2015 Decisions

Opinions of the United

States Court of Appeals

for the Third Circuit

4-21-2015

In re: Diet Drugs

Follow this and additional works at: http://digitalcommons.law.villanova.edu/thirdcircuit_2015

This April is brought to you for free and open access by the Opinions of the United States Court of Appeals for the Third Circuit at Villanova University

School of Law Digital Repository. It has been accepted for inclusion in 2015 Decisions by an authorized administrator of Villanova University School of

Law Digital Repository. For more information, please contact Benjamin.Carlson@law.villanova.edu.

Recommended Citation

"In re: Diet Drugs" (2015). 2015 Decisions. Paper 402.

http://digitalcommons.law.villanova.edu/thirdcircuit_2015/402
NOT PRECEDENTIAL

UNITED STATES COURT OF APPEALS

FOR THE THIRD CIRCUIT

________________

No. 14-3484

________________

In re: Diet Drugs (Phentermine/Fenfluramine/Dexfenfluramine) Products Liability 

Litigation

Robert E. Staggs and Joan E. Staggs, Appellants

________________

Appeal from the United States District Court

for the Eastern District of Pennsylvania

(D.C. Civil Action Nos. 2-99-cv-20593, 2-11-md-01203, 2-16-md-01203)

District Judge: Honorable Harvey Bartle, III

________________

Submitted Under Third Circuit LAR 34.1(a)

April 13, 2015

Before: AMBRO, VANASKIE, and SHWARTZ, Circuit Judges

(Opinion filed: April 21, 2015)

________________

OPINION*

________________

AMBRO, Circuit Judge

 

* This disposition is not an opinion of the full Court and pursuant to I.O.P. 5.7 does not 

constitute binding precedent.
2

Robert and Joan Staggs appeal the District Court’s order denying their challenge 

to the decision of the AHP Settlement Trust not to compensate Robert Staggs for the 

alleged injury due to his use of the diet drugs Pondimin and Redux. We affirm. 

I. Background

Pondimin and Redux caused widespread injuries to tens of thousands of people. 

Their claims are subject to a settlement agreement pursuant to which AHP Settlement 

Trust pays money to those plaintiffs deemed to have suffered compensable injuries.

Staggs used Pondimin and Redux and submitted to AHP Settlement Trust a claim 

for what are known as “Matrix Benefits” after he was diagnosed with mild aortic 

regurgitation, a heart condition in which blood flows backward through the aorta and into 

the left ventricle rather than out of the left ventricle. His claim included a diagnosis by 

Dr. Robert Rosenthal based on a reading of Staggs’s echocardiogram (“EKG”). AHP 

Settlement Trust referred the claim to Dr. Bryan Lucenta, who agreed that there was 

“mild aortic insufficiency.” J.A. 3338.

According to the Settlement Agreement, a claimant suffered a compensable injury 

if an EKG demonstrates mild or greater aortic regurgitation. To measure this, a person 

must view an EKG and record the regurgitant jet height. If this value is 10% or more of 

the left ventricular outflow tract height, the subject of the EKG has at least mild aortic 

regurgitation. Crucially here, according to the Settlement Agreement, the person 

examining the EKG must use the “parasternal long-axis view” to measure regurgitant jet 

height unless that view is unavailable or inadequate, in which case one may use the 
3

“apical long-axis view.” Settlement Agreement § I.22. This is so because the parasternal 

long-axis view is less likely to over-represent regurgitant jet height.

Following Dr. Lucenta’s review, Staggs’s claim was audited. The purpose was to 

determine whether Staggs’s claim had a “reasonable medical basis.” Settlement 

Agreement § VI.E.6. Dr. Robert Gillespie, the auditing cardiologist, reviewed Staggs’s 

claim and determined that his EKG showed only trace aortic regurgitation. He further 

concluded that there was no reasonable medical basis for Dr. Rosenthal’s diagnosis. 

AHP Settlement Trust thus denied Staggs’s claim via a “post-audit determination letter.” 

As the Audit Rules allow, Staggs contested the denial and submitted declarations by Dr. 

Leon Franzin and Dr. Gerald Koppes. 

They opined that the parasternal long-axis view was unavailable, and thus they 

relied on the apical long-axis view to determine that Staggs indeed suffered from mild 

aortic regurgitation. In response, Dr. Gillespie submitted a declaration explaining that the 

parasternal long-axis view was in fact available and that the EKG showed only trace 

aortic regurgitation. Thus, the Trust issued a final post-audit determination letter again 

denying Staggs’s claim. Staggs objected, and the claim went through the settlement’s 

“Show Cause” process, pursuant to which the parties could dispute the claim before the 

District Court.

It referred the Show Cause proceedings to a Special Master, who appointed the 

Technical Advisor, Dr. Sandra Abramson, to review the record of Staggs’s claim, which 

included his EKG and the opinions of Drs. Rosenthal, Lucenta, Gillespie, Franzin and 
4

Koppes. The Technical Advisor agreed with Dr. Gillespie that there was no reasonable 

medical basis for Staggs’s claim and issued a report to that effect.

Staggs disagreed with the Technical Advisor and submitted a response to her 

report. He also tried to submit supplemental reports by Drs. Franzin and Koppes. 

However, the Special Master concluded that, pursuant to Audit Rule 34, these “rebuttals” 

could not be considered as part of the Show Cause record. J.A. 14–15 n.12. The District 

Court agreed, considered the whole Show Cause record (without the rebuttal reports of 

Drs. Franzin and Koppes), and ultimately concluded that the Technical Advisor and Dr. 

Gillespie were correct that there was no reasonable medical basis for Staggs’s claim.

II. Discussion

Staggs raises three issues on appeal. He contends that the District Court (1) 

wrongly applied the “reasonable medical basis” standard by failing to defer to his 

physician’s diagnosis; (2) erred in deciding that there was no reasonable medical basis for 

his claim; and (3) violated the Audit Rules and deprived him of due process of law by 

excluding the rebuttal reports of Drs. Franzin and Koppes.

A. Reasonable Medical Basis 

Staggs argues that the auditing cardiologist’s review of whether a diagnosis has a 

“reasonable medical basis” must defer to the claimant’s attesting physician. From this 

premise, he concludes that the attesting physician’s conclusion must be accepted if it is 

“not absurd, not ridiculous, not extreme, and not excessive.” Appellant Br. at 23. 

It is true that reasonable medical basis review commands a degree of deference: if 

an attesting physician declares a claimant qualifies for matrix benefits and an auditing 
5

cardiologist or the District Court disagrees but nonetheless perceives a reasonable 

medical basis for the claim, the claim must be approved. But, even though those 

reviewing the diagnosis may only examine whether it has a reasonable medical basis and 

not impose their independent judgment of a claimant’s medical condition without regard 

to the attesting physician’s decision, it does not follow that the review is so deferential as 

to require approval of any claim unless it is patently absurd.

Rather than the standard Staggs urges, we adhere to the definition in our precedent 

and the Audit Training Module: a “reasonable medical basis” is a foundation for a 

diagnosis by an unbiased physician using “normal clinical judgment and accepted 

medical standards.” J.A. 1489–90. A reasonable medical basis also exists when a 

diagnosis results from faithful application of the District Court’s orders on “the 

requirements for reading an echocardiogram, see PTO 2640” and “the Auditing 

Cardiologist Training Course, see PTO 2825.” In re Diet Drugs (Phentermine/ 

Fenfluramine/Dexfenfluramine) Prods. Liab. Litig., 543 F.3d 179, 189 n.16 (3d Cir. 

2008).

B. There Was No Reasonable Medical Basis

As stated above, Dr. Rosenthal attested that Staggs suffered from mild aortic 

regurgitation; Dr. Gillespie disagreed. This is a purely factual dispute, and we review the 

District Court’s findings for clear error. The Court referred the parties’ disagreement to a 

Special Master, who in turn appointed a Technical Advisor “to educate [the Special 

Master] in the jargon and theory disclosed by the [evidence] and to think through the 

critical technical problems.” Reilly v. United States, 863 F.2d 149, 158 (1st Cir. 1988). 
6

The core of the parties’ dispute is whether the parasternal long-axis view of 

Staggs’s echocardiogram was available and adequate to evaluate his aortic regurgitation. 

The Technical Advisor, the Special Master, and the District Court all agreed with Dr. 

Gillespie that this preferred view was available and that it showed no reasonable medical 

basis for Staggs’s diagnosis. For his part, Staggs does not contend that the parasternal 

long-axis view suggests he suffers from aortic regurgitation; rather, he argues this view is 

unavailable and that the experts should have relied on the apical long-axis view, which, 

according to his experts, shows mild aortic regurgitation.

The Technical Advisor, duly assisting the Court in sorting out “the critical 

technical problems,” id., in this case—(1) whether the parasternal long-axis view was 

available and (2) whether it revealed aortic regurgitation—reviewed the EKG and 

concluded that the preferred view was available. J.A. 13. She also persuasively 

explained why the apical view in this case was likely to overstate aortic regurgitation. Id. 

She further concluded, based on both views, not only that Staggs did not suffer from 

aortic regurgitation but also that there was no reasonable medical basis for his claim. The 

Advisor’s report explained that the parasternal long-axis view disclosed no regurgitation, 

and the apical long-axis view revealed exaggerated regurgitation.

Staggs gives us no reason to find clearly erroneous the District Court’s factual 

finding that the parasternal long-axis view was available and adequate to determine 

whether he had aortic regurgitation. Instead, he reiterates his expert’s opinion to the 

contrary. Staggs does not contest that the parasternal long-axis view is less likely to 

overestimate aortic regurgitation than the apical long-axis view, and he does not contest 
7

that his experts used the latter, disfavored methodology for examining his EKG. At best, 

Staggs offers an alternative plausible way of reading the evidence, but “[w]here there are 

two permissible views of the evidence, the factfinder’s choice between them cannot be 

clearly erroneous.” Anderson v. Bessemer City, 470 U.S. 564, 574 (1985). In the 

absence of convincing argument to support Staggs’s position, we would “overstep[] the 

bounds of [our] duty” if we second-guessed the District Court’s careful factual finding 

here. Id.

C. The District Court’s Procedures Comport with the Audit Rules and 

Due Process

After the Technical Advisor issued her report, Staggs attempted to rebut it by 

submitting two contradictory expert reports that were not a part of the Show Cause 

record. While parties who disagree with the Technical Advisor are permitted to respond 

to the Advisor’s reports, and while they may consult with experts in drafting their 

responses, the Audit Rules forbid them from submitting additional evidence to 

supplement the Show Cause record. Audit Rule 34, J.A. 1469.

Staggs also argues that the limitation on additional evidence violates the Due 

Process Clause of the Fifth Amendment. “The fundamental requirement of due process is 

the opportunity to be heard ‘at a meaningful time and in a meaningful manner.’” 

Mathews v. Eldridge, 424 U.S. 319, 333 (1976) (quoting Armstrong v. Manzo, 380 U.S. 

545, 552 (1965)). Staggs had this opportunity in spades. He submitted a claim for 

benefits to AHP Settlement Trust; he contested the auditing cardiologist’s finding that his 

claim lacked a reasonable medical basis; he challenged the final post-audit determination 
8

letter before the Special Master; he disputed the Technical Advisor’s report; and he 

appealed the Special Master’s decision to the District Court. At every stage of the 

process, he was represented by counsel. He had ample opportunity to submit evidence 

and argument to decisionmakers, and he took advantage of the thorough process available 

to him. 

As Staggs “had many opportunities to respond” to the post-audit determination 

letter, he “did not suffer a denial of [his] due process rights.” Elliott v. Kiesewetter, 98 

F.3d 47, 60 (3d Cir. 1996). The District Court needed to close the evidentiary record at 

some point; otherwise the endless submissions of and responses to expert reports would 

“grind judicial . . . gears to a screeching halt.” Id. Because the District Court afforded 

Staggs the opportunity to submit expert diagnoses before the Technical Advisor’s report 

and as he had the opportunity to respond to the Technical Advisor’s report in consultation 

with an expert, the District Court’s decision, announced in the Audit Rules, to limit the 

evidentiary record to those documents produced before the Technical Advisor examined 

them comported with due process.

* * * * *

For the foregoing reasons, we affirm.