In Re: Diet Drugs v. , 601 F. App'x 143 ( 2015 )

NOT PRECEDENTIAL
UNITED STATES COURT OF APPEALS
FOR THE THIRD CIRCUIT
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No. 14-3082
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IN RE: DIET DRUGS (PHENTERMINE/FENFLURAMINE/DEXFENFLURAMINE)
PRODUCTS LIABILITY LITIGATION
Patrick J. Venetz and Nancy E. Venetz,
Appellants
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APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE
EASTERN DISTRICT OF PENNSYLVANIA
(D.C. Nos. 2:99-cv-20593; MDL No. 2-16-md-1203; MDL No. 2-11-md-01203)
District Judge: Hon. Harvey Bartle, III
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Submitted Under Third Circuit LAR 34.1(a)
February 10, 2015
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Before: CHAGARES, VANASKIE, and SHWARTZ, Circuit Judges.
(Filed: February 10, 2015)
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OPINION*
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SHWARTZ, Circuit Judge.
Patrick J. Venetz (“Venetz”) and Nancy E. Venetz appeal from the District Court’s
order denying Venetz’s claim for benefits under the Diet Drug Nationwide Class Action
*
This disposition is not an opinion of the full court and, pursuant to I.O.P. 5.7,
does not constitute binding precedent.
Settlement Agreement (the “Settlement Agreement”). For the following reasons, we will
affirm.
I
Venetz’s appeal arises from the multi-district class action litigation regarding the
diet drugs Pondimin® (fenfluramine) and Redux® (dexfenfluramine), previously sold by
American Home Products (“AHP”)1. See In re Diet Drugs Prods. Liab. Litig., 543 F.3d
179, 181 (3d Cir. 2008) (“Patterson”). AHP settled the litigation, placed funds in a trust
for claim payments, and established the “Settlement Trust” (the “Trust”) to review and
administer benefit claims by Pondimin® and Redux® users who suffer from “severe
heart-valve regurgitation” or other “less severe heart-valve conditions that progress to the
more serious levels” during the fifteen-year period following execution of the Settlement
Agreement. In re Diet Drugs Prods. Liab. Litig., 385 F.3d 386, 390–92 (3d Cir. 2004).2
To obtain benefits under the Settlement Agreement, a claimant must complete and
submit to the Trust a multi-part “Green Form.” Patterson, 543 F.3d at 182. In Part I of
the Green Form, the claimant provides personal background information, including the
level of benefits for which he believes he is qualified. Part II of the Green Form is
completed by a board-certified cardiologist or cardiothoracic surgeon (an “attesting
1
AHP changed its name to Wyeth in 2002. See In re Diet Drugs Prods. Liab.
Litig., 385 F.3d 386, 388 n.1 (3d Cir. 2004). Pfizer, Inc. acquired Wyeth in 2009.
2
We have detailed the diet drugs litigation (commonly known as the “Fen-Phen
litigation”) and the settlement in several opinions. See, e.g., Patterson, 543 F.3d at 180–
81; In re Briscoe, 448 F.3d 201, 206–08 (3d Cir. 2006); In re Diet Drugs Prods. Liab.
Litig., 401 F.3d 143, 145–48 (3d Cir. 2005); In re Diet Drugs Prods. Liab. Litig., 282
F.3d 220, 225–29 (3d Cir. 2002).
2
physician”) who has reviewed the claimant’s echocardiogram and attests to the medical
conditions underlying the claimant’s benefits request.
Venetz submitted a “Green Form” for Trust benefits. In it, Robert L. Rosenthal,
M.D. attested that, based on his review of Venetz’s September 29, 2002 echocardiogram,
Venetz had “[m]oderate mitral regurgitation.” JA 3339. Dr. Rosenthal also attested that
Venetz underwent surgery “to repair or replace the aortic and/or mitral valve(s)” due to
his use of Pondimin® or Redux®, JA 3313, and had “[v]entricular fibrillation or
sustained ventricular tachycardia” resulting in “hemodynamic compromise,” JA 3315. In
combination, such conditions would entitle a claimant to benefits at severity “Level V” of
the Settlement Agreement Matrix A-1. 3
Waleed N. Irani, M.D., one of the Trust’s auditing cardiologists, evaluated
Venetz’s claim and applied a “reasonable medical basis” standard to determine the
validity of the moderate mitral regurgitation diagnosis. See Patterson, 543 F.3d at 183–
84. Dr. Irani found that Venetz had only mild mitral regurgitation4 and, contrary to Dr.
Rosenthal, concluded that there “was no reasonable medical basis” to find moderate
3
A claimant’s benefits are determined by a pair of “matrices,” Matrix A and
Matrix B, which classify claimants based on factors such as the severity of their medical
condition, age, length of illness, and the presence of other medical conditions that may
impact their valvular heart disease. Patterson, 543 F.3d at 181. In general, the longer the
claimant took the drug(s) and the more severe the injury, the greater the monetary
compensation. The gross value of Venetz’s claim under Level V of Matrix A-1 is
approximately $1,289,418.
4
The District Court has previously noted that measuring the severity of
regurgitation is critical because “not all levels of mitral regurgitation are medically
significant.” In re Diet Drugs Prods. Liab. Litig., 236 F. Supp. 2d 445, 450 (E.D. Pa.
2002) (“PTO 2640”) (stating that mild and trace mitral regurgitation exists in
approximately ninety percent of the population but moderate levels of mitral
regurgitation can “become[] a serious medical condition”).
3
mitral regurgitation entitling Venetz to Matrix A-1, Level V benefits. JA 3399. As a
result, the Trust denied Venetz’s request for such benefits.
Venetz contested the Trust’s determination and provided declarations by Drs.
Rosenthal and Paul W. Dlabal attesting that Venetz suffered from “at least” moderate
mitral regurgitation. JA 3407, 3413. The Trust forwarded Venetz’s submission to Dr.
Irani. In response, Dr. Irani submitted a declaration again concluding that there was no
reasonable medical basis for the Green Form’s attestation that Venetz’s echocardiogram
showed moderate mitral regurgitation. 5 Based on this declaration, the Trust denied
Venetz’s benefits claim.
5
Specifically, Dr. Irani’s declaration explained:
Only mild mitral regurgitation is present in real time. The Nyquist setting
at those points identified by Drs. Rosenthal and Dlabal is very low, at
41cm/sec, resulting in an increased color signal and falsely inflated jet size
to a[] [regurgitant jet area/left atrial area] ratio of 20% . . . . However, these
still frames do not reflect the actual degree of mitral regurgitation and do
not reasonably support a finding of moderate mitral regurgitation. These
sill [sic] frames reflect inflated jet size due to very low Nyquist setting
resulting in increased color signal. The still frames identified by Drs.
Rosenthal and Dlabal are not representative of mitral regurgitation seen in
real time. Mitral regurgitation is mild in real time.
JA 3460 (emphasis in original). The “Nyquist” limit setting is “particularly important to
the image displayed on the echocardiogram machine.” PTO 2640, 236 F. Supp. 2d at
452. It represents “the highest velocity of blood flow that an echocardiogram machine
can accurately measure.” Id. “For example, if the Nyquist limit is set [to] 70 cm/second,
the machine can only accurately calculate and display the velocity of blood that is
moving slower than 70 cm/second.” Id. As the District Court has explained:
Although medical literature does not propose an optimal Nyquist limit for
echocardiograms, the generally accepted practice is the higher the better.
Accordingly, a Nyquist limit in the 30’s or 40’s may not be as ideal for
4
Venetz disputed this determination and requested that his claim proceed through
the “Show Cause process” set forth in the Settlement Agreement and the Audit Rules.
Accordingly, the Trust applied for and the District Court issued an order (PTO 8986)
requiring Venetz to show cause why his claim for benefits should be paid at the level
stated in his Green Form. The District Court referred the claim to the Special Master for
further proceedings.
In accordance with the Audit Rules, the Special Master appointed a “Technical
Advisor,” Gary J. Vigilante, M.D., to review Venetz’s claim and the parties’ submissions.
Vigilante issued a “Technical Advisor Report” finding no reasonable medical basis for
Dr. Rosenthal’s Green Form attestation that Venetz had moderate mitral regurgitation
because “the echocardiogram of September 29, 2002 was of poor quality and an accurate
[regurgitant jet area] could not be determined.” JA 3604. Although the Report noted
evidence of mitral regurgitation, it “most likely was mild,” with the echocardiogram’s
poor quality rendering it “impossible to quantify [its] severity.” JA 3599.
The District Court affirmed the Trust’s denial of Venetz’s claim, crediting the
opinions of Drs. Irani and Vigilante that Venetz “failed to establish a reasonable medical
basis for finding that he was not diagnosed ‘as having Mild Mitral Regurgitation.’” JA
19 (citing Settlement Agreement § IV.B.2.d.(2)(a), 893–94.). Venetz appeals.
identifying and measuring a mitral regurgitant jet as would a limit in the
60’s or 70’s.
Id.
5
II6
Venetz raises two issues on appeal. First, he asserts that “there is no rule of law”
for determining, nor does the Settlement Agreement define, what constitutes a
“reasonable medical basis” under the Settlement Agreement. Appellant Br. 16–17. As a
result, he argues that deference should be given to his physician, and that the claimant
should be required to show only that his physician’s opinions are not “absurd, ridiculous,
extreme, or irrational.” Reply Br. 26. He further asserts that “the Trust [should be
required to] put forth evidence to show that the attesting physician and any physician in
support of the claim failed to act as ordinary and prudent physicians.” Appellant Br. 24.
Second, he argues that the District Court misapplied that standard in affirming the Trust’s
denial of his benefits claim.
We disagree with both arguments. Although the Settlement Agreement does not
define the term “reasonable medical basis,” JA 964–66, the standard is articulated in,
among other things: (i) the practices identified by the District Court in In re Diet Drugs
6
The District Court had jurisdiction under 28 U.S.C. § 1332. We exercise
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.” Patterson, 543 F.3d at 184 n.10. This abuse of discretion standard applies
because implementation of a settlement usually involves contract interpretation, which
concerns the process by which a court “seeks to ascertain the intent of the parties [that is]
embodied in the language that the parties chose to memorialize their agreement.”
Williams v. Metzler, 132 F.3d 937, 946 (3d Cir. 1997). An abuse of discretion may be
found if the District Court’s decision “rest[s] on a clearly erroneous finding of fact, an
errant conclusion of law or an improper application of law to fact.” Patterson, 543 F.3d
at 184 n.10 (internal quotation marks omitted); see also In re Cendant Corp. Prides Litig.,
233 F.3d 188, 193 (3d Cir. 2000) (noting that unlike contract construction, “contract
interpretation is a question of fact” subject to review under “the clearly erroneous
standard”).
6
Prods. Liab. Litig., 236 F. Supp. 2d 445 (E.D. Pa. 2002) (“PTO 2640”); (ii) other orders
of the District Court, Patterson, 543 F.3d at 186; and (iii) the “Auditing Cardiologist
Training Course,” see id. at 185–86 & 187 n.16 (rejecting argument that “the District
Court has not concretely defined ‘reasonable medical basis’”). As such, the standard
exists and “[Venetz] and h[is] attorneys had sufficient notice” of it. Id. at 187 n.16.
In PTO 2640, the District Court explained that a diagnosis lacks a “reasonable
medical basis” if it is “beyond the bounds of medical reason,” PTO 2640, 236 F. Supp. 2d
at 458, and provided the following examples:
(1) failing to review multiple loops and still frames; (2) failing to have a
Board Certified Cardiologist properly supervise and interpret the
echocardiogram; (3) failing to examine the regurgitant jet throughout a
portion of systole; (4) over-manipulating echocardiogram settings; (5)
setting a low Nyquist limit; (6) characterizing “artifacts,” “phantom jets,”
“backflow” and other low velocity flow as mitral regurgitation; (7) failing
to take a claimant’s medical history; and (8) overtracing the amount of a
claimant’s regurgitation.
JA 16 (citing PTO 2640). Thus, a diagnosis predicated upon any of these facts would
lack a reasonable medical basis.
The Audit Rules also address who bears the burden of showing the existence of a
reasonable medical basis. For instance, under Audit Rule 24, the auditing cardiologist’s
findings are essentially viewed as correct, unless the claimant can show his attesting
physician’s opinion has a reasonable medical basis. Thus, “[o]nce 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.” Patterson, 543 F.3d at 189. To carry this burden, the claimant must
7
present evidence rebutting the auditing cardiologist and/or the Technical Advisor’s
conclusion that the attesting physician lacked a reasonable medical basis for his opinion.
See id. at 190. Therefore, Venetz’s assertion that his doctor’s views should be deemed
presumptively correct and rejected only if they are absurd, ridiculous, extreme, or
excessive, is inconsistent with the factors used to determine whether a reasonable medical
basis exists and the Audit Rules governing the Settlement Trust, which require him to
show why the auditing cardiologist and Technical Advisor are wrong and that his
physicians had a reasonable medical basis for their opinion. We will not disturb the
agreed-upon and court-approved burdens of proof nor read new definitions into the
Settlement Agreement and thus we reject his first argument.
We also reject his second argument, as the District Court did not clearly err in
affirming the Trust’s denial of Venetz’s benefits claim. See In re Orthopedic Bone Screw
Prods. Liab. Litig., 246 F.3d 315, 320 (3d Cir. 2001) (“The test is not what this court
would have done under the same circumstances; that is not enough. [We] must feel that
only one order could have been entered on the facts.” (citation and internal quotation
marks omitted)). Here, the District Court evaluated the medical opinions presented to it
and determined that Venetz failed to rebut the findings of the auditing cardiologist, Dr.
Irani, and the Technical Advisor, Dr. Vigilante. For example, the District Court credited
the Technical Advisor’s finding that Venetz’s “level of regurgitation was inflated ‘due to
inclusion of low velocity nonturbulent flow’ and an “‘inappropriately’ low” Nyquist
limit, and as a result, his echocardiogram “‘was performed significantly below the
appropriate standard of care.’” JA 16–17 (quoting Technical Advisor Report at 7–8, JA
8
3599–3600). Notably, Dr. Dlabal, one of Venetz’s attesting physicians, even conceded
that “‘[t]he Nyquist Limit on this study is set at a somewhat low level.’” JA 16 n.16
(quoting Declaration of Dr. Dlabal at 2, JA 3413). This deficiency shows that that there
is a basis for concluding that Venetz’s doctors’ opinions lacked a reasonable medical
basis. As a result, Venetz has failed to demonstrate that the only conclusion that may be
drawn from the record is that his echocardiogram showed moderate mitral regurgitation.
Thus, the District Court did not abuse its discretion in holding that Venetz failed to meet
his burden of proving that there was a reasonable medical basis for his attesting
physician’s finding of moderate mitral regurgitation. 7
III
For these reasons, we will affirm the District Court’s Order affirming the Trust’s
denial of Venetz’s claim for benefits.
7
Venetz’s assertion that “a report based on more than a single frame will rebut the
auditing cardiologist’s assessment of the entire echocardiogram, provided that the report
includes some indication of the maximum jet’s representativeness,” Appellant Br. 31
(emphasis added) (citing Patterson, 543 F.3d at 185), is without basis. The case upon
which he relies, Patterson, held that an unrepresentative, single frame will never meet a
claimant’s burden, as “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,” 543 F.3d at 185. Thus, the District Court also did not err in crediting
Dr. Ilani’s conclusion that the “still frames” identified by Drs. Rosenthal and Dlabal “do
not reflect the actual degree of mitral regurgitation and do not reasonably support a
finding of moderate mitral regurgitation.” JA 16.
9