2008 Decisions

Opinions of the United

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Precedential or Non-Precedential: Precedential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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http://digitalcommons.law.villanova.edu/thirdcircuit_2008/446
 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)
2

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
 Kenneth Patterson, Ms. Patterson’s spouse, has filed a 1

derivative claim for benefits. 

3

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. Under the 1

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
4

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.
 The District Court has previously described mitral 2

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

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 at 2
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
In re Diet Drugs (PTO 2640), 236 F. Supp. 2d 445, 450 (E.D.

Pa. 2002).

 RJA in the numerator of the fraction represents Regurgitant 3

Jet Area while LAA in the denominator stands for Left Atrial

Area. 

7

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
8

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 FenPhen 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 reevaluation, 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
 “During the fairness hearing before the District Court, 4

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

severe is a moderate at best, etc. This will lead to

numerous mitral valve cases going from FDApositive 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. Under the Policies 4
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).

 On October 15, 2002, the Trust notified Patterson that her 5

claim was selected for audit. Accordingly, the Audit Policies

and Procedures contained in PTO 2457 apply to Patterson’s

claim. 

10

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
The Green Form reflects that Patterson signed the Green 6

Form in March 2002. The Green Form, however, was marked

as “received” in July 2002. 

 Wyeth asserts that Dr. Harris has certified 105 Matrix claims 7

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

C.

In July 2002, Mr. Petroff submitted Patterson’s claim to 6

the Trust. Patterson’s Green Form relied on the certification of

the attesting physician Reed Harris, D.O. Based on a February 7

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.
 The District Court has described “eyeballing” as visually 8

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.

 Under the Audit Policies and Procedures approved in PTO 9

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

“Eyeballing” the echocardiogram, Dr. Churchwell determined 8

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
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

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
 The District Court’s order finally resolved the particular 10

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

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
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

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
 See, e.g., Patterson Reply Br. at 5 (“One appropriate place 11

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

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. These 11

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
 See also id. at 452 (“To confirm mitral regurgitation, a 12

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

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. The District Court held that each

12

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.
18

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
 The District Court approved the training course in PTO 13

2825 (E.D. Pa. Apr. 7, 2003).

19

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. The training course states: 13

Importance of Viewing Multiple Heartbeats

and Frames

As you are aware from your clinical practice, an

echo reader cannot focus on a single frame
 On the same page, the course cites an authoritative medical 14

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

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
area from a number of beats to attain a

representative measure of regurgitant flow.

PTO 2825 (E.D. Pa. Apr. 7, 2003).

21

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
 Because the measurements by Dr. Harris and Dr. Silvestry 15

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. 

In her brief, Patterson also appears to suggest that she was 16

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

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
 The Settlement Agreement incorporates the definitions of 17

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

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
and occupies less than five percent of the left atrial area.

24

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.
25

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 hislanguage – “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
 It appears that Dr. Silvestry was instructed by Patterson’s 18

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

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. Accordingly, we reject Patterson’s 18

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. 
27

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
28

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.