In Re: Diet Drugs ( 2008 )

Opinions of the United
2008 Decisions States Court of Appeals
for the Third Circuit
9-11-2008
In Re: Diet Drugs
Precedential or Non-Precedential: Precedential
Docket No. 07-1957
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PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
No. 07-1957
IN RE: DIET DRUGS (Phentermine/
Fenfluramine/Dexfenfluramine)
PRODUCTS LIABILITY LITIGATION
Gay Patterson and Kenneth Patterson,
Appellants
On Appeal from the United States District Court
for the Eastern District of Pennsylvania
MDL No. 1203
(Honorable Harvey Bartle III)
Argued March 6, 2008
Before: SCIRICA, Chief Judge,
FISHER and ROTH, Circuit Judges.
(Filed September 11, 2008)
KIP A. PETROFF, ESQUIRE (ARGUED)
Petroff & Associates
3838 Oak Lawn Avenue, Suite 1124
Dallas, Texas 75219
WAYNE R. SPIVEY, ESQUIRE
Shrager, Spivey, Sachs & Weinstock
Two Commerce Square, 32nd Floor
2001 Market Street
Philadelphia, Pennsylvania 19103
Attorneys for Appellants
ROBERT D. ROSENBAUM, ESQUIRE (ARGUED)
Arnold & Porter
555 12th Street, N.W.
Washington, D.C. 20004
PETER L. ZIMROTH, ESQUIRE
Arnold & Porter
399 Park Avenue
New York, New York 10022-4690
Attorneys for Appellee,Wyeth Corporation,
f/k/a American Home Products Corporation
ANDREW A. CHIRLS, ESQUIRE (ARGUED)
CHRISTOPHER L. SORIANO, ESQUIRE
WolfBlock
1650 Arch Street, 22nd Floor
2
Philadelphia, Pennsylvania 19103
Attorneys for Appellee, AHP Settlement Trust
OPINION OF THE COURT
SCIRICA, Chief Judge.
Gay Patterson is a claimant seeking payment under the
National Class Action Settlement Agreement (“Settlement
Agreement”) in this multi-district litigation. 1 Under the
Settlement Agreement, Wyeth, formerly American Home
Products Corporation, has contributed funds for the payment of
claims. AHP Settlement Trust (“Trust”) administers and
reviews the claims and awards benefits to class members who
qualify under the terms of the Settlement Agreement.
Patterson contends she suffers from moderate mitral
regurgitation, a medical condition that, if adequately
demonstrated, would qualify her for payment. Patterson
submitted her claim to the Trust, supporting it with an attesting
physician’s interpretation of an echocardiogram. The Trust
referred her claim to an independent auditing cardiologist who
concluded that the attesting physician’s opinion lacked a
1
Kenneth Patterson, Ms. Patterson’s spouse, has filed a
derivative claim for benefits.
3
reasonable medical basis. Accordingly, the Trust denied
Patterson’s claim.
The Trust then applied for an order requiring Patterson to
show cause why the claim should be paid. The District Court
issued an order to show cause and referred the matter to a
special master. After the show cause proceedings, the District
Court denied recovery finding no reasonable medical basis for
Patterson’s claim. We will affirm.
I.
A.
This case is part of a multi-district litigation concerning
diet drugs previously sold by Wyeth – fenfluramine (marketed
as “Pondimin”), and dexfenfluramine (marketed as “Redux”).
In previous decisions, we have provided detailed descriptions of
the diet drugs litigation. See, e.g., In re Briscoe, 448 F.3d 201,
206-08 (3d Cir. 2006); In re Diet Drugs, 401 F.3d 143, 147-48
(3d Cir. 2005); In re Diet Drugs, 385 F.3d 386, 389-92 (3d Cir.
2004); In re Diet Drugs, 282 F.3d 220, 225-29 (3d Cir. 2002).
We limit our discussion here to the facts pertinent to the present
appeal.
In November 1999, Wyeth and the representatives for
plaintiffs entered into the Settlement Agreement. After
conducting fairness proceedings, the District Court certified a
settlement class and approved the Settlement Agreement which
became final upon exhaustion of all appeals.
4
The amount of a claimant’s recovery under the
Settlement Agreement is determined by damage “matrices” that
assess factors such as severity of the medical condition, age of
claimant, and length of illness. Patterson seeks Matrix A-1,
Level II compensation in the amount of $473,032. In order to
recover, a claimant must demonstrate by a reasonable medical
basis that she has a qualifying condition.
The only factor in dispute is the severity of Patterson’s
medical condition, i.e., whether she has mitral regurgitation 2 at
2
The District Court has previously described mitral
regurgitation:
[Mitral regurgitation] involves the backward or
reverse flow of blood through a defective mitral
valve which separates the left atrium of the heart
from the left ventricle.
The heart consists of four chambers: the right
atrium, the right ventricle, the left atrium and the
left ventricle. These chambers are connected by
valves consisting of two leaflets. They open to
allow blood to pass through and then close. This
rapid process ensures the proper directional flow
of blood through the heart.
The chambers of the heart fill and empty in a
seamless, two-phase cardiac cycle that comprises
diastole, the filling cycle, and systole, the
emptying cycle. Initially, deoxygenated blood
5
enters the heart through the right atrium. During
diastole, the tricuspid valve opens and blood is
pumped into the right ventricle where it collects
before being expelled. As systole begins, the
right ventricle contracts and the blood is ejected
into the pulmonary arteries. The blood is then
carried through these arteries into the lungs where
it is re-oxygenated before passing back into the
left atrium of the heart through the pulmonary
veins. During diastole, the mitral valve opens and
blood moves from the left atrium into the left
ventricle. Thereafter, the mitral valve shuts. As
systole begins, the left ventricle contracts and
expels the blood through the open aortic valve
into the aorta and the rest of the body. The aortic
valve then closes to prevent any expelled blood
from returning to the left ventricle.
Mitral regurgitation occurs during the systolic
phase as the left ventricle contracts and pushes
blood into the aorta. Because the leaflets
comprising the mitral valve have failed to shut
properly, blood leaks backward, or regurgitates,
into the left atrium. As a result of this reverse
flow, the heart must work harder to pump the
needed blood throughout the heart and into the
body.
6
a moderate level. The District Court has noted the importance
of measuring the severity of regurgitation because “not all levels
of mitral regurgitation are medically significant.” PTO 2640,
236 F. Supp. 2d at 450. “Mild and trace regurgitation, two
lesser grades of valvular regurgitation identified in medical
literature, are normal and exist in approximately ninety percent
of the population. Only when mitral regurgitation reaches the
moderate level does it become a serious medical condition.” Id.
The Settlement Agreement defines moderate mitral regurgitation
“as regurgitant jet area in any apical view equal to or greater
than 20% of the left atrial area but less than 40% (20 - 40%
RJA/LAA).” 3
B.
In order to make a Matrix claim under the Settlement
Agreement, the claimant must submit a three-part “Green Form”
to the Trust. The Green Form requires disclosure of personal
and medical information as well as a physician’s certification,
based on a reading of an echocardiogram videotape, of the
claimant’s level of valvular heart disease. The District Court
has previously stated: “[f]or moderate mitral regurgitation to be
In re Diet Drugs (PTO 2640), 236 F. Supp. 2d 445, 450 (E.D.
Pa. 2002).
3
RJA in the numerator of the fraction represents Regurgitant
Jet Area while LAA in the denominator stands for Left Atrial
Area.
7
present, the size of the reverse flowing jet of blood at its most
expansive point must encompass between twenty percent and
forty percent of the area of the left atrium.” PTO 2640, 236 F.
Supp. 2d at 450.
Several attorneys, including Patterson’s counsel Kip
Petroff, interpreted the Settlement Agreement to require a
physician’s report to identify only one frame of an
echocardiogram tape showing twenty-to-forty percent
regurgitation. On December 19, 2000, Mr. Petroff circulated a
memorandum describing “Current Developments” in the Fen-
Phen litigation. The memo articulated this expansive
interpretation of the Settlement Agreement:
It is clear that cardiologists who strictly employed
the methodology in the National Settlement
(maximum regurgitant jet/one view only) are
routinely over-reading the echos by at least one
order of magnitude. That methodology is
acceptable in the world of the National
Settlement, but it is not employed in the real
world. We have carefully considered this re-
evaluation, and it is absolutely clear that
employing the National Settlement criteria leads
to across-the-board over estimates of valve
regurgitation, especially of the mitral valve.
Every client who is graded a moderate MR by
National Settlement criteria is a mild at best, a
8
severe is a moderate at best, etc. This will lead to
numerous mitral valve cases going from FDA-
positive to FDA-negative, and that may be one
reason to opt such a client back into the National
Settlement or have a new echo done using
standard methodology.
Memorandum from Kip Petroff and Robert Kisselburgh to All
Referring Attorneys (Dec. 19, 2000).
In a different but related case, the District Court rejected
a similar interpretation. See PTO 2640, 236 F. Supp. 2d at 451
(holding that “[o]nly after reviewing multiple loops and still
frames can a cardiologist reach a medically reasonable
assessment as to whether the twenty percent threshold for
moderate mitral regurgitation has been achieved”). But, because
of Mr. Petroff’s theory and other dubious practices by other law
firms, the Trust was inundated with Green Form claims for
Matrix benefits in unanticipated volumes.4 Under the Policies
4
“During the fairness hearing before the District Court,
experts testified as to their conclusion that, after considering
extensive epidemiological and demographic evidence, $3.75
billion was more than sufficient to pay all Matrix claims
anticipated under the Settlement.” In re Diet Drugs, 385 F.3d
at 391. But “after approval of the Settlement Agreement, the
Trust was inundated with Green Form claims for Matrix benefits
in a volume not anticipated by the experts who testified at the
fairness hearing.” Id. The District Court determined that a
9
and Procedures for Audit and Disposition of Matrix
Compensation Claims, as approved in PTO 2457 (May 31,
2002), the Trust could audit up to 5% of Matrix claims per
quarter, and Wyeth could designate up to 10% of claims per
quarter, for an audit by the Trust. As a result, the Trust risked
paying out millions of dollars to claimants it believed to be
ineligible, but whose claims it could not audit. Wyeth asserts
that out of the thirty claims submitted by Petroff & Associates
and audited under PTO 2457, twenty-five were not payable – a
failure rate of 83%. According to Wyeth, as of March 24, 2004,
Petroff & Associates failed audit more than 70% of the time. In
order to ameliorate the problem, the District Court ordered
audits for all Matrix compensation claims. See PTO 2807 (Mar.
26, 2003).5
significant proportion of the submissions came from a few law
firms which carried out mass screening programs in which
cardiologists retained by the firms “‘made unreasonable
judgments on a broad scale’ concerning the existence, history,
nature, and degree of heart-valve disease claimed.” Id. (quoting
PTO 2640, 236 F. Supp. 2d at 462).
5
On October 15, 2002, the Trust notified Patterson that her
claim was selected for audit. Accordingly, the Audit Policies
and Procedures contained in PTO 2457 apply to Patterson’s
claim.
10
C.
In July 2002,6 Mr. Petroff submitted Patterson’s claim to
the Trust. Patterson’s Green Form relied on the certification of
the attesting physician Reed Harris, D.O.7 Based on a February
8, 2002 echocardiogram, Dr. Harris concluded that Patterson
had a moderate mitral regurgitation ratio of 20% and that her left
atrium was mildly enlarged.
The Trust selected Patterson’s claim for audit. Under the
Audit Policies and Procedures, Patterson had thirty days to
submit “any additional credible medical information” for
consideration by the Trust and the Independent Auditing
Cardiologist. Patterson did not supplement her initial
submission forms. On December 14, 2002, the auditing
cardiologist, Keith B. Churchwell, M.D., concluded that there
was no reasonable medical basis for Dr. Harris’ finding of
moderate mitral regurgitation because the echocardiogram
demonstrated “trivial to mild” mitral regurgitation.
6
The Green Form reflects that Patterson signed the Green
Form in March 2002. The Green Form, however, was marked
as “received” in July 2002.
7
Wyeth asserts that Dr. Harris has certified 105 Matrix claims
under the Settlement Agreement. According to Wyeth, as of
March 24, 2004, Dr. Harris’ audited certifications resulted in a
82% failure rate (18 out of 22 were not payable).
11
“Eyeballing” 8 the echocardiogram, Dr. Churchwell determined
that the “[mitral regurgitant] jet area [was] overestimated in
comparison to [the left atrial] size. < 20%.”
On January 6, 2003, the Trust informed Patterson that her
claim had failed audit and attached Dr. Churchwell’s findings.
Patterson chose to dispute the Post-Audit Determination and
proceed to the Show Cause Proceeding. The District Court
granted the motion and referred the matter to a special master.9
8
The District Court has described “eyeballing” as visually
inspecting an echocardiogram rather than retracing the
regurgitant jet area or the left atrial area with a precise
measuring device. PTO 2640, 236 F. Supp. 2d at 454. When
conducting a visual assessment, the cardiologist reviews the
entire echocardiogram to determine the existence and severity
of the condition.
9
Under the Audit Policies and Procedures approved in PTO
2457, the special master may assign a Technical Advisor to
review the record and prepare a report to the Court “setting forth
his/her opinions regarding the issue(s) in dispute in the audit.”
Audit Policies and Procedures, § VI.J. “Each Technical Advisor
shall be a Board-Certified Cardiologist or Board-Certified
Cardiothoracic Surgeon who has level 3 training in
Echocardiography . . . .” Id. § VI.L. The claimant must pay the
costs of the Technical Advisor in advance of the review. “If the
Trust does not prevail on all aspects of its Application, the Trust
12
Under the Audit Policies and Procedures, “[f]or audits
based . . . on the grounds that no reasonable medical basis exists
for specific answer(s) to the Audit Question(s), the Claimant
shall have the burden of proving that there was a reasonable
medical basis to support the material representation(s) made by
the Attesting Physician in answering the Audit Question(s).”
Audit Policies and Procedures, § VI.D, PTO 2457 (May 31,
2002). To support the attesting physician Dr. Harris’s opinion,
Patterson submitted the report of cardiologist Frank E. Silvestry,
M.D. Dr. Silvestry reviewed the February 2, 2002
echocardiogram tape and “identified the maximum regurgitant
jet . . . emanating from the mitral valve in systole.” Based upon
the maximal jet, drawn at 1:15:38:12 recording time, he
concluded that Patterson had 20.57% mitral regurgitation.
Further, Dr. Silvestry surmised that Dr. Churchwell, the auditing
cardiologist, “may be expressing his . . . qualitative opinion of
the degree of Mitral regurgitation; however, the Settlement
documents specify a scientific and quantitative degree of mitral
shall reimburse the Claimant for the Technical Advisor’s costs.”
Id. § VI.K.
Both the Trust and the claimant have an opportunity to
state a position as to whether a “Technical Advisor” should be
appointed. The Trust requested the assistance of a Technical
Advisor. Patterson noted that she did “not feel it [was]
necessary to hire a Technical Advisor to review this case,” but
acknowledged that she would not object to such an appointment.
The special master did not appoint a Technical Advisor.
13
regurgitation, a degree which is clearly substantiated by the
echocardiogram, and my independent measurements.”
The District Court concluded Patterson “has not met her
burden in proving that there is a reasonable medical basis for
finding that she had moderate mitral regurgitation” because she
failed to rebut or challenge the conclusion that Dr. Harris’
determination was based on improper measurements. In re Diet
Drugs, No. 2:16 MD 1203, 2007 WL 674720, at *2, *4 (E.D.
Pa. Feb. 26, 2007). The court noted that, notwithstanding Dr.
Silvestry’s report, Patterson had “failed to address the improper
measurements underlying the finding of [Dr. Harris].” Id. at *3.
Furthermore, the court rejected Patterson’s suggestion
that she could recover Matrix Benefits by identifying a single
maximum regurgitant jet at the required level of mitral
regurgitation. “[Patterson] has not established that the
‘maximum regurgitant jet’ offered in support of her claim is
representative of her level of mitral regurgitation, therefore, on
this basis as well, [Patterson] has failed to establish a reasonable
medical basis of her claim.” Id. at *4.10
10
The District Court’s order finally resolved the particular
claim at issue. Accordingly, we treat the challenged order as
final and exercise appellate jurisdiction under 28 U.S.C. § 1291.
We review a District Court’s exercise of its equitable authority
to administer and implement a class action settlement for abuse
of discretion. See In re Cendant Corp. Prides Litig., 233 F.3d
188, 192 (3d Cir. 2000). “[T]o find an abuse of discretion the
14
II.
Patterson contends that the District Court erred in several
respects when denying her claim. First, Patterson contends that,
even in a borderline case, measuring a single frame to determine
the severity of mitral regurgitation is an acceptable practice
under the Settlement Agreement. Second, she asserts that the
auditing cardiologist’s visual assessment of the echocardiogram
was insufficient to rebut her attesting physician’s measurements.
According to Patterson, the Settlement Agreement always
requires a quantitative measurement of the regurgitant jets.
Finally, Patterson contends that the District Court misapplied the
reasonable medical basis standard by applying it to Dr.
Silvestry’s opinion, rather than the attesting physician Dr.
Reed’s opinion. Accordingly, Patterson asserts it was improper
for the court to deny her claim based on its rejection of Dr.
Silvestry’s method of evaluating her echocardiogram. We
disagree.
A.
Patterson contends that the identification, in her case, of
District Court’s decision must rest on ‘a clearly erroneous
finding of fact, an errant conclusion of law or an improper
application of law to fact.’” In re Nutraquest, Inc., 434 F.3d
639, 645 (3d Cir. 2006) (quoting In re Orthopedic Bone Screw
Prods. Liab. Litig., 246 F.3d 315, 320 (3d Cir. 2001)).
15
a single frame of an echocardiogram constitutes a reasonable
medical basis because her doctor reviewed the entire
echocardiogram. Patterson asserts that in order to find a “true”
maximum jet, a cardiologist must review multiple loops and
frames and compare regurgitant jets. Wyeth and the Trust
contend that, even if Patterson’s doctor reviewed the entire
echocardiogram, he failed to indicate that the identified
maximum jet was representative of her condition and not an
isolated and non-recurring incident.
In determining whether a single frame of an
echocardiogram constitutes a reasonable medical basis for
finding moderate mitral regurgitation, the parties agree that the
District Court’s prior decisions are instructive.11 These
decisions indicate that the Settlement Agreement requires a
cardiologist to review the echocardiogram for a regurgitant jet
that is representative of the severity of the claimant’s medical
condition. The identification of a single jet without any
explanation or indication of its representativeness will not
satisfy the claimant’s burden.
In PTO 2640, the District Court examined seventy-eight
claims determined by the Trust to be medically unreasonable
because the echocardiograms showed no significant levels of
11
See, e.g., Patterson Reply Br. at 5 (“One appropriate place
to look for guidance in evaluating a Diet Drug Claim includes
the Orders that the District Court has issued thus far in this
lengthy litigation.”).
16
mitral regurgitation. The court noted that “[f]or moderate mitral
regurgitation to be present, the size of the reverse flowing jet of
blood at its most expansive point must encompass between
twenty percent and forty percent of the area of the left atrium,”
PTO 2640, 236 F. Supp. 2d at 450, and discussed the Settlement
Agreement’s “protocol” for measuring regurgitation. “Only
after reviewing multiple loops and still frames can a cardiologist
reach a medically reasonable assessment as to whether the
twenty percent threshold for moderate mitral regurgitation has
been achieved.” Id. at 451.12 The District Court held that each
of the disputed claims lacked a reasonable medical basis, and in
most cases, the measured jet was not a true regurgitant jet but
rather a phantom jet or a backflow. Id. at 454, 458.
12
See also id. at 452 (“To confirm mitral regurgitation, a
cardiologist will have to review numerous frames and loops.”);
id. at 454 (accepting the “analysis, conclusions, and opinions”
of an expert witness, Dr. Dent, because “[h]e did not simply
look at one frame of an echocardiogram and reach an opinion
about the severity of mitral regurgitation”); id. at 457 (noting
that an attesting physician “frequently mistook backflow and
mild mitral regurgitation for moderate or more severe
regurgitation” because “[u]nlike Dr. Dent who based this
assessment on reviews of both the digitized images and the
videotapes, [the attesting physician] did not analyze the
videotapes for all of the echocardiograms to which she
attested”).
17
Since PTO 2640, the District Court has repeatedly
criticized the use of a single frame of an echocardiogram as the
sole basis for a claim of mitral regurgitation. “[F]or a
reasonable medical basis to exist, a claimant must demonstrate
that a finding of the requisite level of regurgitation is
representative of the level of regurgitation throughout an
echocardiogram.” In re Diet Drugs, No. 2:16 MD 1203, 2007
WL 1461441, at *5 (E.D. Pa. May 16, 2007); In re Diet Drugs,
No. 2:16 MD 1203, 2007 WL 1462407, at *4 (E.D. Pa. May 16,
2007). “Nothing in the Settlement Agreement suggests that it is
permissible for a claimant to rely on isolated instances of what
appears to be the requisite level of regurgitation to meet this
definition.” In re Diet Drugs, 2007 WL 1461441, at *5 n.12.
Even though “one of the endnotes in the Green Form refers to
obtaining the regurgitant jet area from a ‘maximum or average
[of] three planes,’ this does not mean that a claim is
compensable based only on the maximum or average regurgitant
jet measured.” In re Diet Drugs, 2007 WL 1462407, at *4. “To
conclude otherwise would allow claimants who do not have
moderate or greater mitral regurgitation to receive Matrix
Benefits, which would be contrary to the intent of the Settlement
Agreement.” Id.
To illustrate, the District Court has, in disagreement with
the auditing cardiologist, awarded Matrix compensation when
the evidence shows a representative regurgitant jet of sufficient
magnitude. In In re Diet Drugs, No. 99-20593, 2007 WL
320407 (E.D. Pa. Jan. 29, 2007), the attesting physician found
18
a regurgitation ratio of 24 percent and concluded the claimant
suffered from moderate mitral regurgitation. Upon review, the
auditing cardiologist concluded that the attesting physician’s
opinion lacked a reasonable medical basis. During the show
cause proceedings, a technical advisor concluded the
echocardiogram demonstrated moderate mitral regurgitation.
Importantly, the technical advisor found an average of 22
percent mitral regurgitation over four cardiac cycles. Id. at *3.
“Under these circumstances, claimant has met her burden in
establishing a reasonable medical basis for her claim.” Id.; see
also In re Diet Drugs, No. 2:16 MD 1203, 2007 WL 1118379,
at *3-4 (E.D. Pa. Apr. 12, 2007) (holding that claimant
demonstrated reasonable medical basis for moderate mitral
regurgitation and an abnormal left atrial dimension based on
Technical Advisor’s opinion, which examined three different
views of the heart).
In addition to the District Court’s instructions on what is
medically reasonable, the Auditing Cardiologist Training Course
is instructive. 13 The training course states:
Importance of Viewing Multiple Heartbeats
and Frames
As you are aware from your clinical practice, an
echo reader cannot focus on a single frame
13
The District Court approved the training course in PTO
2825 (E.D. Pa. Apr. 7, 2003).
19
without reference to the overall level of
regurgitation as assessed using multiple frames
and heartbeats. Only after reviewing multiple
loops and still frames can a cardiologist reach a
Medically Reasonable assessment as to whether
any of the various thresholds established by the
Settlement for the different severity levels of
regurgitation have been achieved, such as the
20% threshold for moderate mitral regurgitation.
The interpreter or auditor thus must properly
appreciate the level of regurgitation where a
single frame may not appropriately represent the
true volume of the regurgitation during systole.
PTO 2825 (E.D. Pa. Apr. 7, 2003).14
14
On the same page, the course cites an authoritative medical
text, A.E. Weyman, Principles and Practice of Echocardiography
436 (1994):
When the duration of systole changes (changing
heart rate) or when regurgitant flow is confined to
only a portion of systole (i.e., mitral valve
prolapse), the relationship of the peak area to the
regurgitant volume will vary. In patients with
premature beats or atrial fibrillation, the color jet
area may vary from cycle to cycle as the duration
of systole and ventricular pressure change. In
such cases, it is important to average the color jet
20
As noted, Patterson contends that the Settlement
Agreement allows a cardiologist to measure a single maximum
jet. Furthermore, Patterson asserts that “[t]here is no factual
basis for concluding that the maximum regurgitant jet is not
representative of the regurgitation throughout the
echocardiogram or that [Dr. Silvestry] did not review all the
loops and frames.” Patterson Br. at 7.
Dr. Silvestry’s report indicated: “On May 7, 2003, I
reviewed and analyzed Ms. Patterson’s echocardiographic study
. . . and performed my own measurements of the left atrial and
regurgitant jet area. I identified the maximum regurgitant jet
and measured its area using EchoAnalysis software.” Based on
this statement, Patterson contends that Dr. Silvestry could not
have identified the maximum regurgitant jet without reviewing
multiple loops and comparing regurgitant jets. But even if we
were to assume that Dr. Silvestry reviewed multiple loops, the
question of representativeness remains. Under the Settlement
Agreement, Patterson has the burden of proof to demonstrate her
entitlement to benefits. A general statement that a doctor
reviewed an echocardiogram does not necessarily mean the
measured jet is representative of the claimant’s true level of
mitral regurgitation.
We cannot agree with Patterson’s argument that, in a
area from a number of beats to attain a
representative measure of regurgitant flow.
PTO 2825 (E.D. Pa. Apr. 7, 2003).
21
borderline case such as this, the measurement of a single frame
in an echocardiogram, without evidence showing that the
depicted jet is a true regurgitant jet, i.e., representative of the
claimant’s actual level of mitral regurgitation, constitutes a
reasonable medical basis for recovering Matrix compensation.15
To hold otherwise would permit claimants whose
echocardiograms show an aberrant jet in a single frame to
recover payment from the Trust.16
B.
Next, Patterson contends that an auditing cardiologist
must make quantitative measurements in order to determine the
15
Because the measurements by Dr. Harris and Dr. Silvestry
were at or slightly above the 20 percent threshold, we need not
address whether indications of representativeness are required
in a more clear-cut case of mitral regurgitation.
16
In her brief, Patterson also appears to suggest that she was
denied procedural fairness, asserting that the District Court has
not concretely defined “reasonable medical basis” and decides
the merit of claims on a case-by-case basis. However, at the
time of Patterson’s briefs and Dr. Silvestry’s report in May
2003, the District Court had clearly announced the requirements
for reading an echocardiogram, see PTO 2640, and had
approved the Auditing Cardiologist Training Course, see PTO
2825. Thus, Patterson and her attorneys had sufficient notice of
the reasonable medical basis standard.
22
percentage of mitral regurgitation. She argues that a visual
assessment is not precise enough to compute the minimum 20%
regurgitation required by the Settlement Agreement. Patterson
asserts because her case is a close one – Dr. Harris measured
20% regurgitation and Dr. Silvestry measured 20.57%
regurgitation – the District Court should not have relied upon
the auditing cardiologist’s visual assessment to reject Patterson’s
claim. Wyeth and the Trust demur, contending that an auditing
cardiologist may visually determine whether a qualifying
condition exists. That is, an auditing cardiologist need not make
a quantitative measurement when the echocardiogram clearly
shows an amount of mitral regurgitation consistent with the
general population. According to Wyeth and the Trust, since
Dr. Churchwell found only trivial to mild mitral regurgitation,17
17
The Settlement Agreement incorporates the definitions of
mitral regurgitation described in J.P. Singh, et al., Prevalence of
Clinical Determinants of Mitral, Tricuspid and Aortic
Regurgitation (The Framingham Heart Study), 83 Am J.
Cardiology 897 (1999). “Mild Mitral Regurgitation” is defined
in the Settlement Agreement as: “(1) either the RJA/LAA ratio
is more than five percent (5%) or the mitral regurgitant jet
height is greater than 1 cm from the valve orifice, and (2) the
RJA/LAA ratio is less than twenty percent (20%).” As noted,
RJA in the numerator of the fraction represents Regurgitant Jet
Area while LAA in the denominator stands for Left Atrial Area.
Singh describes “trace” or trivial mitral regurgitation as a mitral
regurgitant jet that remains “within 1 cm from the valve orifice”
23
it was unnecessary to take quantitative measurements.
While conducting the audit of Patterson’s claim, Dr.
Churchwell reviewed the echocardiogram tape, a copy of the
Green Form, and Patterson’s medical records. Dr. Churchwell
conducted a visual assessment of the echocardiogram and
concluded there was no reasonable basis for Dr. Harris’
determination. Dr. Churchwell noted that Dr. Harris
“overestimated” the mitral regurgitant jet area in relation to the
left atrial size. Furthermore, Dr. Churchwell determined that
Patterson’s mitral regurgitation was “trivial to mild” and “<
20%.”
The purpose of the auditing cardiologist review is to
examine the claimant’s medical condition using normal clinical
judgment and accepted medical standards to determine whether
the attesting physician’s conclusions had a reasonable medical
basis. The District Court has, on numerous occasions, accepted
an auditing cardiologist’s medical opinion when based upon a
visual assessment of an echocardiogram and still frames. In
doing so, the District Court observed that “‘[e]yeballing’ the
regurgitant jet to assess severity is well accepted in the world of
cardiology.” PTO 2640, 236 F. Supp. 2d at 454. We agree and
understand that “eyeballing” is proper when an echocardiogram
clearly indicates that the claimant’s level of mitral regurgitation
is consistent with the general population.
and occupies less than five percent of the left atrial area.
24
In order to diagnose a patient, a cardiologist will visually
review an echocardiogram tape to determine whether a
condition is present. As noted, mild and trace regurgitation
occur normally in 90% of the population. Accordingly, if an
echocardiogram shows a normal amount of regurgitation – i.e.,
clearly below the qualifying threshold – an auditing cardiologist
need not measure the maximum jet. But if the amount of
regurgitation is at or near the threshold, in this case 20%, it
would appear to be necessary to measure particular frames to
quantify the severity of the condition. After reviewing the
echocardiogram, Dr. Churchwell visually determined that Dr.
Harris’ measurement – 20% mitral regurgitation –
“overestimated” Patterson’s level of regurgitation and Dr.
Churchwell characterized her symptoms as “trivial to mild.”
Although Dr. Churchwell could have been more precise, it
appears that his language – “overestimated” and “trivial to mild”
– indicates he found regurgitation well below the 20% threshold,
making a quantitative measurement unnecessary in this case.
Under ordinary circumstances, a visual review by the
auditing cardiologist indicating mitral regurgitation at or near
the threshold would appear to call for more than “eyeballing” by
the auditing cardiologist. Nevertheless, even if this case is, as
Patterson asserts, close to the threshold, Dr. Churchwell’s
determination does not preclude recovery of Matrix
compensation – it merely shifts the burden back to Patterson.
Audit Policies & Procedures § VI.D., PTO 2457 (May 31,
2002). If the auditing doctor’s visual assessment is wrong, the
25
claimant has the opportunity to offer a rebuttal and present
additional evidence. As noted, Patterson submitted a report by
Dr. Silvestry identifying and measuring the maximum
regurgitant jet. However, a report based upon a single frame
measurement does not rebut an auditing cardiologist’s
assessment of the entire echocardiogram. Because Dr.
Silvestry’s report does not include any indication of the
maximum regurgitant jet’s representativeness, Patterson has
failed to meet her burden.18 Accordingly, we reject Patterson’s
argument that Dr. Churchwell’s method of reviewing her
echocardiogram was insufficient to support the Trust’s denial of
her claim.
C.
Finally, Patterson contends that the District Court erred
because it rejected the medical report submitted during the show
cause proceedings rather than that of the original attesting
doctor. She argues that “the standard is whether there is a
reasonable medical basis for the attesting physician’s opinion,
not the reviewing physician’s opinion.” Patterson Br. at 7.
18
It appears that Dr. Silvestry was instructed by Patterson’s
counsel to review the echocardiogram according to their
interpretation of the Settlement Agreement. Dr. Silvestry’s
report indicates that his opinion was “intended to provide legal
consultation” and should not be relied upon “for the diagnosis,
prognosis, or treatment” of the claimant’s medical condition.
26
Once the Trust denies a claim and the claim advances to
a show cause proceeding, the claimant has the burden of proving
there was a reasonable medical basis for the attesting
physician’s representations. Audit Policies & Procedures §
VI.D., PTO 2457 (May 31, 2002). The District Court
acknowledged and applied the correct standard under the
Settlement Agreement. According to the District Court, “[t]he
issue presented for resolution of this claim is whether
[Patterson] has met her burden in proving that there is a
reasonable medical basis for the attesting physician’s finding
that she had moderate mitral regurgitation.” In re Diet Drugs,
2007 WL 674720, at *2. The court concluded that “the attesting
physician’s answer lacks a reasonable medical basis . . . because
the attesting physician’s finding failed to reflect the actual level
of [Patterson’s] mitral regurgitation.” Id. at *3. It faulted
Patterson for failing to “address the improper measurements
underlying the finding of her attesting physician.” Id.
As noted, in an attempt to support her claim, Patterson
submitted a certification prepared by Dr. Silvestry. But because
Dr. Silvestry’s report identified the maximum regurgitant jet
without any discussion of its representativeness, the court
concluded that the report did not support Patterson’s contention
that Dr. Harris’ opinion had a reasonable medical basis. Id. at
*4 (“Claimant has not established that the ‘maximum regurgitant
jet’ offered in support of her claim is representative of her level
of mitral regurgitation . . . .”).
Dr. Churchwell found trivial to mild mitral regurgitation
27
in Patterson’s echocardiogram. Under the Audit Policies and
Procedures, Patterson had the burden to prove that Dr. Harris’
opinion had a reasonable medical basis. Patterson had the
opportunity to show that Dr. Harris’ finding represented the
actual level of Patterson’s mitral regurgitation. But Dr.
Silvestry’s report failed to satisfy Patterson’s burden because it
only identified a single maximum regurgitant jet without any
indication of the jet’s representativeness. Accordingly, the
District Court properly rejected Dr. Silvestry’s report because it
failed to rebut Dr. Churchwell’s conclusion that Dr. Harris’
report lacked a reasonable medical basis.
III.
For the foregoing reasons, we will affirm.
28