the fact that Christina stated that she had just
started exercising, but does not contain any other information
about Christina’s weight history. (Ex. 1008 at 000598-600.) Dr.
Smiley testified that she would normally put information about
weight history in the “personal history” section of her note.
(Smiley: 1-152.)
74. At the conclusion of the March 19, 2010
36
appointment, Dr. Smiley gave Christina a tip sheet on nutrition,
and consults (or referrals) for a nutritional program and for the
Tripler Bariatric Surgery Program. (Id. 1-153.) The referral to
the Bariatric Surgery Program read “32 year old healthy
nonsmoker, BMI 41, would like to be enrolled in Bariatric
Program. Please evaluate and treat. Thanks, NS.” (Ex. 1008 at
000602.)
75. Because of the referral entered into the AHLTA
record, shortly after the appointment with Dr. Smiley, Christina
received a call from the nurse-coordinator for Tripler’s
Bariatric Surgery Program, Yvette Williams, inviting Christina to
an Information Session for the Tripler Bariatric Surgery Program.
(Christina: 5-47-48; Williams: 1-55.)
C.
Christina’s Enrollment and Participation in Tripler’s
Bariatric Surgery Program
76. On March 30, 2010, Christina attended the
Information Session at the Tripler Bariatric Surgery Program.
Christina’s weight was documented as 221.1. pounds on that date,
and her BMI was recorded as 41.78. (Ex. 1008 at 000601.) The
Information Session included a 90-minute group presentation on
bariatric surgery led by Dr. John Schriver. (Id.)
77. Christina testified at trial that she had not made
up her mind about having surgery after the Information Session.
(Christina: 5-57.) Conversely, Angelo Rivera testified that
Christina had essentially decided to have the surgery after
37
attending the Information Session, and that she knew she wanted
Roux en Y gastric bypass surgery. (Rivera: 3-114-117.) He
testified that she “had a positive attitude about” the surgery
after the Information Session, and that she “felt like it was
something that could work for her, that it would be successful in
helping her lose the weight.” (Id. at 3-114.)
78. As noted above, the Court has found that there were
two primary criteria used at Tripler in 2010 to screen patients
to determine their eligibility for the Tripler Bariatric Surgery
Program: (1) the patient must have a BMI of 40 or above with no
comorbidities, or 35 or above with at least one obesity-related
comorbidity; and (2) the patient must have failed “all medical
weight loss options and [feel] that any further non-surgical
attempts would be futile.” (Ex. J5.) Dr. Lim confirmed that these
were the Tripler eligibility requirements, and that the second
prong requires that the patient have tried “some weight loss
program.” (9/4/13 (Ex. 355) at 28-31, 38-39, 71.)
79. Patients were enrolled in the Tripler Bariatric
Surgery Program during the Information Session. (Ex. 166 (Tripler
Pre-Op Pathway).) As to the first prong of Tripler’s eligibility
test, Christina had no comorbidities and her BMI was above 40 at
the time she attended the Information Session. (Ex. 1008 at
000601.) As to the second prong, there is no entry in Christina’s
AHLTA medical records regarding Christina’s weight loss history
38
until well after the March 30, 2010 Information Session. Her
medical records up until March 30, 2010 do reflect a BMI that
fluctuated between 35.9 and 42.06; however, they do not contain
any mention of prior weight loss attempts. (See Ex. 1008.)
Indeed, Christina’s weight loss history is first mentioned in the
AHLTA records in a medical note entered by Andrew Ching on May
20, 2010. (Ex. 1008 at 000620.)
80. On April 13, 2010, Christina attended a 210-minute
group orientation session to begin the First Phase of the LEAN
Healthy Lifestyles Program, as a part of her participation in the
Tripler Bariatric Surgery Program. On that date, her height was
measured at 61.5 inches, her weight was 224 pounds, and her BMI
was automatically calculated as 41.64. (Ex. 1008 at 000606.) The
LEAN Healthy Lifestyles Program was a “behavior modification
program focusing on healthy lifestyles” that all Tripler
Bariatric Surgery Program patients were required to complete.
(Verschell: 10-117, 12-83-84.) Prior to surgery, patients were
required to lose at least 5% of their body weight through the
LEAN program. (Lim 9/4/13 (Ex. 355) at 34.) Dr. Verschell, the
head of the LEAN program, testified that overweight service
members who participated in the LEAN program via telehealth met
or exceeded the national rates of average weight loss of 8% to
10% per year. (Id. at 10-172-173.) Dr. Verschell also testified
that frequent and long-term contact with a behavior modification
39
program such as the LEAN Healthy Lifestyles Program can be a
successful, nonsurgical method of preventing weight regain. (Id.
at 10-182-183.)
81. On April 23, 2010, Christina attended a 30-minute
behavioral therapy group session as part of the Second Phase of
the LEAN Healthy Lifestyles Program. On that date, her height was
measured at 61 inches, her weight was 221 pounds, and her BMI was
automatically calculated as 41.76. (Ex. 1008 at 000614-615.)
Christina attended another 30-minute behavioral therapy group
session on May 19, 2010, at which time her weight was 217 pounds,
and her BMI was calculated as 41. (Id. at 000618-619.)
82. On May 20, 2010, Christina attended a 90-minute
individualized behavior therapy session in conjunction with
participation in the LEAN Healthy Lifestyles Program. (Id. at
000621.) This was a one-on-one session with Andrew Ching, a
psychology technician. (Id.) Mr. Ching testified that he was not
involved in screening patients for surgery eligibility. (Ching:
2-75.) He testified that he may have asked Christina at some
point whether she was sure she wanted to continue with surgery,
but that he did not make recommendations regarding surgery. (Id.
at 2-85.) Mr. Ching also testified that Dr. Verschell, his
supervisor, would typically briefly check in on the patient at
some point during the one-on-one sessions. (Id. at 2-78.)
83. On May 20, 2010, Christina weighed 219 pounds and
40
her BMI was automatically calculated as 41.05. (Ex. 1008 at
000620.) During the 90-minute session, Mr. Ching took a medical
history from Christina. In the medical note from the session, Mr.
Ching writes that “Christina states that her weight problems
began at age 25 . . . Christina states that in the past she has
attempted to use diet pills as a way to lose weight.” (Id.) Mr.
Ching testified that Christina was an enthusiastic participant in
the LEAN Healthy Lifestyles Program, and that she was successful
at losing weight through the program. (Id. 2-84.)
84. On June 21, 2010, Christina attended a 60-minute
behavioral assessment/therapy session with Andrew Ching. (Ex.
1008 at 000641.) As of that date, Christina weighed 213 pounds,
and her BMI was calculated to be 40.25. (Id.) The medical note
from this session indicates that Christina expressed an interest
in trying the prescription weight-loss medication orlistat (the
lower-dose, over-the-counter version is called Alli). (Id.; see
also Verschell: 12-100-101.) Dr. Verschell prescribed orlistat
for Christina, and she appears to have taken it from around June
30, 2010 to sometime between July 7, 2010 and July 13, 2010. (See
Ex. 1008 at 000645-000653.) On July 7, 2010, Christina weighed
212 pounds and her BMI was calculated at 40.13. (Id. at 000647.)
85. As noted above, Dr. Verschell was Andrew Ching’s
supervisor, and checked in on Christina during her sessions with
Mr. Ching. Dr. Verschell testified at trial that Christina lost
41
weight and learned and practiced behaviors in the LEAN Healthy
Lifestyles Program that would allow her to keep off the weight.
(Verschell: 12-86.) Dr. Verschell further testified that he
recalled that “on at least two occasions” he discussed with
Christina her successful participation in the LEAN Healthy
Lifestyles Program and “talked with her about whether she wanted
to proceed with surgery.” (Id. at 10-153-154.) Dr. Verschell
further testified that Christina told him that she believed
surgery “was in her best interest,” and “that it would be
difficult to keep the weight off without the surgery.” (Id. at
10-154.) Dr. Verschell testified that it was not his job or
practice to make a recommendation one way or another to patients
regarding bariatric surgery. (Id. at 12-93-94.) He also stated
that, if a patient wanted surgery and was ready to have surgery,
he would want them to have the surgery. (Id. at 12-91-92.) Dr.
Verschell stated that he never raised the issue of whether
Christina’s success in the LEAN program suggested that she may
not need to proceed with surgery at a multidisciplinary team
meeting, or with Christina’s surgeon.2/ (Id. 12-87-88.)
86. On June 21, 2010, Dr. Verschell sent an electronic
2/
The Court notes that some of the entries made in
Christina’s electronic medical records were described by Dr.
Verchell as “templates” that were “copied forward.” Thus, some
entries are not specific to the patient. (Verschell: 10-146-147,
12-93, 12-104-107.) Christina’s medical records appear to contain
several instances of such templates. (See Ex. 1008 at 000652,
000693, 000698, 000714, 000721.)
42
note to Captain Benjamin Wunderlich, a Registered Dietician who
worked with Christina in the Tripler Bariatric Surgery Program,
which read: “Bariatric patient ready for individualized dietary
counseling. She’s doing very well - maybe you can review the need
for surgery?” (Ex. 1008 at 000648; Verschell: 12-116.) As of that
date, Christina weighed 213 pounds, and her BMI was calculated to
be 40.25. (Ex. 1008 at 000641.) Dr. Verschell testified that he
did not follow up with Captain Wunderlich after sending the note.
(Verschell: 12-116-117.)
87. Christina continued to meet with Andrew Ching often
during the month of July. On July 14, 2010, Christina weighed 208
pounds and her BMI was automatically calculated as 38.04. (Ex.
1008 at 000652.) As of that date, Christina reported to Andrew
Ching that she was on a 1-cup diet of approximately 700 calories
per day. (Id. at 000653.) On July 19, 2010, Christina weighed 207
pounds, and her BMI was calculated as 38.48. (Id. at 000657.) On
July 21, 2010, Christina weighed 206 pounds and had a BMI of
38.92. (Id. at 000659.) On July 28, 2010, Christina weighed 203
pounds and had a BMI of 38.26. (Id. at 000672.)
88. Captain Wunderlich also met with Christina
periodically throughout her time in the Tripler Bariatric Surgery
Program. He first met with Christina on May 26, 2010.
(Wunderlich: 3-48.) Captain Wunderlich testified that, at that
time, Christina had already been accepted into the Tripler
43
Bariatric Surgery Program, and that he was not involved in
screening patients for eligibility. (Id. at 3-16-17, 3-31.)
Captain Wunderlich also testified that he never recommended that
Christina postpone surgery in light of her success losing weight
through the LEAN Healthy Lifestyles Program. (Id. at 3-32.)
89. During an August 16, 2010 appointment with Captain
Wunderlich, Christina voiced a concern about “slowing down her
weight loss so she does not turn into a skeleton.” (Ex. 1008 at
000691.) On that date, Christina weighed 199 pounds and her BMI
was calculated as 37.6. (Id.) Captain Wunderlich testified that
Christina was losing weight because she was under-consuming
calories; however, he did not document this concern in her
medical record. (Wunderlich: 3-34-36.) During a September 3, 2010
appointment with Captain Wunderlich, Christina apparently again
voiced a concern “about losing too much weight and being unable
to stop weight loss so she does not become skeletal thin.” (Ex.
1008 at 000699-700). As of that date, Christina weighed 189
pounds and her BMI was calculated as 35.86. (Id. at 000699.)
90. As a part of his work with Christina to prepare her
for surgery and for her post-surgical dietary restrictions,
Captain Wunderlich put Christina on a liquid diet for some period
prior to surgery. (Wunderlich: 3-24-25.) Captain Wunderlich
testified that his general practice was to have patients start
with a two-day clear liquid diet, and then do seven days of a
44
full liquid diet, and then five days of a pureed diet. After this
period of time, patients would return to their one-cup diet to
work on portion control. Finally, about a week before surgery,
patients would again start a full liquid diet of no more than
1200 calories per day to help reduce the liver size in
preparation for surgery. (Id. at 3-25.) Based on the AHLTA
records, it appears Christina completed her trial liquid diet
over the period of time between August 18, 2010 and September 3,
2010. (Ex. 1008 at 000693, 000700.) She was apparently again
placed on the liquid diet the week before her surgery on
September 27, 2010. (Wunderlich: 3-25.)
91. As a part of the Tripler Bariatric Program’s
requirements for surgery, Captain Xavier Pena, a post-doctoral
psychology intern at Tripler in 2010, was tasked with performing
an independent psychological evaluation to determine whether
there were any serious psychological issues that would prevent
Christina from being an appropriate candidate for bariatric
surgery. (Pena: 10-65-66.) Dr. Pena testified that he was not
involved in screening patients for eligibility for surgery, and
that he believed patients would be evaluated by a surgeon for
eligibility prior to having their independent psychological
evaluation. (Id. at 10-89-90.)
92. On September 8, 2010, Christina met with Dr. Pena.
On that date, her weight was 196 pounds and her BMI was
45
calculated as 37.03. (Ex. 1008 at 000706.) The medical note Dr.
Pena wrote states that Christina “reported a personal history of
weight problems for the past 8 years,” and that “[d]espite
previous attempts at weight loss in the past 8 years including
exercise and Alli she began to consider having the gastric bypass
surgery approx 9 months ago . . ..” (Id.) It also states that
Christina identified “her health, ability to do those things she
used to be able to do, and her son as her primary motivators for
having the gastric bypass surgery.” (Id.) With respect to the
timing of Christina’s use of Alli, Dr. Pena’s note is unclear;
however, as noted above, Dr. Verschell testified that he had
prescribed orlistat (a higher-dose, prescription version of Alli)
to Christina in June 2010 during her participation in the LEAN
program. (Ex. 1008 at 000641; Verschell: 12-100-101.)
93. Dr. Pena met with Christina for a follow-up
appointment on September 15, 2010. The September 8, 2010 note was
“copied forward” into the September 15, 2010 note, which
additionally stated that Christina demonstrated that she was
knowledgeable about the surgery and had an understanding of the
risks and benefits involved. (Ex. 1008 at 000717-718; Pena: 10102-103.) Dr. Pena testified at trial that this assessment was
based essentially on his asking the patient whether they
understood the risks and benefits, and that if they answered
“yes,” that would be sufficient for his limited purpose. (Pena:
46
10-107-108.) Dr. Pena also testified that patients who had
progressed through the Tripler Bariatric Surgery Program were
likely to be “psychologically committed to surgery.” (Id. at 10112.)
94. The evidence adduced at trial demonstrated that
Christina had a consistent pattern of weight loss while
particpating in the LEAN Healthy Lifestyles Program. (Ex. 117.)
Despite some testimony, as noted above, that Christina was on a
liquid diet for some amount of time in preparation for surgery,
her preoperative weight loss appears to have been relatively
steady. (Wunderlich: 3-24-25; Ex. 117.)
95. Numerous witnesses testified that Christina was
very successful losing weight through participation in the LEAN
Healthy Lifestyles Program. (Williams: 1-91-92; Ching: 2-84;
Verschell: 12-87; Wunderlich: 3-32-33.)
96. The Court finds that through her participation in
the LEAN Healthy Lifestyles Program from approximately April 13,
2010 until the date of her surgery on September 27, 2010,
Christina lost approximately 34 pounds, and her BMI decreased
from above 41 to around 36.
D.
The Preoperative Meeting with Dr. Payne
97. On September 14, 2010, Christina met with her
bariatric surgeon, Dr. John Payne, for her preoperative
appointment. (Ex. 1008 at 000709.) On that date, Christina
47
weighed 193.9 pounds. (Id.) Her BMI was calculated to be 34.35;
however, this was based on the mistaken entry of her height as 63
inches tall. (Id.) Taking into account Christina’s actual
documented height of 61 inches, her BMI on that date was
approximately 36.6.
98. Dr. Payne testified that the preoperative meeting
was not for the purpose of approving Christina for surgery
because “[t]hat had already been pretty well determined.” (Payne:
2-140-141.) Rather, Dr. Payne stated, his “job was to talk with
her about which procedure [she wanted] and to explain to her what
she had to look forward to in terms of risks and complications .
. ..” (Id. at 2-141.) Dr. Payne also testified that it “seemed
unnecessary” to discuss with Christina whether she should
postpone surgery in light of her weight loss, because she had
already decided that surgery was what she wanted. (Id.) Dr, Payne
stated that he was “not sure” whether he considered Christina’s
BMI at all on the date of the preoperative meeting because
Tripler’s policy was that the BMI taken on the date of the
Information Session was “the one of record.” (Id. at 2-143.)
Indeed, Dr. Payne stated that it was “irrelevant” to the question
of eligibility for surgery if the patient’s BMI fell during the
time she was in the Bariatric Surgery Program (but before
surgery). (Id. at 2-117-118.) Dr. Payne also testified that he
never gave Christina a recommendation for or against surgery.
48
(Id. at 2-114.)
99. Dr. Payne testified that he spent over twenty
minutes discussing the diagnosis, treatments, alternatives, and
potential side effects, as well as the possible risks of Roux en
Y gastric bypass surgery. (Id. at 2-141; see also Ex. 1008 at
000710.) He also testified that he told Christina that she would
probably regain the weight she had lost if she did not have
surgery, regardless of whether she stayed in the LEAN Healthy
Lifestyles Program. (Payne: 2-191.) Dr. Payne also acknowledged
that this message regarding potential weight regain without
surgery was also included on the computer-generated informed
consent form. (Id. at 2-190-191.)
100. With respect to complications, Dr. Payne testified
that his complication rate was quite low, in the range of 1% to
3%, and that he always informed his patients of that rate. (Id.
at 2-109-113.) The Court heard testimony from Dr. Lim; however,
that the actual range of serious complications is closer to
around 20%. (Lim 9/4/13 (Ex. 355) at 64-65.) As noted above, the
medical literature appears to echo this higher complication rate.
(Ex. 1031 (2008 SAGES Guidelines) at 13/31; Ex. 273 (2013 Jones
Article) at 008443.) Dr. Payne testified that informing patients
regarding complication rates involved a balance between “letting
them know about that and terrifying them.” (Payne: 2-162.)
101. Christina testified as to her recollection of the
49
preoperative visit, stating that it “really wasn’t that in
depth,” and that Dr. Payne confirmed which surgery she was going
to have and then went “over the dates that are available and kind
of the recovery time kind of thing.” (Christina: 5-70.) Angelo
Rivera, who also attended the preoperative meeting with Dr.
Payne, testified that Dr. Payne “explained the risks and benefits
of going forward or not going forward.” (Rivera: 3-131.)
102. On September 24, 2010, Christina had her preanesthetic evaluation at Tripler. On that date, she weighed 189
pounds. (Ex. J1 at 001152.)
E.
The Day of Surgery
103. On the day of surgery, September 27, 2010, Dr.
Plackett, a general surgery resident and administrative chief
resident at Tripler, was asked to go over the informed consent
form with Christina and obtain her consent for the procedure.
(Plackett: 10-7-8.)
104. Tripler apparently had a policy that informed
consent must be obtained within thirty days of a planned surgical
procedure; however, there was also testimony that the informed
consent process began at the Information Session and was an
ongoing process throughout the program. (Williams: 1-99-100;
Plackett: 10-45; Leitman: 4-114-115; Jones: 7-176-178.)
105. Apparently as a part of this ongoing process, the
Tripler staff, including Dr. Payne, advised Christina that she
50
would regain the weight she lost through the LEAN Healthy
Lifestyles Program if she did not have bariatric surgery.
(Christina: 5-67-68; Payne: 2-191.) Penny Ball, a patient in the
Tripler Bariatric Surgery Program in 2009 and 2010, stated that
Tripler staff “forewarned” patients during their orientation to
the program that the nutritionists “would probably discourage us
on the surgery” because “that’s their job to do that,” but that,
even if they lost some weight in the program, the patients would
probably gain the weight back unless they had surgery. (Ball (Ex.
353) at 37-38, 47-48.) There was, however, contrary testimony
regarding the information provided with respect to weight regain
from several Tripler providers. Dr. Verschell testified that he
would never tell a patient that she would likely regain all the
weight she had lost through the LEAN program without surgery.
(Verschell: 12-88-89.) Dr. Verschell stated that he would
“wouldn’t have said that she would have probably lost all her
weight because that, generally speaking, doesn’t happen,” but
that he would also never tell Christina that she would regain all
the lost weight without surgery “[b]ecause it’s not a foregone
conclusion.” (Id.) Andrew Ching and Nurse Williams echoed this
testimony, stating that they too never told patients that they
would regain any lost weight if they did not have surgery.
(Ching: 2-85; Williams: 1-102-103.)
106. One of the risks of bariatric surgery is that the
51
patient will eventually regain weight lost following surgery.
(See Ex. 273.) Nevertheless, the Court finds it troubling that
some staff members of the Tripler Bariatric Surgery Program
promoted the LEAN Healthy Lifestyles Program as an effective
program to achieve sustained weight loss, while at the same time
other staff members counseled Christina that any weight she lost
through the LEAN program would not be sustainable without
surgery. The Court is also troubled by the fact that, while
Christina was informed of the risks of having weight loss
surgery, she was also told that the risks of not having surgery
(weight regain and eventual development of comorbidities) may be
even greater, even though she had already successfully lost
approximately 34 pounds in the LEAN Healthy Lifestyles Program.
107. Dr. Plackett testified that he did not recall
specifically meeting with Christina on September 27, 2010, but
assumed he had done so because of his signature on the informed
consent form. (Ex. 1004; Plackett: 10-11.) Because he did not
recall meeting with Christina specifically, Dr. Plackett’s
testimony was based on his normal practice. (Plackett: 10-11-12.)
Dr. Plackett explained that he was typically called in to do the
informed consent as the administrative chief resident if all of
the paperwork had not been completed during the preoperative
meeting. (Id. at 10-9-10.) He also testified that, if there were
no questions from the patient, it typically took him about five
52
minutes to provide the information necessary for a patient to
give informed consent. (Id. at 10-29.)
108. The informed consent form, which Christina signed,
includes a brief description of the operation, a list of the
risks of the procedure and the common complications, and
statements regarding the likely outcome and the necessary postoperative follow-up care. (Ex. 1004 at 000475.) It states that
the alternatives to the operation are medical diets or other
bariatric surgical procedures. (Id.) The form states that the
“risks and benefits” associated with those alternatives are that
“[m]edical weight loss has few risks, although sustained weight
loss is usually not attained.” (Id.) The risks associated with
forgoing any treatment are stated as “[l]ack of weight loss and
medical illness associated with obesity.” (Id.)
109. Dr. Plackett testified that he would typically go
through the form line by line with the patient and explain each
element, including providing an explanation of how the surgery is
performed, the risks associated with the surgery (e.g., bleeding,
leakage, strictures, nutritional deficiencies), and the
alternatives and the risks associated with those alternatives
(including a statement that, often, weight lost through diet and
exercise is regained). (Plackett: 10-12-14.) Dr. Plackett
testified that it was not his standard practice to discuss the
patient’s BMI on the date of surgery, or to provide patients with
53
specific percentages associated with complication risks. (Id. at
10-47, 10-56.) He also testified that he would not have discussed
with Christina whether she should have attempted other weight
loss approaches before trying surgery because it was his
understanding that that conversation would have occurred when the
patient first entered the Bariatric Surgery Program. (Id. at 1051.) Dr. Plackett testified that he gave patients an opportunity
to ask any questions they may have, and that surgery would be
canceled if a patient expressed “significant reservations” or did
not indicate a full understanding of the consent form. (Id. at
10-17-18.)
110. Christina testified that she did not recall
signing the consent form or having it explained to her.
(Christina: 5-147-148.) She also testified that she did not
recall having a conversation with Dr. Plackett prior to surgery,
and only recalled meeting him after her surgery. (Id.)
Nevertheless, Christina testified that she did recall signing
some papers on the date of surgery, and that the signature on the
informed consent form was, indeed, hers. (Id. at 5-47, 5-152154.) She also testified that she signed the informed consent
form only after she was in a hospital gown and hooked up to an
IV. (Id. at 5-154.) This testimony is contradicted by testimony
by Angelo Rivera that the consent forms were signed prior to
Christina being prepped for surgery, and the testimony of Dr.
54
Plackett that consent forms were signed while patients were still
in street clothes and that a patient would never have been
permitted to move forward with surgery if she had been on any
sort of medication at the time she signed the informed consent
forms. (Rivera: 3-157; Plackett: 10-19.) The Court found
Christina’s credibility somewhat questionable, as she was often
unable to recall numerous important details; although, the Court
recognizes that Christina has suffered severe post-surgical
complications.
111. Both Christina and Angelo Rivera testified that
Christina was nervous before surgery and unsure whether she
should go through with it. (Christina: 5-73-74; Rivera: 3-156157.) Angelo testified that Christina expressed her anxiety about
the operation after she had signed the consent form. (Rivera: 3157.)
112. On the date of surgery, Christina weighed 189.5
pounds and her BMI was automatically calculated (based on a
mistaken height of 63 inches) to be 34.3. (Ex. J1 at 001197.)
Using her actual height (as discussed above), her BMI on that
date was approximately 36. Thus, since entering the Tripler
Bariatric Surgery Program on March 30, 2010, Christina had lost
approximately 34 pounds through the LEAN Healthy Lifestyles
Program. The evidence adduced at trial suggests that a person
with a normal, healthy weight would have a BMI of 18.5 to 24.9.
55
(Jones: 4-147, 8-62; Ex. J5 at 0011571.) Thus, a patient who is
61 inches tall would have a normal, healthy weight if she weighed
between 101 pounds and 132 pounds. (Jones: 7-166; 8-62-63, 8-66.)
Christina’s documented weight on the date she attended the
Information Session was 221 pounds, indicating that Christina had
at least 89 pounds of excess weight at that time. Thus,
Christina’s loss of 34 pounds in the LEAN program represented a
loss of approximately 15% of her body weight and 38% of her
excess body weight.
113. The Court finds that, as a part of the informed
consent process, none of Christina’s providers discussed with her
the fact that her BMI had fallen below 40 with no comorbidities,
and that this indicated, according to the prevailing standards of
conduct in the applicable medical community, that the risks of
the surgery outweighed the potential benefits for her.
VI.
Christina’s Post-Surgery Complications
114. On September 27, 2010, Christina Mettias underwent
the Roux en Y bariatric surgery at Tripler Army Medical Center.
(Ex. 1 at 001148-001151.) As a direct result of complications of
the surgery, Christina reasonably and necessarily required the
medical treatments detailed below. Because Christina was at the
time still a military dependent, all of the following medical
treatments were covered by Tricare. (Tr. 12:-122-123.)
115. Christina’s post-operative course was complicated
56
by tachycardia and anemia for which she received a transfusion of
two units of packed red blood cells. (Id. at 001145.)
116. On October 1, 2010, Christina was discharged and
prescribed liquid narcotics for pain. (Id. at 001173-001175.)
117. On October 9, 2010, Christina was re-admitted to
Tripler Army Medical Center after she appeared in the Emergency
Room, reporting sharp and non-radiating pain in her left lower
chest and left upper abdominal area. (Ex. 2 at 001530-0011542.)
It appeared that she had a hematoma, or bleed. As a result, on
October 11, 2010, Christina underwent laparoscopic surgery,
during which surgeons lysed adhesions, and evacuated “some dark
blackish thick fluid” and a “large pocket of what seemed to be a
liquefied hematoma.” (Id. at 001543-001544.) On October 15, 2010,
Christina was discharged. (Id. at 001539.)
118. On October 26, 2010, Christina was re-admitted to
Tripler after she again came to the Emergency Room, reporting
persistent left shoulder pain that radiated down her left lateral
chest to her left lower back, despite being on prescription
narcotic pain medication. (Ex. 3 at 001910-001912.) A CT scan
showed fluid collection near the gastric remnant, with
re-accumulation of the intra-abdominal fluid collection in the
same location of her previous hematoma. On October 27, 2010, a
limited Scout CAT scan was performed and a “pig tail” catheter
drain was placed in the area of the fluid collection. Christina
57
was discharged on November 2, 2010 with the fluid drain still in
place. (Id. at 001921-001925.)
119. In December of 2010, Christina met with Dr. Payne,
got the drain removed, and traveled back east to Alabama to spend
Christmas with her family. (Christina: 5-82-83.) On December 20,
2010, Christina went to the Emergency Room of the Southeast
Alabama Medical Center, reporting “7 out of 10” abdominal pain. A
CT scan revealed a post-operative seroma, or fluid build-up. (Ex.
76 at 004506; 004513.) On the advice of the Alabama doctors,
Christina return to Hawaii for treatment. (Christina: 5-85-86.)
120. On January 3, 2011, Christina was re-admitted to
Tripler. A CAT scan of her abdomen showed re-accumulation of the
intra-abdominal hematoma near the gastric remnant and a right
adnexal mass. (Ex. 4 at 0002433-002437.) Thus, on January 6,
2011, Christina was taken back to surgery and underwent a
diagnostic laparoscopy, lysis of adhesions, partial gastrectomy,
esophageal dilation, repair or the gastrojejunostomy and
placement of a gastric feeding tube. During the operations,
surgeons perforated Christina’s gastric pouch and diaphragm. (Id.
at 002440-002447.)
121. On January 8, 2011, Christina went into
hypercapnic respiratory failure, requiring intubation, and
breathing via a ventilator. (Id. at 0002440.) On January 10,
2011, Christina was still in critical condition, with persistent
58
tachycardia, hypertension, and leukocytosis and infection from
the multiple bowel perforations. An x-ray revealed that her
feeding tube might have become dislodged. For this reason she was
taken back to surgery for a diagnostic laparoscopy, washout and
“NG” tube verification. Surgery revealed a probable persistent
leak near the revised gastric pouch with poor surrounding tissues
for repair. (Id. at 002440; 002450-002451.)
122. On February 22, 2011, Christina was taken to Pali
Momi Medical Center, where a stent was surgically placed in her
esophagus. The surgeons also removed a JP drain placed in a prior
surgery that had eroded into the esophagus. (Id. at 002440.)
123. On February 23, 2011, despite receiving “several
boluses of narcotics,” Christina reported significant pain.
Physicians at Tripler switched her from Fentanyl to Dilaudid to
address the pain. Beginning March 4, 2011, narcotic medications,
including Roxycodone, Tylenol, and Dilaudid, were ordered to
control Christina’s pain. On March 10, 2011, after a Pain
Management Service consult, Christina’s pain medication was
changed to Oxycontin for long-acting pain control, Roxicet for
breakthrough pain, and Gabapentin. (Id. 4 at 002440-002441.)
124. On March 15, 2011, Christina was discharged. Her
medications included Promethazine (Phenergan) for nausea,
Oxycodone (Roxicet) and Oxycontin for pain. She was discharged
with a gastric tube and a JP drain in place. (Id. at 002442.)
59
125. On March 27, 2011, Christina was re-admitted to
Tripler from the Emergency Room for complaints of inability to
swallow foods and liquids, vomiting, and abdominal and epigastic
pain. (Ex. 5 at 007372-007375.) She was given IV medications to
control nausea and abdominal pain. A CT scan was performed on
March 28, 2011 to evaluate the esophageal stent placement, and on
April 1, 2011 Christina was discharged. Her pain medications
included Oxycodone and Tylenol. (Id. at 007381-007386.)
126. On April 12, 2011, Christina went to the Emergency
Room at Tripler, reporting retching and abdominal, epigastric,
and back pain. Christina was admitted for close monitoring, pain
management, and nutritional management. (Ex. 6 at 007721,
007724.) She was given IV pain medication and was fed through a
G-tube. During her hospital course she was brought to Pali Momi
Medical Center for an esophagogastroduodenoscopy (“EGD”). Her
G-tube feedings were discontinued on April 30, 2011, and she was
discharged on May 5, 2011, with prescriptions for Roxicodone
elixir, Oxycodone and Gabapentin, and Dilaudid (for breakthrough
pain). (Id. at 007726; 007728-007729; Ex. 51.)
127. On May 16, 2011, Christina was re-admitted to
Tripler for bilateral lower abdominal pain, described as a
“burning” sensation, with a two-day history of bloody stools,
diarrhea, chronic pain, nausea, vomiting, and an intolerance to
food and fluids. The diagnostic assessment was that of a “33 year
60
old female with complicated surgical history, chronic caloric
insufficiency, chronic narcotic dependence, worsening of chronic
abdominal pain, diarrhea, melena [(bloody stool)].” (Ex. 7 at
008960-008964.) Laboratory analysis of stool samples revealed a
bacterial infection. Christina was treated with antibiotics and
discharged on May 26, 2011. (Id. at 008970-008974.)
128. On May 31, 2011, Christina was re-admitted to
Tripler due to burning epigastric pain, nausea, vomiting,
fatigue, and inability to take foods or fluids by mouth. A CT
scan revealed a ventral hernia in the left lower quadrant, and a
knuckle of her small bowel was found to be incompletely
protruding into this hernia. An EGD was performed for narrowing
in her esophagus and her ongoing epigastric pain. A balloon
dilation was performed, and biopsies were taken. An esophageal
stricture was noted. Christina was discharged on June 5, 2011.
(Ex. 8 at 009434-009437, 009444-009454; Ex. 52.)
129. On July 7, 2011, Christina was readmitted to
Tripler after she went to the Emergency Department reporting
persistent mid-epigastric abdominal pain, similar to her chronic
pain, but which had worsened over the previous week. Christina
described the pain as intermittent “stabbing,” worsened by
movement. She underwent an EGD and was treated with IV fluids for
dehydration. The diagnostic assessment advised to “consider pain
management consult in am,” and “consult GI for repeat EGD to
61
evaluate for re-stenosis.” Christina was discharged on July 11.
(Ex. 9 at 009712; 009715; 009737-009741, 00943-009744; Ex. 53.)
130. On August 4, 2011, Christine was again re-admitted
to Tripler after she reported an inability to swallow food and
medication, feeling that foods and medication were sticking in
her throat (dysphagia). Christina reported massive left sided
chest pain and right upper quadrant pain, and that all of her
pain might be exacerbated by her inability to swallow her pain
medication. (Ex. 10 at 010040.) On August 5, 2011 Christina
underwent an EGD with balloon dilatation and steroid injection at
her esophageal stricture. Her pain was controlled with
intravenous pain medication (Dilaudid). Her dysphagia gradually
improved but she continued to regurgitate food with meals. On
August 10, 2011, she underwent a second EGD. She experienced
small amounts of regurgitation after meals. She was discharged on
August 12, 2011. (Id. at 010052-010056; Ex. 54.)
131. On August 29, 2011 and October 17, 2011, Christina
underwent additional EGDs at Tripler. (Ex. 56; Ex. 57.)
132. On October 17, 2011, Christina underwent a celiac
plexus block at the Honolulu Spine Center to address her chronic
abdominal pain. (Ex. 58 at 006922-006923.)
133. On November 10, 2011, Christina underwent a
bilateral T11 and T12 intercostal nerve blocks, or injections of
medicine to her nerves to address the pain in her chest and
62
abdomen, at the Honolulu Spine Center. (Id. at 006913-006919.)
134. On November 18, 2011, Christina underwent an EGD
and balloon dilation at Tripler. (Ex. 59.) On December 13, 2011,
Christina underwent another EGD with placement of a stent at
Tripler. (Ex. 60; Ex. 11 at 010459-010460.) On the same day,
Christina was re-admitted to Tripler for observation and pain
management. Christina reported that the injections and nerve
blocks at the Honolulu Spine Center did not control her pain. She
reported taking Roxicet and wearing Fentanyl patches for pain.
During her hospitalization, Christina had frequent vomiting and
was not given her IV Zofran and Phenergan as needed. She was
noted to be in a great deal of pain. On December 18, 2011,
consults (or referrals) were placed to the Psychiatry Service and
Pain Management to assist with Christina’s “chronic pain and
visceral hypersensitivity given her multiple prior surgeries
[and] complications.” Upon discharge, the pain anesthesia
provider prescribed Dilaudid pills to wean her off IV dilaudid
pushes, Tylenol elixir, Roxanol Elixier, Fentanyl Patches, and
Effexor. Christina was discharged December 23, 2011. (Ex. 11 at
010451-010457; 010459.)
135. On January 3, 2012, Dr. Nancy Smiley had a
telephone conversation with Christina, during which she
documented “chronic pain” as part of Christina’s medical history.
(Ex. 47 at 001031.) Dr. Smiley understood that the chronic pain
63
had been occurring since the gastric bypass surgery of September
27, 2010. (Smiley: 2-21.) Christina had an in-person appointment
with Dr. Smiley the next day to follow up with pain management.
Christina reported being unable to eat due to food getting stuck
in her throat. She admitted to feeling depressed, not sleeping
well, and having a lot of pain. (Ex. 48 at 001034.) Dr. Smiley
prescribed Zoloft for depression, anxiety, and chronic pain, and
Pamelor for chronic pain. (Smiley: 2-25.) In the time that she
treated her, Dr. Smiley did not find Christina to be
drug-seeking, and Christina did not appear to desire to stay in
the hospital longer than necessary. (Id. at 2-26.)
136. On January 18, 2012, Christina underwent an EGD at
Tripler. (Ex. 62.) On January 24, 2012, she underwent anther EGD
with removal of esophageal stent at Pali Momi Medical Center.
During the procedure “severe stenosis” was identified, and the
scope could not traverse that area until after a balloon
dilation. The stent was found to have migrated and was now
embedded in the gastric pouch. (Ex. 63.)
137. Christina left Hawaii and moved to Dothan, Alabama
in or around February 2012. On February 24, 2012, Christina
underwent an EGD at the Dothan Surgery Clinic. (Ex. 64.) On March
23, 2012, she underwent another EGD at the Southeast Alabama
Medical Center in Dothan. (Ex. 65.) On April 19, 2012, Christina
underwent another EGD at the Dothan Surgery Clinic. (Ex. 66.)
64
138. On May 1, 2012, Christina was admitted to the
Southeast Alabama Medical Center for a cholecystectomy and lysis
of adhesions. She was noted to have “a significant amount of pain
initially post-operatively in addition to nausea and vomiting.”
After improvement, she was discharged on May 3, 2012. (Ex. 67 at
004131-004132; Ex. 68 at 004126-004127.)
140. On May 10, 2012, Dr. George Smallfield of the
University of Alabama Hospital at Birmingham proposed a dilation
with Savory dilators, as opposed to the balloon dilations and
stenting that Christina had received in the past. Dr. Smallfield
noted that if dilation with Savory dilators was unsuccessful,
surgery may be required. (Ex. 69.) On May 16, 2012, Christina
underwent an EGD with Dr. Smallfield, and on May 23, 2012,
Christina underwent a repeat EGD, again with Dr. Smallfield.
(Exs. 70, 71.)
141. Thereafter, Christina underwent numerous
subsequent EGDs in Dothan. (Exs. 72, 73, 74, 75, 77, 81, 84, 86.)
142. On February 6, 2013, Christina was admitted to
Flowers Hospital in Dothan for evaluation of a fibroid (a
noncancerous growth), as well as abdominal and pelvic pain. Under
general anesthesia, Christina underwent a diagnostic laparoscopy,
lysis of adhesions, a laparoscopic hysterectomy, and removal of a
right round ligament fibroid. The surgeon noted “severe abdominal
and pelvic adhesions.” (Ex. 79 at 006238; Ex. 80.) Adhesions, or
65
scar tissue formations between organs, can cause blockages within
organs, and when they block the gastrointestinal tract, the
patient cannot eat and vomits. (Leitman: 4-62-63.) Adhesions can
also cause pain. (Id. at 4-62.)
143. On May 6, 2013, Christina was again admitted to
Flowers Hospital and underwent another surgery for lysis of
adhesions (or, surgery to address scar tissue forming between
organs). (Ex. 82.) On June 18, 2013, she was admitted to
Southeast Alabama Medical Center and underwent surgery to repair
an incisional hernia. She was discharged after two days. (Ex.
83.)
144. On January 22, 2014, Christina was treated for
severe epigastric pain at the Digestive Health Specialists of
Dothan, Alabama. (Ex. 85.)
145. As is made clear by the foregoing, Christina has
had a great number of procedures which have created scar tissue,
or adhesions, which have caused pain, and for which she has been
prescribed painkillers. Christina will always have some adhesions
and her pain is not likely to go away. (Leitman: 4-62-63.)
146. On September 25 and October 29, 2014, Christina
underwent a multidisciplinary evaluation at the Doleys Clinic.
(Ex. 87.) On October 8, 2014, Christina also underwent a pain
management evaluation at the Doleys Clinic. The resulting
recommendations included pool therapy, Butrans patches, and Norco
66
for breakthrough pain. (Ex. 88 at 007501.) Dr. Doleys noted that
Christina continues to be a candidate for a potential intrathecal
pump depending on how she responds to other therapies “as there
does appear to be some opioid responsiveness to her pain.”
Christina’s treatment is ongoing. (Ex. 89 at 007499.)
147. Christina Mettias’ quality of life has been
substantially worsened by the complications she has endured as a
result of the Roux en Y surgery of September 27, 2010. Due to the
complications resulting from the surgery, Christina has
experienced chronic pain, which will likely last at least to some
extent for the remainder of her life. (Leitman: 4-64.) Moreover,
her pain is difficult to control with oral medications because
her digestive tract has been shortened, and medications are
malabsorbed. (Smith: 6-51-52.)
148. The gastric bypass surgery of September 27, 2010
has caused Christina to develop a chronic eating problem, namely,
intolerance to oral foods and dysphagia (the sense of having food
stuck in the throat). (Smith: 6-50, 6-65; Leitman: 4-59.) She has
also developed dumping syndrom, which causes on-going bladder and
bowel accidents. (Smith: 6-50-51, 6-65, 6-90-91; Leitman: 4-6768.) Unfortunately, there is no cure for Christina’s chronic
pain, chronic eating problems, chronic malabsorption, fatigue and
lack of endurance. (Smith: 6-73.)
149. In sum, the Court finds that as a proximate and
67
legal result of the Roux en Y gastric bypass surgery, Christina
suffered numerous serious injuries and complications, including a
perforated esophagus, perforated diaphragm, chronic esophageal
fistula, gastric bleeding with chronic hematoma, left pleural
effusion, and persistent nutritional deficiencies. These injuries
have left her partially and permanently disabled, disfigured, in
constant pain, chronically fatigued, unable to maintain her close
relationship with her son, N.M., and other loved ones, in need of
medical, rehabilitative and life care, and at risk for future
complications.
150. The injuries and complications Christina suffered
as a consequence of the Roux en Y gastric bypass surgery also
caused some disruption and injury to her relationship with her
son, N.M. Christina testified that N.M. was visiting over the
summer during the time she was in the hospital because of
complications from her surgery. (Christina: 5-103-104.) She
further testified that their relationship has been affected
because she can’t take care of him any longer, and he now has to
take care of her sometimes, helping her when she’s sick and
getting her her medicine. (Id. at 5-104.)
151. Christina life expectancy, based upon the National
Vital Statistics Report, is 82 years of age. (Smith: 6-77-78.)
Ms. Smith testified that she corroborated the life expectancy
with Christina’s treating physicians. (Id. at 6-78.) There has
68
been no testimony rebutting Ms. Smith’s regarding life
expectancy, and no testimony that Christina’s injuries may render
her life expectancy shorter than average. The Government has
argued that Christina received “the full benefit from the
surgery” and that it “improved her life expectancy.” (Tr. 12-12.)
Conversely, Plaintiffs’ counsel has acknowledged that the Court
may, based upon the evidence adduced at trial regarding
Christina’s myriad health problems, conclude that some reduction
in life expectancy is appropriate. (Id. at 12-10-11.) During
closing arguments, Plaintiffs’ counsel suggested a ten percent
reduction in life expectancy might be appropriate. The Court
finds, however, that the only evidence specifically regarding
life expectancy adduced at trial was the testimony of Ms. Smith.
The Court therefore finds that Christina has a life expectancy of
82 years of age.
CONCLUSIONS OF LAW
Having evaluated the factual aspects of Plaintiffs’
claims, this Court will now further address the legal issues of
the FTCA, vicarious liability, medical negligence, informed
consent, and loss of filial consortium.
I.
The FTCA and Vicarious Liability
1. “Under the FTCA, the United States is liable for
certain torts ‘in the same manner and to the same extent as a
private individual under like circumstances,’ 28 U.S.C. § 2674,
69
‘in accordance with the law of the place where the [alleged] act
or omission occurred,’ 28 U.S.C. § 1346(b).” McMillan v. United
States, 112 F.3d 1040, 1043 (9th Cir. 1997) (alteration in
original). Thus, for purposes of this lawsuit, the FTCA subjects
the United States to suit insofar as a private individual, in
this case a private hospital, would be subject to suit under
Hawaii law. See id.
2. Hawaii law dictates that, “[u]nder the theory of
respondeat superior, an employer may be liable for the negligent
acts of its employees that occur within the scope of their
employment.” Wong–Leona v. Hawaiian Indep. Refinery, 879 P.2d
538, 543 (Haw. 1994). As such, the Government, through its
operation of Tripler, is potentially subject to liability for the
allegedly negligent acts of its employees, including but not
limited to Dr. John Payne, who were acting within the scope of
their employment in treating Christina. The Court therefore turns
to Plaintiffs’ claims against the Tripler providers.
II.
Medical Negligence
3. In order to prevail on a medical malpractice claim,
a plaintiff must prove the following elements by a preponderance
of the evidence: (1) a duty requiring the defendant to conform to
a certain standard of conduct, (2) a failure on the dependent’s
part to conform to that standard, (3) a reasonably close causal
connection between the conduct and the resultant injury, and (4)
70
actual loss or damage. Takayama v. Kaiser Found. Hosp., 923 P.2d
903, 915–16 (Haw. 1996) (quoting Knodle v. Waikiki Gateway Hotel,
Inc., 742 P.2d 377, 383 (Haw. 1987)) (alteration in original);
see also Bernard v. Char, 903 P.2d 676, 682 (Haw. 1995).
4. As to liability, “the established standard of care
for all professionals is to use the same degree of skill,
knowledge, and experience as an ordinarily careful professional
would exercise under similar circumstances.” Kaho‘ohanohano v.
Dep’t of Human Servs., 178 P.3d 538, 572 (Haw. 2008). “[T]he
standard of care for a claim based on allegedly negligent medical
treatment must be established by reference to prevailing
standards of conduct in the applicable medical community.” Carr
v. Strode, 904 P.2d 489, 499 n. 6 (Haw. 1995).
5. The standard of care, as well as any breach thereof,
must generally be established through expert medical testimony.
See Kaho‘ohanohano, 178 P.3d at 572 (“[I]n medical malpractice
actions, expert opinion is generally required to determine the
‘degree of skill, knowledge, and experience required of the
physician, and the breach of the medical standard of care.’”
(quoting Exotics Hawaii–Kona, Inc. v. E.I. Du Pont de Nemours &
Co., 172 P.3d 1021, 1044 (Haw. 2007))). “[I]t is generally not
sufficient for a plaintiff’s expert witness (i.e., one qualified
in medicine, or dentistry, as the case may be) to testify as to
what he or she would have done in treating a particular patient.”
71
Bernard, 903 P.2d at 682. “The expert must go further and state
that the defendant’s treatment deviated from any of the methods
of treatment approved by the standards of the profession.” Id.
6. With respect to causation, “[i]n a medical
malpractice action, a plaintiff must show with reasonable medical
probability a causal nexus between the physician’s treatment or
lack thereof and the plaintiff’s injury.” Craft, 893 P.2d at 156
(citing McBride v. United States, 462 F.2d 72, 75 (9th Cir.
1972)).
7. In the case at bar, the Court finds and concludes
that the standard of care in the applicable medical community was
that a patient must have a BMI of 40 or above with no
comorbidities, or 35 and above with comorbidities, in order to be
eligible and an appropriate candidate for bariatric surgery.
Thus, the standard of care required that the Tripler providers
offer bariatric surgery to Christina only if she met this BMI
criterion. The Court finds that Christina’s surgeon and other
medical providers knew or should have known, both on September
14, 2010 (the date of her preoperative meeting to schedule
surgery) and on the date of surgery (September 27, 2010), that
Christina had lost approximately 34 pounds through the LEAN
program and therefore had a BMI of approximately 36, with no
comorbidities. In light of this, the Court finds and concludes
that Tripler breached the applicable standard of care by offering
72
and performing bariatric surgery on Christina on September 27,
2010, despite the fact that Tripler staff knew or should have
known that Christina’s BMI at the time of her preoperative
meeting with Dr. Payne did not meet the BMI eligibility criterion
established by the relevant medical community.
8. The Court has also found that, in addition to the
BMI criterion, the standard of care for bariatric surgery
required that a patient have failed in a formal weight loss
program of some kind prior to being offered surgery. The Court
finds and concludes that Tripler breached the applicable standard
of care by offering and performing bariatric surgery on Christina
on September 27, 2010, despite the fact that Tripler staff knew
or should have known that Christina had never failed in a
nonsurgical weight loss program of any kind as of the date she
was screened for entry into the Tripler Bariatric Surgery
Program. The Court notes that, on May 20, 2010, during her
session with Andrew Ching, Christina stated “that in the past she
ha[d] attempted to use diet pills as a way to lose weight.” (Ex.
1008 at 000706.) Similarly, on September 8, 2010, Dr. Pena noted
that Christina reported that “[d]espite previous attempts at
weight loss in the past 8 years including exercise and Alli she
began to consider having the gastric bypass surgery[.]” (Id. at
000706.) Nevertheless, as of March 30, 2010, when Christina was
first enrolled in the Tripler Bariatric Surgery Program,
73
Christina’s medical records made no mention of any prior weight
loss attempts on her part. Further, the prior weight loss
attempts that are noted (albeit rather vaguely) clearly do not
suggest that Christina had ever participated in any sort of
formal weight loss program prior to entering the Tripler
Bariatric Surgery Program. Thus, at the time Christina enrolled
in the Tripler Bariatric Surgery Program, she had no documented
failed attempts in any formal, nonsurgical weight loss program.
The Tripler providers therefore breached the standard of care by
enrolling Christina in the Tripler Bariatric Surgery Program
without conducting an adequate inquiry of her weight loss history
and without confirming, based on that history, that she had, in
fact, made documented prior attempts at weight loss through a
nonsurgical program of some kind.
9. Moreover, the Court finds and concludes that Tripler
breached the applicable standard of care by offering and
performing bariatric surgery on Christina despite the fact that
Tripler staff knew or should have known that Christina succeeded
in losing approximately 34 pounds (approximately 15% of her body
weight) through her participation in Tripler’s LEAN Healthy
Lifestyles Program, which (as discussed above) was the only
nonsurgical weight loss program Christina had tried prior to
surgery. The Court is mindful that Dr. Jones emphasized many
times that 95% of obese people typically regain any weight they
74
may lose without surgical intervention. (Jones: 8-89-90.)
Nevertheless, given Christina’s success in losing 34 pounds
through the LEAN program, and the evidence adduced at trial
supporting the LEAN program participants’ ability to lose weight
and sustain such losses, the Court cannot find that any further
nonsurgical weight loss efforts on Christina’s part would have
been “futile.” (See Ex. J5.) Thus, Christina did not even meet
Tripler’s own eligibility requirements, which state that a
patient must have failed “all medical weight loss options and
[feel] that any further non-surgical attempts would be futile.”
(Id.) Indeed, Dr. Verschell testified that frequent and long-term
contact with a behavior modification program such as the LEAN
Healthy Lifestyles Program can be a successful, nonsurgical
method of preventing weight regain. (Verschell: 10-182-183.)
Moreover, the NIH Consensus Statement noted that “[t]he
possibility should not be excluded that the highly motivated
patient can achieve sustained weight reduction by a combination
of supervised low-calorie diets and prolonged, intensive behavior
modification therapy.” (Ex. J4 at 4.) The Court therefore finds
and concludes that, in accordance with the standard of care in
the applicable medical community, Christina’s obvious success in
losing weight through the LEAN program disqualified her from
weight loss surgery on September 27, 2010. The Tripler providers
therefore breached the standard of care by offering Christina
75
bariatric surgery even after her demonstrated success in a
nonsurgical weight loss program.
10. Thus, the Court finds and concludes that Tripler
breached the applicable standard of care by offering and
performing Roux en Y gastric bypass surgery on Christina on
September 27, 2010. The Court further finds that Tripler’s breach
of the applicable standard of care proximately and legally caused
Christina to undergo Roux en Y gastric bypass surgery on
September 27, 2010, resulting in the severe and debilitating
complications and injuries set forth herein. The Court therefore
finds in favor of Plaintiffs, based upon the preponderance of the
evidence, as to the medical negligence claim.
III. Informed Consent
Because the Court has determined that Tripler breached
the applicable standard of care by offering bariatric surgery to
Christina on September 27, 2010, it need not reach the issue of
whether Tripler also breached the requirement that it obtain
Christina’s informed consent prior to surgery. Nevertheless, for
the purpose of providing a complete record, and in the
alternative, the Court provides the following conclusions of law
regarding the issue of informed consent.
11. In Hawaii, failure to obtain informed consent
establishes a separate cause of action sounding in tort. Haw.
Rev. Stat. § 671-1.
76
12. To establish a claim of negligent failure to obtain
informed consent under Hawaii law, the plaintiff must demonstrate
by a preponderance of the evidence that: (1) the physician owed a
duty to disclose the risk of one or more of the collateral
injuries that the patient suffered; (2) the physician breached
that duty; (3) the patient suffered injury; (4) the physician’s
breach of duty was a cause of the patient’s injury in that (a)
the physicians treatment was a substantial factor in bringing
about the patient’s injury and (b) a reasonable person in the
plaintiff patient’s position would not have consented to the
treatment that led to the injuries had the plaintiff patient been
properly informed; and (5) no other cause is a superseding cause
of the patient’s injury. Barcai v. Betwee, 50 P.3d 946, 959–60
(Haw. 2002) (citing Bernard v. Char, 903 P.2d 667, 670, 676 (Haw.
1995)).
13. Physicians have a duty to reasonably inform
patients regarding those items set forth in Haw. Rev. Stat.
§ 671-3:
(1)
(2)
(3)
(4)
(5)
The condition to be treated;
A description of the proposed treatment or
procedure;
The intended and anticipated results of the
proposed treatment or procedure;
The recognized alternative treatments or
procedures, including the option of not
providing these treatments or procedures;
The recognized material risks of serious
complications or mortality associated with:
(A) The proposed treatment or procedure;
(B) The recognized alternative treatments or
77
(6)
procedures; and
(C) Not undergoing any treatment or
procedure; and
The recognized benefits of the recognized
alternative treatments or procedures.
14. Hawaii courts have adopted the patient-oriented
standard for determining whether particular information must be
disclosed to a patient. Ray v. Kapiolani Med. Specialists, 259
P.3d 569, 583 (Haw. 2011). Under the patient-oriented standard,
the scope of a physician’s duty of disclosure is measured by what
a reasonable patient would need to know in order to make an
informed and intelligent decision regarding proposed medical
treatment. Id.
15. As noted above, the Tripler staff, including Dr.
Payne, advised Christina that she would regain the weight she
lost through the LEAN Healthy Lifestyles Program if she did not
have bariatric surgery, with Dr. Payne telling Christina that she
would likely regain the weight even if she continued in the LEAN
program. (Christina: 5-67-68; Payne: 2-191; Ball (Ex. 353) at 3738, 47-48; Plackett: 10-12-14.) Indeed, the informed consent form
Christina signed expressly stated that a risk of not having the
surgery was that “sustained weight loss is usually not attained.”
(Ex. 1004 at 000475.) This was despite the fact that this alleged
risk is not factored into the analysis regarding the
appropriateness of surgery adopted by the NIH, SAGES, ASMBS, or
Tripler itself. (See generally Ex. J4 (NIH Consensus Statement);
78
Ex. 1029 (ASMBS Guidelines); Ex. 1031 (SAGES Guidelines); see
also Ex. Ex. 121 (Ernsberger Report) at 11.)
Moreover, there was strong testimony, including from
Dr. Verschell, the head of the LEAN program, that frequent and
long-term contact with a behavior modification program such as
the LEAN Healthy Lifestyles Program can be a successful,
nonsurgical method of preventing weight regain. (Verschell:
10-182-183.) Indeed, Dr. Verschell testified that Christina lost
weight and learned and practiced behaviors in the LEAN Healthy
Lifestyles Program that would allow her to keep off the weight.
(Id. at 12-86.) Dr. Verschell testified that he would never tell
a patient that she would likely regain all the weight she had
lost through the LEAN program without surgery, and Andrew Ching
and Yvette Williams both echoed this testimony. (Verschell:
12-88-89; Ching: 2-85; Williams: 1-102-103.) Based on all of the
evidence before it, the Court finds and concludes that, under the
circumstances of this case, it was a breach of the standard of
care for Tripler staff to advise Christina that she would
invariably regain the weight she had lost through the LEAN
Healthy Lifestyles Program if she did not go forward with
surgery.
16. The Court also finds and concludes that the
approach taken by the Tripler Bariatric Surgery Program, wherein
Christina was never provided with advice or a recommendation that
79
she should postpone her gastric bypass surgery in light of her
nonsurgical weight loss and the drop in her BMI, failed to
adequately apprise Christina of information that a reasonable
patient would need to make an informed decision regarding
bariatric surgery. Specifically, the BMI patient eligibility
criterion reflects a consensus by the medical community that the
risks of bariatric surgery outweigh its benefits if it is
performed on a patient whose BMI falls below 40 and who has no
comorbidities. In light of this consensus, Tripler staff were
required to recommend that Christina cancel or at least delay
bariatric surgery when she successfully lost weight through the
LEAN Healthy Lifestyles Program and her BMI fell below 40.
Indeed, when Christina lost weight through the LEAN Healthy
Lifestyles Program and no longer met the BMI criterion for
surgery eligibility, the standard of care required the Tripler
providers to deny her bariatric surgery until such time as she
might fail to sustain the weight losses she achieved through the
LEAN program. The Court finds that Tripler failed to do so. The
Roux en Y gastric bypass surgery is a serious and delicate
operation, involving the rearrangement of Christina’s digestive
system and results in an overall complication rate of 20%; yet,
the Tripler providers failed to give Christina any recommendation
as to the appropriateness of surgery, and did not provide all of
the information necessary for her to make her own informed
80
decision about whether to go forward.
17. In sum, the Court finds that Christina was not
provided with sufficient, accurate information such that she was
able to give informed consent to the gastric bypass surgery
performed on September 27, 2010. The Court further finds that a
properly informed, reasonable person in Christina’s position
would not have consented to the gastric bypass surgery that led
to her injuries. The Court therefore finds in favor of
Plaintiffs, based on the preponderance of the evidence, as to the
informed consent claim.
IV.
Negligent Infliction of Emotional Distress as to N.M.
18. The Hawaii Supreme Court has determined that
a plaintiff may recover for negligent infliction of emotional
distress (“NIED”), absent any physical manifestation of his
psychological injury or actual physical presence within a zone of
danger, where “a reasonable person, normally constituted, would
be unable to adequately cope with the mental stress engendered by
the circumstances of the case . . . . Thus, an NIED claim is
nothing more than a negligence claim in which the alleged actual
injury is wholly psychic and is analyzed utilizing ordinary
negligence principles.” Kaho‘ohanohano v. Dep’t of Human Serv.,
178 P.3d 538, 582–83 (Haw. 2008) (internal citations omitted).
19. The Court finds and concludes that Plaintiffs have
failed to put on any evidence demonstrating the requisite degree
81
of emotional distress on the part of N.M. N.M. did not testify at
trial, and there was sparse testimony from other witnesses
suggesting that a reasonable person in N.M.’s position would not
be able to adequately cope with the mental stress engendered by
his mother’s medical complications. The Court therefore concludes
that Plaintiffs have failed to prove their NIED claim.
V.
Loss of Parental Consortium
20. What remains is Christina’s claim, on behalf of
N.M., for loss of parental consortium. “Loss of filial consortium
is a recognized cause of action in Hawaii under [the state’s]
wrongful death statute, Hawaii Revised Statutes (HRS) § 663–3.”
Masaki v. Gen. Motors Corp., 780 P.2d 566, 576 (Haw. 1989).
Likewise, this district court has found that the similar cause of
action for loss of parental consortium also exists under Hawaii
law. Marquardt v. United Airlines, Inc., 781 F. Supp. 1487, 1492
(D. Haw. 1992). Loss of consortium is a derivative claim, which
means that a claim by a child for loss of consortium is
derivative of the damages to the parent. See, e.g., Omori v. Jowa
Haw. Co., 981 P.2d 703, 703 (Haw. 1999).
21. Here, the Court finds and concludes that the
injuries and complications Christina suffered as a consequence of
the Roux en Y gastric bypass surgery have caused some disruption
and injury to her relationship with her son, N.M. Christina
testified that N.M. was visiting over the summer during the time
82
she was in the hospital because of complications from her
surgery. (Christina: 5-103-104.) She further testified that she
can no longer take care of N.M., and that he now has to take care
of her sometimes, helping her when she’s sick and getting her her
medicine. (Id. at 5-104.) In light of the severe complications
Christina suffered and her partial and permanent disability, as a
proximate and legal result of Tripler’s negligence, Plaintiff
N.M. is entitled to recover general damages for his past and
future loss of parental care, companionship, society, comfort,
and protection in the amount set forth below.
VI.
Damages
22. Hawaii law governs the elements and measures of
damages to be awarded in this case. See Shaw v. United States,
741 F.2d 1202, 1205 (9th Cir. 1984).
23. The Court has reviewed the Life Care Plan prepared
by Kathy Smith, R.N., which was reviewed and approved by Dr.
Leitman and Christina’s current treating physicians. The Court
also reviewed the Life Care Plan prepared by John Fountaine, the
Government’s life care plan expert; however, the Court finds the
Life Care Plan prepared by Ms. Smith to be far more detailed,
thorough, and reflective of Christina’s actual needs. In
addition, the Court has heard and considered the testimony of Ms.
Smith and Dr. Leitman regarding Christina’s future life care
needs, as well as the testimony of defense witnesses concerning
83
these issues. The Court finds and concludes that the elements of
the Life Care Plan prepared by Ms. Smith are reasonably and
necessarily required as a result of the gastric bypass surgery,
and that the costs for the goods and services as specified in the
Life Care Plan are reasonable. (See Ex. 127.)
24. As a proximate and legal result of Tripler’s
negligence, Christina is entitled to recover economic damages for
her future life care expenses. The Court must consider both the
inflation rate and the discount rate when computing the present
value of an award when competent evidence is presented on each.
See Alma v. Mfrs. Hanover Trust Co., 684 F.2d 622 (9th Cir.
1982). The Court has reviewed the economic analysis prepared by
Dr. Tom Loudat, and has heard and considered the testimony
provided by Dr. Loudat regarding the economic analysis. The Court
finds that Dr. Loudat’s present value calculations of Christina’s
future life care costs, based on Ms. Smith’s Life Care Plan, are
based on a reliable methodology and are accurate. Accordingly,
the Court finds that Christina is entitled to compensation in the
amount of $1,874,240 representing the present value of her future
life care needs resulting from the Roux en Y gastric bypass
surgery. (Ex. 377.)
25. As a proximate and legal result of Tripler’s
negligence, Christina is entitled to recover economic damages for
her loss of income. The Court must discount past and future lost
84
income to reflect lost wage income after both state and federal
taxes have been deducted. See Jones & Laughlin Steel Corp. v.
Pfeifer, 462 U.S. 523, 536 (1983); Shaw, 741 F.2d at 1205. The
Court finds and concludes that Christina has been at least
partially disabled as a result of the Roux en Y gastric bypass
surgery. Prior to undergoing surgery, Christina was enrolled in
an Associates degree program, and had an occupational objective
of a career in Healthcare Administration. At the time of her
surgery, she had one year remaining to complete the program. Dr.
Loudat testified that Christina’s estimated retirement age is 63.
The Government introduced scant evidence disputing Christina’s
claimed lost earnings, or Christina’s assertion that, but for the
surgery, she would have attained her Associates degree and
started a career in Healthcare Administration. The Court
therefore finds that, but for the surgery and Christina’s
resultant injuries, she would have completed her Associates
degree in August 2011 and commenced working in Healthcare
Administration in the beginning of 2012. As such, the Court finds
that Dr. Loudat’s present value calculations of Christina’s
probable lost earnings resulting from her disability are
reasonable. The Court therefore awards compensation for
Christina’s lost past earnings in the amount of $84,519, and for
her lost future earnings in the amount of $816,548.
26. As a proximate and legal result of Tripler’s
85
negligence, the Court concludes that Christina is entitled to
recover general damages in the amount of the statutory maximum
pursuant to Haw. Rev. Stat. § 663-8.7 of $375,000 for her actual
physical pain and suffering, and a total of $1,000,000 for her
past and future loss of enjoyment of life, her mental anguish and
emotional distress, her disfigurement, and her loss of past and
future filial care and companionship.
27. As a proximate and legal result of Tripler’s
negligence, N.M. is entitled to recover general damages for his
past and future loss of parental care, companionship, society,
comfort, and protection in the amount of $100,000.
28. Plaintiffs may recover their costs, and shall file
with the magistrate judge within fourteen days from the date of
this decision the necessary affidavits to resolve the question of
costs.
29. Sovereign immunity bars an award of attorneys’ fees
against the United States unless a statute expressly authorizes
such an award. The FTCA does not contain any such express waiver.
See Anderson v. United States, 127 F.3d 1190, 1191-92 (9th Cir.
1997). Thus, Plaintiffs are not entitled to an award of
attorneys’ fees in the instant suit.
DECISION
And now, following the conclusion of a bench trial in
this matter, and in accordance with the foregoing findings of
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facts and conclusions of law, it is hereby ordered that judgment
shall enter in favor of Plaintiffs and against the United States
in the above matter in the amount of $4,150,307 to Plaintiff
Christina Mettias, and $100,000 to Plaintiff Christina Mettias as
next friend of her minor son, N.M.
IT IS SO ORDERED.
DATED:
Honolulu, Hawaii, April 21, 2015
________________________________
Alan C. Kay
Senior United States District Judge
Mettias v. United States, Civ. No. 12-00527 ACK KSC, Findings of Fact,
Conclusions of Law, and Decision.
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