PRECEDENTIAL

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

_____________

No. 12

- 1180

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In Re: DIET DRUGS (PHENTERMINE/FENFLURAMINE/

DEXFENFLURAMIN E ) PRODUCT LIABILITY LITIGATION,

Carmen Cauthen and Ricky Leon Cauthen, Appellants

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On Appeal from the United States District Court for the Eastern District of Pennsylvania (D.C. No s

. 2

- 99

- cv

- 20593 , 2

- 12

- md

- 01203 ) District Judge: Hon. Harvey Bartle, III

_______________

Argued

November 1 3 , 2012

Before: SCIRICA, FISHER, and JORDAN

, Circuit Judges

.

(Filed : January 28, 2013 )

_______________2 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

Ra ymond 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 100223 Geoffrey J. Michael Anna K. Thompson

Daniel S. Pariser

Arnold & Porter LLP

555 Tw elfth 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

Philade lphia, 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

_______________4 JORDAN, Circuit Judge.

In November 1999, Wyeth L

. L

. C

. (“Wyeth”) entered into a nationwide class action settlement agreement (the “Settlement Ag reement”) with the users of certain diet drugs linked to various health problems. The United States District

Court for the Eastern Di s trict of Pennsylvania certified the settlement class and entered a pre

- trial order enjoining

members of the class from su ing Wyeth for inj u ries 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 hyp ertension (“PPH”), a condition that she alle g es was caused by the d iet d rugs. 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 re a sons that follow, w e will

affirm.

I. Background

A. Class Action Suit and Settlement Agreement

Between 199 4 and 1997, American Home Products Corporation , now Wyeth, marketed an d sold fenfluramine and dexfenfluramine, prescri p tion 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 the5 market i n 1997. Tho u sands 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 Unite d States District Court for the Eastern District of Pennsylvania for consolidated pre

- trial

procee d ings

. Nearly two years later, Wyeth entered into a Settlement Agreement with users of the d iet d rugs 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 Agre e ment, and

entered P re

- T rial O rder (“PTO”) No. 1415

. That order provided that the District Court “retains continuing and exclusive juris di c tion over this action and each of the Parties, including [Wyeth] and the class members, to a d minister, supervise, interpret and enforce the Settlement in accordance
with its terms.” (Supp lemental App. at 8.)

Aside from certain narrow exceptions, the Settlement Agreement enjoins class members from suing Wyeth for all

d iet d rug

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

this case: the Se t tlement Agreement allows class members to sue Wyeth if they can demonstrate that they deve l oped PPH 1

thr oug h the use of the d iet d rugs

. To qualify for the exception, a class member must draw on “[m]edical records”

to demonstrate the “e x clus [ 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 & Louis e J. Gordy, Attorneys’ Textbook of Medicine ¶ 205.75 (3d ed. 2011).6 conditions. ( App . at 787

- 88.) To exclude one such condition,

which is referred to as “great er than mild r e strictive lung disease,” a class member is required by § I.46.a(2)(c) of the Settlement Agreement to produc e “p ulmonary function tests” 2
(“PFTs”) show ing that the class member‟s “total lung capacity” is greater than “60% of predicted at rest .” ( Id

. (Settl e ment Agreement, § I.46.a(2)(c) ).)

B. The Cauthens’ Lawsuit

In June 2011, the Cauthen s filed a complaint in the

Philade l phia County Court of Common Pleas, alleging that

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

PPH “ as a r esult of ingesting Diet Drugs.” ( Id . at 3.) T he Cauthens produced a “ [ p ] ulmonary consultation note” prepared by Dr. Terry Fo r tin ( id . at 795

- 97), a cardiologist certified by the American Board of Internal Med i cine. Dr.

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

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

and Dr. Fortin acknowledged that Ms. Cauthen‟s lungs “clearly have some restri c tion.” ( Id . at 796.)

Because Ms. Cauthen‟s only PFT showed that she had lung capaci ty 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 cir culation.” Pulmonary function tests: MedlinePlus Medical Encyclopedia (Dec. 12, 2011), http://www.nlm.nih.gov/medlineplus/ency/article/003853.htm (last visited Jan. 3, 2013).7 bringing their claim , as Ms. Cauthen did not satisfy § I.46.a(2)(c) of the Settlement Agreement

. T he 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. Forti n stating that, “to a reasonable degree of medical certainty[,] ... Ms. Cauthen has primary pulmonary hype r tension 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

mea s ured values for pulmonary function test s obtained on a patient at any particular point with normative values derived from population studies.” ( Id . at 809.) “The perce n tage of predicted normal [lung capacity],” she continued, “is used to grade the severity of the abnormality.” ( Id .) She exp lained 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 .) A c cording to Dr. Fortin, the “standard average

refere nce” 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 demographic8 profile ), yields Ms. Cauthen‟s percentage of lu ng capacity predicted at rest, 56.4 pe r cent.

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 asse rted, “are only averages and may vary in actual practice.” ( Id . at 809.) “The

5.37 liter re f

erence 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 jus t a predicted ave r age 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 availab le 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 th e percent predicted calculation on a [PFT] and must rely on

other m e thods in order to determine a specific patient‟s true total lung capacity, such as radiology studies and an exam of9 the patient‟s body habitus.” ( Id . at 810.) In fact, Dr. Fortin

claimed

, “whet h er [Ms. Cauthen‟s] total lung capacity percent predicted calculation is 56% or 60 % is clinically irrelevant” ( id .)

, a nd “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, t he District Court held that the Cauthen s had not produced a PFT that supported t he i r 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 declar a tion did not alter
the Court‟s conclusion fo r 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. M s. Cauthen thus did not meet the definition of PPH pr o vided in § I.46.a(2)(c)

. Second, th e Settlement Agreement requires class member s who wish to

make a claim related to PPH to establish, “through a pulmonary function test only, the a b sence 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 Agre e ment as sufficient to establish a PPH

claim , the Court held that it wa s 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.10 The District Court accordingly entered PTO No. 8753 granting Wyeth‟s motion and enjoining the Cauthens from prosecuting their lawsuit in state court. The Ca u thens then

filed this timely appeal.

II. Discussion 4

On appeal, the Cauthens argue that the District Court erred in two general ways. F irst

, the y 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 reform ed the Settlement Agreement

, given changes in diagnostic capabi l ities that have

render ed obs olete 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 ther e fore have jurisdiction under 28 U.S.C. § 1292(a)(1). We apply “plenary review to a district court‟s construction of settlement agre e ments,” but we r eview 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.”).11 de m onstrate 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 Cenda nt 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 Pla s tics, 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 m arks 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 Penns ylvania law 5

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 Appellant s ‟ Opening Br. at 29 (citing Pennsylvania contract law); Appellee‟s Br. at 13 (same). )12 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

t he 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 standard s , we cannot credit the Cauthens‟ arguments that Dr. Fortin‟s decla ration 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. Ca u then‟s PPH is

not related to ... restrictive lung disease,” M s. 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 lu ng capacity to be less than 60 percent of predi cted

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 prima ry pulmonary hypertension.” ( Id . at 811.) According to their argument, the District Court should have disregard ed the requirements of the Settl e ment Agreement

because a physician unilaterally decla re d that Ms. Cauthen has PPH that was caused by the diet drugs and not restrictive lung disease.13 The Settlement Agreement , however, clearly and unambiguously states that a putative PPH plaintiff must demonstrate, through a PFT, that her total lung capacit y is greater than 60 percent of predicted at rest . That is the only

way
, under the specific terms of that a greement

, 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 pr e dicted 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 require s 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 requir e ments 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 Appellant s ‟ 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

settle ment”).) Dr. Fo r tin‟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

P laintiff‟s true lung c a pacity in the algorithmic formula used

to calcul ate lung funct ion.” (Appellant s ‟ 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 co n clude.14 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 overstate d Dr. Fortin‟s position . She never sai d that Ms. Cauthen‟s lung

capac i ty 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

c a pacity is greater than 60 percent. 6 The District Court

6 The Cauthens conte nd 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 Se t tlement Agreement. There , the District Court interprete d 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 plai n tiff‟s “normal pulmonary artery wedge pressure” is less than or equal to 1 5 mm Hg. (App. at 42.10 ( Settl e ment Agreement, § I.46.a(1)(a)) .) The putative plaintiff produced a “Cardiac

Catheterization R e port” showing a wedge pressure range of 14 to 16 mm Hg. (App. at 14 .) Because the report straddled the range of the PPH except ion, the District Court considered

a declar a tion by the plaintiff‟s medical expert who reviewed

the c ardiac 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 sati s fied 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 cardiac15 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 re port 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

put a tive plaintiff‟s pressure fell outside the PPH exception (greater than 15 mm Hg), or w it h in it (less than or equal to 15 mm Hg), Ms. Cauthen‟s PFT unambiguously falls short of the

PPH exce p tion 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

pr e dicted 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 bec ause 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

d e finition ... have a reasonable me dical basis in fact.” ( Id. ) The District Court accordingly exceeded its authority as a gatekeeper, they argue, by rejecting Dr. Fortin‟s expert

op i nion 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 kno w ledge, as embodied in her declaration, would not “help the trier of fact to understand the evidence or to16 determine a fact in issue.” Fe d. R. Evid. 702(a). To determine whether a declaration is helpful, this Court looks to the “„proffered connection between the scie n tific research or test result to be presented and particular disputed factual
issues in the case.‟” In re Paoli R.R. Yard P CB 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 th e expert‟s conclusions in order to determine whether they could reliably flow from the facts known to the expert and methodology used.” O d di 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 „helpfu l ness‟

standa rd requires a valid scientific connection to the pertinent inquiry as a precondition to admissibility.” In re Paoli , 35 F.3d at 743 (internal qu o tation marks omitted).

Dr. Fortin‟s declaration did not conclude that Ms. Cauthen‟s total lung capacity is gre ater than 60 percent o f 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.

Ca u then‟s total lung capacity, demonstrated by a PFT to be 3.03 liters, is greater than 60 percent of pr e dicted at rest. At best, Dr. Fortin‟s declaration would provide evidence that Ms.

Cauth en‟s total lung capacity predicted at rest might not be 5617 B. The Cauthens’ Reformation Argument

In the alternative, the Cauthens contend that the

District Court , which “retai ns a special responsibility to see to the administration of justice” in a cla ss action settlement (Appellant s ‟ 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. For tin‟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 pneumotacho meter 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 “sc ientific connection” needed to bridge the gap between a percentage of lung capacity that falls below 60

pe r cent and one that does not. Accordingly, Dr. Fortin ‟ s declaration is not an expert opinion that could be “ helpful ” to

a tr i er of fact , even if there were a fact question

.18 (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

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. 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 judic ial

resources;

... preventing district courts from being reversed on grounds that were ne ver urged or argued before them, ” i d. (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 t hat the waiver rule “is one of discretion

rather tha n 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 will19 still address arguments raised for the first time on appeal in exceptional circumstanc es,” 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 t here are no exc eptional circumstances in this case that would permit us to ignore the
waiver rule. “ T he 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 diagnos tic technology and procedures. W ithout 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. W hile a district court retains “general equit a ble power to modify the terms of a class action settlement,” In r e 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 p roof 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 diagnosti c procedures20 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.