In Re Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Product Liability Litigation

PRECEDENTIAL

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

_____________

No. 12-1180

_____________

In Re: DIET DRUGS

(PHENTERMINE/FENFLURAMINE/

DEXFENFLURAMINE)

PRODUCT LIABILITY LITIGATION,

Carmen Cauthen and Ricky Leon Cauthen,

Appellants

_______________

On Appeal from the United States District Court

for the Eastern District of Pennsylvania

(D.C. Nos. 2-99-cv-20593, 2-12-md-01203)

District Judge: Hon. Harvey Bartle, III

_______________

Argued

November 13, 2012

Before: SCIRICA, FISHER, and JORDAN, Circuit Judges.

(Filed: January 28, 2013)

_______________

W. Steven Berman

Napoli Bern Ripka & Associates

1 Greentree Center - #201

Marlton, NJ 08053

Paul J. Napoli

Napoli, Kaiser, Bern & Associates

3500 Sunrise Highway - #T-207

Great River, NJ 11739

Denise A. Rubin [ARGUED]

Napoli, Bern, Ripka & Shkolnik

350 Fifth Avenue - #7413

New York, NY 10118

Counsel for Appellants

Heidi L. Levine

DLA Piper LLP (US)

1251 Avenue of the Americas

New York, NY 10020

Raymond M. Williams

DLA Piper LLP (US)

1650 Market Street - #4900

Philadelphia, PA 19103

Anand Agneshwar [ARGUED]

Arnold & Porter LLP

399 Park Avenue

New York, NY 10022

2

Geoffrey J. Michael

Anna K. Thompson

Daniel S. Pariser

Arnold & Porter LLP

555 Twelfth Street, NW

Washington, DC 20004

Counsel for Appellees Wyeth LLC

And Wyeth Pharmaceuticals Inc.

Michael D. Fishbein

Laurence S. Berman

Arnold Levin

Mary E. Gately

Levin, Fishbein, Sedran & Berman

510 Walnut Street - #500

Philadelphia, PA 19106

Charles R. Parker

Locke Lord

600 Travis Street - #3600

Houston, TX 77002

Counsel for Class Counsel and Plaintiffs Liaison

Counsel

Jules S. Henshell

Semanoff, Ormsby, Greenberg & Torchia

2617 Huntingdon Pike

Huntingdon Valley, PA 18974

Counsel for AHP Settlement Trust

_______________

OPINION OF THE COURT

_______________

3

JORDAN, Circuit Judge.

In November 1999, Wyeth L.L.C. (“Wyeth”) entered

into a nationwide class action settlement agreement (the

“Settlement Agreement”) with the users of certain diet drugs

linked to various health problems. The United States District

Court for the Eastern District of Pennsylvania certified the

settlement class and entered a pre-trial order enjoining

members of the class from suing Wyeth for injuries related to

those drugs. Appellants Carmen and Ricky Leon Cauthen

brought a lawsuit against Wyeth in the Court of Common

Pleas of Philadelphia County, Pennsylvania, seeking to

redress Ms. Cauthen‟s injuries from primary pulmonary

hypertension (“PPH”), a condition that she alleges was caused

by the diet drugs. Wyeth moved the District Court to enjoin

the suit, arguing that it did not qualify under the Settlement

Agreement as a cause of action that could proceed despite the

settlement. The District Court agreed and enjoined the

Cauthens‟ lawsuit. For the reasons that follow, we will

affirm.

I. Background

A. Class Action Suit and Settlement Agreement

Between 1994 and 1997, American Home Products

Corporation, now Wyeth, marketed and sold fenfluramine and

dexfenfluramine, prescription weight loss drugs. After

studies linked the drugs to valvular heart disease, and

following a U.S. Food and Drug Administration (“FDA”)

public health advisory, Wyeth withdrew the drugs from the

4

market in 1997. Thousands of individuals subsequently filed

suit, alleging that they had been injured by the drugs.

In December 1997, the Judicial Panel on Multidistrict

Litigation entered an order transferring all diet drug cases in

federal court to the United States District Court for the

Eastern District of Pennsylvania for consolidated pre-trial

proceedings. Nearly two years later, Wyeth entered into a

Settlement Agreement with users of the diet drugs in the

United States and presented the agreement to the District

Court for approval. On August 28, 2000, the District Court

certified the class, approved the Settlement Agreement, and

entered Pre-Trial Order (“PTO”) No. 1415. That order

provided that the District Court “retains continuing and

exclusive jurisdiction over this action and each of the Parties,

including [Wyeth] and the class members, to administer,

supervise, interpret and enforce the Settlement in accordance

with its terms.” (Supplemental App. at 8.)

Aside from certain narrow exceptions, the Settlement

Agreement enjoins class members from suing Wyeth for all

diet drug-related injuries. One of the exceptions is at issue in

this case: the Settlement Agreement allows class members to

sue Wyeth if they can demonstrate that they developed PPH1

through the use of the diet drugs. To qualify for the

exception, a class member must draw on “[m]edical records”

to demonstrate the “exclus[ion]” of certain medical

1

PPH is a condition that “deprives the lungs of oxygen

[and] can cause hypoxemia and hypercapnia, resulting in

ventilator insufficiency.” 14 Roscoe N. Gray & Louise J.

Gordy, Attorneys’ Textbook of Medicine ¶ 205.75 (3d ed.

2011).

5

conditions. (App. at 787-88.) To exclude one such condition,

which is referred to as “greater than mild restrictive lung

disease,” a class member is required by § I.46.a(2)(c) of the

Settlement Agreement to produce “pulmonary function tests”2

(“PFTs”) showing that the class member‟s “total lung

capacity” is greater than “60% of predicted at rest.” (Id.

(Settlement Agreement, § I.46.a(2)(c)).)

B. The Cauthens’ Lawsuit

In June 2011, the Cauthens filed a complaint in the

Philadelphia County Court of Common Pleas, alleging that

Ms. Cauthen, a member of the settlement class, developed

PPH “as a result of ingesting Diet Drugs.” (Id. at 3.) The

Cauthens produced a “[p]ulmonary consultation note”

prepared by Dr. Terry Fortin (id. at 795-97), a cardiologist

certified by the American Board of Internal Medicine. Dr.

Fortin stated in the consultation note that, based on a PFT she

had conducted, Ms. Cauthen‟s “total lung capacity [is] 56%,”

and Dr. Fortin acknowledged that Ms. Cauthen‟s lungs

“clearly have some restriction.” (Id. at 796.)

Because Ms. Cauthen‟s only PFT showed that she had

lung capacity of less than 60 percent of predicted at rest,

Wyeth notified the Cauthens that they were prohibited from

2

“Pulmonary function tests are a group of tests that

measure how well the lungs take in and release air and how

well they move gases such as oxygen from the atmosphere

into the body‟s circulation.” Pulmonary function tests:

MedlinePlus Medical Encyclopedia (Dec. 12, 2011),

http://www.nlm.nih.gov/medlineplus/ency/article/003853.htm

(last visited Jan. 3, 2013).

6

bringing their claim, as Ms. Cauthen did not satisfy

§ I.46.a(2)(c) of the Settlement Agreement. The Cauthens

declined to drop the lawsuit. Wyeth then filed a motion in the

District Court seeking to enjoin the Cauthens‟ state court

lawsuit for failing to satisfy the precondition for suit provided

by the Settlement Agreement. Opposing Wyeth‟s motion, the

Cauthens submitted a declaration by Dr. Fortin stating that,

“to a reasonable degree of medical certainty[,] … Ms.

Cauthen has primary pulmonary hypertension secondary to

her use of [one of the diet drugs] in early 1997.” (Id. at 808.)

In her declaration, Dr. Fortin alluded to the

requirement in § I.46.a(2)(c) of the Settlement Agreement

that lung capacity must be greater than 60 percent of

predicted at rest, and she said that “[i]nsight into underlying

pathophysiology can often be gained by comparing the

measured values for pulmonary function tests obtained on a

patient at any particular point with normative values derived

from population studies.” (Id. at 809.) “The percentage of

predicted normal [lung capacity],” she continued, “is used to

grade the severity of the abnormality.” (Id.) She explained

that the normative values used to calculate a patient‟s

percentage of lung capacity predicted at rest “are based upon

averages for persons of similar height, weight, age, ethnicity,

etc.” (Id.) According to Dr. Fortin, the “standard average

reference” used to calculate Ms. Cauthen‟s percentage of lung

capacity was 5.37 liters, a value “taken from the Crapo/Hsu

Duke modified guide at [Duke] University.” (Id. at 810.) Dr.

Fortin further explained that, through a battery of tests

conducted on April 28, 2009, she had determined that Ms.

Cauthen had a lung capacity of 3.03 liters. Dividing 3.03

(Ms. Cauthen‟s lung capacity) by 5.37 (the average lung

capacity of individuals matching Ms. Cauthen‟s demographic

7

profile), yields Ms. Cauthen‟s percentage of lung capacity

predicted at rest, 56.4 percent.

Dr. Fortin went on to downplay that result by

challenging the accuracy of the denominator in the above

equation. The figures used to represent average lung capacity

by demographic characteristics, she asserted, “are only

averages and may vary in actual practice.” (Id. at 809.) “The

5.37 liter reference is only a reference value,” she continued,

“and does not actually represent M[s]. Cauthen‟s total lung

capacity. … [T]he 5.37 liter reference value is just a

predicted average of [a] wom[a]n‟s total lung capacity who

fits Ms. Cauthen‟s age, height, race and weight.” (Id. at 810.)

In fact, Dr. Fortin claimed, the value taken from the

Crapo/Hsu Duke modified guide “is just one of the many

references available that are out there.” (Id.) Without

providing any other reference, Dr. Fortin concluded “to a

reasonable degree of medical certainty that we just do not

know conclusively what the true reference value for Ms.

Cauthen should be.” (Id.) Dr. Fortin did offer, however, that,

“[i]f we were to use a reference value of 5.05, just 32ccs less

than the 5.37 reference originally used[,] then Ms. Cauthen‟s

total lung capacity percent predicted calculation would be

60%.” (Id. at 811.)

Dr. Fortin also asserted that comparing an individual‟s

lung capacity with the average capacity of persons having a

similar demographic profile is important but not

determinative in diagnosing PPH. “Cardiologists,” she

assured the District Court, “know about the limitations of the

percent predicted calculation on a [PFT] and must rely on

other methods in order to determine a specific patient‟s true

total lung capacity, such as radiology studies and an exam of

8

the patient‟s body habitus.” (Id. at 810.) In fact, Dr. Fortin

claimed, “whether [Ms. Cauthen‟s] total lung capacity percent

predicted calculation is 56% or 60% is clinically irrelevant”

(id.), and “Ms. Cauthen‟s diet drug use was the cause of her

[PPH]” (id. at 811). Without further explanation, Dr. Fortin

declared that, “[b]ased upon [her] review of the April 28,

2009 Pulmonary Function Test and other objective tests,”3

she had “ruled out any restrictive lung disease as a cause of

Ms. Cauthen‟s [PPH].” (Id.)

Unconvinced, the District Court held that the Cauthens

had not produced a PFT that supported their claim that Ms.

Cauthen “does not have greater than mild restrictive lung

disease,” as required by § I.46.a(2)(c) of the Settlement

Agreement. (Id. at 7.) Dr. Fortin‟s declaration did not alter

the Court‟s conclusion for two reasons. First, the doctor

acknowledged that Ms. Cauthen‟s only PFT demonstrated

that she has a total lung capacity of only 56 percent of

predicted at rest. Ms. Cauthen thus did not meet the

definition of PPH provided in § I.46.a(2)(c). Second, the

Settlement Agreement requires class members who wish to

make a claim related to PPH to establish, “through a

pulmonary function test only, the absence of greater than mild

restrictive lung disease.” (Id. at 6.). Because Dr. Fortin‟s

declaration is not the type of medical record contemplated in

the Settlement Agreement as sufficient to establish a PPH

claim, the Court held that it was not relevant to determining

whether Ms. Cauthen satisfies § I.46.a(2)(c).

3

Dr. Fortin did not explain what those tests were or

how they led her to her ultimate diagnosis.

9

The District Court accordingly entered PTO No. 8753

granting Wyeth‟s motion and enjoining the Cauthens from

prosecuting their lawsuit in state court. The Cauthens then

filed this timely appeal.

II. Discussion4

On appeal, the Cauthens argue that the District Court

erred in two general ways. First, they claim that the District

Court misunderstood Dr. Fortin‟s declaration and that her

declaration demonstrates that Ms. Cauthen in fact has PPH

that was caused by her use of the diet drugs and not by mild

restrictive lung disease. Second, they argue in the alternative

that, even if Ms. Cauthen does not meet the technical

definition of PPH provided by the Settlement Agreement, the

District Court should have reformed the Settlement

Agreement, given changes in diagnostic capabilities that have

rendered obsolete the requirement that a putative plaintiff

4

The District Court had jurisdiction pursuant to 28

U.S.C §§ 1332 and 1407. The District Court‟s order directing

the Cauthens to dismiss their complaint in the Court of

Common Pleas of Philadelphia County is an injunction, and

we therefore have jurisdiction under 28 U.S.C. § 1292(a)(1).

We apply “plenary review to a district court‟s construction of

settlement agreements,” but we review any underlying factual

findings for clear error. Coltec Indus., Inc. v. Hobgood, 280

F.3d 262, 269 (3d Cir. 2002); cf. In re Cendant Corp. Prides

Litig., 233 F.3d 188, 193 (3d Cir. 2000) (“[C]ontract

construction, that is, the legal operation of the contract, is a

question of law mandating plenary review,” while “contract

interpretation is a question of fact, and review is according to

the clearly erroneous standard.”).

10

demonstrate lung capacity greater than 60 percent of

predicted at rest.

A. The Effect of Dr. Fortin’s Declaration

Settlement agreements are interpreted according to

“basic contract principles.” In re Cendant Corp. Prides

Litig., 233 F.3d 188, 193 (3d Cir. 2000). When the terms of a

contract are clear and unambiguous, its meaning “must be

determined from the four corners of the contract.” Glenn

Distribs. Corp. v. Carlisle Plastics, Inc., 297 F.3d 294, 300

(3d Cir. 2002); see also Am. Eagle Outfitters v. Lyle & Scott

Ltd., 584 F.3d 575, 587 (3d Cir. 2009) (“When the words are

clear and unambiguous, the intent of the parties must be

determined from the express language of the agreement.”

(internal quotation marks omitted)). In contrast, “if the

written contract is ambiguous, a court may look to extrinsic

evidence to resolve the ambiguity and determine the intent of

the parties.” Glenn Distribs., 297 F.3d at 300. A contract

provision is ambiguous under Pennsylvania law5

if, and only if, it is reasonably or fairly

susceptible of different constructions and is

capable of being understood in more senses

than one and is obscure in meaning through

indefiniteness of expression or has a double

meaning. A contract is not ambiguous if the

court can determine its meaning without any

guide other than a knowledge of the simple

5

The parties agree that Pennsylvania law controls this

issue. (See Appellants‟ Opening Br. at 29 (citing

Pennsylvania contract law); Appellee‟s Br. at 13 (same).)

11

facts on which, from the nature of the language

in general, its meaning depends; and a contract

is not rendered ambiguous by the mere fact that

the parties do not agree on the proper

construction.

Duquesne Light Co. v. Westinghouse Elec. Corp., 66 F.3d

604, 614 (3d Cir. 1995) (internal quotation marks omitted).

Under those standards, we cannot credit the Cauthens‟

arguments that Dr. Fortin‟s declaration either supplanted the

requirements of the Settlement Agreement or otherwise

satisfied them.

First, the Cauthens contend that, because a board

certified cardiologist “determined that Ms. Cauthen‟s PPH is

not related to … restrictive lung disease,” Ms. Cauthen “has

the right to make a claim against [Wyeth] for PPH under the

definition of PPH in the Settlement Agreement” (Appellants‟

Opening Br. at 27), notwithstanding that her sole PFT showed

her total lung capacity to be less than 60 percent of predicted

at rest. Specifically, the Cauthens point to Dr. Fortin‟s

statements that “whether [Ms. Cauthen‟s] total lung capacity

percent calculation is 56% or 60% is clinically irrelevant”

(App. at 810), and that, “to a reasonable degree of medical

certainty[,] … Ms. Cauthen‟s diet drug use was the cause of

her primary pulmonary hypertension.” (Id. at 811.)

According to their argument, the District Court should have

disregarded the requirements of the Settlement Agreement

because a physician unilaterally declared that Ms. Cauthen

has PPH that was caused by the diet drugs and not restrictive

lung disease.

12

The Settlement Agreement, however, clearly and

unambiguously states that a putative PPH plaintiff must

demonstrate, through a PFT, that her total lung capacity is

greater than 60 percent of predicted at rest. That is the only

way, under the specific terms of that agreement, to rule out

“greater than mild restrictive lung disease” as a cause of PPH.

Ms. Cauthen produced only one PFT, which showed that her

lung capacity was only 56 percent of predicted at rest. Her

physician‟s confident assertion that Ms. Cauthen‟s PPH was

caused by the diet drugs is therefore irrelevant in the face of

the Settlement Agreement, which requires a showing that a

putative plaintiff‟s lung capacity is greater than 60 percent of

predicted at rest.

Second, the Cauthens argue that Dr. Fortin‟s

declaration is not meant to replace the requirements of

§ I.46.a(2)(c), but rather that the declaration is a “medical

record” that confirms the absence of greater than mild

restrictive lung disease. (See Appellants‟ Opening Br. at 25

(when considered in light of Dr. Fortin‟s declaration, “Ms.

Cauthen has presented a pulmonary function test to

demonstrate that she has PPH in accord with the

settlement”).) Dr. Fortin‟s declaration, they contend,

“demonstrates a lung capacity of at least 60% when the 5.37

total lung volume … is even slightly reduced to reflect the

Plaintiff‟s true lung capacity in the algorithmic formula used

to calculate lung function.” (Appellants‟ Opening Br. at 25-

26.) The District Court therefore erred, the Cauthens argue,

when it did not interpret the declaration to mean that Ms.

Cauthen‟s percentage of lung capacity predicted at rest was

actually greater than 60 percent, or, at least, a jury should be

given the chance to so conclude.

13

Even if the Settlement Agreement could be read to

allow Dr. Fortin‟s declaration to be an adequate substitute for

or adjunct to a PFT, however, the Cauthens have overstated

Dr. Fortin‟s position. She never said that Ms. Cauthen‟s lung

capacity is actually greater than 60 percent of predicted at

rest, only that it cannot be known “what the true reference

value for Ms. Cauthen should be.” (App. at 810.)

Accordingly, the Cauthens cannot credibly say that Dr.

Fortin‟s declaration establishes that Ms. Cauthen‟s lung

capacity is greater than 60 percent.6 The District Court

6

The Cauthens contend that this case should be

governed by PTO No. 3699, a case in which the District

Court considered and accepted a medical expert‟s declaration

as a means of satisfying a separate provision of the Settlement

Agreement. There, the District Court interpreted a provision

of the PPH exception that requires a putative plaintiff to

produce “a diagnosis based on examinations and clinical

findings … by cardiac catheterization” that the plaintiff‟s

“normal pulmonary artery wedge pressure” is less than or

equal to 15 mm Hg. (App. at 42.10 (Settlement Agreement,

§ I.46.a(1)(a)).) The putative plaintiff produced a “Cardiac

Catheterization Report” showing a wedge pressure range of

14 to 16 mm Hg. (App. at 14.) Because the report straddled

the range of the PPH exception, the District Court considered

a declaration by the plaintiff‟s medical expert who reviewed

the cardiac catheterization report and opined that the

plaintiff‟s “wedge pressure [was] 14 mm Hg” and thus fell

under the wedge pressure requirement. (App. at 14.) Based

on that declaration, the Court found that the plaintiff satisfied

the PPH exception and declined to enjoin his claims.

The facts of PTO No. 3699 are much different than

those of this case. Whereas the results of the cardiac

14

therefore did not err in concluding that the Settlement

Agreement unambiguously requires a showing through a PFT

that a putative plaintiff‟s lung capacity is greater than 60

percent of predicted at rest and that Dr. Fortin‟s declaration

did not provide that showing.7

catheterization report in PTO No. 3699 spanned the threshold

wedge pressure value required by the Settlement Agreement,

hindering the District Court‟s ability to determine whether the

putative plaintiff‟s pressure fell outside the PPH exception

(greater than 15 mm Hg), or within it (less than or equal to 15

mm Hg), Ms. Cauthen‟s PFT unambiguously falls short of the

PPH exception embodied in § I.46.a(2)(c). The District Court

did not need the assistance of a medical expert to understand

that a lung capacity percentage that is less than 60 percent of

predicted at rest falls outside the exception.

7

The Cauthens also argue that the District Court

should have allowed a jury to consider Dr. Fortin‟s

declaration under rule 702 of the Federal Rules of Evidence.

They assert that because Dr. Fortin is unquestionably an

expert in the field of cardiac medicine, her opinion “would be

admissible in a court of law” (Appellants‟ Opening Br. at 37),

and because her opinion would be admissible, it would “[b]y

definition … have a reasonable medical basis in fact.” (Id.)

The District Court accordingly exceeded its authority as a

gatekeeper, they argue, by rejecting Dr. Fortin‟s expert

opinion as “evidence that could not be considered under the

strictures of the Settlement Agreement.” (Id. at 38.)

But the Cauthens have not established the

requirements of rule 702. First, Dr. Fortin‟s specialized

medical knowledge, as embodied in her declaration, would

not “help the trier of fact to understand the evidence or to

15

determine a fact in issue.” Fed. R. Evid. 702(a). To

determine whether a declaration is helpful, this Court looks to

the “„proffered connection between the scientific research or

test result to be presented and particular disputed factual

issues in the case.‟” In re Paoli R.R. Yard PCB Litig., 35

F.3d 717, 743 (3d Cir. 1994) (quoting United States v.

Downing, 753 F.2d 1224, 1237 (3d Cir. 1985)); see also

Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 591

(1993) (adopting Downing‟s connection requirement). A

court “must examine the expert‟s conclusions in order to

determine whether they could reliably flow from the facts

known to the expert and methodology used.” Oddi v. Ford

Motor Co., 234 F.3d 136, 146 (3d Cir. 2000) (internal

quotation marks omitted). Even if a party proffers expert

testimony based on scientific knowledge, “„[a] court may

conclude that there is simply too great a gap between the data

and the opinion proffered.‟” Id. (quoting Gen. Elec. Co. v.

Joiner, 522 U.S. 136, 146 (1997)). “Rule 702‟s „helpfulness‟

standard requires a valid scientific connection to the pertinent

inquiry as a precondition to admissibility.” In re Paoli, 35

F.3d at 743 (internal quotation marks omitted).

Dr. Fortin‟s declaration did not conclude that Ms.

Cauthen‟s total lung capacity is greater than 60 percent of

predicted at rest. She asserted only that Ms. Cauthen‟s lung

capacity percentage cannot be determined because “we just

do not know conclusively what the true reference value for

Ms. Cauthen should be.” (App. at 810.) That cannot help the

trier of fact reach the necessary conclusion that Ms.

Cauthen‟s total lung capacity, demonstrated by a PFT to be

3.03 liters, is greater than 60 percent of predicted at rest. At

best, Dr. Fortin‟s declaration would provide evidence that Ms.

Cauthen‟s total lung capacity predicted at rest might not be 56

16

B. The Cauthens’ Reformation Argument

In the alternative, the Cauthens contend that the

District Court, which “retains a special responsibility to see to

the administration of justice” in a class action settlement

(Appellants‟ Opening Br. at 35 (internal quotation marks

omitted)), should have reformed the Settlement Agreement.

Although they never sought reformation of the Settlement

Agreement before the District Court, they now argue that the

Court should have reformed the Settlement Agreement

because diagnostic procedures for PFTs have changed. They

claim support for that argument in the following statement in

Dr. Fortin‟s declaration:

Automated spirometry systems usually have

built-in software that can generate a preliminary

interpretation, especially for spirometry.

Today, most clinical pulmonary function testing

laboratories use a microprocessor-driven

pneumotachometer to measure air flow directly

and then to mathematically derive volume.

These pre-programmed values are based upon

averages for persons of similar height, weight,

age, ethnicity, etc.

percent. But a trier of fact could not use the declaration to

conclude that Ms. Cauthen‟s total lung capacity is actually

greater than 60 percent, and Dr. Fortin failed entirely to

provide the “scientific connection” needed to bridge the gap

between a percentage of lung capacity that falls below 60

percent and one that does not. Accordingly, Dr. Fortin‟s

declaration is not an expert opinion that could be “helpful” to

a trier of fact, even if there were a fact question.

17

(App. at 809.) Placing emphasis on the word “today,” the

Cauthens interpret that statement to mean that “on the modern

pneumotachometers used at the present time, pre-

programmed algorithms measure air flow directly and then

mathematically derive volume, precluding manual

adjustments to the algorithms that were permitted on the older

machines in use when the Settlement Agreement was

negotiated and entered.” (Appellants‟ Opening Br. at 23-24.)

Essentially, the Cauthens argue that modern diagnostic

instruments are cause for reformation of the agreement.

Because they did not raise that argument below, it is

waived. “It is axiomatic that arguments asserted for the first

time on appeal are deemed to be waived and consequently are

not susceptible to review in this Court absent exceptional

circumstances.” Tri-M Grp., L.L.C. v. Sharp, 638 F.3d 406,

416 (3d Cir. 2011) (internal quotation marks omitted). That

“general rule serves several important judicial interests,”

including “protecting litigants from unfair surprise;

promoting the finality of judgments and conserving judicial

resources; … preventing district courts from being reversed

on grounds that were never urged or argued before them,” id.

(alteration and internal quotation marks omitted), “ensuring

that the necessary evidentiary development occurs in the trial

court, and preventing surprise to the parties when a case is

decided on some basis on which they have not presented

argument,” Barefoot Architect, Inc. v. Bunge, 632 F.3d 822,

835 (3d Cir. 2011).

It is true that the waiver rule “is one of discretion

rather than jurisdiction, and it may be relaxed whenever the

public interest so warrants.” Id. at 834-35 (citation,

alteration, and internal quotation marks omitted). “[W]e will

18

still address arguments raised for the first time on appeal in

exceptional circumstances,” and we retain the discretion,

“exercised on the facts of individual cases,” to determine

“what questions may be taken up and resolved for the first

time on appeal.” Tri-M Grp., 638 F.3d at 416 (internal

quotation marks omitted). But there are no exceptional

circumstances in this case that would permit us to ignore the

waiver rule. “The waiver rule applies with greatest force

where the timely raising of the issue would have permitted

the parties to develop a factual record.” Barefoot Architect,

632 F.3d at 835. The parties did not develop in the District

Court the arguments in favor and against reformation, and

that Court was not allowed to perform its vital function of

developing a complete factual record on the relevant changes,

if any, in diagnostic technology and procedures. Without the

aid of factual development by the District Court, we cannot

adequately evaluate the merit of Dr. Fortin‟s assertion that

diagnostic technologies have changed to such a degree that

reformation is called for.8

8

Even in the absence of a waiver, it appears that the

Cauthens would have difficulty with the merits of their

argument. While a district court retains “general equitable

power to modify the terms of a class action settlement,” In re

Cendant, 233 F.3d at 194, when the plaintiff demonstrates

that there has been “a significant change either in factual

conditions or in law,” Rufo v. Inmates of Suffolk Cnty. Jail,

502 U.S. 367, 384 (1992), Dr. Fortin‟s declaration alone

provides little proof that diagnostic procedures have indeed

changed to the degree that reformation is warranted. Dr.

Fortin said that “[t]oday, most … laboratories use a

microprocessor-driven pneumotachometer.” (App. at 809.)

She did not, however, explain how diagnostic procedures

19

III. Conclusion

For the foregoing reasons, we will affirm the decision

of the District Court.

were different in the past or why the recent changes create the

need to reform the Settlement Agreement.

20